Electrosurgical instrument for applying non-therapeutic RF signals
By using non-therapeutic radio frequency signals in electrosurgical device systems, verifying its type, and switching to the treatment mode after verification is passed, the problem of difficult to effectively verify tissue type in the prior art is solved, and tissue sealing and cutting is improved Efficiency and safety.
Patent Information
- Application Number
- CN202380049443.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-06-30
- Filing Date
- 2023-06-27
- Publication Date
- 2025-02-11
AI Technical Summary
Existing electrosurgical devices are difficult to effectively verify whether the tissue type and captured tissue are correct during tissue sealing and cutting, resulting in limited treatment efficiency and safety.
An electrosurgical instrument system was designed to capture tissue using an end effector and test the tissue through a non-therapeutic radio frequency signal, providing additional details of the tissue. After verifying the tissue type, the system can switch operation modes to apply therapeutic energy signals to the tissue to seal or weld the tissue.
The system is able to effectively verify the captured tissue type, ensure the precise application of therapeutic signals, and improve the efficiency and safety of tissue sealing and cutting.
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Figure CN119421668A_ABST
Abstract
Description
Background Art
[0001] Many surgical instruments include a tissue cutting element and one or more elements that transmit radiofrequency (RF) energy to tissue (e.g., to coagulate or seal tissue). Examples of such electrosurgical instruments are the Tissue sealing devices. Additional examples of such devices and related concepts are disclosed in the following documents: U.S. Patent No. 6,500,176, entitled “Electrosurgical Systems and Techniques for Sealing Tissue,” issued on 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 on 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 on November 18, 2014, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,888,809, entitled “Motor Driven Electrosurgical Device with Mechanical and Electrical No. 9,161,803, entitled “Control Features for Articulating Surgical Device,” issued on January 30, 2018, the disclosure of which is incorporated herein by reference in its entirety; No. 9,877,720, entitled “Control Features for Articulating Surgical Device,” issued on January 30, 2018, the disclosure of which is incorporated herein by reference in its entirety; No. 9,545,253, entitled “Surgical Instrument with Contained Dual Helix Actuator Assembly,” issued on January 17, 2017, the disclosure of which is incorporated herein by reference in its entirety; and No. 9,526,565, entitled “Electrosurgical Devices,” issued on December 27, 2016, the disclosure of which is incorporated herein by reference in its entirety.
[0002] While various surgical instruments have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0003] While this specification results in claims that particularly point out and distinctly claim such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate the same elements, and wherein:
[0004] Figure 1 depicts a perspective view of an exemplary electrosurgical instrument;
[0005] Figure 2 Depicted Figure 1 A perspective view of an exemplary articulation assembly and end effector of an electrosurgical instrument;
[0006] Figure 3 Depicted Figure 2 An exploded view of the articulation assembly and end effector;
[0007] Figure 4 Depicted Figure 2 A perspective view of an end effector;
[0008] Figure 5 Depicted Figure 2 An exploded perspective view of an end effector;
[0009] Figure 6 Describes the areas where you can use Figure 1 An illustrative schematic diagram of a system of an electrosurgical instrument;
[0010] Figure 7 Describes the areas where you can use Figure 1 Another illustrative schematic diagram of a system for an electrosurgical instrument;
[0011] Figure 8 An exemplary circuit diagram of a manually switched rectifier circuit is depicted;
[0012] Fig. 9 depicts an exemplary circuit diagram of a signal conditioning circuit;
[0013] Fig.10 An exemplary circuit diagram depicting an internal power supply circuit;
[0014] Fig.11 Depicts an exemplary circuit diagram of a MOSFET driver and relay circuit;
[0015] Fig.12 depicts an exemplary circuit diagram of a voltage and current sensing circuit;
[0016] Fig.13 An exploded perspective view depicting an example of a cable and connector assembly;
[0017] Fig.14 An exemplary impedance triangle is depicted;
[0018] Fig.15 depicts a set of illustrative example waveforms;
[0019] Fig.16 Another set of illustrative example waveforms are depicted;
[0020] Fig.17 Another illustrative example waveform is depicted;
[0021] Fig.18 Another illustrative example waveform is depicted;
[0022] Fig.19 Another set of illustrative example waveforms are depicted;
[0023] Fig. 20 Another illustrative example waveform is depicted;
[0024] Fig.21 Another illustrative example waveform is depicted;
[0025] Fig. 22 depicts a set of illustrative graphical examples of impedance magnitude and phase as a function of frequency for different tissues and materials;
[0026] Fig.23 An illustrative example of the cross-correlation of two waveforms is depicted;
[0027] Fig.24 depicts another illustrative example of a zero crossing detection circuit and associated waveforms;
[0028] Fig.25 depicts a graphical representation of impedance magnitude and phase angle of a waveform applied to tissue as a function of time; and
[0029] Fig.26 Various graphs plotting impedance magnitude and jaw gap versus time are depicted.
[0030] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present technology may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the present technology and, together with the description, explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0031] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments and advantages of the present technology will become apparent to those skilled in the art from the following description, which is by way of example, one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
[0032] It should also be understood that any one or more of the teachings, expressions, implementations, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, implementations, examples, etc. described herein. Therefore, the following teachings, expressions, implementations, examples, etc. should not be considered isolated from each other. According to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0033] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is closer to the surgeon or other operator, and the term "distal" refers to a position where an element is closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.
[0034] Improved systems and methods for sealing and cutting tissue using surgical instruments are disclosed herein. Specifically, the system can capture patient tissue using an end effector and then test the tissue using a non-therapeutic (i.e., low-power) signal to ensure that appropriate tissue is captured. Once the non-therapeutic signal is applied, received, and analyzed, the system can provide additional details about the tissue. Assuming the additional details confirm that the captured tissue is the desired tissue, the system can switch operating modes and apply a therapeutic energy signal to the tissue, thereby sealing or cauterizing the tissue.
[0035] I. Examples of Electrosurgical Instruments
[0036] Figures 1 to 5 An exemplary electrosurgical instrument 100 is shown. Figure 1As best shown in , the electrosurgical instrument 100 includes a handle assembly 120, a shaft assembly 140, an articulation assembly 110, and an end effector 180. As will be 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 in the end effector so that therapeutic RF energy can be applied to seal or weld the tissue. However, it should be understood that, based on the teachings of this document, it is obvious to those skilled in the art that the electrosurgical instrument 100 can be configured to seal or weld tissue by any other suitable means. For example, the electrosurgical instrument 100 can be configured to seal or weld tissue via an ultrasonic blade, a nail, etc. In this example, the electrosurgical instrument 100 is electrically connected to a waveform generator 200 via a power cable 10, which is capable of delivering therapeutic energy and non-therapeutic energy.
[0037] Waveform generator (200) may be configured to provide all or a portion of the power requirements for electrosurgical instrument (100). As will be apparent to one skilled in the art in view of the teachings herein, any suitable waveform generator (200) may be used. By way of non-limiting example, waveform generator (200) may include a GEN04 or GEN11 (e.g., a GEN1100) sold by Ethicon, LLC. (Cincinnati, Ohio). Figure 7 ). In addition, or in the alternative, waveform generator 200 may be constructed in accordance with at least some 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 incorporated herein by reference in its entirety. Although in the present example, electrosurgical instrument 100 is coupled to waveform generator 200 via power cable 10, electrosurgical instrument 100 may include an internal power source or multiple power sources, such as batteries and / or supercapacitors, to electrically power electrosurgical instrument 100. Of course, any suitable combination of power sources may be utilized to power electrosurgical instrument 100, as will be apparent to one skilled in the art in light of the teachings herein.
