Systems and methods for tissue sealing and cutting

Abstract

Electrosurgical device systems comprising an electrosurgical device comprising a sealing electrode and a cutting element and methods of operating the electrosurgical device can comprise activating sealing energy to perform a sealing operation to seal an anatomic structure with the sealing electrode of the electrosurgical device, determining a first parameter indicative of progress of the sealing operation, comparing the first parameter to a first threshold parameter, automatically activating the cutting element to perform a cutting operation to cut the anatomic structure with the electrosurgical device if the first parameter of the sealing energy is within a tolerance band of the first threshold parameter, completing the sealing operation, and completing the cutting operation.

Description

SYSTEMS AND METHODS FOR TISSUE SEALING AND CUTTINGPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 740,482, filed December 31, 2024, the contents of which are incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] The present disclosure is generally directed to, but not by way of limitation, systems, devices and methods for performing tissue sealing and cutting procedures, such as can be used in various surgical procedures. More specifically, but not by way of limitation, the present disclosure is directed to systems and methods for controlling energy delivery modes for tissue sealing and cutting procedures.BACKGROUND

[0003] Various different types of energy, e.g., radio frequency (RF) or other electromagnetic energy, plasma energy, resistive heating, and ultrasound energy, can be used for vessel sealing, tissue cutting or cautery, tissue ablation, and tissue coagulation, among other things, alone or in combination with mechanical energy delivery (e.g., using a sharp cutting instrument) or manipulation (e.g., using a forceps). Many types of monopolar and bipolar energy devices exist for different surgical purposes. In an example of an electrosurgical device, e.g., a device configured to deliver electrical energy, a forceps can be utilized for laparoscopic surgery. The forceps can be deployed inside a patient and can include a tissue gripping assembly and a cutting assembly. Further, the forceps can utilize electrical energy in the gripping assembly. Electrosurgical sealing forceps can further include or use an energy device such as RF, ultrasonic, and microwave vessel sealing devices. The gripping assembly can clamp tissue, and biological matter of the clamped tissue, such as one or both of elastin and collagen of the clamped tissue, can be melted by the energy device to seal the tissue. For example, collagen can melt before elastin, e.g., at lower temperatures.

[0004] Electrosurgical medical devices generally fall into one of two categories: monopolar medical devices and bipolar medical devices. A monopolar medical device can1Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01include an active electrode electrically connected to an electrosurgical generator. A return electrode is also electrically connected to the electrosurgical generator and can be placed in contact with a patient. Typical return electrodes in a monopolar medical device can take the form of a patient pad that is located remotely from the electrosurgical medical device. In use, electrical current is passed from the electrosurgical generator to the active electrode, through a site or a region of the anatomy of the patient (e.g., a tissue or a vessel) to the patient pad, and back to the electrosurgical generator. A bipolar medical device can include an active electrode and a return electrode adjacent or proximate to the active electrode, both of which are electrically connected to an electrosurgical generator. Furthermore, each electrode of a bipolar device can be located on or in the electrosurgical medical device. In use, an anatomic feature such as a vessel is placed between the active and return electrodes, and electrical current passes from the electrosurgical generator to the active electrode, through the anatomic feature to the adjacent return electrode, and then back to the electrosurgical generator.

[0005] Examples of tissue sealing devices are described in Pat. No. US 9,918,774 to Batchelor et al, titled “Resistively Heated Electrosurgical Device”; Pat. No. US 11,020,166 to Batchelor et al., titled “Multifunctional Medical Device”; Pat. No. US 9,474,569 to Manzo et al., titled “Surgical Instrument with End Effector Comprising Jaw Mechanism and Translating Component, and Related Method”; and Pub. No. US 2021 / 0153927 to Ross et al., titled “Electrosurgical Instrument with Compliant Elastomeric Electrode.” Pat. No. US 7,033,356 to Latterell et al, titled “Bipolar Electrosurgical Instrument for Cutting Desiccating and Sealing Tissue” describes electrosurgical forceps with jaws containing componentry configured to seal and cut tissue. Existing electrosurgical devices capable of sealing and cutting tissue require a user to manually initiate the tissue sealing function, evaluate when to cease the tissue sealing, and then manually initiate the cutting function.OVERVIEW OF THE PRESENT DISCLOSURE

[0006] Surgical instruments configured to perform both sealing and cutting functions are becoming increasingly useful. These devices can utilize bipolar sealing energy in the form of Radio Frequency (RF) energy, which can be used for vessel sealing. RF sealing devices are becoming common in surgical procedures, at times even replacing scalpel and sutures. RF vessel sealing devices can apply alternating current (AC) energy at high frequency to modify the targeted tissues with electrical energy. For example, RF energy can more effectively affect the collagen fibers within tissue without the electrical muscle stimulation associated 2Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01with direct current (DC) or low frequency AC. For this and other reasons, RF vessel sealing devices can simplify and reduce the time that procedures take compared to traditional methods, such as scalpel and suture procedures. Additionally, since the tissue of the patient is used to seal the vessel, the introduction of foreign objects into the wound site, from more traditional methods, such as sutures, which, in some cases, may cause a reaction in the patient, can be avoided. As such, bipolar RF energy is typically favored for performing tissue sealing operations.

[0007] Some sealing devices also include a cutting element to cut tissue after a seal is formed. For example, some devices may include a cutting electrode (either a monopolar or bipolar electrode) or a cutting member (such as a mechanical blade) to cut tissue after a sealing action is complete.

[0008] Some conventional sealing devices incorporate two-stage sealing and cutting operations wherein the sealing operation and the cutting operation comprise two discrete operations from the operator. Thus, it is typically the case where the sealing operation is performed and concluded before the cutting operation is performed. For example, many handheld devices utilize separate buttons for activating sealing energy and cutting energy. Alternatively, many handheld devices use electrical sealing power and mechanical cutting means. In any event, it is up to the discretion and judgment of the operator to determine when to stop applying sealing energy and start performing the cutting operation, such as by switching buttons. Some electrosurgical systems provide a limited amount of feedback, such as by outputting an audible or visual alarm, when the system determines that it is likely a sealing operation has been completed. For example, the system can emit a beep when it is determined that the seal is complete, or a level of resistance can be displayed on output monitor or screen for reference by the operator to aid in completing a sealing operation. However, it is still up to the operator to ultimately decide that the sealing is complete, thereby requiring the surgeon to switch to operating the cut button. As previously mentioned, some handheld systems and robotic systems utilize electrical cutting energy (e.g., monopolar or bipolar energy) or a mechanical cutting blade. In the case of a handheld electrosurgical sealing device, a first sealing button can control output of a waveform suitable for sealing tissue and not destroying the tissue, e.g., to allow the collagen to form a seal, and a second cutting button can control output of a waveform or blade to destroy and cut tissue.3Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0009] In view of these problems and constraints recognized by the present inventor, the presently disclosed subject matter can provide solutions to these and other problems, such as by providing an electrosurgical system having a controller and instructions stored therein for controlling generation of electrosurgical sealing energy and activation of a cutting element (e.g., either via electrosurgical cutting energy for a cutting electrode or via a control signal for an actuator of a cutting member, such as a cutting blade) to automatically perform both operations. As such, reliance on judgment or an operator in determining when to transition from a sealing operation to a cutting operation can be reduced or eliminated in various embodiments. In examples, an electrosurgical device can be used with the electrosurgical system that includes only a single energy activation button. Thus, the electrosurgical system can control output of sealing energy and a cutting function or operation with a single push of a single button. Additionally, robotic surgical systems can be automatically controlled to transition from performing a sealing operation to performing a cutting operation.

[0010] When the controller for the electrosurgical systems of the present disclosure, whether hand-held or robotic, determines that a seal is completed or sufficiently completed, or predicted to be successfully completed, the electrosurgical system can activate a cutting operation (either via cutting energy or via movement of a cutting blade). In examples, the sealing operation and the cutting operation can be activated sequentially such that the sealing operation is completed before the cutting operation is initiated. In examples, the sealing energy and the cutting operation can be activated in a blended manner such that the sealing operation is partially completed when the cutting operation is initiated, thereby allowing contemporaneous completion of both operations. In examples, the sealing energy and the cutting operation can be activated simultaneously. With the present disclosure, it is even possible for a cutting operation to be performed before a sealing operation, such as if an anatomic structure is being clamped to stop blood flow and / or it is predicted, such as via sensed tissue or device parameters, that a sealing operation is likely to be successfully completed.

[0011] The electrosurgical systems of the present disclosure can determine that a seal is completed or suitably completed to allow cutting to commence by monitoring the state of tissue, monitoring the state of the electrosurgical device and / or by monitoring time. In examples, the control system can monitor electrical parameters of the sealing energy, such as phase angle, resistance, impedance, voltage, current and power to determine a tissue state. In4Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01examples, the control system can monitor total energy input into the tissue to determine when boiling of fluid within the tissue occurs to determine a tissue state. In examples, the control system can monitor a jaw state of an end effector including the electrosurgical electrodes or pressure between jaws to determine a state of an electrosurgical device. In examples, the control system can monitor a visual state of the tissue within jaws of an end effector to determine if a cutting operation can be commenced, such as by determining a color or a change in color of tissue.

[0012] In examples, the electrosurgical systems of the present disclosure can determine if a minimum or maximum magnitude, a change or a rate of change of the sensed electrosurgical sealing energy or determined device state is sufficient, e.g., meets or exceeds a predetermined threshold, to determine when a sealing operation is sufficient for cutting to commence. In additional examples, the electrosurgical systems of the present disclosure can determine if the early progress of a sensed electrosurgical sealing energy or an early device state corresponds to feedback expected to eventually achieve a desired seal if a sealing operation is carried to conclusion, thereby predicting a successful seal operation before a sealing operation has started or while a sealing operation is being performed, so that a cutting operation can begin even before blood flow within the tissue has been inhibited or stopped. In examples, the control system can utilize time measurements to determine when the application of electrosurgical sealing energy is sufficiently applied to begin the cutting operation.

[0013] In examples, the electrosurgical systems of the present disclosure can determine multiple tissue states, e.g., resistance and phase angle, device states, e.g., jaw position and jaw pressure, time states and combinations thereof to determine when to transition between performing a sealing operation and performing a cutting operation.

[0014] In an example, a method of operating an electrosurgical device comprising a sealing electrode and a cutting element can comprise activating sealing energy to perform a sealing operation to seal an anatomic structure with the sealing electrode of the electrosurgical device, determining a first parameter indicative of progress of the sealing operation, comparing the first parameter to a first threshold parameter, automatically activating the cutting element to perform a cutting operation to cut the anatomic structure with the electrosurgical device if the first parameter of the sealing energy is within a5Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01tolerance band of the first threshold parameter, completing the sealing operation, and completing the cutting operation.

[0015] In an additional example, an electrosurgical device can comprise a shaft comprising a distal end section and a proximate end section, a jaw assembly coupled to the distal end section of the shaft, the jaw assembly comprising a first jaw member, a second jaw member, a first sealing electrode positioned on the first jaw member, a second sealing electrode positioned on the second jaw member, a cutting element positioned on one of the first jaw member or the second jaw member, wherein the first sealing electrode and the second sealing electrode are configured to deliver sealing energy for performing a tissue sealing operation on an anatomic structure, and the cutting element is configured to perform a tissue cutting operation on the anatomic structure, and a monitoring device configured to evaluate performance of the tissue sealing operation, a controller, and a memory device comprising instructions that, when executed by the controller, are configured to cause the controller to operate the monitoring device to determine a first parameter of the tissue sealing operation, and based on the first parameter of the tissue sealing operation determined by the monitoring device, automatically initiate the tissue cutting operation without additional user input if the first parameter is within a tolerance band of a first threshold parameter.

[0016] In another example, an electrosurgical device can comprise a shaft comprising a distal end section and a proximate end section; and a jaw assembly coupled to the distal end section of the shaft, wherein the jaw assembly comprises a first jaw member, a second jaw member, a cutting electrode positioned on one of the first jaw member or the second jaw member, a first sealing electrode positioned on the first jaw member, the first sealing electrode comprising a first contact surface angled toward the cutting electrode, and a second sealing electrode positioned on the second jaw member, the second sealing electrode comprising a second contact surface angled toward the cutting electrode, wherein the first sealing electrode and the second sealing electrode are configured to deliver sealing energy for performing a tissue sealing operation on an anatomic structure, and the cutting electrode is configured to perform a tissue cutting operation on the anatomic structure.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. l is a side view of an example electrosurgical system having an end effector comprising forceps for performing cutting and sealing operations.6Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0018] FIG. 2 is a block diagram showing example components of an electrosurgical system having electrodes capable of performing one or more of the methods, procedures and / or operations discussed herein.

[0019] FIG. 3 A is a perspective view of a jaw assembly of a forceps comprising electrodes in accordance with some aspects of the present disclosure.

[0020] FIG. 3B is a side view of the jaw assembly of FIG. 3 A with an anatomic vessel positioned between jaw members.

[0021] FIG. 4 is a schematic cross-sectional view of the jaw assembly of FIG. 3 A showing electrodes configured in accordance with some aspects of the present disclosure.

[0022] FIG. 5 is a close-up schematic view of the bottom jaw of the jaw assembly of FIG.3 A showing a vessel.

[0023] FIG. 6 is a block diagram of an electrosurgical system for performing sealing and cutting operations of tissue engaged by an electrosurgical instrument and obtaining electrical feedback from the biological tissue being operated upon.

[0024] FIG. 7 is a graph depicting examples of an electrical-power schedule used to control electrical power provided to biological tissue having sealing and cutting operations performed thereon.

[0025] FIG. 8 is a block diagram illustrating example methods of performing an electrosurgical sealing and cutting operation of the present disclosure involving sensing of an electrical parameter of tissue being sealed to determine when to commence cutting operations.

[0026] FIG. 9 is a block diagram illustrating example methods of performing an electrosurgical sealing and cutting operation of the present disclosure involving sensing energy consumption to boil of tissue being sealed to determine when to commence cutting operations.

[0027] FIG. 10A is a block diagram showing example components of an electrosurgical system having a video feedback system capable of performing one or more of the methods, procedures and operations discussed herein.

[0028] FIG. 10B is a schematic perspective view of an electrosurgical end effector suitable for use with the electrosurgical system of FIG. 10A and that includes an external camera device.7Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0029] FIG. 10C is a block diagram illustrating example methods of performing sealing and cutting operations of the present disclosure involving determining device states to determine when to commence cutting operations.

[0030] FIG. 11 A a diagram illustrating a method for activating cutting energy based upon a preset time from when sealing energy is activated, wherein the cutting energy is activated at least partially contemporaneously with the sealing energy.

[0031] FIG. 1 IB a diagram illustrating a method for activating cutting energy based upon a preset time from when sealing energy is activated, wherein the cutting energy is activated after the sealing energy.

[0032] FIG. 11C a diagram illustrating a method for activating cutting energy based upon a preset time from when sealing energy is activated, wherein the cutting energy is activated in between first and second stage sealing energy applications.

[0033] FIG. 1 ID a diagram illustrating a method for activating cutting energy based upon a preset time from when sealing energy is concluded, wherein the cutting energy is activated after a pause in the application of sealing energy.

[0034] FIG. 12A is a schematic illustration of an articulatable shaft suitable for use with the jaw assembly of FIG. 3 A.

[0035] FIG. 12B is a schematic illustration of a robotic surgical system suitable for use with the systems, devices and methods described herein, such as the articulatable shaft of FIG. 12 A.

[0036] FIG. 13 A is a schematic illustration of an electrosurgical end effector connected to a single radio frequency (RF) energy source for performing both sealing and cutting operations.

[0037] FIG. 13B is a schematic illustration of an electrosurgical end effector connected to two radio frequency (RF) energy sources for performing sealing and cutting operations, respectively.

[0038] FIG. 14A is a schematic illustration of an end effector clamping down on an anatomic vessel before sealing energy is applied and a timescale of power to be applied to the anatomic vessel to perform a sealing operation.

[0039] FIG. 14B is a schematic illustration of the end effector of FIG. 14A clamping down on an anatomic vessel and a first phase application of sealing energy where steam8Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01begins to form between walls of the anatomic structure, as indicated on the timescale of applied power.

[0040] FIG. 14C is a schematic illustration of the end effector of FIG. 14B clamping down on an anatomic vessel and a second phase application of sealing energy where steam begins to form within tissue of the anatomic structure, as indicated on the timescale of applied power.

[0041] FIG. 14D is a schematic illustration of the end effector of FIG. 14C clamping down on an anatomic vessel and application of cutting energy, as indicated on the timescale of applied power.

[0042] FIG. 14E is a schematic illustration of the end effector of FIG. 14D clamping down on an anatomic vessel and a third phase application of sealing energy causing congealing of collagen, as indicated on the timescale of applied power.

[0043] FIG. 15 is a schematic diagram of a machine learning model system illustrating inputs for determining cycles of energy application to achieve automatic sealing and cutting effects.

[0044] FIG. 16 is a schematic diagram of a computing system for use with the electrosurgical systems described herein.DETAILED DESCRIPTION

[0045] FIG. 1 is a schematic side view of electrosurgical system 100. Electrosurgical system 100 can comprise medical device 102 and processing unit 104, which can be connected to user interface 105. Medical device 102 can comprise handpiece 106 and end effector assembly 108. As described herein, electrosurgical system 100 can be configured to allow end effector assembly 108 to perform a sealing operation and a cutting operation. Specifically, in some embodiments, end effector assembly 108 may include a cutting blade (alternatively referred to herein as a “cutting member”) to perform the cutting operation. However, in alternative embodiments end effector assembly 108 may perform the cutting operation via electrosurgical cutting energy (either bipolar or monopolar energy).

[0046] Electrosurgical system 100 can be configured to deliver bipolar sealing energy in RF and resistive forms to a pair of bipolar electrodes, and in embodiments in which the cutting operation is performed via electrosurgical cutting energy, bi-polar or monopolar cutting energy may be delivered in RF and / or resistive forms to bipolar electrodes or a single monopolar electrode positioned between the bipolar electrodes. Furthermore, in various 9Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01embodiments, electrosurgical system 100 can be configured to automatically perform a cutting operation while or after sealing energy is being delivered to perform a sealing operation. In examples, processing unit 104 can use feedback obtained while performing sealing to decide when to begin the cutting operation, thereby reducing the risk of incompletely forming the seal and shortening the time it takes to complete cutting after the seal is formed. The feedback can be obtained from the tissue being sealed, such as by sensing an electrical parameter or color of the tissue within the end effector assembly 108; by sensing a state of medical device 102, such as a position or pressure being applied by end effector assembly 108 or temperature within an end effector; or by determining a time limit, such as from when sealing begins or when sealing is concluded.

[0047] End effector assembly 108 can comprise jaw assembly 110. Alternatively, or additionally, end effector assembly 108 can include or use a “J-shaped Hook” type electrode or other electrode types for surgery. Jaw assembly 110 can comprise first jaw member 112 and second jaw member 114. First jaw member 112 and second jaw member 114 can be pivotably coupled about a pivot axis at pivot point 116 located on or distal of shaft 118. Shaft 118 can couple end effector assembly 108 to handpiece 106. Drives 120 can be included or used in medical device 102, such as housed within handpiece 106 and mechanically coupled to end effector assembly 108. Also, drives 120 can be included at or near the distal end of end effector assembly 108 to directly drive jaw assembly 110 without linkages extending through shaft 118. Drives 120 can be any suitable drive associated or coupled with the end effector assembly 108 in any arrangement, including, e.g., robotic applications.

[0048] Medical device 102 can comprise lever 122, trigger 123, first button 124, knob 125 and second button 126. Shaft 118 can include articulating section 127. Lever 122 can be used to actuate first jaw member 112 and / or second jaw member 114, such as to cause relative rotation therebetween. Trigger 123 can be used to activate articulating section 127, so as to cause bending of shaft 118. First button 124 can be used to lock first jaw member 112 and second jaw member 114 in place, such as in a relative rotational position. Knob 125 can be used to rotate shaft 118 to change the radial orientation of first jaw member 112 and second jaw member 114. Second button 126 can be used to activate electrosurgical energy of jaw assembly 110, as can be generated at processing unit 104. In a particular example, second button 126 can be used to deliver bipolar energy and / or monopolar energy to first jaw10Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01member 112 and second jaw member 114, such as with a single depression of second button 126. However, the functionality of lever 122, trigger 123, first button 124, knob 125 and second button 126 can be arranged in other configurations or combinations. Handpiece 106 can include grip 107, e.g., a pistol grip, to facilitate ergonomic grasping of medical device 102 and ergonomic access to lever 122, trigger 123, first button 124, knob 125 and second button 126.

[0049] As mentioned, end effector assembly 108 can include a cutting member. In examples, the cutting member can comprise a knife, a razor or another type of blade or saw configured to cut, slice or incise tissue positioned between first jaw member 112 and second jaw member 114. The cutting member can be connected to one of drives 120 or another device, such as a motor or linear actuator, to move the cutting member forward and backward, e.g., distally and proximally, between first jaw member 112 and second jaw member 114. As described herein a drive connected to the cutting member can be connected to processing unit 104 to be automatically activated to perform a cutting operation when, for example, the triggers discussed herein have been reached. In operation, the cutting member can be retracted into shaft 118 while first jaw member 112 and second jaw member 114 engage tissue and perform a sealing operation, for example. After the sealing operation, a user of medical device 102 can press an activator, such as lever 122 (FIG. 1) on handpiece 106, to cause the cutting member to move distally in between first jaw member 112 and second jaw member 114, thereby slicing through tissue held in place by first jaw member 112 and second jaw member 114. After the slicing operation, the cutting member can be retracted back into shaft 118 out of first jaw member 112 and second jaw member 114. In examples, the cutting member can be configured according to the cutting blades described in US 2024 / 0081848 Al to Holton et al., titled “Forceps with Two-Part Drive Bar,” the entire contents of which are incorporated herein by this reference.

[0050] Electrosurgical system 100 can also include or use one or more of sensor 128 for determining a tissue characteristic or an activation energy characteristic. For example, sensor 128 can comprise sensors for sensing an electrical parameter or imaging sensors for sensing a video parameter. Sensor 128 can include an electrical sensor for measuring one or more electrical properties such as electrical properties of tissue, e.g., resistance, capacitance, or inductance. In examples, sensor 128 can include or comprise a resistance sensor. In examples, sensor 128 can comprise a temperature sensor. In examples, sensor 128 can11Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01include or comprise a pressure sensor. More specifically, sensor 128 can also include an electrical sensor or electrode, such as for providing electrical characterization (e.g., phase angle, resistance) of tissue compressed between first jaw member 112 and second jaw member 114, either during or after or interleaved with application of electrosurgical treatment energy to the tissue. Sensor 128 can be located internally within the end effector assembly 108, for example, a component of one or more of first jaw member 112 and second jaw member 114, as shown in FIG. 3B, or externally to end effector assembly 108, as shown in FIG. 10B. As depicted in FIG. 1, sensor 128 can be integrated at or near the end effector assembly 108. In examples, sensor 128 can be separate from end effector assembly 108, such as extending from another shaft of medical device 102, a shaft of another instrument, or such a shaft as extending from another device such as a robotic arm or videoscope. In examples, sensor 128 can comprise one or more imaging sensors, e.g., cameras, located at or near the distal end of end effector assembly 108, on a jaw of the jaw assembly 110, or integrated with an end effector assembly 108, such as a J-hook. However, imaging sensors or cameras can be attached to other portions of medical device 102.

[0051] In the illustrative example, electrosurgical system 100 can provide waveforms to one or more electrodes, such as first electrode 140, second electrode 142 and third electrode 144 of FIG. 2 and FIG. 3 A. Such energy output can be used to treat the tissue, such as to seal, cut, ablate, fulgurate, and / or desiccate, among other effects. End effector assembly 108 can include one or more of first electrode 140, second electrode 142 and third electrode 144 integrated into a forceps, as well as a remote return electrode, such as, but not limited to a return electrode pad that can be placed, for example, on the body of the patient, such as pad 148 (FIG. 2). Waveforms delivered by processing unit 104 can be configured for monopolar and bipolar operation, as well as RF operation and resistive operation. The energy outputs of the present disclosure can be configured to automatically seal and cut tissue in a single operation and can therefore, in some cases, have lower energy output, reducing energy consumption of the device and reduce procedure times.

[0052] FIG. 2 is a schematic illustration of circuitry of electrosurgical system 100.Electrosurgical system 100 can comprise medical device 102 and processing unit 104.Medical device 102 can comprise handpiece 106 and end effector assembly 108. Processing unit 104 can comprise and therapy power supply 132. Therapy power supply 132 can provide therapeutic power to medical device 102. Medical device 102 can include first12Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01electrode 140, second electrode 142, third electrode 144. Pad 148 can be in electrical communication with medical device 102 and therapy power supply 132.

[0053] First therapeutic power connection 150, which can include first therapeutic power switch 152, can extend between therapy power supply 132 and first electrode 140. Second therapeutic power connection 154, which can include second therapeutic power switch 156, can extend between therapy power supply 132 and first electrode 140. Third therapeutic power connection 158 can extend between therapy power supply 132 and first electrode 140, which can provide therapeutic power to first electrode 140. When first therapeutic power switch 152, second therapeutic power switch 156, or both is open, therapeutic power is restricted from communicating to first electrode 140. However, when at least one of first therapeutic power switch 152 and second therapeutic power switch 156 are closed, therapeutic power can be provided from therapy power supply 132 to first electrode 140.

[0054] Fourth therapeutic power connection 170 and fifth therapeutic power connection 172 can extend between therapy power supply 132 and second electrode 142 and third electrode 144, respectively. Sixth therapeutic power connection 174, which can include electrode switch 176, can extend between therapy power supply 132 and third electrode 144. Pad connection 178 can extend between therapy power supply 132 and pad 148. When electrode switch 176 is open, therapeutic power is restricted from communicating to third electrode 144. However, when electrode switch 176 is closed, therapeutic power can be provided from therapy power supply 132 to third electrode 144. In examples, fourth therapeutic power connection 170 can additionally be provided with an electrode switch similar to electrode switch 176.

[0055] During operation, when at least one of first therapeutic power switch 152 and second therapeutic power switch 156 are closed, therapeutic power can be communicated from therapy power supply 132 to first electrode 140 and communicated back to therapy power supply 132 via second electrode 142, third electrode 144, or both (i.e., bipolar mode). Alternatively, therapeutic power can be communicated back to therapy power supply 132 via pad 148 (monopolar mode).

[0056] Moreover, by closing electrode switch 176, therapeutic power can be communicated from therapy power supply 132 to third electrode 144 and back to therapy power supply 132 via second electrode 142 (bipolar mode). While therapeutic power is communicated between second electrode 142 and third electrode 144, therapeutic power, can13Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01be provided to first electrode 140. Moreover, one of first therapeutic power switch 152 and second therapeutic power switch 156 can be opened to prevent the supply of therapeutic power to first electrode 140 while therapeutic power is being communicated between second electrode 142 and third electrode 144.

[0057] With the present disclosure, RF sealing energy can be delivered to second electrode 142 and third electrode 144 to seal a vessel. During application of the RF sealing energy, sensor 128 (FIG. 1), or another sensing arrangement such as the electrosurgical electrodes or a camera, can obtain feedback from the tissue to which sealing therapy is being delivered from second electrode 142 and third electrode 144 or from the device applying energy to the tissue. The feedback from sensor 128 can be in the form of an electrical parameter, such as resistance measurements, voltage measurements, phase angle measurements and power measurements, that can be correlated to resistance values of different tissue types that provide indications of when sealing is complete or near complete. However, other types of feedback can be used. For example, pressure feedback, temperature feedback and video feedback can be used. In examples, multiple types of feedback can be used to provide increasing levels of certainty regarding the status or completion of the sealing operation. When it is determined that the sealing operation is complete, e.g., blood flow has been stopped within sealed tissue, or nearly complete, e.g., blood flow has been sufficiently slowed or weakened, therapeutic power can be communicated from therapy power supply 132 to first electrode 140 to cut the sealed tissue or to mechanically cut the sealed tissue as described herein. In additional examples, cutting of tissue being sealed can be based on predicting that the tissue will be able to be sealed. Thus, when it is predicted that the sealing operation will be complete or partially complete, e.g., when it is determined that sensed or monitored characteristics of the tissue, or proxies thereof, are adequately progressing toward sealing, therapeutic power can be communicated from therapy power supply 132 to first electrode 140 to cut the tissue to be sealed or to mechanically cut the tissue to be sealed as described herein. For example, when jaws of a forceps are actively clamping down on tissue to inhibit or prevent blood flow therethrough, cutting operations can commence as soon as the system is able to confidently predict that sealing will be completed upon application of the desired or intended amount of energy is applied, thereby allow cutting to begin sooner and reducing the overall time to perform a seal and cut operation. In examples, conditions14Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01that can lead to the prediction of an unsuccessful sealing operation can include the presence of a foreign object within sealing jaws or if there is too much steam or moisture in the tissue.

