Tissue sensing circuitry for surgical instruments

Abstract

A surgical instrument includes an end effector having first and second jaws that cooperate to grip an in vivo material of a patient, and a first electrode that delivers an electrical signal to the in vivo material. The instrument also includes a second electrode that receives the electrical signal from the first electrode, and circuitry housed within the end effector. The circuit includes a microcontroller that controls delivery of the electrical signal to the first electrode, wherein the electrical signal is delivered through the in vivo material to the second electrode. The circuitry also determines an electrical impedance of the in vivo material, and determines at least one of the presence or absence of tissue in the in vivo material or a characteristic of tissue in the in vivo material.

Description

Background Art

[0001] In some surgical environments, endoscopic surgical instruments may be superior to traditional open surgical devices in order to make smaller incisions in the patient's body, which can reduce postoperative recovery time and complications. Some endoscopic surgical instruments may be suitable for placing the distal end effector at the desired surgical site through the cannula of a trocar. These distal end effectors (e.g., internal cutters, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasound, RF, lasers, etc.) can engage tissue in a variety of ways to achieve diagnostic or therapeutic effects. Endoscopic surgical instruments may include a shaft between the end effector and the handle portion manipulated by the clinician. Such a shaft can be inserted into the desired depth and rotated around the longitudinal axis of the shaft, thereby facilitating the positioning of the end effector in the patient's body. The end effector may also be further facilitated by including one or more articulation joints or features so that the end effector can selectively perform articulation or otherwise deflect relative to the longitudinal axis of the shaft.

[0002] The example of endoscopic surgical instrument comprises surgical stapler.Some such staplers are operable to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the severed tissue layers together near the severed ends of the tissue layers. Merely exemplary surgical staplers are disclosed in U.S. Patent No. 7,380,696, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism,” issued on June 3, 2008; U.S. Patent No. 8,408,439, entitled “Surgical Stapling Instrument with An Articulatable End Effector,” issued on April 2, 2013; U.S. Patent No. 8,453,914, entitled “Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly,” issued on June 4, 2013; and U.S. Patent No. 11,241,269, entitled “Surgical Devices Switchable Between Monopolar Functionality and Bipolar Functionality,” issued on February 8, 2022. The disclosures of each of the above-referenced U.S. patents and U.S. patent publications are incorporated herein by reference.

[0003] Other endoscopic surgical instruments may include a tissue cutting element and one or more elements that transmit energy to tissue (e.g., to cohere or seal the tissue). Examples of such electrosurgical instruments are the Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. 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 Tissu e,” 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; and U.S. Patent No. 8,888,809, entitled “Motor Driven Electrosurgical Device with Mechanical and Electrical Feedback”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent 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; U.S. Patent No. 9,545,253, entitled “Surgical Instrument with Contained DualHelix Actuator Assembly,” issued on 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 on December 27, 2016, the disclosure of which is incorporated herein by reference in its entirety.

[0004] 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

[0005] While this specification results in claims that particularly point out and distinctly claim this technology, it is believed that this technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate like elements, and wherein:

[0006] Figure 1 depicts a perspective view of an exemplary articulating surgical stapling instrument;

[0007] Figure 2 Depicts Figure 1 A side view of the device;

[0008] Figure 3 Depicts Figure 1 A perspective view of an open end effector in an instrument;

[0009] Figure 4A Depicts Figure 3 The end effector along Figure 3 a side cross-sectional view taken along line 4-4 of FIG. 1 , wherein the firing beam of the end effector is in a proximal position;

[0010] Figure 4B Depicts Figure 3 The end effector along Figure 3 a side cross-sectional view taken along line 4-4 of FIG. 1 , wherein the firing beam is in a distal position;

[0011] Figure 5 Depicts the Figure 3 The line 5-5 is intercepted Figure 3 An end cross-sectional view of an end effector;

[0012] Figure 6 Depicts Figure 3 An exploded perspective view of an end effector;

[0013] Figure 7 Depicts Figure 3 a perspective view of an end effector positioned at tissue and having been actuated once in the tissue;

[0014] Figure 8 Depicts a device having a Figure 1 A top elevational view of another exemplary end effector jaw of an electrode array for use with a surgical stapling instrument;

[0015] Figure 9 Depicts a device having a Figure 1 A perspective view of another exemplary end effector of an electrode array for use with a surgical stapling instrument;

[0016] Figure 10A Depicts a device having a Figure 1 A perspective view of a portion of another exemplary end effector of an electrode array for use with a surgical stapling instrument;

[0017] Figure 10B Describes a Figure 10A A perspective view of a staple cartridge used in conjunction with an end effector portion;

[0018] Figure 10C Depicts the combination Figure 10A The end effector portion and Figure 10B A side elevation view of another exemplary end effector of a staple cartridge;

[0019] Figure 11A Depicts a device having a Figure 1 A perspective view of another exemplary end effector of an electrode array for use with a surgical stapling instrument;

[0020] Figure 11B Depicts a device having a Figure 1 A perspective view of another exemplary end effector of an electrode array for use with a surgical stapling instrument;

[0021] Figure 12 Depicts a device having a Figure 1 A perspective view of an illustrative wireless end effector with an electrode array for use with a surgical stapling instrument;

[0022] Figure 13 Depicts a device having a Figure 1 A partial perspective view of another exemplary end effector of an electrode array for use with a surgical stapling instrument;

[0023] Figure 14 Describes a Figure 1 A diagrammatic view of an exemplary microcontroller for use with a surgical stapling instrument;

[0024] Figure 15A A microcontroller is depicted and configured to communicate with Figure 1 A perspective view of an exemplary end effector jaw for use with a surgical stapling instrument;

[0025] Figure 15B A microcontroller is depicted and configured to communicate with Figure 1 A perspective view of an exemplary staple cartridge for use with a surgical stapling instrument;

[0026] Figure 16 depicts a diagrammatic view of an illustrative example impedance triangle;

[0027] Figure 17 Depicted by Figure 1 a diagrammatic representation of a set of illustrative example waveforms generated and measured by a surgical stapling instrument; and

[0028] Figure 18A flow chart depicts an illustrative method of utilizing tissue sensing circuitry to determine the presence and type of tissue placed in contact with an electrode.

[0029] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out 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 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

[0030] 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 provided by way of example, which is one of the best modes contemplated for implementing the present technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0031] It should also 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 following teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Based on 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.

