CN111526816A - Detecting the presence of an end effector in a liquid - Google Patents

Abstract

The invention discloses a surgical instrument. The surgical instrument includes an end effector that includes an ultrasonic blade and a clamp arm. The clamp arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamp arm. The surgical instrument also includes an ultrasonic transducer configured to generate an ultrasonic energy output and a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade. The surgical instrument further includes a control circuit configured to detect submersion of the end effector in a liquid and compensate for heat flux loss due to the submersion of the end effector in the liquid.

Description

Detecting the presence of end effectors in liquids

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application requires a US provisional patent entitled CONTROLLING AN ULTRASONIC SURGICALINSTRUMENT ACCORDING TO TISSUE LOCATION, filed on August 23, 2018, pursuant to 35 USC § 119(e) Priority to application 62/721,995, the disclosure of which is incorporated herein by reference in its entirety.

This patent application is subject to the provisions of 35 U.S.C. § 119(e) of U.S. Provisional Patent Application 62/721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS, filed on August 23, 2018 Priority, this provisional patent application is incorporated herein by reference in its entirety.

This patent application is subject to a U.S. provisional filing titled INTERRUPTION OF ENERGY DUE TOINADVERTENT CAPACITIVE COUPLING, filed on August 23, 2018, pursuant to 35 U.S.C. § 119(e) Priority to patent application 62/721,999, the disclosure of which is incorporated herein by reference in its entirety.

This patent application is entitled BIPOLAR COMBINATION DEVICETHAT AUTOMATICALLY ADJUSTS PRESSURE BASED US Provisional Patent Application 62/721,994 to ON ENERGY MODALITY), the disclosure of which is incorporated herein by reference in its entirety.

This patent application is entitled RADIO FREQUENCY ENERGY DEVICE FORDELIVERING COMBINED ELECTRICAL SIGNALS, filed on August 23, 2018, pursuant to 35 U.S.C. § 119(e) Priority to US Provisional Patent Application 62/721,996, the disclosure of which is incorporated herein by reference in its entirety.

THIS PATENT APPLICATION SUBJECT TO 35 U.S.C. SECTION 119(e) ALSO REQUIRES US Provisional Patent Application 62/692,747, U.S. Provisional Patent Application 62/692,748, filed June 30, 2018, entitled SMART ENERGY ARCHITECTURE, and filed June 30, 2018, and entitled SMART ENERGY DEVICES), the disclosure of each of which is incorporated by reference herein in its entirety.

This patent application also claims TEMPERATURE CONTROL INULTRASONIC DEVICE AND CONTROL SYSTEM, filed March 8, 2018, entitled TEMPERATURE CONTROL INULTRASONIC DEVICE AND CONTROL SYSTEM, under 35 U.S.C. § 119(e). US Provisional Patent Application Serial No. 62/640,417 to THEREFOR and ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR, filed March 8, 2018, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR The benefit of priority from US Provisional Patent Application Serial No. 62/640,415, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety.

This patent application, filed March 20, 2018, entitled CAPACITIVE COUPLED RETURNPATH PAD WITH SEPARABLE ARRAY U.S. Provisional Patent Application 62/650,898 to ELEMENTS, U.S. Provisional Patent Application Serial No. 62/650,887, filed March 30, 2018, entitled SURGICAL SYSTEMS WITH OPTIMIZEDSENSING CAPABILITIES, 2018 U.S. Provisional Patent Application Serial No. 62/650,882, filed March 30, entitled SMOKE EVACUATION MODULE FOR INTERACTIVESURGICAL PLATFORM, and filed March 30, 2018, entitled Surgical Smoke Evacuation The benefit of priority from US Provisional Patent Application Serial No. 62/650,877 to SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety.

This patent application also requires U.S. Provisional Patent Application Serial No. 62/611,341, filed December 28, 2017, entitled INTERACTIVE SURGICAL PLATFORM, U.S. Provisional Patent Application Serial No. 62/611,340, filed December 28, 2017, titled CLOUD-BASED MEDICALANALYTICS, and titled ROBOT ASSISTED, filed December 28, 2017 SURGICAL PLATFORM), the disclosure of each of which is incorporated herein by reference in its entirety.

Background technique

In a surgical environment, a smart energy device may need to be in a smart energy architecture environment.

Description of drawings

The various aspects are characterized with particularity in the appended claims. However, the various aspects (with respect to surgical tissue and methods) and their further objects and advantages are best understood by reference to the following description taken in conjunction with the following drawings.

1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.

3 is a surgical hub paired with a visualization system, a robotic system, and a smart instrument in accordance with at least one aspect of the present disclosure.

4 is a partial perspective view of a surgical hub housing and a combined generator module slidably received in a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure.

5 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a fume extraction component in accordance with at least one aspect of the present disclosure.

6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular enclosure configured to accommodate multiple modules in accordance with at least one aspect of the present disclosure.

7 illustrates a vertical modular enclosure configured to accommodate a plurality of modules in accordance with at least one aspect of the present disclosure.

8 illustrates a surgical data network including a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility or dedicated to Any room in a surgically operated medical facility is connected to the cloud.

9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure.

11 illustrates an aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.

12 shows a logic diagram of a control system for a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

15 illustrates sequential logic circuitry configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

16 illustrates a surgical instrument or tool that includes multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure.

17 is a schematic illustration of a robotic surgical instrument configured to operate the surgical tools described herein in accordance with at least one aspect of the present disclosure.

18 shows a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.

19 is a schematic illustration of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.

20 is a system configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub in accordance with at least one aspect of the present disclosure.

21 illustrates an example of a generator in accordance with at least one aspect of the present disclosure.

22 is a surgical system including a generator and various surgical instruments that may be used therewith, according to at least one aspect of the present disclosure.

23 is an end effector according to at least one aspect of the present disclosure.

24 is an illustration of the surgical system of FIG. 22 in accordance with at least one aspect of the present disclosure.

25 is a model showing dynamic branch currents in accordance with at least one aspect of the present disclosure.

26 is a structural view of a generator architecture in accordance with at least one aspect of the present disclosure.

27A-27C are functional views of a generator architecture in accordance with at least one aspect of the present disclosure.

28A-28B are structural and functional aspects of a generator in accordance with at least one aspect of the present disclosure.

29 is a schematic diagram of one aspect of an ultrasound drive circuit.

30 is a schematic diagram of a transformer coupled to the ultrasound drive circuit shown in FIG. 29 in accordance with at least one aspect of the present disclosure.

31 is a schematic diagram of the transformer shown in FIG. 30 coupled to a test circuit in accordance with at least one aspect of the present disclosure.

32 is a schematic diagram of a control circuit in accordance with at least one aspect of the present disclosure.

33 shows a simplified circuit block diagram illustrating another circuit included within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure.

34 illustrates a generator circuit divided into stages in accordance with at least one aspect of the present disclosure.

35 illustrates a generator circuit divided into multiple stages, wherein a first stage circuit is common to a second stage circuit, in accordance with at least one aspect of the present disclosure.

36 is a schematic diagram of one aspect of a drive circuit configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure.

37 is a schematic diagram of a transformer coupled to the RF driver circuit shown in FIG. 34 in accordance with at least one aspect of the present disclosure.

38 is a schematic diagram of a circuit including separate power sources for a high power energy/drive circuit and a low power circuit in accordance with one aspect of the present disclosure.

Figure 39 shows a control circuit that allows a dual generator system to switch between RF generator and ultrasonic generator energy modalities of a surgical instrument.

40 shows a schematic diagram of an aspect of a surgical instrument including a feedback system for use with the surgical instrument in accordance with an aspect of the present disclosure.

41 illustrates one aspect of the basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate a plurality of electrical signal waveforms for use in a surgical instrument, in accordance with at least one aspect of the present disclosure wave shape.

42 illustrates an aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of waveforms for use in electrical signal waveforms in a surgical instrument, in accordance with at least one aspect of the present disclosure.

43 illustrates discrete-time digital electrical signals according to at least one aspect of the present disclosure in accordance with analog waveforms (shown superimposed on discrete-time digital electrical signal waveforms for comparison purposes) in accordance with at least one aspect of the present disclosure. A cycle of signals.

44 is an illustration of a control system configured to provide gradual closing of the closure member as the closure member is advanced distally to close the clamp arms to apply a closing force load at a desired rate, according to one aspect of the present disclosure .

45 illustrates a proportional-integral-derivative (PID) controller feedback control system according to an aspect of the present disclosure.

46 is a front exploded view of a modular handheld ultrasonic surgical instrument showing the left housing half removed from the handle assembly to expose the communicative coupling to the multi-lead handle terminal assembly, according to one aspect of the present disclosure device identifier.

47 is a detailed view of the trigger portion and switch of the ultrasonic surgical instrument shown in FIG. 46 in accordance with at least one aspect of the present disclosure.

48 is a partial enlarged perspective view of an end effector according to at least one aspect of the present disclosure from a distal end having jaw members in an open position.

49 is a system diagram of a segmented circuit including multiple independently operating circuit segments in accordance with at least one aspect of the present disclosure.

50 is a circuit diagram of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure.

51 illustrates an aspect of an end effector including an RF data sensor coupled to a jaw member in accordance with at least one aspect of the present disclosure.

52 illustrates an aspect of the flex circuit shown in FIG. 51 to which a sensor may be mounted or formed integrally therewith, in accordance with at least one aspect of the present disclosure.

53 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system in accordance with at least one aspect of the present disclosure.

54 is a spectrum of the same ultrasound device with a number of different states and conditions of the end effector, wherein the phase and magnitude of the impedance of the ultrasound transducer are plotted as a function of frequency, according to at least one aspect of the present disclosure.

55 is a graphical representation of a graph of a set of 3D training data S in which ultrasound transducer impedance magnitude and phase are plotted as a function of frequency in accordance with at least one aspect of the present disclosure.

56 is a logic flow diagram depicting a control routine or logic configuration for determining a jaw condition based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure.

57 is a circular diagram of complex impedance plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure.

58 is a circle diagram of complex admittance plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure.

59 is a circular diagram of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer.

60 is a graphical display of an impedance analyzer showing an impedance/admittance graph for an open-jawed and unloaded ultrasound device, wherein red depicts admittance and blue depicts impedance, according to at least one aspect of the present disclosure.

61 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure showing an impedance/admittance circle diagram of an ultrasound device with jaws clamped on dry chamois, wherein red depicts admittance and blue Color depicts impedance.

62 is a graphical display of an impedance analyzer showing an impedance/admittance circle diagram of an ultrasound device with jaw tips clamped to wet chamois skin, wherein red depicts admittance, in accordance with at least one aspect of the present disclosure Blue depicts impedance.

63 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure showing an impedance/admittance circle diagram of an ultrasound device with jaws fully clamped on wet chamois, wherein red depicts admittance, Blue depicts impedance.

64 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure showing an impedance/admittance plot with frequencies swept from 48 kHz to 62 kHz to capture multiple resonances of an ultrasound device with jaws open, with gray Overlay helps to see circles.

65 is a logic flow diagram of a process depicting a control program or logic configuration for determining jaw conditions based on an estimate of the radius and offset of the impedance/admittance circle in accordance with at least one aspect of the present disclosure.

66A-66B are complex impedance spectra of the same ultrasound device with cool (blue) and warm (red) ultrasound blades in accordance with at least one aspect of the present disclosure, wherein

66A is a graphical representation of impedance phase angle as a function of resonant frequency of the same ultrasonic device with cool (blue) and warm (red) ultrasonic blades; and

66B is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasound device with cool (blue) and warm (red) ultrasound blades.

67 is a schematic diagram of a Kalman filter that improves a temperature estimator and state space model based on impedance measured across an ultrasound transducer at various frequencies, according to at least one aspect of the present disclosure.

68 are three probability distributions employed by the state estimator of the Kalman filter shown in FIG. 67 to maximize estimates in accordance with at least one aspect of the present disclosure.

Figure 69A is a graphical representation of temperature versus time for an ultrasound device reaching a maximum temperature of 490°C without temperature control.

69B is a graphical representation of temperature versus time for an ultrasound device reaching a maximum temperature of 320°C under temperature control, in accordance with at least one aspect of the present disclosure.

70A-70B are graphical representations of adjusting the ultrasonic power applied to the ultrasonic transducer into feedback control upon detection of a sudden drop in temperature of the ultrasonic blade, wherein

Figure 70A is a graphical representation of ultrasound power as a function of time; and

70B is a graph of ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.

71 is a logic flow diagram of a process depicting a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure.

72 is a timeline depicting situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

73 illustrates an end effector of an electrosurgical instrument according to at least one aspect of the present disclosure.

74 is a graph depicting amplitude versus time for a treatment cycle generated by a transducer of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

FIG. 75A shows various stages of closure of the end effector of FIG. 73 .

FIG. 75B shows various stages of closure of the end effector of FIG. 73 .

76 is a logic flow diagram of a process depicting a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

77 is a logic flow diagram depicting a process for selecting a control program or logic configuration for an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

78 is a logic flow diagram of a process depicting a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

78A is a schematic diagram of a tissue contact circuit showing the circuit being completed to a pair of spaced-apart contact pads when in contact with tissue.

79 is a logic flow diagram of a process depicting a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

80 is a schematic diagram illustrating a control circuit including an absolute positioning system in accordance with at least one aspect of the present disclosure.

81 is a logic flow diagram of a process depicting a control program or logic configuration for switching between energy operating modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

82 is a depiction for adjusting the energy delivered to the tissue gripped by the end effector of the electrosurgical instrument and the energy delivered to the motor of the electrosurgical instrument based on predetermined thresholds of the monitored parameters in accordance with at least one aspect of the present disclosure A logic flow diagram of a process that controls a program or a logic configuration.

83 is a logic flow diagram depicting a process for adjusting a control program or logic configuration of various electromechanical systems of an ultrasonic surgical instrument based on predetermined thresholds of monitored parameters in accordance with at least one aspect of the present disclosure.

84 is a graph representing tissue impedance (Z), power (P), and force (F) at the distal portion (tip) of an end effector of an electrosurgical instrument that grips tissue in accordance with at least one aspect of the present invention Graph, tissue impedance (Z), power (P) and force (F) are plotted on the Y-axis against time (t) on the X-axis.

Figure 85 is a graph showing power (P) as a function of time (t) in diagnostic mode (top graph) and response mode (bottom graph).

86 is a logic flow diagram of a process depicting a control program or logic configuration for detecting and compensating for immersion of an ultrasonic blade in a liquid in accordance with at least one aspect of the present disclosure.

87 depicts a graphical representation of power (p) delivered to an end effector and tissue temperature as a function of closure driver displacement in accordance with at least one aspect of the present disclosure.

88 is a logic flow diagram of a process depicting a control program or logic configuration for detecting and compensating for immersion of an ultrasonic blade in a liquid, in accordance with at least one aspect of the present disclosure.

89 is a graph including four curves, wherein the first curve from the top represents voltage (V) and current (I) versus time (t) and the second curve represents time (t) in accordance with at least one aspect of the present disclosure Power (P) versus time (t), the third plot represents temperature (T) versus time (t), and the fourth plot represents tissue impedance (Z) versus time (t).

90 is a depiction of using a value of tissue impedance (Z) as a trigger condition to step up voltage (V) toward the end of a tissue treatment cycle applied to tissue by an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure A logic flow diagram of a process that controls a program or a logic configuration.

91 is a depiction of using the value of tissue temperature (T) as a trigger condition to step up voltage (V) toward the end of a tissue treatment cycle applied to tissue by an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure A logic flow diagram of a process that controls a program or a logic configuration.

92 is a logic flow diagram depicting a process for a control program or logic configuration for adjusting the power (P) of the RF component of the combination device based on the temperature (T) monitored by the ultrasonic component of the combination device in accordance with at least one aspect of the present disclosure picture.

93 is a graph including three curves, wherein the first curve from the top represents the power (P) delivered to the tissue captured between the jaws of the bipolar RF component of the combined device in accordance with at least one aspect of the present disclosure , where the second curve represents the tissue temperature measured by the ultrasound component of the combined device, and where the third curve represents the dual non-treatment frequencies used by the ultrasound component to determine tissue temperature.

94 is a logic flow diagram of a process depicting a control program or logic configuration for actively adjusting the frequency of an RF waveform of an RF electrosurgical instrument or RF component of a combination device based on measured tissue impedance in accordance with at least one aspect of the present disclosure .

SUMMARY OF THE INVENTION

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes an ultrasonic blade and a gripping arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm between. The surgical instrument also includes an ultrasonic transducer configured to generate an ultrasonic energy output and a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade. The surgical instrument further includes a control circuit configured to detect immersion of the end effector in liquid and to compensate for heat caused by the immersion of the end effector in the liquid flux loss.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes an ultrasonic blade and a gripping arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm between. The surgical instrument further includes an ultrasonic transducer configured to generate an ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade, and configured to actuate movement of the clamp arm to move A drive member transitioning the end effector to the closed configuration. The surgical instrument further includes a control circuit configured to monitor the position of the drive member, monitor the temperature of the ultrasonic blade, and prevent the temperature from exceeding a predetermined threshold prior to the closed configuration.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes a first jaw and a second jaw. The second jaw is movable relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first jaw and the between the second jaws. The end effector also includes an ultrasonic component configured to deliver ultrasonic energy to the grasped tissue and a radio frequency (RF) component configured to deliver RF energy to the grasped tissue. The surgical instrument also includes a control circuit configured to operate the ultrasound component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

Detailed ways

The applicant of this patent application has the following US patent applications filed on August 28, 2018, the disclosures of each of these patent applications are incorporated herein by reference in their entirety:

U.S. Patent Application Docket No. END8536USNP2/180107-2, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR;

U.S. Patent Application Docket No. END8560USNP2/180106-2, entitled TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR;

US Patent Application Docket No. END8561USNP1/180144-1, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS;

U.S. Patent Application Docket No. END8563USNP1/180139-1, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISUELOCATION;

U.S. Patent Application Docket No. END8563USNP2/180139-2, entitled CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE;

US Patent Application Docket No. END8563USNP3/180139-3 entitled DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;

U.S. Patent Application Docket No. END8563USNP4/180139-4, entitled DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT;

U.S. Patent Application Docket No. END8563USNP5/180139-5, entitled DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR;

U.S. Patent Application Docket No. END8564USNP1/180140-1, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;

US Patent Application Docket No. END8564USNP2/180140-2, entitled MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT;

U.S. Patent Application Docket No. END8565USNP1/180142-1, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;

U.S. Patent Application Docket No. END8565USNP2/180142-2, entitled Adding Radio Frequency to Generate Padless Monopolar Loops (PAD-LESS);

US Patent Application Docket No. END8566USNP1/180143-1, entitled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY; and

- US Patent Application Docket No. END8573USNP1/180145-1, entitled ACTIVATION OF ENERGY DEVICES.

The applicant of this patent application has the following U.S. patent applications filed on August 23, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application 62/721,995, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;

U.S. Provisional Patent Application 62/721,998, entitled SITUATIONALAWARENESS OF ELECTROSURGICAL SYSTEMS;

U.S. Provisional Patent Application 62/721,999, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;

U.S. Provisional Patent Application 62/721,994, entitled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASEDON ENERGY MODALITY; and

- US Provisional Patent Application 62/721,996 entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.

The applicant of this patent application has the following U.S. patent applications filed on June 30, 2018, the disclosures of each of these patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application 62/692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;

U.S. Provisional Patent Application 62/692,748, entitled SMART ENERGYARCHITECTURE; and

- US Provisional Patent Application 62/692,768, entitled SMART ENERGYDEVICES.

The applicant of this patent application has the following US patent applications filed on June 29, 2018, the disclosures of each of these patent applications are incorporated herein by reference in their entirety:

US Patent Application Serial No. 16/024,090, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;

US Patent Application Serial No. 16/024,057, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;

US Patent Application Serial No. 16/024,067, entitled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ONPERIOPERATIVE INFORMATION;

US Patent Application Serial No. 16/024,075, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;

US Patent Application Serial No. 16/024,083, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;

US Patent Application Serial No. 16/024,094, entitled SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES;

U.S. Patent Application Serial No. 16/024,138, entitled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TOCANCEROUS TISSUE;

US Patent Application Serial No. 16/024,150, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;

U.S. Patent Application Serial No. 16/024,160, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY;

US Patent Application Serial No. 16/024,124, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;

US Patent Application Serial No. 16/024,132, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT;

US Patent Application Serial No. 16/024,141, entitled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;

U.S. Patent Application Serial No. 16/024,162, entitled SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;

US Patent Application Serial No. 16/024,066, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;

US Patent Application Serial No. 16/024,096, entitled SURGICAL EVACUATION SENSOR ARRANGEMENTS;

US Patent Application Serial No. 16/024,116, entitled SURGICAL EVACUATION FLOW PATHS;

US Patent Application Serial No. 16/024,149, entitled SURGICAL EVACUATION SENSING AND GENERATOR CONTROL;

US Patent Application Serial No. 16/024,180, entitled SURGICAL EVACUATION SENSING AND DISPLAY;

US Patent Application Serial No. 16/024,245, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVESURGICAL PLATFORM);

US Patent Application Serial No. 16/024,258, entitled SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM;

US Patent Application Serial No. 16/024,265, entitled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE); and

- US Patent Application Serial No. 16/024,273, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

The applicant of the present patent application has the following US provisional patent applications filed on June 28, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

US Provisional Patent Application Serial No. 62/691,228, entitled A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices;

US Provisional Patent Application Serial No. 62/691,227, entitled controlling a surgical instrument according to sensed closure parameters;

U.S. Provisional Patent Application Serial No. 62/691,230, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;

U.S. Provisional Patent Application Serial No. 62/691,219, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;

U.S. Provisional Patent Application Serial No. 62/691,257, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEMPARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVESURGICAL PLATFORM);

U.S. Provisional Patent Application Serial No. 62/691,262, entitled SURGICAL EVACUATION SYSTEM WITH ACOMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKEEVACUATION DEVICE); and

- US Provisional Patent Application Serial No. 62/691,251, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

The applicant of this patent application has the following US provisional patent applications filed on April 19, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

- US Provisional Patent Application Serial No. 62/659,900, entitled METHOD OFHUB COMMUNICATION.

The applicant of this patent application has the following US provisional patent applications filed on March 30, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application 62/650,898, filed March 30, 2018, entitled CAPACITIVE COUPLED RETURN PATH PAD WITHSEPARABLE ARRAY ELEMENTS;

U.S. Provisional Patent Application Serial No. 62/650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;

US Patent Application Serial No. 62/650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and

- US Patent Application Serial No. 62/650,877, entitled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.

The applicant of this patent application has the following US patent applications filed on March 29, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Patent Application Serial No. 15/940,641, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

US Patent Application Serial No. 15/940,648, entitled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICESAND DATA CAPABILITIES;

US Patent Application Serial No. 15/940,656, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATINGROOM DEVICES;

US Patent Application Serial No. 15/940,666, entitled SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;

U.S. Patent Application Serial No. 15/940,670, entitled COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARYSOURCES BY INTELLIGENT SURGICAL HUBS;

US Patent Application Serial No. 15/940,677, entitled SURGICAL HUB CONTROL ARRANGEMENTS;

U.S. Patent Application Serial No. 15/940,632, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD;

US Patent Application Serial No. 15/940,640, entitled COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHAREDWITH CLOUD BASED ANALYTICS SYSTEMS);

US Patent Application Serial No. 15/940,645, entitled SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;

US Patent Application Serial No. 15/940,649, entitled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH ANOUTCOME;

U.S. Patent Application Serial No. 15/940,654, entitled SURGICALHUB SITUATIONAL AWARENESS;

US Patent Application Serial No. 15/940,663, entitled SURGICAL SYSTEM DISTRIBUTED PROCESSING;

US Patent Application Serial No. 15/940,668, entitled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;

US Patent Application Serial No. 15/940,671, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATINGTHEATER;

US Patent Application Serial No. 15/940,686, entitled DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;

U.S. Patent Application Serial No. 15/940,700, entitled STERILEFIELD INTERACTIVE CONTROL DISPLAYS;

US Patent Application Serial No. 15/940,629, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

U.S. Patent Application Serial No. 15/940,704, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINEPROPERTIES OF BACK SCATTERED LIGHT;

US Patent Application Serial No. 15/940,722, entitled CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY; and

- US Patent Application Serial No. 15/940,742, entitled DUAL CMOS ARRAY IMAGING.

US Patent Application Serial No. 15/940,636, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. Patent Application Serial No. 15/940,653, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;

US Patent Application Serial No. 15/940,660, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATION STO A USER;

U.S. Patent Application Serial No. 15/940,679, entitled CLOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OFLARGER DATA SET);

US Patent Application Serial No. 15/940,694, entitled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION;

U.S. Patent Application Serial No. 15/940,634, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES;

U.S. Patent Application Serial No. 15/940,706, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and

- US Patent Application Serial No. 15/940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES.

US Patent Application Serial No. 15/940,627, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

US Patent Application Serial No. 15/940,637, entitled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,642, entitled CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,676, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,680, entitled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,683, entitled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,690, entitled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

- US Patent Application Serial No. 15/940,711, entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

The applicant of this patent application has the following US provisional patent applications filed on March 28, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application Serial No. 62/649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

U.S. Provisional Patent Application Serial No. 62/649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD;

U.S. Patent Application Serial No. 62/649,300, entitled SURGICALHUB SITUATIONAL AWARENESS;

U.S. Provisional Patent Application Serial No. 62/649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER;

US Patent Application Serial No. 62/649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

U.S. Provisional Patent Application Serial No. 62/649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINEPROPERTIES OF BACK SCATTERED LIGHT;

US Patent Application Serial No. 62/649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. Provisional Patent Application Serial No. 62/649,333, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER;

U.S. Provisional Patent Application Serial No. 62/649,327, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES;

U.S. Provisional Patent Application Serial No. 62/649,315, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;

US Patent Application Serial No. 62/649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;

US Patent Application Serial No. 62/649,320, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Provisional Patent Application Serial No. 62/649,307, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

- US Provisional Patent Application Serial No. 62/649,323, entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

The applicant of this patent application has the following US provisional patent applications filed on March 8, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application Serial No. 62/640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR; and

- US Provisional Patent Application Serial No. 62/640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR.

The applicant of this patent application has the following US provisional patent applications filed on December 28, 2017, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application Serial No. 62/611,341, Provisional Patent Application Serial No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM;

U.S. Provisional Patent Application Serial No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and

- US Patent Application Serial No. 62/611,339, entitled ROBOTASSISTED SURGICAL PLATFORM.

Before describing various aspects of the surgical device and generator in detail, it should be noted that the application or use of the illustrative examples is not limited to the details of construction and the arrangement of components shown in the accompanying drawings and detailed description. The illustrative examples can be implemented alone or in combination with other aspects, alterations and modifications, and can be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terminology and expressions used herein have been chosen for the convenience of the reader in describing the exemplary embodiments and are not for the purpose of limitation. Furthermore, it should be understood that one or more of the aspects, aspects and/or examples of expressions described below may be combined with any one or more of the expressions of other aspects, aspects and/or examples described below.

Various aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured for transecting and/or coagulating tissue, eg, during a surgical procedure. Aspects of the electrosurgical device may be configured for transecting, coagulating, scaling, welding, and/or drying tissue, eg, during a surgical procedure.

1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (eg, cloud 104 that may include a remote server 113 coupled to storage 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 , which may include a remote server 113 . In one example, as shown in FIG. 1 , surgical system 102 includes visualization system 108 , robotic system 110 , and hand-held intelligent surgical instrument 112 configured to communicate with each other and/or with hub 106 . In some aspects, surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of hand-held intelligent surgical instruments 112, where M, N, O, and P are greater than or An integer equal to one.

FIG. 3 depicts an example of the surgical system 102 for performing a surgical procedure on a patient lying flat on an operating table 114 in a surgical operating room 116 . The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118 , a patient side cart 120 (surgical robot), and a surgical robotic hub 122 . The patient side cart 117 can maneuver at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient while the surgeon views the surgical site through the surgeon's console 120 . Images of the surgical site may be obtained by a medical imaging device 124 , which may be maneuvered by the patient side cart 120 to orient the imaging device 124 . The robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118 .

Other types of robotic systems may be readily adapted for use with surgical system 102 . Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in US Provisional Patent Application Serial No. 62/611,339, filed December 28, 2017, entitled ROBOT ASSISTED SURGICAL PLATFORM, The disclosure of this patent is incorporated herein by reference in its entirety.

Various examples of cloud-based analytics performed by the cloud 104 and suitable for use in the present disclosure are described in US Provisional Patent Application Serial No. entitled "CLOUD-BASED MEDICAL ANALYTICS", filed on Dec. 28, 2017 62/611,340, the disclosure of which is incorporated herein by reference in its entirety.

In various aspects, imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.

Optical components of imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical site, including light reflected or refracted from tissue and/or surgical instruments.

One or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical or luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (ie, detectable by) the human eye, and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in air from about 380 nm to about 750 nm.

The invisible spectrum (ie, the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (ie, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.

In various aspects, imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes) ), endoscopy, laryngoscopy, nasopharyngeal-renal endoscopy, sigmoidoscopy, thoracoscopy and hysteroscopy.

In one aspect, the imaging device employs multispectral monitoring to discern topography and underlying structure. A multispectral image is an image that captures image data across a specific wavelength range of the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and UV. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green and blue receptors. Use of Multispectral Imaging under the title "Advanced Imaging Acquisition Module" in U.S. Provisional Patent Application Serial No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM" Described in more detail, the disclosure of this patent is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field after completing a surgical task to perform one or more of the previously described tests on the treated tissue.

It goes without saying that strict sterilization of operating rooms and surgical equipment is required during any surgical procedure. The stringent hygiene and sterilization conditions required in the "surgical room" (ie, operating room or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize anything that comes into contact with the patient or penetrates the sterile field, including the imaging device 124 and its attachments and components. It should be understood that a sterile field may be considered a designated area that is considered to be free of microorganisms, such as within a tray or sterile towel, or a sterile field may be considered an area around a patient that is ready for a surgical procedure. A sterile field may include properly dressed scrubbing team members, as well as all furniture and fixtures in the area.

In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays, strategically arranged relative to the sterile field, as shown in FIG. 2 shown in. In one aspect, visualization system 108 includes interfaces for HL7, PACS, and EMR. The various components of visualization system 108 are described in US Provisional Patent Application Serial No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," and entitled "Advanced Imaging Acquisition Module." ” described below, the disclosure of this patent application is incorporated herein by reference in its entirety.

As shown in FIG. 2 , the main display 119 is positioned in the sterile field to be visible to the operator at the operating table 114 . Furthermore, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. Visualization system 108 directed by hub 106 is configured to utilize displays 107, 109 and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, hub 106 may enable imaging system 108 to display a snapshot of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining a real-time feed of the surgical site on main display 119 . A snapshot on the non-sterile display 107 or 109 may allow a non-sterile operator to perform, for example, diagnostic steps associated with a surgical procedure.

In one aspect, the hub 106 is further configured to route diagnostic input or feedback entered at the visualization tower 111 by a non-sterile operator to a primary display 119 within the sterile field, where it can be viewed by a sterile operator on the console. In one example, the input may be a modified form of a snapshot displayed on the non-sterile display 107 or 109 , which may be routed through the hub 106 to the main display 119 .

Referring to FIG. 2 , surgical instrument 112 is used in a surgical procedure as part of surgical system 102 . The hub 106 is further configured to coordinate the flow of information to the display of the surgical instrument 112 . For example, US Provisional Patent Application Serial No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered at visualization tower 111 by a non-sterile operator may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the operator of surgical instrument 112 may observe the input or feedback. Exemplary surgical instruments suitable for use with surgical system 102 are described in U.S. Provisional Patent Application Serial No. 62/611,341, filed December 28, 2017, entitled "SURGICAL INSTRUMENT HARDWARE (INTERACTIVE SURGICAL PLATFORM)," Surgical Instrument Hardware", the disclosure of this patent is incorporated herein by reference in its entirety.

Referring now to FIG. 3 , hub 106 is depicted in communication with visualization system 108 , robotic system 110 , and hand-held intelligent surgical instrument 112 . The hub 106 includes a hub display 135 , an imaging module 138 , a generator module 140 , a communication module 130 , a processor module 132 and a storage array 134 . In certain aspects, as shown in FIG. 3 , the hub 106 also includes a fume extraction module 126 and/or a suction/flush module 128 .

During surgical procedures, energy applied to tissue for sealing and/or cutting is often associated with evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid, power, and/or data lines from different sources often become tangled during surgical procedures. Valuable time can be lost addressing this issue during the surgical procedure. Disconnecting a line may require disconnecting the line from its corresponding module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of tangles between such lines.

Aspects of the present disclosure provide a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combined generator module slidably received in a docking base of the hub housing. The docking base includes data contacts and power contacts. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component seated in a single unit. In one aspect, the combination generator module further includes a smoke exhaust component for connecting the combination generator module to at least one energy delivery cable of a surgical instrument, configured to exhaust smoke, fluids generated by applying therapeutic energy to tissue and/or at least one fume extraction component for particulates, and a fluid line extending from the remote surgical site to the fume extraction component.

In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

Certain surgical procedures may require the application of more than one type of energy to tissue. One type of energy may be more beneficial for cutting tissue, while a different type of energy may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace the various modules.

Aspects of the present disclosure provide modular surgical housings for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking base including a first docking port , the first docking port includes first data and power contacts, wherein the first energy generator module is slidably moved into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably moved out of the electrical engagement with the first power and data contacts,

Further described above, the modular surgical housing further includes a second energy generator module configured to generate a second energy different from the first energy for application to tissue, and two docking bases, the second docking base including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contacts.

Additionally, the modular surgical housing also includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

Referring to FIGS. 3-7 , aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of generator module 140 , fume extraction module 126 , and suction/irrigation module 128 . The hub modular housing 136 also facilitates interactive communication between the modules 140 , 126 , 128 . As shown in FIG. 5 , generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single unit slidably inserted into hub modular housing 136 in the housing unit 139. As shown in FIG. 5 , generator module 140 may be configured to connect to monopolar device 146 , bipolar device 147 , and ultrasound device 148 . Alternatively, generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and/or ultrasonic generator modules that interact through hub modular housing 136 . The hub modular housing 136 may be configured to facilitate insertion of multiple generators and interactive communication between generators docked into the hub modular housing 136 such that the generators will act as a single generator.

In one aspect, the hub modular housing 136 includes a modular power and communication backplane 149 with external and wireless communication connections to enable removable attachment of the modules 140, 126, 128 and intercommunication between them.

In one aspect, the hub modular housing 136 includes a docking base or drawer 151 (also referred to herein as a drawer) configured to slidably receive the modules 140 , 126 , 128 . FIG. 4 shows a partial perspective view of the surgical hub housing 136 and combined generator module 145 that can be slidably received in the docking base 151 of the surgical hub housing 136 . The docking ports 152 with power and data contacts on the back of the combination generator module 145 are configured to, when the combination generator module 145 is slid into position within the corresponding docking base 151 of the hub module housing 136 The docking ports 150 engage power and data contacts of corresponding docking bases 151 of the hub modular housing 136 . In one aspect, the combined generator module 145 includes bipolar, ultrasonic and monopolar modules and a fume extraction module integrated together into a single housing unit 139, as shown in FIG. 5 .

In various aspects, the fume extraction module 126 includes a fluid line 154 that conveys trapped/collected smoke and/or fluids from the surgical site to, for example, the fume extraction module 126 . Vacuum suction from the fume extraction module 126 may draw fume into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid line may be in the form of a flexible pipe terminated at the fume extraction module 126 . Common conduits and fluid lines define a fluid path extending toward the fume extraction module 126 received in the hub housing 136 .

In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and an aspiration fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubes extending from the surgical site toward the aspiration/irrigation module 128 . One or more drive systems may be configured to flush fluid to and draw fluid from the surgical site.

In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, aspiration tube, and irrigation tube. The aspiration tube may have an inlet at its distal end and the aspiration tube extends through the shaft. Similarly, the aspiration tube can extend through the shaft and can have an inlet adjacent to the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic energy and/or RF energy to the surgical site and is coupled to generator module 140 by a cable that initially extends through the shaft.

The flush tube may be in fluid communication with the fluid source, and the aspiration tube may be in fluid communication with the vacuum source. A fluid source and/or a vacuum source may be seated in the aspiration/irrigation module 128 . In one example, the fluid source and/or vacuum source may be seated in the hub housing 136 independently of the suction/irrigation module 128 . In such examples, the fluid interface can connect the aspiration/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking bases on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules with their corresponding docking bases. Corresponding ports in the docking base of the hub modular housing 136 engage. For example, as shown in FIG. 4 , combined generator module 145 includes side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bases 151 of hub modular housing 136 . The brackets cooperate to guide the docking port contacts of the combined generator module 145 in electrical engagement with the docking port contacts of the hub modular housing 136 .

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received in the drawers 151 . For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 vary in size and are each designed to accommodate a particular module.

Additionally, the contacts of a particular module can be keyed to engage the contacts of a particular drawer to avoid inserting a module into a drawer with mismatched contacts.

As shown in FIG. 4 , the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by a communication link 157 to facilitate interaction between modules seated in the hub modular housing 136 communication. Alternatively or additionally, the docking port 150 of the hub modular housing 136 may facilitate wireless interactive communication between modules seated in the hub modular housing 136 . Any suitable wireless communication may be employed, such as, for example, Air Titan-Bluetooth.

FIG. 6 shows a single power bus attachment for multiple lateral docking ports of lateral modular housing 160 configured to accommodate multiple modules of surgical hub 206 . Lateral modular housing 160 is configured to accommodate and interconnect modules 161 laterally. The modules 161 are slidably inserted into the docking bases 162 of the lateral modular housing 160 , which includes a backplane for interconnecting the modules 161 . As shown in FIG. 6 , modules 161 are arranged laterally in lateral modular housing 160 . Alternatively, the modules 161 may be arranged vertically in a transverse modular housing.

FIG. 7 shows a vertical modular housing 164 configured to house a plurality of modules 165 of surgical hub 106 . The modules 165 are slidably inserted into docking bases or drawers 167 of a vertical modular housing 164 that includes a base plate for interconnecting the modules 165 . Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases the vertical modular housing 164 may include laterally arranged drawers. Additionally, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164 . In the example of FIG. 7 , a display 177 is provided for displaying data related to the operation of the module 165 . Additionally, the vertical modular housing 164 includes a main module 178 that houses a plurality of sub-modules slidably received in the main module 178 .

In various aspects, imaging module 138 includes an integrated video processor and a modular light source and is suitable for use with various imaging devices. In one aspect, the imaging device consists of a modular housing that can be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, light source module, and camera module. The light source module and/or the camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Likewise, the light source module can be configured to deliver white light or different light, depending on the surgical procedure.

During a surgical procedure, it can be inefficient to remove the surgical device from the surgical site and replace it with another surgical device that includes a different camera or a different light source. Temporary loss of sight to the surgical field can lead to undesired consequences. The modular imaging device of the present disclosure is configured to allow for the in-stream replacement of a light source module or camera module during a surgical procedure without having to remove the imaging device from the surgical site.

In one aspect, an imaging device includes a tubular housing that includes a plurality of channels. The first channel is configured to slidably receive a camera module that can be configured to snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module that can be configured to snap-fit engagement with the second channel. In another example, the camera module and/or the light source module may be rotated to a final position within their respective channels. A threaded engagement may be used instead of a snap fit engagement.

In various examples, multiple imaging devices are placed at different locations in the surgical field to provide multiple views. Imaging module 138 may be configured to switch between imaging devices to provide the best view. In various aspects, imaging module 138 may be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use in the present disclosure are described in US Patent 7,995,045, entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued August 9, 2011, which is incorporated by reference The full text is incorporated herein. Additionally, US Patent 7,982,776, entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued July 19, 2011, describes various methods for removing motion artifacts from image data. system, which is hereby incorporated by reference in its entirety. Such systems may be integrated with imaging module 138 . In addition, US Patent Application Publication Nos. 2011/0306840 published on December 15, 2011 and entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTUREINTRACORPOREAL APPARATUS and published on August 28, 2014 and entitled Use US Patent Application Publication 2014/0243597 for SYSTEM FOR PERFORMING AMINIMALLY INVASIVESURGICAL PROCEDURE, each of the above patents is incorporated herein by reference in its entirety.

FIG. 8 shows a surgical data network 201 including a modular communication hub 203 configured as a modular device located in one or more operating rooms of a medical facility or specially equipped for surgical procedures Any room in the medical facility is connected to a cloud-based system (eg, cloud 204, which may include remote server 213 coupled to storage device 205). In one aspect, the modular communication hub 203 includes a network hub 207 and/or a network switch 209 in communication with a network router. Modular communication hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another as well as cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic across the surgical data network and configuration of each port in the network hub 207 or network switch 209 . An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

Modular devices 1 a - 1 n located in the operating room may be coupled to the modular communication hub 203 . Network hub 207 and/or network switch 209 may be coupled to network router 211 to connect devices 1 a - 1 n to cloud 204 or local computer system 210 . Data associated with the devices 1a-1n may be transmitted via routers to cloud-based computers for remote data processing and manipulation. Data associated with devices 1a-1n may also be transmitted to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transmitted via network router 211 to cloud 204 for data processing and manipulation. Data associated with devices 2a-2m may also be transmitted to local computer system 210 for local data processing and manipulation.

It should be appreciated that the surgical data network 201 may be extended by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 211 . The modular communication hub 203 may be included in a modular control tower configured to receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be included in the modular control tower. The modular communication hub 203 is connected to the display 212 to display images obtained by some of the devices 1a-1n/2a-2m, for example, during a surgical procedure. In various aspects, devices 1a-1n/2a-2m may include, for example, various modules such as imaging module 138 coupled to an endoscope, generator module 140 coupled to an energy-based surgical device, smoke evacuation module 126, suction Contactless in/irrigation module 128 , communication module 130 , processor module 132 , storage array 134 , surgical devices connected to displays, and/or other modular devices connectable to modular communication hub 203 of surgical data network 201 sensor module.

In one aspect, the surgical data network 201 may include a combination of one or more network hubs, one or more network switches, and one or more network routers that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to a network hub or network switch may collect data in real time and transmit the data to a cloud computer for data processing and manipulation. It should be understood that cloud computing relies on sharing computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for "internet", although the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a "type of Internet-based computing" in which various services (such as servers, storage, and applications) are delivered to a surgical site (eg, fixed, mobile, ad hoc, or on-site) A modular communication hub 203 and/or computer system 210 in an operating room or space) and devices connected to the modular communication hub 203 and/or computer system 210 via the Internet. Cloud infrastructure may be maintained by cloud service providers. In this case, the cloud service provider may be the entity that coordinates the use and control of the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform extensive computations based on data collected by intelligent surgical instruments, robots, and other computerized devices located in operating rooms. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the Surgical Data Network provides improved surgical outcomes, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue status to assess leakage or perfusion of the sealed tissue following the tissue sealing and cutting procedure. At least some of the devices 1a-1n/2a-2m may be employed to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes localization and edge confirmation of tissues and phenotypes. At least some of the devices 1a-1n/2a-2m may be employed to identify the anatomy of the body using various sensors integrated with imaging devices and techniques, such as overlaying images captured by multiple imaging devices. Data (including image data) collected by devices 1a-1n/2a-2m may be transmitted to cloud 204 or local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Data can be analyzed to improve surgical procedure outcomes by determining whether further treatments such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions can be pursued. Such data analysis can be further processed with outcome analysis, and the use of standardized methods can provide useful feedback to confirm surgical treatment and surgeon behavior, or recommend modifications to surgical treatment and surgeon behavior.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 through wired channels or wireless channels, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, the hub 207 may be implemented as a local network broadcaster operating at the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connections to devices 1a-1n located in the same operating room network. The network hub 207 collects the data in packets and sends it to the router in half-duplex mode. The network hub 207 does not store any Media Access Control/Internet Protocol (MAC/IP) used to transmit device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 has no routing tables or intelligence about where to send the information and broadcast all network data on each connection and through the cloud 204 to the remote server 213 (FIG. 9). The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can introduce security risks and cause bottlenecks.

In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 through a wired channel or a wireless channel. The network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. Network switch 209 sends data to network router 211 in frames and operates in full duplex mode. Multiple devices 2a-2m can transmit data through the network switch 209 simultaneously. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204 . The network router 211 works in the network layer of the OSI model. Network router 211 creates routes for transmitting data packets received from network hub 207 and/or network switch 211 to cloud-based computer resources for further processing and manipulation by any of devices 1a-1n/2a-2m or all collected data. The network router 211 may be employed to connect two or more different networks located in different locations, such as, for example, different operating rooms of the same medical facility or different networks located in different operating rooms of different medical facilities. Network router 211 sends data to cloud 204 in packets and operates in full duplex mode. Multiple devices can send data simultaneously. The network router 211 uses the IP address to transmit data.

In one example, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to connect to a host. A USB hub can expand a single USB port to multiple levels so that more ports are available for connecting devices to a host system computer. The network hub 207 may include wired or wireless capabilities for receiving information over wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

In other examples, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for short wavelength UHF radios over short distances (using 2.4 to 2.485 GHz in the ISM band Waves) to exchange data from fixed and mobile devices and build Personal Area Networks (PANs). In other aspects, the operating room devices 1a-1n/2a-2m can communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 Series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, and designated as 3G, 4G, 5G and Any other wireless and wired protocols above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO et al.

The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a type of data known as a frame. Frames carry data generated by devices 1a-1n/2a-2m. When the frame is received by the modular communication hub 203, it is amplified and transmitted to the network router 211, which transmits the data to the cloud computing resource using various wireless or wireline communication standards or protocols as described herein.

Modular communication hub 203 can be used as a stand-alone device or connected to compatible network hubs and network switches to form larger networks. The modular communication hub 203 is generally easy to install, configure and maintain, making it a good option for networking the operating room devices 1a-1n/2a-2m.

FIG. 9 shows a computer-implemented interactive surgical system 200 . The computer-implemented interactive surgical system 200 is similar to the computer-implemented interactive surgical system 100 in many respects. For example, computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to surgical system 102 . Each surgical system 202 includes at least one surgical hub 206 in communication with the cloud 204 , which may include a remote server 213 . In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices, such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room . As shown in FIG. 10 , modular control tower 236 includes modular communication hub 203 coupled to computer system 210 . As shown in the example of FIG. 9 , modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239 , generator module 240 coupled to energy device 241 , smoke evacuator module 226 , suction/irrigation module 228 , a communication module 230 , a processor module 232 , a storage array 234 , a smart device/apparatus 235 optionally coupled to a display 237 , and a contactless sensor module 242 . The operating room equipment is coupled to cloud computing resources and data storage via the modular control tower 236 . Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices/apparatus 235, visualization system 208, etc. may be coupled to modular control tower 236 via wired or wireless communication standards or protocols, as described herein. Modular control tower 236 may be coupled to hub display 215 (eg, monitor, screen) to display and overlay images received from imaging modules, device/instrument displays, and/or other visualization systems 208 . The hub display may also combine images and overlay images to display data received from devices connected to the modular control tower.

FIG. 10 shows surgical hub 206 including multiple modules coupled to modular control tower 236 . Modular control tower 236 includes modular communication hub 203 (eg, network connectivity device) and computer system 210 to provide, eg, local processing, visualization, and imaging. As shown in FIG. 10 , the modular communication hub 203 can be connected in a hierarchical configuration to expand the number of modules (eg, devices) that can be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210 , cloud computing resources, or both. As shown in FIG. 10, each of the network hubs/switches in modular communication hub 203 includes three downstream ports and one upstream port. An upstream hub/switch is connected to the processor to provide a communication connection with cloud computing resources and the local display 217 . Communication with the cloud 204 may be through wired or wireless communication channels.

Surgical hub 206 employs non-contact sensor modules 242 to measure the dimensions of the operating room, and uses an ultrasonic or laser type non-contact measurement device to generate a map of the surgical room. Ultrasound-based non-contact sensor module scans operating rooms by transmitting a burst of ultrasound and receiving echoes as it bounces off the walls of the operating room, as described in a December 28, 2017 submission titled "INTERACTIVE SURGICAL PLATFORM)" is described under the title "Surgical Hub SpatialAwareness Within an Operating Room" in U.S. Provisional Patent Application Serial No. 62/611,341, which is incorporated herein by reference in its entirety, wherein the sensor The module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by transmitting laser pulses, receiving laser pulses bouncing off the walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to size and adjust the operating room Bluetooth pairing distance limit.