[0058] FIG. 3A is a perspective view of jaw assembly 110 comprising first jaw member 112 and second jaw member 114. Jaw assembly 110 can be connected to shaft 118. First jaw member 112 and second jaw member 114 can be connected at pivot point 116.

[0059] First jaw member 112 can comprise elongate body 200 comprising first plate 202A and second plate 202B. First insulator 204 can be positioned between first plate 202A and second plate 202B. Second jaw member 114 can comprise elongate body 210 comprising first plate 212A and second plate 212B. Second insulator 214 can be positioned between first plate 212A and second plate 212B. First electrode 216 can be positioned on second insulator 214. In examples, first electrode 216 can comprise first electrode 140 of FIG. 2, elongate body 210 can comprise second electrode 142 of FIG. 2, and elongate body 200 can comprise third electrode 144 of FIG. 2.

[0060] First insulator 204 and second insulator 214 can be fabricated from an insulating material and can function to restrict or prevent accidental arcing and / or heat transfer between the electrodes. First plate 202A, second plate 202B, first plate 212A and second plate 212B can each include a functional feature. For example, the functional feature can comprise teeth, such as serrations. Furthermore, as shown in FIG. 5, one or more of first plate 202A, second plate 202B, first plate 212A and second plate 212B can include one or more standoffs or stops, such as standoff 222A and standoff 222B, to prevent direct contact between first jaw member 112 and second jaw member 114.

[0061] One or both of first jaw member 112 and second jaw member 114 can be rotatable relative to shaft 118. One or none of first jaw member 112 and second jaw member 114 can be stationary relative to shaft 118. Thus, one or both of first jaw member 112 and second jaw member 114 can be moveable, independently or cooperatively, such as via operation of lever 122 (FIG. 1). Medical device 102 of FIG. 3 A can perform in one or more of the modes described herein. That is, first electrode 140, second electrode 142 and third electrode 144 can be used in one or more modes to seal, cut, cautery, ablate, and / or coagulate tissue in various modes of application of energy, including RF AC energy and resistive DC energy. For example, therapeutic power can be communicated to first electrode 140, to or through tissue, and back to therapy power supply 132 via pad 148 (FIG. 2), via one or both of second electrode 142 and third electrode 144, or a combination thereof. In other arrangements,15Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01therapeutic power can be supplied between second electrode 142 and third electrode 144 and back to therapy power supply 132.

[0062] FIG. 3B is a side view of the jaw assembly 110 of FIG. 3 A with target object 220 positioned between first jaw member 112 and second jaw member 114. First jaw member 112 and second jaw member 114 of jaw assembly 110 can be movable between a first position in which first jaw member 112 and second jaw member 114 are spaced apart from each other, such as to allow for placement of target object 220 therebetween, and a second position in which first jaw member 112 and second jaw member 114 are positioned closer to each other than in the first position, such as to grasp target object 220. As depicted in FIG.3B, end effector assembly 108 can grasp target object 220, which can comprise a blood vessel or other target object of the anatomy of a living organism, an anatomical feature, tissue, veins, arteries, or a combination thereof of a human or animal subject. In an example, end effector assembly 108 can be used in electrosurgical system 100 such as to compress one or more of lymphatics, tissue pedicles, arteries, and veins, such as with diameter DI or similar cross-sectional dimension ranging from about 0.5 mm to about 7 mm, or larger. Herein, a diameter of a vessel can refer to either of a measured diameter or an average diameter along a length of interest of a vessel of interest. With the present disclosure, as explained in greater detail below with reference to FIG. 13A through FIG. 14E, end effector assembly 108 can be used in electrosurgical system 100 to form seals along the axis of target object 220 (extending into the plane of FIG. 3B) that are sufficiently strong to seal against blood pressure within target object that is present within vessels having diameter DI greater than 7 mm.

[0063] First jaw member 112 can include sensor 128 and second jaw member 114 can include sensor 128. Each instance of sensor 128 can be positioned on first jaw member 112 and second jaw member 114, respectively, to contact target object 220 to obtain readings therebetween. As discussed herein, one or more of sensor 128 can be used to obtain feedback regarding target object 220 or a state of end effector assembly 108, such as pressure and temperature, in order for processing unit 104 to generate and control initiation and completion of sealing and cutting energy in an automated and timely fashion.

[0064] FIG. 4 is a schematic cross-sectional view of jaw assembly 110 of FIG. 3 A showing first electrode 140, which can comprise a monopolar electrode, and second electrode 142 and third electrode 144, which can comprise a bipolar electrode.16Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0065] First electrode 140 can comprise an elongate wire-like body have a rectangular cross-sectional profile, but can have other shapes, such as circular. First electrode 140 can be fabricated from a conductive material. In examples, first electrode 140 can be fabricated from steel, such as stainless steel.

[0066] First insulator 204 and second insulator 214 can be fabricated of any suitable material capable of preventing or inhibiting electrical flow.

[0067] Second electrode 142 can be comprised of first plate 202A and first plate 212A. Third electrode 144 can be comprised of second plate 202B and second plate 212B. In examples, second electrode 142 and third electrode 144 can be fabricated from steel, such as stainless steel.

[0068] As shown in FIG. 5, first plate 212A can include standoff 222A and second plate 212B can include standoff 222B. Standoff 222 A and standoff 222B can be used to prevent arcing between first plate 202A and first plate 212A and second plate 202B and second plate 212B, respectively, by preventing contact therebetween. Arcing can divert energy between the plates rather than through tissue positioned therebetween. Standoff 222A and standoff 222B can comprise small pads or stops of insulating material that can be placed at intervals along the length of second plate 202B and second plate 212B. In examples, standoff 222 A and standoff 222B can be configured similarly to the stops described in in Pub. No. US 2021 / 0307859 Al to Nelson et al., titled “Sealer Divider,” the entire contents of which are hereby incorporated herein in their entirety by this reference.

[0069] In examples, first insulator 204 can comprise an anvil against which first electrode 140 can press against when first jaw member 112 and second jaw member 114 are pushed toward each other. In examples, first insulator 204 can be deformable or resilient so that first electrode 140 can be pushed into first insulator 204. However, in examples, first insulator 204 can be rigid.

[0070] First electrode 140 can be positioned midway between first plate 212 A and second plate 212B. First electrode 140 can extend away from elongate body 210 a greater amount than first plate 212A and second plate 212B.

[0071] FIG. 5 is a close-up schematic view of second jaw member 114 of FIG. 4 showing target object 220. The tip of first electrode 140 can be positioned distance D4 from first plate 212A. By symmetry, the tip of first electrode 140 can also be positioned distance D4 away from second plate 212B. Second plate 212B can have thickness Tl. First plate 212A can be17Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01configured similarly as second plate 212B so as to also have thickness Tl. Second jaw member 114 can have width W1. In examples, target object 220 can have diameter D5.

[0072] As discussed above, the effectiveness of sealing target object 220 when target object 220 comprises a blood vessel can depend on diameter D5 of target object 220. As diameter D5 of target object 220 increases, the pressure of blood within a blood vessel increases so that a stronger seal is more beneficial in stopping the blood flow. As such, it can be advantageous to have width W1 of first plate 212A and second plate 212B be wide to allow for the sealing of larger blood vessels. However, it can be advantageous to have the overall size of jaw assembly 110 be small so that jaw assembly 110 can be inserted into anatomy in a minimally invasive manner. More particularly, it can be desirable to have the overall size of jaw assembly 110 be small to fit within other medical instruments, such as a laparoscope, an endoscope and the like or to be used in a robotic surgical system. As such, it can be desirable to have width W1 be small. Furthermore, it can be desirable to have distance D4 large in order to prevent arcing of current between first electrode 140 and one or both of first plate 212A and second plate 212B.

[0073] Thus, there is a conflict in increasing the thickness of first plate 212A and second plate 212B because if the thickness is increased toward the outside of the device so that W1 increases, jaw assembly 110 will have a larger footprint and if the thickness is increased toward first electrode 140 there is a potential for increased arcing as D4 decreases. As discussed with reference to FIG. 13A through FIG. 14E, the present disclosure can provide a solution to this problem by controlling output of cutting energy in coordination with biological occurrences within the tissue being sealed, such as during jaw bounce from pressure increases, to provide effective cutting energy at lower voltages, thereby allowing the thickness Tl of first plate 212A and second plate 212B to be increased in the direction of first electrode 140 without increasing the risk of arcing, thereby also allowing the size of jaw assembly 110 to be reduced.

[0074] Additionally, the present disclosure provides multiple methods for controlling application of an electrosurgical device to automatically effect sealing and cutting of tissue. As discussed herein, in examples, sealing a tissue is intended to prevent blood from being able to pass through the tissue and cutting is intended to separate one portion of tissue from another portion on opposite sides of the seal. Thus, the electrosurgical device can be configured to provide sealing energy to first suitably modify the tissue to prevent blood flow18Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01and then to perform a cutting operation (either by applying cutting energy or by moving a cutting blade) to sever the tissue to detach opposing sides of the tissue without disturbing the seal. Typically, the cutting operation is performed after the sealing operation has been completed, thereby requiring judgment from an operator in determining when the sealing operation is completed as well as time to perform an evaluation of the sealing and thereafter perform the cutting operation. With the present disclosure, the status of the sealing operation can be monitored to watch for the occurrence of events associated with changes in the biological material that signify sealing has occurred or has nearly occurred, thereby allowing the automatic occurrence of a cutting operation at a time when the tissue is biologically ready to receive a cut. In additional examples of the present disclosure, a cutting operation can begin when a monitoring system is able to predict at a first point in time before the tissue is biologically ready to receive a cut that sealing will occur at a future second point in time. For example, monitored feedback can inform the sealing system that sealing will likely occur as anticipated through the initial monitoring of the sealing operation. As such a cutting operation can commence before a semi-stable seal is achieved to further shorten the time of a seal and cut procedure. As mentioned, the gripping of the jaws onto an anatomic structure can cause collapsing of the anatomic structure and provide pressure to prevent bleeding until the seal is complete. In order to make sure that the clamped tissue is going to respond to the seal energy, some sealing energy at the beginning of the procedure can be output. This initial sealing energy output can be used to obtain feedback about the expected progression of the sealing operation. If the monitored sealing parameter, e.g., an electrical property of the tissue, a color of the tissue, a state of the jaws, etc., indicates a seal will progress, the cutting operation can be initiated. If the monitored sealing parameter is not progressing as expected, the sealing operation can be delayed. Examples where tissue might not be sealable can include there being an electrically conductive external element between the jaws, such as metal staples, or if the tissue is so moist, that the energy draw to create steam (the drying and heating of the tissue) prevents the tissue from becoming modified. Thus, the system can wait until a user removes the staples or seals at another location away from the staples or until steam is generated to sufficiently dry the tissue before initiating the cutting operation. The cutting operation can subsequently be initiated if the monitored progress of the sealing operation returns to expected results.19Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0075] FIG. 6 through FIG. 9 are discussed with relation to sensing and monitoring electrical events within tissue that can indicate sealing status. Thus, the present inventor has recognized that certain electrical parameters of tissue can serve as a proxy for the state of the tissue along the sealing process that can be used to automatically trigger a cutting operation in a timely manner.

[0076] FIG. 10A through FIG. 10C are discussed with relation to determining and monitoring device events of the instrument applying the electrosurgical energy that can indicate sealing status. Thus, the present inventor has recognized that certain state parameters of an electrosurgical device reacting to the application of sealing energy can serve as a proxy for the state of the tissue along the sealing process that can be used to automatically trigger a cutting operation in a timely manner.

[0077] FIG. 11 A through FIG. 11C are discussed with relation to determining and monitoring time events regarding the application of energy that can indicate sealing status. Thus, the present inventor has recognized that certain time parameters relative to the commencement and completion of a sealing operation can serve as a proxy for the state of the tissue along the sealing process that can be used to automatically trigger a cutting operation in a timely manner.

[0078] Electrosurgically sealing or coagulating biological tissue engaged by an electrosurgical instrument is an electrosurgical technique used in various medical procedures. In such techniques, the engaged biological tissue can be electrosurgically sealed by heating the engaged biological tissue in a controlled manner. In some medical procedures, the biological tissue that is being sealed is a vessel. Without wishing to be bound by theory, it is believed that heating of the vessel causes the collagen found in the vessel walls to become denatured. This denatured collagen forms a gel-like substance acting as glue between the vessel walls. When forced together and maintained together while cooling, opposite walls of a vessel will then form a seal.

[0079] Heating of the vessel is carefully controlled so that neither too little nor too much energy is provided to the vessel, particularly during sealing. If too much energy is provided thereto, then charring and / or burning of the vessel wall can occur. If too little energy is provided thereto, then seal quality of the vessel can be poor. One measure of seal quality is a pressure difference that the sealed vessel can withstand without bursting. Low quality seals can be compromised when the pressure applied thereto exceeds some value. For example, if20Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01the seal width is inadequate along a vessel, blood pressure within the vessel can burst the seal.

[0080] The rate at which the energy is provided to the vessel can also be carefully controlled so as to facilitate rapid performance of the electrosurgical procedure. Rapid performance of electrosurgical procedures reduces the time and difficulty of these procedures. The rate of heating, however, should not be so rapid as to cause uncontrolled boiling of fluid within the biological tissue. Uncontrolled boiling can rupture engaged or nearby biological tissues and / or compromise the quality of the seal.

[0081] Heating of the engaged biological tissue can be controlled by controlling the electrical power of an electrotherapeutic signal provided to and dissipated by the engaged biological tissue. Such electrical power can be controlled according to a sealing schedule. For example, the sealing schedule can be indicative of a product of a voltage difference across an electrical current conducted by the engaged biological tissue. Thus, the sealing schedule can be an electrical-power schedule.

[0082] One or more techniques for providing electrotherapy can be provided according to a treatment plan or another plan. The plan can include a recipe, prescription, regimen, methodology, or the like. The plan can include one or more temporal aspects, such as a schedule, such as can include occurrence or recurrence (or inhibition or suppression) timing, frequency, type, relative combination (e.g., coagulation relative to cutting), temperature or the like. The plan can include electrotherapy waveform information, such as can include pulse width, duty cycle, on duration, off duration, repetition rate, amplitude, phase, or the like. Different outputs can be used depending on the fluid content of the tissue, the collagen content of the tissue and the thickness of the tissue. Specifically, the greater the fluid amount, collagen amount or thickness, longer or greater amounts of energy can applications be applied. In examples, high fat tissue has high resistance and thus does not need as much energy to coagulate before cutting. The plan need not be static or a priori in nature, but can include one or more dynamic aspects, such as can be modified or governed, such as by diagnostic, operational, or other information obtained during or between electrotherapy delivery instances, including in a closed-loop, or other feedback manner or machine learning input, as is described with reference to CDSS 800 of FIG. 15. Such plans can be determined automatically, by the device, e.g., without requiring user input, or may involve user input, such as can be provided before, during, or after one or more portions of operations of the21Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01electrotherapy device according to the plan. The plan can involve communicating with or using another device, such as to receive or provide one or any combination of inputs, outputs, or instructions, operating parameters, or measured data. One or more aspects of the plan can be recorded or encoded onto a medium, such as a computer or other machine-readable medium, such as can be a tangible medium.

[0083] The present disclosure includes, among other things, treatment plans to facilitate commencement of a cutting operation at different stages of the application of sealing energy. In some examples, the sealing signal can be reduced or terminated, and the cutting signal can be initiated in response to a termination criterion being met. In some examples, the termination criterion is a current characteristic, such as, for example, a decrease in current conducted by the engaged biological tissue. In some examples, the termination criterion is a resistance characteristic, such as, for example, an increase in the electrical resistance of the engaged biological tissue. Such an increase in the electrical resistance in excess of a predetermined delta resistance value can be used as a termination criterion, for example, where the predetermined delta resistance value is the difference between the measured resistance (or impedance) and the lowest value of the resistance (or impedance) measured in the pulse. In some examples, the termination criterion is a device state, such as, for example, a sensed change in position of jaws or a sensed change in color of tissue between jaws, predetermined or calculated based on some condition. In some examples, the termination criterion is a temporal condition, such as, for example, a time duration, predetermined or calculated based on some condition. The termination criterion can comprise a combination of two or more of these examples.

[0084] Tissue State

[0085] FIG. 6 is a block diagram of an electrosurgical system for sealing biological tissue engaged by an electrosurgical instrument. In FIG. 6, electrosurgical system 300 can include electrosurgical generator 312 and electrosurgical instrument 314. Electrosurgical instrument 314 can be any electrosurgical instrument configured to engage and deliver an electrotherapeutic signal to biological tissue, particularly those described herein. In examples, electrosurgical instrument 314 can comprise medical device 102 of FIG. 1.Electrosurgical generator 312 can be configured to generate electrotherapeutic signals, such as a high frequency (AC) electrical signal and a direct current (DC) signal, that22Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01electrosurgical instrument 314 delivers to engaged biological tissue, such as target object 220 of FIG. 3B.

[0086] In some examples, electrosurgical instrument 314 comprises a forceps having a handpiece coupled to opposable jaw members via a shaft assembly, such as jaw assembly 110 of FIG. 3A through FIG. 5. In other examples, electrosurgical instrument 314 comprises a conductive spatula, a conductive pad, or other electrosurgical device. These various types of electrosurgical instruments have various ways of engaging biological tissues (e.g., clamping, touching, surrounding, penetrating, radiating, etc.)

[0087] Electrosurgical generator 312 can include instrument interface 342, electricalenergy source 344, measurement circuit 346, control circuit 348, and user interface 350. Instrument interface 342 can include signal drivers, buffers, amplifiers, ESD protection devices, and electrical connector 352, for example. Electrical connector 352 can be configured to electrically connect electrosurgical instrument 314 to electrosurgical generator 312 so as to provide electrical communication between electrosurgical generator 312 and electrosurgical instrument 314. Such electrical communication can be used to transmit operating power and / or electrical signals therebetween. Electrosurgical instrument 314, in turn, can provide electrical communication between electrical connector 352 and biological tissue engaged thereby.

[0088] Electrical-energy source 344 can be configured to generate an electrotherapeutic signal to be delivered to the engaged biological tissue via electrical connection to electrosurgical instrument 314. The generated electrotherapeutic signal can be controlled so as to obtain the desired result for a specific electrosurgical procedure. In one example, for example, the electrotherapeutic signal is configured to resistively heat the engaged biological tissue so as to surgically affect the engaged biological tissue, such as to perform a sealing operation and / or a cutting operation. Electrical-energy source 344 can be configured to deliver high frequency RF energy.

[0089] Measurement circuit 346 can be configured to measure one or more electrical parameters of biological tissue engaged by connection to electrosurgical instrument 314. Measurement circuit 346 can be in electrical communication with electrosurgical instrument 314 when electrosurgical generator 312 is electrically connected to electrosurgical instrument 314 via electrical connector 352. Various examples of measurement circuit 346 are configured to measure various electrical parameters, such as between jaws of electrosurgical23Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01instrument 314. For example, measurement circuit 346 can be configured to measure voltage difference delivered across and / or electrical current conducted by the engaged biological tissue. In some examples, measurement circuit 346 is configured to measure DC and or AC electrical parameters, such as resistance and / or, impedance, of the engaged biological tissue. In some examples, measurement circuit 346 can be configured to measure phase angle between voltage and current delivered across biological tissue. In some examples, measurement circuit 346 is configured to measure power and / or energy input to the engaged biological tissue.

[0090] Measured parameters, such as voltage difference delivered across and / or electrical current conducted by the engaged biological tissue can be used to determine other electrical metrics. For example, measurements of voltage difference delivered across and / or electrical current conducted by the engaged biological tissue can be used to determine electrical resistance of the engaged biological tissue. Measurements of voltage difference delivered across and electrical current conducted by the engaged biological tissue, as well as the phase angle therebetween can be used to determine complex impedance of the engaged biological tissue. Measurements of voltage difference delivered across and electrical current conducted by the engaged biological tissue, as well as the phase angle therebetween also can be used to determine apparent power (VA) and / or real power (W) provided to the engaged biological tissue.

[0091] Such measurements of electrical parameters can be used for controlling electrotherapeutic signals, e.g., sealing signals and / or cutting signals, during delivery to an engaged biological tissue. For example, measurements of the voltage difference delivered across and measurements of the electrical current conducted by the engaged biological tissue can be used to determine and / or control the real power provided to the engaged tissue. This determined real power can then be compared with an electrotherapeutic schedule.Electrotherapeutic schedules can be stored in memory 356 for different electrical parameters discussed herein, such as threshold electrical levels, e.g., resistance, power, when a sealing operation is expected to be completed, or sufficiently completed, or if progressing along a trend that indicates a seal will be completed before it is substantially completed, e.g., predicted to occur, to allow for the beginning of cutting, for different types of tissues. Such a comparison could be used to generate a measurement signal. Measurements of electrical parameters can also be used to determine phase-control criteria for controlling phases of24Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01electrotherapy. Phase-control criteria can include criteria for commencement and termination of a phase, as well as criteria for intra-phase control. Phase-control criteria can additionally include criteria for initiating a cutting operation.

[0092] Control circuit 348 can be configured to control operation of electrical-energy source 344 and / or measurement circuit 346. Control circuit 348 can be electrically connected to electrical-energy source 344 and measurement circuit 346. Control circuit 348 can cause electrical-energy source to provide an electrotherapeutic signal to biological tissue engaged by electrical connection to electrosurgical instrument 314. Control circuit 348 can cause electrical-energy source 344 to generate the electrotherapeutic signal according to an electrotherapeutic schedule such that the generated electrotherapeutic signal is controlled for a specific electrosurgical procedure. For example, control circuit 348 can be used to generate a sealing signal and determine one or more points along the performance of the sealing operation where a cutting signal can be generated.

[0093] Various electrotherapeutic schedules can be used to effectuate various types of electrotherapy, such as a sealing operation involving the application of sealing energy. For example, in some examples, real power (W) of the electrotherapeutic signal provided to the engaged biological tissue is controlled according to an electrical-power schedule. In other examples, voltage difference (V) of the electrotherapeutic signal delivered across the engaged biological tissue is controlled according to a voltage schedule. In other examples, electrical current (A) of the electrotherapeutic signal conducted by the engaged biological tissue can be controlled according to an electrical-current schedule. In still other examples, apparent power (VA) of the electrotherapeutic signal provided to the engaged biological tissue can be controlled according to a voltage-amperage schedule. The schedules can be calibrated for different types of tissue. Further, the electrotherapeutic schedules can include activation points for cutting energy, as well as termination points for both sealing and cutting energy.

[0094] Control circuit 348, for example, can cause electrical-energy source 344 to provide energy to engaged biological tissue, such that a product of a voltage difference across and an electrical current conducted by the engaged biological tissue is controlled according to the electrotherapeutic schedule. Control circuit 348 can use the comparison of the determined real power with an electrotherapeutic schedule to generate a measurement signal. Such a measurement signal can be used in a closed-loop feedback system that includes electrical-energy source 344, so as to generate the electrotherapeutic signal according to the25Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01electrotherapeutic schedule to apply sealing energy. The measurement signal can also be used to determine a point along the electrotherapeutic schedule where cutting can begin so that control circuit 348 can automatically activate cutting energy or activate movement of a cutting blade.

[0095] As illustrated in FIG. 6, control circuit 348 can include processor 354 and memory 356. Control circuit 348 can include a timer and / or a clock. In some examples, the timer and / or the clock are part of processor 354. In other examples, the timer and / or clock are separate from the processors 54. Processor 354, in one example, can be configured to implement functionality and / or process instructions for execution within electrosurgical system 300. For instance, processor 354 can be capable of receiving from and / or processing instructions stored in program memory 356P. Processor 354 can then execute program instructions so as to cause electrical-energy source 344 to generate the electrotherapeutic signal according to predetermined electrotherapeutic schedules, including the application of sealing energy and the subsequent automatic application of cutting energy. The predetermined electrotherapeutic schedules can be retrieved from data memory 356D, for example. Processor 354 can compare electrical parameters measured by measurement circuit 346 with a retrieved predetermined electrotherapeutic schedule. Processor 354 can send commands to electrical-energy source 344 and / or measurement circuit 346. Processor 354 also can also send or receive information from user interface 350.

[0096] In various examples, electrosurgical generator 312 can be realized using the elements illustrated in FIG. 6 or various other elements. For example, processor 354 can include any one or more of a microprocessor, a control circuit, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

[0097] Memory 356 can be configured to store information within electrosurgical system 300 during operation. Memory 356, in some examples, is described as computer-readable storage media. In some examples, a computer-readable storage media can include a non-transitory medium. The term “non-transitory” can indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium can store data that can, over time, change (e.g., in RAM or cache). In some examples, memory 356 can comprise a temporary memory, meaning that a primary purpose of memory 356 is not long-term storage. Memory 356, in some examples, is described as26Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01volatile memory, meaning that memory 356 does not maintain stored contents when power to electrosurgical system 300 is turned off. Examples of volatile memories can include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories. In some examples, memory 356 can be used to store program instructions for execution by processor 354. Memory 356, in one example, is used by software or applications running on electrosurgical system 300 (e.g., a software program implementing electrical control of an electrotherapeutic signal provide to biological tissue engaged by an electrosurgical instrument) to temporarily store information during program execution, such as, for example, in data memory 356D.

[0098] In some examples, memory 356 can also include one or more computer-readable storage media. Memory 356 can be configured to store larger amounts of information than volatile memory. Memory 356 can further be configured for long-term storage of information. In some examples, memory 356 includes non-volatile storage elements.Examples of such non-volatile storage elements can include magnetic hard discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.

[0099] User interface 350 can be used to communicate information between electrosurgical system 300 and a user (e.g., a surgeon or technician). User interface 350 can include a communications module. User interface 350 can include various user input and output devices. For example, user interface can include various displays, audible signal generators, as well switches, buttons, touch screens, mice, keyboards, etc.

[0100] User interface 350, in one example, can utilize the communications module to communicate with external devices via one or more networks, such as one or more wireless or wired networks or both. The communications module can include a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other examples of such network interfaces can include Bluetooth, 3G, 4G, and Wi-Fi radio computing devices as well as Universal Serial Bus (USB) devices.

[0101] FIG. 7 is a graph depicting non-limiting examples of an electrotherapeutic schedule or plan used to control electrical power provided to biological tissue being sealed. In FIG. 7, Graph 380 has horizontal axis 382, vertical axis 384A, vertical axis 384B and vertical axis 384C, and functional relation 386A, functional relation 386B and functional27Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01relation 386C. Horizontal axis 382 is indicative of time (seconds). Horizontal axis has time tO through time tlO, which signify transition times between the interrogation, drying, sealing and cutting phases disclosed in the discussion pertaining to the methods of graph 380 for generating an electrotherapeutic signal for treating a biological tissue engaged by an electrosurgical instrument. These phases, the interrogation, first drying, sealing and cutting phases, are also notated at various locations of graph 380. It should be noted that the graph of FIG. 7 is meant for purposes of explanation only. The graph of FIG. 7 depicts an example of a response, and different tissues can react differently.