[0032] 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 of an element closer to the surgeon or other operator, and the term "distal" refers to a position of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0033] I. Exemplary Surgical Stapler

[0034] Figures 1 to 7 An example of a surgical stapling and severing instrument (10) is depicted, Figure 11 and 2. The instrument (10) of this example is sized to be inserted through a trocar cannula, thoracotomy or other incision into a surgical site of a patient to perform a surgical procedure. The instrument (10) of this example includes a handle portion (20) connected to a shaft (22). The shaft (22) terminates distally in an articulation joint (11), which is further coupled to an end effector (12). It should be understood that terms such as "proximal" and "distal" used herein refer to the handle portion (20) of the instrument (10) that the clinician grasps. Therefore, the end effector (12) is located distally relative to the more proximal handle portion (20).

[0035] Once the articulation joint (11) and the end effector (12) are inserted into the patient, the articulation joint (11) can be remotely articulated via the articulation control (13), such as Figure 1 , so that the end effector (12) can be deflected from the longitudinal axis (LA) of the shaft (22) by a desired angle (α). By way of example only, the articulation joint (11) and / or articulation control (13) may be constructed and operable in accordance with at least some of the teachings of the following U.S. Patents: U.S. Patent No. 9,186,142, filed on November 17, 2015, entitled "Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks," the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 9,795,379, issued on October 24, 2017, entitled "Surgical Instrument with Multi-Diameter Shaft," the disclosure of which is incorporated herein by reference in its entirety. Various other suitable forms that the articulation joint (11) and articulation control (13) may take will be apparent to those skilled in the art in light of the teachings herein.

[0036] The end effector (12) of this example includes a lower jaw (16) and an upper jaw in the form of a pivotable anvil (18). By way of example only, the lower jaw (16) may be constructed and operated according to at least some of the teachings of the following U.S. Patent No. 9,808,248, entitled "Installation Features for Surgical Instrument End Effector Cartridge," issued on November 7, 2017, the disclosure of which is incorporated herein by reference in its entirety. The anvil (18) may be constructed and operated according to at least some of the teachings of U.S. Patent No. 10,092,292, entitled "Staple Forming Features for Surgical Stapling Instrument," issued on October 9, 2018, the disclosure of which is incorporated herein by reference in its entirety. Various other suitable forms that the lower jaw (16) and anvil (18) may take will be apparent to those skilled in the art in light of the teachings herein.

[0037] The handle portion (20) includes a pistol grip (24) and a closure trigger (26). The closure trigger (26) is capable of pivoting toward the pistol grip (24) so that the anvil (18) is clamped or closed toward the lower jaw (16) of the end effector (12). Such closure of the anvil (18) is provided by a closure tube (32) and a closure ring (33), both of which translate longitudinally relative to the handle portion (20) in response to pivoting of the closure trigger (26) relative to the pistol grip (24). The closure tube (32) extends along the length of the shaft (22); and the closure ring (33) is positioned distally of the articulation joint (11). The articulation joint (11) is operable to transmit longitudinal motion from the closure tube (32) to the closure ring (33).

[0038] The handle portion (20) also includes a firing trigger (28). An elongated member (not shown) extends longitudinally through the shaft (22) and, in response to actuation of the firing trigger (28), transmits a longitudinal firing motion from the handle portion (20) to the firing beam (14), for example, via a motor (140) (not shown) housed within the handle portion (20). This distal translation of the firing beam (14) causes the tissue held in the end effector (12) to be sutured and severed, as will be described in more detail below. Thereafter, the triggers (26, 28) are released to release the tissue from the end effector (12).

[0039] like Figures 4A to 4BAs seen in FIG, the firing beam (14) of this example includes a transversely oriented upper pin (38), a firing beam cap (44), a transversely oriented middle pin (46), and a distally located cutting edge (48). The upper pin (38) is positioned within the longitudinal anvil slot (42) of the anvil (18) and is capable of translating within the longitudinal anvil slot. The firing beam cap (44) is positioned by extending the firing beam (14) through the lower jaw slot (45) ( Figure 4B 9,717,497, entitled "Lockout Feature for Movable Cutting Member of Surgical Instrument," issued on August 1, 2017, the disclosure of which is incorporated herein by reference in its entirety. Other suitable forms that the firing beam (14) may take will be apparent to those skilled in the art based on the teachings herein.

[0040] Figure 3 The present example is shown with the firing beam (14) positioned proximally and the anvil (18) pivoted to an open position, thereby allowing an unspent staple cartridge (37) to be removably installed into the channel of the lower jaw (16). Figures 5 and 6 As seen in FIG. 3 , the staple cartridge (37) of this example includes a cartridge body (70) exhibiting an upper platform (72) coupled to a lower cartridge tray (74). Figure 3 As seen in FIG. 1 , a vertical slot (49) is formed through a portion of the staple cartridge (37). Figure 3 As seen in FIG, three rows of nail holes (51) are formed through the upper platform (72) on one side of the vertical slot (49), and another set of three rows of nail holes (51) are formed through the upper platform (72) on the other side of the vertical slot (49). Of course, any other suitable number of nail rows may be provided (e.g., two rows, four rows, any other number). See again Figures 4A to 6, a wedge-shaped slide (41) and a plurality of nail drivers (43) are captured between the magazine body (70) and the tray (74), wherein the wedge-shaped slide (41) is located proximal to the nail driver (43) before the firing instrument (10) is fired to release the nail (47). The wedge-shaped slide (41) is capable of moving longitudinally within the nail magazine (37); and the nail driver (43) is capable of moving vertically within the nail magazine (37). The nails (47) are also positioned within the magazine body (70) above the corresponding nail driver (43). Specifically, each nail (47) is driven vertically by the nail driver (43) within the magazine body (70) to drive the nail (47) out through the associated nail hole (51). As shown Figures 4A to 4B and Figure 6 As seen in FIG, the wedge sled (41) has an inclined cam surface that pushes the staple drivers (43) upward as the wedge sled (41) is driven distally through the staple cartridge (37).

[0041] By way of example only, the staple cartridge (37) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent No. 9,517,065, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," issued on December 13, 2016, the disclosure of which is incorporated herein by reference in its entirety. Other suitable forms that the staple cartridge (37) may take will be apparent to those skilled in the art in view of the teachings herein.