Computer system 210 includes processor 244 and network interface 245 . Processor 244 is coupled to communication module 247, storage device 248, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus. The system bus can be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any of the various available bus architectures, including but not limited to 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI) or any other peripheral bus.

软件的内部只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、和/或一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、具有12个模拟输入信道的一个或多个12位模数转换器(ADC)，其细节可见于产品数据表。Controller 244 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the tradename ARM Cortex. In one aspect, the processor may be an on-chip commercially available, eg, Texas Instruments LM4F230H5QR ARM Cortex-M4F processor core that includes 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) memory, prefetch buffer for improved performance above 40MHz, 32KB single-cycle sequential random access memory (SRAM), loaded with

Internal Read Only Memory (ROM) for software, 2KB Electrically Erasable Programmable Read Only Memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Inputs (QEI) ) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.

In one aspect, the processor 244 may include a safety controller including two series of controllers based (such as the TMS570 and RM4x) known under the trade names also produced by Texas Instruments For Hercules ARM Cortex R4. Safety controllers can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

System memory includes volatile memory and nonvolatile memory. A basic input/output system (BIOS), which contains the basic routines for transferring information between elements within a computer system, such as during startup, is stored in non-volatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM) that acts as external cache memory. Additionally, RAM is available in various forms such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM) Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM) ).

Computer system 210 also includes removable/non-removable, volatile/non-volatile computer storage media, such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, magnetic disk storage may include storage media alone or in combination with other storage media, including but not limited to optical disk drives such as compact disk ROM devices (CD-ROMs), compact disk recordable drives (CD-R drives), compact disk rewritable drives (CD-RW drive) or digital versatile disk ROM drive (DVD-ROM). To facilitate the connection of the disk storage device to the system bus, removable or non-removable interfaces may be used.

It should be understood that computer system 210 includes software that acts as an intermediary between a user and the underlying computer resources described in a suitable operating environment. Such software includes operating systems. An operating system, which may be stored on disk storage, is used to control and allocate the resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored in system memory or disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into computer system 210 through one or more input devices coupled to I/O interface 251 . Input devices include, but are not limited to, pointing devices such as mice, touch balls, styluses, touch pads, keyboards, microphones, joysticks, game pads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, material camera, etc. These and other input devices are connected to the processor through the system bus via one or more interface ports. The one or more interface ports include, for example, serial ports, parallel ports, game ports, and USB. One or more output devices use the same type of ports as one or more input devices. Thus, for example, a USB port can be used to provide input to a computer system and output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers) that require special adapters among other output devices. Output adapters include, by way of example, but are not limited to, providing a connection between an output device and a system bus The device's video and sound cards. It should be noted that other devices or systems such as one or more remote computers provide both input and output capabilities.

Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as one or more cloud computers, or local computers. The one or more remote cloud computers may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer-to-peer devices, or other public network nodes, etc., and typically include the elements described with respect to the computer system. many or all of them. For simplicity, only memory storage devices with one or more remote computers are shown. One or more remote computers are logically connected to the computer system through a network interface, and then physically connected via a communication connection. Network interfaces encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Network (ISDN) and variants thereof, packet-switched networks, and Digital Subscriber Line (DSL).

In various aspects, computer system 210, imaging module 238 and/or visualization system 208 of FIG. 10, and/or processor module 232 of FIGS. 9-10 may include an image processor, an image processing engine, a media processor, or a Any dedicated digital signal processor (DSP) that processes digital images. Image processors may employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. A digital image processing engine can perform a series of tasks. The image processor may be a system-on-a-chip with a multi-core processor architecture.

One or more communication connections refer to the hardware/software used to connect the network interface to the bus. Although the communication connection is shown for example clarification inside the computer system, it may also be located outside the computer system 210 . The hardware/software necessary to connect to the network interface includes, for exemplary purposes only, internal and external technologies, such as modems, including conventional telephone-grade modems, cable and DSL modems, ISDN adapters, and Ethernet cards.

11 shows a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In an illustrative aspect, the USB hub device 300 employs a TUSB2036 integrated circuit hub from Texas Instruments. The USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 in accordance with the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, where each port includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

The USB hub 300 device is implemented with a digital state machine rather than a microcontroller, and does not require firmware programming. A fully compliant USB transceiver is integrated into the circuitry for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304 , 306 , 308 . The downstream USB transceiver ports 304, 306, 308 support both full-speed and low-speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured in a bus-powered or self-powered mode and includes hub power logic 312 for managing power.

The USB hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. SIE 310 typically includes up to transaction level signaling. The functions it handles can include: packet identification, transaction sequencing, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non-return to zero inversion (NRZI) data encoding/decoding and bit stuffing, CRC generation and Check (token and data), packet ID (PID) generation and check/decode, and/or serial-to-parallel/parallel-to-serial conversion. 310 receives clock input 314 and is coupled to suspend/resume logic and frame timer 316 circuits and hub repeater circuit 318 to control upstream USB transceiver port 302 and downstream USB transceiver port 304 through port logic circuits 320, 322, 324 , 306, 308 communication. SIE 310 is coupled via interface logic to command decoder 326 to control commands from the serial EEPROM via serial EEPROM interface 330 .

In various aspects, the USB hub 300 can connect 127 functions configured in up to six logical layers (hierarchies) to a single computer. Additionally, the USB hub 300 can be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power configuration is bus-powered and self-powered. The USB hub 300 can be configured to support four power management modes: a bus powered hub with individual port power management or set of port power management, and a self powered hub with individual port power management or set of port power management. In one aspect, USB hub 300, upstream USB transceiver port 302 is plugged into a USB host controller using a USB cable, and downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and the like.

Surgical Instrument Hardware

12 shows a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. System 470 includes control circuitry. Control circuitry includes microcontroller 461 including processor 462 and memory 468 . For example, one or more of the sensors 472 , 474 , 476 provide real-time feedback to the processor 462 . A motor 482 driven by a motor driver 492 is operatively coupled to the longitudinally movable displacement member to drive the clamp arm closure member. Tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided at the tool driver interface to control closure tube travel, shaft rotation, articulation, or clamp arm closure, or combinations thereof. Display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. The information displayed on the display 473 may be superimposed with images acquired via the endoscopic imaging module.

软件的内部ROM、2KB电EEPROM、一个或多个PWM模块、一个或多个QEI模拟、具有12个模拟输入信道的一个或多个12位ADC，其细节可见于产品数据表。In one aspect, microprocessor 461 may be any single-core or multi-core processor, such as those known under the tradename ARM Cortex from Texas Instruments. In one aspect, the microcontroller 461 may be a LM4F230H5QR ARM Cortex-M4F processor core available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ ), prefetch buffer for improved performance above 40MHz, 32KB single-cycle SRAM, loaded with

Internal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, details of which can be found in the product data sheet.

In one aspect, microcontroller 461 may include a safety controller including two families of controllers based (such as the TMS570 and RM4x) known as commercial products also produced by Texas Instruments Named the Hercules ARM Cortex R4. Safety controllers can be configured specifically for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

The microcontroller 461 can be programmed to perform various functions, such as precise control of the speed and position of the knife, articulation system, gripper arm, or a combination of the above. In one aspect, microcontroller 461 includes processor 462 and memory 468 . Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical link to an articulation or knife system. In one aspect, the motor driver 492 may be A3941 available from Allegro Microsystems, Inc. Other motor drives can be easily replaced for use in tracking system 480 including an absolute positioning system. A detailed description of the absolute positioning system is in US Patent Application Publication 2017/0296213, published October 19, 2017, entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT As described, this patent application is incorporated herein by reference in its entirety.

The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 may be configured to compute the responses in the software of the microcontroller 461 . The calculated response is compared to the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external influences on the system.

In one aspect, motor 482 may be controlled by motor driver 492 and may be employed by a firing system of a surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In other arrangements, the motor 482 may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Motor driver 492 may include, for example, an H-bridge driver including field effect transistors (FETs). Motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly can include a battery, which can include a plurality of battery cells connected in series that can be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cells may be lithium-ion batteries, which may be coupled to and detachable from the power components.

Driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specially designed for inductive loads such as brushed DC motors. Driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate at reduced gate drive as low as 5.5V. A bootstrap capacitor can be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side driver allows DC (100% duty cycle) operation. The full bridge can be driven in either fast decay mode or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can pass through either the high-side FET or the low-side FET. Power FETs are protected from breakdown by resistor-adjustable dead time. Integral diagnostics provide indications of undervoltage, overtemperature, and power bridge faults, and can be configured to protect the power MOSFETs under most short-circuit conditions. Other motor drives can be easily replaced for use in tracking system 480 including an absolute positioning system.

Tracking system 480 includes a controlled motor drive circuit arrangement including position sensor 472 in accordance with one aspect of the present disclosure. A position sensor 472 for an absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member that includes a rack of drive teeth for meshing engagement with corresponding drive gears of the gear reducer assembly. In other aspects, the displacement member represents a firing member that can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which longitudinal displacement member may be adapted and configured as a rack including drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to close and open a clamp arm of a stapler, a clamp arm of an ultrasonic or electrosurgical device, or a combination thereof. Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, gripper arm, or any element that can be displaced. Thus, the absolute positioning system can actually track the displacement of the clamping arm by tracking the linear displacement of the longitudinally movable drive member.

In other aspects, the absolute positioning system can be configured to track the position of the clamp arm during closing or opening. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Accordingly, the longitudinally movable drive member, or clamp arm, or combination thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact displacement sensors or non-contact displacement sensors. Linear displacement sensors may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), sliding potentiometers, magnetic sensing systems including movable magnets and a series of linearly arranged Hall effect sensors, Magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, comprising a fixed light source and a series of Optical sensing system of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

The electric motor 482 may include a rotatable shaft operatively interfacing with a gear assembly mounted on the displacement member in meshing engagement with a set or rack of drive teeth. The sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The transmission and sensor arrangement may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system, and the output indicator shows the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member for opening and closing the gripping arm.

A single rotation of the sensor element associated with position sensor 472 is equivalent to the longitudinal linear displacement d ₁ of the displacement member, where d ₁ is the movement of the displacement member from point “a” to after a single rotation of the sensor element coupled to the displacement member. Longitudinal linear distance of point "b". The sensor arrangement may be connected via gear reduction such that the position sensor 472 only completes one or more revolutions for the full travel of the displacement member. The position sensor 472 may complete multiple rotations for the full travel of the displacement member.

A series of switches (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide a unique position signal for more than one rotation of the position sensor 472 . The state of the switch is fed back to the microcontroller 461 which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d ₁ +d ₂ +...d _n of the displacement member. The output of position sensor 472 is provided to microcontroller 461 . The position sensor 472 of this sensor arrangement may include a magnetic sensor, an analog rotary sensor (eg, a potentiometer), an array of analog Hall effect elements that output a unique combination of position signals or values.

Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic or vector component of the magnetic field. The techniques used to create the two types of magnetic sensors described above cover many aspects of physics and electronics. Technologies for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spins, superconducting quantum interferometers (SQUIDs), Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junction, giant magneto Impedance, magnetostrictive/piezoelectric composites, magneto-sensitive diodes, magneto-sensitive transistors, optical fibers, magneto-optical, and MEMS-based magnetic sensors, etc.

In one aspect, the position sensor 472 for the tracking system 480 including the absolute positioning system includes a magnetic rotary absolute positioning system. Position sensor 472 may be implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 472 interfaces with microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power component and includes four Hall effect elements located in the area of the position sensor 472 on the magnet. A high-resolution ADC and an intelligent power management controller are also provided on-chip. Coordinate Rotation Digital Computer (CORDIC) processors (also known as bitwise and Volder's algorithms) are provided to perform simple and efficient algorithms to compute hyperbolic and trigonometric functions that require only addition, subtraction, digit shifts and table lookups operate. Angular position, alarm bits, and magnetic field information are communicated to microcontroller 461 through a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. Position sensor 472 provides 12 or 14 bit resolution. Position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

Tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers, such as PID, state feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: voltage in this case. Other examples include PWM of voltage, current and force. In addition to the position measured by position sensor 472, one or more other sensors may be provided to measure physical parameters of the physical system. In some aspects, one or more other sensors may include sensor arrangements such as those described in US Patent 9,345,481, issued May 24, 2016, entitled STAPLE CARTRIDGE TISSUE THICKNESS, This patent is incorporated herein by reference in its entirety; US Patent Application Publication 2014/0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS, published Sep. 18, 2014, is incorporated by reference herein in its entirety and U.S. Patent Application Serial No. 15, entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTORVELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017 /628,175, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system will have limited resolution and sampling frequency. The absolute positioning system may include comparison and combination circuits to combine the calculated and measured responses using algorithms (such as weighted averages and theoretical control loops) that drive the calculated responses towards the measured responses. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, inductive resistance, to predict the state and output of the physical system by knowing the inputs.

Thus, the absolute positioning system provides the absolute position of the displacement member when the instrument is powered on, and does not retract or advance the displacement member to the reset (zero or home) position as may be required by conventional rotary encoders, which are 482 The number of forward or backward steps taken is counted to deduce the position of device actuators, drive rods, knives, etc.

Sensors 474 (such as, for example, strain gauges or micro-strain gauges) are configured to measure one or more parameters of the end effector, such as, for example, the magnitude of the strain exerted on the anvil during the clamping operation, which may be Indicates the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to processor 462 . Alternatively or in addition to sensor 474, sensor 476 (such as, for example, a load cell) may measure the closing force applied by the closing drive system to a stapler in an ultrasonic or electrosurgical instrument or an anvil in a clamping arm. Sensors 476 (such as, for example, load cells) may measure the firing force applied to the closure member of the clamp arm coupled to the surgical instrument or tool or the force applied by the clamp arm to tissue located in the jaws of the ultrasonic or electrosurgical instrument . Alternatively, current sensor 478 may be employed to measure the current drawn by motor 482 . The displacement member may also be configured to engage the clamp arm to open or close the clamp arm. The force sensor can be configured to measure the clamping force on the tissue. The force required to advance the displacement member may correspond to the current drawn by the motor 482, for example. The measured force is converted into a digital signal and provided to processor 462 .

In one form, the strain gauge sensor 474 may be used to measure the force applied to the tissue by the end effector. Strain gauges may be coupled to the end effector to measure forces on tissue treated by the end effector. The system for measuring force applied to tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a microstrain gauge configured to measure, for example, one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the magnitude or magnitude of the strain applied to the jaw member of the end effector during a clamping operation, which can be indicative of tissue compression. The measured strain is converted into a digital signal and provided to the processor 462 of the microcontroller 461 . The load sensor 476 can measure the force used to operate the knife element, eg, to cut tissue captured between the anvil and the staple cartridge. The load cell 476 can measure the force used to operate the clamp arm element, eg, to capture tissue between the clamp arm and the ultrasonic blade or to capture tissue between the clamp arm and the jaws of an electrosurgical instrument. A magnetic field sensor can be employed to measure the thickness of the trapped tissue. The magnetic field sensor measurements may also be converted into digital signals and provided to processor 462 .

Microcontroller 461 may use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, measured by sensors 474, 476, respectively, to characterize the selected position of the firing member and/or the velocity of the firing member. corresponding value. In one case, memory 468 may store techniques, formulas, and/or look-up tables that may be employed by microcontroller 461 in evaluation.

The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, as shown in Figures 8-11.

FIG. 13 shows a control circuit 500 configured to control various aspects of a surgical instrument or tool in accordance with one aspect of the present disclosure. Control circuit 500 may be configured to implement the various processes described herein. Circuit 500 may include a microcontroller including one or more processors 502 (eg, microprocessors, microcontrollers) coupled to at least one memory circuit 504 . The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement the various processes described herein. Processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include volatile storage media and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508 . The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

FIG. 14 shows a combinational logic circuit 510 configured to control various aspects of a surgical instrument or tool according to an aspect of the present disclosure. Combinatorial logic circuit 510 may be configured to implement the various processes described herein. Combinatorial logic circuit 510 may include a finite state machine including combinatorial logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide an output 516.

15 illustrates sequential logic circuitry 520 configured to control various aspects of a surgical instrument or tool in accordance with one aspect of the present disclosure. Sequential logic circuit 520 or combinational logic 522 may be configured to implement the various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522 , at least one memory circuit 524 , and clock 529 . At least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. Combinatorial logic 522 is configured to receive data associated with a surgical instrument or tool from input 526 , process the data through combinatorial logic 522 and provide output 528 . In other aspects, a circuit may include a combination of a processor (eg, processor 502, Figure 13) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may include a combination of combinational logic circuits (eg, combinational logic circuit 510 , FIG. 14 ) and sequential logic circuit 520 .

Figure 16 illustrates a surgical instrument or tool that includes multiple motors that can be activated to perform various functions. In some cases, a first motor may be activated to perform a first function, a second motor may be activated to perform a second function, and a third motor may be activated to perform a third function. In some cases, the multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing motion, closing motion, and/or articulation in the end effector. Firing motion, closing motion, and/or articulation can be transmitted to the end effector, for example, through a shaft assembly.

In some cases, the surgical instrument system or tool may include a firing motor 602 . The firing motor 602 is operably coupled to a firing motor drive assembly 604 that can be configured to transmit firing motion generated by the motor 602 to the end effector, in particular for displacing the clamp arm closure member. The closure member can be retracted by reversing the direction of the motor 602, which also causes the clamp arms to open.

In some cases, the surgical instrument or tool may include a closure motor 603 . The closure motor 603 may be operably coupled to a closure motor drive assembly 605 configured to transmit the closure motion generated by the motor 603 to the end effector, in particular for displacing the closure tube to close the anvil And compress the tissue between the anvil and the staple cartridge. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 configured to transmit the closure motion generated by the motor 603 to the end effector, in particular for displacing the closure tube to close the gripper arm And compress the tissue between the clamping arm and the ultrasonic blade or jaw member of the electrosurgical device. The closing motion may, for example, transition the end effector from an open configuration to an approximated configuration to capture tissue. The end effector can be transitioned to the open position by reversing the direction of the motor 603 .

In some cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b can be operably coupled to respective articulation motor drive assemblies 608a, 608b, which can be configured to transmit the articulation generated by the motors 606a, 606b to the end effector. In some cases, articulation allows the end effector to articulate relative to the axis, eg.

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions, while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector, while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire the plurality of staples and/or advance the cutting edge, while the articulation motor 606 remains inactive. Additionally, the closure motor 603 can be activated simultaneously with the firing motor 602 to advance the closure tube or closure member distally, as described in more detail below.

In some cases, the surgical instrument or tool can include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may adjust one of the plurality of motors at a time. For example, the common control module 610 may be individually coupled to and detachable from the plurality of motors of the surgical instrument. In some cases, multiple motors of a surgical instrument or tool may share one or more common control modules such as common control module 610 . In some cases, multiple motors of a surgical instrument or tool may independently and selectively engage the common control module 610 . In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 is selectively switchable between operatively engaging the articulation motors 606a, 606b and operatively engaging the firing motor 602 or the closing motor 603. In at least one example, as shown in FIG. 16, the switch 614 can move or transition between a plurality of positions and/or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 can electrically couple the common control module 610 to the closing motor 603; in the third position 618a , the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 can electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some cases, separate common control modules 610 may be electrically coupled to firing motor 602, closure motor 603, and articulation motors 606a, 606b simultaneously. In some cases, switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor used to actuate the jaws.

In various cases, as shown in FIG. 16, the common control module 610 may include a motor driver 626, which may include one or more H-bridge field effect FETs. The motor driver 626 may regulate the power delivered from the power source 628 to the motor coupled to the common control module 610 , eg, based on input from the microcontroller 620 (“controller”). In some cases, when the motor is coupled to the common control module 610, the microcontroller 620 may be employed, for example, to determine the current drawn by the motor, as described above.

In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform various functions and/or calculations described herein. In some cases, one or more of memory units 624 may be coupled to processor 622, for example. In various aspects, microcontroller 620 may communicate over wired or wireless channels or a combination thereof.

In some cases, power source 628 may be used to power microcontroller 620, for example. In some cases, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some cases, the battery pack can be configured to be releasably mounted to the handle for powering the surgical instrument 600 . Multiple battery cells connected in series may be used as power source 628 . In some cases, power source 628 may be replaceable and/or rechargeable, for example.

In various cases, processor 622 may control motor driver 626 to control the position, rotational direction, and/or speed of motors coupled to common controller 610 . In some cases, processor 622 may signal motor driver 626 to stop and/or deactivate motors coupled to common controller 610 . It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other device that combines the functions of a computer's central processing unit (CPU) on one integrated circuit or at most several integrated circuits Basic computing device. The processor 622 is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides results as output. Because the processor has internal memory, it is an example of sequential digital logic. The processor operates on numbers and symbols represented by the binary number system.

软件的内部ROM、2KB的EEPROM、一个或多个PWM模块、一个或多个QEI模拟、具有12个模拟输入信道的一个或多个12位ADC、以及易得的其它特征件。可容易地换用其它微控制器，以与模块4410一起使用。因此，本公开不应限于这一上下文。In one instance, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex by Texas Instruments. In some cases, microcontroller 620 may be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) of on-chip memory, pre-processors for improved performance above 40MHz fetch buffer, 32KB of single-cycle SRAM, loaded with

Internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers can easily be exchanged for use with module 4410. Therefore, the present disclosure should not be limited in this context.

In some cases, memory 624 may include program instructions for controlling each of the motors of surgical instrument 600 that may be coupled to common controller 610 . For example, memory 624 may include program instructions for controlling firing motor 602, closing motor 603, and articulation motors 606a, 606b. Such program instructions may cause the processor 622 to control firing, closure and articulation functions according to input from an algorithm or control program of the surgical instrument or tool.

In some cases, one or more mechanisms and/or sensors such as sensor 630 may be used to alert processor 622 of program instructions that should be used in a particular setting. For example, sensor 630 may alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, sensor 630 may include, for example, a position sensor that may be used to sense the position of switch 614 . Thus, the processor 622 may use program instructions associated with firing the closing member of the clamp arm coupled to the end effector when the switch 614 is detected in the first position 616, for example, by the sensor 630; Sensor 630 detects that switch 614 is in second position 617 using program instructions associated with closing the anvil; Program instructions associated with articulating the end effector.

17 is a schematic illustration of a robotic surgical instrument 700 configured to operate the surgical tools described herein, according to one aspect of the present disclosure. Robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of displacement members, distal/proximal displacement of closure tubes, shaft rotation, and articulation with single or multiple articulation drive links. In one aspect, surgical instrument 700 may be programmed or configured to individually control a firing member, closure member, shaft member, or one or more articulation members, or a combination thereof. Surgical instrument 700 includes control circuitry 710 configured to control a motor-driven firing member, closure member, shaft member, or one or more articulation members, or a combination thereof.

In one aspect, robotic surgical instrument 700 includes control circuitry 710 configured to control gripping arm 716 and closure member 714 portions of end effector 702 , ultrasonic transducer 719 coupled to ultrasonic generator 721 excitation The ultrasonic blade 718, shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704e. The position sensor 734 may be configured to provide feedback of the position of the closure member 714 to the control circuit 710 . Other sensors 738 may be configured to provide feedback to the control circuit 710 . Timer/counter 731 provides timing and count information to control circuit 710 . An energy source 712 may be provided to operate the motors 704a - 704e and a current sensor 736 provides motor current feedback to the control circuit 710 . Motors 704a - 704e may be individually operated in open loop or closed loop feedback control by control circuit 710 .

In one aspect, control circuitry 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause one or more processors to perform one or more tasks. In one aspect, the timer/counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuit 710 to correlate the position of the closure member 714 as determined by the position sensor 734 with the output of the timer/counter 731, The control circuit 710 is enabled to determine the position of the closure member 714 at a particular time (t) relative to the starting position or at a time (t) when the closing member 714 is in a particular position relative to the starting position. The timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.

In one aspect, control circuitry 710 may be programmed to control the function of end effector 702 based on one or more tissue conditions. Control circuitry 710 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. The control circuit 710 may be programmed to select a firing control sequence or a closure control sequence based on tissue conditions. The firing control program may describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower speed and/or at a lower power. When thinner tissue is present, the control circuit 710 can be programmed to translate the displacement member at a higher speed and/or at a higher power. The closure control program can control the closure force applied by the clamp arms 716 to the tissue. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.

In one aspect, the control circuit 710 may generate a motor setpoint signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the corresponding motor drive signal. In some examples, the motors 704a-704e may be brushless DC motors, and the corresponding motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some examples, the motor controllers 708a-708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.

In some examples, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the displacement member's travel. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select the firing control program in a closed-loop configuration. The response of the instrument may include the translation distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy supplied to one of the motors 704a-704e during the open loop portion, the pulse width of the motor drive signal Sum etc. After the open loop portion, the control circuit 710 may implement the selected firing control routine for the second portion of displacement member travel. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data describing the position of the displacement member in a closed-loop fashion to translate the displacement member at a constant velocity.

In one aspect, motors 704a - 704e may receive power from energy source 712 . The energy source 712 may be a DC power source driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as closure member 714, clamp arm 716, shaft 740, articulation 742a, and articulation 742b, via respective transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 can sense the position of the closure member 714 . Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of closure member 714 . In some examples, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as closure member 714 is translated distally and proximally. The control circuit 710 can track the pulses to determine the position of the closure member 714 . Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of the closure member 714 . Also, in some examples, position sensor 734 may be omitted. Where motors 704a-704e are stepper motors, control circuit 710 may track the position of closure member 714 by aggregating the number and direction of steps that motor 704 has been instructed to perform. Position sensor 734 may be located in end effector 702 or at any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force, and has an encoder for sensing rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firing member such as the closure member 714 portion of the end effector 702 . Control circuit 710 provides motor setpoints to motor control 708a, which provides drive signals to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744a is coupled to transmission 706a , which is coupled to closure member 714 . The transmission 706a includes movable mechanical elements such as rotating elements and firing members to control the distal and proximal movement of the closure member 714 along the longitudinal axis of the end effector 702 . In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set including a first knife drive gear and a second knife drive gear. Torque sensor 744a provides a firing force feedback signal to control circuit 710 . The firing force signal represents the force required to fire or displace the closure member 714 . The position sensor 734 may be configured to provide the position of the closure member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710 . The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710 . When ready for use, control circuit 710 may provide a firing signal to motor control 708a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start of stroke position to an end of stroke position distal to the start of stroke position. When the closure member 714 is translated distally, the clamp arm 716 is closed toward the ultrasonic blade 718 .

In one aspect, the control circuit 710 is configured to drive a closure member, such as the clamp arm 716 portion of the end effector 702 . Control circuit 710 provides motor setpoints to motor control 708b, which provides drive signals to motor 704b. The output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission 706b coupled to clamp arm 716 . The transmission 706b includes movable mechanical elements such as rotating elements and closing members to control the movement of the clamp arms 716 from the open and closed positions. In one aspect, the motor 704b is coupled to a closing gear assembly that includes a closing reduction gear set supported in meshing engagement with the closing spur gear. Torque sensor 744b provides a closing force feedback signal to control circuit 710 . The closing force feedback signal represents the closing force applied to the clamp arm 716 . The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710 . An additional sensor 738 in the end effector 702 may provide a closing force feedback signal to the control circuit 710 . The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718 . When ready for use, control circuit 710 may provide a close signal to motor control 708b. In response to the closure signal, the motor 704b advances the closure member to grasp the tissue between the clamp arm 716 and the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740 , to rotate the end effector 702 . Control circuit 710 provides motor setpoints to motor control 708c, which provides drive signals to motor 704c. The output shaft of motor 704c is coupled to torque sensor 744c. Torque sensor 744c is coupled to transmission 706c coupled to shaft 740 . The transmission 706c includes movable mechanical elements, such as rotating elements, to control the clockwise or counterclockwise rotation of the shaft 740 up to 360° and more. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) the proximal end of the proximal closure tube to pass through A rotating gear assembly operably supported on the tool mounting plate is operably engaged. Torque sensor 744c provides a rotational force feedback signal to control circuit 710 . The rotational force feedback signal represents the rotational force applied to the shaft 740 . The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710 . Additional sensors 738 such as shaft encoders may provide the rotational position of the shaft 740 to the control circuit 710 .

In one aspect, the control circuit 710 is configured to articulate the end effector 702 . Control circuit 710 provides motor setpoints to motor control 708d, which provides drive signals to motor 704d. The output of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission 706d coupled to articulation member 742a. The transmission 706d includes movable mechanical elements, such as articulation elements, to control the ±65° articulation of the end effector 702 . In one aspect, the motor 704d is coupled to an articulation nut rotatably journaled on the proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. Torque sensor 744d provides an articulation force feedback signal to control circuit 710 . The articulation force feedback signal represents the articulation force applied to the end effector 702 . A sensor 738 , such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710 .

In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate disks on the robotic interface (rack), which are driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b can be actuated antagonistically with respect to the other link to provide resistance to the head to maintain motion and load when the head is not moving, and when the head is not moving. Provides joint motion as the head articulates. The articulation members 742a, 742b are attached to the head with a fixed radius as the head rotates. Therefore, when the head rotates, the mechanical advantage of the push-pull link changes. This change in mechanical advantage may be more pronounced for other articulation link drive systems.

In one aspect, one or more of the motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical link with a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are the unmeasured, unpredictable effects of things such as tissue, the surrounding body, and friction on a physical system. Such external influences may be referred to as drag forces, which act against one of the electric motors 704a-704e. External influences such as drag forces can cause the operation of the physical system to deviate from the desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 734 interfaces with controller 710 to provide an absolute positioning system. The location may include a Hall effect element located above the magnet and coupled to a CORDIC processor, also known as the bitwise method and Volder's algorithm, provided to implement for computing hyperbolic and trigonometric functions Simple and efficient algorithms for hyperbolic and trigonometric functions that only require addition, subtraction, digit shift and table lookup operations.

In one aspect, the control circuit 710 may be in communication with one or more sensors 738 . Sensors 738 may be positioned on end effector 702 and adapted to operate with robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or for measuring tip Any other suitable sensor for one or more parameters of actuator 702 . Sensors 738 may include one or more sensors. Sensors 738 may be located on the clamp arm 716 to determine tissue location using segmented electrodes. Torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, among others. Thus, the control circuit 710 can sense (1) the closing load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the ultrasonic blade 718 having tissue thereon. part, and (4) the load and position on the two articulation rods.

In one aspect, the one or more sensors 738 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the clamp arm 716 during a clamp condition. The strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 738 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between clamp arm 716 and ultrasonic blade 718 . The sensor 738 may be configured to detect the impedance of the tissue segment located between the clamp arm 716 and the ultrasonic blade 718, the impedance being indicative of the thickness and/or filling of the tissue located therebetween.

In one aspect, sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switches may be solid state devices such as transistors (eg, FETs, junction FETs, MOSFETs, bipolar transistors, etc.). In other implementations, the sensors 738 may include electrical conductorless switches, ultrasonic switches, accelerometers, inertial sensors, and the like.

In one aspect, the sensor 738 may be configured to measure the force exerted on the clamp arm 716 by the closed drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and clamp arm 716 to detect the closing force applied to clamp arm 716 by the closure tube. The force exerted on the clamp arm 716 may be indicative of the tissue compression experienced by the tissue segment captured between the clamp arm 716 and the ultrasonic blade 718 . One or more sensors 738 may be positioned at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and to evaluate the closing force applied to the clamp arm 716 in real-time.

In one aspect, a current sensor 736 may be used to measure the current drawn by each of the motors 704a-704e. The force required to propel any of the movable mechanical elements, such as closure member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted into a digital signal and provided to processor 710 . The control circuit 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the closure member 714 in the end effector 702 at or near the target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controller, including but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controller. Robotic surgical instrument 700 may include a power source to, for example, convert signals from a feedback controller into physical inputs such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force. Additional details are disclosed in U.S. Patent Application Serial No. 15/636,829, filed June 29, 2017, entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, the entirety of which begins with Incorporated herein by reference.

18 shows a schematic diagram of a surgical instrument 750 configured to control distal translation of a displacement member, according to one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control the distal translation of a displacement member, such as closure member 764 . Surgical instrument 750 includes an end effector 752 , which may include a clamp arm 766 , a closure member 764 , and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .

The position, motion, displacement, and/or translation of linear displacement members such as closure member 764 may be measured by absolute positioning systems, sensor arrangements, and position sensors 784 . Since the closure member 764 is coupled to the longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784 . Accordingly, in the following description, the position, displacement, and/or translation of the closure member 764 may be accomplished by the position sensor 784 described herein. Control circuitry 760 may be programmed to control translation of a displacement member such as closure member 764 . In some examples, control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for performing causing the one or more processors to control the displacement member in the manner described (eg, closing the component 764). In one aspect, the timer/counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure member 764 as determined by the position sensor 784 with the output of the timer/counter 781, This allows the control circuit 760 to determine the position of the closure member 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.

Control circuit 760 may generate motor setpoint signal 772 . The motor setpoint signal 772 may be provided to the motor controller 758 . The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774 . In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754 . Also, in some examples, motor controller 758 may be omitted, and control circuit 760 may generate motor drive signal 774 directly.

Motor 754 may receive power from energy source 762 . Energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to closure member 764 via transmission 756 . Transmission 756 may include one or more gears or other linkage components to couple motor 754 to closure member 764 . The position sensor 784 can sense the position of the closure member 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of closure member 764 . In some examples, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as closure member 764 is translated distally and proximally. The control circuit 760 can track the pulses to determine the position of the closure member 764 . Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of the closure member 764 . Also, in some examples, position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 may track the position of closure member 764 by aggregating the number and direction of steps the motor 754 has been instructed to perform. Position sensor 784 may be located in end effector 752 or at any other portion of the instrument.

Control circuitry 760 may be in communication with one or more sensors 788 . Sensors 788 may be positioned on end effector 752 and adapted to operate with surgical instrument 750 to measure various derived parameters such as gap distance and time, tissue compression and time, and anvil strain and time. Sensors 788 may include, for example, magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or for measuring end effector 752 any other suitable sensor of one or more parameters. Sensors 788 may include one or more sensors.

In some cases, the one or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the clamp arm 766 during a clamp condition. The strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between clamp arm 766 and ultrasonic blade 768 . The sensor 788 may be configured to detect the impedance of the tissue segment located between the clamp arm 766 and the ultrasonic blade 768, the impedance being indicative of the thickness and/or filling of the tissue located therebetween.

Sensor 788 may be configured to measure the force exerted on clamp arm 766 by the closed drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and clamp arm 766 to detect the closing force applied to clamp arm 766 by the closure tube. The force exerted on the clamp arm 766 may represent the tissue compression experienced by the tissue segment captured between the clamp arm 766 and the ultrasonic blade 768 . One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and to evaluate the closing force applied to the clamp arm 766 in real-time.

A current sensor 786 may be used to measure the current drawn by the motor 754 . The force required to advance closure member 764 may correspond to the current drawn by motor 754, for example. The force is converted into a digital signal and provided to control circuit 760 .

The control circuit 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the closure member 764 in the end effector 752 at or near the target speed. Surgical instrument 750 may include a feedback controller, which may be one of any feedback controller, including but not limited to, for example, PID, state feedback, LQR, and/or an adaptive controller. Surgical instrument 750 may include a power source to, for example, convert signals from a feedback controller into physical inputs such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force.

The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or closure member 764 through a brushed DC motor with a gearbox and mechanical link to the articulation and/or knife system. Another example is an electric motor 754 that operates displacement members and articulation drives such as interchangeable shaft assemblies. External influences are the unmeasured, unpredictable effects of things such as tissue, the surrounding body, and friction on a physical system. Such external influences may be referred to as drag forces acting in opposition to the electric motor 754 . External influences such as drag forces can cause the operation of the physical system to deviate from the desired operation of the physical system.

Various example aspects relate to a surgical instrument 750 including an end effector 752 having a motor-driven surgical sealing and cutting implementation. For example, the motor 754 can drive the displacement member distally and proximally along the longitudinal axis of the end effector 752 . The end effector 752 can include a pivotable clamp arm 766, and the ultrasonic blade 768 is positioned opposite the clamp arm 766 when configured for use. The clinician can grasp the tissue between the gripping arm 766 and the ultrasonic blade 768, as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, eg, by depressing the trigger of the instrument 750 . In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from the proximal stroke start position to the distal stroke end position distal to the stroke start position. Closure member 764 with a cutting element positioned at the distal end may cut tissue between ultrasonic blade 768 and clamp arm 766 as the displacement member is translated distally.

In various examples, surgical instrument 750 may include control circuitry 760 programmed to control distal translation of a displacement member, such as closure member 764, based on one or more tissue conditions. Control circuitry 760 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. Control circuitry 760 may be programmed to select a control program based on tissue conditions. The control program may describe the distal movement of the displacement member. Different control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and/or at a lower power. When thinner tissue is present, the control circuit 760 can be programmed to translate the displacement member at a higher speed and/or at a higher power.

In some examples, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's travel. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control program. The response of the instrument may include the translation distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy supplied to the motor 754 during the open loop portion, the sum of the pulse widths of the motor drive signal, and the like. After the open loop portion, the control circuit 760 may implement the selected firing control routine for the second portion of the displacement member travel. For example, during the closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 to translate the displacement member at a constant speed based on translation data describing the position of the displacement member in a closed-loop fashion. Additional details are disclosed in US Patent Application Serial No. 15/720,852, filed September 29, 2017, entitled SYSTEM AND METHODS FOR CONTROLLING ADISPLAY OF A SURGICAL INSTRUMENT, which patent The entirety of the application is incorporated herein by reference.

19 is a schematic diagram of a surgical instrument 790 configured to control various functions, according to one aspect of the present disclosure. In one aspect, surgical instrument 790 is programmed to control the distal translation of a displacement member, such as closure member 764 . Surgical instrument 790 includes an end effector 792, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768, which may be coupled to one or more RF electrodes 796 (shown in dashed lines). out) interchange or work in conjunction with one or more RF electrodes 796. Ultrasonic blade 768 is coupled to ultrasonic transducer 769 driven by ultrasonic generator 771 .

In one aspect, the sensors 788 may be implemented as limit switches, electromechanical devices, solid state switches, Hall effect devices, MR devices, GMR devices, magnetometers, and the like. In other implementations, the sensor 638 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switches may be solid state devices such as transistors (eg, FETs, junction FETs, MOSFETs, bipolar transistors, etc.). In other implementations, sensors 788 may include electrical conductorless switches, ultrasonic switches, accelerometers, inertial sensors, and the like.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system including a monolithic magnetic rotary position sensor implemented as an AS5055EQFT, commercially available from Austria Microsystems, AG. Position sensor 784 may interface with controller 760 to provide an absolute positioning system. The location may include a Hall effect element located above the magnet and coupled to a CORDIC processor, also known as the bitwise method and Volder's algorithm, provided to implement for computing hyperbolic and trigonometric functions Simple and efficient algorithms for hyperbolic and trigonometric functions that only require addition, subtraction, digit shift and table lookup operations.

In some examples, position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 can track the position of the closure member 764 by aggregating the number and direction of steps the motor has been instructed to perform. Position sensor 784 may be located in end effector 792 or at any other portion of the instrument.

Control circuitry 760 may be in communication with one or more sensors 788 . Sensor 788 may be positioned on end effector 792 and adapted to operate with surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensors 788 may include, for example, magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or for measuring end effectors 792 any other suitable sensor of one or more parameters. Sensors 788 may include one or more sensors.

An RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is disposed in the end effector 792 to operate in place of or in conjunction with the ultrasonic blade 768 . For example, ultrasonic blades are made of conductive metal and can be used as a return path for electrosurgical RF current. Control circuitry 760 controls the delivery of RF energy to RF electrodes 796 .

Additional details are disclosed in US Patent Application Serial No. 15/636,096, filed June 28, 2017, entitled SURGICAL SYSTEM COUPLABLE WITHSTAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), which is hereby incorporated by reference in its entirety.

Adaptive Ultrasonic Knife Control Algorithm

In various aspects, an intelligent ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, an ultrasonic blade adaptive control algorithm is configured to identify tissue types and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize tissue types. The following sections of this disclosure describe an algorithm for detecting the collagen/elasticity ratio of tissue to tune the amplitude of the distal tip of the ultrasonic blade. Various aspects of intelligent ultrasonic energy devices are described herein in connection with, eg, FIGS. 1-94. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-94 and the description associated therewith.

Tissue type identification and device parameter adjustment

In certain surgical procedures, it is desirable to employ adaptive ultrasonic blade control algorithms. In one aspect, an adaptive ultrasonic blade control algorithm may be employed to adjust parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device can be adjusted based on the position of the tissue within the jaws of the ultrasonic end effector (eg, the position of the tissue between the clamping arm and the ultrasonic blade). The impedance of the ultrasound transducer can be used to differentiate the percentage of tissue in the distal end or the proximal end of the end effector. The response of the ultrasound device may be based on the tissue type or the compressibility of the tissue. In another aspect, parameters of the ultrasound device may be adjusted based on the identified tissue type or parameterization. For example, the magnitude of the mechanical displacement of the distal tip of the ultrasonic blade can be tuned based on the ratio of collagen to elastin tissue detected during the tissue identification process. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including infrared (IR) surface reflectance and specific emissivity. The force applied to the tissue by the clamp arm and/or the travel of the clamp arm to create clearance and compression. Electrical continuity across the jaws equipped with electrodes can be used to determine the percentage of jaws covered by tissue.

20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub in accordance with at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute one or more adaptive ultrasonic blade control algorithms 802 as described herein with reference to FIGS. 53-94. In another aspect, the device/instrument 235 is configured to execute one or more adaptive ultrasonic blade control algorithms 804 as described herein with reference to FIGS. 53-94. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to FIGS. 53-94.

The generator module 240 may include a patient isolation stage in communication with the non-isolated stage via a power transformer. The secondary winding of the power transformer is contained in the isolation stage, and may include a tap configuration (eg, center tap or non-center tap configuration) to define a drive signal output that is used to deliver the drive signal to different Surgical instruments such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multifunctional surgical instruments that include ultrasonic and RF energy modalities that can be delivered separately or simultaneously. Specifically, the drive signal output may output an ultrasonic drive signal (eg, a 420V root mean square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (eg, a 100V RMS drive signal) Output to RF electrosurgical instrument 241 . Aspects of generator module 240 are described herein with reference to Figures 21-28B.

The generator module 240 or the device/instrument 235 or both are coupled to a modular control tower 236 that is connected to a number of operating room devices such as, for example, smart surgical instruments, robotics, and other computerized devices located in the operating room device, as described with reference to Figures 8-11, eg.

21 shows an example of a generator 900, which is a form of generator configured to be coupled to an ultrasonic instrument and further configured to perform adaptive ultrasound in a surgical data network including a modular communication hub Knife control algorithm, as shown in Figure 20. Generator 900 is configured to deliver multiple energy modalities to a surgical instrument. Generator 900 provides RF and ultrasound signals for delivering energy to surgical instruments independently or simultaneously. The RF signal and the ultrasound signal may be provided individually or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (eg, ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.) through a single port, and these signals Can be delivered to the end effector separately or simultaneously to treat tissue. Generator 900 includes processor 902 coupled to waveform generator 904 . Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in memory coupled to processor 902, which is not shown for clarity of the present disclosure. The digital information associated with the waveform is provided to a waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is fed to amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to power transformer 908 . The signal is coupled through a power transformer 908 to the secondary side in the patient isolation side. A first signal of a first energy modality is provided to the surgical instrument between terminals labeled ENERGY ₁ and RETURN. The second signal of the second energy mode is coupled across capacitor 910 and provided to the surgical instrument between terminals labeled ENERGY ₂ and RETURN. It should be understood that more than two energy modes may be output, and thus the subscript "n" may be used to designate that up to n ENERGY _n terminals may be provided, where n is a positive integer greater than one. It should also be understood that up to n return paths RETURN _n may be provided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across terminals labeled ENERGY ₁ and RETURN paths to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across the terminals labeled ENERGY ₂ and the RETURN path to measure the output voltage therebetween. As shown, the current sensing circuit 914 is placed in series with the RETURN branch on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return leg. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to respective isolation transformers 916 , 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918 . The outputs of isolation transformers 916 , 928 , 922 on the primary side of power transformer 908 (non-patient isolation side) are provided to one or more ADC circuits 926 . The digitized output of ADC circuit 926 is provided to processor 902 for further processing and calculations. The output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument, and to calculate parameters such as output impedance. Input/output communication between processor 902 and patient isolation circuitry is provided through interface circuitry 920 . Sensors may also be in electrical communication with processor 902 through interface 920 .

In one aspect, the impedance can be sensed by the processor 902 by either a first voltage sensing circuit 912 coupled across the terminal labeled ENERGY ₁ /RETURN or a second voltage coupled across the terminal labeled ENERGY ₂ /RETURN The output of circuit 924 is determined by dividing the output of current sensing circuit 914 placed in series with the RETURN branch on the secondary side of power transformer 908 . The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916 , 922 , and the output of the current sensing circuit 914 is provided to another isolation transformer 916 . Digitized voltage and current sense measurements from ADC circuit 926 are provided to processor 902 for use in calculating impedance. For example, the first energy modality ENERGY ₁ may be ultrasonic energy, and the second energy modality ENERGY ₂ may be RF energy. However, in addition to ultrasound and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example shown in FIG. 21 shows that a single return path RETURN may be provided for two or more energy modalities, in other aspects multiple return paths RETURN may be provided for each energy modality ENERGY _{n n} . Thus, as described herein, the ultrasound transducer impedance can be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914 , and the tissue impedance can be measured by dividing the output of the second voltage sensing circuit 924 The output is divided by the output of the current sense circuit 914 to measure.

As shown in FIG. 21, a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to operate at one or more energy modalities (eg, depending on the type of tissue treatment being performed). Power is provided to the end effector in a form such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation and/or microwave energy, etc.). For example, the generator 900 may deliver energy with higher voltages and lower currents to drive ultrasonic transducers, lower voltages and higher currents to drive RF electrodes for sealing tissue, or coagulation waveforms to use For use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from generator 900 can be manipulated, switched or filtered to provide frequencies to the end effector of the surgical instrument. The connection of the ultrasound transducer to the generator 900 output will preferably be between the outputs labeled ENERGY ₁ and RETURN, as shown in FIG. 21 . In one example, the connection of the RF bipolar electrode to the generator 900 output would preferably be between the outputs labeled ENERGY ₂ and RETURN. In the case of a monopolar output, the preferred connection would be an active electrode (eg, pencil or other probe) to the ENERGY ₂ output and a suitable return pad to the RETURN output.

Additional details are disclosed in US Patent TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLYGENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, issued March 30, 2017, entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLYGENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS In Application Publication 2017/0086914, the entirety of this patent application is incorporated herein by reference.

As used throughout this specification, the term "wireless" and derivatives thereof may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through a non-solid medium using modulated electromagnetic radiation. The term does not imply that the associated devices do not contain any wires, although in some respects they may not. The communication module can implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev- DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and their Ethernet derivatives, and any other wireless and wireline protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev -DO etc.

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, typically a memory or some other data stream. The term as used herein refers to a central processing unit (central processing unit) in one or more systems, particularly a system-on-a-chip (SoC), that combines multiple specialized "processors".

As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all components of a computer or other electronic system. It can contain digital, analog, mixed-signal, and generally RF functionality—all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), Wi-Fi module or co-processor. The SoC may or may not contain built-in memory.

As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU of a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include as one of its components a microcontroller. A microcontroller may contain one or more core processing units (CPUs) as well as memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash or OTP ROM, and a small amount of RAM are also often included on the chip. In contrast to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used in embedded applications.

As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This can be a link between two components of a computer or a controller on an external device that manages the operation of the device (and connections to the device).

软件的内部只读存储器(ROM)、2KB的电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、具有12个模拟输入信道的一个或多个12位模数转换器(ADC)、以及易得的其它特征。Any of the processors or microcontrollers as described herein may be any single-core or multi-core processor, such as those offered by Texas Instruments under the tradename ARM Cortex. In one aspect, the processor may be, for example, the LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) On-chip memory, prefetch buffer for improved performance over 40MHz, 32KB of single-cycle serial random access memory (SRAM), loaded with

Internal Read Only Memory (ROM) for software, 2KB of Electrically Erasable Programmable Read Only Memory (EEPROM), one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) emulation , one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features that are readily available.

In one example, the processor may include a safety controller including two families of controllers, such as the TMS570 and the Hercules ARMCortex R4, also offered by Texas Instruments. RM4x. Safety controllers can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

Modular devices include modules receivable within a surgical hub (as described in connection with Figures 3 and 9) and surgical devices or instruments that can be connected to the various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular devices described herein may be controlled by a control algorithm. Control algorithms may be executed on the modular device itself, on the surgical hub paired with a particular modular device, or on both the modular device and the surgical hub (eg, via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (ie, through sensors in, on, or connected to the modular device). This data may be related to the patient being operated on (eg, tissue properties or insufflation pressure) or the modular device itself (eg, the rate at which the blade is advanced, motor current or energy level). For example, a control algorithm for a surgical stapling and cutting instrument may control the rate at which the instrument's motor drives its blade through tissue based on the resistance the blade encounters as it advances.

