This disclosure relates to hysterectomy and, more particularly, to systems for performing a colpotomy procedure.
Colpotomy, one of the final steps in a hysterectomy, requires making a circular incision in vaginal tissue to separate the uterus from the vagina with a cutting tool such as a electrosurgical instrument. This incision is typically performed with the aid of a uterine manipulator. Uterine manipulators are conventionally used during laparoscopic hysterectomy procedures to position the vagina and the cervix to facilitate separation and to enable removal of the uterus or other tissue specimens subsequent to performance of a colpotomy.
In accordance with an aspect of this disclosure, an electrosurgical colpotomy system includes an energy source and a uterine manipulator. The uterine manipulator extends to a distal tip and supports a colpotomy cup. The colpotomy cup has an active electrode in electrical communication with the energy source. The active electrode is positioned to simultaneously treat a circumference of tissue in contact therewith.
In aspect, the colpotomy cup may include one or more return electrodes positioned thereon in electrical communication with the active electrode. The one or more return electrodes may be disposed on an inner surface of colpotomy cup. The one or more return electrodes may be disposed on an outer surface of colpotomy cup. The distal tip may include an electrically conductive surface that is disposed in electrical communication with the active electrode. The electrically conductive surface of the distal tip may be configured to act as a return electrode.
In various aspects, the active electrode may be configured to axially translate relative to the colpotomy cup. The uterine manipulator may support a drive mechanism that is operably coupled to the active electrode. The drive mechanism may be actuatable to enable the active electrode to distally translate to a position that extends beyond a distal end face of the colpotomy cup.
In some aspects, the distal tip may support an inflatable balloon.
In various aspects, the colpotomy cup may include a platform assembly including elongated rods that longitudinally space the active electrode from a distal end face of the colpotomy cup.
According to another aspect, a robotic colpotomy system includes a robotic arm, an instrument drive unit supported on the robotic arm, and a uterine manipulator coupled to the instrument drive unit and defining a longitudinal axis. The uterine manipulator has a proximal housing assembly and an elongated shaft assembly that extends distally from the proximal housing assembly. The elongated shaft assembly supports a colpotomy assembly on a distal end portion thereof. The colpotomy assembly includes a colpotomy cup and extends distally to a distal tip. The colpotomy cup is rotatable relative to the proximal housing assembly in response to actuation of the instrument drive unit.
In aspects, the colpotomy cup may include one or more protrusions on a distal end face thereof. The one or more protrusions may be positioned to delineate a vaginal fornix as the colpotomy cup rotates about the longitudinal axis of the uterine manipulator.
In some aspects, the colpotomy cup may include lights positioned to rotate with the colpotomy cup. The lights may be positioned to delineate a vaginal fornix as the colpotomy cup rotates about the longitudinal axis of the uterine manipulator.
In aspects, the colpotomy cup may include one or more sidewalls and a tubular cutting member supported adjacent to the one or more sidewalls and rotatable relative to the one or more sidewalls.
In various aspects, the colpotomy cup may include a plurality of leaflets. The plurality of leaflets may be removably coupled to the distal tip. The plurality of leaflets may be coupled to a gear assembly that is rotatable relative to the distal tip to move the leaflets relative to one another.
According to still another aspect, a robotic colpotomy system includes a robotic arm, an instrument drive unit supported on the robotic arm, and a uterine manipulator supported on the robotic arm and defining a longitudinal axis. The uterine manipulator is coupled to the instrument drive unit and has an elongated shaft assembly. The elongated shaft assembly supports a colpotomy assembly on a distal end portion thereof. The colpotomy assembly includes a colpotomy cup and extends distally to a distal tip. The colpotomy cup is axially movable relative to the distal tip in response to actuation of the instrument drive unit.