[0042] By advancing the closure tube (32) and the closure ring (33) distally to allow the end effector (12) to Figures 4A to 4B In the closed position shown, the firing beam (14) is advanced into engagement with the anvil (18) by passing the upper pin (38) into the longitudinal anvil slot (42). Figure 5 (as shown) is located at the distal end of the firing beam (14) and is configured to engage the wedge slide (41) so that when the firing trigger (28) is actuated, the push block (80) pushes the wedge slide (41) distally as the firing beam (14) is advanced distally through the staple cartridge (37). During such firing, the cutting edge (48) of the firing beam (14) enters the vertical slot (49) of the staple cartridge (37), thereby severing the tissue clamped between the staple cartridge (37) and the anvil (18). Figures 4A to 4BAs shown, the middle pin (46) and the push block (80) together actuate the nail magazine (37) by entering the narrow slot (49) in the nail magazine (37) to drive the wedge slide (41) into upward contact with the nail driver (43), thereby driving the nail (47) outward through the nail hole (51) and causing the nail to engage with the nail forming recess (53) on the inner surface of the anvil (18) ( Figure 3 as shown) to form contact. Figure 4B The firing beam (14) is shown fully translated distally after severing and stapling the tissue. Figures 4A to 4B The nail forming recess (53) is intentionally omitted in the view in FIG; however, the nail forming recess (53) is as shown in FIG. Figure 3 It should also be understood that Figure 5 The anvil (18) is intentionally omitted from the view.

[0043] Figure 7 The end effector (12) is shown having been actuated through layers (92, 94) of tissue (90) in a single stroke. As shown, the cutting edge (48) ( Figure 7 1 and 2. The staples (47) are arranged in a scissor-like pattern, and the staple drivers (43) are arranged to cut through the tissue (90) while the staple drivers (43) drive three alternating rows of staples (47) through the tissue (90) on each side of the cutting line created by the cutting blades (48). In this example, the staples (47) are all oriented substantially parallel to the cutting line, but it should be understood that the staples (47) can be positioned in any suitable orientation. In this example, after the first stroke is completed, the end effector (12) is withdrawn from the trocar, the empty staple cartridge (37) is replaced with a new staple cartridge, and then the end effector (12) is reinserted through the trocar or incision to the suturing site for further cutting and suturing. This process can be repeated until the desired number of incisions and staples (47) has been provided. The anvil (18) may need to be closed to facilitate insertion and withdrawal through the trocar; and the anvil (18) may need to be opened to facilitate replacement of the staple cartridge (37).

[0044] In this version, the instrument (10) further includes an electric motor (not shown) housed within the handle portion (20) that provides motorized control of the firing beam (14). By way of example only, such motorization may be provided in accordance with at least some of the teachings of the following U.S. Patents: U.S. Patent No. 9,622,746, entitled "Distal Tip Features for End Effector of Surgical Instrument," published on April 18, 2017, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 8,210,411, entitled "Motor-Driven Surgical Instrument," published on July 3, 2012, the disclosure of which is incorporated herein by reference in its entirety. Other suitable components, features, and configurations for providing motorization of the firing beam (14) will be apparent to those skilled in the art in light of the teachings herein. It will also be appreciated that some other versions may provide for manual actuation of the firing beam (14) such that the motor may be omitted.

[0045] In a motorized version of the instrument (10), the instrument (10) may further include a manual return switch or "panic switch" (not shown) positioned on or within the handle portion (20), such as within or below a user-accessible panel or "panic door" (not shown), the panic switch being configured to enable an operator to quickly initiate proximal retraction of the firing beam (14) during the firing stroke. In other words, the panic switch may be manually actuated when the firing beam (14) is only partially advanced distally. Such a panic switch may provide additional functionality in accordance with at least some of the teachings of U.S. Patent No. 9,622,746, which is incorporated herein by reference.

[0046] The instrument (10) of this example also includes a display screen (117) on the exterior of the handle portion (20), such that the display screen (117) is readily visible to the user. The display screen (117) can be configured to provide the user with a visual indication of one or more states of the instrument (10), such as the remaining power level of the battery (142) (e.g., a removable battery pack) and / or various other conditions of the instrument (10).

[0047] II. End Effector Features for Measuring Tissue Electrical Impedance

[0048] In some cases, it may be desirable to configure the end effector (12) of the surgical stapling instrument (10) to be capable of sensing at least one of the presence (including its longitudinal position), absence, or characteristics of an in vivo material (such as patient tissue) positioned between the jaws (16, 18) during a surgical procedure. As used herein, the term "in vivo material" encompasses any biological or non-biological material that may be located within a patient's body cavity in which a surgical procedure is being performed with the instrument (10).

[0049] Various exemplary electrode arrays suitable for use with the end effector (12) are described in greater detail below, wherein each such electrode array includes one or more cooperating electrode pairs that are laterally opposed to each other and electrically coupled to a source of electrical energy and are configured to deliver bipolar radiofrequency (RF) energy (i.e., non-therapeutic RF energy, also referred to herein as electrical signals) to a living body material at relatively low diagnostic levels. Specifically, each cooperating electrode pair includes a first electrode configured to deliver the electrical signal to a living body material positioned between the end effector jaws (16, 18) and in contact with the electrodes, and a second electrode configured to receive the electrical signal after the electrical signal has passed through the tissue. In other versions of the exemplary examples described below, a surgical instrument may include a first electrode presented by the end effector and a second electrode positioned distal to the end effector, wherein the first and second electrodes cooperate to direct a monopolar RF electrical signal through the living body material. In this type of version, the second electrode may be in the form of an electrical grounding pad secured to the patient's skin, such as disclosed in any of the references incorporated herein by reference.

[0050] As described in more detail below, Figures 8 to 13 Several exemplary electrode arrays are shown, each having one or more cooperating electrode pairs configured to transmit RF electrical signals through material within the body, such as tissue. While in each exemplary version, the electrode array is shown and described as being integrated into a single end effector jaw, in other versions, the electrode array may be integrated into both end effector jaws, such that a given cooperating electrode pair includes a first electrode on a first end effector jaw and a second electrode on a second end effector jaw.

[0051] As shown below Figures 14 to 18Described in more detail, the electrodes of the electrode array can be electrically coupled to a compact-sized tissue sensing circuit that is integrated into a component of the end effector (12), such as the lower jaw (16) or the staple cartridge (37), and is configured to measure the electrical impedance of the in vivo material positioned between and in contact with a given pair of electrodes. Based on the measured electrical impedance, the tissue sensing circuit can determine at least one of the presence of tissue in the in vivo material, the absence of tissue in the in vivo material, or a characteristic of the tissue forming at least a portion of the in vivo material. The instrument (10) can then take a responsive action based on the impedance measurement and determination, which responsive action may include providing a notification to the operator. While the illustrative configurations described below are disclosed in conjunction with surgical stapling instruments, it should be understood that such configurations may also be applied to various other types of surgical instruments, such as surgical instruments that are operable to, for example, grasp tissue and / or treat tissue using ultrasonic energy and / or RF energy.