22 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 that may be used therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument and the surgical instrument 1106 is an RF electrosurgical instrument , and the multifunctional surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. Generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104 , an RF electrosurgical instrument 1106 , and an integrated RF concurrent delivery from the generator 1100 . Multifunctional surgical instrument 1108 of energy and ultrasonic energy. Although in the form of FIG. 22 the generator 1100 is shown separate from the surgical instruments 1104 , 1106 , 1108 , in one form the generator 1100 may be integral with any of the surgical instruments 1104 , 1106 , 1108 formed to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100 . Generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a plurality of surgical instruments 1104 , 1106 , 1108 . The first surgical instrument is ultrasonic surgical instrument 1104 and includes handpiece 1105 (HP), ultrasonic transducer 1120 , shaft 1126 and end effector 1122 . The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 that are acoustically coupled to the ultrasonic transducer 1120 . Handpiece 1105 includes a combination of trigger 1143 for operating clamp arm 1140 and toggle buttons 1134a, 1134b, 1134c for energizing and driving ultrasonic blade 1128 or other functions. Toggle buttons 1134a, 1134b, 1134c may be configured to energize ultrasonic transducer 1120 with generator 1100.

The generator 1100 is further configured to drive the second surgical instrument 1106 . The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127 and an end effector 1124 . The end effector 1124 includes electrodes in the gripping arms 1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. These electrodes are coupled to and powered by a bipolar energy source within generator 1100 . The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142a, 1142b and an energy button 1135 for actuating the energy switch to energize the electrodes in the end effector 1124.

Generator 1100 is further configured to drive multifunctional surgical instrument 1108 . The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129 and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120 . Handpiece 1109 includes a combination of trigger 1147 for operating clamp arm 1146 and toggle buttons 1137a, 1137b, 1137c for energizing and driving ultrasonic blade 1149 or other functions. Toggle buttons 1137a, 1137b, 1137c may be configured to power ultrasonic transducer 1120 with generator 1100 and ultrasonic blade 1149 with a bipolar energy source also contained within generator 1100.

Generator 1100 may be configured for use with a variety of surgical devices. According to various forms, generator 1100 may be configurable for use with different types of surgical instruments including, for example, ultrasonic surgical instrument 1104 , RF electrosurgical instrument 1106 , and RF integrated with simultaneous delivery from generator 1100 Multifunctional surgical instrument 1108 of energy and ultrasonic energy. Although in the form of FIG. 22 the generator 1100 is shown separate from the surgical instruments 1104 , 1106 , 1108 , in another form the generator 1100 may be integral with any of the surgical instruments 1104 , 1106 , 1108 formed to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100 . Generator 1100 may also include one or more output devices 1112 . Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in US Patent Publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.

或其它合适的低摩擦材料形成。可安装垫1163，以用于与刀1128协作，其中夹持臂1140的枢转运动将夹持垫1163定位成与刀1128大体平行并接触。通过该构造，可将待夹持的组织咬合可被抓握在组织垫1163和刀1128之间。组织垫1163可具有锯齿状配置，包括多个轴向间隔开的朝近侧延伸的抓持齿1161，以与刀1128协作增强对组织的抓持。夹持臂1140可从图23中所示的打开位置以任何合适的方式转变到闭合位置(其中夹持臂1140与刀1128接触或接近刀1128)。例如，手持件1105可包括钳口闭合触发器。当由临床医生致动时，钳口闭合触发器可以任何合适的方式枢转夹持臂1140。23 is an end effector 1122 of an example ultrasound device 1104 in accordance with at least one aspect of the present disclosure. The end effector 1122 can include a blade 1128, which can be coupled to the ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 can vibrate, and when in contact with tissue, can cut and/or coagulate tissue, as described herein. According to various aspects, and as shown in FIG. 23 , the end effector 1122 may further include a gripper arm 1140 that may be configured to act in cooperation with the blade 1128 of the end effector 1122 . With the knife 1128, the clamping arm 1140 may include a set of jaws. Clamp arm 1140 may be pivotally connected at the distal end of shaft 1126 of instrument portion 1104 . The clamp arm 1140 can include a clamp arm tissue pad 1163 that can be

or other suitable low friction materials. A pad 1163 may be mounted for cooperation with the knife 1128, wherein pivotal movement of the clamp arm 1140 positions the clamp pad 1163 generally parallel and in contact with the knife 1128. With this configuration, the tissue to be clamped can be gripped between the tissue pad 1163 and the knife 1128. The tissue pad 1163 may have a serrated configuration including a plurality of axially spaced, proximally extending gripping teeth 1161 to cooperate with the knife 1128 to enhance gripping of tissue. The clamp arm 1140 may transition from the open position shown in FIG. 23 to a closed position (wherein the clamp arm 1140 is in contact with or proximate to the knife 1128) in any suitable manner. For example, handpiece 1105 may include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.

Generator 1100 may be activated to provide drive signals to transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 ( FIG. 24 ) that is coupled to the generator 1100 via a foot switch cable 1432 . The clinician can activate the ultrasound transducer 1120 by depressing the foot switch 1430, and thereby activate the ultrasound transducer 1120 and the knife 1128. In addition, or in lieu of foot switch 1430, aspects of device 1104 may utilize one or more switches positioned on handpiece 1105 that, when activated, may enable generator 1100 to activate transduction device 1120. In one aspect, for example, the one or more switches may include a pair of toggle buttons 1134a, 1134b, 1134c (FIG. 22), for example, to determine the mode of operation of the device 1104. When toggle button 1134a is depressed, for example, ultrasonic generator 1100 may provide a maximum drive signal to transducer 1120, causing it to generate maximum ultrasonic energy output. Depressing toggle button 1134b may cause ultrasound generator 1100 to provide a user-selectable drive signal to ultrasound transducer 1120, causing it to produce less than a maximum ultrasound energy output. Additionally or alternatively, the device 1104 may include a second switch to, for example, indicate the position of a jaw closure trigger for operating the jaws via the clamp arm 1140 of the end effector 1122. Additionally, in some aspects, the ultrasound generator 1100 may be activated based on the position of the jaw closure trigger (eg, ultrasound energy may be applied when the clinician depresses the jaw closure trigger to close the jaws via the clamp arms 1140 ) .

Additionally or alternatively, the one or more switches may include a toggle button 1134c that, when depressed, causes the generator 1100 to provide a pulsed output (FIG. 22). The pulses may be provided, for example, at any suitable frequency and grouping. In certain aspects, for example, the power level of the pulse may be the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.

It should be understood that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, device 1104 may be configured with only two toggle buttons: toggle button 1134a for generating maximum ultrasonic energy output and toggle button 1134c for generating pulsed output at or below the maximum power level. As such, the drive signal output configuration of generator 1100 may be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, certain drive signal configurations may be controlled based on, for example, EEPROM settings in generator 1100 and/or one or more user power level selections.

In certain aspects, a two-position switch may be provided in place of toggle button 1134c (FIG. 22). For example, the device 1104 may include a toggle button 1134a and a two-position toggle button 1134b for producing continuous output at a maximum power level. In the first detent position, the toggle button 1134b may generate a continuous output at less than the maximum power level, and in the second detent position, the toggle button 1134b may generate a pulsed output (eg, at the maximum power level or less, depending on the EEPROM settings) maximum power level).

In some aspects, the RF electrosurgical end effectors 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, eg, via a cable. The electrodes can be used, for example, to measure the impedance of tissue occlusion that exists between the clamping arms 1142a, 1146 and the blades 1142b, 1149. Generator 1100 may provide signals (eg, non-therapeutic signals) to the electrodes. For example, the impedance of tissue occlusion can be found by monitoring the current, voltage, etc. of the signal.

In various aspects, generator 1100 may include several separate functional elements, such as modules and/or blocks, as shown in the illustrations of surgical system 1000 of FIGS. 24 , 22 . Different functional elements or modules may be configured to drive different kinds of surgical devices 1104 , 1106 , 1108 . For example, the ultrasound generator module may drive an ultrasound device, such as the ultrasound surgical device 1104 . The electrosurgical/RF generator module can drive the electrosurgical device 1106 . For example, the modules may generate corresponding drive signals for driving the surgical devices 1104 , 1106 , 1108 . In various aspects, the ultrasonic generator module and/or the electrosurgical/RF generator module may each be integrally formed with generator 1100 . Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100 . (The module is shown in phantom to illustrate this portion.) Furthermore, in some aspects, the electrosurgery/RF generator module may be integrally formed with the ultrasound generator module, or vice versa.

According to the described aspects, the ultrasonic generator module may generate one or more drive signals of a specific voltage, current, and frequency (eg, 55,500 cycles per second or Hz). The one or more drive signals may be provided to the ultrasound device 1104, particularly the transducer 1120, which may operate, eg, as described above. In one aspect, the generator 1100 can be configured to generate a drive signal of a specific voltage, current, and/or frequency output signal that is modifiable in terms of high resolution, accuracy, and reproducibility.

According to the described aspects, the electrosurgery/RF generator module may generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgical applications, drive signals may be provided to electrodes of, for example, electrosurgical device 1106, as described above. Thus, generator 1100 may be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat tissue (eg, coagulation, cauterization, tissue welding, etc.).

The generator 1100 may include an input device 2150 (FIG. 27B) located, for example, on the front panel of the generator 1100 console. Input device 2150 may include any suitable device that generates signals suitable for programming the operation of generator 1100 . In operation, a user may use the input device 2150 to program or otherwise control the operation of the generator 1100. The input device 2150 may include generators that may be used by the generator (eg, by one or more processors included in the generator) to control the operation of the generator 1100 (eg, an ultrasonic generator module and/or an electrosurgical/RF generator). any suitable means of signalling the operation of the module). In various aspects, the input device 2150 includes one or more of the following: buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, remote connections to general purpose or special purpose computers. In other aspects, the input device 2150 may include, for example, a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor, for example. Thus, through the input device 2150, the user may set or program various operating parameters of the generator, such as, for example, the drive signal(s) generated by the ultrasonic generator module and/or the electrosurgical/RF generator module. Current (I), Voltage (V), Frequency (f) and/or Period (T).

The generator 1100 may also include an input device 2140 (FIG. 27B) located, for example, on the front panel of the generator 1100 console. Output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (eg, LCD displays, LED indicators), audio feedback devices (eg, speakers, buzzers), or haptic feedback devices (eg, haptic actuators).

While certain modules and/or blocks of generator 1100 may be described by way of example, it will be appreciated that greater or fewer numbers of modules and/or blocks may be used and still fall within the scope of the described aspects. Additionally, although various aspects may be described in terms of modules and/or blocks for ease of illustration, such modules and/or blocks may be implemented by one or more hardware components (eg, a processor, a digital signal processor (DSP), a Programmed logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers) and/or software components (eg, programs, subroutines, logic), and/or a combination of hardware and software components are implemented.

In one aspect, the ultrasound generator driver module and electrosurgery/RF driver module 1110 (FIG. 22) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. Modules may include various executable modules such as software, programs, data, drivers, application programming interfaces (APIs), and the like. Firmware may be stored in non-volatile memory (NVM) such as bit-masked read only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM protects the flash memory. The NVM may include other types of memory including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery-backed random access memory (RAM) such as Dynamic RAM (DRAM), Double Data Rate DRAM (DDRAM), and/or Synchronous DRAM (SDRAM)).

In one aspect, a module includes hardware components implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating data for operating the devices 1104, 1106, 1108, and The corresponding output drive signals of 1106 and 1108. In aspects in which the generator 1100 is used in conjunction with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and/or coagulation mode of operation. Electrical characteristics of device 1104 and/or tissue may be measured and used to control operational aspects of generator 1100 and/or may be provided as feedback to a user. In aspects in which the generator 1100 is used in conjunction with the device 1106, the drive signal may supply electrical energy (eg, RF energy) to the end effector 1124 in cutting, coagulation, and/or dehydration modes. Electrical characteristics of device 1106 and/or tissue may be measured and used to control operational aspects of generator 1100 and/or may be provided as feedback to a user. In various aspects, as previously described, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits, and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions to generate various components for actuating the devices 1104, 1106, 1108 (eg, the ultrasound transducer 1120 and the end effectors 1122, 1124, 1125). ) of the step function output signal.

Electromechanical ultrasound systems include ultrasonic transducers, waveguides, and ultrasonic blades. Electromechanical ultrasound systems have an initial resonant frequency defined by the physical properties of the ultrasound transducer, waveguide, and ultrasound blade. The resonant frequency of the ultrasonic transducer excited by the alternating voltage _Vg (t) signal and the current _Ig (t) signal is equal to the electromechanical ultrasonic system. When the ultrasonic electromechanical system is at resonance, the phase difference between the voltage _Vg (t) signal and the current _Ig (t) signal is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. The compliance of the ultrasonic blade (modeled as an equivalent capacitance) causes the resonant frequency of the electromechanical ultrasonic system to shift as it heats up. Therefore, the inductive impedance is no longer equal to the capacitive impedance, resulting in a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasound system. The system now operates "off-resonance". The mismatch between the drive frequency and the resonant frequency is manifested by the phase difference between the voltage _Vg (t) signal and the current _Ig (t) signal applied to the ultrasound transducer. The generator electronics can easily monitor the phase difference between the voltage _Vg (t) and current _Ig (t) signals and can continuously adjust the drive frequency until the phase difference is zero again. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Changes in phase and/or frequency can be used as an indirect measure of the temperature of the ultrasonic blade.

As shown in Figure 25, the electromechanical properties of the ultrasound transducer can be modeled as an equivalent circuit comprising a first branch having a static capacitance and a series-connected circuit having a defined electromechanical property of the resonator The second "dynamic" branch of inductance, resistance and capacitance. Known ultrasonic generators may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using a tuned inductor, the generator's drive signal current represents the dynamic branch current, and thus the generator can control its drive signal to maintain the ultrasonic transducer's resonant frequency. Tuning the inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasound transducers with different static capacitances require different tuning inductors.

25 shows an equivalent circuit 1500 of an ultrasound transducer, such as ultrasound transducer 1120, according to one aspect. Circuit 1500 includes a first "dynamic" branch having series-connected inductance L _s , resistance R _s and capacitance C _s that define the electromechanical characteristics of the resonator, and a second capacitive branch C ₀ having static capacitance. A drive current _Ig (t) may be received from the generator at a drive voltage _Vg (t), with a dynamic current _Im (t) flowing through the first branch and currents Ig(t) _-Im ( _t ) flowing over capacitor branch. Control of the electromechanical properties of the ultrasound transducer can be achieved by appropriate control of _Ig (t) and _Vg (t). As noted above, known generator architectures may include a tuning inductor _Lt (shown in phantom in Figure 25) in a parallel resonant circuit for tuning the static capacitance _C0 to the resonant frequency such that substantially All of the generator's current output _Ig (t) flows through the dynamic branch. In this way, control of the dynamic branch current _Im (t) is achieved by controlling the generator current output _Ig (t). However, the tuning inductor _Lt is specific to the static capacitance _C0 of the ultrasound transducer, and different ultrasound transducers with different static capacitances require different tuning inductors _Lt. Furthermore, since the tuning inductor _Lt matches the nominal value of the static capacitance _C0 at a single resonant frequency, precise control of the dynamic branch current _Im (t) is ensured only at this frequency. As the frequency shifts downward with transducer temperature, precise control of the dynamic branch current is compromised.

Various aspects of generator 1100 may monitor dynamic branch current _Im ( _t ) independently of tuning inductor Lt. Instead, generator 1100 may use measurements of electrostatic capacitance _C0 (along with drive signal voltage and current feedback data) between the application of power for a particular ultrasonic surgical device 1104 to progress on a dynamic basis (eg, in real time) ) determines the value of the dynamic branch current _Im (t). Thus, such aspects of generator 1100 can provide virtual tuning to simulate a tuned system or resonate with any value of electrostatic capacitance C ₀ at any frequency, not just as indicated by the nominal value of electrostatic capacitance C ₀ resonance at a single resonant frequency.

26 is a simplified block diagram of one aspect of generator 1100 that provides inductorless tuning, among other benefits, as described above. 27A-27C illustrate the architecture of the generator 1100 of FIG. 26, according to one aspect. Referring to FIG. 26 , the generator 1100 may include a patient isolation stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560 . The secondary winding 1580 of the power transformer 1560 is contained in the isolation stage 1520 and may include a tap configuration (eg, center tap or off-center tap configuration) to define the drive signal outputs 1600a, 1600b, 1600c for driving the drive The signals are output to different surgical devices (such as, for example, ultrasonic surgical device 1104 and electrosurgical device 1106). Specifically, drive signal outputs 1600a, 1600b, 1600c can output drive signals (eg, 420V RMS drive signals) to ultrasonic surgical device 1104, and drive signal outputs 1600a, 1600b, 1600c can output drive signals (eg, 100V RMS drive signals) signal) is output to the electrosurgical device 1106, where output 1600b corresponds to the center tap of the power transformer 1560. Non-isolated stage 1540 may include power amplifier 1620 having an output connected to primary winding 1640 of power transformer 1560 . In certain aspects, power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may also include a programmable logic device 1660 for supplying a digital output to a digital-to-analog converter (DAC) 1680, which in turn supplies a corresponding analog signal to the power Input to Amplifier 1620. In certain aspects, programmable logic device 1660 may include, for example, a field programmable gate array (FPGA). As the input of power amplifier 1620 is controlled via DAC 1680, programmable logic device 1660 can thus control a number of parameters (eg, frequency, waveform shape, waveform amplitude) of the drive signal appearing at drive signal outputs 1600a, 1600b, 1600c any of . In certain aspects and as described below, programmable logic device 1660, in conjunction with a processor (eg, processor 1740 described below), may implement a number of digital signal processing (DSP)-based algorithms and/or other control algorithms to control Parameters of the drive signal output by the generator 1100 .

Power may be supplied to the power rails of power amplifier 1620 through switch mode regulator 1700 . In certain aspects, the switch mode regulator 1700 may include, for example, an adjustable buck regulator. As noted above, the non-isolated stage 1540 may further include a processor 1740, which in one aspect may include a DSP processor such as an ADSP-21469 SHARC DSP, available, for example, from Analog Devices, Inc., Norwood, MA. Norwood, Mass.). In certain aspects, processor 1740 may control operation of switch-mode power converter 1700 in response to voltage feedback data received by processor 1740 from power amplifier 1620 via analog-to-digital converter (ADC) 1760 . In one aspect, for example, the processor 1740 may receive as input, via the ADC 1760, the waveform envelope of the signal (eg, RF signal) being amplified by the power amplifier 1620. Processor 1740 may then control switch mode regulator 1700 (eg, via a pulse width modulation (PWM) output) such that the mains voltage supplied to power amplifier 1620 tracks the waveform envelope of the amplified signal. By dynamically modulating the mains voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly increased relative to a fixed mains voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.

In certain aspects and as discussed in more detail in connection with FIGS. 28A-28B , programmable logic device 1660 in conjunction with processor 1740 may implement a direct digital synthesizer (DDS) control scheme to control the waveform of the drive signal output by generator 1100 shape, frequency and/or amplitude. In one aspect, for example, programmable logic device 1660 may implement DDS control algorithm 2680 (Fig. 28A). This control algorithm is particularly useful for ultrasound applications where an ultrasound transducer, such as ultrasound transducer 1120, can be driven by a pure sinusoidal current at its resonant frequency. Because other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the dynamic branch current can correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by the generator 1100 is affected by various sources of distortion present in the output drive circuits (eg, power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal can be input into an algorithm, such as an error control algorithm implemented by processor 1740, that compensates for distortion by pre-distorting or modifying the waveform samples stored in the LUT, as appropriate, on a dynamically advancing basis (eg, in real-time). In one form, the amount or degree of predistortion applied to the LUT samples may be based on the error between the calculated dynamic branch current and the desired current waveform shape, wherein the error may be determined on a sample-by-sample basis . In this way, the pre-distorted LUT samples, when processed by the drive circuit, can cause the dynamic branch drive signal to have a desired waveform shape (eg, sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such aspects, the LUT waveform samples will thus not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the dynamic branch drive signal when distortion effects are accounted for.

Non-isolated stage 1540 may further include ADC 1780 and ADC 1800 coupled to the output of power transformer 1560 via respective isolation transformers 1820, 1840 for voltages to the drive signal output by generator 1100, respectively and current for sampling. In certain aspects, the ADCs 1780, 1800 may be configured to sample at high speed (eg, 80Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling speed of the ADCs 1780, 1800 can achieve approximately 200X (depending on frequency) oversampling of the drive signal. In certain aspects, the sampling operations of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high-speed sampling in aspects of generator 1100, computation of complex currents flowing through dynamic branches can be achieved, among other things (which in some aspects can be used to achieve the above-described DDS-based waveform shape control) , accurate digital filtering of sampled signals, and calculation of actual power consumption with high precision. The voltage and current feedback data output by ADCs 1780 , 1800 may be received and processed (eg, FIFO buffered, multiplexed) by programmable logic device 1660 and stored in data memory for subsequent retrieval by, eg, DSP processor 1740 . As mentioned above, the voltage and current feedback data can be used as input to an algorithm for pre-distorting or modifying the LUT waveform samples in a dynamically advancing fashion. In certain aspects, when a voltage and current feedback data pair is acquired, this may require that for each stored voltage and The current feedback data pairs are indexed. Synchronizing the LUT samples and the voltage and current feedback data in this manner facilitates accurate timing and stability of the predistortion algorithm.

In certain aspects, the voltage and current feedback data may be used to control the frequency and/or amplitude (eg, current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data may be used to determine impedance phase, such as the phase difference between voltage and current drive signals. The frequency of the drive signal can then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (eg, 0°), thereby minimizing or reducing the effects of harmonic distortion, and accordingly to improve impedance phase measurement accuracy. The determination of the phase impedance and the frequency control signal may be implemented in the processor 1740 , for example, where the frequency control signal is supplied as an input to a DDS control algorithm implemented by the programmable logic device 1660 .

Impedance phase can be determined by Fourier analysis. In one aspect, a Fast Fourier Transform (FFT) or Discrete Fourier Transform (DFT) as follows may be used to determine the difference between the generator voltage _Vg (t) drive signal and the generator current _Ig (t) drive signal The phase difference of:

Evaluating the Fourier transform at sinusoidal frequency yields:

Other methods include weighted least squares estimation, Kalman filtering and space vector based techniques. For example, almost all processing in FFT or DFT techniques can be performed in the digital domain with the aid of eg 2 channel high speed ADCs 1780, 1800. In one technique, digital signal samples of the voltage and current signals are Fourier transformed using an FFT or DFT. The phase angle at any point in time can be calculated by

为相位角，f为频率，t为时间，并且

为在t＝0处的相位。in

is the phase angle, f is the frequency, t is the time, and

is the phase at t=0.

Another technique for determining the phase difference between the voltage _Vg (t) signal and the current _Ig (t) signal is the zero crossing method and yields very accurate results. For the voltage _Vg (t) signal and the current _Ig (t) signal with the same frequency, each negative-to-positive zero crossing of the voltage signal _Vg (t) triggers the start of the pulse, while the current signal _Ig (t) Each negative to positive zero crossing triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the bursts can be passed through an averaging filter to obtain a measure of the phase difference. Also, if positive to negative zero crossings are used in a similar fashion, and the results are averaged, any effects of DC and harmonic components can be reduced. In one implementation, the analog voltage _Vg (t) signal and current _Ig (t) signal are converted to digital signals that are high when the analog signal is positive and high when the analog signal is negative case the digital signal is low. High-accuracy phase estimation requires sharp transitions between high and low values. In one aspect, Schmitt triggers and RC stabilization networks can be used to convert analog signals to digital signals. In other aspects, edge-triggered RS flip-flops and auxiliary circuits may be employed. In yet another aspect, the zero-crossing technique may employ exclusive-or (XOR) gates.

Other techniques for determining the phase difference between voltage and current signals include Lissajous plots and monitoring of images; methods such as the three-voltmeter method, the cross-coil method, the vector voltmeter, and the vector impedance method; and the use of phase standard instruments, locking Phase loops, and "Phase Measurements" as Peter O'Shea, 2000 CRC Press LLC, <http://www.engnetbase.com> (Peter O'Shea, 2000 CRC Press LLC, <http://www. engnetbase.com>), which is incorporated herein by reference.

In another aspect, for example, current feedback data may be monitored to maintain the current magnitude of the drive signal at the current magnitude set point. The current magnitude setpoint may be specified directly or determined indirectly based on specific voltage magnitude and power setpoints. In certain aspects, control of the current magnitude may be accomplished by a control algorithm in the processor 1740, such as, for example, a proportional-integral-derivative (PID) control algorithm. Variables controlled by the control algorithm to appropriately control the current magnitude of the drive signal may include, for example, scaling of LUT waveform samples stored in programmable logic device 1660 and/or DAC 1680 via DAC 1860 (which supplies input to power amplifier 1620 ) of the full-scale output voltage.

The non-isolated stage 1540 may further include a processor 1900 for providing user interface (UI) functions, among other things. In one aspect, processor 1900 may include, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, San Jose, Calif., for example. Examples of UI functions supported by processor 1900 may include audible and visual user feedback, communication with peripheral devices (eg, via a Universal Serial Bus (USB) interface), communication with footswitch 1430, communication with input device 2150 (eg, via a Universal Serial Bus (USB) interface) For example, a touch screen display), and communication with an output device 2140 (eg, a speaker). Processor 1900 may communicate with processor 1740 and programmable logic devices (eg, via a serial peripheral interface (SPI) bus). Although the processor 1900 may primarily support UI functionality, it may also cooperate with the processor 1740 in certain aspects to achieve risk mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and/or other input (eg, touch screen input 2150, foot switch 1430 input, temperature sensor input 2160), and deactivation occurs when an error condition is detected drive output of the device 1100.

In certain aspects, processor 1740 ( FIGS. 26 , 27A ) and processor 1900 ( FIGS. 26 , 27B ) may determine and monitor the operational status of generator 1100 . For the processor 1740, the operational status of the generator 1100 may indicate, for example, which control and/or diagnostic procedures the processor 1740 implements. For the processor 1900, the operational state of the generator 1100 may, for example, indicate which elements of the user interface (eg, display screen, sound) are presented to the user. The processors 1740, 1900 may independently maintain the current operating state of the generator 1100 and identify and evaluate possible transitions to the current operating state. The processor 1740 may act as a subject in this relationship and determine when transitions between operational states will occur. The processor 1900 can notice valid transitions between operating states and can verify whether a particular transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a particular state, processor 1900 can verify that the requested transition is valid. In the event that the processor 1900 determines that the requested transition between states is invalid, the processor 1900 may cause the generator 1100 to enter a fail mode.

The non-isolated stage 1540 may further include a controller 1960 (FIGS. 26, 27B) for monitoring the input device 2150 (eg, capacitive touch sensor, capacitive touch screen for switching the generator 1100 on and off). In certain aspects, controller 1960 may include at least one processor and/or other controller device in communication with processor 1900 . In one aspect, for example, the controller 1960 may include a processor (eg, a Mega168 8-bit controller available from Atmel Corporation (Atemel)) configured to monitor the user input. In one aspect, the controller 1960 may include a touch screen controller (eg, the QT5480 touch screen controller available from Atmel Corporation (Atemel)) to control and manage the acquisition of touch data from the capacitive touch screen.

In certain aspects, when generator 1100 is in a "power off" state, controller 1960 may continue to receive operating power (eg, via a power source from generator 1100, such as power source 2110 (FIG. 26) discussed below) pipeline). In this manner, the controller 1960 may continue to monitor the input device 2150 (eg, a capacitive touch sensor located on the front panel of the generator 1100 ) for turning the generator 1100 on and off. When the generator 1100 is in the "power off" state, if activation of the user "on/off" input device 2150 is detected, the controller 1960 may wake up the power source (eg, enable one or more DCs of the power source 2110) /DC voltage converter 2130 (FIG. 26) operation). The controller 1960 can thus begin a sequence of transitioning the generator 1100 to the "power on" state. Conversely, when the generator 1100 is in the "power on" state, if activation of the "on/off" input device 2150 is detected, the controller 1960 may begin a sequence of transitioning the generator 1100 to the "power off" state. In certain aspects, for example, controller 1960 may report activation of "on/off" input device 2150 to processor 1900, which in turn implements the required sequence of processes to transition generator 1100 to "power off" state. In such aspects, the controller 1960 may not have the independent ability to remove power from the generator 1100 after the "power off" state has been established.

In certain aspects, the controller 1960 may cause the generator 1100 to provide audible or other sensory feedback for alerting the user that a "power on" or "power off" sequence has begun. This alert may be provided at the beginning of a "power on" or "power off" sequence and before other processes associated with the sequence begin.

In certain aspects, isolation stage 1520 may include instrument interface circuitry 1980 for use in, for example, control circuitry of a surgical device (eg, control circuitry including handpiece switches) and components of non-isolation stage 1540 (such as, for example, programmable logic device 1660 ). , processor 1740, and/or processor 1900) to provide a communication interface. Instrument interface circuitry 1980 may exchange information with components of non-isolated stage 1540 via a communication link that maintains an appropriate degree of electrical isolation between stages 1520, 1540, such as, for example, an infrared (IR) based communication link. For example, the instrument interface circuit 1980 may be powered using a low dropout voltage regulator powered by an isolation transformer that is driven from the non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 can include a programmable logic device 2000 in communication with the signal conditioning circuit 2020 (FIGS. 26 and 27C). Signal conditioning circuit 2020 may be configured to receive a periodic signal (eg, a 2 kHz square wave) from programmable logic device 2000 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal can be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent to the surgical device control circuit (eg, by using conductive pairs in a cable connecting the generator 1100 to the surgical device) and monitored to determine the status or configuration of the control circuit. For example, the control circuit may include multiple switches, resistors, and/or diodes to modify one or more characteristics (eg, amplitude, correction) of the interrogation signal such that the control circuit can be uniquely identified based on the one or more characteristics status or configuration. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of the voltage signal present at the input of the control circuit as a result of the interrogation signal passing through the control circuit. Programmable logic device 2000 (or a component of non-isolation stage 1540) can then determine the state or configuration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 can include a first data circuit interface 2040 to implement the programmable logic device 2000 (or other elements of the instrument interface circuit 1980) and be disposed in or otherwise associated with a surgical device information exchange between the first data circuits. In certain aspects, the first data circuit 2060 may be provided in a cable integrally attached to the surgical device handpiece, or in an adapter for interfacing a particular surgical device type or model with the generator 1100, for example. In certain aspects, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read only memory (EEPROM) device. In certain aspects and referring again to FIG. 26, the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and include suitable circuitry (eg, discrete logic devices, processors) to implement programmable logic Communication between the apparatus 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral with the logic device 2000 .

In certain aspects, the first data circuit 2060 can store information associated with an associated particular surgical device. Such information may include, for example, model number, serial number, multiple operations in which the surgical device has been used, and/or any other type of information. This information may be read by the instrument interface circuit 1980 (eg, through the programmable logic device 2000 ), transmitted to the components of the non-isolated stage 1540 (eg, to the programmable logic device 1660 , the processor 1740 , and/or the processor 1900 ) , to be presented to the user via the output device 2140 and/or to control the function or operation of the generator 1100 . Additionally, any type of information may be sent to the first data circuit 2060 via the first data circuit interface 2040 (eg, using the programmable logic device 2000) to be stored therein. Such information may include, for example, an updated number of operations in which the surgical device was used and/or the date and/or time of its use.

As previously discussed, surgical instruments are detachable from the handpiece (eg, instrument 1106 is detachable from handpiece 1107) to facilitate instrument interchangeability and/or disposability. In such situations, the ability of known generators to identify the particular instrument configuration used and optimize control and diagnostic procedures accordingly may be limited. However, solving this problem by adding readable data circuitry to the surgical device instrument is problematic from a compatibility standpoint. For example, designing a surgical device to maintain backward compatibility with generators that lack the requisite data reading capabilities may be impractical due to, for example, different signal schemes, design complexity, and cost. Other aspects of the instrument address these issues by using data circuits that can be implemented economically in existing surgical instruments with minimal design changes to maintain the compatibility of the surgical device with current generator platforms.

Additionally, aspects of generator 1100 may enable communication with instrument-based data circuitry. For example, generator 1100 may be configured to communicate with a second data circuit included in an instrument of the surgical device (eg, instrument 1104, 1106, or 1108). The instrument interface circuit 1980 may include a second data circuit interface 2100 for enabling this communication. In one aspect, the second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces may be used. In some aspects, the second data circuit can generally be any circuit used to transmit and/or receive data. In one aspect, the second data circuit may store information associated with an associated particular surgical instrument. Such information may include, for example, model number, serial number, multiple operations in which the surgical instrument has been used, and/or any other type of information. Additionally or alternatively, any type of information may be sent to the second data circuit via the second data circuit interface 2100 (eg, using the programmable logic device 2000 ) to be stored therein. Such information may include, for example, an updated number of operations in which the surgical instrument was used and/or the date and/or time of its use. In certain aspects, the second data circuit may transmit data collected by one or more sensors (eg, instrument-based temperature sensors). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication (eg, an LED indication or other visual indication) to the user based on the received data.

In certain aspects, the second data circuit and the second data circuit interface 2100 can be configured such that communication between the programmable logic device 2000 and the second data circuit can be achieved without providing additional conductors for this purpose (eg, holding a handheld (dedicated conductor of the cable connected to the generator 1100). In one aspect, for example, the information may be communicated using a single bus communication scheme implemented on existing cables, such as one of the conductors used to transmit the interrogation signal from the signal conditioning circuit 2020 to the control circuit in the handpiece. Information is transmitted to and from the second data circuit. In this manner, design changes or modifications to the surgical device that might otherwise be necessary may be minimized or reduced. Furthermore, the presence of the second data circuit can be "invisible" to generators that do not have the requisite data read capability because different types of communications can be implemented on a common physical channel (with or without band separation) ”, thus enabling backward compatibility of surgical device instruments.

In certain aspects, isolation stage 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to drive signal output 1600b to prevent DC current from flowing to the patient. For example, signal blocking capacitors may be required to comply with medical regulations or standards. Although failures are relatively rare in single capacitor designs, such failures can have negative consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage from the point between the blocking capacitors 2960-1, 2960-2 is detected by, for example, the ADC 2980, to Used to sample the voltage induced by the leakage current. The sample may be received by programmable logic device 2000, for example. Based on the change in leakage current (as indicated by the voltage samples in the aspect of Figure 26), the generator 1100 can determine when at least one of the blocking capacitors 2960-1, 2960-2 has failed. Thus, the aspect of Figure 26 has benefits relative to a single capacitor design with a single point of failure.

In certain aspects, the non-isolated stage 1540 can include a power source 2110 for outputting DC power at the appropriate voltage and current. The power source may include, for example, a 400W power source for outputting a system voltage of 48VDC. As described above, the power source 2110 may further include one or more DC/DC voltage converters 2130 for receiving the output of the power source to generate a DC output at the voltage and current required by the various components of the generator 1100 . As described above in connection with the controller 1960, when the controller 1960 detects that the user activates the "on/off" input device 2150 to enable operation of the DC/DC voltage converter 2130 or to wake up the DC/DC voltage converter 2130, the DC One or more of the /DC voltage converters 2130 may receive input from the controller 1960 .

28A-28B illustrate certain functional and structural aspects of one aspect of generator 1100. Feedback indicative of the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 can be implemented as 2-channel ADCs and can sample the feedback signal at high speed (eg, 80Msps) to allow oversampling of the drive signal (eg, about 200x oversampling). The current and voltage feedback signals may be appropriately conditioned (eg, amplified, filtered) in the analog domain before being processed by the ADCs 1780, 1800. Current and voltage feedback samples from ADCs 1780 , 1800 may be buffered individually and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic device 1660 . 28A-28B, programmable logic device 1660 includes an FPGA.

The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of processor 1740. The PDAP may include a packaging unit for implementing any of a variety of methods for associating multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by programmable logic device 1660 may be stored at one or more memory addresses that are associated or indexed with the LUT address of the LUT sample. In another aspect, feedback samples corresponding to particular LUT samples output by programmable logic device 1660 may be stored at a common memory location along with the LUT addresses of the LUT samples. In any case, the feedback samples can be stored such that the addresses of the LUT samples from which the particular set of feedback samples originated can be subsequently determined. As discussed above, synchronizing the LUT sample addresses and feedback samples in this manner facilitates proper timing and stability of the predistortion algorithm. A direct memory access (DMA) controller implemented at block 2166 of processor 1740 may store feedback samples (and, where applicable, any LUT sample address data) at designated memory locations 2180 (eg, internal RAM) of processor 1740 ).

Block 2200 of processor 1740 may implement a predistortion algorithm for predistorting or modifying LUT samples stored in programmable logic device 1660 on a dynamic-running basis. As described above, the predistortion of the LUT samples can compensate for various sources of distortion present in the output driver circuit of generator 1100 . The predistorted LUT samples, when processed by the drive circuit, will thus give the drive signal the desired waveform shape (eg, sinusoidal shape) to optimally drive the ultrasound transducer.

At block 2220 of the predistortion algorithm, the current through the dynamic branch of the ultrasound transducer is determined. Can be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when appropriately scaled, can represent _Ig and _Vg in the model of FIG. 25 discussed above), ultrasonic transducer static capacitance _C0 The value of , and the known value of the drive frequency, use Kirchhoff's current law to determine the dynamic branch current. Dynamic branch current samples may be determined for each set of stored current and voltage feedback samples associated with the LUT samples.

At block 2240 of the predistortion algorithm, each dynamic branch current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine a difference or sample magnitude error between the compared samples. For this determination, samples of the desired current waveform shape may be supplied, for example, from a waveform shape LUT 2260 that contains amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 for comparison may be determined by the LUT sample address associated with the dynamic branch current sample for comparison. Thus, the input of the motion branch current to block 2240 may be synchronized to the input of its associated LUT sample address to block 2240. Therefore, the number of LUT samples stored in programmable logic device 1660 and the number of LUT samples stored in waveform shape LUT 2260 may be equal. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 may be a substantially sine wave. Other waveform shapes may be desired. For example, it is envisaged that a fundamental sine wave for driving the main longitudinal motion of the ultrasonic transducer superimposed with one or more other drive signals at other frequencies may be used, such as for driving advantageous vibrations for lateral or other modes The third harmonic of at least two mechanical resonances.

Each value of the sample magnitude error determined at block 2240 is transmitted to the LUT of programmable logic device 1660 (shown at block 2280 in Figure 28A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, the value of the sample amplitude error for the same LUT address previously received), the LUT 2280 (or other control block of the programmable logic device 1660) can pre- Distorts or modifies the value of the LUT samples stored at the LUT address such that the sample magnitude error is reduced or minimized. It should be understood that such predistortion or modification of each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the generator's output current matching or conforming to the desired current waveform represented by the samples of the waveform shape LUT2260. shape.

Current and voltage magnitude measurements, power measurements, and impedance measurements may be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored at memory location 2180 . Before these quantities are determined, the feedback samples may be appropriately scaled and, in some aspects, processed through a suitable filter 2320 to remove noise generated by, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the generator's drive output signal. In certain aspects, filter 2320 may be a finite impulse response (FIR) filter applied to the frequency domain. Such aspects may use a Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In some aspects, the resulting spectrum can be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and/or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.

At block 2340 (FIG. 28B), a root mean square (RMS) calculation may be applied to a certain sample size of current feedback samples representing an integer number of cycles of the drive signal to generate a measurement I _rms representing the drive signal output current.

At block 2360, a root mean square (RMS) calculation may be applied to a certain sample size of voltage feedback samples representing an integer number of cycles of the drive signal to determine a measurement _Vrms representing the drive signal output voltage.

At block 2380, the current and voltage feedback samples may be multiplied point by point, and the samples representing an integer number of cycles of the drive signal may be averaged to determine a measure _Pr of the generator's true output power.

At block 2400, _a measure of the apparent output power of the generator, Pa, may be determined as the product V _rms · I _rms .

At block 2420, the measurement of the magnitude of the load resistance, Zm, may be determined as the quotient _{Vrms / Irms} .

In certain aspects, the quantities I _rms , V _rms , Pr , _Pa and Z _m determined at blocks ₂₃₄₀ , 2360 , 2380 , 2400 and 2420 may be used by generator 1100 to implement various control and/or diagnostic procedures any of the. In certain aspects, any of these quantities may be communicated to the user via, for example, output device 2140 integral with generator 1100 or connected to generator 1100 through a suitable communication interface (eg, a USB interface). . For example, various diagnostic procedures may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, proximity instrument overload, frequency lock failure, overcurrent condition, overpower condition, voltage sense failure, Current sensing failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure or blocking capacitor failure.

Block 2440 of processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (eg, an ultrasound transducer) driven by generator 1100 . As described above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (eg, 0°), the effects of harmonic distortion can be minimized or reduced , and the accuracy of the phase measurement increases.

The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before using the feedback samples in the phase control algorithm, the feedback samples may be appropriately scaled and processed in some respects through a suitable filter 2460 (which may be the same as filter 2320) to remove, for example, the data acquisition process and induction the noise generated by the harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the generator's drive output signal.

At block 2480 of the phase control algorithm, the current through the dynamic branch of the ultrasound transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Thus, for each set of stored current and voltage feedback samples associated with the LUT samples, the output of block 2480 may be a dynamic branch current sample.

At block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of the dynamic branch current samples determined at block 2480 and the corresponding voltage feedback samples. In certain aspects, the impedance phase is determined as an average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.

At block 2520 of the phase control algorithm, the impedance phase value determined at block 2220 is compared to the phase setpoint 2540 to determine the difference or phase error between the compared values.

At block 2560 (FIG. 28A) of the phase control algorithm, based on the value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420, a frequency output for controlling the frequency of the drive signal is determined. The value of the frequency output may be continuously adjusted by block 2560 and communicated to DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at the phase set point (eg, zero phase error). In certain aspects, the impedance phase can be adjusted to the 0° phase set point. This way, any harmonic distortion will be centered around the peaks of the voltage waveform, enhancing the accuracy of the phase impedance determination.

Block 2580 of processor 1740 may implement algorithms for modulating the current magnitude of the drive signal to control the drive signal current according to a user-specified set point or according to requirements specified by other processes or algorithms implemented by generator 1100, voltage and power. Control of these quantities may be accomplished, for example, by scaling the LUT samples in LUT 2280 and/or by adjusting the full-scale output voltage of DAC 1680 (which supplies input to power amplifier 1620 ) via DAC 1860 . Block 2600 (which may be implemented as a PID controller in some aspects) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180 . The current feedback samples can be compared to the "current demand" I _d value specified by the controlled variable (eg, current, voltage, or power) to determine whether the drive signal is supplying the necessary current. Where the drive signal current is the controlled variable, the current demand I _d may be directly specified by the current setpoint 2620A(I _sp ). For example, the RMS value of the current feedback data (as determined in block 2340) may be compared to a user-specified RMS current setpoint _Isp to determine appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point _Isp , the LUT scaled and/or full scale output voltage of the DAC 1680 may be adjusted by block 2600 such that the drive signal current is increased. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point _Isp , block 2600 may adjust the LUT scaled and/or full scale output voltage of the DAC 1680 to reduce the drive signal current.

Where the drive signal voltage is the controlled variable, the current demand I _d may be specified indirectly, eg, based on the current required to maintain the desired voltage set point 2620B (V _sp ) given by the load impedance magnitude Z _m measured at block 2420 ( For example, I _d =V _sp /Z _m ). Similarly, where the drive signal power is the control variable, the current demand I _d may be specified indirectly, eg, based on the current required for the desired set point 2620C (P _sp ) given by the voltage V _rms measured at block 2360 (eg, I _d =P _sp /V _rms ).

Block 2680 (FIG. 28A) may implement a DDS control algorithm for controlling the drive signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a numerically controlled oscillator (NCO) algorithm for generating samples of the waveform at a fixed clock rate using a point (memory location)-skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that acts as an address pointer for retrieving LUT samples from LUT 2280. In one aspect, the phase accumulator may be a D-step, modulus N phase accumulator, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 may cause the phase accumulator to sequentially point to each address of the LUT 2280, resulting in a waveform output that replicates the waveform stored in the LUT 2280. When D>1, the phase accumulator can skip addresses in LUT 2280, resulting in a higher frequency waveform output. Therefore, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately changing the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440 . The output of block 2680 may supply the input of DAC 1680, which in turn supplies a corresponding analog signal to the input of power amplifier 1620.

Block 2700 of processor 1740 may implement a switch mode converter control algorithm for dynamically modulating the mains voltage of power amplifier 1620 based on the waveform envelope of the amplified signal, thereby increasing the efficiency of power amplifier 1620. In certain aspects, the characteristics of the waveform envelope may be determined by monitoring one or more signals contained in power amplifier 1620 . In one aspect, the waveform envelope can be characterized, for example, by monitoring the minimum value of the drain voltage (eg, MOSFET drain voltage) modulated according to the envelope of the amplified signal. The minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by ADC 1760, where the output minimum voltage sample is received at block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control the PWM signal output by PWM generator 2760, which in turn controls the mains voltage supplied by switch mode regulator 1700 to power amplifier 1620. In certain aspects, as long as the value of the minimum voltage sample is less than the minimum target 2780 input into block 2720, the mains voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample. For example, block 2740 may result in supplying a low rail voltage to power amplifier 1620 when the minimum voltage sample indicates a low envelope power level, wherein the full rail voltage is supplied only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, block 2740 may keep the mains voltage at a minimum value suitable to ensure proper operation of the power amplifier 1620.

29 is a schematic diagram of one aspect of a circuit 2900 suitable for driving an ultrasound transducer, such as ultrasound transducer 1120, in accordance with at least one aspect of the present disclosure. Circuit 2900 includes analog multiplexer 2980. Analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A such as ultrasound, battery and power control circuits. A current sensor 2982 is coupled in series with the return or ground leg of the power source circuit to measure the current provided by the power source. A field effect transistor (FET) temperature sensor 2984 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically generates a system reset if the main program neglects to periodically maintain it. It is set to automatically reset circuit 2900 when it shuts down or freezes due to software or hardware failure. It should be understood that the circuit 2900 may be configured as an RF driver circuit for driving an ultrasound transducer or for driving an RF electrode such as the circuit 3600 shown in FIG. 36, for example. Thus, referring now back to FIG. 29, circuit 2900 can be used to interchangeably drive both ultrasound transducers and RF electrodes. If driven at the same time, filter circuits may be provided in the corresponding first stage circuits 3404 (FIG. 34) to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned US Patent Publication US-2017-0086910-A1 entitled TECHNIQUES FORCIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated by reference in its entirety. into this article.

The driver circuit 2986 provides left and right ultrasonic energy outputs. A digital signal representing the signal waveform is provided to the SCL-A, SDA-A inputs of the analog multiplexer 2980 from a control circuit such as control circuit 3200 (FIG. 32). A digital to analog converter 2990 (DAC) converts the digital input to an analog output to drive a pulse width modulation (PWM) circuit 2992 coupled to an oscillator 2994. A PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to a first transistor output stage 2998a to drive a first ultrasound (LEFT) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to the second transistor output stage 2998b to drive a second ultrasound (RIGHT) energy output. A voltage sensor 2999 is coupled between the ultrasound LEFT/RIGHT output terminals to measure the output voltage. The driver circuit 2986, the first driver circuit 2996a and the second driver circuit 2996b, and the first transistor output stage 2998a and the second transistor output stage 2998b define a first stage amplifier circuit. In operation, control circuit 3200 (FIG. 32) employs circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and 42) to generate digital waveform 4300 (FIG. 43). The DAC 2990 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

30 is a schematic diagram of a transformer 3000 coupled to the circuit 2900 shown in FIG. 29 in accordance with at least one aspect of the present disclosure. The ultrasonic LEFT/RIGHT input terminal (primary winding) of transformer 3000 is electrically coupled to the ultrasonic LEFT/RIGHT output terminal of circuit 2900 . The secondary winding of transformer 3000 is coupled to positive electrode 3074a and negative electrode 3074b. The positive electrode 3074a and the negative electrode 3074b of the transformer 3000 are coupled to the positive terminal (stack 1) and the negative terminal (stack 2) of the ultrasound transducer. In one aspect, transformer 3000 has a turns ratio n ₁ :n ₂ of 1:50.