[0102] Vertical axis 384A is indicative of electrical power (W) provided to biological tissue engaged by an electrosurgical instrument. Functional relation 386A indicates a nonlimiting example of a power / time relation corresponding to the electrotherapeutic signal generated based on the non-limiting example of method 400 illustrated in FIG. 8. Vertical axis 384B is indicative of electrical current conducted by the engaged biological tissue.Functional relation 386B indicates the electrical current / time relation pertaining to the electrical current conducted by the engaged biological tissue to which the electrotherapeutic signal generated via method 400 is provided. Vertical axis 384C is indicative of electrical resistance of the engaged biological tissue. Functional relation 386C indicates electrical -resistance / time relation corresponding to the electrical resistance of the engaged biological tissue to which the electrotherapeutic signal generated via method 400 is provided.

[0103] In examples, electrical properties, e.g., resistance, of tissue can be sensed between first jaw member 112 and second jaw member 114, such as at second electrode 142 and third electrode 144 (FIG. 4) to evaluate the performance of sealing operation 390. Specifically, electrical properties can be sensed between first plate 202 A and first plate 212A and between second plate 202B and second plate 212B. In additional examples, electrical properties can be sensed between first electrode 140 and one of second electrode 142 and third electrode 144. More specifically, electrical parameters can be sensed between first electrode 140 and one of first plate 202 A and second plate 202B. Conventional sensing systems involve sensing only between bipolar electrodes. However, with the present disclosure, sensing may be conducted between a monopolar electrode and one of the bipolar electrodes, if desired. Such sensing configurations can allow for more flexibility in obtaining sensing readings potentially without interfering with any electrosurgical operations.28Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0104] In some examples, functional relation 386A can be a pre-defined power curve, including an interrogation phase, a drying phase, and a sealing phase. In the specific nonlimiting example shown in FIG. 7, the drying phase depicts first and second drying intervals. From time tO to time tl, the power / time relation of functional relation 386A indicates the interrogation phase. In some examples, the duration of the interrogation phase is as short as is needed to obtain a reference measurement of the engaged biological tissue. For example, the duration of the interrogation phase can be less than 1.0, 0.5, 0.25, or 0.1 seconds. As indicated in graph 380, the interrogation phase is a constant-power schedule or plan having power Pl (W). From time tO to time tl, electrical current / time relation of functional relation 386B indicates an interrogation rapid electrical current rise, followed by an electrical current plateau, which is then followed by a slight decrease in electrical current conducted by the engaged biological tissue. Because power is controlled to be constant throughout this interrogation phase, the voltage applied across the engaged biological tissue is inversely related (in a multiplicative sense as opposed to an additive sense) to the electrical current / time relation. The resistance of the engaged biological tissue can initially decrease as the temperature of the fluid in the tissue increases. Because this is the first time the interrogation phase is performed, the measured electrical resistance is not less than a minimum resistance previously measured, and therefore the method advances to the first drying phase.

[0105] From time tl to time t2, power / time relation of functional relation 386A indicates the first interval of the drying phase. As indicated in graph 380, the first drying interval of the drying phase is an electrical-power schedule or plan that monotonically increases from power Pl to power P2 (W). From time tl to time t2, electrical current / time of functional relation 386B indicates electrical current conducted by the engaged biological tissue increases throughout the first interval of the drying phase. Because power is controlled throughout this first interval of the drying phase according to a drying schedule or plan, a product of the voltage applied across the engaged biological tissue and the electrical current / time relation should yield power / time relation of functional relation 386 A. Although not depicted, in some examples, the electrical-resistance / time relation of functional relation 386C can indicate that electrical resistance of the engaged biological tissue initially can decrease as the tissue warms, but then can increase as the tissue begins to dry during the first interval of the drying phase. Such increasing electrical resistance can indicate drying of the29Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01engaged biological tissue. Because the electrical current does not decrease below a fraction of a previously measured maximum electrical current before power / time relation of functional relation 386 A ramps to a predetermined threshold, the method advances to the second interval of the drying phase. If the current were to have dropped below the fraction of the previously measured maximum electrical current during this first interval of the drying phase, the subsequent second interval of the drying phase would not be necessary (e.g., it could be bypassed).

[0106] From time t2 to time t3, power / time relation of functional relation 386 A indicates the second interval of the drying phase. As indicated in graph 380, the second interval of the drying phase is an electrical-power schedule or plan that monotonically increases from power P2 to power P3 (W). Using the techniques described above with respect to FIG. 1 through FIG. 6, a control circuit, such as the control circuit 348 of FIG. 6, can control an energy delivery of the therapeutic signal provided to the biological tissue during a portion of a therapeutic phase according to an incremental change in energy delivery as a function of a change in a measured electrical parameter of the biological tissue. For example, a control circuit can incrementally modify the power as a function of current. In some examples, the function of current is a function of an instantaneous measured change in current. In some examples, the function of the instantaneous measured change in current is a linear function. In other examples, the control circuit can incrementally modify the power as a function of resistance.

[0107] From time t2 to time t3, electrical current / time relation of functional relation 386B indicates electrical current conducted by the engaged biological tissue increases at the beginning of the second interval of the drying phase, but peaks and then decreases at the end of the second drying phase. It should be noted that a second interval of the drying phase may not be needed. In some examples, power can be controlled throughout this second interval of the drying phase such that a product of the voltage applied across the engaged biological tissue and the electrical current / time relation can yield a particular power / time relation of functional relation 386 A.

[0108] In some examples, the second interval of the drying phase is monotonically increasing, but at a slower rate of increase than that of the first interval of the drying phase. In other examples, the second interval of the drying phase is linearly increasing until the provided power equals a predetermined maximum level, after which time the provided power30Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01is held constant. Because the decrease in electrical current All e.g., a measured change in current, results in a current that is less than a predetermined fraction of the maximum electrical current measured, the method returns to the interrogation phase, which is shown at time t3. In other words, the change in electrical current All causes the method to enter the interrogation phase at time t3. It should be noted that in the non-limiting example shown in FIG. 7, the change in electrical current All that causes the method to enter the interrogation phase is after time t2. However, in other examples, the change in electrical current All that causes the method to enter the interrogation phase can be after time tl during the first interval of the drying phase, and a second interval of the drying phase may not be needed. If, however, the decrease in electrical current All had instead been less than the predetermined fraction of the maximum electrical current measured, then the method would have remained in the drying phase.

[0109] As seen in FIG. 7, in some examples, the pre-defined power curve of functional relation 386A can include two or more linear portions, such as shown between time tl and time t2 and between time t2 and time t3.

[0110] From time t3 to time t4, power / time relation of functional relation 386 A depicts the interrogation phase again. As indicated in graph 380, the interrogation phase is a constant-power schedule of power Pl (W). Because power is controlled to be constant throughout this interrogation phase, the voltage applied across the engaged biological tissue is inversely related (in a multiplicative sense as opposed to an additive sense) to the electrical current / time relation. Electrical-resistance / time relation of functional relation 386C indicates that the electrical resistance of the engaged biological tissue is decreasing throughout this performance of the interrogation phase. Decreasing electrical resistance can be a result of condensing of fluid in the tissue or migration of fluid into the tissue. Because the measured electrical resistance is not greater than a sum of the reference resistance and a predetermined delta resistance, the method advances again to the first drying phase.

[0111] From time t4 to time t5, power / time relation of functional relation 386A indicates another first interval of the drying phase. The power / time relation from time t4 to time t5 is similar to the power / time relation of functional relation 386A from time tl to time t2 and, for purposes of conciseness will not be described in detail again.

[0112] From time t5 to time t6, power / time relation of functional relation 386 A indicates another second interval of the drying phase. The power / time relation from time t5 to time t631Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01is similar to the power / time relation of functional relation 386A from time t2 to time t3 and, for purposes of conciseness will not be described in detail again. Because power is controlled to be constant throughout this second interval of the drying phase, a product of the voltage applied across the engaged biological tissue and the electrical current / time relation should yield power / time relation of functional relation 386A. Because the decrease in electrical current AI2, e.g., a measured change in current, is less than a predetermined fraction of the maximum electrical current measured, the method returns to the interrogation phase.

[0113] From time t6 to time t7, power / time relation of functional relation 386 A indicates another interrogation phase. The power / time relation from time t6 to time t7 is similar to the power / time relation of functional relation 386 A from times t3 to t4 and, for purposes of conciseness will not be described in detail again. Because the measured electrical resistance is now greater than a sum of the reference resistance and a predetermined delta resistance, the method advances to the sealing phase.

[0114] From time t7 to time t8, power / time relation of functional relation 386 A indicates the sealing phase. As indicated in graph 380, the sealing phase is an electrical -power schedule or plan that monotonically increases from power Pl to power P3 (W). From time t7 to time t8, electrical current / time relation of functional relation 386B indicates an increasing electrical current conducted by the engaged biological tissue throughout the sealing phase. Electrical-resistance / time relation of functional relation 386C indicates that the electrical resistance of the engaged biological tissue is increasing this performance of the sealing phase. Increasing electrical resistance can be a result of drying and thereby sealing of the engaged biological tissue. Because the measured electrical resistance is now greater than a predetermined termination resistance, the sealing phase is terminated, and the method can proceed to the cutting phase.

[0115] Functional relation 386A, functional relation 386B and functional relation 386C can form sealing operation 390. FIG. 7 further shows cutting operation 392 including functional relation 394A, functional relation 394B and functional relation 394C. Cutting operation 392 can extend from time t7.5 to time t9 to time tlO. With the present disclosure, control circuit 348 can be configured to automatically initiate cutting energy at a desired, predetermined time along horizontal axis 382 based on sensed levels of one or more of functional relation 386A, functional relation 386B and functional relation 386C. FIG. 7 shows the cutting phase starting at time t7.5 before the sealing phase is completed at time t8.32Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01As such, functional relation 394A, functional relation 394B and functional relation 394C can overlap with functional relation 386A, functional relation 386B and functional relation 386C in region 398A, region 398B and region 398C, respectively. However, as discussed herein, the cutting phase can start at time t8 when the sealing phase is completed, or a time t9 with interval 396 being included between the sealing phase and the cutting phase. Thus, in the other mentioned examples, cutting can begin at time t8 such that interval 396 is zero, or even before time t8 at time t7.5 such that interval 396 is negative. In the various methods described herein, the cut output can comprise bipolar RF AC outputs, monopolar RF outputs and combination outputs of RF and resistance heating. In additional example, mechanical cutting can be used as is known in the art.

[0116] FIG. 7 provides a discussion of various examples of how electrotherapeutic sealing can be monitored and terminated based on, for example, sensed resistance. With the present disclosure, other electrical parameters can be sensed to determine when to terminate sealing as well as to determine when to commence cutting relative to the sealing operation.

[0117] Impedance or Resistance

[0118] As discussed with reference to FIG. 7, the resistance (R) and impedance (Z) of tissue can change during the application of energy during a vessel sealing cycle. It is noted that impedance equals resistance in a purely resistive circuit when DC current is applied to tissue between electrodes, but impedance is a function of resistance (Z = (RA2 + XA2) when AC current is applied to tissue between electrodes. These changes of resistance and impedance can occur as the heating of the tissue, via the conduction of current through the tissue, causes temperature to rise due to the natural resistance of the tissue to the current passage, which causes tissue drying, e.g., fluid being forced out of the tissue as steam. The tissue heating can also produce state changes, e.g., water to steam and vice versa, within the tissue. When heating is applied to tissue, fluid within the tissue can become steam. Some of this steam can escape from the tissue if enough heat is applied. When heating ceases, steam that has not escaped from the tissue can revert back to fluid inside the tissue. A more complete description of the effects of the application of energy in drying tissue, the different stages thereof in sealing cycles, and the sensing of electrical parameters in tissue being dried can be found in Pat. No. US 11,672,588 to Batchelor et al., titled “Phase Angle Measurement Techniques in Electrosurgical Systems,” the entire contents of which are incorporated herein by this reference. Thus, the application of energy to the tissue and the water located therein33Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01can cause the natural tissue resistance and impedance to rise. Predetermined values of resistance and impedance levels where sufficient water has left the tissue to levels where sealing has been started and / or finished can be determined for different tissue types.Processing unit 104 (FIG. 1) can be provided with threshold resistance and / or impedance levels for different tissue types and thicknesses for comparison to sensed resistance and impedance values to determine when sealing is sufficiently far enough along to begin cutting or to determine that sealing is sufficiently progressing toward completing a seal or substantially completing as seal, e.g., predicted to occur, such that cutting can begin. In examples, some tissues can cut easier with lower resistive heating and higher amounts of RF application, while other tissues can cut easier with higher resistive heating and lower amounts of RF application.

[0119] As tissue resistance rises, it becomes more and more difficult to create a complete electrosurgical cut until a point is met where the voltage and power required to overcome the resistance and impedance of the tissue is so high, that the voltages cause direct arcing to the return electrodes or other structures, leaving the tissue cut incomplete and or highly charred. Charring of tissue is not desirable as the body identifies charring as a foreign body and often activated an immune response, causing localized inflammation etc. Therefore, thermal margin, e.g., a burning of the tissue that causes a change in color from reddish or pinkish to tannish or whitish as the tissue is blanched by hot steam leaving the tissue, associated with the sealing process can be monitored to ensure that the thermal margin does not progress to the area of tissue where cutting is to be performed, additionally providing a trigger point for the initiation of cutting. Note, further discussion of thermal margin is discussed below with reference to FIG. 10B. Thus, cutting operation 392 can commence before the resistance level reaches the peak of region 398C or some other predetermined level of resistance. As such, with the present disclosure, resistance levels can be sensed in order to wind down sealing energy before charring occurs and to allow cutting energy to be applied without having to wait for a resistance level rise indicating a seal is complete.

[0120] In examples, the resistance and impedance levels can be sensed using the cut electrode, e.g., first electrode 140, the seal plates, e.g., first plate 212A and second plate 212B, and combinations of these electrodes. In examples, the resistance and impedance readings can be obtained by sending a test current between electrodes. For example, a small amount of energy, such as ten watts, can be placed across the electrodes that is not large34Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01enough to impact the tissue, but can be sensed by a controller. Such a test signal can be sent in between sending sealing energy or simultaneously with sealing energy, such as if two energy sources are being used to generate the test signal and the sealing signal.

[0121] At a predetermined state, such as within region 398C of functional relation 386C, when the impedance and / or resistance between the cut and return electrodes meets a specific criterion, the cut output of the RF stage, e.g., cutting operation 392, can be initiated, causing the cut process to initiate in the tissue, during or after the seal cycle. The specific criterion can comprise a percentage of an originally detected value (%R), a delta shift (AR), a minimum R value (RMin), a maximum R value (RMax) or combinations of these as a value. In examples, point 399B can comprise a certain %R, e.g., 75%, of the difference between point 399 A and point 399C that can trigger cutting; point 399B can comprise a certain AR, e.g., a number of ohms, from point 399A that can trigger cutting, point 399B can comprise a certain RMin that is to be achieved to trigger cutting; point 399B can comprise a certain RMax that is to be reached to trigger cutting. Once it has been determined that the resistance changed to a limit, a point, a delta or another predetermined relationship, it can be determined that the tissue has been sealed and cutting can begin. As shown in FIG. 7, cutting can begin at time t7.5 before sealing is completed at time t8. However, as mentioned, cutting can begin later than time t7.5 depending on the set trigger point.

[0122] Triggers to stop the sealing and / or the cutting output can be the same triggers, hence when a set endpoint is reached, both the cut and the seal output are stopped, or the seal and the cut could have different triggers allowing them to stop at the same time, the cut output to stop first or the seal output to stop first. Examples of these different end points include the seal end point being based on a resistance delta between the seal electrodes, and the end point of the impedance or resistance being the trigger to stop further cutting output. In examples, sealing can stop at point 399B and cutting can stop at point 399C, both sealing and cutting can stop at point 399C, sealing can stop at point 399B and cutting can stop at point 399D, or sealing can stop at point 399C and cutting can stop at point 399D.

[0123] In examples, a method to seal and cut biological tissue can comprise imparting an alternating current (AC) sealing signal between a set of sealing electrodes, determining the electrical impedance or resistance of biological tissue disposed between the sealing electrodes (return) and cut electrode(s) while the AC sealing signal is imparted between the set of sealing electrodes, and in response to the impedance or resistance of biological tissue35Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01disposed between the sealing electrodes reaching a first resistance or impedance threshold value, imparting a cutting output, either between a set of cutting electrodes or via a cutting blade, while the AC sealing output is imparted between the cutting electrodes.

[0124] Phase angle or phase shift

[0125] Another indicator that can be sensed and monitored to determine when to begin the cutting operation can comprise phase angle (9) or phase shift. The phase angle of an oscillating electrical output, such as RF sealing energy, comprises a phase shift where the phase angle of two components of an output, typically voltage and current, is shifted over time, while the amplitude is unchanged. Moisture levels in tissue can affect phase angle. Thus, as moisture is driven out of tissue by drying of tissue, the phase angle can correspondingly change. So as the phase angle changes, it can be determined if sufficient sealing has occurred or is likely to occur to switch to cutting. Thus, processing unit 104 (FIG. 1) can be provided with threshold phase angle or phase changes for different tissue types and thicknesses for comparison to sensed phase angle values to determine when sealing is sufficiently far enough along to begin cutting.

[0126] Changes in phase angle are typically unwanted phenomena, as they reduce the delivered total wattage. For example, power equals voltage multiplied by current (P=V*i). With oscillating output of RF energy, the delivery of voltage and current can have peaks that are delivered out of synch. Where they cross is maximum power. The further the peak voltage and current are away from each other, the more the power drops. However, phase angle can be used to predict the tissue state. The voltage and current do not necessarily need to be in synch at the beginning of the application of sealing energy, so changes in phase angle can provide a sufficient trigger for cutting. For example, in the beginning of a sealing operation metal-to-metal contact between electrodes could result in one phase angle while the introduction of tissue between the electrodes can result in a change of the phase angle.

[0127] In examples, the phase angle or phase shift levels can be sensed using the cut electrode, e.g., first electrode 140, the seal plates, e.g., first plate 212A and second plate 212B, and combinations of these electrodes. In examples, the phase angle or phase shift levels can be obtained during application of sealing energy. As discussed, cutting can begin before sealing is completed. In examples, cutting can commence a predetermined amount of time, e.g., 0.5 seconds, after a phase angle change is sensed to allow for collagen to be affected by the sealing energy.36Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0128] Therefore, at a predetermined state, such as when the phase angle meets a specific criterion, the cut output of the RF stage, e.g., cutting operation 392, is initiated, causing the cut process to initiate in the tissue, during or after the seal cycle. The specific criterion can comprise a percentage of an originally detected value (%9), a delta shift (A0), a minimum 9 value (9Min), a maximum 9 value (9Max) or combination of these as a value. Once it has been determined that the phase angle changed to a limit, a point, a delta or another predetermined relationship, it can be determined that the tissue has been sealed and cutting can begin. As shown in FIG. 7, cutting can begin at time t7.5 before sealing is completed at time t8. However, as mentioned, cutting can begin later than time t7.5 depending on the set trigger point. As previously discussed, cutting can be performed by cutting energy (e.g., bipolar or monopolar electrosurgical energy) or mechanically via a cutting blade.

[0129] Triggers to stop the sealing and / or the cutting output can be the same triggers, hence when a set endpoint is reached, both the cut and the seal output are stopped, or the seal and the cut could have different triggers allowing them to stop at the same time, the cut output to stop first or the seal output to stop first. Examples of these different end points include the seal end point being based on a resistance delta, and the end point of the phase angle being the trigger to stop further cutting output.

[0130] In examples, a method to seal and cut biological tissue can comprise imparting an alternating current (AC) sealing signal between a set of sealing electrodes, determining phase angle of biological tissue disposed between the set of sealing electrodes while the AC sealing signal is imparted between the set of sealing electrodes, and in response to the phase angle of biological tissue disposed between the sealing electrodes reaching a first phase angle threshold value, imparting a cutting output, either between a set of cutting electrodes or via a cutting blade, while the AC sealing output is imparted between the cutting electrodes.

[0131] Voltage

[0132] Another indicator that can be sensed and monitored to determine when to begin the application of the cutting operation can comprise voltage (V). As resistance goes up the voltage additionally goes up to meet the drop in current based on power equaling the product of resistance multiplied by current squared (P=R*iA2). Thus, the voltage required during vessel sealing can be used as an indicator of the stage of vessel sealing in a similar manner that resistance can be used. This is facilitated by the fluid content of a vessel typically being reduced by the application of energy, before the voltage required by the system increases as37Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01the tissue dries. Thus, processing unit 104 (FIG. 1) can be provided with threshold voltage levels for comparison to sensed voltage values to determine when sealing is sufficiently far enough along, or is trending toward being sufficiently performed, e.g., predicted to occur, to begin cutting.

[0133] In examples, the power levels can be sensed using a cut electrode, e.g., first electrode 140, the seal plates, e.g., first plate 212A and second plate 212B, and combinations of these electrodes. Voltage can be used as a trigger for commencing cutting based on either sensing of voltage throughout the entire vessel sealing cycle or at specific stages within the sealing cycle. Some seal cycles for example have pulsed stages, where a number of higher energy applications are interspersed with lower periods of energy application. Voltage can be monitored in either these high output energy application parts of the cycle or during the lower wattage output parts of the cycle. Alternatively, the voltage can be used as a trigger in the latter stages of a seal cycle, when the fluid has been considered to be appropriately boiled off and the end of the seal cycle process is complete or nearly complete. Additionally, the sensing of voltage can be used as a trigger to commence the cutting cycle based on sensing voltage during a preset pulse of high energy delivery or lower energy delivery in the sealing cycle. On a non-pulsed output, the voltage could be more simply considered throughout the process and have a triggering value at anywhere in the output.

[0134] At a predetermined state, when the delivered voltage to meet a predetermined power meets a specific criterion, the cut output of the RF stage can be initiated, causing the cut process to initiate in the tissue, during the seal cycle or after. The specific criterion can comprise a predetermined voltage level (V), a percentage of an originally detected value (%V), a delta shift of voltage (AV), a minimum voltage level (VMin), a maximum voltage level (Vmax) or combinations of these as a value. Once it has been determined that the voltage changed to a limit, a point, a delta or another predetermined relationship, it can be determined that the tissue has been sealed and cutting can begin. As shown in FIG. 7, cutting can begin at time t7.5 before sealing is completed at time t8. However, as mentioned, cutting can begin later than time t7.5 depending on the set trigger point.

[0135] Triggers to stop the sealing and cutting output can be the same triggers discussed above, hence when a set endpoint is reached, both the cut and the seal output are stopped, or the seal and the cut could have different triggers allowing them to stop at the same time, the cut first or seal first. Examples of these different end points to stop cutting include the seal38Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01end point being based on a resistance delta, and the end point of the voltage being the trigger to stop further cutting output.

[0136] In examples, a method to seal and cut biological tissue can comprise imparting an alternating current (AC) sealing signal between a set of sealing electrodes, determining the voltage to achieve a predetermine wattage applied to biological tissue disposed between the set of sealing electrodes while the AC sealing signal is imparted between the set of sealing electrodes, and in response to the voltage required to achieve a predetermined wattage applied to biological tissue disposed between the sealing electrodes reaching a first delivered or calculated threshold value, imparting a cutting output, either between a set of cutting electrodes or via a cutting blade, while the AC sealing output is imparted between the cutting electrodes.

[0137] Power (Wattage)

[0138] Another indicator that can be sensed and monitored to determine when to begin the application of the cutting operation can comprise power (P). The power used during vessel sealing can be used as an indicator of the stage of vessel sealing. As discussed, fluid content of a vessel is typically reduced as energy is applied. Therefore, in a system with a maximum voltage, the total power delivery cannot be met as the current draw of the high resistance material is not great enough and the voltage is limited by the system. Since power equals the product of current multiplied by voltage (P=i*V), the wattage or power, typically meets a point where it can no longer be met, indicating that the tissue state has significantly progressed towards a state of sealing completion. Because of this, the ability to reach a predetermined power in a system limited by voltage, current or both can be used as a trigger for cutting. Thus, processing unit 104 (FIG. 1) can be provided with threshold power levels for comparison to sensed power values to determine when sealing is sufficiently far enough, or is trending toward being sufficiently performed, e.g., predicted to occur, along to begin cutting.

[0139] In examples, the power levels can be sensed using a cut electrode, e.g., first electrode 140, the seal plates, e.g., first plate 212A and second plate 212B, and combinations of these electrodes. The power level can be used as a trigger for commencing cutting based on either sensing throughout the entire vessel sealing cycle or at specific stages within the sealing cycle. Some seal cycles for example have pulsed stages, where a number of higher energy applications are interspersed with lower periods of energy application. Power can be39Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01monitored in either these high output energy application parts of the cycle or during the lower predetermined wattage setting output parts of the cycle. Alternatively, the power can be used as a trigger in the latter stages of a seal cycle, when the fluid has been considered to be appropriately boiled off and the end of the seal cycle process is complete or nearly complete. Additionally, the sensing of power can be used as trigger to commence the cutting cycle based on sensing power during a preset pulse of high energy delivery or lower energy delivery in the sealing cycle. On a non-pulsed output, the power could be more simply considered throughout the process and have a triggering value at anywhere in the output.

[0140] At a predetermined state, such as within region 398 A of functional relation 386 A, when the delivered power to meet a predetermined power value meets a specific criterion, the cut output of the RF stage can be initiated, causing the cut process to initiate in the tissue, during the seal cycle or after. The specific criterion can comprise a predetermined power (wattage) (P), a percentage of an originally detected value (%P), a delta shift of power (AP), a minimum power level (PMin), a maximum power level (Pmax) or combinations of these values. In examples, point 397B can comprise a certain %P, e.g., 75%, of the difference between point 397A and point 397C that can trigger cutting; point 397B can comprise a certain AP, e.g., a number of Watts, from point 397A that can trigger cutting, point 397B can comprise a certain PMin that is to achieved to trigger cutting; point 397B can comprise a certain PMax that is to be reached to trigger cutting. Once it has been determined that the resistance changed to a limit, a point, a delta or another predetermined relationship, it can be determined that the tissue has been sealed or close to being sealed and cutting can begin. As shown in FIG. 7, cutting can begin at time t7.5 before sealing is completed at time t8.

[0141] Triggers to stop the sealing and cutting output can be the same triggers discussed above, hence when a set endpoint is reached, both the cut and the seal output are stopped, or the seal and the cut could have different triggers allowing them to stop at the same time, the cut output to stop first or the seal output to stop first. Examples of these different end points to stop can include the seal end point being based on a resistance delta, and the end point of the current being the trigger to stop further cutting output. In examples, sealing can stop at point 397B and cutting can stop at point 397C, both sealing and cutting can stop at point 397C, sealing can stop at point 397B and cutting can stop at point 397D, or sealing can stop at point 397C and cutting can stop at point 397D.40Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0142] In examples, a method to seal and cut biological tissue can comprise imparting an alternating current (AC) sealing signal between a set of sealing electrodes, determining the delivered power in a voltage limited or current limited or both system to achieve a predetermine wattage applied to biological tissue disposed between the set of sealing electrodes while the AC sealing signal is imparted between the set of sealing electrodes, and in response to the deliverable powers ability to achieve a predetermined wattage applied to biological tissue disposed between the sealing electrodes reaching a first delivered or calculated threshold value, imparting a cutting output, either between a set of cutting electrodes or via a cutting blade, while the AC sealing output is imparted between the cutting electrodes.

[0143] FIG. 8 is a block diagram illustrating method 400 including operation 402 through operation 422 in performing methods of operation of medical device 102 (FIG. 1) with processing unit 104 to automatically initiate cutting operations based on sensing of electrical parameters during sealing operations. Though discussed with reference to FIG. 1 through FIG. 7 and a particular medical device, method 400 can encompass the use of any medical device having monopolar and / or bipolar energy cycles, either with or without a cutting blade, consistent with the methods and systems described herein. Method 400 can additionally include fewer or greater operations other than operation 402 to operation 422. Additionally, in other examples, operation 402 through operation 422 can be performed in other sequences.