[0052] A. Exemplary End Effector Electrode Arrays

[0053] Now see Figure 8 , an exemplary electrode array (800) is depicted according to at least one non-limiting aspect of the present disclosure. Although the electrode array (800) is depicted as Figures 1 to 7 Although the electrode array (800) is a component of the lower jaw (16) of the end effector (12) of the present invention, it should be understood that the electrode array (800) can be implemented in the jaws of various other types of surgical instruments. Figure 8 As shown, the upper jaw (16) of the end effector (12) can define an elongated channel (821) that traverses the longitudinal axis (L) of the end effector (12). Specifically, the channel (821) can be defined by one or more side walls (825A, 825B) of the lower jaw (16), the one or more side walls extending along the longitudinal axis (L) on opposite sides of the longitudinal axis (L). For example, the electrode array (800) can include eight pairs of electrodes (822, 824), each pair of electrodes having a rectangular shape and constructed of titanium, wherein each electrode (822, 824) is configured to cooperate with a laterally opposing electrode (822, 824) to transmit an RF electrical signal through tissue positioned in contact with the two electrodes (822, 824). In other versions, the array (800) can include electrodes (822, 824) of different numbers, geometries, and / or materials, depending on the intended application and / or user preference. In other implementations, certain electrodes (824) of the array (800) may be configured differently relative to other electrodes (822). For example, certain electrodes (824) may be positioned around a cut line (826) and may be configured such that the electrodes (824) provide increased resolution on either side of the cut line (826).

[0054] according to Figure 8In another non-limiting aspect of the present invention, the electrode array (800) may include one or more electrodes (822, 824) integrated into the side walls (825A, 825B) of the lower jaw (16) of the end effector (12). Specifically, each electrode (822, 824) may be over-mounted or over-molded onto the wall (825A, 825B). Of course, other integration means may be used to achieve a similar effect. In some embodiments, certain electrodes (824) may be positioned around a cutting line (826) of the end effector (12) such that those electrodes (824) are capable of cutting tissue around the cutting line (826) when activated. In other versions, the electrode array (800) may be integrated into the upper jaw (18) of the end effector (12).

[0055] Now refer to Figure 9 , another end effector 900 is depicted according to at least one non-limiting aspect of the present disclosure. According to some implementations, and as Figure 9 As shown, the end effector (900) may include an electrode array (904) mounted on a separate consumable (906), the separate consumable being configured to be inserted into a channel (902) defined by side walls (903A, 903B) of the end effector (900), wherein each electrode (904) is configured to cooperate with a laterally opposing electrode (904) to transmit an RF electrical signal through tissue positioned to contact the two electrodes (904). The channel (902) and the side walls (903A, 803B) may be configured to accommodate the separate consumable (906). For example, the side walls (903A, 903B) may include an inner surface composed of a conductive material such that when the separate consumable is inserted into the channel (902), the conductive material is placed in electrical communication with the electrodes (904). Additionally or alternatively, the channel may include one or more electrical contacts configured to place the electrode (904) in electrical communication with a flexible conductor (908) capable of carrying a multiplexed signal, wherein the flexible conductor (908) traverses the channel (902).

[0056] Therefore, in some implementations, and as Figure 9As shown, the electrode array (904) can be attached to a separate consumable (906) and thus selectively clamped into the channel (902). In this way, a single end effector (900) can be configured to selectively accommodate many separate consumables (906), wherein each separate consumable (906) can include a different array of electrodes (904) in a different configuration. In addition, the separate consumable (906) can define a second channel (912) that is configured to accommodate a cartridge for surgical procedures (e.g., a staple cartridge, an electrosurgical cartridge, etc.). Thus, various combinations of separate consumables (906) and cartridges can be used by the same end effector (900). In addition, the electrode (904) can receive and transmit signals via a flexible conductor (908) that can be used to generate insights according to previously disclosed techniques, regardless of the type of cartridge loaded into the end effector (900). According to some non-limiting aspects, the flexible conductor (908) can be guided through the end effector (900) and the surgical instrument.

[0057] Now see 10A to 10C , another end effector (1000) is depicted according to at least one example of the present disclosure. In some implementations, and as shown, the end effector (1000) can house a cartridge (1006) configured to perform a surgical procedure (e.g., a staple cartridge, an electrosurgical cartridge, etc.), and the electrode array (1004) can be disposed on the cartridge (1006) itself. Each electrode (1004) is configured to cooperate with a laterally opposed electrode (1004) to transmit an RF electrical signal through tissue positioned to contact the two electrodes (1004). See specifically FIG. 10A to FIG. 10B , the side walls (1003A, 1003B) of the end effector (1000) (in this case defined by a tray of a bin (1006) similar to the tray (74)) can again define a channel (1002), and the channel can be configured to accommodate the body of the bin (1006). The end effector (1000) can also include a flexible conductor (1008) capable of carrying a multiplexed signal, wherein the flexible conductor traverses the channel (1002). In some embodiments, the flexible conductor (1008) can be arranged in a manner similar to that of the reference Figure 9 Methods of the methods described with respect to end effector (900) are guided through end effector (1000) and the surgical instrument.

[0058] For example, the side walls (1003A, 1003B) may include an inner surface composed of a conductive material such that when a separate consumable is inserted into the channel (1002), the conductive material is placed in electrical communication with the electrode (1004), such as Figure 10CAlternatively, the channel may include one or more electrical contacts configured to enable the electrode (1004) to be placed in electrical communication with a flexible conductor (1008) capable of carrying a multiplexed signal, wherein the flexible conductor (1008) traverses the channel (1002).

[0059] In another specific implementation, and as Figure 10C As shown, inserting cartridge (1006) into end effector (1000) is depicted in accordance with at least one non-limiting aspect of the present disclosure. Figure 10C In a non-limiting aspect of the present invention, the end effector (1000) may include a conductive element (1012) configured to be electrically engaged with a corresponding conductive element (1010) on the cartridge (1006). The conductive elements (1010), (1012) may be further configured for multiplexing signal transmission, such that a multiplexed signal sent through the flexible conductor (1008) of the end effector (1000) can be transmitted to and from each electrode (1004) of the array positioned on the cartridge (1006). In another specific embodiment, the electrode array (1004) can be integrated into the cartridge (1006), which can be a consumable. The electrodes (1004) can be electrically integrated into the cartridge (1006) via electrical connections between a multiplexing integrated circuit within the cartridge and the conductive elements (1010, 1012). Because cartridge (1006) may include multiplexed electronics, the conductive elements (1010, 1012) that must interface between end effector (1000) and cartridge (1006) may be simplified.