31 is a schematic diagram of the transformer 3000 shown in FIG. 30 coupled to a test circuit 3165 in accordance with at least one aspect of the present disclosure. Test circuit 3165 is coupled to positive electrode 3074a and negative electrode 3074b. Switch 3167 is placed in series with an inductor/capacitor/resistor (LCR) load that simulates the load of the ultrasound transducer.

32 is a schematic diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery pack. The battery pack is an energy source for various local power sources 3215. The control circuit includes a main processor 3214, which is coupled to various downstream circuit. ^In one aspect, the interface host 3218 is a general purpose serial interface, such as an I2C serial interface. The main processor 3214 is further configured to drive switches 3224 through general purpose input/output (GPIO) 3220, a display 3226 (eg, and an LCD display) and various indicators 3228 through GPIO 3222. The watchdog processor 3216 is arranged to control the main processor 3214. A switch 3230 is placed in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

In one aspect, main processor 3214 is coupled to circuit 2900 (FIG. 29) through output terminals SCL-A, SDA-A. The main processor 3214 includes memory for storing, for example, a table of digitized drive signals or waveforms that are transmitted to the circuit 2900 to drive the ultrasound transducer 1120. In other aspects, the main processor 3214 may generate and transmit the digital waveform to the circuit 2900, or may store the digital waveform for later transmission to the circuit 2900. The main processor 3214 can also provide RF drive through output terminals SCL-B, SDA-B, and can provide various sensors (eg, Hall effect sensors, magnetorheological fluid (MRF) through output terminals SCL-C, SDA-C ) sensors, etc.). In one aspect, the main processor 3214 is configured to sense the presence of ultrasound drive circuitry and/or RF drive circuitry to enable appropriate software and user interface functions.

软件的内部只读存储器(ROM)、2KB的电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QED模拟、具有12个模拟输入信道的一个或多个12位模数转换器(ADC)、以及易得的其它特征件。可很方便地换用其它处理器，因此，本公开不应限于这一上下文。In one aspect, the main processor 3214 may be, for example, a LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) of on-chip memory, A prefetch buffer designed to improve performance over 40MHz, 32KB of single-cycle serial random access memory (SRAM), loaded with

Internal read-only memory (ROM) for software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QED analog, One or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, as well as other features readily available. Other processors may be readily interchanged and, therefore, the present disclosure should not be limited in this context.

33 shows a simplified circuit block diagram showing another circuit 3300 contained within a modular ultrasonic surgical instrument 3334 in accordance with at least one aspect of the present disclosure. The circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (eg, a battery), a switch 3306 (such as a metal oxide semiconductor field effect transistor (MOSFET) power switch), a driver circuit 3308 (PLL), a transformer 3310, Signal smoothing circuit 3312 (also known as a matching circuit, and may be, for example, a tank circuit), sensing circuit 3314, transducer 1120, and shaft assemblies (eg, shaft assemblies 1126, 1129), which are included herein Ultrasonic transmission waveguides terminated at the ultrasonic blades (eg, ultrasonic blades 1128, 1149), which may be referred to simply as waveguides.

A feature of the present disclosure that cuts off the dependence on high voltage (120 VAC) input power (a characteristic of ultrasonic cutting devices in general) is to utilize low voltage switches during the entire wave formation process and amplify the drive signal only directly before the transformer stage. Thus, in one aspect of the present disclosure, power is derived from only one battery or set of batteries that is small enough to fit within the handle assembly. State-of-the-art battery technology provides high-power batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasound device, a reduction in manufacturing cost can be achieved.

The output of power source 3304 is fed to and powers processor 3302. The processor 3302 receives and outputs signals, and as will be described below, the processor 3302 operates according to custom logic or according to a computer program executed by the processor 3302. As mentioned above, the circuit 3300 may also include a memory 3326, preferably including random access memory (RAM), which stores computer readable instructions and data.

The output of power source 3304 is also directed to switch 3306 having a duty cycle controlled by processor 3302. By controlling the on-time of switch 3306, processor 3302 can specify the total amount of power ultimately delivered to transducer 1120. In one aspect, switch 3306 is a MOSFET, but other switches and switch configurations are also adaptable. The output of switch 3306 is fed to drive circuit 3308, which includes, for example, a phase detection phase locked loop (PLL) and/or a low pass filter and/or a voltage controlled oscillator. The output of switch 3306 is sampled by processor 3302 to determine the voltage and current (V _IN and I _IN ) of the output signal, respectively. These values are used in a feedback architecture to adjust the pulse width modulation of switch 3306. For example, the duty cycle of switch 3306 may vary from about 20% to about 80%, depending on the desired and actual output from switch 3306 .

The driver circuit 3308, which receives the signal from the switch 3306, includes an oscillator circuit (VCO) that converts the output of the switch 3306 into an electrical signal having an ultrasonic frequency (eg, 55 kHz). As described above, this ultrasonically shaped smoothed version is ultimately fed to the ultrasonic transducer 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.

The output of the driver circuit 3308 is a transformer 3310 capable of boosting one or more low voltage signals to higher voltages. It should be noted that the upstream switching before the transformer 3310 is performed at low (eg, battery driven) voltages, which has not been possible so far with ultrasonic cutting and cauterizing devices. This is due, at least in part, to the fact that the device advantageously uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices, and allow higher currents to pass. Therefore, the switching stage (pre-transformer) can be characterized as low voltage/high current. In order to ensure a low on-resistance of the amplifier MOSFET(s), the MOSFET(s) are operated at eg 10V. In this case, a separate 10VDC power source can be used to power the MOSFET gate, which ensures that the MOSFET is fully turned on and achieves a fairly low on-resistance. In one aspect of the present disclosure, transformer 3310 steps up the battery voltage to 120V root mean square (RMS). Transformers are known in the art and therefore are not described in detail herein.

In such circuit configurations, circuit component degradation can negatively affect the circuit performance of the circuit. One factor that directly affects component performance is heat. Known circuits typically monitor switching temperature (eg, MOSFET temperature). However, due to technological advancements in MOSFET design and corresponding size reductions, MOSFET temperature is no longer a valid indicator of circuit load and heat. Thus, in accordance with at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because the transformer 3310 operates at or very close to its maximum temperature during device use. The additional temperature will cause the core material (eg, ferrite) to crack and permanent damage can occur. The present disclosure may respond to the maximum temperature of the transformer 3310 by, for example, reducing the drive power in the transformer 3310, signaling to the user, turning off the power, pulsing the power, or other suitable response.

In one aspect of the present disclosure, the processor 3302 is communicatively coupled to an end effector (eg, 1122, 1125) for placing material in physical contact with the ultrasonic blade (eg, 1128, 1149). A sensor is provided that measures a gripping force value (existing within a known range) at the end effector, and based on the received gripping force value, the processor 3302 varies the dynamic voltage _VM . Since a high force value in combination with a set rate of motion can result in a high blade temperature, a temperature sensor 3332 is communicatively coupled to the processor 3302 , wherein the processor 3302 is operable to receive and interpret the current temperature of the blade indicative of the temperature sensor 3336 signal and determine the target frequency of knife motion based on the received temperature. In another aspect, a force sensor such as a strain sensor or a pressure sensor can be coupled to the trigger (eg, 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor such as a strain sensor or a pressure sensor may be coupled to the switch button such that the magnitude of the displacement corresponds to the force applied by the user to the switch button.

In accordance with at least one aspect of the present disclosure, the PLL portion of the driver circuit 3308 coupled to the processor 3302 can determine and communicate the frequency of the waveguide motion to the processor 3302. The processor 3302 stores the frequency value in the memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time after the device was turned off, and if the elapsed time is less than a predetermined value, retrieve the last waveguide motion frequency. The unit can then start up at the previous frequency, which is presumably the optimum frequency for the current load.

Modular battery powered handheld surgical instrument with multistage generator circuit

In another aspect, the present disclosure provides a modular battery powered handheld surgical instrument having a multi-stage generator circuit. A surgical instrument is disclosed that includes a battery assembly, a handle assembly, and a shaft assembly, wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first stage circuit configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second stage circuit coupled to the first stage circuit to receive, amplify, and apply the analog waveform to a load.

In one aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including a control circuit including the battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly including a first stage circuit coupled to a processor, the first stage circuit including a digital-to-analog (DAC) converter and a first stage amplifier circuit, wherein the DAC is configured to receive the digital waveform and converting the digital waveform to an analog waveform, wherein the first stage amplifier circuit is configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the first stage amplifier circuit to The analog waveform is received, the analog waveform is amplified, and the analog waveform is applied to a load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.

The load may include any one of, or any combination of, ultrasonic transducers, electrodes, or sensors. The first stage circuit may include a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit may be configured to drive the first stage ultrasound drive circuit and the first stage high frequency current drive circuit independently or simultaneously. The first stage ultrasound drive circuit may be configured to be coupled to the second stage ultrasound drive circuit. The second stage ultrasound driver circuit may be configured to be coupled to the ultrasound transducer. The first stage high frequency current drive circuit may be configured to be coupled to the second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to be coupled to the electrodes.

The first stage circuit may include a first stage sensor driver circuit. The first stage sensor driver circuit may be configured as a second stage sensor driver circuit. The second stage sensor driver circuit may be configured to be coupled to the sensor.

In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including a control circuit including the battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured To generate a digital waveform; a handle assembly including a common first stage circuit coupled to a processor, the common first stage circuit including a digital-to-analog (DAC) converter and a common first stage amplifier circuit, wherein the DAC is configured to receive and convert the digital waveform to an analog waveform, wherein the common first stage amplifier circuit is configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to A common first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.

The load may include any one of, or any combination of, ultrasonic transducers, electrodes, or sensors. The common first stage circuit may be configured to drive ultrasound, high frequency current or sensor circuits. The common first stage driver circuit may be configured to be coupled to the second stage ultrasound driver circuit, the second stage high frequency driver circuit, or the second stage transducer driver circuit. The second stage ultrasound drive circuit may be configured to be coupled to the ultrasound transducer, the second stage high frequency drive circuit may be configured to be coupled to the electrodes, and the second stage sensor drive circuit may be configured to be coupled to the sensor.

In another aspect, the present disclosure provides a surgical instrument comprising a control circuit comprising a memory coupled to a processor, wherein the processor is configured to generate a digital waveform; a handle assembly comprising a common first stage circuit coupled to the processor, the common first stage circuit configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; and a shaft assembly including a second stage circuit, The second stage circuit is coupled to a common first stage circuit to receive and amplify the analog waveform; wherein the shaft assembly is configured to be mechanically and electrically connected to the handle assembly.

The common first stage circuit may be configured to drive ultrasound, high frequency current or sensor circuits. The common first stage driver circuit may be configured to be coupled to the second stage ultrasound driver circuit, the second stage high frequency driver circuit, or the second stage transducer driver circuit. The second stage ultrasound drive circuit may be configured to be coupled to the ultrasound transducer, the second stage high frequency drive circuit may be configured to be coupled to the electrodes, and the second stage sensor drive circuit may be configured to be coupled to the sensor.

34 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3400 divided into multiple stages. For example, the surgical instrument of surgical system 1000 may include generator circuit 3400 divided into at least two circuits: a first that implements RF energy operation only, ultrasonic energy operation only, and/or a combination of RF energy operation and ultrasonic energy operation Stage circuit 3404 and second stage circuit 3406. The combined modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integrally formed with the modular shaft assembly 3414 . As previously discussed throughout this specification in connection with the surgical instruments of surgical system 1000 , battery assembly 3410 and shaft assembly 3414 are configured to be mechanically and electrically connected to handle assembly 3412 . The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3414.

Turning now to FIG. 34, the generator circuit 3400 is divided into stages located in a plurality of modular assemblies of a surgical instrument, such as the surgical instrument of the surgical system 1000 described herein. In one aspect, the control stage circuit 3402 may be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is the control circuit 3200 as described in connection with FIG. 32 . The control circuit 3200 includes a processor 3214 that includes an internal memory 3217 ( FIG. 34 ) (eg, volatile and non-volatile memory), and is electrically coupled to a battery 3211 . The battery 3211 supplies power to the first stage circuit 3404, the second stage circuit 3406 and the third stage circuit 3408, respectively. As previously described, the control circuit 3200 uses the circuits and techniques described in connection with FIGS. 41 and 42 to generate the digital waveform 4300 (FIG. 43). Returning to FIG. 34, the digital waveform 4300 can be configured to independently or simultaneously drive ultrasound transducers, high frequency (eg, RF) electrodes, or a combination thereof. If driven at the same time, filter circuits may be provided in the corresponding first stage circuits 3404 to select the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned US Patent Publication US-2017-0086910-A1 entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated by reference in its entirety. into this article.

First stage circuits 3404 (eg, first stage ultrasound drive circuit 3420, first stage RF drive circuit 3422, and first stage sensor drive circuit 3424) are located in the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides the ultrasonic driving signal to the first stage ultrasonic driving circuit 3420 via the outputs SCL-A and SDA-A of the control circuit 3200 . The first stage ultrasound driver circuit 3420 is described in detail in conjunction with FIG. 29 . Control circuit 3200 provides RF drive signals to first stage RF drive circuit 3422 via outputs SCL-B, SDA-B of control circuit 3200 . The first stage RF driver circuit 3422 is described in detail in conjunction with FIG. 36 . The control circuit 3200 provides sensor drive signals to the first stage sensor drive circuit 3424 via the outputs SCL-C, SDA-C of the control circuit 3200 . Generally speaking, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuits 3406 . The output of the first stage circuit 3404 is provided to the input 3406 of the second stage circuit.

The control circuit 3200 is configured to detect which modules are inserted into the control circuit 3200 . For example, the control circuit 3200 is configured to detect whether the first stage ultrasound driver circuit 3420 , the first stage RF driver circuit 3422 , or the first stage sensor driver circuit 3424 located in the handle assembly 3412 is connected to the battery assembly 3410 . Likewise, each of the first stage circuits 3404 can detect which second stage circuits 3406 are connected to it, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to generate. Similarly, each of the second stage circuits 3406 can detect which third stage circuit 3408 or components are connected to it, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to generate.

In one aspect, the second stage circuits 3406 (eg, the ultrasonic drive second stage circuit 3430, the RF drive second stage circuit 3432, and the sensor drive second stage circuit 3434) are located in the shaft assembly 3414 of the surgical instrument. The first stage ultrasound drive circuit 3420 provides signals to the second stage ultrasound drive circuit 3430 via the outputs US-Left/US-Right. The second stage ultrasonic drive circuit 3430 is described in detail in conjunction with FIGS. 30 and 31 . In addition to the transformer (FIGS. 30 and 31), the second stage ultrasound drive circuit 3430 may also include filters, amplifiers, and signal conditioning circuits. The first stage high frequency (RF) current driver circuit 3422 provides a signal to the second stage RF driver circuit 3432 via the outputs RF-Left/RF-Right. In addition to the transformer and blocking capacitors, the second stage RF driver circuit 3432 may include filters, amplifiers, and signal conditioning circuits. The first stage sensor driver circuit 3424 provides signals to the second stage sensor driver circuit 3434 via outputs Sensor-1/Sensor-2. Depending on the type of sensor, the second stage sensor driver circuit 3434 may include filters, amplifiers, and signal conditioning circuits. The output of the second stage circuit 3406 is provided to the input of the third stage circuit 3408 .

In one aspect, tertiary circuitry 3408 (eg, ultrasound transducer 1120, RF electrodes 3074a, 3074b, and sensor 3440) may be located in various components 3416 of the surgical instrument. In one aspect, the second stage ultrasound drive circuit 3430 provides a drive signal to the ultrasound transducer 1120 piezoelectric stack. In one aspect, the ultrasonic transducer 1120 is located in an ultrasonic transducer assembly of a surgical instrument. However, in other aspects, the ultrasonic transducer 1120 may be located in the handle assembly 3412, the shaft assembly 3414, or the end effector. In one aspect, the second stage RF drive circuit 3432 provides drive signals to RF electrodes 3074a, 3074b typically located in the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides drive signals to various sensors 3440 located throughout the surgical instrument.

35 illustrates a generator circuit 3500 divided into multiple stages, wherein a first stage circuit 3504 is common to a second stage circuit 3506 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into multiple stages. For example, the surgical instrument of surgical system 1000 may include generator circuit 3500 that is divided into at least two circuits: one that implements high frequency (RF) energy operation only, that implements only ultrasonic energy operation, and/or that implements both RF energy operation and ultrasonic energy operation. Combined first stage amplifier circuit 3504 and second stage amplifier circuit 3506. The combined modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integrally formed with the modular shaft assembly 3514. As previously discussed throughout this specification in connection with the surgical instruments of surgical system 1000 , battery assembly 3510 and shaft assembly 3514 are configured to be mechanically and electrically connected to handle assembly 3512 . The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3514.

As shown in the example of FIG. 35, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 previously described. The handle assembly 3512 connected to the battery assembly 3510 includes a common first stage driver circuit 3420. As previously mentioned, the first stage driver circuit 3420 is configured to drive ultrasound, high frequency (RF) current and sensor loads. The output of the common first stage driver circuit 3420 can drive any of the second stage circuits 3506, such as the second stage ultrasound driver circuit 3430, the second stage high frequency (RF) current drive circuit 3432, and/or the second stage sensor Driver circuit 3434. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage driver circuit 3420 detects which second stage circuit 3506 is located in the shaft assembly 3514. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage driver circuit 3420 determines which of the second stage circuits 3506 (eg, second stage ultrasound driver circuit 3430, second stage RF driver circuit 3432, and/or or a second stage sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 to provide the appropriate digital waveform 4300 (FIG. 43) to the second stage circuit 3506 to drive the appropriate load, such as ultrasonic, RF or transducer. It should be appreciated that the identification circuit may be included in various components 3516 in the tertiary circuit 3508, such as the ultrasound transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Therefore, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

36 is a schematic diagram of one aspect of a circuit 3600 configured to drive a high frequency current (RF) in accordance with at least one aspect of the present disclosure. Circuit 3600 includes analog multiplexer 3680 . Analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A such as RF, battery and power control circuits. A current sensor 3682 is coupled in series with the return or ground leg of the power source circuit to measure the current provided by the power source. A field effect transistor (FET) temperature sensor 3684 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program neglects to periodically maintain it. It is set to automatically reset circuit 3600 when it shuts down or freezes due to software or hardware failure. It should be appreciated that, for example, the circuit 3600 may be configured for driving RF electrodes or for driving the ultrasound transducer 1120 as described in connection with FIG. 29 . Thus, referring now back to FIG. 36, circuit 3600 can be used to interchangeably drive both ultrasound electrodes and RF electrodes.

The driver circuit 3686 provides the Left RF energy output and the Right RF energy output. Digital signals representing signal waveforms are provided to the SCL-A, SDA-A inputs of analog multiplexer 3680 from a control circuit such as control circuit 3200 (FIG. 32). A digital to analog converter 3690 (DAC) converts the digital input to an analog output to drive a pulse width modulation (PWM) circuit 3692 coupled to an oscillator 3694. The PWM circuit 3692 provides a first gate drive circuit 3696a coupled to the first transistor output stage 3698a to drive the first RF+(Left) energy output. The PWM circuit 3692 also provides a second gate drive circuit 3696b coupled to the second transistor output stage 3698b to drive a second RF-(Right) energy output. A voltage sensor 3699 is coupled between the RFLeft/RF output terminals to measure the output voltage. The driver circuit 3686, the first driver circuit 3696a and the second driver circuit 3696b, and the first transistor output stage 3698a and the second transistor output stage 3698b define a first stage amplifier circuit. In operation, control circuit 3200 (FIG. 32) employs circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and 42) to generate digital waveform 4300 (FIG. 43). The DAC 3690 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

37 is a schematic diagram of a transformer 3700 coupled to the circuit 3600 shown in FIG. 36 in accordance with at least one aspect of the present disclosure. The RF+/RF input terminal (primary winding) of transformer 3700 is electrically coupled to the RFLeft/RF output terminal of circuit 3600. One side of the secondary winding is coupled in series with the first blocking capacitor 3706 and the second blocking capacitor 3708 . A second latch capacitor is coupled to the second stage RF driver circuit 3774a positive terminal. The other side of the secondary winding is coupled to the second stage RF driver circuit 3774b negative terminal. The second stage RF driver circuit 3774a positive output is coupled to the ultrasonic blade, and the second stage RF driver circuit negative ground terminal 3774b is coupled to the outer tube. In one aspect, the transformer has a turns ratio n ₁ :n ₂ of 1:50.

38 is a schematic diagram of a circuit 3800 that includes separate power sources for high power energy/drive circuits and low power circuits in accordance with at least one aspect of the present disclosure. The power source 3812 includes a primary battery pack including a first main battery 3815 and a second main battery 3817 (eg, a lithium ion battery) connected to the circuit 3800 through a switch 3818, and a secondary battery pack, the secondary battery The battery pack includes a secondary battery 3820 that is connected to the circuit through a switch 3823 when the power source 3812 is inserted into the battery pack. Secondary battery 3820 is a drop-resistant battery with component parts that are resistant to gamma or other radiation sterilization. For example, a switched mode power source 3827 and optional charging circuitry within the battery pack can be incorporated to allow the secondary battery 3820 to reduce the voltage sag of the primary cells 3815, 3817. This ensures a fully charged unit that is easy to introduce into the sterile field at the outset of surgery. Primary batteries 3815, 3817 can be used to directly power motor control circuit 3826 and energy circuit 3832. Motor control circuit 3826 is configured to control a motor, such as motor 3829 . Power source/battery pack 3812 may include a dual-type battery assembly including primary Li-ion cells 3815, 3817 and secondary NiMH cells 3820 with dedicated energy cells 3820 to control handle electronics 3830 from dedicated power cells 3815, 3817 to run motor control circuit 3826 and energy circuit 3832. In this case, as the primary batteries 3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 descend, the circuit 3810 is pulled from the secondary battery 3820 involved in the driving handle electronics 3830. In one aspect, the circuit 3810 can include a unidirectional diode that will not allow current to flow in the opposite direction (eg, from a battery involved in driving the energy circuit and/or motor control circuit to a motor control circuit involving the driving electronics circuit) ).

Additionally, a gamma friendly charging circuit may be provided that includes a switch mode power source 3827 that uses diode and vacuum tube components to minimize voltage sag at predetermined levels. Switch-mode power source 3827 can be eliminated with a minimum voltage drop that includes separation of the NiMH voltage (3 NiMH cells). Additionally, a modular system may be provided in which the radiation hardening components are located in the module so that the module can be sterilized by radiation sterilization. Other non-radiation hardening components may be included in other modular components and connections made between modular components such that the component parts operate together as if the components were located together on the same circuit board. If only two NiMH cells are desired, the diode and vacuum tube based switch mode power source 3827 allows for sterilizable electronics within the disposable primary battery pack.

Turning now to FIG. 39, a control circuit 3900 for operating a battery 3901 powered RF generator circuit 3902 for use with a surgical instrument is shown in accordance with at least one aspect of the present disclosure. The surgical instrument is configured to surgically coagulate/cut the living tissue using both ultrasonic vibration and high frequency current, and to surgically coagulate the living tissue using the high frequency current.

FIG. 39 shows a control circuit 3900 that allows a dual generator system to switch between the RF generator circuit 3902 mode and the ultrasonic generator circuit 3920 mode of the surgical instrument of the surgical system 1000 . In one aspect, a current threshold in the RF signal is detected. When the impedance of the tissue is low, the high frequency current through the tissue is high when RF energy is used as the source of treatment for the tissue. According to one aspect, a visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 can be configured to be on during the high current period. When the current is below the threshold, the visual indicator 3912 is in an off state. Accordingly, the phototransistor 3914 can be configured to detect the transition from the on state to the off state and dissociate the RF energy, as shown in the control circuit 3900 shown in FIG. 39 . Thus, when the energy button is released and the energy switch 3926 is turned on, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are kept switched off.

Referring to FIG. 39, in one aspect, a method of managing an RF generator circuit 3902 and an ultrasonic generator circuit 3920 is provided. RF generator circuit 3902 and/or ultrasonic generator circuit 3920 may be located, for example, in handle assembly 1109, ultrasonic transducer/RF generator assembly 1120, battery assembly, shaft assembly 1129, and/or nozzle of multifunction electrosurgical instrument 1108 . If the energy switch 3926 is turned off (eg, open), the control circuit 3900 remains in the reset state. Thus, when the energy switch 3926 is turned on, the control circuit 3900 is reset, and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are turned off. When the energy switch 3926 is squeezed and the energy switch 3926 is engaged (eg, closed), RF energy is delivered to the tissue, and the visual indicator 3912 operated by the current sensing step-up transformer 3904 will illuminate when the tissue impedance is low . The light from the visual indicator 3912 provides a logic signal to keep the ultrasonic generator circuit 3920 in an off state. Once the tissue impedance increases above the threshold and the high frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to an off state. The logic signal generated by this transition closes the relay 3908, thereby closing the RF generator circuit 3902 and opening the ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.

Still referring to FIG. 39, in one aspect, a dual generator circuit configuration employs an onboard RF generator circuit 3902 powered by a battery 3901 for one modality, and employs a second, onboard ultrasonic generator circuit 3920, the ultrasonic generator circuit The 3920 may be onboard the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or ultrasonic transducer/RF generator assembly 1120 of the multifunction electrosurgical instrument 1108. The ultrasonic generator circuit 3920 is also battery 3901 operated. In various aspects, the RF generator circuit 3902 and the ultrasonic generator circuit 3920 may be integral components of the handle assembly 1109 or separable components. According to various aspects, having dual RF generator circuits 3902/ultrasonic generator circuits 3920 as part of handle assembly 1109 may eliminate the need for complex wiring. The RF generator circuit 3902/ultrasonic generator circuit 3920 can be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of cordless generator systems.

Either type of system may have independent controls for modalities that do not communicate with each other. Surgeons activate RF and ultrasound separately and at their discretion. Another approach would be to provide a fully integrated communication scheme that shares buttons, tissue status, instrument operating parameters (such as jaw closure, force, etc.) and algorithms for managing tissue processing. Various combinations of this integration can be implemented to provide appropriate levels of functionality and performance.

As described above, in one aspect, the control circuit 3900 includes a battery 3901 powered RF generator circuit 3902 that includes the battery as an energy source. As shown, RF generator circuit 3902 is coupled to two conductive surfaces, referred to herein as electrodes 3906a, 3906b (ie, active electrode 3906a and return electrode 3906b), and is configured to use RF energy (eg, high frequency current ) drive electrodes 3906a, 3906b. The first winding 3910a of the step-up transformer 3904 is connected in series with one pole of the bipolar RF generator circuit 3902 and the return electrode 3906b. In one aspect, the first winding 3910a and return electrode 3906b are connected to the negative terminal of the bipolar RF generator circuit 3902. The other pole of the bipolar RF generator circuit 3902 is connected to the active electrode 3906a through the switch contact 3909 of the relay 3908, or any suitable electromagnetic switching device including an armature which is moved by the electromagnet 3936 to operate the switch contact Point 3909. When the electromagnet 3936 is energized, the switch contacts 3909 are closed, and when the electromagnet 3936 is de-energized, the switch contacts 3909 are open. When the switch contacts are closed, RF current flows through conductive tissue (not shown) located between electrodes 3906a, 3906b. It will be appreciated that, in one aspect, the active electrode 3906a is connected to the positive pole of the bipolar RF generator circuit 3902.

Visual indicator circuit 3905 includes step-up transformer 3904, series resistor R2, and visual indicator 3912. Visual indicator 3912 may be adapted for use with surgical instrument 1108 and other electrosurgical systems and tools, such as those described herein. The first winding 3910a of the step-up transformer 3904 is connected in series with the return electrode 3906b, and the second winding 3910b of the step-up transformer 3904 is connected in series with the resistor R2, and the visual indicator 3912 includes, for example, a NE-2 type neon bulb.

In operation, when the switch contact 3909 of the relay 3908 is open, the active electrode 3906a is disconnected from the positive terminal of the bipolar RF generator circuit 3902 and no current flows through the tissue, return electrode 3906b and the first terminal of the step-up transformer 3904. A winding 3910a. Therefore, the visual indicator 3912 is not powered and does not emit light. When the switch contact 3909 of the relay 3908 is closed, the active electrode 3906a is connected to the anode of the bipolar RF generator circuit 3902, enabling current to flow through the tissue, the return electrode 3906b and the first winding 3910a of the step-up transformer 3904 to Tissue manipulations such as cutting and cauterizing tissue.

As a function of the impedance of the tissue between the active electrode 3906a and the return electrode 3906b, a first current flows through the first winding 3910a, thereby providing a first voltage across the first winding 3910a of the step-up transformer 3904. The boosted second voltage is induced on the second winding 3910b of the step-up transformer 3904. The secondary voltage appears across resistor R2 and energizes the visual indicator 3912 when the current through the tissue is greater than a predetermined threshold, illuminating the neon bulb. It should be understood that the circuit and component values are exemplary and not limiting. When the switch contacts 3909 of the relay 3908 are closed, current flows through the tissue and the visual indicator 3912 is turned on.

输出变高并且被施加到与门3932的另一个输入。Turning now to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, a logic high is applied to the input of the first inverter 3928 and a logic low is applied to one of the two inputs of the AND gate 3932 One. Therefore, the output of AND gate 3932 is low and transistor 3934 is turned off to prevent current flow through the windings of electromagnet 3936. When the electromagnet 3936 is de-energized, the switch contacts 3909 of the relay 3908 remain open and prevent current flow through the electrodes 3906a, 3906b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, causing the output to go high and resetting the flip-flop 3918 (eg, D-type flip-flop). At this point, the Q output is driven low to turn off the ultrasonic generator circuit 3920 and

The output goes high and is applied to the other input of AND gate 3932.

When the user presses the energy switch 3926 on the instrument handle to apply energy to the tissue between the electrodes 3906a, 3906b, the energy switch 3926 closes and applies a logic low at the input of the first inverter 3928, which inverts Inverter 3928 applies a logic high to the other inputs of AND gate 3932, causing the output of AND gate 3932 to go high and turn on transistor 3934. In the on state, the transistor 3934 conducts and sinks current flowing through the windings of the electromagnet 3936 to energize the electromagnet 3936 and close the switch contacts 3909 of the relay 3908. As described above, when the switch contact 3909 is closed, current can flow through the electrodes 3906a, 3906b and the first winding 3910a of the step-up transformer 3904 when tissue is between the electrodes 3906a, 3906b.

输出，并且Q输出保持低，且

输出保持高。因此，当视觉指示器3912保持通电时，超声发生器电路3920被关闭，并且多功能电外科器械的超声换能器3922和超声刀3924未被激活。As described above, the magnitude of the current flowing through the electrodes 3906a, 3906b depends on the impedance of the tissue located between the electrodes 3906a, 3906b. Initially, the tissue impedance is low, and the magnitude of the current through the tissue and the first winding 3910a is high. Therefore, the voltage applied to the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by the visual indicator 3912 turns on the phototransistor 3914, which pulls the input of the inverter 3916 low and causes the output of the inverter 3916 to go high. The high input of CLK applied to flip-flop 3918 does not affect the Q of flip-flop 3918 or

output, and the Q output remains low, and

output remains high. Thus, when the visual indicator 3912 remains energized, the ultrasonic generator circuit 3920 is turned off, and the ultrasonic transducer 3922 and ultrasonic blade 3924 of the multifunctional electrosurgical instrument are not activated.

输出的逻辑低计时。在Q输出处的逻辑高接通超声发生器电路3920以激活超声换能器3922和超声刀3924，从而开始切割位于电极3906a、3906a之间的组织。其同时或接近同时与超声发生器电路3920接通，

输出触发器3918变低并且使与门3932的输出变低并且关闭晶体管3934，从而使电磁铁3936断电并打开继电器3908的开关触点3909以切断流经电极3906a、3906b的电流。When the tissue between the electrodes 3906a, 3906b dries, the impedance of the tissue increases and the current through the tissue decreases due to the heat generated by the current flowing through the tissue. As the current through the first winding 3910a decreases, the voltage on the second winding 3910b also decreases, and when the voltage falls below the minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and phototransistor 3914 turn off . When phototransistor 3914 is off, a logic high is applied to the input of inverter 3916 and a logic low is applied to the CLK input of flip-flop 3918 for a logic high to the Q output and to

Logic low timing of the output. A logic high at the Q output turns on the ultrasonic generator circuit 3920 to activate the ultrasonic transducer 3922 and the ultrasonic blade 3924 to begin cutting the tissue between the electrodes 3906a, 3906a. It is connected to the ultrasonic generator circuit 3920 at or near the same time,

Output flip-flop 3918 goes low and causes the output of AND gate 3932 to go low and turns off transistor 3934, de-energizing electromagnet 3936 and opening switch contact 3909 of relay 3908 to cut current through electrodes 3906a, 3906b.

When the switch contact 3909 of the relay 3908 is open, no current flows through the electrodes 3906a, 3906b, the tissue and the first winding 3910a of the step-up transformer 3904. Therefore, no voltage is developed on the second winding 3910b and no current flows through the visual indicator 3912.

输出保持相同。因此，当无电流从双极RF发生器电路3902流过电极3906a、3906b时，超声刀3924保持激活并继续切割端部执行器的钳口之间的组织。当用户释放器械柄部上的能量开关3926时，能量开关3926打开并且第一逆变器3928的输出变低，并且第二逆变器3930的输出变高以复位触发器3918，从而使Q输出变低并关闭超声发生器电路3920。与此同时，

输出变高并且电路现在处于断开状态并且准备好被用户致动器械柄部上的能量开关3926以关闭能量开关3926、将电流施加到位于电极3906a、3906b之间的组织，并重复如上所述的施加RF能量和超声能量到组织的循环。When the user squeezes the energy switch 3926 on the instrument handle to keep the energy switch 3926 closed, the Q output of the trigger 3918 and

The output remains the same. Thus, when no current flows from the bipolar RF generator circuit 3902 through the electrodes 3906a, 3906b, the ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 on the handle of the instrument, the energy switch 3926 opens and the output of the first inverter 3928 goes low and the output of the second inverter 3930 goes high to reset the flip-flop 3918, causing the Q output Go low and turn off ultrasonic generator circuit 3920. at the same time,

The output goes high and the circuit is now open and ready for the user to actuate the energy switch 3926 on the instrument handle to close the energy switch 3926, apply current to the tissue between the electrodes 3906a, 3906b, and repeat as described above The cycle of applying RF energy and ultrasonic energy to tissue.

40 shows an illustration of a surgical system 4000 representing one aspect of the surgical system 1000 including a feedback system for use with any of the surgical instruments of the surgical system 1000, which may include Or implement many of the features described herein. Surgical system 4000 can include a generator 4002 coupled to a surgical instrument that includes an end effector 4006 that can be activated when a clinician operates a trigger 4010. In various aspects, the end effector 4006 can include an ultrasonic blade to deliver ultrasonic vibrations for surgical coagulation/cutting of living tissue. In other aspects, the end effector 4006 can include conductive elements coupled to a source of electrosurgical high frequency current for surgical coagulation or cautery of living tissue, and a mechanical knife with sharp edges or for cutting of living tissue Ultrasound knife. When the trigger 4010 is actuated, the force sensor 4012 may generate a signal indicative of the amount of force applied to the trigger 4010 . In addition to or in place of the force sensor 4012, the surgical instrument can include a position sensor 4013 that can generate a signal indicative of the position of the trigger 4010 (eg, the degree to which the trigger has been depressed or otherwise actuated). ). In one aspect, the position sensor 4013 may be a sensor positioned with an outer tubular sheath or a reciprocating tubular actuating member within the outer tubular sheath of the surgical instrument. In one aspect, the sensor may be a Hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors can be used in proximity switches, positioning, speed detection and current sensing applications. In one aspect, the Hall effect sensor operates as an analog transducer, returning voltage directly. Using a known magnetic field, its distance from the Hall plate can be determined.

Control circuitry 4008 may receive signals from sensors 4012 and/or 4013 . Control circuit 4008 may include any suitable analog circuit or digital circuit components. The control circuit 4008 may also communicate with the generator 4002 and/or the transducer 4004 to be based on the force applied to the trigger 4010 and/or the position of the trigger 4010 and/or the position of the outer tubular sheath relative to the position of the outer tubular sheath as described above. The position of the reciprocating tubular actuation member within (eg, as measured by a Hall effect sensor and magnet combination) modulates the power delivered to the end effector 4006 and/or the generator level of the end effector 4006 or ultrasonic Knife value. For example, as more force is applied to the trigger 4010, more power and/or higher ultrasonic blade amplitude can be delivered to the end effector 4006. According to various aspects, the force sensor 4012 may be replaced by a multi-position switch.

According to various aspects, the end effector 4006 can include a clamp or clamping mechanism. When the trigger 4010 is initially actuated, the gripping mechanism can be closed, thereby gripping tissue between the gripping arm and the end effector 4006. As the force applied to the trigger increases (eg, as sensed by force sensor 4012 ), control circuit 4008 may increase the power delivered by transducer 4004 to end effector 4006 and/or into end effector 4006 The resulting generator level or ultrasonic blade amplitude. In one aspect, the trigger position as sensed by the position sensor 4013 or the clamp or gripper arm position as sensed by the position sensor 4013 (eg, with a Hall effect sensor) may be used by the control circuit 4008 to set the end execution The power and/or amplitude of the device 4006. For example, the power and/or amplitude of the end effector 4006 may increase as the trigger moves further toward the fully actuated position, or as the clamp or gripper arm moves further toward the ultrasonic blade (or end effector 4006).

According to various aspects, the surgical instrument of surgical system 4000 may also include one or more feedback devices for indicating the amount of power delivered to end effector 4006 . For example, speaker 4014 may emit a signal indicative of end effector power. According to various aspects, speaker 4014 may emit a series of pulsed sounds, wherein the frequency of the sound is indicative of power. In addition to or in place of speaker 4014, the surgical instrument may include a visual display 4016. Visual display 4016 may indicate end effector power according to any suitable method. For example, the visual display 4016 may include a series of LEDs, with the end effector power being indicated by the number of LEDs illuminated. Speaker 4014 and/or visual display 4016 may be driven by control circuit 4008 . According to various aspects, the surgical instrument can include a ratchet device coupled to trigger 4010. The ratchet mechanism can generate an audible sound when more force is applied to the trigger 4010, thereby providing an indirect indication of end effector power. Surgical instruments may include other features that may enhance safety. For example, the control circuitry 4008 may be configured to prevent power exceeding a predetermined threshold from being delivered to the end effector 4006 . Additionally, control circuitry 4008 may implement a delay between the time to indicate (eg, through speaker 4014 or visual display 4016) the change in end effector power and the time to deliver the change in end effector power. This gives the clinician sufficient warning that the level of ultrasound power to be delivered to the end effector 4006 will change.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 can be configured to digitally generate an electrical signal waveform such that it is desired to digitize the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. 41 illustrates one aspect of the basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, which is configured to generate a plurality of waveforms of an electrical signal waveform. The generator software and digital controls can command the FPGA to scan addresses in the lookup table 4104, which in turn provides varying digital input values to the DAC circuit 4108 feeding the power amplifier. Addresses can be scanned based on frequencies of interest. Using this lookup table 4104 can generate various types of waveforms that can be fed into tissue or transducers, RF electrodes simultaneously, into multiple transducers simultaneously, into multiple RF electrodes simultaneously , or fed into a combination of RF instruments and ultrasonic instruments. Additionally, multiple look-up tables 4104 representing multiple wave shapes can be created, stored, and applied to the tissue from the generator.

The waveform signal can be configured to control the output current, output voltage of the ultrasound transducer and/or RF electrodes or multiples thereof (eg, two or more ultrasound transducers and/or two or more RF electrodes) , or at least one of output power. Additionally, where the surgical instrument includes an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator may be configured to provide a waveform signal to at least one surgical instrument, wherein the waveform signal corresponds to at least one of the plurality of waveforms in the table. Additionally, the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may include information associated with the plurality of wave shapes, and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table that may be stored in the generator's FPGA. The table may be addressed in any manner that facilitates sorting of wave shapes. According to one aspect, the table (which may be a direct digital synthesis table) is addressed according to the frequency of the waveform signal. Additionally, the information associated with the plurality of wave shapes may be stored in a table as digital information.

The analog electrical signal waveform can be configured to control the output current of the ultrasound transducer and/or RF electrodes or multiples thereof (eg, two or more ultrasound transducers and/or two or more RF electrodes), At least one of output voltage or output power. Additionally, where the surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, wherein the analog electrical signal waveform corresponds to at least one waveform of a plurality of waveforms stored in the look-up table 4104 . Additionally, the analog electrical signal waveforms provided to the two surgical instruments may include two or more waveforms. The look-up table 4104 can include information associated with a plurality of waveform shapes, and the look-up table 4104 can be stored within the generator circuit or the surgical instrument. In one aspect or example, the lookup table 4104 may be a direct digital synthesis table, which may be stored in the generator circuit or in the FPGA of the surgical instrument. The lookup table 4104 may be addressed in any manner that conveniently classifies the wave shape. According to one aspect, lookup table 4104, which may be a direct digital synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Additionally, the information associated with the plurality of wave shapes may be stored in lookup table 4104 as digital information.

With the widespread use of digital techniques in instruments and communication systems, digital control methods for generating multiple frequencies from a reference frequency source have evolved and are known as direct digital synthesis. The infrastructure is shown in Figure 41. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit, and to a memory circuit located in the generator circuit of the surgical system 1000 . DDS circuit 4100 includes address counter 4102 , look-up table 4104 , registers 4106 , DAC circuit 4108 and filter 4112 . The stable clock _fc is received by the address counter 4102 and the register 4106 drives a programmable read only memory (PROM) that stores one or more integer cycles of a sine wave (or other arbitrary waveform) in a lookup table 4104 middle. As address counter 4102 steps through memory locations, the value stored in lookup table 4104 is written to register 4106, which is coupled to DAC circuit 4108. The corresponding digital magnitude of the signal at the memory location of the lookup table 4104 drives the DAC circuit 4108 , which in turn generates the analog output signal 4110 . The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise is basically the phase noise of the reference clock _fc . The first analog output signal 4110 output from the DAC circuit 4108 is filtered by the filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has frequency f _output .

Because the DDS circuit 4100 is a sampled data system, the issues involved in sampling must be considered: quantization noise, aliasing, filtering, etc. For example, higher order harmonics of the output frequency of the DAC circuit 4108 are folded back into the Nyquist bandwidth, making them unfilterable, whereas higher order harmonics of the output of a phase locked loop (PLL) based synthesizer can be filtered. Lookup table 4104 contains an integer number of cycles of signal data. The final _output frequency fout can be changed by changing the reference clock frequency _fc or by reprogramming the PROM.

The DDS circuit 4100 may include a plurality of look-up tables 4104, where the look-up tables 4104 store waveforms represented by a predetermined number of samples, where the samples define a predetermined shape of the waveform. Thus, multiple waveforms with unique shapes can be stored in multiple lookup tables 4104 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for superficial tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4100 can create a plurality of waveform look-up tables 4104 and, during the tissue processing process (eg, "on-the-fly" or virtual real-time based on user or sensor input), based on the desired Tissue effects and/or tissue feedback, switching between different wave shapes stored in separate lookup tables 4104.

Thus, switching between wave shapes can be based on, for example, tissue impedance and other factors. In other aspects, the look-up table 4104 can store an electrical signal waveform shaped to maximize the power delivered into the tissue per cycle (ie, a trapezoidal or square wave). In other aspects, lookup table 4104 may store waveforms synchronized in a manner that maximizes the power delivery of the multifunctional surgical instruments of surgical system 1000 when delivering RF drive signals and ultrasonic drive signals. In other aspects, the look-up table 4104 can store electrical signal waveforms to simultaneously drive the ultrasound energy and RF therapy energy, and/or sub-therapeutic energies, while maintaining ultrasound lock. Customized waveform shapes and their tissue effects specific to different instruments can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (eg, EEPROM) of the surgical system 1000, and used when connecting the multifunctional surgical instrument. to the generator circuit to be extracted. An example of an exponentially decaying sinusoid as used in many high crest factor "coagulation" waveforms is shown in Figure 43.

A more flexible and efficient implementation of DDS circuit 4100 employs a digital circuit known as a digitally controlled oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit such as DDS circuit 4200 is shown in FIG. 42 . In this simplified block diagram, DDS circuit 4200 is coupled to a processor, controller, or logic device of the generator, and connected to memory circuits located in the generator or in any of the surgical instruments of surgical system 1000 . DDS circuit 4200 includes load register 4202 , parallel incremental phase register 4204 , adder circuit 4216 , phase register 4208 , look-up table 4210 (phase to amplitude converter), DAC circuit 4212 , and filter 4214 . Adder circuit 4216 and phase register 4208 form part of phase accumulator 4206. Clock frequency f _c is applied to phase register 4208 and DAC circuit 4212 . The load register 4202 receives a tuning word that specifies the output frequency as a fraction of the reference clock frequency signal _fc . The output of the load register 4202 is provided in the tuning word M to the parallel incremental phase register 4204.

DDS circuit 4200 includes a sampling clock that generates a clock frequency fc, a phase accumulator ₄₂₀₆ , and a look-up table 4210 (eg, a phase-to-amplitude converter). The contents of phase accumulator ₄₂₀₆ are updated once every clock cycle fc. The number M stored in parallel increment phase register 4204 is added to the number in phase register 4208 by adder circuit 4216 when the time of phase accumulator 4206 is updated. Assume that the numbers in the parallel increment phase register 4204 are 00...01 and the initial contents of the phase accumulator 4206 are 00...00. Phase accumulator 4206 updates 00...01 every clock cycle. If the phase accumulator 4206 is 232 bits wide, then 232 clock cycles (over 4 billion) are required before the phase accumulator 4206 returns to 00...00, and the cycle repeats.

The truncated output 4218 of the phase accumulator 4206 is provided to a phase to amplitude converter lookup table 4210, and the output of the lookup table 4210 is coupled to a DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as the address of a sine (or cosine) lookup table. The addresses in the lookup table correspond to the phase points on the sine wave from 0° to 360°. Lookup table 4210 contains the corresponding digital amplitude information for one complete cycle of the sine wave. Thus, lookup table 4210 maps the phase information from phase accumulator 4206 to a digital magnitude word, which in turn drives DAC circuit 4212. The output of the DAC circuit is a first analog signal 4220 and is filtered by filter 4214. The output of filter 4214 is a second analog signal 4222, which is provided to a power amplifier coupled to the output of the generator circuit.

In one aspect, the electrical signal waveform can be digitized into 1024 (210) phase points, but the waveform shape can be digitized into any suitable number of 2n phase points in the range of 256 (28) to 281,474,976,710,656 (248), where n is positive Integer as shown in Table 1. The electrical signal waveform can be represented as An (θ _n ), where the normalized amplitude A at point _n is represented by the phase angle θ _n referred to as the phase point at point n. The number n of discrete phase points determines the tuning resolution of the DDS circuit 4200 (and the DDS circuit 4100 shown in Figure 41).

Table 1 specifies electrical signal waveforms that are digitized into multiple phase points.

N Stage Points 2ⁿ 8 256 10 1,024 12 4,096 14 16,384 16 65,536 18 262,144 20 1,048,576 twenty two 4,194,304 twenty four 16,777,216 26 67,108,864 28 268,435,456 … … 32 4,294,967,296 … … 48 281,474,976,710,656 … …

Table 1

The generator circuit algorithm and digital control circuit scan the addresses in the lookup table 4210, which in turn provides varying digital input values to the DAC circuit 4212 feeding the filter 4214 and power amplifier. Addresses can be scanned based on frequencies of interest. Various types of shapes can be generated using lookup tables that can be converted to analog output signals by DAC circuit 4212, filtered by filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, or in the form of RF energy is fed to the tissue, or is fed to the tissue in the form of ultrasonic vibrations that deliver energy to the tissue in the form of heat. The output of the amplifier may be applied, for example, to an RF electrode, to multiple RF electrodes simultaneously, to an ultrasound transducer, to multiple ultrasound transducers simultaneously, or to a combination of RF and ultrasound transducers. combination. Additionally, multiple waveform tables can be created, stored, and applied to tissue from the generator circuit.

Referring back to Figure 41, for n=32 and M=1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, the phase register 1708 "rolls over" twice as fast and the output frequency doubles. This can be summarized as follows.

