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WO2024150187A1 - Instruments chirurgicaux, systèmes et procédés incorporant une fonctionnalité d'énergie ultrasonore et de chauffage thermique - Google Patents

Instruments chirurgicaux, systèmes et procédés incorporant une fonctionnalité d'énergie ultrasonore et de chauffage thermique Download PDF

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Publication number
WO2024150187A1
WO2024150187A1 PCT/IB2024/050331 IB2024050331W WO2024150187A1 WO 2024150187 A1 WO2024150187 A1 WO 2024150187A1 IB 2024050331 W IB2024050331 W IB 2024050331W WO 2024150187 A1 WO2024150187 A1 WO 2024150187A1
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WO
WIPO (PCT)
Prior art keywords
tissue
ultrasonic
heating element
jaw member
thermal heating
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.)
Ceased
Application number
PCT/IB2024/050331
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English (en)
Inventor
William E. Robinson
Iv James D. Allen
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Covidien LP
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Covidien LP
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Filing date
Publication date
Application filed by Covidien LP filed Critical Covidien LP
Publication of WO2024150187A1 publication Critical patent/WO2024150187A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • 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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A61B18/085—Forceps, scissors
    • 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
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
    • 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
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00077—Electrical conductivity high, i.e. electrically conducting
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00089—Thermal conductivity
    • A61B2018/00095—Thermal conductivity high, i.e. heat conducting
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • 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
    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • 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

  • the present disclosure relates to energy based surgical instruments and, more particularly, to surgical instruments, systems, and methods incorporating ultrasonic energy and thermal heating functionality to facilitate tissue treatment.
  • Ultrasonic surgical instruments and systems utilize ultrasonic energy, i.e., ultrasonic vibrations, to treat tissue. More specifically, ultrasonic surgical instruments and systems utilize mechanical vibration energy transmitted at ultrasonic frequencies to treat tissue.
  • An ultrasonic surgical device may include, for example, an ultrasonic blade and a clamp mechanism to enable clamping of tissue against the blade. Ultrasonic energy transmitted to the blade causes the blade to vibrate at very high (e.g., ultrasonic) frequencies, which allows for heating tissue clamped against or otherwise in contact with the blade to treat the tissue.
  • Thermal heating may also be utilized to treat tissue.
  • a thermal heating element may include a resistive circuit configured to heat up in response to application of electrical energy to the resistive circuit.
  • the thermal heating element when sufficiently heated, may be utilized to heat tissue in thermal communication with the thermal heating element to treat the tissue.
  • distal refers to the portion that is described which is farther from an operator (whether a human surgeon or a surgical robot), while the term “proximal” refers to the portion that is being described which is closer to the operator.
  • Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, design variations, and/or other variations and tolerances, up to and including plus or minus 10 percent. Further, any or all of the aspects described herein, to the extent consistent, may be used in conjunction with any or all of the other aspects described herein.
  • a surgical instrument including an ultrasonic blade configured to operably couple to an ultrasonic transducer and receive ultrasonic energy from the ultrasonic transducer, and a jaw member movable relative to the ultrasonic blade between an open position and a clamping position for clamping tissue between the jaw member and the ultrasonic blade.
  • the jaw member includes a thermal heating element including at least one resistive circuit configured to generate heat in response to application of energy to the at least one resistive circuit.
  • the thermal heating element is configured to heat tissue clamped between the jaw member and the ultrasonic blade.
  • the jaw member further includes a jaw liner configured to oppose the ultrasonic blade in the clamping position of the jaw member.
  • the jaw liner is compliant.
  • the jaw member further includes at least one plate defining a tissue-contacting surface and configured to conduct thermal energy from the thermal heating element to tissue to heat tissue clamped between the jaw member and the ultrasonic blade.
  • the at least one plate may be thermally conductive and electrically conductive or may be thermally conductive and electrically non-conductive.
  • the at least one resistive circuit is configured to receive an AC signal and to heat to at least 200°C in response to receipt of the AC signal.
  • the at least one resistive circuit is configured to generate heat variably along at least one of: at least a portion of a length of the at least one resistive circuit or at least a portion of a width of the at least one resistive circuit.
  • the at least one resistive circuit includes first and second electrically isolated resistive circuits.
  • a surgical system includes an ultrasonic transducer configured to output ultrasonic energy, an energy source configured to output an AC signal, a housing, a shaft extending distally from the housing, and an end effector assembly disposed at a distal end portion of the shaft.
  • the end effector assembly includes an ultrasonic blade configured to operably couple to and receive the ultrasonic energy from the ultrasonic transducer, and a jaw member movable relative to the ultrasonic blade between an open position and a clamping position for clamping tissue between the jaw member and the ultrasonic blade.
  • the jaw member includes a thermal heating element configured to receive the AC signal from the energy source and to generate heat for heating tissue clamped between the jaw member and the ultrasonic blade in response to receipt of the AC signal.
  • the energy source is disposed on or within the housing.
  • the ultrasonic transducer is disposed on or within the housing.
  • the jaw member further includes a jaw liner configured to oppose the ultrasonic blade in the clamping position of the jaw member.
  • the jaw liner may be compliant.
  • the thermal heating element includes at least one resistive circuit configured to generate heat in response to receipt of the AC signal from the energy source.
  • the jaw member further includes at least one plate defining a tissue-contacting surface.
  • the at least one plate is configured to conduct thermal energy from the thermal heating element to tissue to heat tissue clamped between the jaw member and the ultrasonic blade.
  • the thermal heating element is configured to heat to at least 200°C in response to receipt of the AC signal.
  • the thermal heating element is configured to generate heat variably along at least one of: at least a portion of a length of the thermal heating element or at least a portion of a width of the thermal heating element.
  • a method of surgery provided in accordance with the present disclosure includes clamping tissue between an ultrasonic blade and a jaw member, transmitting ultrasonic energy to the ultrasonic blade to heat the clamped tissue, and heating a thermal heating element of the jaw member to heat the clamped tissue.
  • transmitting the ultrasonic energy and heating the thermal heating element are performed simultaneously.
  • transmitting the ultrasonic energy to heat the clamped tissue and/or heating the thermal heating element to heat the clamped tissue seals the clamped tissue.
  • transmitting the ultrasonic energy to heat the clamped tissue and/or heating the thermal heating element to heat the clamped tissue dissects the clamped tissue.
  • FIG. 1 is a side view of a surgical system provided in accordance with the present disclosure including a surgical instrument and a surgical generator;
  • FIG. 2 is perspective view of another surgical system provided in accordance with the present disclosure including a surgical instrument incorporating one or more surgical generators and one or more power sources;
  • FIG. 3 is a schematic illustration of a robotic surgical system provided in accordance with the present disclosure.