[0060] Now see Figure 11A , another end effector (1100A) is depicted according to at least one non-limiting aspect of the present disclosure. The end effector (1100A) can be configured to accommodate a mixing cartridge (1106A), wherein an electrode array (1104A) is positioned on the cartridge (1106A). Each electrode (1104A) is configured to cooperate with a laterally opposing electrode (1104A) to transmit an RF electrical signal through tissue positioned in contact with the two electrodes (1104A). Each electrode (1104A) can be configured to be in electrical communication with a flexible conductor (1108) capable of carrying a multiplexed signal. In another specific implementation, when the cartridge (1106A) is mounted within the end effector (1100A), the flexible conductor (1108) can traverse a channel defined by the end effector (1100A) and can be guided through the end effector (1100A) and the surgical instrument in a manner similar to those described herein.

[0061] See also Figure 11B, depicts a similar but slightly different end effector (1100B) according to at least one non-limiting aspect of the present disclosure. Notably, the electrode array (1104B) is different from Figure 11A Thus, a plurality of conductive elements (1112) corresponding to each electrode (1104B) are provided in each wall (1103A, 1103B) of the end effector (1100B). Thus, each electrode (1104B) of the array can receive a desired signal from the multiplexed signal traversing the flexible conductor (1108).

[0062] It should be understood that in some specific implementations, such as Figures 11A to 11B As shown, the electrode arrays (1104A, 1104B) can be positioned on a cartridge (1106A, 1106B), which can be electrically configured with one or more electrical surfaces (e.g., metal plating, metal tabs bent around the sides, through-holes through the cartridge, etc.) for the intended connection of each electrode (1104A, 1104B) to the appropriate portion of the flexible conductor (1108). Thus, multiplexing occurs within the end effector (1100A, 1100B), but each electrode (1104A, 1104B) still receives the appropriate signal via the electrical connections.

[0063] Now see Figure 12 , another end effector (1200) is depicted according to at least one non-limiting example of the present disclosure. Similar to Figures 11A to 11B In the case of an end effector (1100A, 1100B) of the present invention, the electrode array (1204) may be integrated on the cartridge (1206) itself, wherein each electrode (1204) is configured to cooperate with a laterally opposed electrode (1204) to transmit an RF electrical signal through tissue positioned in contact with both electrodes (1204). However, multiplexing may occur within the cartridge (1206) or end effector (1200) via a flexible conductor (1208) capable of carrying the multiplexed signal. Regardless, Figure 12 The end effector (1200) may further include a wireless communication module (1214) configured to enable communication via an infrastructure network (e.g., cellular, etc.) or ad hoc networks (e.g. Near field communication, RFID, etc.) to wirelessly send and receive multiplexed signals to and from the control circuit and / or surgical hub.

[0064] Thus, wireless communication module (1214) may serve as a communication interface between end effector (1200) and a surgical hub and / or control circuitry, thereby eliminating the need for the routing described with reference to Figures 10 and 11. It should be understood that wireless communication module (1214) may be similarly applied to any of the surgical instruments and / or end effectors disclosed herein, thereby simplifying, and in some aspects eliminating, the routing of the flexible conductors disclosed herein.

[0065] Now see Figure 13 , another end effector (1300) is depicted according to at least one non-limiting example of the present disclosure. As shown, the end effector (1300) may include a first jaw and a second jaw. For example, the second jaw may be configured as an anvil of the end effector (1300), and a separate consumable (1306) may be configured to be selectively coupled to the second jaw. Although Figure 9 A separate consumable (906) is shown coupled to Figure 9 The bottom jaw of the end effector (900) of the present invention, but a separate consumable (1306) can be connected to the second jaw or the top jaw (1302) of the end effector (1300). Nevertheless, the electrode array (1304) can be connected to the separate consumable (1306) and, when connected to the conductive element on the second jaw (1302), electrically connected to the flexible conductor (1308). Each electrode (1304) is configured to cooperate with a laterally opposed electrode (1304) to transmit an RF electrical signal through tissue positioned to contact the two electrodes (1304). The flexible conductor (1308) can be capable of carrying multiplexed signals, wherein the flexible conductor (1308) is configured similarly to the reference Figure 9 to Figure 1 1. Alternatively, the method may be used to traverse the end effector (1300) and the surgical instrument. Figure 12 A wireless implementation of the invention is used to send signals to and receive signals from the electrode array (1204).

[0066] In an alternative version of any of the exemplary electrode arrays described above, each pair of laterally opposed electrodes arranged along the length of the end effector can be electrically isolated from one another and can be configured to independently communicate with a controller of the surgical instrument. Based on the electrical impedance readings associated with the various electrode pairs, the controller can determine the longitudinal position of tissue located between the end effector jaws relative to the end effector.

[0067] B. Exemplary Tissue Sensing Circuits

[0068] Figure 14A tissue sensing circuit (1400) is shown coupled to one or more tissue sensing electrodes (1450), such as two or more pairs of electrodes (1450), wherein each pair of electrodes is configured to deliver bipolar RF energy to the tissue. The electrodes (1450) can be integrated into a surgical instrument actuator, such as an end effector (12), and can operate in any of the exemplary manners disclosed above. As shown, the tissue sensing circuit (1400) can include various components. For example, the tissue sensing circuit (1400) can include a digital microcontroller (1410) configured to synthesize a signal having a fixed fundamental frequency (f) via a digital-to-analog converter port. c ) output sinusoidal signal. The tissue sensing circuit (1400) may also include an optional bandpass filter (1420) that can improve the sinusoidal signal by removing undesirable impurities. The tissue sensing circuit (1400) may also include a voltage controlled current source (VCCS) (1430) that converts the signal into a current limited collateral output that ensures that the tissue sensing electrode (1450) is safe for the patient. An op-amp (1440) may also be present in the tissue sensing circuit (1400) to add gain to the return signal from the electrode.

