CN114901167A - Electrosurgical instrument with monopolar and bipolar energy capabilities - Google Patents
Electrosurgical instrument with monopolar and bipolar energy capabilities Download PDFInfo
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- CN114901167A CN114901167A CN202080091268.4A CN202080091268A CN114901167A CN 114901167 A CN114901167 A CN 114901167A CN 202080091268 A CN202080091268 A CN 202080091268A CN 114901167 A CN114901167 A CN 114901167A
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Abstract
An electrosurgical instrument includes an end effector including a first jaw, a second jaw, and a circuit. The first jaw includes a first conductive backbone, a first insulating coating selectively covering a portion of the first conductive backbone, and a first jaw electrode including an exposed portion of the first conductive backbone. The second jaw includes a second conductive backbone, a second insulating coating selectively covering portions of the second conductive backbone, and a second jaw electrode including an exposed portion of the second conductive backbone. The circuitry is configured to transmit bipolar RF energy and monopolar RF energy to the tissue through the first jaw electrode and the second jaw electrode. The monopolar RF energy shares a first electrical path and a second electrical path defined by the circuitry for transmitting the bipolar RF energy.
Description
Cross Reference to Related Applications
This non-provisional application claims the benefit of U.S. provisional patent application serial No. 62/955,299 entitled "DEVICES AND SYSTEMS FOR ELECTROSURGERY" filed 2019, 12, 30, 2019, in accordance with 35 u.s.c. 119(e), the disclosure of which is incorporated herein by reference in its entirety.
Background
The present invention relates to surgical instruments designed for treating tissue, including but not limited to surgical instruments configured to cut and fasten tissue. The surgical instrument may comprise an electrosurgical instrument powered by a generator to effect tissue dissection, cutting and/or coagulation during a surgical procedure. The surgical instrument may comprise an instrument configured to cut and staple tissue using surgical staples and/or fasteners. The surgical instrument may be configured for open surgical procedures, but has application in other types of surgical procedures (such as laparoscopic, endoscopic, and robotic-assisted procedures), and may include an end effector that is articulatable relative to a shaft portion of the instrument to facilitate precise positioning within a patient.
Disclosure of Invention
In various embodiments, an electrosurgical instrument including an end effector is disclosed. The end effector includes a first jaw, a second jaw, and a circuit. The first jaw includes a first electrically conductive backbone, a first insulating coating selectively covering a portion of the first electrically conductive backbone, and a first jaw electrode including an exposed portion of the first electrically conductive backbone. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a second electrically conductive backbone, a second insulating coating selectively covering portions of the second electrically conductive backbone, and a second jaw electrode including an exposed portion of the second electrically conductive backbone. The circuitry is configured to transmit bipolar RF energy and monopolar RF energy to the tissue via the first jaw electrode and the second jaw electrode. The monopolar RF energy shares a first electrical path and a second electrical path defined by the circuit for transmitting bipolar RF energy.
In various embodiments, an electrosurgical instrument is disclosed that includes an end effector and a circuit. The end effector includes at least two electrode sets, a first jaw, and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The end effector is configured to deliver a combination of bipolar RF energy and monopolar RF energy from the at least two electrode sets to the grasped tissue. The circuit is configured to be capable of transmitting bipolar RF energy and monopolar RF energy. The monopolar RF energy shares an active path and a return path defined by the circuit for transmitting bipolar RF energy.
In various embodiments, an electrosurgical instrument including an end effector is disclosed. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a composite skeleton of at least two different materials configured to selectively create an electrically conductive portion and a thermally isolated portion.
In various embodiments, a method for manufacturing jaws of an end effector of an electrosurgical instrument is disclosed. The method includes preparing a composite skeleton of the jaws by fusing titanium powder with ceramic powder in a metal injection molding process and selectively coating the composite skeleton with an electrically insulating material to produce a plurality of electrodes.
Drawings
The novel features of the various aspects are set forth with particularity in the appended claims. However, the aspects described, both as to organization and method of operation, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which:
fig. 1 illustrates an example of a generator for use with a surgical system according to at least one aspect of the present disclosure;
FIG. 2 illustrates a surgical system including a generator and an electrosurgical instrument configured for use therewith, in accordance with at least one aspect of the present disclosure;
FIG. 3 illustrates a schematic view of a surgical instrument or tool in accordance with at least one aspect of the present disclosure;
FIG. 4 is an exploded view of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 5 is a cross-sectional view of the end effector of FIG. 4;
6-8 depict three different modes of operation of the end effector of FIG. 4 prior to application of energy to tissue;
9-11 depict three different modes of operation of the end effector of FIG. 4 during application of energy to tissue;
FIG. 12 illustrates a method of manufacturing jaws of an end effector in accordance with at least one aspect of the present disclosure;
FIG. 13 illustrates a method of manufacturing jaws of an end effector in accordance with at least one aspect of the present disclosure;
FIG. 14 illustrates a partial perspective view of jaws of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 15 illustrates a step of a process of making the jaws of FIG. 14;
FIG. 16 illustrates a step of a process of making the jaws of FIG. 14;
FIGS. 17-19 illustrate steps of a process of manufacturing the jaws of FIG. 14;
FIG. 20 illustrates a cross-sectional view of a jaw of an end effector of an electrosurgical instrument taken through line 20-20 in FIG. 22, in accordance with at least one aspect of the present disclosure;
FIG. 21 illustrates a cross-sectional view of the jaws of the end effector of the electrosurgical instrument taken through line 21-21 in FIG. 22;
FIG. 22 illustrates a perspective view of jaws of an end effector of the electrosurgical instrument of FIG. 20;
FIG. 23 illustrates a cross-sectional view of a jaw of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 24 illustrates a partial perspective view of jaws of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 25 illustrates a cross-sectional view of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 26 illustrates a partially exploded view of an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure;
FIG. 27 illustrates an exploded perspective assembled view of a portion of an electrosurgical instrument including an electrical connection assembly in accordance with at least one aspect of the present disclosure;
FIG. 28 illustrates a top view of the electrical pathway defined in the surgical instrument portion of FIG. 27, in accordance with at least one aspect of the present disclosure;
fig. 29 illustrates a cross-sectional view of a flexible circuit in accordance with at least one aspect of the present disclosure;
fig. 30 illustrates a cross-sectional view of a flexible circuit extending through a coil form in accordance with at least one aspect of the present disclosure;
fig. 31 illustrates a cross-sectional view of a flexible circuit extending through a coil form in accordance with at least one aspect of the present disclosure;
fig. 32 illustrates a cross-sectional view of a flexible circuit extending through a coil form in accordance with at least one aspect of the present disclosure;
fig. 33 illustrates a cross-sectional view of a flexible circuit extending through a coil form in accordance with at least one aspect of the present disclosure;
FIG. 34 is a graph illustrating a power scheme for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector, according to at least one aspect of the present disclosure;
FIG. 35 is a graph illustrating a power scheme for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector and a plurality of measured parameters of the end effector and tissue in accordance with at least one aspect of the present disclosure;
fig. 36 is a schematic view of an electrosurgical system according to at least one aspect of the present disclosure;
FIG. 37 is a table illustrating a power scheme for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector, according to at least one aspect of the present disclosure;
38-40 illustrate a tissue treatment cycle applied by an end effector to a tissue treatment area according to at least one aspect of the present disclosure;
fig. 41 illustrates an end effector applying therapeutic energy to tissue grasped by the end effector, the therapeutic energy being generated by a monopolar power source and a bipolar power source, in accordance with at least one aspect of the present disclosure;
fig. 42 shows a simplified schematic diagram of an electrosurgical system according to at least one aspect of the present disclosure;
fig. 43 is a graph illustrating a power scheme for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector, and corresponding temperature readings of the tissue treatment region, in accordance with at least one aspect of the present disclosure;
FIG. 44 illustrates an end effector treating an artery according to at least one aspect of the present disclosure;
FIG. 45 illustrates an end effector treating an artery according to at least one aspect of the present disclosure;
fig. 46 illustrates an end effector applying therapeutic energy to tissue grasped by the end effector, the therapeutic energy being generated by a monopolar power source and a bipolar power source, in accordance with at least one aspect of the present disclosure;
fig. 47 shows a simplified schematic diagram of an electrosurgical system according to at least one aspect of the present disclosure;
FIG. 48 is a graph illustrating a power scheme including a treatment portion and a non-treatment range for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector, according to at least one aspect of the present disclosure; and is
Fig. 49 is a graph illustrating a power scheme for coagulating and cutting a tissue treatment region in a treatment cycle applied by an end effector, and corresponding monopolar and bipolar impedances and ratios thereof, according to at least one aspect of the present disclosure.
Detailed Description
The applicant of the present application owns the following U.S. patent applications filed on even date herewith and each incorporated herein by reference in its entirety:
attorney docket number END9234USNP1/190717-1M entitled "METHOD FOR AN ELECTRROSURGICAL PROCEDURE";
attorney docket number END9234USNP2/190717-2 entitled "articulable minor insert";
attorney docket number END9234USNP3/190717-3 entitled "SURGICAL INSTRUMENT WITH JAW ALIGNMENT FEATURES";
attorney docket number END9234USNP4/190717-4 entitled "SURGICAL INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR";
attorney docket number END9234USNP5/190717-5 entitled "ELECTROSURURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING ELECTRORDES";
attorney docket number END9234USNP6/190717-6 entitled "ELECTROSURURGICAL INSTRUMENTS WITH ELECTRODES BIASING SUPPORT";
attorney docket number END9234USNP7/190717-7 entitled "electroturgical instument WITH flexibile along assets";
attorney docket number END9234USNP8/190717-8 entitled "ELECTROSURURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS";
attorney docket number END9234USNP9/190717-9 entitled "ELECTROSURURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER SOURCES";
attorney docket number END9234USNP10/190717-10 entitled "ELECTROSURURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES";
attorney docket number END9234USNP11/190717-11, entitled "ELECTROSURURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE ENERGY DENSITIES";
attorney docket number END9234USNP13/190717-13 entitled "ELECTROSURURGICAL END EFFECTORS WITH THERMALLY INSULATED AND THERMALLY CONDUCTIVE PORTIONS";
attorney docket number END9234USNP14/190717-14 entitled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR MODES";
attorney docket number END9234USNP15/190717-15 entitled "ELECTROSURURGICAL INSTRUMENT FOR DELIVERING BLENDING ENGAGEMENT TO TISSUE";
attorney docket number END9234USNP16/190717-16 entitled "CONTROL PROGRAM adaptive BASED ON DEVICE STATUS AND USER INPUT";
attorney docket number END9234USNP17/190717-17 entitled "CONTROL PROGRAM FOR MODULAR COMMUNICATION ENERGY DEVICE"; and
attorney docket number END9234USNP18/190717-18, entitled "SURGICAL SYSTEM COMMUNICATION PATHWAYS".
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 30.12.2019, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application serial No. 62/955,294 entitled "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMMUNICATION ENGINE MODAL END-EFFECTOR";
U.S. provisional patent application serial No. 62/955,292 entitled "COMBINATION ENERGY modified END-effect"; and
U.S. provisional patent application serial No. 62/955,306 entitled "SURGICAL INSTRUMENT SYSTEMS".
The applicant of the present patent application owns the following U.S. patent applications, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 16/209,395 entitled "METHOD OF HUB COMMUNICATION", now U.S. patent application publication No. 2019/0201136;
U.S. patent application Ser. No. 16/209,403 entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB", now U.S. patent application publication No. 2019/0206569;
U.S. patent application Ser. No. 16/209,407 entitled "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL", now U.S. patent application publication No. 2019/0201137;
U.S. patent application Ser. No. 16/209,416 entitled "METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS", now U.S. patent application publication No. 2019/0206562;
U.S. patent application Ser. No. 16/209,423 entitled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS", now U.S. patent application publication No. 2019/0200981;
U.S. patent application Ser. No. 16/209,427 entitled "METHOD OF USING INFORMATION FLUX CIBLE CIRCULATIES WITH MULTIPLE SENSOR TO OPTIMIZATION PERFOMANCE OF RADIO FREQUENCY DEVICES", now U.S. patent application publication No. 2019/0208641;
U.S. patent application Ser. No. 16/209,433 entitled "METHOD OF SENSING PARTITITE FROM SMOKE EVACUATED FROM A PATIENT, ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATION THE FUNCTION PARAMETERS OF THE SYSTEM TO HUB", now U.S. patent application publication No. 2019/0201594;
U.S. patent application Ser. No. 16/209,447, entitled "METHOD FOR SMOKE EVACUTION FOR SURGICAL HUB", now U.S. patent application publication No. 2019/0201045;
U.S. patent application Ser. No. 16/209,453, entitled "METHOD FOR CONTROLLING SMART ENERGY DEVICES", now U.S. patent application publication No. 2019/0201046;
U.S. patent application Ser. No. 16/209,458, entitled "METHOD FOR SMART ENERGY DEVICE FRASTRUCTURURE", now U.S. patent application publication No. 2019/0201047;
U.S. patent application Ser. No. 16/209,465 entitled "METHOD FOR ADAPTIVE CONTROL FOR SURGICAL NETWORK CONTROL AND INTERACTION", now U.S. patent application publication No. 2019/0206563;
U.S. patent application Ser. No. 16/209,478 entitled "METHOD FOR APPARATUS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE OF ADJUNCTIONING FUNCTION BASE A SENSED STATION OR USAGE", now U.S. patent application publication No. 2019/0104919;
U.S. patent application Ser. No. 16/209,490 entitled "METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION", now U.S. patent application publication No. 2019/0206564;
U.S. patent application Ser. No. 16/209,491 entitled "METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON STATIONAL AWARESS", now U.S. patent application publication No. 2019/0200998;
U.S. patent application Ser. No. 16/562,123 entitled "METHOD FOR CONSTRUCTION AND USE A MODULAR SURGICAL ENERGY SYSTEM WITH MULTIPLE DEVICES";
U.S. patent application Ser. No. 16/562,135 entitled "METHOD FOR CONTROLLING AN ENERGY MODULE OUTPUT";
U.S. patent application Ser. No. 16/562,144 entitled "METHOD FOR CONTROLLING A MODULAR ENERGY SYSTEM USER INTERFACE"; and
U.S. patent application Ser. No. 16/562,125, entitled "METHOD FOR COMMUNICATING BETWEEN MODULES AND DEVICES IN A MODULAR SURGICAL SYSTEM".
Before explaining aspects of an electrosurgical system in detail, it should be noted that the illustrative examples are not limited in application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative examples may be implemented or incorporated in other aspects, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative examples for the convenience of the reader and are not for the purpose of limitation. Moreover, it should be understood that one or more of the following described aspects, expressions, and/or examples may be combined with any one or more of the other following described aspects, expressions, and/or examples.
Various aspects relate to an electrosurgical system that includes an electrosurgical instrument that is powered by a generator to effect tissue dissection, cutting and/or coagulation during a surgical procedure. Electrosurgical instruments may be configured for use in open surgical procedures, but may also find application in other types of procedures, such as laparoscopic, endoscopic, and robotically-assisted procedures.
As described in greater detail below, electrosurgical instruments generally include a shaft having a distally mounted end effector (e.g., one or more electrodes). The end effector is positionable against tissue such that an electrical current is introduced into the tissue. The electrosurgical instrument can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into and returned from the tissue through the active and return electrodes, respectively, of the end effector. During monopolar operation, current is introduced into tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) separately positioned on the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and/or between the tissues, and thus may be particularly useful, for example, in sealing blood vessels.
Fig. 1 shows an example of a generator 900 configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF signals and/or ultrasonic signals for delivering energy to the surgical instrument. The generator 900 includes at least one generator output that can deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.) through a single port, and these signals can be delivered separately or simultaneously to the end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to be capable of generating a variety of signal waveforms based on information stored in a memory coupled to the processor 902, which memory is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to a waveform generator 904, which includes one or more DAC circuits to convert a digital input to an analog output. The analog output is fed to an amplifier 906 for signal conditioning and amplification. The regulated and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled to the secondary side of the patient isolation side through a power transformer 908. A first signal of a first ENERGY mode is provided to a first ENERGY mode labeled ENERGY 1 And a terminal of a RETURN. A second signal of a second ENERGY mode is coupled across capacitor 910 and provided to a second terminal labeled ENERGY 2 And a terminal of the RETURN. It will be appreciated that more than two ENERGY modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGY may be provided n A terminal, wherein n is a positive integer greater than 1. It should also be understood that up to "n" RETURN paths RETURN may be provided without departing from the scope of this disclosure n 。
The first voltage sensing circuit 912 is coupled to a voltage source labeled ENERGY 1 And across the terminals of the RETURN path to measure the output voltage therebetween. A second voltage sense circuit 924 is coupled to the voltage sense circuit labeled ENERGY 2 And across the terminals of the RETURN path to measure the output voltage therebetween. As shown, a current sensing circuit 914 is placed in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. The outputs of the first 912 and second 924 voltage sensing circuits are provided to respective isolation transformers 928, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The output of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (not the patient isolation side) is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. Output voltage and output current feedback information may be employed to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input/output communication between the processor 902 and the patient isolation circuitry is provided through an interface circuit 920. The sensors may also be in electrical communication with the processor 902 through an interface circuit 920.
In one aspect, the impedance may be determined by the processor 902 by coupling in a frequency domain labeled ENERGY 1 First voltage sense circuit 912 coupled across terminals of/RETURN or otherwise labeled ENERGY 2 Output of the second voltage sense circuit 924 across terminals of RETURN divided by the secondary side of the power transformer 908Is determined by the output of the current sense circuit 914 disposed in series with the RETURN leg of (a). The outputs of the first 912 and second 924 voltage sensing circuits are provided to separate isolation transformers 928, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first ENERGY modality ENERGY 1 May be RF monopole ENERGY, and a second ENERGY modality ENERGY 2 May be RF bipolar energy. However, in addition to bipolar and monopolar RF energy modalities, other energy modalities include ultrasound energy, irreversible and/or reversible electroporation, and/or microwave energy, among others. Also, while the example shown in fig. 1 shows that a single RETURN path RETURN may be provided for two or more ENERGY modalities, in other aspects, a single RETURN path RETURN may be provided for each ENERGY modality ENERGY n Providing multiple RETURN paths RETURN n 。
As shown in fig. 1, the generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with higher voltages and lower currents to drive an ultrasound transducer, with lower voltages and higher currents to drive an RF electrode for sealing tissue, or with a coagulation waveform for spot coagulation using monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be at what is labeled ENERGY 2 And the output of RETURN. In the case of a single pole output, the preferred connection would be ENERGY 2 An active electrode (e.g., a pencil or other probe) at the output and a suitable RETURN pad connected to the RETURN output.
Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," published 3, 30, 2017, which is incorporated herein by reference in its entirety.
Fig. 2 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates both RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 2, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, in one form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may be configured for wired or wireless communication.