  • FIG. 4 is a longitudinal, cross-sectional view of an end effector assembly configured for use with the surgical instrument of FIG. 1, surgical system of FIG. 2, robotic surgical system of FIG. 3, and/or any other suitable surgical instrument or system;
  • FIG. 5 is a perspective view of a portion of a jaw member configured for use with the end effector assembly of FIG. 4;
  • FIG. 6 is an exploded, perspective view of the portion of the jaw member of FIG. 5;
  • FIG. 7 is a transverse, cross-sectional view of a portion of a thermal heating element of the jaw member of FIG. 5;
  • FIGS. 8A-8F are transverse, cross-sectional views illustrating assembly of the jaw member of FIG. 5;
  • FIG. 9 is a perspective view of a portion of another jaw member configured for use with the end effector assembly of FIG. 4;
  • FIG. 10 is an exploded, perspective view of the portion of the jaw member of FIG. 9;
  • FIGS. 11A-11E are transverse, cross-sectional views illustrating assembly of the jaw member of FIG. 9;
  • FIGS. 12-14 are schematic drawings illustrating various circuit configurations for use with the thermal heating element of the jaw member of FIG. 5, the jaw member of FIG. 9, or any other suitable jaw member;
  • FIGS. 15-17 illustrate various heating trace configurations for use with the thermal heating element of the jaw member of FIG. 5, the jaw member of FIG. 9, or any other suitable jaw member.
  • Surgical instrument 100 includes a handle assembly 110, an elongated assembly 150 extending distally from handle assembly 110, an end effector assembly 160 disposed at a distal end of elongated assembly 150, and a cable assembly 190 operably coupled with handle assembly 110 and extending therefrom for connection to surgical generator 200.
  • Surgical generator 200 includes a display 210, a plurality user interface features 220, e.g., buttons, touch screens, switches, etc., an ultrasonic energy plug port 230, and an electrical energy plug port 240.
  • Surgical generator 200 may further include additional ports 250, 260 to provide additional functionality, e.g., a monopolar plug port for supplying monopolar energy, a bipolar plug port for supplying bipolar energy, a microwave plug port for supplying microwave energy, a vacuum plug port enabling suction, a fluid plug port enabling irrigation, additional power ports for supplying AC and/or DC electrical power, etc.
  • one or more common ports may be configured to act as any two or more of ports 230-260.
  • Surgical instrument 100 is configured to supply electrical energy to a thermal heating element 540 (FIG. 6) of jaw member 164 of end effector assembly 160, e.g., to heat thermal heating element 540 (FIG. 6) for treating tissue in contact with jaw member 164, and to supply ultrasonic energy to ultrasonic blade 162 of end effector assembly 160, e.g., for treating tissue in contact with ultrasonic blade 162.
  • surgical generator 200 is configured to provide electrical energy, e.g., AC electrical power, for output through electrical energy plug port 240 to surgical instrument 100 to energize thermal heating element 540 (FIG. 6) to heat thermal heating element 540 (FIG. 6) for treating tissue in contact with jaw member 164 of end effector assembly 160.
  • surgical generator 200 is configured to provide ultrasonic drive signals for output through ultrasonic plug port 230 to surgical instrument 100 to drive ultrasonic transducer 140 to produce ultrasonic energy for transmission along ultrasonic waveguide 154 to ultrasonic blade 162 of end effector assembly 160 to heat and, thereby treat tissue in contact with ultrasonic blade 162.
  • handle assembly 110 includes a housing 112, an activation button 120, and a clamp lever 130.
  • Housing 112 is configured to support ultrasonic transducer 140.
  • Ultrasonic transducer 140 may be permanently engaged within housing 112 or removable therefrom.
  • Ultrasonic transducer 140 includes a piezoelectric stack or other suitable ultrasonic transducer components electrically coupled to surgical generator 200, e.g., via one or more of first electrical lead wires 197, to enable communication of ultrasonic drive signals to ultrasonic transducer 140 to drive ultrasonic transducer 140 to produce ultrasonic vibration energy that is transmitted along ultrasonic waveguide 154 of elongated assembly 150 to ultrasonic blade 162 of end effector assembly 160 of elongated assembly 150, as detailed below. Feedback and/or control signals may likewise be communicated between ultrasonic transducer 140 and surgical generator 200.
  • Ultrasonic transducer 140 may include a stack of piezoelectric elements secured, under pre-compression between proximal and distal end masses or a proximal end mass and an ultrasonic horn with first and second electrodes electrically coupled between piezoelectric elements of the stack of piezoelectric elements to enable energization thereof to produce ultrasonic energy.
  • suitable ultrasonic transducer configurations including plural transducers and/or non- longitudinal, e.g., torsional, transducers are also contemplated.
  • An activation button 120 is disposed on housing 112 and coupled to or between ultrasonic transducer 140 and/or surgical generator 200, e.g., via one or more of first electrical lead wires 197, to enable activation of ultrasonic transducer 140 in response to depression of activation button 120.
  • activation button 120 may include an ON/OFF switch.
  • activation button 120 may include multiple actuation switches to enable activation from an OFF state to different ON states corresponding to different activation settings, e.g., a first ON state corresponding to a first activation setting (such as a LOW power and/or tissue sealing setting) and a second ON state corresponding to a second activation setting (such as a HIGH power and/or tissue transection setting).
  • a first ON state corresponding to a first activation setting such as a LOW power and/or tissue sealing setting
  • a second ON state corresponding to a second activation setting such as a HIGH power and/or tissue transection setting
  • separate activation buttons may be provided, e.g., a first actuation button for activating a first activation setting and a second activation button for activating a second activation setting. Additional activation buttons, sliders, wheels, etc. are also contemplated to enable control of various different activation settings from housing 112.
  • Elongated assembly 150 of surgical instrument 100 includes an outer drive sleeve 152, an inner support sleeve 153 (FIG. 4) disposed within outer drive sleeve 152, ultrasonic waveguide 154 extending through inner support sleeve 153 (FIG. 4), a drive assembly (not shown), a rotation knob 156, and end effector assembly 160 including ultrasonic blade 162 and jaw member 164.
  • Rotation knob 156 is rotatable in either direction to rotate elongated assembly 150 in either direction relative to handle assembly 110.
  • the drive assembly operably couples a proximal portion of outer drive sleeve 152 to clamp lever 130 of handle assembly 110.
  • a distal portion of outer drive sleeve 152 is operably coupled to jaw member 164 and a distal end of inner support sleeve 153 (FIG. 4) pivotably supports jaw member 164.
  • clamp lever 130 is selectively actuatable, e.g., between an un-actuated position and a fully actuated position, to thereby actuate the drive assembly to move outer drive sleeve 152 about inner support sleeve 153 (FIG. 4) to pivot jaw member 164 relative to ultrasonic blade 162 of end effector assembly 160 from an open position towards a closed position for clamping tissue between jaw member 164 and ultrasonic blade 162.
  • the configuration of outer and inner sleeves 152, 153 (FIG.
  • outer sleeve 152 is the support sleeve and inner sleeve 153 (FIG. 4) is the drive sleeve.
  • Other suitable drive structures as opposed to a sleeve are also contemplated such as, for example, drive rods, drive cables, drive screws, etc.
  • the drive assembly may be tuned to provide a jaw clamping force, or jaw clamping force within a jaw clamping force range, to tissue clamped between jaw member 164 and ultrasonic blade 162, such as described in U.S. Patent Application Pub. No. 2022/0117622, the entire contents of which are hereby incorporated herein by reference.
