Uterine manipulator with neutral return electrode

Abstract

A uterine manipulator having a neutral return electrode is disclosed. The uterine manipulator includes an elongated shaft having a distal portion configured to be inserted into a uterus through a lumen of a cervix and a return electrode coupled to the elongated shaft. The return electrode is configured to be electrically coupled to an electrosurgical generator.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 089,147, filed October 8, 2020, the entire contents of which are incorporated herein. TECHNICAL FIELD

[0003] This document relates generally, but not by way of limitation, to surgical devices that can be used in various surgical procedures. More particularly, but not by way of limitation, the present application relates to surgical devices that can be used to treat the reproductive system of a female patient. BACKGROUND

[0004] Many surgical procedures involve treating or removing a subcutaneous target tissue, such as a diseased or unwanted tissue or growth, that is located within a patient. As such, these procedures require access to and visualization of the patient’s internal anatomy.

[0005] The anatomy of the female reproductive system includes, among other things, the ovaries, fallopian tubes, uterus, cervix, and vagina. Due to certain gynecological conditions, such as cancer or severe pain and heavy bleeding, it is sometimes necessary to treat a patient’s uterus. One option for treating the uterus includes surgically removing the uterus via a hysterectomy.

[0006] One type of hysterectomy is known as a total hysterectomy and involves the complete removal of the patient’s uterus and cervix. Initially, hysterectomies were performed via an incision in the patient’s abdomen. As surgical tools and procedures have advanced, hysterectomies have evolved to include vaginal techniques and laparoscopic techniques. Today, hysterectomies involve one of four main approaches: total abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH), laparoscopic hysterectomy (TLH), and laparoscopically assisted vaginal hysterectomy (LSH).

[0007] Medical literature has shown that TLH and LSH can be more useful than the conventional TAH and TVH approaches. The TLH and LSH approaches can be desirable because the TLH and LSH approaches have several potential benefits, including, for example, less postoperative pain, shorter hospital stays, and faster recovery times. It can be beneficial if more of the hysterectomies performed each year are performed via the TLH or LSH approaches. Generally, the reasons why hysterectomies are not performed using the TLH or LSH approaches typically include the limitations of laparoscopic surgical procedures.

[0008] Limitations of performing a hysterectomy, and particularly a laparoscopic hysterectomy, can include limited visibility, which can make it difficult to determine whether a surgical tool such as a colpotomy cup is properly positioned, e.g., placed against the uterus proximate the cervix. Colpotomy cups can be used in a cauterization / cutting procedure known as colpotomy for resection of the uterus. These challenges can also exist in non-laparoscopic hysterectomies, other uterine treatments, and other surgical procedures.

[0009] Colpotomy is a procedure in which an incision is made in the vagina to perform a hysterectomy, to gain access to visualize other pelvic structures, or to perform a surgical procedure on a fallopian tube or ovary. To perform a colpotomy, a surgeon introduces a medical instrument including an end effector (e.g., an end effector assembly) at a distal end into the patient’s vagina through the vaginal opening and positions a cutting guide (e.g., a colpotomy cup) of the end effector near the surgical site proximate the cervix. The distal end of the end effector can also include a uterine manipulator to displace the uterus around to gain visibility or access to various tissues during the procedure. The cutting guide can be used to guide a cutting device for performing a colpotomy through the vagina proximate the cervix and around the cervix. Performing a colpotomy can be a difficult procedure for a surgeon because other tissues, such as the intestines (e.g., rectum, colon) and bladder, are very close to the colpotomy incision site in the vaginal wall. Thus, there is a need for improved instruments, systems, and methods for performing surgical procedures, including but not limited to surgical procedures requiring a colpotomy.

[0010] Some surgical procedures including hysterectomy can be performed via electrosurgery. Electrosurgery can include the passage of an electric current through a target tissue to produce a desired tissue effect. Electrosurgical tissue effects can include cutting, coagulation, desiccation, fulguration, and ablation. The target tissue, which acts as a resistor in the electrical circuit, is heated by its conduction of the electric current. There are two main types of electrosurgery, monopolar electrosurgery and bipolar electrosurgery. In monopolar electrosurgery, a radiofrequency (RF) current is delivered from an electrosurgical generator through an active electrode into a target tissue where a colpotomy is to be performed. The current then travels through the patient and is received by a return electrode (e.g., a neutral return electrode) and returned to the electrosurgical generator. A conventional return electrode includes a return electrode pad or plate that is placed in contact with the skin of the patient. The return electrode pad is intended to minimize any effects on the tissue at the return electrode.

[0011] In bipolar surgical procedures, electrodes are arranged in pairs on the surgical instrument and no separate return electrode, e.g., a return electrode pad to be in contact with the patient, is needed. The intended current flow between a pair of bipolar electrodes (“+ / -” and “- / +”) is typically close together and uses a relatively low voltage. Thus, bipolar systems typically have a short distance between the tissue to be cut and the return electrode.

[0012] Limitations of monopolar electrosurgical procedures include the current that travels through the patient between the active electrode and the return electrode. The distance between the target tissue at the surgical site, e.g., the uterus, and the location of the return electrode pad placed under the patient or the plate adhered to the patient’s skin causes the energy to travel through the patient from the target tissue, e.g., the uterus, to the skin on the torso or leg through the intervening tissue before being received by the return electrode plate that collects the energy and returns it to the electrosurgical generator. Monopolar electrosurgical procedures typically require higher voltages than bipolar electrosurgical procedures. In addition, if the return electrode is not in good contact with the patient, or if the area of contact is not sufficient to disperse the current, heating of the tissue can occur. If the surgeon cannot determine whether the return electrode is correctly placed and in sufficient contact with the patient, the current flow at the return electrode can exceed the target range.

[0013] Thus, there is a need for improved instruments, systems, and methods for electrosurgical procedures that minimize the current flow through tissue that is not the target tissue, and the effects on tissue that is not the target tissue, to monitor whether the return electrode is in sufficient contact with the patient. SUMMARY

[0014] The present inventors have recognized that among other things, problems to be solved in performing tissue resection procedures, such as colpotomy, include the desire to better focus and control the electrical energy applied to the target tissue while minimizing damage to non-target tissue. In addition, the inventors have recognized that it would be useful if the surgeon could determine whether a medical device, such as a colpotomy cup or other uterine device, is in the desired position, treatment position, surgical position, is fully inserted or properly in situ. The present subject matter can provide solutions to these and other problems and is not limited to colpotomy and other uterine procedures.

[0015] The present disclosure can be used with systems and methods for transvaginal delivery of a neutral return electrode for electrosurgery and other tissue treatment that includes application of electrical signals to tissue. In some examples, the neutral return electrode can be used to position a guide, or the guide can be used to position the neutral return electrode. In some examples, the neutral return electrode can be used to position a guide, such as a tissue resection device, relative to uterine anatomy, e.g., relative to at least one of a uterine cervix, a uterine cervical lumen, a vaginal vault, a cervico-vaginal junction, or other anatomical location for an end effector used to perform a colpotomy, or to anchor an end effector relative to anatomical structures.

[0016] In an example, a uterine manipulator includes an elongated shaft including a distal portion configured to be inserted into a uterus through a lumen of a uterine cervix, and a separate return electrode coupled to the elongated shaft. The separate return electrode can be configured to be electrically coupled to an electrosurgical generator.

[0017] In an example, a method of determining an in situ position of a transvaginally insertable uterine device includes emitting a drive signal to be received by a separate return electrode located on the uterine device, receiving at least a portion of the emitted drive signal from the separate return electrode, monitoring an electrical characteristic of the separate return electrode based on the emitted drive signal and the received at least a portion of the emitted drive signal to determine whether a threshold has been exceeded, and enabling emission of a second signal to an active electrode based at least in part on the threshold being exceeded.

[0018] In an example, a tissue resection system includes a uterine manipulator including an elongated shaft having a distal portion configured to be inserted into a uterus through a lumen of a uterine cervix, and a separate return electrode coupled to the elongated shaft, the separate return electrode having a first electrode and a second electrode, the separate return electrode configured to be electrically coupled to an electrosurgical generator. The tissue resection system can also include a colpotomy cup coupled to the elongated shaft, the colpotomy cup configured to be positioned in situ around the uterine cervix, wherein a distal portion of the colpotomy cup is configured to delineate a target tissue to be treated, and a cutting device including an active electrode for treating the target tissue, the cutting device configured to be electrically connected to an output of the electrosurgical generator.