The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105(HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 acoustically coupled to an ultrasonic transducer 1120. The handpiece 1105 includes a combination of a trigger 1143 for operating the clamp arm 1140 and toggle buttons 1137, 1134b, 1134c for energizing the ultrasonic blade 1128 and driving the ultrasonic blade or other functions. The toggle buttons 1137, 1134b, 1134c may be configured to enable the generator 1100 to power the ultrasound transducer 1120.
The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a hand piece 1107(HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1145, 1142b and returns through the electrical conductor portion of the shaft 1127. The electrodes are coupled to and powered by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1145, 1142b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124. The second surgical instrument 1106 may also be used with a return pad to deliver monopolar energy to tissue.
The generator 1100 is also configured to drive a multi-function surgical instrument 1108. The multifunctional surgical instrument 1108 includes a hand piece 1109(HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a combination of a trigger 1147 for operating the clamp arm 1146 and switch buttons 11310, 1137b, 1137c for energizing and driving the ultrasonic blade 1149 or other functions. The toggle buttons 11310, 1137b, 1137c may be configured to enable the generator 1100 to power the ultrasonic transducer 1120, and the bipolar energy source also contained within the generator 1100 to power the ultrasonic blade 1149. Monopolar energy may be delivered to the tissue in combination with bipolar energy or separately from bipolar energy.
The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 2, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, in another form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may also include one or more output devices 1112. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. patent application publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.
Fig. 3 shows a schematic view of a surgical instrument or tool 600 including multiple motor assemblies that may be activated to perform various functions. In the example shown, the closure motor assembly 610 is operable to transition the end effector between an open configuration and a closed configuration, and the articulation motor assembly 620 is operable to articulate the end effector relative to the shaft assembly. In some instances, multiple motor assemblies can be individually activated to cause firing, closing, and/or articulation motions in the end effector. Firing motions, closing motions, and/or articulation motions can be transmitted to the end effector, for example, by a shaft assembly.
In some cases, the closure motor assembly 610 includes a closure motor. The closure member 603 can be operably coupled to a closure motor drive assembly 612, which can be configured to transmit closure motions generated by a motor to the end effector, in particular for displacing the closure member for closure to transition the end effector to a closed configuration. The closing motion can transition, for example, the end effector from an open configuration to a closed configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor.
In some instances, the articulation motor assembly 620 comprises an articulation motor operably coupled to an articulation drive assembly 622 that may be configured to transmit articulation motions generated by the motor to the end effector. In some cases, the articulation can articulate the end effector relative to the shaft, for example.
One or more of the motors of the surgical instrument 600 may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor used to actuate the jaws.
In various instances, the motor assemblies 610, 620 include one or more motor drivers, which may include one or more H-bridge FETs. The motor driver may regulate the power delivered to the motor from the power source 630 based on input from, for example, a microcontroller 640 ("controller") of the control circuit 601. In some cases, microcontroller 640 may be used to determine, for example, the current drawn by the motor.
In some cases, microcontroller 640 may include a microprocessor 642 ("processor") and one or more non-transitory computer-readable media or storage units 644 ("memory"). In some cases, memory 644 may store various program instructions that, when executed, may cause processor 642 to perform various functions and/or computations described herein. In some cases, one or more of memory units 644 may be coupled to processor 642, for example. In various aspects, microcontroller 640 may communicate over a wired or wireless channel, or a combination thereof.
In some cases, power source 630 may be used, for example, to supply power to microcontroller 640. In some cases, the power source 630 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In some cases, the battery pack may be configured to be releasably mountable to the handle for supplying power to the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 630. In some cases, power source 630 may be replaceable and/or rechargeable, for example.
In various instances, the processor 642 may control the motor driver to control the position, rotational direction, and/or speed of the motors of the components 610, 620. In some cases, processor 642 may send a signal to a motor driver to stop and/or deactivate the motor. It is to be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) on one integrated circuit or at most several integrated circuits. Processor 642 is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operands of the processor are numbers and symbols represented in a binary numerical system.
In one case, processor 642 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas Instruments, Inc. (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single cycle flash or other non-volatile memory (up to 40MHz) on-chip memory, prefetch buffer for improved performance above 40MHz, 32KB of single cycle SRAM, load withInternal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, and other features readily available. Other microcontrollers could be readily substituted for use with surgical instrument 600. Accordingly, the present disclosure should not be limited to this context.
In certain instances, the memory 644 may include program instructions for controlling each of the motors of the surgical instrument 600. For example, the memory 644 may include program instructions for controlling the closure motor and the articulation motor. Such program instructions may cause the processor 642 to control the closure and articulation functions in accordance with input from an algorithm or control program of the surgical instrument 600.
In some cases, one or more mechanisms and/or sensors, such as sensor 645, may be used to alert processor 642 to program instructions that should be used in a particular setting. For example, the sensor 645 may alert the processor 642 to use program instructions associated with closing and articulating the end effector. In some cases, the sensor 645 may include, for example, a position sensor that may be used to sense the position of the closure actuator. Thus, if the processor 642 receives a signal from the sensor 630 indicative of actuation of the closure actuator, the processor 642 may activate the motor of the closure drive assembly 620 using program instructions associated with the closure end effector.
In some examples, the motor may be a brushless DC electric motor, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motor. Also, in some examples, the motor driver may be omitted and the control circuit 601 may directly generate the motor drive signal.
A common practice during various laparoscopic surgical procedures is to insert a surgical end effector portion of a surgical instrument through a trocar already installed in the abdominal wall of a patient to access a surgical site located within the abdomen of the patient. In its simplest form, a trocar is a pen-like instrument with a sharp triangular point at one end, which is typically used within a hollow tube (referred to as a cannula or sleeve) to create an opening into the body through which a surgical end effector can be introduced. Such an arrangement forms an access port into the body cavity through which a surgical end effector may be inserted. The inner diameter of the trocar's cannula necessarily limits the size of the end effector and drive support shaft of the surgical instrument that can be inserted through the trocar.
Regardless of the particular type of surgical procedure being performed, once the surgical end effector has been inserted into the patient through the trocar cannula, it is often necessary to move the surgical end effector relative to a shaft assembly positioned within the trocar cannula in order to properly position the surgical end effector relative to the tissue or organ to be treated. Such movement or positioning of the surgical end effector relative to the portion of the shaft retained within the trocar cannula is commonly referred to as "articulation" of the surgical end effector. Various articulation joints have been developed to attach a surgical end effector to an associated shaft in order to facilitate such articulation of the surgical end effector. As may be desired, in many surgical procedures, it is desirable to employ a surgical end effector having as large a range of articulation as possible.
Because of the size constraints imposed by the size of the trocar cannula, the articulation joint components must be sized to be freely insertable through the trocar cannula. These dimensional constraints also limit the size and composition of the various drive components and components that operably interface with the motor and/or other control systems supported in a housing that may be hand-held or form part of a larger automated system. In many instances, these drive members must operably pass through the articulation joint in order to operably couple to or operably interface with the surgical end effector. For example, one such drive member is typically used to apply articulation control motions to a surgical end effector. During use, the articulation drive member may be unactuated to position the surgical end effector in an unarticulated position to facilitate insertion of the surgical end effector through the trocar, and then may be actuated to articulate the surgical end effector to a desired position once the surgical end effector has entered the patient.
Thus, the above-described dimensional constraints create a number of challenges for developing an articulation system that can achieve a desired range of articulation, but that accommodates the various different drive systems necessary to operate the various features of the surgical end effector. In addition, once the surgical end effector has been positioned in a desired articulation position, the articulation system and articulation joint must be capable of maintaining the surgical end effector in that position during actuation of the end effector and completion of the surgical procedure. Such articulation joint arrangements must also be able to withstand the external forces experienced by the end effector during use.
Various modes of one or more surgical devices are typically used throughout a particular surgical procedure. For example, a communication pathway extending between the surgical device and the centralized surgical center may facilitate the efficiency of the surgical procedure and increase the success of the surgical procedure. In various instances, each surgical device within the surgical system includes a display, wherein the display communicates the presence and/or operating status of other surgical devices within the surgical system. The surgical center may use the information received over the communication path to assess compatibility of the surgical devices for use with one another, to assess compatibility of the surgical devices for use during a particular surgical procedure, and/or to optimize operating parameters of the surgical devices. As described in more detail herein, the operating parameters of one or more surgical devices may be optimized based on patient demographics, particular surgical procedures, and/or detected environmental conditions (such as tissue thickness).
FIGS. 4 and 5 show an exploded view (FIG. 4) and a cutaway view (FIG. 5) of an END effector 1200 of an electrosurgical instrument (e.g., the surgical instrument described in U.S. patent application attorney docket number END9234USNP 2/190717-2). For example, the END effector 1200 may actuate, articulate, and/or rotate relative to a shaft assembly of a surgical instrument in a manner similar to the END effector described in U.S. patent application attorney docket number END9234USNP 2/190717-2. In addition, the end effector 1200 and other similar end effectors described elsewhere herein may be powered by one or more generators of a surgical system. An exemplary SURGICAL system FOR use with SURGICAL instruments is described in U.S. application No. 16/562,123, entitled "METHOD FOR CONSTRUCTING AND USING a MODULAR SURGICAL ENERGY SYSTEM WITH MULTIPLE DEVICES," filed on 5.9.2019, which is hereby incorporated herein in its entirety.
Referring to fig. 6-8, the end effector 1200 includes a first jaw 1250 and a second jaw 1270. At least one of the first jaw 1250 and the second jaw 1270 can be pivoted toward or away from the other jaw to transition the end effector 1200 between the open configuration and the closed configuration. Jaws 1250, 1270 are configured to grasp tissue between the two jaws to apply at least one of therapeutic energy and non-therapeutic energy to the tissue. Delivery of energy to tissue grasped by jaws 1250, 1270 of end effector 1200 is achieved by electrodes 1252, 1272, 1274 configured to deliver energy in a monopolar mode, a bipolar mode, and/or a combined mode having alternating or mixed bipolar and monopolar energy. The different energy modalities that may be delivered to tissue by the end effector 1200 are described in more detail elsewhere in this disclosure.
In addition to the electrodes 1252, 1272, 1274, a patient return pad is employed in connection with the application of monopolar energy. In addition, electrically isolated generators are used to deliver bipolar and monopolar energy. During use, the patient return pad can detect an accidental power crossing by monitoring power transmission to the return pad via one or more suitable sensors on the return pad. In the case of simultaneous use of the bipolar energy mode and the unipolar energy mode, an unexpected electrical crossover may occur. In at least one example, the bipolar mode uses a higher current (e.g., 2-3 amps) than the current of the unipolar mode (e.g., 1 amp). In at least one example, the return pad includes control circuitry and at least one sensor (e.g., a current sensor) coupled thereto. In use, the control circuit may receive an input indicative of an unexpected power crossing based on measurements of the at least one sensor. In response, the control circuit may employ a feedback system to issue an alarm and/or to suspend application of one or both of the bipolar energy modality and the monopolar energy modality to the tissue.
In addition to the above, jaws 1250, 1270 of end effector 1200 include an angular profile wherein a plurality of angles are defined between discrete portions of each of jaws 1250, 1270. For example, the first angle is defined by the portions 1250a, 1250b (fig. 4) and the second angle is defined by the portions 1250b, 1250c of the first jaw 1250. Similarly, the first angle is defined by portions 1270a, 1270b and the second angle is defined by portions 1270b, 1270c of second jaw 1270. In various aspects, the discrete portions of jaws 1250, 1270 are linear segments. The consecutive linear sections intersect at an angle such as a first angle or a second angle. The linear sections cooperate to form a generally angular profile of each of jaws 1250, 1270. The angular profile is generally curved away from the central axis.
In one example, the first angle and the second angle are the same or at least substantially the same. In another example, the first angle and the second angle are different. In another example, the first angle and the second angle comprise a value selected from the range of about 120 ° to about 175 °. In yet another example, the first angle and the second angle comprise a value selected from the range of about 130 ° to about 170 °.
Further, the portions 1250a, 1270a as proximal portions are larger than the portions 1250b, 1270b as intermediate portions. Similarly, the intermediate portions 1250b, 1270b are larger than the portions 1250c, 1270 c. In other examples, the distal portion may be larger than the medial and/or proximal portions. In other examples, the intermediate portion is larger than the proximal and/or distal portions.
In addition to the above, electrodes 1252, 1272, 1274 of jaws 1250, 1270 include an angular profile similar to the angular profile of jaws 1250, 1270. In the example of fig. 4, 5, the electrodes 1252, 1272, 1274 each include a discrete section 1252a, 1252b, 1252c, 1272a, 1272b, 1272c, 1274a, 1274b, 1274c that defines a first angle and a second angle at their respective intersections, as described above.
When in the closed configuration, jaws 1250, 1270 cooperate to define a tip electrode 1260 formed by electrode portions 1261, 1262 at the distal ends of jaws 1250, 1270, respectively. The tip electrode 1260 can be energized to deliver unipolar energy to tissue in contact therewith. For example, both electrode portions 1261, 1262 may be activated simultaneously to deliver monopolar energy, as shown in fig. 6, or alternatively, only one of the electrode portions 1261, 1262 may be selectively activated to deliver monopolar energy on one side of the distal tip electrode 1260, as shown in fig. 10.
In the closed configuration, the angular profile of jaws 1250, 1270 causes tip electrode 1260 to be on one side of a plane extending laterally between proximal portion 1252c and proximal portion 1272 c. The angular profile may also cause the intersection between the portions 1252b, 1252c, the portions 1272b, 1272c and the portions 1274b, 1274c to be on the same side of the plane as the tip electrode 1260.
In at least one example, jaws 1250, 1270 include conductive armatures 1253, 1273, which may be comprised of or at least partially constructed of an electrically conductive material (e.g., titanium). The armatures 1253, 1273 may be constructed of other conductive materials, such as aluminum. In at least one example, the armatures 1253, 1273 are prepared by injection molding. At each locationIn one example, the armatures 1253, 1273 are selectively coated/covered with an insulating material to prevent thermal and electrical conduction in all but predefined thin energizable regions forming the electrodes 1252, 1272, 1274, 1260. The skeletons 1253, 1273 act as electrodes with electronic focusing, with jaws 1250, 1270 having built-in isolation from one jaw to the other. The insulating material may be an insulating polymer, for example, polytetrafluoroethylene (e.g.,). The energizable zone defined by the electrodes 1252, 1272 is on the interior of the jaws 1250, 1270 and is independently operable in a bipolar mode to deliver energy to tissue grasped between the jaws 1250, 1270. At the same time, the energizable zone defined by the electrode tip 1260 and the electrode 1274 is on the exterior of the jaws 1250, 1270 and can be operated in a monopolar mode to deliver energy to tissue adjacent the outer surface of the end effector 1200. Both jaws 1250, 1270 may be energized to deliver energy in a monopolar mode.
In various aspects, coating 1264 is a high temperature polytetrafluoroethylene (e.g.,) A coating selectively applied to the conductive skeleton, thereby creating a selectively exposed metallic inner portion defining a three-dimensional Geometric Electronic Modulation (GEM) for focused dissection and coagulation. In at least one example, the coating 1264 comprises a thickness of about 0.003 inches, about 0.0035 inches, or about 0.0025 inches. In various examples, the thickness of coating 1264 may be any value selected from the group consisting of: a range of about 0.002 inches to about 0.004 inches, a range of about 0.0025 inches to about 0.0035 inches, or a range of about 0.0027 inches to about 0.0033 inches. The present disclosure contemplates other thicknesses of the coating 1263 that enable three-dimensional Geometric Electronic Modulation (GEM).
The electrodes 1252, 1272, which cooperate to transmit bipolar energy through the tissue, are biased to prevent electrical shorting. As energy flows between the biased electrodes 1252, 1272, tissue grasped therebetween is heated, creating a seal at the region between the electrodes 1252, 1272. At the same time, the areas of jaws 1250, 1270 surrounding electrodes 1252, 1272 are selectively deposited onto jaws 1250, 1270 and not onto electrodes 1252, 1272 due to insulating coating 1264 on such areas to provide a non-conductive tissue contacting surface. Thus, the electrodes 1252, 1272 are defined by the areas of the metal jaws 1250, 1270 that remain exposed after the insulating coating 1264 is applied to the jaws 1250, 1270. While jaws 1250, 1270 are generally formed of an electrically conductive material in this example, the non-conductive areas are defined by an electrically insulating coating 1264.
Fig. 6 illustrates the application of a bipolar energy pattern to tissue grasped between jaws 1250, 1270. In bipolar energy mode, RF energy flows through tissue along a path 1271 that is inclined relative to a curved plane (CL) that extends centrally and longitudinally bisects jaws 1250, 1270 such that electrodes 1252, 1272 are on opposite sides of the curved plane (CL). In other words, the tissue region that actually receives bipolar RF energy will simply be the tissue that contacts and extends between the electrodes 1252, 1257. Thus, tissue grasped by jaws 1250, 1270 will not receive RF energy over the entire transverse width of jaws 1250, 1270. Thus, this configuration may minimize thermal spreading of heat caused by the application of bipolar RF energy to the tissue. Such minimization of heat diffusion may in turn minimize potential collateral damage to tissue adjacent to the particular tissue region that the surgeon wishes to engage/seal/coagulate/cut.
In at least one example, in a closed configuration with no tissue therebetween, a lateral gap is defined between the bias electrodes 1252, 1272. In at least one example, a lateral gap is defined between the bias electrodes 1252, 1272 in the closed configuration by any distance selected from: a range of about 0.01 inches to about 0.025 inches, a range of about 0.015 inches to about 0.020 inches, or a range of about 0.016 inches to about 0.019 inches. In at least one example, the lateral gap is defined by a distance of about 0.017 inches.
In the example shown in fig. 4 and 5, the electrodes 1252, 1272, 1274 have a tapered width as each of the electrodes 1252, 1272, 1274 extends from the proximal end to the distal end. Accordingly, the proximal sections 1252a, 1272a, 1274a include a surface area that is greater than the intermediate portions 1252b, 1272b, 1274b, respectively. Also, intermediate sections 1252b, 1272b, 1274b include a surface that is larger than distal sections 1252c, 1272c, 1274 c.
The angular and narrowing profiles of jaws 1250, 1270 provide end effector 1200 with a curved finger-like or angled hook shape in the closed configuration. By orienting the end effector 1200 such that the electrode tip 1260 points downward toward the tissue, this shape allows for accurate energy delivery to a small portion of tissue using the tip electrode 1260 (fig. 10). In such an orientation, only the electrode tip 1260 is in contact with the tissue, which focuses energy delivery to the tissue.
Further, as shown in fig. 8, the electrodes 1274 extend on an outer surface on the peripheral side 1275 of the second jaw 1270, which provides it with the ability to effectively separate tissue in contact with the end effector 1200 when it is in the closed configuration. To separate tissue, the end effector 1200 is positioned at least partially on the peripheral side 1275 that includes the electrodes 1274. Activation of the monopolar energy mode by jaws 1270 causes monopolar energy to flow through electrode 1274 into tissue in contact therewith.