  • the drive assembly may include a force limiting feature, e.g., a spring, whereby the clamping force applied to tissue clamped between jaw member 164 and ultrasonic blade 162 is limited to a particular jaw clamping force or a jaw clamping force within a jaw clamping force range, such as described in U.S. Patent No. 10,368,898, the entire contents of which are hereby incorporated herein by reference.
  • ultrasonic waveguide 154 extends from handle assembly 110 through inner sleeve 153 (FIG. 4).
  • Ultrasonic waveguide 154 includes ultrasonic blade 162 disposed at a distal end thereof.
  • Ultrasonic blade 162 may be integrally formed with waveguide 154, separately formed and subsequently attached (permanently or removably) to ultrasonic waveguide 154, or otherwise operably coupled with ultrasonic waveguide 154.
  • Ultrasonic waveguide 154 and/or ultrasonic blade 162 may be formed from titanium, a titanium alloy, or other suitable electrically conductive material(s), although non-conductive materials are also contemplated.
  • Ultrasonic waveguide 154 includes a proximal connector (not shown), e.g., a threaded male connector, configured for engagement, e.g., threaded engagement within a threaded female receiver, of ultrasonic transducer 140 such that ultrasonic motion produced by ultrasonic transducer 140 is transmitted along ultrasonic waveguide 154 to ultrasonic blade 162 for treating tissue clamped between ultrasonic blade 162 and jaw member 164 or positioned adjacent to ultrasonic blade 162.
  • proximal connector e.g., a threaded male connector
  • ultrasonic transducer 140 configured for engagement, e.g., threaded engagement within a threaded female receiver
  • Cable assembly 190 of surgical instrument 100 includes a cable 192, an ultrasonic plug 194, and an electrical plug 196.
  • Ultrasonic plug 194 is configured for connection with ultrasonic plug port 230 of surgical generator 200 while electrical plug 196 is configured for connection with electrical plug port 240 of surgical generator 200.
  • cable assembly 190 may include a common plug (not shown) configured to act as both the ultrasonic plug 194 and the electrical plug 196.
  • Plural first electrical lead wires 197 electrically coupled to ultrasonic plug 194 extend through cable 192 and into handle assembly 110 for electrical connection to ultrasonic transducer 140 and/or activation button 120 to enable the selective supply of ultrasonic drive signals from surgical generator 200 to ultrasonic transducer 140 upon activation of ultrasonic energy.
  • plural second electrical lead wires 199 are electrically coupled to electrical plug 196 and extend through cable 192 into handle assembly 110.
  • One or more pairs of second electrical lead wires 199 extend through handle assembly 110 and elongated assembly 150 to jaw member 164 wherein the electrical lead wires 199 of each pair connect to opposing end portions of one or more thermal heater circuits of thermal heating element 540 (FIG.
  • jaw member 164 of end effector assembly 160 to enable energization of thermal heating element 540 (FIG. 6), as detailed below.
  • One or more other second electrical lead wires 199 is electrically coupled to activation button 120 to enable the selective supply of electrical energy from surgical generator 200 to thermal heating element 540 (FIG. 6) of jaw member 164 upon activation of electrical energy.
  • activation button 120 is coupled to or between thermal heating element 540 (FIG. 6) and/or surgical generator 200, e.g., via one or more of second electrical lead wires 199, to enable activation of thermal heating element 540 (FIG. 6) in response to depression of activation button 120.
  • One or more of the ON states of activation button 120 may correspond to one or more activation settings of thermal heating element 540 (FIG.
  • a first ON state corresponding to a first activation setting such as a LOW power mode
  • a second ON state corresponding to a second activation setting such as a HIGH power mode
  • Multiple actuation buttons for activating the different activation settings and/or additional activation buttons, sliders, wheels, etc. are also contemplated to enable control of various different activation settings from housing 112.
  • activation button 120 and/or additional activation buttons, sliders, wheels, etc. may be provided for enabling selective activation of: only ultrasonic energy (in one or more different modes thereof); only thermal heating element 540 (FIG. 6) (in one or more different modes thereof); and/or a combination of ultrasonic energy and thermal heating element 540 (FIG. 6) (in one or more different modes such as, for example, simultaneous activation, alternating activation, consecutive activation, overlapping activation, and/or according to any other suitable activation protocol or algorithm).
  • Generator 200 in addition to providing electrical energy to thermal heating element 540 (FIG. 6), may also provide energy control and/or sensing functionality based upon feedback from thermal heating element 540 (FIG. 6). More specifically, by sensing the current, voltage, power, resistance, and/or other electrical properties associated with the circuit coupled to and including thermal heating element 540 (FIG. 6), generator 200 is capable of: controlling the application of electrical energy to thermal heating element 540 (FIG. 6) to thereby control the temperature to which jaw member 164 is heated; determining a temperature of thermal heating element 540 (FIG.
  • tissue treatment e.g., tissue sealing, tissue dissection, etc.
  • surgical system 10 may be at least partially cordless in that it incorporates an ultrasonic generator, an electrical generator (or suitable electrical circuitry), and/or a power source, e.g., a battery, thereon or therein.
  • a power source e.g., a battery
  • FIG. 2 another surgical system in accordance with the present disclosure is shown illustrated as a surgical instrument 20 supporting an ultrasonic generator 310, a power source (e.g., battery assembly 400), and an electrical generator 600 thereon or therein.
  • Surgical instrument 20 is similar to surgical instrument 100 (FIG. 1) and may include any of the features thereof except as explicitly contradicted below. Accordingly, only differences between surgical instrument 20 and surgical instrument 100 (FIG. 1) are described in detail below while similarities are omitted or summarily described.
  • Housing 112 of surgical instrument 20 includes a body portion 113 and a fixed handle portion 114 depending from body portion 113.
  • Body portion 113 of housing 112 is configured to support an ultrasonic transducer and generator assembly (“TAG”) 300 including ultrasonic generator 310 and ultrasonic transducer 140.
  • TAG 300 may be permanently engaged with body portion 113 of housing 112 or removable therefrom.
  • Fixed handle portion 114 of housing 112 defines a compartment 116 configured to receive battery assembly 400 and electrical generator 600 and a door 118 configured to enclose compartment 116.
  • An electrical connection assembly (not shown) is disposed within housing
  • the electrical connection assembly or a different electrical connection assembly disposed within housing 112 serves to electrically couple activation button 120, electrical generator 600, battery assembly 400, and end effector assembly 160 (e.g., thermal heating element 540 (FIG. 6) of jaw member 164 of end effector assembly 160) with one another when electrical generator 600 and battery assembly 400 are disposed within compartment 116 of fixed handle portion 114 of housing 112, thus enabling activation of surgical instrument 20 to supply electrical energy, e.g., AC electrical power, to thermal heating element 540 (FIG.
  • Electrical generator 600 may be configured to convert DC power, e.g., from battery assembly 400, into AC power for delivery to thermal heating element 540 (FIG. 6) and to control the voltage, current, power, etc. to thermal heating element 540 (FIG. 6) to achieve a desired temperature, duration, and/or other heating effect associated with thermal heating element 540 (FIG. 6).