According to yet another aspect, a robotic colpotomy system includes a robotic arm, an instrument drive unit supported on the robotic arm, and a uterine manipulator supported on the robotic arm and defining a longitudinal axis. The uterine manipulator is coupled to the instrument drive unit and has an elongated shaft assembly. The elongated shaft assembly supports a colpotomy assembly on a distal end portion thereof. The colpotomy assembly includes a colpotomy cup and extends distally to a distal tip. The distal tip is movable relative to colpotomy cup in response to actuation of the instrument drive unit.
In aspects, the colpotomy cup may include a plurality of leaflets, wherein the distal tip is axially movable relative to the colpotomy cup to move the plurality of leaflets from a first position to a second position. In aspects, the distal tip may rotate relative to the colpotomy cup to move the plurality of leaflets from a first position to a second position.
According to a further aspect, a colpotomy cup system includes a plurality of leaflets configured to define a diameter of the colpotomy cup and a cinch coupled to the plurality of leaflets. The cinch is actuatable to move the plurality of leaflets from a first position to a second position to change the diameter of the colpotomy cup.
In aspects, in the first position, adjacent leaflets of the plurality of leaflets may be spaced apart from one another, and in the second position, the adjacent leaflets may be positioned to contact one another.
According to still another aspect, a uterine manipulator includes an elongated shaft assembly and a colpotomy cup assembly supported on a distal end portion of the elongated shaft assembly. The colpotomy cup assembly includes a proximal colpotomy cup and a distal colpotomy cup nested within the proximal colpotomy cup. The proximal colpotomy cup extends radially outward to a first rim. The distal colpotomy cup extends radially outward to a second rim. The first and second rims are longitudinally spaced apart from one another and positioned to define an indentation therebetween. The indentation is configured to define an annular track positioned to guide an independent incising instrument therearound to effectuate a colpotomy incision.
Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims that follow.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of this disclosure and, together with a general description of this disclosure given above, and the detailed description given below, serve to explain the principles of this disclosure, wherein:
Aspects of this disclosure are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal” refers to that portion of structure farther from the user, while the term “proximal” refers to that portion of structure, closer to the user. As used herein, the term “clinician” refers to a doctor, nurse, or other care provider and may include support personnel.
In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
Robotic surgical systems have been used in minimally invasive medical procedures and can include robotic arm assemblies. Such procedures may be referred to as what is commonly referred to as “Telesurgery.” Some robotic arm assemblies include one or more robot arms to which surgical instruments can be coupled. Such surgical instruments include, for example, electrosurgical forceps, cutting instruments, staplers, graspers, electrocautery devices, or any other endoscopic or open surgical devices. Prior to or during use of the robotic surgical system, various surgical instruments can be selected and connected to the robot arms for selectively actuating end effectors of the connected surgical instruments. Some of these surgical instruments utilize electrical energy, for example, to effectuate electrocautery.
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Robotic colpotomy system 10 further includes an energy source such as an electrosurgical generator 50 that couples to uterine manipulator 100 and/or any number of other surgical instruments such as an electrosurgical probe or an electrocautery blade 60 via an electrosurgical cable 99 and a connector assembly 104 supported by sterile interface module 40 and/or proximal housing assembly 102 of uterine manipulator 100. For a more detailed description of one example of an electrosurgical generator, reference can be made to U.S. Pat. No. 8,784,410, the entire contents of which are incorporated by reference herein. For a more detailed description of one example of connector assembly 104, reference can be made to U.S. Patent Application No. 62/823,036, filed Mar. 25, 2019, and entitled “Robotic Surgical Systems with Electrical Switch of Instrument Attachment,” the entire contents of which are incorporated by reference herein. For a more detailed description of one example of an electrocautery blade 60, reference can be made to U.S. Pat. No. 8,128,622 or 8,460,289, the entire contents of each of which are incorporated herein by reference.