[0069] In some specific implementations, and as Figure 14 As shown, the microcontroller (1410) can recreate or act as an analog circuit. Therefore, the microcontroller (1410) can be equipped with, access to, or include advanced embedded analog, mixed-signal, and digital signal processing (DSP) capabilities. It should be understood that although various microcontroller configurations are discussed herein, any feasible microcontroller can be used. By way of non-limiting example, the microcontroller STM32F3 and / or STM32G4 should be sufficient to perform the methods disclosed herein.

[0070] Now see Figure 15A and Figure 15B , depicts portions of another end effector (1500) according to at least one embodiment of the present disclosure. As shown, the end effector (1500) can house a cartridge (1506) configured to perform a surgical procedure (e.g., a staple cartridge, an electrosurgical cartridge, etc.), and the electrode array can be disposed on the cartridge (1506) itself. In some embodiments, and as Figure 15A As shown schematically, it can be similar to Figure 14The tissue sensing circuit (1501) of the tissue sensing circuit (1400) may reside on or be recessed within an inner surface of the lower jaw (16) of the end effector (1500), such as a sidewall or floor of the lower jaw (16), such that the tissue sensing circuit (1501) is covered by the cartridge (1506) when located within the lower jaw (16). In this embodiment, because the tissue sensing circuit (1501) is permanently attached to or housed within the end effector (1500), specifically the jaw (16), it is not discarded with the cartridge (1506) between firings of the end effector (1500) and is therefore reusable for multiple firings, which may save costs for the user.

[0071] Alternatively, in some implementations, such as Figure 15B As shown, the tissue sensing circuit (1501) may reside on or be contained within a cartridge (1506) that is inserted into the end effector (1500). For example, as schematically shown, the tissue sensing circuit (1501) may be embedded within the tapered distal end of the body of the cartridge (1506). In this embodiment, because the tissue sensing circuit (1501) is permanently attached to or contained within the cartridge (1506), it is discarded along with the cartridge (1506) after the cartridge (1506) is fired and removed from the end effector (1500). Various other embodiments may exist regarding the placement of the tissue sensing circuit (1501) to enable single or multiple uses. In another embodiment, the tissue sensing circuit (1501) may be provided in both the end effector jaws (16) and the cartridge (1506), which may provide redundancy in the event of a failure or malfunction.

[0072] C. System Operation and Capabilities

[0073] This article discusses and Figures 1 to 15B The system shown in FIG provides a surgical stapling instrument (10) configured to clamp tissue using an end effector (12). Once firmly clamped, an electrode (e.g., Figures 8 to 13 The electrodes shown) apply a non-therapeutic (ie, low voltage) waveform to the tissue. The return waveform is then evaluated to measure and / or calculate (eg, using Figure 14The system can then determine the impedance of the tissue within the jaws using a microcontroller (e.g., a microcontroller). More specifically, the system, via one or more subcircuits, delivers non-therapeutic energy to the extracellular and intracellular fluids present within a given (e.g., clamped) region of tissue to determine the phase and magnitude of the impedance of the tissue within the jaws. The system can then forward information associated with the tissue, such as, for example, tissue type, tissue phase, tissue margins, etc. Using this associated information, the system can not only verify that the correct tissue is clamped between the jaws, but can also determine whether any non-tissue material is present between the jaws.

[0074] Figure 16 An illustrative impedance triangle (1601) is shown that may be implemented by the tissue sensing circuit (1400) to determine the electrical impedance of tissue placed in contact with a pair of electrodes of a surgical instrument end effector, such as end effector (12). 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. Thus, as can be seen by the illustrative impedance triangle (1601), the electrodes are used to measure the "resistance" (1602) of each object in the circuit. The system may also determine the "capacitive reactance" (1603) of each object in the circuit and the inductive reactance (1604) of each object in the circuit (1400). As discussed above, and in Figure 16 It is clearly shown that the electrodes (e.g. Figures 8 to 14 The electrodes (shown) send and receive electrical signals to and from the patient's tissue via a microcontroller. As will be understood by one of ordinary skill in the art, the patient's extracellular and intracellular fluids have a capacitive reactance (1603). The "reactance" (1605) can then be calculated by determining the difference between the capacitive reactance and the inductive reactance using the following formula:

[0075] Equation 1: X = ∑(X L -X C ) where X is the total reactance, X L is the inductive reactance, and X C It is capacitive reactance.

[0076] like Figure 16 As shown, the "impedance" (1606) can then be determined using the following formula:

[0077] Equation 2: Where Z is the impedance, R is the resistance, and jX is equal to the square of the difference between the inductive and capacitive reactances (i.e., (X L –X C ) 2 ).

[0078] Figure 17A set of illustrative example waveforms are shown that may be generated and measured by the tissue sensing circuit (1400) to determine the phase of the current and voltage of the circuit, as discussed herein. As will be understood by one skilled in the art, if the circuit contains only resistive terms, the current and voltage will remain in phase, such as shown in graph (1701) and phasor diagram (1704). Alternatively, if the circuit has capacitive objects, or has more capacitive objects than inductive objects, the voltage wave will cause a current wave, such as shown in graph (1702) and phasor diagram (1705). Finally, if the circuit has inductive objects, or has more inductive objects than capacitive objects, the voltage will lag the current, such as shown in graph (1703) and phasor diagram (1706). As discussed above and Figure 16 As shown, human tissue tends to be capacitive in nature, whereas wires, tools, staples, implants, etc. may tend to be inductive in nature.

[0079] Thus, if the measurement of current and voltage produces a current-leading waveform (1702), it indicates that the material between the electrodes is "capacitive" and therefore falls into the category of tissue or fluid (e.g., 1603). Alternatively, if the measurement of current and voltage produces a current-lagging waveform (1703), it indicates that the material between the electrodes is "inductive" and therefore not tissue or fluid (e.g., 1603). Thus, as discussed herein, the electrode (e.g., 1450) sends and receives electrical signals to and from the end effector, which is believed to be in contact with the patient's tissue. The waveform is then analyzed by the tissue sensing circuit (1400) to determine whether the current leads or lags the voltage (e.g., 1702 vs. 1703), which can then be used to confirm which is in contact with the electrode.

[0080] As discussed herein, the system can 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 can pass waveforms of varying frequencies (e.g., in series and / or in parallel) to improve the accuracy of the determination. Thus, in some implementations, multiple waveforms of various frequencies can be added or summed together to produce a multi-sine waveform.