[0144] At operation 402, a medical instrument can be navigated to an anatomic structure, such as target object 220. For example, medical device 102 can be guided to a vessel to perform a sealing and cutting operation. In particular, end effector assembly 108 can be positioned adjacent to target object 220. In examples, shaft 118 of medical device 102 can be inserted into a scope to reach the anatomic structure. The system can utilize imaging guidance to facilitate accurate and efficient locating, ensuring that the instrument is positioned for performing the desired operation. In examples, a robotic surgical system, such as the one described with reference to FIG. 12B, can be used to place shaft 118 at the anatomic structure. In examples, shaft 118 can be articulated, such as by causing bending of articulating section 127 to reach the anatomic structure. This operation can facilitate end effector assembly 108 being correctly aligned with the target tissue, facilitating effective sealing and cutting while minimizing potential damage to surrounding tissues.41Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0145] At operation 404, energy for sealing the anatomic structure with a bipolar electrode can be activated. In examples, the sealing energy can comprise radio frequency (RF) energy. Although other suitable sealing energy can be used such as resistive energy, alternating current (AC) energy and monopolar energy. In examples, therapy power supply 132 can be used to deliver energy to second electrode 142 and third electrode 144. The activation of the sealing energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective sealing without damaging surrounding tissue. The bipolar configuration allows the energy to pass through the tissue between the electrodes, minimizing the risk of unintended tissue damage. For example, RF energy can more effectively reach collagen and elastin fibers within tissue. This operation facilitates achieving a strong and reliable seal and preventing bleeding, thereby ensuring the success of the surgical procedure.

[0146] At operation 406, electrical parameters of the sealing energy activated at operation 404 can be sensed. In examples, processing unit 104 can use one or more of sensor 128 to sense an electrical parameter between second electrode 142 and third electrode 144.Additionally, processing unit 104 can use one or more of first electrode 140, second electrode 142 and third electrode 144 to sense electrical parameters. In a particular example, processing unit 104 can sense between first electrode 140 and either of second electrode 142 and third electrode 144. In examples, processing unit 104 can sense between second electrode 142 and third electrode 144. In examples, the electrical parameter can comprise one or more of resistance, impedance, phase angle, voltage, current and power. By obtaining or capturing these measurements, the system can evaluate the effectiveness of the sealing process (e.g., whether blood flow is likely to have been stopped) and gather data to configure energy delivery for completing both sealing and cutting. In particular, the sensed parameters can be used to initiate a cutting operation and conclude both the sealing operation and the cutting operation. More specifically, the sensed parameters can be used to determine when to begin the cutting operation (either by applying cutting energy via an electrode or by activating a cutting blade within the end effector assembly 108) without user intervention. The cutting operation can begin before the sealing operation before sealing energy is applied, such as when jaws of a forceps are being used to apply pressure to the tissue to prevent blood flow, during the performance of the sealing operation while sealing energy is being applied, or after the sealing operation has been completed after sealing energy is no longer being applied. Thus, the method can ensure that both the sealing and cutting operations are42Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01properly performed in a minimal amount of time without requiring the exercise of judgement from the surgeon.

[0147] At operation 408, the sensed electric parameter can be compared to predetermined electrical values. Predetermined electrical values can be stored in memory of processing unit 104 or in communication with processing unit 104, such as over a networked or cloud connection. The predetermined electrical values can comprise values at which it has been previously determined that a sealing operation has sufficiently progressed to allow a cutting operation to commence, or values or changes in values that indicate a sealing operation is trending toward being sufficiently performed, e.g., predicted to occur. The predetermined electrical values can comprise one or more of a time that a sealing energy has been applied, a sensed magnitude of a sealing parameter, a sensed change in a sealing parameter, and a sensed rate of change of a sealing parameter. The predetermined electrical values can be derived from empirical data from testing conducted on tissue samples.

[0148] At operation 410, it can be determined if the sensed electrical parameter meets the threshold parameter or is within a predetermined tolerance band of the threshold parameter. Processing unit 104 can compare the electrical parameter sensed at operation 406 to a database or library of predetermined electrical values, such as predetermined resistance, impedance, phase angle, voltage, current and power, that have been previously correlated to levels of tissue sealing stored in memory of processing unit 104 or stored in servers connected to processing unit 104. By matching the sensed parameters with these stored values, processing unit can accurately determine if tissue has been sealed, is approaching being adequately sealed or not. This determination can help decide when to begin the cutting operation. Thus, the system can automatically control the transition of the application of sealing energy to the cutting operation, thereby ensuring adequacy of the seal and reducing the total time to perform the sealing and cutting operations. The system can provide outputs of the sensed parameter of operation 406 to a user so that a user can make appropriate modifications or obtain confirmation that sealing has occurred, if desired.

[0149] At operation 412, it can be determined that the sensed electrical parameter has not met the threshold electrical parameter. The sensed electrical parameter not meeting the threshold electrical parameter can indicate that the sealing process has not progressed to the level where cutting can begin. In particular, the sensed electrical parameter not meeting the threshold electrical parameter can indicate electrical parameter levels wherein it has been43Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01determined that tissue is not either fully or partially sealed, e.g., coagulated or cauterized, to a level where blood flow has ceased or diminished such that cutting cannot commence until further sealing is performed. In additional examples, the sensed electrical parameters can indicate or predict that a tissue sealing operation will not currently be performed adequately, such as due to the sensed electrical parameter not being sufficiently large or not changing fast enough due to the possible presence of foreign objects within the jaw, such as a staple or suture. As such, an alarm or warning can be issued by the electrosurgical system so that a user can take corrective action. Thus, method 400 can return to operation 406 to continue to monitor the application of the sealing energy until the sensed electrical parameter has reached the threshold electrical parameter.

[0150] At operation 414, it can be determined that the sensed electrical parameter has met the threshold parameter. The sensed electrical parameter meeting the threshold electrical parameter can indicate that the sealing process has progressed to the level where cutting can begin. In particular, the sensed electrical parameter meeting the threshold electrical parameter can indicate electrical parameter levels where it has been determined that tissue is either fully or partially sealed, e.g., coagulated or cauterized, to a level where blood flow has ceased or diminished such that cutting can commence while sealing is being finished or after sealing has finished. In additional examples, the sensed electrical parameter can meet one or more threshold parameters indicating that the tissue is trending toward successful completion, e.g., predicted to occur, even before the tissue is sealed or substantially sealed. Thus, method 400 can move to operation 416 and operation 418.

[0151] At operation 416, the cutting operation is initiated to cut the anatomic structure. Initiating the cutting operation can be accomplished by moving a cutting blade within the end effector assembly 108 or by activating cutting energy within the end effector assembly. In some such embodiments, cutting energy is applied with a bipolar electrode or a monopolar electrode. In examples, the cutting energy can comprise direct current energy or alternating current energy, such as high frequency radio frequency (RF) energy. This can involve delivering alternating current at a high frequency to first electrode 140. In examples, therapy power supply 132 can be used to deliver energy to first electrode 140. The activation of the cutting energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective cutting without damaging surrounding tissue. Operation 416 can occur44Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01before operation 418, e.g., contemporaneously with application of sealing energy, or can occur after operation 418, e.g., after application of sealing energy.

[0152] At operation 418, the anatomic structure can be sealed with the sealing energy activated at operation 404. Applied electrical energy from second electrode 142 and third electrode 144 can cause the anatomic structure to seal. For example, the electrical energy can cause cauterization of the tissue of target object 220. The sealing process can involve the denaturation of proteins within the tissue, leading to the formation of a coagulum that closes the vessel or tissue structure. The precise application of energy ensures that the seal is strong and reliable, preventing bleeding and maintaining the integrity of the surgical site. This operation can help achieve hemostasis and reduce the risk of postoperative complications. Thus, blood flow through the tissue can be stopped. In examples, the application of sealing energy at operation 418 can contribute to cutting at operation 420.

[0153] At operation 420, the anatomic structure can be cut. For example, energy delivered at operation 416, with or without energy contributions from operation 418, can cause separation of tissue on either side of first electrode 140. Thereafter, application of sealing and cutting energy can cease, such as by causing the application of current to first electrode 140, second electrode 142 and third electrode 144 to cease.

[0154] At operation 422, the medical instrument can be withdrawn or relocated after completing the sealing and cutting operations. This operation can involve retracting medical device 102 from the surgical site to ensure that no additional trauma is caused to the surrounding tissues or damaging the integrity of the sealed and cut areas, preventing any disruption to the achieved hemostasis. If relocation is desirable, such as to the site of another anatomic structure or vessel to be sealed and cut, the instrument can be repositioned to another target site within the anatomy. This can involve navigating through anatomical structures to reach a new area where treatment is to be applied. The system can utilize imaging guidance or robotic assistance to facilitate accurate and efficient relocation, ensuring that the instrument is positioned for subsequent procedures. After all desired surgical procedures or interventions are performed, medical device 102 can be withdrawn and any access portals in the patient can be appropriately closed.

[0155] Energy Consumption to Boil Tissue

[0156] In additional examples of the present disclosure, the trigger for commencing cutting can be based on energy that is consumed to boil (EB) liquid, e.g., water, within tissue.45Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01The energy required to boil tissue can be used as an indicator of the stage of vessel sealing. This is facilitated by the fluid content of a vessel typically being reduced by the application of energy, before the energy provided by the system can appropriately heat the collagen in the tissue to create a seal. Thus, processing unit 104 (FIG. 1) can be provided with threshold energy consumption levels for comparison to sensed energy consumption values to determine when sealing is sufficiently far enough along to begin cutting. Additionally, processing unit 104 can be provided with threshold energy consumption values that indicate that tissue being boiled is trending toward a successful sealing operation so that processing unit 104 can predict that a tissue sealing operation will successfully occur. Processing unit 104 can be provided with energy consumption levels for different types and thicknesses of tissue.Processing unit 104 can be provided with energy consumption levels for different types of sealing jaws. Typically, smaller sealing jaws can have smaller energy input levels than bigger jaws. In an example, for a given set of jaws and tissue type, processing unit 104 can have a threshold energy input level of twelve joules to cause boiling, e.g., reach a threshold resistance level where boiling will occur, that indicates a small enough energy input that indicates a small enough volume of water where sealing will occur with further application of energy.

[0157] Energy consumption to boil tissue (EB) can be used as a trigger for commencing cutting based on sensing when the joules applied to the tissue to create a fluid boiling reaction meets a specific criterion. The specific criterion can comprise a percentage of initial energy application (%EB), a set delta shift (AEB), a predetermined minimum (EBMin), a predetermined maximum (EBMax) or combinations of these values. Once it has been determined that the energy consumption to boil tissue changed to a limit, a point, a delta or another predetermined relationship, it can be determined that the tissue has been sealed or close to being sealed and cutting can begin. As shown in FIG. 7, cutting can begin at time t7.5 before sealing is completed at time t8.

[0158] Triggers to stop the sealing and cutting output can be the same triggers discussed above, hence when a set endpoint is reached, both the cut and the seal output are stopped, or the seal and the cut could have different triggers allowing them to stop at the same time, the cut output to stop first or the seal output to stop first. Examples of these different end points to stop cutting can include the seal end point being based on a resistance delta, and the end point of the phase angle being the trigger to stop further cutting output.46Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0159] In examples, the power levels can be sensed using the cut electrode, e.g., first electrode 140, the seal plates, e.g., first plate 212A and second plate 212B, and combinations of these electrodes.

[0160] In examples, a method to seal and cut biological tissue can comprise imparting an alternating current (AC) sealing signal between a set of sealing electrodes, determining the energy required to initiate boiling of biological tissue disposed between the set of sealing electrodes while the AC sealing signal is imparted between the set of sealing electrodes, and in response to the energy required to cause boiling of biological tissue disposed between the sealing electrodes reaching a first delivered or calculated threshold value, imparting a cutting output, either between a set of cutting electrodes or via a cutting blade, while the AC sealing output is imparted between the cutting electrodes.

[0161] FIG. 9 is a block diagram illustrating method 450 including operation 452 through operation 476 in performing methods of operation of medical device 102 (FIG. 1) with processing unit 104 to automatically initiate cutting operations based on sensing of energy consumed to boil tissue during sealing operations. Though discussed with reference to FIG. 1 through FIG. 7 and a particular medical device, method 450 can encompass the use of any medical device having monopolar and / or bipolar energy cycles, either with or without a cutting blade, consistent with the methods and systems described herein. Method 450 can additionally include fewer or greater operations other than operation 452 to operation 476. Additionally, in other examples, operation 452 through operation 476 can be performed in other sequences.

[0162] At operation 452, a medical instrument can be navigated to an anatomic structure, such as target object 220. For example, medical device 102 can be guided to a vessel to perform a sealing and cutting operation. In particular, end effector assembly 108 can be positioned adjacent to target object 220. In examples, shaft 118 of medical device 102 can be inserted into a scope to reach the anatomic structure. The system can utilize imaging guidance to facilitate accurate and efficient locating, ensuring that the instrument is positioned for performing the desired operation. In examples, a robotic surgical system, such as the one described with reference to FIG. 12B, can be used to place shaft 118 at the anatomic structure. In examples, shaft 118 can be articulated, such as by causing bending of articulating section 127 to reach the anatomic structure. This operation can facilitate end47Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01effector assembly 108 being correctly aligned with the target tissue, facilitating effective sealing and cutting while minimizing potential damage to surrounding tissues.

[0163] At operation 454, energy for boiling the anatomic structure with a bipolar electrode can be activated. In examples, the boiling energy can comprise radio frequency (RF) energy. Although other suitable sealing energy can be used such as resistive and alternating current (AC) energy. In examples, therapy power supply 132 can be used to deliver energy to second electrode 142 and third electrode 144.

[0164] At operation 456, electrical parameters of the boiling energy activated at operation 404 can be sensed. Operation 456 can involve sensing the electrical parameters to determine if sufficient energy has been put into the anatomic structure sufficient to boil liquid therein. In examples, processing unit 104 can use one or more of sensor 128 to sense an electrical parameter between second electrode 142 and third electrode 144. In examples, the electrical parameter can comprise resistance, temperature, total energy applied, energy applied, the rate of energy application over time, and the like. Thus, a sufficient spike in resistance can indicate boiling has occurred.

[0165] At operation 458, the sensed electric parameter can be compared to predetermined electrical values. It can be determined if the sensed electrical parameter meets a threshold parameter. In examples, the threshold parameter can comprise a magnitude or a change in magnitude, etc. The threshold electrical parameter sensed at operation 458 can comprise a prerequisite level of resistance where boiling can be commenced within the tissue.Processing unit 104 can compare the electrical parameter sensed at operation 456 to a database or library of predetermined electrical values, such as resistance, temperature, and energy application rates, that have been previously correlated to levels of tissue sealing stored in memory of processing unit 104 or stored in servers connected to processing unit 104. By matching the sensed parameters with these stored values, processing unit can accurately determine if tissue has been boiled or not. The system can provide outputs of the sensed parameter of operation 406 to a user so that a user can make appropriate modifications, if desired.

[0166] If it is determined that the sensed electrical parameter has not met the threshold parameter, it can be determined that sufficient energy has not been input to the tissue to cause water to change to steam. Thus, method 450 can proceed to operation 460. At operation 460, it can be determined that not enough energy has been put into the tissue such that boiling has48Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01not occurred. Thus, method 450 can return to operation 454 to continue to apply and monitor the application of the bipolar sealing energy.

[0167] If it is determined that the sensed electrical parameter has met the threshold parameter, it can be determined that sufficient energy has been input to the tissue to cause water to change to steam, thereby causing a change or spike in the sensed parameter. Thus, method 450 can proceed to operation 462. At operation 462, it can be determined the magnitude of energy put into the anatomic structure was small or large, wherein a small amount of energy can indicate the presence of a small amount of liquid and a large amount of energy can indicate the presence of a large amount of liquid.

[0168] At operation 462, if the threshold electrical parameter level to boil liquid has been reached, it can be determined how much total energy was input into the tissue to cause boiling. It can then be determined if the amount of energy input into the system is below a threshold level of energy where only a small amount of liquid boils, which can indicate that the tissue is sufficiently dry so that sealing can begin.

[0169] At operation 462, if the total energy level is not below the threshold energy level, method 450 can move to operation 464. That is, the amount of energy put into the anatomic structure can be determined to be associated with a large amount of liquid. Stated another way, the system can determine that a large amount of energy was put into the anatomic structure to cause a large amount of liquid to boil, thereby indicating the presence of a large amount of liquid in the system and likely additional liquid in the anatomic structure. Thus, at operation 464, it can be determined that too much liquid remains in the tissue, and method 450 can return to operation 454 to cause additional boiling.

[0170] In an example, it can be predetermined that a total amount of energy to be used to boil liquid in an anatomic structure for a small amount of liquid that can be tolerated to commence sealing of the tissue can be 10 Watts of power. Thus, if at operation 462 it is determined that thirty Watts of power was put into the anatomic structure to cause boiling, method 400 can determine that a large amount of water remains in the anatomic structure at the time the resistance spiked to the threshold level, specifically too much liquid to cause sealing of the anatomic structure. Thus, method 400 can repeat from operation 454. If at the second occurrence of operation 462 it is determined that fifteen Watts of power was put into the anatomic structure to cause boiling at the time the resistance spiked to the threshold level, it can be determined that too much liquid still remains in the anatomic structure whereby49Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01sealing would still not be effective. Thus, method 400 can repeat from operation 454. If at the third occurrence of operation 462 it is determined that seven Watts of power was put into the anatomic structure, it can be determined that this is below the threshold Wattage of ten Watts. Thus, it can be determined that only a small amount of liquid was boiled from the anatomic structure, thereby indicating that only a small amount of liquid remains in the anatomic structure that will not interfere with the commencement of sealing of the anatomic structure. Thus, at this point, method 400 can determine that the anatomic structure is ready to be sealed.

[0171] At operation 462, if the threshold energy input level is met, method 450 can move to operation 466. At operation 466, it can be determined that a sufficient level of liquid has been removed from the tissue via boiling. Thus, method 450 can continue the sealing operation by delivering an amount of energy sufficient to seal tissue that has already been sufficiently dried. At operation 466, energy for sealing the anatomic structure with a bipolar electrode can be activated. The system can determine that sufficient liquid has been removed from the tissue such that further application of energy will result in sealing or partially sealing the tissue. In examples, the sealing energy can comprise radio frequency (RF) energy. Although other suitable sealing energy can be used such as resistive and alternating current (AC) energy. In examples, therapy power supply 132 can be used to deliver energy to second electrode 142 and third electrode 144. The activation of the sealing energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective sealing without damaging surrounding tissue. The bipolar configuration allows the energy to pass through the tissue between the electrodes, minimizing the risk of unintended tissue damage. For example, RF energy can more effectively reach collagen and elastin fibers within tissue. This operation facilitates achieving a strong and reliable seal and preventing bleeding, thereby ensuring the success of the surgical procedure.

[0172] At operation 468, it can be determined that the anatomic structure is sufficiently sealed to commence cutting operations. Operation 468 can comprise the additional application of sealing energy over what was applied at operations 454 through operation 466. For example, the system can apply an additional second or few seconds of sealing energy to ensure that the anatomic structure is sufficiently sealed. Thus, method 450 can move to operation 470 and operation 472.50Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0173] In additional examples of the present disclosure, cutting operations can commence while the system is determining if liquid within the anatomic structure was, is or has boiled. For example, tissue cutting operations can begin while method 450 is cycling through operation 462 to operation 454. If the system determines that the energy input to boil is progressing along smaller and smaller magnitudes, the system can predict that a seal will be completed once the energy to reach boil passes below the threshold. Thus, the system can initiate cutting operation 470 before surpassing the threshold resistance. In particular, such a scenario can occur when jaws of a forceps or a sealing device are actively applying pressure to the anatomic structure to inhibit or prevent blood flow before and during performance of the sealing operation.

[0174] At operation 470, the cutting operation is initiated to cut the anatomic structure. In examples, operation 470 includes moving a mechanical cutting blade within the end effector assembly 108 or applying cutting energy within the end effector assembly 108. The cutting energy can comprise activation of bipolar energy or monopolar energy. In some examples, first electrode 140 can be activated to provide RF cutting energy. Although other suitable sealing energy can be used such as resistive and alternating current (AC) energy. In examples, therapy power supply 132 can be used to deliver energy to second electrode 142 and third electrode 144. The activation of the cutting energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective cutting without damaging surrounding tissue. The monopolar configuration allows the energy to pass directly into the previously dried tissue from the sealing energy, minimizing the risk of unintended tissue damage. For example, monopolar energy can more effectively penetrate into the dried tissue.

[0175] At operation 472, the anatomic structure can be sealed with the sealing energy activated at operation 404. Applied electrical energy from second electrode 142 and third electrode 144 can cause the anatomic structure to seal. For example, the electrical energy can cause cauterization of the tissue of target object 220. The sealing process can involve the denaturation of proteins within the tissue, leading to the formation of a coagulum that closes the vessel or tissue structure. The precise application of energy ensures that the seal is strong and reliable, preventing bleeding and maintaining the integrity of the surgical site. This operation can help achieve hemostasis and reduce the risk of postoperative complications. Thus, blood flow through the tissue can be stopped. In examples, the application of sealing energy at operation 472 can contribute to cutting at operation 470.51Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0176] At operation 474, that anatomic structure can be cut with the electrical energy or with mechanical energy. For example, energy delivered at operation 470, with or without energy contributions from operation 472, can cause separation of tissue on either side of first electrode 140. Thereafter, application of sealing and cutting energy can cease, such as by causing the application of current to first electrode 140, second electrode 142 and third electrode 144 to cease.

[0177] At operation 476, the medical instrument can be withdrawn or relocated after completing the sealing and cutting operations. This operation can involve retracting medical device 102 from the surgical site to ensure that no additional trauma is caused to the surrounding tissues or damaging the integrity of the sealed and cut areas, preventing any disruption to the achieved hemostasis. If relocation is desirable, such as to the site of another anatomic structure or vessel to be sealed and cut, the instrument can be repositioned to another target site within the anatomy. This can involve navigating through anatomical structures to reach a new area where treatment is to be applied. The system can utilize imaging guidance or robotic assistance to facilitate accurate and efficient relocation, ensuring that the instrument is positioned for subsequent procedures. After all desired surgical procedures or interventions are performed, medical device 102 can be withdrawn and any access portals in the patient can be appropriately closed.

[0178] Combinations

[0179] The above triggers identified to initiate a cut output can be considered in isolation. However, multiple checks can be used wherein rather than a simple, e.g., single, trigger for activating a cutting operation, multiple triggers for evaluating the sealing output can be used in combination to ensure a higher probability that the sealing operation has adequately progressed to allow for cutting. Examples of this can include using the above-described voltage trigger and impedance trigger, or the above-described voltage trigger and phase angle trigger etc. Multiple combinations can also be used. For example, the voltage triggers, phase angle trigger and impedance trigger all have to be initiated prior to the commencement of the cut output.

[0180] Device State

[0181] FIG. 10A shows a block diagram of system 500 for performing one or more of the methods, procedures or operations discussed herein. System 500 can comprise controller 502, camera unit 504 and energy application device 506. Controller 502 can comprise central52Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01processing unit, e.g., CPU 508, image processor 510 and energy generator source 512. In examples, controller 502 can comprise or include processing unit 104 (FIG. 1).

[0182] Controller 502 can comprise a machine configured to receive imaging inputs from camera unit 504 and electrical feedback from energy application device 506 to perform analysis thereof to determine the effectiveness of a tissue sealing operation being performed by energy application device 506 and to automatically initiate the cutting operation without user input based on the analysis performed on the tissue sealing operation. Controller 502 can comprise capital equipment used in an operating room, such as a power supply, electrical generator, imaging unit, illumination unit and the like. Controller 502 can include CPU 508, which can be configured to communicate with image processor 510 and energy generator source 512. CPU can comprise a component of a larger machine configured to allow CPU 508, image processor 510 and energy generator source 512 to operate together. Further details of controller 502 are described with reference to FIG. 16.

[0183] Camera unit 504 can comprise an imaging device, image processor and the like. Camera unit 504 can be used to obtain images of anatomy and images of energy application device 506 within a patient. In examples, camera unit 504 can comprise a charge-coupled device (CCD), a solid state device such as a complementary metal oxide semiconductor (CMOS), a focal plane array (FPA) imaging sensor, another imaging sensor or camera described herein or another device known in the art.

[0184] Energy application device 506 can comprise a device suitable for delivering energy to tissue to perform a medical procedure, such as a therapeutic procedure or diagnostic procedure. Energy application device 506 can comprise a device configured for delivering radio frequency (RF) energy, electromagnetic energy, plasma energy, ultrasound energy and the like. In examples, energy application device 506 can comprise jaw assembly 110, including first jaw member 112, second jaw member 114, second plate 202B, second plate 212B and sensors 128, as shown in FIG. 3B, electrosurgical end effector 530 of FIG.10B and combinations thereof.

[0185] In operation, camera unit 504 and energy application device 506 can be inserted into anatomy of a patient. Jaws of energy application device 506 can be positioned around tissue and can be actuated to apply force to the tissue. Energy application device 506 can be activated to apply energy to the jaws to seal the tissue. For example, a user can push a button or the like on handpiece 106 (FIG. 1) to provide activation energy from energy generator53Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01source 512 to energy application device 506 that can, as described herein, apply sealing energy and automatically determine when to begin the cutting operation. Thus, energy generator source 512 can provide energy transfer to energy application device 506.Simultaneously, camera unit 504 can observe energy application device 506 and the tissue located therein. Camera unit 504 can provide imaging data to image processor 510. Image processor 510 can render the signal from camera unit 504 as an image on display 526. Image processor 510 can additionally identify first jaw member 112 and second jaw member 114 in the images and determine an operative state thereof, e.g., open, closed or intermediate states. Image processor 510 can additionally identify changes in the state, e.g., movement, of first jaw member 112 relative to second jaw member 114 to determine when events occur in anatomic structures therebetween. Image processor 510 can additionally convey the signal from camera unit 504 to CPU 508. CPU 508 can additionally receive input from energy application device 506. For example, energy application device 506 can provide measurements from one or more sensors associated with energy application device 506, such as sensor 128 of FIG. 3B, to energy generator source 512, which can subsequently relay the measurements to CPU 508. As such, CPU 508 can receive imaging signals from camera unit 504 and sensor signals from sensor 128 of energy application device 506, which can be correlated along a common timeline. In examples, output of camera unit 504 and sensor 128 can be processed by an artificial intelligence (Al) engine, such as CDSS 800 of FIG. 15. Changes in sensor output, e.g., one or both of output from sensor 128 and camera unit 504, can be used by CPU 508 to determine if a sealing operation of an anatomic structure has or is progressing to a point where a cutting operation can begin, such as when tissue is sufficiently modified to prevent or inhibit blood flow therethrough. Additionally, CPU 508 can determine or predict if a sealing operation is trending toward being sufficiently performed, even before the tissue has started sealing, is nearly sealed or completely sealed. As discussed below, CPU 508 can look for one or more of changes in the position of first jaw member 112 and second jaw member 114 via pressure sensors or video imaging to determine that jaw bounce has occurred where tissue expands due to vaporizing of liquid, changes in color of anatomic structure within first jaw member 112 and second jaw member 114 that indicate thermal margin, and changes in temperatures within first jaw member 112 and second jaw member 114 that can indicate a change in state of tissue.54Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0186] Controller 502 can comprise output device 520 for providing output and human-perceptible feedback. Output device 520 can comprise display 526, haptic feedback device 522 and audio driver 524. Display 526, also shown in FIG. 1 as user interface 105, can comprise indicia 526A through indicia 526E and dial 528. In other examples, dial 528 can comprise a mechanical dial responsive to output of controller 502. Output device 520 can comprise, or can be in communication with, CPU 508, which can also be in communication with sensors 128 and camera units 504 via image processor 510 and energy generator source 512. In examples, sensors 128 (FIG. 3B) and camera units 504 (FIG. 10A) can be in direct communication with output device 520. In examples, output device 520 can be located on or in processing unit 104 (FIG. 1).