  • DC power may be delivery to thermal heating element 540 (FIG. 6) and controlled to achieve a desired temperature, duration, and/or other heating effect associated with thermal heating element 540 (FIG. 6).
  • electrical generator 600 is omitted and some or all of the above functionality is provided by battery assembly 400.
  • FIG. 3 a robotic surgical system in accordance with the aspects and features of the present disclosure is shown generally identified by reference numeral 1000.
  • robotic surgical system 1000 is generally described. Aspects and features of robotic surgical system 1000 not germane to the understanding of the present disclosure are omitted to avoid obscuring the aspects and features of the present disclosure in unnecessary detail.
  • Robotic surgical system 1000 generally includes a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004.
  • Operating console 1005 may include a display device 1006, which may be set up in particular to display video and/or three dimensional images; and manual input devices 1007, 1008, by means of which a clinician (not shown), for example a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode.
  • Robotic surgical system 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive or other suitable manner.
  • Robotic surgical system 1000 may further include a database 1014, in particular coupled to control device 1004, in which are stored, for example, pre-operative data from patient 1013 and/or anatomical atlases.
  • Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and an attaching drive unit 1009, 1011, to which may be attached, for example, a surgical tool “ST” supporting an end effector assembly 1050, 1060.
  • One of the surgical tools “ST” may be surgical instrument 100 (FIG. 1), surgical instrument 20 (FIG. 2), or any other suitable surgical instrument configured for use, for example, in both an ultrasonic mode and a thermal heating mode, wherein manual actuation features, e.g., actuation button 120 (FIG. 1), clamp lever 130 (FIG.
  • Robotic surgical system 1000 may include or be configured to connect to an ultrasonic generator, an electrical generator, and/or a power source (whether separate components or housed together in a single console).
  • the other surgical tool “ST” may include any other suitable surgical instrument, e.g., an endoscopic camera, other surgical tool, etc.
  • Robot arms 1002, 1003 may be driven by electric drives, e.g., motors, that are connected to control device 1004.
  • Control device 1004 (e.g., a computer) may be configured to activate the motors, in particular by means of a computer program, in such a way that robot arms 1002, 1003, their attaching devices 1009, 1011, and, thus, the surgical tools “ST” execute a desired movement and/or function according to a corresponding input from manual input devices 1007, 1008, respectively.
  • Control device 1004 may also be configured in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the motors.
  • end effector assembly 160 of surgical instrument 100 of surgical system 10 (FIG. 1) is detailed, although the aspects and features of end effector assembly 160 may similarly apply, to the extent consistent, to surgical instrument 20 (FIG. 2) and/or any other suitable surgical instrument or system including robotic surgical systems.
  • End effector assembly 160 includes ultrasonic blade 162 and jaw member 164.
  • Ultrasonic blade 162 may define a linear configuration, may define a curved configuration, or may define any other suitable configuration, e.g., straight and/or curved surfaces, portions, and/or sections; one or more convex and/or concave surfaces, portions, and/or sections; etc.
  • ultrasonic blade 162 may be curved in any direction relative to jaw member 164, for example, such that the distal tip of ultrasonic blade 162 is curved towards jaw member 164, away from jaw member 164, or laterally (in either direction) relative to jaw member 164. Further, ultrasonic blade 162 may be formed to include multiple curves in similar directions, multiple curves in different directions within a single plane, and/or multiple curves in different directions in different planes.
  • ultrasonic blade 162 may additionally or alternatively be formed to include any suitable features, e.g., a tapered configuration, various different cross-sectional configurations along its length, cut outs, indents, edges, protrusions, straight surfaces, curved surfaces, angled surfaces, wide edges, narrow edges, and/or other features.
  • Jaw member 164 may be shaped to at least partially conform to the shape, curvature, etc. of ultrasonic blade 162 to enable clamping of tissue between jaw member 164 and ultrasonic blade 162 at any position along the length of the exposed portion of ultrasonic blade 162.
  • Ultrasonic blade 162 may define a polygonal, rounded polygonal, or any other suitable cross-sectional configuration(s).
  • Ultrasonic waveguide 154 or at least the portion of ultrasonic waveguide 154 proximally adjacent ultrasonic blade 162, may define a cylindrical shaped configuration.
  • Plural tapered surfaces may interconnect the cylindrically shaped ultrasonic waveguide 154 with the polygonal (rounded edge polygonal, or other suitable shape) configuration of ultrasonic blade 162 to define smooth transitions between the body of ultrasonic waveguide 154 and ultrasonic blade 162.
  • Ultrasonic blade 162 may be wholly or selectively coated with a suitable material, e.g., a non-stick material, an electrically insulative material, an electrically conductive material, combinations thereof, etc.
  • Suitable coatings and/or methods of applying coatings include but are not limited to Teflon®, polyphenylene oxide (PPO), deposited liquid ceramic insulative coatings; thermally sprayed coatings, e.g., thermally sprayed ceramic; Plasma Electrolytic Oxidation (PEO) coatings; anodization coatings; sputtered coatings, e.g., silica; ElectroBond® coating available from Surface Solutions Group of Chicago, IL, USA; or other suitable coatings and/or methods of applying coatings.
  • PPO polyphenylene oxide
  • PEO plasma Electrolytic Oxidation
  • jaw member 164 of end effector assembly 160 includes a structural body 182 supporting a jaw assembly 184.
  • Structural body 182 is configured to provide structural rigidity and support to jaw member 164 and to operably connect jaw member 164 to elongated assembly 150 to enable selective movement of jaw member 164 relative to ultrasonic blade 162 between the open and closed positions for clamping tissue therebetween.
  • Structural body 182 includes a pair of proximal flanges 183a pivotably coupled to the inner support sleeve 153 via receipt of pivot bosses (not shown) of proximal flanges 183a within corresponding openings (not shown) defined within the inner support sleeve 153 and operably coupled with outer drive sleeve 152 via a drive pin 155 secured relative to outer drive sleeve 152 and pivotably received within apertures 183b defined within proximal flanges 183a.
  • sliding of outer drive sleeve 152 about inner support sleeve 153 pivots jaw member 164 relative to blade 162 from the open position towards the closed position to clamp tissue between jaw member 164 and ultrasonic blade 162.
  • Structural body 182 further includes a distal extension 183 c extending distally from proximal flanges 183a.
  • Distal extension 183c supports jaw assembly 184 thereon or thereabout.
  • Jaw assembly 184 is fixedly support on distal extension 183c in any suitable manner such as, for example, via overmolding, welding, mechanical engagement, monolithic formation of distal extension 183c as a component of jaw assembly 184, or in any other suitable manner.
  • jaw assembly 184 is removably supported on distal extension 183c to enable removal and replacement of jaw assembly 184 with a similar or different jaw assembly. Configurations of jaw assembly 184 are detailed below with reference to FIGS. 5-17.
  • jaw assembly 184 of jaw member 164 in aspects, includes a jaw liner 510, a jaw plate 520, a first insulator 530, thermal heating element 540, and a second insulator 550.