[0081] Figure 18An exemplary method (1800) is shown for determining the presence and type of tissue placed in contact with an electrode (1450) using a tissue sensing circuit (1400). At step (1801), a user or software can automatically activate the tissue sensing circuit (1400) (e.g., a microcontroller (1410)) to synthesize a non-therapeutic (e.g., low voltage) signal having a fixed fundamental frequency. Once the waveform is synthesized at step (1801), a surgical instrument (e.g., 10) uses the microcontroller (1410) to facilitate delivery of the electrical signal to at least one electrode (1450) at step (1802), wherein the at least one electrode (1450) is in contact with the patient's tissue. When the generated waveform is delivered to the patient's tissue via the electrode (1450), a return signal is measured by the microcontroller (1410) at step (1803), which confirms the presence of tissue at the location of the electrode (1450). At step 1804, the microcontroller 1410 determines at least one characteristic of the detected tissue of the patient, such as the type of tissue, based on the measurement of the return signal. It should be understood that, based on the absence of the return signal, the microcontroller 1410 may determine that tissue is not present at the location of the electrode 1450. Based on the determined presence and characteristics of the detected tissue, or based on the determined absence of tissue, the microcontroller 1410 may then direct the surgical instrument to take a responsive action, such as providing a relevant indication (e.g., visual, audible, and / or tactile) to the operator.

[0082] III. Combined Examples

[0083] 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 scope of any claims that may be made at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided for illustrative purposes only. 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 expressly indicated as such by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or 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.

[0084] Example 1

[0085] A surgical instrument comprising: (a) an end effector configured to interact with a patient's internal body material, the end effector comprising: (i) a first jaw, (ii) a second jaw configured to cooperate with the first jaw to clamp the internal body material, and (iii) a first electrode configured to directly contact the internal body material positioned between the first jaw and the second jaw and deliver an electrical signal to the internal body material; (b) a second electrode configured to receive the electrical signal from the first electrode; and (c) a circuit, The circuit is housed within the end effector, wherein the circuit includes a microcontroller and is configured to: (i) control delivery of the electrical signal to the first electrode such that the electrical signal is transmitted from the first electrode through the intracorporeal material to the second electrode, (ii) determine an electrical impedance associated with the intracorporeal material based on the electrical signal received by the second electrode, and (iii) determine at least one of the following based on the electrical impedance: (A) the presence of tissue in the intracorporeal material, (B) the absence of tissue in the intracorporeal material, or (C) characteristics of tissue forming at least a portion of the intracorporeal material.

[0086] Example 2

[0087] A surgical instrument according to Example 1, wherein the circuit is further configured to be capable of: generating the electrical signal using the microcontroller, wherein the electrical signal has a synthetic waveform.

[0088] Example 3

[0089] The surgical instrument of Example 2, wherein the synthesized waveform has a fixed single fundamental frequency.

[0090] Example 4

[0091] A surgical instrument according to any one of embodiments 2 to 3, wherein the circuit further includes a band pass filter (BPF).

[0092] Example 5

[0093] A surgical instrument according to Example 4, wherein the circuit is configured to pass the composite waveform through the BPF before delivering the composite waveform to the first electrode.

[0094] Example 6

[0095] A surgical instrument according to any one of embodiments 1 to 5, wherein the circuit further includes a voltage controlled current source (VCCS) circuit.

[0096] Example 7

[0097] A surgical instrument according to Example 6, wherein the circuit is further configured to be able to: convert the electrical signal into a current limited signal using the VCCS circuit.

[0098] Example 8

[0099] A surgical instrument according to any one of embodiments 1 to 7, wherein the circuit further includes an operational amplifier, wherein the circuit is further configured to be able to: use the operational amplifier to buffer and amplify the electrical signal before the electrical signal returns from the second electrode to the microcontroller.

[0100] Example 9

[0101] A surgical instrument according to any one of embodiments 1 to 8, wherein the circuit is further configured to be capable of: extracting and analyzing at least one feature from the electrical signal, the at least one feature being a feature selected from the group consisting of the amplitude of the electrical signal and the phase shift of the electrical signal.

[0102] Example 10

[0103] A surgical instrument according to any one of embodiments 1 to 9, wherein the circuit is further configured to be able to identify a current waveform and a voltage waveform associated with the electrical signal delivered to the in vivo material.

[0104] Example 11

[0105] A surgical instrument according to any one of embodiments 1 to 10, wherein the circuit is configured to determine the electrical impedance based on the capacitive reactance and the inductive reactance of the material within the body.

[0106] Example 12

[0107] A surgical instrument according to any one of embodiments 1 to 11, wherein the first electrode and the second electrode are presented by the end effector.

[0108] Example 13

[0109] A surgical instrument according to any one of embodiments 1 to 12, wherein the first electrode is presented by the end effector and the second electrode is positioned away from the end effector.

[0110] Example 14

[0111] A surgical instrument according to any one of embodiments 1 to 13, wherein the end actuator further includes a nail magazine that is removably connected to the second jaw and has a plurality of nails, wherein the microcontroller is fixed to the body of the nail magazine.

[0112] Example 15

[0113] A surgical instrument according to any one of embodiments 1 to 14, wherein the microcontroller is disposed on an inner surface of one of the first jaw or the second jaw.

[0114] Example 16

[0115] A surgical instrument comprising: (a) a body; (b) a shaft extending distally from the body; (c) an end effector located at the distal end of the shaft, wherein the end effector comprises: (i) a first jaw having a plurality of nail-forming recesses configured to form nails; (ii) a second jaw configured to cooperate with the first jaw to clamp a patient's internal body material; and (iii) a nail magazine removably coupled to the second jaw and having a plurality of nails; (d) a first electrode and a second electrode configured to deliver an electrical signal to the internal body material positioned between the first jaw and the second jaw; and (e) e) a circuit electrically coupled to the first electrode and the second electrode and comprising a microcontroller secured to a portion of one of the first jaw, the second jaw, or the staple cartridge, wherein the circuit is configured to: (i) control delivery of the electrical signal to the first electrode such that the electrical signal passes from the first electrode through the intracorporeal material to the second electrode, (ii) determine an electrical impedance associated with the intracorporeal material based on the electrical signal received by the second electrode, and (iii) determine at least one of: (A) the presence of tissue in the intracorporeal material, (B) the absence of tissue in the intracorporeal material, or (C) characteristics of tissue forming at least a portion of the intracorporeal material based on the electrical impedance.

[0116] Example 17

[0117] The surgical instrument according to Example 16, wherein the first electrode and the second electrode are presented by the end effector.