[0187] Display 526 can comprise an active display unit, such as a liquid crystal display, a plasma screen, an organic light-emitting diode display and the like. Display 526 can comprise a touchscreen device. Display 526 can comprise an augmented reality device, such as a heads-up display. Display 526 can be programmed to provide a variety of outputs and receive a variety of user-inputs. CPU 508 can be connected to a memory device, such as memory 356 of FIG. 6, and can include information related to electrical parameters sensed by sensors 128, such as changes in sensed electrical parameters, pressure and temperature that can correspond to changes in the status of therapy procedures being performed on different tissue types with different energy types, baseline or reference information for the electrical parameters, and indicia and instructions to be displayed on display 526 if the sensed electrical parameters do not sufficiently correspond to the baseline or reference information, such as warnings that a procedure has or may not have been completed properly and the like. In examples, display 526 can show various textual messages, such as: “Warning! Tissue cutting is about to commence.”; “Warning! Tissue cutting will begin in 1 second” and the like. In examples, display 526 can provide confirmation that a proper seal has been performed, such as “The sealing operation has been completed.” Thus, CPU 508 can comprise signalprocessing circuitry that can receive an input from sensors 128 and camera units 504 (FIG.10 A), consult a lookup table stored in memory to find output indicia for the corresponding output of sensors 128 and camera units 504 and display on display 526 or provide another feedback output relating to the transition of sealing energy to cutting energy and the like. Activation of at least one of indicia 526A through indicia 526E, as well as haptic feedback device 522, audio driver 524 and dial 528, can provide indications of progress of a procedure55Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01being performed, as can be determined by a predictive engine, e.g., Al or ML system, for example, as discussed with reference to FIG. 15.

[0188] In examples, each of indicia 526A through indicia 526E can be activated to indicate a stage or phase of a procedure that is being performed to provide an indication of how far along the procedure has progressed. In examples, indicia 526A through indicia 526E can provide indicia indicating start of sealing, completion of sealing, start of cutting and completion of cutting in a vessel sealing operation. Each of indicia 526A through indicia 526E can comprise a light emitting diode. In examples, indicia 526E at the bottom of output device 520 and indicia 526A at the top of output device 520 can be activated in opposite manners to indicate opposite ends of a progress spectrum. Thus, indicia 526E can be activated to show a first level of a progress. Indicia 526B, indicia 526C and indicia 526D can be activated to indicate varying levels in between the first and second levels such that a continuous spectrum or a gradual changing of light emitting activation can be provided. Indicia 526A through indicia 526E can update in real-time to indicate the progress in the procedure being performed. Thus, as a surgeon manipulates medical device 102 (FIG.l) to perform a medical procedure, such as a sealing operation, an indication in the completeness of the seal being formed and when cutting energy is or is about to be activated can be provided. In other examples, all of indicia 526A through indicia 526E can be activated, or lit up, and can change colors to indicate the magnitude of the electrical parameter. For example, lighter colors can be used to indicates early stages of a sealing operation and darker colors can be used to indicate later stages of a sealing operation. In examples, indicia 526A through indicia 526E and dial 528 can be provided with labels to translate the progress into actionable feedback for a user, such as by conveying when a cutting operation is to be automatically commenced.

[0189] In an example, display 526 can include dial 528. Dial 528 can include a scale to indicate different information, such as sealing progress and activation of cutting energy. A mechanical or virtual needle can be moved relative to a scale on dial 528 to indicate different levels of sealing progress and when cutting begins. One end of the scale can indicate low progress, e.g., sealing has just started, and the opposite end of the scale can indicate high progress, e.g., cutting is finishing.

[0190] In examples, an audible alarm can be used to provide feedback indicating different progress levels, such as by using audio driver 524. For example, a steady signal can be56Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01emitted that changes pitch, volume or tone based on the progress level. In other examples, an intermittent signal can be emitted that changes intervals based on the progress level. Thus, low pitch or low volume audible alarms can indicate high progress and high pitch or high volume audible alarms can indicate low progress. In examples, no audible alarm can represent high progress and audible alarm can indicate lower progress, with high pitch or volume of the audible alarm indicating even lower progress. In examples, audio driver 524 can emit warning beeps for different stages of the sealing and cutting progress, such as at the beginning of sealing, the end of sealing, the beginning of cutting and the end of cutting, which can occur in different orders as discussed herein.

[0191] In examples, a tactile alarm can be used to provide feedback indicating the sealing and cutting progress, such as by using haptic feedback device 522. For example, a steady vibration can be emitted that changes speed, e.g., frequency, based on the progress level. In other examples, an intermittent signal can be emitted that changes intervals based on the sealing progress level. Thus, low speed vibrations or low frequency vibrations can indicate high progress and high speed vibrations or high frequency vibrations can indicate low progress. In examples, no vibration can represent high progress and vibration can indicate lower progress, with high speed or frequency of the vibration indicating even lower progress.

[0192] FIG. 10B is a schematic perspective view of electrosurgical end effector 530 suitable for use with system 500 of FIG. 10A. Electrosurgical end effector 530 can be attached to shaft 532 and can include or be used with external camera device 534. External camera device 534 can comprise camera unit 504 of FIG. 10 A. Electrosurgical end effector 530 can include or use jaw assembly 536. Electrosurgical end effector 530 can be used to apply sealing and cutting energy to tissue 537. In examples, jaw assembly 536 can comprise “J-shaped Hook” type electrode. Jaw assembly 536 can include first jaw member 538 and second jaw member 540. First jaw member 538 and second jaw member 540 can be pivotably coupled to each other about a pivot axis or other pivot point. Electrosurgical end effector 530 comprises an end effector suitable for use with medical device 102 of FIG. 1. In examples, first jaw member 538 and second jaw member 540 can be used as first jaw member 112 and second jaw member 114 of FIG. 3B.

[0193] External camera device 534 can be separate from electrosurgical end effector 530, such as extending from another shaft or mount extending from shaft 532. In examples, another external camera device can be used that can extend from another device, such as a57Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01robotic arm or videoscope. External camera device 534 can be oriented to view distally of electrosurgical end effector 530 or proximally of electrosurgical end effector, or in both directions.

[0194] External camera device 534 can include cameras 542 capable of illuminating and capturing a tissue image, such as using a focal plane array (FPA) imaging sensor array of pixels. External camera device 534 can include one or more light sources 544, such as for illumination of the surgical site, e.g., distally, or tissue within jaw assembly 536, e.g., proximally. With external camera device 534 integrated into electrosurgical end effector 530, manipulation of the device can simultaneously or concurrently manipulate cameras 542. External camera device 534 can include an optical fiber bundle or other illumination optics such as to communicate light from an external light source to an internal target, and can include one or more of a spectroscopic imaging or analysis sensor, a hyperspectral imaging sensor, a colorimetric imaging sensor, a video camera sensor, an infrared imaging sensor, an ultrasound imaging sensor, a 3D imaging sensor, a LIDAR imaging sensor, an optical coherence tomography (OCT) imaging sensor, a focal plane array (FPA) imaging sensor, or a fluorescence or other shifted-wavelength response imaging sensor.

[0195] With the present disclosure, a user can perform a single activation of second button 126 (FIG. 1) to instruct processing unit 104 or CPU 508 to perform both a seal and a cut automatically. Processing unit 104 can determine a state of medical device 102, which can be used to determine when to commence activation of cutting energy. In examples, a state of jaw assembly 536 can be used to trigger activation of cutting energy. In examples, an imaging state of jaw assembly 536 can be used relative to tissue to trigger activation of cutting energy. In examples, pressure and / or temperature within jaw assembly 536 can be used to trigger activation of cutting energy. Various combinations of these different device states can additionally be used together to trigger cutting energy.

[0196] Jaw State

[0197] Visual feedback systems, such as camera unit 504, can be used to determine distances between first jaw member 538 and second jaw member 540 of jaw assembly 536 of FIG. 10B, for example, and correlate such distances over time. The relative positions of first jaw member 538 and second jaw member 540 can be used to determine when “jaw bounce” occurs resulting from the occurrence of boiling of fluid within tissue.58Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0198] In examples, camera unit 504 can comprise external camera device 534 of FIG.10B. In examples, camera unit 504 can be part of a laparoscopic viewing system into which medical device 102 can be placed. Output of the camera unit 504 can be communicated to processing unit 104 or CPU 508 for display on user interface 105 or output device 520. In additional examples, output of camera unit 504 can be displayed on an Augmented Reality (AR) display where a view of the AR user is augmented prior to being displayed. In examples, camera unit 504 can comprise part of a robotic surgical system, e.g., robotic surgical system 600 of FIG. 12B. In examples, output of camera unit 504 can be processed by an artificial intelligence (Al) engine, such as CDSS 800 of FIG. 15, before being relayed to a user in order to make additions or corrections to the images. Processing of images from camera unit 504 can be used to identify the status of electrosurgical end effector 530 as well as tissue 537 within first jaw member 538 and second jaw member 540 of jaw assembly 536. In particular, processing of images from camera unit 504 can be used to identify first jaw member 538 and second jaw member 540, identify specific points thereon, and determine the angle therebetween. The points on first jaw member 538 and second jaw member 540 can be pre-existing points on first jaw member 538 and second jaw member 540, such as those due to the shape of first jaw member 538 and second jaw member 540 (e.g., a comer or an edge of material), or can be specifically added to first jaw member 538 and second jaw member 540 for the purposes of visual identification. First jaw member 538 and second jaw member 540 can markers, such as marker 546, that can be recognized by camera unit 504. In examples, marker 546 can comprise indicia or physical features that can be tracked by image processor 510 (FIG. 10A) in images from camera unit 504. In examples, marker 546 can comprise a fiducial marker, a bar code, a quick response (QR) code and the like.

[0199] In examples, images from camera unit 504 can be continuously analyzed, but in an effort to minimize the computational burden on the system, images from camera unit 504 can be analyzed only when electrodes of jaw assembly 536 are activated, or actively being moved.

[0200] A number of different triggers could be employed to activate the cut output during the seal output.

[0201] In examples, triggering of cut energy can be caused by a gap, e.g., gap G1 of FIG.3B, between first jaw member 538 and second jaw member 540 meeting a minimum gap value (GMin). Processing unit 104 can monitors gap G1 after a user initiates a seal and cut59Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01action. With sealing output initiated, first jaw member 538 and / or second jaw member 540 can apply energy to tissue, e.g., target object 220 (FIG. 3B) or tissue 537 (FIG. 10B). The sealing energy can cause a reduction in the size of target object 220, causing gap G1 to shrink, such as by the exiting of liquid from tissue. Once gap G1 is reduced to a threshold level, processing unit 104 can trigger activation of cutting energy.

[0202] In examples, rather than a minimum gap distance, processing unit 104 can look for a change in gap G1 distance (AG) from the outset of sealing energy. In such scenarios, gap G1 can be determined from camera unit 504 during initial activation of the combined “seal and cut” command, which can initially only output sealing energy. Once the distance drops, e.g., is reduced, from the initial distance to a new, smaller distance, AG, the cutting energy output can be activated.

[0203] In examples, processing unit 104 can look for a “bounce” in end effector assembly 108 that occurs during sealing. With the present disclosure, the phenomena of “jaw bounce” can be used to identify a particular point in the sealing cycle to initiate cutting or when to start a timer for initiating cutting. During a sealing cycle, first jaw member 538 and second jaw member 540 can be clamped on tissue, e.g., target object 220. During the initial application of sealing energy, first jaw member 538 can be pushed away from second jaw member 540 from the initial clamping position as the initial quantity of fluid is boiled to generate steam. This steam generation takes up more space than the fluid and as such, at some point first jaw member 538 is pushed slightly further away from second jaw member 540 to a slightly more open position. Additional description of jaw bounce is provided with reference to FIG. 14A through FIG. 14E.

[0204] Depending on the waveform type that is used to apply the sealing energy, e.g., pulsed or continuous, the jaw bounce typically happens once per sealing cycle for a continuous waveform output or multiple times for a pulsed waveform output, with the initial pulse typically having the largest jaw displacement due to steam leaving the tissue and typically each subsequent pulse has a lesser displacement.

[0205] In examples, system 500 can be configured to initiate the cutting output at the first occurrence of a jaw bounce, or set a timer for when to start the cutting output. Thus, processing unit 104 (FIG. 1) or system 500 can be provided with threshold jaw state changes for different tissue types and thicknesses for comparison to sensed jaw state values to determine when sealing is sufficiently far enough along to begin cutting. The jaw bounce can60Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01be configured to have a minimum distance that jaw assembly is opened, e.g., a distance from after the jaws are clamped onto tissue before energy is applied. In examples, system 500 can be configured to initiate the cutting output at a specifically identified bounce number, such as the second bounce, third bounce, fourth bounce, or the like. In examples, system 500 can be configured to initiate the cutting output when a bounce delta meets a minimum value. That is, the trigger for activating cutting energy can be when the change in bounce size from one bounce to the next is small. This minimum delta can also provide an indication of the water content in the tissue within end effector assembly 108. The smaller the bounce is, the less water is between first jaw member 112 and second jaw member 114. In vessel sealing, it is desirable to remove all or most water from tissue so that the applied sealing energy can be used to modify the collagen rather than just heating water, as it is this collagen heating that results in the seal formation. System 500 can also be configured to look for jaw bounce with camera unit 504 at times when energy generator source 512 is active. If system 500 does not recognize any jaw bounce during energy application, system 500 can initiate cutting energy. Once cutting has commenced, sealing and cutting can be terminated at any point where the system receives and indication that each process is complete.

[0206] Pressure Feedback

[0207] In various examples of the present disclosure, other feedback regarding the state of first jaw member 538 and second jaw member 540 can be used. Not all sealing systems are used with camera systems, such as camera unit 504, enhanced visualization systems or augmented visualization systems. For example, some sealing systems are used in open procedures where a laparoscope or robot is not used. Also, the ability to see both of first jaw member 538 and second jaw member 540 during surgery with a visualization system is not always possible, such as due to anatomical limitations, such as obstruction of jaw assembly 536 by anatomic structures of anatomy that the device is being used in, preventing visualization of all or some of end effector assembly 108. Additionally, viewing of jaw assembly 536 can be obstructed by electrosurgical smoke, connective tissues or general accessibility issues, which can limit sufficient visualization of jaw assembly 536 suitable for monitoring gap G1 to trigger activation of cutting output.

[0208] To overcome the lack of complete visualization of end effector assembly 108, system 500 can be provided with alternative devices, capabilities and means for determining if sealing has reached a suitable state for cutting be commence based on device state. In61Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01examples, jaw assembly 536 can include sensors, such as sensor 128 of FIG. 3B, to determine a condition of jaw assembly 536 or target object 220. In examples, sensor 128 can comprise a force sensor capable of measure force or pressure applied to one or both of first jaw member 538 and second jaw member 540. By including a force sensor, system 500 can gain an understanding of the position of first jaw member 538 relative to second jaw member 540. In examples, the pressure sensors can be used to sense compression of an overtravel spring. In examples, the pressure sensors can be used to sense increased force on first jaw member 538 and / or second jaw member 540 due to the state change of fluid between first jaw member 538 and second jaw member 540. As such, system 500 can be configured to monitor for and recognize variations in pressure exerted within jaw assembly 536 to initiate activation of cutting energy.

[0209] In examples, pressure sensors can be placed in a jaw member itself, as shown in FIG. 3B. In examples, pressure sensors can be placed in a linkage mechanism responsible for opening and closing of end effector assembly 108, such as in pivot point 116 (FIG. 3B). Thus, jaw bounce can be determined by sensing changes in jaw pressure (APr), minimum jaw pressure (PrMin), maximum jaw pressure (PrMax), after a specific number of jaw bounces has occurred, (Pr#) and timed with seal pulse outputs, e.g., looking for jaw bounces when seal pulses are generated.

[0210] Pressure sensors can be used in first jaw member 538 and second jaw member 540 alone or in combination with a pressure sensor, for example within a cut blade element in the jaw assembly.

[0211] In examples, pressure sensors can comprise electromechanical pressure sensors or optical pressure sensors, as are known in the art, or combinations of these pressure sensors for general pressure sensing outside of electrosurgical sealing and cutting operations. In examples, sensor 128 of FIG. 3B can comprise a strain gauge, a load cell, a piezoresistive sensor, an inductive sensor, a capacitive sensor, or a magnetostrictive sensor.

[0212] Thus, processing unit 104 (FIG. 1) or system 500 can be provided with threshold pressures or pressure changes for different tissue types and thicknesses for comparison to sensed pressure values to determine when sealing is sufficiently far enough along to begin cutting. Additionally, processing unit 104 can be provided with threshold pressures or pressure changes for different tissue types and thickness that indicate when a sealing operation is trending toward being sufficiently performed in order to predict that the sealing62Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01operation will be completed successfully so that a cutting operation can be initiated before a seal is completed, substantially completed or even started. In examples, system 500 can be configured to initiate the cutting output, or set a timer for initiating the cutting output, based on the occurrence of a jaw bounce as determined by pressure sensors in a similar manner for determining jaw bounce based on imaging. Once cutting has commenced, sealing and cutting can be terminated at any point where the system receives an indication that each process is complete.

[0213] Thermal margin recognition:

[0214] In additional examples of the present disclosure, system 500 and camera unit 504 can be configured to look for events to trigger initiation of the cutting operation based on recognized changes in tissue, such as tissue 537. Visual feedback systems, such as camera unit 504, can be used to determine coloration of tissue between first jaw member 538 and second jaw member 540 of jaw assembly 536. The colors of tissue 537 between first jaw member 538 and second jaw member 540 can be used to determine when tissue has been sufficiently transformed, e.g., the melting of collagen, to seal tissue 537 so that cutting can be performed. In additional examples, visual feedback can be obtained to predict when a sealing operation is trending toward a successful completion so that cutting can be performed.

[0215] The colors of tissue 537 can indicate thermal margin. Thermal margin occurs in a tissue being sealed as the fluid in the tissue between first jaw member 538 and second jaw member 540 changes state from liquid to gas, as water and cellular / extracellular fluids essentially convert to steam. The generation of this steam increases the volume of the tissue. Due to the limitations of first jaw member 538 and second jaw member 540 placed on tissue 537, e.g., the jaws forming a barrier to steam escaping, steam moves sideways out jaw assembly 536. As the steam exits, the steam can blanch tissue 537, which can cause a discoloration of tissue 537 similar to burning. Tissue 537 can turn from a reddish or pinkish color to a tannish or whitish color when it is blanched. Or more simply, tissue 537 can turn from a darker color to a lighter color when it is blanched. Thus, portions of tissue 537 in close proximity to first jaw member 538 and second jaw member 540 can be lighter than portions of tissue 537 further away therefrom. Thus, tissue 537 can be considered to have “thermal margin” around the edges of first jaw member 538 and second jaw member 540.

[0216] Thermal margin typically occurs in the early energy pulses, as during these first pulses, the most fluid exists in the tissue being sealed. However, this is dependent on the63Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01amount of energy being applied. If the first pulse provides less energy than the second, the thermal margin may be less. After a sufficient volume of steam has been driven from the tissue, the sealing energy can be used to affect tissue, e.g., congeal collagen, instead of producing steam. In particular, system 500 can be configured to identify the occurrence of thermal margin within tissue.

[0217] As such, system 500 can utilize camera unit 504, along with enhanced visualization, AL or Al derived algorithms such as CDSS 800 of FIG. 15, to generate images of tissue that can indicate when thermal margin has occurred. Processing unit 104 (FIG. 1) or system 500 can be provided with threshold thermal margin changes for different tissue types and thicknesses for comparison to sensed thermal margin values to determine when sealing is sufficiently far enough along to begin cutting. Additionally, processing unit 104 (FIG. 1) or system 500 can additionally be provided with threshold thermal margin changes for different tissue types and thicknesses that indicate when a sealing operation is trending toward being sufficiently performed in order to predict that the sealing operation will be completed successfully so that a cutting operation can be initiated before a seal is completed, substantially completed or even started. The image feedback can be configured to be combined with the RF output, looking for thermal margin increase during pulses. Once there is no increase of thermal margin during an output pulse, the cut output could be initiated. Thus, system 500 can be configured to measure not only the color of tissue 537, but the length of discolorations from first jaw member 538 and second jaw member 540. Pauses can be included, so that while a pulse is detected and no increase in thermal margin noted, the seal output could apply an additional pulse before the cut output is initiated. Once cutting has commenced, sealing and cutting can be terminated at any point where the system receives an indication that each process is complete.

[0218] Temperature

[0219] Another device state that system 500 can be configured to determine is temperature of first jaw member 538 and second jaw member 540. Temperature sensors, such as sensors 128 of FIG. 3B, can be included within first jaw member 538 and second jaw member 540 to determine the progress of a seal output. Temperature sensors can also or alternatively be placed in other areas of jaw assembly 536, other than just the sealing plates. For example, temperature sensors can be included on a cut blade, in jaw over-moldings or64Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01jaw electrical insulators. Temperature can also be monitored visually, through enhanced IR feedback of the tissue or the device jaws.

[0220] The temperature sensors can be placed next to the tissue being sealed, e.g., tissue 537, and can provide a good indicator of the state of the tissue. As the tissue is repeatedly cycled through pulse cycles of sealing energy and fluid and steam repeatedly change states, the tissue can achieve elevated temperatures. Once the tissue achieves a criterion (max temp (TMax), delta from initial temp (AT), etc.), the cut output can be initiated. This can also be combined with the RF output; the temperature is only evaluated during low power or no power areas of the pulse output and not at points in the cycle where steam is being generated.

[0221] Thus, processing unit 104 (FIG. 1) or system 500 can be provided with threshold temperatures or temperature changes for different tissue types and thicknesses for comparison to sensed temperature values to determine when sealing is sufficiently far enough along to begin cutting. Additionally, processing unit 104 can be provided with threshold temperatures or temperature changes for different tissue types and thickness that indicate when a sealing operation is trending toward being sufficiently performed in order to predict that the sealing operation will be completed successfully so that a cutting operation can be initiated before a seal is completed, substantially completed or even started. In examples, system 500 can be configured to initiate the cutting output, or set a timer for initiating the cutting output, based on the occurrence of a temperature as determined by temperature sensor. Once cutting has commenced, sealing and cutting can be terminated at any point where the system receives an indication that each process is complete.

[0222] Timer delay:

[0223] The various device state cut triggers (e.g., jaw state, jaw pressure, jaw temperature, tissue color in jaws) can additionally be combined with various timers.Example timers can be set from the initiation of sealing energy, from the conclusion of sealing energy, at a particular time in the middle of applying sealing energy and the like. Once the device state trigger has been met and the timer has expired, the application of tissue cutting can begin. In place of a fixed time, the timer can comprise a percentage of the total activation time of sealing energy to the timed point. The various timers can be stored in look up tables that relate the number of pulses, the time of sealing energy being applied, the amount of energy applied, the maximum voltage applied, the maximum current applied, the65Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01minimum voltage applied, the minimum current applied, or various combination of these. Algorithms based upon these criteria values can also be used.

[0224] Combinations:

[0225] The above triggers identified to initiate a cut output can be considered in isolation. However, multiple checks can be used wherein rather than a simple, e.g., single, trigger for activating a cutting operation, multiple triggers for evaluating the sealing output can be used in combination to ensure a higher probability that the sealing operation has adequately progressed to allow for cutting. Examples of this can include using the above-described pressure trigger and temperature trigger, or the above-described visual thermal margin trigger and temperature trigger etc. Multiple combinations can also be used. For example, the temperature trigger, pressure trigger and jaw bounce recognition trigger all have to be initiated prior to the commencement of the cut output.

[0226] FIG. 10C is a block diagram illustrating method 550 including operation 552 through operation 572 in performing methods of operation of medical device 102 (FIG. 1) with processing unit 104 to automatically initiate cutting operations based on determining device states during sealing operations. Though discussed with reference to FIG. 1 through FIG. 10B and a particular medical device, method 550 can encompass the use of any medical device having monopolar and / or bipolar energy cycles, either with or without a cut blade, consistent with the methods and systems described herein. Method 550 can additionally include fewer or greater operations other than operation 552 to operation 572. Additionally, in other examples, operation 552 through operation 572 can be performed in other sequences.

[0227] At operation 552, a medical instrument can be navigated to an anatomic structure, such as target object 220. For example, medical device 102 can be guided to a vessel to perform a sealing and cutting operation. In particular, end effector assembly 108 can be positioned adjacent to target object 220. In examples, shaft 118 of medical device 102 can be inserted into a scope to reach the anatomic structure. The system can utilize imaging guidance to facilitate accurate and efficient locating, ensuring that the instrument is positioned for performing the desired operation. In examples, a robotic surgical system, such as the one described with reference to FIG. 12B, can be used to place shaft 118 at the anatomic structure. In examples, shaft 118 can be articulated, such as by causing bending of articulating section 127 to reach the anatomic structure. This operation can facilitate end66Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01effector assembly 108 being correctly aligned with the target tissue, facilitating effective sealing and cutting while minimizing potential damage to surrounding tissues.

[0228] At operation 554, energy for sealing the anatomic structure with a bipolar electrode can be activated. In examples, the sealing energy can comprise radio frequency (RF) energy. Although other suitable sealing energy can be used such as resistive energy, alternating current (AC) energy and monopolar energy. In examples, therapy power supply 132 can be used to deliver energy to second electrode 142 and third electrode 144. The activation of the sealing energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective sealing without damaging surrounding tissue. The bipolar configuration allows the energy to pass through the tissue between the electrodes, minimizing the risk of unintended tissue damage. For example, RF energy can more effectively reach collagen and elastin fibers within tissue. This operation facilitates achieving a strong and reliable seal and preventing bleeding, thereby ensuring the success of the surgical procedure.

[0229] At operation 556, device state parameters of electrosurgical end effector 530 can be determined. In examples, processing unit 104 can use one or more of sensor 128 to sense pressure against one or both of first jaw member 538 and second jaw member 540, temperature of one or both of first jaw member 538 and second jaw member 540 or to cause camera unit 504 to obtain images of first jaw member 538 and second jaw member 540 and tissue 537. By obtaining or capturing these parameters, the system can evaluate the effectiveness of the sealing process (e.g., whether blood flow is likely to have been stopped) and gather data to configure energy delivery for completing both sealing and cutting. In particular, the determined device parameters can be used to initiate a cutting operation and conclude both the sealing operation and the cutting operation. More specifically, the determined device parameters can be used to determine when to begin the cutting operation without user intervention. The cutting operation can begin before the sealing operation before sealing energy is applied, such as when jaws of a forceps are being used to apply pressure to the tissue to prevent blood flow, during the performance of the sealing operation while sealing energy is being applied, or after the sealing operation has been completed after sealing energy is no longer being applied. Thus, the method can ensure that both the sealing and cutting operations are properly performed in a minimal amount of time without requiring the exercise of judgement from the surgeon.67Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0230] At operation 558, the determined device state parameter can be compared to predetermined device state values. Predetermined device state values can be stored in memory of processing unit 104 or system 500, or in communication with processing unit 104 or system 500, such as over a networked or cloud connection. The predetermined device state values can comprise values at which it has been previously determined that a sealing operation has sufficiently progressed to allow a cutting operation to commence, or that indicate a sealing operation is trending toward being completed to allow a cutting operation to commence. The predetermined device state values can comprise one or more of a jaw position, jaw change in position, jaw pressure, jaw temperature, tissue color between jaws and the like. The predetermined device state values can be derived from empirical data from testing conducted on tissue samples.