[0019] In an example, an end effector of a tissue treatment device includes a uterine manipulator, a colpotomy cup coupled to the uterine manipulator, and a protrusion including a return electrode member configured to electrically connect to an electrosurgical generator. The uterine manipulator includes an elongated shaft having a distal end portion, wherein the distal end portion is configured to be inserted into a lumen of a cervix. The colpotomy cup includes a cutting guide having an outer wall portion and a base portion supporting the outer wall portion, the outer wall portion configured to enclose at least a portion of the cervix, the outer wall portion extending along a longitudinal path from a first proximal end portion to a first distal end portion. The protrusion extends distally away from the base portion and is laterally spaced apart from the outer wall portion. The protrusion extends along the longitudinal path such that the protrusion is configured to be inserted into the lumen of the cervix.

[0020] In an example, an end effector of a tissue treatment device includes a uterine manipulator including an elongated shaft extending from a proximal end portion to a distal portion, wherein the distal end portion is configured to be inserted into a lumen of a cervix. A colpotomy cup is coupled to the elongated shaft. A return electrode member is coupled to the colpotomy cup, the return electrode member configured to electrically connect to an electrosurgical generator. Additionally, the return electrode member is actuatable to change from a first state to a second state, wherein in the first state the return electrode member is configured to be inserted into the lumen of the cervix, and wherein in the second state the return electrode member is configured to inhibit proximal removal of the inserted return electrode member relative to the lumen of the cervix.

[0021] In an example, an end effector of a tissue treatment device includes an elongated shaft extending from a proximal end portion to a distal end portion. The proximal end portion is manipulatable by a user or machine to deliver the distal end portion to a treatment site, and the distal end portion is configured to be inserted into a lumen of a cervix. A return electrode is coupled to the distal end portion, and the return electrode is configured to electrically couple to an electrosurgical generator. The return electrode is configured to inhibit proximal movement of the elongated shaft relative to the lumen of the cervix when the return electrode is positioned in the lumen of the cervix.

[0022] In an example, a tissue resection system includes a cutting device including an active electrode configured to receive a signal from a surgical generator, and a cutting guide configured to be inserted into a patient. The cutting guide extends from a proximal end to an opening at a distal end. The distal end includes a perimeter return electrode surrounding the opening, and the perimeter return electrode is configured to electrically connect to the electrosurgical generator.

[0023] This overview is intended to provide a summary of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF DRAWINGS

[0024] FIG. 1 is a schematic illustration of a medial view of female anatomy including a portion of a medical instrument inserted into the abdominal cavity of the female anatomy according to at least one example.

[0025] FIG. 2 is a schematic illustration of a surgical system including an electrosurgical generator assembly, and an isometric view of a portion of an end effector having a return electrode member and a monopolar cutting device according to at least one example.

[0026] FIG. 3 is a schematic illustration of a second surgical system including an electrosurgical generator assembly, and an isometric view of a portion of a second end effector having a return electrode member and an integral cutting device according to at least one example. FIG. 2

[0027] FIG. 4 is a cross-sectional view of female anatomy having an end effector with a return electrode member inserted into the cervix according to at least one example. FIG. 3

[0028] FIG. 5 is a schematic illustration of an isometric view of a second return electrode member that can be used with the end effectors described herein according to at least one example.

[0029] FIG. 6 is a schematic illustration of an isometric view of a third return electrode member that can be used with the end effectors described herein according to at least one example.

[0030] FIG. 7A is a schematic illustration of an isometric view of a fourth return electrode member in a first state that can be used with the end effectors described herein according to at least one example.

[0031] FIG. 7B is a schematic illustration of an isometric view of a fourth return electrode member in a second state that can be used with the end effectors described herein according to at least one example.

[0032] FIG. 8 is a schematic illustration of an isometric view of a fifth return electrode member that depicts a first state and a second state that can be used with the end effectors described herein according to at least one example.

[0033] ​​FIG. 9 is a schematic diagram of a surgical system including an electrosurgical generator assembly according to at least one example and including a cross-sectional view of female anatomy with a third example of an end effector inserted into a cervix, where the end effector is electrically connected to the electrosurgical generator.

[0034] FIG. 10 is a schematic diagram of a surgical system and a patient according to at least one example.

[0035] FIG. 11 is a flowchart of a surgical method for performing a surgical procedure using an end effector of FIG. 9 and a surgical system of FIG. 10 according to at least one example.

[0036] FIG. 12 is a schematic diagram of an isometric view of a fourth example of an end effector including a return electrode member according to at least one example.

[0037] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, various embodiments discussed in the present document. DETAILED DESCRIPTION

[0038] The present disclosure provides systems and methods for performing colpotomy as part of a hysterectomy or other surgical procedure. The present application is described with reference to performing a female pelvic surgery, such as a colpotomy. However, the systems and methods of the present disclosure can be used with other surgeries of the female reproductive system not limited to colpotomy. In particular, the systems and methods can be used in other surgeries that benefit from focusing energy into target tissue to be incised or otherwise treated while minimizing energy transfer to non-target tissue. Further, the examples described in the present disclosure can also be used for treatment, incision, and / or removal of other tissue or organs of both males and females, including but not limited to surgeries of the colon or esophagus. For the purposes of the present disclosure, “proximal” refers to the end of a device that is closer to the device operator during use, and “distal” refers to the end of a device that is further from the device operator during use (see, e.g., FIG. 9 ).

[0039] FIG. 1is a schematic illustration of a medial view of female anatomy in the abdominal cavity AC including a portion of a medical instrument 10 inserted into the patient's vagina V. Normal female pelvic anatomy includes, among other things, the uterus U, cervix C, vagina V, bladder BL, and bowel BO. One of the challenges in performing a colpotomy is that the cervico-vaginal junction CVJ (e.g., the vaginal vault VF) is in close proximity to other organs.

[0040] To perform a colpotomy, a surgeon or other operator inserts a distal portion 12 of the medical instrument 10, including an end effector 14, into the vulvar end VE of the patient's vagina V, thereby guiding the end effector 14 through the passageway of the vagina V and placing the end effector 14 in the vicinity of the cervical end CE of the vagina V proximate the vaginal vault VF. As will be discussed further below, the end effector 14 can serve as a cutting guide for performing a resection during a hysterectomy. In some examples, and as shown in FIG. 2 , the end effector 14 can provide the surgeon with a cutting guide to be used in conjunction with a separate monopolar electrosurgical cutting device. With the end effector 14 in place, the surgeon can perform the cutting. The example of the end effector 14 for performing a colpotomy is provided as an illustrative example. In some examples, the end effector can be configured to provide a guide for placing the medical instrument 10 against the tissue without providing a cutting guide.

[0041] The surgeon can perform the cutting with a variety of different cutting devices. For example, as shown in FIG. 2 , the surgeon can move a separate monopolar cutting device 216 along the distal end of the end effector 214 to cut the vaginal tissue around the cervix C. In other examples, and as shown in FIG. 3 , the end effector 314 can include an integral electrosurgical cutting device (e.g., 316) that can be actuated to rotate around the distal end of the end effector 314. The integral electrosurgical cutting device 316 can perform the cutting from the vaginal side of the cervico-vaginal junction CVJ FIG. 4 . In some procedures, the cutting device 216 or 316 can be used to make a 360 degree cut in the vaginal wall VW separating the cervix C and uterus U from the vagina V, thereby facilitating resection of the uterus U and cervix C from the patient FIG. 1 .

[0042] Returning to FIG. 1The medical instrument 10 can include a handle portion 18, a delivery member 20, and an end effector 14. The handle portion 18 and the delivery member 20 can assist a device operator in delivering the end effector 14 to a cervical end CE of the vagina V. The handle portion 18 can be located at a proximal end portion 20A of the delivery member 20, and the end effector 14 can be located at a distal end portion 20B of the delivery member 20.

[0043] The delivery member 20 can include a body extending from a proximal end portion to a distal end portion, and can include a lumen 20C extending therethrough. In this example, the handle portion 18 or the delivery member 20 can include one or more operator controls 22A, 22B that actuate the end effector 14, e.g., operate the uterine manipulator 24 or the cutting device 16. In some examples, the handle portion 18 and the one or more operator controls 22A, 22B can be omitted, modified, or located elsewhere, e.g., to allow use and operation of the medical instrument 10 in robotic surgery, or in remotely or partially remotely actuated surgery. Any number of operator controls 22A, 22B (including actuators) can be provided. The handle portion 18 is shown as illustrating one possible example.