[0118] Example 18

[0119] A surgical instrument according to any one of Examples 16 to 17, wherein the circuit further includes at least one of a bandpass filter (BPF), a voltage-controlled current source (VCCS) circuit, or an operational amplifier, wherein the circuit is configured to be capable of performing an action selected from the group consisting of: (a) passing a synthesized waveform through the BPF before delivering the electrical signal to the first electrode; (b) converting the electrical signal into a current-limited signal using the VCCS circuit; and (c) buffering and amplifying the electrical signal using the operational amplifier before the electrical signal is returned from the second electrode to the microcontroller.

[0120] Example 19

[0121] A surgical instrument according to any one of embodiments 16 to 18, wherein the microcontroller is configured to determine the electrical impedance based on the capacitive reactance and the inductive reactance of the in vivo material.

[0122] Example 20

[0123] A method for operating a surgical instrument having a first electrode and a second electrode and an end effector housing a microcontroller, the method comprising: (a) controlling the delivery of an electrical signal to the first electrode using the microcontroller, wherein the first electrode is configured to be capable of directly contacting the electrical signal and delivering the electrical signal to an intracorporeal material clamped by the end effector; (b) receiving the electrical signal using the second electrode after the electrical signal passes through the intracorporeal material from the first electrode; (c) determining an electrical impedance associated with the intracorporeal material using the microcontroller based on the electrical signal received by the second electrode; and (d) determining, using the microcontroller based on the electrical impedance, at least one of: (i) the presence of tissue in the intracorporeal material, (ii) the absence of tissue in the intracorporeal material, or (iii) characteristics of tissue forming at least a portion of the intracorporeal material.

[0124] IV. Miscellaneous

[0125] It should be understood that any type of device 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.

[0126] Although the examples herein are primarily described 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 deployment 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 incorporate the teachings herein will be readily apparent to those of ordinary skill in the art.

[0127] 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 in isolation from each other. Based on 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.

[0128] 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 material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein by reference that conflicts with existing definitions or other public material set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public material.

[0129] The types of devices described above can be applied to traditional 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 can be readily incorporated into robotic surgical systems, such as the DAVINCI® system from Intuitive Surgical, Inc. (Sunnyvale, California). TMSimilarly, 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,” issued on August 31, 2004, the disclosure of which is incorporated herein by reference in its entirety.

[0130] 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 cases, these patterns can be repaired for reuse 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 utilize a variety of techniques to disassemble, clean / replace, and reassemble. The use of such technology and the resulting repair device are all within the scope of the present application.

[0131] By way of example only, the devices described herein can be sterilized before and / or after surgery. 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 can 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 can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. The device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0132] Various embodiments of the present invention have been shown and described, and further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled 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 skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, 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 construction and operation shown and described in the specification and drawings.

Claims

1. A surgical instrument comprising: (a) an end effector configured to interact with a material within a patient's body, the end effector comprising: (i) a first jaw, (ii) a second jaw configured to cooperate with the first jaw to grasp the in vivo material, and (iii) a first electrode configured to directly contact the in vivo material positioned between the first jaw and the second jaw and deliver an electrical signal to the in vivo material; (b) a second electrode configured to receive the electrical signal from the first electrode; and (c) an electrical circuit housed within the end effector, wherein the electrical circuit includes a microcontroller and is configured to: (i) controlling the delivery of the electrical signal to the first electrode so that the electrical signal is transmitted from the first electrode through the in vivo material to the second electrode, (ii) determining an electrical impedance associated with the in vivo material based on the electrical signal received by the second electrode, and (iii) determining at least one of the following based on the electrical impedance: (A) the presence of tissue in the in vivo material, (B) the absence of tissue in said in vivo material, or (C) a property of a tissue forming at least a portion of the in vivo material.

2. The surgical instrument according to claim 1, wherein The circuit is further configured to generate the electrical signal using the microcontroller, wherein the electrical signal has a composite waveform.

3. The surgical instrument according to claim 2, wherein: The synthesized waveform has a fixed single fundamental frequency.

4. The surgical instrument according to any one of claims 1 to 3, wherein: The circuit also includes a band pass filter (BPF).

5. The surgical instrument according to claim 4, wherein: The circuit is configured to enable the composite waveform to pass through the BPF before delivering the composite waveform to the first electrode.

6. A surgical instrument according to any preceding claim, wherein: The circuit also includes a voltage controlled current source (VCCS) circuit.

7. The surgical instrument according to claim 6, wherein: The circuit is further configured to convert the electrical signal into a current limited signal using the VCCS circuit.

8. A surgical instrument according to any preceding claim, wherein: The circuit further includes an operational amplifier, wherein the circuit is further configured to be able to: buffer and amplify the electrical signal using the operational amplifier before the electrical signal returns from the second electrode to the microcontroller.

9. A surgical instrument according to any preceding claim, wherein: The circuit is further configured to extract and analyze at least one feature from the electrical signal, the at least one feature being a feature selected from the group consisting of an amplitude of the electrical signal and a phase shift of the electrical signal.

10. A surgical instrument according to any preceding claim, wherein The circuit is further configured to identify a current waveform and a voltage waveform associated with the electrical signal delivered to the in vivo material.

11. A surgical instrument according to any preceding claim, wherein: The circuit is configured to determine the electrical impedance based on the capacitive and inductive reactances of the in-vivo material.

12. A surgical instrument according to any preceding claim, wherein: The first electrode and the second electrode are presented by the end effector.

13. A surgical instrument according to any preceding claim, wherein: The first electrode is presented by the end effector and the second electrode is located distally from the end effector.

14. A surgical instrument according to any preceding claim, wherein: The end effector also includes a staple cartridge removably coupled to the second jaw and having a plurality of staples, wherein the microcontroller is secured to a body of the staple cartridge.

15. A surgical instrument according to any preceding claim, wherein The microcontroller is disposed on an inner surface of one of the first jaw or the second jaw.

16. A method of operating a surgical instrument having a first electrode and a second electrode and an end effector housing a microcontroller, the method comprising: (a) controlling, using the microcontroller, delivery of an electrical signal to the first electrode, wherein the first electrode is configured to directly contact and deliver the electrical signal to an in vivo material held by the end effector; (b) receiving the electrical signal using the second electrode after the electrical signal passes through the in vivo material from the first electrode; (c) determining, with the microcontroller, an electrical impedance associated with the in vivo material based on the electrical signal received by the second electrode; and (d) determining, with the microcontroller, at least one of the following based on the electrical impedance: (i) the presence of tissue in the in vivo material, (ii) the absence of tissue in the in vivo material, or (iii) the nature of the tissue forming at least a part of the in vivo material.

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