Surgical generator

Abstract

To provide a surgical system causing a result effective to biological tissues.SOLUTION: An apparatus and associated method relate to controlling electrical power of an electrotherapeutic signal that is provided to a biological tissue engaged by an electrosurgical instrument during a medical procedure. Electrical power, a product of a voltage difference across and an electrical current conducted by the engaged biological tissue, is controlled according to a therapeutic schedule. The electrotherapeutic schedule can be reduced or terminated in response to a termination criterion being met. In some examples, the termination criterion is a current characteristic, such as a decrease in current conducted by the engaged biological tissue. In some examples, the termination criterion is a biological tissue resistance characteristic, such as an increase in the biological tissue resistance that exceeds a predetermined delta resistance value.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Priority claims This application is based on (1) U.S. Provisional Patent Application No. 62 / 845,647, filed May 9, 2019, by Kester J. Batchelor et al., entitled "Electrosurgically Sealing Biological Tissue by Controlling Power Provided Thereto," and (2) U.S. Provisional Patent Application No. 62 / 905,318, filed September 24, 2019, by Kester J. Batchelor et al., entitled "Electrosurgically Sealing Biological Tissue by Controlling Power Provided Thereto," and (3) U.S. Provisional Patent Application No. 62 / 905,318, filed September 24, 2019, by Huisun Wang et al., entitled "Correcting Tissue Resistance Measurements Using Temporal (4) U.S. Provisional Patent Application No. 62 / 905,366, entitled "PREDICTIVE PHASE CONTROL OF AN ELECTROTHERAPEUTIC PROCEDURE," filed September 24, 2019, by Huisun Wang et al.; (5) U.S. Provisional Patent Application No. 62 / 905,345, entitled "PULSED ELECTRICAL POWER PROVIDED TO SEALED TISSUE TO REDUCE TISSUE STICKING," filed September 24, 2019, by Huisun Wang et al.; and (6) U.S. Provisional Patent Application No. 62 / 905,366, entitled "PREDICTIVE PHASE CONTROL OF AN ELECTROTHERAPEUTIC PROCEDURE," filed September 24, 2019, by Huisun Wang et al.; and (7) U.S. Provisional Patent Application No. 62 / 905,345, entitled "PULSED ELECTRICAL POWER PROVIDED TO SEALED TISSUE TO REDUCE TISSUE STICKING," filed September 24, 2019, by Wayne Williams et al.; No. 62 / 905,360, entitled "PREDICTION," the entire contents of each of which are hereby incorporated by reference in their entirety, and the benefit of priority to each is hereby claimed. [Background technology]

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

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

[0004] Different medical procedures may implement different electrotherapy signals to achieve results specific to those different medical procedures. Various electrical metrics of the electrotherapy signals provided to the engaged biological tissue may be used to characterize those electrotherapy signals. These electrical metrics include polarity (monopolar, bipolar), AC and / or DC, frequency, signal amplitude, attack and decay profiles, etc. An electrosurgical generator that generates these various electrotherapy signals may control one or more of these electrical metrics to provide an electrotherapy signal that produces an effective result on the biological tissue engaged by the electrosurgical instrument. Summary of the Invention [Means for solving the problem]

[0005] The apparatus and associated method relate to a system for providing controlled electrical power to biological tissue. The electrosurgical system includes a forceps having opposable jaw members configured to open and close. The forceps also includes a handpiece having a gripping lever configured to open and close the opposable jaw members. When closed, the opposable jaw members are configured to clamp biological tissue therebetween and provide electrical communication between the opposable jaw members through the clamped biological tissue. The electrosurgical system also includes an electrosurgical generator electrically coupleable to the forceps. The electrosurgical generator includes an electrical energy source that is in electrical communication with the opposable jaw members when the electrosurgical generator is electrically coupled to the forceps. The electrical energy source is configured to generate an electrotherapy signal. The electrosurgical generator includes a control circuit configured to cause the electrical energy source to provide the electrotherapy signal to the clamped biological tissue during an electrotherapy phase. The power of the provided electrotherapy signal is controlled according to an electrotherapy schedule.

[0006] Some examples relate to an electrosurgical generator for providing controlled power to biological tissue engaged by an electrosurgical instrument. The electrosurgical generator includes an electrical connector configured to electrically couple the electrosurgical instrument to the electrosurgical generator and provide electrical communication between the electrosurgical generator and the engaged biological tissue. The electrosurgical generator includes an electrical energy source electrically coupled to the electrical connector and configured to generate an electrotherapy signal. The electrosurgical generator also includes control circuitry configured to cause the electrical energy source to provide the electrotherapy signal to the engaged biological tissue during an electrotherapy phase. The power of the electrotherapy signal is provided according to the engaged biological tissue controlled according to an electrotherapy schedule.

[0007] Some examples relate to a method of providing controlled power to biological tissue engaged by an electrosurgical device. The method includes engaging the biological tissue via the electrosurgical device and providing electrical communication between the electrosurgical device and the engaged biological tissue. The method proceeds, during an electrotherapy phase, to providing an electrotherapy signal to the engaged biological tissue via an electrical energy source in electrical communication with the electrosurgical device. The method also includes controlling the power of the provided electrotherapy signal according to an electrotherapy schedule. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of an electrosurgical system for providing electrical therapy to biological tissue of a surgical patient. [Figure 2] FIG. 1 is a block diagram of an electrosurgical system for sealing biological tissue engaged by an electrosurgical instrument. [Figure 3A] 1 is a flow diagram of a method of sealing biological tissue engaged by an electrosurgical instrument. [Figure 3B] 1 is a flow diagram of a method of sealing biological tissue engaged by an electrosurgical instrument. [Figure 4] 10 is a graph illustrating an example of a power schedule used to control power provided to sealed biological tissue. [Figure 5] 1 is a flow chart illustrating an example of an open circuit verification technique that may be used in a surgical system. [Figure 6] 1 is a flow chart of a method for sealing biological tissue using a power schedule that corresponds to the size of the biological tissue engaged by the electrosurgical instrument. [Figure 7A] 1 is a graph showing measured tissue resistance as a function of forceps jaw temperature. [Figure 7B] 10 is a graph showing the relationship between jaw temperature and time after the end of power application. [Figure 8] 10 is a graph showing resistance compensation versus time after power application. [Figure 9] 1 is a flow diagram of a method for compensating measurements of tissue resistance as a function of time after application of power. [Figure 10A] 10 is a graph of electrical parameters of an electrotherapy signal for electrotherapy having a pulsed adhesion-reducing portion. [Figure 10B] 10 is a graph of electrical parameters of an electrotherapy signal for electrotherapy having a pulsed adhesion-reducing portion. [Figure 10C] 10 is a graph of electrical parameters of an electrotherapy signal for electrotherapy having a pulsed adhesion-reducing portion. [Figure 10D] 10 is a graph of electrical parameters of an electrotherapy signal for electrotherapy having a pulsed adhesion-reducing portion. [Figure 11] 1 is a flow chart of a method for reducing adhesion between biological tissue and an electrosurgical instrument. [Figure 12] 1 is a graph showing an example of impedance angle / time relationships for biological tissue with and without a metal object. [Figure 13] 1 is a flow diagram of a method for determining the presence or absence of a metallic object within biological tissue engaged by an electrosurgical instrument. [Figure 14] 1 is a flow chart illustrating an example of a two-boundary technique that may be used in a surgical system. [Figure 15] 1 is a flow chart illustrating an example of an open circuit verification technique that may be used in a surgical system. [Figure 16] 10 is a flow chart illustrating another example of an open circuit verification technique that may be used in a surgical system. [Figure 17] 1 is a flow chart illustrating an example of a power correction technique that may be used in a surgical system. [Figure 18] FIG. 1 is a simplified block diagram of an example of a combined ultrasonic energy and electrosurgical energy system capable of implementing various techniques of the present disclosure. [Figure 19] 1 is a flow chart illustrating an example of a thermal margin reduction technique that may be used in a combined ultrasonic energy and electrosurgical energy system. [Figure 20] 1 is a flow chart illustrating an example of a thermal margin control technique that may be used in an electrosurgical system. [Figure 21]10 is a flow chart illustrating another example of a thermal margin control technique that may be used in an electrosurgical system. [Figure 22A] 1 is a flow diagram of an example of an energy delivery technique that can use, among other things, the amount of energy delivered to biological tissue in the decision-making process. [Figure 22B] 1 is a flow diagram of an example of an energy delivery technique that can use, among other things, the amount of energy delivered to biological tissue in the decision-making process. [Figure 22C] 1 is a flow diagram of an example of an energy delivery technique that can use, among other things, the amount of energy delivered to biological tissue in the decision-making process. [Figure 22D] 1 is a flow diagram of an example of an energy delivery technique that can use, among other things, the amount of energy delivered to biological tissue in the decision-making process. [Figure 23] 1 is a graph illustrating an example of the relationship between changes in the value of a measured electrical parameter and changes in power. [Figure 24] 10 is a flow chart illustrating another example of a power correction technique that may be used in a surgical system. DETAILED DESCRIPTION OF THE INVENTION

[0009] Apparatus and associated methods relate to applying electrotherapy signals to biological tissue engaged by an electrosurgical device. Control of various electrical metrics of these electrotherapy signals is disclosed below, as are specific electrosurgical techniques for performing such control. This specification provides methods for: i) power control of electrotherapy signals (FIGS. 1-4); ii) predictive phase control of electrotherapy signals (FIGS. 5-6); iii) correcting the measured electrical resistance of engaged biological tissue (FIGS. 7A-7B and 9); iv) modifying initial impedance (FIG. 9); v) pulsing the power of electrotherapy signals to reduce adhesion of biological tissue to an electrosurgical device (FIGS. 10A-10D and 11); vi) determining the presence or absence of conductive foreign bodies within biological tissue engaged by an electrosurgical device (FIGS. 12 and 13); vii) short-circuit error trapping via a band between a trigger value and an escape value (FIG. 14); and viii) detecting and correcting electrical impedance of biological tissue engaged by an electrosurgical device (FIG. 15). ) Open-Circuit Check for Impedance-Limited Endpoint Waveforms (FIGS. 15 and 16), ix) Alternative Power Correction Output in Low-Precision Hardware Systems (FIG. 17), x) Combined Energy Devices with Reduced Thermal Margins (FIGS. 18 and 19), xi) Graduated Impedance Values ​​for Controlling Thermal Margins in Systems with Slow CPUs (FIGS. 20 and 21), xii) Energy Consumption Monitoring and Open-Circuit Assessment (FIGS. 22A-22D), xiii) Dwell Time Between Pulses, and xiv) Incremental Adjustment of Control Parameters as a Function of Monitored Variables. These techniques are listed in separate sections for illustrative purposes only. Unless expressly stated to the contrary, each of these techniques can be used in combination with one or more of the other techniques described in this disclosure.

[0010] Power control of electrotherapy signals (Figures 1 to 4) Electrosurgical sealing or coagulation of biological tissue engaged by an electrosurgical instrument is an electrosurgical technique used in a variety of medical procedures. Engaged biological tissue can be electrosurgically sealed by controlled heating of the engaged biological tissue. In some medical procedures, the biological tissue being sealed is a blood vessel. Heating the blood vessel denatures collagen found in the vessel wall. This denatured collagen forms a gel-like substance that acts as an adhesive between the vessel walls. When pressed together and maintained together during cooling, the opposing walls of the blood vessel form a seal.

[0011] Heating of the vessel is carefully controlled to ensure that neither too little nor too much energy is delivered to the vessel. If too much energy is delivered to the vessel, charring and / or burning of the vessel wall may occur. If too little energy is delivered to the vessel, the quality of the seal on the vessel may be poor. One measure of seal quality is the differential pressure that the sealed vessel can withstand without rupturing. A poor quality seal may be compromised if the applied pressure exceeds a certain value.

[0012] The rate at which energy is delivered to the vessel can also be carefully controlled to facilitate rapid performance of electrosurgical procedures, which reduces the time and difficulty of these procedures. However, the heating rate should not be so rapid as to cause uncontrolled boiling of fluids within the biological tissue, which could result in rupture of the engaged or nearby biological tissue and / or a reduction in the quality of the seal.

[0013] Heating of the engaged biological tissue can be controlled by controlling the power of the electrotherapy signal provided to and dissipated by the engaged biological tissue. Such power can be controlled according to a sealing schedule. For example, the sealing schedule can indicate the product of a voltage difference across the engaged biological tissue and the current conducted by the engaged biological tissue. Thus, the sealing schedule is a power schedule. In some examples, the electrotherapy signal can be reduced or terminated in response to a termination criterion being met. In some examples, the termination criterion is a current characteristic, such as a decrease in the current conducted by the engaged biological tissue. In some examples, the termination criterion is a resistance characteristic, such as an increase in the electrical resistance of the engaged biological tissue. Such an increase in electrical resistance beyond a predetermined delta resistance value can be used as an termination criterion, for example, where the predetermined delta resistance value is the difference between the measured resistance (or impedance) and the lowest value of resistance (or impedance) measured within the pulse. In some examples, the termination criterion is a time condition, such as a duration that is predetermined or calculated based on some condition.

[0014] Electrical impedance is a complex impedance and therefore includes a real component (resistance) and an imaginary component (reactance). This specification describes techniques that use impedance or resistance. It should be understood that complex impedance values ​​are also available and such values ​​can be used in place of resistance values. Conversely, if complex impedance values ​​are not available, resistance values ​​can be used instead unless otherwise specified.

[0015] Additionally, many of the following techniques describe the delivery of electrosurgical energy to biological tissue. Unless indicated to the contrary, each of these techniques can deliver electrosurgical energy using power-controlled or voltage-controlled techniques. In power-controlled implementations, a control circuit can control the delivery of electrosurgical energy using the product of voltage and current applied to the engaged biological tissue, for example, according to a plan or schedule. For example, the control circuit can control the delivery of constant power or monotonically increasing power during a particular phase, such as a desiccation phase.

[0016] This specification describes one or more techniques for providing electrotherapy, which can be delivered according to, among other things, a therapeutic or other plan. A plan can include a recipe, prescription, regimen, methodology, etc. A plan can include one or more temporal aspects, such as a schedule, including, for example, onset or recurrence (or suppression or inhibition) timing, frequency, type, relative combination (e.g., incision and coagulation), etc. A plan can include electrotherapy waveform information, including, for example, pulse width, duty cycle, on-duration, off-duration, repetition rate, amplitude, phases, etc. A plan need not be static or deductive in nature but can include one or more dynamic aspects, such as modified or determined by, for example, diagnostic, operational, or other information obtained during or between electrotherapy delivery instances, such as in closed-loop or other feedback. One or more aspects of a plan can be tailored to a particular patient, a subpopulation of patients, such as those sharing one or more specified characteristics, or a patient population, for example, based on stored patient data or by user input, such as that provided by the patient or caregiver. The plan may include one or more conditional aspects, e.g., one or more branching conditions, which may be determined using, e.g., patient characteristics, diagnostic strategies, efficacy determinations, or operational characteristics of the device or its environment. Such branching conditions may be determined automatically by the device, e.g., without requiring user input, or may require user input, e.g., provided according to the plan before, during, or after one or more portions of the operation of the electrotherapy device. The plan may require communication with or use of another device to receive or provide one or any combination of input, output, or instructions, operating parameters, or measurement data. One or more aspects of the plan may be recorded or encoded on a medium, such as a computer or other machine-readable medium, and such a medium may be tangible.

[0017] In voltage-controlled implementations, the control circuitry can control the voltage of the electrosurgical energy delivered, for example, according to a plan, regimen, or schedule. For example, the control circuitry can control the delivery of a constant voltage or a monotonically increasing voltage during a particular phase, such as a desiccation phase.

[0018] Figure 1 is a perspective view of an electrosurgical system for providing electrotherapy to biological tissue of a surgical patient. In Figure 1, electrosurgical system 10 includes an electrosurgical generator 12 and forceps 14, which are shown engaged with biological tissue 16. Electrosurgical generator 12 generates an electrotherapy signal, which is provided to the engaged biological tissue 16 via forceps 14. While Figure 1 shows forceps 14 engaging and delivering an electrotherapy signal to biological tissue 16, various types of electrosurgical instruments, such as those disclosed above, can be used for such purposes.

[0019] Various types of forceps can similarly be used to deliver electrotherapy signals to the biological tissue 16. For example, the forceps 14 can be medical forceps, dissecting forceps, or electrosurgical forceps (e.g., monopolar or bipolar forceps). In some examples, the forceps 14 can be used in medical-related procedures, such as open and / or laparoscopic medical procedures, to manipulate, engage, grasp, dissect, cauterize, seal, or otherwise affect blood vessels, biological tissue, veins, arteries, or other anatomical features or objects.

[0020] As shown in Figure 1, forceps 14 includes a handpiece 18, a shaft assembly 20, a knife blade assembly 22, and a gripper assembly 24. In some examples, such as the example shown in Figure 1, forceps 14 is electrically connected to an electrosurgical generator 12, which generates and provides an electrotherapy signal to forceps 14. Forceps 14 then electrically communicates the electrotherapy signal to gripper assembly 24 and / or a remote pad, which can be used for various electrosurgical techniques, such as cauterization, sealing, or other such electrosurgical techniques.

[0021] The handpiece 18 includes a handle 26, a gripping lever 28, a knife trigger 30, an electrotherapy activation button 32, and a rotation wheel 34. The gripping assembly 24 includes a first jaw member 36 and a second jaw member 38. The shaft assembly 20 is connected to the handpiece 18 at a proximal end and to the gripping assembly 24 at a distal end. The shaft assembly 20 extends distally in a longitudinal direction 40 from the handpiece 18 to the gripping assembly 24.

[0022] The shaft assembly 20 functions to allow a portion of the forceps 14 (e.g., the gripper assembly 24 and the distal portion of the shaft assembly 20) to be inserted into a patient or other anatomy, while the remainder of the forceps 14 (e.g., the handpiece 18 and the remaining proximal portion of the shaft assembly 20) remains outside the patient or other anatomy. While the shaft assembly 20 is shown in FIG. 1 as being substantially straight, in other examples, it may include one or more angles, bends, and / or arcs. The shaft assembly 20 may be a cylinder having a circular, oval, or other cross-sectional profile, or other elongated member extending from the handpiece 18 to the gripper assembly 24. In some examples, the shaft may be bendable, steerable, or otherwise flexible.

[0023] 1 , shaft assembly 20 may include an elongated, hollow member (e.g., a tubular outer shaft) that surrounds 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 conductive elements (e.g., wires, a conductive outer shaft, and / or a conductive inner shaft, etc.) to provide electrical communication between handpiece 18 and grip assembly 24, thereby communicating electrotherapy signals.

[0024] The grip lever 28, knife trigger 30, electrotherapy activation button 32, and rotation wheel 34 of the handpiece 18 are each configured to cause various actuations of the shaft assembly 20, typically at the distal end. For example, actuation of the grip lever 28 is configured to control movement of the grip assembly 24, which is at the distal end of the shaft assembly 20. The grip lever 28 is a grip actuator movable between an open configuration position (shown in FIG. 1 ) and a closed configuration position in which the grip lever 28 is moved proximally toward the handle 26. Moving the grip lever 28 proximally toward the handle 26 to the closed configuration transitions the grip assembly 24 from the open configuration to the closed configuration. Moving the grip lever 28 distally toward the open configuration position (e.g., releasing the grip lever 28) transitions the grip assembly 24 from the closed configuration to the open configuration.

[0025] Such transition between the open and closed configurations of the grasper assembly 24 is 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 spaced apart, and a closed configuration in which the gap between the first and second jaw members 36, 38 is reduced or eliminated. Various electrosurgical instruments engage the biological tissue 16 in various ways. In some electrosurgical instruments, such as that shown in FIG. 1 , the first and second jaw members 36, 38 are opposable to one another. In the illustrated example, the first and second jaw members 36, 38 are configured to clamp the biological tissue 16 therebetween and provide electrical communication between the opposable jaw members 36, 38 through the clamped biological tissue 16. Other electrosurgical instruments may engage the biological tissue in other ways.

[0026] A mechanical linkage within shaft assembly 20 can be configured to move one or more of first jaw member 36 and second jaw member 38 between open and closed configurations in response to actuation of gripper lever 28. One exemplary mechanism for moving the gripper assembly between open and closed configurations can be found in U.S. Patent Publication No. 2017 / 0196579, filed January 10, 2017, by Batchelor et al., entitled "FORCEPS JAW MECHANISM," the entire contents of which are incorporated herein by reference.

[0027] Actuation of the knife trigger 30 is configured to control movement of the knife blade assembly 22 located at the distal end of the shaft assembly 20. The knife blade assembly 22 is configured to incise, resect, or otherwise affect biological tissue or other object clamped between the first and second jaw members 36, 38. The knife trigger 30 is a knife blade actuator movable between a retracted configuration (shown in FIG. 1 ) and a deployed or extended configuration, in which the knife trigger 30 is moved proximally toward the handle 26 to cause the knife blade assembly 22 to incise the biological tissue 16 clamped between the first and second jaw members 36, 38. Moving the knife trigger 30 proximally toward the handle 26 to the deployed configuration causes the blade of the knife blade assembly 22 to engage the biological tissue 16, thereby incising the biological tissue 16. Moving the knife trigger 30 distally (e.g., releasing the knife trigger 30) causes the knife blade to retract from the clamped biological tissue 16. For example, a mechanical linkage within shaft assembly 20 can be configured to engage and retract the knife blade from engaged biological tissue 16 .

[0028] The rotation wheel 34 is 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 the rotational configuration of the shaft assembly 20. Movement (e.g., rotation) of the rotation wheel 34 rotates 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.

[0029] The therapy activation button 32 is configured to control the generation and / or delivery of an electrical therapy signal to the engaged biological tissue 16. Activating the therapy activation button 32 applies an electrical therapy signal, for example, drawn from the electrosurgical generator 12, 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 a patient or other anatomy. An example of a handpiece utilizing a gripping lever, knife trigger, rotation wheel, and therapy activation button can be found in U.S. Patent No. 9,681,883, entitled "FORCEPS WITH A ROTATION ASSEMBLY," issued June 20, 2017, to Windgassen et al., the entire contents of which are incorporated herein by reference.

[0030] Figure 2 is a block diagram of an electrosurgical system for sealing biological tissue engaged by an electrosurgical instrument. In Figure 2, electrosurgical system 10 includes an electrosurgical generator 12 and an electrosurgical instrument 14'. Electrosurgical instrument 14' can be any electrosurgical instrument configured to engage and deliver an electrotherapy signal to biological tissue. Electrosurgical generator 12 is configured to generate an electrotherapy signal, such as a radio frequency (AC) electrical signal, and electrosurgical instrument 14' delivers the electrical signal to engaged biological tissue 16.

[0031] In some examples, the electrosurgical instrument 14' is a forceps having a handpiece coupled to opposable jaw members via a shaft assembly, such as the forceps 14 shown in Figure 1. In other examples, the electrosurgical instrument 14' is a conductive spatula, conductive pad, or other electrosurgical device. These various types of electrosurgical instruments have different ways of engaging biological tissue (e.g., clamping, touching, surrounding, penetrating, radiating, etc.).

[0032] The electrosurgical generator 12 includes an instrument interface 42, an electrical energy source 44, measurement circuitry 46, control circuitry 48, and a user interface 50. The instrument interface 42 may include, for example, signal drivers, buffers, amplifiers, ESD protection devices, and an electrical connector 52. The electrical connector 52 is configured to electrically couple the electrosurgical instrument 14' to the electrosurgical generator 12 and provide electrical communication between the electrosurgical generator 12 and the electrosurgical instrument 14'. Such electrical communication may be used to transmit operating power and / or electrical signals between the electrosurgical generator 12 and the electrosurgical instrument 14'. The electrosurgical instrument 14' may thereby provide electrical communication between the electrical connector 52 and engaged biological tissue.

[0033] The electrical energy source 44 is configured to generate an electrotherapy signal that is delivered to the engaged biological tissue via the electrically connected electrosurgical device 14'. The generated electrotherapy signal can be controlled to achieve a desired result for a particular electrosurgical procedure. In one example, for example, the electrotherapy signal is configured to resistively heat the engaged biological tissue to surgically affect the engaged biological tissue, such as sealing the engaged biological tissue. Such control of the electrotherapy signal is disclosed further below.

[0034] The measurement circuit 46 is configured to measure one or more electrical parameters of the biological tissue engaged by the connected electrosurgical instrument 14′. The measurement circuit 46 is in electrical communication with the connected electrosurgical instrument 14′ when the electrosurgical generator 12 is electrically connected to the electrosurgical instrument 14′ via the electrical connector 52. Various examples of the measurement circuit 46 are configured to measure various electrical parameters. For example, the measurement circuit 46 can be configured to measure a voltage difference delivered to the engaged biological tissue and / or a current conducted by the engaged biological tissue. In some examples, the measurement circuit 46 can be configured to measure a phase angle between a voltage difference delivered to the engaged biological tissue and a current conducted by the engaged biological tissue. In some examples, the measurement circuit 46 is configured to measure DC and / or AC electrical parameters of the engaged biological tissue.

[0035] Measured parameters such as the voltage difference delivered to and / or the current conducted by the engaged biological tissue can also be used to determine other electrical metrics. For example, measurements of the voltage difference delivered to and / or the current conducted by the engaged biological tissue can be used to determine the electrical resistance of the engaged biological tissue. Measurements of the voltage difference delivered to and the current conducted by the engaged biological tissue, and the phase angle between them, can be used to determine the complex impedance of the engaged biological tissue. Measurements of the voltage difference delivered to and the current conducted by the engaged biological tissue, and the phase angle between them can also be used to determine the apparent power (VA) and / or real power (W) provided to the engaged biological tissue.

[0036] Such measurements of electrical parameters can be used to control the electrotherapy signal during delivery to the engaged biological tissue. For example, measurements of the voltage difference delivered to the engaged biological tissue and measurements of the current conducted by the engaged biological tissue can be used to determine and / or control the effective power provided to the engaged tissue. The effective power thus determined can then be compared to an electrotherapy schedule. Such comparison can be used to generate an error signal. Measurements of electrical parameters can also be used to determine stage control criteria for controlling the stages of electrotherapy. Stage control criteria can include criteria for stage initiation and termination, as well as criteria for intra-stage control.

[0037] Control circuitry 48 is configured to control the operation of electrical energy source 44 and / or measurement circuitry 46. Control circuitry 48 is electrically connected to electrical energy source 44 and measurement circuitry 46. Control circuitry 48 causes the electrical energy source to provide electrotherapy signals to biological tissue engaged by electrically connected electrosurgical instrument 14'. Control circuitry 48 causes electrical energy source 44 to generate the electrotherapy signals according to an electrotherapy schedule, and the generated electrotherapy signals are controlled for a particular electrosurgical procedure.

[0038] Various electrotherapy schedules can be used to achieve various types of electrotherapy. For example, in some examples, the active power (W) of the electrotherapy signal provided to the engaged biological tissue is controlled according to a power schedule. In other examples, the voltage difference (V) of the electrotherapy signal delivered to the engaged biological tissue is controlled according to a voltage schedule. In other examples, the current (A) of the electrotherapy signal conducted by the engaged biological tissue is controlled according to a current schedule. In yet other examples, the apparent power (VA) of the electrotherapy signal provided to the engaged biological tissue can be controlled according to a voltage-amperage schedule.

[0039] For example, control circuitry 48 can cause electrical energy source 44 to provide energy to the engaged biological tissue, such that the product of a voltage difference across the engaged biological tissue and a current conducted by the engaged biological tissue is controlled according to an electrotherapy schedule. Control circuitry 48 can use a comparison of the determined available power to the electrotherapy schedule to generate an error signal. Such an error signal can be used in a closed-loop feedback system that includes electrical energy source 44 to generate an electrotherapy signal according to the electrotherapy schedule.

[0040] As shown in FIG. 2 , the control circuit 48 includes a processor 54 and a memory 56. The control circuit 48 may include a timer and / or a clock. In some examples, the timer and / or clock are part of the processor 54. In other examples, the timer and / or clock are separate from the processor 54. In one example, the processor 54 is configured to perform functions and / or process instructions for execution within the electrosurgical system 10. For example, the processor 54 may receive and / or process instructions stored in a program memory 56P. The processor 54 may then execute program instructions to cause the electrical energy source 44 to generate electrotherapy signals according to a predetermined electrotherapy schedule. The predetermined electrotherapy schedule may be retrieved, for example, from the data memory 56D. The processor 54 may compare electrical parameters measured by the measurement circuit 46 with the retrieved predetermined electrotherapy schedule. The processor 54 may send commands to the electrical energy source 44 and / or the measurement circuit 46. The processor 54 may also send or receive information from the user interface 50.

[0041] 2 or various other elements. For example, the processor 54 may include any one or more of a microprocessor, control circuitry, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

[0042] The memory 56 can be configured to store information within the electrosurgical system 10 during operation. In some examples, the memory 56 is described as a computer-readable storage medium. In some examples, the computer-readable storage medium can include a non-transitory medium. The term “non-transitory” can indicate that the storage medium is not embodied as a carrier wave or a propagated signal. In certain examples, the non-transitory storage medium can store data that can change over time (e.g., in RAM or cache). In some examples, the memory 56 is a transient memory, meaning that the primary purpose of the memory 56 is not long-term storage. In some examples, the memory 56 is described as a volatile memory, meaning that the memory 56 does not retain its stored contents when power to the electrosurgical system 10 is interrupted. Examples of volatile memory can 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 56 is used to store program instructions for execution by the processor 54. In one example, memory 56 is used by software or applications operating on electrosurgical system 10 (e.g., software programs that implement electrical control of electrotherapy signals provided to biological tissue engaged by the electrosurgical instrument) to temporarily store information, such as in data memory 56D, during program execution.

[0043] In some examples, memory 56 may also include one or more computer-readable storage media. Memory 56 may be configured to store larger amounts of information than volatile memory. Memory 56 may further be configured for long-term storage of information. In some examples, memory 56 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 50 can be used to communicate information between the electrosurgical system 10 and a user (e.g., a surgeon or technician). The user interface 50 can include a communications module. The user interface 50 can include various user input / output devices. For example, the user interface can include various displays, audible signal generators, as well as switches, buttons, touchscreens, mice, keyboards, etc.

[0045] In one example, the user interface 50 utilizes 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 may 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 include Bluetooth, 3G, 4G, and Wi-Fi wireless computing devices, as well as universal serial bus (USB) devices.

[0046] 3A-3B are flow diagrams of non-limiting examples of methods for generating an electrical therapy signal for sealing biological tissue engaged by an electrosurgical instrument. The method 100 shown in FIGS. 3A-3B can be used in conjunction with an electrosurgical system, such as the electrosurgical system 10 shown in FIGS. 1-2. Using various techniques described below, the electrosurgical generator can control the energy delivery of the therapy signal provided to the biological tissue during a portion of a therapy phase according to incremental changes in energy delivery as a function of changes in a measured electrical parameter of the biological tissue. In some examples, the control circuitry can control the power of the therapy signal provided to the biological tissue during a portion of a therapy phase according to a therapy plan, such as by controlling the power during a phase providing tissue modification.

[0047] For example, the control circuit can incrementally modify the power as a function of current. In some examples, the function of current is a function of the change in current. The change in current can be the change in current during a pulse and thus may look more like a current value. In some examples, the function of current is a function of the measured instantaneous change in current and thus may look more like a slope of the current function. The control circuit can modify the power based on either these changes in current or the instantaneous change in current. In some examples, the function of the measured instantaneous change in current is a linear function. In other examples, the control circuit can incrementally modify the power as a function of resistance, such as when using a voltage-controlled technique.

[0048] 4, in some examples, the system can use a predefined power curve to control the power of the therapy signal provided to the biological tissue during a portion of the therapy phase. In some examples, the predefined power curve can include two or more linear portions.

[0049] It should be noted that Figures 3A and 3B and Figure 4 are specific, non-limiting examples used for illustrative purposes.

[0050] In some examples, the method can switch from using a power-controlled technique to using a voltage-controlled technique. With a voltage-controlled technique, an upper limit on the current can be set, but the current can be allowed to move freely according to the response impedance, thereby enabling variable power delivery. For example, the control circuit can deliver pulses using a power-controlled technique, and as the resistance increases, a boiling condition is approached or a threshold is reached, and the system can switch to a voltage-controlled technique. In this way, initially, the system can utilize a power-controlled technique to deliver energy more quickly, but as boiling is approached, the system can switch to the more responsive voltage-controlled technique. In some implementations using a voltage-controlled technique, the system can use a predefined voltage curve to control the power of the therapy signal provided to the biological tissue during a portion of the therapy phase. In some examples, the predefined voltage curve can include two or more linear portions.

[0051] In FIG. 3A, method 100 begins at step 102, where electrosurgical system 10 (shown in FIGS. 1-2) is powered up. Then, at step 104, an interrogation phase begins, where control circuitry 48 (shown in FIG. 2) causes electrical energy source 44 (shown in FIG. 2) to provide an interrogation signal, such as an interrogation pulse, to the engaged biological tissue during the interrogation phase. The power (W) of the provided interrogation signal is controlled according to an interrogation schedule. In some examples, the power level provided to the engaged biological tissue during the interrogation phase can be low enough to cause little or no tissue effect. Such low power levels can be provided for the purpose of obtaining measurements of electrical properties of the engaged biological tissue. Such measurements are optionally obtained before electrotherapy is provided to obtain pre-electrotherapy measurements. In some examples, the interrogation schedule indicates providing a constant power during the interrogation phase. Such a schedule can be referred to as a constant power schedule. In some examples, control circuitry 48 terminates the interrogation phase after a predetermined duration.

[0052] In step 106, the controller 48 causes the measurement circuitry 46 (shown in FIG. 2) to measure a first electrical resistance of the engaged biological tissue during the interrogation phase. The first time step 106 is performed, this measured electrical resistance becomes the reference resistance. Then, in step 108, the control circuitry 48 compares the measured electrical resistance to a previously measured minimum resistance (if any). If, in step 108, the measured electrical resistance is less than the minimum resistance, the method proceeds to step 110, where the measured electrical resistance is recorded as a new minimum value, and then the method proceeds to step 116 (the first leg of the drying or dehydration phase begins). However, if, in step 108, the measured electrical resistance is greater than the minimum resistance, the method proceeds to step 112, where the control circuitry 48 compares the measured electrical resistance to the sum of the minimum resistance and a predetermined resistance delta. If, at step 112, the measured electrical resistance is less than the sum of the minimum resistance and the predetermined resistance delta, the method proceeds to step 114 and the measured electrical resistance is ignored. However, if, at step 112, the measured electrical resistance is greater than the sum of the minimum resistance and the predetermined resistance delta, the method proceeds to step 146 shown in Figure 3B.

[0053] At step 116, a first interval of the drying or dehydration phase begins, such as when tissue modification is performed, and control circuitry 48 causes electrical energy source 44 to provide a first drying signal, such as a first drying pulse, to the engaged biological tissue during the first drying interval of the drying phase. The power (W) of the provided first drying signal is controlled according to a first drying schedule or regime, such as using a predefined power curve, such as having a linear ramp rate. In some examples, the first drying schedule or regime is a monotonically increasing power schedule, as shown between times t1 and t2 in the bottom graph of FIG. 4.

[0054] Then, in step 118, control circuitry 48 compares the provided power with a first threshold, such as a first predetermined maximum power. If, in step 118, the provided power is greater than the first predetermined maximum power, the method proceeds to step 130 shown in FIG. 3B, which indicates a second drying interval of the desiccation phase, as shown in the lower graph of FIG. 4 between times t2 and t3. In some examples including a second drying interval, control circuitry 48 may reduce the ramp rate in block 130, as shown in the lower graph of FIG. 4 between times t2 and t3. In this manner, control circuitry 48 may modify energy delivery during a first pulse, such as a first desiccation pulse, in response to a first electrical parameter, e.g., intermittently measured, of the engaged biological tissue satisfying a first threshold.

[0055] The system may, for example, intermittently measure a first electrical parameter, such as current, and reduce or terminate energy delivery during a therapy phase in response to the measured current in the engaged biological tissue meeting a first threshold, such as a predetermined value. In some examples, the predetermined value is an absolute current threshold. In some examples, the predetermined value is a threshold that can vary depending on the pulse count. In some examples, the predetermined value is a change in current relative to an initial current measurement. In some examples, the predetermined value is a change in current relative to a maximum current measurement during a pulse of the therapy signal.

[0056] However, if at step 118 the power provided is less than the first predetermined maximum power, the method proceeds to step 120, where control circuitry 48 causes measurement circuitry 46 to measure a first electrical parameter, such as impedance or current conducted by the engaged biological tissue.

[0057] In step 122, control circuit 48 compares the measured current (or impedance) for this pulse, e.g., a first electrical parameter, to a previously measured maximum current (if any), e.g., a threshold value. If, in step 122, the measured current is greater than the maximum current, the method proceeds to step 124, where the measured current is recorded as a new maximum value, and then the method returns to step 116 to continue the first drying leg of the drying phase by modifying the energy delivery during the first pulse. However, if, in step 122, the measured current is less than the maximum current, the method proceeds to step 126, where control circuit 48 compares the measured current to a predetermined percentage of the maximum current.

[0058] If, at step 126, the measured current, e.g., the first measured current, is greater than a predetermined current threshold, e.g., the second measured current, the method returns to step 116 to continue the first drying interval of the drying phase. In some examples, the predetermined current threshold can be a ratio or percentage of the maximum current, such as, for example, 0.9, 0.8, 0.66, 0.5, and 0.4. In other words, the control circuit 48 can continue the drying signal or pulse in response to the ratio of the first measured current to the second measured current exceeding a predetermined factor indicating that a phase change of the liquid in the engaged biological tissue has not occurred. In other examples, the predetermined current threshold can be a difference rather than a ratio.

[0059] However, if, at step 126, the measured current is less than the predetermined percentage of the maximum current, the method proceeds to step 128, where the first drying pulse of the first drying interval of the drying phase is terminated. The method then returns to step 104, where the interrogation phase is repeated, after which the drying phase can be repeated or the sealing phase can begin. In other words, the system can monitor the current during a therapy phase to determine when the therapy phase should end.

[0060] In some examples, as opposed to determining whether the measured current is less than a predetermined percentage of the maximum current in step 126, control circuitry 48 may determine whether the measured current is less than a predetermined percentage (or offset) of the current value measured at a predetermined time interval after the initiation of the pulse. In the case of an impedance monitoring system, control circuitry 48 may determine whether the measured impedance is greater than a predetermined percentage (or offset) of the resistance value measured at a predetermined time interval after the initiation of the pulse.

[0061] At step 130 (shown in FIG. 3B ), the second section of the drying stage begins, and the control circuitry 48 causes the electrical energy source 44 to provide a second drying signal, such as a second drying pulse, to the engaged biological tissue during the second drying section of the drying stage. While first and second drying sections of the drying stage are shown in FIGS. 3A and 3B , it should be noted that the second drying section of the drying stage need not be present. Conversely, in some examples, the drying stage can end during the first drying section. The power (W) of the provided second drying signal, such as a second drying pulse, is controlled according to a second drying schedule or plan, such as using a predefined power curve. In power-controlled (or voltage-controlled or current-controlled) techniques, the system can control the setting of an operating energy level. A power (or voltage or current) constraint refers to an upper limit or threshold that the controlled current will not cross, and beyond which an error condition occurs.

[0062] In another example, the voltage (V) of the engaged biological tissue is controlled during the second desiccation interval. In voltage-controlled techniques, the system can control the setting of the operating energy level. The voltage constraint refers to an upper limit or threshold that the controlled voltage will not cross, and if exceeded, an error condition occurs. In voltage-controlled implementations, the control circuit can monitor the voltage of the therapy signal, and when a threshold or upper limit is met, the control circuit can maintain the voltage at that threshold. In some voltage-controlled implementations, the voltage can be limited by an upper limit. In other voltage-controlled implementations, the voltage can vary over time.

[0063] In the illustrated example, the second drying interval uses a second drying schedule or regimen that is a monotonically increasing power schedule. In some examples, for example, the second drying schedule or regimen is a linearly increasing power schedule. Then, in step 132, control circuitry 48 compares the provided power with a second predetermined maximum power. If, in step 132, the provided power is greater than the second predetermined maximum power, the method proceeds to step 134, where control circuitry 48 causes electrical energy source 44 to provide power equal to the second predetermined maximum power, e.g., a power cap, and method 100 then proceeds to step 136. However, if, in step 132, the provided power is less than the second predetermined maximum power, the method proceeds to step 136, where control circuitry 48 causes measurement circuitry 46 to measure the current conducted by the engaged biological tissue.

[0064] At step 138, control circuitry 48 compares the measured current to a previously measured maximum current. If, at step 138, the measured current is greater than the maximum current, the method proceeds to step 140, where the measured current is recorded as a new maximum value, and then the method returns to step 130 to continue the second drying phase. However, if, at step 138, the measured current is less than the maximum current, the method proceeds to step 142, where control circuitry 48 compares the measured current to a predetermined percentage of the maximum current. If, at step 142, the measured current is greater than the predetermined ratio or percentage of the maximum current, the method returns to step 130 to continue the second drying leg of the drying phase. In other words, control circuitry 48 can reduce the drying signal or pulse in response to the ratio of the measured first current to the measured second current exceeding a predetermined factor indicative of a phase change of liquid within the engaged biological tissue. In another example, the predetermined current threshold can be a difference. However, if at step 142 the measured current is less than a predetermined percentage of the maximum current, the method exits the second leg of the drying phase and returns to step 104, where the interrogation phase may be repeated, after which the drying phase may be repeated, or the sealing phase may begin. In other words, the system may monitor the current during the therapy phase to determine when the therapy phase should end.

[0065] At step 146, the sealing or coagulation phase begins, and the control circuitry 48 causes the electrical energy source 44 to provide a sealing signal, such as a sealing pulse, e.g., a second pulse, to the engaged biological tissue during the sealing phase, as shown between times t7 and t8 in the lower graph of FIG. 4. The power (W) of the provided sealing signal, such as a sealing pulse, is controlled according to a sealing schedule or scheme. In some examples, the sealing schedule or scheme is a monotonically increasing power schedule. Then, at step 148, the control circuitry 48 compares the provided power with a third predetermined maximum power. Note that this is an example of a predetermined power curve, which happens to have a constant power domain. If, at step 148, the provided power is greater than the third predetermined maximum power, the method proceeds to step 150, where the control circuitry 48 causes the electrical energy source 44 to provide power equal to the third predetermined maximum power. Then, the method 100 proceeds to step 152, where a second parameter of the engaged biological tissue, such as tissue resistance, is measured, e.g., intermittently. However, if at step 148 the power provided is less than the third predetermined maximum power, the method proceeds to step 152 where control circuitry 48 causes measurement circuitry 46 to measure the electrical resistance of the engaged biological tissue.

[0066] In step 154, control circuit 48 compares the measured electrical resistance with a second threshold, such as a calculated ending resistance value. In some examples, the resistance of the calculated ending resistance value is calculated based on a reference resistance, e.g., the first resistance, measured in step 106. For example, the ending resistance value can be a predetermined coefficient multiplied by the measured reference resistance. In some examples, the ending resistance value can be a predetermined resistance delta plus either the measured reference resistance or the minimum resistance measured during that or previous stages. In some examples, the target resistance is a predetermined delta resistance, and the predetermined delta resistance is the change in resistance relative to the minimum resistance measurement during a pulse of the therapy signal.

[0067] If, at step 154, the measured electrical resistance is less than the calculated termination resistance, the method returns to step 146 to continue the sealing phase. However, if, at step 154, the measured electrical resistance is greater than the calculated termination resistance, the sealing phase is terminated and the method ends. In other words, in response to, for example, the intermittently measured impedance satisfying a second threshold, such as changing by, for example, a predetermined delta impedance value, the method can modify the energy delivery of the second pulse, such as by reducing or terminating energy delivery during this therapy phase, such as the sealing phase.

[0068] In some non-limiting examples, the method shown in Figures 3A and 3B can be implemented by a system such that the control circuitry monitors a first electrical parameter, such as current, during a first therapy phase, such as a drying phase, and reduces or terminates a first pulse based on the first electrical parameter, and monitors a second electrical parameter, such as impedance, during a second therapy phase, such as a sealing phase, and reduces or terminates a second pulse based on the second electrical parameter.

[0069] FIG. 4 is a graph illustrating a non-limiting example of an electrotherapy schedule or regimen used to control power provided to sealed biological tissue. In FIG. 4, graph 200 has a horizontal axis 202, vertical axes 204A-204C, and functional relationships 206A-206C. Horizontal axis 202 represents time (seconds). The horizontal axis also has times t0-t8, which represent the transition times between the interrogation phase, the desiccation phase, and the sealing phase, which are disclosed in the discussion of method 100 for generating an electrotherapy signal for treating biological tissue engaged by an electrosurgical instrument. These phases (the interrogation phase, the first desiccation phase, and the sealing phase) are also shown at various locations on graph 200. Note that the graph in FIG. 4 is for illustrative purposes only. The graph in FIG. 4 illustrates one example of a response, and different tissues may react differently.

[0070] Vertical axis 204A represents power (W) provided to engaged biological tissue by the electrosurgical device. Functional relationship 206A represents a non-limiting example power / time relationship corresponding to an electrotherapy signal generated according to the non-limiting example method 100 shown in FIGS. 3A-3B. Vertical axis 204B represents current conducted by engaged biological tissue. Functional relationship 206B represents current / time relationship for current conducted by engaged biological tissue to which an electrotherapy signal generated via method 100 is provided. Vertical axis 204C represents electrical resistance of engaged biological tissue. Functional relationship 206C represents electrical resistance / time relationship corresponding to the electrical resistance of engaged biological tissue to which an electrotherapy signal generated via method 100 is provided.

[0071] In some examples, the functional relationship 206A can be a predefined power curve including an interrogation phase, a drying phase, and a sealing phase. In the specific, non-limiting example shown in FIG. 4, the drying phase represents the first and second drying intervals. From time t0 to t1, the power / time relationship 206A represents the interrogation phase. In some examples, the duration of the interrogation phase is the length required to obtain a baseline measurement of the engaged biological tissue. For example, the duration of the interrogation phase can be less than 1.0, 0.5, 0.25, or 0.1 seconds. As shown in graph 200, the interrogation phase is a constant power schedule or plan with a power P1 (W). From time t0 to t1, the current / time relationship 206B represents a rapid rise in the interrogation current conducted by the engaged biological tissue, followed by a plateau in the current and then a slight decrease in the current. Because the power is controlled to be constant throughout this interrogation phase, the voltage applied to the engaged biological tissue is inversely proportional (in a multiplicative sense, not an additive sense) to the current / time relationship. As the temperature of the fluid within the tissue increases, the resistance of the engaged biological tissue may initially decrease, and since this is the first time the interrogation step is performed, the measured electrical resistance is greater than or equal to the lowest resistance previously measured, and therefore the method proceeds to the first drying step.

[0072] From time t1 to t2, power / time relationship 206A indicates the first interval of the drying stage. As shown in graph 200, the first drying interval of the drying stage is a power schedule or scheme that monotonically increases from power P1 to P2 (W). From time t1 to t2, current / time relationship 206B indicates that the current conducted by the engaged biological tissue increases throughout the first interval of the drying stage. Because power is controlled throughout this first interval of the drying stage according to a desiccation schedule or scheme, the product of the voltage applied to the engaged biological tissue and the current / time relationship should result in power / time relationship 206A. Although not shown, in some examples, electrical resistance / time relationship 206C can indicate that the electrical resistance of the engaged biological tissue may initially decrease as the tissue warms, but then increase as the tissue begins to dry during the first interval of the drying stage. Such increasing electrical resistance can indicate drying of the engaged biological tissue. Because the current falls below a percentage of the previously measured maximum current before the power / time relationship 206A rises to the predetermined threshold, the method proceeds to a second interval of the drying stage. If the current falls below a percentage of the previously measured maximum current during this first interval of the drying stage, then a subsequent second interval of the drying stage may not be necessary (e.g., may be bypassed).

[0073] Between times t2 and t3, power / time relationship 206A indicates a second interval of the drying phase. As shown in graph 200, the second interval of the drying phase is a power schedule or scheme that monotonically increases from power P2 to P3 (W). Using the techniques described above with respect to FIGS. 3A and 3B, a control circuit, such as control circuit 48 of FIG. 2, can control the energy delivery of a therapy signal provided to the biological tissue during a portion of the therapy phase according to incremental changes in energy delivery as a function of changes in a measured electrical parameter of the biological tissue. For example, the control circuit can incrementally modify the power as a function of current. In some examples, the function of current is a function of the instantaneous change in measured current. In some examples, the function of the instantaneous change in measured current is a linear function. In other examples, the control circuit can incrementally modify the power as a function of resistance.

[0074] At times t2-t3, current / time relationship 206B shows that the current conducted by the engaged biological tissue increases at the beginning of the second interval of the drying phase, reaches a peak, and then decreases at the end of the second interval of the drying phase. Note that the second interval of the drying phase is not required. In some examples, power can be controlled throughout this second interval of the drying phase such that the product of the voltage applied to the engaged biological tissue and the current / time relationship can result in a particular power / time relationship 206A.

[0075] In some examples, the second section of the drying phase increases monotonically, but at a slower rate than the first section of the drying phase. In other examples, the second section of the drying phase increases linearly until the provided power equals a predetermined maximum level, after which the provided power is held constant. If a current decrease ΔI1, e.g., a change in the measured current (e.g., block 126 in FIG. 3A ), results in a current less than a predetermined percentage of the measured maximum current, the method returns to the interrogation phase, as shown at time t3. In other words, the current change ΔI1 causes the method to enter the interrogation phase at time t3. Note that in the non-limiting example shown in FIG. 4 , the current change ΔI1 that enters the method into the interrogation phase occurs after time t2. However, in other examples, the current change ΔI1 that enters the method into the interrogation phase can occur after time t1, during the first section of the drying phase, and a second section of the drying phase is not required. However, if instead the current decrease ΔI1 is less than a predetermined percentage of the measured maximum current, the method should remain in the drying phase.

[0076] As seen in FIG. 4, in some examples, the predefined power curve 206A may include two or more linear portions, as shown from t1 to t2 and from t2 to t3.

[0077] Between times t3 and t4, the power / time relationship 206A again indicates an interrogation phase. As shown in graph 200, the interrogation phase is a constant power schedule of power P1 (W). Because the power is controlled to be constant throughout this interrogation phase, the voltage applied to the engaged biological tissue is inversely proportional (in a multiplicative sense, not an additive sense) to the current / time relationship. The electrical resistance / time relationship 206C indicates that the electrical resistance of the engaged biological tissue decreases throughout this execution of the interrogation phase. This decrease in electrical resistance can result in condensation of fluid within the tissue or migration of fluid into the tissue. Because the measured electrical resistance is less than or equal to the sum of the baseline resistance and the predetermined delta resistance, the method again proceeds to the first drying phase.

[0078] At times t4-t5, the power / time relationship 206A shows another first interval of the drying stage. The power / time relationship from times t4-t5 is similar to the power / time relationship 206A from times t1-t2 and will not be described in detail again for purposes of brevity.

[0079] At time t5-t6, power / time relationship 206A indicates another second interval of the desiccation phase. The power / time relationship from time t5-t6 is similar to power / time relationship 206A from time t2-t3 and, for purposes of brevity, will not be described in detail again. Because power is controlled to be constant throughout this second interval of the desiccation phase, the product of the voltage applied to the engaged biological tissue and the current / time relationship should result in power / time relationship 206A. If the current decrease ΔΙ2, e.g., the measured change in current (e.g., block 142 of FIG. 3B), is less than a predetermined percentage of the maximum measured current, the method returns to the interrogation phase.

[0080] At time t6-t7, power / time relationship 206A indicates another interrogation phase. The power / time relationship from time t6-t7 is similar to power / time relationship 206A from time t3-t4 and, for purposes of brevity, will not be described in detail again. Here, the measured electrical resistance is greater than the reference resistance plus the predetermined delta resistance, so the method proceeds to the sealing phase.

[0081] From time t7 to t8, power / time relationship 206A indicates the sealing phase. As shown in graph 200, the sealing phase is a monotonically increasing power schedule or plan from power P1 to power P3 (W). From time t7 to t8, current / time relationship 206B indicates that the current conducted by the engaged biological tissue increases throughout the sealing phase. Electrical resistance / time relationship 206C indicates that the electrical resistance of the engaged biological tissue increases during this sealing phase. This increased electrical resistance can result in desiccation of the engaged biological tissue, thereby achieving sealing. Here, the measured electrical resistance is greater than the predetermined termination resistance, so the sealing phase is terminated and the method ends.

[0082] Predictive stepwise control of electrotherapy signals (Figures 5 and 6) An electrosurgical procedure can have one or more electrotherapy phases. For example, an electrosurgical tissue sealing technique can have an interrogation phase, a desiccation phase, and / or a sealing phase. During each of these electrotherapy phases, a corresponding electrotherapy signal, such as an interrogation signal, a heating signal, a desiccation signal, or an ablation signal, can be provided to the engaged biological tissue by the electrosurgical instrument. The electrotherapy signal provided to the engaged biological tissue can be tailored to the technique being performed and / or the specific tissue. Thus, each electrosurgical signal can be different for different procedures, different tissue types and quantities, and different electrotherapy phases. These differences in the different electrotherapy signals can be achieved using different electrotherapy schedules and / or different phase control criteria. The differences between different electrotherapy schedules can result from differences in the controlled electrical parameters and / or different phase control criteria. As described above, differences in the controlled electrical parameters include the apparent power (VA), real power (W), voltage (V), and / or current (A) of the electrotherapy signal. The phase control criteria include criteria for phase initiation and termination, as well as criteria for intra-phase control. Such tiered control criteria include contemporaneous tiered control criteria and predictive tiered control criteria.

[0083] Concurrent phase control is performed by controlling phases using real-time measurements. Predictive phase control is performed by generating future phase control criteria using reference measurements obtained at reference times. For example, tissue resistance measurements obtained before or during a drying phase can be used to generate a duration for continuing the drying phase. In some examples, the tissue resistance measurements can be used to select one of a plurality of predetermined electrotherapy schedules. The selected electrotherapy schedule from the plurality of predetermined electrotherapy schedules can be used in the next electrotherapy phase.

[0084] The baseline measurement of tissue resistance can indicate, for example, vessel size. Different electrotherapy schedules or plans and / or different step control criteria can be used to heat vessels of different sizes. An appropriate electrotherapy schedule or plan customized for vessel size can provide more reliable sealing and less trauma to nearby tissue. To ensure proper sealing of the engaged vessel, the electrotherapy schedule can be adjusted according to the size of the vessel to be sealed. Vessel size can be estimated based on the measured baseline resistance of the engaged vessel. Vessel sealing can then proceed according to the electrotherapy schedule determined based on the measured baseline resistance of the engaged vessel.

[0085] Techniques for predicting and delivering energy based, among other things, on the size of the detected tissue are described below with respect to Figure 6. After an electrosurgical generator, such as electrosurgical generator 12 of Figure 2, delivers an initial application of energy to biological tissue via an electrosurgical device, a control circuit, such as control circuit 48 of Figure 2, and a measurement circuit, such as measurement circuit 46 of Figure 2, can measure or calculate the tissue impedance at a point in time. The control circuit can then determine the type of tissue in contact with the electrosurgical device, such as between the jaws of the electrosurgical device, for example, a small or large blood vessel, and then deliver energy in accordance with the detected tissue type.

[0086] FIG. 6 is a flow diagram of a method for sealing biological vessels using a power schedule corresponding to the size of the biological vessel engaged by the electrosurgical instrument. The method of FIG. 6 uses three therapy phases: Phase 1 is an interrogation phase, Phase 2 is a dehydration or desiccation phase, and Phase 3 is a vessel coaptation phase. In Phase 1, an electrosurgical system, such as electrosurgical system 10 of FIG. 1, can perform error checking, generate an interrogation signal according to an interrogation schedule, or the like, and deliver the interrogation signal to the engaged tissue. Although illustrated as voltage-controlled in FIG. 6, the control circuitry can deliver energy using a power-controlled technique or a voltage-controlled technique. In a voltage-controlled technique, the current can be capped but allowed to move freely according to the response impedance, thereby allowing for variable power delivery.

[0087] Using the techniques of the present disclosure, the method can begin a stage, such as Stage 2, without the control circuit determining which criteria to use to terminate the stage. For example, as described in more detail below, the method can begin Stage 2, and the control circuit and measurement circuit can determine tissue impedance measurements. In response, the control circuit can determine whether to terminate Stage 2 based on a time measurement or on repeated impedance measurements. In this way, the control circuit has two separate criteria for how to terminate Stage 2, but enters Stage 2 without preselecting which of the two criteria to use.

[0088] At block 1900, Phase 1 begins, and at block 1901, the control circuit and measurement circuit may measure and / or calculate an initial impedance value R0 at time T0. At block 1902, the control circuit may set a voltage ramp rate or slope for Phase 2. The voltage setting may be a constant voltage, an increasing voltage, or a decreasing voltage. For power-controlled implementations, the control circuit may also set a power ramp rate or slope for Phase 2. The power may be a constant power, an increasing power, or a decreasing power. The output of Phase 1 is the initial impedance value R0.

[0089] At block 1904, Phase 2 begins. At block 1906, after a set period of time, the control and measurement circuitry may measure or calculate a baseline impedance R1. The tissue impedance may have changed from an initial impedance R0 to an impedance R1. Impedance R1 is measured to determine whether Phase 2 is an open-loop phase (terminated based on a time criterion, such as by a timer expiring) or a closed-loop phase (terminated based on an impedance criterion, for example). For drier tissue, it may be desirable to perform Phase 2 as open-loop, and for wetter tissue, it may be desirable to perform Phase 2 as closed-loop.

[0090] At block 1908, the control circuit may determine whether the impedance R1 is greater than or equal to a threshold impedance value Ra. In some examples, the impedance Ra may be an absolute impedance. In other examples, the impedance Ra may be a delta value, such as a predetermined increase from the measured initial impedance R0. In some examples, the impedance Ra may be approximately 90 ohms.

[0091] In some examples, in addition to or instead of comparing the measured impedance R1 to the threshold impedance R a, the control circuitry can compare some other measured parameter to a threshold parameter. For example, the control circuitry can compare the measured phase angle to a threshold phase angle. Examples of other parameters that can be used include, but are not limited to, energy delivered over a period of time, current draw, tissue temperature, etc.

[0092] If the control circuit determines that impedance R1 is greater than or equal to impedance Ra (the "Yes" branch of block 1908), the control circuit may execute Phase 2 open-loop at block 1910 and continue delivering power until a timer expires at time T2. Phase 2 is terminated based on a time criteria, such as by a time interval, at block 1912.

[0093] However, if the control circuit determines that impedance R1 is less than or equal to impedance Ra (the "No" branch of block 1908), the control circuit may execute stage 2 as a closed loop starting at block 1914. At block 1916, the control circuit may measure impedance R2N at set time intervals. At block 1918, the control circuit may determine whether the current impedance measurement R2N is greater than or equal to the impedance threshold R2X.

[0094] If the control circuit determines that impedance R2N is less than or equal to impedance R2X (the "No" branch of block 1918), the method may continue applying power and may return to block 1914. The method may repeat the impedance measurements at time intervals in block 1916 and determine whether the new impedance measurements are greater than or equal to the threshold value in block 1918. In this manner, the method may continue applying power and may repeatedly compare the impedance measurements to the threshold impedance value.

[0095] If the control circuit determines that impedance R2N (or any of the subsequent impedance measurements, if necessary) is greater than or equal to impedance R2X (the "Yes" branch of block 1918), the control circuit may terminate Stage 2 at block 1920 based on an impedance criterion (as opposed to the time criterion described above with respect to the open-loop process).

[0096] After the control circuit terminates Phase 2, whether Phase 2 was terminated based on time or an impedance measurement, the control circuit may calculate and store an impedance measurement R3 at block 1922. Next, at block 1924, the control circuit may determine whether the current impedance measurement R3 is less than or equal to an impedance threshold RX.

[0097] If the control circuit determines that impedance R3 is greater than or equal to impedance RX ("Yes" branch of block 1924), the tissue is a small vessel and the method may begin Phase 3 at block 1926. At block 1928, the control circuit may run Phase 3 as an open loop and continue delivering power until a timer expires at time T3. At block 1930, Phase 3 ends based on the time interval.

[0098] However, if the control circuit determines that impedance R3 is less than or equal to impedance Rx (the "No" branch of block 1924), the tissue is a large vessel and the method may begin Phase 3 at block 1932, which the control circuit may execute as a closed loop. At block 1934, the control circuit may measure impedance R3N at set time intervals. At block 1936, the control circuit may determine whether the current impedance measurement R3N is greater than or equal to the impedance threshold R3X.

[0099] If the control circuit determines that impedance R3N is less than or equal to impedance R3X (the "no" branch of block 1936), the control circuit may determine whether a maximum time limit has been reached at block 1938. If the control circuit determines that a maximum time limit has been reached (the "yes" branch of block 1938), the control circuit may terminate Phase 3 at block 1940. In some examples, the time limit may be the elapsed time since the start of Phase 1.

[0100] However, if the control circuit determines that the maximum time limit has not been reached (the "No" branch of block 1938), the control circuit may continue applying power and may return to block 1934. The method may repeat the impedance measurements at time intervals in block 1934 and determine whether the new impedance measurements are greater than or equal to the threshold impedance value R3X in block 1936. In this manner, the method may continue applying power and repeatedly compare the impedance measurements to the threshold impedance value R3X.

[0101] If the control circuit determines that impedance R3N is greater than impedance R3X (the "Yes" branch of block 1936), then at block 1942 the control circuit may terminate stage 3 based on the impedance measurement (as opposed to the time criteria discussed above with respect to the open-loop process of the stage).

[0102] Correction of the measured electrical resistance of engaged biological tissue (Figure 7A-Figure 7B and Figure 9) The various electrical measurements described above can be used in determining an electrotherapy schedule and / or determining tier control criteria. Accurate measurements, therefore, facilitate the generation of an electrotherapy signal that is successful for its therapeutic purpose. The temperature of the electrosurgical device and the biological tissue engaged by the electrosurgical device affects the electrical measurements of the engaged biological tissue. Such temperature / measurement relationships can introduce uncertainty and / or complexity into the use of such electrical measurements when determining an electrotherapy schedule and / or tier control criteria. For example, comparing two electrical measurements of the engaged tissue obtained when the engaged tissue and / or electrosurgical device are at different temperatures can be complicated.

[0103] Some examples correct electrical measurements of the engaged tissue to account for the temperature of the electrosurgical device and / or the biological tissue. For example, the measured electrical resistance of the biological tissue can be corrected based on an actual temperature measurement of the electrosurgical device. In some examples, the electrosurgical device is equipped with a temperature sensor in thermal communication with the distal end that engages the biological tissue. In other examples, the measured electrical resistance of the biological tissue can also be corrected based on a predicted temperature of the tissue and / or the electrosurgical device based on various indirect measurements. For example, the measured tissue resistance can be corrected based on the time interval between a reference time when power was delivered to the biological tissue and the time of measurement. In some examples, the measured tissue resistance can be corrected based on a calculation of the energy provided to the engaged tissue prior to the electrical measurement.

[0104] FIG. 7A is a graph showing measured tissue resistance as a function of forceps jaw temperature. In FIG. 7A, graph 400 includes a horizontal axis 402, a vertical axis 404, and an electrical resistance / temperature relationship 406. Horizontal axis 402 represents forceps jaw temperature. Vertical axis 404 represents the measured electrical resistance of tissue clamped between opposable jaw members of a forceps, such as forceps 14 shown in FIG. 1 . Electrical resistance / temperature relationship 406 represents measurements of specific biological tissue clamped by opposable jaw members heated to various temperatures. Electrical resistance / temperature relationship 406 represents a monotonically decreasing function, such that as jaw temperature increases, the measured electrical resistance decreases. Such variations in measured electrical resistance can result from many factors, including the dependence of electrical resistance on tissue temperature, the tissue-fluid phase, the jaw-tissue interface, jaw temperature, etc.

[0105] Such variations in measured tissue resistance can lead to uncertainty and / or complexity when using such measured electrical resistance to determine electrical therapy schedules and / or stage control criteria. Some electrical resistance dependencies are undesirable because they do not indicate a therapeutic effect on the biological tissue. Therefore, compensation for these undesirable dependencies can improve the quality of such electrical resistance measurements. Various methods of compensating electrical measurements of biological tissue can be implemented to provide measurements that are more indicative of the therapeutic effect of the electrotherapy treatment.

[0106] FIG. 7B is a graph showing the relationship between jaw temperature and time after the end of power application. In FIG. 7B, graph 410 includes a horizontal axis 412, a vertical axis 414, and a temperature-time relationship 416. Horizontal axis 412 indicates time after application of an electrotherapy signal is provided to biological tissue. During this post-treatment time, no power is delivered to the biological tissue. Vertical axis 414 indicates the measured temperature of the opposable jaw members of the forceps used to provide the electrotherapy signal to the tissue. Temperature-time relationship 416 shows measurements of jaw temperature at various post-treatment times. Temperature-time relationship 416 is a monotonically decreasing function of time that asymptotically approaches room temperature. Such a temperature-time relationship can be characterized by a time constant indicating the rate of decay.

[0107] The relationships shown in graphs 400 and 410 can be used when modeling jaw temperature as a function of power application and duration after power application. For example, the power dissipated by biological tissue engaged by an electrosurgical instrument can be used to predict the temperature of the biological tissue, as well as the temperature of the engaging portion of the electrosurgical instrument (e.g., opposable jaw members 36 and 38 shown in FIG. 1 ). Such jaw temperature-power application relationships can be determined theoretically (e.g., using the tissue volume within the engagement range of the opposable jaw members) and experimentally (e.g., by characterizing the instrument). In some examples, the position of the engaged jaw members can be used, for example, when determining the tissue volume within the engagement range of the jaw members. In some examples, a combination of theoretical and experimental characterization can be used to model the relationship between jaw temperature and power application. Jaw temperature-time after treatment can likewise be characterized experimentally and / or theoretically.

[0108] Additionally, electrical resistance dependence, which is undesirable because it does not exhibit a therapeutic effect on biological tissue, can also be characterized experimentally and / or theoretically. These various characterizations or models can then be combined to determine a compensated resistance value based on the measured resistance value. For example, measurements of tissue resistance obtained during application of an electrotherapy signal to the biological tissue can be used to compensate for jaw temperatures calculated based on an electrotherapy schedule. After application of the electrotherapy signal to the biological tissue, a post-treatment duration can be used to compensate the measured tissue resistance.

[0109] FIG. 8 is a graph illustrating electrical resistance compensation versus time after power application. In FIG. 8, graph 420 includes a horizontal axis 422, a vertical axis 424, and a delta resistance / time relationship 426. Horizontal axis 422 indicates time after application of an electrotherapy signal is provided to the biological tissue. During this post-treatment time, no power is delivered to the biological tissue. Vertical axis 424 indicates the delta resistance required to compensate for the measured tissue resistance. In some instances, instead of using an additive delta resistance correction, a multiplicative factor can be used. Delta resistance / time relationship 426 indicates the delta resistance correction factor required to compensate for jaw temperature at various post-treatment times. Delta resistance / time relationship 426 is a monotonically decreasing function of time that asymptotically approaches zero.

[0110] In one example, the measured tissue resistance can be compensated when the electrosurgical device is hotter than a predetermined threshold, rather than when the electrosurgical device is colder than a predetermined threshold. FIG. 8 shows operating intervals 428 and 430 that separate these two compensation regimes (e.g., high and low device regimes). Operating interval 428 extends from a time immediately after application of the electrotherapy signal to the biological tissue to a predetermined time after application of the electrotherapy signal to the biological tissue. During this high device regime, the measured tissue resistance is compensated by adding a predetermined delta resistance value to the measured tissue resistance. In the example shown in FIG. 8, the time that separates the transition from the high device regime to the low device regime is approximately 30 seconds after treatment. In the low device regime, compensation of the measured tissue resistance is not performed.

[0111] Correction of initial impedance (Figure 9) A control circuit of an electrosurgical generator, such as control circuit 48 of electrosurgical generator 12 of FIG. 2, can use a predictive algorithm to generate and deliver electrotherapy signals to biological tissue engaged with the electrosurgical device, such as between the jaws of forceps 14 of FIG. 1. The predictive algorithm can include multiple stages. For example, stage 1 can initially access vascular impedance and various energy delivery parameters using low-power energy. Based on the initial impedance determined in stage 1, the system can determine the size of the vessel to be sealed, set parameters for desiccation of the vascular tissue in stage 2, and provide an appropriate energy level and duration to seal the vessel in stage 3.

[0112] However, accurately predicting vessel size can be difficult. For example, the initial vessel impedance, which can be used to determine vessel size, can be affected by the temperature of the jaws of the electrosurgical device. The jaws may have a high temperature if a user attempts to seal a second vessel immediately after sealing a first vessel. The high temperature can affect the initial vessel impedance measurement.

[0113] The inventors recognized a need to reduce the temperature effect of initial impedance measurements to improve vessel size prediction. As described in more detail below, the inventors recognized that in some examples, a temperature sensor coupled to the jaws can be used to determine the temperature of the jaws, and a correction factor based on the jaw temperature can then be used to modify the measured impedance. In other examples, the inventors recognized that a correction factor based on one or both of the elapsed time since the previous activation or the electrical characteristics of the previous activation can be used to modify the measured impedance. Using the modified impedance values, the electrosurgical system can more accurately predict vessel size, which can be used to determine settings for the electrosurgical generator.

[0114] 9 is a flow diagram of a biological vessel sealing method that can compensate for tissue impedance measurements after power application. At block 2000, control circuitry and measurement circuitry, such as control circuitry 48 and measurement circuitry 46 (both FIG. 2), can measure an initial impedance R0 of biological tissue engaged with an electrosurgical device, such as forceps 14 of FIG. 1, at step 1. At block 2002, the control circuitry and measurement circuitry can measure the temperature of the jaws of the electrosurgical device using a temperature sensor coupled to the jaws.

[0115] In block 2004, using the measured impedance and the measured jaw temperature, the control circuit can consult a stored data log or set, such as a look-up table, to determine or select an adjusted or corrected impedance that is a modification of the initial impedance R0 to offset the jaw temperature.

[0116] The control circuitry can use the determined adjusted impedance to determine vessel size at block 2006. For example, using an algorithm or another stored data set, the control circuitry can use the adjusted impedance to determine vessel size.

[0117] The control circuitry can then use the determined vessel size to determine various electrical parameters that define the electrosurgical signal that the electrosurgical generator will generate and deliver to the biological tissue of the vessel at block 2008. In some examples, the vessel size can be determined to be a small vessel or a large vessel, and there can be two electrosurgical signal settings corresponding to those two vessel sizes. In other examples, there can be a range of vessel sizes and electrosurgical settings corresponding to those vessel sizes.

[0118] At block 2010, the control circuitry can control the delivery of electrosurgical signals to the vessel to perform sealing using the determined signal settings, and the method can end at block 2012.

[0119] Instead of using jaw temperature, some examples may store the time since the last activation, as shown in block 2014. The longer the time, the cooler the jaws have become. In this way, the time since the last activation can be used in place of jaw temperature.

[0120] In block 2004, the control circuit can determine an adjusted impedance using the measured initial impedance R0 and the time elapsed since the last activation. In some examples, the control circuit can compare the elapsed time to a time T, e.g., 20 seconds, and if the elapsed time is equal to or greater than T, the control circuit can use the initial impedance as the adjusted impedance. However, if the elapsed time is equal to or less than T, the control circuit can add a compensation value to the initial impedance R0 to determine the adjusted impedance. As an example, the compensation value can be approximately 80-90 ohms. Note that the compensation value and the time T can depend on the jaw design.

[0121] In some examples, rather than adding a compensation value to determine the adjusted impedance, the control circuit may consult a stored data log or set, such as a look-up table, to determine or select an adjusted impedance that is a modification of the initial impedance R0 to account for the time elapsed since the previous activation.

[0122] After the control circuit determines the adjusted impedance, the method may proceed from block 2006 onwards to determine vessel size, signal settings and perform vessel sealing, as described above.

[0123] In block 2014, in some examples, one or more electrical characteristics from the previous activation can be used in addition to the time elapsed since the last activation. For example, the control circuit can use the amount of energy or current from the previous activation to determine whether the previous activation generated a large amount of heat to the jaws. If the activation was accidental or terminated quickly, little energy or current would have been delivered to the tissue and the jaws would not have heated significantly.

[0124] In some examples, the control circuitry can determine the amount of energy from a previous activation by integrating the power curve of the previous activation. In other examples, the control circuitry can determine the amount of energy from a previous activation by retrieving the application time and average delivered power from a stored data set and multiplying this time by the average delivered power. Combining elapsed time information with energy or current information from a previous activation can improve the accuracy of the initial impedance R0 measurement and increase the system's ability to determine vessel size. Elapsed time, temperature, and electrical properties such as energy and current can be more broadly referred to as "sealing parameters."

[0125] In some examples using both elapsed time and an electrical characteristic, the control circuit may use the initial impedance R0 as the adjusted impedance if the electrical characteristic, such as energy or current, is below a threshold. If the electrical characteristic is not below a threshold, the method may use elapsed time to determine the adjusted impedance.

[0126] If the elapsed time is greater than the threshold, this should indicate that the jaws have cooled sufficiently, and the control circuit can use the initial impedance R0 as the adjusted impedance. However, if the elapsed time is equal to or less than the threshold, the control circuit can add a compensation value of approximately 80-90 ohms to the initial impedance R0 to determine the adjusted impedance.

[0127] In some examples, rather than adding a compensation value to determine the adjusted impedance, the control circuit may consult a stored data log or set, such as a look-up table, to determine or select an adjusted impedance that is a modification of the initial impedance R0 to account for electrical characteristics such as the time elapsed since the previous activation and the energy or current since the previous activation.

[0128] After the control circuit determines the adjusted impedance, the method may proceed from block 2006 onwards to determine vessel size, signal settings and perform vessel sealing, as described above.

[0129] In the example described above, if the control system is unable to definitively determine the elapsed time (and electrical properties such as energy or current, if used), the control circuitry can determine an adjusted impedance corresponding to a large vessel. Defaulting to the large vessel setting can increase the safety of vessel sealing.

[0130] By using the techniques described above, the control circuit can deliver an electrotherapy signal to biological tissue engaged with the electrosurgical device, measure the impedance of the engaged biological tissue, measure a sealing parameter of the electrosurgical device, and determine an adjusted impedance based on the relationship between the sealing parameter of the electrosurgical device and the measured impedance.

[0131] Reduction of biological tissue adhesion to electrosurgical devices by pulsing the power of the electrotherapy signal (FIGS. 10A-10D and 11) 10A-10D are graphs of electrical parameters of an electrotherapy signal for electrotherapy having a pulsed adhesion-reducing portion. In FIG. 10A, graph 500 includes a horizontal axis 502, a vertical axis 504, and a voltage / time relationship 506. Horizontal axis 502 represents time. Vertical axis 504 represents the voltage of the electrotherapy signal provided to the engaged tissue by the electrosurgical instrument. Voltage / time relationship 506 represents a voltage difference measurement obtained at the time represented by horizontal axis 502. The voltage difference is applied to the engaged tissue by the electrosurgical instrument. As shown in graph 500, the voltage / time relationship has four phases 508A-508D. The first phase 508A is the interrogation phase, in which a moderate voltage is provided to the engaged tissue and an initial measurement of tissue resistance is obtained.

[0132] The interrogation phase 508A is followed by a second phase 508B, which is a drying phase. During the drying phase 508B, the voltage difference provided to the engaged tissue increases monotonically. In the illustrated example, the voltage difference provided to the engaged tissue increases linearly. In some examples, the drying phase 508B has an initial slope that is greater than the final slope. In some examples, instead of controlling the voltage difference applied to the engaged tissue during the drying phase, another electrical parameter is controlled. For example, in some examples, the current conducted by the engaged tissue or the power (real power or apparent power) provided to the engaged tissue is controlled.

[0133] Each of these controlled parameters offers various advantages and disadvantages compared to the other controlled parameters. For example, controlling the voltage difference across the engaged tissue requires measurement of only the voltage difference provided to the engaged tissue. However, as the tissue heats up, the tissue resistance generally increases, thereby reducing the current flowing through the tissue. Thus, as the power provided to the tissue decreases in response to the increased tissue resistance, the heating rate slows.

[0134] Controlling the current conducted by the engaged tissue requires a measurement of only the current conducted by the engaged tissue, which can be easily accomplished, for example, by measuring the voltage across a small series resistor. As disclosed above, heating tissue generally increases the tissue resistance, thereby increasing the voltage difference across the tissue. Thus, as the power provided to the tissue increases in response to the increased tissue resistance, the heating rate accelerates.

[0135] However, controlling the active power delivered to the engaged tissue requires measurements of both the voltage difference across the engaged tissue and the current conducted by the engaged tissue. As the tissue heats and the tissue resistance changes, both the voltage applied to the engaged tissue and the current conducted by the engaged tissue are adjusted to maintain power according to the electrotherapy schedule. The heating rate is proportional to, and therefore controlled by, the power delivered to the engaged tissue, e.g., active power (W) or current (I).

[0136] The drying phase 508B is followed by a third phase 508C, which is a sealing phase. During the sealing phase 508C, the voltage difference provided to the engaged tissue is constant. In some examples, the sealing phase 508C is not constant. In some examples, instead of controlling the voltage difference applied to the engaged tissue during the sealing phase, another electrical parameter is controlled.

[0137] The sealing phase 508C is followed by a fourth phase 508D, an adhesion reduction phase. During the adhesion reduction phase, the voltage is pulsed between a maximum voltage value and a minimum voltage value. Such pulsing alternately heats and cools the engaged tissue. The adhesion reduction regimen can have alternating minimum and maximum power values, each of which is below a predetermined threshold configured to allow the temperature of the clamped biological tissue to fall below a liquid / gas phase change threshold and allow liquid to exist within the clamped biological tissue. In some examples, each power minimum of the adhesion reduction regimen is maintained for a first predetermined duration. In some examples, the first predetermined duration is 5 milliseconds or greater. In some examples, the first predetermined duration is 10 milliseconds or greater. In some examples, the first predetermined duration is 50 milliseconds or greater.

[0138] During the cooling portion of the pulse waveform, liquid previously expelled from the engaged tissue can return to the engaged tissue. In the illustrated example, the pulse waveform is periodic, with each cycle being identical to the cycle preceding it. In some examples, the pulse waveform is not periodic. For example, each pulse maximum can be less than the preceding pulse maximum.

[0139] The adhesion reduction phase 508D can be initiated in a variety of ways. The adhesion reduction phase begins after adequate sealing of the engaged tissue is completed. In some examples, predictive phase control can be used to initiate or begin the adhesion reduction phase 508D. For example, at a reference time during the interrogation phase 508A, the drying phase 508B, or the sealing phase 508C, tissue resistance can be measured. The duration of the sealing phase can be predicted based on the tissue resistance measured at the reference time. The adhesion reduction phase 508D can be initiated in response to the predicted duration of the sealing phase having elapsed. In some examples, tissue therapy can continue during the adhesion reduction phase.

[0140] 10B, graph 510 includes a horizontal axis 512, a vertical axis 514, and a tissue resistance / time relationship 516. Horizontal axis 512 represents time. Vertical axis 514 represents the electrical resistance of tissue engaged by the electrosurgical instrument. Tissue resistance / time relationship 516 represents tissue resistance measurements taken at the times represented by horizontal axis 512. As shown in graph 510, tissue resistance is low during interrogation phase 508A, increases during drying phase 508B, and remains high throughout sealing phase 508C. During adhesion reduction phase 508D, tissue resistance alternates between low and high values. Low tissue resistance measurements taken during the minimum of the pulse waveform indicate fluid returning to the engaged tissue.

[0141] 10C, graph 520 includes a horizontal axis 522, a vertical axis 524, and a current / time relationship 526. Horizontal axis 522 represents time. Vertical axis 524 represents the current conducted by tissue engaged by the electrosurgical instrument. Current / time relationship 526 represents current measurements obtained at the time represented by horizontal axis 522. As shown in graph 520, the current increases at the beginning of drying phase 508B but then decreases at the end of drying phase 508B as tissue resistance increases. The current then remains low throughout sealing phase 508C. During adhesion reduction phase 508D, the current is substantially periodic, with a maximum value greater than the current value obtained during sealing phase 508C.

[0142] In FIG. 10D, graph 530 includes a horizontal axis 532, a vertical axis 534, and a power / time relationship 536. Horizontal axis 532 represents time. Vertical axis 534 represents the available power at the tissue engaged by the electrosurgical instrument. Power / time relationship 536 represents a measurement of the power provided to the engaged tissue at the time represented by horizontal axis 532. As shown in graph 530, power increases at the beginning of desiccation phase 508B but then decreases at the end of desiccation phase 508B as tissue resistance increases. During adhesion reduction phase 508D, the power is substantially periodic, with a maximum value greater than the power value achieved during sealing phase 508C. The power peaks at the beginning of the maximum value. These power peaks correspond to peaks in current that occur before liquid is expelled from the engaged tissue.

[0143] 11 is a flow diagram of a method for reducing adhesion between biological tissue and an electrosurgical instrument. In FIG. 11, method 540 begins at step 542, where biological tissue is engaged by an electrosurgical instrument. Then, at step 544, control circuit 48 (shown in FIG. 2) causes electrical energy source 44 (shown in FIG. 2) to provide an interrogation signal to the engaged biological tissue during an interrogation phase. Then, at step 546, control circuit 48 causes measurement circuit 46 (shown in FIG. 2) to measure a reference tissue resistance R REF Then, in step 548, the measured reference resistance R REF Based on the therapy duration T THERAPY is determined.

[0144] At step 550, control circuitry 48 causes electrical energy source 44 to provide an electrotherapy signal to the engaged biological tissue during the electrotherapy phase. Then, at step 552, elapsed therapy time T ELAPSED is the therapy duration T determined in step 548 THERAPY In step 552, the elapsed therapy time T ELAPSED is determined to be the duration of therapy T THERAPY If so, the method returns to step 550 and an electrical therapy signal is provided to the engaged biological tissue. However, at step 552, the elapsed therapy time T ELAPSED is determined to be the duration of therapy T THERAPY If so, method 540 proceeds to step 554, where control circuitry 48 causes electrical energy source 44 to provide a pulsed adhesion reduction signal to the engaged biological tissue during an adhesion reduction phase. After the adhesion reduction phase, the method ends. The pulsed adhesion reduction signal may be determined according to an adhesion reduction schedule. The adhesion reduction schedule may be configured to reduce adhesion and, in some instances, simultaneously provide additional tissue therapy.

[0145] Determining the presence or absence of conductive foreign bodies within biological tissue engaged by an electrosurgical instrument (FIGS. 12 and 13) In various surgical procedures, artificial devices are implanted into patients. For example, screws, bolts, shims, and other mechanical members may fix broken bones. Staples may be used to maintain the desired alignment of treated tissue during surgery. Pacemakers and other electronic devices may be implanted into patients for various purposes. Many of these artificial devices are or contain conductive elements. Conductive objects may interfere with the electrosurgical procedure if found within tissue engaged by the electrosurgical instrument.

[0146] Determining environmental conditions of the electrosurgical device, such as the presence or absence of conductive foreign matter within the engaged tissue, prior to providing an electrotherapy signal to the engaged tissue can prevent undesired tissue modification. The presence or absence of conductive foreign matter within biological tissue engaged by the electrosurgical device can be determined based on impedance angle measurements of the engaged biological tissue. Thus, interrogation of the tissue impedance angle prior to the electrotherapy phase can prevent such undesired tissue modification.

[0147] FIG. 12 is a graph illustrating an example of an impedance angle / time relationship for biological tissue with and without a metal object. In FIG. 12, graph 600 includes a horizontal axis 602, a vertical axis 604, and impedance angle / time relationships 606A-606B. Horizontal axis 602 represents time. Vertical axis 604 represents the impedance angle of biological tissue engaged by an electrosurgical instrument. Impedance angle / time relationships 606A-606B represent impedance angle measurements obtained at the times indicated by horizontal axis 602 during the electrotherapy phase. The impedance angle of biological tissue represents the ratio of the reactive component of the tissue impedance to the resistive component of the tissue impedance. For example, an impedance angle of −90° represents a purely capacitive tissue impedance, an impedance angle of +90° represents a purely inductive tissue impedance, and an impedance angle of 0° represents a purely resistive tissue impedance. In some examples, the measured reference impedance angle is substantially equal to the angular difference between the voltage of the engaged biological tissue measured by the measurement circuit and the current conducted by the engaged biological tissue.

[0148] Impedance angle / time relationship 606A corresponds to tissue without a conductive foreign body. Impedance angle / time relationship 606B corresponds to tissue with a conductive foreign body. As shown in graph 600, both impedance angle / time relationships 606A and 606B show a change in impedance angle during an initial or transient portion of the electrotherapy phase, and then remain substantially constant during a final or steady state portion of the electrotherapy phase. However, the steady state values ​​of the impedance angle for impedance angle / time relationships 606A and 606B differ from one another. Impedance angle / time relationship 606A shows a change in impedance angle θ A , which corresponds to the steady-state value of the impedance angle θ B is smaller than the steady-state value of

[0149] Impedance angle θ A and θ BSuch a difference in impedance angle may be used to determine the presence or absence of a conductive foreign object within the tissue engaged by the electrosurgical instrument. THRESH The measured steady-state impedance angle can be compared to the measured impedance angle of the biological tissue, as in the impedance angle / time relationship 606A. THRESH However, if the measured steady-state impedance angle is less than a predetermined angle threshold θ , as in the impedance angle / time relationship 606B, it can be determined that no conductive foreign object is present. THRESH If the resistance is greater than the predetermined threshold, it can be determined that a conductive foreign body is present. In response, a control circuit, such as control circuit 48 of FIG. 2, can generate an error notification indicating the presence of a conductive foreign body in the engaged biological tissue and reduce or terminate delivery of the therapy signal. However, if a similar impedance is identified with the steady-state impedance angle greater than a predetermined threshold, the control circuit can continue to enable delivery of the therapy signal. Energy can be applied and increased until boiling is detected. When resistance is low in this state, the current should be at the upper end of its typical value until boiling begins.

[0150] In some examples, the impedance or resistance of the engaged biological tissue is measured during the interrogation phase. If the magnitude of the measured impedance or resistance of the engaged biological tissue is less than a predetermined resistance value, the phase angle of the impedance is determined and is adjusted to a predetermined threshold θ THRESH is compared to.

[0151] In some examples, the measured steady-state impedance angle may be greater than or equal to a predetermined angle threshold θ, such as the impedance angle / time relationship 606A. THRESH If the measured reference impedance angle is less than a first angle, e.g., angle θ , an open circuit can be determined. In response, the control circuit can generate an error notification indicating an open circuit and can reduce or terminate delivery of the therapy signal. In some examples, the measured reference impedance angle is less than a first angle, e.g., angle θ . A A second angle, such as angle θB In response to the first angle being less, the control circuit can reduce the power level of the therapy signal. In some examples, the first angle can be approximately 70 degrees, which can be device dependent.

[0152] In this way, the system compares the measured reference impedance angle with the predetermined angle threshold θ THRESH and generating a response indicative of an environmental condition of the device based on a comparison of the measured reference impedance angle with the angle threshold. The response may include a reduction in power and / or may produce a signal indicative of the environmental condition. The response may include a notification signal, such as to indicate the condition to a user.

[0153] 13 is a flow diagram of a method for determining the presence or absence of a metallic object in biological tissue engaged by an electrosurgical instrument. In FIG. 13, method 620 begins at step 622, where biological tissue is engaged by the electrosurgical instrument. Then, at step 624, control circuit 48 (shown in FIG. 2) causes electrical energy source 44 (shown in FIG. 2) to provide an electrotherapy signal to the engaged biological tissue during an electrotherapy phase. Then, at step 626, a predetermined time threshold T is determined when the elapsed therapy time T reaches a steady-state tissue impedance. MEASURE In step 626, the elapsed therapy time T is compared to a time threshold T MEASURE If so, the method 620 returns to step 624 and the electrotherapy schedule continues.

[0154] However, in step 626, the elapsed therapy time T exceeds the time threshold T MEASURE If so, the method 620 proceeds to step 628, where the control circuit 48 communicates the impedance angle θ of the engaged biological tissue to the measurement circuit 46 (shown in FIG. 2). MEAS Then, in step 630, the measured impedance angle θ of the engaged biological tissue is MEAS is a predetermined reference angle θ REF In step 630, the measured impedance angle θ MEAS is the predetermined reference angle θ REFIf so, the control circuitry may generate an error notification and method 620 proceeds to step 632 where therapy is terminated. For example, the control circuitry may generate an error notification indicating the presence of a conductive foreign object within the engaged biological tissue.

[0155] In some examples, a predetermined range of reference angles (e.g., θ MIN <θ MEAS <θ MAX ) can be used to determine whether a conductive foreign object has been engaged by the electrosurgical instrument. However, in step 630, the measured impedance angle θ MEAS is the predetermined reference angle θ REF If so, the method 620 proceeds to step 634 and therapy continues.

[0156] The predetermined impedance angle that defines the boundary separating the presence and absence of conductive foreign matter may vary depending on the particular electrosurgical device, the electrical parameters of the particular electrosurgical signal, the type of biological tissue, etc. For example, the frequency of the electrosurgical signal may relate to the impedance angle that defines the presence / absence threshold.

[0157] Short-circuit error trapping due to the band between the trigger and escape values ​​(Figure 14) As described above, an electrosurgical generator, such as electrosurgical generator 12 of FIG. 2, can coagulate or seal blood vessels or otherwise modify tissue by applying electrical energy via an electrotherapy signal. One problem with the application of such energy is that if an electrode coupled to or integrated with the electrosurgical instrument shorts out, the electrical energy passes primarily through the area of ​​the short circuit rather than through the tissue surrounding the area of ​​the short circuit. In such cases, the tissue is less affected by the application of the electrical energy.

[0158] In one approach, standoffs can be used to prevent opposing electrodes from contacting each other and diverting energy to the contact points rather than to the tissue. However, it can be seen that conductive elements in surgery can result in similar undesirable channeling of energy when grasped by electrosurgical instruments. Examples of such elements include other surgical tools, metal clips, and staples.

[0159] In some systems, the electrosurgical generator can monitor for characteristic (low) electrical impedances (collectively referred to as impedances) and can notify a user, e.g., a surgeon or technician, that such undesirable channeling of energy is currently occurring. If the electrosurgical generator determines that such low electrical impedance exists, the electrosurgical generator can start a timer and alert the user of the problem, e.g., via an audible and / or visual notification.

[0160] The electrosurgical generator may include a delay before any notification of a low impedance occurrence to prevent other occurrences of similar low impedance from falsely signaling the occurrence of a "true short circuit." Other occurrences of low impedance, particularly when used with electrodes with large surface electrical contact areas, may be caused, for example, by the addition of saline to the surgical site, highly conductive secretions (such as gallbladder bile), or thin, moist tissue such as the peritoneum surrounding the kidney.

[0161] When such an environment is encountered, electrical impedance can be raised by extending the application of energy, either by expelling the fluid or by converting the fluid to a gas through a phase change. This is typically achieved within a set period of time, or the user is advised, for example, to dry the tip of the electrosurgical instrument and / or grasp the tissue in an alternative area. Thus, when the cause is tissue-derived and not a foreign body, it is preferable to achieve the intended tissue modification by continuing the application of energy during the initial short circuit condition.

[0162] During the application of energy during a tissue-induced initial short circuit condition, impedance fluctuations may occur, increasing the impedance sufficiently to exceed the short circuit trigger value, but leaving the situation in which the low-impedance environment cannot be overcome by the applied power. In this situation, instead of a fairly rapid short circuit error, such as approximately 3 seconds, energy can be applied until some other time is reached, such as no tissue effect or the maximum activation time error is met. However, this can prolong the procedure, potentially frustrating the user and resulting in a negative user experience. Applying a filter to this situation is limited, and a clearer instruction to eliminate the low-impedance environment would be more useful.

[0163] The inventors have recognized that it would be desirable to provide a system with an improved indication of whether a short circuit in a low impedance environment has been overcome or whether a slight increase (followed by a decrease) in environmental impedance has been achieved. These improvements are particularly desirable in some systems, such as systems with less accurate ability to measure and act on impedance feedback. For example, the system may have inaccuracies that result in an inability to achieve accurate impedance readings due to the low voltage applied during low impedance conditions, which may make it more difficult to detect phase angle shifts caused by the inherent inductivity of the system, as well as inductance introduced by the material between the jaws of the device.

[0164] The inventors have recognized that a two-boundary threshold can be used to provide an improved indication as to whether a short circuit in a low impedance environment has been overcome or whether a slight increase in impedance (followed by a decrease) has been achieved. As described in more detail below, the system can monitor two impedance values: a trigger value and an escape value. The system can use a first impedance value (the "trigger" value) to trigger a short circuit, and the system can use a second impedance value (the "escape" value) greater than the first impedance value to exit the error clock timing routine.

[0165] The inventors recognize that clinicians may locally boil the fluid, which can create impedance-inducing bubbles. At this point, the impedance may increase appreciably, pushing the impedance reading above the first impedance value, but not necessarily outside the range of a short-circuit condition. The inventors recognize that the second impedance value is important because it ensures that the system dries the tissue during the wait period. By using the disclosed two-boundary threshold technique, a short-circuit condition can be quickly communicated to the user, allowing treatment to continue more quickly than would be possible using other techniques.

[0166] Figure 2, discussed above, illustrates one example of a surgical system that can be used to implement various aspects of the two-boundary threshold technique of the present disclosure. As shown in Figure 1, the surgical system of Figure 1 can include an electrosurgical device, such as forceps 14. The forceps 14 can include two jaws, e.g., a first jaw member 36 and a second jaw member 38. In some examples, one of the two jaws can be movable and the other jaw can be stationary. In other examples, both jaws can be movable.

[0167] It should be noted that the two-threshold technique of the present disclosure is not limited to electrosurgical devices that include jaws. Rather, the two-threshold technique can be performed using devices such as spatulas and snares.

[0168] An electrosurgical device, such as forceps 14, can include two or more electrodes sized, shaped, and / or otherwise configured to deliver electrotherapy signals to biological tissue, such as tissue 16 of Figure 1. In some examples, the electrodes can be integral with the jaws, such as first jaw member 36 and second jaw member 38, as in Figure 1. In other examples, the electrodes can be coupled to the jaws.

[0169] An output circuit, including, for example, power supply 44 of Figure 2, can be configured to generate and deliver electrosurgical energy to an output terminal, for example, instrument interface 42 of Figure 2, for delivery to a patient. The output terminal can be coupled to an electrosurgical device, such as forceps 14 of Figure 1, and configured to deliver, for example, high frequency electrosurgical energy, such as RF energy, to biological tissue via an electrotherapy signal.

[0170] A control circuit for a surgical system, such as the control circuit 48 of the surgical system of FIG. 1, can be coupled to the output circuit, and the control circuit can be configured to implement various aspects of the two-boundary threshold technique. For example, a user, such as a surgeon or clinician, can initiate the current delivery of electrosurgical energy to biological tissue of a patient, such as tissue positioned between two jaws of an electrosurgical device. In some examples, a processor, such as the processor 54 of the control circuit 48 of FIG. 2, can control a measurement circuit, such as the measurement circuit 46 of FIG. 2, to measure a first impedance value of tissue in conductive communication with two electrodes of an electrosurgical device, such as the forceps 14 of FIG. 1. In some examples, the tissue can be positioned between the two electrodes of the electrosurgical device.

[0171] The processor can compare the first measured tissue impedance value to a first threshold value, e.g., a trigger value. In a non-limiting example, for illustrative purposes, the trigger value can be approximately 5 ohms. When the first measured impedance value is less than or equal to the first threshold value, the processor, e.g., processor 54 of control circuit 48 of FIG. 2, can start a short-circuit timer included therein. In a non-limiting example, for illustrative purposes, the timer's time limit can be between about 3,000 milliseconds (ms) and about 6,000 ms.

[0172] The processor can control the measurement circuit to measure a second impedance value of tissue positioned between two electrodes of the electrosurgical device. The processor can then compare the second measured impedance value of the tissue with a second threshold, e.g., an escape value, where the second threshold (escape value) is greater than the first threshold (trigger value). In a non-limiting example, for illustrative purposes, the escape value can be approximately 10 ohms.

[0173] The trigger and escape values ​​represent typical values ​​rather than absolute and can depend on many factors such as the impedance within the device, the exposed contact area, the ability of the processor to measure impedance values ​​from feedback, and the length of the cable of the attached device, among others. The trigger and escape values ​​can be adjusted or tailored to suit various systems. In addition, the value of the timer limit can also be adjusted or tailored, which can depend on the manufacturer's understanding of the surgeon's opinion and desire to wait and see if a short circuit error is indicated or if a longer period of power application (standby) is preferred.

[0174] When the second measured impedance value is less than the second threshold and the timer has not met the time limit, the surgical system may continue delivering electrosurgical energy. However, when the second measured impedance value is less than the second threshold and the timer has met the time limit, the control circuit may control the output circuit to reduce or terminate the delivery of electrosurgical energy. In some examples, the control circuit may increase the power or current limit, or both, for a short period of time to continue delivering energy and overcome the moist environment. In some examples, when the timer has met the time limit, the surgical system may generate an indication to the user. For example, a user interface, such as the user interface 50 of the surgical system of FIG. 2, may generate one or both of an audible and a visual indication to the user to indicate that the delivery of electrosurgical energy has been reduced or terminated.

[0175] The delivery of energy can occur during an interrogation phase in which the amount of delivered energy is low but not zero, e.g., during the interrogation phase, the energy delivered is not sufficient to affect tissue.

[0176] In some examples, the control circuitry can be configured to adjust at least one of the first threshold (trigger value), the second threshold (escape value), and the time limit based on at least one characteristic of the electrosurgical device. For example, current density can affect the amount of power of the delivered electrotherapy signal, which can affect the amount of energy the system delivers to the biological tissue. As an example, the surface area of ​​the electrodes of the electrosurgical device can affect the current density. For example, an electrosurgical device with a large surface area and a low-power electrosurgical generator may not have enough current to cause fluid in the tissue to dissipate. Therefore, it may be desirable for the system to wait for a longer period of time before reducing or terminating the delivery of energy to the tissue. To that end, the control circuitry can use the surface area of ​​the electrodes to adjust at least one of the first threshold (trigger value), the second threshold (escape value), and the time limit. For example, the control circuitry can retrieve various one or more parameters of the electrosurgical device stored in a memory device, where the one or more parameters can include the surface area of ​​the electrodes associated with the electrosurgical device.

[0177] Additionally, the jaw force of the electrosurgical device can affect the current density. For example, a stronger jaw force can increase the amount of tissue contact with the electrodes, thereby affecting the boiling point of the tissue. Accordingly, the control circuit can adjust at least one of the first threshold (trigger value), the second threshold (escape value), and the time limit for electrosurgical devices with greater jaw forces. An electrosurgical device, such as the forceps 14 of FIG. 1, can include a jaw force sensor configured to sense jaw force, the jaw force sensor being in communication with a control circuit, such as the control circuit 48 of FIG. 2.

[0178] In addition to the characteristics of the electrosurgical device, at least one of the first threshold (trigger value), second threshold (escape value), and time limit can depend on the procedure. For example, some procedures and / or tissues are wetter than others. As an example, a liver procedure may involve a large amount of blood from the liver. In some procedures, the clinician may introduce a large amount of fluid to clear the tissue. Therefore, during some procedures, it is desirable for the system to wait for a longer period of time before terminating the delivery of energy to the tissue. To that end, in some examples, the control circuit can adjust at least one of the first threshold (trigger value), second threshold (escape value), and time limit, if necessary, to allow the electrosurgical generator additional time to dissipate excess fluid.

[0179] Alternatively, or in addition, characteristics of the electrosurgical device can be used to adjust the thresholds or time limits. For example, the output current of the electrosurgical generator can affect the amount of power of the delivered electrotherapy signal, which can affect the amount of energy the system delivers to the biological tissue. In some examples, for example, based on the output current, the control circuit can adjust at least one of the first threshold (trigger value), the second threshold (escape value), and the time limit to allow the electrosurgical generator additional time to dissipate excess fluid, if necessary.

[0180] In some instances, the two-boundary threshold techniques of the present disclosure can be used during the initial tissue interrogation phase at the beginning of a treatment, while in other instances, these techniques can be used midway through a treatment, such as during a heating or drying phase.

[0181] For illustrative purposes, non-limiting examples of systems with and without escape values ​​are described below. Initially, the clinician may press the activation button and an attempt is made to deliver energy to the electrosurgical device, e.g., the jaws. However, due to the high conductivity of the saline and blood flowing through the electrosurgical device, the electrosurgical generator identifies the impedance as 4 ohms and a short-circuit timer begins.

[0182] In a system without an escape value, the electrosurgical generator can provide energy and the short circuit timer will create an air bubble in the jaws of the device at 1,000 ms of applied energy time, for example, increasing the impedance to 6 ohms. Although the air bubble is transient, the impedance now exceeds the 5 ohm threshold, so the short circuit timer is reset and the electrosurgical generator begins its 3,000 ms countdown again.

[0183] A transient bubble may appear multiple times, being struck by the jaws multiple times, resetting the short-circuit timer each time, until it finally triggers another alarm, such as an extended activation time alarm, for approximately 12,000 ms to 30,000 ms. Clinicians can become frustrated by this experience and may find that they must extract some of the surrounding saline or grasp the tissue in another way to achieve a good seal.

[0184] As mentioned above, in a system without an escape value, the electrosurgical generator can provide energy and the short-circuit timer can cause an air bubble to form, for example, in the jaws of the device, increasing the impedance to 6 ohms at 1,000 ms of applied energy. However, because an escape value of, for example, 10 ohms is required to exit the short-circuit loop, the short-circuit timer continues. Another air bubble may form, again increasing the impedance to 6 ohms, which is again ignored by the short-circuit timer because the impedance does not meet the escape value or upper limit requirement. At 3,000 ms, a short-circuit alarm is presented to the clinician, who now knows that fluid must be removed or the tissue must be grasped differently. This reaction is faster because the upper "escape" value is 10 ohms, allowing the procedure to continue more quickly.

[0185] The two-boundary threshold technique described above can also be incorporated into other systems that utilize a short circuit trigger. For example, when the trigger value is met, the system can interrogate feedback to determine and interpret the current phase angle, while watching to see if the short circuit timer or escape value is met first. If the phase angle is above a certain threshold, the system can determine that the frequency of the phase angle, coupled with a low impedance, indicates that a metal object has been incorrectly (or otherwise) grasped by the electrosurgical device. The system can continue to monitor the phase angle until the upper escape value is met or the short circuit timer, e.g., 3,000 ms, is met.

[0186] 14 is a flow diagram illustrating an example of the two-boundary technique described above. At block 1000, a processor, for example, processor 54 of control circuit 48 of FIG. 2, may determine whether a short circuit flag is set. If the short circuit flag is not set (the "No" branch of block 1000), the processor may compare the measured impedance to a first impedance threshold, for example, a threshold of 5 ohms, at decision block 1002.

[0187] If the processor determines that the impedance is less than the first threshold (the "Yes" branch of block 1002), the processor resets the short circuit timer and sets the short circuit flag at block 1004, and sealing can resume at block 1006. If the processor determines that the impedance is greater than or equal to the first threshold (the "No" branch of block 1002), the processor resets the short circuit timer and removes the short circuit flag at block 1008, and sealing can resume at block 1006.

[0188] However, if the short circuit flag is set ("Yes" branch of block 1000), the processor may compare the measured impedance to a second impedance threshold, for example, a 7 ohm threshold, at decision block 1010. If the processor determines that the impedance is greater than or equal to the second threshold ("No" branch of block 1010), the processor may reset the short circuit timer and clear the short circuit flag at block 1008, and sealing may resume at block 1006. If the processor determines that the impedance is less than the second threshold ("Yes" branch of block 1010), the processor may compare the short circuit timer to a timer limit, for example, 3000 ms, at block 1012.

[0189] If the processor determines that the short circuit timer is greater than the timer limit (the "Yes" branch of block 1012), the processor may generate a short circuit warning, e.g., an audible and / or visual notification, to notify the user at block 1014. If the processor determines that the short circuit timer is less than or equal to the timer limit (the "No" branch of block 1012), sealing may resume at block 1006.

[0190] In this manner, if the impedance is consistently less than a first impedance threshold, e.g., 5 ohms, for at least a duration defined by the short circuit timer, e.g., 3000 ms, a short circuit warning can be generated and the electrotherapy signal reduced or terminated. Hysteresis may occur between the first and second impedance thresholds, e.g., 5 ohms and 7 ohms, such that a timer with a timer limit of, e.g., 3000 ms, is started when the impedance falls below the first threshold, e.g., 5 ohms, and reset when the measured impedance exceeds the second threshold, e.g., 7 ohms.

[0191] Open circuit check for impedance limit endpoint waveforms (Figures 15 and 16) RF vascular sealing devices often use a fixed maximum impedance value to indicate that tissue has been adequately affected, or an impedance delta to detect when tissue has been sufficiently affected. Impedance can also be used to identify whether the jaws of the device have opened during activation. For example, the system may attempt to detect an impedance above a set point to identify an "open circuit," which indicates that the jaws have opened.

[0192] However, in some cases, opening the jaws during start-up can result in a "false positive," where the generator signals a good seal when, in fact, the user has just opened the jaws of the device. For example, when the system is monitoring a "good seal" endpoint of, say, 350 ohms and an "open circuit" error value of, say, 2000 ohms, the system may respond with this false positive during start-up. The user controls the application of energy to the tissue, and the system can monitor the endpoint and the open circuit. In a correct start-up, the application of energy can initially lower the impedance, say, from 30 ohms to 15 ohms, and then increase the tissue impedance as the energy desiccates the tissue. The increase in energy can meet the 350 ohm endpoint value, and the generator can stop applying power and send a signal to the user indicating that the seal is complete.

[0193] In another example, a user controls the application of energy to tissue, which may initially reduce the tissue impedance, say from 30 ohms to 15 ohms, and then the impedance begins to rise. During this rise period, the user slowly (or quickly) opens the jaws. The impedance value increases rapidly, first passing the required 350 ohm boundary, at which point the system cuts power and reports a good seal. Because the energy is cut off (if the tissue were greater than 350 ohms, continued application of energy could create a "tissue stuck to the jaws" situation), and the impedance does not reach the 2000 ohm "open circuit" error value, the system erroneously reports a good seal.

[0194] The inventors have recognized the need to include an open circuit check that begins by starting a timer when a user initiates the current delivery of electrosurgical energy to biological tissue. When the timer reaches a timer limit (or "times out"), the system can determine the impedance value and determine whether the impedance value represents an open circuit. If the impedance value represents an open circuit, the system can reduce or terminate the delivery of energy; if not, the system can allow continued application of energy until the impedance meets an endpoint value.

[0195] Using the proposed timer technique, an electrosurgical generator, for example, electrosurgical generator 12 of FIG. 2, can apply energy to a system to apply energy to biological tissue contacting the electrosurgical device between the jaws of forceps 14 of FIG. 1. When the control circuit determines that the tissue is ready to be driven to a final impedance endpoint value or impedance delta value, a processor, for example, processor 54 of control circuit 48 of FIG. 2, can set a timer, for example, to 50-100 ms.

[0196] When the timer "times out," a measurement circuit, such as measurement circuit 46 in FIG. 2, measures an impedance value. The processor can determine whether the measured impedance represents an open circuit and energy delivery should be reduced or terminated, or whether the measured impedance falls below the open circuit value and energy delivery can continue until the impedance meets the required endpoint value. Using these techniques, there will be a small period during which neither the endpoint value nor the open circuit value can be achieved, but depending on the measured impedance at the end of this period, the processor can decide whether to flag an "open circuit" error and reduce or terminate energy delivery, or continue energy delivery up to the full sealing cycle endpoint impedance value.

[0197] Several possible scenarios that can be undertaken using the open-circuit verification technique are now described. In the first scenario, a user applies energy to tissue, for example, between the jaws of an electrosurgical device, and the tissue impedance decreases and then increases. The processor can recognize that the tissue has been suitably affected and can then start a timer. After a time limit, for example, 50 ms, the impedance falls below an "open-circuit" value, for example, an absolute value of 2000 ohms, or an impedance delta value, but also below the target tissue endpoint value (or impedance delta value). Thus, the processor continues to control the application of power until the target endpoint value is achieved. The processor terminates the application of power and indicates to the user that a good seal has been achieved.

[0198] In some examples, the rate of change of impedance can be a trigger variable: for example, if the rate of change of impedance exceeds a preset value, the generator can report an open circuit and then modify (or terminate or significantly reduce) the energy output.

[0199] In a second scenario, a user applies energy to tissue, for example, between the jaws of an electrosurgical device, and the tissue impedance decreases and then increases. The processor can recognize that the tissue has been successfully affected and can start a timer. After a time limit, for example, 50 ms, the impedance falls below an "open circuit" value, for example, an absolute value of 2000 ohms, or an impedance delta value, but the tissue is above a tissue endpoint value, for example, 350 ohms. The processor terminates the application of power and indicates to the user that a good seal has been achieved.

[0200] In a third scenario, a user applies energy to tissue, for example between the jaws of an electrosurgical device, and the impedance of the tissue decreases and then increases.

[0201] The processor can recognize that tissue has been suitably affected and can then start a timer. The user prematurely releases the tissue, for example by opening the jaws of the device, and the impedance rapidly increases above an endpoint value and then above an open-circuit value, for example, an absolute value of 2000 ohms, or an impedance delta value. After, for example, 50 ms, the processor can determine that the impedance has exceeded the open-circuit value, terminate the application of power, and present an incomplete seal "open circuit" error message to the user.

[0202] The timer duration is important for successful and accurate identification of an open circuit and a good seal. If the duration is too long, a small amount of tissue, such as when a user attempts to affect the fascial material lining the pelvic cavity, may rapidly reach an impedance value greater than the open circuit value. While such tissue is typically initially very conductive, the fluid contents can quickly boil, causing a rapid rise in impedance in a portion of such thin material, for example, within the jaws of the device. For example, if the timer duration is 200 ms, a good seal or tissue modification of the thin fascial material lining the pelvic cavity should result in an error message rather than the appropriate good seal tone.

[0203] If the timer is too short, there is a possibility of a false positive. For example, if the timer is set to 10 ms, the following scenario could occur: The user applies energy to the tissue, and the impedance decreases and then increases. As the impedance increases, the processor determines that the tissue is ready to be driven to the endpoint and starts the timer. If the jaws are opened slowly, the jaw impedance ramp rate will not meet the open-circuit value within 10 ms, so the control circuit continues to apply energy. If the impedance continues to progress toward the open-circuit value of 2000 ohms, for example, the impedance value will pass the endpoint value of 350 ohms, causing the application of power to stop, ultimately giving a false good seal tone.

[0204] The timer value, endpoint impedance, and open circuit impedance can depend on several factors (alone or in combination), such as 1) the amount of power applied to the tissue at that time (which can be a set power or a power that takes that power into account and adjusts the timer and / or impedance value accordingly), 2) the target tissue (previous power feedback can provide an indication of the type of tissue between the jaws and predict the likely or expected impedance gradient rate and adjust the timer and / or impedance value accordingly), and 3) the surface area of ​​the electrode and / or the force applied when the electrode jaws are in the fully closed position.

[0205] Using an open-circuit verification technique described in more detail below, an electrosurgical system, such as system 10 of FIG. 2, can set a timer, e.g., 50 ms to 100 ms, when the tissue is ready to be driven to an endpoint (seal). When the timer reaches its limit and "times out," the system can measure the impedance (or the rate of change of impedance over time) and determine whether that value represents an open-circuit condition or whether to allow continued application of energy until the impedance meets the endpoint value indicating a good seal. In this way, there is a brief period during which neither the endpoint nor the open-circuit value can be achieved. However, depending on the impedance determined at the end of the timer, the system can determine whether to continue to the full sealing cycle endpoint value or indicate the presence of an open circuit.

[0206] 15 is a flow chart illustrating an example of the above-described open circuit verification technique that may be used in a surgical system. As shown in FIG. 1, the surgical system of FIG. 1 may include an electrosurgical device, such as forceps 14. Forceps 14 may include two jaws, e.g., a first jaw member 36 and a second jaw member 38. In some examples, one of the two jaws may be movable and the other jaw may be stationary. In other examples, both jaws may be movable.

[0207] It should be noted that the open circuit verification techniques of the present disclosure are not limited to electrosurgical devices that include jaws. Rather, the open circuit technique can be performed using devices such as spatulas and snares.

[0208] An electrosurgical device, such as forceps 14, can include two or more electrodes sized, shaped, and / or otherwise configured to deliver electrotherapy signals to biological tissue, such as tissue 16 of Figure 1. In some examples, the electrodes can be integral with the jaws, such as first jaw member 36 and second jaw member 38, as in Figure 1. In other examples, the electrodes can be coupled to the jaws.

[0209] An output circuit, including, for example, power supply 44 of Figure 2, can be configured to generate and deliver electrosurgical energy to an output terminal, for example, instrument interface 42 of Figure 2, for delivery to a patient. The output terminal can be coupled to an electrosurgical device, such as forceps 14 of Figure 1, and configured to deliver, for example, high frequency electrosurgical energy, such as RF energy, to biological tissue via an electrotherapy signal. A control circuit of the surgical system, for example, control circuit 48 of the surgical system of Figure 1, can be coupled to the output circuit, and the control circuit can be configured to perform various aspects of an open circuit verification technique.

[0210] 15 , at block 1100, the control circuitry can start a timer when a user, such as a surgeon or clinician, initiates the current delivery of electrosurgical energy to biological tissue positioned between two electrodes of an electrosurgical device. In some examples, the timer can be included within a processor, such as processor 54 of FIG. 2 . In some examples, the control circuitry can set the timer when the control circuitry determines that the tissue is ready to be driven to a final impedance endpoint value (or impedance delta value). In some examples, a processor, such as processor 54 of control circuitry 48 of FIG. 2 , can control a measurement circuit, such as measurement circuit 46 of FIG. 2 , to measure the impedance value of tissue positioned between two electrodes of an electrosurgical device, such as forceps 14 of FIG. 1 .

[0211] At block 1102, the processor may determine whether the timer is greater than a timer limit, e.g., 50 ms to 100 ms. If the timer has not exceeded the time limit (the "No" branch of block 1102), the system may continue delivering electrosurgical energy at block 1104. If the timer has met the time limit (the "Yes" branch of block 1102), the processor may compare the representation of the measured impedance to a first threshold (endpoint value), e.g., 250 to 350 ohms, at block 1106. The first threshold may be stored in a memory, such as memory 56 of FIG. 2.

[0212] If, at block 1108, the processor determines that the representation of the measured impedance is less than the first threshold value (the "Yes" branch of block 1108) (end point value), the processor may continue delivering electrosurgical energy. If the processor determines that the representation of the measured impedance is greater than or equal to the first threshold value (the "No" branch of block 1108), the processor may, at block 1110, compare the representation of the measured impedance to a second threshold value (open circuit value), for example, 2000 ohms. The second threshold value may be stored in a memory, such as memory 56 of FIG. 2.

[0213] If the processor determines that the representation of the measured impedance is less than the second threshold (the "Yes" branch of block 1110), the processor may reduce or terminate the delivery of electrosurgical energy at block 1112. Here, the measured impedance is greater than the first threshold (end point value) and less than the second threshold (open circuit value), indicating that a good seal has been achieved. In some examples, the control circuit may generate a notification to the user to indicate a good seal.

[0214] If the processor determines that the representation of the measured impedance is greater than or equal to the second threshold value (the "No" branch of block 1110), the processor may reduce or terminate the delivery of electrosurgical energy at block 1114. Here, the measured impedance is greater than the first threshold value (the endpoint value) and greater than or equal to the second threshold value (the open circuit value), indicating that an open circuit exists. In some examples, the surgical system may generate an indication to the user to indicate the open circuit. For example, a user interface, such as user interface 50 of the surgical system of FIG. 2, may generate one or both of an audible and a visual indication to the user to indicate that the delivery of electrosurgical energy has been reduced or terminated and that an open circuit has been detected.

[0215] As described above, in some examples, a processor, e.g., processor 54 of control circuit 48 of FIG. 2, can control a measurement circuit, e.g., measurement circuit 46 of FIG. 2, to measure an impedance value of tissue, and the processor can determine whether a representation of the measured impedance exceeds a threshold. In some examples, the representation of the impedance includes a value of the impedance, such as the absolute value of the impedance. In other examples, the representation of the impedance includes a change in the value of the impedance over time (or "delta"), such as the first derivative of the impedance with respect to time.

[0216] 5 is a flow chart illustrating another example of the above-described open circuit verification technique that may be used in a surgical system. In method 300, at block 302, the control circuit may start a timer at the beginning of stage 3. At block 304, the control circuit may apply electrosurgical energy to biological tissue positioned between two electrodes of the electrosurgical device. At block 306, the control circuit may determine whether the endpoint has been met. If the control circuit determines that the endpoint has not been met (the "No" branch of block 306), the control circuit may return to block 304 and continue applying electrosurgical energy to the biological tissue. However, if the control circuit determines that the endpoint has been met (the "Yes" branch of block 306), the method proceeds to block 308.

[0217] At block 308, the control circuit may determine whether the elapsed time is less than or equal to the timer limit. If the control circuit determines that the elapsed time is less than or equal to the timer limit (the "Yes" branch of block 308), the control circuit may reduce the delivery of electrosurgical energy and indicate an open circuit at block 310. If the control circuit determines that the elapsed time is greater than or equal to the timer limit (the "No" branch of block 308), the control circuit may reduce the delivery of electrosurgical energy and indicate that a good seal is present at block 312.

[0218] Figure 16 is a flow chart illustrating another example of the above-described open circuit verification technique that can be used in a surgical system. Figure 16 is similar to Figure 15, except that in Figure 16, the control circuit can compare the rate of change of impedance of the biological tissue over time, for example, 40 kilohms per second, to a threshold value.

[0219] 16 , at block 1200, the control circuitry can start a timer in response to the delivery of electrosurgical energy to biological tissue positioned between two electrodes of an electrosurgical device. In some examples, the timer can be included within a processor, such as processor 54 of FIG. 2. In some examples, the control circuitry can set the timer when the control circuitry determines that the tissue is ready to be driven to a final impedance endpoint value (or impedance delta value). In some examples, a processor, for example, processor 54 of control circuitry 48 of FIG. 2, can control a measurement circuit, for example, measurement circuit 46 of FIG. 2, to measure the impedance value of tissue positioned between two electrodes of an electrosurgical device, for example, forceps 14 of FIG. 1.

[0220] At block 1202, the processor may determine whether the timer is greater than a timer limit, e.g., 50 ms to 100 ms. If the timer has not exceeded the time limit (the "No" branch of block 1202), the system may continue delivering electrosurgical energy at block 1204. If the timer has met the time limit (the "Yes" branch of block 1202), the processor may compare the rate of change of the measured impedance over time to a first threshold (endpoint value) at block 1206. The first threshold may be stored in a memory, such as memory 56 of FIG. 2. A non-limiting example of the rate of change may be 2000 ohms, or 40,000 ohms / second, over a 50 ms period.

[0221] If, at block 1208, the processor determines that the rate of change of the measured impedance is less than the first threshold value (the "Yes" branch of block 1208) (end point value), the processor may continue delivering electrosurgical energy at block 1204. If the processor determines that the rate of change of the measured impedance is greater than or equal to the first threshold value (the "No" branch of block 1208), the processor may compare the rate of change of the measured impedance to a second threshold value (an open circuit value) at block 1210. The second threshold value may be stored in a memory, such as memory 56 of FIG. 2.

[0222] If the processor determines that the rate of change of the measured impedance is less than the second threshold (the "Yes" branch of block 1210), the processor may reduce or terminate the delivery of electrosurgical energy at block 1212. Here, the rate of change is greater than the first threshold (end point value) and less than the second threshold (open circuit value), indicating that a good seal has been achieved. In some examples, the control circuit may generate a notification to the user to indicate a good seal.

[0223] If the processor determines that the rate of change of the measured impedance is greater than or equal to a second threshold (the "No" branch of block 1210), the processor may reduce or terminate the delivery of electrosurgical energy at block 1214. Here, the rate of change is greater than the first threshold (the endpoint value) and greater than or equal to a second threshold (the open circuit value), indicating the presence of an open circuit. In some examples, the surgical system may generate an indication to the user to indicate the open circuit. For example, a user interface, such as user interface 50 of the surgical system of FIG. 2, may generate one or both of an audible and a visual indication to the user to indicate that the delivery of electrosurgical energy has been terminated and that an open circuit has been detected.

[0224] By using the open circuit verification techniques described above, the system can provide fewer false indications of a good seal.

[0225] Alternative power correction output in low-precision hardware systems (Figure 17) Electrosurgical generators are constantly evolving with new "state of the art" hardware that makes the generator more accurate and responsive to feedback from the tissue intended for modification. Improvements in hardware architecture can offer many benefits over less advanced or conventional equivalents, such as faster CPU speeds that can enable faster response times in data collection, analysis, and reaction, as well as new features such as allowing for calculation of phase angle, which can provide a more accurate indication of derived data based on feedback of power delivery, impedance, etc.

[0226] In many cases, it is desirable to obtain the performance of newer "state of the art" hardware with existing hardware already installed in a hospital, and provide the same performance to users with this older installed capital equipment without having to upgrade to new capital equipment. Such performance improvements can be important in some electrosurgical applications to ensure the best possible tissue modification performance for the patient.

[0227] For example, proper power delivery can be important when providing optimal tissue performance in vessel sealing. Too much energy delivered too quickly can result in tissue damage from vapor pockets within the tissue. Slow energy application can significantly extend procedure times, resulting in the patient being under anesthesia for longer periods, reducing the benefit of the surgical outcome, and potentially increasing the risk of patient recovery problems. From a competitive perspective, rapid tissue modification with a high level of confidence in the resulting proper tissue action can be important to having a market-acceptable device.

[0228] Many older electrosurgical systems may not have the ability to accurately measure the phase angle of the RF output. During the sealing process, variations in the tissue grasped between the jaws and interactions with the inherent inductance and capacitance in the output circuit can cause phase angle changes in the RF waveform. Not accounting for this phase angle can lead to inaccurate power and load resistance calculations, so measuring this parameter can increase the accuracy of the system.

[0229] A load is considered inductive when voltage ("E") leads to current ("I") (helpful to remember by the mnemonic "ELI"). A load is considered capacitive when current ("I") leads to voltage ("E") (helpful to remember by the mnemonic "ICE"). In an "ELI" or "ICE" scenario, the phase angle offset results in a misalignment of the current and voltage peaks, resulting in a reduced actual power delivery compared to the apparent power delivery the electrosurgical generator believes it is providing.

[0230] The accuracy of the applied voltage can further complicate this issue. Accuracy of voltage application in older systems can be challenging when the voltage is reduced, especially when the voltage is generated to control the intended high speeds of a unipolar output, e.g., 4000V or more, and then applied to a bipolar output that can be as low as a few tens of volts or less. As a result, hardware manufacturers sometimes create "tuning hardware" that is tuned to a specific impedance and accuracy within the voltage range in which the device typically must function with the expected phase shift. At lower impedance ranges, the voltage levels are so low that the accuracy of the calculated power delivery can be very challenging.

[0231] As an example, to supply a specific power, say 100 W, the system supplies a current (I) at a voltage (V) to meet the power requirement. The impedance determines the voltage and current configuration to deliver the required power. For example, if the impedance is 5 ohms, the electrosurgical generator may provide an output of 4.5 A at 22.22 V.

[0232] As another example, if the same system were to attempt to deliver 30 watts (31.25 watts) into a 5 ohm impedance, the electrosurgical generator could provide approximately 2.5 A of power at 12.5 volts. Consider this 12.5 volt output in a system configured to deliver as much as 4000 volts in some cases. A typical impedance range where older electrosurgical systems become inaccurate is approximately 0 to 50 ohms. With that impedance range, older electrosurgical systems may struggle to apply enough current to dissipate fluid within the tissue to provide a good seal because the power output of the electrosurgical generator is not accurate enough.

[0233] The present inventors have recognized a need for improved power control in conventional electrosurgical systems. To address this need, the present inventors have recognized that applying power compensation to lower impedance values ​​can improve the power control of conventional electrosurgical systems and overcome this lack of precision.

[0234] As shown in Figure 1, the surgical system of Figure 1 can include an electrosurgical device, such as forceps 14. Forceps 14 can include two jaws, e.g., a first jaw member 36 and a second jaw member 38. In some examples, one of the two jaws can be movable and the other jaw can be stationary. In other examples, both jaws can be movable.

[0235] It should be noted that the power correction techniques of the present disclosure are not limited to electrosurgical devices that include jaws. Rather, power correction techniques can be implemented using devices such as spatulas and snares.

[0236] An electrosurgical device, such as forceps 14, can include two or more electrodes sized, shaped, and / or otherwise configured to deliver electrotherapy signals to biological tissue, such as tissue 16 of Figure 1. In some examples, the electrodes can be integral with the jaws, such as first jaw member 36 and second jaw member 38, as in Figure 1. In other examples, the electrodes can be coupled to the jaws.

[0237] An output circuit, including, for example, power supply 44 of Figure 2, can be configured to generate and deliver electrosurgical energy to an output terminal, for example, instrument interface 42 of Figure 2, for delivery to a patient. The output terminal can be coupled to an electrosurgical device, such as forceps 14 of Figure 1, and configured to deliver, for example, high frequency electrosurgical energy, such as RF energy, to biological tissue via an electrotherapy signal. A control circuit of the surgical system, for example, control circuit 48 of the surgical system of Figure 1, can be coupled to the output circuit, and the control circuit can be configured to perform various aspects of the power correction technique.

[0238] 17 is a flow chart illustrating one example of a power correction technique that can be used in a surgical system. At block 1300, a measurement circuit, e.g., measurement circuit 46 of FIG. 2, measures a representation of the impedance of tissue positioned between two electrodes of an electrosurgical device, e.g., forceps 14 of FIG. 1. In some examples, the control circuit can measure a central tendency, such as a mean, median, mode, or other central tendency, during a portion of the output, such as during the last 50 ms of the output, and store these values, such as in memory 56 of FIG. 2.

[0239] At block 1302, the control circuitry may compare the measured impedance representation to a first threshold value, e.g., approximately 50 ohms, stored in a memory, such as memory 56 of FIGURE 2. The first threshold value, e.g., 50 ohms, may be based on an impedance value below which a power correction is required for the electrosurgical system. The first threshold value may be adjusted based on the electrosurgical system.

[0240] If the impedance is greater than or equal to the first threshold (the "No" branch of block 1302), the impedance is high enough that the control circuitry does not need to apply power correction to the power control of the electrosurgical generator, as shown in block 1304. The electrosurgical system can apply power via normal operation.

[0241] However, if the impedance is less than a first threshold value ("Yes" branch of block 1302), the control circuitry may apply a power correction to the power control of the electrosurgical generator. For example, as shown in block 1306, the control circuitry may determine whether the measured impedance is within a first impedance range, e.g., 0 to 100 ohms. If the measured impedance is within the first impedance range ("Yes" branch of block 1306), the control circuitry may select a first power correction associated with the first impedance range and apply the selected first power correction, in block 1308.

[0242] If the measured impedance is not within the first impedance range ("No" branch of block 1306), the control circuit may select a second power compensation associated with a second impedance range, e.g., 20-100 ohms, in block 1310 when the representation of the impedance is within a second range, e.g., 20-100 ohms, and apply the selected second power compensation. As an example, the "desired power" may be 100 W, but the system may actually be only 50 W. A compensation factor may be applied to the measurement to ensure the proper compensation is applied to the output.

[0243] The electrosurgical system can apply power correction using a linear calculation such as the following equation: Corrected power = (((Zload×A)+B)×MeasuredPower) / 1000 Equation (1) where Zload is the measured tissue impedance, A and B are specific power correction values ​​or parameters that can be selected to provide different possible power correction trajectories, and MeasuredPower is the power (V×I) that the electrosurgical system believes it is providing to the tissue. A processor, such as processor 54 of FIG. 2, can retrieve the A and B parameters from a memory, such as memory 56 of FIG. 2, and calculate the corrected power setting using equation (1) above. In a first non-limiting example, for illustrative purposes only, a first calculation of the power correction for 10 ohms can use values ​​of 11 for A and 548 for B. In a second non-limiting example, for illustrative purposes only, a first calculation of the power correction for 50 ohms can use values ​​of 11 for A and 419 for B.

[0244] Using the corrected power setting, the control circuit can deliver electrosurgical energy through the electrodes of the electrosurgical device. In some examples, the control circuit can reduce or terminate application of a selected power correction to the power setting when a representation of the impedance meets or exceeds a threshold value. Continuing with the example described above, the control circuit can initially apply a power correction to a measured impedance of 15 ohms, which is below 50 ohms and within a first range of 0 to 20 ohms, and reduce or terminate application of the power correction when the measured impedance exceeds 20 ohms, above the upper limit of the first range. In some examples, the control circuit can begin applying a new power correction based on a change in impedance. Continuing with the example described above, the control circuit can apply a new power correction to the power setting for a measured impedance of 21 ohms, which is below 50 ohms and within a second range of 20 to 50 ohms.

[0245] In some examples, rather than allowing a single impedance value, e.g., 20 ohms, to represent the difference between a first range, e.g., 0-20 ohms, and a second range, e.g., 20-50 ohms, it may be desirable for the control circuit to use hysteresis to prevent the system from fluctuating between the two power corrections. When implemented, hysteresis can dynamically change the threshold limits depending on the current "state" of the system, thereby preventing unintended fluctuations between at least two thresholds when the measured parameter is near a threshold. This can affect one or both of the upper and lower threshold limits. In this way, the control circuit can dynamically adjust at least one of the upper and lower limits when the impedance representation is within a predetermined percentage or value of the upper or lower limit of the first range.

[0246] For example, specified percentages may be used at the boundaries of these ranges. As an example, for a measured impedance that is within 20% of the 20 ohm upper limit of the first range, the control circuit may dynamically adjust, e.g., increase, one or both of the upper and lower limits associated with the first range.

[0247] In another example, rather than using a percentage for hysteresis, the control circuit can use specified impedance values ​​at the boundaries of these ranges. As an example, for a measured impedance within 4 ohms of an upper limit of 20 ohms of a first range, the control circuit can dynamically adjust, e.g., increase, one or both of the upper and lower limits associated with the first range.

[0248] Although two non-limiting examples of ranges have been described with two corresponding power corrections, it should be noted that in some instances, only one range may provide sufficient power correction, while in other instances, three or more ranges with corresponding power corrections may be used.

[0249] The power correction techniques described above can significantly improve power control in electrosurgical systems to artificially overcome lack of precision. However, in some instances, secondary parameters can be used to provide further precision. For example, power correction can be based on the output during the "tissue sampling" phase. If the tissue has one characteristic, a first power correction can be used. If the tissue has another characteristic, a second power correction can be used. Examples of characteristics that can be used to determine power correction include, but are not limited to, energy delivered over a period of time, calculated impedance, current draw, voltage phase angle, tissue temperature, etc. The processor can use these characteristics alone or in combination to select a power correction. For example, the processor can use both tissue temperature and calculated impedance to select a power correction.

[0250] In an example utilizing one or more secondary parameters to determine a power correction, the measurement circuitry can measure a representation of the impedance of tissue positioned between two electrodes of the electrosurgical device, compare the measured impedance representation to a first threshold value as described above with respect to FIG. 17 , and select a first power correction from two or more power corrections if the impedance is less than the first threshold value, e.g., 50 ohms. The control circuitry can then compare the representation of the one or more secondary parameters to one or more threshold values. When the representation of one (or more) secondary parameters is less than one (or more) threshold values, the control circuitry can select between the previously selected first power correction and one or more other power corrections. The control circuitry can determine that the previously selected first power correction is sufficient, or can determine that a different power correction should be desired to apply to the power setting based on the secondary parameters, e.g., the output current of the power generator, tissue temperature, and voltage phase angle.

[0251] In some examples, if the impedance is below a first threshold, e.g., 50 ohms, the control circuit can select secondary power compensation. If the impedance increases, the control circuit can select primary power compensation. If the impedance continues to increase, the tuning power setting can utilize standard generator control without power compensation.

[0252] In some examples, power correction can be used for a specific period of time, for example, using tissue feedback. For example, using a corrective power setting, the control circuit can deliver electrosurgical energy through the electrodes of the electrosurgical device for a period of a range of impedance values, or until a certain amount of energy has been applied, or a combination of both. Additionally, external metrics, such as duration or user settings, can also be applied.

[0253]

[0013] Figure 24 is a flow chart illustrating another example of a power correction technique that can be used in a surgical system. Figure 24 shows a flow chart that includes two decisions that can use impedance to determine which power correction to apply. In addition, the flow chart can also use impedance as a decision point regarding when to apply a power correction and when to stop applying a power correction.

[0254] At block 2400, Stage 1A may be completed and the generator output may stabilize. At block 2402, Stage 1B may begin and the control circuit may determine the average tissue impedance during the last 50 ms of Stage 1B. At block 2404, the control circuit may determine whether the average impedance is between 0 and 20 ohms. If the average impedance is between 0 and 20 ohms (the "Yes" branch of block 2404), at block 2406, the control circuit may use a first power correction value "X" for Stage 2.

[0255] If the average impedance is not between 0 and 20 ohms ("No" branch of block 2404), then at block 2408 the control circuit may determine whether the average impedance is between 20.01 and 50 ohms. If the average impedance is between 20.01 and 50 ohms ("Yes" branch of block 2408), then at block 2410 the control circuit may use a second power correction value "Y" for stage 2. If the average impedance is not between 20.01 and 50 ohms ("No" branch of block 2408), then at block 2412 the control circuit may determine that no power correction is required for stage 2.

[0256] Combined energy devices with reduced thermal margins (Figures 18 and 19) Surgical systems exist that can deliver two types of energy: ultrasonic energy and electrosurgical energy, such as radiofrequency energy. Ultrasonic energy can provide rapid and precise dissection of tissue, while electrosurgical energy can provide reliable vessel sealing. The systems can deliver the two types of energy simultaneously, or the systems can control the delivery so that the two types of energy are delivered separately.

[0257] 18 is a simplified block diagram of an example of a combined ultrasonic energy and electrosurgical energy system capable of implementing various techniques of the present disclosure. The system 1400 can include a surgical device 1402 coupled to an ultrasonic drive unit 1404 and an electrosurgical drive unit 1406. Additional information regarding such combined ultrasonic energy and electrosurgical energy systems can be found in commonly assigned U.S. Patent No. 8,574,228 to Okada et al., entitled "ULTRASOUND TREATMENT SYSTEM," the entire disclosure of which is incorporated herein by reference. The surgical device 1402 can include an ultrasonic transducer 1408 and a probe 1410. The ultrasonic drive unit 1404 can include a first output circuit 1412 configured to generate a drive signal applied to the ultrasonic transducer 1408 to generate ultrasonic vibrations that are transmitted to the biological tissue via the probe 1410.

[0258] The system 1400 can include control circuitry configured to control various aspects of the operation of the ultrasonic drive unit 1404 and the electrosurgical drive unit 1406. For example, the control circuitry 1414 can be configured to generate and apply signals to a first output circuit 1412 of the ultrasonic drive unit 1404 and to a second output circuit 1416 of the electrosurgical drive unit 1406. In some exemplary configurations, the control circuitry 1414 is similar to the control circuitry 48 of FIG. 2 and can include components that operate similarly to the control circuitry 48 of FIG. 2. In some exemplary configurations, the electrosurgical drive unit 1406 is similar to the electrosurgical generator 12 of FIG. 2 and can include components that operate similarly to the electrosurgical generator 12 of FIG. 2. The second output circuit 1416 can generate a high frequency electrotherapy signal to be delivered to the biological tissue via the probe 1410. The first output circuit 1412 and the second output circuit 1416 are coupled to the control circuitry 1414 and are configured to generate and deliver energy to outputs of the system for delivery to the patient. In some examples, the system may include a speaker 1418 and / or a display 1422 to provide alerts or other audible and / or visual notifications to the user.

[0259] In some examples, the surgical device 1402 can be similar to the surgical device of Figure 1 of commonly assigned U.S. Patent Application Publication No. 20120010539, entitled "OPERATION DEVICE AND SURGICAL APPARATUS" by Yachi et al., the entire disclosure of which is incorporated herein by reference. The surgical device of Figure 1 of U.S. Patent Application Publication No. 20120010539 can perform treatments such as incision and ablation of biological tissue by utilizing ultrasound in conjunction with the application of radiofrequency waves. Additionally, it can also perform coagulation treatments of biological tissue by utilizing ultrasound.

[0260] In some examples, the electrosurgical drive unit 1406 can include a measurement circuit 1420. The measurement circuit 1420 can be similar to the measurement circuit 46 of Figure 2 and can be configured to measure one or more electrical parameters of biological tissue coupled to the surgical device 1402.

[0261] Proper power delivery can be a key factor in achieving optimal tissue performance in vessel sealing. If too much energy is delivered too quickly, vapor pockets can form within the tissue, potentially damaging the tissue surrounding the surgical device. This phenomenon is often referred to as "thermal margin." Combined ultrasonic and electrosurgical energy systems often use waveforms, such as constant pulse rates or ramped outputs of RF energy, along with ultrasonic energy, and stack them on top of each other. This can result in undesirable outcomes, such as a hot surgical device tip and increased thermal margin.

[0262] The inventors have recognized that a combined ultrasonic energy and electrosurgical energy system needs to monitor feedback from the tissue to determine whether a desired vapor pocket has occurred. Using various techniques described below, a combined ultrasonic energy and electrosurgical energy system can monitor feedback from the tissue, such as changes in current draw, changes in impedance values, or changes in impedance over time, to provide an indication that a desired vapor pocket has occurred. At this point, instead of continuing to apply energy to the tissue, one or both of the radio frequency energy, e.g., RF energy and ultrasonic energy, can be reduced or stopped.

[0263] A specific, non-limiting example of using a combined ultrasonic energy and electrosurgical energy system, such as system 1400 of FIG. 18, to modify biological tissue using various techniques of the present disclosure will now be described. The combined ultrasonic energy and electrosurgical energy system can deliver at least two energy modes: a first mode including ultrasonic energy and a second mode including bipolar energy. A control circuit, such as control circuit 1414 of FIG. 18, can monitor feedback from tissue in contact with the surgical device by controlling a measurement circuit, such as measurement circuit 1420 of FIG. 18, to measure a representation of the tissue's impedance. For example, the control circuit can monitor changes in impedance values, which can indicate that a desired maximum amount of vapor is being generated in the tissue and that further generation of vapor would result in excessive thermal margin. In other exemplary implementations, the control circuit can monitor current draw and / or changes in impedance values, such as absolute impedance values.

[0264] After the change in impedance value meets or exceeds a threshold, the control circuit can control the ultrasonic drive unit, e.g., ultrasonic drive unit 1404 of FIG. 18, to stop the ultrasonic output. Additionally, the control circuit can control the electrosurgical drive unit, e.g., electrosurgical drive unit 1406 of FIG. 18, to reduce the output of the high frequency electrotherapy signal generated by the second output circuit 1416 of the electrosurgical drive unit 1406. For example, the high frequency output can be reduced to a level that allows the generated vapor in the tissue to partially or fully revert to a liquid. After this liquid state is achieved, as determined by the control circuit using a set time, feedback control, or both, the system 1400 can again apply power until a vapor production limit is met or an end of energy application cycle is met, for example, by user determination or feedback control.

[0265] 19 is a flow chart illustrating an example of a thermal margin reduction technique that can be used in a combined ultrasonic energy and electrosurgical energy system. At block 1500, a control circuit can control the delivery of energy to biological tissue positioned between two electrodes of an electrosurgical device, where the delivered energy includes at least some ultrasonic energy. For example, the control circuit 1414 of FIG. 18 can control the first output circuit 1412 to deliver ultrasonic energy and the second output circuit 1416 to deliver radio frequency energy, such as RF energy, to tissue in contact with the surgical device 1402 of FIG. 18. As an example, the surgical device can include an ultrasonic forceps having HF electrodes in the jaws.

[0266] At block 1502, the measurement circuitry may measure a representation of a tissue parameter, such as the impedance of the biological tissue. For example, the measurement circuitry 1420 of FIG. 18 measures current draw and / or changes in impedance values, such as absolute impedance values, or changes in impedance (relative values).

[0267] At block 1504, the control circuitry can reduce the level of energy delivery or terminate the delivery of energy based on characteristics of the measured representation of the tissue parameter of the biological tissue. Exemplary characteristics can include, but are not limited to, resistance, impedance, current, phase angle, current draw, and / or voltage required, as well as the change (delta) in one or more of these characteristics and combinations of these characteristics. For example, the control circuitry 1420 of FIG. 18 can control the first output circuitry 1412 of FIG. 18 to reduce the level of ultrasonic energy. In some examples, the control circuitry 1420 can control the first output circuitry 1412 to terminate or reduce the delivery of ultrasonic energy. Termination is an example of a reduction in the delivery of ultrasonic energy.

[0268] In some examples, the delivered energy can be modified by increasing the energy or by temporarily reducing the energy but allowing it to return to the previous level after a short period of time, etc. Temporarily reducing the energy can mean temporarily reducing, e.g., ceasing, energy delivery to or near no energy.

[0269] In some examples, the control circuitry can pause the delivery of energy to allow for condensation of the vapor, as opposed to pausing the energy as an endpoint for activation. By pausing the delivery of energy, the system can establish a fluid condensation dwell time. The system does not need to monitor tissue parameters to identify the endpoint of the combined radiofrequency / ultrasound therapy pulse.

[0270] In other examples, the control circuit 1420 can control the first output circuit 1412 to reduce the level of electrosurgical energy. In some examples, the control circuit 1420 can control the first output circuit 1412 to terminate the delivery of electrosurgical energy.

[0271] The electrosurgical energy can be, for example, power-controlled or voltage-controlled, as described above. In a power-controlled implementation, the control circuit 1420 can control the second output circuit 1416 to deliver electrosurgical energy using the product of the voltage applied to the engaged biological tissue and the current output by the second output circuit 1416, for example, according to a plan, regimen, or schedule. For example, the control circuit can control the second output circuit 1416 to deliver constant power or monotonically increasing power during a particular phase, such as a desiccation phase.

[0272] In a voltage-controlled implementation, the control circuit may control, for example, according to a plan, regimen, or schedule, the voltage of the electrosurgical energy delivered by the second output circuit 1416. For example, the control circuit may control the second output circuit 1416 to deliver a constant voltage or a monotonically increasing voltage during a particular phase, such as a desiccation phase.

[0273] As described above, the control circuitry can reduce the level of or terminate the delivery of energy based on a characteristic of the measured impedance representation of the biological tissue. In some examples, the characteristic of the measured impedance representation is an impedance value, such as an absolute or relative impedance value. In some such examples, the control circuitry can be configured to compare the measured impedance value to a threshold value and reduce the level of or terminate the delivery of energy based on the comparison. For example, the control circuitry can reduce, periodically reduce, or terminate the delivery of one or both of the ultrasonic and electrosurgical energy based on the comparison. By periodically reducing the level, the system can reduce power in various stages during a single output, the output being midway through a full activation.

[0274] In other examples, the characteristic of the measured impedance representation is a change in impedance value. In some such examples, the control circuit can be configured to compare the change in impedance value to a threshold value and reduce the level of or terminate the delivery of energy based on the comparison. For example, the control circuit can reduce the level of or terminate the delivery of one or both of the ultrasonic energy and the electrosurgical energy based on the comparison.

[0275] Using the techniques described above in a combined ultrasonic energy and electrosurgical energy system, the overall power output of the system can be reduced when a vapor pocket occurs, thereby reducing the unwanted thermal margin.

[0276] Stepped Impedance Values ​​to Control Thermal Margin in Systems with Slow CPUs (Figures 20 and 21) It is often desirable to obtain high performance without increasing the processing burden on the system. Slower systems may be cheaper to purchase or maintain, and may perform better if processing is kept low.

[0277] Typically, vapor control and thermal margin control of devices used in vessel sealing can be achieved by monitoring one or more feedback systems, which can be a single true feedback element or multiple interdependent feedback elements, such as calculations based on one or more events or calculations via a decision tree type structure.

[0278] One example of such a system can monitor the difference (or delta) between the calculated lowest impedance encountered and the rolling upper limit impedance. In other examples, the rate of impedance rise over time, the change in phase angle, the change in current draw, and the change in voltage can be used as indicators of vapor generation in the tissue.

[0279] For example, when monitoring the difference (or delta) between the lowest calculated impedance encountered and the rolling upper limit impedance, newer, faster-reacting hardware can use a unique boundary or decision point to determine if an anticipated steam pocket has occurred, and if so, whether the pocket is of such a size that power should be reduced, shut off momentarily, or shut off completely. In older, slower-reacting systems, the rate at which the steam pocket occurs is the same, but the reaction time to reduce or shut off power is slower, potentially resulting in "steam pocket overshoot," which can cause larger thermal margins.

[0280] As an example, if the impedance threshold is set at 55 ohms, older, slower-reacting systems may exceed the 55 ohm threshold and shut off at 70 ohms. In contrast, newer electrosurgical systems may include faster analog-to-digital converters, processors, and other hardware that can enable sampling at millions of samples per second. In such systems, if the impedance threshold is set at 55 ohms, the newer systems may shut off at approximately 55 ohms as desired.

[0281] The present inventors have recognized a need for improved thermal margin control in conventional electrosurgical systems. Through extensive observation of tissue behavior, the inventors have recognized that overshoot typically occurs with early pulse phases of an electrosurgical waveform, resulting in reduced steam generation rates throughout the waveform due to tissue dehydration caused by fluid displacement. Therefore, to solve the overshoot problem and improve thermal margin control, the inventors have recognized that incorporating intelligence within the output is desirable. In particular, the inventors have recognized that an electrosurgical system can count pulses in an electrosurgical signal and assign different values ​​for triggers or thresholds, such as impedance values ​​or impedance deltas, based on the number of pulses. In this manner, the threshold for one or more of the initial electrosurgical energy pulses can be lowered, thereby allowing overshoot and therefore reducing the thermal margin of conventional electrosurgical systems.

[0282] Figure 2, discussed above, illustrates one example of a surgical system that can be used to implement various aspects of the thermal margin control techniques of the present disclosure. As shown in Figure 1, the surgical system of Figure 1 can include an electrosurgical device, such as a forceps 14. The forceps 14 can include two jaws, e.g., a first jaw member 36 and a second jaw member 38. In some examples, one of the two jaws can be movable and the other jaw can be stationary. In other examples, both jaws can be movable.

[0283] It should be noted that the thermal margin control techniques of the present disclosure are not limited to electrosurgical devices that include jaws. Rather, the thermal margin control techniques can be implemented using devices such as spatulas and snares.

[0284] An electrosurgical device, such as forceps 14, can include two or more electrodes sized, shaped, and / or otherwise configured to deliver electrotherapy signals to biological tissue, such as tissue 16 of Figure 1. In some examples, the electrodes can be integral with the jaws, such as first jaw member 36 and second jaw member 38, as in Figure 1. In other examples, the electrodes can be coupled to the jaws.

[0285] An output circuit, including, for example, power supply 44 of Figure 2, can be configured to generate and deliver electrosurgical energy to an output terminal, for example, instrument interface 42 of Figure 2, for delivery to a patient. The output terminal can be coupled to an electrosurgical device, such as forceps 14 of Figure 1, and configured to deliver, for example, high frequency electrosurgical energy, such as RF energy, to biological tissue via an electrotherapy signal. A control circuit of the surgical system, for example, control circuit 48 of the surgical system of Figure 1, can be coupled to the output circuit, and the control circuit can be configured to implement various aspects of the thermal margin control technique.

[0286] 20 is a flow chart illustrating an example of a thermal margin control technique that may be used in an electrosurgical system. At block 1600, a user, such as a surgeon or clinician, may initiate the delivery of electrosurgical energy to a patient's biological tissue, such as tissue positioned between two jaws of an electrosurgical device. At block 1602, a control circuit, such as control circuit 48 of system 10 of FIG. 2, may count the number of electrosurgical pulses delivered.

[0287] At block 1604, the control circuitry can compare the parameter to a threshold value. In some examples, the parameter can be the impedance of the biological tissue, a change (or delta) in the impedance of the biological tissue, a rate of change in the impedance of the biological tissue, a change in the current of the delivered electrosurgical energy pulse, a change in the output voltage of the delivered electrosurgical energy pulse, or a phase angle, e.g., a change in the phase angle between the voltage difference delivered to the biological tissue and the current conducted by the biological tissue. In some examples, a measurement circuitry, e.g., measurement circuitry 46 of FIG. 2, measures an electrical property that can be used by the control unit, e.g., processor 54 of FIG. 2, to measure the parameter or calculate the parameter. In some examples, the control circuitry can reduce the delivery of the multiple electrosurgical energy pulses when the measured impedance representation meets or exceeds an endpoint value, e.g., an endpoint value of about 100 to 600 ohms.

[0288] At block 1606, the control circuitry can adjust the thresholds based on the counting of the electrosurgical energy pulses. That is, the thresholds can be varied from pulse to pulse. For example, for the second pulse, the control circuitry can adjust the impedance delta, for example, from 40 ohms to 45 ohms. In this manner, the control circuitry can set thresholds or boundaries based on the counting of pulses. Adjusting the threshold of one or more of the initial electrosurgical pulses based on the counting of pulses can help offset any overshoot caused by delays in older, slower-reacting electrosurgical generator systems.

[0289] As a non-limiting example, it may be desirable to deliver an energy pulse that produces an impedance change (or impedance delta) of approximately 55 ohms in the biological tissue. When a user initiates delivery of a first pulse of electrosurgical energy, the control circuit, e.g., control circuit 48 of FIG. 2, may reset a counter, e.g., in processor 54 of FIG. 2, and set a parameter, e.g., an impedance change threshold, to a first value. For example, the control circuit may retrieve data from a memory device, e.g., memory 56 of FIG. 2, representing a threshold value for the first pulse and set the impedance delta threshold for the first pulse to the retrieved data representing, e.g., 40 ohms.

[0290] The system can deliver a first energy pulse, and the control circuit can compare a measured parameter, such as impedance delta, with a threshold value of 40 ohms. After the measured parameter reaches 40 ohms, the control circuit can stop delivery of the first pulse. Due to delays in older, slower-reacting electrosurgical generator systems, the system may exceed the 40 ohm threshold and actually stop after the impedance delta reaches approximately 55 ohms. Lowering the threshold value for the first pulse allows for a rapid rise in the first pulse with overshoot, providing an actual impedance of 55 ohms due to the slower system response. As discussed above, an impedance delta of 55 ohms is desirable in some instances.

[0291] Then, in preparation for delivery of a second pulse, the control circuit can adjust the threshold based on the electrosurgical pulse count, where the count is 2, and the control circuit can retrieve data representing the threshold for the second pulse from the memory device and set the impedance delta threshold for the second pulse to the retrieved data representing, for example, 45 ohms.

[0292] The system can deliver a second energy pulse, and the control circuit can compare the measured parameter with an adjusted threshold of 45 ohms. After the measured parameter reaches 45 ohms, the control circuit can stop delivering the second pulse. Due to the delay, the system may exceed the 45 ohm threshold and actually stop after the impedance delta reaches approximately 55 ohms. The adjusted threshold for the second pulse allows for a slightly slower ramp rate for the second pulse, allowing the system to react more slowly and provide an actual impedance of 55 ohms.

[0293] Next, in preparation for delivery of a third pulse, the control circuit can adjust the threshold based on the electrosurgical pulse count, where the count is 3, and the control circuit can retrieve data from the memory device (or use previously retrieved data) representing the threshold for the third pulse and set the impedance delta threshold for the third pulse to the retrieved data representing, for example, 55 ohms.

[0294] The system can deliver a third energy pulse, and the control circuit can compare the measured parameter with an adjusted threshold of 55 ohms. After the measured parameter reaches 55 ohms, the control circuit can stop the delivery of the third pulse. The third pulse can slow the ramp rate sufficiently so that the system can react and stop in time after the impedance delta reaches 55 ohms.

[0295] In this manner, the threshold of one or more of the initial electrosurgical energy pulses can be artificially lowered because the desired threshold, for example, 55 ohms, remains the same regardless of the adjustment, such as 40 ohms, 45 ohms, etc. Artificially lowering the threshold in this manner can allow for overshoot and therefore reduce the thermal margin of conventional electrosurgical systems. Thresholds for additional pulses, such as the fourth, fifth, and more pulses, may not need to be adjusted. For example, the fourth, fifth, and more pulses can be set at, for example, 55 ohms. In other examples, the third, fourth, fifth, and more pulses can also be adjusted.

[0296] In addition to the tiered pulse capability described above, the control circuitry can use a predictor to determine or select a set of pulse ratios to use. For example, the ratios can be between each of the adjusted thresholds and the desired threshold. By way of non-limiting example and for illustrative purposes only, if the desired threshold is 55 ohms and the first, second, and third pulse thresholds are 40, 45, and 50, respectively, the ratios can be 40 / 55, 45 / 50, and 50 / 55.

[0297] The predictor can identify the likelihood of an impedance rise and allow for it in the calculation of adjusted thresholds. For example, tissue with a high initial impedance that drops to a low impedance within the first pulse may indicate a rapid rise in the impedance delta being sought, and therefore a reduced percentage. This is because tissue with a higher initial impedance that drops suddenly may indicate tissue with more fluid and therefore a rapid vapor rise. However, tissue whose impedance delta starts low and then drops further may have a different ratio selector or set of thresholds.

[0298] Various parameters that can be used as predictors include the impedance of the biological tissue, the change (or delta) in the impedance of the biological tissue, the rate of change in the impedance of the biological tissue, the change in the current of the delivered electrosurgical energy pulse, the change in the output voltage of the delivered electrosurgical energy pulse, or the phase angle, for example, the change in the phase angle between the voltage difference delivered to the biological tissue and the current conducted by the biological tissue.

[0299] In some examples, a control circuit, e.g., control circuit 48 of FIG. 2, can compare a first measured parameter to a second measured parameter and adjust a threshold based on a difference between the first measured parameter and the second measured parameter. For example, a measurement circuit, e.g., measurement circuit 46 of FIG. 2, can measure a first impedance delta, e.g., before a first pulse is delivered, and measure a second impedance delta, e.g., after the first pulse is delivered. Based on the difference between the first impedance delta and the second impedance delta, the control circuit can select a particular set of adjusted impedances.

[0300] As a non-limiting example, the control circuit may initially select a first set of adjusted impedance delta thresholds, such as 40 ohms, 45 ohms, and 55 ohms, for the first, second, and third pulses, respectively. However, based on the difference between the first impedance delta and the second impedance delta, the control circuit may select a second set of adjusted impedance delta thresholds, such as 45 ohms, 50 ohms, and 55 ohms, for the first, second, and third pulses, respectively.

[0301] In some examples, the control circuitry can adjust the threshold based on the first measured parameter being greater than the second measured parameter. In other examples, the control circuitry can adjust the threshold based on the first measured parameter being less than the second measured parameter. In some examples, the control circuitry can adjust the threshold based on a rate of change between the first measured parameter and the second measured parameter.

[0302] Other factors can also be used to predict the proper ratio to use. For example, the rate of decrease in initial impedance over time can be used to indicate the rate of rise and therefore the proper threshold or trigger. In addition, initial impedance, or even previous tissue activation, can be used as a predictor. Previous tissue activation can be, for example, the last time the surgeon grasped tissue and pressed the activation button.

[0303] 21 is a flow chart illustrating another example of a thermal margin control technique that can be used in an electrosurgical system. A control circuit, for example, control circuit 48 of system 10 of FIG. 2, can count the number of electrosurgical pulses delivered. In some examples, the control circuit can retrieve data representing the first (and more) threshold values ​​from a memory device, such as memory 56 of FIG. 2. At block 1700, a user, such as a surgeon or clinician, can initiate delivery of a first electrosurgical energy pulse to a patient's biological tissue, such as tissue positioned between the two jaws of an electrosurgical device.

[0304] At block 1702, the control circuitry can compare a first measured impedance representation of the biological tissue, e.g., impedance delta, to a first threshold value, e.g., 40 ohms. In some examples, the measured impedance representation can be the impedance of the biological tissue, a change (or delta) in the impedance of the biological tissue, a rate of change in the impedance of the biological tissue, or a change in the current of the delivered electrosurgical energy pulses. In some examples, the measurement circuitry, e.g., measurement circuitry 46 of FIG. 2, measures the representation of the impedance or measures an electrical property that can be used by the control unit, e.g., processor 54 of FIG. 2, to calculate the representation of the impedance. In some examples, the control circuitry can reduce the delivery of the multiple electrosurgical energy pulses when the measured impedance representation meets or exceeds an endpoint value, e.g., an endpoint value of about 250-350 ohms.

[0305] At block 1704, the control circuitry may reduce or terminate the delivery of a first electrosurgical energy pulse when the first measured impedance representation meets or exceeds a first threshold. For example, the control circuitry may reduce or terminate the delivery of the first pulse when the measured impedance delta meets or exceeds a 40 ohm threshold associated with the first pulse.

[0306] At block 1706, the control circuitry may increase the first threshold to a second threshold based on the pulse count. For example, based on the count being 2, the control circuitry may increase the impedance delta threshold of 40 ohms associated with the first pulse to a threshold impedance delta value of 45 ohms associated with the second pulse.

[0307] At block 1708, the control circuit may control an electrosurgical generator, for example, electrosurgical generator 12 of Figure 2, to deliver a second electrosurgical energy pulse to the tissue. At block 1710, the control circuit may compare a second measured impedance representation of the biological tissue, for example, impedance delta, to a second threshold value, for example, 45 ohms.

[0308] At block 1712, the control circuit may reduce or terminate the delivery of the second electrosurgical energy pulse when the second measured impedance representation meets or exceeds a second threshold. For example, the control circuit may reduce or terminate the delivery of the second pulse when the measured impedance delta meets or exceeds an adjusted 45 ohm threshold for the second pulse.

[0309] In some examples, in preparation for delivery of a third pulse, the control circuitry can adjust the threshold based on an electrosurgical pulse count, where the count is 3, and the control circuitry can retrieve data from a memory device (or use previously retrieved data) representing the threshold for the third pulse and set the impedance delta threshold for the third pulse to the retrieved data representing, for example, 55 ohms.

[0310] As described above with respect to FIG. 20 , a predictor can be used to determine or select a set of pulse ratios to use. For example, a control circuit, e.g., control circuit 48 of FIG. 2 , can compare a first measured parameter to a second measured parameter and adjust a threshold based on the difference between the first and second measured parameters. For example, a measurement circuit, e.g., measurement circuit 46 of FIG. 2 , can measure a first impedance delta, e.g., before a first pulse is delivered, and measure a second impedance delta, e.g., after the first pulse is delivered. Based on the difference between the first impedance delta and the second impedance delta, the control circuit can select a particular set of adjusted impedances.

[0311] For example, the threshold of one or more of the initial electrosurgical energy pulses can be artificially lowered by using the thermal margin control techniques described above with respect to Figures 20 and 21. This artificially lowering of the threshold can allow overshoot and therefore reduce the thermal margin of conventional electrosurgical systems.

[0312] Although described separately, the two-boundary threshold technique, open circuit verification technique, power correction technique, thermal margin reduction technique for combined ultrasonic energy and electrosurgical energy systems, and thermal margin control technique described above can be implemented individually, if desired, or in combinations of two or more of the techniques described in this disclosure.

[0313] For example, a system implementing a two-threshold technique may also implement one or more of the power correction techniques, thermal margin reduction techniques for combined ultrasonic and electrosurgical energy systems, and thermal margin control techniques described above. By way of non-limiting example and for illustrative purposes only, a system implementing a two-threshold technique may also implement a thermal margin control technique that can artificially lower the threshold.

[0314] In another non-limiting example, and by way of illustration only, a combined ultrasonic energy and electrosurgical energy system that implements a thermal margin reduction technique by reducing the level of or terminating the delivery of energy based on characteristics of the measured impedance representation of the biological tissue may also implement a power correction technique that can apply a power correction to the power control of the electrosurgical generator based on whether the measured impedance is within an impedance range, e.g., 0-20 ohms.

[0315] Energy Consumption Monitoring and Open Circuit Assessment (Figures 22A-22D) To aid in determining whether to continue with additional tissue drying phases, the inventors have recognized that, at the end of a drying phase, the amount of energy (and / or charge) delivered to the tissue during the just-completed drying phase (or the just-completed interrogation and desiccation phases) can be evaluated, as described in detail below. If the amount of applied energy (and / or charge) is below the energy (and / or charge) threshold and produces a sufficient impedance delta value, the tissue is sufficiently dried and the process can proceed to the next stage. However, if the amount of applied energy (and / or charge) is above the energy (and / or charge) threshold and produces a sufficient impedance delta value, the tissue is too wet and requires another drying phase.

[0316] 22A-22D show a flow chart of an example of an energy delivery technique that may use, among other things, the amount of energy delivered to the biological tissue in its decision-making process. Although the technique shown in the flow chart of FIG. 22A-22D is described as being power-controlled, in some examples, the technique may also be voltage-controlled.

[0317] Three steps are shown in the flowcharts of Figures 22A-22D and are described in detail below. The portion of the flowchart designated step 1, which may be an interrogation phase or other low-energy phase, may be a power control step (or, in other examples, a voltage control step) in which an electrosurgical generator, such as electrosurgical generator 12 of Figure 2, may control the delivery of a low-power electrotherapy signal, such as 10 W, to the biological tissue. In some examples, step 1 may be considered a vapor dissipation step in which vapor within the tissue generated during step 2 is allowed to dissipate to prevent thermal margins.

[0318] In some examples, step 1 can be set to operate for a specific duration, such as 250 ms, during which time the electrosurgical generator can control power as closely as possible to ensure consistent delivery levels. During step 1, a control circuit, such as control circuit 48 of FIG. 2, in combination with a measurement circuit, such as measurement circuit 46 of FIG. 2, can track various parameters. For example, the control circuit and measurement circuit can begin measuring and storing the maximum and minimum impedance associated with a particular delivered pulse (pulse RMax and pulse RMin) (also tracked in step 2). Additionally, during the application of power in steps 1 and 2, the control circuit and measurement circuit can store values ​​for the amount of energy (and / or charge) delivered to the tissue.

[0319] The amount of energy delivered to the tissue can be measured in Joules and is the integral of the amount of power delivered in Watts. The amount of charge delivered to the tissue can be measured in Coulombs and is the integral of the amount of current delivered in Amperes. While generally illustrated and described below with respect to the amount of energy delivered to the tissue, the techniques of Figures 22A-22D can additionally or alternatively use the amount of charge delivered to the tissue.

[0320] The method shown in FIG. 22A begins at block 1800, where power is turned ON to an electrosurgical generator, such as electrosurgical generator 12 of FIG. 2. At block 1802, the method enters step 1, where the electrosurgical generator can deliver a constant power output "A" for a duration "B." At block 1804, the measurement and control circuitry can read or calculate tissue impedance values, which the control circuitry can then average. In some examples, the average impedance determined during step 1 can affect the ramp rate selected for applying energy in the next power control stage in step 2.

[0321] In FIG. 22B , at block 1806, the method enters step 2, which may be a drying phase. At block 1806, the control circuitry may automatically select a power ramp rate based on the impedance values ​​determined in step 1. Different bands or ranges of impedance values ​​may result in different output power ramp rates. For example, for a lower impedance range, such as 1 ohm to 15 ohms, the control circuitry may select a ramp rate “E” (block 1808) (e.g., 0.05 W / ms), for a medium impedance range, such as 15 ohms to 75 ohms, the control circuitry may select a ramp rate “D” (block 1810) (e.g., 0.035 W / ms), and for a high impedance range, such as 75 ohms to 400 ohms, the control circuitry may select a power ramp rate “F” (block 1812) (e.g., 0.035 W / ms). In some examples, there may be only two ramp rates, such as a fast first ramp rate and a slower second ramp rate, as shown by t1-t2 and t2-t3 in Figure 4. After the power ramp rate is selected at block 1814, the control circuit may set the cumulative pulse energy (and / or charge) value to 0 and apply power to the tissue via the electrotherapy signal at block 1816.

[0322] The method may then perform operations in parallel, including reading or calculating the tissue impedance by the control circuitry at block 1818, and reading or calculating the energy (and / or charge) to be applied during this particular pass at block 1820. In some instances, rather than being performed in parallel, these operations may be interwoven into a single process.

[0323] At block 1820, the control circuitry can read and calculate the energy (e.g., in Joules) (and / or charge, e.g., in Coulombs) applied during this pass to the biological tissue. Then, at block 1822, the control circuitry can add the energy (and / or charge) applied during this pass to the pulse energy (and / or charge) value to generate a cumulative applied energy (and / or charge) value.

[0324] In the example shown in FIG. 22A , after calculating the impedance at block 1818 in parallel with calculating the energy to be applied, the control circuit 48 of FIG. 2 can determine at block 1824 whether the impedance is lower than the previous impedance Rmin. In some examples, when determining the minimum impedance Rmin, the control circuit can start with a default initial impedance, such as 1000 ohms. For example, if the next measured or calculated impedance is 20 ohms, then 20 ohms becomes the new minimum impedance Rmin. Similarly, if the next measured or calculated impedance is 15 ohms, then 15 ohms becomes the new minimum impedance Rmin. The minimum impedance Rmin can be obtained from step 1 or from reading the current impedance.

[0325] If the current impedance reading is lower than the previous impedance Rmin ("Yes" branch of block 1824), the control circuit may store the current impedance reading as the new minimum resistance value Rmin at block 1826. The control circuit may then increase the power (power is increased over time) at block 1828, such as along a specific power ramp trajectory.

[0326] At block 1830, the control circuitry may determine whether the power is greater than the maximum power level for step 2 (power "H"). If the power is less than or equal to the maximum power level (the "No" branch of block 1830), the process returns to block 1816 and another path is initiated. However, if the power is greater than the maximum power level (the "Yes" branch of block 1830), the control circuitry may adjust the power ramp rate or change to a second ramp rate at block 1832. In some examples, the second ramp rate is slower than the first ramp rate.

[0327] At block 1834, the control circuitry may determine whether the applied power is greater than the maximum power level. If the power is less than or equal to the maximum power level (the "No" branch of block 1834), the process returns to block 1816 and another path is initiated. However, if the power is greater than the maximum power level (the "Yes" branch of block 1834), the control circuitry may change the power ramp rate to the maximum power level setting at block 1836, and then the process returns to block 1816 and another path is initiated.

[0328] Referring back to decision block 1824, if the current impedance reading is greater than or equal to the minimum impedance Rmin (the "No" branch of block 1824), the control circuit may determine whether the current impedance reading is greater than the minimum impedance Rmin plus the impedance delta at block 1838. If the current impedance reading is less than or equal to the minimum impedance Rmin plus the impedance delta (the "No" branch of block 1838), the control circuit may proceed to block 1828 and the method may continue as described above.

[0329] In some examples, as opposed to determining whether the measured current is less than a predetermined percentage of the maximum current, in step 1824 control circuitry 48 may determine whether the measured current is less than a predetermined percentage (or offset) of the current value measured at a predetermined time interval after initiation of the pulse. In the case of an impedance monitoring system, control circuitry 48 may determine whether the measured impedance is greater than a predetermined percentage (or offset) of the resistance value measured at a predetermined time interval after initiation of the pulse.

[0330] However, if the current impedance reading is greater than the minimum impedance Rmin plus the impedance delta ("Yes" branch of block 1838), the control circuitry may proceed to decision block 1840. By way of a non-limiting example, the impedance delta may be 55 ohms, the current impedance reading may be 75 ohms, and the minimum impedance Rmin may be 15 ohms. In this non-limiting example, if the current impedance reading, e.g., 75 ohms, is greater than the minimum impedance Rmin, e.g., 15 ohms, plus the impedance delta, e.g., 55 ohms ("Yes" branch of block 1838), the control circuitry may proceed to decision block 1840.

[0331] As described above, the control circuit determined whether there was a set difference between the current impedance reading and the minimum impedance Rmin. If the difference was greater than a set amount, for example, 55 ohms, the control circuit can now determine how much energy was delivered during the previous step 1 and this current phase of step 2. At block 1840, the control circuit can determine whether the amount of energy (or charge) applied is less than an energy threshold (or charge threshold), such as 20 joules (or 2 coulombs of charge). If the amount of energy applied is greater than or equal to the energy threshold (the "No" branch of block 1840), the control circuit can reset the minimum impedance Rmin at block 1842 and return to step 1. Finally, the system returns to the second drying cycle in step 2. In this manner, the control circuit can control the energy delivery of the therapy signal provided to the engaged biological tissue during the second drying phase if the amount of delivered energy exceeds the threshold energy value.

[0332] However, if the amount of energy applied (or the charge applied) is less than the energy threshold (or the charge threshold) (the "Yes" branch of block 1840), the control circuitry may terminate the pulse and proceed to step 3, as shown in block 1844. In this manner, the control circuitry may control the energy delivery of the therapy signal provided to the engaged biological tissue during the termination phase when the amount of energy delivered is less than the threshold energy value.

[0333] Step 3 may be the final stage and begins at block 1846 of FIG. 22C. At block 1846, the control circuitry may store or record the target final impedance. In some examples, the target final impedance may be the last number set. In some examples, the target final impedance may be a delta calculation from the lowest impedance value read or calculated in this step, plus a predetermined percentage or delta value. For example, if the minimum impedance Rmin for this step is 20 ohms, a predetermined delta of 280 ohms may be added to the final target impedance to set the target final impedance value to 300 ohms. In some examples, the target final impedance may be a delta calculation from an impedance measurement taken a predetermined time interval after initiation of the pulse, plus a predetermined percentage or delta value.

[0334] In some examples, the target final impedance can depend on the number of pulses, such as desiccation pulses. For example, if the endpoint depends on the number of pulses and two pulses are delivered to the tissue, the final impedance value can be 320 ohms. However, if five pulses are delivered to the tissue, the final impedance can be 280 ohms. If the endpoint is not achieved within a predetermined amount of time, such as two seconds, the method can return to step 1 in an attempt to drive more fluid from the tissue to reach a satisfactory endpoint impedance.

[0335] At block 1848, the control circuit may reset and start the timer, such as in response to the delivery of electrosurgical energy to biological tissue, such as that positioned between the two jaws of an electrosurgical device or in contact with one or more electrodes. If the predetermined impedance delta between the current impedance reading and the minimum impedance Rmin for this pulse is not met before the time interval is reached, the output returns to the first step, which may indicate that the tissue still contains too much water.

[0336] At block 1850, the control circuitry can set the power output to power level "I." In some examples, the control circuitry can control the delivery of the electrotherapy signal to the tissue using a constant power ramp rate. In some examples, the constant power ramp rate in step 3 can be slower than previous ramp rates, such as in step 2. The control circuitry can continue delivery using a constant power ramp rate until a final impedance value is reached, such as 320 ohms in non-limiting example.

[0337] At block 1852, the control circuitry may begin monitoring tissue impedance. As described below, the control circuitry may, for example, intermittently compare a representation of the biological tissue impedance to a threshold value and continue delivering electrosurgical energy until the threshold value is met, such as at blocks 1862 and 1872. At block 1854, the control circuitry may increase the power to a constant power ramp rate "J". In some examples, before delivering electrosurgical energy at a constant power ramp rate, the control circuitry may deliver the electrosurgical energy at a constant power.

[0338] At block 1856, the control circuitry may determine whether the power is greater than the maximum power level of step 3. If the power is greater than the maximum power level of step 3 (the "Yes" branch of block 1856), the control circuitry may set the power to the maximum power level of step 3 at block 1858 of FIG. 22D. After setting the power to the maximum power level of step 3 at block 1858, or if the power is less than or equal to the maximum power level of step 3 (the "No" branch of block 1856), the control circuitry may compare the timer value to the time interval "R" at decision block 1860.

[0339] If the timer value is less than or equal to the time interval "R" ("No" branch of block 1860), the method may return to block 1854 and the control circuit may increase the power. However, if the timer value is greater than or equal to the time interval "R" ("Yes" branch of block 1860), the control circuit may determine in block 1862 whether the impedance is greater than the minimum value within this pulse plus a predetermined delta impedance, where the predetermined delta impedance is the difference between the measured impedance and the lowest value of the impedance measured within this pulse.

[0340] If the control circuitry determines that the impedance is less than or equal to the target impedance minus the predetermined delta impedance (the "No" branch of block 1862), the method may return to step 1, as shown in block 1864. In this manner, the control circuitry may reduce or terminate energy delivery during a therapy phase, for example, in response to the intermittently measured impedance changing by a predetermined delta impedance value.

[0341] However, if the control circuit determines that the impedance is greater than the target impedance minus the predetermined delta impedance (the "Yes" branch of block 1862), the method may proceed to block 1866 and increase the power to a power ramp rate "J".

[0342] At decision block 1868, the control circuitry may determine whether the current power is greater than the maximum power level of step 3. If the current power is greater than the maximum power level of step 3 (the "Yes" branch of block 1868), the control circuitry may reset the power to the maximum power level "Q" of step 3 at block 1870.

[0343] After setting the power to the maximum power level for step 3 in block 1870, or if the power is less than or equal to the maximum power level for step 3 (the "No" branch of block 1868), the control circuit may determine whether the impedance is greater than the target final impedance "P" in block 1872. If the control circuit determines that the impedance is greater than the target final impedance (the "Yes" branch of block 1872), the seal is complete and the control circuit may turn the electrosurgical generator OFF in block 1874. However, if the control circuit determines that the impedance is less than or equal to the target final impedance (the "No" branch of block 1872), the control circuit may determine whether the timer is greater than the step 3 maximum power timer in block 1876.

[0344] If the timer is greater than the maximum power timer of step 3 ("Yes" branch of block 1876), the method may return to step 1, as shown in block 1878. For example, if the timer times out, this may indicate that the tissue was not sufficiently dehydrated during the previous step. However, if the timer is less than or equal to the maximum power timer of step 3 ("No" branch of block 1876), the method may return to block 1866 and increase the power ramp rate.

[0345] In some examples, the timer of block 1860 may be used to detect a potential open circuit condition. For example, if the jaws of an electrosurgical device, such as forceps 14 of FIG. 1, open during a sealing procedure, the electrosurgical generator may erroneously determine that the accompanying rise in impedance is the result of tissue desiccation.

[0346] Non-limiting values ​​for parameters A through S in FIGS. 22A-22D are shown in Table 1 below.

[0347] [Table 1]

[0348] According to the present disclosure, during step 3, a timer in block 1860 can be started. When the target final impedance (or threshold) is reached, the control circuit can record the elapsed time. If the target final impedance (or threshold) is reached in a very short period of time, such as before the threshold time limit, the control circuit can determine that an open circuit has occurred rather than complete sealing, and can declare an error condition. In other words, the control circuit can declare an error condition if the elapsed time is less than the time limit. The time limit can be 50 ms, 100 ms, or another period of time.

[0349] For example, the control circuit may determine the difference between the minimum measured impedance Rmin and the current or maximum measured impedance and compare the determined difference to a predetermined delta impedance value. In some examples, the control circuit may increase the power ramp rate of the electrosurgical energy in response to this comparison. The control circuit may continue to increase the power ramp rate, such as at block 1854, until the determined difference meets or exceeds the predetermined delta impedance value, such as at block 1862, or until a power limit is reached, such as at block 1858.

[0350] However, in some examples, if the determined difference is greater than or equal to a predetermined delta impedance value and the timer is greater than a threshold time limit, the control circuit can declare an error condition and generate an error signal. In some examples, the open circuit error signal can cause the control circuit to communicate an error message to the user, such as using the user interface 50 of FIG. 2, and quickly terminate power to the electrosurgical device.

[0351] In some examples, the control circuitry does not terminate power at the time mark. Instead, power can continue until a final impedance is reached. At this point, the control circuitry can evaluate the time interval to see if mitigation action is necessary. For example, setting the time interval or threshold too long can result in a false negative (e.g., a good seal is formed, but the system determines an open circuit exists), especially in thin tissue that seals quickly. Setting the time interval or threshold too short can result in a false positive (e.g., a good seal is not formed, but the system does not detect the error), which can occur, for example, when a user slowly opens the jaws.

[0352] Dwell time between pulses It is desirable to deliver the electrotherapy signal using a pulsed waveform. Pulsing the electrosurgical signal can heat the tissue between the jaws of the device. Even without pulsing, the tissue can heat up, and as more and more energy is applied, the fluid within the tissue can reach its boiling point as it passes through different, typically increasing, temperature ranges. The boiling point can depend on the composition of the boiling fluid and the pressure with which the jaws clamp down on the tissue (changing the pressure changes the boiling point). This results in the production of steam.

[0353] As vapor is generated, it can increase tissue impedance, resulting in less heating current flowing through the tissue and more voltage being driven into the tissue. The vapor grows into a vapor pocket, which now has a much larger volume because the vapor undergoes a phase change as it evaporates. This new, larger volume further increases impedance, and therefore more voltage is required to achieve the same power input. After a while, the vapor then transitions from its previous location between the jaws and extends into the surrounding tissue.

[0354] The higher voltages required to power these vapor pockets result in increased tissue adhesion to the energy application surface, such as the jaws, and vapor seeping from the application site into surrounding tissue creates a barrier known as a thermal margin. Thermal margins can damage structures not intended for tissue modification and can ultimately lead to post-operative tissue necrosis and perforation of vital organs or organ structures. To overcome the propagation of vapor pockets into surrounding tissue and the need for higher driving voltages, one control method currently utilized is pulsing.

[0355] Pulsing is when there is a pause in the application of energy delivered to tissue at a level that can modify the tissue. In some instances, energy delivery is stopped for a period of time. In other instances, the energy level can be reduced to a level where the energy does not have a significant tissue effect. It is desirable to apply at least some energy to the tissue rather than stopping delivery completely to allow for continuous or near-instantaneous feedback of tissue status to the control circuitry.

[0356] In some techniques, a fixed period of 250 ms can be used as a rest period or "dwell time" to ensure that the tissue vapor pocket is significantly condensed before energy is reapplied. The dwell time is the time interval following the first pulse and preceding the second pulse. If a dwell time less than 250 ms is used, the vapor pocket may not fully dissipate, and the next application of energy may cause the vapor pocket to rapidly return to its original state.

[0357] This is typically true for the first pulse with a pause of less than 250 ms, but becomes less clear for subsequent pulses. For the second pulse, a dwell time of 200 ms or so may be appropriate, depending on the volume of tissue and associated moisture present between the jaws. Subsequent pulses may require even less time to allow for recondensation of the fluid contents between the jaws of the device, which are now much reduced (e.g., the fifth pulse may require 50 ms or less).

[0358] During these "dwell times," fluid may return to the target tissue. During the dwell time, the generator may provide a low-power signal to the tissue, low enough so as not to cause tissue effects. Typically, a slight decrease in tissue thickness is noted as a result of vessel sealing, and the displaced tissue contains fluid. Steam may also have high pressure and displace fluid by pushing more mobile elements, such as extracellular fluid, out of the area between the device's application plates.

[0359] Unfortunately, not all tissues have the same fluid levels or tissue fluid mobility, nor is the same amount of tissue thickness or width grasped between the jaws of the device for each seal, so a fixed, standard reduction in the pause period between pulses may not provide an effective or accurate pause time controller.

[0360] Additionally, product pressure may exist to keep the overall activation as short as possible. A conservative choice of estimating a long dwell time and applying it to dwell periods that do not require such a long time may unnecessarily extend the overall activation. Unnecessary extension of the overall activation may increase the duration of the procedure and, among other things, may increase user fatigue.

[0361] To overcome the above-described problems, the inventors have recognized that the control circuitry can utilize known characteristics of the tissue between the jaws to accurately predict the most appropriate reduced dwell period. For example, the control circuitry can consult a stored data set, such as a look-up table, and use one or more known characteristics of the tissue to determine the reduced dwell period or "dwell time." The reduced dwell time can reduce the overall activation time of the sealing cycle without affecting low thermal margins, while still providing a high degree of confidence in a secure seal.

[0362] In some examples, a control circuit, such as control circuit 48 of Figure 2, is in electrical communication with two electrodes of a surgical device and can deliver first and second electrosurgical energy pulses to biological tissue, for example, physically engaged with, positioned between, or otherwise coupled to the two electrodes, the first and second electrosurgical energy pulses separated from one another by corresponding dwell times. The control circuit can then determine a dwell time corresponding to at least one of the electrosurgical energy pulses following the first electrosurgical energy pulse.

[0363] In some examples, a control circuit, such as control circuit 48 of FIG. 2, can determine the amount of energy applied to the tissue and use it to determine an optimized dwell time. The amount of fluid between the jaws of the device requires a specific amount of energy to boil at a known rate of energy application. The control circuit can estimate how much fluid is present by determining how much energy was delivered to the jaws to create a thermodynamic change in the tissue. The control circuit can use the determined amount of delivered energy to query a stored data set and identify the appropriate corresponding dwell time. If a large amount of energy is used, resulting in a large vapor-generating pulse cycle, the control circuit can provide a longer dwell time for condensation, and if a smaller amount of energy is used, resulting in a smaller vapor-generating pulse cycle, the control circuit can provide a shorter dwell time for condensation.

[0364] In another example, rather than using a stored data set, such as a look-up table, the control circuit can determine the dwell time as a ratio of the determined energy applied to the jaws. In another example, the control circuit can determine the dwell time as a factor of the determined energy applied to the jaws. As a non-limiting example, if the energy applied to the jaws was 20 joules, the wait time could be 200 ms (X*10 ms). Thus, 30 joules could correspond to 300 ms. The equation X*10 is an example and is not intended to be limiting. This could also be part of a logarithmic scale or other mathematical ratio term.

[0365] Additionally, the period of time required to bring the tissue between the jaws to a boil (at a set or known variable power) is another way to determine a dwell time that is long enough to ensure sufficient coagulation has occurred before applying the next tissue modification level of energy to the tissue. In some examples, the control circuit may attempt to shut off power just before boiling or at as little boiling as possible. The control circuit may determine that if a longer period of time is required to bring the tissue to a boil, more energy will have been delivered to the tissue and therefore a longer dwell time is necessary. For example, the control circuit may start a timer when delivering a pulse to determine whether the tissue has boiled or is close to boiling, and if so, stop the timer and compare the timer to one or more values ​​associated with the corresponding dwell time, and determine or select a dwell time based on this comparison. Increasing the timer value may increase the dwell time. As a non-limiting example, for illustrative purposes only, if 30 joules are required to bring the tissue to a boil or near boiling, a 250 ms dwell may be used, and if 18 joules are required to bring the tissue to a boil or near boiling, a 150 ms dwell may be used. These values ​​may depend on the surface area of ​​the jaws of the device being used, or other factors.

[0366] While the energy applied to the tissue can be a strong indicator of the amount of vapor produced, the impedance of the tissue can also affect the accuracy of the setting. For example, if the tissue has a higher electrical impedance (such as fat), it may take more voltage and less current to boil the tissue; if the tissue is very conductive, the current will do the work and create a larger vapor pocket for the same amount of energy. Therefore, a system that uses the energy application to determine the dwell time and further determines and uses the tissue impedance and energy used to create the boiling action is desirable.

[0367] The control circuit can determine the dwell time using other electrical properties, including one or more of current, reactance, inductance, impedance, resistance, power, phase angle, and energy, to confirm or improve the signal.

[0368] The vapor is a result of the delivered electrical current, which excites molecules in the tissue, causing heating. When more current is required to heat the tissue, it is suggested that more fluid is present in the tissue, and it is understood that the tissue structure itself is much more resistive than the fluid contents. Therefore, depending on a function of the electrotherapy signal, e.g., how the signal applies energy, it is desirable for the control circuitry to determine the peak current applied in the previous pulse, or the current delivered as a function of time, or the total amount of current delivered in that previous pulse. The control circuitry uses the determined current to query a stored data set, such as a lookup table, and determines or selects a dwell time based on the comparison.

[0369] For example, a control circuit such as control circuit 48 of FIG. 2 can control and apply power to the tissue, and current and voltage can flow depending on tissue impedance (this is a simplified explanation for general understanding). The control circuit can determine the total amount of current applied in the previous pulse, such as by integrating the amount of current delivered, which can assist in understanding how much vapor may have been generated during energy application. Current (I) is equal to the rate of change of charge (Q) with respect to time (I=dQ / dt). Therefore, the integral of current I over a period of time is equal to the total amount of charge (Q) during that period.

[0370] Instead of using the total amount of energy delivered to the tissue, the inventors have determined that the total amount of charge delivered can be used to determine the dwell time. In some examples, the control circuitry can determine the dwell time as a ratio of the total amount of charge or as a factor of the total amount of charge. In other examples, the control circuitry can use a stored data set, such as a lookup table, to determine the dwell time using the total amount of charge, or some other mathematically derived calculation can be used to provide an appropriate dwell time, which need not be the same for all energy pulses.

[0371] The dwell time can be further refined by including other factors or exclusions as described above. One example of such an exclusion is that the control circuit can reduce the dwell time because the amount of tissue in the jaws may be significantly impacted if current is delivered for a period greater than 300 ms. Thus, the control circuit can start a timer, compare the timer to a threshold, such as 300 ms, and determine the dwell time based on this comparison. Alternatively, one or more feedback signals, such as the phase angle, can be used to predict the composition of tissue between the energy conducting elements. The control circuit can then factor these feedback signals into its calculations to determine the appropriate dwell time.

[0372] Incremental adjustment of control parameters as a function of monitored variables The initial collagen transition occurs at approximately 58 (±10) degrees Celsius (°C), where a conformal change occurs in collagen fibrils. The main transition can occur at approximately 65 (±10)°C, which corresponds to the collagen gelation process in a hydrated environment and is caused by the breakdown of internal crosslinks. Other critical and significant temperatures limit tissue modification. At typical tissue temperatures of approximately 90-100°C, additional phase changes begin to occur within the tissue, most notably the conversion of water to steam. This transition is undesirable because steam resists energy, which drives fluid removal from the tissue but can also damage surrounding tissue through migration to adjacent structures. This transition is undesirable because such damage cannot be controlled and may affect tissue outside the jaw footprint.

[0373] From a clinical perspective, this means that surgeons must be mindful of any potential "thermal spread" when using devices and activating near delicate adjacent structures, which is undesirable and can lead to accidental tissue damage such as perforation and necrosis, both of which can occur immediately or, even worse, many days after energy application.

[0374] Tissue containing vapor also has a higher electrical resistance than the same tissue containing liquid water. This means that more of the energy driving the tissue state change is converted from electrical current to voltage. Because electrical current typically acts to heat via molecular excitation, it is advantageous to limit the time of the vapor phase for good vessel sealing.

[0375] The present inventors have recognized the need for improved power-controlled (or voltage-controlled) techniques that attempt to maintain the power output in a favorable collagen transition state for longer before control is lost and bubble region generation occurs. Using various techniques described in detail below, an electrosurgical generator, such as electrosurgical generator 12 of FIG. 2, can control the energy delivery of a therapy signal provided to biological tissue during a portion of a therapy phase according to incremental changes in energy delivery as a function of changes in a measured electrical parameter of the biological tissue.

[0376] Applying energy to tissue can produce steam. As the amount of steam increases, impedance also increases. The increase in impedance can indicate steam production. As impedance increases, current decreases and voltage increases (P=V*I) by the same amount of power delivered. If the control circuit continues to apply the same amount of power after it determines that steam is being produced, steam production may undesirably increase, potentially adversely affecting adjacent tissue. However, by using various techniques of the present disclosure, the control circuit can monitor changes in electrical parameters, such as current or impedance, and can reduce power to maintain the tissue in a state where steam is just beginning to be produced, rather than a state where steam is being produced in large quantities, which is desirable for affecting collagen without creating undesirable thermal margins.

[0377] Control circuitry and measurement circuitry, such as control circuitry 48 and measurement circuitry 46 of Figure 2, can monitor the current output of the generator and convert an increase or decrease in current into a corresponding increase or decrease in output power. In some examples, the correlation between the increase or decrease in current and the subsequent power increase or decrease control can be directly proportional.

[0378] In some examples, the control circuit can scale the power application to provide different powers in response to changes in a measured electrical parameter, such as current or impedance. The scaling can be a function of the change in the measured electrical parameter of the biological tissue. In some examples, the function can define a curve. In other examples, the function can be a linear equation, such as a linear conversion from changes in the value of the measured electrical parameter, such as current or impedance, to changes in power or voltage in units such as watts or volts per second. The power (or voltage) can increase or decrease as the current changes. In some examples, the linear equation can be monotonic. In some examples, one or both of a minimum and a maximum value can be defined to allow the control circuit to limit changes in power or voltage.

[0379] 23 is a graph illustrating an example of the relationship between change in value of a measured electrical parameter and change in power. While specifically shown as a relationship between change in current per unit time and change in power in watts per unit time, the described techniques are not limited to current or power. In the example shown in FIG. 23, the y-axis of graph 2100 can represent watts / second and the x-axis can represent change in current / second.

[0380] In one example, the linear equation defining line 2102 may include an offset such that the line does not pass through the origin, so that the change in power is positive when the change in current or delta current value is zero. For example, in graph 2100 showing the relationship between change in power and change in current, line 2102 may have a positive slope and extend through quadrants I, II, and III. As another example, in a graph showing the relationship between change in voltage and change in current, the line may have a negative slope and extend through quadrants I, II, and IV. In the example shown in FIG. 23 , one or both of a maximum slope rate 2104 and a minimum slope rate 2106 may be defined such that the control circuit can, for example, limit the rate of change of power.

[0381] In one example, the relationship between the change in the measured electrical parameter and the incremental change in energy can be stored in a data set, such as a look-up table, and the control circuitry can query the stored data set, compare the change in the measured electrical parameter of the biological tissue with the stored data set, and determine the incremental change in energy delivery based on the comparison.

[0382] Whether using a function, e.g., a linear function, or using a stored data set, the control circuitry can monitor an electrical parameter, such as a change in current, and thus can make real-time (or "on-the-fly") adjustments to a control parameter, such as power or voltage, to control the energy delivery of the therapy signal provided to the biological tissue during a portion of the therapy phase. In this manner, the control circuitry can control the power or voltage of the therapy signal provided to the biological tissue as a function of changes in the measured electrical parameter of the biological tissue. For example, the control circuitry can incrementally modify the power or voltage as a function of current.

[0383] By non-limiting example, a small positive current rate change can result in a moderate power rate change. As another example, a zero current rate change can result in a negative power rate change. As another example, a negative current rate change can result in a large negative power rate change. As another example, a large current rate change can result in a large power rate change. By monitoring the current delta (also called change in current), different power controls can be applied that can drive different tissue results or can be modified to accommodate different application devices.

[0384] When power is applied, the tissue is not yet boiling, so the current can be increased, and as the tissue heats up, it becomes more conductive. Therefore, increasing the power requires more current. Using various techniques of the present disclosure, a control circuit, such as control circuit 48 of FIG. 2, can desirably allow the power to be increased as the current continues to increase, thereby speeding up the time it takes for the collagen to denature. Eventually, a state is reached where power cannot be applied to the tissue any faster without causing tissue rupture. To avoid tissue rupture, the control circuit can define a maximum power (or voltage) value to limit the power (or voltage) applied to the tissue.

[0385] As the amount of vapor increases, the impedance also increases. As the impedance increases, the current decreases and the voltage increases by the same amount as the power delivered (P=V*I). If the control circuit determines that vapor is being produced, the control circuit can rapidly reduce the power, but not so rapidly that vapor production stops. As the impedance continues to increase, the control circuit can determine the amount of energy delivered from the change in impedance. Using the determined amount of energy delivered, the control circuit can stop applying power and pause momentarily to allow the vapor to deflate.

[0386] Biological tissue contains salts, and sodium can burn when energy is applied to the tissue. Burning sodium can have very high conductivity, which can distort measurements used to determine whether to increase or decrease power or voltage. To avoid making real-time decisions based on small, rapid changes such as sodium burning, electrosurgical generators, such as electrosurgical generator 12 of FIG. 2, can include or implement various filters. As an example, a filter can be added to the current sampling to smooth the generator output when considering changes in current delta. The frequency of the filtering can depend on the processing speed of the generator control CPU.

[0387] In some examples, the control circuitry can further determine whether a proposed power (or voltage) increase or decrease should occur. For example, the control circuitry can sample a recent increase or decrease in power (or voltage) and determine whether the increase (or decrease) should continue or whether a recent change in power slope (or voltage slope) is noise or within expected limits. For example, if the past two (or more) power slope values ​​(or voltage slope values) were positive and large, but a recent value indicates a significant negative (decrease) in power, the control circuitry can reverse this decision and decrease the power (or voltage) until a later current delta calculation is evaluated.

[0388] In some examples, the control circuitry may include boundaries on the maximum allowable change and / or maximum allowable power or ramp rate, thereby preventing the generator from being limited solely by hardware or from applying energy to the tissue too quickly. This may be accomplished by limiting the maximum power during a stage, limiting the maximum power change (e.g., limiting the maximum watt ramp rate per second), etc.

[0389] These power (or voltage) control techniques, which can control the energy delivery of a therapy signal provided to biological tissue during a portion of a therapy phase according to incremental changes in energy delivery as a function of changes in a measured electrical parameter of the biological tissue, can be used with a single ramp waveform output or a pulse waveform output. An advantage of a pulse waveform output is that power can be increased quickly when desired. For example, under certain conditions, power can be significantly reduced (or temporarily stopped) to allow vapor to condense and then power to be applied again ramped until the desired tissue effect "end point" is reached.

[0390] Aspects To further illustrate the above-described electrosurgical techniques, a non-limiting list of various aspects is set forth below, each of which can stand alone or can be combined in various permutations or combinations with one or more of the other aspects.

[0391] A. Short-circuit error trapping by band between trigger and escape values Embodiment A1 can include or be used as subject matter (e.g., a system, device, method, article, etc.) that can include or be used as a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver electrosurgical energy to an output terminal for delivery to a patient, wherein the output terminal is configured to couple to an electrosurgical device having two electrodes, and the control circuit is configured to compare a first measured impedance value of biological tissue in electrical communication with the two electrodes of the electrosurgical device to a first threshold value, start a timer when the first measured impedance value is less than or equal to the first threshold value, compare a second measured impedance value of the tissue between the two electrodes to a second threshold value that is greater than the first threshold value, and continue delivery of the electrosurgical energy when the second measured impedance value is less than the second threshold value and the timer does not meet a time limit.

[0392] Embodiment A2 may include or use at least some features of embodiment A1, or optionally in combination with such features, wherein the control circuit is configured to reduce the delivery of electrosurgical energy when the second measured impedance value is less than a second threshold and the timer meets the time limit.

[0393] Embodiment A3 may include or use at least some features of any one or more of embodiments A1 or A2, or optionally in combination with such features, wherein the control circuitry is configured to generate an indication when the timer meets a time limit.

[0394] Embodiment A4 may include or use at least some features of any one or more of embodiments A1 through A3, or may include or use the timer being less than 6 seconds, optionally in combination with such features.

[0395] Embodiment A5 may include or use at least some features of any one or more of embodiments A1 through A4, or optionally in combination with such features, wherein the control circuit is configured to adjust at least one of the first threshold, the second threshold, and the time limit based on at least one characteristic of the electrosurgical device or based on at least one characteristic of an electrosurgical generator configured to be coupled to the electrosurgical device.

[0396] Embodiment A6 can include or use at least some features of any one or more of embodiments A1 through A5, or optionally in combination with such features, wherein at least one characteristic includes the surface area of ​​at least one of the electrodes.

[0397] Embodiment A7 may include or use at least some features of any one or more of embodiments A1 through A6, or optionally in combination with such features, wherein the electrodes are positioned in the jaws of an electrosurgical device and the at least one characteristic includes the jaw force of the electrosurgical device.

[0398] Embodiment A8 may include or use at least some features of any one or more of embodiments A1 through A7, or optionally in combination with such features, wherein at least one characteristic includes the output current of the electrosurgical generator.

[0399] Embodiment A9 may include or use at least some features of any one or more of embodiments A1 through A8, or may optionally include or use in combination with such features, where an electrode is positioned on the jaws of the electrosurgical device and the biological tissue is positioned between two electrodes of the electrosurgical device.

[0400] Embodiment A10 can include or use a method of delivering electrical energy to an electrosurgical device, the method including initiating a current delivery of electrosurgical energy to biological tissue in electrical communication with two electrodes of the electrosurgical device, comparing a first measured impedance value of the tissue to a first threshold value, starting a timer when the first measured impedance value is less than or equal to the first threshold value, comparing a second measured impedance value of the tissue to a second threshold value greater than the first threshold value, and continuing the delivery of electrosurgical energy when the second measured impedance value is less than the second threshold value and the timer has not met a time limit.

[0401] Embodiment A11 may include or use at least some features of embodiment A10, or optionally in combination with such features, to reduce the delivery of electrosurgical energy when the second measured impedance value is less than a second threshold and the timer meets a time limit.

[0402] Embodiment A12 may include or use at least some features of any one or more of embodiments A10 or A11, or optionally in combination with such features, to generate an indication when the timer meets a time limit.

[0403] Embodiment A13 may include or use at least some features of any one or more of embodiments A10 to A12, or may optionally include or use in combination with such features, an electrode positioned on the jaws of an electrosurgical device and the biological tissue positioned between two electrodes of the electrosurgical device.

[0404] Embodiment A14 may include or use at least some features of any one or more of embodiments A10 to A13, or may include or use the timer being less than 6 seconds, optionally in combination with such features.

[0405] Embodiment A15 may include or use at least some features of any one or more of embodiments A10 to A14, or optionally in combination with such features, to adjust at least one of the first threshold, the second threshold, and the time limit based on at least one characteristic of the electrosurgical device or based on at least one characteristic of an electrosurgical generator configured to be coupled to the electrosurgical device.

[0406] Embodiment A16 can include or use at least some features of any one or more of embodiments A10 to A15, or optionally in combination with such features, where at least one characteristic of the electrosurgical device includes the surface area of ​​at least one of the electrodes.

[0407] Embodiment A17 may include or use at least some features of any one or more of embodiments A10 to A16, or optionally in combination with such features, wherein the electrodes are positioned in the jaws of an electrosurgical device and at least one characteristic of the electrosurgical device includes a jaw force of the electrosurgical device.

[0408] Embodiment A18 may include or use at least some features of any one or more of embodiments A10 to A17, or optionally in combination with such features, wherein at least one characteristic of the electrosurgical generator includes the output current of the electrosurgical generator.

[0409] B. Open-circuit confirmation for resistance-limiting endpoint RF waveforms and evaluation of open-circuit time during the termination phase Embodiment B1 can include or can be used with subject matter (e.g., a system, device, method, article, etc.) that can include or can be used with a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver electrosurgical energy to an output terminal for delivery to a patient, wherein the output terminal is configured to couple to an electrosurgical device having two jaws including corresponding electrodes, and wherein the control circuit is configured to start a timer in response to delivery of electrosurgical energy to biological tissue in electrical communication with the two electrodes of the electrosurgical device, and after the timer meets a time limit, compare a representation of impedance with a first threshold value, and continue delivery of the electrosurgical energy when the representation of impedance is less than the first threshold value.

[0410] Embodiment B2 can include or use at least some features of embodiment B1, or optionally in combination with such features, wherein the control circuit is configured to reduce the delivery of electrosurgical energy when the representation of impedance is greater than or equal to a first threshold and less than a second threshold.

[0411] Embodiment B3 can include or use at least some features of embodiments B1 or B2, or optionally in combination with such features, wherein the control circuit is configured to reduce the delivery of electrosurgical energy when the representation of impedance is greater than or equal to a second threshold.

[0412] Embodiment B4 may include or use at least some features of any one or more of embodiments B1 through B3, or optionally in combination with such features, wherein the control circuitry is configured to generate an indication when the representation of the impedance is greater than or equal to a second threshold value.

[0413] Embodiment B5 may include or use at least some features of any one or more of embodiments B1 through B4, or optionally in combination with such features, wherein the control circuitry configured to generate an indication when the representation of impedance is greater than or equal to a second threshold is configured to generate an audible indication.

[0414] Embodiment B6 may include or use at least some features of any one or more of embodiments B1 through B5, or optionally in combination with such features, wherein the control circuitry configured to generate an indication when the representation of impedance is greater than or equal to a second threshold is configured to generate a visual indication.

[0415] Embodiment B7 may include or use at least some features of any one or more of embodiments B1 through B6, or optionally in combination with such features, where the representation of the impedance includes a value of the impedance.

[0416] Embodiment B8 may include or use at least some features of any one or more of embodiments B1 through B7, or optionally in combination with such features, where the representation of the impedance includes a change in the value of the impedance.

[0417] Embodiment B9 can include or can be used for subject matter (e.g., a system, device, method, article, etc.) that can include or can be used for a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver electrosurgical energy to an output terminal for delivery to a patient, wherein the output terminal is configured to couple to an electrosurgical device having two jaws including corresponding electrodes, and wherein the control circuit is configured to start a timer in response to delivery of electrosurgical energy to biological tissue in electrical communication with the two electrodes of the electrosurgical device, and after the timer meets a time limit, compare the rate of change of impedance of the biological tissue with a first threshold, and continue delivery of the electrosurgical energy when the rate of change of impedance is less than the first threshold.

[0418] Embodiment B10 may include or use at least some features of embodiment B9, or optionally in combination with such features, wherein the control circuit is configured to reduce the delivery of energy when the rate of change of impedance is greater than or equal to a first threshold.

[0419] Embodiment B11 may include or use at least some features of any one or more of embodiments B9 or B10, or optionally in combination with such features, wherein the control circuitry is configured to generate an indication when the rate of change of impedance is greater than or equal to a first threshold value.

[0420] Embodiment B12 may include or use at least some features of any one or more of embodiments B9 to B11, or optionally in combination with such features, wherein the control circuitry configured to generate an indication when the rate of change of impedance is greater than or equal to a first threshold is configured to generate the indication.

[0421] Embodiment B13 can include or can employ subject matter (e.g., systems, apparatus, methods, articles, etc.) that can include or can employ a method of delivering electrical energy to an electrosurgical device, the method including, in response to delivery of electrosurgical energy to biological tissue in electrical communication with two electrodes of the electrosurgical device, starting a timer, comparing a representation of the impedance of the biological tissue to a threshold value, continuing delivery of electrosurgical energy until the threshold value is met, recording the elapsed time when the threshold value is reached, and declaring an error condition if the elapsed time is less than the time limit.

[0422] Embodiment B14 may include or use at least some features of embodiment B13, or optionally in combination with such features, determining a difference between the first measured impedance and the second measured impedance, comparing the determined difference to a predetermined delta impedance value, and generating an error signal in response to the determined difference being greater than or equal to the predetermined delta impedance value and the timer being less than a threshold time limit.

[0423] Embodiment B15 may include or use at least some features of any one or more of embodiments B13 or B14, or optionally in combination with such features, and may include or use determining a difference between the first measured impedance and the second measured impedance, comparing the determined difference to a predetermined delta impedance value, and increasing the power ramp rate of the electrosurgical energy in response to the comparison.

[0424] Embodiment B16 may include or use at least some features of any one or more of embodiments B13 through B15, or optionally in combination with such features, continuing to increase the power ramp rate until the determined difference meets or exceeds a predetermined delta impedance value or until a power limit is reached.

[0425] Embodiment B17 may include or use at least some features of any one or more of embodiments B13 to B16, or optionally in combination with such features, and may include or use the power ramp rate being a first power ramp rate and, in response to reaching a power limit, adjusting the power ramp rate from the first power ramp rate to a second power ramp rate that is slower than the first ramp rate.

[0426] Embodiment B18 may include or use at least some features of any one or more of embodiments B13 to B17, or optionally in combination with such features, where the threshold is a first threshold and during the termination phase, may include or use comparing the representation of the impedance of the biological tissue with a second threshold, and delivering electrosurgical energy at a constant power ramp rate until the representation of the impedance meets or exceeds the second threshold.

[0427] Embodiment B19 may include or use at least some features of any one or more of embodiments B13 to B18, or may optionally include or use in combination with such features, delivering electrosurgical energy at a constant power before delivering electrosurgical energy at a constant power ramp rate.

[0428] C. Alternative Power Correction Outputs on Low-Precision Hardware Systems Embodiment C1 can include or be used as subject matter (e.g., a system, apparatus, method, article, etc.) that can include or be used as a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver electrosurgical energy to an output terminal for delivery to a patient, wherein the output terminal is configured to couple to an electrosurgical device having two jaws including corresponding electrodes, and wherein the control circuit is configured to compare a representation of the impedance of biological tissue in electrical communication with the two electrodes of the electrosurgical device with a first threshold value, and when the representation of the impedance is within a first range, select a first power correction from at least two power corrections, and apply the selected first power correction to a power setting of a power generator coupled to the electrosurgical device.

[0429] Embodiment C2 may include or use at least some features of embodiment C1, or optionally in combination with such features, wherein the control circuit is configured to select a second power correction from the at least two power corrections when the representation of the impedance is within a second range.

[0430] Embodiment C3 may include or use at least some features of any one or more of embodiments C1 or C2, or optionally in combination with such features, wherein the control circuitry is configured to compare the representation of the at least one secondary parameter with at least one threshold value, and select a third power correction from the at least two power corrections when the representation of the at least one secondary parameter is less than the at least one threshold value.

[0431] Embodiment C4 may include or use at least some features of any one or more of embodiments C1 through C3, or optionally in combination with such features, wherein the at least one secondary parameter includes one or more of the output current of the power generator, tissue temperature, and phase angle.

[0432] Embodiment C5 may include or use at least some features of any one or more of embodiments C1 to C4, or optionally in combination with such features, wherein the control circuit is configured to deliver electrosurgical energy via the electrodes of the electrosurgical device during a period of time using a corrected power setting.

[0433] Embodiment C6 can include or use at least some features of any one or more of embodiments C1 through C5, or optionally in combination with such features, where the time period is based at least on a range of impedance values.

[0434] Embodiment C7 may include or use at least some features of any one or more of embodiments C1 through C6, or optionally in combination with such features, wherein the duration is based at least on the amount of electrosurgical energy delivered.

[0435] Embodiment C8 may include or use at least some features of any one or more of embodiments C1 to C7, or optionally in combination with such features, wherein the control circuit is configured to deliver electrosurgical energy through an electrode of the electrosurgical device using a correction power setting and to reduce the application of the selected first power correction to the power setting when the representation of the impedance meets or exceeds a second threshold.

[0436] Embodiment C9 may include or use at least some features of any one or more of embodiments C1 to C8, or optionally in combination with such features, and may include or use a corrective power setting to deliver electrosurgical energy via an electrode of an electrosurgical device, and dynamically adjusting at least one of the upper and lower limits when the representation of the impedance is within a predetermined percentage or value of the upper or lower limits of the first range.

[0437] Embodiment C10 can include or can use subject matter (e.g., a system, apparatus, method, article, etc.) that can include or can use a method for delivering electrical energy to an electrosurgical device, the method including comparing a representation of the impedance of biological tissue in electrical communication with two electrodes of the electrosurgical device with a first threshold value, selecting a first power correction from at least two power corrections when the representation of the impedance is within a first range, and applying the selected first power correction to a power setting of a power generator coupled to the electrosurgical device.

[0438] Embodiment C11 may include or use at least some features of embodiment C10, or optionally in combination with such features, selecting a second power correction from the at least two power corrections when the representation of the impedance is within a second range.

[0439] Embodiment C12 may include or use at least some features of any one or more of embodiments C10 or C11, or optionally in combination with such features, including comparing a representation of the at least one secondary parameter with at least one threshold value, and selecting a third power correction from the at least two power corrections when the representation of the at least one secondary parameter is less than the at least one threshold value.

[0440] Embodiment C13 may include or use at least some features of any one or more of embodiments C10 to C12, or optionally in combination with such features, wherein the at least one secondary parameter includes one or more of the output current of the power generator, tissue temperature, and phase angle.

[0441] Embodiment C14 may include or use at least some features of any one or more of embodiments C10 to C13, or may optionally include or use in combination with such features, delivering electrosurgical energy via electrodes of an electrosurgical device during a period of time using a corrective power setting.

[0442] Embodiment C15 can include or use at least some features of any one or more of embodiments C10 to C14, or optionally in combination with such features, where the time period is based at least on a range of impedance values.

[0443] Embodiment C16 may include or use at least some features of any one or more of embodiments C10 to C15, or optionally in combination with such features, wherein the duration is based at least on the amount of electrosurgical energy delivered.

[0444] Embodiment C17 may include or use at least some features of any one or more of embodiments C10 to C16, or optionally in combination with such features, and may include or use a correction power setting to deliver electrosurgical energy through an electrode of an electrosurgical device, and reducing the application of the selected first power correction to the power setting when the representation of the impedance meets or exceeds a second threshold.

[0445] Embodiment C18 includes or uses at least some features of any one or more of embodiments C10 to C17, or optionally in combination with such features, and can include or use a corrected power setting to deliver electrosurgical energy through an electrode of an electrosurgical device, and applying a second power correction to the power setting when the impedance representation is a specified percentage above the upper limit of the first range.

[0446] D. Multi-energy devices with reduced thermal margins Embodiment D1 is a subject matter (e.g., a system, device, method, article, etc.) that can include or use a combined ultrasonic energy and electrosurgical energy system comprising: a control circuit; and an output circuit coupled to the control circuit and configured to deliver energy to an output terminal for delivery to a patient, the output terminal being configured to couple to an electrosurgical device having two jaws including corresponding electrodes, the delivered energy including at least some ultrasonic energy, the control circuit controlling the delivery of energy to biological tissue in electrical communication with the two electrodes of the electrosurgical device, measuring a representation of a tissue parameter of the biological tissue, and configured to reduce the level of delivery of energy or terminate the delivery of energy based on a characteristic of the measured representation of the tissue parameter of the biological tissue, the delivered energy being a combination of electrosurgical energy and ultrasonic energy, and the control circuit configured to reduce the level of delivery of energy or terminate the delivery of energy is configured to reduce the level of ultrasonic energy.

[0447] Embodiment D2 can include or use at least some features of embodiment D1, or optionally in combination with such features, in which the control circuitry configured to reduce the level of ultrasonic energy is configured to terminate the delivery of ultrasonic energy.

[0448] Embodiment D3 may include or use at least some features of any one or more of embodiments D1 or D2, or optionally in combination with such features, wherein the control circuit is configured to reduce the level of electrosurgical energy.

[0449] Embodiment D4 may include or use at least some features of any one or more of embodiments D1 through D3, or optionally in combination with such features, wherein the control circuitry configured to reduce the level of electrosurgical energy is further configured to terminate the delivery of electrosurgical energy.

[0450] Embodiment D5 may include or use at least some features of any one or more of embodiments D1 to D4, or optionally in combination with such features, wherein the delivered energy is a combination of electrosurgical energy and ultrasonic energy, and the electrosurgical energy is power-controlled.

[0451] Embodiment D6 can include or use at least some features of any one or more of embodiments D1 to D5, or optionally in combination with such features, where the delivered energy is a combination of electrosurgical energy and ultrasonic energy, and the electrosurgical energy is voltage-controlled.

[0452] Embodiment D7 may include or use at least some features of any one or more of embodiments D1 through D6, or optionally in combination with such features, where the measured representation of the tissue parameter is an impedance value, and the control circuitry is configured to compare the impedance value to a threshold value and reduce the level of ultrasound energy based on the comparison.

[0453] Embodiment D8 may include or use at least some features of any one or more of embodiments D1 through D7, or optionally in combination with such features, where the measured representation of the tissue parameter is a change in impedance, and the method includes comparing the change in impedance to a threshold value and reducing the level of ultrasound energy based on the comparison.

[0454] Embodiment D9 can include or can use subject matter (e.g., systems, apparatus, methods, articles, etc.) that can include or can use a method for delivering energy to a combined ultrasonic energy and electrosurgical energy device, the method comprising delivering energy to biological tissue in electrical communication with two electrodes of the electrosurgical device, wherein the delivered energy comprises at least some ultrasonic energy; measuring a representation of a tissue parameter of the biological tissue; and reducing the level of delivery of energy or terminating the delivery of energy based on a characteristic of the measured representation of the tissue parameter, wherein the delivered energy is a combination of electrosurgical energy and ultrasonic energy, and reducing the level of delivery of energy or terminating the delivery of energy comprises reducing the level of ultrasonic energy.

[0455] Embodiment D10 can include or use at least some features of embodiment D9, or optionally in combination with such features, where reducing the level of ultrasonic energy includes terminating the delivery of ultrasonic energy.

[0456] Embodiment D11 can include or use at least some features of any one or more of embodiments D9 or D10, or optionally in combination with such features, to reduce the level of electrosurgical energy.

[0457] Embodiment D12 can include or use at least some features of any one or more of embodiments D9 to D11, or optionally in combination with such features, where reducing the level of electrosurgical energy includes terminating the delivery of electrosurgical energy.

[0458] Embodiment D13 can include or use at least some features of any one or more of embodiments D9 to D12, or optionally in combination with such features, where the delivered energy is a combination of electrosurgical energy and ultrasonic energy, and the electrosurgical energy is power-controlled.

[0459] Embodiment D14 can include or use at least some features of any one or more of embodiments D9 to D13, or optionally in combination with such features, wherein the delivered energy is a combination of electrosurgical energy and ultrasonic energy, and the electrosurgical energy is voltage-controlled.

[0460] Embodiment D15 may include or use at least some features of any one or more of embodiments D9 to D14, or optionally in combination with such features, where the measured representation of the tissue parameter is an impedance value, and the method includes comparing the impedance value to a threshold value and reducing the level of ultrasound energy based on the comparison.

[0461] Embodiment D16 may include or use at least some features of any one or more of embodiments D9 to D15, or optionally in combination with such features, where the measured representation of the tissue parameter is a change in impedance, and the method includes comparing the change in impedance to a threshold value and reducing the level of ultrasound energy based on the comparison.

[0462] E. Graded Resistance Values ​​for Controlling Thermal Margin in Systems with Slow CPUs Embodiment E1 can include or can use subject matter (e.g., a system, apparatus, method, article, etc.) that can include or can use a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver energy to an output terminal for delivery to a patient, wherein the output terminal is configured to couple to an electrosurgical device having at least one electrode, and the control circuit is configured to count and deliver electrosurgical energy pulses to biological tissue in communication with the at least one electrode, compare a parameter to a threshold for a plurality of electrosurgical energy pulses, and adjust the threshold based on the counting of the electrosurgical energy pulses.

[0463] Embodiment E2 includes or uses at least some features of embodiment E1, or optionally in combination with such features, wherein the parameter is selected from the group consisting of: impedance of the biological tissue, a change in impedance of the biological tissue, a rate of change of impedance of the biological tissue, a change in phase angle, a change in current of the delivered electrosurgical energy pulse, and a change in output voltage of the delivered electrosurgical energy pulse.

[0464] Embodiment E3 may include or use at least some features of any one or more of embodiments E1 or E2, or optionally in combination with such features, wherein the control circuitry is configured to retrieve data representing the threshold value from the memory device.

[0465] Embodiment E4 may include or use at least some features of any one or more of embodiments E1 through E3, or optionally in combination with such features, wherein the control circuit is configured to compare a first measured parameter and a second measured parameter, and the control circuit configured to adjust the threshold based on the count of electrosurgical energy pulses is configured to adjust the threshold based on a difference between the first measured parameter and the second measured parameter.

[0466] Embodiment E5 may include or use at least some features of any one or more of embodiments E1 through E4, or optionally in combination with such features, wherein the control circuit is configured to compare a first measured parameter to a second measured parameter, and the control circuit configured to adjust the threshold based on the count of electrosurgical energy pulses is configured to adjust the threshold based on the first measured parameter being greater than the second measured parameter.

[0467] Embodiment E6 may include or use at least some features of any one or more of embodiments E1 through E5, or optionally in combination with such features, wherein the control circuit is configured to compare a first measured parameter to a second measured parameter, and the control circuit configured to adjust the threshold based on the count of electrosurgical energy pulses is configured to adjust the threshold based on the first measured parameter being less than the second measured parameter.

[0468] Embodiment E7 may include or use at least some features of any one or more of embodiments E1 through E6, or optionally in combination with such features, wherein the control circuit is configured to determine a rate of change between a first measured parameter and a second measured parameter, and the control circuit configured to adjust the threshold based on the count of electrosurgical energy pulses is configured to adjust the threshold based on the rate of change between the first measured parameter and the second measured parameter.

[0469] Embodiment E8 may include or use at least some features of any one or more of embodiments E1 through E7, or optionally in combination with such features, wherein the control circuitry is configured to adjust the threshold value based on the parameter.

[0470] Embodiment E9 may include or use at least some features of any one or more of embodiments E1 through E8, or optionally in combination with such features, wherein the control circuit is configured to reduce the delivery of the multiple electrosurgical energy pulses when the measured impedance representation meets or exceeds an endpoint value.

[0471] Embodiment E10 is a surgical system comprising a control circuit and an output circuit coupled to the control circuit and configured to deliver energy to an output terminal for delivery to a patient, the output terminal configured to couple to an electrosurgical device having two jaws including corresponding electrodes, the control circuit counting and delivering electrosurgical energy pulses to biological tissue in electrical communication with the two electrodes of the surgical device, delivering a first electrosurgical energy pulse to the biological tissue in electrical communication with the two electrodes of the electrosurgical device for the plurality of electrosurgical energy pulses, comparing a first measured impedance representation of the biological tissue with a first threshold value; The subject matter (e.g., systems, devices, methods, articles, etc.) may include or may be used with a surgical system configured to reduce delivery of a first electrosurgical energy pulse when a first measured impedance representation meets or exceeds a first threshold, increase the first threshold to a second threshold based on pulse counting, deliver a second electrosurgical energy pulse to the tissue, compare the second measured impedance representation of the tissue with the second threshold, and reduce delivery of the second electrosurgical energy pulse when the second measured impedance representation meets or exceeds the second threshold.

[0472] Embodiment E11 may include or use at least some features of embodiment E10, or optionally in combination with such features, wherein the control circuitry is configured to retrieve data representing the first and second threshold values ​​from the memory device.

[0473] Embodiment E12 may include or use at least some features of any one or more of embodiments E10 or E11, or optionally in combination with such features, wherein the control circuitry is configured to compare the first measured impedance representation and the second measured impedance representation and determine a second threshold value based on a difference between the first measured impedance representation and the second measured impedance representation.

[0474] Embodiment E13 may include or use at least some features of any one or more of embodiments E10 to E12, or optionally in combination with such features, wherein the control circuitry is configured to compare the first measured impedance representation and the second measured impedance representation and determine the second threshold value based on the first measured impedance representation being greater than the second measured impedance representation.

[0475] Embodiment E14 may include or use at least some features of any one or more of embodiments E10 to E13, or optionally in combination with such features, wherein the control circuitry is configured to compare the first measured impedance representation and the second measured impedance representation and determine the second threshold value based on the first measured impedance representation being less than the second measured impedance representation.

[0476] Embodiment E15 may include or use at least some features of any one or more of embodiments E10 to E14, or optionally in combination with such features, wherein the control circuitry is configured to determine a rate of change between the first measured impedance representation and the second measured impedance representation, and determine the second threshold value based on the rate of change.

[0477] Embodiment E16 may include or use at least some features of any one or more of embodiments E10 to E15, or optionally in combination with such features, wherein the control circuitry is configured to determine the second threshold value based on the first measured impedance representation.

[0478] Embodiment E17 can include or can employ subject matter (e.g., systems, apparatus, methods, articles, etc.) that can include or can employ a method for delivering electrical energy to an electrosurgical device, the method including counting and delivering a plurality of electrosurgical energy pulses to biological tissue in electrical communication with two electrodes of the electrosurgical device, comparing a parameter to a threshold for the plurality of electrosurgical energy pulses, and adjusting the threshold based on the counting of the electrosurgical energy pulses.

[0479] Embodiment E18 may include or use at least some features of embodiment E17, or optionally in combination with such features, wherein the parameter is selected from the group consisting of: impedance of the biological tissue, a change in impedance of the biological tissue, a rate of change of impedance of the biological tissue, a change in phase angle, a change in current of the delivered electrosurgical energy pulse, and a change in output voltage of the delivered electrosurgical energy pulse.

[0480] ...

Claims

1. a surgical generator configured to generate and provide controlled power of a therapy signal to biological tissue in electrical communication with the device; a control circuit in communication with an electrical energy source, the electrical energy source electrically coupled to the device and configured to generate the therapy signal, the control circuit comprising: configured to control the energy delivery of the therapy signal provided to the biological tissue during a portion of a therapy phase according to an incremental change in energy delivery as a function of a rate of change of the measured electrical parameter of the biological tissue; The function is defined as a linear rate of change bounded by a maximum rate of change and a minimum rate of change.

2. 10. The surgical generator of claim 1, wherein the control circuitry configured to control the energy delivery of the therapy signal comprises: A surgical generator configured to control the power of the therapy signal provided to the biological tissue.

3. 3. The surgical generator of claim 2, wherein the control circuitry configured to control the power of the therapy signal provided to the biological tissue comprises: A surgical generator configured to incrementally modify said power as a function of current.

4. 10. The surgical generator of claim 1, wherein the control circuitry configured to control the energy delivery of the therapy signal comprises: A surgical generator configured to control the voltage of the therapy signal provided to the biological tissue.

5. 5. The surgical generator of claim 4, wherein the control circuit configured to control the voltage of the therapy signal provided to the biological tissue comprises: A surgical generator configured to incrementally modify the voltage as a function of current.

6. 10. The surgical generator of claim 1, wherein the measured electrical parameter comprises a change in impedance.

7. 10. The surgical generator of claim 1, wherein the measured electrical parameter comprises a change in electrical current.

8. 2. The surgical generator of claim 1, wherein the control circuitry comprises: comparing the change in the measured electrical parameter of the biological tissue with a stored data set; The surgical generator configured to determine the incremental change in energy delivery based on the comparison.

9. a surgical generator configured to generate and provide controlled power of a therapy signal to biological tissue in electrical communication with the device; a control circuit in communication with an electrical energy source, the electrical energy source electrically coupled to the device and configured to generate the therapy signal, the control circuit comprising:

1. A surgical generator configured to control the energy delivery of the therapy signal provided to the biological tissue during a portion of a therapy phase in accordance with incremental changes in energy delivery as a function of a rate of change of a measured electrical parameter of the biological tissue, the control comprising scaling power delivered to the biological tissue to provide different power depending on the rate of change of the measured electrical parameter.

10. 10. The surgical generator of claim 9, wherein scaling the power delivered to the biological tissue to provide the different power in response to the change in the measured electrical parameter comprises: scaling the power delivered to the biological tissue to provide different power in response to the change in current.

11. 10. The surgical generator of claim 9, wherein scaling the delivered power to provide the different power in response to the change in the measured electrical parameter comprises: scaling the power delivered to the biological tissue to provide different power in response to the change in impedance.

12. 10. The surgical generator of claim 9, wherein the function is defined by a linear relationship bounded by a maximum rate and a minimum rate.

13. 3. The surgical generator of claim 2, wherein the control circuitry configured to control the power of the therapy signal provided to the biological tissue comprises: A surgical generator configured to incrementally modify said power as a function of current.

14. a surgical generator configured to generate and provide controlled power of a therapy signal to biological tissue in electrical communication with the device; a control circuit in communication with an electrical energy source, the electrical energy source electrically coupled to the device and configured to generate the therapy signal, the control circuit comprising: configured to control the energy delivery of the therapy signal provided to the biological tissue during a portion of a therapy phase according to an incremental change in energy delivery as a function of a rate of change of the measured electrical parameter of the biological tissue; The function is defined as a rate of change bounded by a maximum rate of change and a minimum rate of change.

15. 15. The surgical generator of claim 14, wherein the control circuitry configured to control the energy delivery of the therapy signal comprises: A surgical generator configured to control the power of the therapy signal provided to the biological tissue.

16. 16. The surgical generator of claim 15, wherein the control circuitry configured to control the power of the therapy signal provided to the biological tissue comprises: A surgical generator configured to incrementally modify said power as a function of current.

17. 15. The surgical generator of claim 14, wherein the control circuitry configured to control the energy delivery of the therapy signal comprises: A surgical generator configured to control the voltage of the therapy signal provided to the biological tissue.

18. 18. The surgical generator of claim 17, wherein the control circuitry configured to control the voltage of the therapy signal provided to the biological tissue comprises: A surgical generator configured to incrementally modify the voltage as a function of current.

19. 15. The surgical generator of claim 14, wherein the measured electrical parameter comprises a change in impedance.

20. 15. The surgical generator of claim 14, wherein the measured electrical parameter comprises a change in electrical current.

21. 15. The surgical generator of claim 14, wherein the control circuitry comprises: comparing the change in the measured electrical parameter of the biological tissue with a stored data set; The surgical generator configured to determine the incremental change in energy delivery based on the comparison.

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