[0044] The movable uterine manipulator 24 of the end effector 14 can include an elongate shaft 24A that can be inserted into the opening of the cervix C and through the lumen L of the cervix C into the uterus U. The uterine manipulator 24 can be configured to allow a surgeon to move the uterus U around during a surgical procedure to provide access to a location to be resected. Features of the uterine manipulator described herein can be used together or separately from features described herein with respect to the guide, cutting guide, and colpotomy cup of the end effector.

[0045] FIG. 2 is a schematic diagram of a surgical system 200 including an electrosurgical generator 40 (hereinafter, generator 40), and an isometric view of a portion of an end effector 214 and a monopolar cutting device 216. FIG. 3 Similar to FIG. 2 except that FIG. 3 includes an example of an end effector 314 with an integrated cutting device 316.

[0046] Electrosurgery involves the application of high radiofrequency current to a surgical site to cut, ablate, coagulate, or seal tissue. In a conventional monopolar electrosurgical system, the active electrode is typically part of a surgical instrument held by the surgeon and applied to the tissue to be treated. The active electrode is configured to deliver treatment energy to the tissue. A return electrode is placed on the patient away from the active electrode to safely disperse the current delivered by the active electrode and carry the current back to the surgical generator.

[0047] In a conventional monopolar surgical system for performing colpotomy, an active electrode is located on an electrosurgical cutting device that can be laparoscopically inserted into the body or inserted into an open surgical site to access a first surface of a target tissue, while a return electrode is located on a plate that is adhered to the skin of the patient, such as the back, torso, or leg. Thus, energy delivered from the electrosurgical cutting device relies on energy that must travel from the active electrode to the target tissue (e.g., the vaginal vault near the cervix), through the target tissue from the first surface to a second surface of the tissue and then through the body tissue of the patient until it reaches the return electrode plate adhered to the skin, typically on the leg or torso.

[0048] In contrast to conventional monopolar surgical systems, as shown in the illustrative surgical systems 200, 300 of FIG. 2 and FIG. 3 , the return electrode 242A can be located on a return electrode member 242 that is positioned closer to the treatment site (e.g., the cervico-vaginal junction CVJ) as shown in FIG. 1 , FIG. 4 .

[0049] As shown in FIG. 2 , the end effector 214 can include a colpotomy cup 225 that can include an outer wall portion 252 configured to enclose at least a portion of the cervix C and a base portion 254 that supports the outer wall portion 252. The base portion 254 is configured to be located at a proximal end toward an opening of the cervix C. The outer wall portion 252 can extend from a proximal end portion 225A to a distal end portion 225B along a longitudinal path Al. The distal end portion can include an opening to receive the cervix C. Meanwhile, the outer wall portion 252 and the base portion 254 can form a capture portion and define a cavity 256 to receive the cervix C. The distal end portion 225B of the colpotomy cup 225 can be configured to bound the target tissue to be treated by the cutting device and provide a cutting guide for the surgeon tracking with the monopolar electrosurgical device 216.

[0050] The protrusion 258 can extend distally into the cavity 256 away from the base portion 254 and can include the return electrode member 242. The protrusion 258 can be laterally spaced apart away from the outer wall portion 252. The protrusion 258, including the return electrode member 242, can extend along a longitudinal path (e.g., but not limited to the longitudinal axis Al). The protrusion 258 can be generally centrally located within the colpotomy cup 225 such that the return electrode member 242 can be inserted into the cervix opening C and can remain in contact with the lumen L of the cervix C while the outer wall portion 252 of the colpotomy cup 225 is located around the cervix C (see FIG. 4(Positioning in the example). The return electrode 242A can be configured to be electrically connected to the electrosurgical generator 240 to receive therapeutic energy delivered to the active electrode 216A via the active lead 264 and return the therapeutic energy to the electrosurgical generator 240 via the lead 266.

[0051] Therefore, compared to conventional monopolar electrosurgical systems that rely on return electrode plates that adhere to the patient's skin, FIG. 2 and FIG. 3 The system advantageously positions the return electrode closer to the resection site. In this arrangement, the therapeutic energy delivered by the active electrode 216 (or 316) does not need to travel a long distance through the patient's body tissue before being collected by the return electrode component 242 and delivered to the electrosurgical generator 240.

[0052] FIG. 2 and FIG. 3 The end effector may also include a movable uterine manipulator 224. The uterine manipulator 224 may be configured to allow the surgeon to move the uterus U around during surgery to provide access to the location to be removed, such as near the cervical-vaginal junction (CJV). FIG. 1 , FIG. 4 The uterine manipulator 224 may include an elongated shaft 224A, which can be inserted into the opening of the cervix C and through the cavity L of the cervix C into the uterus U. FIG. 1 , FIG. 4 ).

[0053] In some examples, and as shown, the elongated shaft 224A may extend through the protrusion 258. In other words, the elongated shaft 224A may extend through the return electrode member 242. The uterine manipulator 224 may be coupled to the vaginal incision cup 225 and may be actuated by a control on the handle. FIG. 1 ).

[0054] In some examples, the uterine manipulator 224 may be fixedly coupled to the vaginal incision cup 225. In other examples, the uterine manipulator 224 may be slidably or rotatably coupled to the vaginal incision cup 225.

[0055] FIG. 3 The surgical system 300 is similar to FIG. 2 Surgical systems. However, FIG. 2 It relies on a separate monopolar electrosurgical device 216 to provide the current for processing tissue (e.g., a separate cutting device), while FIG. 3 Includes an integrated electrosurgical cutting device 316 with an active electrode 316A. The same reference numerals may denote the same elements, therefore not all elements will be described in further detail.

[0056] The end effector 314 can extend along a longitudinal axis Al from a proximal end 314A to a distal end 314B. In some examples, an axis is not required and the longitudinal axis Al can instead be described as a general longitudinal path or longitudinal direction. An axis is shown for purposes of describing one illustrative example. The end effector 314 can include a first cutting guide 326, a second cutting guide 328, and a cutting device 316 positioned between the first cutting guide 326 and the second cutting guide 328. The end effector 314 can also include a cutting device actuator configured to distally deploy the cutting device 316. The distal end portion 325B of the colpotomy cup 325 can provide a unitary cutting guide for the electrosurgical cutting device 316. In some examples, only the first cutting guide or the second cutting guide can be provided.

[0057] The cutting device 316 can be rotatably coupled to the colpotomy cup 325 and positioned between the first cutting guide 326 having a first distal peripheral portion 327 and the second cutting guide 328 having a second distal peripheral portion 329. The second cutting guide 328 can be positioned around the first cutting guide 326. The cutting device 316 can be movable relative to at least one of the first distal peripheral portion 327 and the second distal peripheral portion 329 to move along a periphery of the colpotomy cup 325 to treat a target tissue. The periphery can be a circumferential shape, an oblong shape, an elliptical shape, or any other suitable shape to facilitate a desired treatment of the target tissue. The cutting device 316 can be controlled by an operator control portion (e.g., actuation mechanism) 22A, 22B of the medical instrument 10. The actuation mechanism can be any suitable actuation mechanism, such as a mechanical or electric actuation mechanism, configured to actuate movement of the cutting device 316 to protrude at least a portion of the cutting device 316 beyond the distal end portion 325B of the colpotomy cup 325. FIG. 1 The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B).

[0058] The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B). FIG. 1 The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B). FIG. 3 The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B). FIG. 1 The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B). The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B).

[0059] The actuation mechanism can be positioned at any suitable location on the medical instrument 10 (e.g., 10) that facilitates actuation of the cutting device 316, such as at one or more of the end effector 314 (e.g., 314A, 314B), the delivery member 20, and the handle portion 18 (e.g., 18A, 18B). FIG. 1The first user control 22A, which can be operably coupled to the cutting device 316, includes a first actuation mechanism, such as a sliding actuator, to accomplish the movement between the deployed position and the retracted position. The first actuation mechanism can be any actuation mechanism known to those skilled in the art for deploying a cutting device.

[0060] The rotational movement can be accomplished via a second user control 22B FIG. 1 ), which includes a second actuation mechanism, such as a rotational actuator. In one example, the second actuation mechanism can facilitate rotation of the shaft within the delivery member 20 when the shaft is coupled to the cutting device 316. The second actuation mechanism can be any actuation mechanism known to those skilled in the art for controlling rotation of a cutting device 316.