Fig. 9-11 illustrate an end effector 1200' for delivering bipolar energy to tissue through electrodes 1252', 1272' (fig. 9) in a bipolar energy mode of operation, monopolar energy to tissue through electrode tip 1261 in a first monopolar mode of operation, and/or monopolar energy to tissue through external electrode 1274 in a second monopolar mode of operation. The end effector 1200' is similar in many respects to the end effector 1200. Accordingly, for the sake of brevity, the various features of the end effector 1200' previously described with respect to the end effector 1200 are not repeated herein at the same level of detail.
Electrodes 1252', 1272' differ from electrodes 1252 ", 1272" in that they define stepped or non-uniform tissue contacting surfaces 1257, 1277. Electrically conductive skeletons 1253', 1273' of jaws 1250', 1270' include projections or protrusions that form the electrically conductive tissue contacting surfaces of electrodes 1252', 1272'. The coating 1264 partially wraps around the protruding or protruding portions forming the electrodes 1252', 1272', leaving only the conductive tissue contacting surfaces of the electrodes 1252', 1272' exposed. Thus, in the example shown in fig. 9, each of the tissue contact surfaces 1257, 1277 includes a step comprising an electrically conductive tissue contact surface positioned between two insulating tissue contact surfaces that gradually lower the step. In other words, each of tissue contact surfaces 1257, 1277 comprises a first partially electrically conductive tissue contact surface and a second insulative tissue contact surface that is stepped down relative to the first partially electrically conductive tissue contact surface. The method for forming the electrodes 1252', 1272' is described later in connection with fig. 12.
Further, in the closed configuration with no tissue therebetween, the biasing electrodes 1252', 1272' overlap, thereby defining a gap between the opposing insulated outer surfaces of the jaws 1250', 1270'. Thus, this configuration provides electrode surfaces that are vertically offset from each other and laterally offset from each other when jaws 1250', 1270' are closed. In one example, the gap is about 0.01 inches to about 0.025 inches. Further, although overlapping, the electrodes 1252', 1272' are separated by a lateral gap. To prevent electrical shorts, the lateral gap is less than or equal to a predetermined threshold. In one example, the predetermined threshold is selected from the range of 0.006 inches to 0.008 inches. In one example, the predetermined threshold is about 0.006 inches.
Referring again to fig. 7, 10, the tip electrode 1260 is defined by uncoated electrode portions 1261, 1262 that directly precede the circumferentially coated proximal coated portion to allow tip coagulation and cut opening creation from either or both of the jaws 1250, 1270. In certain examples, the electrode portions 1261, 1262 are covered by a spring biased or compliant insulative housing that allows the electrode portions 1261, 1262 to be exposed only when the distal end of the end effector 1200 is pressed against the tissue to be treated.
In addition, sections 1274a, 1274b, 1274c define an angular profile extending along peripheral side 1275 of jaw 1270. The sections 1274a, 1274b, 1274c are defined by uncoated linear portions on the peripheral side 1275 that protrude from the angled body of the skeleton 1273. The sections 1274a, 1274b, 1274c include outer surfaces that are flush with the outer surface of the coating 1264 defined on the peripheral side 1275. In various examples, a horizontal plane extends through the sections 1274a, 1274b, 1274 c. The angular profile of the electrode 1274 is defined in a horizontal plane such that the electrode 1274 does not extend more than 45 degrees off the centerline of curvature to prevent unintended lateral thermal damage when using the electrode 1274 to dissect or separate tissue.
Fig. 14 illustrates jaws 6270 for use with an end effector (e.g., 1200) of an electrosurgical instrument (e.g., an electrosurgical instrument 1106) to treat tissue using RF energy. Further, the jaws 6270 can be electrically coupled to a generator (e.g., generator 1100) and can be energized by the generator to deliver monopolar RF energy to tissue and/or cooperate with another jaw of the end effector to deliver bipolar RF energy to tissue. Further, jaw 6270 is similar in many respects to jaws 1250, 1270. For example, jaw 6270 includes an angular profile similar to that of jaw 1270. Additionally, jaw 6270 presents a heat mitigation improvement that may be applied to one or both of jaws 1250, 1270.
In use, the jaws of an end effector of an electrosurgical instrument are subjected to thermal loads that can interfere with the performance of its electrodes. To minimize thermal load interference without adversely affecting electrode tissue treatment capabilities, the jaws 6270 include an electrically conductive backbone 6273 having a thermally isolating portion and a thermally conductive portion integral with the thermally isolating portion. The thermally conductive portion defines a heat sink and the thermally insulating portion resists heat transfer. In certain examples, the thermally isolating portion comprises an internal gap, void, or dimple that effectively isolates the thermal mass of the outer surface of the jaw 6270 in direct contact with tissue without compromising the electrical conductivity of the jaw 6270.
In the example shown, the thermally conductive section defines a conductive outer layer 6269 that surrounds or at least partially surrounds the inner conductive core. In at least one example, the inner conductive core includes gap setting members, which can extend between opposing sides of the outer layer 6269 in the form of pillars, posts, and/or walls, with gaps, voids, or pits extending between the gap setting members.
In at least one example, the gap setting members form a honeycomb lattice 6267 to provide a directional force capability when the jaws (i.e., jaw 6270 and the other jaw of the end effector) are transitioned to a closed configuration to grasp tissue between the jaws (similar to jaws 1250, 1270 of fig. 6). The directional force can be achieved by aligning the lattice 6267 in a direction intersecting the tissue contacting surface of the jaw 6270 such that its honeycomb walls 6268 are positioned perpendicularly relative to the tissue contacting surface.
Alternatively or additionally, the conductive inner core of the jaws 6270 can include micro-air pockets that can be more evenly distributed and shaped and that do not have predefined tissue relative to the outer shape of the jaws to create a more even stress-strain distribution within the jaws. In various aspects, the electrically conductive skeleton 6273 can be prepared by three-dimensional printing and can include three-dimensionally printed internal depressions that create electrically conductive but phase-proportioned thermally isolated cores.
Still referring to fig. 14, the electrically-conductive skeleton 6273 can be connectable to an energy source (e.g., generator 1100), and includes electrodes 6262, 6272, and 6274 defined on portions of the outer layer 6273 that are selectively uncovered by the coating 1264. Thus, the selective thermal and electrical conductivity of the jaws 6270 controls/focuses energy interaction with the tissue through the electrodes 6272, 6274 while reducing thermal spreading and thermal mass. The thermally isolated portion of the conductive backbone 6273 limits the thermal load on the electrodes 6262, 6272, and 6274 during use.
Further, the outer layer 6273 defines gripping features 6277 that extend on opposite sides of the electrode 6272 and are at least partially covered by the coating 1264. Gripping features 6277 improve the ability of jaws 6270 to adhere to tissue and resist slippage of tissue relative to jaws 6270.
In the example shown, the wall 6268 extends diagonally from a first lateral side of the jaw 6270 to a second lateral side of the jaw 6270. The walls 6268 intersect at a structural node. In the example shown, the intersecting walls 6268 define pockets 6271 that are covered by an outer layer 6269 from the top and/or bottom. Various methods for making the jaws 6270 are described below.
Fig. 12, 13 illustrate methods 1280, 1281 for manufacturing jaws 1273 ", 1273"'. In various examples, one or more of jaws 1250, 1270, 1250', 1270' are manufactured according to methods 1280, 1281. Jaws 1273', 1273 "are prepared by applying coating 1264 (e.g., having thickness d) to the entire outer surface thereof. The electrode is then defined by selectively removing portions of the coating 1264 from the desired region to expose the outer surface of the skeleton 1273 ", 1273'" at such region. In at least one example, selective removal of the coating to form flush conductive and non-conductive surfaces can be performed by etching (fig. 12) or by partially cutting away (fig. 13) tapered portions of the skeleton 1273 "' and their corresponding coating portions. In the example shown in fig. 12, the electrodes 1272 ", 1274" are formed by etching. In the example shown in fig. 13, electrode 1274 "'is formed by raised narrow bands or ridges 1274d extending alongside skeleton 1273"'. The ridges 1274D and a portion of the coating 1264 directly overlying the ridges 1274D are cut away, thereby creating an outer surface of the electrode 1274' "that is flush with the outer surface of the coating 1264.
Thus, jaw 1270 "'manufactured by method 1281 includes a tapered electrode 1274"' that is comprised of a narrow raised electrically conductive portion 1274e extending alongside the skeleton 1273 "', which can help focus energy delivered from the skeleton 1273"' to the tissue, wherein portion 1274e has an electrically conductive outer surface that is flush with the coating 1264.
In another manufacturing process 6200, jaws 6270 can be prepared as depicted in fig. 15. Electrically conductive backbone 6273 is formed with narrow raised strips or ridges 6274e, 6274f that define electrodes 6272 and 6274. In the example shown, the backbone 6273 of the jaw 6270 includes ridges 6274e, 6274f having a flat, or at least substantially flat, outer surface that are configured to define electrodes 6272, 6274. In at least one example, the skeleton 6273 is prepared by 3D printing. Masks 6265, 6266 are applied to the ridges 6274e, 6274f, and a coating 1264 similar to coating 1264 is applied to the backbone 6273. After coating, the masks 6265, 6266 are removed, exposing the outer surfaces of the electrodes 6272, 6274 that are flush with the outer surface of the coating 1264.
Referring to fig. 14 and 15, in various examples, the outer layer 6269 includes laterally extending gripping features 6277 on one or both sides of each of the electrodes 6272. The gripping features 6277 are covered by a coating 1264. In one example, the coating 1264 defines compressible features that cause the gap between the jaws of the end effector to vary as a function of the clamping load applied to the end effector 1200. In at least one example, the coating 1264 on the jaws produces an insulator overlap of at least 0.010"-0.020" along a centerline of the jaws. The coating 1264 can be applied directly on the gripping features 6277 and/or the clip-induced jaw realignment features.
In various aspects, coating 1264 can comprise a coating material, such as titanium nitride, diamond-like carbon coating (DLC), chromium nitride, graphitic TM And the like. In at least one example, DLC consists of an amorphous carbon-hydrogen network with diamond bonds between graphite and carbon atoms. DLC coating 1264 may form a film around backbone 1253, 1273 with low friction and high hardness characteristics (fig. 6). DLC coating 1264 may be doped or undoped and is typically in the form of amorphous carbon (a-C) or hydrogenated amorphous carbon (a-C: H) containing a majority of sp3 bonds. Various surface coating techniques may be used to form the DLC coating 1264, such as those developed by Oerlikon Balzers. In at least one example, DLC coating 1264 is generated using Plasma Assisted Chemical Vapor Deposition (PACVD).
Still referring to fig. 15, in use, electrical energy flows from the electrically-conductive skeleton 6269 through the electrodes 6272 and into the tissue. The coating 1264 prevents electrical energy from being transferred to the tissue from other areas of the outer layer 6269 covered by the coating 1264. As the temperature of the surface of the electrode 6272 increases during tissue treatment, the transfer of thermal energy from the outer layer 6269 to the inner core of the armature 6273 is slowed or reduced due to the gaps, voids, or pockets defined by the walls 6268 of the inner core.
Fig. 16 illustrates a backbone 6290 manufactured for use with jaws of an end effector of an electrosurgical instrument. One or more of frames 1253, 1273, 1253', 1273 "' may comprise a material composition and/or may be manufactured in a similar manner as frame 6290. In the example shown, backbone 6290 is comprised of at least two materials: an electrically conductive material, such as titanium, and a thermally insulating material, such as a ceramic material (e.g., a ceramic oxide). The combination of titanium and ceramic oxide produces a jaw member having composite thermal, mechanical and electrical properties.
In the example shown, composite skeleton 6290 includes a ceramic base 6291 formed, for example, by three-dimensional printing. In addition, composite skeleton 6290 includes a titanium crown 6292 prepared separately from a ceramic base 6291 using, for example, three-dimensional printing. The base portion 6291 and the crown portion 6292 include complementary attachment features 6294. In the example shown, the base 6291 includes posts or protrusions that are received in corresponding holes in the crown 6292. Attachment features 6294 also control retraction. Additionally or alternatively, the contact surfaces of the base portion 6291 and the crown portion 6292 include complementary surface irregularities 6296 specifically designed for mating engagement with each other. Surface irregularities 6296 also resist shrinkage caused by the different material compositions of base 6291 and crown 6292. In various examples, the composite skeleton 6290 is selectively coated with an insulating coating 1264, resulting in exposed portions of the crowns 6292 that define the electrodes, e.g., as described above in connection with the jaws 1250, 1270.
Fig. 17 and 18 illustrate a manufacturing process for manufacturing a backbone 6296 for use with jaws of an end effector of an electrosurgical instrument. One or more of skeletons 1253, 1273, 1253', 1273 "' may comprise a material composition and/or may be manufactured in a similar manner as skeleton 6295. In the example shown, composite skeleton 6295 is produced by injection molding with ceramic 6297 and titanium 6298 powders. The powders are fused together (fig. 18) to form a titanium-ceramic composite 6299 (fig. 19). In at least one example, polytetrafluoroethylene (e.g.,) Coatings may be selectively applied to metal regions of composite skeleton 6295 for thermal isolation and electrical insulation.
Fig. 20-22 illustrate jaws 1290 for use with an end effector (e.g., 1200) of an electrosurgical instrument (e.g., electrosurgical instrument 1106) to treat tissue using RF energy. Further, the jaws 6270 can be electrically coupled to a generator (e.g., generator 1100) and can be energized by the generator to deliver bipolar RF energy to tissue and/or cooperate with another jaw of the end effector to deliver bipolar RF energy to tissue. Further, jaw 1290 is similar in many respects to jaws 1250, 1270. For example, jaw 1290 includes an angular profile similar to the angular or curved profile of jaw 1270.
Additionally, jaw 1290 is similar to jaw 6270 in that jaw 1290 also exhibits thermal mitigation improvements. Like the jaws 6270, the jaws 1290 include a conductive backbone 1293 having a thermally isolated portion and a thermally conductive portion integral with or attached to the thermally isolated portion. The thermally conductive portion defines a heat sink and the thermally insulating portion resists heat transfer. In certain examples, a thermally isolated portion of the conductive skeleton 1293 comprises a conductive core 1297 having an internal gap, void, or pocket effective to isolate the thermal mass of the jaw 1290 defining the outer surface of the electrode 1294 in direct contact with tissue without compromising the electrical conductivity of the jaw 1290. The thermally conductive section defines a conductive outer layer 1303 that surrounds or at least partially surrounds a conductive inner core 1297. In at least one example, the conductive inner core 1297 includes gap setting members 1299, which can extend between opposing sides of the outer layer 1303 of the jaws 1290 in the form of struts, pillars, and/or walls, wherein gaps, voids, or pits extend between the gap setting members.
Alternatively or additionally, the conductive core 1297 can include micro-pits of air distributed in the conductive core 1297 that can be uniformly or non-uniformly distributed. The dimples may comprise predefined or random shapes and may be dispersed at predetermined or random portions of the conductive core 1297. In at least one example, the dimples are dispersed in a manner that produces a more uniform stress-strain distribution within the jaw 1290. In various aspects, the scaffold 1293 can be prepared by three-dimensional printing and can include three-dimensionally printed internal pockets that produce an electrically conductive but commensurately thermally isolated core.
Thus, the jaws 1290 include selective thermal and electrical conductivities that control/focus the energy interaction with the tissue while reducing thermal spread and thermal mass. The thermally isolated portion of the conductive backbone 1293 limits the thermal load on the electrodes of the jaw 1290 during use.
Fig. 22 shows an expanded portion of tissue contacting surface 1291 of jaw 1290. In various aspects, the outer layer 1303 of the skeleton 1293 is selectively coated/covered by a first insulating layer 1264 comprising a first material (e.g., DLC). In the example shown, the DLC coating renders the tissue contacting surface 1291 electrically insulating, except for an intermediate region extending along the length of the tissue contacting surface 1291, which defines an electrode 1294. In at least one example, the DLC coating extends around the backbone 1293, covering the jaw 1290 up to a perimeter defined on opposing sides 1294', 1294 "of the electrode 1294. Conductive regions 1294a, 1294b, 1294c remain exposed and alternate with insulating regions 1298 along the length of electrode 1294. In various aspects, the insulating region 1298 comprises a material comprising high temperature polytetrafluoroethylene (e.g.,). Since the DLC coating is thermally conductive, only the portion of tissue contacting surface 1291 that includes insulating region 1298 is thermally isolated. The portion of the tissue contacting surface 1291 covered with the DLC coating and the thin electrically conductive energizable regions 1294a, 1294b, 1294c is thermally conductive. In addition, only the thin electrically conductive energizable regions 1294a, 1294b, 1294c are electrically conductive. With DLC coatings or polytetrafluoroethylene (e.g. Teflon)) The remainder of the covered tissue contacting surface 1291 is electrically insulating.
Referring to fig. 22, the jaw 1290 includes an angular profile wherein a plurality of angles are defined between discrete portions 1290a, 1290b, 1290c, 1290d of the jaw 1290. For example, a first angle (α 1) is defined by the portions 1290a, 1290b, a second angle (α 2) is defined by the portions 1290b, 1290c, and a third angle (α 3) is defined by the portions 1290c, 1290d of the first jaw 1250. In other examples, at least a portion of the jaws 1290 include a smoothly curved profile without angles. In various aspects, the discrete portions 1290a, 1290b, 1290c, 1290d of the jaw 1290 are linear segments. The continuous linear sections intersect at an angle, such as a first angle (α 1) or a second angle (α 2) and a third angle (α 3). The linear segments cooperate to form a generally curved profile of each of the jaws 1290.
In one example, the angles (α 1, α 2, α 3) comprise the same or at least substantially the same values. In another example, at least two of the angles (α 1, α 2, α 3) comprise different values. In another example, at least one of the angles (α 1, α 2, α 3) includes a value selected from the range of about 120 ° to about 175 °. In yet another example, at least one of the angles (α 1, α 2, α 3) includes a value selected from the range of about 130 ° to about 170 °.
Further, due to the tapered profile of the jaws 1290, the portion 1290a as a proximal portion is larger than the portion 1290b as a medial portion. Similarly, the intermediate portion 1290b is larger than the portion 1290d defining the distal portion of the jaw 1290. In other examples, the distal portion may be larger than the medial and/or proximal portions. In other examples, the intermediate portion is larger than the proximal and/or distal portions. Further, electrodes 1294 of jaw 1290 include an angular profile similar to that of jaw 1290.
Referring to fig. 23, in certain aspects, the jaw 1300 includes a solid conductive skeleton 1301 partially surrounded by a DLC coating 1264. The exposed regions of the skeleton 1301 define one or more electrodes 1302. This arrangement creates a thermally and electrically conductive portion of the jaw 1300 in which thermal energy is indiscriminately delivered, but electrical energy is delivered only through the one or more electrodes 1302.
