Electrosurgical instrument for applying non-therapeutic RF signals

Abstract

The device includes a shaft assembly and an end effector including a first jaw and a second jaw pivotally coupled to each other. The first jaw includes a first electrode and the second jaw includes a second electrode. The jaws can be used to clamp a portion of patient tissue and apply a non-therapeutic or low voltage radio frequency (RF) signal to the tissue. Based on the measured response of current and voltage passing through the tissue, the device can determine various characteristics of the clamped tissue, such as whether the tissue contains body fluid, blood vessels, tendons, intestines, and / or fat. When the clamped tissue is determined to be the correct tissue type, the device can apply a therapeutic RF signal (e.g., a signal capable of sealing or cauterizing the tissue).

Description

Background Art

[0001] Various surgical instruments include an element for tissue incision and one or more elements for delivering radio frequency (RF) energy to tissue (e.g., to coagulate or seal tissue). An example of such an electrosurgical instrument is the ENSEAL® tissue sealing device by Ethicon Endo-Surgery, Inc. (Cincinnati, Ohio).Further examples of such devices and related concepts are disclosed in U.S. Patent No. 6,500,176, entitled "Electrosurgical Systems and Techniques for Sealing Tissue," issued December 31, 2002, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,939,974, entitled "Surgical Instrument Comprising First and Second Drive Systems Actuatable by a Common Trigger Mechanism," issued January 27, 2015, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,888,809, entitled "Surgical Instrument with Jaw Member," issued November 18, 2014, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,161,803, entitled "Motor Driven Electrosurgical Device with Mechanical and Electrical Feedback," issued October 20, 2015, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,877,720, entitled "Control Features for Articulating Surgical Device," issued January 30, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,545,253, entitled "Surgical Instrument with Contained Dual Helix Actuator Assembly," issued January 17, 2017, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 9,526,565, entitled "Electrosurgical Devices," issued December 27, 2016, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Although various surgical instruments have been made and used, it is believed that no one has made or used the invention as claimed in the appended claims prior to the inventors.

Brief Description of the Drawings

[0003] This specification concludes with the claims that specifically point out and clearly claim this technology. However, this technology is considered to be better understood by reading the description of certain specific embodiments below in conjunction with the accompanying drawings, where like reference numerals identify the same elements in the drawings.

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[0004] The drawings are not intended to limit in any way, and it is contemplated that various embodiments of the present technology can be implemented in various other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated herein and forming a part of this specification illustrate some aspects of the present technology and, together with the description, explain the principles of the present technology, but it is understood that the present technology is not limited to the exact arrangements shown.

Best Mode for Carrying Out the Invention

[0005] The following description of specific embodiments of the present technology should not be used for the purpose of limiting its scope. Other embodiments, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for practicing the present technology by way of example. As will be understood, any of the technologies described herein can have other different and obvious aspects without departing from the technology. Therefore, the drawings and description should not be considered limiting, but should be regarded as being essentially exemplary.

[0006] It should be further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will become readily apparent to those skilled in the art upon consideration of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0007] For the sake of clarity of the present disclosure, the terms "proximal" and "distal" are defined herein with respect to a surgeon or other operator who grasps a surgical instrument having a distal surgical end effector. The term "proximal" refers to the position of an element closer to the surgeon or other operator, and the term "distal" refers to the position of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0008] Improved systems and methods for sealing and cutting tissue using a surgical instrument are disclosed herein. Specifically, the system can use an end effector to capture patient tissue and then test the tissue using a non-therapeutic (i.e., low power) signal to ensure that the appropriate tissue is captured. When the non-therapeutic signal is applied, received, and analyzed, the system can provide additional details about the tissue. Assuming that additional details confirm that the captured tissue is the desired tissue, the system switches operating modes and applies a therapeutic energy signal to the tissue, thereby sealing or cauterizing the tissue.

[0009] I. Examples of Electrosurgical Instruments Figures 1-5 illustrate an exemplary electrosurgical instrument 100. As best seen in FIG. 1, the electrosurgical instrument 100 includes a handle assembly 120, a shaft assembly 140, an articulation assembly 110, and an end effector 180. As described in more detail below, the end effector 180 of the electrosurgical instrument 100 is operable to grasp, cut, and seal or weld tissue (e.g., blood vessels, etc.). In this example, the end effector 180 is configured to apply non-therapeutic bipolar radio frequency (RF) energy to identify and / or verify that the correct tissue is present within the end effector so that therapeutic RF energy can be applied to seal or weld the tissue. However, it should be understood that the electrosurgical instrument 100 can be configured to seal or weld tissue through any other suitable means that will be apparent to those skilled in the art in view of the teachings herein. For example, the electrosurgical instrument 100 can be configured to seal or weld tissue via an ultrasonic blade, staples, etc. In this embodiment, the electrosurgical instrument 100 is electrically coupled to a waveform generator 200, and the waveform generator 200 can deliver therapeutic and non-therapeutic energy via a power cable 10.

[0010] The waveform generator 200 may be configured to provide all or part of the power requirements for the use of the electrosurgical instrument 100. As will be apparent to those skilled in the art in view of the teachings herein, any suitable waveform generator 200 may be used. By way of non-limiting example, the waveform generator 200 may include GEN04 or GEN11 (shown in FIG. 7) sold by Ethicon, LLC (Cincinnati, Ohio). Additionally or alternatively, the waveform generator 200 may be constructed in accordance with at least a portion of the teachings of U.S. Patent No. 8,986,302, entitled "Surgical Generator for Ultrasonic and Electrosurgical Devices," issued on March 24, 2015, the disclosure of which is hereby incorporated by reference in its entirety. In this embodiment, the electrosurgical instrument 100 is coupled to the waveform generator 200 via the power cable 10, but the electrosurgical instrument 100 may include an internal power source or sources, such as a battery and / or a supercapacitor, to supply power to the electrosurgical instrument 100. Of course, any suitable combination of power sources may be utilized to supply power to the electrosurgical instrument 100, as will be apparent to those skilled in the art in view of the teachings herein.

[0011] The handle assembly 120 is configured to be grasped with one hand by an operator so that the operator can control and operate the electrosurgical instrument 100 with one hand. Although the electrosurgical instrument 100 is described herein as being primarily used by a human user, it should be noted that there are alternative variations in which one or more robotic systems (e.g., robotic arms) can be used to control and operate the electrosurgical instrument 100. The shaft assembly 140 extends distally from the handle assembly 120 and is connected to the articulation assembly 110. The articulation assembly 110 is also connected to the proximal end of the end effector 180. As described in more detail below, the components of the handle assembly 120 are configured to control the end effector 180, such that the operator can grasp, cut, and seal or weld tissue. The articulation assembly 110 is configured to deflect the end effector 180 from the longitudinal axis (LA) defined by the shaft assembly 140.

[0012] The handle assembly 120 includes a control unit 102 housed within a body 122, a pistol grip 124, a jaw closure trigger 126, a knife trigger 128, a start button 130, an articulation control section 132, and a knob 134. As will be described in more detail below, the jaw closure trigger 126 can pivot toward and away from the pistol grip 124 and / or the body 122 to open and close the jaws 182, 184 of the end effector 180 to grip tissue. Additionally, the knife trigger 128 can pivot toward and away from the pistol grip 124 and / or the body 122 to activate a knife member 176 within the boundaries of the jaws 182, 184 to cut tissue captured between the jaws 182, 184. Further, pressing the start button 130 can apply radio frequency (RF) energy to tissue via electrode surfaces 194, 196 of the jaws 182, 184, respectively. In some variations, the electrode surfaces 194, 196 of the jaws 182, 184 are in a bifurcated configuration where the electrode surfaces 194, 196 move relative to a central axis and move substantially equally and oppositely to each other.

[0013] The body 122 of the handle assembly 120 defines an opening 123 through which a portion of the articulation control section 132 protrudes. The articulation control section 132 is rotatably disposed within the body 122 such that an operator can rotate the portion of the articulation control section 132 that protrudes from the opening 123 to rotate the portion of the articulation control section 132 located within the body 122. Rotation of the articulation control section 132 relative to the body 122 flexes the articulation section 110 to drive deflection of the end effector 180 from a longitudinal axis (LA) defined by the shaft assembly 140. The articulation control section 132 and the articulation section 110 can include any suitable mechanism for driving deflection of the end effector 180 from the longitudinal axis (LA) defined by the shaft assembly 140 as will be apparent to those skilled in the art in view of the teachings herein.

[0014] The knob 134 is rotatably disposed on the distal end of the body 122 and is configured to rotate the end effector 180, the articulation assembly 110, and the shaft assembly 140 about the longitudinal axis (LA) of the shaft assembly 140 with respect to the handle assembly 120. In this embodiment, the end effector 180, the articulation assembly 110, and the shaft assembly 140 are rotated by the knob 134, although the knob 134 may be configured to rotate the end effector 180 and the articulation assembly 110 with respect to a selected portion of the shaft assembly 140. The knob 134 may include any suitable mechanism for rotating the end effector 180, the articulation assembly 110, and the shaft assembly 140, as will be apparent to those skilled in the art in view of the teachings herein.

[0015] The shaft assembly 140 includes a distal portion 142 that extends distally from the handle assembly 120 and a proximal portion 144 that is received within the boundary of the body 122 of the handle assembly 120. Referring now to FIG. 3, the shaft assembly 140 houses a jaw closing connector 160 that couples the jaw closing trigger 126 to the end effector 180. In addition, the shaft assembly 140 houses a portion of a knife member that extends between the distal cutting edge 178 and the knife trigger 128. The shaft assembly 140 also houses an actuating member 112 that couples the articulation assembly 110 to the articulation control section 132. The electrical connector 15 operably couples the electrode surfaces 194, 196 to the activation button 130. As will be described in more detail below, the jaw closing connector 160 is configured to translate with respect to the shaft assembly 140 to open and close the jaws 182, 184 of the end effector 180. On the other hand, the knife member 176 is coupled to the knife trigger 128 of the handle assembly 120 and translates the distal cutting edge 178 within the range of the end effector 180, and the activation button 130 is configured to activate the electrode surfaces 194, 196.

[0016] As best seen in FIGS. 2-5, end effector 180 includes a lower jaw 182 pivotally coupled to upper jaw 184 via a pivotal coupling 198. Lower jaw 182 includes a proximal body 183 that defines a slot 186, and upper jaw 184 includes a proximal arm 185 that defines a slot 188. Lower jaw 182 also defines a central channel 190 configured to receive proximal arm 185 of upper jaw 184, a portion of knife member 176, jaw closure connector 160, and pin 164. Slots 186, 188 slidably receive pin 164 attached to distal coupling portion 162 of jaw closure connector 160, respectively. Additionally, lower jaw 182 includes a force sensor 195 located at the distal tip of lower jaw 182, although force sensor 195 may alternatively be positioned at any other suitable location. Force sensor 195 can communicate with control unit 102. Force sensor 195 may be configured to measure the closing force generated by pivoting jaws 182, 184 to a closed configuration in accordance with the description herein. Further, force sensor 195 can communicate this data to control unit 102. As will be apparent to those skilled in the art in view of the teachings herein, any suitable components can be used for force sensor 195. For example, force sensor 195 can take the form of a strain gauge. In some variations, end effector 180 includes two or more force sensors.

[0017] In this embodiment, force sensor 195 is incorporated into instrument 100 and communicates with control unit 102, although any other suitable sensor or feedback mechanism may be incorporated into instrument 100 additionally or alternatively while communicating with control unit 102 as will be apparent to those skilled in the art in view of the teachings herein. For example, a joint motion sensor or feedback mechanism may be incorporated into instrument 100, and the joint motion sensor communicates a signal to control unit 102 indicative of the degree to which end effector 180 is deflected from the longitudinal axis (LA) by joint motion control section 132 and joint motion section 110.

[0018] As described in more detail below, the jaw closing connector 160 is operable to translate within the central channel 190 of the lower jaw 182. The translation of the jaw closing connector 160 drives the pin 164. Also, as described in more detail below, when the pin 164 is positioned within both slots 186, 188 and the slots 186, 188 are angled relative to each other, the pin 164 cams against the proximal arm 185, pivoting the upper jaw 184 toward and away from the lower jaw 182 about the pivot joint 198. Thus, the upper jaw 184 is configured to pivot toward and away from the lower jaw 182 about the pivot joint 198 to grasp tissue.

[0019] The term "pivot" does not necessarily require rotation about a fixed axis and can include rotation about an axis that moves relative to the end effector 180. Thus, the axis about which the upper jaw 184 pivots about the lower jaw 182 can translate relative to both the upper jaw 184 and the lower jaw 182. As will be apparent to those skilled in the art in view of the teachings herein, any suitable translation of the pivot axis can be used.

[0020] The lower jaw 182 and the upper jaw 184 also define a knife path 192. The knife path 192 is configured to slidably receive the knife member 176 such that the knife member 176 can be retracted and advanced to cut tissue captured between the jaws 182 and 184.

[0021] The lower jaw 182 and the upper jaw 184 each include respective electrode surfaces 194, 196. A power source can extend through the handle assembly 120, the shaft assembly 140, and the articulation assembly 110 and provide RF energy to the electrode surfaces 194, 196 via an electrical coupling 15 that is electrically coupled to one or both of the electrode surfaces 194, 196. The electrical coupling 15 can selectively activate the electrode surfaces 194, 196 in response to an operator pressing the activation button 130. In some instances, the control unit 102 can couple the electrical coupling 15 to the activation button 130 such that the control unit 102 activates the electrode surfaces 194, 196 in response to the operator pressing the activation button 130. The control unit 102 can have any suitable components for performing suitable functions as would be apparent to one of ordinary skill in the art in view of the teachings herein. For example, the control unit 102 can have a processor, a memory unit, suitable circuitry, and the like. Examples of features and functions that can be incorporated into the control unit 102 are described in more detail below.

[0022] As described above, the jaw closure trigger 126 can pivot toward and away from the pistol grip 124 and / or the body 122 to open and close the jaws 182, 184 of the end effector 180 to grip tissue. In particular, as described in more detail below, pivoting the jaw closure trigger 126 toward the pistol grip 124 can proximally activate the jaw closure connector 160 and the pin 164, which in turn cam against a slot 188 in the proximal arm 185 of the upper jaw 182, thereby rotating the upper jaw 184 about a pivot joint 198 toward the lower jaw 182 such that the jaws 184, 184 achieve a closed configuration.

[0023] In some variations, the knife trigger 128 can pivot toward and away from the body 122 and / or the pistol grip 124 to activate the knife member 176 within the knife paths 192 of the jaws 182, 184 to cut tissue captured between the jaws 182, 184. In particular, the handle assembly 120 further includes a knife coupling body 174 slidably coupled along the proximal portion 144 of the shaft assembly 140. The knife coupling body 174 is coupled to the knife member 176 such that translation of the knife coupling body 174 relative to the proximal portion 144 of the shaft assembly 140 translates the knife member 176 relative to the shaft assembly 140.

[0024] In another variation, the knife coupling body 174 may be coupled to a knife actuation assembly such that when the knife trigger 128 pivots toward the body 122 and / or the pistol grip 124, the knife actuation assembly drives the knife coupling body 174 distally, thereby driving the knife member 176 distally within the knife path 192. Since the knife coupling body 174 is coupled to the knife member 176, the knife member 176 translates distally within the shaft assembly 140, within the articulation section 110, and within the knife path 192 of the end effector 180. The knife member 176 includes a distal cutting edge 178 configured to cut tissue captured between the jaws 182, 184. Thus, by pivoting the knife trigger 128, the knife member 176 is actuated within the knife path 192 of the end effector 180 to cut tissue captured between the jaws 182, 184.

[0025] With the distal cutting edge 178 of the knife member 176 actuated to the forward position, the operator can press the activation button 130 to selectively activate the electrode surfaces 194, 196 of the jaws 182, 184 and weld / seal the severed tissue captured between the jaws 182, 184. It should be understood that the operator may also press the activation button 130 at any suitable time during exemplary use to selectively activate the electrode surfaces 194, 196 of the jaws 182, 184. Thus, the operator can also press the activation button 130 while the knife member 176 is being retracted. Next, the operator may release the jaw closure trigger 128 so that the jaws 182, 184 pivot to the open configuration and release the tissue.

[0026] II. Description of the Overall System and Specific Circuits An exemplary schematic diagram of an exemplary system is shown in FIG. 6. As discussed herein, the electrosurgical instrument 100 may include some form of control unit (e.g., the control unit 102 within the handle assembly 120 and / or the control unit mechanism within the waveform generator 200). In some versions, as discussed herein, the control unit may enable the electrosurgical instrument 100 to apply two different types (e.g., therapeutic and non-therapeutic) of RF signals. In some variations discussed in detail herein, a switching system (e.g., a switching relay, etc.) 601 can enable the system to switch or alternately switch between a therapeutic signal and a non-therapeutic signal. In some variations, the therapeutic signal and the non-therapeutic signal may be generated by a single waveform generator 200 including a therapeutic signal generator 201 and a non-therapeutic signal generator 202. However, in some alternative versions, the therapeutic signal generator 201 and the non-therapeutic signal generator 202 may be stand-alone devices.

[0027] As will be described in more detail herein, the process for determining which signal (e.g., treatment vs. non-treatment) the switching system 601 selects may be based on a variety of factors and decisions. In some versions, the processor 602 may be used to facilitate signal selection. As used herein, the term "processor" is to be understood to include a microprocessor, a microcontroller, a field programmable gate array (FPGA) device, and / or any other suitable type(s) of hardware configured to process electrical signals. In further versions, as shown, the system may also include a handswitch rectifier circuit 800 (shown in detail in FIG. 8 and may include a low voltage solid state relay 808 and a sealing circuit 807 configured to connect to drive signal 801 and return signal 802 via pin connector 603), a signal conditioning circuit 900 (shown in detail in FIG. 7), an internal power supply 1000 (shown in detail in FIG. 10), a MOSFET driver circuit 1100 (shown in detail in FIG. 11), a voltage sensing circuit 1210 (shown in detail in FIG. 12), and a current sensing circuit 1220 (shown in detail in FIG. 12). It should be understood that the circuits illustrated and described herein are shown in detail for illustrative purposes only, and the circuits or circuit diagrams should not be considered to be limiting or restrictive to any version disclosed herein. In other words, those skilled in the art will understand that alternative and / or modified circuits may exist both currently and in the future, and those circuits may be used to facilitate particular portions of the designs disclosed herein.

[0028] As a non-limiting example, FIG. 7 shows an exemplary circuit diagram that can be used in a GEN11 waveform generator sold by Ethicon, LLC. Thus, in some variations, as shown in FIG. 7, the system may include a waveform generator 200 that can provide both a therapeutic waveform 202 and a non-therapeutic waveform 201 to a switching system 701, which then selects which waveform to pass onto the end effector 180. Similar to the version described with reference to FIG. 6, the circuit may include a processor 702 and various other circuits (e.g., a signal conditioning circuit 900).

[0029] As shown in FIG. 6 and again as shown below in FIG. 14, the handle assembly 120 may be connected to the waveform generator 200 via a cable 10. In some versions, the system may be adapted to operate on legacy devices. For example, various existing treatment systems can utilize a 9-pin connector (e.g., 603) having at least one available pin that enables the transmission of non-therapeutic energy. Thus, as shown in FIGS. 6 and 13, the system may utilize a pinning connector 603 to pass various signals between the electrosurgical instrument 100 and the waveform generator 200.

[0030] In addition to operating on legacy waveform generation equipment, the systems and methods described herein may also be used on legacy electrosurgical instruments (e.g., similar to those shown in FIG. 1 but without the circuits shown in FIGS. 8 - 13). In other words, there may be some implementations where an external housing (e.g., disposable or reusable) includes the circuits, and thus the functionality, described with reference to FIGS. 8 - 13. In some implementations, the external housing may be attached (e.g., operably coupled) to the handle assembly 120 of the electrosurgical instrument. Alternative implementations may exist where the external housing is coupled to an alternative device or location, such as one of the waveform generators, a patient bed, a surgical tool, or other objects within the operating room. Further, the components that provide the functionality of the components described with reference to FIGS. 8 - 13 need not be housed within a dedicated external housing. Such components may be integrated into another housing with other components. For example, such components may be integrated into a housing such as a waveform generator. FIGS. 8 - 13 show detailed exemplary circuit diagrams of various forms that may be taken by the circuit generally shown in FIG. 6. For example, FIG. 8 shows an example of a form that a rectifier circuit 800 may take. As shown in FIG. 8, the rectifier circuit 800 receives a hand switch drive signal 801 and / or a hand switch return signal 802 (e.g., from a start button 130 or similar trigger device). In some versions, the rectifier circuit may include or be connectable to a solid state relay 808 and / or a sealing circuit 807. Similar to the system shown in FIG. 6, the rectifier circuit 800 may be connected to a signal conditioning circuit 900 and a processor 602. The rectifier circuit 800 may further include a choke (e.g., a common mode choke) or filter 803 that receives the signals 801 / 802 from the handle assembly 120.Next, the drive signal 801 and / or the return signal 802 pass through the electrostatic discharge diode 804 (or transient voltage suppression (TVS) diode) and the capacitor 806, and are then rectified (e.g., using a high-speed Schottky diode 805 bridge-based rectifier) and passed to the next component such as the signal conditioning circuit 900 as shown in FIG. 6. FIG. 9 shows an example of a form that the signal conditioning circuit 900 can take.

[0031] Once rectified, the signal can then be passed to the signal conditioner 900 shown in FIG. 9. In some versions, the conditioner circuit 900 can include one or more resistors 901, one or more capacitors 902, and an operational amplifier (op-amp) 903. In some variations, in addition to or instead of including the capacitor 902, one or more inductors (not shown) are included. In a further version, the op-amp 903 can be configured as a buffer and be a very high impedance input op-amp paired with a passive voltage divider and a passive low-pass filter. In some such scenarios, the buffer op-amp of this circuit can function to limit all input electromagnetic interference and capacitive coupling that the waveform generator 200 can generate. The passive voltage divider and passive filter can attenuate the buffered signal and smooth out transients from the input signal. The resulting signal is presented to the processor 602, which can use the signal to determine whether to use therapeutic energy delivery or non-therapeutic energy delivery. When the handswitch drive signal 801 and / or the handswitch return signal 802 are conditioned (i.e., passed through the circuit 900), they can then be passed to the microprocessor 602 / 702 for evaluation.

[0032] FIG. 10 shows an example of a form that the power supply circuit 1000 of FIG. 6 can take. In some versions, as shown in FIG. 10, the power supply can have an external power supply 1001 and / or a battery power supply 1002. In addition to the two power supplies 1001 / 1002, the power supply circuit 1000 can include a thermistor 1003 and a voltage regulator 1004, each of which has a unique jumper 1005 so that they can be automatically bypassed. In further versions, the power supply circuit can also include one or more diodes 1005 and one or more capacitors 1007.

[0033] FIG. 11 shows an example of a form that the MOSFET relay driver circuit 1100 of FIG. 6 can take. As shown in FIG. 11, the MOSFET relay driver circuit can have one or more MOSFETs 1201 to drive one or more MOSFETs 1202 via a “toggle” input. Then, as shown in FIG. 6, the MOSFET 1202 can be used to change the state of the switching system 601. The MOSFET relay driver circuit 1100, in some versions, is attached to a dual position dual throw (DPDT) electromechanical relay 601. Some variations can include, in addition to or instead of the DPDT relay 601, a plurality of solid state relays, mechanical switches, and / or other components. In some variations, the processor 602 may select when to toggle the energy between therapeutic and non-therapeutic energy delivery based on a hand switch signal. In further versions, due to the electromechanical operation of charging and discharging the coil included in the relay mechanism, a delay of less than 12 ms may be required to toggle. Thus, in some versions, a group of four solid state relays can be used to achieve the same result, but with a much faster response time due to the lack of mechanical redundancy.

[0034] The illustration of the switching circuit 601 in FIG. 6 is shown enclosed by a dashed box in FIG. 11. In some variations, as shown in FIG. 11, the electrosurgical instrument 100 can receive a waveform (e.g., a therapeutic or non-therapeutic waveform) via a transmission path 610 and return the waveform via a return path 620. Thus, in some variations, the therapeutic waveform generator 201 can output a waveform to one side 201A of the transmission relay 610 and receive a waveform obtained from one side 201B of the receiving relay 620 (i.e., the waveform after passing through the electrodes of the end effector 180). Similarly, the non-therapeutic waveform generator 202 can output a waveform to one side 202A of the transmission relay 610 and receive a waveform obtained from one side 202B of the receiving relay 620. Examples of such operations will be described in more detail below with reference to FIGS. 14 - 15.

[0035] In some versions, the switching system 601 can include a double-pole double-throw (DPDT) relay that can have two sets of switches or positions, with each switch having two optional contacts or throws. Each relay position can have connections to the therapeutic energy electrode or return and the non-therapeutic electrode or return. Each position can have a normally open (NO) throw or a normally closed (NC) throw when the relay coil is not energized. In a particular version, the switching system 601 (e.g., the switching relay) can have non-therapeutic energy delivery set to normally closed whenever the user is not pressing the hand switch to enable bioimpedance sensing. However, when the hand switch (e.g., the activation button 130) is actuated, the switching system 601 can switch to the normally open (NO) contacts and initiate therapeutic energy delivery. In some variations, the switching system 601 can be located within the handle 120, and in other variations, it can be within the generator 200 itself.

[0036] As described herein, referring to FIG. 6, the system can have a voltage and current detection system 1200. Referring now to FIG. 12, in some versions, the detection system 1200 can have a voltage sensing component 1210 and a current sensing component 1220 to detect the voltage drop between the transmit relay 610 and the receive relay 620, and the current returning to the waveform generator (e.g., 201 or 202) through the receive relay 620. In some versions, as shown, the sensing circuit can receive a signal from the transmit relay 610 and return the signal to the voltage and current detection system 1200 through the return relay 620. In a further version, the voltage sensing circuit 1210 can include an output 1211 that provides the measured voltage to the processor 602. The voltage sensing circuit 1210 can also have a toggle switch 1212 that can be used to enable or disable the voltage sensing circuit 1210. In an additional version, the current sensing circuit 1220 can include an output 1221 that provides the measured current to the processor 602. The current sensing circuit 1220 can also have a toggle switch 1222 that can be used to enable or disable the current sensing circuit 1220.

[0037] In some versions, as shown in the figure, the voltage sensing circuit 1210 can be composed of two operational amplifiers 1213 operating as an inverter 1230 and an adder amplifier 1214 arranged in series with the inverter. As shown, the input inverting amplifier 1213 is designed to attenuate and invert a stimulation signal (e.g., a transmission signal received from the transmission relay 610) based on the ratio of the feedback resistors. The result of the inverting operational amplifier is a reduced or lower voltage signal. In some versions, this lower voltage signal can then be shifted by the second-stage non-inverting adder amplifier 1214 into a signal that can be detected by a microprocessor (such as the processor 602 shown in FIG. 6). The input of the non-inverting adder amplifier 1214 is a combination of inverting operational amplifiers that output an adjustable DC voltage 1215. The DC voltage 1215 can be supplied by any of a digital-to-analog converter (not shown), a digital potentiometer (not shown), or a voltage reference integrated circuit (not shown). The gain of the non-inverting adder amplifier is 1 plus the ratio of the feedback resistors, as shown in the following formula.

[0038]

Number

[0039] In some versions, the current sensing circuit 1220 can be constructed from a low-impedance sensing resistor connected to a high common-mode differential instrumentation amplifier circuit 1223. The instrumentation amplifier 1223 converts the differential sensing signal into a single-ended low voltage signal. The signal gain is the general device operational amplifier gain of (1 + (R11 + R12) / R10) × (R16 / R14). This low voltage signal is then processed by the second-stage non-inverting adder amplifier 1224. The input of the non-inverting adder amplifier is a combination of the output of the instrumentation operational amplifier 1223 and an adjustable DC voltage 1225 supplied by a digital-to-analog converter (not shown), a digital potentiometer (not shown), or a voltage reference integrated circuit (not shown). The gain of the non-inverting adder amplifier is 1 plus the ratio of R20 / R19.

[0040] Referring now to FIG. 13, an exemplary waveform generator 200 is shown as having a connection point 203 that can receive the pin connections (603 of FIG. 6) described herein. The pin connector 603 is then connected to a plurality of wires / cables that pass through the power cable 10 that connects to the electrosurgical instrument 100. In some versions, the instrument 100 may include a connection port (not shown) that allows for the connection and disconnection of the power adapter 1301.

[0041] III. Description of System Operation and Capabilities The system discussed herein and shown in FIGS. 1 - 13 provides an electrosurgical instrument 100 configured to clamp tissue using an end effector 180. Once clamped firmly, electrodes within the end effector 180 (e.g., electrodes on electrode surfaces 194 and / or 196) apply a non - therapeutic (i.e., low voltage) waveform to the tissue, and a sensor device (e.g., 1200) measures the returning waveform to calculate and measure the impedance of the tissue. More specifically, the system provides non - therapeutic energy to the extracellular and intracellular fluids present within a given (e.g., clamped) region of tissue via one or more sub - circuits to determine the phase and magnitude of the impedance of the tissue within the jaws 182 / 184. The processor 602 can then relay information related to the tissue, such as tissue type, tissue phase, tissue margin, etc. Using this related information, the system can not only verify that appropriate tissue is clamped between the jaws 182 / 184, but also determine whether any non - tissue material is present between the jaws and / or whether an appropriate seal has been created after application of the therapeutic RF.

[0042] Figure 14 shows an exemplary impedance triangle 1401. As will be understood by those skilled in the art, while human tissue may tend to be essentially capacitive, wires, tools, staples, implants, etc. may tend to be essentially inductive. Thus, as can be seen from the exemplary impedance triangle 1401, the "resistance" of each object in the circuit is measured using the waveform and sensor 1200 (1402). The system can also determine the "capacitive reactance" of each object in circuit 1403 and the inductive reactance of each object in circuit 1404. As described above and clearly shown in FIG. 14, the transmitting and receiving electrodes (e.g., the electrodes on electrode surfaces 194, 196), the transmitting handle wire and the receiving handle wire (e.g., 610 and 620), the handle connector (e.g., 1301), and the transmitting wire and the receiving wire (e.g., those included in power cable 10) all have an inductive reactance 1404. In addition, the transmitting and receiving electrodes (e.g., the electrodes on electrode surfaces 194, 196), the handle connector (e.g., 1301), the extracellular fluid, and the intracellular fluid all have a capacitive reactance 1403. Then, the "reactance" 1405 can be calculated by determining the difference between the capacitive reactance and the inductive reactance using the following. Equation 2: X = Σ(X L -X C )

[0043] As shown in FIG. 14, the "impedance" 1406 can be determined using the following.

[0044]

Number

[0045] Figure 15 shows a set of exemplary waveforms. As will be understood by those skilled in the art, when the circuit includes only resistive elements, the current and voltage remain in phase, as shown in graph 1501 and phasor diagram 1504. Alternatively, when the circuit has capacitive elements, or is more capacitive than inductive, the voltage wave leads the current wave, as shown in graph 1502 and phasor diagram 1505. Finally, when the circuit has inductive elements, or more inductive elements than capacitive elements, the voltage lags the current, as shown in graph 1503 and phasor diagram 1506.

[0046] As discussed herein, the system can be useful in passing a non-therapeutic waveform through a portion of a patient's tissue and identifying the tissue type as well as any foreign objects. Thus, in some versions, the system can pass waveforms of varying frequencies (e.g., in series and / or in parallel) to improve the accuracy of the determination. Thus, in some versions, as shown in FIG. 16, multiple waveforms of various frequencies can be added or summed together (1610) to create a multi-sine waveform 1650. As a non-limiting example, a 10 kHz sine wave 1601 may be combined with a 100 kHz sine wave 1602, and a 330 kHz sine wave 1603 and a 1 MHz sine wave 1604 may be combined to create the multi-sine wave 1650.

[0047] Referring now to FIG. 17, the multi-sine waveform 1650 can be sampled or windowed (1701). In some versions, such as those that require the use of a Fast Fourier Transform (FFT), the windowing or sampling can be as small as about one period for the lower frequency waveforms. As shown in graph 1702, the voltage of the multi-sine waveform leads the current and thus indicates a capacitive circuit (e.g., likely tissue). In alternative versions, the system can apply a series of burst waveforms having different frequencies.

[0048] Referring now to FIG. 18, a burst waveform containing a short delay between frequencies is shown in graph 1801. In some versions, as shown, the system can output a burst waveform that is a sine wave, while in other versions, the wave can be square, triangular, ramp, pulse, pseudorandom binary sequence (PRBS), or any waveform. In some versions, the pause between waveforms can be evaluated to determine the "rebound" time. The rebound time can be used to help identify tissue types by assessing how long it takes for a particular tissue to dissipate the waveform and any residual energy.

[0049] FIG. 19 shows various alternative burst versions. Specifically, in one version, amplitude modulation (AM) 1901 can be used, while in another version, frequency modulation (FM) 1902 can be used. Other versions can use phase modulation (PM) 1903 and / or frequency-shift keying (FSK) modulation 1904. Due to the fact that all of the modulation options shown in FIG. 19 involve some kind of shift, they can all be evaluated in a similar manner.

[0050] In a further version, as shown in FIG. 20, the "chirp" function can be used. As understood by those skilled in the art, the chirp wave can be "up-chirp" (i.e., the frequency increases) or "down-chirp" (i.e., the frequency decreases). Thus, in other words, the chirp function is essentially an advanced form of FM1902. The chirp function shown in graph 2001 shows a chirp waveform having increasing frequencies (e.g., 10 kHz, 13.2 kHz, 19.3 kHz, 26.8 kHz, and 1 MHz). FIG. 21 shows a chirp function having the same frequencies as shown in FIG. 20, but with the amplitude 2101 decreasing.

[0051] IV. Waveform Analysis The following discussion provides an exemplary example of how the processor 602 can process feedback signals received from the tissue via the electrode surfaces 194 / 196 in response to non-therapeutic and / or therapeutic signals applied to the tissue via the electrode surfaces 194 / 196. For example, if it is determined that a non-tissue object is clamped between Joe 182 / 184, the processor 602 can warn the user (e.g., via a visual indicator on the electrosurgical instrument 100, a visual indicator within the display device, an audible notification, a tactile notification, etc.) and / or lock out the ability to apply an RF voltage to the end effector 180.

[0052] As discussed herein, the fast Fourier transform (FFT) can be one way to analyze waveforms to determine phase and / or impedance. As understood by those skilled in the art, the FFT function can map a time-domain function to a frequency-domain representation. Generally, the FFT is derived from the following Fourier transform equation.

[0053]

Equation

[0054] In another version, the system can use cross-correlation to measure the time delay of one waveform relative to another, generally represented as follows.

[0055] [Number] Here, x(t) and y(t) are two waveforms as functions of time, τ is the time delay, and R is the cross-correlation that is a function of the time delay τ. Unlike the FFT method, cross-correlation is performed in the time domain and thus no transformation is required.

[0056] As best shown in FIG. 23, cross-correlation evaluates the time delay or shift (e.g., advance or delay) of two waveforms as shown in graph 2301. As understood by those skilled in the art, a cross-correlation graph such as 2302 reaches its maximum height or peak when the time delay τ is equal to zero and the waveforms are aligned on the time axis. Thus, based on the evaluation of the cross-correlation graph 2302 (e.g., determining the time shift from the zero axis), the system can determine whether the voltage waveform lags or leads the current waveform. As discussed herein, specifically referring to FIGS. 14 and 15, when the system knows whether the voltage waveform lags or leads the current waveform, it can determine whether the clamped material is essentially capacitive (e.g., tissue) or essentially inductive (e.g., non-tissue). In a further version, the system can track and evaluate the change in time delay τ over time to determine a specific type of tissue.

[0057] The cross-correlation method is very robust but is somewhat time-consuming. Therefore, in some versions (e.g., when speed is more important than accuracy), the system can use the zero-crossing method. FIG. 24 shows an exemplary waveform in graph 2411. In some versions, as shown, the system can monitor the input voltage 2411 for any zero-crossing (i.e., the point at which the AC waveform crosses the zero value 2401 and there is no voltage). Due to the simple nature of this method, it can be implemented using minimal components (e.g., a single high-speed comparator 2402). As will be understood by those skilled in the art, zero-crossings typically occur twice during each cycle. Therefore, by tracking the timing of the zero-crossings of two or more waveforms (e.g., the transmitted waveform 610 and the received waveform 620), the system can roughly determine how much the waveforms are out of phase and whether the return signal is advancing or lagging, as shown in FIG. 15 and described above. Based on how much the waveforms are out of phase (i.e., the phase angle shown in 2202), the system can determine one or more characteristics regarding the material clamped within the end effector 180.

[0058] Another method of analyzing waveforms to determine phase and / or impedance can involve Pseudo Inverse Matrix Fourier (PIMF) series reconstruction. Spectral analysis using the FFT does not necessarily utilize known information. For example, when exciting the system at a particular frequency of the voltage, spectral analysis of the current passing through the system using the FFT (to thereby calculate the impedance) does not utilize the fact that the frequency components of the current (although of different phases and magnitudes) are the same as the frequency components of the transmitted voltage signal (which is known since it was transmitted). The FFT searches to estimate the phase and magnitude of the current for each single frequency at the frequency resolution of the FFT. However, in a particular system, it may be necessary to analyze only the frequencies transmitted by the voltage.

[0059] Using the FFT, the frequency (w) in radians per second, the phase (phi), and the magnitude (A) of the signal are calculated so that the time-domain signal F(t) can be reconstructed as accurately as possible using the Fourier series as follows.

[0060]

Equation

[0061] Equation 6 can be expressed as follows.

[0062]

Equation

[0063] In this process, it is assumed that the frequency content w n of the signal is unknown. However, assuming that w n is known (such as in the case of a system where the current w n value is the same as the known input voltage w n value), when operating in the digital domain, when f(t) is known, a n and b n can be calculated, where f(t) is represented by discrete points as f(k i ), where i = 0 at time zero and i = t at time t, where

[0064]

Equation

[0065]

Equation

[0066] [Number]

[0067] The notation of Equation 9 can be transformed as follows.

[0068] [Number] Here,

[0069] [Number] are, respectively, the known vectors (measured) and matrices (calculated from the known w n ).

[0070] [Number] can be solved as follows.

[0071] [Number] Here, A + is the pseudo-inverse matrix of A, which for a matrix with linearly independent columns, Equation 14: A + =(A T · A) -1 · A T because

[0072] [Number] is the known signal f(k i ) and the known frequency w nThis is because it is a function that can be solved for all values of i ∈ {0, tf} and n. Solving using Equation 13 for all values of n gives A n and phi n The corresponding values of can be calculated from trigonometric identities.

[0073]

Number

[0074] The following table represents an example comparison of a set of results that can be obtained using the PIMF method versus the FFT method described above.

[0075]

Table 1

[0076] FIG. 25 shows a graphical representation of the magnitude 2510 and phase angle 2520 of the impedance of the waveform applied to the tissue as a function of time. In some variations, as shown, the system can make certain determinations regarding the surgical process based on the impedance and phase. As a non-limiting example, graph 2510 shows the impedance of the tissue that drops significantly during clamping, as shown in period 2511. While the tissue is clamped as shown in period 2512, the impedance remains relatively stable. During this period 2512, the difference in the unique signature of the impedance and phase angle spectrum can indicate the characteristics of the tissue and the tissue response under compression (e.g., fluid leaving the tissue under strain). The therapeutic waveform is applied during period 2513. During this period 2513, the distal electrode is switched to deliver therapeutic energy (e.g., to seal or cauterize the tissue), and the signal can be detected by the high voltage and current therapy sensors. Thus, during this period 2513 of therapeutic energy delivery, the detection signal at the distal electrode can be inactive, which can appear as a rapid variation shown in the graphical representation of the magnitude 2510 of the impedance. Therapeutic energy delivery finally stops as shown in period 2514, and the impedance changes accordingly. The impedance can also be used to detect when the knife member 176 is fired, which is represented in period 2515.

[0077] Finally, after the procedure is complete, the end effector 180 releases the tissue, which is represented in period 2516. The phase angle graph 2520 provides a clear indication of when therapeutic energy is being applied 2521, followed by a time delay 2522 during which the tissue remains stationary before unclamping. As discussed herein, the "rebound" time (i.e., the time required for a particular tissue to allow the waveform and any residual energy to dissipate from the tissue) can be used for tissue identification. Thus, it may be possible to determine the rebound time and thus improve tissue identification by using data from one or both of the two graphs 2510, 2520.

[0078] FIG. 26 shows various graphs plotting the magnitude of the impedance and the jaw gap against time. The first graph 2610 shows the detection before applying any therapeutic waveform (e.g., before sealing). The line 2611 shows the distance between the jaws 182, 184. Thus, as discussed herein and as shown in graph 2610, the impedance of the tissue decreases as the tissue is clamped (i.e., as the distance between the jaws decreases). The second graph 2620 shows an exemplary waveform during sealing. Similar to graph 2610, graph 2620 also shows the jaw gap 2621. In some variations, as shown in graph 2620, during the application of the therapeutic energy 2622, the impedance of the tissue decreases and the distance between the jaws 182, 184 decreases. Finally, graph 2630 shows the recorded impedance of the sealed tissue as well as the jaw gap 2631.

[0079] V. EXAMPLE COMBINATIONS The following examples relate to various non-exhaustive ways in which the teachings herein can be combined or applied. The following examples are not intended to limit the scope of any claims presented at any time in this application or in subsequent filings related to this application. No waiver of any rights is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein can be configured and applied in many other ways. Also, in some variations, it is contemplated that the specific features recited in the following examples can be omitted. Accordingly, none of the aspects or features recited below should be considered important unless so expressly indicated later by the inventors or their successors in interest. If the claims presented in this application or in subsequent applications related to this application include additional features other than those recited below, those additional features should not be considered to have been added for any reason related to patentability.

EXAMPLE

[0080] An apparatus for detecting and sealing tissue, the apparatus comprising: (a) a processor; and (b) an end effector at a distal end of a surgical instrument, the end effector being configured to interact with a patient's tissue, the end effector comprising: (i) a first jaw having a first electrode surface fixed thereto; and (ii) a second jaw pivotally coupled to the first jaw and having a second electrode surface fixed thereto, the first and second electrode surfaces including a plurality of electrodes, the end effector further comprising the second jaw; comprising, wherein (c) the processor is configured to: (i) control delivery and measurement of a non-therapeutic radio frequency (RF) signal to the plurality of electrodes, the plurality of electrodes being configured to contact the patient's tissue; (ii) determine at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (iii) determine, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and (iv) control delivery of a therapeutic RF signal to the plurality of electrodes in response to the determination that the plurality of electrodes are in contact with the intended tissue type The apparatus is configured to perform.

Example

[0081] The apparatus according to Example 1, wherein the first jaw further comprises a first knife path, the second jaw further comprises a second knife path, and both the first knife path and the second knife path are configured to accommodate translation of a knife member through a portion of the end effector.

Example

[0082] The apparatus according to Example 1 or 2, wherein the electrodes are in a branched configuration such that the electrodes are movable relative to a central axis and opposite to each other.

Example

[0083] The device according to any one of Examples 1 to 3, further comprising a switching system configured to switch between a non-therapeutic RF signal and a therapeutic RF signal.

Example

[0084] (a) A voltage sensor device and (b) a current sensor device, and the processor is further configured to (i) obtain the transmission voltage and return voltage of the RF signal from the voltage sensor device and (ii) obtain the transmission current and return current of the RF signal from the current sensor device, and at least one characteristic is based on the transmission voltage, return voltage, transmission current, and return current. The device according to any one of Examples 1 to 4.

Example

[0085] The processor is further configured to (i) determine the capacitive reactance of the circuit based on the transmission voltage and return voltage and (ii) determine the inductive reactance of the circuit based on the transmission voltage and return voltage, and at least one characteristic is based on the transmission voltage, return voltage, transmission current, and return current. The device according to Example 5.

Example

[0086] The processor is further configured to determine the impedance of the circuit based on the capacitive reactance and inductive reactance, and at least one characteristic is based on the transmission voltage, return voltage, transmission current, and return current. The device according to Example 6.

Example

[0087] The RF signal includes a plurality of waveforms summed into a multi-waveform, and each of the plurality of waveforms has a unique frequency. The device according to any one of Examples 1 to 7.

Example

[0088] The RF signal includes a multi-burst waveform having a single or a plurality of different periods, amplitudes, or waveforms. The device according to any one of Examples 1 to 8.

Example

[0089] The RF signal includes at least one of (A) an amplitude-modulated signal, (B) a frequency-modulated signal, (C) a phase-modulated signal, (D) a frequency-shift keying modulation signal, or (E) a chirp waveform, and the device according to any one of Examples 1 to 9.

Example

[0090] The processor is further configured to perform a fast Fourier transform (FFT) on the RF signal, and at least one characteristic is based on the FFT, and the device according to any one of Examples 1 to 10.

Example

[0091] The processor is further configured to perform a cross-correlation analysis on the RF signal, and at least one characteristic is based on the cross-correlation analysis, and the device according to any one of Examples 1 to 11.

Example

[0092] The processor is further configured to perform a zero-crossing analysis on the RF signal, and at least one characteristic is based on the zero-crossing analysis, and the device according to any one of Examples 1 to 12.

Example

[0093] The processor is further configured to perform a pseudo-inverse matrix Fourier (PIMF) analysis on the RF signal, and at least one characteristic is based on the PIMF analysis, and the device according to any one of Examples 1 to 13.

Example

[0094] The processor is further configured to perform an action selected from the group consisting of (i) disabling delivery of a therapeutic RF signal to the plurality of electrodes, (ii) providing a notification to the user, and (iii) modifying the surgical plan, in response to a determination that the plurality of electrodes are not in contact with the intended tissue type, the apparatus according to any one of Examples 1 to 14.

Example

[0095] A method for detecting and sealing tissue, the method comprising: (a) clamping the patient's tissue between a first jaw and a second jaw of an end effector, the first jaw comprising a first electrode surface and the second jaw comprising a second electrode surface; (b) using a processor to control delivery and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes, the plurality of electrodes being in contact with the patient's tissue; (c) determining at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; and (d) determining that the plurality of electrodes are in contact with the intended tissue type based on the at least one characteristic. (e) controlling delivery of a therapeutic RF signal to the plurality of electrodes in response to a determination that the plurality of electrodes are in contact with the intended tissue type. A method comprising the above.

Example

[0096] (a) obtaining a transmission voltage and a return voltage of an RF signal from a voltage sensor device; (b) obtaining a transmission current and a return current of the RF signal from a current sensor device; (c) determining a capacitive reactance of a circuit based on the transmission voltage and the return voltage; (d) determining an inductive reactance of the circuit based on the transmission voltage and the return voltage. The method according to Example 16, further comprising the above, wherein the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current.

Example

[0097] The RF signal includes at least one of (i) an amplitude modulation signal, (ii) a frequency modulation signal, (iii) a phase modulation signal, or (iv) a frequency shift keying modulation signal, and is the method according to any one of Examples 16 or 17.

Example

[0098] The processor further performs at least one of (i) a fast Fourier transform (FFT) on the RF signal, where at least one characteristic is based on the FFT, the FFT, (ii) a cross-correlation analysis on the RF signal, where at least one characteristic is based on the cross-correlation analysis, the cross-correlation analysis, or (iii) a zero-crossing analysis on the RF signal, where at least one characteristic is based on the zero-crossing analysis, and is the method according to any one of Examples 16 to 18.

Example

[0099] A system comprising: (a) a waveform generator; and (b) an electrosurgical device comprising (i) a processor and (ii) a surgical instrument having a distal end with an end effector, the end effector being configured to interact with a patient's tissue, the end effector comprising (A) a first jaw comprising a first electrode and (B) a second jaw pivotally coupled to the first jaw, the second jaw comprising a second electrode, and an electrosurgical device, the processor being configured to (A) control the delivery and measurement of a non-therapeutic radio frequency (RF) signal to the first and second electrodes, the RF signal being generated by the waveform generator, (B) determine at least one characteristic of the patient's tissue based on the non-therapeutic RF signal, (C) determine based on the at least one characteristic that the first and second electrodes are in contact with the intended tissue type, and (D) control the delivery of a therapeutic RF signal to the tissue via the first and second electrodes in response to determining that the first and second electrodes are in contact with the intended tissue type.

[0100] VI. Others It should be understood that any variations of the devices described in the specification may include various other features in addition to, or instead of, those described above in this specification. By way of example only, the devices of the apparatus described in this specification may also include one or more of the various mechanisms disclosed in any of the various references incorporated herein by reference. Various suitable ways of combining such teachings will be apparent to those skilled in the art.

[0101] Although each example in this specification has been described primarily in connection with electrosurgical instruments, it should be understood that the various teachings of this specification can be readily applied to various other types of devices. By way of example only, the various teachings of this specification can be readily applied to other forms of electrosurgical instruments, namely, tissue graspers, tissue retrieval pouch placement instruments, surgical staplers, surgical clip appliers, ultrasonic surgical instruments, and the like. It should also be understood that the teachings of this specification can be readily applied to any of the instruments described in any of the documents cited in this specification, and thus, the teachings of this specification can be readily combined with the teachings of any of the documents cited in this specification in various ways. Other types of instruments into which the teachings of this specification can be incorporated will be apparent to those skilled in the art.

[0102] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described in this specification can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described in this specification. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art by considering the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0103] It should be understood that any patent, publication, or other disclosure material stated to be incorporated herein by reference is incorporated herein only in part or in whole to the extent that the incorporated material does not conflict with existing definitions or other disclosure content described in this disclosure. By itself and to the extent necessary, the disclosure clearly described herein shall prevail over any conflicting description incorporated herein by reference. Although stated to be incorporated into the present application by reference, a material or a part thereof that conflicts with existing definitions or other disclosure content described in the present application is incorporated only to the extent that no conflict occurs between the incorporated content and the existing disclosure content.

[0104] The above-described variations of the device are applicable not only to conventional medical procedures and surgeries performed by medical professionals, but also to robot-assisted medical procedures and robot-assisted surgeries. As just one example, the various teachings herein can be readily incorporated into robotic surgical systems such as the DAVINCI (trademark) system by Intuitive Surgical, Inc., Sunnyvale, California. Similarly, those skilled in the art will recognize that the various teachings herein can be readily combined with the various teachings of U.S. Patent No. 6,783,524, entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument," published on August 31, 2004, the disclosure of which is incorporated herein by reference in its entirety.

[0105] The above-described variations may be designed to be discarded after single use, or they may be designed for multiple uses. In either or both cases, the variations may be reconditioned for reuse after at least one use. Reconditioning may include any combination of a device disassembly process, followed by a cleaning or replacement process of specific parts, and subsequent reassembly. Specifically, some variations of the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. During cleaning and / or replacement of specific parts, some variations of the device may be reassembled for subsequent use either in a reconditioning facility or by an operator immediately prior to the procedure. One skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized in reconditioning the device. The use of such techniques, and the resulting reconditioned device, are all within the scope of this application.

[0106] Merely by way of example, the variations described herein may be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a sealed and enclosed container such as a plastic or TYVEK bag. Next, the container and device may be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electron beams. The radiation can kill bacteria on the device and within the container. Next, the sterilized device may be stored within the sterilized container for later use. The device may also be sterilized using any other technique well known in the art, including but not limited to beta or gamma rays, ethylene oxide, or steam.

[0107] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be made by those skilled in the art without departing from the scope of the present invention by appropriate modifications. Some of such possible modifications have been described, but other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, ratios, processes, etc. discussed above are illustrative and not essential. Accordingly, the scope of the present invention should be considered with respect to the following claims and it is understood that the present invention is not limited to the details of construction and operation shown and described in this specification and the drawings.

[0108] 〔Embodiment〕 (1) An apparatus for detecting and sealing tissue, the apparatus comprising: (a) a processor; (b) an end effector at a distal end of a surgical instrument, the end effector being configured to interact with a patient's tissue, the end effector comprising: (i) a first jaw having a first electrode surface fixed to the first jaw; (ii) a second jaw pivotally coupled to the first jaw and having a second electrode surface fixed to the second jaw, the first electrode surface and the second electrode surface comprising a plurality of electrodes; an end effector; comprising; (c) the processor being: (i) controlling the delivery and measurement of a non-therapeutic radio frequency (RF) signal to the plurality of electrodes, the plurality of electrodes being configured to contact the patient's tissue; (ii) determining at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (iii) determining that the plurality of electrodes are in contact with the intended tissue type based on the at least one characteristic; (iv) controlling the delivery of the therapeutic RF signal to the plurality of electrodes in response to a determination that the plurality of electrodes are in contact with the intended tissue type An apparatus configured to perform the above. (2) The first jaw further comprises a first knife path, the second jaw further comprises a second knife path, and both the first knife path and the second knife path are configured to accommodate the translation of a knife member passing through a portion of the end effector. The apparatus according to embodiment 1. (3) The electrodes are in a branched configuration in which the electrodes are movable relative to each other on opposite sides of a central axis. The apparatus according to embodiment 1 or 2. (4) The apparatus according to any one of embodiments 1 to 3, further comprising a switching system configured to switch between the non-therapeutic RF signal and the therapeutic RF signal. (5) (a) A voltage sensor device, (b) A current sensor device, further comprising: The processor is (i) obtaining the transmission voltage and return voltage of the RF signal from the voltage sensor device, (ii) obtaining the transmission current and return current of the RF signal from the current sensor device and is further configured such that The at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current. The apparatus according to any one of embodiments 1 to 4.

[0109] (6) The processor is (i) determining the capacitive reactance of the circuit based on the transmission voltage and the return voltage, (ii) determining the inductive reactance of the circuit based on the transmission voltage and the return voltage and is further configured such that The at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current. The apparatus according to embodiment 5. (7) The processor is further configured to determine the impedance of the circuit based on the capacitive reactance and the inductive reactance, and the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current, the apparatus according to embodiment 6. (8) The RF signal includes a plurality of waveforms summed into a multi-waveform, and each of the plurality of waveforms has a unique frequency, the apparatus according to any one of embodiments 1 to 7. (9) The RF signal includes a multi-burst waveform having a single or a plurality of different periods, amplitudes, or waveforms, the apparatus according to any one of embodiments 1 to 8. (10) The RF signal is (A) an amplitude modulation signal, (B) a frequency modulation signal, (C) a phase modulation signal, (D) a frequency shift keying modulation signal, or (E) a chirp waveform including at least one of the above, the apparatus according to any one of embodiments 1 to 9.

[0110] (11) The processor is further configured to perform a fast Fourier transform (FFT) on the RF signal, and the at least one characteristic is based on the FFT, the apparatus according to any one of embodiments 1 to 10. (12) The processor is further configured to perform a cross-correlation analysis on the RF signal, and the at least one characteristic is based on the cross-correlation analysis, the apparatus according to any one of embodiments 1 to 11. (13) The processor is further configured to perform a zero-crossing analysis on the RF signal, and the at least one characteristic is based on the zero-crossing analysis, the apparatus according to any one of embodiments 1 to 12. (14) The processor is further configured to perform a pseudo-inverse matrix Fourier (PIMF) analysis on the RF signal, and the at least one characteristic is based on the PIMF analysis, the apparatus according to any one of embodiments 1 to 13. (15) In response to a determination that the plurality of electrodes are not in contact with the intended tissue type, the processor is further configured to perform an action selected from the group consisting of: (i) disabling delivery of a therapeutic RF signal to the plurality of electrodes; (ii) providing a notification to the user; (iii) modifying the surgical plan; The apparatus according to any one of Embodiments 1 to 14, further configured to perform an action selected from the group consisting of:

[0111] (16) A method for detecting and sealing tissue, the method comprising: (a) clamping a patient's tissue between a first jaw and a second jaw of an end effector, the first jaw comprising a first electrode surface and the second jaw comprising a second electrode surface; (b) using a processor to control delivery and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes, the plurality of electrodes being in contact with the patient's tissue; (c) determining at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (d) determining, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; (e) controlling delivery of a therapeutic RF signal to the plurality of electrodes in response to a determination that the plurality of electrodes are in contact with the intended tissue type. A method comprising: (17) (a) obtaining a transmission voltage and a return voltage of the RF signal from a voltage sensor device; (b) obtaining a transmission current and a return current of the RF signal from a current sensor device; (c) determining a capacitive reactance of a circuit based on the transmission voltage and the return voltage; (d) determining an inductive reactance of the circuit based on the transmission voltage and the return voltage; further comprising: The method according to embodiment 16, wherein the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current. (18) The RF signal is (i) an amplitude modulation signal, (ii) a frequency modulation signal, (iii) a phase modulation signal, or (iv) a frequency shift keying modulation signal The method according to embodiment 16 or 17, including at least one of the foregoing. (19) The processor (i) performs a fast Fourier transform (FFT) on the RF signal, and the at least one characteristic is based on the FFT, the FFT (ii) performs a cross-correlation analysis on the RF signal, and the at least one characteristic is based on the cross-correlation analysis, the cross-correlation analysis, or (iii) performs a zero-crossing analysis on the RF signal, and the at least one characteristic is based on the zero-crossing analysis, the zero-crossing analysis The method according to any one of embodiments 16 to 18, further performing at least one of the foregoing. (20) A system (a) a waveform generator, and (b) an electrosurgical device (i) a processor, and (ii) a surgical instrument having a distal end with an end effector, the end effector being configured to interact with a patient's tissue, the end effector (A) a first jaw having a first electrode, and (B) a second jaw pivotally coupled to the first jaw, the second jaw having a second electrode, the electrosurgical device Comprising The processor (A) Controlling the delivery and measurement of a non-therapeutic radio frequency (RF) signal to the first electrode and the second electrode, wherein the RF signal is generated by the waveform generator; (B) Determining at least one characteristic of the tissue of the patient based on the non-therapeutic RF signal; (C) Determining that the first electrode and the second electrode are in contact with the intended tissue type based on the at least one characteristic; (D) Controlling the delivery of a therapeutic RF signal to the tissue via the first electrode and the second electrode in response to determining that the first electrode and the second electrode are in contact with the intended tissue type A system configured to perform the above.

Claims

1. An apparatus for detecting and sealing tissue, the apparatus comprising: (a) a processor; (b) an end effector at a distal end of a surgical instrument, the end effector being configured to interact with a patient's tissue, the end effector comprising: (i) a first jaw having a first electrode surface fixed to the first jaw; (ii) a second jaw pivotally coupled to the first jaw, the second jaw having a second electrode surface fixed to the second jaw, the first electrode surface and the second electrode surface comprising a plurality of electrodes, the end effector comprising: and (c) the processor is configured to: (i) control the delivery and measurement of a non-therapeutic radio frequency (RF) signal to the plurality of electrodes, the plurality of electrodes being configured to contact the patient's tissue; (ii) determine at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (iii) determine, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; (iv) control the delivery of a therapeutic RF signal to the plurality of electrodes in response to the determination that the plurality of electrodes are in contact with the intended tissue type. An apparatus so configured.

2. The first jaw further comprises a first knife path, the second jaw further comprises a second knife path, and both the first knife path and the second knife path are configured to accommodate translation of a knife member through a portion of the end effector. The apparatus according to claim 1.

3. The electrodes are in a branched configuration in which the electrodes are movable relative to a central axis and opposite to each other. The apparatus according to claim 1 or 2.

4. The apparatus according to claim 1, further comprising a switching system configured to switch between the non-therapeutic RF signal and the therapeutic RF signal.

5. (a) a voltage sensor device; (b) a current sensor device; and further comprising the processor is further configured to: (i) obtain a transmission voltage and a return voltage of the RF signal from the voltage sensor device; (ii) obtain a transmission current and a return current of the RF signal from the current sensor device. An apparatus so configured. The apparatus according to claim 1, wherein the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current.

6. The processor is configured to further: (i) determine a capacitive reactance of a circuit based on the transmission voltage and the return voltage; and (ii) determine an inductive reactance of the circuit based on the transmission voltage and the return voltage. The apparatus according to claim 5, wherein the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current.

7. The processor is further configured to determine an impedance of the circuit based on the capacitive reactance and the inductive reactance, and the apparatus according to claim 6, wherein the at least one characteristic is based on the transmission voltage, the return voltage, the transmission current, and the return current.

8. The RF signal includes a plurality of waveforms summed into a multi-waveform, and each of the plurality of waveforms has a unique frequency, the apparatus according to claim 1.

9. The RF signal includes a multi-burst waveform having a single or a plurality of different periods, amplitudes, or waveforms, the apparatus according to claim 1.

10. The RF signal is (A) an amplitude modulation signal, (B) a frequency modulation signal, (C) a phase modulation signal, (D) a frequency shift keying modulation signal, or (E) a chirp waveform. The apparatus according to claim 1, including at least one of the above.

11. The processor is further configured to perform a fast Fourier transform (FFT) on the RF signal, and the apparatus according to claim 1, wherein the at least one characteristic is based on the FFT.

12. The processor is further configured to perform a cross-correlation analysis on the RF signal, and the apparatus according to claim 1, wherein the at least one characteristic is based on the cross-correlation analysis.

13. The processor is further configured to perform a zero-crossing analysis on the RF signal, and the apparatus according to claim 1, wherein the at least one characteristic is based on the zero-crossing analysis.

14. The processor is further configured to perform a pseudo-inverse matrix Fourier (PIMF) analysis on the RF signal, and the apparatus according to claim 1, wherein the at least one characteristic is based on the PIMF analysis.

15. ​ In response to a determination that the plurality of electrodes are not in contact with the intended tissue type, the processor (i) disables delivery of the therapeutic RF signal to the plurality of electrodes, (ii) provides a notification to the user, (iii) modifies the surgical plan, and is further configured to perform an action selected from the group consisting of, the apparatus of claim 1. **Claim 16** A method for detecting and sealing tissue, the method comprising: (a) clamping the patient's tissue between a first jaw and a second jaw of an end effector, the first jaw comprising a first electrode surface and the second jaw comprising a second electrode surface; (b) using a processor to control delivery and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes, the plurality of electrodes being in contact with the patient's tissue; (c) determining at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (d) determining, based on the at least one characteristic, that the plurality of electrodes are in contact with the intended tissue type; (e) controlling delivery of a therapeutic RF signal to the plurality of electrodes in response to a determination that the plurality of electrodes are in contact with the intended tissue type. A method comprising. **Claim 17** (a) obtaining a transmit voltage and a return voltage of the RF signal from a voltage sensor device; (b) obtaining a transmit current and a return current of the RF signal from a current sensor device; (c) determining a capacitive reactance of a circuit based on the transmit voltage and the return voltage; (d) determining an inductive reactance of the circuit based on the transmit voltage and the return voltage; further comprising, wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current, and the return current, the method of claim 16. **Claim 18** The RF signal is (i) an amplitude modulated signal, (ii) a frequency modulated signal, (iii) a phase modulated signal, or (iv) a frequency shift keying modulated signal and includes at least one of, the method of claim 16 or 17. **Claim 19** The processor is (i) a fast Fourier transform (FFT) of the RF signal, wherein the at least one characteristic is based on the FFT, an FFT, (ii) cross-correlation analysis of the RF signal, wherein the at least one characteristic is based on the cross-correlation analysis, cross-correlation analysis, or (iii) zero-crossing analysis of the RF signal, wherein the at least one characteristic is based on the zero-crossing analysis, zero-crossing analysis The method according to claim 16, further comprising performing at least one of the above.

20. A system, (a) a waveform generator; (b) an electrosurgical device, (i) a processor; (ii) a surgical instrument having a distal end with an end effector, the end effector being configured to interact with a patient's tissue, the end effector (A) a first jaw having a first electrode; (B) a second jaw pivotally coupled to the first jaw, the second jaw comprising a second electrode, the second jaw; an electrosurgical device, comprising The processor is (A) controlling the delivery and measurement of a non-therapeutic radio frequency (RF) signal to the first electrode and the second electrode, the RF signal being generated by the waveform generator; controlling; (B) determining at least one characteristic of the patient's tissue based on the non-therapeutic RF signal; (C) determining based on the at least one characteristic that the first electrode and the second electrode are in contact with the intended tissue type; (D) controlling the delivery of a therapeutic RF signal to the tissue via the first electrode and the second electrode in response to determining that the first electrode and the second electrode are in contact with the intended tissue type A system configured to perform.

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