[0061] In a conventional monopolar surgical system, the active electrode is on a surgical instrument that is inserted into the body, e.g., laparoscopically, while the return electrode is on a plate that is adhered to the skin of the patient. In contrast, FIG. 3 The surgical system 300 of FIG. 3 The surgical system 300 of FIG. 3 The surgical system 300 of can act more like a hybrid system between a monopolar system and a bipolar system. In particular, because the active electrode 316A and the return electrode member 242 can both be positioned close together and even on the same end effector 314, rather than on two separate devices that are spaced farther apart, the surgical system 300 can exhibit this pseudo-bipolar aspect. Moreover, although the surgical system 300 is depicted as a monopolar system, in some examples, the end effector 314 can be configured to electrically connect to a bipolar electrosurgical generator rather than a monopolar electrosurgical generator 340.

[0062] FIG. 4 is FIG. 3 a cross-sectional view of a female anatomical structure with the end effector inserted into the cervix. FIG. 4 shows an end effector with an integrated cutting device of FIG. 3 In addition, FIG. 4 an alternative cutting device 216 (a separate monopolar electrosurgical device) of FIG. 2 is also shown in dashed lines. Like reference numerals can refer to like elements, and thus not all elements can be described in further detail.

[0063] As FIG. 4As shown, when the end effector 314 is vaginally inserted with the colpotomy cup 325 in proximity to the cervix C or positioned in situ around the cervix C, the outer surface 242B of the return electrode member 242 is configured to be positioned in contact with the lumen L of the cervix C. At this location, the distance between the application of the therapeutic energy to the tissue at the cervico-vaginal junction CVJ need only travel to the return electrode member 242 inserted into the cervix lumen L, rather than as in a conventional colpotomy procedure: the therapeutic energy must travel all the way to the skin before returning to the electrosurgical generator.

[0064] Additionally, the location of the return electrode member 242 within the cervix lumen L can be an advantageous location to collect therapeutic energy for other steps in a hysterectomy procedure other than colpotomy. The location of the return electrode member 242 in the lumen L of the cervix C can also be advantageously used for other procedures, including abdominal procedures, such as but not limited to rectal, colon, or bladder, as such organs are in proximity to the cervix C or uterus U.

[0065] FIG. 5 、 FIG. 6 、 FIG. 7A 、 FIG. 7B and FIG. 8 illustrate various configurations of return electrode members that can be used with the return electrode member 242 described in FIG. 2 to FIG. 4 . For example, FIG. 5 is a schematic illustration of an isometric view of a second example of a return electrode member 542 that can be used with the end effector described herein. The return electrode member 542 can form an anchor configured to inhibit proximal egress of a distal end portion of the end effector (e.g., 314, uterine manipulator 224, FIG. 3 ) through the lumen L of the cervix C when the end effector is positioned in situ. The return electrode member 542 can have a bore 547 extending from a proximal end portion 547A to a distal end portion 547B to receive the uterine manipulator (224, FIG. 3 ) therethrough. In other examples, the return electrode member 542, as well as the return electrode members described in FIG. 6 、 FIG. 7A 、 FIG. 7B and FIG. 8 may be positioned on or formed as part of the uterine manipulator (e.g., 224) with or without a colpotomy cup (e.g., 225).

[0066] As FIG. 5As shown, the return electrode member 542 can include an outwards-restricting shape, such as a tapered cylinder or cone. The shape of the tapered cylinder can be configured to anchor the return electrode member relative to the lumen of the cervix. Other tapered shapes can be provided, such as but not limited to, a pyramid, a sphere, a cube, a fluted shape, and an irregular shape.

[0067] FIG. 6 is a schematic illustration of an isometric view of a third example of a return electrode member 642 in the form of an anchor (e.g., an electrode anchor) that can be used with the end effectors described herein. As shown, the return electrode member 642 can include a barb 643. The barb 643 can be shaped to allow easy insertion but restrict (though not completely prevent) egress once inserted. The return electrode member 642 can have a bore 647 extending from a proximal end portion 647A to a distal end portion 647B to receive a uterine manipulator (224, FIG. 6 ) through the bore. FIG. 3

[0068] FIG. 7A and FIG. 7B is a schematic illustration of an isometric view of a fourth example of a return electrode member 742 in the form of an anchor (e.g., an electrode anchor) that can be used with the end effectors described herein. FIG. 7A shows the return electrode member 742 in a first state, and FIG. 7B shows the return electrode member 742 in a second state. The return electrode member 742 can include a tube having a slot 745 that is deformable to change the return electrode member 742 from the first state to the second state. The change from the first state to the second state can be caused by, for example, mechanical actuation or electrical actuation. In an example, a proximal end portion 747A of the return electrode member 742 can be fixed to, for example, FIG. 3 the colpotomy cup 325 in FIG. 1, while a distal end portion 747B of the return electrode member 742 is movable relative to the colpotomy cup 225. When at least one cable 749 is pulled distally as shown in FIG. 2B, the distal end portion 747B can move proximally, thereby deforming the return electrode member 742. The return electrode member 742 can deform to cause a change in cross-section in a plane perpendicular to the longitudinal axis Al FIG. 7B ), for example, from a first diameter Dl to a second diameter D2, though the cross-section need not be circular. The return electrode member 742 can have a bore 747 extending from the proximal end portion 747A to the distal end portion 747B to receive a uterine manipulator (224, FIG. 3 ) through the bore. FIG. 3

[0069] FIG. 8 ​​is a schematic illustration of an isometric view of a fifth example of a return electrode member 842 in the form of an electrode anchor that can be used with the end effectors described herein. FIG. 8 The return electrode member 842 is depicted in a first state and a second state. The return electrode member 842 can include a balloon 841 that can expand, for example, by a fluid that can be actuated by a user or a machine (e.g., at a control on a handle FIG. 1 ) to change a size and shape of the return electrode member 842. In examples, the inflation fluid can include a gas or a liquid, such as air, carbon dioxide, or saline or water. In some examples, to receive and transmit electrical energy, the balloon 841 can include at least one of: an electrically conductive material; an electrically conductive material disposed on the balloon 841; an electrically conductive material impregnated into or disposed as a mesh around the balloon 841. The return electrode member 842 can have a bore 847 extending from a proximal end portion 847A to a distal end portion 847B to receive a uterine manipulator (224, FIG. 3 ) through the bore.

[0070] As shown in FIG. 7A to FIG. 7B and FIG. 8 , the return electrode members 742, 842 can form an anchor (e.g., an electrode anchor) that can be actuatable to change from a first state to a second state. In the first state, the return electrode members 742, 842 can be configured to be inserted into the lumen L of the cervix C FIG. 4 ). In the second state, the return electrode members 742, 842 can be configured to inhibit removal of the inserted return electrode members 742, 842 proximally relative to the lumen L of the cervix C. In some examples, the return electrode members 742, 842 can have a first size in the first state and a second size in the second state, where the second size is greater than the first size. In some examples, the return electrode members 742, 842 can have a first diameter D1 in the first state and a second diameter D2 in the second state. The first diameter D1 can be less than the second diameter D2. In some examples, the first state can be described as a collapsed state and the second state can be described as an expanded state. The return electrode members 742, 842 can pass more easily through the lumen L of the cervix C in the collapsed state than in the expanded state. For example, the return electrode members 742, 842 can have a smaller diameter or other cross-section along a plane perpendicular to the longitudinal path A1 FIG. 4 ) than in the expanded state.

[0071] are described together FIG. 9 and FIG. 10 . FIG. 9is a schematic diagram of a surgical system 900 including an electrosurgical generator 940 (hereinafter, generator 940) and a cross-sectional view of a female anatomy with a fourth example of an end effector 914 inserted into a cervix C. Also shown and described in FIG. 10 are features related to FIG. 9 . FIG. 10 is a schematic block diagram of the surgical system 900 including the generator 940 and connections to a patient 1 during use. Like reference numbers can refer to like elements, and therefore not all elements can be described in further detail. FIG. 9

[0072] The movable uterine manipulator 924 of the end effector 914 can include an elongated shaft 924A that can be inserted into an opening of the cervix C and through the lumen L of the cervix C into the uterus U. The uterine manipulator (e.g., 924) can be configured to allow a surgeon to move around the uterus U during a surgical procedure to provide access to a location to be resected. The uterine manipulator 924 can include a return electrode member 942 coupled to the elongated shaft 924A.