Referring now to fig. 24-26, an electrosurgical instrument 1500 includes an end effector 1400 configured to deliver monopolar and/or bipolar energy to tissue grasped by the end effector 1400, as described in greater detail below. The end effector 1400 is similar in many respects to the end effector 1200. For example, the end effector 1400 includes a first jaw 1450 and a second jaw 1470. At least one of the first jaw 1450 and the second jaw 1470 can be moved relative to the other jaw to transition the end effector 1400 from the open configuration to the closed configuration to grasp tissue between the first jaw and the second jaw. Monopolar and bipolar energy may then be used to seal and/or cut the grasped tissue. As described in more detail below, the end effector 1400 utilizes the GEM to adjust the energy density at the tissue treatment interface of the jaws 1450, 1470 to achieve the desired tissue treatment.
As with jaws 1250, 1270, jaws 1450, 1470 include a generally angular profile formed from linear portions that are angled with respect to each other, thereby creating a curved or finger-like shape, as shown in fig. 26. Further, jaws 1450, 1470 include conductive armatures 1452, 1472 having a narrowing horn extending distally along the angular profile of jaws 1450, 1470. The conductive armatures 1452, 1472 may be constructed of an electrically conductive material (e.g., titanium). In certain aspects, each of the conductive armatures 1453, 1473 includes a thermally isolated portion and a thermally conductive portion integral with the thermally isolated portion. The thermally conductive portion defines a heat sink and the thermally insulating portion resists heat transfer. In certain examples, the thermally isolated portions of the scaffold 1453, 1473 define an inner core that includes an internal gap, void, or dimple that effectively isolates the thermal mass of the outer surface of the jaws 1452, 1472 that is in direct contact with tissue without compromising the electrical conductivity of the jaws 1450, 1470.
The thermally conductive section includes a conductive outer layer 1469, 1469' surrounding or at least partially surrounding the inner conductive core. In at least one example, the inner conductive core includes gap setting members that may extend in the form of posts, and/or walls between opposing sides of the outer layer 1469, 1469' of each of the jaws 1250, 1270, wherein gaps, voids, or dimples extend between the gap setting members. In at least one example, the gap setting members form a honeycomb lattice structure 1467, 1467'.
In addition to the above, the conductive backbone 1453, 1473 includes a first electrically conductive portion 1453a, 1473a that extends distally along the angular profile of the jaw 1450, 1470, and a second electrically conductive portion 1453b, 1473b of a tapered electrode that protrudes from the first electrically conductive portion 1453a, 1473a and extends distally along at least a portion of the tapered body of the backbone 1453, 1473. In at least one example, the first conductive portion 1453a, 1473a is thicker than the second conductive portion 1453b, 1473b in a transverse cross-section (e.g., fig. 25) of the tapered body of the armature 1453, 1473. In at least one example, the second electrically conductive portion 1453b, 1473b is integral with or permanently attached to the first electrically conductive portion 1453a, 1473a such that electrical energy flows from the first electrically conductive portion 1453a, 1473a to tissue only through the second electrically conductive portion 1453b, 1473 b. The electrically insulating layer 1464, 1464' is configured to electrically insulate the first electrically conductive portion 1453a, 1473a completely, while not electrically insulating the second electrically conductive portion 1453b, 1473 b. At least the outer surface of the second conductive portion 1453b, 1473b defining the electrode 1452, 1472 is not covered by the electrically insulating layer 1464, 1464'. In the example shown, the electrodes 1452, 1472 and electrically insulating layers 1464, 1464' define a flush tissue treatment surface.
As described above, the first conductive portions 1453a, 1473a are substantially thicker than the second conductive portions 1453b, 1473b and are wrapped with an electrically insulating layer 1464, 1464', which causes the second conductive portions 1453b, 1473b to become high energy density regions. In at least one example, electricityThe insulating layers 1464, 1464' are formed from high temperature polytetrafluoroethylene (e.g.,) The coating, DLC coating and/or ceramic coating is configured for insulation and resistance to coke adhesion. In various examples, the thicker first electrically conductive portion 1453a conducts more potential power with less resistance to the tissue contacting second electrically conductive portion 1453b, resulting in a higher energy density at the electrode 1452.
In various aspects, the outer surface of the electrodes 1452, 1472 comprises a continuous linear segment that extends along the angled tissue treatment surface of the jaws 1450, 1470. The linear segments intersect at a predefined angle and have a width that gradually narrows as the linear segments extend distally. In the example shown in fig. 24, electrode 1452 includes segments 1452a, 1452b, 1452c, 1452d, and electrode 1472 includes segments 1472a, 1472b, 1472c, 1472 d. The electrode 1452 of jaw 1450 is illustrated by dashed lines on jaw 1470 of fig. 24 to illustrate the lateral position of the electrode 1452 relative to the electrode 1452 in the closed configuration of the end effector 1400. The electrodes 1452, 1472 are laterally offset from one another in the closed configuration. In the bipolar energy mode, electrical energy supplied by a generator (e.g., generator 1100) flows from the first conductive portion 1453a to the electrode 1452 of the second conductive portion 1453b and from the electrode 1452 to tissue grasped between the jaws 1450, 1470. Bipolar energy then flows from the tissue to the electrode 1472 of the second electrically conductive portion 1473b and from the electrode 1472 to the first electrically conductive portion 1473 a.
In various aspects, as shown in fig. 24, 25, the second jaw 1470 also includes an electrode 1474 spaced apart from the backbone 1473. In at least one example, the electrode 1474 is a monopolar electrode configured to deliver monopolar energy to tissue grasped between the jaws 1450, 1470 in a closed configuration. The return pad may be placed under the patient, for example, to receive monopolar energy from the patient. As with the electrode 1472, the electrode 1474 includes continuous linear segments 1474a, 1474b, 1474c, 1474d that extend distally along an angular profile defined by the second jaw 1470 from the electrode proximal end to the electrode distal end. In addition, the electrode 1474 is laterally offset from the electrodes 1472, 1452.
The electrode 1474 includes a base 1474e in the carriage 1480 that extends distally along the angular profile of the second jaw 1470 from the carriage proximal end 1480a to the carriage distal end 1480 b. The brackets 1480 are centered relative to the lateral edges 1470e, 1470f of the second jaw 1470. The electrode 1474 also includes a tapered edge 1474f that extends from the base 1474e beyond the side wall of the bracket 1480. In addition, the bracket 1480 is partially embedded in a valley defined on the outer tissue treatment surface of the narrowed curved body. Bracket 1480 is spaced from the tapered body of backbone 1473 by an electrically insulative coating 1464'. As shown in fig. 24, the base 1480 has a width that gradually narrows as the base extends along an angular profile from the base proximal end 1480a to the base distal end 1480 b.
In various examples, the bracket 1480 is constructed of a compliant substrate. In the uncompressed state, as shown in fig. 25, the side walls of the carriage 1480 extend beyond the tissue treatment surface of the jaws 1472. As tissue is compressed between jaws 1450, 1470, the compressed tissue applies a biasing force against the side walls of carriage 1480, further exposing tapered edges 1474f of electrodes 1474.
One or more of the jaws described in the present disclosure include a stop member or gap setting member that is a feature that extends outwardly from one or both of the tissue treatment surfaces of the jaws of the end effector. The stop member helps to maintain a separation or predetermined gap between the jaws in the closed configuration, wherein there is no tissue between the jaws. In at least one example, the side walls of the bracket 1480 define such stop members. In another example, the stop member may be in the form of an insulating post or laterally extending spring biased feature that allows the gap between opposing jaws and the closed configuration to vary based on the clamping load.
Most electrosurgical generators use a constant power mode. In constant power mode, the power output remains constant because the impedance increases. In constant power mode, the voltage increases as the impedance increases. The increased voltage results in thermal damage to the tissue. The energy output of the GEM focusing jaws 1250, 1270, for example, by controlling the size and shape of the electrodes 1252, 1272, 1274, 1260, 1294, 1472, 1452, 1474, as described above, and modulating the power level based on tissue impedance to generate a low pressure plasma.
In some cases, the GEM maintains a constant minimum voltage required to cut at the surgical site. The generator (e.g., 1100) regulates the power in order to maintain the voltage as close as possible to the minimum voltage required for cutting at the surgical site. To achieve arc plasma and cutting, current is pushed by voltage from the narrowing portions of the electrodes 1252, 1272, 1274, 1260, 1294, 1472, 1452, 1474 to the tissue. In some examples, a minimum voltage of about 200 volts is maintained. Cutting with greater than 200 volts increases thermal damage, and cutting with less than 200 volts results in minimal arcing and resistance in the tissue. Thus, the generator (e.g., 1100) regulates power to ensure that the minimum voltage is utilized that arc plasma and cuts may still be formed.
Referring primarily to fig. 26, a surgical instrument 1500 includes an end effector 1400. The surgical instrument 1500 is similar in many respects to other surgical instruments described in U.S. patent application attorney docket number END9234USNP 2/190717-2. Various actuation and articulation mechanisms described elsewhere in connection with such surgical instruments may similarly be used to articulate and/or actuate the surgical instrument 1500. For the sake of brevity, this mechanism is not repeated here.
The end effector 1400 includes an end effector frame assembly 11210 that includes a distal frame member 11220 rotatably supported in a proximal frame housing 11230. In the example shown, the distal frame member 11220 is rotatably attached to the proximal frame housing 11230 by an annular rib on the distal frame member 11220 that is received within an annular groove in the proximal frame housing 11230.
Electrical energy is transmitted to the electrodes 1452, 1472, 1474 of the end effector 1400 by one or more flexible circuits extending distally through or alongside the distal frame member 11220. In the example shown, the flexible circuit 1490 is fixedly attached to the first jaw 1450. More specifically, the flexible circuit 1490 includes a distal portion 1492 that is fixably attached to an exposed portion 1491 of the first jaw 1450 that is not covered by the insulation layer 1464.
In the example shown in fig. 26, the slip ring 1550a is configured to transmit bipolar energy to the electrode 1452 of the jaw 1450. Slip ring 1550b cooperates with similar electrical contacts and electrodes 1472 to define a return path for bipolar energy. In addition, slip ring 1550c cooperates with similar electrical contacts and electrode 1474 to provide a pathway for monopolar electrical energy to enter tissue. Bipolar and unipolar electrical energy may be delivered to the slip rings 1550a, 1550b by one or more electrical generators (e.g., generator 1100). Bipolar and monopolar electrical energy may be delivered simultaneously or separately, as described in more detail elsewhere herein.
In various examples, the slip rings 1550a, 1550b, 1550c are integrated electrical slip rings having mechanical features 1556a, 1556b, 1556c configured to enable coupling of the slip rings 1550a, 1550b, 1550c to an insulating support structure 1557, or a conductive support structure coated with an insulating material, as shown in fig. 26. Further, the slip rings 1550a, 1550b, 1550c are spaced apart enough to ensure that if the conductive fluid fills the space between the slip rings 1550a, 1550b, 1550c, no electrical short circuit will occur. In at least one example, the core flat stamped metal shaft member includes a three-dimensionally printed or overmolded non-conductive portion for supporting the slip ring assembly 1550.
Fig. 27 illustrates a portion of an electrosurgical instrument 12000 that includes a surgical end effector 12200 that can be coupled to a proximal shaft section by an articulation joint in various suitable manners. In certain instances, the surgical end effector 12200 includes an end effector frame assembly 12210 that includes a distal frame member 12220 rotatably supported in a proximal frame housing attached to an articulation joint.
The surgical end effector 12200 includes a first jaw 12250 and a second jaw 12270. In the example shown, the first jaw 12250 is pivotally secured to the distal frame member 12220 for selective pivotal travel relative thereto about a first jaw axis FJA defined by a first jaw pin 12221. The second jaw 12270 is pivotally secured to the first jaw 12250 for selective pivotal travel relative to the first jaw 12250 about a second jaw axis SJA defined by the second jaw pin 12272. In the example shown, the surgical end effector 12200 employs an actuator yoke assembly 12610 that is pivotally coupled to the second jaw 12270 by a second jaw attachment pin 12273 for pivotal travel about a jaw actuation axis JAA that is proximal to and parallel to the first jaw axis FJA and the second jaw axis SJA. The actuator yoke assembly 12610 includes a proximal threaded drive shaft 12614 that is threadedly received in a threaded bore 12632 in the distal lock plate 12630. A threaded drive shaft 12614 is mounted to the actuator yoke assembly 12610 for relative rotation therebetween. A distal lock plate 12630 is supported for rotational travel within the distal frame member 12220. Thus, rotation of distal lock plate 12630 will result in axial travel of actuator yoke assembly 12610.
In some cases, distal lock plate 12630 comprises a portion of end effector lock system 12225. End effector lock system 12225 also includes a double acting rotary lock head 12640 attached to a rotary drive shaft 12602 of the various types disclosed herein. The locking head 12640 includes a first plurality of radially disposed distal locking features 12642 that are adapted to lockingly engage a plurality of proximally facing radial grooves or recesses 12634 formed in the distal locking plate 12630. When the distal locking features 12642 are in locking engagement with the radial grooves 12634 in the distal lock plate 12630, rotation of the rotary lock head 12640 will cause the distal lock plate 12630 to rotate within the distal frame member 12220. Also in at least one example, the rotational locking head 12640 further comprises a second series of proximally facing proximal locking features 12644 adapted to lockingly engage a corresponding series of locking recesses provided in the distal frame member 12220. Locking spring 12646 is used to bias the rotational locking head distally into locking engagement with distal locking plate 12630. In various instances, the rotational locking head 12640 may be pulled proximally by an unlocking cable or other member in the manner described herein. In another arrangement, the rotary drive shaft 12602 may be configured to also move axially to move the rotary locking head 12640 axially within the distal frame member 12220. When the proximal locking feature 12644 in the rotary locking head 12640 is in locking engagement with the series of locking recesses in the distal frame member 12220, rotation of the rotary drive shaft 12602 will cause the surgical end effector 12200 to rotate about the shaft axis SA.
In some instances, the first jaw 12250 and the second jaw 12270 are opened and closed as follows. To open and close the jaws, the rotational lock head 12640 is in locking engagement with the distal lock plate 12630, as discussed in detail above. Thereafter, rotation of the rotary drive shaft 12602 in the first direction will rotate the distal lock plate 12630, which will axially drive the actuator yoke assembly 12610 in the distal direction DD and move the first and second jaws 12250, 12270 toward the open position. Rotation of the rotary drive shaft 12602 in a second, opposite direction will drive the actuator yoke assembly 12610 axially proximally and draw the jaws 12250, 12270 toward the closed position. To rotate the surgical end effector 12200 about the axis SA, the locking cable or member is pulled proximally to cause the rotational lock head 12640 to disengage the distal lock plate 12630 and engage the distal frame member 12220. Thereafter, when the rotary drive shaft 12602 is rotated in the desired direction, the distal frame member 12220 (and the surgical end effector 12200) will rotate about the shaft axis SA.
FIG. 27 further illustrates an electrical connection assembly 5000 for electrically coupling the jaws 12250, 12270 to one or more power sources, such as generators 3106, 3107 (FIG. 36). The electrical connection assembly 5000 defines two separate electrical pathways 5001, 5002 that extend through the electrosurgical instrument 12000, as shown in fig. 27. In a first configuration, the electrical pathways 5001, 5002 cooperate to deliver bipolar energy to the end effector 12200, with one of the electrical pathways 5001, 5002 acting as a return pathway. Further, in the second configuration, the electrical pathways 5001, 5002 deliver monopolar energy 12200 separately and/or simultaneously. Thus, in the second configuration, both of the electrical pathways 5001, 5002 may function as supply pathways. In addition, the electrical connection assembly 5000 may be used with other surgical instruments (e.g., surgical instrument 1500) described elsewhere herein to electrically couple such surgical instruments with one or more power sources (e.g., generators 3106, 3107).
In the example shown, the electrical pathways 5001, 5002 are implemented using a flexible circuit 5004 that extends at least partially through the coiled tubing 5005. As shown in fig. 30, the flexible circuit 5004 includes two separate conductive trace elements 5006, 5007 embedded in a PCB (printed circuit board) substrate 5009. In certain instances, the flexible circuit 5004 may be attached to a core flat stamped metal shaft member with a 3D printed or overmolded plastic housing to provide all-axis filling/support.
In an alternative example, as shown in fig. 32, the flexible circuit 5004' extending through the coil form 5005' may include conductive trace elements 5006', 5007' that are twisted in a helical profile in the PCB substrate 5009' that results in a reduction in the overall size of the flexible circuit 5004' and, in turn, a reduction in the inner/outer diameter of the coil form 5005 '. Fig. 31 and 32 illustrate other examples of flexible circuits 5004 ", 5004 '" that extend through the coil tubes 5005', 5005 "and include conductive trace elements 5006", 5007 "and 5006 '", 5007' ", respectively, that include alternative profiles for size reduction. For example, the flexible circuit 5004 '"includes a folded profile, while the flexible circuit 5004' includes trace elements 5006", 5007 "on opposite sides of the PCB 5009".
In addition to the above, vias 5001, 5002 are defined by trace portions 5006a-5006g, 5007a-5007g, respectively. The trace portions 5006b, 5006c and trace portions 5007b, 5007c are in the form of rings that define a ring assembly 5010 that maintains an electrical connection through the passageways 5001, 5002 while allowing the end effector 12200 to rotate relative to the shaft of the surgical instrument 12000. Further, trace portions 5006e, 5007e are disposed on opposite sides of the actuator yoke assembly 12610. In the example shown, the portions 5006e, 5007e are disposed about an aperture configured to receive the second jaw attachment pin 12273, as shown in fig. 27. The trace portions 5006e, 5007e are configured to be in electrical contact with corresponding portions 5006f, 5007f disposed on the second jaw 12270. Further, when the first jaw 12250 is assembled with the second jaw 12270, the trace portions 5007f, 5007g become electrically connected.
Referring to fig. 29, the flexible circuit 5014 includes spring biased trace elements 5016, 5017. The trace elements 5016, 5017 are configured to be able to apply a biasing force against the corresponding trace elements to ensure that an electrical connection therewith is maintained, particularly when the corresponding trace portions are moved relative to each other. One or more of the trace portions of the vias 5001, 5002 can be modified to include spring biased trace elements in accordance with the flexible circuit 5014.
Referring to fig. 34, a graph 3000 illustrates a power scheme 3005' of a tissue treatment cycle 3001 applied by the end effector 1400, or any other suitable end effector of the present disclosure, to tissue grasped by the end effector 1400. The tissue treatment cycle 3001 includes a tissue coagulation phase 3006, the tissue coagulation phase 3006 including an eclosion section 3008, a tissue warming section 3009, and a sealing section 3010. The tissue treatment cycle 3001 further includes a tissue transection or cutting phase 3007.