  • Jaw liner 510 is received within a longitudinally extending channel 522 defined within jaw plate 520 and may be secured therein in any suitable manner such as, for example, forging, adhering, overmolding, mechanical capture (e.g., wherein jaw liner 510 is shaped complementary to channel 522 to facilitate slidable mechanical engagement and retention therein), combinations thereof, etc.
  • Jaw liner 510 may be flush with tissue contacting surface 526 of jaw plate 520, may protrude from tissue contacting surface 526 of jaw plate 520 towards ultrasonic blade 162, or may be recessed relative to tissue contacting surface 526 of jaw plate 520. Further, jaw liner 510 may define a width less than, equal to, or greater than the width of ultrasonic blade 162.
  • Jaw liner 510 is fabricated from a compliant material such as, for example, polytetrafluoroethylene (PTFE). Jaw liner 510 is received within channel 522 of jaw plate 520 and positioned relative to jaw member 164 such that, in the closed position of jaw member 164, jaw liner 510 opposes and is aligned with ultrasonic blade 162 (and, in aspects, contacts ultrasonic blade 162).
  • PTFE polytetrafluoroethylene
  • jaw liner 510 together with the alignment thereof relative to ultrasonic blade 162 enables the clamping of tissue between jaw liner 510 and ultrasonic blade 162 and also allows ultrasonic blade 162 to vibrate while in contact with jaw liner 510 (direct contact or indirect contact with tissue clamped therebetween) without damaging components of ultrasonic surgical instrument 100 (FIG. 1) and without compromising the hold on tissue clamped between jaw member 164 and ultrasonic blade 162.
  • Jaw liner 510 may be configured to inhibit or limit contact between jaw plate 520 and ultrasonic blade 162; however, given that thermal heating element 540 heats tissue via conductive heating (rather than joule heating as with monopolar Radio Frequency (RF) energy, bipolar RF energy, and other electromagnetic energies wherein electrical energy is transmitted through tissue), complete isolation and avoidance of contact (or electrical coupling) between jaw plate 520 and ultrasonic blade 162 is not required (e.g., since such contact would not result in electrical shorting).
  • conductive heating rather than joule heating as with monopolar Radio Frequency (RF) energy, bipolar RF energy, and other electromagnetic energies wherein electrical energy is transmitted through tissue
  • Jaw plate 520 includes a top portion 524 defining tissue contacting surface 526 and including channel 522 defined longitudinally therethrough to divide tissue contacting surface 526 into first and second longitudinally extending surface portions on either side of jaw liner 510 such that top portion 524 defines a generally U-shaped configuration, although top portion 524 need not be continuous and/or connected at the distal tip of jaw plate 520.
  • Jaw plate 520 further includes a flange 528 depending from top portion 524 and extending about the outer periphery of top portion 524. Flange 528 may extend from top portion 524 in generally perpendicular orientation relative thereto or in any other suitable manner.
  • jaw plate 520 As a result of this configuration of jaw plate 520, top portion 524 and flange 528 cooperate to define an internal cavity 529 (FIG. 8A) within jaw plate 520.
  • Flange 528 defines a generally U-shaped configuration and may or may not be continuous and/or connected at the distal tip of jaw plate 520 (and/or other locations).
  • Jaw plate 520 may be formed from a thermally and, in aspects, electrically conductive, material such as, for example, stainless steel.
  • first insulator 530 is an electrical insulator configured to electrically insulate jaw plate 520 and thermal heating element 540 from one another and is disposed within internal cavity 529 of jaw plate 520 on an interior surface of jaw plate 520 opposite tissue contacting surface 526 (see FIG. 8B).
  • First insulator 530 defines a generally U-shaped configuration to accommodate jaw liner 510 therein, although first insulator 530 need not be continuous and/or connected at the distal tip thereof.
  • First insulator 530 may be formed from ceramic or other suitable material, e.g., PTFE, PEEK, PEI.
  • Thermal heating element 540 includes first and second portions 541a, 541b spaced apart from one another and configured to extend longitudinally along either side of channel 522 (and, thus, either side of jaw liner 510 when jaw assembly 184 is fully assembled).
  • First and second portions 541a, 541b are electrically coupled with one another via a conductive bridge 541c at the distal end thereof such that thermal heating element 540 defines a generally U-shaped configuration.
  • conductive bridge 541c is omitted or replaced with an insulative bridge such that first and second portions 541a, 541b remain electrically isolated from one another.
  • each of first and second portions 541a, 541b of thermal heating element 540 includes a base substrate 542, an insulating layer 544 disposed on at least one face of base substrate 542, and a resistive trace circuit 546 disposed on the insulating layer 544 on at least one face of base substrate 542. Resistive trace circuits 546 of thermal heating element 540 extending longitudinally along first and second portions 541a, 541b and are electrically connected with one another at the distal ends thereof via conductive bridge 541c.
  • resistive trace circuits 546 may loop back along respective first and second portions 541a, 541b on the same or opposite face of the corresponding base substrate 542 such that first and second portions 541a, 541b define independent circuits.
  • Other configurations are also contemplated such as those detailed below with reference to FIGS. 12-14.
  • resistive trace circuits 546 are configured to connect to electrical lead wires (e.g., wires 199 (FIG. 1)) to define one or more completed circuits including resistive trace circuits 546, an energy source (e.g., surgical generator 200 (FIG. 1) or surgical generator 600 (FIG. 2) and/or battery assembly 400 (FIG. 2)), and, in aspects, an activation source (e.g., activation button(s) 120 (FIG.
  • an energy source e.g., surgical generator 200 (FIG. 1) or surgical generator 600 (FIG. 2) and/or battery assembly 400 (FIG. 2)
  • an activation source e.g., activation button(s) 120 (FIG.
  • thermal heating element 540 may be energized to heat tissue from one side thereof, while energization of ultrasonic blade 162 heats tissue from the opposite side thereof, thus facilitating tissue treatment, e.g., enabling strong tissue seals, enabling faster tissue sealing and/or tissue dissection, enabling sealing and/or dissection of thicker or larger tissue, enabling sealing and/or dissection of different tissue types, combinations thereof, etc.
  • Base substrate 542 may be formed from any suitable material such as, for example, ceramic, stainless steel, aluminum, aluminum alloys, titanium, titanium alloys, other suitable materials, combinations thereof, etc.
  • Base substrate 542 may be formed via laser cutting, machining, casting, forging, fine-blanking, or any other suitable method.
  • Base substrate 542 may define a thickness of, in aspects, from about 0.003 in to about 0.030 in; in other aspects, from about 0.004 in to about 0.015 in; and in still other aspects, from about 0.005 in to about 0.012 in.
  • the thickness of base substrate 542 need not be uniform but, rather, may vary along the length and/or width of thermal heating element 540 to achieve a desired configuration of thermal heating element 540.
  • Insulating layer 544 which may be an electrically insulating layer, as noted above, may be disposed on either or both sides of base substrate 542.
  • Insulating layer 544 may be a Plasma Electrolytic Oxidation (PEO) coating formed via PEO of either or both sides of base substrate 544.