[0073] The return electrode member 942 can include a split return electrode 942A. The split return electrode 942A can provide a variety of benefits. Some benefits of the split return electrode include returning current to the generator 940, as part of a return electrode monitoring (REM) system for monitoring whether the split return electrode member 942A is in sufficient contact with tissue and determining whether the end effector 914 is properly inserted and positioned. Determining whether the end effector 914 is properly inserted into the patient 1 can include providing the end effector 914 including the uterine manipulator 924 having a split return electrode 942A configured to sense when the elongated shaft 924 of the uterine manipulator is positioned in situ at a desired location. The desired location (e.g., treatment location, surgical location, resection location, therapy location) can include at least in part a location of the split return electrode at which a desired threshold of contact with tissue has been met or exceeded. The desired threshold of contact can be a predetermined threshold of contact. These features and other features are described further herein, particularly with reference to FIG. 9 to FIG. 11 .

[0074] The split return electrode 942A can have a first return electrode 944 and a second return electrode 946. The split return electrode 942A can be configured to be electrically coupled to the generator 940, for example, with FIG. 2 and FIG. 3 ​The electrosurgical generator 240 shown in FIG. 9 is similar or identical to the monopolar generator 240 shown in FIG. 1. The generator 940 can include an active output terminal 962, an active lead 964, a first return lead 966A, a second return lead 966B, and a return terminal 968.

[0075] The split return electrode 942A has advantages that can be used for return electrode monitoring (REM). See also U.S. Patent No. 6,179,665, which is incorporated herein by reference in its entirety. FIG. 10 The generator 940 circuitry is described. The REM system 970, which includes circuitry in the generator 940, can monitor the area of contact between the patient 1 and the first electrode 944 and the second electrode 946 by monitoring one or more electrical characteristics of the first electrode 944 and the second electrode 946. By monitoring the signals sent to and received from the split return electrode 942A, the REM system 970 can prevent tissue damage caused by incomplete contact or contact interruption between the split return electrode 942A and the tissue of the patient (e.g., the cervix C, the uterus U). If the REM system 970 determines from the monitored electrical characteristics that contact with the patient 1 is insufficient, the generator 940 can prevent delivery of energy to the active electrode 316A (or alternatively 216A, 216) of the cutting device 316.

[0076] The split return electrode 942A can be monitored by the generator 940 to determine the degree of contact with the patient 1. In one non-limiting example for purposes of illustration, the REM system 970 can form a resonant system with the split return electrode 942A, which can resonate at a particular interrogation frequency. The REM system 970 can detect the signal in response to a drive signal (e.g., a monitoring signal) provided at a predetermined clock frequency, for example, from the controller 980 FIG. 10 ). Thereafter, the REM system 970 can generate a voltage indicative of the resonance. When the impedance between the first return electrode 944 and the second return electrode 946 changes, the resonance of the REM system 970 also changes, which causes the amplitude to change. By monitoring the change in amplitude, the REM system 970 can determine the magnitude of the impedance between the first electrode 944 and the second electrode 946, which reflects the level of contact of the first electrode 944 and the second electrode 946 with the patient 1. In particular, the magnitude of the impedance can be indicative of the contact of the first electrode 944 with the interior portion of the uterus U and the contact of the second electrode 946 with the lumen L of the cervix C FIG. 9 ). In some examples, each of the first electrode 944 and the second electrode 946 can be arranged to contact either or both of the cervix C and the uterus U.

[0077] In other examples, the REM system 970 in the generator 940 can measure not only the magnitude of the impedance, but also the voltage V, the current I, and the phase relative to the frequency of the waveform This allows the REM system 970 to measure a shift in frequency as well as a shift in amplitude. The shift in frequency can be indicative of a shift in reactance across the REM system 970. The reactance can provide a measure of contact of the separate return electrode 942A with the cervix C and uterus U tissue. As the separate return electrode 942A is inserted into the patient's cervix C and uterus U, the reactance (e.g., capacitance) can change the resonant frequency of the REM system 970. Detection of the reactance can be used as an indicator of the amount of contact of the separate return electrode 942A, and thus the amount of contact of the uterine manipulator 924 with the uterus U and cervix C. In some examples, reference is made to FIG. 9 The separate return electrode 942A described can replace any other return electrode described herein, for example, the return electrode of reference FIG. 2 to FIG. 4 In other words, the return electrode member 242 in FIG. 2 and FIG. 3 may incorporate the separate return electrode 942A features.

[0078] As shown in FIG. 9 , the separate return electrode 942A can include a first electrode 944 and a second electrode 946. The second electrode 946 can be located proximal to the first electrode 944. The first electrode 944 or the second electrode 946 (as well as any return electrode described herein) can extend circumferentially around the uterine manipulator 924, however, this is not required. In some examples, the separate return electrode 942A need not encircle the uterine manipulator 924, or as applied to the example of FIG. 2 to FIG. 3 , the separate return electrode need not encircle the protrusion 258. The first electrode 944 can have a first surface area and the second electrode 946 can have a second surface area. In some examples, the first surface area and the second surface area can be equal or substantially equal. In examples of FIG. 9 , the first surface area is greater than the second surface area, for example, in a range of at least 20% to 200% greater, and possibly more preferably 50% to 150% greater. Such an arrangement can result in a uterine manipulator 924 where, when the end effector 914 is positioned in situ at a surgical site as shown in FIG. 9 , the first electrode 944 can be configured to be located mostly or entirely in the cervix C or uterus U, and the second electrode 946 can be configured to be located mostly or entirely in the cervix C. In other examples, the first surface area can be less than the second surface area.

[0079] Further as shown in FIG. 9As shown, the first electrode 944 can have a first longitudinal length LI extending along a longitudinal path of the elongate shaft 924A (which can be a longitudinal axis Al, but need not be an axis), and the second electrode 946 can have a second longitudinal length L2 extending along a longitudinal path (which can be a longitudinal axis Al, but need not be an axis). The first longitudinal length LI can be equal to or substantially equal to the second longitudinal length L2. However, as shown in the example of FIG. 9, the first longitudinal length LI can be greater than the second longitudinal length L2. In other examples, the first longitudinal length LI can be less than the second longitudinal length L2. FIG. 9

[0080] The split return electrode 942A can return energy to the generator 940 and can also function in monitoring contact of the return electrode 942 with tissue. In addition, the split return electrode 942A can provide other benefits that cannot be achieved with a traditional return electrode or a traditional split return electrode pad. For example, FIG. 9 The split return electrode 942A in combination with the generator 940 REM system 970 (e.g., circuitry) can also monitor the position of the end effector 914 and can determine when the uterine manipulator 924 or the colpotomy cup 925 is in a desired position, such as fully or completely inserted into the patient 1, such as the distal end portion (e.g., rim) of the cup fully or completely delineating the vaginal vault, or the split return electrode 942A is fully or completely in contact with tissue.

[0081] For example, when the uterine manipulator 924 is inserted in situ with the colpotomy cup 925 in contact with a target anatomical structure (e.g., the vaginal vault VF, the cervix C, the lumen L of the cervix, the cervico-vaginal junction CVJ, or tissue proximate the cervix C FIG. 1 ), the second return electrode 944 can be configured to contact the lumen L of the cervix C. In this arrangement, an electrical property (such as, but not limited to, impedance or reactance) can change depending on the position of the uterine manipulator 924 relative to the anatomy of the patient 1. By monitoring the signals to and from the split return electrode 942A, the generator 940 can determine whether the first electrode 944 and / or the second electrode 946 are in a desired position, such as in contact with the lumen L of the cervix C. Upon determining that the split return electrode 942A is in contact with the lumen L of the cervix C, the surgical generator 940 can allow the delivery of therapeutic energy to the active electrode 316A (or in alternative examples, the active electrode 216A). However, if it is determined that the first electrode and / or the second electrode 946 are not in contact with the lumen L of the cervix C, or if the electrical property, such as the impedance or reactance value, does not meet or cross a threshold, the generator 940 can inhibit the delivery of therapeutic energy to the active electrode 316 (or in alternative examples, the active electrode 216A, see FIG. 9 ​The delivery of therapeutic energy to the active electrode (316A or 216A) is suppressed when the end effector 914 is not fully inserted, reducing the risk of heating tissue near the separation return electrode 942A above the desired temperature.

[0082] Generator 940 may include a user interface 960 to allow a user to control generator 940 and provide indications or display outputs to the user. In some examples, user interface 960 may include, but is not limited to, a display, input knob, keypad, touchscreen, and audible, visual, or tactile alarms. User interface 960 may allow a user to adjust the power, waveform, and other parameters of the RF energy to achieve a desired waveform for a specific type of tissue treatment.