Fig. 36 illustrates an electrosurgical system 3100 including a control circuit 3101 configured to execute a power scheme 3005'. In the example shown, the control circuit 3101 includes a storage medium in the form of a memory 3103 and a controller 3104 of a processor 3102. The storage medium stores program instructions for executing the power scheme 3005'. In accordance with the power scheme 3005', the electrosurgical system 3100 includes a generator 3106 configured to supply monopolar energy to the end effector 1400, and a generator 3107 configured to supply bipolar energy to the end effector 1400. In the example shown, the control circuit 3101 is depicted separately from the surgical instrument 1500 and the generators 3106, 3107. However, in other examples, the control circuit 3101 may be integrated with the surgical instrument 1500, the generator 3106, or the generator 3107. In various aspects, the power schemes 3005' may be stored in the memory 3103 in the form of algorithms, equations, and/or look-up tables, or any other suitable format. The control circuitry 3101 may cause the generators 3106, 3107 to supply monopolar and/or bipolar energy to the end effector 1400 according to the power scheme 3005'.
In the example shown, the electrosurgical system 3100 also includes a feedback system 3109 in communication with the control circuit 3101. For example, the feedback system 3109 may be a stand-alone system or may be integrated with the surgical instrument 1500. In various aspects, the control circuit 3101 may employ a feedback system 3109 to perform a predetermined function, e.g., sounding an alarm when one or more predetermined conditions are met. In some cases, feedback system 3109 may include, for example, one or more visual feedback systems, such as a display screen, a backlight, and/or LEDs. In some cases, feedback system 3109 may include, for example, one or more audio feedback systems, such as a speaker and/or buzzer. In some cases, feedback system 3109 may include, for example, one or more haptic feedback systems. In some cases, feedback system 3109 may include a combination of visual, audio, and/or tactile feedback systems, for example. In addition, the electrosurgical system 3100 also includes a user interface 3110 in communication with the control circuit 3101. For example, the user interface 3110 may be a stand-alone interface or may be integrated with the surgical instrument 1500.
In various aspects, the control circuitry 3101 may receive user input from the user interface 3110. User input actuation controlAt time t, circuit 3101 1 Initiates execution of the power scheme 3005'. Alternatively, initialization of execution of the power scheme 3005' may be automatically triggered by a sensor signal from one or more sensors 3111 in communication with the control circuitry 3101. For example, the power scheme 3005' may be automatically triggered by the control circuit 3101 in response to a sensor signal indicative of a predetermined gap between the jaws 1450, 1470 of the end effector 1400.
During the eclosion segment 3008, the control circuit 3101 causes the generator 3107 to gradually increase the bipolar energy power supplied to the end effector 1400 to reach a predetermined power value P1 (e.g., 100W) and maintain the bipolar energy power at or substantially at the predetermined power value P1 throughout the remainder of the eclosion segment 3008 and the tissue warming segment 3009. The predetermined power value P1 may be stored in memory 3103 and/or may be provided by a user through user interface 3110. During the sealing section 3010, the control circuit 3101 causes the generator 3107 to gradually reduce the bipolar energy power. Bipolar energy application ends at the end of the seal section 3010 of the tissue coagulation phase 3006 and before the start of the cutting/transecting phase 3007.
In addition to the above, e.g. at t 2 The control circuit 3101 causes the generator 3107 to begin supplying monopolar energy power to the electrode 1474 of the end effector 1400. Monopolar energy application to the tissue begins at the end of the eclosion section 3008 and the beginning of the tissue warming section 3009. The control circuit 3101 causes the generator 3107 to gradually increase the monopolar energy power to reach a predetermined power level P2 (e.g., 75W), and maintain, or at least substantially maintain, the predetermined power level P2 within the remaining portion of the tissue warming section 3009 and the first portion of the sealing section 3010. The predetermined power level P2 may also be stored in memory 3103 and/or may be provided by a user through a user interface 3110.
During the seal section 3010 of the tissue coagulation stage 3006, the control circuitry 3101 causes the generator 3107 to gradually increase the monopolar energy power supplied to the end effector 1400. The beginning of the tissue transection phase 3007 is driven by an inflection point in the monopolar energy profile 3030, wherein the previous gradual increase in monopolar energy experienced during the sealing section 3010 is followed by a gradual rise to a predetermined maximum threshold power level P3 (e.g., 150W) sufficient to transect the coagulated tissue.
At t 4 At this point, the control circuit 3101 causes the generator 3107 to step up the monopolar energy power supplied to the end effector 1400 to a predetermined maximum threshold power level P3 and for a predetermined period of time (t) 4 -t 5 ) Or the predetermined maximum threshold power level P3 is maintained, or at least substantially maintained, until the end of the tissue transection phase 3007. In the example shown, the unipolar energy power is terminated by control circuit 3101 at t 5. The transection of the tissue mechanically continues because jaws 1450, 1470 continue to apply pressure to the grasped tissue until at t 6 The tissue transection phase 3007 is completed. Alternatively, in other examples, the control circuit 3101 may cause the generator 3107 to continue to supply monopolar energy capability to the end effector 1400 until the end of the tissue transection phase 3007.
The control circuitry 3101 may employ sensor readings of the sensor 3111 and/or a timer clock of the processor 3102 to determine when to cause the generator 3107 and/or the generator 3106 to begin, increase, decrease, and/or terminate energy supply to the end effector 1400 according to a power scheme (e.g., power scheme 3005'). For example, control circuit 3101 may be implemented by clocking one or more timers from one or more predetermined time periods (e.g., t) 1 -t 2 、t 2 -t 3 、t 3 -t 4 、t 5 -t 6 ) Count down to execute the power scheme 3005', these predetermined time periods may be stored in memory 3103. Although the power scheme 3005' is time-based, the control circuitry 3101 may adjust the predetermined time period of any of the individual segments 3008, 3009, 3010 and/or phases 3006, 3007 based on sensor readings received from one or more of the sensors 3111 (e.g., tissue impedance sensors).
The end effector 1400 is configured to deliver three different energy modalities to the grasped tissue. The first energy modality applied to the tissue during the eclosion section 3008 includes bipolar energy but not unipolar energy. The second energy modality is a hybrid energy modality comprising a combination of monopolar and bipolar energy, and is applied to tissue during the tissue warming phase 3009 and the tissue sealing phase 3010. Finally, the third energy modality includes monopolar energy but no bipolar energy and is applied to the tissue during the cutting phase 3007. In various aspects, the second energy modality includes a power level that is the sum 3040 of the power levels of the monopolar energy and the bipolar energy. In at least one example, the power level of the second energy modality includes a maximum threshold Ps (e.g., 120W).
In various aspects, the control circuit 3101 causes monopolar and bipolar energy to be delivered to the end effector 1400 from two different generators 3106, 3107. In at least one example, energy from one of the generators 3106, 3107 may be detected using a return path of the other generator, or with an attached electrode of the other generator shorted to an unintended tissue interaction. Thus, parasitic loss of energy through an unintended return path can be detected by a generator connected to the return path. Unintentional conductive paths may be mitigated by implementing voltages, powers, waveforms, or timing between uses.
An integrated sensor within the flex circuit of the surgical instrument 1500 may detect energization/shorting of the electrode/conductive path when no electrical potential should be present and prevent the ability of the conductive path once inadvertent use is sensed. Furthermore, directional electronic gating elements that prevent cross-talk from one generator down to the source of another generator may also be utilized.
One or more of the electrodes described in this disclosure (e.g., the electrodes 1452, 1472, 1474 connected to the jaws 1450, 1470) may include a segmented pattern having segments that connect together when the electrodes are energized by a generator (e.g., generator 1100). However, when the electrodes are not energized, the segments are separated to prevent the circuit from shorting across the electrodes to other areas of the jaws.
In various aspects, a heat resistive electrode material is used with the end effector 1400. The material may be configured to inhibit current flow through the electrode at or above a predetermined temperature level, but to continue to allow energization of other portions of the electrode below a temperature threshold.
Fig. 37 shows a table representing an alternative power scheme 3005 ", which may be stored in memory 3103 and executed by processor 3102 in a similar manner as power scheme 3005'. In executing the power scheme 3005 ", the control circuit 3101 relies on the jaw aperture in addition to, or instead of, the time to set the power values of the generators 3106, 3107. Thus, the power scheme 3005 "is a jaw-hole based power scheme.
In the example shown, jaw hole d from power scheme 3005 ″ 0 、d 1 、d 2 、d 3 、d 4 Corresponding to the time value t from the power scheme 3005 1 、t 2 、t 3 、t 4 . Thus, the feathered section corresponds to from about d 1 To about d 2 (e.g., about 0.700 "to about 0.500") of a jaw orifice. Further, the tissue warming zone corresponds to from about d 2 To about d 3 (e.g., about 0.500 "to about 0.300") of a jaw orifice. Further, the seal section corresponds to from about d 2 To about d 3 (e.g., about 0.030 "to about 0.010"). Further, the tissue cutting stage corresponds to from about d 3 To about d 4 (e.g., about 0.010 "to about 0.003").
Accordingly, control circuit 3101 is configured to cause generator 3106 to begin supplying bipolar energy power to end effector 1400 when readings from one or more of sensors 3111 correspond to, for example, predetermined jaw aperture d1, thereby initializing the emergence zone. Likewise, control circuit 3101 is configured to cause generator 3106 to stop supplying bipolar energy power to end effector 1400 when readings from one or more of sensors 3111 correspond to, for example, predetermined jaw aperture d2, thereby terminating the feathering zone. Likewise, the control circuit 3101 is configured to cause the generator 3107 to begin supplying monopolar energy power to the end effector 1400 when readings from one or more of the sensors 3111 correspond to, for example, the predetermined jaw aperture d2, thereby initiating the warming segment.
In the example shown, the jaw aperture is defined by the distance between two corresponding reference points on the jaws 1450, 1470. When the jaws 1450, 1470 are in a closed configuration with no tissue therebetween, the corresponding reference points are in contact with each other. Alternatively, the jaw aperture may be defined by the distance between jaws 1450, 1470 measured along a line intersecting jaws 1450, 1470 and perpendicularly intersecting a longitudinal axis extending centrally through end effector 1500. Alternatively, the jaw aperture may be defined by a distance between first and second parallel lines that intersect jaws 1450, 1470, respectively. The distance extends along a line perpendicular to the first and second parallel lines and extends through the intersection between the first parallel line and the first jaw 1450 and through the intersection between the second parallel line and the second jaw 1470.
Referring to fig. 35, in various examples, an electrosurgical system 3100 (fig. 36) is configured to perform a tissue treatment cycle 4003 using a power scheme 3005. The tissue treatment cycle 4003 includes an initial tissue contact phase 4013, a tissue coagulation phase 4006, and a tissue transection phase 4007. The tissue contact stage 4013 includes an open configuration section 4011 wherein tissue is not located between jaws 1450 and 1470, and a properly oriented section 4012 wherein jaws 1450 and 1470 are properly positioned relative to a desired tissue treatment area. The tissue coagulation stage 4006 includes a feathered section 4008, a tissue warming section 4009, and a sealing section 3010. The transection stage 4007 comprises a tissue cutting section. The tissue treatment cycle 4003 involves applying bipolar energy and monopolar energy to the tissue treatment region separately and simultaneously according to the power scheme 3005. The tissue treatment cycle 4003 is similar in many respects to the tissue treatment cycle 3001, and is not repeated herein for the sake of brevity.
Fig. 35 shows a graph 4000 representing a power scheme 3005 similar in many respects to power scheme 3005'. For example, the control circuitry 3101 may execute the power plan 3005 in a similar manner as the power plan 3005' to deliver three different energy modalities to the tissue treatment region for three consecutive time periods of the tissue treatment cycle 4001. In the feathering section 4008, a first energy modality that includes bipolar energy but does not include unipolar energy is at t 1 To t 2 Is applied to the tissue treatment area. In the tissue warming section 4009 and the tissue sealing section, as including monopolar energy and bipolar energyA second energy mode of the combined mixed energy mode of extreme energies is at t 2 To t 4 Is applied to the tissue treatment area. Finally, in the tissue transection phase 4007, a third energy modality that includes monopolar energy but does not include bipolar energy 4010 is at t 4 To t 5 Is applied to the tissue. Further, the second energy modality includes a power level that is a sum of power levels of the monopolar energy and the bipolar energy. In at least one example, the power level of the second energy modality includes a maximum threshold (e.g., 120W). In various aspects, the power scheme 3005 can be delivered to the end effector 1400 from two different generators 3106, 3107. For the sake of brevity, additional aspects of power scheme 3005 that are similar to aspects of power scheme 3005' are not repeated herein at the same level of detail.
In various aspects, the control circuitry 3101 causes the generators 3106, 3107 to adjust the bipolar and/or unipolar power levels of the power scheme 3005 applied by the end effector 1400 to the tissue treatment area based on one or more measured parameters (including tissue impedance 4002, jaw motor speed 27920d, jaw motor force 27920c, jaw aperture 27920b of the end effector 1400, and/or the current draw of the motor effecting the end effector closure). Fig. 35 is a graph 4000 illustrating the correlation between such measurement parameters and the power scheme 3005 over time.
In various examples, control circuitry 3101 causes generators 3106, 3107 to adjust the power level of a power scheme (e.g., power schemes 3005, 3005') applied by end effector 1400 to a tissue treatment region based on one or more parameters (e.g., tissue impedance 4002, jaw/closure motor speed 27920d, jaw/closure motor force 27920c, jaw gap/aperture 27920b of end effector 1400, and/or current draw by the motor) determined by one or more sensors 3111. For example, the control circuitry 3101 may cause the generators 3106, 3107 to adjust the power level based on the pressure within the jaws 1450, 1470.
In at least one example, the power level is inversely proportional to the pressure within the jaws 1450, 1470. The control circuit 3101 may utilize such inverse correlations to select a power level based on the pressure value. In at least one example, a current draw of a motor that effects end effector closure is employed to determine a pressure value. Alternatively, the inverse correlation utilized by control circuitry 3101 may be based directly on current draw as a proxy for stress. In various examples, the greater the compression that jaws 1450, 1470 apply to the tissue treatment area, the lower the power level that control circuit 3101 sets, which helps to minimize sticking and inadvertent cutting of tissue.
The control circuitry 3101 may rely on one or more of such cues to implement and/or adjust the default power scheme 3005 in the tissue treatment cycle 4003. In certain examples, control circuitry 3101 may rely on sensor readings of one or more sensors 3111 to detect, for example, when one or more monitored parameters satisfy one or more predetermined conditions, which may be stored in memory 3103. The one or more predetermined conditions may reach a predetermined threshold and/or detect a meaningful increase and/or decrease in one or more of the monitored parameters. The satisfaction of the predetermined condition or lack thereof constitutes a trigger/confirmation point for performing and/or adjusting part of the default power scheme 3005 in the tissue treatment cycle 4003. Control circuitry 3101 may rely on the hints only when executing and/or adjusting the power scheme, or alternatively, use the hints to direct or adjust a timer clock of a time-based power scheme (e.g., power scheme 3005').
For example, the tissue impedance decreases abruptly (A) 1 ) To a predetermined threshold value (Z) 1 ) Independent of or in combination with jaw motor force increase (A) 2 ) To a predetermined threshold value (F) 1 ) And/or jaw aperture reduction (A) 3 ) Coincident occurrence of a predetermined threshold (d1) (e.g., 0.5 ") may trigger control circuit 3101 to initiate the tissue coagulation phase by activating the application of bipolar energy to the tissue treatment region4006, a feathered section 4008. The control circuit 3101 may signal the generator 3106 to begin supplying bipolar power to the end effector 1400.
Further, the jaw motor speed after activation of the bipolar energy is reduced (B) 1 ) To a predetermined value (v1) triggers control circuit 3101 to signal generator 3106 to signal the power level (B) of the bipolar energy 2 ) Stabilize at a constant or at least substantially constant value (e.g., 100W).
In yet another example, at t 2 The displacement from the eclosion section 4008 to the warming section 4009, which triggers activation of monopolar energy application to the tissue treatment region (D1), is consistent with the following: jaw motor force increase (C) 2 ) To a predetermined threshold value (F) 2 ) Jaw hole reduction (C) 3 ) To a predetermined threshold (e.g., 0.03 ") and/or tissue impedance reduction (C1) to a predetermined value Z 2 . Satisfaction of one, or in some cases two, or in some cases all of conditions C1, C2, C3 causes the control circuit 3101 to cause the generator 3101 to begin applying monopolar energy to the tissue treatment region. In another example, satisfaction of one or in some cases two or in some cases all of conditions C1, C2, C3 at or about time t2 triggers application of unipolar energy to the tissue treatment region.
Activation of the unipolar energy by generator 3107 in response to an activation signal by control circuit 3101 results in a mixture of unipolar and bipolar energy (D) 1 ) Is delivered to the tissue treatment area, which results from the Z-axis in the impedance 2 To Z 3 A faster decrease (E1) (compared to a steady decrease (C1) before the unipolar energy is activated) characterizes a shift in the impedance curve. In the example shown, the tissue impedance Z 3 Defining a minimum impedance for the tissue treatment cycle 4003.
In the example shown, if (E) 1 ) Minimum impedance value Z 3 And (E) 3 ) Predetermined maximum jaw motor force threshold (F) 3 ) And/or (E) 2 ) The predetermined jaw aperture threshold ranges (e.g., 0.01"-0.003") are consistent, or at least substantially consistent, then the control circuitry 3101 determines that an acceptable seal is achieved. One or some of conditions E1, E2, E3Satisfaction of both or in some cases all signals the displacement of control circuit 3101 from warming section 4009 to sealing section 4010.
Beyond the above, the minimum impedance value Z is 3 At t 4 The impedance level gradually increases to a threshold value Z4 corresponding to the end of sealing section 4010. Satisfaction of the threshold Z4 causes the control circuit 3101 to signal the generator 3107 to gradually increase the monopolar power level to begin the tissue transection phase 4007 and to signal the generator 3106 to terminate the application of bipolar energy to the tissue treatment region.
In various examples, control circuit 3101 may be configured to be able (G) 2 ) Verification of following (G) 1 ) The impedance gradually changing from its minimum value Z 3 Increasing, decreasing jaw motor force, and/or before incrementally increasing the power level of the monopolar energy to cut tissue (G) 3 ) The jaw motor force has been reduced to a predetermined threshold (e.g., 0.01 "-0.003").
However, if the jaw motor force continues to increase, the control circuit 3101 may pause the application of unipolar energy to the tissue treatment region for a predetermined period of time to allow the jaw motor force to begin to decrease. Alternatively, the control circuit may signal the generator 3107 to deactivate the unipolar energy and complete the seal using only the bipolar energy.
In some cases, the control circuit 3101 may employ a feedback system 3109 to alert a user and/or provide instructions or suggestions to halt the application of monopolar energy. In some cases, the control circuitry 3101 may instruct the user to utilize a mechanical knife to transect tissue.