[0231] At operation 560, it can be determined if the determined device state parameter meets the threshold parameter or is within a predetermined tolerance band of the threshold parameter. Processing unit 104 can compare the determined device state parameter determined at operation 556 to a database or library of predetermined device state values, such as predetermined jaw position values, jaw pressure values, jaw temperature values, tissue colors and the like, that have been previously correlated to levels of tissue sealing stored in memory of processing unit 104 or stored in servers connected to processing unit 104. By matching the sensed parameters with these stored values, processing unit can accurately determine if tissue has been sealed, is approaching being adequately sealed or not. This determination can help decide when to begin the cutting operation. Thus, the system can automatically control the transition of the application of sealing energy to the cutting operation, thereby ensuring adequacy of the seal and reducing the total time to perform the sealing and cutting operations. The system can provide outputs of the sensed parameter of operation 406 to a user so that a user can make appropriate modifications or obtain confirmation that sealing has occurred, if desired.

[0232] At operation 562, it can be determined that the determined device state parameter has not met the threshold device state parameter. The determined device state parameter not meeting the threshold device state parameter can indicate that the sealing process has not progressed to the level where cutting can begin. In particular, the determined device state parameter not meeting the threshold device state parameter can indicate device state parameter levels wherein it has been determined that tissue is not either fully or partially68Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01sealed, e.g., coagulated or cauterized, to a level where blood flow has ceased or diminished such that cutting cannot commence until further sealing is performed. Thus, method 550 can return to operation 556 to continue to monitor the application of the sealing energy until the determined device state parameter has reached the threshold device state parameter.

[0233] At operation 564, it can be determined that the determined device state parameter has met the threshold parameter. The determined device state parameter meeting the threshold device state parameter can indicate that the sealing process has progressed to the level where cutting can begin. In particular, the determined device state parameter meeting the threshold device state parameter can indicate device state parameter levels where it has been determined that tissue is either fully or partially sealed, e.g., coagulated or cauterized, to a level where blood flow has ceased or diminished such that cutting can commence while sealing is being finished or after sealing has finished. Thus, method 550 can move to operation 566 and operation 568.

[0234] At operation 566, the cutting operation is initiated (e.g., via movement of a cut blade or by activating cutting energy for cutting the anatomic structure). In examples in which cutting energy is used, the cutting energy can comprise direct current energy or alternating current energy, such as high frequency radio frequency (RF) energy. This can involve delivering alternating current at a high frequency to first electrode 140. In examples, therapy power supply 132 can be used to deliver energy to first electrode 140. The activation of the cutting energy can be controlled to ensure that it is applied precisely to the target tissue, facilitating effective cutting without damaging surrounding tissue. Operation 566 can occur before operation 568, e.g., contemporaneously with application of sealing energy, or can occur after operation 568, e.g., after application of sealing energy.

[0235] At operation 568, the anatomic structure can be sealed with the sealing energy activated at operation 554. Applied electrical energy from second electrode 142 and third electrode 144 can cause the anatomic structure to seal. For example, the electrical energy can cause cauterization of the tissue of target object 220. The sealing process can involve the denaturation of proteins within the tissue, leading to the formation of a coagulum that closes the vessel or tissue structure. The precise application of energy ensures that the seal is strong and reliable, preventing bleeding and maintaining the integrity of the surgical site. This operation can help achieve hemostasis and reduce the risk of postoperative complications.69Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01Thus, blood flow through the tissue can be stopped. In examples, the application of sealing energy at operation 558 can contribute to cutting at operation 570.

[0236] At operation 570, the anatomic structure can be cut. For example, energy delivered at operation 566, with or without energy contributions from operation 568, can cause separation of tissue on either side of first electrode 140. Thereafter, application of sealing and cutting energy can cease, such as by causing the application of current to first electrode 140, second electrode 142 and third electrode 144 to cease.

[0237] At operation 572, the medical instrument can be withdrawn or relocated after completing the sealing and cutting operations. This operation can involve retracting medical device 102 from the surgical site to ensure that no additional trauma is caused to the surrounding tissues or damaging the integrity of the sealed and cut areas, preventing any disruption to the achieved hemostasis. If relocation is desirable, such as to the site of another anatomic structure or vessel to be sealed and cut, the instrument can be repositioned to another target site within the anatomy. This can involve navigating through anatomical structures to reach a new area where treatment is to be applied. The system can utilize imaging guidance or robotic assistance to facilitate accurate and efficient relocation, ensuring that the instrument is positioned for subsequent procedures. After all desired surgical procedures or interventions are performed, medical device 102 can be withdrawn and any access portals in the patient can be appropriately closed.

[0238] Activation of Cutting Energy Based on Time State

[0239] As discussed herein, it can be desirable to automatically trigger and perform a tissue cutting operation while a tissue sealing operation is still being performed or thereafter without having to receive a user input. With the present disclosure, an electrosurgical system can be configured to automatically initiate the activation of a cutting operation while a sealing operation is being performed, whether sealing energy is actively being applied or in between applications of sealing energy, based on an amount of time that has passed from a specific event, wherein the amount of time and specific event can be predetermined. One or more time periods and trigger events can be predetermined based on empirical data that indicates advantageous points along a sealing process timeline where activation of the cutting output can begin. As discussed, the cutting operation can commence before a sealing operation is complete due to collagen being melted to a point where blood flow is substantially arrested, particularly with the aid of clamping force from a jaw assembly.70Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01Predetermined timers, time periods and time limits can be stored in memory of processing unit 104 (FIG. 1), electrosurgical system 300 (FIG. 6) and / or system 500 (FIG. 10A) or in communication with either of those systems, such as over a networked or cloud connection.

[0240] The total amount of time that sealing energy is applied can depend on multiple factors, including the amount of electrosurgical energy that a device can deliver, the size of the tissue being sealed, e.g., the diameter of a vessel, the size of jaws in a jaw assembly, and the like. An additional factor that can influence the formation of a seal includes force that is applied to the tissue from jaws during the sealing process. Many electrosurgical devices are configured to seal vessels having diameters in the range of approximately three millimeters to approximately seven millimeters. In examples, the time it can take for an electrosurgical device to seal such vessels can be in the range of approximately two seconds to approximately three seconds. The use of more recently developed algorithms for the application of RF sealing cycles, for example, has substantially reduced sealing as compared to technology used many years ago. With the present disclosure, the understanding of biological sealing mechanics can further shorten combined tissue sealing and cutting operations, with the timing to start a cutting operation being based on a set time from the initiation or conclusion of the seal output, with the set time representing a time when the tissue has undergone sufficient biomechanical transformation to limit or stop blood flow so that cutting can be performed.

[0241] With reference to FIG. 11 A, in a first example, a preset time from the initiation of a sealing operation can be used for all device configurations, regardless of jaw size or other device parameters. A preset time at which it has previously been determined that it is acceptable to commence cutting can be used. The preset time can comprise a point where fluid has been significantly boiled out of the tissue and collagen begins to be heated. At such time, the collagen can begin to melt to limit blood flow so that, along with clamping forces of a jaw assembly, cutting can be commenced. The preset time can comprise an average time for a given tissue size and electrosurgical device that it takes for collagen to begin to be heated. For example, an electrosurgical device having an average seal time of approximately three seconds can have the cutting output activated at approximately two-and-a-half seconds. The cutting output (e.g., cutting energy) can be continuously applied while sealing energy is continuously applied, or the cutting output can be applied only between sealing energy pulses71Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01until the sealing operation is completed, after which point cutting output can be applied as needed or desired to complete a cutting operation.

[0242] FIG. 11 A shows method 576 including the application of sealing energy and cutting energy at different timespans along timeline 578. Processing unit 104 (FIG. 1) or system 500 can initiate sealing energy at time Tl. Processing unit 104 can initiate a timer at time Tl. After preset time 580 has elapsed, processing unit 104 can activate cutting energy at time T2. In the illustrated example of FIG. 11 A, cutting energy can commence while sealing energy is being applied. As mentioned, cutting energy can be applied during continuous application of sealing energy or can be intermittently applied between pulses of sealing energy. In the illustrated example, sealing energy can terminate before cutting energy terminates at time T3 and cutting energy can continue to time T4. However, in additional examples sealing energy and cutting energy can terminate at the same time.

[0243] With reference to FIG. 1 IB, in another example, an electrosurgical device having an average seal time of approximately three seconds can have cutting energy activated at approximately three seconds. The cutting energy can be applied immediately after the sealing energy completes the sealing operation and terminates.

[0244] FIG. 1 IB shows method 582 including the application of sealing energy and cutting energy at different timespans along timeline 584. Processing unit 104 (FIG. 1) can initiate sealing energy at time Tl . Processing unit 104 can initiate a timer at time Tl . After time 586 has elapsed, processing unit 104 can activate cutting energy at time T2. In the illustrated example of FIG. 11B, cutting energy can commence immediately after application of sealing energy has concluded, regardless of the form of the sealing energy, e.g., continuous or pulsed. Cutting energy can continue to time T3 until the cut is complete.

[0245] With reference to FIG. 11C, in another example, an electrosurgical device having an average seal time of approximately three seconds can have cutting energy activated at approximately two-and-a-half seconds, at which point the sealing energy can be stopped while the cutting energy is applied, before switching back to application of sealing energy for a second or follow-up sealing process, such as for an additional half second. The performance of two separate sealing operations can potentially have advantages in that the pause between sealing operations can produce a time gap that can allow any steam pockets remaining within the tissue to collapse so the tissue can be reheated with the second stage sealing energy to finish the sealing process. The second stage sealing energy can be applied72Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01to tissue that is still warm from the previous sealing operation, which can help improve the seal quality. For example, the clamping force of the jaws can improve over the first stage sealing process due to the tissue being severed and tension within the tissue being released. As such, a device configured to apply only one pressure to tissue during a sealing process can effectively apply a two-stage pressure to the seal area to improve the seal. Thus, the time from starting the second stage sealing process to stopping the second stage sealing process can be less than a half second. However, in examples of this embodiment, the total time to perform cutting and sealing can be increased compared to, for example, the embodiment of FIG. 1 IB, depending on the time each sealing stage and cutting is performed.

[0246] FIG. 11C shows method 588 including the application of sealing energy and cutting energy at different timespans along timeline 590. Processing unit 104 (FIG. 1) or system 500 can initiate first-stage sealing energy at time Tl. Processing unit 104 can initiate a timer at time Tl. After time 592 has elapsed, processing unit 104 can activating cutting energy at time T2. In the illustrated example of FIG. 11C, cutting energy can commence immediately after application of sealing energy has concluded at time T2, regardless of the form of the sealing energy. Cutting energy can continue until time T3. Additionally, at time T3, second stage sealing energy can be applied and can continue to time T4. As mentioned, the time between time T3 and time T4 can be the same, equal or longer than a difference between time 586 (FIG. 1 IB) and time 592. Though FIG. 11C shows three discrete energy application stages, each stage can be blended with an adjacent stage as discussed herein. For example, cutting can begin before the first stage sealing is complete, similar to what is shown in FIG. 1 IB and / or the second stage sealing can begin before the cutting is complete.

[0247] With reference to FIG. 1 ID, in additional examples, preset times for initiating cutting energy can comprise times starting from the conclusion of a sealing operation or sealing cycle. Such times can produce a predetermined delay between the sealing operation and the cutting operation. For example, standard sealing cycles can be applied for time periods for which it is determined that any or most fluid within a tissue is or is likely to have been converted into steam and entered the cutting area of the jaw, therefore making the tissue to be cut a much higher electrical impedance. At such point, the cut output can be initiated. The predetermined pause between cutting and sealing can, therefore, allow for the use of lower power output for cutting by avoiding having to cut tissue with a higher electrical impedance. During the pause, processing unit 104 or system 500 can optionally continue to73Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01produce a low power output that is small enough to not affect the tissue, but that can allow for electrical parameter sensing, such as resistance or impedance as discussed herein. In examples, the sensing signal can be in the range of approximately eight Watts (eight Joules) to approximately ten Watts (ten Joules). In such examples, once the electrical parameter feedback indicates that the sealing cycle is complete, the cut output can be initiated. As such, the pause between the sealing cycles can be variable.

[0248] FIG. 1 ID shows method 594 including the application of sealing energy and cutting energy at different timespans along timeline 596. Processing unit 104 (FIG. 1) or system 500 can initiate sealing energy at time Tl. Sealing energy can be applied for a period of time until sealing is completed or substantially completed. Processing unit 104 can initiate a timer at time T2 at the time sealing is concluded. Time 598 can comprise a pause between the application of sealing energy and cutting energy. After time 598 has elapsed, processing unit 104 or system 500 can activate cutting energy at time T3. Cutting energy can continue until time T4.

[0249] In additional examples, various alarms can be generated by processing unit 104 or system 500 at different stages along the sealing and cutting processes. For example, at the conclusion of the sealing cycle at time T2, a first alarm can be issued as is done in state-of-the-art systems. With the present disclosure, an alarm can be additionally or alternatively issued at time T3 when activation of cutting energy is triggered. The alarms can provide a user time before cutting energy is applied to check the sealing operation, such as by visually inspecting the tissue to check for thermal reactions of steam production, e.g., thermal margin or color changes, produced during activation of the sealing energy. In examples, the alarms can comprise haptic feedback. If the user is not satisfied with the sealing operation, the user can discontinue the application of any energy to the tissue, such as by releasing the activation button, e.g., second button 126 of FIG. 1. Thereafter, the user can directly apply sealing energy to finish the sealing operation and then subsequently apply cutting energy to perform the cutting operation. Thus, a single button system can be used where the activation of a single button can automatically progress through sealing and cutting operations, with the pause therebetween and associated warnings (visual, audio, haptic, combinations) providing the user an opportunity to manually override the automatic energy application for cutting to satisfactorily finish the seal and then manually applying the cutting energy. In examples, alarms can be used at any of the times specified in FIG. 11 A through FIG. 1 ID.74Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0250] The predetermined time presets can also be determined specifically for particular electrosurgical devices. In examples, electrosurgical devices having large jaws can have a different cutting energy initiation preset time from the start of the seal time, compared to an electrosurgical device having smaller jaws. Larger sealing jaws typically take longer times to seal tissue because they are engaging larger surface areas of tissue and therefore are displacing larger volumes of fluid from the tissue.

[0251] In additional examples, the predetermined cutting start times can be based on the type of procedure that the electrosurgical device is going to be used to perform. For example, some procedures interact with tissues having more conductive fluids than other tissues.Increased conductivity of tissue fluids can increase seal times, thereby benefitting from longer predetermined times for activating cutting energy.

[0252] In examples, processing unit 104 (FIG. 1) or system 500 can include look-up tables for identifying electrosurgical devices connected thereto and for providing times for specific procedures and tissues. The look-up tables can include predetermined start times for the application of cutting energy starting from when sealing energy is first applied for various jaw sizes and tissue types. The predetermined cutting energy start times can additionally be provided by other sources, such as from the electrosurgical device itself or memory devices connected to the electrosurgical device. For example, structured data identifying an electrosurgical device and associated preset cutting energy initiation times can be stored within one or more barcodes attached to each device.

[0253] Activation of Cutting Operation Based on Combinations Sensed Electrical Parameters, Device State, Time, etc.

[0254] As discussed herein, the present disclosure provides a plurality of trigger points at which a cutting operation can be automatically applied, based on a user instructing an electrosurgical system to perform a sealing operation, such as by depressing a single button. The present disclosure also provides a plurality of ways in which an electrosurgical system can decide when a cutting operation can begin, whether the sealing energy has finished being applied or not. As such, an operator of the electrosurgical device need not independently validate the sealing operation before starting the cutting operation, which can save time in performing electrosurgical procedures.

[0255] With the present disclosure, activation of the cutting output (e.g., movement of a cutting blade or application of cutting energy) can be triggered by combinations of time state,75Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01tissue state and device state that indicate the formed seal is sufficiently formed, or that predict a seal will be completed, to allow for cutting. The present disclosure provides multiple different feedback elements that can be obtained during a sealing cycle that can be used to determine the state of the tissue being sealed. These feedback elements can be used to provide activation triggers for the cutting output of the vessel sealing. These feedback elements can be determined based on empirical evidence gathered during experimental research. Values for these feedback elements can be stored in memory of the electrosurgical systems of the present disclosure so that as feedback is obtained during a sealing cycle, the requisite level of the feedback element for triggering the cutting output can be determined.

[0256] Thus, with the present disclosure, multiple activation triggers can be determined in order to increase the probability or confidence level of a user that that the seal has in fact been sufficiently formed. The combined triggers can be determined independently or can be determined sequentially. As discussed herein, the activation triggers can be set to initiate cutting during application of sealing energy, during pauses in activation of sealing energy, or after the application of sealing energy has concluded.

[0257] As discussed herein, there are generally three categories of activation triggers for activating the cutting operation base on input obtained from a sealing operation: 01) Tissue State, 02) Device State, and 03) Time Stage.

[0258] 01) Reaction to tissue state. As discussed herein with reference to FIG. 7 through FIG. 9, tissue sealing state can be determined from a sealing operation based on changes in electrical parameters sensed during the sealing operation. The sensed electrical parameters can include resistance, impedance, phase angle, voltage, current, power, energy consumption to boil, and the like.

[0259] 02) Reaction to device state. As discussed herein with reference to FIG. 10A through FIG. 10C, tissue sealing state can be determined from a sealing operation based on changes device state or images of a device. The determined device states can include jaw position, jaw pressure, jaw temperature, changes in imaging of thermal margin, and the like.

[0260] 03) Reaction to time state. As discussed with reference to FIG. 11A through FIG.1 ID, tissue sealing state can be determined form a sealing operation based on changes in time determined during the sealing operation. The determined time states can include time between activation of sealing energy to a point during activation of sealing energy, time between activation of sealing energy to conclusion of sealing energy, time between activation76Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01of sealing energy to conclusion of first stage of sealing energy, time between conclusion of sealing energy and conclusion of an energy pause, and the like.

[0261] The various monitored trigger feedback mechanisms can be combined in various combinations within each category or between multiple categories to provide compound or two-stage cutting energy triggers. As such, various groupings of triggers can include:

[0262] A) More than one reaction to tissue state could be used to trigger the cut cycle.

[0263] B) More than one reaction to the device state could be used to trigger the cut cycle.

[0264] C) More than one reaction to the time state could be used to trigger the cut cycle.

[0265] D) Combinations of the tissue state and device state could be used to trigger the cut cycle.

[0266] E) Combinations of the tissue state and time state could be used to trigger the cut cycle.

[0267] F) Combinations of the device state and time state could be used to trigger the cut cycle.

[0268] G) Combinations of the tissue state, time state and device state could be used to trigger the cut cycle.

[0269] H) Multiples of any of the above states could be used in conjunction with single or multiples of other states. For example, multiple tissue states can be combined with a time state change to trigger the cut cycle.

[0270] Multiple Tissue States

[0271] The present disclosure provides multiple tissue states, including resistance, impedance, phase angle, voltage, current, power and energy consumption to boil, that can be used to determine a trigger for activating the cutting output. As discussed herein, electrical state triggers can comprise a) a percentage of an originally detected electrical value, b) a delta shift, c) a minimum electrical value, d) a maximum electrical value, other electrical value thresholds mentioned herein and combinations of these values. Thus, multiple tissue state outputs of the present disclosure that can be combined to generate the cutting trigger.

[0272] Example combinations can comprise:

[0273] 1) when the energy consumption to boil the tissue in any pulse is less than a specific value, and 2) if a resistance delta is subsequently met. Note, this example is configured to have the first trigger met before the second trigger can be met; and77Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0274] 1) when the energy consumption to boil the tissue in any pulse is less than a specific value, and 2) if a resistance delta has also been met. Note, in this example, the first trigger and the second trigger can be met any time.

[0275] The above cases utilize two tissue states being determined prior to cut delivery. Alternatives can include more than two states being considered. Any of the combinations of trigger states can be triggered in parallel, serially or at any time throughout the seal cycle.

[0276] Multiple Device States

[0277] The present disclosure provides multiple device states including jaw state, jaw pressure, jaw temperature, thermal margin (device imaging state), that can be used to determine a trigger activating the cutting operation. As discussed herein, device states can include a) a percentage of an originally detected jaw opening value (e.g., distance or jaw angle), b) a delta shift in a jaw opening value, c) a minimum jaw opening value, d) a maximum jaw opening value, e) a percentage of an originally detected jaw pressure, f) a delta shift in a jaw pressure, g) a minimum jaw pressure value, h) a maximum jaw pressure value, i) a percentage of an originally detected jaw temperature, j) a delta shift in a jaw temperature value, k) a minimum jaw temperature value, 1) a maximum jaw pressure value, m) a percentage of an originally detected tissue color, n) a delta shift in a tissue color value, o) a minimum tissue color value, p) a maximum tissue color value, other device state value thresholds mentioned herein and combinations of these values. Thus, multiple device state outputs of the present disclosure that can be combined to generate a cutting trigger.

[0278] Example combinations can comprise:

[0279] 1) when the pressure between the jaws has cycled through a high and low range during pulsing, until the pressure differential (delta) during the sealing cycle meets a maximum value, and 2) that the temperature minimum has been met; and

[0280] 1) when the pressure between the jaws has cycled through a high and low range during pulsing, until the pressure differential (delta) during the sealing cycle meets a maximum value, 2) a visual feedback of thermal margin has been noted by the system, and 3) that the temperature minimum has been met.

[0281] The above cases utilize two or three device states being required prior to cut delivery. Alternatives can include more than three states being considered. Any of the combinations of trigger states can be triggered in parallel, serially or at any time throughout the seal cycle.78Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0282] Multiple Time States

[0283] The present disclosure provides multiple time states from which a cutting operation can begin, including a preset time from when sealing has started (the beginning of a seal cycle), a preset time within a sealing cycle, and a preset time from when sealing stops (the end of a seal cycle). The present disclosure also describes safety features that can be implemented to allow a user to manually intervene before the automated cutting operation begins, such as various audio, visual and haptic alarms. Thus, multiple time state outputs of the present disclosure that can be combined to generate a cutting trigger.

[0284] Examples of these can comprise:

[0285] 1) a preset time for the device to activate, followed by 2) a preset pause period (with indication to the surgeon that cut activation is about to start that provides an opportunity to release the activation switch) and then the system provides the cut output.

[0286] The above case utilizes two time states prior to cut delivery. Alternatives can include more than two states being considered. Any of the combinations of time states can be triggered in parallel, serially or at any time throughout the seal cycle.

[0287] Combination of Tissue and Device State

[0288] The present disclosure provides multiple tissue and device states that can be used together to determine a trigger for activating the cutting output. In an example, a sensed voltage can be used to determine a tissue state once the voltage reaches a maximum value, and a temperature sensor can be used to determine a device state once the temperature reaches a minimum value. These can be used in combination prior to activating the cut output. Any of the above described tissue states and device states can be triggered in parallel, serially or at any time throughout the seal cycle.

[0289] Combination of Tissue and Time State

[0290] The present disclosure provides multiple tissue states and time states that can be used together to determine a trigger for activating the cutting output. In an example, a sensed voltage to determine a tissue state once the voltage has met a specific maximum value, can be used in combination with a timer from commencement of the seal cycle that meets a minimum time duration to trigger the cutting output. These can be used in combination prior to activating the cut output. Any of the above-described tissue states and time states can be triggered in parallel or serially throughout the seal cycle.

[0291] Combinations of Device State and Time State79Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0292] The present disclosure provides multiple device states and time states that can be used together to determine a trigger for activating the cutting operation. In an example, visual feedback of a thermal margin once the thermal margin has met a specific maximum value, e.g., color, can be used in combination with a timer from commencement of the seal cycle that meets a minimum time duration to trigger the cutting output. These can be used in combination prior to activating the cut output. Any of the above-described tissue states and time states can be triggered in parallel or serially throughout the seal cycle.

[0293] Combination of Time, Device and Tissue State

[0294] The present disclosure provides multiple time, device and tissue states that can be used together to determine a trigger for activating the cutting output. In an example, a sensed voltage can be used to determine a tissue state once the voltage reaches a maximum value, a temperature sensor can be used to determine a device state once the temperature reaches a minimum value, and a minimum time duration can be used to determine when the cut output can commence. These can be used in combination prior to activating the cut output. Any of the above-described tissue states, device states and time states can be triggered in parallel or serially during the seal cycle.

[0295] Multiples of One State Used with Another State

[0296] The present disclosure provides multiple tissue states, device states and time states that can be used together to determine a trigger for activating the cutting operation. In an example, a sensed voltage to determine a tissue state once the voltage has met a specific maximum value can be used in combination with the energy consumption required to boil the tissue in a specific seal output ‘pulse’ along with a temperature sensor meeting a predetermined minimum value. Thus, the illustrated example uses two tissue states along with one device state. These can be used in combination prior to activating the cut output, specifically the voltage being required to meet a set value after an energy pulse has boiled tissue with less than a specific amount of energy and that the temperature measurement has meet a required minimum value. Any of the above-described tissue states and time states can be triggered in parallel or serially throughout the seal cycle.

[0297] Sample Electrosurgical Device with Articulating Features

[0298] FIG. 12A is a schematic illustration of shaft 118 of FIG. 1 including articulating section 127 configured to allow angulation of jaw assembly 110 relative to axis AA (i.e., the central axis of shaft 118). Jaw assembly 110 can be rotated or bent away from axis AA to80Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01form angle a relative to axis AA. Curvature of shaft 118 can be achieved by actuation of a control feature on handpiece 106, such as trigger 123. Further actuation or depression of trigger 123 can result in further bending of shaft 118 and further movement of jaw assembly 110 away from axis AA. Rotation of jaw assembly 110 about axis AA can be achieved by rotation of knob 125 (FIG. 1), which is transmitted through articulating section 127. A clockwise / counterclockwise rotation of knob 125 can result in a corresponding clockwise / counterclockwise rotation of jaw assembly 110. Thus, the plane in which the deflection occurs corresponds to the plane of rotation of articulating section 127. In examples, jaw assembly 110 can be rotated three-hundred-sixty-degrees about axis AA so as to provide bending in any radial direction. The portion of shaft 118 proximal of articulating section 127 can be rigid.

[0299] Articulating section 127 can comprise a flexible portion of shaft 118 that is more bendable than other sections of shaft 118 so as to be deflectable when subject to an articulation force, but that can hold its position when the articulation force is removed. Bending of articulating section 127 can be achieved by actuation of pull wires within shaft 118, as is known in the art. In examples, articulating section 127 can be fabricated from a gooseneck tube, such as those fabricated from a round coil spring interlaced with a wedge-shaped coil.

[0300] In order to accommodate articulating section 127, other components within shaft 118 can also be flexible. Thus, it can be difficult to incorporate non-bendable or rigid members within shaft 118, particularly those that are in close proximity to end effector assembly 108, such as rigid cutting blades used in the prior art. With the present disclosure, because jaw assembly can utilize electrosurgical energy to perform cutting, a rigid cutting blade can be omitted in certain implementations, and articulating section 127 can be brought close to jaw assembly so that distance D2 is small. When a rigid cutting blade is used, the cutting blade is typically as long as or nearly as long the jaw members of jaw assembly 110, e.g., D3. Thus, in order to use a rigid cutting member distance D2 is typically approximately equal or nearly equal to distance D3. However, with the present disclosure, distance D2 can be shorter than distance D3 because the rigid cutting blade is omitted and replaced by electrosurgical cutting. Thus, articulating section 127 can be brought into close proximity to jaw assembly 110 to allow for tight bending or turning of jaw assembly 110.81Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0301] In examples, medical device 102 can be configured to devices described in Pat. No. US 9,271,797 B2 to Adler et al., titled “Robotic Surgery,” the entire contents of which are hereby incorporated herein in their entirety by this reference.

[0302] FIG. 12B is a schematic view of robotic surgical system 600 having articulating arm 602 including end effector 612 of the present disclosure comprising a monopolar electrode and a bipolar electrode with a heating element.

[0303] Articulating arm 602 can comprise a multi -joint structure driven by a plurality of wires, and a wire tension sensor provided to the wires that drive a manipulator unit and a gripping unit, the wire tension sensor detecting gripping force, the robot system executing gripping control processing based on an obtained wire tension value (the gripping force).

[0304] Robotic surgical system 600 can comprise controller 604, input unit 606 and treatment instrument drive unit 608. Articulating arm 602 can be a subordinate multi-joint electric treatment instrument that follows an operation of input unit 606, which can comprise an instruction input device. End effector 612 can have a function of a bipolar and monopolar high-frequency treatment instrument with a heating element as described herein.