[0083] FIG. 10 yes FIG. 9 A schematic block diagram of a surgical system 900, which includes a generator 940 and a connection to the patient 1 during use. Although relative to... FIG. 9 Includes FIG. 3 and FIG. 9 The end effector 914 of the integrated cutting device 316 described herein is illustrated in a schematic block diagram, but in some examples, FIG. 9 The integrated cutting device 316 can be omitted and replaced with FIG. 2 The standalone monopolar electrosurgical device 216 described in [the text] (in [the text]) FIG. 9 (Seen in dashed lines). Whether the active electrode 316A is provided as an integrated cutting device 316 or as an alternative, a separate monopolar electrosurgical device 216 with an active electrode 216A, the active electrode 316A (or 216A) can be coupled to the active output terminal 962 of the generator 940. Further description is given with reference to the cutting device as an integrated cutting device 316 with an active electrode 316A. The generator 940 can supply electrosurgical RF energy to the active electrode 316A via an active lead 964 (e.g., an electrosurgical cable) connected to the active output terminal 962, thereby enabling the active electrode 316A to treat tissue. This energy is returned to the generator 940 via a separation return electrode 942A via a first lead 966A and a second lead 966B to the return terminal 968. Additionally, the generator 940 can be configured to monitor the degree of contact between the cervix C or the uterus U to confirm sufficient contact between the separation return electrode 942A and the tissue, thereby minimizing the possibility of tissue damage.

[0084] The generator 940 can include a controller 980, a DC power supply 982, and an RF output stage 984 that converts the DC power to RF energy and delivers the RF energy to the active electrode 316A. The RF output can generate a sinusoidal waveform with high RF energy. The RF output can generate multiple waveforms with various suitable parameters for different types of electrosurgical treatments.

[0085] The controller 980 can include a processor 986 (e.g., processing circuitry) that is electrically connected to a memory 988 (e.g., a non-transitory computer readable medium, RAM). The processor 986 can be operably connected to the power supply 982 and the RF output stage 984 to enable the processor 986 to control the output of the generator 940 according to an open or closed loop scheme.

[0086] The generator 940 can include a REM system 970 with a detection circuit 990 that can be coupled to the first and second electrodes 944, 946 of the split return electrode 942A of the end effector 914. The end effector 914, when inserted into the patient 1 through the vaginal canal, can return electrosurgical energy from the first and second electrodes 944, 946 to the generator 940 via the first and second lead wires 966A, 966B. In at least one illustrative example, the first and second lead wires 966A, 966B can be coupled in one return line and can terminate at a secondary winding 995 of a transformer 992. The first and second lead wires 966A, 966B can be connected by a capacitor 994 and a capacitor 996. A return lead 998 can be coupled between the capacitor 994 and the capacitor 996 and can be configured to return the treatment electrosurgical energy to the RF output stage 984. The transformer 992 can also include a primary winding electrically connected to the detection circuit 990. The REM system 970 can also include a sensor, such as a voltage sensor 991 or a current sensor 993 on the primary side of the transformer 992.

[0087] The components of the REM system 970, such as the transformer 992, the first and second electrodes 944, 946, the capacitor 994, the capacitor 996, and the detection circuit 990, can form a resonant system that is adapted to resonate at a particular interrogation frequency from the controller 980. For example, the controller 980 can provide a drive signal REM CLK to the detection circuit 990 at a particular interrogation frequency. The drive signal REM CLK is a clock signal generated by the controller 980 at a desired frequency. The drive signal can be a constant, physiologically benign waveform that the detection circuit 990 transmits to the first electrode 944. The drive signal can then pass through the patient, be collected by the second electrode 946, and returned to the detection circuit 990. The detection circuit 990 can then measure a response signal for the drive signal and monitor changes in the received response signal.

[0088] The response signal (e.g., return drive signal) is modified by the impedance of the first electrode 944 and the second electrode 946. As the impedance between the first electrode 944 and the second electrode 946 changes due to movement of the end effector 914 along the vaginal path, the resonance of the detection circuit 990 relative to other components also changes. The change in resonance, in turn, affects a change in the amplitude of the drive signal. Thus, detection is performed between the first electrode 944 and the second electrode 946 by monitoring the change in amplitude of the drive signal. The detection circuit 990 then provides the impedance measurement to the controller 980, which determines whether the impedance is within a predetermined range. If the impedance is outside the range or exceeds one or more thresholds, which can indicate that the end effector 914 is at or beyond a proper position or does not have the desired contact with tissue, the controller 980 can send instructions to the user interface 960 to alert the user with an alarm or indicator. The controller 980 can also adjust the output of the generator 940, for example, to allow delivery of therapeutic energy if the end effector 914 is in a treatment position or has sufficient contact with tissue, or can prohibit delivery of therapeutic energy to the electrodes 916A of the cutting device 916 if the end effector 914 is not in a desired position, such as a treatment position or site FIG. 9 ) of the patient. In some examples, the controller 980 can send a query to the user as to whether they wish to allow delivery of therapeutic energy based at least in part on the alarm or indicator (e.g., operator override).

[0089] The above-described operation of the detection circuit 990 using a single frequency signal enables measurement of relative changes in impedance magnitude. In other examples, the REM system 970 can monitor the split return electrode 942A in any manner known in the art. In one such other example, the detection circuit 990 can track the frequency response of the REM system 970 and determine the complex impedance across it. Impedance can describe not only the relative magnitudes of voltage and current, but also the relative phase. Impedance is a “complex” value, which can include a portion related to resistance and a portion related to reactance. The generator 940 can use any suitable detection circuit 990 to monitor the split return electrode 942A to determine whether the end effector 914 is fully inserted into the vaginal cavity.

[0090] While memory 988 is illustrated in an example implementation as a single machine-readable medium, the term “machine-readable medium” can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) that store the one or more sets of instructions FIG. 9 and FIG. 10 methods of the surgical system 900, for example, for performing procedures such as FIG. 11The method 1100 described herein includes one or more instructions. The term "machine-readable medium" should also be understood to include any tangible medium capable of storing, encoding, or carrying instructions that are executed by a machine and cause the machine to perform any one or more methods of this disclosure, or any tangible medium capable of storing, encoding, or carrying data structures used by or associated with such instructions. Therefore, the term "machine-readable medium" should be understood to include, but is not limited to, solid-state memory, as well as optical and magnetic media. Specific examples of machine-readable media include non-volatile memory, such as, but not limited to, semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), and flash memory devices); magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0091] FIG. 11 This is a flowchart of a method for determining the in-situ location of a transvaginal medical device, and in some steps, it uses... FIG. 9 and FIG. 10 The surgical system 900 performs the relevant treatment method. Method 1100 can be used to place a uterine device or perform tissue resection surgery, including but not limited to vaginoplasty. Method 1100 can be performed by a generator 940, such as by a controller 980 including a processor 986 and a memory 988.

[0092] In some examples, aspects of any of the end effectors 14, 214, 314, and 914, and aspects of any of the cutting devices 216 or 316, can be used with method 1100; however, method 1100 can also be used with other surgical systems. Similarly, FIG. 9 and FIG. 10 The surgical system 900 can be used in conjunction with other methods. The exemplary methods of this disclosure are particularly suitable for surgeries where there is limited visibility of the tissue to be removed and adjacent anatomical structures, such as laparoscopic surgery.

[0093] Step 1110 may include: issuing a drive signal (e.g., a monitoring signal) to be received by a disconnection return electrode located on an end effector, such as a uterine device.

[0094] Step 1120 may include: receiving the returned drive signal (e.g., at least a portion of the emitted drive signal) from the disconnected return electrode (e.g., after the drive signal has passed through the patient's tissue).

[0095] Step 1130 can include monitoring an electrical characteristic of the separate return electrode based on the issued drive signal and the returned drive signal to determine whether the electrical characteristic is within a predetermined range or has surpassed a threshold. In some examples, the range or threshold can indicate that the end effector is fully inserted, not inserted, not fully inserted, incorrectly inserted, or position is indeterminable. Any number of ranges or thresholds can be provided to convey various conditions of the position and location of the end effector. The monitored electrical characteristic can include any suitable electrical characteristic such as, but not limited to, impedance, reactance, voltage, current, or phase.

[0096] Step 1140 can include that based on the electrical characteristic surpassing the threshold or reaching the predetermined range, the method can include allowing a second signal to be issued to the active electrode. The second signal can be a tissue treatment signal.

[0097] Other steps of the method 1100 can include issuing an indication signal to an indicator to indicate that the uterine device is in a desired position (e.g., a predetermined position, a treatment position, a surgical position, an ablation position, a therapeutic position, a position of the separate return electrode that has met or surpassed a desired contact threshold with tissue) based at least in part on the monitored electrical characteristic surpassing the threshold or entering the predetermined range. The desired contact threshold can be a predetermined contact threshold.

[0098] Variations of the method 1100 are not limited to a colposcopy procedure, the method 1100 can be used to directly in situ guide an end effector in other procedures to determine whether the end effector is located in a treatment position. For example, as in determining whether a uterine ablation device is inserted in situ.

[0099] FIG. 12 is a schematic illustration of an isometric view of a fourth example of an end effector 1214 including a return electrode member 1242. In addition to the return electrode member positions described above, FIG. 1 to FIG. 10 The return electrode member 1242 can be positioned on an inner surface 1251 of a colposcopy cup 1225 so as to be in contact with the exterior / sides of the cervix C when inserted transvaginally and positioned at the cervico-vaginal junction (CVJ, FIG. 1 ) in situ treatment position.

[0100] In other words, the colposcopy cup 1225 can form a cutting guide extending from a proximal end to a distal end and can include a perimeter return electrode 1242 around the opening, where the perimeter return electrode 1242 can be configured to be electrically connected to an electrosurgical generator (e.g., FIG. 4 240 in FIG. 1; FIG. 9The return electrode member 1242B can be positioned on the inner surface 1251 of the episiotomy cup 1225. Any of the aspects of the return electrode members described herein can be applied to the return electrode member 1242B. In some examples, the return electrode member 1242B can be positioned on the outer surface 1253 of the episiotomy cup 1225 or on the distal end of the episiotomy cup, for example on the rim as shown by return electrode member 1242C.

[0101] Benefits of the systems and methods of the present disclosure can include: 1) improved positioning of the midline return electrode for abdominal surgery, for example, uterine surgery; 2) improved accuracy of the episiotomy cup against the uterus or ensuring full insertion of the uterine manipulator; and 3) improved tissue resection devices, which reduces the likelihood of inadvertent injury to adjacent tissue, for example, injury to the bowel or bladder in episiotomy.

[0102] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of the like components. The drawings illustrate generally, by way of example, various embodiments discussed in the present document.

[0103] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the application can be practiced. These embodiments are also referred to as "examples." Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those shown or described herein, or any other examples of the elements in the examples (or one or more aspects thereof), as well as examples using any other component.

[0104] In this document, the terms“a” or“an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of“at least one” or“one or more.” In this document, the term“or” is used to refer to a nonexclusive or, such that“A or B” includes“A but not B,”“B but not A,” and“A and B,” unless otherwise indicated. In this document, the terms“including” and“comprising” are used as the plain English equivalents of the respective terms“including” and“comprising.” Also, in the following claims, the terms“including” and“comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms“first,”“second,” and“third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0105] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used in addition to those described specifically herein, per the general knowledge of the skilled artisan after reviewing the above description. This Summary is provided to give a quick overview of the technical disclosure. The Summary is submitted without loss of generality so that the reader can quickly determine the substance of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or the meaning of the claims. In addition, in the above Detailed Description, various features can be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This should not be interpreted as intending that the claimed subject matter requires features to be used in any combination. Rather, inventive subject matter can be practiced without all features of a particular disclosed embodiment. Accordingly, the appended claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment, which can be used in combination with other claims. The scope of the application should be determined, not with reference to the above description, but rather with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0106] Various annotations and examples

[0107] Example 1 is a uterine manipulator comprising: an elongated shaft comprising a distal portion configured to be inserted into a uterus through a lumen of a cervix; and a separate return electrode coupled to the elongated shaft, wherein the separate return electrode is configured to be electrically coupled to an electrosurgical generator.

[0108] In Example 2, the subject matter of Example 1 includes, wherein the separate return electrode is configured to sense when the elongated shaft is in a treatment position.

[0109] In Example 3, the subject matter of Examples 1-2 includes, wherein the split return electrode comprises a first electrode and a second electrode, and wherein the second electrode is located proximally of the first electrode.

[0110] In Example 4, the subject matter of Examples 1-3 includes, wherein the split return electrode comprises a first electrode and a second electrode, and wherein the first electrode has a first surface area and the second electrode has a second surface area, wherein the first surface area is greater than the second surface area.

[0111] In Example 5, the subject matter of Examples 1-4 includes, wherein the split return electrode comprises a first electrode located distally of a second electrode, and wherein the first electrode has a first longitudinal length extending along a longitudinal path of the elongate shaft, and wherein the second electrode has a second longitudinal length extending along the longitudinal path, and wherein the first longitudinal length is greater than the second longitudinal length.

[0112] In Example 6, the subject matter of Examples 1-5 includes a colpotomy cup, wherein the split return electrode comprises a first electrode and a second electrode, and wherein the second electrode is configured to contact a lumen of a cervix when the distal portion is inserted in situ with the colpotomy cup in contact with the cervix.

[0113] Example 7 is a method of determining an in situ position of a uterine device insertable transvaginally, the method comprising: emitting a drive signal to be received by a split return electrode located on the uterine device; receiving at least a portion of the emitted drive signal from the split return electrode; monitoring an electrical characteristic of the split return electrode based on the emitted drive signal and the received at least a portion of the emitted drive signal to determine whether a threshold has been exceeded; and based at least in part on the threshold being exceeded, allowing a second signal to be emitted to an active electrode.

[0114] In Example 8, the subject matter of Example 7 includes, wherein based at least in part on the monitored electrical characteristic exceeding the threshold, a signal is emitted to a user interface to indicate that the uterine device is in a treatment position.

[0115] In Example 9, the subject matter of Examples 7-8 includes, wherein the split return electrode comprises a first electrode and a second electrode, and wherein the first electrode is located distally of the second electrode along an elongate shaft of the uterine device.

[0116] In Example 10, the subject matter of Examples 7-9 includes, wherein monitoring the electrical characteristic comprises: monitoring an impedance of the split return electrode.

[0117] In Example 11, the subject matter of Examples 7-10 includes, wherein the uterine device is a uterine manipulator.

[0118] In Example 12, the subject matter of Examples 7-11 includes, wherein the uterine device is a colpotomy cup device.

[0119] Example 13 is a tissue resection system comprising: a uterine manipulator comprising an elongated shaft having a distal portion configured to be inserted into a uterine cavity through a cervical canal; a split return electrode coupled to the elongated shaft, the split return electrode having a first electrode and a second electrode, the split return electrode configured to be electrically coupled to an electrosurgical generator; a colpotomy cup coupled to the elongated shaft, the colpotomy cup configured to be positioned in situ around a cervix, wherein a distal portion of the colpotomy cup is configured to delineate a target tissue to be treated; and a cutting device comprising an active electrode for treating the target tissue, the cutting device configured to be electrically connected to an output of the electrosurgical generator.

[0120] In Example 14, the subject matter of Example 13 includes, wherein the colpotomy cup is configured to be delivered transvaginally to a first surface of the target tissue, and the cutting device is configured to be delivered laparoscopically to a second surface of the target tissue opposite the first surface.

[0121] In Example 15, the subject matter of Examples 13-14 includes, wherein the cutting device is coupled to the colpotomy cup and is actuatable to move along a perimeter of the colpotomy cup to treat the target tissue.

[0122] In Example 16, the subject matter of Examples 13-15 includes the electrosurgical generator, wherein the electrosurgical generator is configured to: issue a drive signal to the split return electrode; receive at least a portion of the issued drive signal from the split return electrode; monitor an electrical characteristic of the split return electrode based on the issued drive signal and the received at least a portion of the issued drive signal to determine whether a threshold has been exceeded; and based at least in part on the threshold being exceeded, allow a second signal to be issued to the active electrode.

[0123] Example 17 is an end effector of a tissue treatment device comprising: a uterine manipulator comprising an elongated shaft having a distal end portion, wherein the distal end portion is configured to be inserted into a cervical canal; and a colpotomy cup coupled to the uterine manipulator, the colpotomy cup comprising: a cutting guide having an outer wall portion and a base portion supporting the outer wall portion, the outer wall portion configured to enclose at least a portion of a cervix, the outer wall portion extending along a longitudinal path from a first proximal end portion to a first distal end portion; and a projection extending distally away from the base portion, the projection laterally spaced apart from the outer wall portion and extending along the longitudinal path, wherein the projection is configured to be inserted into the cervical canal, and wherein the projection comprises a return electrode member configured to be electrically connected to an electrosurgical generator.

[0124] In Example 18, the subject matter of Example 17 includes, wherein the return electrode member includes an anchor, wherein the anchor is configured to inhibit egress of a distal portion of the anchor through a lumen of the cervical canal when positioned in situ.

[0125] In Example 19, the subject matter of Examples 17-18 includes, wherein the return electrode member is actuatable to change from a first state to a second state, wherein, in the first state, the return electrode member is configured to be inserted into the lumen of the cervical canal, and wherein, in the second state, the return electrode member is configured to inhibit proximal removal of the inserted return electrode member relative to the lumen of the cervical canal.

[0126] Example 20 is an end effector of a tissue treatment device, comprising: a uterine manipulator including an elongated shaft extending from a proximal end portion to a distal end portion, wherein the distal end portion is configured to be inserted into a lumen of a cervical canal; a colpotomy cup coupled to the elongated shaft; and a return electrode member coupled to the colpotomy cup, the return electrode member configured to be electrically coupled to an electrosurgical generator, wherein the return electrode member is actuatable to change from a first state to a second state, wherein, in the first state, the return electrode member is configured to be inserted into the lumen of the cervical canal, and wherein, in the second state, the return electrode member is configured to inhibit proximal removal of the inserted return electrode member relative to the lumen of the cervical canal.

[0127] In Example 21, the subject matter of Example 20 includes, wherein the colpotomy cup further comprises: an outer wall portion configured to enclose at least a portion of the cervical canal, the outer wall portion extending along a longitudinal path from a first proximal end portion to a first distal end portion; and a base portion coupled to the outer wall portion, wherein the return electrode member is laterally spaced apart from the outer wall portion and coupled to the outer wall portion by the base portion.

[0128] In Example 22, the subject matter of Examples 20-21 includes, wherein the first state is a collapsed state, and wherein the second state is an expanded state.

[0129] In Example 23, the subject matter of Examples 20-22 includes, wherein the return electrode member has a first size in the first state and a second size in the second state, and wherein the second size is greater than the first size.

[0130] In Example 24, the subject matter of Examples 20-23 includes, wherein the return electrode member has a first diameter in the first state and a second diameter in the second state.

[0131] In Example 25, the subject matter of Examples 20-24 includes, wherein the return electrode member includes an inflatable balloon.

[0132] In Example 26, the subject matter of Examples 20-25 includes, wherein the return electrode member comprises a barb.

[0133] In Example 27, the subject matter of Examples 20-26 includes, wherein the return electrode member comprises a slotted tube that is actuatable to change from a first state to the second state.

[0134] In Example 28, the subject matter of Examples 20-27 includes, wherein the return electrode member comprises a tapered cylinder configured to anchor at least a portion of the return electrode member relative to a lumen of the cervix.

[0135] Example 29 is an end effector of a tissue treatment device, comprising: an elongated shaft extending from a proximal end portion to a distal end portion, wherein the proximal end portion is manipulatable by a user or machine to deliver the distal end portion to a treatment site, and wherein the distal end portion is configured to be inserted into a lumen of a cervix; and a return electrode coupled to the distal end portion, wherein the return electrode is configured to be electrically coupled to an electrosurgical generator, and wherein the return electrode is configured to inhibit proximal movement of the elongated shaft relative to the lumen of the cervix when the return electrode is positioned in the lumen of the cervix.

[0136] In Example 30, the subject matter of Example 29 includes: a cutting device comprising an active electrode; and a cutting guide coupled to the elongated shaft, wherein the cutting guide is configured to support the cutting device.

[0137] In Example 31, the subject matter of Examples 29-30 includes: a first cutting guide having a first distal peripheral portion; a second cutting guide having a second distal peripheral portion, the second cutting guide being positioned around the first cutting guide; and a cutting device comprising an active electrode positioned between the first cutting guide and the second cutting guide, wherein the cutting device is movable relative to at least one of the first distal peripheral portion and the second distal peripheral portion.

[0138] Example 32 is a tissue resection system, comprising: a cutting device comprising an active electrode configured to receive a signal from a surgical generator; and a cutting guide configured to be inserted into a patient, the cutting guide extending from a proximal end to an opening at a distal end, wherein the distal end comprises a peripheral return electrode around the opening, wherein the peripheral return electrode is configured to be electrically connected to the electrosurgical generator.

[0139] Example 33 is at least one machine readable medium comprising instructions, which when executed by processing circuitry, cause the processing circuitry to perform operations to implement any of Examples 1 to 32.

[0140] Example 34 is an apparatus comprising means to implement any of Examples 1 to 32.

[0141] Example 35 is a system to implement any of Examples 1 to 32.

[0142] Example 36 is a method to implement any of Examples 1 to 32.

Claims

1. A uterine manipulator, comprising: An elongated shaft, the elongated shaft including a distal portion configured to be inserted into the uterus through a lumen of the cervix; as well as A vaginal incision cup, the vaginal incision cup being connected to the elongated shaft, and including an outer wall portion, a base portion supporting the outer wall portion, and a protrusion extending distally away from the base portion. in: The protrusion is configured to be inserted into the lumen of the cervix; The protrusion includes a separation return electrode, which includes a first electrode and a second electrode located proximal to the first electrode; Each of the first electrode and the second electrode is configured to be electrically connected to an electrosurgical generator to receive monitoring signals and return response signals, which can be used to determine the level of contact between the first electrode and the second electrode and the cervix; Each of the first and second electrodes is further configured to receive electrical signals from the active electrode via the cervix and return the electrical signals to the electrosurgical generator; and The elongated shaft is configured to pass through the protrusion.

2. The uterine manipulator according to claim 1, wherein, The level of contact can be used to identify the treatment location.

3. The uterine manipulator according to claim 1, wherein, The first electrode has a first surface area, and the second electrode has a second surface area, wherein the first surface area is larger than the second surface area.

4. The uterine manipulator according to claim 1, wherein, The first electrode has a first longitudinal length extending along the longitudinal path of the elongated axis, and the second electrode has a second longitudinal length extending along the longitudinal path, and the first longitudinal length is greater than the second longitudinal length.

5. A tissue resection system, comprising: A uterine manipulator, the uterine manipulator including an elongated shaft having a distal portion configured to be inserted into the uterus through a lumen of the cervix; A vaginal incision cup connected to the elongated shaft is configured to be positioned in situ around the cervix, wherein the distal portion of the vaginal incision cup is configured to delineate the target tissue to be treated. The vaginal incision cup has an outer wall portion, a base portion supporting the outer wall portion, and a protrusion extending distally away from its base portion. The elongated shaft passes through the protrusion, which is configured to be inserted into the lumen of the cervix, and the protrusion includes a separation return electrode having a first electrode and a second electrode. A cutting device, comprising an active electrode for treating the target tissue, the cutting device being configured to be electrically connected to the output of an electrosurgical generator. in: Each of the first and second electrodes is configured to be electrically connected to the electrosurgical generator to receive monitoring signals from the electrosurgical generator and return response signals to the electrosurgical generator, the response signals being usable to determine the contact level between the first and second electrodes and the cervix; and Each of the first electrode and the second electrode is also configured to receive electrical signals from the active electrode via the cervix and return the electrical signals to the electrosurgical generator.

6. The tissue resection system according to claim 5, wherein, The vaginal incision cup is configured to be delivered vaginally to a first surface of the target tissue, and the cutting device is configured to be delivered laparoscopically to a second surface of the target tissue opposite to the first surface.

7. The tissue resection system according to claim 5, wherein, The cutting device is coupled to the vaginal incision cup and can be actuated to move along the periphery of the vaginal incision cup to treat the target tissue.

8. The tissue resection system according to claim 5, further comprising the electrosurgical generator, wherein, The electrosurgical generator is configured to: A monitoring signal is sent to the separation return electrode, and Receive at least a portion of the emitted monitoring signal from the separated return electrode; and a controller configured to: The electrical characteristics of the separated return electrode are monitored based on at least a portion of the emitted monitoring signal and the received emitted monitoring signal to determine whether a threshold has been exceeded. as well as The delivery of therapeutic energy to the active electrode is permitted, at least in part, based on the threshold being exceeded.

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