For a phase accumulator 4206 configured to accumulate n bits (n is typically in the range 24 to 32 in most DDS systems, but as previously mentioned ⁿ can be selected from a wide range of options), there are 2 possible phase point. The digital word M in the incremental phase register represents the amount by which the phase accumulator is incremented per clock cycle. If f _c is the clock frequency, the frequency of the output sine wave is equal to:

对于n＝32，该分辨率大于四十亿分之一。在DDS电路4200的一个方面，不是所有来自相位累加器4206的位被传递到查找表4210，而是被截断，仅留下例如前13至15个最高有效位(MSB)。这减小了查找表4210的大小并且不影响频率分辨率。相位截断仅向最终输出添加小但可接受量的相位噪声。The above formula is called the DDS "tuning formula". Note that the frequency resolution of the system is equal to

For n=32, the resolution is greater than one part in four billion. In one aspect of the DDS circuit 4200, not all bits from the phase accumulator 4206 are passed to the lookup table 4210, but are truncated, leaving only the first 13 to 15 most significant bits (MSBs), for example. This reduces the size of the lookup table 4210 and does not affect the frequency resolution. Phase truncation only adds a small but acceptable amount of phase noise to the final output.

The electrical signal waveform can be characterized by current, voltage or power at a predetermined frequency. Additionally, where any of the surgical instruments of surgical system 1000 includes an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is characterized by a predetermined waveform shape stored in the look-up table 4210 (or the look-up table 4104 of FIG. 41 ). Additionally, the electrical signal waveform may be a combination of two or more waveforms. Lookup table 4210 may include information associated with multiple wave shapes. In one aspect or example, lookup table 4210 may be generated by DDS circuit 4200 and may be referred to as a direct digital synthesis table. DDS works by first storing a large number of repetitive waveforms in onboard memory. The cycles of the waveform (sine, triangle, square, arbitrary) can be represented by a predetermined number of phase points as shown in Table 1 and stored into memory. Once the waveform is stored in memory, it can be generated at a very precise frequency. The direct digital synthesis table may be stored in non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry in the generator circuit. Lookup table 4210 may be addressed by any suitable technique that facilitates sorting of wave shapes. According to one aspect, the lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, the information associated with the plurality of wave shapes may be stored in memory as digital information or as part of a lookup table 4210.

In one aspect, the generator circuit can be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to simultaneously provide an electrical signal waveform, which may be characterized by two or more waveforms, to two surgical instruments via an output channel of the generator circuit. For example, in one aspect, the electrical signal waveform includes a first electrical signal (eg, an ultrasound drive signal), a second RF drive signal, and/or a combination thereof for driving the ultrasound transducer. Additionally, the electrical signal waveforms may include multiple ultrasound drive signals, multiple RF drive signals, and/or a combination of multiple ultrasound drive signals and RF drive signals.

Furthermore, a method of operating a generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of the surgical instruments of the surgical system 1000, wherein generating the electrical signal waveform includes receiving from a memory and the electrical signal waveform associated information. The generated electrical signal waveform includes at least one waveform. Furthermore, providing the generated electrical signal waveform to at least one surgical instrument includes simultaneously providing the electrical signal waveform to at least two surgical instruments.

Generator circuits as described herein may allow various types of direct digital synthesis tables to be generated. Examples of wave shapes of RF/electrosurgical signals generated by generator circuits suitable for processing various tissues include RF signals with high crest factor (which can be used for surface coagulation in RF mode), low crest factor RF signals (which can be used for surface coagulation in RF mode). available for deeper tissue penetration), as well as waveforms that promote effective touch coagulation. The generator circuit can also employ a direct digital synthesis look-up table 4210 to generate multiple wave shapes and can quickly switch between specific wave shapes based on the desired tissue effect. Switching may be based on tissue impedance and/or other factors.

In addition to the traditional sine/cosine wave shapes, the generator circuit may also be configured to generate one or more wave shapes (ie, trapezoidal or square waves) that maximize the power into the tissue in each cycle. The generator circuit may provide one or more wave shapes that are synchronized to maximize power delivered to the load and maintain ultrasonic lock when the RF signal and the ultrasonic signal are driven simultaneously, provided that the generator circuit Includes circuit topologies capable of driving RF signals and ultrasound signals simultaneously. Additionally, customized waveforms specific to the instrument and its tissue effects can be stored in non-volatile memory (NVM) or instrument EEPROM and can be retrieved when any of the surgical instruments of surgical system 1000 are connected to the generator circuit extract.

The DDS circuit 4200 may include a plurality of look-up tables 4104, where the look-up tables 4210 store waveforms represented by a predetermined number of phase points (also referred to as samples), where the phase points define a predetermined shape of the waveform. Thus, multiple waveforms with unique shapes can be stored in multiple lookup tables 4210 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for superficial tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4200 can create a plurality of waveform look-up tables 4210, and during the tissue processing process (eg, "on-the-fly" or virtual real-time based on user or sensor input), based on the desired Tissue effects and/or tissue feedback, switching between different wave shapes stored in different lookup tables 4210.

Thus, switching between wave shapes can be based on, for example, tissue impedance and other factors. In other aspects, the look-up table 4210 can store electrical signal waveforms that are shaped to maximize the power delivered into the tissue per cycle (ie, a trapezoidal or square wave). In other aspects, the look-up table 4210 may store waveforms that are synchronized in such a way that when the RF signal and the ultrasonic drive signal are delivered, they maximize power delivery by any of the surgical instruments of the surgical system 1000 . In other aspects, look-up table 4210 can store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energies simultaneously, while maintaining ultrasound lock. In general, the output wave shape may be in the form of a sine wave, cosine wave, pulse wave, square wave, or the like. However, more complex and customized waveforms that are specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical instrument (eg, EEPROM), and when the surgical instrument is Extracted when connected to the generator circuit. An example of a custom wave shape is the exponentially decaying sinusoid used in many high crest factor "clot" waveforms, such as shown in Figure 43.

43 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 of an analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison) in accordance with at least one aspect of the present disclosure. The horizontal axis represents time (t), while the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is, for example, a digital discrete-time version of the desired analog waveform 4304 . The digital electrical signal waveform 4300 is generated by storing a magnitude phase point 4302 that represents the magnitude of each clock cycle T _clk over one cycle or period T _o . The digital electrical signal waveform 4300 is generated over one period _To by any suitable digital processing circuit. The magnitude phase points are digital words stored in the memory circuit. In the examples shown in Figures 41 and 42, the digital word is a six-bit word capable of storing magnitude phase points at 26-bit or 64-bit resolution. It should be understood that the examples shown in Figures 41 and 42 are for illustrative purposes and that in actual implementations, the resolution may be higher. The digital amplitude phase points 4302 over one cycle _To are stored in memory as a string of words in lookup tables 4104, 4210, as described in conjunction with Figures 41, 42, for example. To generate an analog version of the analog waveform 4304, the amplitude phase points 4302 are sequentially read from memory in clock cycles T _clk from 0 to T _o and converted by the DAC circuits 4108 , 4212 , also described in conjunction with FIGS. 41 , 42 . Additional cycles may be generated by repeatedly reading the amplitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to T _o as many cycles or cycles as possible. A smoothed analog version of the analog waveform 4304 is achieved by filtering the outputs of the DAC circuits 4108, 4212 with filters 4112, 4214 (FIGS. 41 and 42). The filtered analog output signals 4114, 4222 (FIGS. 41 and 42) are applied to the input of the power amplifier.

44 is a schematic diagram of a control system 12950 configured to provide a closure member (eg, a closure member) when the displacement member is advanced distally and coupled to a clamp arm (eg, an anvil), according to one aspect of the present disclosure The gradual closing of the tube) reduces the closing force load on the closing member and reduces the firing force load on the firing member at the desired rate. In one aspect, the control system 12950 may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) that continuously calculates the difference between the desired set point and the measured process variable from the error value, based on proportional, integral, and derivative terms (sometimes separately Denoted as P, I and D) Correction is applied. Nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 may be the PID controller 12972 as shown in FIG. 45 , and the secondary controller 12955 may also be the PID controller 12972 as shown in FIG. 45 . Primary controller 12952 controls primary process 12958 and secondary controller 12955 controls secondary process 12960. The output 12966 of the primary process 12958 is the subtraction of the _first summer 12962 from the main set point SP1. The first summer 12962 produces a single sum output signal that is applied to the main controller 12952. _The output of the primary controller 12952 is the secondary set point SP2. The output 12968 of the secondary process 12960 is the subtraction of the _second summer 12964 from the secondary set point SP2.

In the case of controlling the displacement of the closure tube, the control system 12950 can be configured such that the master set point SP1 is the desired closing force value, and the master controller 12952 is configured to receive from _a torque sensor coupled to the output of the closure motor Closing force and determine the set point SP ₂ motor speed of the closing motor. In other aspects, the closing force may be measured with strain gauges, load cells, or other suitable force sensors. The closing motor speed setpoint SP ₂ is compared to the actual speed of the closing tube, which is determined by the secondary controller 12955. The actual velocity of the closed tube can be measured by comparing measured displacement of the closed tube with the position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoders or rotary encoders may be employed to measure the displacement of the closed tube. The output 12968 of the secondary process 12960 is the actual velocity of the closed tube. This closed tube speed output 12968 is provided to primary process 12958 which determines the force acting on the closed tube and feeds back to summer ₁₂₉₆₂ which subtracts the measured closing force from main set point SP1 . The main set point SP ₁ may be an upper threshold or a lower threshold. Based on the output of the adder 12962, the main controller 12952 controls the speed and direction of the closing motor. _The secondary controller 12955 controls the speed of the closing motor based on the actual speed of the closing tube measured by the secondary process 12960 and the secondary set point SP2, which speed is based on the actual firing force and the firing force upper and lower thresholds. Compare.

FIG. 45 shows a PID feedback control system 12970 according to one aspect of the present disclosure. Primary controller 12952 or secondary controller 12955 or both may be implemented as PID controller 12972. In one aspect, the PID controller 12972 may include a proportional element 12974 (P), an integral element 12976 (I), and a derivative element 12978 (D). The outputs of P element 12974, I element 12976, D element 12978 are summed by summer 12986, which provides control variable μ(t) to process 12980. The output of process 12980 is the process variable y(t). Summer 12984 calculates the difference between the desired set point r(t) and the measured process variable y(t). The PID controller 12972 continuously calculates the error value e(t) (eg, the difference between the closing force threshold and the measured closing force) as the desired setpoint r(t) (eg, the closing force threshold) and measures The difference between the process variables y(t) (e.g., velocity and direction of the closed tube), and based on the values calculated by proportional element 12974 (P), integral element 12976 (I), and derivative element 12978 (D), respectively Proportional, integral, and derivative terms are used to apply corrections. The PID controller 12972 attempts to minimize the error e(t) over time by adjusting the control variables μ(t) (eg, the speed and direction of the closed tube).

According to the PID algorithm, the "P" element 12974 calculates the current value of the error. For example, if the error is large and positive, the control output will also be large and positive. According to the present disclosure, the error term e(t) differs between the expected closing force of the closed tube and the measured closing force. The "I" element 12976 calculates the past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying a stronger action. The "D" element 12978 calculates the likely future trend of this error based on its current rate of change. For example, continuing the P example above, when a large positive control output successfully brings the error closer to zero, it also puts the process in the path of a large negative error in the nearest future. In this case, the derivative becomes negative and the D module reduces the intensity of the action to prevent this overshoot.

It should be understood that other variables and set points may be monitored and controlled in accordance with the feedback control systems 12950, 12970. For example, the adaptive closure member speed control algorithm described herein may measure at least two of the following parameters: firing member stroke position, firing member load, displacement of cutting element, speed of cutting element, closed tube travel position, closed tube load and many more.

Ultrasonic surgical devices, such as ultrasonic scalpels, are used in a variety of applications in surgical procedures because of their unique performance characteristics. Depending on the specific device configuration and operating parameters, an ultrasonic surgical device can provide substantially simultaneous tissue transection and hemostasis through coagulation, advantageously minimizing patient trauma. An ultrasonic surgical device may include a handpiece that includes an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer having a distally mounted end effector (eg, a knife tip) to cut and seal tissue . In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be detachable from the handpiece, as in the case of disposable or interchangeable instruments. The end effector transmits ultrasonic energy to the tissue in contact with the end effector to effect the cutting and sealing action. Ultrasonic surgical devices of this nature can be configured for open surgical use, laparoscopic or endoscopic surgical procedures, including robotic-assisted procedures.

The ultrasonic energy cuts and coagulates tissue using temperatures lower than those used in electrosurgical procedures, and can be delivered to the end effector by an ultrasonic generator in communication with the handpiece. Vibrating at high frequency (eg, 55,500 cycles per second), the ultrasonic blade denatures proteins in the tissue to form a viscous coagulum. The pressure exerted by the blade surface on the tissue collapses the vessel and causes the coagulum to form a hemostatic seal. The surgeon can control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time for which the force is applied, and the selected offset level of the end effector.

The ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch with static capacitance and a second "dynamic" branch with series connected inductance, resistance and capacitance, the inductance, resistance and The capacitance defines the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using a tuned inductor, the generator's drive signal current represents the dynamic branch current, and thus the generator can control its drive signal to maintain the ultrasonic transducer's resonant frequency. Tuning the inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasound transducers with different static capacitances require different tuning inductors.

Additionally, in some ultrasonic generator architectures, the generator's drive signal exhibits asymmetric harmonic distortion, which complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion in current and voltage signals.

Additionally, electromagnetic interference in noisy environments can reduce the generator's ability to maintain lock on the ultrasonic transducer's resonant frequency, thereby increasing the likelihood of invalid control algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue to treat and/or destroy tissue are also increasingly used in surgical procedures. Electrosurgical devices include handpieces and instruments with distally mounted end effectors (eg, one or more electrodes). The end effector can be positioned against tissue such that electrical current is introduced into the tissue. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is introduced into and returned from the tissue through the active and return electrodes of the end effector, respectively. During monopolar operation, electrical current is introduced into the tissue through the active electrode of the end effector and returned through a return electrode (eg, a ground pad) positioned separately on the patient's body. The heat generated by the electrical current flowing through the tissue can form a hemostatic seal within and/or between the tissue, and thus can be particularly useful for sealing blood vessels, for example. The end effector of the electrosurgical device may also include a cutting member movable relative to the tissue and electrodes for transecting the tissue.

Electrical energy applied by the electrosurgical device can be delivered to the instrument through a generator in communication with the handpiece. The electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range 300kHz to 1MHz, as described in EN60601-2-2:2009+A11:2011, Definition 201.3.218 - High frequencies. For example, frequencies in unipolar RF applications are typically limited to less than 5MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200 kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low frequency currents. If the risk analysis shows that the likelihood of neuromuscular stimulation has been reduced to an acceptable level, bipolar techniques can be used at lower frequencies. Generally, frequencies above 5 MHz are not used to minimize problems associated with high frequency leakage currents. It is generally considered that 10 mA is the lower threshold for tissue thermal effects.

During its operation, an electrosurgical device can transmit low frequency RF energy through tissue, which causes ion oscillations or friction and, in effect, resistive heating, which increases the temperature of the tissue. Because a sharp boundary can be created between the affected tissue and surrounding tissue, the surgeon is able to operate with a high level of precision and control without damaging adjacent non-target tissue. The low operating temperature of RF energy may be suitable for removing soft tissue, shrinking soft tissue, or shaping soft tissue while sealing blood vessels. RF energy may be particularly well suited to connective tissue, which is primarily composed of collagen and shrinks when exposed to heat.

Ultrasound and electrosurgical devices often require different generators due to their unique drive signal, sensing, and feedback requirements. Additionally, in situations where the instruments are disposable or interchangeable with handpieces, the ability of the ultrasonic and electrosurgical generators to identify the specific instrument configuration used and optimize the control and diagnostic procedures accordingly is limited. Additionally, capacitive coupling between the generator's non-isolated circuits and the patient's isolated circuits, especially when higher voltages and frequencies are used, can result in patient exposure to unacceptable levels of leakage current.

Furthermore, ultrasound and electrosurgical devices often require different user interfaces for different generators due to their unique drive signal, sensing and feedback needs. In such conventional ultrasound and electrosurgical devices, one user interface is configured for use with an ultrasonic instrument, while another user interface may be configured for use with an electrosurgical instrument. Such user interfaces include hand and/or foot activated user interfaces, such as hand activated switches and/or foot activated switches. As aspects of combined generators for use with ultrasonic and electrosurgical instruments are contemplated in the ensuing disclosure, additional user interfaces configured to operate with ultrasonic and/or electrosurgical instrument generators are also contemplated.

Additional user interfaces for providing feedback to users or other machines are contemplated in subsequent disclosures to provide feedback indicative of the operating mode or status of the ultrasonic and/or electrosurgical instrument. Providing user and/or machine feedback for operating a combination of ultrasonic and/or electrosurgical instruments will require providing sensory feedback to the user as well as electrical/mechanical/electromechanical feedback to the machine. Incorporation of visual feedback devices (eg, LCD displays, LED indicators), audio feedback devices (eg, speakers, buzzers), or haptic feedback devices (eg, speakers, buzzers) for combined ultrasonic and/or electrosurgical instruments is contemplated in subsequent disclosures For example, haptic actuators).

Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation, and/or microwave techniques, among others. Accordingly, the techniques disclosed herein may be applicable to ultrasound, bipolar or monopolar RF (electrosurgery), irreversible and/or reversible electroporation, and/or microwave-based surgical instruments, among others.

Various aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured for transecting and/or coagulating tissue, eg, during a surgical procedure. Aspects of the electrosurgical device may be configured for transecting, coagulating, scaling, welding, and/or drying tissue, eg, during a surgical procedure.

Aspects of the generator utilize high-speed analog-to-digital sampling of generator drive signal currents and voltages (eg, approximately 200 oversampling, depending on frequency) and digital signal processing to provide many advantages over known generator architectures and benefit. In one aspect, the generator may determine the dynamic branch current of the ultrasonic transducer based on, for example, current and voltage feedback data, the value of the ultrasonic transducer static capacitance, and the value of the drive signal frequency. This provides the benefit of a substantially tuned system and simulates the existence of a system that is tuned or resonated at any frequency with any value of static capacitance (eg, C ₀ in FIG. 25 ). Therefore, control of the dynamic branch current can be achieved by tuning the effect of static capacitance without the need to tune the inductor. Additionally, eliminating the tuning inductor may not degrade the frequency locking capability of the generator, since frequency locking may be achieved by properly processing the current and voltage feedback data.

High-speed analog-to-digital sampling of generator drive signal currents and voltages, as well as digital signal processing, also enables accurate digital filtering of the samples. For example, aspects of the generator may utilize a low-pass digital filter (eg, a finite impulse response (FIR) filter) that attenuates between the fundamental drive signal frequency and the second harmonic to reduce Asymmetric harmonic distortion and EMI induced noise in current and voltage feedback samples. The filtered current and voltage feedback samples generally represent the fundamental drive signal frequency, thus enabling more accurate impedance phase measurements relative to the fundamental drive signal frequency and improving the generator's ability to maintain resonant frequency lock. The accuracy of the impedance phase measurement can be further enhanced by averaging the falling edge measurement and the rising edge phase measurement, and by adjusting the measured impedance phase to 0°.

Aspects of the generator may also utilize high-speed analog-to-digital sampling of generator drive signal current and voltage and digital signal processing to determine actual power consumption and other quantities with high accuracy. This may allow the generator to implement a variety of algorithms available, such as, for example, controlling the amount of power delivered to the tissue as its impedance changes and controlling the power delivery to maintain a constant rate of tissue impedance increase. Some of these algorithms are used to determine the phase difference between the generator drive signal current signal and the voltage signal. At resonance, the phase difference between the current signal and the voltage signal is zero. This phase changes when the ultrasound system goes out of resonance. Various algorithms can be employed to detect the phase difference and adjust the drive frequency until the ultrasound system returns to resonance, ie, the phase difference between the current signal and the voltage signal is zero. Phase information can also be used to infer the condition of the ultrasonic blade. As discussed in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Therefore, the phase information can be used to control the temperature of the ultrasonic blade. This can be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold.

Various aspects of the generator may have the wide frequency range and increased output power necessary to drive both ultrasonic and electrosurgical devices. The lower voltage, higher current needs of electrosurgical devices can be met by dedicated taps on broadband power transformers, eliminating the need for separate power amplifiers and output transformers. In addition, the generator's sensing and feedback circuitry can support a large dynamic range that meets the needs of both ultrasonic and electrosurgical applications with minimal distortion.

Various aspects can provide a simple, economical means for generators to use existing multi-conductor generator/handpiece cables to read and optionally write data circuits (eg, A single wire bus device, such as a single wire protocol EEPROM known under the trade name "1-Wire"). In this way, the generator can retrieve and process instrument specific data from instruments attached to the handpiece. This enables the generator to provide better control and improved diagnostics and error detection. Additionally, the ability of the generator to write data to the instrument provides possible new functionality in, for example, tracking instrument usage and capturing operational data. Furthermore, the use of frequency bands allows for backward compatibility with existing generators for instruments containing bus devices.

The disclosed aspects of the generator provide active cancellation of leakage currents caused by unintended capacitive coupling between non-isolated circuits and patient isolation circuits of the generator. In addition to reducing patient risk, the reduction in leakage current also reduces electromagnetic radiation.

These and other benefits of various aspects of the present disclosure will be apparent from the detailed description below.

It should be understood that the terms "proximal" and "distal" are used herein with respect to the clinician grasping the handpiece assembly. Thus, the end effector is distal relative to the more proximal handpiece. It should also be understood that, for convenience and clarity, spatial terms such as "top" and "bottom" are also used herein with respect to a clinician holding the handpiece assembly. However, surgical devices are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

46 is a front exploded view of the modular handheld ultrasonic surgical instrument 6480 showing the left housing half removed from the handle assembly 6482, exposing the communicatively coupled to the multi-lead handle, according to one aspect of the present disclosure Device identifier for the external terminal assembly. In an additional aspect of the present disclosure, the modular handheld ultrasonic surgical instrument 6480 is powered using a smart or smart battery. However, the smart battery is not limited to the modular handheld ultrasonic surgical instrument 6480, and as will be explained, can be used in a variety of devices, which may or may not have different power requirements (eg, current and voltage) from each other. According to one aspect of the present disclosure, the smart battery assembly 6486 is advantageously capable of identifying the particular device to which it is electrically coupled. It does this through encrypted or unencrypted identification methods. For example, smart battery assembly 6486 may have connecting portions, such as connecting portion 6488. The handle assembly 6482 may also be provided with a device identifier communicatively coupled to the multi-lead handle terminal assembly 6491 and operable to communicate at least one piece of information about the handle assembly 6482. This information can be correlated with the number of times the handle assembly 6482 has been used, the number of times the ultrasonic transducer/generator assembly 6484 has been used (currently disconnected from the handle assembly 6482), the waveguide shaft assembly 6490 has been used (currently connected to the handle) assembly 6482), the type of waveguide shaft assembly 6490 currently connected to the handle assembly 6482, the type or identity of the ultrasonic transducer/generator assembly 6484 currently connected to the handle assembly 6482, and/or many other characteristics . When the smart battery assembly 6486 is inserted into the handle assembly 6482, the connecting portion 6488 within the smart battery assembly 6486 is in communicative contact with the device identifier of the handle assembly 6482. The handle assembly 6482 can communicate information to the smart battery assembly 6486 through hardware, software, or a combination thereof (whether by self-priming or in response to a request from the smart battery assembly 6486). The communication identifier is received by the connection portion 6488 of the smart battery pack 6486. In one aspect, once the intelligent battery assembly 6486 receives the information, the communication portion can be operated to control the output of the intelligent battery assembly 6486 to meet the specific power requirements of the device.

In one aspect, the communications portion includes a processor 6493 and a memory 6497, which may be separate components or a single component. The processor 6493 in combination with the memory can provide intelligent power management for the modular handheld ultrasonic surgical instrument 6480. This aspect is particularly advantageous because ultrasonic devices, such as the modular handheld ultrasonic surgical instrument 6480, have power requirements (frequency, current, and voltage) that may be unique to the modular handheld ultrasonic surgical instrument 6480. In fact, the modular handheld ultrasonic surgical instrument 6480 may have specific power requirements or limitations for one size or type of outer tube 6494, and may have a second type of waveguide for a different size, shape, and/or configuration different power requirements.

Accordingly, the smart battery assembly 6486 in accordance with at least one aspect of the present disclosure allows the battery assembly to be used between several surgical instruments. Because the smart battery assembly 6486 can identify which device it is attached to and can change its output accordingly, operators of various surgical instruments utilizing the smart battery assembly 6486 no longer need to worry about what they are trying to install in the electronic device they are using internal power source. This is especially advantageous in operating environments where the battery assembly needs to be replaced or interchanged with another surgical instrument during complex surgical procedures.

In another aspect of the present disclosure, the smart battery pack 6486 stores in memory 6497 a record of each use of a particular device. This record may be useful for assessing the useful life or end of allowable life of the device. For example, once the device has been used 20 times, such batteries in the smart battery pack 6486 connected to the device will refuse to power it because the device is defined as a "no longer reliable" surgical instrument. Reliability is determined based on a number of factors. One factor may be wear, which can be estimated in a number of ways, including the number of times the device has been used or activated. After a certain number of uses, components of the device may become worn and exceed tolerances between components. For example, the smart battery assembly 6486 can sense the number of button pushes received by the handle assembly 6482 and can determine when the maximum number of button pushes has been reached or exceeded. The smart battery assembly 6486 may also monitor the impedance of the button mechanism, which may change, for example, when the handle is contaminated with, for example, saline.

This wear can lead to unacceptable failures during procedures. In some aspects, the smart battery assembly 6486 can identify which components are grouped together in the device, and even how many uses the component has undergone. For example, if the smart battery assembly 6486 is a smart battery according to the present disclosure, it can well identify the handle assembly 6482, the waveguide shaft assembly 6490, and the ultrasonic transducer/generator assembly 6484 before the user attempts to use the composite device . The memory 6497 within the smart battery assembly 6486 can record, for example, when the ultrasonic transducer/generator assembly 6484 is operated and how, when, and for the duration of operation. If the ultrasonic transducer/generator assembly 6484 has an independent identifier, the smart battery assembly 6486 can track usage of the ultrasonic transducer/generator assembly 6484 and once the handle assembly 6482 or ultrasonic transducer/generator assembly 6484 Power is denied to the ultrasonic transducer/generator assembly 6484 beyond its maximum number of uses. The ultrasonic transducer/generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other components may also include a memory chip that records this information. In this way, any number of smart batteries in the smart battery assembly 6486 can be used with any number of ultrasonic transducer/generator assemblies 6484, staplers, vessel sealers, etc. and still be able to determine the ultrasonic transducer/generator assembly 6484. Total number of uses or total use time of stapler, vessel sealer, etc., or total actuation time, etc. or charge or discharge cycles. Smart functionality may reside external to battery assembly 6486 and may reside in handle assembly 6482, ultrasonic transducer/generator assembly 6484, and/or shaft assembly 6490, for example.

The surgical instrument accurately distinguishes actual use of the ultrasonic transducer/generator assembly 6484 in a surgical procedure when counting the use of the ultrasonic transducer/generator assembly 6484 to intelligently terminate the life of the ultrasonic transducer/generator assembly 6484 Completion of and transient loss of actuation of the ultrasound transducer/generator assembly 6484 due to, for example, battery replacement or temporary delays in surgical procedures. Therefore, as an alternative to simply counting the number of activations of the ultrasonic transducer/generator assembly 6484, a real-time clock (RTC) circuit can be implemented to track the amount of time the ultrasonic transducer/generator assembly 6484 is actually turned off. From the measured length of time, it can be determined by appropriate logic if the shutdown is significant enough to be considered the end of an actual use, or too short to be considered the end of a use. Thus, in some applications, the method may more accurately determine the useful life of the ultrasound transducer/generator assembly 6484 than simple "activation-based" algorithms, which may provide, for example, that occur during surgical procedures Ten "activations", and thus ten activations should instruct the counter to increment by one. In general, the type and system's internal clock will prevent misuse of devices designed to fool simple "activation-based" algorithms, and when the ultrasonic transducer/generator assembly 6484 or smart battery is required only for legitimate reasons The simple unmating case of component 6486 will prevent incorrect recording of full use.

Although the ultrasonic transducer/generator assembly 6484 of the surgical instrument 6480 is reusable, in one aspect, a limited number of uses may be provided because the surgical instrument 6480 is subjected to harsh conditions during cleaning and sterilization. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the exterior surface, the actual material used has a limited life expectancy. This lifetime is determined by various characteristics, which may include, for example, the number of times the battery pack has actually been sterilized, the time the battery pack has been manufactured, and the number of times the battery pack has been recharged. In addition, the life of the battery cell itself is limited. The software of the present disclosure employs the algorithm of the present disclosure that verifies the number of uses of the ultrasonic transducer/generator assembly 6484 and the smart battery assembly 6486, and disables the devices when the number of uses is reached or exceeded. The exterior of the battery pack can be analyzed with each of the possible sterilization methods. Based on the most severe sterilization process, the maximum number of sterilizations allowed can be defined and stored in the memory of the smart battery pack 6486. If the charger is assumed to be unsanitized and the smart battery pack 6486 is used after charging, the charge count can be defined as equal to the number of sanitizations encountered for that particular battery pack.

In one aspect, hardware in the battery pack can be disabled to minimize or eliminate safety concerns due to continuous leakage from the battery cells after software disables the battery pack. Under certain low voltage conditions, there may be situations where the battery's internal hardware cannot disable the battery. In such cases, in one aspect, the charger can be used to "kill" the battery. Due to the fact that the battery microcontroller is off in its charger, unsterile, System Management Bus (SMB) based Electrically Erasable Programmable Read-Only Memory (EEPROM) can be used in the battery microcontroller and charger exchange information between them. Therefore, serial EEPROM can be used to store information that can be written and read even when the battery microcontroller is turned off, which is very beneficial when trying to exchange information with chargers or other peripherals. The example EEPROM can be configured to contain enough memory registers to store at least (a) the usage count limit when the battery should be disabled (battery usage count), (b) the number of procedures the battery has undergone (battery procedure count), and/or Or (c) the number of times the battery has been charged (charge count), etc. Some of the information stored in the EEPROM, such as the usage count register and the charge count register, is stored in a write-protected portion of the EEPROM to prevent the user from changing the information. In one aspect, the use and counters are stored with corresponding bit-reversed secondary detectors to detect data corruption.

Any residual voltage in the SMBus pipeline can damage the microcontroller and corrupt the SMBus signal. Therefore, to ensure that the SMBus lines of the battery controller do not carry voltage when the microcontroller is off, relays are provided between the external SMBus lines and the battery microcontroller board.

During charging of the smart battery pack 6486, an "end of charge" is determined for a battery within the smart battery pack 6486 when, for example, when a constant current/constant voltage charging scheme is employed, the current flowing into the battery falls below a given threshold in a tapered manner "situation. To accurately detect this "end of charge" condition, the battery microcontroller and buck board are powered down and shut down during battery charging to reduce any current draw that can be caused by the board and can interfere with tapered current detection. Also, the microcontroller and buck board are powered down during charging to prevent any damage to the SMBus signal.

Regarding the charger, in one aspect, the smart battery assembly 6486 is prevented from being inserted into the charger in any manner other than the correct insertion position. Accordingly, the exterior of the smart battery assembly 6486 is provided with a charger retention feature. The cup used to securely hold the smart battery assembly 6486 in the charger is configured with a profile that matches the taper geometry to prevent accidental insertion of the smart battery assembly 6486 in any way other than the correct (intended) way. It is also contemplated that the presence of the smart battery assembly 6486 may be detected by the charger itself. For example, the charger can be configured to detect the presence of an SMBus transformer from the battery protection circuit and a resistor located in the protection board. In such a case, the charger will be able to control the voltage exposed at the pins of the charger until the smart battery assembly 6486 is properly seated or in place on the charger. This is because the exposed voltage at the pins of the charger would present the danger and risk that an electrical short could occur across the pins and cause the charger to inadvertently start charging.

In some aspects, the smart battery assembly 6486 can communicate to the user through audio and/or visual feedback. For example, the smart battery pack 6486 can cause the LEDs to light up in a predetermined manner. In this case, even though the microcontroller in the ultrasonic transducer/generator assembly 6484 controls the LEDs, the microcontroller receives instructions to execute directly from the smart battery assembly 6486.

In yet another aspect of the present disclosure, the microcontroller in the ultrasonic transducer/generator assembly 6484 enters a sleep mode when not in use for a predetermined period of time. Advantageously, when in sleep mode, the clock speed of the microcontroller is reduced, thereby cutting current consumption significantly. As the processor continues to ping and wait to sense the input, it continues to draw some current. Advantageously, the microcontroller and battery controller can directly control the LEDs when the microcontroller is in this power saving sleep mode. For example, a decoder circuit can be built into the ultrasound transducer/generator assembly 6484 and connected to the communication lines so that when the ultrasound transducer/generator assembly 6484 microcontroller is "off" or in "sleep mode" , the LEDs can be independently controlled by the processor 6493. This is a power saving feature that does not require waking up the microcontroller in the ultrasound transducer/generator assembly 6484. Saves power by allowing the generator to be turned off while still being able to effectively control user interface indicators.

On the other hand, one or more microcontrollers are slowed down to save power when not in use. For example, the clock frequency of both microcontrollers can be reduced to save power. In order to maintain synchronous operation, the microcontrollers coordinate changes in their respective clock frequencies to perform a decrease and then a subsequent frequency increase at about the same time when full speed operation is required. For example, when entering idle mode, the clock frequency decreases, and when exiting idle mode, the frequency increases.

In another aspect, the smart battery assembly 6486 is capable of determining the amount of available power remaining within its cells, and is programmed to only operate the devices attached to it if it determines that there is sufficient battery power to operate the device predictably throughout the intended procedure. connected surgical instruments. For example, if there is not enough power in the unit to operate the surgical instrument for 20 seconds, the smart battery assembly 6486 can remain in a non-operating state. According to one aspect, the smart battery assembly 6486 determines the amount of power remaining in the battery at the end of its most recent aforementioned function (eg, surgical cutting). Thus, in this regard, if, for example, during this procedure, the smart battery assembly 6486 determines that the cell is underpowered, it will not allow subsequent functions to be performed. Alternatively, if the smart battery component 6486 determines that there is sufficient power for subsequent procedures during the procedure and is below the threshold, it will not interrupt the ongoing procedure, but will allow it to complete, and then prevent additional procedures occur.

The following explains the advantages of maximizing the use of a device with the smart battery assembly 6486 of the present disclosure. In this example, a different set of devices have different ultrasound transmission waveguides. By definition, a waveguide may have a corresponding maximum allowable power limit beyond which the waveguide is overstressed and eventually ruptured. One waveguide from the set of waveguides will naturally have the smallest maximum power tolerance. Due to the lack of intelligent battery power management of prior art batteries, the output of prior art batteries must be limited by the value of the minimum maximum allowable power input for the smallest/thinest/most fragile waveguide envisioned and used in the device/battery setting. This is true even when larger, thicker waveguides can be attached to the handle later and by definition allow for greater force to be applied. This limitation also exists for maximum battery power. For example, if a battery is designed for use in multiple devices, its maximum output power will be limited by the lowest maximum power rating of any of the devices in which the battery is to be used. With this configuration, one or more devices or device configurations will not be able to utilize the battery to the fullest because the battery is unaware of the specific limitations of a particular device.

In one aspect, the smart battery pack 6486 can be used to intelligently bypass the ultrasound device limitations described above. The smart battery assembly 6486 can produce one output for one device or a specific device configuration, and the same smart battery assembly 6486 can later produce a different output for a second device or device configuration. This versatile smart battery surgical system is ideal for modern operating rooms where space and time are at a premium. By having smart battery packs operate many different devices, nurses can easily manage the storage, retrieval and inventory of these battery packs. Advantageously, in one aspect, a smart battery system according to the present disclosure may employ one type of charging station, thereby increasing ease and efficiency of use and reducing the cost of surgical room charging devices.

Additionally, other surgical instruments, such as powered staplers, may have different power requirements than the modular handheld ultrasonic surgical instrument 6480. According to various aspects of the present disclosure, the smart battery assembly 6486 can be used with any of a range of surgical instruments, and can be manufactured to tailor its own power output to the particular device in which it is installed. In one aspect, this power regulation is accomplished by controlling the duty cycle of a switch-mode power source (such as buck, buck-boost, boost, or integral with or otherwise coupled to smart battery assembly 6486 and subject to Other configurations of its control are performed. In other aspects, the smart battery assembly 6486 can dynamically change its power output during device operation. For example, in vascular sealing devices, power management provides improved tissue sealing. In these devices, the need for Large constant current value. The total power output needs to be adjusted dynamically because when the tissue is sealed, its impedance changes. Aspects of the present disclosure provide a smart battery assembly 6486 with variable maximum current limit. Based on application or device requirements, The current limit may change from one application (or device) to another application (or device).

47 is a detailed view of the trigger 6483 portion and switches of the ultrasonic surgical instrument 6480 shown in FIG. 46, in accordance with at least one aspect of the present disclosure. Trigger 6483 is operably coupled to jaw member 6495 of end effector 6492. The ultrasonic blade 6496 is powered by the ultrasonic transducer/generator assembly 6484 when the activation switch 6485 is activated. Continuing now with FIG. 46 and referring also to FIG. 47 , trigger 6483 and activation switch 6485 are shown as parts of handle assembly 6482 . Trigger 6483 activates end effector 6492, which has cooperative association with ultrasonic blade 6496 of waveguide shaft assembly 6490 to enable communication between end effector jaw member 6495 and ultrasonic blade 6496 to communicate with tissue and/or or other substances in various types of contact. The jaw members 6495 of the end effector 6492 are generally pivoting jaws for grasping or clamping onto tissue disposed between the jaws and the ultrasonic blade 6496. In one aspect, audible feedback is provided in the trigger when the trigger is fully depressed. Noise can be generated by the thin metal part of the trigger snap when closed. This feature adds an audible component to user feedback that informs the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure is being applied to complete the vessel seal. In another aspect, a force sensor such as a strain gauge or pressure sensor can be coupled to the trigger 6483 to measure the force applied to the trigger 6483 by the user. In another aspect, a force sensor such as a strain gauge or pressure sensor can be coupled to the switch 6485 button such that the magnitude of the displacement corresponds to the force applied by the user to the switch 6485 button.

When depressed, activation switch 6485 places modular handheld ultrasonic surgical instrument 6480 in an ultrasonic mode of operation that induces ultrasonic motion at waveguide shaft assembly 6490. In one aspect, depressing the activation switch 6485 causes electrical contacts within the switch to close, thereby completing the electrical circuit between the smart battery assembly 6486 and the ultrasonic transducer/generator assembly 6484 to apply electrical energy to the ultrasonic transducer, such as previously mentioned. On the other hand, depressing the activation switch 6485 closes the electrical contacts to the smart battery pack 6486. Of course, herein, the description of closed electrical contacts in an electrical circuit is merely an exemplary general description of the operation of a switch. There are many alternative aspects that may include opening contacts or processor-controlled power delivery that receives information from the switch and directs a corresponding circuit response based on the information.

48 is an enlarged partial perspective view of the end effector 6492 according to at least one aspect of the present disclosure, viewed from the distal end, with the jaw members 6495 in an open position. 48, a perspective partial view of the distal end 6498 of the waveguide shaft assembly 6490 is shown. The waveguide shaft assembly 6490 includes an outer tube 6494 surrounding a portion of the waveguide. The ultrasonic blade 6496 portion of the waveguide 6499 protrudes from the distal end 6498 of the outer tube 6494. It is the ultrasonic blade 6496 part that contacts the tissue and delivers its ultrasonic energy to the tissue during the medical procedure. The waveguide shaft assembly 6490 also includes a jaw member 6495 coupled to the outer tube 6494 and the inner tube (not visible in this view). The jaw member 6495 along with the inner and outer tubes of the waveguide 6499 and the ultrasonic blade 6496 portion may be referred to as the end effector 6492. As will be explained below, the outer tube 6494 and the inner tube, not shown, slide longitudinally relative to each other. When relative movement between the outer tube 6494 and the inner tube, not shown, occurs, the jaw members 6495 pivot at the pivot point, causing the jaw members 6495 to open and close. When closed, the jaw members 6495 exert a clamping force on the tissue located between the jaw members 6495 and the ultrasonic blade 6496, ensuring positive and effective blade-to-tissue contact.

49 is a system diagram 7400 of a segmented circuit 7401 including a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 in accordance with at least one aspect of the present disclosure. A circuit segment of the plurality of circuit segments of segmented circuit 7401 includes one or more circuits and one or more sets of machine-executable instructions stored in one or more memory devices. The one or more circuits of the circuit section are coupled to electrically communicate through one or more wired or wireless connection media. The plurality of circuit segments are configured to transition between three modes, including a sleep mode, a standby mode, and an operating mode.

In one aspect shown, the plurality of circuit sections 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 first start up in standby mode, second transition to sleep mode, and again transition to operating mode. In other aspects, however, the plurality of circuit segments can transition from any of the three modes to any other of the three modes. For example, multiple circuit segments may transition directly from a standby mode to an operational mode. Voltage control circuitry 7408 may place individual circuit segments into particular states based on the execution of machine-executable instructions by the processor. The states include a power-off state, a low-energy state, and a power-on state. The powered-off state corresponds to the sleep mode, the low-energy state corresponds to the standby mode, and the powered-on state corresponds to the operating mode. Transitioning to a low energy state can be accomplished, for example, by using a potentiometer.

In one aspect, the plurality of circuit sections 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can transition from sleep mode or standby mode to operating mode according to a power-on sequence. The plurality of circuit segments may also transition from an operating mode to a standby mode or a sleep mode according to a power-down sequence. The power-on sequence and power-off sequence may be different. In some aspects, the energizing sequence includes energizing only a subset of the circuit segments of the plurality of circuit segments. In some aspects, the power down sequence includes powering down only a subset of the circuit segments of the plurality of circuit segments.

Referring back to system diagram 7400 in FIG. 49, segment circuit 7401 includes a plurality of circuit sections including transition circuit section 7402, processor circuit section 7414, handle circuit section 7416, communication circuit Section 7420, display circuit section 7424, motor control circuit section 7428, energy processing circuit section 7434, and shaft circuit section 7440. The transition circuit section includes wake-up circuit 7404 , boost current circuit 7406 , voltage control circuit 7408 , safety controller 7410 and POST controller 7412 . Transition circuit section 7402 is configured to implement power down and power up sequences, security detection protocols, and POST.

In some aspects, the wake-up circuit 7404 includes an accelerometer button sensor 7405. In various aspects, transition circuit section 7402 is configured to be in an energized state, while other circuit sections of the plurality of circuit sections of segmented circuit 7401 are configured to be in a low energy state, a deenergized state, or an energized state. Accelerometer button sensor 7405 can monitor movement or acceleration of surgical instrument 6480 as described herein. For example, the movement may be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction relative to the three-dimensional Euclidean space by, eg, a user of the surgical instrument. When the accelerometer button sensor 7405 senses motion or acceleration, the accelerometer button sensor 7405 sends a signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply a voltage to the processor circuit section 7414 to switch the processor and the volatile The memory transitions to the power-on state. In various aspects, the processor and volatile memory are in a powered-on state before the voltage control circuit 7409 applies voltage to the processor and volatile memory. In operating mode, the processor can initiate a power-up sequence or a power-down sequence. In various aspects, the accelerometer button sensor 7405 may also send a signal to the processor to cause the processor to begin a power-on sequence or power-off sequence. In some aspects, the processor begins a power-up sequence when most of the individual circuit segments are in a low-energy state or a powered-down state. In other aspects, the processor begins a power-down sequence when most of the individual circuit segments are in a powered-on state.

Additionally or alternatively, the accelerometer button sensor 7405 can sense external motion within a predetermined vicinity of the surgical instrument. For example, the accelerometer button sensor 7405 can sense that the user of the surgical instrument 6480 described herein is moving the user's hand around a predetermined proximity. When the accelerometer button sensor 7405 senses this external motion, the accelerometer button sensor 7405 can send a signal to the voltage control circuit 7408 and to the processor, as previously described. After receiving the transmitted signal, the processor may initiate a power-up sequence or a power-down sequence to transition one or more circuit segments between the three modes. In various aspects, a signal sent to the voltage control circuit 7408 is sent to verify that the processor is in an operational mode. In some aspects, the accelerometer button sensor 7405 can sense when the surgical instrument has been dropped and send a signal to the processor based on the sensed drop. For example, the signals may indicate errors in the operation of individual circuit segments. One or more sensors may sense damage or failure of the affected individual circuit segments. Based on the sensed damage or failure, the POST controller 7412 may perform POST on the corresponding individual circuit segments.

The power up sequence or power down sequence may be defined based on the accelerometer button sensor 7405 . For example, the accelerometer button sensor 7405 may sense a particular motion or sequence of motions indicative of selection of a particular circuit segment of a plurality of circuit segments. Based on the sensed motion or series of sensed motions, the accelerometer button sensor 7405 may transmit a signal to the processor that includes an indication of one or more of the plurality of circuit segments when the processor is in a powered-on state device. Based on the signal, the processor determines a power-up sequence that includes the selected one or more circuit segments. Additionally or alternatively, a user of the surgical instrument 6480 described herein may select the number and order of circuit segments to define a power-on sequence or power-off sequence based on interaction with a graphical user interface (GUI) of the surgical instrument.

In various aspects, the accelerometer button sensor 7405 may only send a signal to the voltage control circuit 7408 and to the voltage control circuit 7408 when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein or external movement within a predetermined vicinity above a predetermined threshold. The processor sends the signal. For example, a signal may only be sent if motion is sensed for 5 seconds or more, or if the surgical instrument has moved 5 inches or more. In other aspects, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and to the processor only when the accelerometer button sensor 7405 detects a swinging motion of the surgical instrument. The predetermined threshold reduces unexpected transitions of circuit segments of the surgical instrument. As previously described, the transition may include transitioning to an operating mode in accordance with a power-on sequence, a transition to a low energy mode in accordance with a power-down sequence, or a transition to a sleep mode in accordance with a power-down sequence. In some aspects, the surgical instrument includes an actuator actuatable by a user of the surgical instrument. Actuation is sensed by accelerometer button sensor 7405. The actuator can be a slider, toggle switch or momentary contact switch. Based on the sensed actuation, the accelerometer button sensor 7405 can send a signal to the voltage control circuit 7408 and to the processor.

The boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier (such as a relay or transistor) and is configured to amplify the magnitude of the current of the individual circuit segments. The initial magnitude of the current corresponds to the source voltage supplied by the battery to the segment circuit 7401. Suitable relay systems include solenoids. Suitable transistors include field effect transistors (FETs), MOSFETs and bipolar junction transistors (BJTs). The boost current circuit 7406 can amplify the magnitude of the current corresponding to individual circuit segments or circuits that require more current draw during operation of the surgical instrument 6480 described herein. For example, an increase in current to the motor control circuit section 7428 may be provided when more input power is required by the motor of the surgical instrument. An increase in the current provided to an individual circuit segment may result in a corresponding decrease in the current of another circuit segment or circuit segments. Additionally or alternatively, the increase in current may correspond to the voltage provided by an additional voltage source operating in conjunction with the battery.

The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to supply voltage to or remove voltage from the plurality of circuit sections. The voltage control circuit 7408 is further configured to increase or decrease the voltage provided to the plurality of circuit segments of the segment circuit 7401 . In various aspects, the voltage control circuit 7408 includes combinational logic circuits, such as a multiplexer (MUX) for select inputs, multiple electronic switches, and multiple voltage converters. Electronic switches of the plurality of electronic switches may be configured to switch between open and closed configurations to disconnect or connect individual circuit segments from the battery. The plurality of electronic switches may be solid state devices such as transistors or other types of switches such as wireless switches, ultrasonic switches, accelerometers, inertial sensors, and the like. The combinational logic circuit is configured to select individual electronic switches for switching to an open configuration to enable application of voltages to corresponding circuit segments. The combinational logic circuit is further configured to select individual electronic switches for switching to a closed configuration to enable removal of voltage from the corresponding circuit segment. Combinatorial logic circuits can implement a power-off sequence or power-on sequence by selecting multiple individual electronic switches. Multiple voltage converters may provide boost voltages or buck voltages to multiple circuit segments. The voltage control circuit 7408 may also include a microprocessor and memory devices.

Safety controller 7410 is configured to perform safety checks on circuit segments. In some aspects, the safety controller 7410 performs safety checks when one or more individual circuit segments are in an operational mode. A safety inspection can be performed to determine whether there are any errors or defects in the function or operation of the circuit section. Safety controller 7410 may monitor one or more parameters of the plurality of circuit segments. The security controller 7410 may verify the identity and operation of the plurality of circuit segments by comparing one or more parameters to predefined parameters. For example, if the RF energy modality is selected, the safety controller 7410 may verify that the axis's articulation parameters match the predefined articulation parameters to verify operation of the RF energy modality of the surgical instrument 6480 described herein. In some aspects, the safety controller 7410 can monitor a predetermined relationship between one or more characteristics of the surgical instrument through sensors to detect a malfunction. A failure may occur when one or more characteristics are not consistent with a predetermined relationship. When the safety controller 7410 determines that there is a fault, there is an error, or that some operation of the plurality of circuit sections is not verified, the safety controller 7410 prevents or disables the operation of the particular circuit section that caused the fault, error, or verification failure.

The POST controller 7412 performs POST to verify correct operation of the various circuit segments. In some aspects, a POST is performed on an individual circuit segment of the plurality of circuit segments before the voltage control circuit 7408 applies a voltage to the individual circuit segment to transition the individual circuit segment from a standby mode or a sleep mode to an operating mode . If a single circuit segment fails POST, the particular circuit segment does not transition from standby mode or sleep mode to operational mode. POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses actuation of the handle controls of the surgical instrument 6480 described herein. In some aspects, the POST controller 7412 can transmit a signal to the accelerometer button sensor 7405 to verify the operation of the individual circuit segments that are part of the POST. For example, upon receiving the signal, the accelerometer button sensor 7405 may prompt a user of the surgical instrument to move the surgical instrument to a number of varying positions to ensure operation of the surgical instrument. The accelerometer button sensor 7405 may also monitor the output of a circuit section or circuits of a circuit section that are part of the POST. For example, accelerometer button sensor 7405 may sense incremental motor pulses generated by motor 7432 to verify operation. The motor controller of the motor control circuit 7430 may be used to control the motor 7432 to generate incremental motor pulses.

In various aspects, the surgical instruments 6480 described herein can include additional accelerometer button sensors. The POST controller 7412 may also execute control programs stored in the memory device of the voltage control circuit 7408. The control program may cause the POST controller 7412 to transmit a signal requesting matching encryption parameters from the plurality of circuit segments. Failure to receive matching encryption parameters from individual circuit segments indicates to the POST controller 7412 that the corresponding circuit segment is damaged or malfunctioning. In some aspects, if the POST controller 7412 determines based on the POST that the processor is damaged or malfunctioning, the POST controller 7412 may send a signal to the one or more secondary processors to cause the one or more secondary processors to perform the processing critical functions that the device cannot perform. In some aspects, if the POST controller 7412 determines, based on POST, that one or more circuit segments are not functioning properly, the POST controller 7412 may initiate a correct operation while locking out those circuit segments that failed POST or were not operating properly. Reduced performance mode for those circuit segments. Locking circuit sections may function similarly to circuit sections in standby mode or sleep mode.

The processor circuit section 7414 includes a processor and volatile memory. The processor is configured to initiate a power-up sequence or a power-down sequence. To initiate the power-on sequence, the processor transmits a power-on signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply a voltage to a plurality or subset of the plurality of circuit segments according to the power-on sequence. To initiate the power-down sequence, the processor transmits a power-down signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to remove voltage from a plurality or subset of the plurality of circuit segments according to the power-down sequence.

The handle circuit section 7416 includes a handle control sensor 7418. The handle control sensor 7418 can sense actuation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, the one or more handle controls include clamp controls, release buttons, articulation switches, energy activation buttons, and/or any other suitable handle controls. The user can activate the energy activation button to select between RF energy mode, ultrasonic energy mode, or a combination of RF energy mode and ultrasonic energy mode. The handle control sensor 7418 may also facilitate attachment of the modular handle to a surgical instrument. For example, the handle control sensor 7418 can sense proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to the user of the surgical instrument. The LCD display 7426 may provide a graphical indication of the sensed attachment. In some aspects, the handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor may initiate a power-up sequence or a power-down sequence.

Communication circuit section 7420 includes communication circuit 7422 . The communication circuit 7422 includes a communication interface to facilitate communication of signals between individual circuit segments of the plurality of circuit segments. In some aspects, the communication circuit 7422 provides a path for electrical communication for the modular components of the surgical instrument 6480 described herein. For example, when the modular shaft and modular transducer are attached together to the handle of a surgical instrument, a control program can be uploaded to the handle through the communication circuit 7422.

Display circuit section 7424 includes LCD display 7426. LCD display 7426 may include a liquid crystal display, LED indicators, and the like. In some aspects, the LCD display 7426 is an organic light emitting diode (OLED) screen. The display can be placed on the surgical instrument 6480 described herein, embedded in or positioned away from the surgical instrument. For example, a display can be placed on the handle of a surgical instrument. The display is configured to provide sensory feedback to the user. In various aspects, the LCD display 7426 also includes a backlight. In some aspects, the surgical instrument may also include audio feedback devices such as speakers or buzzers and haptic feedback devices such as haptic actuators.

Motor control circuit section 7428 includes motor control circuit 7430 coupled to motor 7432 . Motor 7432 is coupled to the processor through drivers and transistors such as FETs. In various aspects, the motor control circuit 7430 includes a motor current sensor in signal communication with the processor to provide a signal to the processor indicative of a measure of current draw of the motor. The processor transmits the signal to the display. The display receives the signal and displays a measurement of the current draw of the motor 7432. The processor may, for example, use this signal to monitor that the current draw of the motor 7432 is within acceptable ranges, to compare the current draw to one or more parameters of the plurality of circuit segments, and to determine one or more of the patient treatment sites parameter. In various aspects, the motor control circuit 7430 includes a motor controller for controlling operation of the motor. For example, the motor control circuit 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of the motor 7432. This adjustment is done based on measuring the current through the motor 7432 by the motor current sensor.

In various aspects, the motor control circuit 7430 includes force sensors to measure the force and torque generated by the motor 7432. Motor 7432 is configured to actuate the mechanisms of surgical instrument 6480 described herein. For example, the motor 7432 is configured to control actuation of the shaft of the surgical instrument for gripping, rotation and articulation functions. For example, the motor 7432 can actuate a shaft to effect a gripping motion with the jaws of a surgical instrument. The motor controller can determine whether the material held by the jaws is tissue or metal. The motor controller can also determine how well the jaws grip the material. For example, the motor controller may determine how the jaws are opened or closed based on the sensed motor current or derivative of the motor voltage. In some aspects, the motor 7432 is configured to actuate the transducer to apply torque to the handle or to control the articulation of the surgical instrument. The motor current sensor can interact with the motor controller to set the motor current limit. When the current meets a predefined threshold limit, the motor controller initiates a corresponding change in motor control operation. For example, exceeding the motor current limit causes the motor controller to reduce the current draw of the motor.

The energy processing circuit section 7434 includes RF amplifier and safety circuits 7436 and ultrasonic signal generator circuit 7438 to implement the energy modularization functionality of the surgical instrument 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 is configured to control the RF modality of the surgical instrument by generating RF signals. The ultrasonic signal generator circuit 7438 is configured to control the ultrasonic energy modality by generating ultrasonic signals. The RF amplifier and safety circuit 7436 and the ultrasonic signal generator circuit 7438 may operate in conjunction to control the combination of RF energy modalities and ultrasonic energy modalities.

Shaft circuit section 7440 includes shaft module controller 7442 , modular control actuators 7444 , one or more end effector sensors 7446 and non-volatile memory 7448 . The axis module controller 7442 is configured to control a plurality of axis modules including control programs to be executed by the processor. The multiple shaft module implements shaft modalities such as ultrasound, a combination of ultrasound and RF, RF I-knife and RF opposable jaws. The axis module controller 7442 can select the axis modality for execution by the processor by selecting the corresponding axis module. The modular control actuator 7444 is configured to actuate the axis modally according to the selected axis. After initiation of actuation, the shaft articulates the end effector according to one or more parameters, routines or programs specific to the selected shaft modality and the selected end effector modality. The one or more end effector sensors 7446 located at the end effector may include force sensors, temperature sensors, current sensors, or motion sensors. One or more end effector sensors 7446 transmit data regarding one or more operations of the end effector based on the energy modality implemented by the end effector. In various aspects, the energy modality includes an ultrasonic energy modality, an RF energy modality, or a combination of an ultrasonic energy modality and an RF energy modality. The non-volatile memory 7448 stores the axis control program. A control program includes one or more parameters, routines, or programs specific to an axis. In various aspects, non-volatile memory 7448 may be ROM, EPROM, EEPROM, or flash memory. Non-volatile memory 7448 stores a shaft module corresponding to the selected shaft of surgical instrument 6480 described herein. The shaft module may be changed or upgraded in non-volatile memory 7448 by the shaft module controller 7442, depending on the surgical instrument shaft to be used in the operation.

50 is a schematic diagram of circuitry 7925 of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein includes a drive mechanism 7930 configured as a drive shaft and/or gear member in order to perform various operations associated with the surgical instrument 6480. In one aspect, the drive mechanism 7930 includes a rotational drivetrain 7932 configured to rotate the end effector relative to the handle housing, eg, about a longitudinal axis. The drive mechanism 7930 also includes a closing powertrain 7934 configured to close the jaw members to grasp tissue with the end effector. Additionally, the drive mechanism 7930 includes a firing drivetrain 7936 configured to open and close the gripping arm portion of the end effector to grasp tissue with the end effector.

The drive mechanism 7930 includes a selector gearbox assembly 7938 that can be located in the handle assembly of the surgical instrument. Proximate the selector gearbox assembly 7938 is a function selection module that includes a first motor 7942 for selectively moving gear elements within the selector gearbox assembly 7938 to selectively transmit power One of the systems 7932, 7934, 7936 is positioned as an input to an optional second motor 7944 and motor drive circuit 7946 (shown in dashed lines to indicate that the second motor 7944 and motor drive circuit 7946 are optional components) The drive components are engaged.

Still referring to FIG. 50, the motors 7942, 7944 are coupled to motor control circuits 7946, 7948, respectively, which are configured to control the operation of the motors 7942, 7944, including the flow of electrical energy from the power source 7950 to the motors 7942, 7944. The power source 7950 may be a DC battery (eg, a rechargeable lead-based, nickel-based, lithium-ion-based battery, etc.), or any other power source suitable for providing electrical power to a surgical instrument.

The surgical instrument also includes a microcontroller 7952 ("controller"). In some cases, the controller 7952 may include a microprocessor 7954 ("processor") and one or more computer-readable media or memory units 7956 ("memory"). In some cases, memory 7956 may store various program instructions that, when executed, may cause processor 7954 to perform various functions and/or calculations described herein. Power source 7950 may be configured to supply power to controller 7952, for example.

The processor 7954 can communicate with the motor control circuit 7946. Additionally, memory 7956 may store program instructions that, when executed by processor 7954 in response to user input 7958 or feedback element 7960, may cause motor control circuitry 7946 to actuate motor 7942 to generate at least one rotational motion to cause selector gear Gear elements within the case assembly 7938 are selectively moved to selectively position and move one of the powertrains 7932 , 7934 and 7936 into engagement with the input drive member of the second motor 7944 . Additionally, the processor 7954 can communicate with the motor control circuit 7948. The memory 7956 may also store program instructions that, when executed by the processor 7954 in response to user input 7958, cause the motor control circuit 7948 to actuate the motor 7944 to generate at least one rotational motion to drive, for example, a rotational movement with the second motor 7948. The drivetrain with the input drive components engaged.

Controller 7952 and/or other controllers of the present disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, microcontrollers, on-chip System (SoC), and/or Single In-Line Package (SIP). Examples of discrete hardware elements may include circuits and/or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In some cases, for example, the controller 7952 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates.

软件的内部ROM、2KB的EEPROM、一个或多个PWM模块、一个或多个QEI模拟、具有12个模拟输入信道的一个或多个12位ADC、以及易得的其它特征件。可很方便地换用其它微控制器，来与本公开联合使用。因此，本公开不应限于这一上下文。In some cases, the controller 7952 and/or other controllers of the present disclosure may be, for example, a LM 4F230H5QR available from Texas Instruments. In some cases, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) on-chip memory, prefetch for improved performance above 40MHz buffer, 32KB of single-cycle SRAM, loaded with

Internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers can easily be exchanged for use in conjunction with the present disclosure. Therefore, the present disclosure should not be limited in this context.

In various cases, one or more of the various steps described herein may be performed by a finite state machine including a combinational or sequential logic circuit coupled to at least one memory circuit. At least one storage circuit stores the current state of the finite state machine. Combinatorial or sequential logic circuits are configured to enable finite state machines to reach these steps. Sequential logic circuits may be synchronous or asynchronous. In other cases, for example, one or more of the various steps described herein may be performed by circuitry including a combination of processor 7958 and a finite state machine.

In various circumstances, it may be advantageous to be able to assess the functional status of a surgical instrument to ensure that it is functioning properly. For example, the drive mechanisms described above (configured to include various motors, drivetrains, and/or gear components in order to perform various operations of the surgical instrument) may wear out over time. This can occur in normal use, and in some cases the drive mechanism may wear out faster due to abuse. In some cases, the surgical instrument may be configured to perform a self-assessment to determine the status (eg, health) of the drive mechanism and its various components.

For example, a self-assessment can be used to determine when a surgical instrument is able to perform its function or when some of the components should be replaced and/or repaired prior to re-sterilization. Evaluation of the drive mechanism and its components, including but not limited to the rotary driveline 7932, the closing driveline 7934, and/or the firing driveline 7936, can be accomplished in various ways. The magnitude of the deviation from the predicted performance can be used to determine the likelihood of a sensed failure and the severity of such failure. Several metrics are available, including: periodic analysis of repeatable predictable events, spikes or dips above expected thresholds, and width of failures.

In various cases, characteristic waveforms of a normally functioning drive mechanism or one or more components thereof may be used to assess the state of the drive mechanism or one or more components thereof. One or more vibration sensors may be positioned relative to the normally functioning drive mechanism or one or more components thereof to record various vibrations that occur during operation of the normally functioning drive mechanism or one or more components thereof. The recorded vibrations can be used to create characteristic waveforms. Future waveforms can be compared to characteristic waveforms to assess the state of the drive mechanism and its components.

Still referring to FIG. 50 , the surgical instrument 7930 includes a powertrain failure detection module 7962 configured to record and analyze one or more acoustic outputs of one or more of the powertrains 7932 , 7934 and/or 7936 . The processor 7954 can communicate with or otherwise control the module 7962. As described in more detail below, the modules 7962 may be embodied as various means, such as circuitry, hardware, computer program products including computer-readable storage of computer-readable program instructions executable by a processing device (eg, the processor 7954) media (eg, memory 7956)), or some combination thereof. In some aspects, processor 36 may include module 7962 or otherwise control this module.

Turning now to FIG. 51 , end effector 8400 includes RF data sensors 8406 , 8408a , 8408b located on jaw member 8402 . End effector 8400 includes jaw member 8402 and ultrasonic blade 8404. Jaw member 8402 is shown gripping tissue 8410 located between jaw member 8402 and ultrasonic blade 8404. The first sensor 8406 is located in the central portion of the jaw member 8402. The second sensor 8408a and the third sensor 8408b are located on the lateral portion of the jaw member 8402. The sensors 8406, 8408a, 8408b are mounted or integral with a flex circuit 8412 (shown more particularly in FIG. 52) that is configured to be fixedly mounted to the jaw member 8402.

End effector 8400 is an example end effector for a surgical instrument. Sensors 8406, 8408a, 8408b are electrically connected to a control circuit such as control circuit 7400 (FIG. 63) via interface circuits. The sensors 8406, 8408a, 8408b are battery powered and the signals generated by the sensors 8406, 8408a, 8408b are provided to the analog and/or digital processing circuitry of the control circuitry.

In one aspect, the first sensor 8406 is a force sensor for measuring the normal force F3 applied to the tissue 8410 by the jaw member 8402. The second sensor 8408a and the third sensor 8408b include one or more elements for applying RF energy to the tissue 8410, measuring parameters such as tissue impedance, downward force Fl, lateral force F2, and temperature. Electrodes 8409a, 8409b are electrically coupled to a power source and apply RF energy to tissue 8410. In one aspect, the first sensor 8406 and the second sensor 8408a and the third sensor 8408b are strain gauges for measuring force or force per unit area. It will be appreciated that the measurements of downward force Fl, lateral force F2, and normal force F3 can be easily converted to pressure by determining the surface area on which the force sensors 8406, 8408a, 8408b act. Additionally, as specifically described herein, the flex circuit 8412 may include temperature sensors embedded in one or more layers of the flex circuit 8412. One or more temperature sensors can be arranged symmetrically or asymmetrically and provide temperature feedback of the tissue 8410 to the ultrasound drive circuit and the control circuit of the RF drive circuit.

FIG. 52 shows an aspect of the flex circuit 8412 shown in FIG. 51, wherein the sensors 8406, 8408a, 8408b may be mounted to or formed integrally with the flex circuit. The flex circuit 8412 is configured to be fixedly attached to the jaw member 8402. As shown in particular in Figure 52, asymmetric temperature sensors 8414a, 8414b are mounted to the flex circuit 8412 to be able to measure the temperature of tissue 8410 (Figure 51).

FIG. 53 is an alternative system 132000 for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system 132002 in accordance with at least one aspect of the present disclosure. System 132000 can be incorporated into a generator. The processor 132004 coupled to the memory 132026 programs the programmable counter 132006 to tune to the output frequency _fo of the ultrasound electromechanical system 132002. The input frequency is generated by crystal oscillator 132008 and input into fixed counter 132010 to scale the frequency to an appropriate value. The outputs of fixed counter 132010 and programmable counter 132006 are applied to phase/frequency detector 132012. The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a tuning voltage _Vt that is applied to a voltage controlled oscillator 132016 (VCO). The VCO 132016 applies the output frequency _fo to the ultrasound transducer portion of the ultrasound electromechanical system 132002, which is modeled as an equivalent circuit as shown herein. The voltage and current signals applied to the ultrasound transducer are monitored by voltage sensor 132018 and current sensor 132020.

The outputs of voltage sensor 132018 and current sensor 132020 are applied to another phase/frequency detector 132022 to determine the phase angle between the voltage and current as measured by voltage sensor 132018 and current sensor 13020. The output of the phase/frequency detector 132022 is applied to one channel of a high speed analog-to-digital converter 132024 (ADC) and provided to the processor 132004 therethrough. Optionally, the outputs of voltage sensor 132018 and current sensor 132020 may be applied to respective channels of dual-channel ADC 132024 and provided to processor 132004 for zero-crossing, FFT, or other algorithms described herein for determining the applied Phase angle between the voltage signal and the current signal to the ultrasound electromechanical system 132002.

Optionally the tuning voltage V _t (which is proportional to the output frequency f _o ) can be fed back to the processor 132004 via the ADC 132024 . This will provide a feedback signal proportional to the output frequency _fo to the processor 132004, and this feedback can be used to adjust and control the output frequency _fo .

Estimation of jaw status (pad burn-through, nails, breaking knife, bone in jaws, tissue in jaws)

The challenge with ultrasonic energy delivery is that applying ultrasonic sound to the wrong material or to the wrong tissue can lead to device failure, such as burn-through of the jaw pad or fracture of the ultrasonic blade. It is also desirable to detect what is in the jaws of the end effector of an ultrasound device and the state of the jaws without adding additional sensors in the jaws. Positioning the sensor in the jaws of an ultrasonic end effector presents reliability, cost, and complexity challenges.

来估计钳口的状态(夹持臂垫烧穿、钉、断裂刀、钳口中的骨、钳口中的组织、钳口闭合时的背切等)。绘制阻抗Z_g(t)、量值|Z|和相位

作为频率f的函数。In accordance with at least one aspect of the present disclosure, an ultrasonic spectral smart blade algorithm technique may be employed based on the impedance of an ultrasonic transducer configured to drive an ultrasonic transducer blade

to estimate the state of the jaws (clamp arm pad burn-through, nails, breaking knives, bone in the jaws, tissue in the jaws, dorsal cuts when the jaws are closed, etc.). Plot impedance Z _g (t), magnitude |Z| and phase

as a function of frequency f.

Dynamic Mechanical Analysis (DMA, also known as Dynamic Mechanical Spectroscopy or simply Mechanical Spectroscopy) is a technique used to study and characterize materials. Applying a sinusoidal stress to a material and measuring the strain in the material allows the complex modulus of the material to be determined. Spectroscopy applied to ultrasound devices consists of exciting the tip of the ultrasonic blade by a frequency sweep (composite signal or conventional frequency sweep) and measuring the complex impedance produced at each frequency. Complex impedance measurements of ultrasonic transducers over a range of frequencies are used in classifiers or models to infer characteristics of ultrasonic end effectors. In one aspect, the present disclosure provides a method for determining the state of an ultrasonic end effector (clamping arms, jaws) to drive automation in an ultrasonic device (such as disabling power to protect the device, executing adaptive algorithms, retrieving information , identifying organizations, etc.).

被绘制为频率f的函数。光谱图132030在三维空间中绘制，其中频率(Hz)沿x轴绘制，相位(Rad)沿y轴绘制，量值(欧姆)沿z轴绘制。54 is a spectrum 132030 of an ultrasound device having a variety of different states and conditions of an end effector with impedance _Zg (t), magnitude |Z| and phase in accordance with at least one aspect of the present disclosure

is plotted as a function of frequency f. Spectrogram 132030 is plotted in three-dimensional space with frequency (Hz) plotted along the x-axis, phase (Rad) plotted along the y-axis, and magnitude (ohms) plotted along the z-axis.

Spectral analysis of different jaw engagements and device states yields different complex impedance signature patterns (fingerprints) across frequency ranges for different conditions and states. When plotted, each state or condition has a different pattern of features in 3D space. These characteristic patterns can be used to estimate the condition and state of the end effector. FIG. 54 shows the spectra of air 132032, clamp arm pad 132034, chamois 132036, nail 132038, and breaking knife 132040. Antelope Skin 132036 can be used to characterize different types of tissue.

The spectrogram 132030 can be evaluated by applying a low power electrical signal on the ultrasound transducer to generate non-therapeutic excitation of the ultrasound blade. Low power electrical signals can be applied in the form of swept or complex Fourier series to measure impedance on ultrasound transducers in series (sweep) or parallel (composite signal) frequency range using FFT

How to classify new data

For each feature pattern, a parametric line can be fitted to the data used for training using a polynomial, Fourier series, or any other form of parametric formulation that is convenient. A new data point is then received and classified by using the Euclidean vertical distance from the new data point to the trajectories that have been fitted to the feature pattern training data. The vertical distance of this new data point to each trajectory (each trajectory representing a different state or condition) is used to assign the point to a certain state or condition.

The probability distribution of the distance of each point in the training data from the fitted curve can be used to estimate the probability of a correctly classified new data point. This essentially constructs a two-dimensional probability distribution in a plane perpendicular to the fitted trajectory at each new data point of the fitted trajectory. The new data point can then be included in the training set based on its probability of correct classification to form an adaptive learning classifier that can easily detect high-frequency changes in state but can adapt to slow-occurring biases in system performance , such as a dirty unit or worn pads.

被绘制为频率f的函数。3D训练数据集(S)曲线132042在三维空间中以图形方式描绘，其中相位(Rad)沿x轴绘制，频率(Hz)沿y轴绘制，量值(欧姆)沿z轴绘制，并且参数傅立叶级数被拟合到3D训练数据集(S)。用于数据分类的方法基于3D训练数据集(S0用于生成曲线图132042)。55 is a graphical representation of a graph 132042 of a set of 3D training data sets (S) with ultrasound transducer impedance _Zg (t), magnitude |Z| and phase in accordance with at least one aspect of the present disclosure

is plotted as a function of frequency f. 3D training data set (S) curve 132042 is graphically depicted in three-dimensional space with phase (Rad) plotted along the x-axis, frequency (Hz) along the y-axis, magnitude (ohms) along the z-axis, and the parametric Fourier The series are fitted to the 3D training dataset (S). The method for data classification is based on the 3D training dataset (S0 is used to generate the graph 132042).

The parametric Fourier series fitted to the 3D training dataset (S) is given by:

从

到

的垂直距离由下式找到：for new points

from

arrive

The vertical distance of is found by:

when:

but:

D=D _⊥

的概率。The probability distribution D can be used to estimate the data points belonging to group S

The probability.

control

Based on the classification of data measured before, during or after activation of the ultrasound transducer/knife, a variety of automated tasks and safety measures can be implemented. Similarly, the state of the tissue located in the end effector and the temperature of the ultrasonic blade can also be inferred to some extent and used to better inform the user of the state of the ultrasonic device or protect critical structures, etc. In commonly owned U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR, which is incorporated by reference Incorporated herein in its entirety), temperature control of the ultrasonic blade is described.

Similarly, power can be reduced when the ultrasonic blade has a high probability of contacting the clamp arm pads (eg, there is no tissue between them), or if the ultrasonic blade is likely to have broken or if the ultrasonic blade is likely to contact metal (eg, nails) deliver. In addition, if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad, no reverse cutting is allowed.

Integrate other data to improve classification

The system can be used in conjunction with other information provided by sensors, users, patient metrics, environmental factors, etc. by combining the data from the process with the aforementioned data through the use of probability functions and Kalman filters. Given a large number of uncertain measurements with varying degrees of confidence, the Kalman filter determines the maximum likelihood that a state or condition will occur. Since this method allows probabilities to be assigned to newly classified data points, the information of the algorithm can be implemented using other measurements or estimates in the Kalman filter.

56 is a logic flow diagram 132044 depicting a control program or logic configuration for determining a jaw condition based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure. Before determining the jaw condition based on the complex impedance characteristic pattern (fingerprint), use a reference complex impedance characteristic pattern or a training data set (S) characterizing various jaw conditions (including but not limited to Air 132032, Clamp Arm Pads 132034, Antelope Skins 132036, Nails 132038, Break Knives 132040, and various tissue types and conditions) populate the database. Antelope hides (dry or wet, whole bytes or ends) can be used to characterize different types of tissue. The data points used to generate the reference complex impedance signature pattern or training data set (S) are obtained by applying a sub-therapy drive signal to the ultrasound transducer, sweeping the drive frequency from below resonance to above resonance over a predetermined range of frequencies, measuring Complex impedance at each frequency and record data points. The data points are then fitted to a curve using a variety of numerical methods including polynomial curve fitting, Fourier series and/or parametric formulations. This paper describes a parametric Fourier series fitted to a reference complex impedance feature pattern or training dataset (S).

Once the reference complex impedance signature pattern or training data set (S) is generated, the ultrasound instrument measures new data points, classifies the new points, and determines whether the new data points should be added to the reference complex impedance signature pattern or training data set(s).

处理器或控制电路接收132048复阻抗测量数据点，并将该复阻抗测量数据点与参考复阻抗特征图案中的数据点进行比较132050。处理器或控制电路基于比较分析的结果对该复阻抗测量数据点进行分类132052，并基于比较分析的结果分配132054端部执行器的状态。Turning now to the logic flow diagram of FIG. 56, in one aspect, the processor or control circuit measures 132046 the complex impedance of the ultrasound transducer, where the complex impedance is defined as

The processor or control circuit receives 132048 complex impedance measurement data points and compares 132050 the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern. The processor or control circuit classifies 132052 the complex impedance measurement data points based on the results of the comparative analysis and assigns 132054 the state of the end effector based on the results of the comparative analysis.

被绘制为频率f的函数。曲线拟合包括多项式曲线拟合、傅立叶级数和/或参数公式。In one aspect, the processor or control circuit receives the reference complex impedance characteristic pattern from a database or memory coupled to the processor. In one aspect, a processor or control circuit generates a reference complex impedance characteristic pattern as follows. A drive circuit coupled to the processor or control circuit applies a non-therapeutic drive signal to the ultrasound transducer, the non-therapeutic drive signal starting at an initial frequency, ending at a final frequency, and at frequencies in between. A processor or control circuit measures the impedance of the ultrasound transducer at each frequency and stores data points corresponding to each impedance measurement. The processor or control circuit curve-fits multiple data points to generate a three-dimensional curve representing a reference complex impedance characteristic pattern, where magnitude |Z| and phase

is plotted as a function of frequency f. Curve fitting includes polynomial curve fitting, Fourier series and/or parametric formulations.

In one aspect, a processor or control circuit receives a new impedance measurement data point and uses the Euclidean vertical distance from the new impedance measurement data point to the locus that has been fitted to the reference complex impedance signature pattern to update the new impedance measurement data point. The impedance measurement data points are classified. The processor or control circuit estimates the probability of correct classification of the new impedance measurement data point. The processor or control circuit adds the new impedance measurement data point to the reference complex impedance feature pattern based on the estimated probability of correctly classifying the new impedance measurement data point. In one aspect, the processor or control circuit classifies the data based on a training data set (S), wherein the training data set (S) includes a plurality of complex impedance measurements, and the curve uses a parametric Fourier series to fit the training data Set (S), where S is defined herein, and where probability distributions are used to estimate the probability of new impedance measurement data points belonging to group S.

Model-Based Jaw Classifier State

There has been interest in classifying substances, including the type and condition of tissue, located within the jaws of ultrasound devices. In various aspects, it can be shown that with high data sampling and fine pattern recognition, such classification is possible. The method is based on impedance as a function of frequency (where magnitude, phase and frequency are plotted in 3D, the pattern looks like the bands shown in FIGS. 54 and 55 ) and the logic flow diagram of FIG. 56 . The present disclosure provides an alternative smart knife algorithmic approach based on mature models for piezoelectric transducers.

For example, an equivalent electrical lumped parameter model is known to be an accurate model of a physical piezoelectric transducer. It is based on the Mittag-Leffler expansion of tangents near mechanical resonance. A circle is formed when the complex impedance or complex admittance is plotted as the relationship between the imaginary and real components. 57 is a graph 132056 of complex impedance plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure. 58 is a graph 132058 of complex admittance plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure. The circles depicted in Figures 57 and 58 are taken from the IEEE 177 standard, which is incorporated herein by reference in its entirety. Tables 1-4 are taken from the IEEE 177 standard and are disclosed herein for completeness.

A circle is formed when the frequency sweeps from below resonance to above resonance. Instead of extruding the circle in 3D, determine the circle and estimate the radius (r) and offset (a, b) of the circle. These values are then compared to established values for the given conditions. These conditions could be: 1) the jaws are open and nothing, 2) the ends are engaged, 3) the jaws are fully engaged and have nails. If the scan generates multiple resonances, there will be a different characteristic circle for each resonance. If the resonances are separated, each circle will be drawn before the next. Instead of fitting a 3D curve with a series of approximations, fit a circle to the data. The radius (r) and offset (a, b) can be calculated using a processor programmed to perform various mathematical or numerical techniques described below. These values can be estimated by capturing an image of the circle, and using image processing techniques to estimate the radius (r) and offset (a, b) that define the circle.

59 is a graph 132060 of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer with lumped parameter input and output specified below. The values of the lumped parameter model are used to generate the complex admittance. Apply a moderate load to the model. The resulting admittance circle generated in MathCad is shown in Figure 59. When the frequency is swept from 54kHz to 58kHz, a circle graph 132060 is formed.

The lumped parameter input values are:

Co=3.0nF

Cs=8.22pF

Ls=1.0H

Rs=450Ω

The output of the model based on the input is:

The output values were used to draw the circle graph 132060 shown in Figure 59. The circle graph 132060 has a radius (r) and the center 132062 is offset (a, b) from the origin 132064 as follows:

r=1.012*10 ³

a=1.013*10 ³

b=-954.585

In accordance with at least one aspect of the present disclosure, the sums A-E specified below are required to estimate the circle chart 132060 of the example given in FIG. 59 . Several algorithms exist to compute the fit to the circle. A circle is defined by its radius (r) and center offset (a, b) from the origin:

r ² =(xa) ² +(yb) ²

The modified least squares method (Umbach and Jones) is convenient because simple closed-form solutions exist for a, b, and r.

The caret on the variable "a" represents an estimate of the true value. A, B, C, D and E are the sum of various products calculated from the data. For completeness, they are included in this article as follows:

Z1,i is the first vector of the real component, called conductance;

Z2,i is the second vector of the imaginary component, called susceptance; and

Z3,i is the third vector, representing the frequency at which the admittance is calculated.

The present disclosure will apply to ultrasound systems and possibly to electrosurgical systems, even though electrosurgical systems do not rely on resonance.

60-64 show images acquired from an impedance analyzer showing impedance/admittance diagrams of an ultrasound device with the end effector jaws in various open or closed configurations and loads. In accordance with at least one aspect of the present disclosure, the circle graph in the form of solid lines depicts impedance and the circle diagram in dashed line form depicts admittance. For example, an impedance/admittance diagram is generated by connecting an ultrasound device to an impedance analyzer. Sets the impedance analyzer display to complex impedance and complex admittance, which can be selected from the impedance analyzer's front panel. For example, as described below in connection with FIG. 60, an initial display may be obtained with the jaws of the ultrasonic end effector in the open position and the ultrasonic device in an unloaded state. The impedance analyzer's auto-zoom display can be used to generate complex impedance and admittance plots. The same display is used for subsequent runs of the ultrasound device with different load conditions, as shown in subsequent Figures 60-64. Data files can be uploaded using the LabVIEW application. In another technique, a display image may be captured using a camera, such as a smartphone camera (like an iPhone or Android). As such, the display's image may include some "keystone distortion" and may generally appear not parallel to the screen. Using this technique, the traces of the circle chart on the display will appear distorted in the captured image. Using this method, the material located in the jaws of the ultrasonic end effector can be classified.

Complex impedance and complex admittance are the reciprocals of each other. No new information can be added by observing both. Another consideration includes determining how sensitive an estimate is to noise when using complex impedance or complex admittance.

In the examples shown in Figures 60-64, the scope of the impedance analyzer is set to capture only the main resonance. By sweeping over a wider range of frequencies, more resonances may be encountered and multiple circles can be formed. The equivalent circuit of the ultrasound transducer can be created by a first "dynamic" branch with series connected inductance Ls, resistance Rs and capacitance Cs (which define the electromechanical properties of the resonator) and a second capacitive branch with static capacitance C0 model. In the impedance/admittance diagram shown in the next 60-64, the component values of the equivalent circuit are:

Ls=L1=1.1068H

Rs=R1=311.352Ω

Cs=C1=7.43265pF

C0=C0=3.64026nF

The oscillator voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500μS/div. Measurements that characterize the values of the impedance (Z) and admittance (Y) charts can be obtained at the locations on the chart indicated by the impedance and admittance cursors.

The state of the jaws: open and no load

60 is a graphical display 132066 of an impedance analyzer showing complex impedance (Z)/admittance (Y) graphs 132068, 132070 for an open-jawed and unloaded ultrasound device, in accordance with at least one aspect of the present disclosure, Graph 132068 in the form of a solid line depicts the complex impedance, and graph 132070 in the form of a dashed line depicts the complex admittance. The oscillator voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500μS/div. Measurements that can characterize the values of the complex impedance (Z) and complex admittance (Y) charts 132068 , 132070 can be obtained at the locations indicated by the impedance cursors 132072 and admittance cursors 132074 on the charts 132068 , 132070 . Thus, impedance cursor 132072 is located at a portion of impedance chart 132068 equal to approximately 55.55 kHz, and admittance cursor 132074 is located at a portion of admittance chart 132070 equal to approximately 55.29 kHz. As depicted in Figure 60, the position of the impedance cursor 132072 corresponds to the following values:

R=1.66026Ω

X=-697.309Ω

where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the following values:

G=64.0322μS

B=1.63007mS

where G is conductance (real value) and B is susceptance (imaginary value).

Condition of jaws: clamped on dry chamois

61 is a graphical display 132076 of an impedance analyzer showing the complex impedance (Z)/admittance of an ultrasound device with the jaws of the end effector clamped on dry chamois, according to at least one aspect of the present disclosure (Y) Graphs 132078, 132080, with impedance graph 132078 shown in solid lines and admittance graph 132080 shown in dashed lines. The voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500μS/div.

Measurements that characterize the values of the complex impedance (Z) and complex admittance (Y) charts 132078 , 132080 may be obtained at the locations indicated by the impedance cursors 132082 and admittance cursors 132084 on the charts 132078 , 132080 . Thus, impedance cursor 132082 is located at a portion of impedance diagram 132078 equal to approximately 55.68 kHz, and admittance cursor 132084 is located at a portion of admittance diagram 132080 equal to approximately 55.29 kHz. As depicted in Figure 61, the position of the impedance cursor 132082 corresponds to the following values:

R=434.577Ω

X=-758.772Ω

where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132084 corresponds to the following values:

G=85.1712μS

B=1.49569mS

where G is conductance (real value) and B is susceptance (imaginary value).

Condition of the jaws: the ends are clamped to the wet chamois hide

62 is a graphical display 132086 of an impedance analyzer showing the complex impedance (Z)/admittance (Y) circle of an ultrasound device with jaw tips clamped on wet chamois hides in accordance with at least one aspect of the present disclosure Graphs 132098, 132090, where the impedance graph 132088 is shown in solid lines and the admittance graph 132090 is shown in dashed lines. The voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500μS/div.

Measurements that characterize the values of the complex impedance (Z) and complex admittance (Y) charts 132088, 132090 can be obtained at the locations indicated by the impedance cursor 132092 and admittance cursor 132094 on the charts 132088, 132090. Thus, impedance cursor 132092 is located at a portion of impedance diagram 132088 equal to approximately 55.68 kHz, and admittance cursor 132094 is located at a portion of admittance diagram 132090 equal to approximately 55.29 kHz. As depicted in Figure 63, the impedance cursor 132092 corresponds to the following values:

R=445.259Ω

X=-750.082Ω

where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, admittance cursor 132094 corresponds to the following values:

G=96.2179μS

B=1.50236mS

where G is conductance (real value) and B is susceptance (imaginary value).

Condition of jaws: fully gripped on wet chamois

63 is a graphical display 132096 of an impedance analyzer showing a complex impedance (Z)/admittance (Y) circle for an ultrasound device with jaws fully clamped on wet chamois, according to at least one aspect of the present disclosure Graphs 132098, 132100, where the impedance graph 132098 is shown in solid lines and the admittance graph 132100 is shown in dashed lines. The voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500μS/div.

Measurements that characterize the values of the impedance and admittance charts 132098, 132100 can be obtained at the locations indicated by the impedance cursor 13212 and admittance cursor 132104 on the charts 132098, 1332100. Thus, impedance cursor 132102 is located at a portion of impedance chart 132098 equal to approximately 55.63 kHz, and admittance cursor 132104 is located at a portion of admittance chart 132100 equal to approximately 55.29 kHz. As depicted in Figure 63, impedance cursor 132102 corresponds to the value of resistance R (real value, not shown) and the value of reactance X (imaginary value, also not shown).

Similarly, admittance cursor 132104 corresponds to the following values:

G=137.272μS

B=1.48481mS

where G is conductance (real value) and B is susceptance (imaginary value).

The state of the jaws: open and no load

64 is a graphical display 132106 of an impedance analyzer showing an impedance (Z)/admittance (Y) graph with frequency swept from 48 kHz to 62 kHz to capture jaws open and Multiple resonances of an unloaded ultrasound device, where the area represented by rectangle 132108 shown in dashed lines is to aid in viewing the impedance diagrams 132110a, 132110b, 132110c and admittance diagrams 132112a, 132112b, 132112c shown in solid lines . The voltage applied to the ultrasound transducer was 500 mV and the frequency was swept from 48 kHz to 62 kHz. The impedance (Z) scale is 500Ω/div and the admittance (Y) scale is 500μS/div.

Measurements that characterize the values of the impedance and admittance circles 132110a-c, 132112a-c may be obtained at the locations indicated by the impedance and admittance cursors 132114 and 132116 on the impedance and admittance circles 132110a-c, 132112a-c . Thus, impedance cursor 132114 is located at a portion of impedance plots 132110a-c equal to about 55.52 kHz, and admittance cursor 132116 is located at a portion of admittance plots 132112a-c equal to about 59.55 kHz. As depicted in Figure 64, impedance cursor 132114 corresponds to the following values:

R=1.86163kΩ

X=-536.229Ω

where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, admittance cursor 132116 corresponds to the following values:

G=649.956μS

B=2.51975mS

where G is conductance (real value) and B is susceptance (imaginary value).

Because there are only 400 samples over the entire scan range of the impedance analyzer, there are only a few points about resonance. Therefore, the circle on the right becomes irregular. But that's only because of the impedance analyzer and the setup used to cover multiple resonances.

When there are multiple resonances, more information is available to improve the classifier. Graph 132110a-c, 132112a-c fits can be calculated for each resonance encountered to keep the algorithm running fast. Therefore, once there is an intersection of complex admittances (representing a circle) during the scan, the fit can be calculated.

Benefits include data-based in-jaw classifiers and well-known models of ultrasound systems. Counting and characteristics of circles are well known in the visual system. Therefore, data processing is easy. For example, there is a closed-form solution that calculates the radius and axis offset of a circle. This technique can be relatively fast.

Table 2 is a list of symbols for lumped parameter models for piezoelectric transducers (from the IEEE 177 standard).

Table 2

Table 3 is a list of symbols for transport networks (from the IEEE 177 standard).

* refers to real roots; complex roots are ignored.

table 3

Table 4 is a list of solutions for various eigenfrequency (from the IEEE 177 standard).

Solutions for various eigenfrequencies

* refers to real roots; complex roots are ignored

Table 4

Table 5 is the loss of three types of piezoelectric materials.

Minimum value of ratio Q ^r /r expected for various types of piezoelectric vibrators

table 5

Table 6 shows the jaw conditions, i.e. based on real-time measurements of the complex impedance/admittance, radius (re) and offset (ae and be) of the circle represented by the measured variables Re, Ge, Xe, Be Estimated parameters, and parameters of the reference circle graph based on real-time measurements of the complex impedance/admittance, radius (rr) and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref, as described in Figures 60-64. These values are then compared to established values for the given conditions. These conditions could be: 1) the jaws are open and nothing, 2) the ends are engaged, 3) the jaws are fully engaged and have nails. The equivalent circuit of the ultrasonic transducer is modeled as follows, and the frequency is swept from 55kHz to 56kHz:

Ls=L1=1.1068H

Rs=R1=311.352Ω

Cs=C1=7.43265pF, and

C0=C0=3.64026nF.

Table 6

In use, the ultrasonic generator scans the frequency, records the measured variables, and determines the estimated values Re, Ge, Xe, Be. These estimates are then compared to reference variables Rref, Gref, Xref, Bref stored in memory (eg, in a look-up table) and the jaw condition is determined. The reference jaw conditions shown in Table 6 are examples only. More or fewer reference jaw conditions can be sorted and stored in memory. These variables can be used to estimate the radius and offset of the impedance/admittance circle.

65 is a logic flow diagram of a process depicting a control program or logic configuration for determining jaw conditions based on estimates of the radius (r) and offset (a, b) of the impedance/admittance circle in accordance with at least one aspect of the present disclosure Figure 132120. Initially, a database or look-up table is populated with reference values based on the reference jaw conditions as described in conjunction with FIGS. 60-64 and Table 6. Set the reference jaw condition and sweep the frequency from a value below resonance to a value above resonance. The reference values Rref, Gref, Xref, Bref that define the corresponding impedance/admittance diagram are stored in a database or look-up table. During use, under the control of a control program or logic configuration, the processor or control circuitry of the generator or instrument sweeps 132122 the frequency from below resonance to above resonance. The processor or control circuit measures and records 132124 the variables Re, Ge, Xe, Be that define the corresponding impedance/admittance diagram (eg, stores them in memory) and compares them with the variables stored in the database or look-up table. The reference values Rref, Gref, Xref, Bref are compared 132126. The processor or control circuit determines 132128 (eg, estimates) the end effector jaw condition based on the comparison.

temperature inference

的图形表示133000，并且图66B为作为具有冷超声刀和热超声刀的相同超声装置的共振频率f_o的函数的阻抗量值|Z|的图形表示133010。阻抗相位角

和阻抗量值|Z|在共振频率f_o处处于最小值。66A-66B are graphical representations 133000, 133010 of complex impedance spectra of the same ultrasonic device with a cold (room temperature) ultrasonic blade and a thermal ultrasonic blade in accordance with at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to an ultrasonic blade at room temperature, and a hot ultrasonic blade refers to an ultrasonic blade that has been frictionally heated in use. Figure 66A is the impedance phase angle as a function of the resonant frequency _fo of the same ultrasonic device with cold and hot ultrasonic blades

133000, and FIG. 66B is a graphical representation 133010 of impedance magnitude |Z| as a function of the resonant frequency _fo of the same ultrasonic device with cold and hot ultrasonic blades. Impedance phase angle

and the impedance magnitude |Z| is at a minimum at the resonant frequency _fo .

The ultrasound transducer impedance Z _g (t) can be measured as the ratio of the drive signal generator voltage V _g (t) drive signal and current I _g (t) drive signal:

处于最小值或大约0Rad，如由冷刀曲线图133002所指示的。如图66B中所示，当超声刀为冷的并且超声换能器在机电共振频率f_o下被激发时，阻抗量值|Z|为800Ω，例如阻抗量值|Z|处于最小阻抗处，并且驱动信号幅值由于超声机电系统的串联共振等效电路而处于最大值处，如图25中所描绘。As shown in Figure 66A, when the ultrasonic blade is cold (eg, at room temperature) and not frictionally heated, the electromechanical resonance frequency _fo of the ultrasonic device is approximately 55,500 Hz, and the excitation frequency of the ultrasonic transducer is set is 55,500Hz. Therefore, when the ultrasonic transducer is excited at the electromechanical resonance frequency _fo and the ultrasonic blade is cold, the phase angle

At a minimum value or about 0Rad, as indicated by the cold knife graph 133002. As shown in Figure 66B, when the ultrasonic blade is cold and the ultrasonic transducer is excited at the electromechanical resonance frequency _fo , the impedance magnitude |Z| is 800Ω, eg, the impedance magnitude |Z| is at the minimum impedance, And the drive signal amplitude is at a maximum due to the series resonance equivalent circuit of the ultrasonic electromechanical system, as depicted in FIG. 25 .

为零，阻抗量值|Z|处于最小阻抗处(例如，800Ω)，并且信号幅值由于超声机电系统的串联共振等效电路而处于峰值或最大值。当超声刀的温度增加时，由于在使用中生成的摩擦热，超声装置的机电谐振频率f_o’减小。因为超声换能器仍在55,500Hz的先前(冷刀)机电共振频率f_o下由发生器电压V_g(t)信号和发生器电流I_g(t)信号驱动，所以超声装置非共振f_o’操作，从而引起发生器电压V_g(t)信号和发生器电流I_g(t)信号之间的相位角

偏移。相对于55,500Hz的先前的(冷刀)机电谐振频率，还存在阻抗量值|Z|的增大和驱动信号的峰值量值的下降。因此，可通过在机电共振频率f_o由于超声刀的温度变化而改变时测量发生器电压V_g(t)信号和发生器电流I_g(t)信号之间的相位角

来推断超声刀的温度。Referring now back to Figures 66A and 66B, when the ultrasonic transducer is driven by the generator voltage _Vg (t) signal and the generator current _Ig (t) signal at the electromechanical resonant frequency _fo of 55,500 Hz, the generator voltage Phase angle between the V _g (t) signal and the generator current I _g (t) signal

At zero, the impedance magnitude |Z| is at the minimum impedance (eg, 800Ω), and the signal amplitude is at a peak or maximum value due to the series resonant equivalent circuit of the ultrasonic electromechanical system. As the temperature of the ultrasonic blade increases, the electromechanical resonant frequency _fo ' of the ultrasonic device decreases due to frictional heat generated in use. Because the ultrasonic transducer is still driven by the generator voltage _Vg (t) signal and the generator current _Ig (t) signal at the previous (cold knife) electromechanical resonant frequency _fo of 55,500 Hz, the ultrasonic device is non-resonant _fo ' operation, resulting in a phase angle between the generator voltage V _g (t) signal and the generator current I _g (t) signal

offset. There is also an increase in impedance magnitude |Z| and a decrease in the peak magnitude of the drive signal relative to the previous (cold knife) electromechanical resonant frequency of 55,500 Hz. Therefore, the phase angle between the generator voltage Vg(t) signal and the generator current _Ig (t) signal can be measured by measuring the phase angle between the generator voltage _Vg (t) signal and the generator current Ig(t) signal when the electromechanical resonant frequency _fo changes due to the temperature change of the ultrasonic blade

to infer the temperature of the ultrasonic scalpel.

为零。As mentioned earlier, an electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasound blade. The ultrasonic transducer can be modeled as an equivalent series resonant circuit (see Figure 25) comprising a first branch with static capacitance and a series connected inductance, resistance with electromechanical properties that define the resonator and the second "dynamic" branch of the capacitor. Electromechanical ultrasound systems have an initial electromechanical resonant frequency defined by the physical properties of the ultrasound transducer, waveguide, and ultrasound blade. The ultrasound transducer is excited by an alternating voltage _Vg (t) signal and a current _Ig (t) signal at a frequency equal to the electromechanical resonant frequency (eg, the resonant frequency of the electromechanical ultrasound system). Phase angle between the voltage V _g (t) signal and the current I _g (t) signal when the electromechanical ultrasound system is excited at the resonant frequency

zero.

In other words, at resonance, the simulated inductive impedance of the electromechanical ultrasound system is equal to the simulated capacitive impedance of the electromechanical ultrasound system. The compliance of the ultrasonic blade (modeled to simulate capacitance) causes the resonant frequency of the electromechanical ultrasonic system to shift when the ultrasonic blade is heated, eg, due to frictional engagement with tissue. In this example, as the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasonic system decreases. Consequently, the simulated inductive impedance of the electromechanical ultrasound system is no longer equal to the simulated capacitive impedance of the electromechanical ultrasound system, resulting in a mismatch between the drive frequency of the electromechanical ultrasound system and the new resonant frequency. Thus, with a thermosonic blade, the electromechanical ultrasonic system operates "non-resonantly". The mismatch between the drive frequency and the resonant frequency appears as the phase angle between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasonic transducer

相位角

可通过傅立叶分析、加权最小二乘估计、卡尔曼滤波、基于空间矢量的技术、零点交叉方法、Lissajous图、三伏特计法、交叉线圈法、矢量伏特计和矢量阻抗法、相位标准器械、锁相环路等来确定。发生器可连续地监测相位角

并调节驱动频率，直到相位角

变为零。此时，新驱动频率等于机电超声系统的新谐振频率。相位角

和/或发生器驱动频率的变化可用作超声刀的温度的间接或推断的测量值。As previously discussed, the generator electronics can easily monitor the phase angle between the voltage _Vg (t) signal and the current _Ig (t) signal applied to the ultrasound transducer

Phase angle

Available by Fourier analysis, weighted least squares estimation, Kalman filtering, space vector based techniques, zero crossing method, Lissajous plot, three voltmeter method, crossed coil method, vector voltmeter and vector impedance method, phase standard instrument, phase locked loop Road to be determined. Generator continuously monitors phase angle

and adjust the drive frequency until the phase angle

becomes zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Phase angle

And/or changes in generator drive frequency can be used as an indirect or inferred measure of the temperature of the ultrasonic blade.

Various techniques can be used to estimate temperature from data in these spectra. Most notably, the dynamic relationship between the temperature of the ultrasonic blade and the measured impedance can be modeled using a time-varying nonlinear state-space formulation

Within the generator drive frequency range, where the range of generator drive frequencies is specific to the device model.

temperature estimation method

One aspect of estimating or inferring the temperature of the ultrasonic blade can include three steps. First, a state-space model of temperature and frequency depending on time and energy is defined. To model temperature as a function of frequency content, a set of nonlinear state space formulations were used to model the relationship between electromechanical resonant frequency and temperature of the ultrasonic blade. Second, a Kalman filter is applied to improve the accuracy of the temperature estimator and state-space model over time. Again, a state estimator is provided in the feedback loop of the Kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to adjust the temperature of the ultrasonic blade. These three steps are described below.

step 1

The first step is to define a state-space model of temperature and frequency depending on time and energy. To model temperature as a function of frequency content, a set of nonlinear state space formulations were used to model the relationship between electromechanical resonant frequency and temperature of the ultrasonic blade. In one aspect, the state space model is given by:

的变化率和超声刀的温度

的变化率。

表示可测量且可观察的变量(诸如机电超声系统的固有频率F_n(t)、超声刀的温度T(t)、施加到超声刀的能量E(t)和时间t)的可观察性。超声刀的温度T(t)可观察为估计值。The state-space model represents the natural frequency of the electromechanical ultrasound system with respect to the natural frequency _Fn (t), temperature T(t), energy E(t) and time t

The rate of change and the temperature of the ultrasonic knife

rate of change.

Represents the observability of measurable and observable variables such as the natural frequency _Fn (t) of the electromechanical ultrasound system, the temperature T(t) of the ultrasonic blade, the energy E(t) applied to the ultrasonic blade, and the time t. The temperature T(t) of the ultrasonic blade can be observed as an estimated value.

Step 2

The second step is to apply a Kalman filter to improve the temperature estimator and state space model. Figure 67 is an illustration of a Kalman filter 133020 that improves the temperature estimator and state space model based on impedance according to the following formula:

It represents the impedance across the ultrasound transducer measured at various frequencies in accordance with at least one aspect of the present disclosure.

包括机电超声系统的固有频率F_n(t)、超声刀的温度T(t)、施加到超声刀的能量E(t)、相位角

和时间t。到控制器K 133028的输入为

并且控制器K 133028的输出u被馈送回到状态估计器133026和设备133024的t。The Kalman filter 133020 can be employed to improve the performance of temperature estimation and allow the addition of external sensors, models or prior information to improve temperature prediction in noisy data. Kalman filter 133020 includes adjuster 133022 and plant 133024. In contrast theory, device 133024 is a combination of process and actuator. Device 133024 is said to have a transfer function that indicates the relationship between the input and output signals of the system. Regulator 133022 includes state estimator 133026 and controller K 133028. State adjuster 133026 includes feedback loop 133030. The state adjuster 133026 receives y, the output of the device 133024 as input and feeds back the variable u. The state estimator 133026 is an internal feedback system that converges with the true value of the system state. The output of the state estimator 133026 is the full feedback control variable

Including the natural frequency F _n (t) of the electromechanical ultrasonic system, the temperature T(t) of the ultrasonic blade, the energy E(t) applied to the ultrasonic blade, the phase angle

and time t. The input to the controller K 133028 is

And the output u of controller K 133028 is fed back to state estimator 133026 and t of device 133024.

Kalman filtering (also known as Linear Quadratic Estimation (LQE)) is an algorithm that uses a series of measurements (including statistical noise and other inaccuracies) observed over time and The joint probability distribution of the variables of the frame and thus the maximum likelihood estimates of the actual measurements are calculated to produce estimates of the unknown variables. The algorithm works in a two-step process. In the prediction step, the Kalman filter 133020 produces estimates of the current state variables and their uncertainties. Once the outcome of the next measurement is observed (necessarily corrupted by a certain amount of error (including random noise)), these estimates are updated using a weighted average, the higher the weight given, the more certainty the estimate is made . The algorithm is recursive and works in real-time, using only current input measurements and previously computed states and their uncertainty matrices; no additional past information is required.

The Kalman filter 133020 uses a kinetic model of the electromechanical ultrasound system, control inputs known to the system, and multiple time-series measurements (observations) of the natural frequency and phase angle of the signal applied to the ultrasound transducer (eg, The magnitude and phase of the electrical impedance of the ultrasonic transducer) to form an estimate of the amount of change in the electromechanical ultrasound system (its state) to better predict the performance of the ultrasonic blade portion of the electromechanical ultrasound system than an estimate obtained using only one single measurement temperature. Thus, the Kalman filter 133020 is an algorithm that includes sensor and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.

Kalman filter 133020 efficiently handles uncertainty due to noisy measurements of the signal applied to the ultrasound transducer to measure natural frequency and phase shift data, and also efficiently handles uncertainty due to random external factors . The Kalman filter 133020 produces an estimate of the state of the electromechanical ultrasound system from the predicted state of the system and the average of the new measurements using the weighted average. Weighted values provide a better (ie, smaller) estimate uncertainty and are more "trustworthy" than unweighted values. The weights may be calculated from covariance, a measure of the estimated uncertainty of the prediction of the state of the system. The result of the weighted average is a new state estimate that lies between the predicted state and the measured state, and has a better estimate uncertainty than one alone. This process repeats at each step, with new estimates and their covariances informing the predictions used in the following iterations. This recursive nature of the Kalman filter 133020 requires only the last "best guess" of the state of the electromechanical ultrasound system rather than the entire history to calculate the new state.

The relative certainty of measurement and current state estimation is an important consideration, and it is common to discuss the filter response in terms of the gain K of the Kalman filter 133020. The Kalman gain, K, is the relative weight given to measurements and current state estimates, and can be "tuned" to achieve specific performance. With a high gain K, the Kalman filter 133020 puts more weight on the most recent measurements and therefore follows them more responsively. With a low gain K, the Kalman filter 133020 follows the model predictions more closely. In extreme cases, a high gain close to one will cause the estimated trajectory to be more jumpy, while a low gain close to zero will smooth out noise but reduce responsiveness.

When performing the actual computation of the Kalman filter 133020 (described below), the state estimates and covariances are encoded as matrices to handle the multiple dimensions involved in a single set of computations. This allows linear relationships between different state variables (such as position, velocity and acceleration) to be represented in either of the transition models or covariances. Using the Kalman filter 133020 does not assume that the error is Gaussian. However, in the special case where all errors are Gaussian distributed, the Kalman filter 133020 produces accurate conditional probability estimates.

Step 3

The third step uses the state estimator 133026 in the feedback loop 133032 of the Kalman filter 133020 to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to adjust the temperature of the ultrasonic blade.

68 is a graphical depiction 133040 of three probability distributions used by the state estimator 133026 of the Kalman filter 133020 shown in FIG. 67 to maximize estimated values in accordance with at least one aspect of the present disclosure. The probability distributions include the previous probability distribution 133042, the predicted (state) probability distribution 133044, and the observed probability distribution 133046. In accordance with at least one aspect of the present disclosure, three probability distributions 133042, 133044, 1330467 are used for feedback control of the power applied to the ultrasound transducer to adjust based on impedance measured across the ultrasound transducer at various frequencies temperature. The estimator used in feedback control of the power applied to the ultrasonic transducer to adjust temperature based on impedance is given by the following expression:

It is the impedance across the ultrasound transducer measured at various frequencies in accordance with at least one aspect of the present disclosure.

The previous probability distribution 133042 includes the state variance defined by the following expression:

用于预测系统的下一个状态，该状态表示为预测(状态)概率分布133044。观察概率分布133046是观察方差σ_m用于限定增益的系统的状态的实际观察的概率分布，该增益由以下表达式给出：State variance

Used to predict the next state of the system, represented as a predicted (state) probability distribution 133044. The observation probability distribution 133046 is the probability distribution of the actual observations of the state of the system for which the observation variance _σm is used to define the gain given by:

feedback control

The power input is reduced to ensure that the temperature (as estimated by the state estimator and Kalman filter) is controlled.

In one aspect, the initial proof of concept assumed a static linear relationship between the natural frequency of the electromechanical ultrasound system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasound system (ie, adjusting the temperature with feedback control), the temperature of the ultrasonic blade tip can be directly controlled. In this example, the temperature of the distal tip of the ultrasonic blade can be controlled to not exceed the melting point of the Teflon pad.

69A is a graphical representation 133050 of temperature versus time for an ultrasound device without temperature feedback control. The temperature (°C) of the ultrasonic blade is shown along the vertical axis, and the time (seconds) is shown along the horizontal axis. The test was performed with chamois skins located in the jaws of the ultrasound device. One jaw is the ultrasonic knife, while the other jaw is the clamping arm with TEFLON pads. The ultrasonic blade is excited at the resonant frequency while frictionally engaging the chamois skin clamped between the ultrasonic blade and the clamping arm. Over time, the temperature (°C) of the ultrasonic blade increased due to the frictional engagement with the chamois hide. Over time, the temperature profile 133052 of the ultrasonic blade increased until the antelope hide sample was cut after approximately 19.5 seconds at a temperature of 220°C, as indicated at point 133054. In the absence of temperature feedback control, after cutting the antelope hide samples, the temperature of the ultrasonic blade increased to ~380°C up to ~490°C well above the melting point of TEFLON. At point 133056, the temperature of the ultrasonic blade reached a maximum temperature of 490°C until the TEFLON pad was completely melted. After the pad disappeared completely, the temperature of the ultrasonic blade dropped slightly from the peak temperature at point 133056.

69B is a graph of temperature versus time for an ultrasound device with temperature feedback control in accordance with at least one aspect of the present invention. The temperature (°C) of the ultrasonic blade is shown along the vertical axis, and the time (seconds) is shown along the horizontal axis. The test was performed with a sample of chamois hide in the jaws of the ultrasound device. One jaw is the ultrasonic knife, while the other jaw is the clamping arm with TEFLON pads. The ultrasonic blade is excited at the resonant frequency while frictionally engaging the chamois skin clamped between the ultrasonic blade and the clamping arm pad. The temperature profile 133062 of the ultrasonic blade increased over time until the antelope hide sample was cut after about 23 seconds at a temperature of 220°C, as indicated at point 133064. With temperature feedback control, as indicated at point 133066, the temperature of the ultrasonic blade increases up to a maximum temperature of about 380°C, just below the melting point of TEFLON, and then decreases to a temperature of about 330°C as generally indicated at region 133068 average value, thereby preventing the TEFLON pad from melting.

Application of Intelligent Ultrasonic Knife Technology

When the ultrasonic blade is immersed in a fluid-filled surgical field, the ultrasonic blade cools during activation, making it less effective to seal and cut tissue in contact with it. Cooling of the ultrasonic blade can lead to longer activation times and/or hemostasis problems because not enough heat is delivered to the tissue. To overcome the cooling of the ultrasonic blade, more energy delivery may be required to shorten the transection time and achieve proper hemostasis under these fluid immersion conditions. Using a frequency temperature feedback control system, if it is detected that the ultrasonic blade starts below a certain temperature or remains at a certain temperature for a period of time, the output power of the generator can be increased to compensate for the presence of blood/saline/other fluids in the surgical field induced cooling.

Accordingly, the frequency temperature feedback control system described herein can improve the performance of an ultrasonic device, especially when the ultrasonic blade is partially or fully positioned or immersed in a fluid-filled surgical field. The frequency temperature feedback control systems described herein minimize long activation times and/or potential problems with ultrasound device performance in fluid-filled surgical settings.

As mentioned earlier, the temperature of the ultrasonic blade can be inferred by detecting the impedance of the ultrasonic transducer given by:

来推断。相位角

信息也可用于推断超声刀的条件。如本文所具体讨论，相位角

作为超声刀的温度的函数而变化。因此，相位角

信息可用于控制超声刀的温度。这可例如通过当超声刀运行过热时降低递送到超声刀的功率，并且当超声刀运行过冷时增加递送到超声刀的功率来实现。图70A-70B为用于在检测到超声刀的温度骤降时调节施加到超声换能器的超声功率的温度反馈控制的图形表示。Or in other words, by detecting the phase angle between the voltage _Vg (t) signal and the current _Ig (t) signal applied to the ultrasonic transducer

to infer. Phase angle

The information can also be used to infer the condition of the ultrasonic scalpel. As discussed specifically herein, the phase angle

as a function of the temperature of the ultrasonic blade. Therefore, the phase angle

The information can be used to control the temperature of the ultrasonic blade. This can be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold. 70A-70B are graphical representations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a temperature dip in the ultrasonic blade is detected.

70A is a graphical representation of ultrasound power output 133070 as a function of time in accordance with at least one aspect of the present disclosure. The power output of the ultrasonic generator is shown along the vertical axis, and the time (seconds) is shown along the horizontal axis. FIG. 70B is a graphical representation of ultrasonic blade temperature 133080 as a function of time in accordance with at least one aspect of the present disclosure. Ultrasonic blade temperature is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade increased with the application of constant power 133072, as shown in Figure 70A. During use, the temperature of the ultrasonic blade suddenly dropped. This can be caused by a variety of conditions, however, during use, it can be inferred that the temperature of the ultrasonic blade drops as it is immersed in a fluid-filled surgical field (eg, blood, saline, water, etc.). At time _t0 , the temperature of the ultrasonic blade drops below the desired minimum temperature 133082, and the frequency temperature feedback control algorithm detects the temperature drop and begins to increase or "ramp up" the power, such as by the power delivered to the ultrasonic blade Ramp 133074 is shown to begin raising the temperature of the ultrasonic blade above the desired minimum temperature 133082.

Referring to Figures 70A and 70B, the ultrasonic generator output is substantially constant power 133072 as long as the temperature of the ultrasonic blade remains above the desired minimum temperature 133082. At _t0 , the processor or control circuitry in the generator or the instrument or both detects that the temperature of the ultrasonic blade has dropped below the desired minimum temperature 133072 and starts the frequency temperature feedback control algorithm to raise the temperature of the ultrasonic blade to Minimum desired temperature above 133082. Therefore, the generator power begins to ramp up 133074 at t ₁ corresponding to the sudden drop in temperature of the ultrasonic blade detected at t ₀ . Under the frequency temperature feedback control algorithm, the power continues to ramp 133074 until the temperature of the ultrasonic blade is above the desired minimum temperature 133082.

基于相位角

发生器使用本文结合图66A-68所述的技术来推断133096超声刀的温度。发生器通过将超声刀的推断温度与预定的期望温度进行比较来确定133098超声刀的温度是否低于期望的最小温度。然后发生器基于比较来调节施加到超声换能器的功率电平。例如，当超声刀的温度达到或高于期望的最小温度时，该方法沿“否”分支继续，并且当超声刀的温度低于所期望的最小温度时，该过程沿“是”分支继续。当超声刀的温度低于期望的最小温度时，发生器例如通过增加电压V_g(t)信号和/或电流I_g(t)信号来增加133100到超声换能器的功率水平，以升高超声刀的温度并继续增加施加到超声换能器的功率水平，直到超声刀的温度增加到最小期望温度以上为止。71 is a logic flow diagram 133090 of a process depicting a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. According to this process, the processor or control circuitry of the generator or instrument or both executes one aspect of the frequency-temperature feedback control algorithm discussed in connection with Figures 70A and 70B to apply 133092 a power level to the ultrasound The desired temperature is achieved at the knife. The generator monitors ₁₃₃₀₉₄ the phase angle between the voltage _Vg (t) signal and the current Ig(t) signal applied to drive the ultrasonic transducer

based on phase angle

The generator inferred the temperature of the 133096 ultrasonic blade using the techniques described herein in connection with Figures 66A-68. The generator determines 133098 whether the temperature of the ultrasonic blade is below a desired minimum temperature by comparing the inferred temperature of the ultrasonic blade to a predetermined desired temperature. The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, the method continues along the "no" branch when the temperature of the ultrasonic blade is at or above the desired minimum temperature, and the process continues along the "yes" branch when the temperature of the ultrasonic blade is below the desired minimum temperature. When the temperature of the ultrasonic blade is lower than the desired minimum temperature, the generator increases 133100 the power level to the ultrasonic transducer, for example by increasing the voltage _Vg (t) signal and/or the current _Ig (t) signal, to increase The temperature of the ultrasonic blade and continue to increase the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases above the minimum desired temperature.

situational awareness

Referring now to FIG. 72, a timeline 5200 depicting situational awareness of a hub, such as surgical hub 106 or 206, is shown. Timeline 5200 is an illustrative surgical procedure and background information that the surgical hub 106, 206 may derive from the data received from the data source at each step in the surgical procedure. Timeline 5200 depicts typical steps that nurses, surgeons, and other medical personnel will take during a segmentectomy procedure, starting with the establishment of the operating room and ending with the transfer of the patient to the post-operative recovery room.

The situational awareness surgical hubs 106 , 206 receive data from data sources throughout the surgical procedure, including data generated each time a medical staff utilizes a modular device paired with the surgical hubs 106 , 206 . Surgical hubs 106, 206 may receive this data from paired modular devices and other data sources, and continually derive inferences (ie, contextual information) about ongoing procedures as new data is received, such as the procedure being performed at any given time which step. The situational awareness system of the surgical hub 106, 206 can, for example, record data related to the process used to generate the report, verify the steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be related to specific process steps, Modular devices are adjusted based on context (eg, activating a monitor, adjusting the field of view (FOV) of a medical imaging device, or changing the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and taking any other such actions described above.

As a first step 5202 in this exemplary procedure, hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

In a second step 5204, the staff scans the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with the list of supplies used in the various types of procedures and confirms that the supplied mix corresponds to the thoracic procedure. Additionally, the surgical hub 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for a thoracic wedge procedure, or otherwise do not correspond to a thoracic wedge procedure).

In a third step 5206, the medical staff scans the patient belt via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 can then confirm the identity of the patient based on the scanned data.

In the fourth step 5208, the medical staff turns on the auxiliary equipment. The auxiliary devices utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke evacuators, insufflators, and medical imaging devices. When activated, as part of its initialization process, auxiliary devices that are modular devices may automatically pair with surgical hubs 106, 206 located in a specific vicinity of the modular device. The surgical hub 106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device paired with it during this preoperative phase or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on that particular combination of paired modular devices. Based on a combination of data from the patient's EMR, the list of medical supplies used in the procedure, and the type of modular device connected to the hub, the surgical hub 106, 206 can typically infer the specific procedure the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can retrieve the procedure's steps from memory or the cloud, and then cross-reference it with subsequent data from a connected data source (eg, a modular device) and patient monitoring devices) to infer what steps of the surgical procedure the surgical team is performing.

In a fifth step 5210, the staff member attaches the EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with surgical hubs 106 , 206 . When the surgical hub 106, 206 begins to receive data from the patient monitoring device, the surgical hub 106, 206 thus confirms that the patient is in the operating room.

In the sixth step 5212, the medical staff induces anesthesia of the patient. The surgical hubs 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the preoperative portion of the lung segmental resection procedure is completed and the surgical portion begins.

Seventh step 5214, the lung of the patient being operated on is folded (while ventilation is switched to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 can infer that the surgical portion of the procedure has begun, as it can compare the detection of the patient's lung collapse to the expected steps of the procedure (which may have been previously accessed or retrieved) to determine that collapsing the lung is the specific Surgical steps in the protocol.

In an eighth step 5216, a medical imaging device (eg, an endoscope) is inserted and video from the medical imaging device is initiated. The surgical hub 106, 206 receives medical imaging device data (ie, video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmentectomy, not a lobectomy (note that the wedge procedure has been determined based on the data received at the second step 5204 of the procedure by the surgical hub 106, 206). exclude). Data from the medical imaging device 124 (FIG. 2) can be used to determine contextual information related to the type of procedure being performed in a number of different ways, including by determining the angle of the medical imaging device relative to the visualization orientation of the patient's anatomy, monitoring the The number of medical imaging devices utilized (ie, activated and paired with the surgical hub 106, 206), and the type of visualization device utilized for monitoring. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's thorax above the diaphragm, while one technique for performing a VATS segmentectomy places the camera relative to the segmental fissure Anterior intercostal position. For example, using pattern recognition or machine learning techniques, situational awareness systems can be trained to recognize the location of medical imaging devices based on visualizations of patient anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As another example, a technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures not used in VATS pneumonectomy . By tracking any or all of these data from the medical imaging device, the surgical hub 106, 206 can thus determine the specific type of surgical procedure being performed and/or the technique used for the particular type of surgical procedure.

In a ninth step 5218, the surgical team begins the dissection step of the protocol. The surgical hub 106, 206 can infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may intersect the received data with the retrieval steps of the surgical procedure to determine that the energy instrument fired at that point in the procedure (ie, after the previously discussed procedure steps are completed) corresponds to the dissection step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team continues with the ligation step of the protocol. The surgical hub 106, 206 can infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and cutting instruments indicating that the instruments are being fired. Similar to the previous steps, the surgical hub 106, 206 may derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instruments with the retrieval step in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, performing the segmental resection portion of the protocol. The surgical hubs 106, 206 may infer that the surgeon is transecting soft tissue based on data from the surgical stapling and cutting instruments, including data from their cartridges. The bin data may correspond, for example, to the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the bin data can indicate the type of tissue being stapled and/or transected. In this case, the type of staples fired are for soft tissue (or other similar tissue types), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is in progress.

Then perform the twelfth step 5224 node dissection step. The surgical hub 106, 206 may infer that the surgical team is dissecting the node and performing leak testing based on data received from the generator indicating that the RF or ultrasonic instrument is firing. For this particular procedure, the RF or ultrasound instrument used after transection of the soft tissue corresponds to a nodal dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon periodically switches back and forth between surgical stapling/cutting instruments and surgical energy (ie, RF or ultrasonic) instruments, depending on the specific steps in the protocol, as different instruments are better suited for specific tasks. Thus, the particular sequence in which the stapling/cutting instrument and the surgical energy instrument are used may indicate the steps of the procedure that the surgeon is performing. Additionally, in some cases, robotic tools may be used for one or more steps in a surgical procedure, and/or a hand-held surgical instrument may be used for one or more steps in a surgical procedure. One or more surgeons may, for example, alternate between robotic tools and hand-held surgical instruments and/or may use the device simultaneously. At the completion of the twelfth step 5224, the incision is closed and the postoperative portion of the procedure begins.

Thirteenth step 5226, reverse anesthetize the patient. For example, the surgical hub 106, 206 may infer that the patient is waking up from anesthesia based on, for example, ventilator data (ie, the patient's breathing rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP and other data from the patient monitoring device, the surgical hub 106, 206 can infer that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hubs 106 , 206 may determine or infer each step of a given surgical procedure from data received from various data sources communicatively coupled to the surgical hubs 106 , 206 when does it happen.

Situational awareness is further described in US Provisional Patent Application Serial No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, which is incorporated herein by reference in its entirety. In some cases, the operation of a robotic surgical system, including the various robotic surgical systems disclosed herein, may be determined by the hub 106 , 206 based on its situational awareness and/or feedback from its components and/or based on information from the cloud 102 control.

Situational Awareness for Electrosurgical Systems

Electrosurgical instruments are used to treat various tissue types by applying energy to the tissue. As described in connection with FIGS. 22-24, electrosurgical instruments (eg, surgical instruments 1104, 1106, 1108) may be connected to generator 1100 and include an end effector ( For example, end effectors 1122, 1124, 1125).

In various aspects, an end effector may be used to seal, weld, or coagulate a blood vessel by applying energy to the blood vessel while tissue, such as a blood vessel, is grasped by the end effector. Since blood vessels are often surrounded by protective tissue, the tissue must be separated to expose the blood vessels for an effective seal. However, tissue separation requires less energy than tissue sealing or coagulation. Also, the amount of tissue to be separated varies depending on, for example, the anatomical location of the blood vessel, the state of the tissue, and the type of surgery performed.

One technique for treating tissue, including blood vessels, involves dissociating the inner muscle layer of the vessel and moving it away from the adventitial layer of the arteries prior to sealing and/or transecting the vessel. To more efficiently separate tissue layers of blood vessels, low levels of energy sufficient to separate the tissue but not enough to coagulate or seal the tissue can be generated and delivered to the tissue. Subsequently, high levels of energy are used to seal or coagulate the tissue.

Successful energy treatment of tissue grasped by the end effector depends on selecting an appropriate energy operating mode for each closure phase of the end effector. Additionally, the closure phase of the end effector may be determined by various situational parameters such as tissue type, anatomical location and/or composition. Various suitable situational parameters are described in conjunction with FIG. 72 under the heading "Situational Awareness".

Aspects of the present disclosure present various processes for selecting different energy modes for different closure stages of an end effector of an electrosurgical instrument. The selection may be based, at least in part, on one or more situational parameters.

In various aspects, tissue interaction with the end effector during closure provides one or more situational parameters that can be used to select or adjust the energy pattern used to treat the tissue. Figure 73 shows the end effector 131000 extending from the shaft 131001 and undergoing a closing motion to grasp tissue "T". The end effector 131000 includes a first jaw 131002 and a second jaw 131004. At least one of the first jaw 131002 and the second jaw 131004 is movable relative to the other to grasp tissue therebetween. In various aspects, the closing phase may be defined by one or more angular positions of the first jaw 131002 relative to the second jaw 131004 or one or more angular distances between the first jaw 131002 and the second jaw 131004 .

In the example of Figure 73, the first jaw 131002 is movable relative to the second jaw 131004 to transition the end effector between open and closed configurations through different stages of closure to grip tissue Between jaws 131002, 131004. Figure 73 depicts two closure stages. During the first closed phase, the first jaw 131002 moves an angular distance θ1 from the open configuration.

The first closing phase is followed by a second closing phase extending an angular distance θ2 from the open configuration of the end effector 131000 . Although only two closure stages are depicted in the example of Figure 73, end effectors according to the present disclosure may be transitioned through more or less than two closure stages.

75A and 75B are schematic illustrations of the end effector 131000 undergoing a closing motion to separate, seal, and transect tissue "T". In Figure 75A, the end effector 131000 is in the first closed phase and has established initial contact with tissue "T". In Figure 75B, the first jaw 131002 has completed the first closing phase and is about to begin the second closing phase.

Referring to Figure 74, graph 131010 depicts a first treatment cycle 131012 applied to tissue "T" of Figures 75A and 75B. Time is represented on the x-axis, while magnitude is represented on the y-axis. The first treatment cycle 131012 includes an initial tissue separation energy mode that achieves tissue separation by applying a first energy to tissue "T" in a first closure phase. The first treatment cycle 131012 also includes a tissue sealing energy mode that achieves tissue sealing by applying a second energy to the tissue "T" that is greater than the first energy in the second closure phase.

A second therapy cycle 131014 is also depicted in graph 131010 of FIG. 74 . The second treatment cycle 131014 includes only the tissue sealing energy mode. In other words, in the second treatment cycle 131014, the tissue sealing energy pattern does not follow the initial tissue separation energy pattern. The second treatment cycle 131014 is suitable for certain situations where tissue separation is not required.

76 is a logic flow diagram depicting a process 131020 of a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument. Process 131020 detects 131022 the closing phase of end effector 131000. The process 131020 further selects 131024 between energy modes delivering different energy outputs based on the detected closure phase of the end effector 131000. In one example, a first energy mode delivering a first energy output is selected in a first closure phase, and a second energy mode delivering a second energy output greater than the first energy output is selected in a second closure phase. The first energy output is sufficient to separate tissue "T" but not sufficient to seal tissue "T", while the second energy output is sufficient to seal tissue "T".

In certain aspects, one or more processes of the present disclosure may be performed by a control circuit of an electrosurgical instrument, such as control circuit 710 of surgical instrument 700, control circuit 760 of surgical instrument 750, and/or control circuit 760 of surgical instrument 790 . In certain aspects, as shown in FIG. 13 , a control circuit 500 for performing one or more processes of the present disclosure may include one or more processors 502 (eg, microprocessors) coupled to at least one memory circuit 504 , microcontroller), the at least one memory circuit stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more of the processes of the present disclosure may be performed by one or more of the control circuits depicted in FIGS. 14 , 15 . In certain aspects, an electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more procedures of the present disclosure.

77 is another logic flow diagram depicting a process 131030 of a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument. Process 131030 selects an operating mode from among operating modes delivering different energy outputs based on sensor signals indicative of the closing phase of the end effector 131000. In one example, the process of FIG. 77 is performed by a control circuit connected to one or more sensors configured to generate sensor signals indicative of the closing phase of the end effector 131000. The sensor signal is received 131032 by a control circuit that selects an energy operating mode from among operating modes delivering different energy outputs based on the received sensor signal. For example, the control circuit determines whether the sensor signal received at 131034 indicates that the end effector 131000 is in the first closed phase. If so, the control circuit selects the first mode of operation which causes the first energy output to be delivered 131036 to tissue "T". If the received sensor signal does not indicate that the end effector is in the first closed phase, the control circuit further determines 131038 whether the received sensor signal indicates that the end effector 131000 is in the second closed phase. If so, the control circuit selects a second mode of operation that causes a second energy output greater than the first energy output to be delivered 131039 to tissue "T".

In various examples, the control circuitry of the ultrasonic surgical instrument is configured to cause the transducer to vary the magnitude of the ultrasonic energy output in response to the gripping member transitioning from the first closed phase to the second closed phase.

In various examples, the control circuit is configured to correlate the change in magnitude of the energy output with the transition from the first closed phase to the second closed phase. In various examples, the second energy output is sufficient to seal and coagulate tissue, while the first energy output is sufficient to separate tissue but not sufficient to seal and coagulate tissue. Although only two modes of energy operation are depicted in the example of FIG. 77 , electrosurgical instruments according to the present disclosure may include more or less than two modes of energy operation, each corresponding to a predetermined closure phase of the end effector 131000 . In various examples, the tissue separation mode is defined by a lower amplitude and/or frequency than the tissue coagulation and sealing modes.

78 is another logic flow diagram depicting a process 131040 of a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument. Process 131040 is similar in many respects to the process of FIG. 76 . Additionally, process 131040 determines 131042 when initial contact with tissue "T" is achieved as the first jaw 131002 moves between the open and closed configurations through the closed phase (see Figure 75A). More specifically, the selection between the energy operating modes of the electrosurgical instrument is based on the closure phase in which initial contact with tissue "T" is detected.

In various aspects, initial tissue contact can be detected by a tissue contact circuit that includes a first jaw electrode and a second jaw electrode. The first jaw electrode is coupled to one pole of the electrosurgical energy source, and the second jaw electrode is coupled to the opposite pole of the electrosurgical energy source. When tissue is in contact with both the first jaw electrode and the second jaw electrode, the tissue contact circuit is in a closed configuration, allowing non-therapeutic signals to pass between the jaws 131002, 131004. Thus, when tissue is between the jaws 131002, 131004, electrical continuity is established, and when no tissue is between the jaws 131002, 131004, electrical continuity is not established.

In various aspects, initial tissue contact is achieved when the jaws 131002, 131004 apply sufficient compression to the tissue "T" captured therebetween to close the sensing circuit "SC".

78A is a schematic diagram of an exemplary tissue contact circuit showing the circuit being completed to a pair of spaced-apart contact pads when in contact with tissue. Contact of the jaws 131002, 131004 with tissue "T" closes the otherwise open sensing circuit "SC" by establishing contact with a pair of opposing plates "P1, P2" disposed on the jaws 131002, 131004. Closure of the sensing circuit "SC" causes the sensor signal to be transmitted to the control circuit (eg, Figures 13-14, 17-19). The sensor signal indicates that initial tissue contact has been established. In US Patent No. 8,181,839, filed June 27, 2011 (titled SURGICAL INSTRUMENT EMPLOYING SENSORS, issued May 5, 2012, the entire disclosure of which is incorporated herein by reference) Figure 78A and other examples are further described in .

79 is another logic flow diagram depicting a process 131050 of a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument based on the closure phase in which initial contact with tissue "T" is detected. Process 131050 includes receiving 131052 a first sensor signal and a second sensor signal. In one example, the process 131050 is performed by a control circuit (eg, FIGS. 13-14 , 17-19 ) connected to at least one first sensor configured to generate a closed phase indicative of the end effector 131000 sensor signal. The control circuit is also connected to at least one second sensor configured to generate a sensor signal indicative of detection of initial contact with tissue "T". Sensor signals from the first sensor and the second sensor are transmitted to the control circuit.

Process 131050 further determines 131054 whether the first sensor signal indicates that the end effector 131000 is in the first closed phase. If so, process 131050 further determines 131056 whether the second sensor signal indicates that initial tissue contact has been established.

If the first sensor signal indicates that the end effector 131000 is in the first closed phase, and the second sensor signal indicates that initial tissue contact has been established, then the first energy output is delivered 131058 to tissue "T". In one example, the control circuit selects a first mode of operation that causes a first energy output to be delivered 131058 to tissue "T".

Conversely, if the end effector 131000 is not in the first closure stage, the process 131050 further determines 131060 whether the end effector 131000 is in the second closure stage. If so, process 131050 further determines 131062 whether the second sensor signal indicates that initial tissue contact has been established during the second closure phase.

If the first sensor signal indicates that the end effector 131000 is in the second closing phase, and the second sensor signal indicates that initial tissue contact has been established during the second closing phase, then a second energy output greater than the first energy output is delivered 131064 to the tissue "T". In one example, the control circuit selects a second mode of operation that causes a second energy output to be delivered 131064 to tissue "T".

In other words, detection of initial contact with tissue in the first closure phase causes the control circuit to cause the first energy output to be delivered to tissue "T", while detection of initial contact with tissue in the second closure phase causes control The circuit causes the second energy output to be delivered to tissue "T". As described above, in various aspects, the second energy output is sufficient to seal and coagulate tissue, while the first energy output is sufficient to separate tissue but not sufficient to seal and coagulate tissue.

In various aspects, as described in more detail above, the closure phase may be defined by the angular position or range of angular positions of the first jaw 131002 relative to the second jaw 131004. In some cases, the first closed stage and the second closed stage may span a predetermined portion of the maximum angular distance between the jaws 131002, 131004 in the open configuration. The end effector 131000 completes a complete closed cycle by moving the first jaw 131002 relative to the second jaw 131004 a maximum angular distance.

In one example, the first closing stage spans a first angular distance and the second closing stage spans a second angular distance. In one example, the first angular distance and the second angular distance are equal or at least substantially equal. In one example, the second angular distance directly follows the first angular distance. Alternatively, in another example, the first angular distance is spaced apart from the second angular distance. In one example, the ratio of the first angular distance to the second angular distance is selected from the range of, for example, about half to about two.

In one example, the first closure stage spans the first half of the maximum angular distance, and the second closure stage spans the second half of the maximum angular distance. Thus, according to procedure 131050, detection of initial tissue contact at any point up to 50% of the complete closed cycle of the end effector 131000 results in a first energy output, while detection of initial tissue at points beyond the 50% mark Contact produces a second energy output.

Angular position is not the only identifying characteristic of the closing phase of the end effector 131000. The closing movement of the end effector 131000 is driven by the longitudinally movable drive member 131110 as described below in connection with FIG. 80 . The longitudinal position of the longitudinally movable drive member 131110 is another identifying feature of the closing phase. The longitudinal movement of the longitudinally movable drive member 131110 corresponds to the angular movement of the first jaw 131002 relative to the second jaw 131004 and is monitored by the absolute positioning system 7000 .

In various examples, the control circuitry of the electrosurgical instrument (eg, FIGS. 13-14 , 17-19 ) includes a storage medium that stores, among other things, informational characteristics of the closure phase of the end effector 131000 , such as the start of the closure phase , the end of the closure phase, one or more angular positions of the first jaw 131002 associated with the closure phase and/or one or more longitudinal positions of the longitudinally movable drive member 131110 associated with the closure phase.

As shown in FIG. 80, the absolute positioning system 7000 is configured to track the closure of the end effector 131000. Depending on the stored information and the output of the absolute positioning system 7000, the control circuitry of the electrosurgical instrument (eg, FIGS. 13-14, 17-19) can transition the end effector 131000 between an open configuration and a closed configuration time to determine its closing stage.

In certain aspects, the drive system is configured to apply a drive motion to actuate the end effector 131000 through the closure phase. The drive system can use an electric motor 131102. In various forms, the motor 131102 may be, for example, a DC brush drive motor with a maximum rotation of approximately 25,000 RPM. In other arrangements, the motor 131102 may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery 1104 (or "power source" or "power pack") such as a lithium ion battery, for example, may provide power to the control circuitry and ultimately to the motor 131102.

The electric motor 131102 may include a rotatable shaft 7016 operatively interfacing with a gear reducer assembly 7014 mounted in meshing engagement with a set of drive teeth or racks on the longitudinally movable drive member 131110. In use, the polarity of the voltage provided by the battery 1104 can operate the electric motor 131102 in a clockwise direction, wherein the polarity of the voltage applied by the battery 1104 to the electric motor 131102 can be reversed to operate the electric motor 131102 in a counterclockwise direction. When the electric motor 131102 is rotated in one direction, the longitudinally movable drive member 131110 will be driven axially in the distal direction "D", thereby moving the first jaw 131002 from the open configuration to the closed configuration through the closing phase. When the motor 131102 is driven in the opposite rotational direction, the drive member 131110 will be driven axially in the proximal direction "P", thereby transitioning the first jaw 131002 back to the open configuration.

80 is a schematic diagram of an absolute positioning system 7000 that includes a microcontroller 7004 controlled motor drive circuit arrangement including a sensor arrangement 7002, according to one embodiment. Electrical and electronic circuit elements associated with absolute positioning system 7000 and/or sensor arrangement 7002 are supported by a control circuit board assembly. The microcontroller 7004 generally includes a memory 7006 and a microprocessor 7008 ("processor") operably coupled thereto. The processor 7008 controls the motor driver 7010 circuitry to control the position and velocity of the motor 131102. The motor 131102 is operably coupled to the sensor arrangement 7002 and the absolute position sensor 7012 arrangement to provide the microcontroller 7004 with each possible position of the longitudinally movable drive member 131110 and thus each possible position of the first jaw 131002 Unique location signal.

The unique position signal is provided to microcontroller 7004 via feedback element 7024. It should be understood that the unique position signal may be an analog signal or a digital value based on the interface between the position sensor 7012 and the microcontroller 7004. In one aspect, the interface between the position sensor 7012 and the microcontroller 7004 is a standard serial peripheral interface (SPI), and the only position signal is a digital value representing the position of the sensor element 7026 within one revolution. A value representing the absolute position of sensor element 7026 within one revolution may be stored in memory 7006. The absolute position feedback value of the sensor element 7026 corresponds to the position of the first jaw 131002 .

Additionally, other sensors 7018 may be provided to measure other parameters associated with the absolute positioning system 7000. One or more display indicators 7020 may also be provided, which may include sounding components.

The sensor arrangement 7002 provides a unique position signal corresponding to the position of the longitudinally movable drive member 131110. The electric motor 131102 may include a rotatable shaft 7016 operatively interfacing with a gear assembly 7014 mounted in meshing engagement with a set of drive teeth or racks on the longitudinally movable drive member 131110. Sensor element 7026 may be operably coupled to gear assembly 7014 such that a single rotation of sensor element 7026 corresponds to some linear longitudinal translation of longitudinally movable drive member 131110.

The sensor arrangement 7002 of the absolute positioning system 7000 employs a position sensor 7012 that generates a unique position signal for each rotational position in a single revolution of the sensor element associated with the position sensor 7012. Thus, a single rotation of the sensor element associated with the position sensor 7012 corresponds to a longitudinal linear displacement d1 of the longitudinally movable drive member 131110 . In other words, d1 is the longitudinal linear distance that the longitudinally movable drive member 131110 moves from point "a" to point "b" after a single revolution of the sensor element coupled to the longitudinally movable drive member 131110. A series of switches 7022a through 7022n (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide a unique position signal for more than one rotation of the position sensor 7012. The states of switches 7022a-7022n are fed back to microcontroller 7004, which applies logic to determine a unique position signal corresponding to longitudinal linear displacement d1+d2+...dn of longitudinally movable drive member 131110, which unique position signal corresponds to At the only position of the first jaw 131002 between the open and closed configurations.

In various aspects, the position sensors 7012 of the sensor arrangement 7002 may include, for example, one or more magnetic sensors, analog rotary sensors (eg, potentiometers), arrays of analog Hall effect elements, etc., which output a unique combination of position signals or values.

In various aspects, the motor 131102 is replaced with a manual trigger that manually drives the longitudinally movable drive member 131110. The manual trigger may be part of the handle of the ultrasonic surgical instrument. In such aspects, absolute positioning system 7000 is configured to track manual advancement and retraction of longitudinally movable drive member 131110.

In various aspects, the microcontroller 7004 can be programmed to perform various functions, such as precise control of the speed and position of the first jaw 131002. Using known physical characteristics, the microcontroller 7004 can be designed to determine the position of the first jaw 131002 and/or the rate of movement of the first jaw 131002 throughout its range of motion, which can further be used to determine the first jaw 131002 The current closed phase of port 131002. In US Patent Application Serial No. 13/803,210, filed March 14, 2013, entitled SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS, which is hereby incorporated by reference in its entirety Additional details regarding the absolute positioning system are disclosed in this document).

In certain aspects, the closing phase is defined or characterized by a predetermined location that may be stored in a storage medium of the control circuit (eg, Figures 13-15, Figures 17-19). The position sensor 7012 transmits a sensor signal indicative of the position of the longitudinally movable drive member 131110 along its range of motion to the control circuit. Since the position of the longitudinally movable drive member 131110 corresponds to the position of the first jaw 131002, the control circuit can evaluate the closing stage of the end effector 131000 based on the received sensor signals and predetermined position data stored in the storage medium.

For example, a first closure phase may span a first range of positions, and a second closure phase may span a second range of positions beyond the first range of positions. Accordingly, a sensor signal from position sensor 7012 indicating that the position of longitudinally movable drive member 131110 is within the first range of positions causes processor 7008 to determine that end effector 131000 is in the first closed phase, and thus select the first energy mode of operation. On the other hand, the sensor signal from the position sensor 7012 indicating the position of the longitudinally movable drive member 131110 is within the second position range causes the processor 7008 to determine that the end effector 131000 is in the second closed phase and therefore select a different A second energy operation mode of an energy operation mode. As described above, the second mode of operation of energy may produce a second output of energy sufficient to seal and coagulate tissue, while the first mode of operation of energy may produce a first output of energy sufficient to separate tissue but not sufficient to seal and coagulate tissue.

Another identifying characteristic of the closing phase of the end effector 131000 includes closing speed. The motor 131102 (FIG. 80) may be configured to actuate the movable drive member 131110 that longitudinally drives the first jaw 131002 at a constant speed. However, as the first jaw 131002 interacts with tissue "T", the speed of closure may vary depending on the characteristics of the portion of tissue "T" with which the first jaw 131002 interacts. Thus, a change in closing speed can be an identifying characteristic of the closing phase of the end effector 131000. The speed of closure may vary as the end effector 131000 transitions from one tissue portion to another (eg, from a tissue portion suitable for tissue separation to a tissue portion suitable for tissue sealing). Changes in the rate of movement of the first jaw 131002 may indicate completion of tissue separation prior to tissue sealing and coagulation.

In certain aspects, the closing phase is defined or characterized by a predetermined rate of motion that may be stored in a storage medium of the control circuit (eg, Figures 13-15, Figures 17-19). The rate of movement of the longitudinally movable drive member 131110, which corresponds to the rate of movement of the first jaw 131002, can be determined based on the sensor signal of the position sensor 7012. In certain aspects, a change in the rate of movement of the longitudinally movable drive member 131110 indicates a transition from the first closed phase to the second closed phase, which may cause the control circuit to switch from the first energy mode of operation to the second energy mode of operation.

Another identifying feature of the closed phase of the end effector 131000 includes the clamping load. Like closure speed, the load exerted by the end effector 131000 on the tissue "T" can vary depending on the characteristics of the tissue "T" portion with which the first jaw 131002 interacts. Thus, a change in clamping load can be an identifying feature of the closing phase of the end effector 131000. The clamping load can vary as the end effector 131000 transitions from one tissue portion to another (eg, from a tissue portion suitable for tissue separation to a tissue portion suitable for tissue sealing). Changes in clamping load can indicate the completion of tissue separation prior to tissue sealing and coagulation.

81 is a logic flow diagram of a process 131070 depicting a control program or logic configuration for switching between energy operating modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. Process 131070 includes detecting 131072 the closing speed and gripping load of the end effector 131000. The closing speed can be monitored via the absolute positioning system 7000 . The clamping load can be determined using sensors 8406, 8408a, 8408b, as described in connection with FIGS. Sensors 8406, 8408a, 8408b are electrically connected to a control circuit, such as control circuit 7400 (FIG. 49), via an interface circuit. Process 131070 also includes determining 131074 whether the closing speed has changed beyond a predetermined threshold. The storage medium of the control circuit performing the process 131070 may store the value of the predetermined threshold. The current closing speed may be compared to a predetermined threshold to determine whether the current closing speed has reached or exceeded the predetermined threshold. Process 131070 also determines 131076 whether the clamp load has changed beyond a predetermined threshold. The storage medium of the control circuit performing the process 131070 may store the value of the predetermined threshold. The current clamping load may be compared to a predetermined threshold to determine whether the current clamping load meets or exceeds the predetermined threshold. The occurrence of either of these two events will cause the process 131070 to switch 131078 from the tissue separation energy mode to the tissue seal energy mode.

In various cases, end effector 131000 may be an ultrasonic end effector suitable for use with ultrasonic surgical instrument 1104, an RF end effector suitable for use with RF electrosurgical instrument 1106, or an ultrasonic end effector suitable for use with multiple The functional surgical instrument 1108 is used in the form of a combined end effector as described in connection with FIGS. 17-19, 22-24. Any of the instruments 1104, 1106, 1108 may be configured to perform one or more of the procedures 131020, 131030, 131040, 131050, 131070, as described above.

In an example where the end effector 131000 is in the form of an ultrasonic end effector, the jaws 131002, 131004 may be in the form of clamping members and ultrasonic blades. The clamping member is movable relative to the ultrasonic blade to grasp tissue therebetween. As described in more detail above, the ultrasonic generator can be activated to apply power to an ultrasonic transducer that is acoustically coupled to the ultrasonic blade via an ultrasonic guide.

In various aspects, a first ultrasound frequency may be first set during a first closure phase to mechanically separate layers of muscle tissue of the vessel during a second closure phase prior to application of the second ultrasound frequency, thereby cutting and sealing the vessel.

The ultrasonic generator module is programmed to output a first drive frequency f1 during the first closing phase, where the first frequency f1 is a significantly deviated resonant frequency, such as fo/2, 2fo or other structural resonant frequencies, where fo is the resonant frequency ( For example, 55.5kHz). The first frequency f1 in combination with the clamping force provides the ultrasonic blade with a low level of mechanical vibration to mechanically separate the muscle tissue layers of the blood vessel (sub-treatment) without causing the significant heating that typically occurs during resonance. During the second closure phase, the ultrasound generator module is programmed to automatically switch the drive frequency to the resonant frequency fo to transect and seal the vessel.

In various aspects, the ultrasonic surgical instrument is connected to a surgical hub that interacts with the cloud-based system, as described in connection with FIGS. 1-11 . In such cases, the control circuitry of the electrosurgical instrument may receive input regarding various situational parameters collected by the surgical hub and/or the cloud-based system. Such inputs may be useful in selecting an appropriate energy operating mode. Furthermore, the energy level generated by the transducer can be tailored specifically to the type of tissue being treated. Situational parameters include, but are not limited to, tissue type, tissue anatomical location, and/or tissue composition. For example, the energy required for tissue separation in the liver or other solid organs may differ from other organs. In addition, the energy level used for tissue dissociation can be increased to accommodate tissue adhesion or other indeterminate connective tissue as reported with surgical hubs. Additional details regarding situational awareness of surgical hubs, cloud-based systems, and various surgical instruments are described under the heading "Situational Awareness."

Different electromechanical systems controlling electrosurgical instruments

Various surgical instruments include end effectors that clamp tissue and apply RF energy, ultrasonic energy, or a combination of RF energy and ultrasonic energy to the clamped tissue, as described in connection with FIGS. 22-24 . Optimal tissue treatment is achieved by carefully modulating energy application to tissue and tissue compression through separate systems that affect each other's effect on tissue. For example, the application of energy to the tissue may be affected by the water content of the tissue, which is affected by the compression applied to the tissue. Increasing the compression applied to the tissue increases the rate at which tissue water content flows out of the tissue held by the end effector, which in turn affects tissue conductivity.

Aspects of the present disclosure provide various processes for modulating systems of electrosurgical instruments that act on tissue alone but have associated effects on the tissue. The use of the same parameters to modulate the electrosurgical instrument's separate systems with correlated effects on tissue ensures consistency in the effects of the systems on tissue. In other words, relying on the same parameters to coordinate the operation of such systems can achieve results that are more relevant to the organization.

In certain aspects, one or more of the disclosed processes may be performed by a control circuit of an electrosurgical instrument, such as control circuit 710 of surgical instrument 700 and/or control circuit 760 of surgical instruments 750, 790. In certain aspects, as shown in FIG. 13 , control circuitry for performing one or more processes may include one or more processors 502 (eg, microprocessors, microcontrollers) coupled to at least one memory circuit 504 ), the at least one memory circuit stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more of the processes may be performed by one or more of the control circuits depicted in Figures 14, 15. In certain aspects, an electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more procedures.

82 is a logic flow diagram depicting a process 131100 of a control program or logic configuration for modulating a system of surgical instruments (eg, surgical instruments 700, 750, 790, 1104, 1106, 1108) in accordance with at least one aspect of the present disclosure. Process 131100 monitors 131101 parameters of the surgical instrument. In various examples, the electrosurgical instrument includes an end effector 131000 . In some examples, the parameter is the impedance of the tissue grasped by the end effector 131000. In another example, the parameter is the temperature of the grasped tissue.

Process 131100 further causes 131104 a change in energy delivered to the tissue in response to reaching or exceeding 131106 the upper predetermined threshold of the parameter. The process 131100 further causes a change 131108 in the energy delivered to the motors (eg, motors 603, 704a, 754) of the surgical instrument in response to reaching or exceeding 131109 the lower predetermined threshold of the parameter. The motor is operably coupled to the end effector 131000 such that energy delivered to the motor causes the motor to transition the end effector 131000 toward the closed configuration. Accordingly, process 131100 implements a change in end effector closure in response to meeting or exceeding the lower predetermined threshold of the 131109 parameter.

In the example of Figure 82, the change in end effector closure is achieved by changing the energy delivered to the motor. In other cases, the change in end effector closure may be accomplished differently, eg, by a gearbox assembly. The clutch mechanism may be configured to engage or disengage the gearbox assembly to increase or decrease the speed of the drive shaft coupled to the motor, which in turn causes the desired change in end effector closure.

Where tissue impedance (Z) is the monitored parameter, tissue impedance (Z) may be monitored by one or more sensors as described in connection with Figures 18, 19, 21, 78A. For example, the end effector 131000 can be equipped with the tissue contacting circuit of Figure 78A, where the tissue "T" is grasped between the plates P1, P2. Tissue impedance (Z _tissue ) can be calculated based on:

where V is voltage, I is current, and Z _{sense circuit} is the predetermined impedance of sense circuit "SC" as shown in Figure 78A. In various examples, as shown in conjunction with FIG. 21 , tissue impedance (Z) may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914 .

和/或发生器驱动频率的变化可以用作超声刀的温度的间接或推断测量结果，该测量结果继而可以用于估计或推断被抓握在超声端部执行器的超声刀和夹持构件之间的组织的温度。Where tissue impedance (Z) is the monitored parameter, tissue impedance (Z) may be monitored by one or more temperature sensors. Alternatively, tissue temperature can be determined, as described above in connection with FIGS. 51-53 , wherein the flex circuit 8412 can include a temperature sensor embedded in one or more layers of the flex circuit 8412. One or more temperature sensors can be arranged symmetrically or asymmetrically and provide tissue 8410 temperature feedback to the ultrasound drive circuit and/or the control circuit of the RF drive circuit. In other examples, as shown in conjunction with Figures 66A-66B, the phase angle

and/or changes in the generator drive frequency can be used as an indirect or inferred measurement of the temperature of the ultrasonic blade, which in turn can be used to estimate or infer the relationship between the ultrasonic blade and the clamping member being gripped by the ultrasonic end effector. the temperature of the tissue in between.

83 is another logic flow diagram of a process 131120 depicting a control program or logic configuration of a system for modulating electrosurgical instruments (eg, surgical instruments 700, 750, 790, 1104, 1108) in accordance with at least one aspect of the present disclosure . Process 131120 monitors 131121 parameters associated with the electrosurgical instrument. As described above in connection with process 131120, this parameter may be the impedance or temperature associated with the electrosurgical instrument. Process 131120 further causes a change 131124 of the first electromechanical system of the electrosurgical instrument in response to reaching or exceeding 131126 the upper predetermined threshold of the parameter. The process 131120 further causes a change 131128 of a second electromechanical system of the electrosurgical instrument different from the first electromechanical system in response to reaching or exceeding 131129 a lower predetermined threshold of the parameter.

FIG. 84 is a graph 131130 illustrating an implementation 131120 in conjunction with an ultrasonic surgical instrument including the ultrasonic end effector 1122 of FIG. 23 . The first electromechanical system is represented by a transducer 1120 and an ultrasonic blade 1128, which is acoustically coupled to the ultrasonic transducer 1120 via a waveguide. The ultrasonic transducer 1120 may be energized with the generator 1100 . When driven by the ultrasonic transducer 1120, the ultrasonic blade 1128 can vibrate, and when in contact with tissue, can cut and/or coagulate tissue, as described herein.

The second electromechanical system is represented by the motor-driven gripping arm 1140 of the end effector 1122 . The motorized movement of the gripping arm of the ultrasonic surgical instrument is described in more detail in connection with FIGS. 46-50. The gripping arm 1140 can be operably coupled to a motor that can drive the gripping arm 1140 to transition the end effector 1122 between an open configuration and a closed configuration to grasp tissue between the gripping arm 1122 and the ultrasound Between 1128 knives.

Referring to Figure 84, graph 131130 includes three curves 131132, 131134, 131136 showing tissue impedance (Z), power (P), and force (F) plotted on the Y-axis versus time (t) on the X-axis. The force (F) is determined at the distal portion (tip) of the end effector 1122 . The upper and lower thresholds are defined in impedance curve 131132. At t ₁ and t ₄ , when impedance (Z) reaches or exceeds the upper threshold defined in impedance curve 131132, power (P) is adjusted in power curve 131134. Thus, the energy delivered to the transducer 1120 of the first electrosurgical system is controlled by the upper threshold of the impedance (Z) parameter. At _t2 and _t3 , when the impedance value reaches or exceeds the lower threshold defined in impedance curve 131132, the end force (F) is adjusted in force curve 131136. Thus, the force applied by the gripping member 1122 to the tissue is controlled by the lower threshold of the impedance (Z) parameter.

In various examples, when the tissue impedance (Z) reaches or exceeds a lower threshold, the current (I) delivered to the motor can be varied in order to effect a variation in the force applied by the gripping member 1122 to the tissue. In at least one example, as shown in Figure 84, when the tissue impedance (Z) reaches or exceeds a lower predetermined threshold, the motor current (I) can be increased to increase the clamping force applied to the tissue.

Due to the pivotal movement of the clamping arms of the ultrasonic surgical instrument, more compression is applied to the tissue positioned proximally between the jaws than to the tissue positioned distally between the jaws. The reduced compression of tissue at the distal portion of the jaws can reduce the heat flux to the tissue at the distal portion of the jaws below a threshold level required to effectively treat the tissue.

In various aspects, the clamp arm may be equipped with tissue sensing circuitry configured to determine the position of tissue clamped between the jaws of the end effector. In US Patent No. 8,181,839, filed June 27, 2011 (titled SURGICAL INSTRUMENT EMPLOYING SENSORS, issued May 5, 2012, the entire disclosure of which is incorporated herein by reference) Examples of suitable tissue sensing circuits are further described in . Also in US Provisional Application No. 62/650,887, filed March 30, 2018, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, which is hereby incorporated by reference in its entirety. Various tissue sensing techniques are described. In at least one example, the tissue sensing circuit includes two electrodes spaced apart. When tissue is in contact with both electrodes, the tissue sensing circuit closes, allowing a sensor signal indicative of the presence of tissue to be transmitted to the control circuit (eg, Figures 13-14, 17-19).

The clamp arm load can be adjusted based on the detected tissue position. For example, higher loads may be applied where tissue is concentrated in the distal portion of the jaws. The higher clamping arm load can be maintained until the clamping tissue at the distal portion of the jaws is almost completely coagulated. The clamp arm load is then reduced to avoid driving the ultrasonic blade into the clamp arm's pad. In one example, a high clamp arm load can be maintained up to a predetermined angular distance between the clamp arm and the ultrasonic blade. Once the clamp arm reaches or exceeds the predetermined angular distance, the clamp arm load is reduced.

In certain aspects, in conjunction with the combined device, RF energy can be mixed with modulation of the clamping arm loading in order to provide sufficient heat flux to coagulate tissue concentrated at the distal tip portion of the jaws.

Detecting the presence of end effectors in liquids

The frequency response associated with immersion of the ultrasonic blade in the liquid is similar to the frequency response associated with thick tissue clamped between the clamping member and the ultrasonic blade. To avoid the generator erroneously triggering tissue treatments specific to thick tissue, it is desirable to detect when the ultrasonic blade is immersed in liquid.

As described above in connection with FIGS. 70A-71 , an ultrasonic surgical instrument or a combined electrosurgical instrument including an ultrasonic component is configured to detect the presence of an ultrasonic blade in a liquid (eg, blood, saline, immersion in water, etc.).

As mentioned earlier, the temperature of the ultrasonic blade can be inferred by detecting the impedance of the ultrasonic transducer given by:

来推断。相位角

信息也可用于推断超声刀的条件。如本文所具体讨论，相位角

作为超声刀的温度的函数而变化。因此，相位角

信息可用于控制超声刀的温度。Or in other words, by detecting the phase angle between the voltage _Vg (t) signal and the current _Ig (t) signal applied to the ultrasonic transducer

to infer. Phase angle

The information can also be used to infer the condition of the ultrasonic scalpel. As discussed specifically herein, the phase angle

as a function of the temperature of the ultrasonic blade. Therefore, the phase angle

The information can be used to control the temperature of the ultrasonic blade.

70A-70B are graphical representations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a temperature dip in the ultrasonic blade is detected. The temperature of the ultrasonic blade increased with applied power 133072, as shown in Figure 70A. During use, the temperature of the ultrasonic blade suddenly dropped. It can be inferred that when the ultrasonic blade is immersed in a fluid-filled surgical field (eg, blood, saline, water, etc.), its temperature will drop.

Immersion of the ultrasonic blade in liquid causes some of the heat generated by the ultrasonic blade to dissipate into the liquid. Therefore, immersion increases the heat flux required to perform effective treatments such as tissue coagulation. In order to modulate the heat flux to a level sufficient for effective treatment, the generator modulates the power delivered to the ultrasound transducer.

In some cases, a mixture of RF energy and ultrasound energy can be employed to adjust the heat flux to a level sufficient for effective treatment. In some cases, the compressive force applied to the tissue between the ultrasonic blade and the clamping arm of the surgical instrument can be modulated to adjust the heat flux to a level sufficient for effective treatment.

On the other hand, as shown in Figure 85, the detection of immersion of the ultrasonic blade in the liquid can be inferred from the frequency response of the waveguide/transducer.

Referring to Figure 85, power (P) is plotted as a function of time in diagnostic mode (as shown in curve 131140) and in response mode (as shown in curve 131142). Power (P) is plotted on the vertical axis, while time (t) is plotted on the horizontal axis. The frequency response of the waveguide/transducer in liquid is different from the ideal frequency response of the waveguide/transducer in air and is below the predetermined threshold curve 131141. When the ultrasonic blade is immersed in liquid, the frequency response curve 131143 of the waveguide/transducer flattens, rather than having the characteristic increase and flat area expected in the ideal frequency response curve 131145 for effective tissue treatment.

86 is a logic flow diagram of a process 131150 depicting a control program or logic configuration for detecting and compensating for immersion of an ultrasonic blade in a liquid in accordance with at least one aspect of the present disclosure. Process 131150 monitors 131152 the power delivered to the tissue over time and compares it to a predetermined threshold. As shown in Figure 85, process 131150 may sample the power change ([delta]P/[delta]t) over a predetermined period of time and compare it to a predetermined threshold slope. If the determined slope (δp/δt) is below the threshold slope, it can be concluded that the ultrasonic blade is immersed in a liquid that wets/cools the blade, thereby increasing the heat flux required for the blade to perform effective treatment (curve 131145). To compensate 131156, more power (curve 131147) is delivered to the transducer. The increased power is chosen to be sufficient to produce the desired frequency response when adjusted by the wetting effect of the liquid (curve 131145). However, if the determined slope ([delta]p/[delta]t) is greater than the threshold slope, power delivery to the ultrasound transducer continues as planned.

As shown in curve 131142 of Figure 85, a modified power curve 131147 is delivered to the tissue in response to detection of immersion of the ultrasonic end effector in the fluid. Modified power curve 131147 compensates for liquid immersion. In the example of curve 131142, a modified power (P) curve 131147 increases the power delivered to the transducer by a predetermined factor/percentage in order to achieve the desired power curve 131145.

In another aspect, detection of immersion of the end effector in liquid may be determined by a liquid sensing circuit in the end effector. The liquid sensing circuit can include two electrodes on the end effector, which can be positioned on separate jaws. Alternatively, the electrodes can be positioned on the same jaw. The presence of liquid between the electrodes completes a circuit that transmits a signal that can be used to detect immersion of the end effector in the liquid. In response to detection as described above, the power delivered to the ultrasonic transducer can be modulated to compensate for the wetting/cooling effects of immersion of the end effector in the liquid.

Depending on the degree to which the end effector is immersed in the liquid and/or the temperature of the liquid, an algorithm can be selected to compensate for the heat lost to the liquid in order to achieve effective treatment of the tissue. In at least one example, the power (P) delivered to the ultrasound transducer can be modulated as described above to counteract the effects of immersion. Alternatively, a compressive force can be applied to the tissue between the clamping arm and the ultrasonic blade to counteract the effects of immersion. In various aspects, both power (P) and tissue compression can be modulated to counteract the effects of liquid immersion. Mixed RF and ultrasound energy modalities can also be used to minimize the effects of immersion, and can be used in combination with increased ultrasound power, RF power, or clamp arm pressure to achieve effective treatment of the tissue.

Referring to Figure 87, a graph 131160 depicts the displacement of the end effector by an electrosurgical instrument as a function of the displacement of the closure driver (eg, closure member 764 of Figures 18, 19) that controls the transition of the end effector 131000 to the closed configuration 131000 (FIG. 73) power delivered to tissue (P) and temperature (T) of tissue grasped by end effector 131000. As described herein, the end effector 131000 treats tissue by grasping tissue and applying RF energy and/or ultrasound energy to the grasped tissue.

In addition to the above, a closure driver is operably coupled to at least one of the jaws 131002, 131004 and is movable to transition the end effector 131000 between an open configuration and a closed configuration to grip tissue Between jaws 131002, 131004. Thus, the movement of the closing driver may represent or be associated with the closing movement of the end effector 131000. Thus, there is a correlation between the compressive force applied by the end effector 131000 to the tissue captured between the jaws 131002, 131004 and the closure driver displacement.

Graph 131160 represents a tissue treatment cycle of end effector 131000. Power (P) is represented on the left vertical axis, temperature (T) is represented on the right vertical axis, and closed drive displacement or translation (δ) is represented on the horizontal axis. Each delta on the horizontal axis of the graph 131160 represents the distance traveled by the closed drive from the starting position.

The phases of the tissue treatment cycle are defined by the closed driver position. In various aspects, it is desirable to maintain tissue at a desired temperature or within a desired temperature range during one or more phases of a tissue treatment cycle. The power (P) delivered to the tissue can be adjusted to maintain tight control of the tissue temperature.

In the example of Figure 87, initial stage 131162 depicts a gradual increase in power (P) to power level (P1 ) as the closed drive translates to δ1. The power (P) is then maintained at a power level (P1) corresponding to a temperature of about 60°C in a first stage 131164. At this temperature, the tissue undergoes collagen denaturation. Near the end of the first phase 131164, the power level is raised again to the power level (P2) at the beginning of the second phase 131166, which corresponds to a temperature between 60°C and 100°C. Towards the end of the second stage 131166, the power level is again raised to a power level (P4) that is configured to bring the tissue to and/or exceed a temperature of 100°C.

On the horizontal axis, the first stage 131164 is defined between a first position at δ1 and a second position at δ2. The power (P) is maintained at the power level (P1) when the closed drive is translated to the second position at δ2. The tissue temperature was maintained at 60°C to promote collagen denaturation.

The second stage 131166 is defined between the second position at δ2 and the third position at δ3. The power (P) is maintained at the power level (P2) when the closed drive is translated to the third position at [delta]3. During the second stage 131166, it is desirable to maintain the tissue temperature between 60°C and 100°C to minimize collateral damage to surrounding tissue that may be caused by the steam generated at 100°C. However, in some cases, as shown in curve portion 131168 of graph 131160, tissue temperature may rise to 100°C prematurely before the closure actuator reaches delta _maximum . In various aspects, as shown in FIG. 87, a predetermined power threshold (P3) is set to prevent the tissue from prematurely reaching a boiling temperature of 100°C.

88 is a logic flow diagram depicting a process 131170 of a control program or logic configuration to maintain tissue temperature below 100°C when the clamp arm transitions to the closed configuration at delta _maximum . Process 131170 monitors 131172 closed driver position and/or displacement. In one example, the closed driver position and/or displacement can be monitored by an absolute positioning system 7000 as described in more detail in connection with FIG. 80 .

Process 131170 also monitors 131172 tissue temperature, which may be estimated based on, for example, the temperature of the ultrasonic blade. If the end effector 131000 is in the form of an ultrasonic end effector or a combination end effector, the ultrasonic blade temperature can be determined by detecting the impedance of the ultrasonic transducer given by:

来推断，如本文所述。另选地，端部执行器131000可以配备有用于测量组织温度的一个或多个温度传感器。Or in other words, by detecting the phase angle between the voltage _Vg (t) signal and the current _Ig (t) signal applied to the ultrasonic transducer

to infer, as described in this paper. Alternatively, the end effector 131000 may be equipped with one or more temperature sensors for measuring tissue temperature.

Based on the monitored temperature and position information, process 131170 determines 131174 whether the temperature of the tissue will reach or exceed 100°C prematurely before the closure actuator reaches or exceeds delta _max , as shown in curve portion 131168 of graph 131160 . If so, process 131170 adjusts 131176 the power (P) to a level below or equal to a predetermined power threshold (P3) in order to prevent the temperature of the tissue (T) from reaching 100°C before the closure actuator reaches or exceeds delta _max , as shown in the curve shown in section 131169.

In certain aspects, process 131170 may be performed at least in part by control circuitry ( FIG. 13 ) that includes one or more processors 502 (eg, microprocessors, microcontrollers) coupled to at least one memory circuit 504 , the at least one memory circuit stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the process 131170. For example, the control circuit may receive closed drive position information from the absolute positioning system 7000 . The tissue temperature may be determined by the processor 502 from the temperature sensor readings or the determined ultrasonic blade temperature, as described herein.

In addition to the above, it can be determined 131174 whether the temperature of the tissue will reach or exceed delta _max 100 prematurely when the drive is turned off, for example by calculating a temperature trajectory from the position, power and/or temperature data at the end of the second stage 131166 °C. In one example, for example, the processor 502 may be used to calculate the temperature trajectory according to one or more tables and/or formulas stored in the memory circuit 504 .

In various aspects, process 131170 may be performed by one or more of the control circuits depicted in FIGS. 14 , 15 . In certain aspects, the electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing process 131170.

In at least one example, as shown in FIG. 87, reaching or exceeding a predetermined threshold temperature T1 between 60°C and ₁₀₀ °C at a predetermined threshold position _δ3 less than δmax may indicate that the temperature of the tissue will be at the closing actuator 100°C is reached or exceeded prematurely before the delta _max is reached or exceeded. Thus, if the determined temperature is greater than or equal to the predetermined threshold temperature T ₁ at the predetermined position threshold δ3, then process 131170 determines ₁₃₁₁₇₄ that the temperature of the tissue will prematurely reach or exceed 100°C before the closure actuator reaches or exceeds δmax.

Referring to FIG. 89, graph 131180 includes four curves 131182, 131184, 131186, 131188. Curve 131182 represents voltage (V) and current (I) versus time (t), curve 131184 represents power (P) versus time (t), and curve 131186 represents temperature (T) versus time (t), While curve 131188 represents tissue impedance (Z) versus time (t). In curve 131188, an impedance bathtub is depicted (eg, tissue impedance initially decreases, then stabilizes, and finally increases with respect to time, the curve resembles a bathtub shape).

Here, time zero represents the first point in time at which electrosurgical energy is applied to tissue at the surgical site. The Y-axis represents the level of tissue impedance (Z) present when a substantially constant level of power (P) is applied to the tissue (as shown in the corresponding portion of curve 131184). At time zero, the tissue exhibits an initial impedance level (Z initial). The initial impedance level (Zinitial) may be based on the natural physiological properties of the tissue such as density, moisture content, and type of tissue. For a short period of time, the impedance level actually drops slightly as power is continuously applied to the tissue. Eventually the minimum impedance level (Zmin) is reached. From here, the total impedance level increases.

Current (I) increases and voltage (V) decreases as tissue impedance (Z) decreases towards minimum tissue impedance (Zmin) over time (tl). The current curve depicted in curve 131182 corresponds to the voltage curve L1. The current curves corresponding to the voltage curves L2 and L3 are omitted for clarity. During the initial time period (t1), the temperature of the tissue was gradually increased to 100°C. Once the water in the tissue begins to evaporate, the tissue impedance (Z) increases significantly, causing the current (I) through the tissue to decay. As the tissue impedance (Z) increases to 100Ω, the tissue temperature also increases to 110°C, which constitutes the boiling point of some tissue oils.

To achieve effective tissue treatment, it is desirable to keep the tissue below a predetermined maximum temperature. To prevent the temperature of the tissue from exceeding a predetermined maximum threshold temperature, the voltage (V) is raised as shown in the voltage (V) curves L2 and L3. Increasing the voltage (V) prevents the temperature of the tissue from exceeding the predetermined threshold temperature, as shown in the temperature curve L3" corresponding to the voltage curve L3, or at least rapidly returns the temperature of the tissue to below the predetermined threshold temperature, as shown in the voltage curve L3" The temperature profile of L2 is shown in L2". In contrast, without increasing the voltage (V), as shown in the voltage curve L1, the tissue temperature of the tissue increases significantly above the predetermined threshold temperature, as shown in the corresponding temperature curve L1".

In at least one example, as shown in FIG. 89, the predetermined maximum temperature is about 130°C. In order to keep the tissue below the predetermined maximum temperature, the voltage (V) is increased in order to slow down further temperature increases, and eventually reverse the temperature increase.

In the example of Figure 89, when the tissue impedance (Z) reaches 100Ω, the tissue temperature reaches about 110°C, and when the tissue impedance (Z) reaches 450Ω, the tissue temperature (T) reaches about 130°C.

Procedures 131190 (FIG. 90) and 131200 (FIG. 91) depict using such values of tissue impedance (Z) and temperature (T) as triggering conditions to target tissue applied by end effector 131000 as shown in FIG. 89 The control program or logic configuration for raising the voltage (V) at the end of the therapy cycle. This disclosure contemplates other values of tissue impedance (Z) and tissue temperature (T) that can be used as trigger conditions to raise voltage (V). In various examples, as shown in curve 131188 of FIG. 89, the threshold tissue impedance (Z) may be about 100Ω. In other examples, the threshold tissue impedance (Z) may be about 450Ω. In various examples, as shown in curve 131186 of FIG. 89, the threshold temperature (T) may be about 110°C. In other examples, the threshold temperature (T) may be about 130°C.

In one example, as shown in process 131190 of Figure 90, tissue impedance (Z) can be monitored 131192 and used to determine 131194 when a voltage (V) increase 131196 is triggered. As described herein in connection with Figure 78A, for example, a sensing circuit can be used to determine tissue impedance (Z). The ultrasound driver circuit and/or the control circuit of the RF driver circuit (eg, FIGS. 13-15 ) can be used to perform process 131190 based on input received from the sensing circuit.

来推断超声刀的温度。另选地，可以确定组织温度，如上文结合图51-53所述，其中柔性电路8412可包括嵌入柔性电路8412的一层或多层中的温度传感器。一个或多个温度传感器可对称地或非对称地布置，并向超声驱动电路和/或RF驱动电路的控制电路(例如，图13-15)提供组织8410温度反馈。控制电路可以用于基于温度反馈来执行过程131200。In another example, as shown in process 131200 of FIG. 91 , tissue temperature (T) can be monitored 131202 and used to determine 131204 when a voltage (V) increase 131206 is triggered. As described herein in connection with Figures 66A-68, the generator is based on the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to drive the ultrasound transducer

to infer the temperature of the ultrasonic scalpel. Alternatively, tissue temperature can be determined, as described above in connection with FIGS. 51-53 , wherein the flex circuit 8412 can include a temperature sensor embedded in one or more layers of the flex circuit 8412. One or more temperature sensors can be arranged symmetrically or asymmetrically and provide tissue 8410 temperature feedback to the ultrasound drive circuit and/or the control circuit of the RF drive circuit (eg, FIGS. 13-15 ). Control circuitry may be used to perform process 131200 based on temperature feedback.

In various examples, the voltage (V) increases in steps, as shown by the voltage curves L2, L3. In other examples, the voltage (V) may be gradually increased.

In at least one example, two different upper limit temperatures are set to affect the power level. In addition to the maximum temperature thresholds, primary and secondary minimum shutdown temperature thresholds are also available.

Ultrasound and RF Surgical Instruments Portfolio

As described above, the end effector 131000 (FIG. 73) may be adapted for use with a combination electrosurgical instrument that provides tissue treatment by applying radio frequency (RF) energy alone or in combination with ultrasonic vibration. In US Patent Publication 2017/0202609 (titled Modular Battery Powered Hand-Held Surgical Instrument With Curved End Effectors Having Asymmetric Engagement Between Jaw and Knife Examples of generators configured to drive ultrasonic transducers and RF electrodes of end effectors are discussed in greater detail in Engagement Between Jaw and Blade), which is incorporated by reference in its entirety.

In various aspects, an end effector 131000 including an ultrasonic component and an RF component is configured to modulate one or more parameters of the RF component based on tissue temperature measurements performed by the ultrasonic component. Accordingly, the ultrasound component may be utilized in a non-therapeutic diagnostic mode, while the RF component may be utilized in a therapeutic mode to adjust one or more parameters of the RF component in real time.

92 is a process 131210 depicting a control program or logic configuration for utilizing an ultrasound component in a non-therapeutic diagnostic mode and utilizing an RF component in a therapeutic mode.

Process 131210 monitors 131212 the temperature of the ultrasonic blade. Process 131210 further determines 131214 whether the temperature of the ultrasonic blade is greater than or equal to a predetermined threshold temperature. If so, process 131210 adjusts the power (P) of the RF components to reduce the energy delivered to the tissue.

来推断超声刀的温度。由于超声刀的温度对应于由组合装置的端部执行器131000捕获的组织的温度，因此超声部件可以用于诊断非治疗模式，以监测组织温度并提供反馈信息以便调节RF部件的功率水平。As described in connection with Figures 66A-68, the generator is based on the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to drive the ultrasound transducer

to infer the temperature of the ultrasonic scalpel. Since the temperature of the ultrasonic blade corresponds to the temperature of the tissue captured by the end effector 131000 of the combination device, the ultrasonic component can be used in a diagnostic non-therapeutic mode to monitor tissue temperature and provide feedback to adjust the power level of the RF component.

93 is a graph 131220 illustrating performing a process 131210 in accordance with at least one aspect of the present disclosure. Graph 131220 includes three curves 131222, 131224, 131226 that depict power (P), temperature (T), and phase, respectively, on the vertical axis. Curve 131222 represents power (P) versus time (t) delivered to tissue captured between jaws 131002, 131004 of end effector 131000 of the combined device. Curve 131224 represents temperature (T) versus time (t) for the ultrasonic blade of end effector 131000. Curve 131226 represents the dual non-treatment frequencies used by the ultrasonic component to determine the temperature of the ultrasonic blade and, in turn, the temperature of the tissue (as described in more detail in connection with FIGS. 66A-68). The ultrasound component can be configured to detect a transition of tissue temperature to or above a predetermined _threshold temperature (Tthreshold), as shown in curve 131224. The power (P) level of the RF component can then be adjusted (from P1 to P2) to prevent excessive temperature as shown in curve 131222.

In at least one example, the power (P) level of the RF component is adjusted to keep the tissue temperature below 100°C to prevent collateral damage to surrounding tissue from the steam, while still being gripped by the end effector 131000 of the combined device Collagen in the tissue is locally coagulated. In at least one example, the power (P) level of the RF component is adjusted to maintain tissue temperature below 130°C, thereby preventing tissue charring that may occur at such temperatures. In at least one example, the temperature feedback provided by the ultrasonic component allows the RF component to adjust the power slope based on tissue phase transitions during the tissue treatment cycle.

In various aspects, a process includes a control program or logic configuration for differentiating sections of an ultrasonic blade based on temperature. This process separates very hot smaller sections of the ultrasonic blade from moderately hot larger sections. In at least one aspect, the process includes applying multiple frequencies through 55.5Khz, which is the standard frequency, and then alternatively using, for example, 3 times the 150KHz frequency to determine two different resonant frequencies, which would allow the ultrasonic blade to be determined A small portion of a very hot temperature, or a larger portion of an ultrasonic blade with a moderately hot temperature.

94 is a logic flow diagram depicting a process 131230 of a control program or logic configuration for adjusting the frequency of an RF waveform of an RF electrosurgical instrument or RF component of a combination device based on measured tissue impedance in accordance with at least one aspect of the present disclosure. In at least one example, tissue impedance is measured 131232 before or during an initial portion of a tissue treatment cycle and used to select 131231 between predetermined high frequency 131234 and low frequency 131236 options of the RF waveform applied to the tissue.

Process 131230 addresses low power transmission conditions. If it is determined that the measured tissue impedance is at or below a predetermined threshold, the high frequency RF waveform is selected for the treatment cycle. High frequency RF waveforms are configured to drive tissue impedance higher to account for low power delivery. However, if the measured tissue impedance is determined to be greater than or equal to the predetermined threshold, then the low frequency RF waveform is selected for the treatment cycle. In various aspects, tissue impedance can be measured by one or more sensors as described in connection with Figures 18, 21, 78A.

In various aspects, one or more processes of the present disclosure may be performed by a control circuit of an electrosurgical instrument, such as control circuit 710 of surgical instrument 700 , control circuit 760 of surgical instrument 750 , and/or control circuit 760 of surgical instrument 790 . In certain aspects, as shown in FIG. 13 , control circuitry for performing one or more processes of the present disclosure may include one or more processors 502 (eg, microprocessors, microcontroller), the at least one memory circuit stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more of the processes of the present disclosure may be performed by one or more of the control circuits depicted in FIGS. 14 , 15 . In certain aspects, an electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more procedures of the present disclosure.

Various aspects of the subject matter described herein are set forth in the following numbered examples:

Example 1 - A surgical instrument comprising an end effector comprising an ultrasonic blade and a gripping arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm between. The surgical instrument also includes an ultrasonic transducer configured to generate an ultrasonic energy output and a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade. The surgical instrument further includes a control circuit configured to detect immersion of the end effector in liquid and to compensate for heat caused by the immersion of the end effector in the liquid flux loss.

基于施加到所述超声换能器的所述电压Vg(t)信号和电流Ig(t)信号之间的所述相位角

来推断所述超声刀的温度，以及将所述超声刀的推断温度与预定温度进行比较。Embodiment 2 - The surgical instrument of Embodiment 1, wherein detecting immersion comprises monitoring the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasonic transducer

Based on the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasound transducer

to infer the temperature of the ultrasonic blade, and compare the inferred temperature of the ultrasonic blade with a predetermined temperature.

Embodiment 3 - The surgical instrument of Embodiment 1 or Embodiment 2, further comprising a fluid sensing circuit, and wherein detecting the immersion comprises receiving a signal from the fluid sensing circuit.

Embodiment 4 - The surgical instrument of any one of Embodiments 1 to 3, wherein compensation for heat flux is achieved by adjusting power to the ultrasonic transducer.

Embodiment 5 - The surgical instrument of any one of Embodiments 1 to 4, wherein the compressive load applied to the tissue clamped between the clamp arm and the ultrasonic blade is adjusted by adjusting to compensate for the heat flux.

Example 6 - A surgical instrument comprising an end effector comprising an ultrasonic blade and a gripping arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm between. The surgical instrument further includes an ultrasonic transducer configured to generate ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade, and configured to actuate movement of the gripping arm to A drive member transitioning the end effector to the closed configuration. The surgical instrument further includes a control circuit configured to monitor the position of the drive member, monitor the temperature of the ultrasonic blade, and prevent the temperature from exceeding a predetermined threshold prior to the closed configuration.

来推断所述温度。Embodiment 7 - The surgical instrument of Embodiment 6, wherein based on the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasonic transducer

to infer the temperature.

Embodiment 8 - The surgical instrument of embodiment 6 or embodiment 7, wherein the position of the drive member is determined by an absolute positioning system.

Embodiment 9 - The surgical instrument of any one of Embodiments 6 to 8, wherein the predetermined threshold is 100°C.

Embodiment 10 - The surgical instrument of any one of Embodiments 6 to 9, wherein preventing the temperature from exceeding a predetermined threshold is achieved by adjusting the power delivered to the ultrasound transducer.

Embodiment 11 - The surgical instrument of any one of Embodiments 6 to 10, wherein the closed configuration corresponds to a predetermined distance traveled by the drive member from the starting position.

Embodiment 12 - The surgical instrument of any one of Embodiments 6 to 10, wherein the closed configuration corresponds to the maximum compression applied to the tissue by the clamping arms.

Example 13 - A surgical instrument including an end effector including a first jaw and a second jaw. The second jaw is movable relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first jaw and the between the second jaws. The end effector also includes an ultrasonic component configured to deliver ultrasonic energy to the grasped tissue and a radio frequency (RF) component configured to deliver RF energy to the grasped tissue. The surgical instrument also includes a control circuit configured to operate the ultrasonic component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

Embodiment 14 - The surgical instrument of Embodiment 13, wherein the non-therapeutic diagnostic mode includes determining at least one temperature of the grasped tissue.

Embodiment 15 - The surgical instrument of Embodiment 13 or Embodiment 14, wherein the ultrasonic component comprises an ultrasonic transducer.

来推断所述温度。Embodiment 16 - The surgical instrument of Embodiment 15, wherein based on a phase angle between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasonic transducer

to infer the temperature.

Embodiment 17 - The surgical instrument of any one of Embodiments 13 to 16, wherein the treatment mode includes applying RF energy to seal grasped tissue.

Embodiment 18 - The surgical instrument of any one of Embodiments 13 to 17, wherein the ultrasonic component comprises an ultrasonic transducer, and wherein the RF component comprises an RF electrode.

Embodiment 19 - The surgical instrument of Embodiment 18, further comprising a generator configured to drive the ultrasonic transducer and the RF electrode.

While various forms have been illustrated and described, it is not the intention of the applicants to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations and equivalents of these forms may be made without departing from the scope of the present disclosure, and many modifications, variations, changes, substitutions, Combinations and Equivalents. Also, alternatively, the structure of each element associated with the described form may be described as a means for providing the function performed by the element. Additionally, where materials are disclosed for certain components, other materials may also be used. Therefore, it should be understood that the foregoing detailed description and the appended claims are intended to cover all such modifications, combinations and variations as fall within the scope of the present disclosure. The appended claims are intended to cover all such modifications, variations, changes, substitutions, alterations and equivalents.

The foregoing detailed description has illustrated various forms of apparatus and/or methods using block diagrams, flowcharts, and/or examples. So long as such block diagrams, flowcharts and/or examples include one or more functions and/or operations, those skilled in the art will understand each function and/or operation in such block diagrams, flowcharts and/or examples or operations may be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein may be implemented as one or more computer programs (eg, as one or more computer programs) running on one or more computers one or more programs), as one or more programs running on one or more processors (eg, as one or more programs running on one or more microprocessors), as firmware, or as Indeed any combination of them is equivalently implemented in whole or in part in an integrated circuit, and it would be within the skill of those skilled in the art to design electronic circuits and/or code software and/or hardware in accordance with the present invention. In addition, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in a variety of forms, and that exemplary forms of the subject matter described herein are applicable regardless of use in actual implementation. What is the specific type of signal bearing medium distributed.

Instructions for programming logic to perform the various disclosed aspects may be stored in memory within the system, such as dynamic random access memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed over a network or through other computer-readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (eg, a computer), but is not limited to a floppy disk, optical disk, optical disk, read only memory (CD-ROM), magneto-optical disk, Read Only Memory (ROM), Random Access Memory (RAM), Erasable Programmable Read Only Memory (EPROM), Electrically Erasable Programmable Read Only Memory (EEPROM), magnetic or optical cards, flash memory, or via A tangible, machine-readable storage device used in the transmission of information over the Internet by electrical, optical, acoustic, or other forms of propagated signals (eg, carrier waves, infrared signals, digital signals, etc.). Accordingly, non-transitory computer-readable media includes any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (eg, a computer processor that includes one or more individual instruction processing cores, processing units, processing devices, microcontrollers, microcontroller units, controllers, digital signal processors (DSPs), programmable logic devices (PLDs), programmable logic arrays (PLAs), field programmable gate arrays (FPGAs), state machines Circuitry, firmware that stores instructions for execution by programmable circuitry, and any combination thereof. The control circuits may be implemented collectively or individually as circuitry that forms part of a larger system, such as an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server , smart phones, etc. Thus, as used herein, "control circuit" includes, but is not limited to, an electronic circuit having at least one discrete circuit, an electronic circuit having at least one integrated circuit, an electronic circuit having at least one application specific integrated circuit, forming a general-purpose computer configured by a computer program Apparatus (eg, a general-purpose computer configured by a computer program at least partially implementing the processes and/or apparatus described herein, or a microprocessor configured by a computer program at least partially implementing the processes and/or apparatus described herein) electronic circuits that form memory devices (eg, random access memory), and/or electronic circuits that form communication devices (eg, modems, communication switches, or optoelectronic devices). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to applications, software, firmware, and/or circuitry configured to perform any of the foregoing operations. Software may be embodied as a software package, code, instructions, sets of instructions, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or a set of instructions and/or data hard-coded (eg, non-volatile) in a memory device.

As used in any aspect herein, the terms "component," "system," "module," etc. may refer to a computer-related entity, hardware, a combination of hardware and software, software, or software in execution.

As used in any aspect herein, an "algorithm" refers to an organized sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states, which may (but need not necessarily be) ) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared and otherwise manipulated. Often used to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.

The network may include a packet-switched network. The communication devices may be capable of communicating with each other using the selected packet-switched network communication protocol. An exemplary communication protocol may include an Ethernet communication protocol that may allow communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard titled "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and/or later versions of this standard. Alternatively or additionally, the communication devices may be able to communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform or conform to standards promulgated by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may be able to communicate with each other using a frame relay communication protocol. The Frame Relay communication protocol may conform or conform to standards published by the Consultative Committee for International Telephone and Telephony (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard named "ATM-MPLS Network Interworking 2.0" published by the ATM Forum in August 2001 and/or a higher version of the standard. Of course, different and/or later developed connection-oriented network communication protocols are also contemplated herein.

Unless explicitly stated otherwise in the above disclosure, it is understood that in the above disclosure, discussions using terms such as "processing," "estimating," "calculating," "determining," "displaying," refer to computer systems or similar Acts and processes of electronic computing devices that manipulate data represented as physical (electronic) quantities within the registers and memory of a computer system and convert it into data similarly represented as computer system memory or registers or other such information storage, transmission or Displays other data of physical quantities within the device.

One or more components may be referred to herein as "configured to", "configurable to be", "operable/operable", "adapted/adaptable", "capable", "conformable" /fit to" etc. Those skilled in the art will recognize that unless the context dictates otherwise, "configured to" may generally encompass active state components and/or inactive state components and/or standby state components.

The terms "proximal" and "distal" are used herein with respect to a clinician manipulating the handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It should also be understood that, for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in connection with the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Those of skill in the art will recognize that the terms used herein, in general, and in the appended claims in particular (eg, the body of the appended claims) are generally intended to be "open" terms (eg, the term "" Including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "including" should be interpreted as "including but not limited to", etc.). It will also be understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present . For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, use of such phrases should not be taken to imply that introduction of a claim expression by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim expression to containing only one such expression even when the same claim includes the introductory phrases "one or more" or "at least one" and phrases such as "an" or "an" (eg, "an" and/or "an" should generally be When interpreted as an indefinite article meaning "at least one" or "one or more"); this also applies to the use of the definite article for introducing claim expressions.

Additionally, even if a specific number of an introduced claim recitation is explicitly recited, one skilled in the art will recognize that such recitation should generally be construed to mean at least the recited number (eg, in the absence of other modifiers, to "" The "naked narration of two narrations" generally means at least two narrations, or two or more narrations). Furthermore, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, such constructions are, in general, intended to have the meaning that those skilled in the art would understand the convention ( For example, "a system having at least one of A, B, and C" would include, but not be limited to, having A only, B only, C only, A and B together, A and C together, B and C together, and/or A , B and C together etc.). In those cases where a convention similar to "at least one of A, B, or C, etc." is used, such constructions are generally intended to have the meaning that those skilled in the art would understand the convention (eg, "A system having at least one of A, B, or C" shall include, but is not limited to, having A only, B only, C only, A and B together, A and C together, B and C together, and/or A, B systems such as with C). It will also be understood by those skilled in the art that generally, unless the context dictates otherwise, the presentation of two or more alternative terms and/or phrases in the detailed description, claims or drawings should be construed as The possibility of including one of the terms, either of the terms, or both of the terms is encompassed. For example, the phrase "A or B" will generally be understood to include the possibilities of "A" or "B" or "A and B".

With regard to the appended claims, those skilled in the art will understand that the operations recited therein can generally be performed in any order. Additionally, although various operational flowcharts are presented in one or more sequences, it should be understood that the various operations may be performed in other orders than shown, or may be performed concurrently. Unless context dictates otherwise, examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reversed, or other altered orderings. Furthermore, terms like "responsive to," "related to," or other past-tense adjectives are generally not intended to exclude such variations unless the context dictates otherwise.

It is worth mentioning that any reference to "an aspect", "an aspect", "an example", "an example" means that the particular feature, structure or characteristic described in connection with the said aspect is included in at least in one aspect. Thus, the appearances of the phrases "in one aspect," "in an aspect," "in an example," "in an example" in various places throughout the specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects.

Any patent applications, patents, non-patent publications or other publications mentioned in this specification and/or listed in any Application Data Sheet are incorporated herein by reference to the extent that the incorporated material is inconsistent herein. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or part thereof, that is said to be incorporated herein by reference but which conflicts with existing definitions, representations or other disclosed material listed herein will not arise only between the incorporated material and the existing disclosed material merged to the extent of conflict.

In general terms, a number of benefits have been described that result from employing the concepts described herein. The foregoing detailed description has been presented in one or more forms for the purposes of illustration and description. These detailed descriptions are not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications and variations of the present invention are possible in light of the above teachings. The form or forms was chosen and described in order to illustrate principles and practical application, to thereby enable others of ordinary skill in the art to utilize various forms and modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.

Claims (19)

1. A surgical instrument comprising: An end effector comprising: Ultrasound scalpel; and a clamping arm movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the ultrasonic blade between the clamping arms; an ultrasonic transducer configured to generate ultrasonic energy output; a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade; and a control circuit, the control circuit is configured to: detecting immersion of the end effector in the liquid; and Compensate for heat flux losses due to the immersion of the end effector in the liquid. 2. The surgical instrument of claim 1, wherein detecting the immersion comprises: Monitoring the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasonic transducer

Based on the phase angle between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasound transducer

to infer the temperature of the ultrasonic blade; and The inferred temperature of the ultrasonic blade is compared to a predetermined temperature. 3. The surgical instrument of claim 1, further comprising a liquid sensing circuit, and wherein detecting the immersion comprises receiving a signal from the liquid sensing circuit. 4. The surgical instrument of claim 1, wherein compensation for heat flux is achieved by adjusting power to the ultrasonic transducer. 5. The surgical instrument of claim 1, wherein compensation for heat flux is achieved by adjusting the compressive load applied to the tissue clamped between the clamp arm and the ultrasonic blade. 6. A surgical instrument comprising: An end effector comprising: Ultrasound scalpel; and a clamping arm movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the ultrasonic blade between the clamping arms; an ultrasonic transducer configured to generate ultrasonic energy output; a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade; a drive member configured to actuate movement of the clamp arm to transition the end effector to the closed configuration; and a control circuit, the control circuit is configured to: monitoring the position of the drive member; monitoring the temperature of the ultrasonic blade; and The temperature is prevented from exceeding a predetermined threshold prior to the closed configuration. 7. The surgical instrument of claim 6, wherein based on a phase angle between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasonic transducer

to infer the temperature. 8. The surgical instrument of claim 6, wherein the position of the drive member is determined by an absolute positioning system. 9. The surgical instrument of claim 6, wherein the predetermined threshold is 100°C. 10. The surgical instrument of claim 6, wherein preventing the temperature from exceeding the predetermined threshold is accomplished by adjusting the power delivered to the ultrasound transducer. 11. The surgical instrument of claim 6, wherein the closed configuration corresponds to a predetermined distance traveled by the drive member from a starting position. 12. The surgical instrument of claim 6, wherein the closed configuration corresponds to maximum compression applied to the tissue by the gripping arm. 13. A surgical instrument comprising: An end effector comprising: the first jaw; A second jaw movable relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue in the between the first jaw and the second jaw; an ultrasonic component configured to deliver ultrasonic energy to the grasped tissue; and a radio frequency (RF) component configured to deliver RF energy to the grasped tissue; and A control circuit configured to operate the ultrasound component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue. 14. The surgical instrument of claim 13, wherein the non-therapeutic diagnostic mode includes determining at least one temperature of grasped tissue. 15. The surgical instrument of claim 14, wherein the ultrasonic component comprises an ultrasonic transducer. 16. The surgical instrument of claim 15, wherein based on a phase angle between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasonic transducer

to infer the temperature. 17. The surgical instrument of claim 13, wherein the treatment mode includes applying RF energy to seal grasped tissue. 18. The surgical instrument of claim 13, wherein the ultrasonic component comprises an ultrasonic transducer, and wherein the RF component comprises an RF electrode. 19. The surgical instrument of claim 18, further comprising a generator configured to drive the ultrasonic transducer and the RF electrode.

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