Bipolar forceps for testing vessel sealing

Abstract

To provide a forceps system for sealing a blood vessel.SOLUTION: A forceps system for sealing a vessel may include a first jaw and an opposing second jaw. At least one of the first jaw and the second jaw includes at least a first electrode having a first electrode portion and a second electrode portion laterally separated to permit electrical isolation between the first electrode portion and the second electrode portion, the first electrode portion and the second electrode portion being individually operationally addressable to permit blood vessel characteristics to be individually tested by the first electrode portion and the second electrode portion. This can help allow each side of the target sealing region of the vessel to be tested individually.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 063,505, filed August 10, 2020, the contents of which are incorporated herein in their entirety. [Background technology]

[0002] Electrosurgery is the application of electrical signals (electrotherapy signals) to alter in some way the living tissue of a surgical patient. Various electrosurgical techniques are used to cut, coagulate, desiccate, or discharge tissue. These electrosurgical techniques and others can be performed during various medical procedures, such as, for example, laparoscopic surgery. These medical procedures may include appendectomy, cholecystectomy, colectomy, cystectomy, gastric banding, gastric bypass, hernia repair, nephrectomy, fundoplication, prostatectomy, sleeve gastrectomy, and others. Each of these medical procedures may have one or more electrotherapy phases, such as, for example, an interrogation phase, a heating phase, a desiccation phase, and a cauterization phase.

[0003] The electrical therapy signals used during such medical procedures may be generated by the electronics unit and then delivered to the biological tissue via an electrosurgical instrument that may be electrically connected to the electronics unit. The electrosurgical instrument may be configured to mechanically and electrically engage the biological tissue to which the electrical therapy signals are delivered. Various types of such electrosurgical instruments may be used, including, for example, various types of forceps, conductive spatulas, electrical pads, etc.

[0004] Different electrical therapy signals may be implemented for different medical procedures to achieve results specific to those different medical procedures. Various electrical indices of the electrical therapy signals delivered to the engaged biological tissue may be used to characterize the electrical therapy signals. These electrical indices may include polarity (monopolar, bipolar), AC and / or DC, frequency, signal amplitude, seizure and decay profiles, etc. The electronics unit that generates these various electrical therapy signals may control one or more of these electrical indices to deliver one or more electrical therapy signals that produce effective results to the biological tissue engaged by the electrosurgical instrument.

[0005] Bipolar forceps can be used to seal and cut tissue, such as blood vessels. Bipolar forceps can include jaws that can be used to grasp the tissue of interest, and each jaw can host one or more electrodes. Bipolar forceps can be used to seal blood vessels (e.g., by coagulating the tissue) by passing an electrical current from a first electrode through the tissue to a second electrode. Bipolar forceps can also include blades for cutting the blood vessel after sealing.

[0006] This disclosure presents a system and method using forceps and blades for cutting blood vessels that allows for testing the seal on each side of the cut individually, as opposed to the traditional standard method of measuring both sides of the cut. At least one forceps jaw can include a transverse cleft between electrode portions, allowing current to be individually directed through one side or the other to test tissue parameters (e.g., impedance, resistance, or phase angle) of the cut on that side to determine the seal strength of the cut on that side. Summary of the Invention [Problem to be solved by the invention]

[0007] Electrosurgical forceps are often used to seal tissue (such as a blood vessel) and then bisect the sealed tissue to obtain two sealed tissue sections. After sealing the tissue but before severing, the seal can be tested to ensure that the seal is good and will not rupture. However, conventional testing techniques rely on electrical parameters of the entire seal, including both sides, as a single standard electrical parameter indicative of the seal. Once severed, the two halves of the seal may contain one good seal and one less good seal. This poses a risk of rupturing the second seal. The methods and systems discussed herein allow both sides of the seal to be tested independently and also allow the operator to understand whether one or both sides of the seal need to be repaired or redone before severing.

[0008] Radiofrequency ("RF") vascular sealing is often used to seal and cut various tissues. Often, a seal is created with an HF vascular sealing device and then cut. An insufficient seal can result in failure of one side of the sealed vessel, while the other side of the vessel has a strong seal. This can occur due to abnormal tissue structure, deposits within the tissue, or tissue weakness. The seal can be tested by electrical feedback from the sealing device to a generator. However, traditional testing methods do not test each side of the seal individually, but instead rely on feedback to the generator regarding a "complete sealing cycle," which does not allow for individual evaluation of either side of the seal. [Means for solving the problem]

[0009] Disclosed herein is a method and associated system that allows for separate evaluation of both sides of the seal at some point during or after the sealing process, allowing for improved understanding of whether one side of the seal has a problem during the sealing and cutting procedure, thereby avoiding cutting an improperly sealed vessel and allowing for greater efficiency with less bleeding during electrosurgical procedures using bipolar forceps.

[0010] In one example, a forceps system for sealing a blood vessel can include a forceps including a first jaw and an opposing second jaw. At least one of the first jaw and the second jaw can include at least a first electrode having first and second electrode portions laterally separated to enable electrical isolation between the first and second electrode portions. The first and second electrode portions can be independently addressable to enable individual testing of blood vessel properties by the first and second electrode portions.

[0011] In one example, a method for testing a seal of a blood vessel can include placing independently operatively positionable first and second electrode portions on opposite sides of the blood vessel, using the first electrode portion to independently test a first tissue parameter on the first side of the blood vessel, and using the second electrode portion to independently test a second tissue parameter on the second side of the blood vessel.

[0012] In the drawings, which are not necessarily drawn to scale, the same numerals may represent similar components in different views. The same numerals with different subscripts may represent different instances of similar components. The drawings generally illustrate by way of example, not by way of limitation, various embodiments discussed herein. [Brief explanation of the drawings]

[0013] [Figure 1]1 depicts an example electrosurgical system for bipolar vessel sealing, including a generator and an instrument having bipolar electrodes. [Figure 2] FIG. 1 depicts a control unit of an electrosurgical system. [Figure 3A] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 3B] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 3C] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 4A] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 4B] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 4C] FIG. 1 is a schematic diagram of an example bipolar electrode. [Figure 5] FIG. 1 is a perspective view of an example electrode configuration. [Figure 6] FIG. 1 is a perspective view of an example electrode configuration having multiple sensor electrodes. [Figure 7] FIG. 1 is a perspective view of an example electrode configuration having a separate electrode as the sensor electrode. [Figure 8] FIG. 1 is a perspective view of an example electrode configuration with two sensor electrodes on a plate. [Figure 9] FIG. 10 is a perspective view of an example electrode configuration with sensor electrodes on the outside of the main plate. [Figure 10] FIG. 1 is a perspective view of an example electrode configuration having multiple electrodes. [Figure 11] FIG. 1 is a perspective view of an electrode configuration with a sensor electrode array. [Figure 12] 1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 13] 1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 14] 1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 15]1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 16] 1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 17] 1 is a flowchart illustrating an example method for testing sealed blood vessels. [Figure 18] 1 is a flowchart illustrating an example method for testing sealed blood vessels. DETAILED DESCRIPTION OF THE INVENTION

[0014] In particular, the present disclosure describes an electrosurgical system for sealing and cutting blood vessels that can be useful for enabling more focused testing of seals using laterally separated, electrically isolated electrodes that can be independently positioned to test opposing sides of a target seal area.

[0015] Electrosurgical sealing or coagulation of biological tissue engaged with an electrosurgical instrument is an electrosurgical technique used in a variety of medical procedures. Engaged biological tissue can be electrosurgically sealed by heating the engaged biological tissue in a controlled manner. In some medical procedures, the biological tissue being sealed is a vessel, such as a blood vessel. Heating the blood vessel can denature collagen found in the vessel wall. This denatured collagen can form a gel-like substance that acts as an adhesive between the vessel walls. When forced together and maintained together while cooling, opposing walls of the vessel can form a seal.

[0016] Heating of the vessel can be carefully controlled so that neither too little nor too much energy is delivered to the vessel. Delivering too much energy can result in charring and / or burning of the vessel wall. Delivering too little energy can result in a poor seal on the vessel. One measure of seal quality is the pressure differential that the sealed vessel can withstand without rupturing. A poor quality seal can be compromised if the seal meets one or more criteria, such as an applied pressure exceeding a threshold.

[0017] The rate at which energy is delivered to the vessel can also be carefully controlled to facilitate rapid performance of electrosurgical procedures. Rapid performance of electrosurgical procedures reduces the time and difficulty of these procedures. However, the rate of heating should not be so rapid as to cause uncontrolled boiling of fluid within the tissue, which could rupture the engaging or nearby tissue and / or compromise the quality of the seal.

[0018] Heating of the engaged biological tissue can be controlled by controlling the power of the electrical treatment signal delivered to and dissipated by the engaged biological tissue. Such power can be controlled according to a sealing energy application schedule. The sealing schedule can represent the product of the voltage difference across the engaged biological tissue and the current conducted by the engaged biological tissue. Thus, the sealing schedule can be presented as a power schedule.

[0019] In bipolar vessel sealing, the resulting seal can be tested from upper jaw to lower jaw, such as during or at the end of a vessel sealing cycle. This testing can be accomplished by testing impedance, resistance, phase angle, temperature, applied power, or a combination thereof. For example, detecting an increase in the electrical resistance of the engaged biological tissue beyond a predetermined threshold can indicate that sealing is complete. Such an increase in electrical resistance beyond a specified resistance change value can be used, for example, as a termination criterion for sealing the vessel, where the specified resistance change value is the difference between the measured resistance (or impedance) and the lowest or other baseline value of resistance (or impedance) measured by the pulse.

[0020] However, one approach to testing a vessel seal involves measuring or sensing electrical parameters, such as resistance or impedance, as an average across the entire seal, from the upper jaw to the lower jaw of the sealing forceps. This approach results in average sensing data acquired between two electrodes, allowing information from both sides of the seal to be represented and fused. After sealing, the target seal area of ​​the vessel is cut into two sections, one seal per section. If one side of the seal is good and the other side fails or has poor pressure resistance, the seal may leak or rupture during or after the cutting operation. Therefore, it is beneficial to independently test the integrity of both sides of the seal, especially before cutting.

[0021] FIG. 1 illustrates an example of a portion of an electrosurgical system 10 for bipolar vessel sealing, including a generator and forceps having bipolar electrodes for cutting, testing, sealing, or otherwise affecting tissue. In FIG. 1, the forceps are depicted as laparoscopic forceps. In other examples, the forceps may be laparotomy forceps or other suitable types of forceps. In FIG. 1, the electrosurgical system 10 may include an electrosurgical generator and control electronics unit 12 and forceps 14, which are shown engaged with biological tissue 16. The electronics unit 12 may generate an electrical therapy signal that may be delivered to the engaged biological tissue 16, such as via the forceps 14.

[0022] The forceps 14 may be electrosurgical forceps, such as bipolar forceps, and may be used in medical procedures, such as open and / or laparoscopic medical procedures, to manipulate, engage, grasp, cut, cauterize, seal, or otherwise affect blood vessels, living tissue, veins, arteries, or other anatomical features or objects.

[0023] The forceps 14 may include a handpiece 18, a shaft assembly 20, a knife blade assembly 22, and a gripper assembly 24. The forceps 14 may be electrically connected to the electronics unit 12, which may generate and supply electrical treatment signals to the forceps 14. In this case, the forceps 14 may electrically transmit the electrical treatment signals to the gripper assembly 24, which may be used for various electrosurgical techniques, such as cauterization, sealing, and other such electrosurgical techniques.

[0024] The handpiece 18 may include a handle 26, a gripping lever 28, a knife trigger 30, an electrical treatment activation button 32, and a rotation wheel 34. The gripping assembly 24 may include a first jaw member 36 and a second jaw member 38. The shaft assembly 20 is coupled to the handpiece 18 at a proximal end and to the gripping assembly 24 at a distal end. The shaft assembly 20 may extend distally from the handpiece 18 in a longitudinal direction 40 to the gripping assembly 24.

[0025] The shaft assembly 20 can function to allow a portion of the forceps 14 (e.g., the gripping assembly 24 and the distal portion of the shaft assembly 20) to be inserted into a patient or other biological tissue while the remaining portion of the forceps 14 (e.g., the handpiece 18 and the remaining proximal portion of the shaft assembly 20) is outside of the patient or other biological tissue. The shaft assembly 20 can include one or more corners, bends, and / or arcs. The shaft assembly 20 can be a cylinder or other elongated member having a circular, elliptical, or other cross-sectional profile that extends from the handpiece 18 to the gripping assembly 24. The shaft can be bendable, steerable, or otherwise curveable.

[0026] In some examples, shaft assembly 20 may include an elongated, hollow member (e.g., a tubular outer shaft) that may enclose knife blade assembly 22 and a mechanical linkage for coupling knife blade assembly 22 to knife trigger 30. Generally, shaft assembly 20 may be any elongated member having sufficient rigidity to transmit force along longitudinal direction 40. Shaft assembly 20 may also include one or more electrically conductive elements (e.g., electrical wires, an outer conductive shaft, and / or an inner conductive shaft, etc.) through which electrical treatment signals may be transmitted, such as for electrical communication between handpiece 18 and grip assembly 24.

[0027] The grip lever 28, knife trigger 30, electrical treatment activation button 32, and rotation wheel 34 of the handpiece 18 can each be configured to provide various actuations, such as at or near the distal end of the shaft assembly 20. For example, actuation of the grip lever 28 can be configured to control movement of the grip assembly 24 at the distal end of the shaft assembly 20. The grip lever 28 can include a grip actuator movable between an open configuration position (shown in FIG. 1 ) and a closed configuration position in which the grip lever 28 moves proximally toward the handle 126. Proximal movement of the grip lever 28 toward the handle 126 to the closed configuration position transitions the grip assembly 24 from the open configuration to the closed configuration. Distal movement of the grip lever 28 to the open configuration position (e.g., releasing the grip lever 28) can transition the grip assembly 24 from the closed configuration to the open configuration.

[0028] This transition between the open and closed configurations of the grasper assembly 24 can be achieved by moving one or more of the first and second jaw members 36, 38 between an open configuration (shown in FIG. 1 ), in which the first and second jaw members 36, 38 are separated, and a closed configuration, in which the gap between the first and second jaw members 36, 38 is reduced. In the electrosurgical system 10, the first and second jaw members 36, 38 are opposable and can be configured to clamp biological tissue 16 between the jaw members in a manner that allows electrical communication between the opposable first and second jaw members 36, 38 through the clamped biological tissue 16, such as for testing, cutting, sealing, or other diagnosis or treatment of the biological tissue 16.

[0029] A mechanical linkage within the shaft assembly 20 can be configured to move one or more of the first jaw member 36 and the second jaw member 38 between an open configuration and a closed configuration, such as in response to actuation of the gripping lever 28.

[0030] Actuation of the knife trigger 30 can be configured to control operation of the knife blade assembly 22 at the distal end of the shaft assembly 20. The knife blade assembly 22 can be configured to cut, resect, or otherwise affect biological tissue or other objects clamped between the first and second jaw members 36, 38. The knife trigger 30 can include a knife blade actuator movable between a cutting blade retracted configuration position and a cutting blade deployed or extended configuration position in which the knife trigger 30 is moved proximally toward the handle 126 to cause the knife blade assembly 22 to cut the biological tissue 16 clamped between the first and second jaw members 36, 38. When the knife trigger 30 is moved proximally toward the handle 126 to the deployed configuration position, the cutting blade of the knife blade assembly 22 can engage and thereby cut the biological tissue 16. When the knife trigger 30 is moved distally, the cutting blade can be retracted from the clamped biological tissue 16.

[0031] The rotation wheel 34 can be configured to control the rotational configuration of one or more of the knife blade assembly 22 and the gripper assembly 24 at the distal end of the shaft assembly 20 and / or to control the rotational configuration of the shaft assembly 20. Movement of the rotation wheel 34 can rotate one or more of the shaft assembly 20, the knife blade assembly 22, and the gripper assembly 24 about an axis extending in the longitudinal direction 40. Such rotational control can facilitate alignment of the gripper assembly and / or the knife blade assembly with the clamped biological tissue 16.

[0032] The treatment activation button 32 can be configured to control the generation and / or delivery of an electrical treatment signal to the engaged biological tissue 16. When the treatment activation button 32 is activated, for example, an electrical treatment signal derived from the electronics unit 12 can be applied to one or more of the first and second jaw members 36, 38, a remote pad (not shown), or other portions of the forceps 14 to cauterize, seal, or otherwise electrically affect the patient or other biological tissue.

[0033] Figure 2 depicts a block diagram of an electrosurgical system 200, which may include an electronics unit 212 and a forceps 214 as discussed above with reference to Figure 1. The electronics unit 212 may be configured to generate an electrical treatment signal, such as a high frequency ("HF") electrical signal, which the forceps 214 delivers to the engaged biological tissue 216.

[0034] The electronics unit 212 may include an instrument interface 242, an electrical energy source 244, measurement circuitry 246, control circuitry 248, and a user interface 250. The instrument interface 242 may include, among other components, signal drivers, buffers, amplifiers, ESD protection devices, and an electrical connector 252. The electrical connector 252 may be configured to electrically couple the forceps 214 to the electronics unit 212 for electrical communication between the electronics unit 212 and the forceps 214. Such electrical communication may be used to transmit operating power and electrical signals therebetween. The forceps 214 may be in electrical communication between the electrical connector 252 and biological tissue with which it is engaged.

[0035] The electrical energy source 244 can be configured to generate an electrical treatment signal to be delivered to the engaged biological tissue via the electrically connected forceps 214. The generated electrical treatment signal can be controlled to achieve a desired result for a particular electrosurgical procedure. For example, the electrical treatment signal can be configured to resistively heat the engaged biological tissue to produce a surgical effect, such as sealing the engaged biological tissue.

[0036] The measurement circuit 246 can be configured to measure one or more electrical parameters of the biological tissue engaged by the connected forceps 214. The measurement circuit 246 can be in electrical communication with the connected forceps 214 when the electronics unit 212 is electrically connected to the forceps 214 via the electrical connector 252. Various examples of the measurement circuit 246 can be configured to measure one or more of a variety of electrical parameters. For example, the measurement circuit 246 can be configured to measure a voltage difference across the engaged biological tissue 216 and a current conducted by the engaged biological tissue 216. In some examples, the measurement circuit 246 can be configured to measure a phase angle between a voltage difference applied across the engaged biological tissue and a current conducted by the engaged biological tissue. In some examples, the measurement circuit 246 can be configured to measure one or more DC and / or AC electrical parameters of the engaged biological tissue.

[0037] The measured one or more parameters can be used to determine one or more other indicators. For example, measurements of the voltage difference across the engaged biological tissue, the current conducted by the engaged biological tissue, or the phase angle between them can be used to determine electrical resistance, complex impedance, or even the apparent power (VA) or real power (W) delivered to the engaged biological tissue. Measurements of such electrical parameters can be used to control the delivery of electrical therapy signals to the engaged biological tissue.

[0038] The control circuit 248 can be electrically connected to the electrical energy source 244 and the measurement circuit 246 and can be configured to control their operation. The control circuit 248 can cause the electrical energy source 244 to deliver an electrical treatment signal to the biological tissue engaged by the electrically connected forceps 14. The control circuit 248 can cause the electrical energy source 244 to generate the electrical treatment signal according to an electrical treatment schedule such that the generated electrical treatment signal is controlled for a particular electrosurgical procedure. Such electrical treatment schedules can be used to implement various types of electrical treatments. In some examples, the active power (W), voltage difference (V), current (A), or apparent power (VA) of the electrical treatment signal delivered to the engaged biological tissue can be controlled according to the power schedule.

[0039] Control circuitry 248 can cause electrical energy source 244 to supply energy to the engaged biological tissue such that the product of the voltage difference across the engaged biological tissue and the current conducted by the engaged biological tissue is controlled according to the electrical treatment schedule. Control circuitry 248 can use a comparison of the determined effective power to the electrical treatment schedule to generate an error signal or other indicator signal used to provide information to a user or other device. Such indicator signals can be used in a closed-loop feedback system that includes electrical energy source 244 to generate an electrical treatment signal according to the electrical treatment schedule.

[0040] The control circuitry 248 may include a processor 254 and a memory 256. The control circuitry 248 may include a timer or a clock. The processor 254 may be configured to implement functions or process instructions for execution within the electrosurgical system 10, such as instructions stored in a program memory 256P. The processor 154 executes these program instructions to cause the electrical energy source 244 to generate electrical treatment signals according to a specified electrical treatment schedule. The specified electrical treatment schedule may be retrieved, for example, from a data memory 256D. The processor 254 may compare one or more electrical parameters measured by the measurement circuitry 246 with the retrieved specified electrical treatment schedule. The processor 254 may send one or more commands to the electrical energy source 244 and / or the measurement circuitry 246. The processor 254 may also send or receive information from the user interface 250.

[0041] Figure 2 depicts an example schematic diagram of a portion of an electronics unit. In various examples, electronics unit 12 of Figure 1 can be implemented using various elements of Figure 2 or various other elements. For example, processor 254 can include any one or more of a microprocessor, control circuitry, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

[0042] The memory 256 can be configured to store information within the electrosurgical system 210 during operation. The memory 256 is described in some examples as a computer-readable storage medium. In some examples, the computer-readable storage medium may include a non-transitory medium. The term “non-transitory” may indicate that the storage medium is not embodied as a carrier wave or propagating signal. In some examples, the non-transitory storage medium may store data that may change over time (e.g., in RAM or cache). In some examples, the memory 256 is a transient memory, meaning that the primary purpose of the memory 256 is not long-term storage. The memory 256 is described in some examples as a volatile memory, meaning that the memory 256 does not retain its stored content when power to the electrosurgical system 200 is turned off. Examples of volatile memory may include random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), and other forms of volatile memory. In some examples, the memory 256 is used to store program instructions executed by the processor 254. Memory 256, in one example, is used by software or applications (e.g., software programs that implement electrical control of electrical treatment signals delivered to biological tissue engaged by an electrosurgical instrument) running on electrosurgical system 200 to temporarily store information during program execution, such as in data memory 256D.

[0043] The memory 256 may also include one or more computer-readable storage media. The memory 256 may be configured to store larger amounts of information than volatile memory. The memory 256 may also be configured for long-term storage of information. In some examples, the memory 256 includes non-volatile storage elements. Examples of such non-volatile storage elements may include magnetic hard disks, optical disks, flash memory, or forms of electrically programmable memory (EPROM) or electrically erasable programmable memory (EEPROM).

[0044] The user interface 250 can be used to communicate information between the electrosurgical system 200 and a user (e.g., a surgeon or technician). The user interface 250 can include a communications module. The user interface 250 can include various user input / output devices. For example, the user interface can include various display devices, audible signal generators, as well as switches, buttons, touchscreens, mice, keyboards, etc.

[0045] The user interface 250, in one example, can utilize a communications module to communicate with external devices over one or more networks, such as one or more wireless and / or wired networks. 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 capable of transmitting and receiving information. Other examples of such network interfaces can include Bluetooth, 3G, 4G, and Wi-Fi wireless computing devices, as well as universal serial bus (USB) devices.

[0046] 3A-3C show an example schematic of a forceps 300 that can be configured to cut and seal a bipolar tissue cut. The forceps 300 can include a first jaw 310 having a first electrode 312, which can include an individually operatively positionable first portion 314 and a second portion 316. The forceps 300 can also include a second jaw 320 having a second electrode 322. A portion of the blade slot 315 can be located on the first jaw 310, such as between the first portion 314 and the second portion 316 of the first electrode 312.

[0047] The first jaw 310 and the second jaw 320 may be opposing arms of the forceps 300 and may be shaped, sized, or formed to clamp or treat a vessel or other tissue therebetween. The forceps jaws 310, 320 may be connected at a proximal portion by a hinge or other pivoting feature that may allow the jaws to open and close, such as during operation of the forceps 300, as discussed with reference to FIG. 1 . A distal portion of the forceps 300 may host a first electrode 312 and a second electrode 322. The first jaw 310 may include at least a portion of a blade slot 315. The forceps 300 may be movable between an open position in which the distal portions of the first jaw 310 and the second jaw 320 are spaced apart and a closed position in which the first jaw 310 and the second jaw 320 are brought together.

[0048] An optional blade slot 315 can extend longitudinally along at least a portion of the first jaw 310. The blade slot 315 can be shaped and dimensioned to receive a blade that can extend into the slot to enable cutting.

[0049] The first electrode 312 and the second electrode 322 can be used as electrotherapy electrodes, such as to apply radio frequency (RF) or other electrotherapy energy to seal tissue. The first electrode 312 and the second electrode 322 can be in electrical communication with the electronics unit 12, which can supply electrical current to a target tissue site for treatment. The first electrode 312 can be located on the first jaw 310 of the forceps 300, and the second electrode 322 can be located on the second jaw 320 of the forceps 300.

[0050] The first electrode 312 and the second electrode 322 can be shaped as plates extending along the surfaces of the first jaw 310 and the second jaw 320, respectively, or in other shapes or sizes as desired, as described below with reference to Figures 5-11. The first electrode 312 and the second electrode 322 can be of similar or different shapes and sizes. In some cases, the first electrode 312 and the second electrode 322 can each include multiple portions that can be addressed for operation individually or in groups to function as a multi-electrode.

[0051] The first and second portions 314, 316 of the first electrode 312 may be independently addressable such that they can be electrically isolated from one another and separately actuated for sensing, sealing, or other actuation purposes. The first and second portions 314, 316 may be individually or separately connected to the electrosurgical generator and control electronics unit 12 so that each portion 314, 316 can be activated separately. Connection between these portions 314, 316 and the unit 12 may be made, for example, using separate, distinct conductors of the forceps 300 extending to each portion 314, 316. Such separate conductors may be electrically isolated, thereby allowing electrical communication with only one of the portions 314, 316. In one example, the separate conductors may extend through the jaws of the forceps and back to a switching matrix in the handle. In one example, switching circuitry may be implemented in the forceps 300 toward the distal portion to enable independent actuation of at least two electrode portions.

[0052] For example, the first electrode 312 can be divided into two or more electrically insulable portions, such as a first portion 314 and a second portion 316, to enable testing of two sides of a target sealing region created by the forceps 300. This can be useful for enabling independent interrogation of two sides of the target sealing region, such as testing these separate sides of the target sealing region for sealing adequacy, such as before cutting tissue between the separate sides of the target sealing region. In some cases, two sides of an intended cutting zone or two sides of a blade slot can be tested similarly to the target sealing region. For example, the first portion 314 and the second portion 316 of the first electrode 312 can be laterally separated by a channel, zone, blade slot 315, or the like. This allows the first portion 314 to be positioned on a first side of the target sealing region and the second portion 316 to be positioned on laterally opposing sides of the target sealing region, allowing the sealing properties of the corresponding locations to be individually tested prior to cutting tissue therebetween. In the forceps 300, the second electrode 322 can include a single electrode without multiple portions, or the second electrode 322 can include multiple portions corresponding to respective portions of the first electrode 312, as shown and described with reference to Figures 4A-4B below.

[0053] 3A depicts a sealing step in which a target sealing area, such as a blood vessel, can be sealed using forceps 300. In FIG. 3A, forceps 300 can clamp a portion of target tissue 330 (such as a blood vessel) between first jaw 310 and second jaw 320.

[0054] During the sealing phase, the first electrode 312 and the second electrode 322 can be set to different polarities. Electrical energy from the sealing signal or pulse can be transmitted alternately between the first electrode 312 and the second electrode 322 through the tissue between the sides of the jaws to coagulate the tissue between the jaws. This can create a target seal region 340 of the target tissue between the jaws. The target seal region 340 can have a first side 342 and a second side 344. The tissue can be sealed, dried, or otherwise prepared as described in U.S. Provisional Patent Application No. 62 / 845,647, the entirety of which is incorporated herein by reference, including its description of calibration and preparation.

[0055] One or more electrical parameters of the sealing signal or sealing pulse, such as resistance, impedance, or phase angle, can be monitored during or after the sealing phase. When an individual monitored electrical parameter, or a derived composite indication, meets one or more criteria (e.g., a predetermined electrical parameter reaches a predetermined threshold), the system can indicate that the sealing phase is complete and that the desired sealing endpoint has been reached. This can be communicated to the operator through an indication, such as a user interface, a light, a sound, a tactile indication, or other suitable signal.

[0056] 3B and 3C, each lateral side of the target sealing area 340 created in FIG. 3A can be tested individually. First, as shown in FIG. 3B, the first side 342 of the target sealing area 340 is tested. Next, in FIG. 3C, the second side 344 of the target sealing area 340 is tested. For testing purposes, the first jaw 310 can include the first electrode 312 itself, or portions 314, 316 thereof, that can function as an electrical signal sensor, such as to detect an electrical signal that can be transmitted to a sensor interface circuit to measure the conductivity, resistivity, impedance, phase angle, reactance, resistance, capacitance, inductance, or a combination of one or more of these, of tissue within the target sealing area 340 in the surgical environment. In some cases, the electrical signal can include one or more of the first electrode portion 314, the second electrode portion 316, or the second electrode 322, in combination with each other or with one or more other sensor electrodes that can be coupled to a sensor interface circuit.

[0057] For example, selected electrodes or electrode portions can be used to detect electrical signals from which the sensor interface circuitry can process and extract indices of the real or complex-valued electrical impedance or conductance (e.g., conductivity, resistivity, impedance, conductance, phase angle, reactance, resistance, capacitance, inductance, etc.) of the target tissue. The level of coagulation of the seal can affect these electrical signals and electrical properties.

[0058] In some cases, the electrical signal interface circuitry can be provided with an impedance sensor that can deliver a specified current or voltage to tissue using an electrosurgical signal or a separate electrical test signal, and the sensor can measure a response voltage or current that is representative of tissue impedance, such as when subtracting the series impedance of the lead or electrode. A three- or four-point probe or similar impedance sensing electrode configuration can be used, such as to enable detection of a response variable by a high-input impedance sensing interface amplifier that is isolated from the effects of large test or electrosurgical signals through the impedance of the lead wires connected to the electrodes used to deliver such signals. For example, such a three- or four-point probe can use bipolar electrodes to deliver the test or electrosurgical signal and can include one or more additional electrodes for sensing the response variable to the high-input impedance sensing interface amplifier. Thus, the impedance sensor can include using the first electrode 312, additional or separate impedance sensing electrodes.

[0059] Impedance information may also include phase angle information, which may describe the phase relationship between current and voltage in an AC circuit, such as in high frequency AC electrosurgical applications. The phase angle may indicate the phase difference between the voltage applied to the tissue impedance and the current driven through the tissue impedance. Because tissue impedance may include reactive components such as capacitance and inductance, the resulting current either lags the applied voltage (e.g., a phase shift due to the inductive component) or leads the applied voltage (e.g., a phase shift due to the capacitive component). The phase angle may be determined, for example, by comparing the current and voltage at a given time with times corresponding to detected edges of the current and voltage or other reference values ​​or thresholds.

[0060] The phase angle signal processing circuitry can accomplish this comparison by applying techniques such as a discrete Fourier transform (DFT). For example, samples of the analyzed signal can be correlated point-by-point with both a sine function and a cosine function, respectively. Conveniently, the cosine portion can be referred to as real and the sine portion as imaginary. If the analyzed signal has no phase shift, the DFT result will be 100% real. If the analyzed signal has a 90-degree phase shift, the DFT result will be 100% imaginary. If the DFT result has both real and imaginary components, the phase angle can be calculated as the arctangent of the ratio of the imaginary value to the real value.

[0061] One or more electrical properties of the target tissue, such as conductivity, resistivity, impedance, or phase angle, can be sensed throughout the electrosurgical testing phase or during one or more "sensing pulses" that can be delivered intermittently during the electrosurgical testing phase.

[0062] 3B, the first portion 314 of the first electrode 312 can be set to an opposite polarity as the second electrode 322. The second portion 316 of the first electrode 312, which can be electrically isolated and driven separately from the first portion 314, can either be grounded or configured to operate as a floating output while the first portion 314 of the first electrode 312 and the second electrode 322 are used to test tissue properties for the side of the target seal region 340 closest to the first portion 314 of the first electrode 312. In this case, current flows from the second electrode 322 through the first side 342 of the target seal region 340 to the first portion 314 of the first electrode 312, excluding the second portion 316 of the first electrode 312. Thus, the first portion 314 of the first electrode 312 functions as a local tissue property sensor to provide an electrical signal from which the sensor interface circuitry can detect one or more of impedance, resistance, or other electrical parameters of current or power that are indicative of the local quality of the seal formed in the current-carrying portion of the target seal region 340. The control circuitry 148 can compare the parameter to one or more criteria, such as a threshold, such as to indicate whether the strength of the seal on the first side 342 of the target seal region 340 meets one or more criteria to be considered sufficient.

[0063] After the first side of the target sealing area 340 has been tested, the second side 344 of the target sealing area 340 can be tested, as shown in FIG. 3C . Here, the second portion 316 of the first electrode 312 can be set to a polarity opposite that of the second electrode 322. The first portion 314 of the first electrode 312, which can be electrically isolated and driven separately from the second portion 316, can either be grounded or configured to operate as a floating output while the second portion 316 of the first electrode 312 and the second electrode 322 are used to test tissue properties for the side of the target sealing area 340 closest to the second portion 316 of the first electrode 312. In this case, current can flow from the second electrode 322, through the second side 344 of the target sealing area 340, to the second portion 316 of the first electrode 312, excluding the first portion 314 of the first electrode 312. Thus, the second portion 316 of the first electrode 312 functions as a local tissue property sensor, such as to provide an electrical signal from which the sensor interface circuitry can detect one or more of the impedance, resistance, or other electrical parameters of the current or power across the local tissue, which the control circuitry 148 can compare to one or more criteria, such as a threshold value, such as to determine whether the strength of the seal on the second side 344 of the target seal region 340 can be considered sufficient.

[0064] This sensory data evaluation can occur after the attempted seal is complete, such as during the sealing process or in a separate post-seal energy application test phase. Optionally, testing the seal quality on each side of the target seal region 340 individually can be performed before cutting the vessel at a location between these two individually verified seal locations. The integrity of each side of the seal can be determined by the control circuitry and displayed to an operator of the forceps 300, such as a surgeon. If the seal integrity is found to be unacceptable on one or more sides of the seal, the system can display a warning to the operator not to proceed with the cut, attempt and test a reseal, or abort or otherwise prevent or disable the cut. For example, one or both sides of the target seal region 340 can be additionally treated with additional electrical treatment energy to promote additional sealing. An example of a process for determining whether additional sealing energy is required is discussed below with reference to FIGS. 12-18.

[0065] 4A-4C show an example schematic of a portion of a forceps 400 configured to cut and seal a bipolar tissue cut. The forceps 400 can include a first jaw 410 having a first electrode 412, which can include an individually operatively positionable first portion 414 and a second portion 416. The forceps 400 can also include a second jaw 420 having a second electrode 422, which can include an individually operatively positionable third portion 424 and a fourth portion 426. A portion of the blade slot 415 can be located on the first jaw 410, such as between the first portion 414 and the second portion 416 of the first electrode 412. A portion of the second blade slot 425 can be located on the second jaw 420, such as between the third portion 424 and the fourth portion 426. Forceps 400 functions similarly to and may include similar components as forceps 300 discussed above, except where otherwise noted.

[0066] The first electrode 412 and the second electrode 422 can be shaped as plates extending along the surfaces of the first jaw 410 and the second jaw 420, respectively, or in other shapes or sizes as desired, as described below with reference to Figures 5-11. The first electrode 412 and the second electrode 422 can be of similar or different shapes and sizes. In some cases, the first electrode 412 and the second electrode 422 can each include multiple portions that can be individually or collectively addressed for operative positioning to function as a multi-electrode.

[0067] For example, in forceps 400, second electrode 422 can be divided into two or more electrically isolable portions, such as third portion 424 and fourth portion 426, to enable testing of two sides of a target sealing region created by forceps 400. This can be useful for enabling two sides of the target sealing region to be interrogated and sealed independently, such as to test these separate sides of the target sealing region for seal adequacy, such as before cutting tissue between these two separate sides of the target sealing region. For example, third portion 424 and fourth portion 426 of second electrode 422 can be laterally separated, such as by a channel, zone, or blade slot 315. This allows third portion 424 to be positioned on a first side of the target sealing region and fourth portion 426 to be positioned on laterally opposing sides of the target sealing region (or on laterally opposing sides of the blade slot), allowing the sealing characteristics of the corresponding locations to be independently tested prior to cutting tissue therebetween. The second electrode 422 of the forceps 400 having the independently operatively positionable third and fourth portions 424, 426 may allow for more directional testing and sealing of the target portion of the blood vessel compared to the second electrode 322 of the forceps 300 not having these independently operatively positionable portions. The forceps 400 of Figures 4A-4C may include additional wiring compared to the forceps 300 described above, since each electrode portion may be electrically connected.

[0068] FIG. 4A depicts a sealing step in which a target sealing region, such as a blood vessel, can be sealed using forceps 400. In FIG. 4A, the forceps 400 can clamp a portion of target tissue 430 (such as a blood vessel) between a first jaw 410 and a second jaw 420. During the sealing step, the first electrode 412 and the second electrode 422 can be set to different polarities. Electrical energy from a sealing signal or pulse can be transmitted alternately between the first electrode 412 and the second electrode 422 through the tissue and between the sides of the jaws to coagulate the tissue between the jaws. This can create a target sealing region 440 of the target tissue between the jaws. The target sealing region 440 can have a first side 442 and a second side 444. Prior to such sealing, the system can be calibrated. The sealing step can be performed similarly to the method described with reference to FIG. 3A above. In FIGS. 4B and 4C, each lateral side of the target sealing region 440 created in FIG. 4A can be independently tested. First, as shown in FIG. 4B , a first side 442 of the target sealing area 440 is tested. Then, in FIG. 4C , a second side 444 of the target sealing area 440 is tested. For testing purposes, the first electrode 412 itself, or portions 414, 416 thereof, or the second electrode 422 itself, or portions 424, 426 thereof, can function as an electrical signal sensor, such as to detect an electrical signal that can be transmitted to a sensor interface circuit to measure the conductivity, resistivity, impedance, phase angle, reactance, resistance, capacitance, inductance, or one or more combinations thereof, of tissue within the target sealing area 440 of the surgical environment. In some cases, the electrical signal sensor can include one or more of the first electrode 412, portions 414, 416 thereof, the second electrode 422, portions 424, 426 thereof, in combination with each other or with one or more additional sensor electrodes that can be coupled to a sensor interface circuit.

[0069] 4B , the first portion 414 of the first electrode 412 can be set to an opposite polarity as the third portion 424 of the second electrode 422. The second portion 416 of the first electrode 412 and the fourth portion 426 of the second electrode 422 can either be grounded or configured to operate as floating outputs while the first portion 414 and the third portion 424 are used to test tissue properties for the side of the target seal area 440 closest to the electrode portions 414, 424. In this case, current flows from the first portion 424 of the second electrode 422 through the first side 442 of the target seal area 440 to the first portion 414 of the first electrode 412, excluding the second portion 416 of the first electrode 412 and the fourth portion 426 of the second electrode 422. Thus, the first portion 414 of the first electrode 412 functions as a local tissue property sensor to provide an electrical signal from which the sensor interface circuitry can detect one or more of impedance, resistance, or other electrical parameters of current or power indicative of the local quality of the seal formed in the current-carrying portion of the target seal region 440. The control circuitry 148 can compare the parameter to one or more criteria, such as a threshold value, to indicate whether the strength of the seal on the first side 442 of the target seal region 440 meets one or more criteria to be considered sufficient.

[0070] After the first side of the target seal area 440 has been tested, the second side 444 of the target seal area 440 can be tested, as shown in FIG. 4C , where the second portion 416 of the first electrode 412 can be set to an opposite polarity to the polarity of the third portion 424 of the second electrode 422. The first portion 414 of the first electrode 412 (which can be electrically isolated and independently driven from the second portion 416) and the fourth portion 426 of the second electrode 422 (which can be electrically isolated and independently driven from the third portion 424) can either be grounded or configured to function as floating outputs, while the opposing electrode portions 416, 424 can be used to test tissue properties for the second side of the target seal area 440. In this case, current can flow from the fourth portion 424 of the second electrode 422 through the second side 444 of the target seal area 440 to the second portion 416 of the first electrode 412, excluding the first portion 414 of the first electrode 412 and the third portion 424 of the second electrode 422. Thus, the second portion 416 of the first electrode 412 can function as a sensor electrode to detect impedance, resistance, or other electrical parameters of current or power occurring across the seal. In the forceps 400, sealing and / or measuring can additionally or alternatively occur diagonally between the third portion 424 and the second portion 416, or between the fourth portion 426 and the first portion 414. A control circuit, such as the control circuit 148 of the system 10, can compare the sensed signal to a threshold to indicate the strength of the target seal area 440 for the first side 442.

[0071] This sensory data evaluation can occur during the sealing process or after the attempted seal is completed, such as in a separate post-seal energy application test phase. An example process for determining whether additional sealing energy is required is discussed below with reference to Figures 12-18.

[0072] 5-11 illustrate various examples of sensor electrode configurations that can be used to test two sides of a seal made at a target sealing area using forceps, such as forceps 300 or forceps 400. FIG. 5 illustrates a perspective view of an example first jaw 500. An electrode 510 can be present on the jaw 500 and can include at least two independently positionable electrode portions 514 and 516, separated by a blade slot 515 and a longitudinally aligned separator zone 518. In some cases, the blade slot 515 can extend along the entire length of the jaw 500, such as to the distal end of the jaw 500. In this case, the blade slot 515 can include a blade, and the blade slot 515 and blade can replace the longitudinally aligned separator 518. The electrode 510 can be electrically connected to an external generator (not shown), such as by electrical wires 520 and 522.

[0073] The electrode portions 514 and 516 may include respective plates for applying current to the target tissue region. The electrode portions 514 and 516 may be laterally separated from one another by a slot 515 and a longitudinally aligned separator zone 518 to allow them to be independently operatively positionable or electrically isolated from one another. The electrode portions 514 and 516 may be selectively and independently operatively positionable to deliver current to the target tissue region. In FIG. 5 , the electrode portions 514, 516 may also extend from the proximal end to the distal end of the jaw 500, the blade slot 515. The electrode portions 514, 516 may also be independently operatively positionable to allow for localized individualized testing of each side of a trial seal created with the electrode 510.

[0074] 6 shows a perspective view of a forceps jaw 600 configuration having multiple sensor electrodes 610, where the sensor electrodes 610 may be adjacent to or integral with one or more electrodes on the jaw 600, or may be additional or alternative sensor electrodes. For example, the sensor electrodes may be remote and electrically isolated from one or more main electrode plates used during application of the seal.

[0075] FIG. 7 shows a perspective view of an electrode configuration on a jaw 700 having two separate electrodes 710, 712, also for use as sensor electrodes. The two electrodes 710, 712 may be separated by a gap 713 between the electrodes 710, 712 and a distal longitudinal recess 715. Here, the electrodes 710, 712 are used as electrodes for sealing against the target tissue. The jaw 700 may optionally include insulated sensing electrodes 714, 716 that are electrically isolated from the electrodes 710, 712. The sensing electrodes 710, 712 may be used to sense the integrity of the seal, as described below with reference to FIGS. 12-18, and may perform repetitive, pulsatile, or continuous cycles of sealing and testing.

[0076] FIG. 8 shows an example perspective view of a jaw 800 with an electrode configuration in which two sensor electrodes 814, 816 are attached to electrode plates 810, 812. Here, the electrode plates 810, 812 can function as electrodes for sealing and cutting target tissue on the jaw 800. Sensor electrodes 814, 815 for sensing an electrical parameter and determining the seal integrity of one or more sides of the seal or opposing sides of the blade slot can be separate from, but attached to, the electrodes 810, 812. The sensor electrodes 814, 816 can be attached within the plate boundary, such as in the center or on one side or the other, depending on the type of seal being made and the location of the seal for testing. The sensor electrodes 814, 816 can emit a sensing pulse separate from the electrical energy supplied to create the seal by coagulation when testing the seal is desired.

[0077] FIG. 9 shows a perspective view of a jaw 900 with an electrode configuration in which sensor electrodes 912, 914 are located on the outside of the main electrode plate 910. The sensor electrodes 912, 914 can be attached to the outer edge of the jaw 900, the inner edge of the jaw 900, or a combination thereof. The sensor electrodes 912, 914 can be driven separately from the plate 910. For example, the plate 910 can be driven to seal a vessel, and the sensor electrodes 912, 914 can be driven during a test mode to deliver one or more pulses for tracking one or more electrical parameters correlated with the integrity of the seal. This can enable testing of the edges of the seal created by the plate. In the jaw 900, the sensor electrodes 912, 914 can be located on or near the side edges of the jaw, such as closer to the side edges than the blade slots. In some cases, the sensor electrodes 912, 914 may be located on or near the blade slot, such that they would otherwise be located closer to the slot than the side edges.

[0078] 10 shows a perspective view of a jaw 1000 having an electrode configuration with multiple electrodes 1010, 1012, 1014, 1016, 1018, 1020, 1022, and 1024. The electrodes are spaced apart and electrically isolated from one another in the jaw 1000. The electrodes 1010, 1012, 1014, 1016, 1018, 1020, 1022, and 1024 located around the periphery of the jaw 1000 can function as both sealing electrodes and tissue property sensing electrodes.

[0079] For example, electrodes 1010, 1012, 1014, 1016, 1018, 1020, 1022, and 1024 can be plates for bipolar vessel sealing. Electrodes 1010, 1012, 1014, 1016, 1018, 1020, 1022, and 1024 can be individually actuable to seal a vessel and to test the seal created in the vessel. In some cases, a portion of the electrodes can be configured for sealing, and other electrodes can be configured as sensor electrodes for testing the seal. Multiple electrodes can allow for more localized testing of portions of the seal.

[0080] FIG. 11 shows a perspective view of a jaw 1100 with an electrode configuration including a sensor electrode array 1110. The array 1110 may include insulated sensor electrodes, such as spaced sensor electrodes separate from the electrode plate used for sealing. The array 1110 may be evenly distributed across the surface of such a plate on the jaw 1100. The array 1110 may enable sensing of various portions of the seal throughout the length and width of the jaw 1100. Each sensor electrode of the array 1110 may be individually distinct to provide a complete picture of the surface of the seal across the area of ​​the jaw 1100 and to provide detailed information about such seal.

[0081] 12 shows a flowchart depicting an example method 1200 for testing a sealed blood vessel. Method 1200 can evaluate sensor electrode signals compared to one or more known values. Initially, in step 1210, a seal is created in target tissue, such as a blood vessel, using a bipolar forceps or the like having any of the electrode configurations discussed above until the normal endpoint of such seal is reached (step 1212).

[0082] Next, in step 1214, the first (left) side of the seal can be tested. A parameter, such as impedance, on the first side of the seal or cutting slot can be collected by the sensor electrodes and evaluated as discussed above with respect to forceps 300 and 400. The value of the parameter, such as impedance, can be compared to the value of a known parameter (e.g., impedance, resistance, phase angle, etc.). In some cases, the sensed value on either side of the seal can be compared to a known value, such as a threshold value. In some cases, signals from both sides of the seal can be compared to each other to determine whether an anomaly exists between the two sides of the seal.

[0083] If the values ​​of the parameters acquired by the sensor electrodes meet the seal quality criteria, the system indicates 1216 that the first side of the seal is "good" or complete, and can continue to test the second (right) side of the seal 1222. Optionally, one side of the seal can be retested as needed.

[0084] Alternatively, if the parameters are not sufficient, the system may indicate that the first side of the seal is "bad" or incomplete (step 1218). In this case, an additional seal may be applied to the first side (step 1220). The first side of the seal may then be retested (step 1214). This retest may be repeated as necessary.

[0085] Once the seal is tested and found to be "good," the second (right) side of the seal can be tested in the same manner (step 1222). The second side of the seal can be designated as good (step 1224) or designated as bad (step 1226). If the seal on the second side is bad (step 1226), it can be resealed (step 1228) and then retested (step 1222). This can be repeated as necessary.

[0086] If the second side seal is good (step 1224), the system can indicate that the seal is complete (step 1230) and the operator can proceed with the procedure, such as proceeding to the cutting step. In some cases, the left and right sides of the seal can be tested simultaneously or in reverse order.

[0087] 13 shows a flowchart depicting an example method 1300 for testing a sealed vessel. Method 1300 may allow an operator to manually select whether to proceed with the procedure based on testing the seal.

[0088] In method 1300, a seal can be made in a target tissue, such as a blood vessel, at step 1310, such as with a bipolar forceps having any of the electrode configurations discussed above. The seal can be made at step 1312 until a normal endpoint for the seal is reached.

[0089] In method 1300, the first and second sides of the seal can be tested in either order, or possibly simultaneously. The first side of the seal can be tested in step 1314. If the first side of the seal is bad (step 1316), a warning can be presented to an operator in step 1318, such as via a user interface, text, light, audible noise, or other indicator. Alternatively, if the first side of the seal is good (step 1320), testing of the second side can begin.

[0090] The operator can then decide when to proceed to the next step of testing the second side of the seal (step 1322). Similarly, if the second side is shown to be bad (step 1324), the system can indicate this to the operator (step 1326). Conversely, if the second side of the seal is good (step 1328), the system can indicate a perfect seal to the operator (step 1330).

[0091] 14 shows a flowchart illustrating an example method 1400 for testing a sealed vessel. Method 1400 may include testing the seal while current is applied to the seal.

[0092] Initially, a seal may be initiated against a target tissue, such as a blood vessel, using a bipolar forceps or the like having any of the electrode configurations discussed above, in step 1410. In method 1400, the first and second sides of the seal may be tested in either order, or possibly simultaneously.

[0093] In one example, the first side of the seal may be tested (step 1412), such as by sensing an electrical parameter of the first side of the seal and comparing the sensed parameter to a known or threshold parameter value to determine if the first side of the seal is intact, as previously discussed. If the first side of the seal is not intact (step 1414), energization of the seal may continue in step 1416. If energization continues, the first side may be retested in step 1412.

[0094] Once the first side of the seal is deemed complete (step 1418), the second side of the seal can be tested (step 1420). The second side of the seal can be tested in a manner similar to the first side. If the second side of the seal is deemed incomplete (step 1422), the seal can continue to be energized (step 1416) and testing can resume (steps 1412, 1420) until both sides of the seal are deemed complete (step 1424). The system can then indicate to the user that the seal is complete (step 1426).

[0095] In this way, sensing of either side of the seal can occur while the seal is in place. Similarly, the devices discussed herein can be configured to reduce pressure on the sealed side and increase pressure on the unsealed side when each side of the seal is independently energized during application.

[0096] Figure 15 shows a flowchart depicting, by way of example, a method 1500 for testing a sealed vessel using a two-seal system such as those shown in Figures 4A-4C above. In method 1500, driving a sealing waveform (step 1510) can be performed simultaneously across both sections of the device until a successful seal endpoint is reached, creating a seal in the vessel (step 1512). The vessel can then be severed between the two sets of electrode portions (step 1514).

[0097] Simultaneously, each side of the cut seal can be tested. On the first side, the electrode portion (or additional sensor electrodes) facing the first side can be used to test the first side seal for specified electrical parameters in step 1516. If the first side seal is deemed "good" based on the generated electrical parameters, the first side test can proceed awaiting a signal from the second side test (step 1518). Optionally, second side seal testing, additional sealing, and retesting can be performed following the first side test.

[0098] However, if the first-side seal is deemed "bad" or incomplete based on the generated electrical parameters, an additional set of energy can be applied to the first-side seal to reseal that side (step 1520). For example, the seal can be energized only on the first side to reseal or secure the seal as needed. After resealing, the first-side seal can be retested (step 1522). If the seal is "good," first-side testing can proceed awaiting a signal from second-side testing (step 1518). However, if the first-side seal is still "bad," resealing and retesting can be repeated as necessary until a good first-side seal is obtained.

[0099] Simultaneously, the second-side seal can be tested in step 1526. Like the other side, the second-side seal can be tested for one or more electrical parameters using the electrodes that function as sensor electrodes or using additional sensor electrodes. If the second-side seal is "good," the second side can proceed awaiting a signal from the first-side test (step 1528). However, if the second-side seal is "bad" or incomplete, an additional set of energy can be applied to the second-side seal to reseal that side (step 1530). After resealing, the second-side seal can be retested (step 1532). If the seal is "good," the second-side test can proceed awaiting a signal from the first-side test (step 1528). However, if the first-side seal is still "bad," resealing and retesting can be repeated as necessary until a good second-side seal is obtained.

[0100] Once both the first and second sides indicate a good seal, the system may indicate to the user that the sealing and cutting as a whole is complete (step 1540).

[0101] 16 shows a flowchart illustrating an example method 1600 for testing a sealed vessel using a two seal system, where energization of two separate seals can be initiated at steps 1610 and 1620.

[0102] In step 1610, the first seal may be energized, and energy may be applied to the target tissue to coagulate the tissue and create a seal until a normal endpoint is reached in step 1612. The first seal may then be tested, such as by monitoring and recording one or more electrical properties of the sealed target tissue, such as impedance, resistance, phase angle, or other parameters, using sensor electrodes. Based on the detected electrical parameters, the system may determine whether the seal is "good" or "bad." If the seal is "bad," the system may prompt continued energization or resealing of the first seal, followed by additional testing of the first seal.

[0103] In step 1620, which may be simultaneous with step 1610, the second seal may be energized and energy applied to the target tissue to coagulate the tissue and create a seal until a normal endpoint is reached in step 1622. In this case, the system may pause function with respect to the second seal until a signal is received indicating that the first seal is "good." At this point, the second seal may be tested in step 1624. If the second seal is "bad," the system may prompt continued energization or resealing of the second seal before further testing of the second seal. If the seal is "good," the system may indicate that both the first and second seals are complete, allowing the operator to continue the procedure. This process may be performed in stages, with additional sealing energy applied and retesting performed until the tissue parameters meet the target values.

[0104] FIG. 17 shows a flowchart depicting example methods 1700A and 1700B for testing a sealed vessel. In method 1700A, the sealing step can be initiated (step 1702), both sides of the seal (or the seal on both sides of the blade slot) can be tested (step 1704), and then each side of the seal can be tested individually (step 1706), resulting in a good seal (step 1708). In method 1700B, the sealing step can be initiated (step 1710), and each side can be tested individually (step 1712), resulting in a good seal (step 1714). The systems discussed herein can be used to test each side of the seal simultaneously, alternately, or repeatedly as needed, depending on the requirements of a given operation. Testing can be performed during, after, or between sealing steps, before or after cutting, or more than once as needed.

[0105] 18 shows a flow chart illustrating an exemplary method 1800 for testing sealed blood vessels using an atypical pulse waveform. In method 1800, a sealing phase can be initiated at step 1810.

[0106] Once activated, the first side can be monitored in step 1812 simultaneously with the second side in step 1814. For example, one or more sensor electrodes can be used to monitor one or more electrical parameters on either the first side or the second side of the applied seal. Depending on the sensed parameters, the first side or second side seal can be modified as needed in steps 1816 and 1818, respectively.

[0107] Various notes and examples Example 1 can include a forceps system for sealing a blood vessel, the forceps system comprising forceps including a first jaw and an opposing second jaw, at least one of the first jaw and the second jaw including at least a first electrode having first and second electrode portions laterally separated to enable electrical isolation between the first and second electrode portions, the first and second electrode portions being independently operable and positionable to enable individual testing of blood vessel properties by the first and second electrode portions.

[0108] Example 2 can include example 1, comprising a slot between at least a portion of the laterally separated first and second electrode portions.

[0109] Example 3 can include any of Examples 1-2, further comprising a retractable blade extendable within a slot between the first electrode portion and the second electrode portion.

[0110] Example 4 can include any of Examples 1-3, wherein the first electrode portion and the second electrode portion are laterally separated by a slot.

[0111] Example 5 can include any of Examples 1-4, wherein the first electrode portion and the second electrode portion each extend from between a distal portion and a proximal portion of the first jaw.

[0112] Example 6 can include any of Examples 1-5, wherein the other of the first jaw and the second jaw includes a second electrode.

[0113] Example 7 can include any of Examples 1-6, wherein the first electrode and the second electrode comprise a first plate electrode and a second plate electrode.

[0114] Example 8 can include any of Examples 1-7, wherein the first electrode and the second electrode are located on or near a lateral edge of at least one of the first jaw and the second jaw.

[0115] Example 9 can include any of Examples 1-8, wherein the first electrode and the second electrode are located on or near the slot in at least one of the first jaw and the second jaw.

[0116] Example 10 can include any of Examples 1-9, wherein the second electrode comprises a third electrode portion and a fourth electrode portion, and the third electrode portion and the fourth electrode portion are laterally separated to enable electrical isolation between the third electrode portion and the fourth electrode portion.

[0117] Example 11 can include any of Examples 1-10, wherein the third electrode portion and the fourth electrode portion are independently positionable to enable individual testing of vascular properties by the third electrode portion and the fourth electrode portion.

[0118] Example 12 can include any of Examples 1-11, further comprising one or more sensor electrodes electrically isolated from the first electrode.

[0119] Example 13 can include any of Examples 1-12, wherein the one or more sensor electrodes comprise a standoff on at least one of the first jaw and the second jaw.

[0120] Example 14 can include a method of testing a seal of a blood vessel, the method including the steps of placing independently operatively positionable first and second electrode portions on opposite sides of a target seal region, using the first electrode portion to independently test a first tissue parameter on a first side of the target seal region, and using the second electrode portion to independently test a second tissue parameter on a second side of the target seal region.

[0121] Example 15 may include Example 14, and further includes, after individually testing the first tissue parameter and the second tissue parameter, cutting a target sealing region of the blood vessel using a blade positionable between the first electrode portion and the second electrode portion.

[0122] Example 16 may include any of Examples 14-15, further including at least partially sealing the target sealing region with forceps having the first electrode portion and the second electrode portion prior to testing the first tissue parameter and the second tissue parameter.

[0123] Example 17 may include any of Examples 14-16, wherein the steps of individually testing a first tissue parameter on a first side of the target sealing region of the blood vessel using the first electrode portion and individually testing a second tissue parameter on a second side of the target sealing region of the blood vessel using the second electrode portion are performed while applying sealing energy to the target sealing region of the blood vessel.

[0124] Example 18 may include any of Examples 14-17, and further includes selectively applying resealing energy, at least in part, to at least one of a first side or a second side of the targeted sealing region of the blood vessel based on at least one of the first tissue parameter or the second tissue parameter.

[0125] Example 19 can include any of Examples 14-18, wherein at least partially applying the resealing energy includes incrementally applying additional sealing energy and retesting until the tissue parameter meets the target value.

[0126] Example 20 may include any of Examples 14-19, wherein the steps of separately testing a first tissue parameter on a first side of the target sealing region of the blood vessel using the first electrode portion and separately testing a second tissue parameter on a second side of the target sealing region of the blood vessel using the second electrode portion are performed simultaneously.

[0127] Example 21 may include a method of testing a seal of a blood vessel, the method including the steps of placing individually operatively positionable first and second electrode portions in respective sub-regions of a target seal region, individually and iteratively sealing and testing a first tissue parameter of the first sub-region using the first electrode portion until at least one first criterion is met, and individually and iteratively sealing and testing a second tissue parameter of the second sub-region using the second electrode portion until at least one second criterion is met.

[0128] Example 22 can include example 21, wherein at least one of the first criterion or the second criterion represents seal integrity of corresponding ones of the respective first sub-regions and second sub-regions.

[0129] Each of these non-limiting examples can stand on its own or can be combined with one or more other examples in various permutations or combinations.

[0130] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the shown or described elements are present. Furthermore, the inventors also contemplate examples that use any combination or permutation of the shown or described elements (or one or more aspects thereof) with respect to a particular example (or one or more aspects thereof), or with respect to any other example (or one or more aspects thereof) shown or described herein.

[0131] In the event of a conflict between the usages herein and any document incorporated by reference, the usages in this specification shall control.

[0132] As is common in patent documents, the terms "a" or "an" are used herein to include one or more, regardless of any other instance or usage of "at least one" or "one or more." The term "or" is used herein to refer to a non-exclusive "or," such that "A or B" includes "A but not B," "B but not A," or "A and B," unless otherwise stated. The terms "including" and "in which" are used herein as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the appended claims, the terms "including" and "comprising" are open-ended, i.e., systems, devices, articles, compositions, formulations, or processes that include elements in addition to those recited after such terms in a claim are still deemed to be within the scope of that claim. Furthermore, in the appended claims, the terms "first," "second," and "third," etc., are used merely as labels and do not impose numerical requirements on their objects.

[0133] Examples of the methods described herein may be at least partially implemented by a machine or computer. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device to perform the methods described in the examples. An implementation of such a method may include code, such as microcode, assembly language code, high-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Furthermore, in one example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), etc.

[0134] The above description is illustrative, not limiting. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments may be available to those skilled in the art upon reviewing the above description. The Abstract is provided in accordance with 37 C.F.R. §1.72(b) to enable the reader to quickly ascertain the nature of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as indicating that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Accordingly, the appended claims are incorporated into the Detailed Description herein as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [Additional note 1] 1. A forceps system for sealing a blood vessel, the forceps system comprising: a forceps including a first jaw and an opposing second jaw; at least one of the first jaw and the second jaw includes at least a first electrode having a first electrode portion and a second electrode portion, the first electrode being laterally separated to allow electrical isolation between the first electrode portion and the second electrode portion; A forceps system, wherein the first electrode portion and the second electrode portion are independently positionable to allow blood vessel characteristics to be tested individually by the first electrode portion and the second electrode portion. [Additional note 2] 2. The forceps system of claim 1, further comprising a slot between at least a portion of the laterally separated first and second electrode portions. [Additional note 3] The forceps system of claim 2, further comprising a retractable blade extendable within the slot between the first electrode portion and the second electrode portion. [Additional note 4] 3. The forceps of claim 2, wherein the first electrode portion and the second electrode portion are laterally separated by the slot. [Additional note 5] 3. The forceps of claim 2, wherein the first electrode portion and the second electrode portion each extend from between a distal portion and a proximal portion of the first jaw. [Additional note 6] The forceps system of claim 1, wherein the other of the first jaw and the second jaw includes a second electrode. [Additional note 7] 7. The forceps of claim 6, wherein the first electrode and the second electrode comprise a first plate electrode and a second plate electrode. [Additional note 8] 7. The forceps of claim 6, wherein the first electrode and the second electrode are located at or near a lateral edge of at least one of the first jaw and the second jaw. [Additional note 9] 7. The forceps of claim 6, wherein the first electrode and the second electrode are located in or near a slot in at least one of the first jaw and the second jaw. [Additional Note 10] the second electrode comprises a third electrode portion and a fourth electrode portion; The forceps system of claim 6, wherein the third electrode portion and the fourth electrode portion are laterally separated to enable electrical isolation between the third electrode portion and the fourth electrode portion. [Additional Note 11] The forceps of claim 10, wherein the third electrode portion and the fourth electrode portion are independently operable to allow vascular characteristics to be tested individually by the third electrode portion and the fourth electrode portion. [Additional Note 12] The forceps described in Appendix 1, further comprising one or more sensor electrodes electrically insulated from the first electrode. [Additional Note 13] 13. The forceps of claim 12, wherein the one or more sensor electrodes include a separation portion on at least one of the first jaw and the second jaw. [Additional Note 14] 1. A method for testing a seal in a blood vessel, the method comprising: placing first and second independently operatively addressable electrode portions on opposite sides of a target sealing area; using the first electrode portion to individually test a first tissue parameter on a first side of the target seal area; separately testing a second tissue parameter on a second side of the target seal area using the second electrode portion; A method comprising: [Additional Note 15] 15. The method of claim 14, further comprising, after individually testing the first tissue parameter and the second tissue parameter, cutting the target sealing region of the blood vessel using a blade positionable between the first electrode portion and the second electrode portion. [Additional Note 16] The method of claim 14, further comprising at least partially sealing the target sealing area using forceps having the first electrode portion and the second electrode portion before testing the first tissue parameter and the second tissue parameter. [Additional Note 17] 15. The method of claim 14, wherein the steps of individually testing a first tissue parameter on a first side of the target sealing region of the blood vessel using the first electrode portion and individually testing a second tissue parameter on a second side of the target sealing region of the blood vessel using the second electrode portion are performed while applying sealing energy to the target sealing region of the blood vessel. [Additional Note 18] 15. The method of claim 14, further comprising selectively applying resealing energy at least in part to at least one of the first side or the second side of the target sealing region of the blood vessel based on at least one of the first tissue parameter or the second tissue parameter. [Additional Note 19] 20. The method of claim 18, wherein at least partially applying resealing energy comprises incrementally applying additional sealing energy and retesting until the tissue parameter meets a target value. [Additional Note 20] 15. The method of claim 14, wherein the steps of individually testing a first tissue parameter on a first side of the target sealing region of the blood vessel using the first electrode portion and individually testing a second tissue parameter on a second side of the target sealing region of the blood vessel using the second electrode portion are performed simultaneously. [Additional Note 21] 1. A method for testing a seal in a blood vessel, the method comprising: placing individually operatively addressable first and second electrode portions in respective sub-regions of the target sealing region; individually and repeatedly sealing and testing a first tissue parameter of a first of the sub-regions using the first electrode portion until at least one first criterion is met; individually and repeatedly sealing and testing a second tissue parameter of a second of the sub-regions using the second electrode portion until at least one second criterion is met; A method comprising: [Additional note 22] 22. The method of claim 21, wherein at least one of the first criterion or the second criterion represents the integrity of the seal of a corresponding one of the first and second sub-regions. [Explanation of symbols]

[0135] 10 Electrosurgical System 12 Electrosurgical Generator and Control Electronics Unit, Electronics Unit 14 Forceps 16 Biological Tissue 18 Handpiece 20 Shaft Assembly 22 Knife Blade Assembly 24 Gripper Assembly 26 Handle 28 Gripping lever 30 Knife Trigger 32 Electrical treatment start button 34 Spinning Wheel 36 First jaw member 38 Second jaw member 200 Electrosurgical System 212 Electronics Unit 214 Forceps 216 Engaged biological tissue 242 Device Interface 244 Electrical Energy Sources 246 Measurement circuit 248 Control Circuit 250 User Interface 252 Electrical Connector 254 processors 256 memory 256D data memory 256P program memory 300 forceps 310 First Jaw 312 First electrode 314 First Part 315 blade slot 316 Second Part 320 Second Jaw 322 Second electrode 330 Target tissue 340 Target sealing area 342 First Side 344 Second Side 400 forceps 410 First Jaw 412 First electrode 414 First Part 415 blade slot 416 Second Part 420 Second Jaw 422 Second electrode 424 Third Part 425 Second Blade Slot 426 Fourth Part 430 Target tissue 440 Target sealing area 442 First Side 444 Second Side 500 First Jaw 510 electrode 514 Electrode part 515 blade slot 516 Electrode part 518 Separator Zone 520 Electric wire 522 Electric wire 600 Forceps jaw 610 Sensor Electrode 700 Jaw 710 Detection electrode 712 Detection electrode 713 Gap 714 Insulation detection electrode 716 Insulation detection electrode 800 Jaw 810 Electrode Plate 812 Electrode Plate 814 Sensor electrode 816 Sensor electrode 900 Jaw 912 Sensor Electrode 914 Sensor Electrode 910 Main electrode plate 1000 Jaw 1010, 1012, 1014, 1016, 1018, 1020, 1022, 1024 electrode 1100 Jaw 1110 Sensor electrode array

Claims

1. 1. A forceps system for sealing a blood vessel, comprising: A forceps including a first jaw and a second jaw opposing the first jaw, the first jaw includes a first electrode, a second electrode, and a slot between at least a portion of the first electrode portion and at least a portion of the second electrode portion; a forceps, the second jaw including a third electrode positioned opposite the first electrode and a fourth electrode positioned opposite the second electrode; A circuit comprising: configured to conduct a first current between the first electrode and the third electrode to form a first side of a sealed region of a blood vessel; configured to conduct a second current between the first electrode and the third electrode to form a second side of the sealing region, the sealing region extending between the first side of the sealing region and the second side of the sealing region; configured to conduct a third current between the second electrode and the third electrode after the first current and the second current have been conducted to electrically test the first side of the sealed region; a circuit configured to conduct a fourth current between the first electrode and the fourth electrode after the first current and the second current have been conducted to electrically test the second side of the sealed region; A forceps system comprising:

2. The forceps system of claim 1 , further comprising a retractable blade extendable within the slot between the first electrode and the second electrode.

3. The forceps system of claim 1 , wherein the first electrode and the second electrode each extend between a distal portion and a proximal portion of the first jaw.

4. The forceps system of claim 1 , wherein the first electrode comprises a first plate electrode and the second electrode comprises a second plate electrode.

5. The forceps system of claim 1 , wherein the first electrode is located at or near a lateral edge of the first jaw.

6. The forceps system of claim 1 , wherein the first electrode is located at or near the slot.

7. The forceps system of claim 1 , further comprising one or more sensor electrodes electrically isolated from the first electrode.

8. The forceps system of claim 7 , wherein the one or more sensor electrodes comprise spaced apart portions on at least one of the first jaw and the second jaw.

9. The forceps system of claim 1 , wherein the third current operates a grounded or floating output while the fourth current is conducted.

10. The forceps system of claim 1 , wherein the circuit is disposed on the forceps toward a distal portion of the forceps.

11. 2. The forceps system of claim 1, wherein the circuitry is configured to perform an electrical test of the first side of the sealing region on the blood vessel by determining at least one of an impedance of the first side of the sealing region, a resistance of the first side of the sealing region, or a phase angle imparted by the first side of the sealing region in response to the third current.

12. The slot extends longitudinally; The forceps system of claim 1 , wherein the first jaw includes a fifth electrode longitudinally adjacent the first electrode.

13. The forceps system of claim 1 , wherein the fourth current operates a grounded or floating output while the third current is conducted.

14. 2. The forceps system of claim 1, wherein the forceps is configured to hold the blood vessel between the first jaw and the second jaw and not release the blood vessel from between the first jaw and the second jaw while the first current, the second current, the third current, and the fourth current are directed.

15. The slot extends longitudinally; The forceps system of claim 1 , wherein the first jaw and the second jaw are laterally adjacent.

16. 2. The forceps system of claim 1, wherein the circuitry is configured to perform an electrical test of the second side of the sealing region on the blood vessel by determining at least one of an impedance of the second side of the sealing region, a resistance of the second side of the sealing region, or a phase angle imparted by the second side of the sealing region in response to the current.

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