[0305] Controller 604 can comprise input unit 606 which is configured to instruct a position, a posture, and gripping of robotic treatment instrument embodied by articulating arm 602, controller 604 that controls articulating arm 602, and tension sensor signal processor 609 which is configured to detect a gripping state.

[0306] Input unit 606 can include operating portion 606a in which a plurality of joint members and rod members are alternately coupled with each other and a controller that converts movement of operating portion 606a into electrical signals and then outputs the converted signal as an operation signal. Moreover, operating portion 606a can include a switch that is configured to instruct operations for effecting an opening / closing operation of end effector 612 to grip tissue and release the tissue.

[0307] Controller 604 can comprise operation setting unit 631 that is configured to set various kinds of settings for articulating arm 602; CPU 632 that executes processing for each later-described sensor signal and various kinds of arithmetic operations, and outputs a control signal to each constituent unit in the system; memory 633 that stores programs for driving, obtained arithmetic operation results, and communication data; motor driver 636 that drives and controls motors 625 in motor drive unit 621 based on the control signal; motor driver communication unit 637 that is configured to communicate with motor drive unit 621; and82Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01tension sensor communication unit 638 that is configured to communicate with tension sensor signal processor 609.

[0308] Operation setting unit 631 includes operation switch 635a, operation switch 635b, operation switch 635c, operation switch 635d and operation switch 635e that are configured to set various kinds of settings and a display panel 634 that displays contents of an operation instructed by a user.

[0309] Articulating arm 602 includes end effector 612 having the multi-joint structure driven by the wires. End effector 612 can be provided at an end of manipulator unit 611 to grip tissue (a vessel or anatomic structure described herein), and sheath portion 615 which is inserted into an endoscope channel and can move forward and backward. It is to be noted that articulating arm 602 is not necessarily restricted to a usage pattern that it is inserted into the endoscope to be used, and it can be utilized separately from the endoscope. Also, end effector 612 can be an electrosurgical instrument having a configuration that two gripping members which are formed of a conductor or have opposed electrodes provided thereto, the treatment instrument opening / closing to grip living tissue and performing high-frequency treatment.

[0310] Manipulator unit 611 can be provided at a distal end of sheath portion 615 and is formed of at least two rod portions 614 and at least one of joint portions 613 that couples rod portions 614 with each other, resulting in manipulator unit 611 having at least one degree of freedom. For example, manipulator unit 611 can have one degree of freedom in a vertical direction. In examples, manipulator unit 611 can be configured in such a manner the plurality of rod portions 614 and joint portions 613 are alternately coupled to provide different rotation surfaces of joints, so as to have six degrees of freedom in X, Y, and Z directions, a rotating direction, a yawing direction, and a pitch direction, resulting in that manipulator unit 611 can freely bend to lift up and move end effector 612. Each of the two gripping members (jaws) of end effector 612 and the respective joint portions 613 can be connected with wires 617 inserted in manipulator unit 611, sheath portion 615, and external connecting portion 616. When these wires 617 are pulled and paid out from the external connecting portion 616, the gripping members can be opened / closed, and the respective joint portions 613 can be bent and stretched at desired angles. This opening / closing operation and the bending / stretching operation are carried out by treatment instrument drive unit 608.83Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0311] For example, if each of rod portions 614 has a cylindrical shape, a connecting configuration of rod portions 614 and wires 617 in this embodiment is achieved by coupling each of rod portions 614 with joint portions 613 at two cylinder opening ends in the horizontal direction to allow the bending operation, disposing an end of each of wires 617 to each of two cylinder opening ends in the vertical direction orthogonal to the horizontal direction, and coupling the other end of the same with a manipulator (e.g., a pulley pivotally supported by a motor). When bending rod portions 614 with respect to joint portions 613, one of wires 617 is pulled and the other of wires 617 is paid out, resulting in rod portions 614 bending upward (or downwards) around a coupling portion between rod portions 614 and joint portions 613. Of course, this embodiment is not restricted to such a multi -joint structure, and a generally known multi -joint structure can be applied to this embodiment.

[0312] Treatment instrument drive unit 608 can include motor drive unit 621 with a plurality of motors which are individually controlled. Motor drive unit 621 can include pulleys 624 coupled with wires 617, motors 625 which axially support the respective pulleys 624, wire tension sensors 623 which measure tensile force of respective wires 617, and a motor driver communication unit 626 which communicates with controller 604.

[0313] In this embodiment, one of pulleys 624 is coupled with a set of wires 617 connected with the two movable gripping members of end effector 612 or respective joint portions 613 through a wire coupling portion 622. Furthermore, although the description has been given on the example where a combination of the motor and the pulley is a manipulator that drives wires 617, a combination of a servomotor and a bar-like coupling tool may also be adopted. In this case, two wires are coupled with both ends of the bar-like coupling tool and fixing a central portion of this tool to the servomotor. Moreover, electric hydrodynamic drive based on a combination of a hydraulic piston, an electric pump, and a valve can also be considered. In this case, wires are respectively coupled with the two hydraulic pistons, and the valve is opened / closed to pull / pay out the wires.

[0314] Motor drive unit 621 can further include a motor that rotates articulating arm 602 on a longitudinal axis, a motor that moves articulating arm 602 forward and backward relative to sheath portion 615, and an encoder that measures a rotating angle of each motor. It is to be noted that wire tension sensor 623 can be arranged in wire coupling portion 622. As the wire tension sensor 623, a strain gauge that can detect a slight change in length of each of wires 617 in a longitudinal axis direction can be used. A wire tension value measured by84Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01wire tension sensor 623 is output to tension sensor signal processor 609 through cable 641 and further supplied to controller 604 through cable 644. robotic treatment instrument

[0315] As described herein, it can be advantageous for end effector 612 to be small to fit within an endoscope. Additionally, it can be desirable for one of joint portions 613 to be located close to end effector 612 to allow movement inputs entered at input unit 606 to be accurately translated to end effector 612 and to allow end effector 612 to be positioned close to target anatomy that may be located in hard-to-reach places within the anatomy. End effector 612 can include bipolar and / or monopolar sealing and cutting electrodes and / or a heating element that can allow for sealing and cutting operations to be performed in a small package with reduced risk of arcing and with articulation close to the jaws of end effector 612, as described herein. Thus, end effector 612 need not include a rigid cutting blade that can reduce the articulation capabilities of end effector 612.

[0316] FIG. 13 A is a schematic illustration of electrosurgical end effector 700 connected to electrical generator 702A. Electrosurgical end effector 700 can comprise first jaw member 704 and second jaw member 706. First jaw member 704 can comprise first seal plate 708 A, second seal plate 710A, first electrode 712, first insulator 713, second electrode 714 and second insulator 715. Anatomic vessel 716 can be positioned within electrosurgical end effector 700 between first jaw member 704 and second jaw member 706. Electrical generator 702A can be connected to first seal plate 708 A and second seal plate 710A via connector 718 and switch 720. Electrical generator 702A can be connected to first seal plate 708B and second seal plate 710B via connector 722. Electrical generator 702 A can be connected to first electrode 712 via connector 718, switch 720 and connector 724. Anatomic vessel 716 can comprise first wall 726A, second wall 726B and internal lumen 728.

[0317] Sample Electrosurgical End Effector with Angled Seal Plates

[0318] FIG. 13 A shows electrical generator 702A connected to electrosurgical end effector 700 to deliver power alternatively to first electrode 712 or first seal plate 708A, second seal plate 710A, first seal plate 708B and second seal plate 710B. Thus, switch 720 can be alternately positioned to perform monopolar operations with first electrode 712 and / or second electrode 714, or bipolar operations with first seal plate 708A, second seal plate 710A, or with first seal plate 708B and second seal plate 710B. In monopolar energy application, electrical current can pass from first electrode 712 to second electrode 714. In examples, second electrode 714 can be omitted. First insulator 713 and second insulator 71585Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01can inhibit the spread or arcing of current from first electrode 712 and second electrode 714. As discussed below, monopolar energy can be applied to anatomic vessel 716 to cut therethrough. In bipolar energy application, electrical current can pass from first seal plate 708 A and second seal plate 710A to first seal plate 708B and second seal plate 71 OB, respectively. As discussed below, bipolar energy can be applied to anatomic vessel 716 to provide sealing of anatomic vessel 716 on either side of first electrode 712 and second electrode 714.

[0319] In examples first seal plate 708 A through second seal plate 71 OB can be shaped to urge fluid within anatomic structure 716 toward first electrode 712 and second electrode 714. In particular, first seal plate 708 A through second seal plate 710B can be angled relative to a horizontal clamping plane to urge steam between first jaw member 704 and second jaw member 706 toward first electrode 712 and second electrode 714. For example, as shown in FIG. 13B, first seal plate 710A can have a contact surface facing toward anatomic vessel 716 that forms angle AB relative to a horizontal plane. Second seal plate 710B can have a contact surface with the inverse angle. As such, first seal plate 710A and second seal plate 710B can open toward first electrode 712 and second electrode 714. Similarly, first seal plate 708A and second seal plate 708B can be angled relative to each other to open toward first electrode 712 and second electrode 714. As such, first seal plate 708A through second seal plate 710B can have surfaces that are disposed in a rhombus-like arrangement to focus steam generated within anatomic vessel 716 toward the center of electrosurgical end effector 700, thereby allowing steam generated therein to more readily provide the anvil functionality described herein of pushing anatomic vessel 716 into first electrode 712 and second electrode 714. In examples, angle AB can be in the range of approximately one-half of a degree to approximately twenty degrees. In additional examples, angle AB can be in the range of approximately three degrees to approximately twelve degrees. In an example, angle AB can be approximately six degrees. In example, angle AB can be configured based on the diameter of vessels expected to be sealed with electrosurgical end effector 700.

[0320] FIG. 13B is a schematic illustration of electrosurgical end effector 700 connected to electrical generator 702A and electrical generator 702B. Electrosurgical end effector 700 can be configured similarly as described with reference to FIG. 13 A. However rather than first electrode 712 being connected to electrical generator 702A with connector 724, first electrode 712 is connected to electrical generator 702B with connector 730 and second seal86Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01plate 710A and second seal plate 71 OB with connector 732. Additionally, switch 720 can be omitted from connector 718. As such, electrical generator 702 A can be activated to apply current to first seal plate 708 A and second seal plate 710A, which can pass to first seal plate 708B and second seal plate 71 OB, respectively, and electrical generator 702B can be activated to apply current to first electrode 712, which can pass to second electrode 714.

[0321] The systems of FIG. 13 A and FIG. 13B can be incorporated into any of the other electrosurgical systems described herein, such as electrosurgical system 100 of FIG. 1, electrosurgical system 300 of FIG. 6 and system 500 of FIG. 10A, for example. Thus, electrosurgical end effector 700 can comprise part of medical device 102, electrosurgical instrument 314, energy application device 506 or any other device described herein. As discussed below with reference to FIG. 14A through FIG. 14E, electrosurgical end effector 700 and systems connected thereto can be configured to apply cutting energy at a point in the sealing process where anatomic vessel 716 can act as an anvil to push against first electrode 712 and second electrode 714, thereby improving the cutting action and reducing the amount of energy to be put into anatomic vessel 716 to perform the cut.

[0322] FIG. 14A is a schematic illustration of electrosurgical end effector 700 clamping down on anatomic vessel 716 before sealing energy is applied. FIG. 14A shows timescale 740 have x-axis 742 indicating time and y-axis 744 indicating power. Timescale 740 includes plot 746 of power to be applied to anatomic vessel 716 to perform a sealing operation via first seal plate 708 A, second seal plate 710A, first seal plate 708B and second seal plate 710B.

[0323] FIG. 14A shows electrosurgical end effector 700 before the application of energy of plot 746 from any of first seal plate 708 A, second seal plate 710A, first seal plate 708B, second seal plate 710B, first electrode 712 and second electrode 714. Relative to the positions of FIG. 13 A or FIG. 13B, electrosurgical end effector 700 can be actuated such that first jaw member 704 and second jaw member 706 are brought closer to each other to clamp down on anatomic vessel 716. Thus, first seal plate 708 A and second seal plate 710A are brought closer to first seal plate 708B and second seal plate 710B and are pushed into opposite sides of anatomic vessel 716. Additionally, first electrode 712 and second electrode 714 can be pushed into opposite sides of anatomic vessel 716. As such, internal lumen 728 can be compressed in three locations so that first wall 726A and second wall 726B are pushed87Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01into engagement with each other, thereby forming first pocket 734A and second pocket 734B within internal lumen 728.

[0324] Power to be applied to anatomic vessel 716 shown in plot 746 of timescale 740 has not yet commenced in FIG. 14 A. Thus, FIG. 14A illustrates electrosurgical end effector 700 grasping anatomic vessel 716 to begin a sealing and cutting operation. Anatomic vessel 716 thereby applies outward counterforce to first jaw member 704 and second jaw member 706.

[0325] FIG. 14B is a schematic illustration of electrosurgical end effector 700 of FIG. 14A clamping down on anatomic vessel 716 with a first stage of sealing energy being applied thereto. FIG. 14B shows the application of sealing energy at point 748 on plot 746 of timescale 740. Timescale 740 additionally shows plot 750 of impedance along x-axis 742. As plot 746 rises indicating increased power input to anatomic vessel 716, plot 750 of impedance spikes at the onset of energy input and then slowly decreases as temperature rises within anatomic vessel 716. Correspondingly, steam 736A and steam 736B form in first pocket 734A and second pocket 734B. Collagen and other matter within first wall 726A and second wall 726B have not yet begun to transform into sealed structures as steam is driven out of the tissue.

[0326] FIG. 14C is a schematic illustration of electrosurgical end effector 700 of FIG. 14B clamping down on anatomic vessel 716 with a second stage of sealing energy being applied thereto. FIG. 14C shows the application of sealing energy at point 752 on plot 746 of timescale 740. As plot 746 rises indicating increased power input to anatomic vessel 716, plot 750 of impedance continues to slowly decrease as temperatures rises within anatomic vessel 716. Steam 736A and steam 736B continues to build in first pocket 734A and second pocket 734B. Furthermore, steam 738 A and steam 738B can form within first wall 726A and second wall 726B, respectively, as temperatures rise to a point where more liquid can convert to steam.

[0327] As steam generation increases within anatomic structure, particularly steam 736 A and steam 736B within first pocket 734A and second pocket 734B, respectively, first pocket 734A and second pocket 734B can increase in volume. Thus, anatomic vessel 716 can comprise a pressure vessel that expands in size to apply pressure to and push first jaw member 704 and second jaw member 706 away from each other. Additionally, the increase in diameter of anatomic vessel 716 from the increase of pressure within first pocket 734A and88Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01second pocket 734B can push first wall 726A and second wall 726B into first electrode 712 and second electrode 714. As such, anatomic vessel 716 can form an anvil for cutting of itself. That is, anatomic structure can become harder so that first electrode 712 and second electrode 714 can be pushed into anatomic vessel 716 with reduced ability of anatomic structure to shrink away from first electrode 712 and second electrode 714. Thus, the expansion of anatomic vessel 716 due to internal pressure increase from steam generation can force first wall 726 A and second wall 726B into engagement with first electrode 712 and second electrode 714, respectively, to facilitate the transfer of cutting energy from one or both of first electrode 712 and second electrode 714 into anatomic vessel 716.

[0328] FIG. 14D is a schematic illustration of electrosurgical end effector 700 of FIG. 14C clamping down on anatomic vessel 716 with cutting energy being applied thereto. FIG.14D also shows the application of sealing energy at point 754 on plot 746 of timescale 740. As plot 746 rises indicating increased power input to anatomic vessel 716, plot 750 of impedance continues to slowly decrease as temperature rises within anatomic vessel 716. Steam 736A and steam 736B continue to build in first pocket 734A and second pocket 734B. Furthermore, steam 738 A and steam 738B can form within first wall 726 A and second wall 726B, respectively.

[0329] At point 754 on plot 745 cutting energy can be applied by one or both of first electrode 712 and second electrode 714 causing anatomic vessel 716 to sever, thereby separating anatomic vessel 716 into two portions. Thus, plot 745 drops indicating a sharp drop in energy input to anatomic vessel 716 for the sealing operation. Note, cutting output of first electrode 712 is not reflected in timescale 740. The system of electrosurgical end effector 700 can determine when to apply the cutting energy based on looking for, e.g., sensing or observing, conditions of anatomic vessel 716 and / or electrosurgical end effector 700 indicative of when anatomic vessel 716 has increased in size due to pressure increases. Such conditions can be stored in memory of electrosurgical systems connected to electrosurgical end effector 700. Increase in size of anatomic vessel 716 can be correlated to various tissue states, device states and time states as described herein. However, rather than the tissue states, device states and time states being specifically correlated to formation of sealed tissue during the sealing operation, the tissue states, device states and time states can be correlated to steam expansion of anatomic vessel 716. However, steam expansion of89Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01anatomic vessel 716 and conditions favorable for sealing, e.g., conditions when sealed tissue begins to form, can occur at the same, such as when jaw bounce occurs, as described herein.

[0330] FIG. 14E is a schematic illustration of electrosurgical end effector 700 of FIG. 14D clamping down on anatomic vessel 716 with a third stage of sealing energy being applied thereto. FIG. 14E shows the application of sealing energy at point 756 on plot 746 of timescale 740. As plot 746 rises indicating increased power input to anatomic vessel 716, plot 750 of impedance can rise as the tissue of anatomic structure dries out to form first seal 739 A and second seal 739B. Steam 736 A and steam 736B can continue to build in first pocket 734A and second pocket 734B, which are now joined, as all liquid is driven from first wall 726A and second wall 726B. First seal 739A and second seal 739B can comprise locations where first wall 726A and second wall 726B are bonded together.

[0331] FIG. 14A through FIG. 14B additionally illustrate a method wherein the total energy applied to perform a cutting operation can be reduced as compared to at other times along the sealing process. As mentioned, reduced level of cutting energy can be used because of the force of anatomic vessel 716 pushing into first electrode 712 and second electrode 714. With the ability to cut anatomic vessel 716 with a reduced amount of energy, there is less potential for arcing between first electrode 712 and second electrode 714 and first seal plate 708 A, second seal plate 710A, first seal plate 708B and second seal plate 710B. As such, the size of electrosurgical end effector 700 can be reduced as compared to other designs, as discussed herein.

[0332] FIG. 15 is a schematic illustration showing a diagram of an exemplary computer-based clinical decision support system (CDSS), e.g., CDSS 800, that is configured to provide an output indicative of the energy desirable to perform sealing and cutting operations with an electrosurgical device. CDSS 800 can include processing unit 104 (FIG. 1), system 500 (FIG. 10 A), machine 900 (FIG. 16) and combinations thereof. The output can be provided to a user and / or to an electrosurgical device to perform an actively applied sealing and cutting operation and in particular an automatically initiated cutting operation after a sealing operation has commenced. The output can be automatically adjusted to perform electrosurgical operations including initiating a cut output during or after initiation of sealing energy. For example, CDSS 800 can determine a tissue state, a device state or a time state at which point an electrosurgical sealing operation is ready to allow a cutting operation to be performed. A cutting operation is ready to be performed when a sealing operation is90Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01sufficiently progressed to substantially stop blood flow, with or without the aid of clamping force from forceps. In additional examples, a cutting operation is ready to be performed when feedback indicates a trend toward successful completion such that successful sealing can be predicted. CDSS 800 can automatically determine the appropriate time for the cutting operation and perform such cutting operation without user intervention. An exemplary system output can comprise generation of electrical signals to perform a cutting and / or sealing operation, and audio, haptic and graphical or textual outputs to a user, such as at user interface 105 (FIG. 1) to inform the user of energy being applied. The output can include feedback regarding tissue state, device state and time state, feedback regarding progress through a sealing cycle and progress through a cutting cycle, a user prompt, a user confirmation and the like, as well as warnings perceivable by the user regarding any potential issues detected by the system. In examples, CDSS 800 can automatically apply cutting energy cycles when one or more of the determined tissue state, device state and time state triggers have identified by the system, or can suggest cutting energy cycles to a user, who can affirm or modify the suggested cutting energy cycle. An exemplary system output can comprise disabling an electrosurgical instrument if a tissue cannot be identified or if a sealing or cutting operation has not been fully performed, until another sealing or cutting operation, e.g., a proper sealing or cutting operation, has been performed so that cutting can be performed. The output can comprise changing the state of any one or more of such as of first therapeutic power switch 152, second therapeutic power switch 156 and electrode switch 176 of FIG. 2.

[0333] The output can be based on input from one or more of sensing electrodes (e.g., one or more of first electrode 140, second electrode 142, third electrode 144), sensor 128, camera unit 504 and external camera device 534, for example. The artificial intelligence model can analyze electrical output of electrodes, temperature and pressure outputs of sensor 128 and video image outputs of camera unit and external camera device 534 to determine the progress of a tissue sealing operation and to identify a point within the sealing operation to perform a cutting operation. Output of the electrodes, sensor 128, camera unit 504 and external camera device 534 can include magnitudes of tissue, device and time state values, changes in tissue, device and time state values, rates of change of tissue, device and time state values and the like as discussed herein.91Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0334] In various embodiments, CDSS 800 can include input interface 802 through which output of electrodes, sensor 128 camera unit 504 and external camera device 534 which are specific to a patient (e.g., specific to data obtained while applying electrosurgical energy to a specific patient) are provided as input features to an artificial intelligence (Al) model, e.g., Al model 804, processor 806 which performs an inference operation in which the output of electrodes, sensor 128 camera unit 504 and external camera device 534 are applied to the Al model to generate the feedback signals including operator warnings and system adjustments, and a user interface (UI) through which the feedback signals are communicated to a user, e.g., a clinician, such as user interface 350 (FIG. 6) and user interface 105 (FIG. 1).

[0335] In some embodiments, input interface 802 may be a direct data link between CDSS 800 and one or more medical devices, e.g., medical device 102 (FIG. 1) and energy application device 506 (FIG. 10A), that generate at least some of the input features. For example, input interface 802 can transmit output of electrodes, sensor 128 camera unit 504 and external camera device 534 directly to CDSS 800 during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, input interface 802 can be a classical user interface that facilitates interaction between a user and CDSS 800. For example, input interface 802 can facilitate a user interface through which the user can manually enter patient information (heigh, weight, age, etc.), tissue type (blood vessel, artery, carotid artery, renal artery, vein, etc.), procedure type (sealing, cutting, cauterizing, etc., or Hysterectomy vs tissue dissection in a Nissen fundoplication) or output of electrodes, sensor 128 camera unit 504 and external camera device 534 (e.g., rate of change of resistance, temperature, tissue color). Additionally, or alternatively, input interface 802 can provide CDSS 800 with access to an electronic patient record 809 in database 810 from which one or more input features may be extracted. In any of these cases, input interface 802 is configured to collect one or more of the following input features, as well as others, in association with a specific patient on or before a time at which CDSS 800 is used to assess if appropriate levels of sealing and cutting energy are being applied to particular types of tissue:

[0336] procedure type;

[0337] tissue type;

[0338] electrosurgical / medical device type;

[0339] j aw size;

[0340] a percentage of an originally detected electrical value;92Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0341] a delta shift in an electrical value;

[0342] a minimum electrical value;

[0343] a maximum electrical value;

[0344] a percentage of an originally detected jaw opening value (e.g., distance or angle between jaws);

[0345] a delta shift in a jaw opening value;

[0346] a minimum jaw opening value;

[0347] a maximum jaw opening value;

[0348] a percentage of an originally detected jaw pressure value;

[0349] a delta shift in a jaw pressure value;

[0350] a minimum jaw pressure value;

[0351] a maximum jaw pressure value;

[0352] a percentage of an originally detected jaw temperature value;

[0353] a delta shift in a jaw temperature value;

[0354] a minimum jaw temperature value;

[0355] a maximum jaw pressure value;

[0356] a percentage of an originally detected tissue color value;

[0357] a delta shift in a tissue color value;

[0358] a minimum tissue color value;

[0359] a maximum tissue color value,

[0360] a preset time from when sealing has started (the beginning of a seal cycle);

[0361] a preset time within a sealing cycle;

[0362] a preset time from when sealing stops (the end of a seal cycle); and

[0363] other tissue state, device state and time state value thresholds mentioned herein and combinations of these values.

[0364] Based on one or more of the above input features, processor 806 can perform an inference operation using the Al model to generate one or more feedback signals discussed herein for generating instructions for a user or controlling a function of the medical device, such as to automatically initiate a cutting energy output without user intervention. For example, input interface 802 can deliver the output of electrodes, sensor 128 camera unit 504 and external camera device 534 into an input layer of the Al model which propagates these input features through the Al model to an output layer. The Al model can provide a93Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. Al model explores the study and construction of algorithms (e.g., machine-learning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0365] There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs.Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.

[0366] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM).

[0367] Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and autoencoders.

[0368] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machinelearning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically94Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0369] The machine learning model can be an artificial neural network in some implementations. Artificial neural networks are artificial in the sense that they are computational entities, inspired by biological neural networks but modified for implementation by computing devices. Artificial neural networks are used to model complex relationships between inputs and outputs or to find patterns in data, where the dependency between the inputs and the outputs cannot be easily ascertained. A neural network typically includes an input layer, one or more intermediate (“hidden”) layers, and an output layer, with each layer including a number of nodes. The number of nodes can vary between layers. A neural network is considered “deep” when it includes two or more hidden layers. The nodes in each layer connect to some or all nodes in the subsequent layer and the weights of these connections are typically learnt from data during the training process, for example through backpropagation in which the network parameters are tuned to produce expected outputs given corresponding inputs in labeled training data. Thus, an artificial neural network is an adaptive version of electrosurgical system 100 (FIG. 1), electrosurgical system 300 (FIG. 6) or system 500 (FIG. 10A) that is configured to change its structure (e.g., the connection configuration and / or weights) based on information that flows through the network during training, and the weights of the hidden layers can be considered as an encoding of meaningful patterns in the data.

[0370] A fully connected neural network is one in which each node in the input layer is connected to each node in the subsequent layer (the first hidden layer), each node in that first hidden layer is connected in turn to each node in the subsequent hidden layer, and so on until each node in the final hidden layer is connected to each node in the output layer.

[0371] In an example, the machine learning model can include or use a Convolutional Neural Network (CNN). A CNN is a type of artificial neural network, and like the artificial neural network described above, a CNN is made up of nodes and has learnable weights. However, the layers of a CNN can have nodes arranged in three dimensions: width, height, and depth, corresponding to the 2^2 array of pixel values in each video frame (e.g., the width and height) and to the number of video frames in the sequence (e.g., the depth). The nodes of a layer may only be locally connected to a small region of the width and height layer before95Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01it, called a receptive field. The hidden layer weights can take the form of a convolutional filter applied to the receptive field. In some examples, the convolutional filters can be two-dimensional, and thus, convolutions with the same filter can be repeated for each frame (or convolved transformation of an image) in the input volume or for designated subset of the frames. In other examples, the convolutional filters can be three-dimensional and thus extend through the full depth of nodes of the input volume. The nodes in each convolutional layer of a CNN can share weights such that the convolutional filter of a given layer is replicated across the entire width and height of the input volume (e.g., across an entire frame), reducing the overall number of trainable weights and increasing applicability of the CNN to data sets outside of the training data. Values of a layer may be pooled to reduce the number of computations in a subsequent layer (e.g., values representing certain pixels may be passed forward while others are discarded), and further along the depth of the CNN pool masks may reintroduce any discarded values to return the number of data points to the previous size. A number of layers, optionally with some being fully connected, can be stacked to form the CNN architecture. The machine learning model can also be at least one of Support Vector Machine (SVM), K-Nearest Neighbors (KNN), Artificial Neural Network (ANN), or an ensemble model combining the SVM and ANN.