In the example shown, the control circuit 3101 maintains (H) the stepped up unipolar power until a spike (I) is detected in the tissue impedance. The control circuit 3101 may be controlled at slave Z 3 To Z 4 After detecting a gradual increase in impedance level to Z 5 After the spike (I), the generator 3107 is caused to terminate (J) the application of unipolar energy to the tissue. The spike indicates completion of the tissue treatment cycle 4003.
In various examples, the control circuit 3101 prevents the electrodes of the jaws 1450, 1470 from being energized before a suitable closing threshold is reached. The closure threshold may be based on a predetermined jaw hole threshold and/or a predetermined jaw motor force threshold, for example, which may be stored in memory 3103. In such examples, the control circuit 3101 may not act on user input through the user interface 3110 requesting the therapy cycle 4003. In some cases, the control circuit 3101 may respond by alerting the user through the feedback system 3109 that the appropriate closure threshold has not been reached. Control circuitry 3101 may also provide override options to the user.
Finally, at time t 4 And t 5 Monopolar energy is the only energy delivered to cut patient tissue. The force of the jaws gripping the end effector may vary when cutting patient tissue. At time t at force 27952 for clamping jaws 3 And t 4 With a reduced steady state level thereof maintained in between, identifying an efficient and/or effective tissue cut by the surgical instrument and/or surgical center. At time t when force 27954 for gripping jaws 3 And t 4 In the event that its steady-state level is maintained in between, inefficient and/or ineffective tissue cutting is identified by the surgical instrument and/or surgical center. In such cases, the error may be communicated to the user.
Referring to fig. 38-42, the surgical instrument 1601 includes an end effector 1600 that is similar in many respects to the end effectors 1400, 1500, which are not repeated herein at the same level of detail for the sake of brevity. The end effector 1600 includes a first jaw 1650 and a second jaw 1670. At least one of the first jaw 1650 and the second jaw 1670 can be moved to transition the end effector 1600 from the open configuration to the closed configuration to grasp tissue (T) between the first jaw 1650 and the second jaw 1670. The electrodes 1652, 1672 are configured to be capable of cooperating to deliver bipolar energy from the bipolar energy source 1610 to tissue, as shown in fig. 39. The electrode 1674 is configured to deliver monopolar energy from the monopolar energy source 1620 to the tissue. Return pad 1621 defines a return path for the unipolar energy. In at least one example, monopolar energy and bipolar energy are delivered to the tissue simultaneously (fig. 36) or in an alternating manner, as shown in fig. 36, for example, to seal and/or cut the tissue.
Fig. 42 shows a simplified schematic diagram of an electrosurgical system 1607 that includes a monopolar power source 1620 and a bipolar power source 1610 connectable to an electrosurgical instrument 1601 including an end effector 1600. The electrosurgical system 1607 also includes a conductive circuit 1602 that is selectively transitionable between a connected configuration with the electrode 1672 and a disconnected configuration with the electrode 1672. The switching mechanism may be comprised of any suitable switch that can, for example, open and close the conductive circuit 1602. In the connected configuration, electrode 1672 is configured to cooperate with electrode 1652 to deliver bipolar energy to tissue, where conductive circuit 1602 defines a return path for the bipolar energy after passing through the tissue. However, in the open configuration, the electrode 1672 is isolated and thus becomes an inert inner conductive and outer insulating structure on the jaw 1670. Thus, in the disconnected configuration, electrode 1652 is configured to be capable of delivering monopolar energy to tissue in addition to, or separate from, the monopolar energy delivered by electrode 1674. In an alternative example, electrode 1652, rather than electrode 1672, can be transitioned between a connected configuration and a disconnected configuration with conductive circuit 1602, allowing electrode 1672 to deliver monopolar energy to tissue in addition to or separate from the monopolar energy delivered by electrode 1674.
In various aspects, the electrosurgical instrument 1601 further includes a control circuit 1604 that is configured to adjust the level of monopolar and bipolar energy delivered to the tissue to minimize unintended thermal damage to surrounding tissue. The adjustment may be based on readings of at least one sensor, such as a temperature sensor, an impedance sensor, and/or a current sensor. In the example shown in fig. 41 and 42, the control circuitry 1604 is coupled to temperature sensors 1651, 1671 on the jaws 1650, 1670, respectively. The control circuit 1604 adjusts the level of monopolar and bipolar energy delivered to the tissue based on the temperature readings of the sensors 1651, 1671.
In the example shown, the control circuitry 1604 includes a storage medium in the form of a memory 3103 and a controller 3104 of a processor 3102. The memory 3103 stores program instructions that, when executed by the processor 3102, cause the processor 3102 to adjust the level of monopolar and bipolar energy delivered to the tissue based on sensor readings received from one or more sensors (e.g., temperature sensors 1651, 1671). In various examples, the control circuitry 1604 may adjust the default power scheme 1701 based on readings from one or more sensors (e.g., temperature sensors 1651, 1671), as described in more detail below. Power scheme 1701 is similar in many respects to power scheme 3005', which is not repeated here at the same level of detail for the sake of brevity.
Fig. 43 illustrates temperature-based adjustment of the power scheme 1701 for energy delivery to tissue grasped by the end effector 1600. Graph 1700 depicts time on the x-axis and power and temperature on the y-axis. In the tissue emergence zone (t) 1 -t 2 ) The control circuit 1604 causes the power level of the bipolar energy to gradually increase to a predetermined threshold (e.g., 120W), which causes the temperature of the tissue grasped by the end effector 1600 to gradually increase to a temperature within a predetermined range (e.g., 100-120 ℃). The power level of the bipolar energy then maintains the predetermined threshold as long as the tissue temperature remains within the predetermined range. In the tissue warming zone (t) 2 -t 3 ) The control circuit 1604 activates the monopolar energy and gradually decreases the power level of the bipolar energy while gradually increasing the power level of the monopolar energy to maintain the tissue temperature within a predetermined range.
In the example shown, in the tissue sealing section (t) 3 -t 4 ) During this time, the control circuit 1604 detects that the tissue temperature has reached the upper limit of the predetermined range based on the readings of the temperature sensors 1651, 1671. The control circuit 1604 responds by stepping down the power level of the unipolar energy. In other examples, the reduction may be performed gradually. In some examples, the reduction value or a manner for determining the reduction value, such as a table or equation, may be stored in memory 3103. In some examples, the reduction value may be a percentage of the current power level of the unipolar energy. In other examples, the decrease value may be based on a previous power level of the monopolar energy corresponding to a tissue temperature within a predetermined range. In some examples, the reduction may be performed in multiple steps spaced apart in time. After each downward step, the control circuit 1604 allowsAllowing a predetermined period of time to pass before assessing the tissue temperature.
In the example shown, the control circuit 1604 maintains the power level of the bipolar energy according to the default power scheme 1701, but reduces the power level of the monopolar energy to maintain the temperature of the tissue within a predetermined range while the tissue sealing is complete. In other examples, the reduction in power level of the monopolar energy is combined or replaced by reducing the power level of the bipolar energy.
In addition to the above, an alarm may be issued by the feedback system 3109 to complete transection of tissue using a mechanical knife, e.g., instead of monopolar energy to avoid unintended lateral thermal damage to surrounding tissue. In certain examples, the control circuit 1604 may temporarily suspend the monopolar energy and/or the bipolar energy until the temperature of the tissue returns to a level within a predetermined temperature range. The monopolar energy may then be reactivated to perform transection of the sealing tissue.
Referring to fig. 44, the end effector 1600 is applying unipolar energy to a tissue treatment region 1683 at a blood vessel, such as an artery grasped by the end effector 1600. Monopolar energy flows from the end effector 1600 to the treatment region 1683, and ultimately to a return pad (e.g., return pad 1621). The temperature of the tissue at the treatment region 1683 rises as monopolar energy is applied to the tissue. However, the actual heat spread 1681 is greater than the expected heat spread 1682 due to, for example, a constricted portion 1684 of an artery that inadvertently absorbs monopolar energy.
In various aspects, the control circuit 1604 monitors thermal effects at the treatment region 1683 that result from applying unipolar energy to the treatment region 1683. The control circuit 1604 may further detect a failure of the monitored thermal effect to follow a predetermined correlation between the applied unipolar energy and the thermal effect expected from the application of unipolar energy at the treatment region. In the example shown, unintentional energy expenditure at the constricted portion of the artery reduces the thermal effect at the treatment region, which is detected by the control circuit 1604.
In certain examples, the memory 3103 stores a predetermined correlation algorithm between the unipolar energy level as applied to the tissue treatment region grasped by the end effector 1600 and the thermal effect expected from the application of the unipolar energy to the tissue treatment region. The correlation algorithm may be in the form of, for example, an array, a look-up table, a database, a mathematical equation or formula, or the like. In at least one example, the stored correlation algorithm defines a correlation between a power level of the unipolar energy and an expected temperature. The control circuit 1604 may use the temperature sensors 1651, 1671 to monitor the temperature of tissue at the treatment region 1683, and may determine whether the monitored temperature readings correspond to expected temperature readings at a particular power level.
If failure to comply with the stored correlation is detected, the control circuitry 1604 may be configured to be able to take certain actions. For example, the control circuitry 1604 may alert a user to a malfunction. Additionally or alternatively, the control circuit 1604 may reduce or suspend the delivery of unipolar energy to the treatment region. In at least one example, the control circuitry 1604 may adjust or shift from monopolar energy to bipolar energy application to the tissue treatment region to confirm the presence of parasitic power draw. If the parasitic power draw is confirmed, the control circuitry 1604 may continue to use bipolar energy at the treatment region. However, if the control circuitry 1604 rejects the presence of parasitic power draw, the control circuitry 1604 may reactivate or re-increase the unipolar power level. The control circuitry 1604 may effect changes to the unipolar and/or bipolar power levels, for example, by signaling the unipolar power source 1620 and/or the bipolar power source 1610.
In various aspects, one or more imaging devices (e.g., multispectral range 1690 and/or infrared imaging devices) may be used to monitor spectral tissue changes and/or thermal effects at tissue treatment region 1691, as shown in fig. 45. Imaging data from one or more imaging devices may be processed to estimate the temperature at the tissue treatment region 1691. For example, when monopolar energy is applied to the treatment region 1691 by the end effector 1600, the user can guide the infrared imaging device at the treatment region 1691. As treatment area 1691 heats up, its infrared thermal signature changes. Thus, the change in thermal characteristics corresponds to a change in temperature of the tissue at treatment area 1691. Accordingly, the temperature of the tissue at the treatment region 1691 can be determined based on the thermal characteristics captured by the one or more imaging devices. If the estimated temperature based on the thermal characteristics at treatment region 1691 associated with a particular fractional level is less than or equal to the expected temperature at the power level, the control circuit 1604 detects a difference in thermal effects at treatment region 1691.
In other examples, thermal signatures captured by one or more imaging devices are not converted to estimated temperatures. Instead, it is directly compared to the thermal signature stored in memory 3103 to assess whether a power level adjustment is required.
In certain examples, the memory 3103 stores a predetermined correlation algorithm between the power level of the monopolar energy as applied to the tissue treatment region 1691 grasped by the end effector 1600 and the thermal signature expected from the application of the monopolar energy to the tissue treatment region. The correlation algorithm may be in the form of, for example, an array, a look-up table, a database, a mathematical equation or formula, or the like. In at least one example, the stored correlation algorithm defines a correlation between a power level of the unipolar energy and an expected thermal signature or a temperature associated with the expected thermal signature.
Referring to fig. 46 and 47, the electrosurgical system includes an electrosurgical instrument 1801 having an end effector 1800 similar in many respects to the end effectors 1400, 1500, 1600, which, for the sake of brevity, are not repeated here at the same level of detail. The end effector 1800 includes a first jaw 1850 and a second jaw 1870. At least one of the first jaw 1850 and the second jaw 1870 is movable to transition the end effector 1800 from the open configuration to the closed configuration to grasp tissue (T) between the first jaw 1850 and the second jaw 1870. The electrodes 1852, 1872 are configured to be able to cooperate to deliver bipolar energy to tissue. The electrode 1874 is configured to be capable of delivering unipolar energy to tissue. In at least one example, monopolar energy and bipolar energy are delivered to tissue simultaneously or in an alternating manner, as shown in fig. 34, for example, to seal and/or cut tissue.
In the example shown, bipolar energy and unipolar energy are generated by separate generators 1880, 1881 and are provided to the tissue by separate circuits 1882, 1883 connecting the generators 1880 to the electrodes 1852, 1872 and the generators 1881 to the electrodes 1874 and return pads 1803, respectively. The associated power level is bipolar energy delivered to the tissue by electrodes 1852, 1872 and set by generator 1880, and the power level associated with monopolar energy delivered to the tissue by electrode 1874 is set by generator 1881 according to, for example, power scheme 3005'.
In use, as shown in fig. 46, the end effector 1800 applies bipolar and/or monopolar energy to the tissue treatment region 1804 to seal, and in some cases transect, tissue. However, in some cases, the energy is offset from the intended target at the tissue treatment region 1804, resulting in off-site thermal damage to surrounding tissue. To avoid or at least reduce such occurrences, the surgical instrument 1801 includes impedance sensors 1810, 1811, 1812, 1813 positioned between different electrodes and at different locations, as shown in fig. 46, in order to detect out-of-site thermal damage.
In various aspects, the surgical system 1807 further includes a control circuit 1809 coupled to the impedance sensors 1810, 1811, 1812, 1813. The control circuit 1809 may detect off-site or unexpected thermal damage based on one or more readings of the impedance sensors 1810, 1811, 1812, 1813. In response, the control circuit 1809 can alert the user to the offsite thermal injury and instruct the user to halt energy delivery to the tissue treatment region 1804, or automatically halt energy delivery while maintaining bipolar energy according to a predetermined power scheme (e.g., power scheme 3005') to complete tissue sealing. In some cases, the control circuitry 1809 may instruct the user to employ a mechanical knife to transect the tissue to avoid further ex-situ thermal damage.
Still referring to fig. 46, impedance sensor 1810 is configured to be capable of measuring the impedance between bipolar electrodes 1852, 1872. Additionally, impedance sensor 1811 is configured to be able to measure the impedance between electrode 1874 and return pad 1803. Further, impedance sensor 1812 is configured to be able to measure the impedance between electrode 1872 and return pad 1803. Further, the impedance sensor 1813 is configured to be able to measure the impedance between the electrode 1852 and the return pad 1803. In other examples, additional impedance sensors are added in-line between unipolar circuit 1882 and bipolar circuit 1883, which may be used to measure impedance at various locations to detect out-of-site thermal anomalies with greater specificity with respect to location and impedance path.
In various aspects, the out-of-site thermal injury occurs in tissue on one side (left/right) of the end effector 1800. The control circuit 1809 may detect the side where the off-site thermal damage occurred by comparing the readings of the impedance sensors 1810, 1811, 1812, 1813. In one example, non-proportional changes in unipolar and bipolar impedance readings indicate off-site thermal damage. Conversely, if a proportion in the impedance reading is detected, the control circuit 1809 remains free of off-site thermal damage. In one example, as described in more detail below, ex-site thermal damage may be detected by the control circuit 1809 according to a ratio of bipolar impedance to unipolar impedance.
Fig. 48 shows a graph 1900 depicting time on the x-axis and power on the y-axis. Graph 1900 shows a power scheme 1901 that is similar in many respects to the power scheme 3005' shown in FIG. 34, and is not repeated at the same level of detail for the sake of brevity. The control circuit 3101 causes the power scheme 1901 to be applied by the generators 1880(gen.2), 1881(gen.1) to effect a tissue treatment cycle by the end effector 1800. The power scheme 1901 includes a therapeutic power component 1902 and a non-therapeutic or sensing power component 1903. The therapeutic power component 1902 defines monopolar and bipolar power levels similar to those described in connection with the power scheme 3005'. The sensing power components 1903 include monopolar 1905 and bipolar 1904 sensing picks that are delivered at various points throughout the tissue treatment cycle performed by the end effector 1800. In at least one example, the sensing picks 1903, 1904 of the sensing power component are delivered at a predetermined current value (e.g., 10mA) or a predetermined range. In at least one example, three different sensing pickups are utilized to determine the location/orientation of potential off-site thermal damage.
The control circuitry 3101 can determine whether to transfer energy to the non-tissue therapy directional site during a tissue treatment cycle by causing the sensing picks 1903, 1904 to be delivered at predetermined time intervals. Control circuitry 3101 may then evaluate the return path conductivity based on the delivered sense pickups. If it is determined that the energy is offset from the target site, control circuitry 3101 may take one or more reactive actions. For example, control circuit 3101 may adjust the power scheme 1901 applied by generators 1880(gen.2), 1881 (gen.1). The control circuit 3101 may halt bipolar and/or monopolar energy application to the target site. In addition, the control circuit 3101 may issue a warning to the user, for example, through the feedback system 3109. However, if it is determined that the energy offset is not detected, the control circuit 3101 continues to execute the power scheme 1901.
In various aspects, for example, the control circuit 3101 evaluates the return path conductivity by comparing the measured return conductivity to a predetermined return path conductivity stored in memory 3103. If the comparison indicates that the measured and predetermined return path conductivities are different than the predetermined threshold, the control circuit 3101 ends with the energy being shifted to the non-tissue treatment targeted site and performs one or more of the previously described reactive measures.
Fig. 49 is a graph 2000 illustrating a power scheme 2001 interrupted due to detected out-of-site thermal damage at t 3'. Power scheme 2001 is similar in many respects to the power schemes shown in fig. 34, 48, which are not repeated herein at the same level of detail for the sake of brevity. For example, the control circuit 1809 causes the generators 1880 (curve 2010), 1881 (curve 2020) to apply the power schedule 2001 in order to achieve a tissue treatment cycle by the end effector 1800. In addition to the power scheme 2001, the graph 2000 also depicts a bipolar impedance 2011 (Z) Bipolar junction ) Unipolar impedance 2021 (Z) Monopole ) And the ratio 2030 of the unipolar impedance to the bipolar impedance on the y-axis (Z) Monopole /Z Bipolar junction ). During normal operation, when monopolar and bipolar energy are simultaneously applied to the tissue, the bipolar impedance 2011 (Z) Bipolar junction ) And monopole impedance 2021 (Z) Monopole ) The values of (a) remain proportional, or at least substantially proportional. Thus, during normal operation, the constant or at least substantially constant impedance ratio 2030 (Z) of the unipolar impedance 2021 and the bipolar impedance 2011 Monopole /Z Bipolar junction ) Is maintained within a predetermined range 2031.
In various aspects, the control circuit 1809 monitors the impedance ratio 2030 to assess whether monopolar energy is deflected to a non-tissue therapy targeted site. Deflection changes the detected bipolar impedance 2011 (Z) Bipolar junction ) And monopole impedance 2021 (Z) Monopole ) Which changes the impedance ratio 2030. A change in the impedance ratio 2030 within the predetermined range 2031 may cause the control circuit 1908 to issue a warning. However, if the change extends to or below the lower threshold 2031 of the predetermined range, the control circuitry 1908 may take additional reactive action.
In the example shown, for the initial portion of the treatment cycle involving mixed monopolar and bipolar energy application to tissue, the impedance ratio 2030 (Z) Monopole /Z Bipolar junction ) Remain constant or at least substantially constant. However, at B1, a difference occurs in which the impedance of the monopole (Z) Monopole ) Unexpectedly drop, or interact with, bipolar impedance (Z) Bipolar junction ) Disproportionately decreased, indicating potential off-site thermal damage. In at least one example, the control circuit 1809 monitors a ratio of unipolar impedance to bipolar impedance (Z) Monopole /Z Bipolar junction ) And if the change lasts for a predetermined amount of time, and/or its value changes to or below the lower threshold of the predetermined range 2031, an out-of-site thermal damage is detected. At B1, since the detected impedance ratio 2030 is still within the predetermined range 2031, the control circuit 3101 issues a warning only through the feedback system 3109 that the off-site thermal damage has been detected and continues to monitor the impedance ratio 2030.
At t3', the control circuit 3101 further detects that the impedance ratio 2030 has become a value at or below the lower threshold value of the predetermined range 2031. In response, the control circuit 3101 may issue another warning, and optionally, may instruct the user to halt energy delivery to the tissue at B2, or automatically halt energy delivery while maintaining or adjusting the power level of the bipolar energy to complete the tissue seal without the need for monopolar energy. In certain examples, the control circuitry 1809 further instructs the user to employ a mechanical knife (t 4') to transect the tissue to avoid further ex-site thermal damage. In the example shown, the control circuit 1809 further causes the generator 1880 to adjust its power level to complete the tissue seal without monopolar energy and to increase the period of time for the assignment of the tissue seal segment from time t4 to time t 4'. In other words, the control circuit 1809 will increase bipolar energy delivery to the tissue to compensate for the loss of monopolar energy by increasing the bipolar power level and its delivery time.
Various aspects of the subject matter described herein are set forth in the following examples.
Various aspects of the subject matter described herein are set forth in the following examples.
Example set 1
Example 1-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a tapered body extending from a proximal end to a distal end. The tapered body comprises a conductive material. The tapered body includes a first conductive portion extending from the proximal end to the distal end, and a second conductive portion defining a tapered electrode protruding from the first conductive portion and extending distally along at least a portion of the tapered body. The second conductive portion is integral with the first conductive portion. The first conductive portion is thicker than the second conductive portion in a transverse cross-section of the tapered body. The second jaw further includes an electrically insulating layer configured to electrically insulate the first electrically conductive portion from tissue, and not the second electrically conductive portion. The first conductive portion is configured to enable transmission of electrical energy to tissue only through the second conductive portion.
Example 2-the electrosurgical instrument of example 1, wherein the tapered electrode comprises an outer surface that is flush with an outer surface of the electrically insulating layer.
Example 3-the electrosurgical instrument of examples 1 or 2, wherein the tapered electrode has a width that gradually narrows as the tapered electrode extends from the proximal end toward the distal end.
Example 4-the electrosurgical instrument of examples 1, 2, or 3, wherein the electrical energy is delivered to the tissue through an outer surface of the tapered electrode.
Example 5-the electrosurgical instrument of examples 1, 2, 3, or 4, wherein the first jaw comprises a first electrode extending distally along at least a portion of the first jaw, wherein the tapered electrode is a second electrode, and wherein the first electrode is laterally offset from the second electrode in the closed configuration.
Example 6-the electrosurgical instrument of example 5, wherein the second jaw further comprises a third electrode spaced apart from the tapered body.
Example 7-the electrosurgical instrument of example 6, wherein the third electrode extends distally from the electrode proximal end to the electrode distal end along an angular profile defined by the second jaw.
Example 8-the electrosurgical instrument of example 7, wherein the third electrode includes a base positioned in the carriage extending distally from the carriage proximal end to the carriage distal end along an angular profile of the second jaw.
Example 9-the electrosurgical instrument of example 8, wherein the bracket is centrally located relative to a lateral edge of the second jaw.
Example 10-the electrosurgical instrument according to examples 8 or 9, wherein the third electrode further comprises a tapered edge extending from the base beyond the side wall of the bracket.
Example 11-the electrosurgical instrument of examples 8, 9, or 10, wherein the carrier is comprised of a compliant substrate.
Example 12-the electrosurgical instrument of examples 8, 9, 10, or 11, wherein the bracket is partially embedded in a valley defined in the tapered body.
Example 13-the electrosurgical instrument of examples 8, 9, 10, 11, or 12, wherein the bracket is spaced apart from the tapered body by an electrically insulating coating.
Example 14-the electrosurgical instrument of examples 8, 9, 10, 11, 12, or 13, wherein the base comprises a base proximal end, a base distal end, and a width that tapers as the base extends along an angular profile from the base proximal end to the base distal end.
Example 15-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a conductive body including a tapered angular profile extending from a proximal end to a distal end. The conductive body includes a first conductive portion extending from the proximal end to the distal end, and a second conductive portion defining a tapered electrode protruding from the first conductive portion and extending distally along at least a portion of the conductive body. The second conductive portion is integral with the first conductive portion. The first conductive portion is thicker than the second conductive portion. The second jaw further includes an electrically insulating layer configured to electrically insulate the first electrically conductive portion from tissue, and not the second electrically conductive portion. The first conductive portion is configured to enable transmission of electrical energy to tissue only through the second conductive portion.
Example 16-the electrosurgical instrument of example 15, wherein the tapered electrode has a width that gradually narrows as the tapered electrode extends from the proximal end toward the distal end.
Example 17-the electrosurgical instrument of examples 15 or 16, wherein the first jaw comprises a first electrode extending distally along at least a portion of the first jaw, wherein the tapered electrode is a second electrode, and wherein the first electrode is laterally offset from the second electrode in the closed configuration.
Example 18-the electrosurgical instrument of examples 15, 16, or 17, wherein the second jaw further comprises a third electrode spaced apart from the conductive body.
Example 19-the electrosurgical instrument of example 18, wherein the third electrode extends distally along at least a portion of the tapered angular profile.
Example 20-the electrosurgical instrument according to example 19, wherein the third electrode comprises a base positioned in the cradle extending distally from the cradle proximal end to the cradle distal end along at least a portion of the tapered angular profile, and wherein the cradle is comprised of a compliant substrate.
Example set 2
Example 1-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a linear portion that cooperates to form an angular profile and a treatment surface that includes a segment that extends along the angular profile. The sections comprise different geometries and different conductivities. The segments are configured to produce a variable energy density along the treatment surface.
Example 2-the electrosurgical instrument of example 1, wherein the section comprises a proximal section and a distal section. The proximal section includes a first surface area. The distal section includes a second surface area. The second surface area is less than the first surface area.
Embodiment 3-the electrosurgical instrument of embodiments 1 or 2, wherein at least one of the segments comprises a conductive treatment region longitudinally interrupted by a non-conductive treatment region.
Example 4-the electrosurgical instrument of examples 1, 2, or 3, wherein the variable energy density is predetermined based on different geometries of the segments and selection of different conductivities.
Embodiment 5-the electrosurgical instrument of embodiments 1, 2, 3, or 4, wherein at least one of the sections has a tapered width along its length.
Example 6-the electrosurgical instrument of examples 1, 2, 3, 4, or 5, wherein the segment extends along a peripheral side of the second jaw.
Example 7-the electrosurgical instrument of examples 1, 2, 3, 4, 5, or 6, wherein the segment is defined in the second jaw but not the first jaw.
Example 8-the electrosurgical instrument of examples 1, 2, 3, 4, 5, 6, or 7, wherein the second jaw comprises an electrically conductive backbone partially coated with a first material and a second material, wherein the first material is thermally conductive and electrically insulative, and wherein the second material is thermally insulative and electrically insulative.
Example 9-the electrosurgical instrument of example 8, wherein the first material comprises diamond-like carbon.
Example 10-the electrosurgical instrument of examples 8 or 9, wherein the second material comprises polytetrafluoroethylene.
Example 11-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a tapered body extending from a proximal end to a distal end. The tapered body includes a tissue contacting surface. The tissue contacting surface includes an insulating layer comprising a first material. The insulating layers extend on opposite sides of a middle region extending along the length of the tapered body. The tissue contacting surface further comprises a section configured to generate a variable energy density along the tissue contacting surface. The segments include conductive segments and insulating segments that alternate with the conductive segments along the intermediate regions. The insulating segment comprises a second material different from the first material.
Example 12-the electrosurgical instrument of example 11, wherein the conductive section comprises a proximal section and a distal section. The proximal section includes a first surface area. The distal section includes a second surface area. The second surface area is less than the first surface area.
Example 13-the electrosurgical instrument of examples 11 or 12, wherein the second jaw comprises an electrically conductive backbone partially coated with the first material.
Example 14-the electrosurgical instrument of example 13, wherein the electrically-conductive backbone comprises an inner thermally-isolated core and an outer thermally-conductive layer at least partially surrounding the inner thermally-isolated core.
Example 15-the electrosurgical instrument of examples 11, 12, 13, or 14, wherein the variable energy density is predetermined based on different geometries of the conductive segments and selection of different conductivities.
Example 16-the electrosurgical instrument of examples 11, 12, 13, 14, or 15, wherein at least one of the sections has a tapered width along its length.
Example 17-the electrosurgical instrument of examples 11, 12, 13, 14, 15, or 16, wherein the segment extends along a peripheral side of the second jaw.
Example 18-the electrosurgical instrument of examples 11, 12, 13, 14, 15, 16, or 17, wherein the segment is defined in the second jaw but not the first jaw.
Example 19-the electrosurgical instrument of examples 11, 12, 13, 14, 15, 16, 17, or 18, wherein the first material comprises diamond-like carbon.
Example 20-the electrosurgical instrument of examples 11, 12, 13, 14, 15, 16, 17, 18, or 19, wherein the second material comprises polytetrafluoroethylene.
Example set 3
Example 1-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw, a second jaw, and a circuit. The first jaw includes a first electrically conductive backbone, a first insulating coating selectively covering a portion of the first electrically conductive backbone, and a first jaw electrode including an exposed portion of the first electrically conductive backbone. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a second electrically conductive backbone, a second insulating coating selectively covering portions of the second electrically conductive backbone, and a second jaw electrode including an exposed portion of the second electrically conductive backbone. The electrical circuit is configured to deliver bipolar RF energy and monopolar RF energy to the tissue via the first jaw electrode and the second jaw electrode. The monopolar RF energy shares a first electrical path and a second electrical path defined by the circuit for transmitting bipolar RF energy.
Embodiment 2-the electrosurgical instrument of embodiment 1, wherein the electrical circuit defines a third electrical path separate from the first and second electrical paths.
Example 3-the electrosurgical instrument of examples 1 or 2, wherein the end effector comprises a cutting electrode electrically insulated from the first and second electrically conductive strands.
Example 4-the electrosurgical instrument of example 3, wherein the cutting electrode is configured to receive cutting monopolar RF energy through a third electrical path.
Example 5-the electrosurgical instrument of example 4, wherein the cutting electrode is configured to cut tissue with cutting monopolar RF energy after coagulation of the tissue has been initiated by the bipolar RF energy.
Example 6-the electrosurgical instrument of examples 3, 4, or 5, wherein the cutting electrode is centrally located in one of the first and second jaws.
Example 7-the electrosurgical instrument of examples 4 or 5, wherein the end effector is configured to deliver cutting monopolar RF energy and bipolar RF energy to tissue simultaneously.
Example 8-the electrosurgical instrument of examples 1, 2, 3, 4, 5, 6, or 7, wherein the first jaw electrode comprises a first distal tip electrode, and wherein the second jaw electrode comprises a second distal tip electrode.
Example 9-the electrosurgical instrument of example 8, wherein the first and second electrically conductive scaffolds are simultaneously energized to deliver monopolar RF energy to the tissue surface through the first and second distal tip electrodes.
Example 10-the electrosurgical instrument of examples 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the second jaw comprises a dissection electrode extending along a peripheral surface of the second jaw.
Example 11-an electrosurgical instrument comprising an end effector and an electrical circuit. The end effector includes at least two electrode sets, a first jaw, and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The end effector is configured to deliver a combination of bipolar RF energy and monopolar RF energy from the at least two electrode sets to the grasped tissue. The circuit is configured to be capable of transmitting bipolar RF energy and monopolar RF energy. The monopolar RF energy shares an active path and a return path defined by the circuit for transmitting bipolar RF energy.
Example 12-the electrosurgical instrument of example 11, wherein at least two electrode sets include three electrical interconnects used together in an electrical circuit.
Example 13-the electrosurgical instrument according to examples 11 or 12, wherein the at least two electrode sets include three electrical interconnects that define at least a portion of an electrical circuit and another separate electrical circuit.
Example 14-the electrosurgical instrument of example 13, wherein separate electrical circuits lead to at least two electrode sets of cutting electrodes that are isolated and centered in one of the first and second jaws.
Example 15-the electrosurgical instrument of example 14, wherein the cutting electrode is configured to cut tissue after coagulation of the tissue has been initiated using the second and third electrodes of the at least two electrode sets.
Example 16-the electrosurgical instrument of examples 14 or 15, wherein at least two electrode sets are configured to deliver monopolar RF energy and bipolar RF energy to tissue simultaneously.
Example 17-an electrosurgical instrument, the electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a composite skeleton of at least two different materials configured to selectively create an electrically conductive portion and a thermally isolated portion.
Example 18-the electrosurgical instrument of example 17, wherein the composite scaffold comprises a titanium ceramic composite.
Example 19-the electrosurgical instrument of examples 17 or 18, wherein the composite scaffold comprises a ceramic base and a titanium crown attachable to the ceramic base.
Example 20-the electrosurgical instrument according to examples 17, 18 or 19, wherein the composite skeleton portion is coated with an electrically insulating material.
Example 21-a method for manufacturing jaws of an end effector of an electrosurgical instrument. The method includes preparing a composite skeleton of the jaws by fusing titanium powder with ceramic powder in a metal injection molding process and selectively coating the composite skeleton with an electrically insulating material to produce a plurality of electrodes.
Example set 4
Example 1-an electrosurgical instrument comprising a first jaw and a second jaw. The first jaw is configured to define a first electrode. The first jaw includes a first electrically conductive skeleton and a first electrically insulating layer. The first electrically conductive skeleton includes: a first thermally isolating core; and a first thermally conductive outer layer integral with and extending at least partially around the first thermally isolating core. The first electrode is defined by selectively applying the first electrically insulating layer to an outer surface of the first thermally conductive outer layer. The second jaw is configured to define a second electrode. The second jaw includes a second electrically conductive skeleton and a second electrically insulating layer. The second electrically conductive skeleton includes: a second thermally insulating core; and a second thermally conductive outer layer integral with and extending at least partially around the second thermally isolating core. The second electrode is defined by selectively applying the second electrically insulating layer to an outer surface of the second thermally conductive outer layer.
Example 2-the electrosurgical instrument of example 1, wherein the first electrode is configured to transmit RF energy to the second electrode through tissue positioned between the first electrode and the second electrode in a bipolar energy mode of operation.
Embodiment 3-the electrosurgical instrument of embodiments 1 or 2, wherein the first thermal isolation core comprises an air pocket.
Embodiment 4-the electrosurgical instrument of embodiments 1, 2, or 3, wherein the first thermal isolation core comprises a lattice structure.
Example 5-the electrosurgical instrument of examples 1, 2, 3, or 4, wherein the second jaw comprises a third electrode, and wherein the third electrode is defined by selectively applying a second electrically insulating layer to an outer surface of the second thermally conductive outer layer.
Example 6-the electrosurgical instrument of example 5, wherein the third electrode is configured to deliver RF energy to tissue in contact with the third electrode in a monopolar energy mode of operation.
Embodiment 7-the electrosurgical instrument of embodiments 1, 2, 3, 4, 5, or 6, wherein at least one of the first and second electrically insulating layers comprises a diamond-like material.
Example 8-the electrosurgical instrument of examples 1, 2, 3, 4, 5, 6, or 7, wherein the first jaw comprises a tissue contacting surface, and wherein the first thermally isolated core comprises a lattice structure comprising walls that stand in a direction transverse to the tissue contacting surface.
Example 9-the electrosurgical instrument of example 8, wherein the direction is perpendicular to the tissue contacting surface.
Example 10-an electrosurgical instrument, comprising jaws configured to define an electrode. The jaw includes a first electrically-conductive portion, a second electrically-conductive portion, and an electrically-insulative layer. The first electrically-conductive portion is configured to resist heat transfer therethrough. The second electrically conductive portion is integral with and extends at least partially around the first electrically conductive portion. The second electrically-conductive portion is configured to define a heat sink. The electrode is defined by selectively applying the electrically insulating layer to an outer surface of the second electrically conductive portion.
Example 11-the electrosurgical instrument of example 10, wherein the electrode is configured to transmit RF energy to tissue positioned against the electrode.
Example 12-the electrosurgical instrument of examples 10 or 11, wherein the first electrically-conductive portion comprises an air pocket.
Example 13-the electrosurgical instrument of examples 10, 11, or 12, wherein the first electrically-conductive portion comprises a lattice structure.
Embodiment 14-the electrosurgical instrument of embodiments 10, 11, 12, or 13, wherein the electrically insulating layer comprises a diamond-like material.
Example 15-the electrosurgical instrument of examples 10, 11, 12, 13, or 14, wherein the jaws comprise a tissue contacting surface, and wherein the first electrically conductive portion comprises a lattice structure comprising walls that stand in a direction transverse to the tissue contacting surface.
Example 16-the electrosurgical instrument of example 15, wherein the direction is perpendicular to the tissue contacting surface.
Example 17-an electrosurgical instrument comprising jaws configured to define an electrode. The jaws include an electrically conductive backbone and an electrically insulating layer. The electrically conductive skeleton includes: a thermally insulating core; and a thermally conductive outer layer integral with and extending at least partially around the thermally insulating core. The electrode is defined by selectively applying the electrically insulating layer to the outer surface of the thermally conductive outer layer.
Example 18-the electrosurgical instrument of example 17, wherein the thermal isolation core comprises a lattice structure.
Example 19-the electrosurgical instrument of example 18, wherein the jaws comprise a tissue contacting surface, and wherein the lattice structure comprises walls that stand in a direction transverse to the tissue contacting surface.
Example 20-the electrosurgical instrument of example 19, wherein the direction is perpendicular to the tissue contacting surface.
Example set 5
Example 1-an electrosurgical instrument, the electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. The first jaw includes a first electrode. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a second electrode configured to deliver first monopolar energy to tissue, a third electrode, and a conductive circuit selectively transitionable between a connected configuration with the third electrode and a disconnected configuration with the third electrode. In the connected configuration, the third electrode is configured to be cooperable with the first electrode to deliver bipolar energy to tissue. The conductive circuit defines a return path for the bipolar energy. In the disconnected configuration, the first electrode is configured to deliver the second monopolar energy to the tissue.
Example 2-the electrosurgical instrument of example 1, further comprising a switching mechanism for alternating between a connected configuration and a disconnected configuration.
Example 3-the electrosurgical instrument of examples 1 or 2, further comprising a switching mechanism for alternating between delivering bipolar energy and second monopolar energy to the tissue through the first electrode.
Example 4-the electrosurgical instrument of examples 1, 2, or 3, wherein the end effector is configured to deliver bipolar energy and the first monopolar energy to tissue simultaneously.
Example 5-the electrosurgical instrument of examples 1, 2, 3, or 4, wherein the end effector is configured to deliver a mixture of bipolar energy and first monopolar energy to tissue.
Example 6-the electrosurgical instrument of example 5, wherein the level of bipolar energy and first monopolar energy in the energy blend is determined based on at least one reading of a temperature sensor indicative of at least one temperature of tissue.
Example 7-the electrosurgical instrument of examples 5 or 6, wherein the level of bipolar energy and first monopolar energy in the energy blend is determined based on at least one reading of an impedance sensor indicative of at least one impedance of tissue.
EXAMPLE 8-the electrosurgical instrument of examples 5, 6, or 7, wherein the level of bipolar energy and the first monopolar energy in the energy mix is adjusted to reduce the detected lateral thermal damage beyond the tissue treatment region between the first jaw and the second jaw.
Example 9-an electrosurgical instrument comprising an end effector and a control circuit. The end effector includes a first jaw, a second jaw, and at least one sensor. The first jaw includes a first electrode. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The second jaw includes a second electrode configured to deliver monopolar energy to tissue; and a third electrode configured to be capable of cooperating with the first electrode to deliver bipolar energy. The control circuitry is configured to implement a predetermined power regime to seal and cut tissue during a tissue treatment cycle. The power scheme includes predetermined power levels of monopolar energy and bipolar energy. The control circuit is further configured to adjust at least one of the predetermined power levels of the monopolar energy and the bipolar energy based on readings of the at least one sensor during the tissue treatment cycle.
Example 10-the electrosurgical instrument of example 9, wherein the predetermined power profile includes simultaneous application of bipolar energy and monopolar energy and separate application of bipolar energy and monopolar energy to tissue during a tissue treatment cycle.
Example 11-the electrosurgical instrument of examples 9 or 10, wherein the predetermined power profile includes applying bipolar energy to the tissue instead of monopolar energy in a feathering section of the tissue treatment cycle, and simultaneously applying bipolar energy and monopolar energy to the tissue in a tissue warming section and a tissue sealing section of the tissue treatment cycle.
Example 12-the electrosurgical instrument of example 11, wherein the power scheme further comprises applying monopolar energy to the tissue instead of bipolar energy in the transecting section of the tissue treatment cycle.
Example 13-the electrosurgical instrument of examples 9, 10, 11, or 12, wherein the at least one sensor comprises an impedance sensor.
Example 14-the electrosurgical instrument of example 13, wherein the control circuit is configured to monitor an impedance ratio of the monopolar tissue impedance to the bipolar tissue impedance based on readings from the impedance sensor.
Example 15-the electrosurgical instrument of example 14, wherein a change in the impedance ratio within a predetermined range causes the control circuit to issue a warning.
Example 16-the electrosurgical instrument of example 15, wherein a change in the impedance ratio at or below a lower threshold of the predetermined range causes the control circuit to adjust the predetermined power scheme.
Example 17-the electrosurgical instrument of examples 15 or 16, wherein a change in the impedance ratio at or below a lower threshold of the predetermined range causes the control circuit to pause the application of unipolar energy to tissue.
Example 18-the electrosurgical instrument of example 17, wherein a change in the impedance ratio at or below a lower threshold of the predetermined range further causes the control circuit to adjust the application of bipolar energy to tissue to complete sealing tissue.
Example 19-an electrosurgical instrument comprising an end effector and a control circuit. The end effector includes a first jaw and a second jaw. The first jaw includes a first electrode. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The tissue is located at a target site. The second jaw includes a second electrode configured to deliver monopolar energy to tissue; and a third electrode configured to be capable of cooperating with the first electrode to deliver bipolar energy. The control circuitry is configured to implement a predetermined power regime to seal and cut tissue during a tissue treatment cycle. The power scheme includes predetermined power levels of monopolar energy and bipolar energy. The control circuit is further configured to be capable of detecting an energy excursion from the target site and adjusting at least one of the predetermined power levels of the monopolar energy and the bipolar energy to mitigate the energy excursion.
Example 20-the electrosurgical instrument of example 19, wherein the predetermined power profile includes simultaneous application of bipolar energy and monopolar energy applied to tissue separately during a tissue treatment cycle.
Example 21-the electrosurgical instrument of examples 19 or 20, wherein the predetermined power profile comprises applying bipolar energy to the tissue instead of monopolar energy in a feathering section of the tissue treatment cycle, and applying bipolar energy and monopolar energy to the tissue simultaneously in a tissue warming section and a tissue sealing section of the tissue treatment cycle.
Example set 6
Example 1-an electrosurgical system, the electrosurgical system comprising an end effector and a control circuit. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The control circuitry is configured to simultaneously and separately apply two different energy modalities to tissue during a tissue treatment cycle that includes a tissue coagulation phase and a tissue transection phase.
Embodiment 2-the electrosurgical system of embodiment 1, wherein the first energy modality is a monopolar energy modality.
Embodiment 3-the electrosurgical system of embodiment 2, wherein the second energy modality is a bipolar energy modality.
Example 4-the electrosurgical system of examples 2 or 3, wherein the control circuitry is configured to activate application of the monopolar energy modality to the tissue prior to completion of the tissue coagulation phase by the bipolar energy modality.
Example 5-the electrosurgical system of examples 2 or 3, wherein the control circuitry is configured to activate application of a monopolar energy modality to the tissue prior to deactivation of application of a bipolar energy modality to the tissue.
Example 6-the electrosurgical system of examples 3, 4, or 5, wherein the control circuit is configured to apply the monopolar energy modality and the bipolar energy modality simultaneously to the tissue during the tissue coagulation phase.
Example 7-the electrosurgical system of examples 1, 2, 3, 4, 5, or 6, wherein the control circuit comprises a processor and a storage medium, and wherein the application of the two different energy modalities to the tissue is based on a default power profile stored in the storage medium.
Example 8-the electrosurgical system of example 7, further comprising at least one sensor, and wherein the control circuit is configured to modify the default power scheme based on one or more sensor readings of the at least one sensor.
Example 9-an electrosurgical instrument comprising an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The end effector is configured to apply three different energy modalities to tissue during a tissue treatment cycle that includes a tissue coagulation phase and a tissue transection phase.
Example 10-the electrosurgical instrument of example 9, wherein the first energy modality comprises bipolar energy.
Example 11-the electrosurgical instrument of example 10, wherein the second energy modality comprises an energy mix of monopolar energy and bipolar energy.
Example 12-the electrosurgical instrument of example 11, wherein the third energy modality includes monopolar energy but does not include bipolar energy.
Example 13-the electrosurgical instrument of examples 11 or 12, wherein activation of the application of monopolar energy to the tissue is configured to begin prior to completion of the tissue coagulation phase.
Example 14-the electrosurgical instrument according to examples 12 or 13, wherein activation of monopolar energy application to tissue is configured to begin prior to deactivation of application of a bipolar energy modality to tissue.
Example 15-the electrosurgical instrument of examples 9, 10, 11, 12, 13, or 14, further comprising a control circuit, wherein the control circuit comprises a processor and a storage medium, and wherein the application of the two different energy modalities to the tissue is based on a default power scheme stored in the storage medium.
Example 16-the electrosurgical instrument of example 15, further comprising at least one sensor, wherein the control circuit is configured to adjust the default power profile during a tissue treatment cycle based on one or more sensor readings of the at least one sensor.
Example 17-an electrosurgical system, comprising a first generator configured to output bipolar energy, a second generator configured to output monopolar energy, a surgical instrument electrically coupled to the first generator and the second generator, and a control circuit. The surgical instrument includes an end effector. The end effector includes a first jaw and a second jaw. At least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw. The control circuit includes a processor and a storage medium including program instructions that, when executed by the processor, cause the processor to cause the first and second generators to apply a predetermined power regime to the end effector. The power scheme includes simultaneous application of bipolar energy and monopolar energy to the tissue separately and simultaneously during a tissue treatment cycle.
Example 18-the electrosurgical system of example 17, further comprising at least one sensor, wherein the control circuit is configured to adjust the power schedule during a tissue treatment cycle based on one or more sensor readings of the at least one sensor.
Example 19-the electrosurgical system of examples 17 or 18, wherein the power scheme includes applying bipolar energy to tissue instead of monopolar energy in a feathering section of the tissue treatment cycle, and simultaneously applying bipolar energy and monopolar energy to tissue in a tissue warming section and a tissue sealing section of the tissue treatment cycle.
Example 20-the electrosurgical system of examples 17, 18, or 19, wherein the power scheme further comprises applying monopolar energy to the tissue instead of bipolar energy in the transecting section of the tissue treatment cycle.
While several forms have been illustrated and described, it is not the intention of the applicants to restrict or limit the scope of the appended claims to such detail. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of the present disclosure, and will occur to those skilled in the art. Further, alternatively, the structure of each element associated with the described forms may be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may also be used. It should be understood, therefore, that the foregoing detailed description and the appended claims are intended to cover all such modifications, combinations and permutations as fall within the scope of the disclosed forms of the invention. It is intended that the following claims cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
The foregoing detailed description has set forth various forms of the devices and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and/or writing the code for the software and or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as one or more program products in a variety of forms, and that an illustrative form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.
Instructions for programming logic to perform the various disclosed aspects may be stored within a memory in a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Further, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc read-only memories (CD-ROMs), and magneto-optical disks, read-only memories (ROMs), Random Access Memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or a tangible, machine-readable storage device used in transmitting information over the internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
As used in any aspect herein, the term "control circuitry" can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor that includes one or more separate instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Programmable Logic Arrays (PLAs), Field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, e.g., an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that implements, at least in part, the methods and/or apparatus described herein, or a microprocessor configured by a computer program that implements, at least in part, the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion, or some combination thereof.
As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., non-volatile) in a memory device.
As used in any aspect herein, the terms "component," "system," "module," and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, or software in execution.
An "algorithm," as used in any aspect herein, is a self-consistent sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states which may, but do not necessarily, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. And are used to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or conditions.
The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may be capable of allowing communication using the transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with the ethernet Standard entitled "IEEE 802.3 Standard" promulgated by the Institute of Electrical and Electronics Engineers (IEEE) at 12 months 2008 and/or higher versions of the Standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or be compatible with standards promulgated by the international telecommunication union, telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the international telegraph telephone consultancy (CCITT) and/or American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS Network Interworking 2.0" promulgated by the ATM forum at 8 months 2001 and/or higher versions of that standard. Of course, different and/or later-developed connection-oriented network communication protocols are also contemplated herein.
Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
One or more components may be referred to herein as "configured to be able," "configurable to be able," "operable," "adapted/adaptable," "able," "conformable/conforming," or the like. Those skilled in the art will recognize that "configured to be able to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state unless the context indicates otherwise.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.
In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing in the detailed description, claims, or drawings, should be understood to encompass the possibility of including one of the terms, either of the terms, or both terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".
Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. Additionally, while the various operational flow diagrams are listed in one or more sequences, it should be understood that the various operations may be performed in other sequences than the illustrated sequences, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.
It is worthy to note that any reference to "an aspect," "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.
In this specification, unless otherwise indicated, the term "about" or "approximately" as used in this disclosure refers to an acceptable error for a particular value as determined by one of ordinary skill in the art, depending in part on how the value is measured or determined. In certain embodiments, the term "about" or "approximately" means within 1, 2, 3, or 4 standard deviations. In certain embodiments, the term "about" or "approximately" means within 50%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.05% of a given value or range.
In the present specification, unless otherwise indicated, all numerical parameters should be understood as being referred to or modified in all instances by the term "about" where the numerical parameter is characterized by the inherent variability of the underlying measurement technique used to determine the numerical value of the parameter. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter described herein should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
Any numerical range recited herein includes all sub-ranges subsumed within the recited range. For example, a range of "1 to 10" includes all sub-ranges between the recited minimum value of 1 and the recited maximum value of 10 (including 1 and 10), that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10. Moreover, all ranges recited herein include the endpoints of the listed ranges. For example, a range of "1 to 10" includes the endpoints 1 and 10. Any upper limit recited in this specification is intended to include all lower limits subsumed therein and any lower limit recited in this specification is intended to include all higher limits subsumed therein. Accordingly, applicants reserve the right to modify this specification (including the claims) to specifically list any sub-ranges encompassed within the specifically listed range. All such ranges are inherently described in this specification.
Any patent applications, patents, non-patent publications or other published materials mentioned in this specification and/or listed in any application data sheet are herein incorporated by reference, to the extent that the incorporated materials are not inconsistent herewith. Thus, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
In summary, a number of benefits have been described that result from employing the concepts described herein. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms selected and described are to be illustrative of the principles and practical applications to thereby enable one of ordinary skill in the art to utilize the various forms and modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.
Claims (21)
1. An electrosurgical instrument comprising an end effector, the end effector comprising:
a first jaw, the first jaw comprising:
a first electrically conductive backbone;
a first insulating coating selectively covering portions of the first electrically conductive backbone; and
a first jaw electrode comprising an exposed portion of the first electrically conductive skeleton;
a second jaw, wherein at least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw, the second jaw comprising:
a second electrically conductive skeleton;
a second insulating coating selectively covering portions of the second electrically conductive skeleton; and
a second jaw electrode comprising an exposed portion of the second electrically conductive skeleton; and
an electrical circuit configured to be capable of transmitting bipolar RF energy and monopolar RF energy to the tissue through the first jaw electrode and the second jaw electrode, wherein the monopolar RF energy shares first and second electrical paths defined by the electrical circuit for transmitting the bipolar RF energy.
2. An electrosurgical instrument according to claim 1, wherein the electrical circuit defines a third electrical pathway separate from the first and second electrical pathways.
3. The electrosurgical instrument of claim 2, wherein the end effector comprises a cutting electrode electrically insulated from the first and second electrically conductive scaffolds.
4. The electrosurgical instrument of claim 3, wherein the cutting electrode is configured to receive cutting monopolar RF energy through the third electrical path.
5. The electrosurgical instrument of claim 4, wherein the cutting electrode is configured to cut the tissue with the cutting monopolar RF energy after coagulation of the tissue has been initiated by the bipolar RF energy.
6. The electrosurgical instrument of claim 3, wherein the cutting electrode is centrally located in one of the first and second jaws.
7. The electrosurgical instrument of claim 4, wherein the end effector is configured to deliver the cutting monopolar RF energy and the bipolar RF energy to the tissue simultaneously.
8. The electrosurgical instrument of claim 1, wherein the first jaw electrode comprises a first distal tip electrode, and wherein the second jaw electrode comprises a second distal tip electrode.
9. The electrosurgical instrument of claim 8, wherein first and second electrically conductive scaffolds are simultaneously energized to deliver the monopolar RF energy to a tissue surface through the first and second distal tip electrodes.
10. The electrosurgical instrument of claim 1, wherein the second jaw comprises a dissection electrode extending along a peripheral surface of the second jaw.
11. An electrosurgical instrument, comprising:
an end effector, the end effector comprising:
at least two electrode sets;
a first jaw; and
a second jaw, wherein at least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw, and wherein the end effector is configured to deliver a combination of bipolar RF energy and monopolar RF energy from the at least two electrode sets to the grasped tissue; and
circuitry configured to be capable of transmitting the bipolar RF energy and the monopolar RF energy, wherein the monopolar RF energy shares an active path and a return path defined by the circuitry for transmitting the bipolar RF energy.
12. The electrosurgical instrument of claim 11, wherein the at least two electrode sets comprise three electrical interconnects used together in the circuit.
13. The electrosurgical instrument of claim 11, wherein the at least two electrode sets comprise three electrical interconnects defining at least a portion of the electrical circuit and another separate electrical circuit.
14. The electrosurgical instrument of claim 13, wherein the separate electrical circuit leads to a cutting electrode of the at least two electrode sets, the cutting electrode being isolated and centrally located in one of the first and second jaws.
15. The electrosurgical instrument of claim 14, wherein the cutting electrode is configured to cut the tissue after coagulation of the tissue has been initiated using the second and third electrodes of the at least two electrode sets.
16. The electrosurgical instrument of claim 15, wherein the at least two electrode sets are configured to deliver the monopolar RF energy and the bipolar RF energy to the tissue simultaneously.
17. An electrosurgical instrument, comprising:
an end effector, the end effector comprising:
a first jaw; and
a second jaw, wherein at least one of the first jaw and the second jaw is movable to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw, and wherein the second jaw comprises a composite scaffold of at least two different materials configured to selectively create an electrically conductive portion and a thermally isolated portion.
18. The electrosurgical instrument of claim 17, wherein the composite backbone comprises a titanium ceramic composite.
19. The electrosurgical instrument of claim 18, wherein the composite scaffold comprises:
a ceramic base; and
a titanium crown attachable to the ceramic base.
20. The electrosurgical instrument of claim 17, wherein the composite backbone portion is coated with an electrically insulating material.
21. A method for manufacturing jaws of an end effector of an electrosurgical instrument, the method comprising:
preparing a composite skeleton of the jaws by fusing titanium powder with ceramic powder in a metal injection molding process; and
selectively coating the composite skeleton with an electrically insulating material to produce a plurality of electrodes.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US201962955299P | 2019-12-30 | 2019-12-30 | |
US62/955,299 | 2019-12-30 | ||
US16/885,881 US20210196361A1 (en) | 2019-12-30 | 2020-05-28 | Electrosurgical instrument with monopolar and bipolar energy capabilities |
US16/885,881 | 2020-05-28 | ||
PCT/IB2020/060780 WO2021137025A1 (en) | 2019-12-30 | 2020-11-16 | Electrosurgical instrument with monopolar and bipolar energy capabilities |
Publications (1)
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CN114901167A true CN114901167A (en) | 2022-08-12 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN202080091268.4A Pending CN114901167A (en) | 2019-12-30 | 2020-11-16 | Electrosurgical instrument with monopolar and bipolar energy capabilities |
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JP (1) | JP2023508549A (en) |
CN (1) | CN114901167A (en) |
BR (1) | BR112022012592A2 (en) |
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2020
- 2020-11-16 CN CN202080091268.4A patent/CN114901167A/en active Pending
- 2020-11-16 JP JP2022540431A patent/JP2023508549A/en active Pending
- 2020-11-16 BR BR112022012592A patent/BR112022012592A2/en unknown
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JP2023508549A (en) | 2023-03-02 |
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