[0038] The handle assembly 120 is configured to be grasped by one hand of an operator so that the operator can control and manipulate the electrosurgical instrument 100 with one hand. Although the electrosurgical instrument 100 is primarily described herein as being used by a human user, it should be noted that there are alternative versions in which one or more robotic systems (e.g., robotic arms) can be used to control and manipulate 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 will be described in more detail below, the components of the handle assembly 120 are configured to control the end effector 180 so 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.
[0039] The handle assembly 120 includes a control unit 102, a pistol grip 124, a jaw closure trigger 126, a knife trigger 128, an activation button 130, an articulation control 132, and a knob 134 housed within a body 122. As will be described in more detail below, the jaw closure trigger 126 can be pivoted 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 grasp tissue. Additionally, the knife trigger 128 can be pivoted toward and away from the pistol grip 124 and / or the body 122 to actuate the knife member 176 within the jaws 182, 184 to cut tissue captured between the jaws 182, 184. Additionally, the activation button 130 can be pressed to apply radio frequency (RF) energy to tissue via electrode surfaces 194, 196 of the jaws 182, 184, respectively. In some versions, electrode surfaces (194, 196) of jaws (182, 184) have a bifurcated configuration, wherein electrode surfaces (194, 196) move relative to a central axis and are substantially equal and opposite to one another.
[0040] Body 122 of handle assembly 120 defines an opening 123 through which a portion of an articulation control 132 protrudes. Articulation control 132 is rotatably disposed within body 122 such that an operator can rotate the portion of articulation control 132 protruding from opening 123 to rotate the portion of articulation control 132 located within body 122. Rotation of articulation control 132 relative to body 122 will cause articulation segment 110 to bend in order to drive deflection of end effector 180 from a longitudinal axis (LA) defined by shaft assembly 140. As will be apparent to one skilled in the art in view of the teachings herein, articulation control 132 and articulation segment 110 may include any suitable features to drive deflection of end effector 180 from a longitudinal axis (LA) defined by shaft assembly 140.
[0041] Knob 134 is rotatably disposed on the distal end of body 122 and is configured to rotate end effector 180, articulation assembly 110, and shaft assembly 140 relative to handle assembly 120 about the longitudinal axis (LA) of shaft assembly 140. Although in the current example, end effector 180, articulation assembly 110, and shaft assembly 140 are rotated by knob 134, knob 134 may be configured to rotate end effector 180 and articulation assembly 110 relative to a selected portion of shaft assembly 140. As will be apparent to one skilled in the art in view of the teachings herein, knob 134 may include any suitable features to rotate end effector 180, articulation assembly 110, and shaft assembly 140.
[0042] The shaft assembly 140 includes a distal portion 142 extending distally from the handle assembly 120, and a proximal portion 144 received within the body 122 of the handle assembly 120. Referring now to Figure 3 , the shaft assembly 140 houses a jaw closure connector 160 that couples the jaw closure trigger 126 with the end effector 180. In addition, the shaft assembly 140 houses a portion of a knife member extending between the distal cutting edge 178 and the knife trigger 128. The shaft assembly 140 also houses an actuation member 112 that couples the articulation assembly 110 with the articulation control 132; and an electrical connector 15 that operatively couples the electrode surfaces 194, 196 with the actuation button 130. As will be described in greater detail below, the jaw closure connector 160 is configured to be translatable relative to the shaft assembly 140 to open and close the jaws 182, 184 of the end effector 180; while the knife member 176 is coupled to the knife trigger 128 of the handle assembly 120 to translate the distal cutting edge 178 within the confines of the end effector 180; and the activation button 130 is configured to activate the electrode surfaces 194, 196.
[0043] like Figures 2 to 5As best shown in FIG. 1 , the end effector 180 includes a lower jaw 182 pivotally coupled to an upper jaw 184 via a pivot coupling 198. The lower jaw 182 includes a proximal body 183 defining a slot 186, while the upper jaw 184 includes a proximal arm 185 defining a slot 188. The lower jaw 182 also defines a central passage 190 that is configured to receive the proximal arm 185 of the upper jaw 184, a portion of the knife member 176, the jaw closure connector 160, and the pin 164. The slots 186, 188 each slidably receive the pin 164 that is attached to the distal coupling portion 162 of the jaw closure connector 160. In addition, the lower jaw 182 includes a force sensor 195 located at the distal end of the lower jaw 182, but the force sensor 195 may alternatively be located at any other suitable location. The force sensor 195 may communicate with the control unit 102. As described herein, force sensor (195) may be configured to measure the closing force generated by pivoting jaws (182, 184) into a closed configuration. Additionally, force sensor (195) may transmit this data to control unit (102). As will be apparent to one skilled in the art in view of the teachings herein, any suitable component may be used for force sensor (195). For example, force sensor (195) may take the form of a strain gauge. In some variations, end effector (180) includes more than one force sensor.
[0044] As will be apparent to those skilled in the art in view of the teachings herein, while in the present example force sensor (195) is incorporated into instrument (100) and in communication with control unit (102), any other suitable sensor or feedback mechanism may additionally or alternatively be incorporated into instrument (100) and in communication with control unit (102). For example, an articulation sensor or feedback mechanism may be incorporated into instrument (100), wherein the articulation sensor transmits a signal to control unit (102) indicating the extent to which end effector (180) is deflected from longitudinal axis (LA) by articulation control (132) and articulation section (110).
[0045] As will be described in more detail below, the jaw closure connector 160 is operable to translate within the central channel 190 of the lower jaw 182. Translation of the jaw closure connector 160 drives the pin 164. As will also be described in more detail below, with the pin 164 positioned within both slots 186, 188 and with the slots 186, 188 angled relative to one another, the pin 164 cams the proximal arm 185 to pivot the upper jaw 184 about the pivot coupling 198 toward and away from the lower jaw 182. Thus, the upper jaw 184 is configured to pivot about the pivot coupling 198 toward and away from the lower jaw 182 to grasp tissue.
[0046] The term “pivot” does not necessarily require rotation about a fixed axis, but may include rotation about an axis that moves relative to end effector (180). Thus, the axis about which upper jaw (184) pivots about lower jaw (182) may translate relative to both upper jaw (184) and lower jaw (182). Any suitable translation of the pivot axis may be used, as will be apparent to those skilled in the art in view of the teachings herein.
[0047] The lower jaw 182 and the upper jaw 184 also define a knife passage 192. The knife passage 192 is configured to slidably receive the knife member 176 so that the knife member 176 can be retracted and advanced to cut tissue captured between the jaws 182, 184.
[0048] Lower jaw 182 and upper jaw 184 each include a respective electrode surface 194, 196. A power source may provide RF energy to electrode surfaces 194, 196 via electrical coupling 15, which extends through handle assembly 120, shaft assembly 140, joint motion assembly 110, and is electrically coupled to one or both of electrode surfaces 194, 196. Electrical coupling 15 may selectively activate electrode surfaces 194, 196 in response to an operator pressing activation button 130. In some cases, control unit 102 may couple electrical coupling 15 to activation button 130 so that control unit 102 activates electrode surfaces 194, 196 in response to an operator pressing activation button 130. As will be apparent to one skilled in the art in light of the teachings herein, control unit 102 may have any suitable components in order to perform suitable functions. For example, control unit 102 may have a processor, a memory unit, suitable circuitry, etc. Examples of features and functions that may be incorporated into control unit 102 will be described in more detail below.
[0049] As described above, the jaw closure trigger 126 can be pivoted 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 grasp tissue. Specifically, as will be described in greater detail below, pivoting the jaw closure trigger 126 toward the pistol grip 124 can proximally actuate the jaw closure connector 160 and the pin 164, which in turn cams the slot 188 of the proximal arm 185 of the upper jaw 184, thereby rotating the upper jaw 184 about the pivot coupling 198 toward the lower jaw 182, so that the jaws 182, 184 achieve a closed configuration.
[0050] In some versions, knife trigger 128 can be pivoted toward and away from body 122 and / or pistol grip 124 to actuate knife member 176 within knife passage 192 of jaws 182, 184 to cut tissue captured between jaws 182, 184. Specifically, handle assembly 120 also includes a knife coupling body 174 slidably coupled along proximal portion 144 of shaft assembly 140. Knife coupling body 174 is coupled to knife member 176 such that translation of knife coupling body 174 relative to proximal portion 144 of shaft assembly 140 translates knife member 176 relative to shaft assembly 140.
[0051] In another version, the knife coupling body 174 can be coupled to the knife actuation assembly such that when the knife trigger 128 is pivoted toward the body 122 and / or the pistol grip 124, the knife actuation assembly 168 drives the knife coupling body 174 distally, thereby driving the knife member 176 distally within the knife passage 192. Because the knife coupling body 174 is coupled to the knife member 176, the knife member 176 translates distally within the shaft assembly 140, the articulation section 110, and the knife passage 192 of the end effector 180. The knife member 176 includes a distal cutting edge 178 that is configured to sever tissue captured between the jaws 182, 184. Thus, pivoting the knife trigger 128 causes the knife member 176 to actuate within the knife passage 192 of the end effector 180 to sever tissue captured between the jaws 182, 184.
[0052] With the distal cutting edge 178 of the knife member 176 actuated to the advanced position, the operator can press the activation button 130 to selectively activate the electrode surfaces 194, 196 of the jaws 182, 184 to weld / seal the severed tissue captured between the jaws 182, 184. It should be understood that the operator can also press the activation button 130 to selectively activate the electrode surfaces 194, 196 of the jaws 182, 184 at any suitable time during the exemplary use. Thus, the operator can also press the activation button 130 when the knife member 176 is retracted. Next, the operator can release the jaw closure trigger 128, causing the jaws 182, 184 to pivot to the open configuration, thereby releasing the tissue.
[0053] II. Description of the entire system and specific circuits
[0054] An illustrative schematic diagram of an example system is shown in Figure 6. As discussed herein, the electrosurgical instrument 100 may include some form of control unit (e.g., a control unit 102 in the handle assembly 120 and / or a control unit feature in the waveform generator 200). In some versions, and 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 versions that will be discussed in detail herein, a switching system (e.g., a switching relay, etc.) 601 may allow the system to switch or alternate between therapeutic signals and non-therapeutic signals. In some versions, the therapeutic signals and the non-therapeutic signals may be generated by a single waveform generator 200 that includes 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 separate devices.
[0055] As will be described in greater detail herein, the process for determining which signal (e.g., therapeutic versus non-therapeutic) the switching system 601 selects can be based on a variety of factors and determinations. In some versions, a processor 602 can be used to facilitate signal selection. As used herein, the term "processor" should be understood to include a microprocessor, a microcontroller, a field programmable gate array (FPGA) device, and / or any other suitable type of hardware configured to process electrical signals. In another version, and as shown, the system can also include: a manually switched rectifier circuit 800 (in Figure 8 , which may include a low voltage solid state relay 808 and a sealed circuit 807 configured to be connected to a drive signal 801 and a return signal 802 via a pin connector 603); a signal conditioning circuit 900 (in Figure 7 Detailedly shown in FIG); internal power supply 1000 (in Fig.10 MOSFET driver circuit 1100 (shown in detail in Fig.11 ); voltage sensing circuit 1210 (in Fig.12 ); and current sensing circuit 1220 (in Fig.12 It should be understood that the circuits shown and discussed herein are shown in detail for illustrative purposes only, and no circuit or circuit diagram should be considered as a limitation or restriction on any version disclosed herein. In other words, those skilled in the art will understand that alternative and / or modified circuits may exist now and in the future, and that those circuits may be used to facilitate certain portions of the designs disclosed herein.
[0056] By way of non-limiting example, Figure 7 An exemplary circuit diagram that may be employed in the GEN 11 waveform generator sold by Ethicon, LLC is shown. Thus, in some versions, and as Figure 7As shown, 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 in turn selects which waveform to deliver to the end effector 180. Figure 6 In the discussed version, the circuit may include processor 702 and various other circuits (eg, signal conditioning circuit 900).
[0057] like Figure 6 shown, and again in the following Fig.14 In some versions, handle assembly 120 may be connected to waveform generator 200 via cable 10. In some versions, the system may be adapted to operate on conventional equipment. For example, various existing treatment systems may utilize a 9-pin connector (e.g., 603) having at least one available pin to allow transmission of non-therapeutic energy. Thus, as Figure 6 and Fig.13 As shown, the system may utilize a pinned connector 603 to transmit various signals between the electrosurgical instrument 100 and the wave generator 200 .
[0058] In addition to operating on conventional waveform generating equipment, the systems and methods described herein may also be used with conventional electrosurgical instruments (e.g., similar to Figure 1 Electrosurgical instruments shown, but not Figures 8 to 13 In other words, there may be some embodiments in which the outer housing (e.g., disposable or reusable) includes a reference Figures 8 to 13 The described circuits and thus include functionality. In some implementations, the outer housing can be mounted (e.g., operatively coupled) to the handle assembly 120 of the electrosurgical instrument. There can be alternative implementations in which the outer housing is coupled to an alternative device or location (such as, for example, one of a waveform generator, a patient bed, a surgical tool, or other object in an operating room). In addition, reference is provided to Figures 8 to 13 The components of the described components' functionality need not be contained within a dedicated external housing. Such components may be integrated into another housing along with other components. For example, such components may be integrated into the housing of a waveform generator or the like. Figures 8 to 13 It shows that Figure 6 The circuits shown more generally in the FIGURES take various forms of detailed example circuit diagrams. For example, Figure 8 8 shows an example of a form that the rectifier circuit 800 may take. Figure 8 As shown, rectifier circuit 800 receives manual switch drive signal 801 and / or manual switch return signal 802 (e.g., from activation button 130 or similar triggering device). In some versions, rectifier circuit may include or be connected to solid state relay 808 and / or sealed circuit 807. Figure 6In the illustrated system, a rectifier circuit 800 may be connected to the signal conditioning circuit 900 and the processor 602. The rectifier circuit 800 may also include a choke (e.g., a common mode choke) or filter 803 that receives the signal 801 / 802 from the handle assembly 120. The drive signal 801 and / or the return signal 802 may then pass through an electrostatic discharge diode 804 (or transient voltage suppression (TVS) diode) and a capacitor 806 before being rectified (e.g., using a rectifier based on a fast Schottky diode 805 bridge) and passed to the next component, such as Figure 6 The signal conditioning circuit 900 is shown. Fig. 9 An example of a form that signal conditioning circuit 900 may take is shown.
[0059] Once rectified, the signal can then be passed to Fig. 9 Signal conditioner 900 shown. In some versions, the regulator circuit 900 may 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 capacitor 902, one or more inductors (not shown) are also included. In another version, op amp 903 can be a very high impedance input op amp configured as a buffer and paired with a passive voltage divider and a passive low-pass filter. In some such scenarios, the buffer op amp of the circuit can be used to limit all incoming electromagnetic interference and capacitive coupling that can be generated by the waveform generator 200. The passive voltage divider and the 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 decide when to use therapeutic or non-therapeutic energy delivery. Once the manual switch drive signal 801 and / or the manual switch return signal 802 (i.e., through the circuit 900) are adjusted, it can then be passed to the microprocessor 602 / 702 for evaluation.
[0060] Fig.10 It shows that Figure 6 The power supply circuit 1000 takes an example of a form. In some versions, and as Fig.10 As shown, the power supply may 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 may include a thermistor 1003 and a voltage regulator 1004, each of which has its own jumper 1005 so that they can be automatically bypassed. In another version, the power supply circuit may also include one or more diodes 1005 and one or more capacitors 1007.
[0061] Fig.11 It shows that Figure 6The MOSFET relay driver circuit 1100 takes the form of an example. Fig.11 As shown, the MOSFET relay driver circuit may have one or more MOSFETs 1201 to drive one or more MOSFETs 1202 via a "Toggle" input. Then, as Figure 6 As shown, MOSFET 1202 can be used to change the state of switching system 601. In some versions, MOSFET relay driver circuit 1100 is attached to dual position double throw (DPDT) electromechanical relay 601. In addition to or instead of including DPDT relay 601, some variants may include multiple solid state relays, mechanical switches and / or other components. In some versions, processor 602 can select when to deliver conversion energy from treatment and non-treatment energy based on manual switch signal. In other versions, due to the electromechanical action of charging and discharging the coil contained in the relay mechanism, a delay of less than 12ms may be required to change. Therefore, in some versions, a group of 4 solid state relays can be used to achieve the same result, but with much faster response time due to lack of mechanical redundancy.
[0062] Figure 6 A graphical illustration of the switching circuit 601 is shown as consisting of Fig.11 In some versions, and as Fig.11 As shown, electrosurgical instrument 100 may receive a waveform (e.g., therapeutic or non-therapeutic) via transmit path 610 and return the waveform via return path 620. Thus, in some versions, therapeutic waveform generator 201 may output a waveform to one side 201A of transmit relay 610 and receive the resulting waveform (i.e., the waveform after it passes through the electrode of end effector 180) from one side 201B of receive relay 620. Similarly, non-therapeutic waveform generator 202 may output a waveform to one side 202A of transmit relay 610 and receive the resulting waveform from one side 202B of receive relay 620. Figure 14 to Figure 15 Examples of such operations are described in more detail.
[0063] In some versions, the switching system 601 may include a double pole double throw (DPDT) relay that may have two sets of switches or positions, wherein each switch has two option contacts or throws. Each relay position may have a connection to a therapeutic energy electrode or loop and a non-therapeutic electrode or loop. When the relay coil is not energized, each position may have a normally open (NO) or normally closed (NC) throw. In certain versions, the switching system 601 (e.g., a switching relay) may have a non-therapeutic energy delivery that is set to be normally closed whenever the user does not depress the manual switch to allow bioimpedance sensing. However, once actuation of the manual switch (e.g., activation button 130) has occurred, the switching system 601 may throw to the normally open (NO) contact and begin therapeutic energy delivery. In some versions, the switching system 601 may be located in the handle 120, while in other versions, it may be located in the generator 200 itself.
[0064] As discussed in this article, reference Figure 6 , the system may have a voltage and current detection system 1200. Now referring to Fig.12 In some versions, the detection system 1200 may have a voltage sensing component 1210 and a current sensing component 1220 to detect the voltage drop between the sending relay 610 and the receiving relay 620 and the current returned to the waveform generator (e.g., 201 or 202) via the receiving relay 620. In some versions, and as shown, the sensing circuit may receive a signal from the sending relay 610 and pass the signal back to the voltage and current detection system 1200 via the return relay 620. In other versions, the voltage sensing circuit 1210 may include an output 1211 that provides the measured voltage to the processor 602. The voltage sensing circuit 1210 may also have a changeover switch 1212 that can be used to enable or disable the voltage sensing circuit 1210. In additional versions, the current sensing circuit 1220 may include an output 1221 that provides the measured current to the processor 602. The current sensing circuit 1220 may also have a changeover switch 1222 that can be used to enable or disable the current sensing circuit 1220.
[0065] In some versions, and as shown, the voltage sensing circuit 1210 may be comprised of two operational amplifiers 1213 operating as inverters 1230 and a summing amplifier 1214 placed in a series configuration with the inverters. As shown, the input inverting amplifier 1213 is designed to attenuate and invert the excitation signal (e.g., the transmit signal received from the transmit relay 610) based on the ratio of the feedback resistors. The result of the inverting operational amplifier will be an attenuated or lower voltage signal. In some versions, this lower voltage signal may then be shifted by a second stage non-inverting summing amplifier 1214 to a level that can be sensed by a microprocessor such as Figure 6The input of the non-inverting summing amplifier 1214 is a combination of the inverting op amp output and a tunable DC voltage 1215. The DC voltage 1215 may be provided 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 summing amplifier is one plus the ratio of the feedback resistor, as shown in the following equation:
[0066] Equation 1:
[0067] In some versions, the current sensing circuit 1220 may be constructed of a low impedance sense resistor connected to a high common mode differential instrument amplifier circuit 1223. Instrument amplifier 1223 converts the differential sense signal to a single ended low voltage signal. The signal gain is (1+(R11+R12) / R10) times the common instrument op amp gain of (R16 / R14). The low voltage signal is then processed by a second stage non-inverting summing amplifier 1224. The input to the non-inverting summing amplifier is a combination of the instrument op amp 1223 output and a tunable DC voltage 1225 provided 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 summing amplifier is one plus the ratio of R20 / R19.
[0068] Reference now Fig.13 , the example waveform generator 200 is shown as having a pin connector ( Figure 6 Pin connector 603 is then connected to a plurality of wires / cables passing through power cable 10 connected to electrosurgical instrument 100. In some versions, instrument 100 may include a connection port (not shown) that allows connection and disconnection of power adapter 1301.
[0069] III. Description of System Operation and Capabilities
[0070] This article discusses and Figures 1 to 13The system shown in provides an electrosurgical instrument 100 that is configured to clamp tissue using an end effector 180. Once firmly clamped, electrodes in 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 return 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 in a given (e.g., clamped) area of the tissue via one or more subcircuits to determine the phase and magnitude of the impedance of the tissue within the jaws 182 / 184. The processor 602 can then forward information associated with the tissue, such as, for example, tissue type, tissue phase, tissue edges, etc. Using this associated information, the system can not only verify that the correct tissue is clamped between the jaws 182 / 184, but can also determine whether there is any non-tissue material between the jaws, and / or whether a correct seal has been formed after applying the therapeutic RF.
[0071] Fig.14 An exemplary impedance triangle 1401 is shown. As will be appreciated by one skilled in the art, human tissue may tend to be capacitive in nature, while wires, tools, staples, implants, etc. may tend to be inductive in nature. Therefore, as can be seen by the exemplary impedance triangle 1401, the waveform and sensor 1200 are used to measure 1402 the "resistance" of each object in the circuit. The system may also determine the "capacitive reactance" of each object in the circuit 1403 and the inductive reactance of each object in the circuit 1404. As discussed above, and in Fig.14 As clearly shown in FIG. 1 , the transmit and receive electrodes (e.g., electrodes on electrode surfaces 194, 196), the transmit and receive handle wires (e.g., 610 and 620), the handle connector (e.g., 1301), and the transmit and receive wires (e.g., included in the power cable 10) all have an inductive reactance 1404. In addition, the transmit and receive electrodes (e.g., 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. The "reactance" 1405 can then be calculated by determining the difference between the capacitive reactance and the inductive reactance using the following formula:
[0072] Equation 2: X = ∑(X L -X C ).
[0073] like Fig.14 As shown, the "impedance" 1406 can then be determined using the following formula:
[0074] Equation 3:
[0075] Fig.15A set of illustrative example waveforms are shown. As will be appreciated by those skilled in the art, if the circuit contains only resistive terms, the current and voltage will remain in phase, such as shown in graph 1501 and phasor diagram 1504. Alternatively, if the circuit has capacitive objects, or objects that are more capacitive than inductive, the voltage wave will cause a current wave, such as shown in graph 1502 and phasor diagram 1505. Finally, if the circuit has inductive objects, or objects that are more inductive than capacitive, the voltage will lag the current, such as shown in graph 1503 and phasor diagram 1506.
[0076] As discussed herein, the system may pass a non-therapeutic waveform through a portion of the patient's tissue to help identify the type of tissue and any foreign objects. Thus, in some versions, the system may deliver waveforms of varying frequencies (e.g., in series and / or in parallel) to improve the accuracy of the determination. Thus, in some versions, and as Fig.16 As shown, multiple waveforms of various frequencies may be added or summed together 1610 to produce a multi-sine waveform 1650. By way of non-limiting example, a 10 kHz sine wave 1601 may be combined with a 100 kHz sine wave 1602, a 330 kHz sine wave 1603 and a 1 MHz sine wave 1604 may be combined to produce a multi-sine wave 1650.
[0077] Reference now Fig.17 , the multi-sine waveform 1650 may be sampled or windowed 1701. In some versions, such as those requiring the use of a Fast Fourier Transform (FFT), the windowing or sampling may be as small as a single cycle of the lower frequency waveform. As shown in graph 1702, the voltage of the multi-sine waveform leads the current and is therefore indicative of a capacitive circuit (e.g., possibly tissue). In an alternative version, the system may apply a series of burst waveforms having different frequencies.
[0078] Reference now Fig.18 , a burst waveform including brief delays between frequencies is shown in graph 1801. In some versions, and as shown, the system may output a burst waveform that is a sine wave, while in other versions the wave may be a square, triangle, ramp, pulse, pseudo-random binary sequence (PRBS), or arbitrary waveform. In some versions, the pause between waveforms may be evaluated to determine a "bounce" time. The rebound time may be used to help identify tissue types by evaluating how long certain tissues take to allow the waveform and any residual energy to dissipate from the tissue.
[0079] Fig.19Various alternative burst types are shown. Specifically, in one type, amplitude modulation (AM) 1901 may be used; and in another type, frequency modulation (FM) 1902. Other types may use phase modulation (PM) 1903 and / or frequency shift keying (FSK) modulation 1904. Fig.19 All of the modulation options shown involve some type of shifting, so they can all be evaluated in a similar manner.
[0080] In another version, a "chirp" function may be used, such as Fig. 20 As will be appreciated by those skilled in the art, a chirp wave can be "chirped up" (i.e., increasing in frequency) or "chirped down" (i.e., decreasing in frequency). Thus, in other words, the chirp function is essentially an advanced form of FM 1902. The chirp function shown in graph 2001 shows a chirp waveform with increasing frequencies (e.g., 10 kHz, 13.2 kHz, 19.3 kHz, 26.8 kHz, and 1 Mhz). Fig.21 Shows that with Fig. 20 A chirp function of the same frequency but with reduced amplitude 2101 is shown.
[0081] IV. Waveform Analysis
[0082] The following discussion provides illustrative examples of how the processor 602 may process feedback signals received from 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 the jaws 182 / 184, the processor 602 may alert the user (e.g., via a visual indicator on the electrosurgical instrument 100, a visual indicator in a display device, an audible notification, a tactile notification, etc.) and / or lock the ability to apply RF voltage to the end effector 180.
[0083] As discussed herein, a Fast Fourier Transform (FFT) can be one method of analyzing a waveform to determine phase and / or impedance. As will be appreciated by those skilled in the art, the FFT function can map a time domain function into a frequency domain representation. In general, the FFT is derived from the Fourier transform equation, which is:
[0084] Equation 4:
[0085] Where x(t) is the time domain signal, X(f) is the FFT, and ft is the frequency to be analyzed. Once the waveform or waveforms have been transformed into the frequency domain, the system can evaluate and determine the frequency, impedance, and / or phase angle based on known characteristics. For example, Fig. 22Two graphs are shown, including one graph 2201 that plots frequency versus impedance and one graph 2202 that plots frequency versus phase angle. As can be seen in graphs 2201 and 2202, various tissue types (e.g., body fluids, blood vessels, tendons, intestines, and fat) each have different values based on the applied frequency. In some versions, trends may become apparent in the data. Therefore, in some versions, the system may include an artificial intelligence module that can train on a data set and learn how to adapt and predict the type of tissue based on frequency and its associated impedance and / or phase angle. In other versions, the tissue type may simply be a value that is referenced and / or searched (e.g., a database) and is associated with the sensed information (e.g., the voltage and current sensed by sensor 1200).
[0086] In another version, the system can use cross-correlation to measure the time delay of one waveform relative to another waveform and can be generally expressed as:
[0087] Equation 5:
[0088] Where x(t) and y(t) are two waveforms as functions of time, where τ is the time delay, and where R is the cross-correlation, which is a function of the time delay τ. Unlike the FFT method, the cross-correlation occurs in the time domain, so no transform is required.
[0089] like Fig.23 As best shown in , the cross-correlation evaluates the time delay or shift (e.g., lead or lag) of the two waveforms, such as shown in graph 2301. As will be appreciated by those skilled in the art, when the time delay τ is equal to zero and the waveforms are aligned on the time axis, the cross-correlation graph (such as 2302) reaches its maximum height or peak. Therefore, 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 with reference to Fig.14 and Fig.15 Once the system knows whether the voltage waveform lags or leads the current waveform, the system can determine whether the clamped material is capacitive in nature (e.g., tissue) or inductive in nature (e.g., non-tissue). In another version, the system can track and evaluate changes in the time delay τ over time to determine the specific type of tissue.
[0090] The cross-correlation method is a very robust, but somewhat time intensive method. Therefore, in some versions (eg, where speed is evaluated over accuracy), the system may use a zero-crossing method. Fig.24An example waveform is shown in graph 2411. In some versions, and as shown, the system may monitor input voltage 2411 for any zero crossings (i.e., points when the alternating waveform crosses zero value 2401 and no voltage is present). Due to the simple nature of the method, the method may be implemented using minimal components (e.g., a single high speed comparator 2402). As will be appreciated by those skilled in the art, zero crossings typically occur twice during each cycle. Thus, by tracking the timing of zero crossings of two or more waveforms (e.g., transmit waveform 610 and receive waveform 620), the system can roughly determine how out of phase the waveforms are, and whether the return signal is leading or lagging, such as Fig.15 Based on how the waveforms are out of phase (ie, the phase angle shown at 2202 ), the system can determine one or more characteristics about the material clamped in the end effector 180 .
[0091] Another method of analyzing a waveform to determine phase and / or impedance may include a pseudo-inverse matrix Fourier (PIMF) series reconstruction. Spectral analysis using an FFT may not necessarily exploit known information. For example, when a system is excited with a voltage at a particular frequency, spectral analysis of the current through the system (and thereby calculating impedance) using an FFT does not exploit the fact that the frequency content of the current (although at a different phase and magnitude) will be the same as the frequency content of the transmitted voltage signal (which is known because it is transmitted). The FFT searches to estimate the phase and magnitude of the current at every single frequency in the frequency resolution of the FFT. However, in some systems, only the frequencies transmitted in the voltage need to be analyzed.
[0092] Using the FFT, the frequency in radians per second (w), phase (phi), and magnitude (A) of the signal are calculated so that the time domain signal F(t) can be reconstructed as closely as possible using the Fourier sequence, as follows:
[0093] Equation 6:
[0094] Where A0 is the DC offset of the signal.
[0095] Equation 6 can be expressed as follows:
[0096] Equation 7:
[0097] In this process, it is assumed that the frequency content of the signal w n is unknown. However, if we assume that w n is known (such as when the current w n Value and known input voltage w n values), then if f(t) is known when working in the digital domain, it is possible to calculate a n and bn , where f(t) is given by f(k i ), where i = 0 at time zero and i = t at time t, where (i is an element of a positive integer). The signal f(t) now becomes:
[0098] Equation 8:
[0099] When the rows of the column vector correspond to the following f(t)@k i Equation 7 can be used to define the following relationship, which is valid for all i∈{0,tf} and p represents the discrete frequency of the input signal:
[0100] Equation 9:
[0101]
[0102] The notation in Equation 9 can be simplified as follows:
[0103] Equation 10:
[0104] in:
[0105] Equation 11:
[0106] as well as:
[0107] Equation 12:
[0108] are respectively known vectors (measured) and matrices (from known w n calculate). Now we can solve it as follows:
[0109] Equation 13:
[0110] Among them A + is the pseudo-inverse of A for a matrix with linearly independent columns and is:
[0111] Equation 14: A + =(A T A) -1 ·A T
[0112] because
[0113] Equation 15:
[0114] Now the known signal f(k i ) and the known frequency w nis a function of , and can therefore be solved for all values of i∈{0,tf} and n. Once Equation 13 is solved for each value of n, A can be calculated from the trigonometric identities n and phi n The corresponding value of:
[0115] Equation 16:
[0116] as well as
[0117] Equation 17:
[0118] The following table shows an example of a comparison of a set of results that can be obtained using the PIMF method described above and the FFT method:
[0119] surface
[0120]
[0121] Fig.25 A graphical representation of impedance magnitude 2510 and phase angle 2520 of a waveform applied to tissue as a function of time is shown. In some versions, and as shown, the system may make specific determinations about a surgical procedure based on impedance and phase. As a non-limiting example, graph 2510 shows the impedance of the tissue dropping significantly during clamping, which is shown in time period 2511. When the tissue is clamped as shown in time period 2512, the impedance remains relatively stable. During this time period 2512, the difference in the unique features of the impedance spectrum and the phase angle spectrum can indicate the properties of the tissue and the tissue response under compression (e.g., fluid leaving the tissue under strain). The therapeutic waveform is applied during the time period 2513. During this time period 2513, the distal electrode is switched to therapeutic energy delivery (e.g., to seal or cauterize tissue), and the signal can be sensed by the high voltage and current therapeutic sensor. Therefore, during this time period 2513 of therapeutic energy delivery, the sensed signal at the distal electrode can be inactive, which can be manifested as the rapid fluctuations shown in the graphical representation of impedance magnitude 2510. The therapeutic energy delivery eventually stops, as shown in period 2514, where the impedance changes accordingly. Impedance can also be used to detect when the knife member 176 is fired, which is represented in period 2515.
[0122] Finally, after the procedure is complete, the end effector 180 releases the tissue, which is represented in time period 2516. The phase angle graph 2520 provides a clear indication 2521 of when the treatment energy is applied, followed by a time delay 2522 where the tissue is at rest before release. As discussed herein, the "rebound" time (i.e., how long certain tissues take to allow the waveform and any residual energy to dissipate from the tissue) can be used for tissue identification. Therefore, by using data from one or both of the two graphs 2510, 2520, it is possible to determine the rebound time and thus improve tissue identification.
[0123] Fig.26 Various graphs are shown that plot impedance magnitude and jaw gap versus time. First graph 2610 shows sensing prior to application of any therapeutic waveform (e.g., pre-sealing). Line 2611 shows the distance between jaws 182, 184. Thus, as discussed herein, and as shown in graph 2610, the impedance of the tissue decreases as it is clamped (i.e., as the distance between the jaws decreases). Second graph 2620 shows an example waveform during sealing. Similar to graph 2610, graph 2620 also shows jaw gap 2621. In some versions, and as shown in graph 2620, during application of therapeutic energy 2622, the impedance of the tissue decreases and the distance between jaws 182, 184 decreases. Finally, graph 2630 shows the recorded impedance of the sealed tissue and jaw gap 2631.
[0124] V. Combination Embodiments
[0125] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. The following examples are not intended to limit the coverage of any claims that may be proposed at any time in this patent application or in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise explicitly indicated by the inventor or the successor with an interest in the inventor at a later date. If any claim proposed in this patent application or in the subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.
[0126] Example 1
[0127] A device for detecting and sealing tissue, the device comprising: (a) a processor; (b) an end effector at a distal end of a surgical instrument, the end effector being configured to interact with tissue of a patient, the end effector comprising: (i) a first jaw, the first jaw comprising a first electrode surface fixed relative to the first jaw; and (ii) a second jaw, the second jaw being pivotally coupled to the first jaw, the second jaw comprising a second electrode surface fixed relative to the second jaw, wherein the first electrode surface and the second electrode surface comprise a plurality of electrodes; (c) wherein the processor is configured to: (i) control delivery of a non-therapeutic radio frequency (RF) signal to and measurement of the non-therapeutic radio frequency (RF) signal to the plurality of electrodes, wherein the plurality of electrodes are configured to contact the tissue of the patient; (ii) determine at least one characteristic of the tissue of the patient based on the non-therapeutic RF signal; (iii) determine that the plurality of electrodes are in contact with an expected tissue type based on the at least one characteristic; and (iv) in response to determining that the plurality of electrodes are in contact with the expected tissue type, control delivery of a therapeutic RF signal to the plurality of electrodes.
[0128] Example 2
[0129] According to the device described in Example 1, the first jaw also includes a first knife passage, and the second jaw also includes a second knife passage, and the first knife passage and the second knife passage are together configured to accommodate the translation of the knife member through a portion of the end actuator.
[0130] Example 3
[0131] Embodiment 2 The apparatus of any one of embodiments 1 to 2, wherein the electrodes have a bifurcated configuration, wherein the electrodes are movable relative to each other about a central axis.
[0132] Example 4
[0133] According to the device of any one of embodiments 1 to 3, the device also includes a switching system, and the switching system is configured to be able to switch between the non-therapeutic RF signal and the therapeutic RF signal.
[0134] Example 5
[0135] According to the device described in any one of embodiments 1 to 4, the device also includes: (a) a voltage sensor device; and (b) a current sensor device; wherein the processor is further configured to be able to: (i) obtain a transmit voltage and a return voltage for the RF signal from the voltage sensor device, and (ii) obtain a transmit current and a return current for the RF signal from the current sensor device, wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current and the return current.
[0136] Example 6
[0137] The apparatus of embodiment 5, wherein the processor is further configured to be capable of: (i) determining a capacitive reactance of the circuit based on the transmit voltage and the return voltage, and (ii) determining an inductive reactance of the circuit based on the transmit voltage and the return voltage, wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current, and the return current.
[0138] Example 7
[0139] The apparatus of embodiment 6, wherein the processor is further configured to be capable of: determining an impedance of the circuit based on the capacitive reactance and the inductive reactance, wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current, and the return current.
[0140] Example 8
[0141] An apparatus as in any one of embodiments 1 to 7, wherein the RF signal comprises a plurality of waveforms summed into a multi-waveform, wherein each of the plurality of waveforms has a unique frequency.
[0142] Example 9
[0143] The apparatus according to any one of embodiments 1 to 8, wherein the RF signal comprises a multi-burst waveform having single or multiple different periods, amplitudes or wave shapes.
[0144] Example 10
[0145] An apparatus according to any one of embodiments 1 to 9, wherein the RF signal includes at least one of the following items: (A) an amplitude modulated signal, (B) a frequency modulated signal, (C) a phase modulated signal, (D) a frequency shift keying modulated signal, or (E) a chirped waveform.
[0146] Embodiment 11
[0147] The apparatus of any one of embodiments 1 to 10, wherein the processor is further configured to be capable of performing a fast Fourier transform (FFT) on the RF signal, and wherein the at least one characteristic is based on the FFT.
[0148] Example 12
[0149] The apparatus of any one of embodiments 1 to 11, wherein the processor is further configured to be capable of performing a cross-correlation analysis on the RF signal, wherein the at least one characteristic is based on the cross-correlation analysis.
[0150] Example 13
[0151] The apparatus of any one of embodiments 1 to 12, wherein the processor is further configured to be capable of performing a zero-crossing analysis on the RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
[0152] Embodiment 14
[0153] The apparatus of any one of embodiments 1 to 13, wherein the processor is further configured to be capable of performing a pseudo-inverse matrix Fourier (PIMF) analysis on the RF signal, wherein the at least one characteristic is based on the PIMF analysis.
[0154] Embodiment 15
[0155] A device according to any one of embodiments 1 to 14, wherein the processor is further configured to be capable of performing an action selected from the group consisting of: (i) prohibiting delivery of therapeutic RF signals to the plurality of electrodes, (ii) providing a notification to a user, and (iii) modifying the surgical plan in response to determining that the plurality of electrodes are not in contact with the expected tissue type.
[0156] Example 16
[0157] A method for detecting and sealing tissue, the method comprising: (a) clamping tissue of a patient between a first jaw and a second jaw of an end effector, wherein the first jaw includes a first electrode surface and the second jaw includes a second electrode surface; (b) using a processor to control the delivery of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes and the measurement of the non-therapeutic radio frequency (RF) signal, wherein the plurality of electrodes are 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 that the plurality of electrodes are in contact with an expected tissue type based on the at least one characteristic; and (e) in response to determining that the plurality of electrodes are in contact with the expected tissue type, controlling the delivery of a therapeutic RF signal to the plurality of electrodes.
[0158] Embodiment 17
[0159] According to the method described in Example 16, the method also includes: (a) obtaining a transmit voltage and a return voltage for the RF signal from a voltage sensor device; (b) obtaining a transmit current and a return current for the RF signal from a current sensor device; (c) determining the capacitive reactance of the circuit based on the transmit voltage and the return voltage; and (d) determining the inductive reactance of the circuit based on the transmit voltage and the return voltage; wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current and the return current.
[0160] Embodiment 18
[0161] A method according to any one of embodiments 16 to 17, wherein the RF signal includes at least one of the following items: (i) an amplitude modulated signal, (ii) a frequency modulated signal, (iii) a phase modulated signal, or (iii) a frequency shift keying modulated signal.
[0162] Embodiment 19
[0163] A method according to any one of embodiments 16 to 18, wherein the processor also performs at least one of the following items: (i) a fast Fourier transform (FFT) of the RF signal, wherein the at least one characteristic is based on the FFT; (ii) a cross-correlation analysis of the RF signal, wherein the at least one characteristic is based on the cross-correlation analysis; or (iii) a zero-crossing analysis of the RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
[0164] Embodiment 20
[0165] A system comprising: (a) a waveform generator; and (b) an electrosurgical device, the electrosurgical device comprising: (i) a processor, (ii) a surgical instrument having a distal end with an end effector, the end effector being configured to interact with tissue of a patient, the end effector comprising: (A) a first jaw, the first jaw comprising a first electrode, and (B) a second jaw, the second jaw pivotally coupled to the first jaw, the second jaw comprising a second electrode; wherein the processor is configured to: (A) control delivery of a non-therapeutic radio frequency (RF) signal to and measurement of the non-therapeutic radio frequency (RF) signal generated by the waveform generator, (B) determine at least one characteristic of the tissue of the patient based on the non-therapeutic RF signal, (C) determine that the first electrode and the second electrode are in contact with an expected tissue type based on the at least one characteristic, and (D) in response to determining that the first electrode and the second electrode are in contact with the expected tissue type, control delivery of a therapeutic RF signal to the tissue via the first electrode and the second electrode.
[0166] VI. Miscellaneous
[0167] It should be understood that any type of apparatus described herein may also include various other features in addition to or as an alternative to those described above. By way of example only, any device herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference. Various suitable ways in which such teachings may be combined will be apparent to those of ordinary skill in the art.
[0168] Although the examples herein are described primarily in the context of electrosurgical instruments, it should be understood that the various teachings herein can be readily applied to a variety of other types of devices. By way of example only, the various teachings herein can be readily applied to other types of electrosurgical instruments, tissue graspers, tissue recovery capsule configuration instruments, surgical staplers, surgical clip appliers, ultrasonic surgical instruments, and the like. It should also be understood that the teachings herein can be readily applied to any of the instruments described in any of the references cited herein, such that the teachings herein can be readily combined with the teachings of any of the references cited herein in a variety of ways. Other types of instruments that can be combined with the teachings herein will be apparent to those of ordinary skill in the art.
[0169] It should be 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 above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art based on the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0170] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions or other public materials described in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein but conflicting with existing definitions or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.
[0171] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM Similarly, one of ordinary skill in the art will recognize that the various teachings herein may be readily combined with the various teachings of U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” issued Aug. 31, 2004, the disclosure of which is incorporated herein by reference in its entirety.
[0172] The patterns described above can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case or both, these patterns can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some patterns of the device can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some patterns of the device can be reassembled at a repair facility or reassembled by the operator before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.
[0173] By way of example only, the types described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0174] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.
Claims
1. A device for detecting and sealing tissue, the device comprising: (a) processor; (b) an end effector at a distal end of the surgical instrument, the end effector being configured to interact with tissue of a patient, the end effector comprising: (i) a first jaw comprising a first electrode surface fixed relative to the first jaw, and (ii) a second jaw pivotally coupled to the first jaw, the second jaw comprising a second electrode surface fixed relative to the second jaw, wherein the first electrode surface and the second electrode surface comprise a plurality of electrodes; (c) wherein the processor is configured to: (i) controlling the delivery of non-therapeutic radio frequency (RF) signals to the plurality of electrodes and measuring the non-therapeutic radio frequency (RF) signals, wherein the plurality of electrodes are configured to be in contact with the tissue of the patient; (ii) determining at least one characteristic of the tissue of the patient based on the non-therapeutic RF signal; (iii) determining that the plurality of electrodes are in contact with an expected tissue type based on the at least one characteristic; (iv) in response to determining that the plurality of electrodes are in contact with the expected tissue type, controlling delivery of therapeutic RF signals to the plurality of electrodes.
2. The device according to claim 1, the first jaw further includes a first knife passage, and the second jaw further includes a second knife passage, and the first knife passage and the second knife passage are together configured to accommodate translation of a knife member through a portion of the end actuator.
3. The device according to claim 1 or claim 2, wherein: The electrodes have a bifurcated configuration, wherein the electrodes are movable relative to each other with respect to a central axis.
4. The apparatus according to any one of claims 1 to 3, further comprising a switching system configured to be able to switch between the non-therapeutic RF signal and the therapeutic RF signal.
5. The apparatus according to any preceding claim, further comprising: (a) Voltage sensor device; and (b) current sensor device; Wherein, the processor is further configured to: (i) obtaining a transmission voltage and a return voltage for the RF signal from the voltage sensor device, and (ii) obtaining a transmission current and a return current for the RF signal from the current sensor device, Wherein, the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current and the return current.
6. The device according to claim 5, wherein: The processor is further configured to: (i) determining a capacitive reactance of a circuit based on the transmit voltage and the return voltage, and (ii) determining the inductive reactance of the circuit based on the send voltage and the return voltage, Wherein, the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current and the return current.
7. The device according to claim 6, wherein: The processor is further configured to be capable of determining an impedance of the circuit based on the capacitive reactance and the inductive reactance, wherein the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current, and the return current.
8. Apparatus according to any preceding claim, wherein: The RF signal includes a plurality of waveforms summed into a multi-waveform, wherein each of the plurality of waveforms has a unique frequency.
9. Apparatus according to any preceding claim, wherein: The RF signal includes a multi-burst waveform having single or multiple different periods, amplitudes or wave shapes.
10. Apparatus according to any preceding claim, wherein: The RF signal includes at least one of the following: (A) Amplitude modulated signal, (B) Frequency modulated signal, (C) Phase modulated signal, (D) a frequency shift keying modulated signal, or (E) Chirp waveform.
11. Apparatus according to any preceding claim, wherein: The processor is further configured to perform a Fast Fourier Transform (FFT) on the RF signal, and wherein the at least one characteristic is based on the FFT.
12. Apparatus according to any preceding claim, wherein: The processor is further configured to perform a cross-correlation analysis on the RF signal, wherein the at least one characteristic is based on the cross-correlation analysis.
13. Apparatus according to any preceding claim, wherein: The processor is further configured to perform a zero-crossing analysis on the RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
14. Apparatus according to any preceding claim, wherein: The processor is further configured to perform a pseudo-inverse matrix Fourier (PIMF) analysis on the RF signal, wherein the at least one characteristic is based on the PIMF analysis.
15. Apparatus according to any preceding claim, wherein: The processor is further configured to, in response to determining that the plurality of electrodes are not in contact with the expected tissue type, perform an action selected from the group consisting of: (i) inhibiting delivery of therapeutic RF signals to the plurality of electrodes, (ii) provide notice to users, and (iii) Modification of surgical plan.
16. A method for detecting and sealing tissue, the method comprising: (a) clamping tissue of a patient between a first jaw and a second jaw of an end effector, wherein the first jaw includes a first electrode surface and the second jaw includes a second electrode surface; (b) using a processor to control the delivery of and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes, wherein the plurality of electrodes are in contact with tissue of the patient; (c) determining at least one characteristic of the tissue of the patient based on the non-therapeutic RF signal; (d) determining that the plurality of electrodes are in contact with an expected tissue type based on the at least one characteristic; and (e) in response to determining that the plurality of electrodes are in contact with the expected tissue type, controlling delivery of therapeutic RF signals to the plurality of electrodes.
17. The method according to claim 16, further comprising: (a) obtaining a transmission voltage and a return voltage for the RF signal from a voltage sensor device; (b) obtaining a transmission current and a return current for 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; as well as (d) determining an inductive reactance of the circuit based on the transmit voltage and the return voltage; Wherein, the at least one characteristic is based on the transmit voltage, the return voltage, the transmit current and the return current.
18. The method according to claim 16 or claim 17, wherein: The RF signal includes at least one of the following: (i) Amplitude modulated signal, (ii) frequency modulated signal, (iii) a phase modulated signal, or (iv) Frequency shift keying modulated signal.
19. The method according to any one of claims 16 to 18, wherein: The processor also performs at least one of the following: (i) a fast Fourier transform (FFT) of the RF signal, wherein the at least one characteristic is based on the FFT, (ii) a cross-correlation analysis of the RF signal, wherein the at least one characteristic is based on the cross-correlation analysis, or (iii) a zero-crossing analysis of the RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
20. A system, comprising: (a) Waveform generator; and (b) an electrosurgical device, the electrosurgical device comprising: (i) processor, (ii) a surgical instrument having a distal end with an end effector, the end effector being configured to interact with tissue of a patient, 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; Wherein, the processor is configured to: (A) controlling the delivery of a non-therapeutic radio frequency (RF) signal to the first electrode and the second electrode and measuring the non-therapeutic radio frequency (RF) signal, 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 an expected tissue type based on the at least one characteristic, and (D) In response to determining that the first electrode and the second electrode are in contact with the expected tissue type, controlling delivery of a therapeutic RF signal to tissue via the first electrode and the second electrode.
Citation Information
Patent Citations
Electrosurgical systems and techniques for sealing tissue
US6500176B1
Robotic surgical tool with ultrasound cauterizing and cutting instrument
US6783524B2
Surgical instrument with jaw member
US8888809B2
Surgical instrument comprising first and second drive systems actuatable by a common trigger mechanism
US8939974B2
Surgical generator for ultrasonic and electrosurgical devices
US8986302B2