Robotic colpotomy system 10 employs various robotic elements to assist the clinician and allow remote operation (or partial remote operation) of surgical instrumentation such as uterine manipulator 100. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with robotic colpotomy system 10 to assist the clinician during the course of an operation or treatment, and which can be included with, and/or part of one or more drive mechanisms 106 of uterine manipulator 100, sterile interface module 40, and/or instrument drive unit 30. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
Robotic colpotomy system 10 includes a medical work station (not shown) that may be employed with one or more consoles positioned next to the operating theater or located in a remote location. In this instance, one team of clinicians may prep the patient for surgery and configure robotic colpotomy system 10 with uterine manipulator 100 while another clinician (or group of clinicians) remotely controls uterine manipulator 100 via the one or more consoles. As can be appreciated, a highly skilled clinician may perform multiple operations in multiple locations without leaving his/her remote console. This can be economically advantageous and a benefit to the patient or a series of patients. For a detailed description of exemplary medical work stations and/or components thereof, reference may be made to U.S. Pat. No. 8,828,023 and PCT Application Publication No. WO2016/025132, the entire contents of each of which are incorporated by reference herein.
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Robotic surgical system 10 can be in the form of an electrosurgical colpotomy system. In general, components of the electrosurgical colpotomy system can be used to effectuate a colpotomy. Briefly, when using a uterine manipulator for colpotomy during a laparoscopic hysterectomy, a colpotomy cup can be used as a backstop for a clinician to circumferentially cut along with a laparoscopic tool (e.g., radiofrequency or “RF” tool) around the uterus. To make such a circumferential cut uniform, the clinician is required to determine the location of a rim of the colpotomy cup. Indeed, to identify the exact location of the rim, the clinician may be required to repeatedly move the uterine manipulator as the cut is made. This movement can be cumbersome and/or time consuming, particularly when clinician must also coagulate and transect uterine arteries in order to minimize blood loss during the colpotomy.
In order to improve such colpotomy procedures, uterine manipulator 100, for instance, can be used to selectively treat (e.g., coagulate, cut, etc.) tissue “T” such as vaginal or uterine tissue quickly and effectively. Briefly, uterine manipulator 100 may utilize bipolar energy to complete the colpotomy procedure safely with adequate coagulation and controlled thermal spread.
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Colpotomy cup 130 of uterine manipulator 100 includes an inner return electrode 132, which may have an annular or ring configuration, supported on an inner surface thereof and an outer return electrode 134, which may have an annular or ring configuration, supported on an outer surface thereof. Inner and/or outer return electrodes 132, 134 are conductive and are configured to act as return paths for electrical energy. Although shown supported on a distal end portion of colpotomy cup 130, inner and/or outer return electrodes 132, 134 can be disposed along the entirety and/or portions (continuous and/or discontinuous) of colpotomy cup 130. Inner and/or outer return electrode 132, 134 may include metallic material and/or may be incorporated in and/or layered/coated on inner and/or outer surfaces of colpotomy cup 130. Inner and/or outer return electrodes 132, 134 may be wired to energy source 50. Colpotomy cup 130 further includes an active electrode 136 that may be axially (e.g., distally) advanced relative to colpotomy cup 130, as indicated by arrows “A” (
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By attaching uterine manipulator 100 to robotic arm assembly 20 of robotic surgical system 10, for example, additional advantages and capabilities that are not necessarily cost effective or viable with a manually operated uterine manipulator are achieved. The following aspects of this disclosure particularly benefit from such motion/force.
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Securement of any of the components of the disclosed devices may be effectuated using known securement techniques such welding, crimping, gluing, fastening, etc.
Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary aspects, and that the description, disclosure, and figures should be construed merely as exemplary of particular aspects. It is to be understood, therefore, that this disclosure is not limited to the precise aspects described, and that various other changes and modifications may be effectuated by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown or described in connection with certain aspects may be combined with the elements and features of certain other aspects without departing from the scope of this disclosure, and that such modifications and variations are also included within the scope of this disclosure. Accordingly, the subject matter of this disclosure is not limited by what has been particularly shown and described.
This application claims the benefit of U.S. Provisional Application Ser. No. 62/987,926, filed Mar. 11, 2020, the entire contents of which are incorporated by reference herein.
Number | Date | Country | |
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62987926 | Mar 2020 | US |