  • PEO Plasma Electrolytic Oxidation
  • Other suitable materials for insulating layer 544 e.g., PTFE, PEEK, PEI, glass, etc., and/or methods of forming insulating layer 544, e.g., sintering, anodization, deposition, spraying, adhesion, mechanical attachment, etc., on either or both sides of base substrate 542 are also contemplated.
  • insulating layer 544 is disposed on both sides of base substrate 542, the sides may be of the same or different materials and/or of the same or different thicknesses. Insulating layer 544 may define a thickness (on either or both sides of base substrate 542), in aspects, from about 0.0005 in to about 0.0015 in; in other aspects, from about 0.0007 in to about 0.0013 in; and in still other aspects, from about 0.0009 in to about 0.0012 in. In aspects wherein an insulating base substrate 542, e.g., ceramic, is utilized, insulating layer 544 may be omitted.
  • multiple insulating layers 544 are provided on the same side, e.g., two insulating layers 544 on top of one another, each of which may define a thickness (similar or different from one another) within the above noted ranges or which may collectively define a thickness within the above noted ranges.
  • the number of layers 544 and/or thicknesses of layers 544 need not be uniform but, rather, may vary along the lengths and/or widths of first and second portions 541a, 541b of thermal heating element 540 to achieve a desired configuration of thermal heating element 540.
  • Resistive trace circuit 546 is disposed on insulating layer 544 (or directly on base substrate 542 where base substrate 542 itself is electrically insulating) on one face of first and second portions 541a, 541b of thermal heating element 540, although it is also contemplated that a resistive trace circuit 546 extend to the other face of either or both portions 541a, 541b of thermal heating element 540 or that second resistive trace circuits 546 be provided on the other face(s) of first and second portions 541a, 541b of thermal heating element 540.
  • Each resistive trace circuit 546 may be formed from, for example, platinum, nichrome, a ferritic iron-chromium-aluminum alloy (e.g., kanthal®), combinations thereof, or other suitable metal(s) and may be disposed on the corresponding insulating layer 544 via a deposition process, e.g., sputtering, via screen printing, via sintering, or in any other suitable manner.
  • Resistive trace circuits 546 may define a thickness, in aspects, from about 0.1 to 500 microns.
  • the thicknesses (and/or width) of resistive trace circuits 546 may vary along the lengths and/or widths of first and second portions 541a, 541b of thermal heating element 540 to achieve a desired configuration of thermal heating element 540.
  • a cross-section of thermal heating element 540 achieves resistance in a range of about 5 ohms to about 100 ohms at room temperature.
  • the cross-section achieves an increase in resistance at running temperature, e.g., 550°C, of from about 23 ohms to about 150 ohms with a Temperature Coefficient of Resistance (TCR) ranging from about 1000 ppm/°C to about 3500 ppm/°C.
  • thermal heating element 540 further includes an encapsulating layer 548 disposed on either or both faces of first and second portions 541a, 541b of thermal heating element 540.
  • encapsulating layer 548 may encapsulate base substrate 542, insulating layer 544, and resistive trace circuits 546 on one or both faces of either or both of first and second portions 541a, 541b of thermal heating element 540.
  • Encapsulating layer 548 may define a thickness (on either or both face), in aspects, from about 0.0005 in to about 0.0015 in; in other aspects, from about 0.0007 in to about 0.0013 in; and in still other aspects, from about 0.0009 in to about 0.0012 in.
  • the thickness may extend, in any of the ranges above or any other suitable range up to about 0.005 inches. This thickness may be uniform or varied along the widths and/or lengths of first and second portions 541a, 541b of thermal heating element 540 to achieve a desired configuration.
  • thermal heating element 540 may be configured to receive an applied voltage (VAC), e.g., the voltage output from surgical generator 200 (FIG. 1), surgical generator 600 (FIG. 2), or battery assembly 400 (FIG. 2), to thermal heating element 540, in aspects, from about 5 volts to about 300 volts; in other aspects, from about 10 volts to about 200 volts; and in still other aspects, from about 25 volts to about 100 volts.
  • VAC applied voltage
  • Thermal heating element 540 may be configured to operate in one or more different modes, e.g., controllable/settable at the energy source and/or activation source. More specifically, thermal heating element 540 may have a single operating mode and corresponding operating temperature for all functions, or may have multiple operating modes each having a corresponding operating temperature for one or more functions such as, for example: sealing without ultrasonic energy, sealing with ultrasonic energy, dissection without ultrasonic energy, dissection with ultrasonic energy, slow dissection, fast dissection, sealing small to medium tissue (e.g., up to 7mm in diameter), sealing large tissue (e.g., 7-10mm diameter), sealing extra large tissue (e.g., over 10mm in diameter), sealing certain tissue types (fatty tissue, lung tissue, liver tissue, vascular tissue, etc.), etc.
  • sealing medium tissue e.g., up to 7mm in diameter
  • sealing large tissue e.g., 7-10mm diameter
  • sealing extra large tissue e.g., over 10mm in diameter
  • sealing certain tissue types
  • thermal heating element 540 may be heated to an operating temperature, in aspects, of about 200°C to about 250°C; in aspects, up to at least about 300°C; in other aspects, from about 300°C to about 550°C; in yet other aspects, about or at least 550°C; and in still yet other aspects, from about 400°C to about 500°C. Combinations of the above temperatures and temperature ranges are also contemplated.
  • the temperature of thermal heating element 540 may vary along the length and/or width of thermal heating element 540 to achieve a desired thermal gradient profile in use and, thus, the temperatures noted herein may be average temperatures (e.g., obtained via averaging temperature measurements at several locations along the length and/or width of thermal heating element 540), or may represent the temperature at a particular reference point along thermal element 130 (e.g., at a length-wise and/or width-wide midpoint).
  • Second insulator 550 is an electrical and thermal insulator and is positioned within internal cavity 529 of jaw plate 520 on an interior surface of jaw plate 520. Second insulator 550 is formed from a material capable of withstanding high temperatures such as, for example, up to at least 400°C or 600°C, although other configurations are also contemplated. Second insulator 550 defines a plate body 552 and a plurality of supports 554 extending from plate body 552 and positioned to define a first receptacle 556 shaped complementary to and configured to receive at least a portion of thermal heating element 540.
  • Supports 554 and/or different supports of second insulator 550 are further configured to define a second receptacle 558 configured to receive a portion of jaw liner 510.
  • second insulator 550 facilitates positioning and/or retention of thermal heating element 540 and/or jaw liner 510 relative to jaw plate 520.
  • Second insulator 550 may be formed from molding (e.g., overmolding), thereby defining first receptacle 556 and/or second receptacle 558 about thermal heating element 540 and/or jaw liner 510, respectively.
  • either or both receptacles 556, 558 may be pre-formed for subsequent positioning of thermal heating element 540 and/or jaw liner 510 within the respective receptacle 556, 558.
  • second insulator 550 serves to enclose first insulator 530 and thermal heating element 540 within internal cavity 529 of jaw plate 520.
  • a jaw housing 560 (FIG. 8F) is overmolded or otherwise provided to surround at least a portion of jaw assembly 184 and distal extension 183c of structural body 182 to secure jaw assembly 184 relative to structural body 182 (see FIGS. 4 and 8F).
  • distal extension 183c of structural body 182 may be positioned in abutment with second insulator 550 within or adjacent to internal cavity 529 of jaw plate 520 prior to overmolding jaw housing 560 (see FIGS. 4 and 8F) about flange 528 of jaw plate 520 and distal extension 183c of structural body 182 (FIG. 4).
  • jaw plate 520 may include apertures 570 (as shown) and/or slots, channels, or other features to facilitate inflow of overmold to ensure retention of jaw housing 560 (FIG. 8F) about jaw assembly 184.
  • jaw assembly 184 and, ultimately, jaw member 164 (FIG. 4) is detailed. Although detailed in one order, it is contemplated that the assembly of jaw assembly 184 and/or jaw member 164 (FIG. 4) may be accomplished in a different order and/or with certain assembly steps performed simultaneously or overlapping with one another.
  • jaw plate 520 is formed (e.g., via stamping, metal injection molding (MIM), or in any other suitable manner) or obtained.
  • first insulator 530 is positioned within internal cavity 529 of jaw plate 520 on an interior surface of jaw plate 520 opposite tissue contacting surface 526 (see FIG. 8B), e.g., via spraying, a deposition process, prior formation and subsequent adhesion, or in any other suitable manner.
  • first insulator 530 may be held in place for securement in subsequent retention steps.
  • thermal heating element 540 is disposed in internal cavity 529 of jaw plate 520 in abutting contact with first insulator 530. Thermal heating element 540 may be secured in position at this point or held in place for securement in subsequent retention steps.
  • second insulator 550 is overmolded into internal cavity 529 of jaw plate 520 to partially surround thermal heating element 540 and retain thermal heating element 540 (and, in aspects, first insulator 530) within internal cavity 529 and relative to jaw plate 520.
  • second insulator 550 is positioned and/or retained in any other suitable manner.
  • jaw liner 510 is inserted through channel 522 of jaw plate 520 and the corresponding channels defined within first insulator 530 and thermal heating element 540 and may be retained therein via the overmolding of second insulator 550 (where jaw liner 510 is inserted prior to overmolding of second insulator 550) or may be retained in channel 522 in any other suitable manner such as, for example, press-fitting complementary mechanical engagement, etc.
  • jaw liner 510 is inserted through channel 522 in a drop-in manner, wherein jaw liner 510 is inserted in a direction substantially perpendicular to tissue contacting surface 526 of jaw plate 520.
  • jaw liner 510 is inserted through channel 522 in a slide-in manner, wherein jaw liner 510 is inserted in a direction substantially parallel to tissue contacting surface 526 of jaw plate 520, e.g., from the proximal end thereof.
  • jaw assembly 184 in order to secure jaw assembly 184 to distal extension 183c of structural body 182 (FIG. 4) to complete assembly of jaw member 164, jaw assembly 184 is positioned on distal extension 183 c such that distal extension 183 c abuts second insulator 550 within or adjacent to internal cavity 529 of jaw plate 520 and, thereafter, jaw hosing 560 is overmolded about flange 528 of jaw plate 520 and distal extension 183c to capture and retain jaw assembly 184 about distal extension 183c.
  • the overmold material forming jaw housing 560 may penetrate apertures 570 (or other suitable features) (FIG. 6) of jaw plate 520 to facilitate engagement and retention of the various components of jaw member 164 (FIG. 4).
  • Jaw assembly 1184 includes a jaw liner 610, a first insulator 630, a thermal heating element 640, and a second insulator 650.
  • Jaw liner 610 and thermal heating element 640 may be configured similar to and include any of the features of jaw liner 510 and thermal heating element 540, respectively, as detailed above (see FIGS. 5-7).
  • Thermal heating element 640 more specifically, includes first and second spaced apart portions 641a, 641b electrically coupled, in aspects, by a conductive bridge 641c or, alternatively, maintained separate to define separate circuits.
  • First insulator 630 includes first and second spaced apart plates 634 each defining a tissue contacting surface 636.
  • the space 632 defined between plates 634 forms a channel configured to receive jaw liner 610.
  • the first and second plates 634 may be connected at their distal ends to define a generally U-shaped configuration or may remain spaced, as shown, to enable jaw liner 610 to extend to the distal end of jaw assembly 1184.
  • First insulator 630 is an electrical insulator and may be formed from ceramic or other suitable material, e.g., PTFE, PEEK, PEI.
  • Second insulator 650 is an electrical and thermal insulator and includes a base 652 and a top portion 654 disposed on base 652 to define a table-like configuration. Second insulator 650 defines a channel 656 configured to receive jaw liner 610 therein in any suitable manner, e.g., similarly as detailed above with respect to the retention of jaw liner 510 (FIG. 5 and 6). Top portion 654 of second insulator 650 is configured to support first and second spaced apart portions 641a, 641b of thermal heating element 640 on either side of channel 656. Top portion 654 of second insulator 650 is further configured to support, partially on top of and partially surrounding thermal heating element 640, first insulator 630 on either side of channel 656. Second insulator 650 may otherwise be configured similar to and include any of the features of second insulator 550 (FIGS. 5 and 6) as detailed above.
  • a jaw housing 660 (FIG. 1 IE) is overmolded or otherwise provided to surround at least a portion of jaw assembly 1184 and distal extension 183 c of structural body 182 to secure jaw assembly 1184 relative to structural body 182 (see FIGS. 4 andl lE), similarly as detailed above with respect to jaw assembly 184 (FIGS. 4-6 and 8F).
  • second insulator 650 may include apertures 670 (as shown) and/or slots, channels, or other features to facilitate inflow of overmold to ensure retention of jaw housing 660 (FIG. 1 IE) about jaw assembly 1184.
  • assembly of jaw assembly 1184 and, ultimately, jaw member 164 (FIG. 4) is detailed. Although detailed in one order, it is contemplated that the assembly of jaw assembly 1184 and/or jaw member 164 (FIG. 4) may be accomplished in a different order and/or with certain assembly steps performed simultaneously or overlapping with 1 one another. Further, to the extent consistent, the assembly of jaw assembly 1184 may be similar to and include any of the features of the assembly of jaw assembly 184 as detailed above (see FIGS. 8A-8F).
  • second insulator 650 is formed (e.g., via forging, molding, or in any other suitable manner) or obtained.
  • first and second portions 641a, 641b of thermal heating element 640 are disposed on top portion 654 of second insulator 650 and, with reference to FIG. 11C, first and second spaced apart plates 634 are then disposed on first and second portions 641a, 641b, respectively, of thermal heating element 640 and/or on top portion 654 of second insulator 650 (e.g., on the sections of top portion 654 not occupied by thermal heating element 640).
  • jaw liner 610 is positioned between first and second spaced apart plates 634 of first insulator 630 and first and second portions 641a, 641b of thermal heating element 640 and within channel 656.
  • jaw assembly 1184 in order to secure jaw assembly 1184 to distal extension 183c of structural body 182 (FIG. 4) to complete assembly of jaw member 164, jaw assembly 1184 is positioned on distal extension 183c such that distal extension 183c abuts second insulator 650 and, thereafter, jaw hosing 660 is overmolded about second insulator 650 and distal extension 183c to capture and retain jaw assembly 1184 about distal extension 183c.
  • the overmold material forming jaw housing 660 may penetrate apertures 670 (or other suitable features) (FIG. 9) to facilitate engagement and retention of the various components of jaw member 164 (FIG. 4).
  • the thermal heating elements 540, 640 of jaw assemblies 184, 1184 may include one or more resistive trace circuits 546 defining one or more heater circuits.
  • first and second resistive trace circuits 546 electrically connected via a conductive bridge 541c at the distal ends thereof may be connected to lead wires 199 at the proximal ends thereof that complete the circuit to an energy source 1200 (and, in aspects, an activation source), to define a single thermal heater circuit 1210.
  • first and second resistive trace circuits 546 are electrically isolated from one another and separately connected to lead wires 199 at the proximal ends thereof to complete two separate circuits back to an energy source 1300 (and, in aspects, an activation source), to define first and second thermal heater circuits 1310, 1320 laterally spaced on either side of the jaw assembly (e.g., jaw assemblies 184, 1184 (FIGS. 7 and 10, respectively)).
  • an energy source 1300 and, in aspects, an activation source
  • FIG. 14 illustrates still another example wherein inner and outer pairs of resistive trace circuits 546 are electrically isolated from one another.
  • the first and second resistive trace circuits 546 of the inner pair are electrically connected via an inner conductive bridge 541c (or inner portion of a conductive bridge 541c) and the first and second resistive trace circuits 546 of the outer pair are electrically connected via an outer conductive bridge 541c (or outer portion of a conductive bridge 541c).
  • the resistive trace circuits 546 of the inner and outer pairs are electrically isolated from one another and separately connected to lead wires 199 at the proximal ends thereof to complete two separate circuits back to an energy source 1400 (and, in aspects, an activation source), to define inner and outer thermal heater circuits 1410, 1420 defining generally U-shaped configurations extending about the jaw assembly (e.g., jaw assemblies 184, 1184 (FIGS. 7 and 10, respectively)).
  • thermal heater circuits are also contemplated.
  • each circuit may be controlled and energized independently.
  • a control algorithm may be implemented together with the application of ultrasonic energy or separately therefrom to facilitate tissue sensing and/or tissue treatment.
  • the one or more circuits may be controlled in terms of voltage supplied, ON/OFF duration, number of circuits ON/OFF, etc.
  • temperature of the thermal heating element, jaw member, or tissue
  • tissue sealing such as, for example, to achieve desired temperatures associated with and/or desired temperature profiles between an initial temperature before tissue sealing, a sealing temperature during tissue sealing, and a final temperature after tissue sealing.
  • Additional or alternative algorithms may include varying ON/OFF time (and/or time in certain modes), varying the circuits activated, varying or controlling to power consumed, varying or controlling to a rate of change of power, etc.
  • portions of the resistive trace circuit(s) may be varied to achieve uniform or variable heating (according to a desired profile along the length and/or width) of the thermal heating element and/or of the jaw assembly.
  • one or more of the resistive trace circuits 546 may include one or more linear portions 1500 (FIG. 15) while one or more of the resistive trace circuits 546 may include one or more tortuous portions 1600 (FIG. 16). Each of the one or more tortuous portions 1600 (FIG.
  • tortuous portion 1600 defines a non-linear, tortuous path such as, for example, a square-wave shaped configuration (as shown), although other suitable configurations are also contemplated such as, for example, a sine-wave shaped configuration, a triangle-wave shaped configuration, a sawtooth-wave shaped configuration, combinations thereof (as mixed wave shapes or discrete wave shapes in a pattern), any of the above shapes with intermediate (periodic or random) longitudinal, linear segments (or other suitable segments), etc.
  • the tortuous path defined by tortuous portion 1600 (FIG. 16) need not define a waveform-shaped configuration (or combination thereof) and need not define a repeating configuration. That is, tortuous portion 1600 (FIG. 16) may define a configuration of substantially uniform amplitude and frequency; however, variations are also contemplated, for example, wherein tortuous portion 1600 (FIG. 16), as shown, defines an increasing frequency in a left-to-right direction.
  • Tortuous portions 1600 (FIG. 16) as compared to linear portions 1500 (FIG. 15) include a greater amount of the resistive trace circuit 546 for a given length and, thus, enable increased heating at locations where resistive trace circuit 546 includes tortuous portions 1600 (FIG. 16) as compared to linear portions 1500 (FIG. 15).
  • one or more of resistive trace circuits 546 may include a portion 1700 having one or more temperature control features 1710 which may include, for example, electrically conductive material disposed on resistive trace circuit 546 and/or areas of increased or decreased thickness of resistive trace circuit 546 (and/or the encapsulating layer and/or insulating layer of the thermal heating element).
  • temperature control features 1710 configured (at least partially) as electrically conductive material, such features 1710 function to reduce temperature at the locations where provided since the features 1710 do not generate resistive heating (because they are conductors) and because current travels through the path of least resistance, thus bypassing the resistive heating portions in favor of the electrically conductive portions disposed thereon.
  • the one or more of resistive trace circuits 546 may be configured such that a variation along the length of the jaw assembly (at the tissue contacting surface thereof) and/or across a width of the jaw assembly (at the tissue contacting surface thereof) is less than about 25°C or, in aspects, less than about 10°C or, in still other aspects, less than about 5°C.
  • other configurations are also contemplated such as, for example, wherein temperature variations outside the above-noted values are purposefully provided to achieve a desired temperature gradient along and/or across the jaw assembly.

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Abstract

Instrument chirurgical comprend un ensemble effecteur terminal ayant une lame ultrasonore conçue pour se coupler fonctionnellement à un transducteur ultrasonore et recevoir de l'énergie ultrasonore provenant du transducteur ultrasonore, ainsi qu'un élément de mâchoire mobile par rapport à la lame ultrasonore entre une position ouverte et une position de serrage pour serrer un tissu entre l'élément de mâchoire et la lame ultrasonore. L'élément de mâchoire comprend un élément de chauffage thermique conçu pour générer de la chaleur en réponse à la réception d'énergie et pour chauffer un tissu serré entre l'élément de mâchoire et la lame ultrasonore. Un système chirurgical comprend en outre le transducteur ultrasonore et/ou une source d'énergie conçu pour fournir l'énergie à l'élément chauffant thermique. Le système peut également comprendre un boîtier, ayant une tige s'étendant de manière distale à partir de celui-ci, qui supporte l'ensemble effecteur terminal au niveau d'une partie d'extrémité distale de celui-ci.
PCT/IB2024/050331 2023-01-13 2024-01-12 Instruments chirurgicaux, systèmes et procédés incorporant une fonctionnalité d'énergie ultrasonore et de chauffage thermique Ceased WO2024150187A1 (fr)

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