WO2023114840A1 - Coupelle de colpotomie pour faciliter la suture d'un manchon vaginal - Google Patents

Coupelle de colpotomie pour faciliter la suture d'un manchon vaginal Download PDF

Info

Publication number
WO2023114840A1
WO2023114840A1 PCT/US2022/081551 US2022081551W WO2023114840A1 WO 2023114840 A1 WO2023114840 A1 WO 2023114840A1 US 2022081551 W US2022081551 W US 2022081551W WO 2023114840 A1 WO2023114840 A1 WO 2023114840A1
Authority
WO
WIPO (PCT)
Prior art keywords
vaginal
distal
tissue
patient
colpotomy
Prior art date
Application number
PCT/US2022/081551
Other languages
English (en)
Inventor
Catherine Withers
Benjamin PAVLOS
Original Assignee
Hologic, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hologic, Inc. filed Critical Hologic, Inc.
Publication of WO2023114840A1 publication Critical patent/WO2023114840A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/4241—Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483—Hand-held instruments for holding sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A61B2017/4225—Cervix uteri
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00559—Female reproductive organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar

Definitions

  • the present disclosure relates generally to surgical devices and surgical techniques, and more specifically, to surgical device and surgical techniques for performing a hysterectomy on a patient.
  • Hysterectomy which is the surgical removal of the uterus, and in some cases the Fallopian tubes and ovaries, is the second most common major operation among women who are of reproductive age in the United States today, second only to cesarean section.
  • National Women’s Health Information Center over 600,000 American women have a hysterectomy every year, totaling more than 5 billion dollars in medical expenses.
  • Hysterectomy may be performed for a variety of reasons, including removal of reproductive system cancers, prophylactic treatment for those with a strong history of such cancers, treatment for severe and intractable endometriosis and severe fibroids, chronic pelvic pain, and uterine prolapse.
  • Hysterectomies may be categorized by the anatomical structures that are removed along with the uterus from the patient.
  • One type of hysterectomy is known as a radical hysterectomy, which involves the complete removal of a patient’s uterus, cervix, upper vagina, and parametrium.
  • Another hysterectomy procedure is known as a total hysterectomy, which only involves the complete removal of a patient’s uterus and cervix.
  • a patient may only require supracervical hysterectomy (also known as a partial hysterectomy), which involves the removal of the uterus but otherwise leaves the cervix in situ.
  • Hysterectomies may also be categorized by the surgical approach utilized to remove the uterus and any other associated anatomical structures. Many different surgical approaches are available for performing a hysterectomy, and the degree of intrusiveness and recovery time are dependent on the surgical method chosen. Initially, hysterectomy procedures were only performed via an open incision in a patient’s abdomen, such that the uterus of the patient can be manually accessed (total abdominal hysterectomy (TAH)). About 15% of all hysterectomies in the U.S. are carried out using a TAH procedure, which typically requires a 2-day to 4-day hospital stay, results in a relatively long recovery time (typically 6-8 weeks), and produces large, noticeable, and permanent external scarring. However, a TAH procedure generally requires less surgical skill and time.
  • TAH total vaginal hysterectomy
  • LAVH laparoscopically assisted vaginal hysterectomy
  • a TVH involves making an incision in the vagina and removing the uterus and cervix through the vaginal incision.
  • a TVH avoids visible scarring and typically allows for a quicker recovery, as well as less postoperative pain and complications compared to other types of hysterectomies, and is typically the most cost-effective hysterectomy procedure.
  • risks associated with a TVH include a slight, but serious risk of shortening or damaging the vagina, which may be caused by the expansion induced to the vaginal area to permit access of the surgeon’s hands to the cervical area through the vagina.
  • the choice of the TVH approach is limited, since it is not appropriate if space is required to view abdominal anatomical structures, or if there is a danger of the presence of the cancer cells, or if the uterus is not too enlarged, or if the patient has not delivered vaginally.
  • the uterus is accessed through small incisions made in the patient’s belly to provide laparoscopic ports for the laparoscopic equipment (which may be robotically assisted), such as for visualization, surgical procedures, and insufflation.
  • laparoscopic equipment which may be robotically assisted
  • a uterine manipulator inserted through the vagina, is used to maneuver the uterus and to create space for the laparoscopic equipment and provide access to the desired tissue layers.
  • the uterus and cervix may then be laparoscopically severed from the vagina while the uterus, fallopian tubes and ovaries are viewed via a camera attached to a laparoscope.
  • the detached uterus and cervix may then be morcellated and removed through one of the laparoscopic ports or removed through the vagina, depending on the size of the uterus.
  • the cervix of the patient may be left intact in a supracervical (subtotal) laparoscopic hysterectomy (LSH).
  • LSH laparoscopic hysterectomy
  • the TLH (or the LSH) approach is considered to be the least invasive, which avoids the open abdominal incision required for TAH procedures and trauma induced to the vaginal area during VH procedures, and generally results in less blood loss, thereby resulting in less patient discomfort, reduced complications, reduced hospital state (on average, one day), and faster return to normal activity (on average, two weeks).
  • the TLH also reduces blood loss compared to a TVH, since it allows the blood vessels to be detached from the uterus.
  • the TLH approach is especially difficult to perform due to a higher degree of difficulty in securing the uterine arteries and ligaments associated with this approach.
  • the posterior side of the uterus is particularly difficult to reach via a TLH, since the visual feedback is poor and special caution is needed to prevent damaging surround structures, such as the bladder or intestines.
  • An LAVH is similar to the TLH, except that, rather than laparoscopically, the uterus and cervix are severed from inside of the vagina, with the laparoscopic tools only used for guiding the procedure and visualizing structures, in addition to detaching the uterus from surrounding upper supporting structures (such as the infundibular pelvic and round ligaments. The uterus and cervix are then removed through the vagina.
  • TAH total abdominal hysterectomies
  • vaginal cuff an opening in the vaginal wall, referred to as a vaginal cuff, is left behind that must be closed via a suturing procedure.
  • the less invasive hysterectomy procedures i.e. , the TVH, TLH, or LAVH
  • the geometry of this opening can make it difficult to suture effectively, especially when using laparoscopy tools during a TLH or LAVH.
  • vaginal cuff dehiscence which is a potentially catastrophic event where the vaginal cuff opens such that the bowel may herniate through the vagina, may occur, thereby requiring immediate surgery.
  • the incidence of vaginal cuff dehiscence after a TLH has been found to be approximately 0.5-4%.
  • a modifiable risk factor for vaginal cuff dehiscence is surgical technique, which has significant inter-operator variability. For example, once the uterus is severed from the vagina, such that the tissue has been completely separated, the optimal tissue to be sutured must be located. However, it is very difficult to locate and consistently suture this optimal tissue to close the vaginal cuff.
  • an intravaginal colpotomy assembly comprises an elongate shaft, a handle assembly coupled to a proximal end of the elongate shaft, and a colpotomy cup coupled to a distal end of the elongate shaft.
  • the colpotomy cup comprises a cup wall, and a plurality of member lumens that longitudinally extend along the cup wall.
  • the cup wall may be, e.g., cylindrical or frusto-conical.
  • the member lumens may have any suitable number (e.g., at least six member lumens) and may be circumferentially disposed about the cup wall in an equi-distant manner.
  • Each of the member lumens has a proximal entry port in which a distal end an elongate tissue-penetrating member may be inserted, and a distal exit port out which the distal end of the elongate tissuepenetrating member, such that the distal end of the elongate tissue-penetrating member deflects radially outward.
  • the intravaginal colpotomy assembly may optionally further comprise a cutting head including the colpotomy cup and a cutting element mechanically coupled to the colpotomy cup.
  • the cutting element may be configured for circumferentially incising a vaginal-cervical junction between a vagina and a cervix of the patient.
  • the colpotomy cup further comprises a deflection surface disposed distal to the distal exit ports of the plurality of member lumens.
  • the deflection surface is configured for deflecting a distal end of an elongate tissuepenetrating member radially outward when the distal end of the elongate tissuepenetrating member is inserted from the proximal entry port out of the distal exit port of the respective member lumen.
  • the deflection surface may be convex and have a perimeter greater than a perimeter of the distal exit ports.
  • distal ends of the plurality of member lumens curve radially outward, such that the distal end of the elongate tissue-penetrating member deflects radially outward as the distal end of the elongate tissue-penetrating member exits the distal exit port of the respective member lumen.
  • the cup wall is monolithic, with the plurality of member lumens longitudinally passing through the monolithic cup wall.
  • the cup wall comprises an inner rigid wall portion and an outer elastomeric wall portion, with the plurality of member lumens longitudinally extending along an outer surface of the outer elastomeric wall portion.
  • the intravaginal colpotomy assembly may further comprise an elastomeric covering configured to be removably disposed over the inner rigid wall portion of the colpotomy cup, such that the elastomeric covering forms the outer elastomeric wall portion of the colpotomy cup and the plurality of member lumens.
  • the elastomeric covering may further comprise a plurality of tubes through which the plurality of member lumens respectively longitudinally extends.
  • the elastomeric covering may further comprise an enlarged distal rim over which the distal ends of the plurality of member lumens are disposed, such that the plurality of member lumens curve radially outward.
  • the elastomeric covering may comprise a pneumo-occluder extending around the outer elastomeric wall portion.
  • the elongate tissue-penetrating member may be a suture shuttle.
  • such suture shuttle may comprise a wire having an eyelet configured for being affixed to a suture.
  • such suture shuttle may comprise a tube having a lumen configured for passing a suture.
  • the suture shuttle further comprises a stylet having a tissue-penetrating distal tip, wherein the stylet is configured for being disposed within the lumen of the tube, such that the tissue-penetrating distal tip extends from a distal end of the tube.
  • the elongate tissue-penetrating member is a tissue anchor including an elongate shaft having a tissue-penetrating distal tip configured for piercing through a first side of tissue and exit out of a second side of tissue opposite the first side of tissue when the tissue anchor is distally advanced.
  • the tissue anchor further includes a tissue retention assembly proximal to the tissuepenetrating distal tip, and configured for passing from the first side of tissue and exiting out of the second side of tissue behind the tissue-penetrating distal tip when the tissue anchor is distally advanced, and engaging the second side of tissue when the tissue anchor is proximally retracted, thereby retaining the tissue-penetrating distal tip on the second side of the tissue.
  • the tissue retention assembly may comprise one or more barbs.
  • the tissue retention assembly is configured for being dynamically activated to assume a high-profile state for engaging the second side of tissue, thereby retaining the tissue-penetrating distal tip on the second side of the tissue when the tissue anchor is proximally retracted, and dynamically deactivated to assume a low-profile state for disengaging the second side of tissue when the tissue anchor is proximally retracted, thereby allowing the tissue-penetrating distal tip to be proximally retracted from the second side of tissue.
  • Such tissue retention assembly may, e.g., comprise at least two elements (e.g., wires), each having a first end stably affixed to the elongate shaft, and a second end slidably disposed relative to the elongate shaft.
  • Each of the elements may be configured for laterally bending in response to displacing the second end towards the first end of the respective one of the at least two elements, such that the tissue retention assembly assumes the high- profile state, and configured for laterally straightening in response to displacing the second end away from the first end of the respective one of the at least two elements, such that the tissue retention assembly assumes the low-profile state.
  • the tissue retention assembly comprises only two elements, e.g., clocked 180° from each other when the tissue retention assembly assumes the high- profile state, or clocked 90° from each other when the tissue retention assembly assumes the high-profile state.
  • the tissue retention assembly may further comprise a ring to which the second ends of the respective elements are affixed, with the ring slidably disposed around the elongate shaft, such that ring may be distally displaced to displace the second ends of the elements respectively towards the first ends of the elements.
  • the tissue retention assembly may further comprise a hub stably affixed to the elongate shaft distal to the ring, with the ring being configured for being interference fit with the hub to lock the tissue retention assembly in the high profile state when the ring is distally displaced.
  • a method of performing a medical procedure on a patient comprising positioning a colpotomy cup at a vaginal fornix of the patient, introducing at least one elongate device through at least one member lumen of the colpotomy cup until a distal end of each of the at least one elongate device pierces at least one puncture point in tissue of the patient, and after the introducing step, transecting a uterus and cervix from a vagina of the patient (e.g., using a cutting element affixed to the colpotomy cup), and creating a vaginal cuff comprising the at least one puncture point.
  • the tissue having the puncture point(s) is the vaginal-cervical junction of the patient, in which case, transecting the uterus and cervix from the vagina of the patient may comprise circumferentially incising the vaginal-cervical junction of the patient distal to the at least one puncture point.
  • Another method further comprises deflecting a distal end of the at least one elongate device radially outward prior to respectively piercing the at least one puncture point in the tissue of the patient.
  • each of the elongate device(s) is a suture shuttle
  • each of the puncture point(s) is a suture point
  • the method may further comprise employing the suture shuttle(s) to thread a distal end of at least one suture through the suture point(s).
  • the vaginal cuff may be closed with the suture(s).
  • This method may further comprise removing the suture shuttle(s) from patient after the distal end of the suture(s) is threaded through the suture shuttle(s), but before the vaginal cuff is closed with the suture(s).
  • a plurality of suture shuttles may be respectively introduced through the plurality of member lumens of the colpotomy cup until the distal ends of the plurality of suture shuttles respectively pierce a plurality of suture points in the tissue of the patient.
  • the method may further comprise removing the colpotomy cup from the vaginal cavity, thereby leaving the plurality of suture shuttles in the vaginal cuff.
  • one of the suture shuttles may then be employed to thread one end of a suture from the abdominal cavity, through one of the suture points on a first side of the vaginal cuff, and into the vaginal cavity, and another of the suture shuttles may be employed to thread the one end of the suture from the vaginal cavity, through another one of the suture points on a second side of the vaginal cuff opposite the first side of the vaginal cuff, and into the abdominal cavity.
  • a single suture shuttle may be sequentially introduced through the plurality of member lumens until the distal end of the single suture shuttle respectively pierces each of the plurality of suture points in the tissue of the patient.
  • the single suture shuttle may be employed to thread one end of a first suture between the abdominal cavity and the vaginal cavity through a first one of the suture points, and to thread one end of a second suture between the abdominal cavity and the vaginal cavity through a second one of the suture points.
  • each of the elongate device(s) is a tissue anchor
  • each of the puncture point(s) is an anchor point
  • the method may further comprise employing the tissue anchor(s) to collapse the vaginal cuff.
  • the method may further comprise suturing the collapsed vaginal cuff (e.g., laparoscopically) and removing the tissue anchor(s) from the vaginal cuff after the collapsed vaginal cuff has been sutured.
  • the tissue anchor(s) may be employed to close the vaginal cuff by pulling the tissue anchor(s) towards a plane between the opposite sides of the vaginal cuff, thereby collapsing opposite sides of the vaginal cuff toward each other toward the plane.
  • a plurality of tissue anchors may be respectively introduced through the plurality of lumens of the colpotomy cup until the distal ends of the plurality of tissue anchors respectively pierce the plurality of anchor points in the tissue of the patient, with at least two of the anchor points being on opposite sides of the vaginal cuff.
  • the plurality of tissue anchors may then be pulled towards a plane between the opposite sides of the vaginal cuff, thereby collapsing the opposite sides of the vaginal cuff together towards the plane.
  • One method may further comprise removing the colpotomy cup from the vaginal cavity, thereby leaving the plurality of tissue anchors in the vaginal cuff, affixing proximal ends of the tissue anchors to a tool, inserting the tool within the vaginal cavity after removing the colpotomy cup from the vaginal cavity, and operating the tool to pull the plurality of tissue anchors at least partially radially inward, thereby moving the opposite sides of the vaginal cuff toward each other.
  • a cover for a preexisting colpotomy cup comprises a cup-shaped elastomeric wall configured for being removably fitted over the pre-existing colpotomy cup, and a plurality of member lumens that longitudinally extend along the cup-shaped elastomeric wall.
  • Each of the member lumens has a proximal entry port and a distal exit port, and is sized receive an elongate tissue-penetrating member.
  • the cover further comprises a plurality of elastomeric tubes disposed on an outer surface of the cup-shaped elastomeric wall, with the member lumens being respectively formed through the plurality of elastomeric tubes.
  • the cover may further comprise an enlarged elastomeric distal rim located adjacent the distal exit ports, and over which distal ends of the plurality of elastomeric tubes are disposed, such that a distal end of the elongate tissue-penetrating member deflects radially outward as the distal end of the elongate tissue-penetrating member exits the distal exit port of the respective member lumen.
  • the cover further comprises an inflatable ring disposed around the cup-shaped elastomeric wall.
  • a colpotomy cup assembly comprises a colpotomy cup having a rigid cup-shaped wall, and the afore- described cover disposed over the rigid cup-shaped wall.
  • a vaginal cuff closure tool comprises a connector device to which proximal ends of a plurality of tissue anchors distally anchored to a vaginal-cervical junction of the patient having a vaginal cuff are configured for being removably affixed, and a distal housing sized to fit within a vaginal cavity of a patient.
  • the distal housing has a bore configured for partially enclosing the distally anchored plurality of tissue anchors, and a distal aperture through the distally anchored plurality of tissue anchors is configured for extending.
  • the distal aperture may have a suitable aspect ratio (e.g., at least 2:1 , at least 5:1 , or at least 10:1).
  • the distal housing has opposing rectilinear edges that at least partially define the distal aperture.
  • the shape of the distal aperture is a non-square rectangle.
  • the distal housing has a planar cavity disposed between the bore and the distal aperture.
  • Such planar cavity is sized to spatially constrain the distally anchored plurality of elongated tissue anchors extending from the bore in a first plane, and to spatially expand the distally anchored plurality of elongated tissue anchors extending from the bore in a second plane perpendicular to the first plane.
  • the planar cavity may have a first cross-sectional dimension that is substantially greater than a minimum cross-sectional dimension of the bore, and a second cross- sectional dimension that is substantially less than the minimum cross-sectional dimension of the bore.
  • the planar cavity may have an aspect ratio that matches an aspect ratio of the distal aperture.
  • the distal housing has a first pair of opposing bearing surfaces to which at least two of the distally anchored plurality of elongated tissue anchors are configured for bearing against when spatially constrained from the bore by the planar cavity in the first plane, and a second pair of opposing bearing surfaces to which at least two of the distally anchored plurality of elongated tissue anchors are configured for bearing against when spatially expanded from the bore by the planar cavity in the second plane.
  • the vaginal cuff closure tool further comprises a carriage to which the connector device is affixed.
  • the carriage is configured for being slidably engaged within a proximal end of the distal housing, such that proximal translation of the carriage relative to the distal housing applies tensile forces to proximal ends of the distally anchored plurality of tissue anchors to collapse opposite ends of the vaginal cuff together.
  • the tensile forces may be applied to the proximal ends of the distally anchored plurality of tissue anchors are longitudinal tensile forces within in a plane between the opposite sides of the vaginal cuff, and the distal aperture may be configured for translating at least a portion of the longitudinal tensile forces into lateral tensile forces at the distal ends of the plurality of distally anchored plurality of tissue anchors orthogonal to the plane, thereby collapsing the opposite ends of the vaginal cuff together towards the plane.
  • the carriage comprises a shaft configured for being slidably disposed within the bore of the distal housing.
  • the shaft may have a bore in which the connector is affixed and through which the plurality of distally anchored tissue anchors may extend.
  • the bore of the distal housing may have an enlarged proximal bore portion in which the shaft of the carriage is slidably disposed, and a reduced distal bore portion disposed between the enlarged proximal bore portion and the distal aperture.
  • Such reduced distal bore portion may be sized to spatially constrain the distally anchored plurality of elongated tissue anchors extending from the bore of the shaft in the second plane.
  • the shaft may be configured for being ratcheted with the bore of the distal housing along a plurality of different positions relative to the distal housing when the carriage is proximally translated relative to the distal housing.
  • the distal housing may comprise a series of teeth extending along an inner surface of the distal housing, in which case, the carriage may comprise a cog disposed on the shaft and configured for incrementally engaging the series of teeth as the carriage is proximally translated relative to the distal housing.
  • a method of using the afore-described vaginal cuff closure tool comprises anchoring the distal ends of the plurality of tissue anchors respectively at a plurality of anchor points of a vaginal- cervical junction of a patient.
  • anchoring the distal ends of the plurality of tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of a patient comprises distally advancing the plurality of tissue anchors within the vaginal cavity of the patient, through the plurality of anchor points of the vaginal-cervical junction, and into an abdominal cavity of the patient, and proximally retracting the plurality of tissue anchors until the distal ends of the plurality of elongated tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of the patient.
  • anchoring the distal ends of the plurality of tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of the patient comprises positioning a colpotomy cup at the vaginal fornix of the patient, and distally advancing the plurality of tissue anchors through a plurality of member lumens of the colpotomy cup until the distal ends of plurality of tissue anchors respectively pass from the vaginal cavity, through the plurality of anchor points of the vaginal-cervical junction, and into the abdominal cavity of the patient.
  • the method may further comprise removing the colpotomy cup from the vaginal cavity, thereby leaving the distal ends of the plurality of tissue anchors respectively anchored to the plurality of anchor points at the vaginal-cervical junction of the patient.
  • the method further comprises transecting a uterus and cervix from a vagina of the patient, thereby creating a vaginal cuff comprising the plurality of anchor points, affixing the proximal ends of the distally anchored plurality of tissue anchors to the connector device, disposing the plurality of tissue anchors through the distal aperture of the distal housing, inserting the distal housing within a vaginal cavity of the patient until the distal housing is positioned at a vaginal fornix of the patient, proximally translating the carriage relative to the distal housing, thereby applying tensile forces to the proximal ends of the plurality of tissue anchors, such that the opposite ends of the vaginal cuff are collapsed together, and suturing the collapsed vaginal cuff (e.g., laparoscopically).
  • the carriage is proximally translated relative to the carriage while inserting the distal housing within the vaginal cavity of the patient.
  • the carriage may be proximally translated relative to the carriage by holding the carriage still in position while the distal housing is inserted into the vaginal cavity of the patient, or the carriage may be proximally translated relative to the carriage by proximally displacing the carriage while the distal housing is inserted into the vaginal cavity of the patient.
  • the carriage is proximally translated relative to the carriage by proximally displacing the carriage after the distal housing has been positioned at the vaginal fornix of the patient.
  • the connector device applies longitudinal tensile forces to the proximal ends of the distally anchored plurality of tissue anchors along a plane, while the distal aperture translates the longitudinal tensile forces applied to the proximal ends of the distally anchored plurality of tissue anchors into lateral tensile forces that are applied to the distal ends of the distally anchored tissue anchors orthogonal to the plane, thereby collapsing the opposite ends of the vaginal cuff together towards the plane.
  • the plurality of anchor points may comprise a first set of anchor points to which the distal ends of a first set of the plurality of tissue anchors are anchored, and a second set of anchor points to which the distal ends of a second set of the plurality of tissue anchors are anchored.
  • the first and second anchor points are respectively located at different halves of the vaginal-cervical junction.
  • Another method further comprises locking the carriage relative to the distal housing while suturing the collapsed vaginal cuff, such that the carriage is prevented from distally translating relative to the distal housing. Still another method further comprises removing the plurality of tissue anchors from the sutured vaginal cuff.
  • a method of closing a vaginal cuff comprises anchoring the distal ends of a plurality of tissue anchors respectively at a plurality of anchor points of a vaginal-cervical junction of a patient.
  • anchoring the distal ends of the plurality of tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of a patient comprises distally advancing the plurality of tissue anchors within the vaginal cavity of the patient, through the plurality of anchor points of the vaginal-cervical junction, and into an abdominal cavity of the patient, and proximally retracting the plurality of tissue anchors until the distal ends of the plurality of elongated tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of the patient.
  • the plurality of anchor points comprises a first set of anchor points to which the distal ends of a first set of the plurality of tissue anchors are anchored, and a second set of anchor points to which the distal ends of a second set of the plurality of tissue anchors are anchored.
  • the first and second anchor points are respectively located at different halves of the vaginal-cervical junction divided by the plane.
  • the method further comprises transecting a uterus and cervix from a vagina of the patient, thereby creating a vaginal cuff comprising the plurality of anchor points, disposing the plurality of tissue anchors through a distal aperture of a housing, applying longitudinal tensile forces to proximal ends of the tissue anchors along a plane between opposite sides of the vaginal cuff, translating at least a portion of the longitudinal tensile forces into lateral tensile forces that are applied to the distal ends of the tissue anchors orthogonal to the plane, thereby collapsing opposite ends of the vaginal cuff together toward the plane, and suturing the collapsed vaginal cuff (e.g., laparoscopically).
  • a kit for collapsing a vaginal cuff of a patient comprises a connector device having a plurality of connectors to which proximal ends of a plurality of tissue anchors distally anchored to a vaginal-cervical junction of the patient are configured for being removably affixed.
  • the plurality of connectors comprises a plurality of sockets in which plugs affixed to the proximal ends of the distally anchored tissue anchors are configured to be removably mated.
  • the kit further comprises a carriage including a shaft having a bore in which the connector device is configured for being removably affixed.
  • the carriage comprises at least one aperture disposed within a bore of the shaft, and the connector device comprises at least one detent configured for respectively engaging the at least one aperture when the connector device is proximal slid within the bore of the shaft.
  • the connector device and the bore of the shaft may be keyed, such that the connector device is prevented from rotating within the bore of the shaft.
  • the kit further comprises two distal housing halves configured for being laterally mated to each other over the shaft to form a distal housing sized to fit within a vaginal cavity of a patient.
  • the distal housing comprises a bore in which the shaft is slidably disposed and through which a portion of the distally anchored tissue anchors are housed, and a distal aperture through which the distally anchored tissue anchors extend between the distal housing and the vaginal-cervical junction.
  • the distal aperture may have a suitable aspect ratio (e.g., at least 2:1 , at least 5:1 , or at least 10:1 ).
  • the distal housing has opposing rectilinear edges that at least partially define the distal aperture.
  • the shape of the distal aperture is a non-square rectangle.
  • the distal housing has a planar cavity disposed between the bore and the distal aperture.
  • Such planar cavity is sized to spatially constrain the distally anchored plurality of elongated tissue anchors extending from the bore in a first plane, and to spatially expand the distally anchored plurality of elongated tissue anchors extending from the bore in a second plane perpendicular to the first plane.
  • the planar cavity may have a first cross-sectional dimension that is substantially greater than a minimum cross-sectional dimension of the bore, and a second cross- sectional dimension that is substantially less than the minimum cross-sectional dimension of the bore.
  • the planar cavity may have an aspect ratio that matches an aspect ratio of the distal aperture.
  • the distal housing has a first pair of opposing bearing surfaces to which at least two of the distally anchored plurality of elongated tissue anchors are configured for bearing against when spatially constrained from the bore by the planar cavity in the first plane, and a second pair of opposing bearing surfaces to which at least two of the distally anchored plurality of elongated tissue anchors are configured for bearing against when spatially expanded from the bore by the planar cavity in the second plane.
  • the shaft is slidably disposed in the bore of the distal housing to allow proximal translation of the carriage relative to the distal housing in a manner that applies tensile forces to proximal ends of the distally anchored plurality of tissue anchors to collapse opposite ends of the vaginal cuff together.
  • the tensile forces applied to the proximal ends of the distally anchored plurality of tissue anchors may be longitudinal tensile forces within in a plane between the opposite sides of the vaginal cuff, and the distal aperture may be configured for translating at least a portion of the longitudinal tensile forces into lateral tensile forces at the distal ends of the plurality of distally anchored plurality of tissue anchors orthogonal to the plane, thereby collapsing the opposite ends of the vaginal cuff together towards the plane.
  • the bore of the distal housing may have an enlarged proximal bore portion in which the shaft of the carriage is slidably disposed, and a reduced distal bore portion disposed between the enlarged proximal bore portion and the distal aperture.
  • Such reduced distal bore portion may be sized to spatially constrain the distally anchored plurality of elongated tissue anchors extending from the bore of the shaft in the second plane.
  • the shaft may be configured for being ratcheted with the bore of the distal housing along a plurality of different positions relative to the distal housing when the carriage is proximally translated relative to the distal housing.
  • the distal housing may comprise a series of teeth extending along an inner surface of the distal housing, in which case, the carriage may comprise a cog disposed on the shaft and configured for incrementally engaging the series of teeth as the carriage is proximally translated relative to the distal housing.
  • a method of using the afore-mentioned kit comprises anchoring the distal ends of the plurality of tissue anchors respectively at a plurality of anchor points of a vaginal-cervical junction of a patient.
  • anchoring the distal ends of the plurality of tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of a patient comprises distally advancing the plurality of tissue anchors within the vaginal cavity of the patient, through the plurality of anchor points of the vaginal-cervical junction, and into an abdominal cavity of the patient, and proximally retracting the plurality of tissue anchors until the distal ends of the plurality of elongated tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of the patient.
  • anchoring the distal ends of the plurality of tissue anchors respectively at the plurality of anchor points of the vaginal-cervical junction of the patient comprises positioning a colpotomy cup at the vaginal fornix of the patient, and distally advancing the plurality of tissue anchors through a plurality of member lumens of the colpotomy cup until the distal ends of plurality of tissue anchors respectively pass from the vaginal cavity, through the plurality of anchor points of the vaginal-cervical junction, and into the abdominal cavity of the patient.
  • the method may further comprise removing the colpotomy cup from the vaginal cavity, thereby leaving the distal ends of the plurality of tissue anchors respectively anchored to the plurality of anchor points at the vaginal-cervical junction of the patient.
  • the method further comprises transecting a uterus and cervix from a vagina of the patient, thereby creating a vaginal cuff comprising the plurality of anchor points, and coupling the proximal ends of the distally anchored plurality of tissue anchors respectively to the plurality of connectors of the connector device.
  • the plurality of connectors comprises a plurality of sockets, in which case, the proximal ends of the distally anchored plurality of tissue anchors may be coupled respectively to the plurality of connectors of the connector device by mating plugs affixed to the proximal ends of the distally anchored tissue anchors respectively within the plurality of sockets.
  • the method further comprises coupling the connector device, with the affixed proximal ends of the distally anchored plurality of tissue anchors, in the bore of the shaft, and laterally mating the two distal housing halves to each other over the shaft to form the distal housing.
  • coupling the connector device in the bore of the shaft comprises sliding the connector device proximally along the bore from a proximal end of the shaft towards the distal end of the shaft.
  • the method further comprises inserting the distal housing within a vaginal cavity of the patient until the distal housing is positioned at a vaginal fornix of the patient, proximally translating the carriage relative to the distal housing, thereby applying tensile forces to the proximal ends of the plurality of tissue anchors, such that the opposite ends of the vaginal cuff are collapsed together, and suturing the collapsed vaginal cuff (e.g., laparoscopically).
  • the carriage is proximally translated relative to the carriage while inserting the distal housing within the vaginal cavity of the patient.
  • the carriage may be proximally translated relative to the carriage by holding the carriage still in position while the distal housing is inserted into the vaginal cavity of the patient, or the carriage may be proximally translated relative to the carriage by proximally displacing the carriage while the distal housing is inserted into the vaginal cavity of the patient.
  • the carriage is proximally translated relative to the carriage by proximally displacing the carriage after the distal housing has been positioned at the vaginal fornix of the patient.
  • the connector device applies longitudinal tensile forces to the proximal ends of the distally anchored plurality of tissue anchors along a plane, while the distal aperture translates the longitudinal tensile forces applied to the proximal ends of the distally anchored plurality of tissue anchors into lateral tensile forces that are applied to the distal ends of the distally anchored tissue anchors orthogonal to the plane, thereby collapsing the opposite ends of the vaginal cuff together towards the plane.
  • the plurality of anchor points may comprise a first set of anchor points to which the distal ends of a first set of the plurality of tissue anchors are anchored, and a second set of anchor points to which the distal ends of a second set of the plurality of tissue anchors are anchored.
  • the first and second anchor points are respectively located at different halves of the vaginal-cervical junction.
  • Another method further comprises locking the carriage relative to the distal housing while suturing the collapsed vaginal cuff, such that the carriage is prevented from distally translating relative to the distal housing. Still another method further comprises removing the plurality of tissue anchors from the sutured vaginal cuff.
  • the method may further comprise distally translating the carriage relative to the distal housing, thereby relaxing the proximal ends of the plurality of tissue anchors, proximally retracting the distal housing from the vaginal cavity of the patient, while leaving the distal ends of the plurality of tissue anchors anchored respectively at the plurality of anchor points of the vaginal-cervical junction of the patient, laterally de-mating the two distal housing halves from each other, decoupling the connector device, with the affixed proximal ends of the distally anchored plurality of tissue anchors, from the bore of the shaft, decoupling the proximal ends of the distally anchored plurality of tissue anchors respectively from the plurality of connectors of the connector device, and removing the plurality of tissue anchors from the vaginal-cervical junction of the patient.
  • FIG. 1 is a plan view of a hysterectomy system constructed in accordance with one embodiment of the present inventions
  • FIG. 2 is a top proximal perspective view of a colpotomy device of an intravaginal colpotomy assembly used in the hysterectomy system of Fig. 1 ;
  • FIG. 3 is a plan view of the intravaginal colpotomy assembly of Fig. 2 in relation to the anatomy of a female patient;
  • Fig. 4 is a cross-sectional view of one embodiment of a colpotomy cup of the colpotomy device of Fig. 2;
  • Fig. 5 is a profile view of the colpotomy cup of Fig. 4;
  • Fig. 6 is a proximal axial view of the colpotomy cup of Fig. 4;
  • Fig. 7 is a top proximal perspective view of the colpotomy cup of Fig. 4;
  • Fig. 8 is a top distal perspective view of the colpotomy cup of Fig. 4;
  • Fig. 9 is a profile view of an alternative embodiment of a colpotomy cup of the colpotomy device of Fig. 2;
  • Fig. 10 is a profile view of another alternative embodiment of a colpotomy cup of the colpotomy device of Fig. 2;
  • FIG. 11 is a plan view of a hysterectomy system constructed in accordance with another embodiment of the present inventions.
  • FIG. 12 is a cut-away view of a cutting head of an intravaginal colpotomy assembly used in the hysterectomy system of Fig. 11 ;
  • Fig. 13 is a plan view of the intravaginal colpotomy assembly of Fig. 12 in relation to the anatomy of a female patient;
  • Fig. 14 is a cross-sectional view of one embodiment of a cutting head of the colpotomy device of Fig. 12;
  • Fig. 15 is a profile view of the cutting head of Fig. 14;
  • FIG. 16 is a distal perspective view of the cutting head of Fig. 14;
  • FIG. 17 is a plan view of a hysterectomy system constructed in accordance with still another embodiment of the present inventions.
  • FIG. 18 is a top distal perspective view of a cutting head of an intravaginal colpotomy assembly used in the hysterectomy system of Fig. 17;
  • Fig. 19 is a distal axial view of the cutting head of Fig. 18;
  • Fig. 20 is a plan view of the intravaginal colpotomy assembly of Fig. 17 in relation to the anatomy of a female patient;
  • Fig. 21 is a top proximal perspective view of an alternative embodiment of a colpotomy cup that can be used in the intravaginal colpotomy assembly illustrated in Fig. 2;
  • Fig. 22 is a distal axial view of the colpotomy cup of Fig. 21 ;
  • Fig. 23 is a cross-sectional view the colpotomy cup of Fig. 21 ;
  • