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WO2025081187A1 - Détection de tissu avec un outil de résection à ultrasons - Google Patents

Détection de tissu avec un outil de résection à ultrasons Download PDF

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Publication number
WO2025081187A1
WO2025081187A1 PCT/US2024/051403 US2024051403W WO2025081187A1 WO 2025081187 A1 WO2025081187 A1 WO 2025081187A1 US 2024051403 W US2024051403 W US 2024051403W WO 2025081187 A1 WO2025081187 A1 WO 2025081187A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
ultrasonic instrument
tissue
drive signal
frequency
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/051403
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English (en)
Inventor
Adam D. DOWNEY
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Stryker Corp
Original Assignee
Stryker Corp
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Filing date
Publication date
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Publication of WO2025081187A1 publication Critical patent/WO2025081187A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00973—Surgical instruments, devices or methods pedal-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320084—Irrigation sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2068—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis using pointers, e.g. pointers having reference marks for determining coordinates of body points
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots

Definitions

  • a system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
  • One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
  • One general aspect includes a surgical system for detecting tissue types using an ultrasonic instrument for resecting patient tissue.
  • the surgical system includes a power supply configured to source varying AC drive signals to the ultrasonic instrument to induce varying vibrations in a tip of the ultrasonic instrument.
  • the system includes at least one sensor for measuring at least one electrical characteristic of the AC drive signals.
  • the system includes one or more controllers coupled to the at least one sensor and the power supply and configured to: operate the ultrasonic instrument in a tissue resection mode in which a first AC drive signal is sourced to the ultrasonic instrument that induces vibrations in the tip of the ultrasonic instrument for resecting patient tissue; operate the ultrasonic instrument in a tissue sense mode in which a second AC drive signal is sourced to the ultrasonic instrument that induces vibrations in the tip for sensing patient tissue, the second AC drive signal being lower power than the first AC drive signal; obtain at least one measured first electrical characteristic of the second AC drive signal; determine a first frequency corresponding to a target vibratory characteristic of the ultrasonic instrument based on the at least one measured first electrical characteristic; determine a type of patient tissue being contacted by a distal region of the tip based on the determined first frequency; and control operation of the surgical system based on the determined type of patient tissue.
  • a tissue resection mode in which a first AC drive signal is sourced to the ultrasonic instrument that induces
  • implementations related to this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the configured actions of the one or more controllers, and methods for detecting tissue types using an ultrasonic instrument for resecting patient tissue each comprising performance of the above actions.
  • One general aspect includes a surgical system for detecting tissue types using an ultrasonic instrument for resecting patient tissue.
  • the surgical system includes a power supply configured to source varying AC drive signals to the ultrasonic instrument to induce varying vibrations in a tip of the ultrasonic instrument.
  • the system includes at least one sensor for measuring at least one electrical characteristic of the AC drive signals.
  • the system includes one or more controllers coupled to the at least one sensor and the power supply and configured to: source an AC drive signal to the ultrasonic instrument that induces vibrations in a tip of the ultrasonic instrument for resecting patient tissue; obtain at least one measured first electrical characteristic of the AC drive signal; determine one or more frequency characteristics of the AC drive signal based on the at least one measured first electrical characteristic, each of the frequency characteristics corresponding to a frequency other than a fundamental frequency of the AC drive signal; determine a type of patient tissue being contacted by a distal region of the tip based on the determined one or more frequency characteristics; and control operation of the surgical system based on the determined type of patient tissue.
  • One general aspect includes a surgical system for detecting tissue types using an ultrasonic instrument for resecting patient tissue.
  • the surgical system includes a power supply configured to source varying AC drive signals to the ultrasonic instrument to induce varying vibrations in a tip of the ultrasonic instrument.
  • the system includes at least one sensor for measuring at least one electrical characteristic of the AC drive signals.
  • the system includes one or more controllers coupled to the at least one sensor and the power supply and configured to: operate the ultrasonic instrument in a tissue resection mode in which an AC drive signal is sourced to the ultrasonic instrument that induces vibrations in a tip of the ultrasonic instrument for resecting patient tissue and in which suction is provided at a distal region of the tip through at least a portion of the ultrasonic instrument; obtain at least one measured first electrical characteristic of the AC drive signal; determine a type of patient tissue being contacted by the distal region of the tip based on the at least one measured first electrical characteristic; and regulate the suction provided at the distal region of the tip when operating in the tissue resection mode based on the determined type of patient tissue.
  • the method includes obtaining a voltage measurement and a current measurement of the second AC drive signal when the distal region of the tip is in contact with the patient tissue, determining a frequency corresponding to a target vibratory characteristic of the ultrasonic instrument based on the voltage measurement and the current measurement, determining a type of patient tissue being contacted by the distal region of the tip based on the determined frequency, and controlling operation of the surgical system based on the determined type of patient issue.
  • Implementations of any of the aspects may include a robotic manipulator coupled to the ultrasonic instrument and configured to guide the ultrasonic instrument to treat the patient tissue, and may include controlling the robotic manipulator based on the determined type of patient tissue, such as by adjusting a parameter of a virtual object (e.g., haptic object) associated with the patient tissue and used to control the robotic manipulator.
  • a robotic manipulator coupled to the ultrasonic instrument and configured to guide the ultrasonic instrument to treat the patient tissue
  • controlling the robotic manipulator based on the determined type of patient tissue, such as by adjusting a parameter of a virtual object (e.g., haptic object) associated with the patient tissue and used to control the robotic manipulator.
  • a virtual object e.g., haptic object
  • FIG. 2 illustrates the ultrasonic resection system in additional detail according to an exemplary aspect.
  • the ability to leverage an ultrasonic instrument operative to resect patient tissue to also sense the type of tissue being contacted by the instrument offers several benefits.
  • implementations described herein may enable continued sensing of the tissue type while fragmenting the tissue (e.g., instead of stopping fragmentation to probe for the tissue type), and also enable sensing tissue using the same instrument as used for resection (e.g., instead of prolonging a procedure by switching between a fragmentation instrument and a probing instrument), thus improving procedure speed.
  • the robotic manipulator 14 may be configured to provide haptic feedback and/or to constrain movement of the ultrasonic instrument 15 as the ultrasonic instrument 15 is moved by the surgeon relative to the target volume to avoid adjacent objects.
  • the surgical navigation system 12 may be configured to track a pose (i.e., location and orientation) of objects of interest within the surgical workspace using tracker-based localization.
  • the tracked objects may include, but are not limited to, anatomical structures of the patient and surgical instruments such as the ultrasonic instrument 15.
  • the tracked anatomical structures of the patient may include soft and hard tissues such as fat, ligaments, muscle, skin, and bone.
  • the tracked surgical instruments may include, in addition to the ultrasonic instrument 15, retractors, other cutting tools, inserters, implants, and waste management devices used during the surgical procedure.
  • the position sensor may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. No. 8,702,626, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,320,711, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,190,389, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,123,722, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,720,521, the disclosure of which is incorporated by reference herein; U.S. Pat. Pub. No. 2014/0364725, the disclosure of which is incorporated by reference herein; U.S. Pat.
  • the surgical navigation system 12 may identify a target volume of patient tissue to be treated and potential obstacles in the surgical workspace based on the tracked objects, and generate virtual objects corresponding to the tracked objects in a known coordinate system. The surgical navigation system 12 may then control the robotic manipulator 14 to maneuver and/or guide the ultrasonic instrument 15 based on the virtual objects, such as to lead the ultrasonic instrument 15 to the patient tissue to be treated and/or away from contact with anything beyond the target volume of patient tissue to be treated. In this way, the surgical navigation system 12 may both improve surgical accuracy and eliminate damage to surgical instruments caused by unintended contact with other objects, which may result in undesired debris at the target site.
  • the object to which each tracker 16 is affixed may be rigid and inflexible so that movement of the object cannot or is unlikely to alter the positional relationship between the object and the tracker 16.
  • the relationship between a tracker 16 in the surgical workspace and an object to which the tracker 16 is attached may remain fixed, notwithstanding changes in the position of the object within the surgical workspace.
  • the trackers 16 may be firmly affixed to patient bones such as vertebra V, and to surgical instruments such as retractors and the ultrasonic instrument 15.
  • the navigation controller 24 may infer the pose of the object to which the tracker 16 is affixed based on the determined position of the tracker. In some implementations, the navigation controller 24 may also infer the poses of relatively non-rigid and flexible patient tissues based on the determined poses of other tracked objects adjacent to or having a known relationship to the patient tissues. Additionally or alternatively, the navigation controller 24 may be configured to cooperate with one or more flexible trackers attached to the patient and registered with patient tissue of interest such as non-rigid and flexible patient tissue so as to track such patient tissue in the known coordinate system.
  • Each tracker 16 may also include a tracker controller 50 communicatively coupled to the markers 48 and to the navigation controller 24.
  • the tracker controllers 50 may be configured to control the rate and order in which the markers 48 fire, such as at the direction of the navigation controller 24.
  • the tracker controllers 50 may cause the markers 48 of each tracker 16 to fire at different rates and/or times to facilitate differentiation of the markers 48 by the navigation controller 24.
  • the navigation controller 24 may form a bi-directional infrared communication channel with each tracker controller 50 to control the timing of the firing of the active marker 48 operated by the tracker controller 50, write/read nonvolatile data, and get the status (e.g., battery level, broken LEDs) of the trackers 16 or the objects to which the trackers 16 are affixed.
  • markers 48 of the trackers 16 may be realized as passive markers, such as reflectors that reflect light emitted from the localizer camera 20.
  • the localizer camera 20 may include a light source 51 (FIG. 1) that illuminates the trackers 16 with light, such as nonvisible light (e.g., infrared or ultraviolet). The markers 48 may then be configured to reflect the light back towards the localizer camera 20, which may then be detected by the optical sensors 38.
  • the navigation controller 24 may receive relationship data 54 indicating a pose of the coordinate system associated with the vertebra V relative to the coordinate system associated with the tracker 16. In this way, responsive to identifying the pose of the tracker 16 relative to a known coordinate system, the navigation controller 24 may reference the relationship data 54 for the tracker 16 to determine the pose of the coordinate system associated with the vertebra V, and correspondingly of the vertebra V, relative to the known coordinate system.
  • the localizer camera 20 may be configured to generate image data based on the optical-based signals received from the optical sensors 38, and communicate such image data to the navigation controller 24.
  • the image data may indicate the image and/or image plane positions represented by the optical-based signals received from each optical sensor 38.
  • the navigation controller 24 may be configured to track the poses of anatomical structures of interest by tracking poses of trackers 16 attached to such structures. Additionally or alternatively, the navigation controller 24 may be configured to track the poses of anatomical structures based on images of the anatomical structures received prior to and/or during the procedure.
  • the surgical system 10 may include an imaging system coupled to the navigation controller 24 and configured to generate images of patient anatomical structures, such as that described in PCT Application No. PCT/US2023/017790. Similar to the ultrasonic instrument 15, the imaging system may include a tracker 16 having a fixed relationship with pixel coordinates of the images generated by the imaging system, which may be stored by the navigation controller 24 as further relationship data 54.
  • the navigation controller 24 may then be configured to control operation of the robotic manipulator 14 and/or ultrasonic instrument 15 based on a tracked position of the distal region 84 of the tip 82, such as via the tracker 16B coupled to the ultrasonic instrument 15, relative to the virtual objects in the known coordinate system.
  • the handpiece 86 may form a proximal end of the ultrasonic instrument 15, and the tip 82 coupled to the handpiece 86 may form a distal end of the ultrasonic instrument 15.
  • Proximal may be understood as towards an operator holding the ultrasonic instrument 15 and away from the tissue to which the tip 82 is being applied
  • distal may be understood as away from the operator and towards the tissue to which the tip 82 of the ultrasonic instrument 15 is being applied.
  • the handpiece 86 may include a housing 88 that defines a handle for the operator to grasp and maneuver the ultrasonic instrument 15, and may also include a transducer 90 disposed in a void defined by the housing 88.
  • the transducer 90 may include one or more drivers 92, such as piezoelectric crystals.
  • the drivers 92 may be disc shaped, and may be arranged within the housing 88 end to end in a stack.
  • Each driver 92 may be formed from a material that, upon application of an alternating electrical current, undergoes momentary expansions and contractions along the longitudinal axis of the driver 92, namely, the axis that extends between the proximally and distally directed faces of the driver 92. Insulating discs may be disposed between and tightly abut adjacent drivers 92.
  • the transducer 90 may further include a tube 94, which may extend through the collinear longitudinal axes of the drivers 92.
  • the horn 96 may be configured to amplify this movement. Consequently, the distal end of the hom 96 and, by extension, the tip 82, may each move back and forth along its longitudinal axis between a fully contracted position to a fully extended position, thereby producing a longitudinal vibrating motion.
  • the maximum peak-to-peak vibration of the tip head 84 representing a single movement from the fully contracted position to the fully extended position, may be 1000 microns, or 500 microns, or 300 microns.
  • some tips 82 removably coupleable to the handpiece 86 may be configured to vibrate both longitudinally and torsionally and/or substantially torsionally at their tip heads 84.
  • Such a tip 82 may include a feature along its length, such as helical grooves, that is configured to convert at least a portion of the longitudinal vibrations applied to the proximal end of the tip 82 into vibrations at the tip head 84 having both a longitudinal component and a torsional component and/or having substantially only a torsional component.
  • the mechanical components of the ultrasonic instrument 15 may include those components that vibrate in response to the sourced AC drive signal to treat patient tissue, such as and without limitation, the drivers 92, tube 94, horn 96, tip 82, and proximal end mass described above.
  • the impedance Z o provided by the drivers 92 may be primarily capacitive. Accordingly, the drivers 92 may be represented by a capacitor with capacitance C o .
  • the ultrasonic controller 150 may be configured to regulate the AC drive signal developed across the secondary winding 164 by regulating the AC signal developed across the primary winding 162, such as by supplying a control signal to the DC supply 156 that sets the potential of the signal applied to the center tap of the primary winding 162, and/or by supplying a control signal to the amplifier 158 that corresponds to a target AC drive signal to be developed across the secondary winding 164.
  • the ultrasonic controller 150 may be configured to induce a target AC drive signal across the secondary winding 164 by supplying a control signal to the amplifier 158 that includes at least one frequency corresponding to that of the target AC drive signal, and at least one amplitude proportional to that of the target AC drive signal.
  • the ultrasonic controller 150 may be configured with a digital signal synthesis (DDS) component for generating the control signal.
  • DDS digital signal synthesis
  • the amplifier 158 Responsive to receiving the control signal, the amplifier 158 may be configured to develop an AC signal across the primary winding 162 that is proportional to the target AC drive signal, which in turn may induce the target AC drive signal across the secondary winding 164 for being sourced to the ultrasonic instrument 15.
  • the ultrasonic controller 150 may be configured to control both the frequency and amplitude of the vibrations of the tip 82.
  • the ultrasonic controller 150 may thus be configured to determine a value for the frequency f of the AC drive signal such that the following Equation is true: where i s is the current of the AC drive signal sourced to the ultrasonic instrument 15 and C o is the capacitance of the drivers 92. Responsive to determining such value, the ultrasonic controller 150 may be configured to set the frequency of the AC drive signal to the value, thereby causing the ultrasonic instrument 15 to operate at or near resonance. Each value to which the frequency of the AC drive signal is regulated to track a resonant frequency of the ultrasonic instrument 15 may generally be referred to as a determined or calculated resonant frequency of the ultrasonic instrument 15.
  • the ultrasonic controller 150 may be configured to repeatably alternate between or perform in parallel the operations of regulating the frequency of the AC drive signal to a target vibratoiy characteristic, such as based on Equation (2), and setting the voltage v s of the AC drive signal so that the mechanical current i M , such as calculated according to Equation (1), corresponds to the target ultrasonic energy level.
  • the ultrasonic controller 150 may be configured to regulate the frequency and voltage v s of the sourced AC drive signal based on the obtained measurements of the voltage v s and/or current i s of the AC drive signal. Further during operation of the ultrasonic instrument 15, the control console 80, or more particularly the ultrasonic controller 150, may be configured to determine whether the ultrasonic instrument 15 is in a loaded state (e.g., contacting patient tissue) based on obtained measurements of the voltage v s and/or the current i s of the sourced AC drive signal, and if so, utilize a set frequency of the AC drive signal (e.g., determined resonant frequency of the ultrasonic instrument 15) to determine a type of the contacted tissue.
  • a set frequency of the AC drive signal e.g., determined resonant frequency of the ultrasonic instrument 15
  • the ultrasonic controller 150 may then be configured to adjust operation of the surgical system 10 based on the determined tissue type, such as according to a predefined ultrasonic energy profile associated with the determined tissue type within the console storage 152 or navigation storage 25.
  • the navigation controller 24 may be configured to track a pose of the ultrasonic instrument 15, or more particularly a position of the distal region 84 of the tip 82, relative to a virtual object associated with patient tissue in a known coordinate system, such as to display guidance, control operation of the ultrasonic instrument 15, and/or control movement of the robotic manipulator 14 based on the tracked pose.
  • the virtual object may generally correspond to a boundary of one or more tissue types.
  • the navigation controller 24 in cooperation with the ultrasonic controller 150 of the ultrasonic resection system 11, may be configured to determine whether the determined tissue type corresponds to that indicated by the tracked position of the distal region 84 of the tip 82 relative to the virtual object. If not, then the navigation controller 24 may be configured to adjust a parameter (e.g., shape, position, pose) of the virtual object in the known coordinate system based on the determined tissue type, such that the adjusted virtual object represents the determined tissue type in the corresponding tracked position of the distal region 84 of the tip 82.
  • a parameter e.g., shape, position, pose
  • the handpiece 86 of the ultrasonic instrument 15 may include a handpiece (HP) memory 184 disposed therein.
  • the HP memory 184 may be an EPROM, an EEPROM, or an RFID tag.
  • the ultrasonic controller 150 Responsive to connecting the ultrasonic instrument 15 to the control console 80, the ultrasonic controller 150 may be configured to read the data stored in the HP memory 184 using the memory reader 182, and to tailor operation of the control console 80 based on the read data.
  • the control console 80 may include a communication interface, such as a coil 186, connected to the memory reader 182.
  • the coil 186 may be integral with the socket 102 of the control console 80.
  • the ultrasonic instrument 15 may include a tip memory 190.
  • the tip 82 may be removable from the handpiece 86 so the handpiece 86 can be used with varying interchangeable tips 82, and different tips 82 may have different structural characteristics and operational limitations.
  • the HP memory 184 may store data identifying the handpiece 86 and operational parameters specific to the handpiece 86, including the capacitance of the drivers 92 and operational parameters specific to the secondary drive component of the sourced AC drive signal (which may be powered through the handpiece 86), and the tip memory 190 may store data identifying the tip 82 currently coupled to the handpiece 86 and operational parameters specific to the tip 82.
  • the tip memory 190 may be disposed in the sleeve 42. To the extent the ultrasonic instrument 15 is sense enabled, the tip memory 190 may also store tissue type data 172A and tissue sense data 191 that is specific to the tip 82, as described in more detail below.
  • the tip memory 190 may be the same type of memory as the HP memory 184 (c.g., an EPROM, an EEPROM, or an RFID tag).
  • a determination may be made of whether the ultrasonic instrument 15 is actuated, such as by the ultrasonic controller 150.
  • the ultrasonic controller 150 may be configured to monitor for depression of the foot pedal 138, as described above.
  • the process 700 may be configured to default to operating the ultrasonic instrument 15 in the tissue sense mode. Additionally or alternatively, the determination of which mode in which to operate the ultrasonic instrument 15 may be based on the tracked position of the distal region 84 of the tip 82 relative to the patient tissue, and/or based on a type of tissue previously detected to be in contact with the distal region 84 of the tip 82. For instance, response to the tracked position or previously detected type of tissue indicating contact with non-targeted tissue, the ultrasonic controller 150 may be configured to operate the ultrasonic instrument 15 in the tissue sense mode.
  • the low power AC drive signal sourced in the tissue sense mode may be configured to induce a mechanical current i M in the ultrasonic instrument 15 of no more thanlO mA, or more particularly no more than 5 mA, or further more particularly no more than 2 mA, and/or induce vibrations at the distal region 84 of the tip 82 having an amplitude of no more than 30 microns, or more particularly no more than 10 microns, or further more particularly no more than 3 microns.
  • irrigation and suction may be disabled during operation of the ultrasonic instrument 15 in the tissue sense mode, which may assist in improving the accuracy of the tissue sensing.
  • the mechanical resistance R M of the ultrasonic instrument 15 may thus be calculated by calculating the mechanical current i M being induced in the ultrasonic instrument 15 based on the obtained current and voltage measurements as described above, and dividing the obtained voltage measurement by the determined mechanical current i M according to Ohm’s law.
  • the calculated mechanical resistance R M may then be compared with a resistance threshold (e.g., 2 kQ) corresponding to the contact of the distal region 84 of the tip 82 with tissue, which like the previous example may be indicated by the data read from the ultrasonic instrument 15. Responsive to the mechanical resistance R M being greater than or equal to the resistance threshold, a determination may be made that the ultrasonic instrument 15 is in a loaded state. Otherwise, it may be determined that the ultrasonic instrument 15 is currently in an unloaded state.
  • a resistance threshold e.g. 2 kQ
  • the process 700 may proceed to block 716 to determine an unloaded resonant frequency of the ultrasonic instrument 18.
  • the ultrasonic controller 150 may be configured to implement loops of tracking the resonant frequency of the ultrasonic instrument 15 based on a measured current and voltage of the AC drive signal, and setting the frequency of the AC drive signal based on the same. In the regular- course of tracking the resonant frequency as described above, the ultrasonic controller 150 may thus be configured to determine the resonant frequency of the ultrasonic instrument 18 based on the voltage and current measurements obtained in block 712.
  • the tissue type data 172 may indicate that a frequency difference greater than or equal to a first threshold (e.g., 350 Hz) corresponds to very hard tissue; a frequency difference greater than or equal to a second threshold (e.g., 175 Hz) and less than the first threshold corresponds to hard tissue; a frequency difference greater than or equal to a third threshold (e.g., 40 Hz) and less than the second threshold corresponds to medium hard tissue; and a frequency difference less than the third threshold corresponds to soft tissue.
  • a first threshold e.g., 350 Hz
  • a second threshold e.g., 175 Hz
  • a third threshold e.g. 40 Hz
  • a determined loaded resonant frequency of the ultrasonic instrument 15 may be compared to a determined unloaded resonant frequency of the ultrasonic instrument 15 to determine the type of contacted patient tissue.
  • the process 700 may determine the type of contacted tissue based on a difference between two determined loaded resonant frequencies of the ultrasonic instrument 15, as described below.
  • the low power AC drive signal sourced to the ultrasonic instrument 15 in block 710 may be generated as a pulsed signal including a plurality of pulses each extending between an upper target amplitude (e.g., 8 mA) and a lower target amplitude (e.g., 3 mA).
  • the lower and upper target amplitudes for the AC drive signal may be indicated by the tissue sense data 191 read from the tip memory 190, and/or may correspond a user selection of a given tissue type or procedure, as described above.
  • the ultrasonic controller 150 may be configured to implement the loaded method until it is detected that the ultrasonic instrument 15 is again in an unloaded state, in which case the ultrasonic instrument 15 may revert to the unloaded method for a set number of cycles, then proceed with the loaded method, and so on.
  • varying types of tissue such as varying types of targeted tissue, may each be associated within the tissue type data 172 with a different ultrasonic energy profile to be induced in the ultrasonic instrument 15 when operating in the tissue resection mode responsive to the determined type of tissue corresponding to the given tissue type.
  • the ultrasonic energy profiles may each define one or more parameters (e.g., target mechanical current i M , pulsing parameters) for the AC drive signal sourced to the ultrasonic instrument 15 in the tissue resection mode.
  • relatively stiffer tissues such as bone
  • ultrasonic energy profiles for operating the ultrasonic instrument 15 at relatively high power levels, which may induce vibrations of greater amplitude and thus provide more resection power, than that of relatively softer tissues.
  • the ultrasonic controller 150 may thus be configured to automatically initiate operation of the ultrasonic instrument 15 in the tissue resection mode and according to the ultrasonic energy profile associated with the tissue type.
  • block 724 may include executing a corresponding pre-breakthrough protocol, such as deactivating operation of the ultrasonic instrument 15, or operating the ultrasonic instrument in the tissue resection mode but with a reduced power level (e.g., lower target mechanical current i M , pulsed mode).
  • a corresponding pre-breakthrough protocol such as deactivating operation of the ultrasonic instrument 15, or operating the ultrasonic instrument in the tissue resection mode but with a reduced power level (e.g., lower target mechanical current i M , pulsed mode).
  • At least one of the virtual objects for controlling operation of the robotic manipulator 14 may be a haptic object configured to cause the robotic manipulator 14 to apply forces on the movement of the ultrasonic instrument 15 that simulate an attraction or repulsion sensation, such as to guide the distal region 84 of the tip 82 to treat target tissue while avoiding contact with non-targeted tissue.
  • block 724 may include adjusting a parameter of such virtual objects based on the determined tissue type by adjusting one or more of a position, pose, shape, or force associated with such objects.
  • a given haptic object may be configured to attract the distal region 84 of the tip 82 from a position within the intervertebral disc space towards the end plate so as facilitate the removal of cartilage from the end plate.
  • the surgical navigation system 12 may be configured to adjust the haptic object so as to repel movement of the distal region 84 of the tip 82 away from the end plate, such as to avoid undesired resection thereof.
  • the process 700 may proceed to block 802 of the process 800, as illustrated in FIG. 8.
  • the ultrasonic instrument 15 may be driven with a high power AC drive signal that induces vibrations in the tip 82 of the ultrasonic instrument 15 for resecting patient tissue.
  • the high power AC drive signal may be configured to drive the ultrasonic instrument 15 according to desired resection parameters set by the operator, such as a target ultrasonic energy level set via the foot pedal 138 and console settings as described above.
  • the high power AC drive signal may be configured to induce a mechanical current i M of greater than 100 mA and/or induce vibrations having an amplitude of greater than 100 microns.
  • block 802 may also include supplying fluid to a distal region 84 of the tip 82 through at least a portion of the ultrasonic instrument 15, and/or providing suction at the distal region 84 of the tip 82 through at least a portion of the ultrasonic instrument 15, such as to irrigate and/or aspirate the fragmented tissue from the surgical site, respectively.
  • the tissue type data 172 may indicate multiple sets of thresholds each available for utilization as the above-described thresholds, and each corresponding to a different tissue type and/or procedure type selectable by the user.
  • the determination of each frequency characteristic may be based on both the magnitude of the frequency bin corresponding to the characteristic, and also a corresponding magnitude of a frequency bin corresponding to the fundamental drive frequency of the sourced AC drive signal. For instance, the frequency characteristic for each frequency bin may be determined by subtracting the magnitude of the bin from the magnitude of a frequency bin corresponding to the fundamental frequency.
  • a difference between the upper frequency and the lower frequency of the allowed frequency range associated with the tissue resection mode may be less than a difference between the upper frequency and the lower frequency of the allowed frequency range associated with the tissue sense mode.
  • the ultrasonic controller 150 may be able to detect larger frequency jumps in the tissue sense mode while preventing the tip 82 from unintentionally exhibiting vibrations of an undesired vibratory mode in the tissue resection mode.
  • the allowed frequency ranges for the tissue resection mode and the tissue sense mode may be indicated by the read tissue sense data 191.
  • Some or all hardware features of a controller may be defined using a language for hardware description, such as IEEE Standard 1364-2005 (commonly called “Verilog”) and IEEE Standard 1076-2008 (commonly called “VHDL”).
  • the hardware description language may be used to manufacture and/or program a hardware circuit.
  • some or all features of a controller may be defined by a language, such as IEEE 1666-2005 (commonly called “SystemC”), that encompasses both code, as described below, and hardware description.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Dentistry (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un système chirurgical comprend un instrument à ultrasons pouvant fonctionner dans un mode de détection de tissu et un mode de résection de tissu. Dans le mode de résection de tissu, un premier signal de commande en courant alternatif (CA) est envoyé à l'instrument à ultrasons qui induit des vibrations dans une pointe de l'instrument pour réséquer un tissu de patient, et dans le mode de détection de tissu, un second signal de commande en CA est envoyé à l'instrument à ultrasons qui induit des vibrations dans la pointe qui sont insuffisantes pour réséquer le tissu de patient. Une fréquence correspondant à une caractéristique de vibration cible de l'instrument à ultrasons est déterminée sur la base d'une mesure de tension et d'une mesure de courant du second signal de commande en CA, et est utilisée pour déterminer un type de tissu de patient en contact avec la région distale de la pointe. Le fonctionnement du système chirurgical est ensuite commandé en fonction du type de tissu déterminé.
PCT/US2024/051403 2023-10-11 2024-10-15 Détection de tissu avec un outil de résection à ultrasons Pending WO2025081187A1 (fr)

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US202363589630P 2023-10-11 2023-10-11
US63/589,630 2023-10-11
US202363589988P 2023-10-12 2023-10-12
US63/589,988 2023-10-12

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