[0372] In some examples, the Al model may be trained continuously or periodically prior to performance of the inference operation by the processor 806. Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the adjustments to the electrosurgical device and feedback and warnings produced to the user. For example, a rate of change in the increase of resistance sensed in an end effector during performance of a tissue sealing procedure on a specific patient can be compared to rates of change in the increase of resistance for particular types of tissue. The rate of change in resistance for the specific patient can identify when sealing of tissue for that patient is complete or almost complete. The Al model can determine the type of tissue by selecting a tissue type having a rate of change in resistance that most closely matches the sensed rate of change of resistance. Thereafter, the Al model can consult lookup tables stored in memory to determine at which point a change in resistance of the tissue indicates sealing is substantially complete. The aforementioned example, uses rate of change of resistance to determine a tissue type; however, any of the other parameters listed herein based96Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01on tissue state, device state and time state, and combinations thereof, can be used to identify tissue type. The Al model can generate output signals to apply the cutting energy cycle. The Al model can evaluate the effectiveness of the prescribed energy cycle that has been applied by consulting lookup tables stored in memory having rates of change in resistance for other tissue sealing procedures known to have produced a proper seal. Thus, the Al model can learn new energy cycles to provide effective sealing and cutting operations that minimize energy expenditure and reduce procedure time.

[0373] During and / or subsequent to the inference operation, the visual, audible or tactile alarm may be communicated to the user via the user interface (UI) and / or automatically cause an apparatus connected to processor 806 to perform a desired action. For example, the output signal can comprise a signal to activate a cutting electrode. The output signal can comprise instructions for activating any one or more of first therapeutic power switch 152, second therapeutic power switch 156 and electrode switch 176 of FIG. 2 to automatically initiate application of cutting and sealing energy. For example, the output signal can comprise a signal to activate a visual, audible or tactile alarm for a user. The visual, audible or tactile alarm can provide a confidence level or progress level for the tissue sealing or cutting operation. The visual, audible or tactile alarm can provide information to the user, such as by specifically informing the user that an inadequate seal was likely to have been performed along with directions to re-execute the sealing procedure, e.g., in the same tissue location, or perform a secondary sealing procedure, e.g., on adjacent tissue before the cutting operation will be applied. The output signal can modify operation of the electrosurgical device, such as by adjusting output of the sealing energy, cutting energy or by locking the electrosurgical device or a portion of the electrosurgical device, such as jaw assembly 110, until the user acknowledges the visual, audible or tactile alarm and / or instructions.

[0374] FIG. 16 illustrates generally a block diagram of an example machine 900 upon which any one or more of the techniques (e.g., methodologies or operations) discussed herein can be performed, such as methods for determining and applying sealing and cutting energy in various cycles. Portions of this description can apply to the computing framework of various portions of the electrosurgical systems and devices and clinical decision support systems (e.g., machine learning video analysis systems) in accordance with examples as discussed in this document.97Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0375] Processing unit 104 (FIG. 1), electrosurgical system 300 (FIG. 6) and system 500 (FIG. 10A) can comprise examples of machine 900. Likewise, CDSS 800 can be incorporated into machine 900. In examples, processing unit 104 can operate as a standalone device or can be connected (e.g., networked) to other machines. In a networked deployment, processing unit 104 can operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, processing unit 104 can act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. Processing unit 104 (FIG. 1), electrosurgical system 300 (FIG. 6) and / or system 500 (FIG. 10A) can be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0376] Examples, as described herein, can include, or can operate by, logic or a number of components, or mechanisms. Circuit sets are a collection of circuits implemented in tangible entities that include hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership can be flexible over time and underlying hardware variability. Circuit sets include members that can, alone or in combination, perform specified operations when operating. In an example, hardware of the circuit set can be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set can include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a non-transitory computer readable medium physically modified (e.g., magnetically, electrically, movable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuit set in hardware via the variable connections to carry out portions of the specific operation when in operation.Accordingly, the computer readable medium is communicatively coupled to the other98Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01components of the circuit set member when the device is operating. In an example, any of the physical components can be used in more than one member of more than one circuit set. For example, under operation, execution units can be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.

[0377] Processing unit 104 (FIG. 1), electrosurgical system 300 (FIG. 6) and / or system 500 (FIG. 10A) (e.g., a computer system, machine 900) can include, or be connected to, CPU 902 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), main memory 904 and static memory 906, some or all of which can communicate with each other via interlink 908 (e.g., bus). Processing unit 104 can further include display unit 910 (e.g., a raster display, vector display, holographic display, user interface 105 (FIG. 1), etc.), alphanumeric input device 912 (e.g., a keyboard), and user interface (UI) navigation device 914 (e.g., a mouse). In an example, display unit 910, alphanumeric input device 912 and navigation device 914 can be a touch screen display. Processing unit 104 can additionally include storage device 916 (e.g., a drive unit), signal generation device 918 (e.g., a speaker), network interface device 920, and one or more sensors 921, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensors. Processing unit 104 can include output controller 928, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.). Processing unit 104 can additionally be connected to sensing electrodes (e.g., one or more of first electrode 140, second electrode 142, third electrode 144), sensor 128, camera unit 504 and external camera device 534, for example, of medical device 102 (FIG. 1), electrosurgical system 300 (FIG. 6) and / or system 500 (FIG. 10 A).

[0378] Storage device 916 can include machine-readable medium 922 on which is stored one or more sets of data structures or instructions 924 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein, such as the operations described with reference to FIG. 8, FIG. 9, FIG. 10C, FIG. 11 A through FIG. 1 ID and FIG.13A through FIG. 14E. Instructions 924 can also reside, completely or at least partially, within main memory 904 and / or within static memory 906 during execution thereof by99Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01processing unit 104. In an example, one or any combination of main memory 904, static memory 906, or the storage device 916 can constitute machine readable media.

[0379] While machine-readable medium 922 is illustrated as a single medium, the term “machine readable medium” can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more or instructions 924. As discussed herein, instructions 924 can include baseline or threshold electrical parameter (e.g., resistance, impedance, phase angle, energy delivered), device parameters (e.g., jaw position, jaw pressure, jaw temperature, relative tissue and jaw color), and time parameters (e.g., time from initiation of sealing energy, time from conclusion of sealing energy) and changes in these parameters that indicate a type of tissue and types of treatment parameters, e.g., cycling of sealing and cutting energy, to perform sealing and / or cutting of each tissue type. In particular, instructions 924 can include instructions for automatically initiating cutting energy based on the parameters obtained during application of sealing energy. Instructions 924 can include such information for different types and combinations of medical devices, jaw sizes, activation or treatment energies, e.g., RF or resistive, monopolar, bipolar, tissue types and the like. Instructions 924 can comprise instructions related to comparing obtained signals from sensing electrodes (e.g., one or more of first electrode 140, second electrode 142, third electrode 144), sensor 128, camera unit 504 and external camera device 534 to the stored baseline or threshold values to determine a tissue type and appropriate energy levels and cycle patterns, such as to automatically initiate cutting energy. Instructions 924 can comprise instructions for comparing output of sensor 128 along a common timeline. Instructions 924 can comprise instructions for activating first electrode 140, second electrode 142 and third electrode 144 and controlling or preventing the operation of medical device 102 (FIG. 1). Instructions 924 can include instructions for operation of first therapeutic power switch 152, second therapeutic power switch 156 and electrode switch 176 of FIG. 2, as well as other components of medical device 102.

[0380] The term “machine readable medium” can include any medium that is capable of storing, encoding, or carrying instructions for execution by processing unit 104 and that cause processing unit 104 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples can include solid-state memories, and optical and magnetic media. In an example, a massed machine-readable100Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine-readable media can include: nonvolatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EPSOM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0381] Instructions 924 can further be transmitted or received over communication network 926 using a transmission medium via network interface device 920 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks can include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, network interface device 920 can include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to communication network 926. In an example, network interface device 920 can include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by processing unit 104, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.

[0382] The present disclosure provides systems and methods for determining when to perform a tissue cutting operation within a tissue sealing operation. In examples, the tissue cutting operation can be automatically initiated by an electrosurgical system without any additional user intervention. Thus, a user can simply initiate a tissue sealing operation with a single user input, e.g., button push or trigger pull, and the electrosurgical system can evaluate the sealing operation for an appropriate time to cut the tissue, e.g., at a time when blood flow101Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01within the tissue is sealed or a time that pressure has accumulated within the tissue from steam such that the tissue can act as an anvil for the cutting operation.

[0383] Tissue cutting operations can be triggered by tissue state. Tissue state triggers can comprise electrical parameters reaching threshold values, such as resistance / impedance measurements, phase angle changes, voltage levels and power / wattage thresholds. Tissue state triggers can comprise energy consumption to reach a boiling point of tissue.

[0384] Tissue cutting operations can be triggered by device state. Device state triggers can comprise jaw position changes including jaw bounce, pressure feedback between jaw members, temperature measurements and visual feedback of tissue color changes.

[0385] Tissue cutting operations can be triggered by time state. Time state triggers can comprise preset time from initiation of sealing energy, preset time after completion of sealing energy, time between sealing energy pulses and variable timing based on tissue response.

[0386] Additionally, multiple trigger states can be combined for increased reliability, such as by using both electrical parameters and device state measurements, combining pressure and temperature readings, and using visual confirmation with electrical measurements.

[0387] Electrosurgical systems can be configured to start cutting while sealing is still in progress, wait until sealing is complete before cutting, include a pause between sealing and cutting, and provide warnings before cutting begins.

[0388] Trigger points can be adjusted based on tissue type identified during sealing, size of jaw assembly being used, type of procedure being performed and presence of conductive fluids.

[0389] The present disclosure provides several benefits over previous electrosurgical systems. Electrosurgical systems of the present disclosure provide improved surgical efficiency. For example, combined monopolar and bipolar functionality in a single device for both sealing and cutting operations improves procedure times and sealing efficacy. Devices of the present disclosure can include single-button activation for both sealing and cutting operations, thereby reducing procedure time. Furthermore, automated transition from sealing to cutting without requiring additional user input can shorten procedure times and reduce reliance on operator judgment in determining when to transition between operations.

[0390] The present disclosure also provides enhanced safety features, including the potential for lower voltage requirements for cutting operations while maintaining102Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01effectiveness, reduced risk of arcing between electrodes, automated monitoring that prevents premature cutting before sealing is complete, and providing visual and audible feedback systems to inform operators of procedure status.

[0391] In some examples of the present disclosure, the need for a rigid cutting blade can be eliminated, thereby allowing for better articulation capabilities near the jaw assembly, smaller end effector design that can fit within endoscopes, and closer positioning of articulating sections to the end effector.Examples

[0392] Example l is a method of operating an electrosurgical device comprising a sealing electrode and a cutting element, the method comprising: activating sealing energy to perform a sealing operation to seal an anatomic structure with the sealing electrode of the electrosurgical device; determining a first parameter indicative of progress of the sealing operation; comparing the first parameter to a first threshold parameter; automatically activating the cutting element to perform a cutting operation to cut the anatomic structure with the electrosurgical device if the first parameter of the sealing energy is within a tolerance band of the first threshold parameter; completing the sealing operation; and completing the cutting operation.

[0393] In Example 2, the subject matter of Example 1 optionally includes continuing to seal the anatomic structure if the first parameter is not within the tolerance band of the first threshold parameter.

[0394] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the cutting element is a cutting electrode or a mechanical blade within the electrosurgical device.

[0395] In Example 4, the subject matter of Example 3 optionally includes wherein the cutting electrode is a bipolar electrode or a monopolar electrode.

[0396] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the cutting element is automatically activated while the sealing energy is activated.

[0397] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the cutting element is automatically activated after the sealing energy is terminated.103Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0398] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include determining a second parameter indicative of progress of the sealing operation; and comparing the second parameter to a second threshold parameter.

[0399] In Example 8, the subject matter of Example 7 optionally includes automatically activating the cutting element to cut the anatomic structure with electrode when: the first parameter of the sealing energy is within a tolerance band of the first threshold parameter before the second parameter of the sealing energy is within a second tolerance band of the second threshold parameter.

[0400] In Example 9, the subject matter of any one or more of Examples 7-8 optionally include automatically activating the cutting element to cut the anatomic structure with a cutting electrode when: the second parameter of the sealing energy is within a tolerance band of the first threshold parameter at any point while the second parameter of the sealing energy is within a second tolerance band of the second threshold parameter.

[0401] In Example 10, the subject matter of any one or more of Examples 7-9 optionally include wherein each of the first parameter and the second parameter are comprise at least one of a tissue state, a device state and a time state.

[0402] In Example 11, the subject matter of any one or more of Examples 1-10 optionally include wherein the sealing operation and the cutting operation are completed after a single user input is activated.

[0403] In Example 12, the subject matter of Example 11 optionally includes wherein the single user input comprises a single trigger pull or a single button push.

[0404] In Example 13, the subject matter of any one or more of Examples 1-12 optionally include wherein the first threshold parameter correlates to a point within the sealing operation wherein steam pressure within the anatomic structure causes a jaw bounce.

[0405] In Example 14, the subject matter of any one or more of Examples 1-13 optionally include wherein the first threshold parameter correlates to a point within the sealing operation before blood flow is sufficiently stopped.

[0406] In Example 15, the subject matter of Example 14 optionally includes wherein the first threshold parameter provides an indication that the sealing operation is trending toward completion.

[0407] In Example 16, the subject matter of any one or more of Examples 1-15 optionally include wherein the first threshold parameter correlates to a point within the104Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01sealing operation wherein blood flow through the anatomic structure is sufficiently stopped to allow the cutting operation to begin.

[0408] In Example 17, the subject matter of Example 16 optionally includes wherein blood flow through the anatomic structure is sufficiently stopped when at least some collagen within the anatomic structure has melted.

[0409] In Example 18, the subject matter of any one or more of Examples 16-17 optionally include wherein: the sealing electrode is a bipolar electrode comprising a first seal plate and a second seal plate; and the cutting element is a cutting electrode.

[0410] In Example 19, the subject matter of Example 18 optionally includes wherein the cutting electrode is a monopolar electrode or a bipolar electrode.

[0411] In Example 20, the subject matter of any one or more of Examples 18-19 optionally include wherein the electrosurgical device comprises a forceps comprising: a first jaw including the first seal plate and the cutting electrode; and a second jaw including the second seal plate.

[0412] In Example 21, the subject matter of Example 20 optionally includes wherein determining the first parameter indicative of the progress of the sealing operation comprises determining a tissue state of the anatomic structure.

[0413] In Example 22, the subject matter of Example 21 optionally includes wherein determining the tissue state of the anatomic structure comprises: determining a first sealing energy electrical parameter indicative of progress of the sealing operation.

[0414] In Example 23, the subject matter of Example 22 optionally includes wherein determining the first sealing energy electrical parameter indicative of progress of the sealing operation comprises sensing at least one of resistance or impedance, phase angle, voltage and current and power.

[0415] In Example 24, the subject matter of Example 23 optionally includes wherein sensing at least one of resistance or impedance, phase angle, voltage or current and power comprises sensing between the cutting electrode and the sealing electrode.

[0416] In Example 25, the subject matter of any one or more of Examples 23-24 optionally include wherein the first threshold parameter comprises at least one of a minimum electrical value, a maximum electrical value, a magnitude of change in an electrical value and a percentage change from an initial electrical value.105Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0417] In Example 26, the subject matter of any one or more of Examples 20-25 optionally include wherein determining the first parameter indicative of the progress of the sealing operation comprises determining a device state of an end effector engaged with the anatomic structure.

[0418] In Example 27, the subject matter of Example 26 optionally includes wherein determining the first parameter indicative of the progress of the sealing operation comprises sensing a parameter of the end effector correlated to an event in the sealing operation.

[0419] In Example 28, the subject matter of Example 27 optionally includes wherein sensing the parameter of the end effector correlated to the event in the sealing operation comprises determining pressure within the end effector.

[0420] In Example 29, the subject matter of any one or more of Examples 26-28 optionally include wherein determining pressure within the end effector comprises determining pressure with one or more pressure sensors embedded within the forceps.

[0421] In Example 30, the subject matter of Example 29 optionally includes wherein determining pressure within the end effector comprises sensing pressure of the anatomic structure engaged with the one or more pressure sensors.

[0422] In Example 31, the subject matter of any one or more of Examples 27-30 optionally include wherein sensing the parameter of the end effector correlated to the event in the sealing operation comprises determining temperature within the end effector.

[0423] In Example 32, the subject matter of Example 31 optionally includes wherein determining temperature within the end effector comprises sensing temperature with one or more temperature sensors embedded within the forceps.

[0424] In Example 33, the subject matter of Example 32 optionally includes wherein determining temperature within the end effector comprises sensing temperature of the anatomic structure engaged with the one or more temperature sensors.

[0425] In Example 34, the subject matter of any one or more of Examples 27-33 optionally include wherein sensing the parameter of the end effector correlated to the event in the sealing operation comprises determining a relative position between a first jaw member and a second jaw member of the end effector.

[0426] In Example 35, the subject matter of Example 34 optionally includes wherein determining the relative position between the first jaw member and the second jaw member comprises determining the relative position via an imaging sensor.106Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0427] In Example 36, the subject matter of any one or more of Examples 34-35 optionally include wherein determining the relative position between the first jaw member and the second jaw member comprises determining a reduced distance between the first jaw member and the second jaw member compared to a starting distance when the end effector is first clamped down in the anatomic structure.

[0428] In Example 37, the subject matter of any one or more of Examples 34-36 optionally include wherein determining the relative position between the first jaw member and the second jaw member comprises determining an increased distance between the first jaw member and the second jaw member at any point during the sealing operation.

[0429] In Example 38, the subject matter of Example 37 optionally includes wherein determining the increased distance between the first jaw member and the second jaw member at any point during the sealing operation comprises determining one or more jaw bounces occurring due to steam generation within the anatomic structure.

[0430] In Example 39, the subject matter of any one or more of Examples 27-38 optionally include wherein sensing the parameter of the end effector correlated to the event in the sealing operation comprises determining a condition of the anatomic structure within the end effector.

[0431] In Example 40, the subject matter of Example 39 optionally includes wherein determining a condition of the anatomic structure comprises viewing a change a thermal margin of the anatomic structure.

[0432] In Example 41, the subject matter of Example 40 optionally includes wherein viewing the change in the thermal margin comprises determining a color of the anatomic structure within the end effector.

[0433] In Example 42, the subject matter of any one or more of Examples 40-41 optionally include wherein viewing the change in the thermal margin comprises determining a change of color of the anatomic structure adjacent the end effector.

[0434] In Example 43, the subject matter of any one or more of Examples 1-42 optionally include wherein determining the first parameter indicative of the progress of the sealing operation comprises determining a time state of the sealing operation.

[0435] In Example 44, the subject matter of Example 43 optionally includes wherein determining the time state of the sealing operation comprises determining an expiration of a107Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01first timer started at commencement of the sealing operation, wherein the cutting operation begins at the expiration of the first timer.

[0436] In Example 45, the subject matter of Example 44 optionally includes performing a second sealing operation after the cutting operation is completed.

[0437] In Example 46, the subject matter of any one or more of Examples 43-45 optionally include wherein determining the time state of the sealing operation comprises determining an expiration of a first timer started at completion of the sealing operation, wherein the cutting operation begins at the expiration of the first timer.

[0438] In Example 47, the subject matter of Example 46 optionally includes a pause in time between completion of the sealing operation and commencement of the cutting operation.

[0439] In Example 48, the subject matter of any one or more of Examples 43-47 optionally include providing an alarm before initiating the cutting operation.

[0440] Example 49 is an electrosurgical device comprising: a shaft comprising a distal end section and a proximate end section; a jaw assembly coupled to the distal end section of the shaft, the jaw assembly comprising: a first jaw member; a second jaw member; a first sealing electrode positioned on the first jaw member; a second sealing electrode positioned on the second jaw member; a cutting element positioned on one of the first jaw member or the second jaw member; wherein the first sealing electrode and the second sealing electrode are configured to deliver sealing energy for performing a tissue sealing operation on an anatomic structure, and the cutting element is configured to perform a tissue cutting operation on the anatomic structure; and a monitoring device configured to evaluate performance of the tissue sealing operation; a controller; and a memory device comprising instructions that, when executed by the controller, are configured to cause the controller to: operate the monitoring device to determine a first parameter of the tissue sealing operation; and based on the first parameter of the tissue sealing operation determined by the monitoring device, automatically initiate the tissue cutting operation without additional user input if the first parameter is within a tolerance band of a first threshold parameter.

[0441] In Example 50, the subject matter of Example 49 optionally includes wherein the controller is further configured to: compare the first parameter to a first threshold parameter; and continuing delivering the sealing energy for performing the tissue sealing operation to108Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01seal the anatomic structure if the first parameter is not within a tolerance band of a first threshold parameter.

[0442] In Example 51, the subject matter of any one or more of Examples 49-50 optionally include wherein the cutting element is a cutting electrode or a mechanical blade.

[0443] In Example 52, the subject matter of Example 51 optionally includes wherein the cutting electrode is a bipolar electrode or a monopolar electrode.

[0444] In Example 53, the subject matter of any one or more of Examples 49-52 optionally include wherein the controller is configured to activate the cutting element while the sealing energy is activated.

[0445] In Example 54, the subject matter of any one or more of Examples 49-53 optionally include wherein the controller is configured to activate the cutting element after the sealing energy is terminated.

[0446] In Example 55, the subject matter of any one or more of Examples 49-54 optionally include wherein the monitoring device is configured to determine a second parameter indicative of progress of the tissue sealing operation, and wherein the controller is configured to compare the second parameter to a second threshold parameter.

[0447] In Example 56, the subject matter of Example 55 optionally includes wherein the controller is configured to automatically activate the cutting element when the first parameter is within a tolerance band of the first threshold parameter before the second parameter is within a second tolerance band of the second threshold parameter.

[0448] In Example 57, the subject matter of any one or more of Examples 55-56 optionally include wherein each of the first parameter and the second parameter comprise at least one of a tissue state, a device state and a time state.

[0449] In Example 58, the subject matter of any one or more of Examples 49-57 optionally include wherein the controller is configured to complete the tissue sealing operation and the tissue cutting operation after a single user input is activated.

[0450] In Example 59, the subject matter of Example 58 optionally includes wherein the single user input comprises a single trigger pull or a single button push.

[0451] In Example 60, the subject matter of any one or more of Examples 49-59 optionally include wherein the first threshold parameter correlates to a point within the tissue sealing operation wherein steam pressure within tissue causes a jaw bounce.109Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

[0452] In Example 61, the subject matter of any one or more of Examples 49-60 optionally include wherein the first threshold parameter correlates to a point within the tissue sealing operation before blood flow is sufficient...

Claims

THE CLAIMED INVENTION IS:

1. An electrosurgical device comprising:a shaft comprising a distal end section and a proximate end section;a jaw assembly coupled to the distal end section of the shaft, the jaw assembly comprising:a first jaw member;a second jaw member;a first sealing electrode positioned on the first jaw member;a second sealing electrode positioned on the second jaw member; a cutting element positioned on one of the first jaw member and / or the second jaw member and configured to perform a cutting operation; and a monitoring device configured to evaluate performance of a sealing operation of the jaw assembly;a controller; anda memory device comprising instructions that, when executed by the controller, are configured to cause the controller to:operate the monitoring device to determine a first parameter of the sealing operation; andbased on the first parameter of the sealing operation determined by the monitoring device, automatically initiate the cutting operation without additional user input if the first parameter is within a tolerance band of a first threshold parameter.

2. The electrosurgical device of claim 1, wherein the controller is further configured to:compare the first parameter to the first threshold parameter; andcontinuing delivering sealing energy for performing the sealing operation if the first parameter is not within a tolerance band of the first threshold parameter.

3. The electrosurgical device of claim 1, wherein the cutting element is a cutting electrode or a mechanical blade.117Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W014. The electrosurgical device of claim 1, wherein the monitoring device is configured to determine a second parameter indicative of progress of the sealing operation, and wherein the controller is configured to compare the second parameter to a second threshold parameter.

5. The electrosurgical device of claim 4, wherein the controller is configured to automatically activate the cutting element when the first parameter is within a tolerance band of the first threshold parameter before the second parameter is within a second tolerance band of the second threshold parameter.

6. The electrosurgical device of claim 1, wherein the controller is configured to complete the sealing operation and the cutting operation after a single user input is activated.

7. The electrosurgical device of claim 1, wherein:the first sealing electrode and second sealing electrode form a bipolar electrode pair;andthe cutting element is a cutting electrode.

8. The electrosurgical device of claim 1, wherein the monitoring device is configured to determine a time state of the sealing operation.

9. The electrosurgical device of claim 8, wherein the controller comprises a first timer started at commencement of the sealing operation, and wherein the controller is configured to initiate the cutting operation at expiration of the first timer.

10. The electrosurgical device of claim 9, wherein the controller is configured to perform a second sealing operation after the cutting operation is completed.

11. An electrosurgical device comprising:a shaft comprising a distal end section and a proximate end section; anda jaw assembly coupled to the distal end section of the shaft, the jaw assembly comprising:a first jaw member;118Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01a second jaw member;a cutting electrode positioned on one of the first jaw member or the second jaw member;a first sealing electrode positioned on the first jaw member, the first sealing electrode comprising a first contact surface angled toward the cutting electrode; anda second sealing electrode positioned on the second jaw member, the second sealing electrode comprising a second contact surface angled toward the cutting electrode.

12. The electrosurgical device of claim 11, wherein:the first jaw member and the second jaw member are configured to engage along a clamping plane; andthe first contact surface and the second contact surface are arranged oblique to the clamping plane.

13. The electrosurgical device of claim 12, wherein:the first contact surface is angled relative to the clamping plane and a first angle and the second contact surface is angled relative to the clamping plane at a second angle.

14. The electrosurgical device of claim 13, wherein the first angle and the second angle are each in the range of approximately one-half degree to approximately twenty degrees.

15. The electrosurgical device of claim 14, wherein the first angle and the second angle are each in the range of approximately three degrees to approximately twelve degrees.

16. The electrosurgical device of claim 14, wherein the first angle and the second angle are equal.

17. The electrosurgical device of claim 11, further comprising:119Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01a monitoring device configured to determine a jaw bounce between the first jaw member and the second jaw member caused by sealing of an anatomic structure;a controller; anda memory device comprising instructions that, when executed by the controller, are configured to cause the controller to:automatically initiate a cutting operation without additional user input if the jaw bounce is determined to have occurred.

18. A method of operating an electrosurgical device comprising a sealing electrode and a cutting element, the method comprising:activating sealing energy to perform a sealing operation to seal an anatomic structure with the sealing electrode of the electrosurgical device;determining a first parameter indicative of progress of the sealing operation; comparing the first parameter to a first threshold parameter;automatically activating the cutting element to perform a cutting operation to cut the anatomic structure with the electrosurgical device if the first parameter of the sealing energy is within a tolerance band of the first threshold parameter; completing the sealing operation; andcompleting the cutting operation.

19. The method of claim 18, further comprising continuing to seal the anatomic structure if the first parameter is not within the tolerance band of the first threshold parameter.

20. The method of claim 18, wherein the cutting element is a cutting electrode or a mechanical blade within the electrosurgical device.

21. The method of claim 18, further comprising:determining a second parameter indicative of progress of the sealing operation; and120Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01comparing the second parameter to a second threshold parameter.

22. The method of claim 21, further comprising automatically activating the cutting element to cut the anatomic structure with electrode when:the first parameter of the sealing energy is within a tolerance band of the first threshold parameter before the second parameter of the sealing energy is within a second tolerance band of the second threshold parameter.

23. The method of claim 21, further comprising automatically activating the cutting element to cut the anatomic structure with a cutting electrode when:the second parameter of the sealing energy is within a tolerance band of the first threshold parameter at any point while the second parameter of the sealing energy is within a second tolerance band of the second threshold parameter.

24. The method of claim 18, wherein the sealing operation and the cutting operation are completed after a single user input is activated.

25. The method of claim 18, wherein determining the first parameter indicative of the progress of the sealing operation comprises determining a time state of the sealing operation.121Attorney Docket No. 5409.974WO1Client Reference No. GAP25030-SDMS-W01

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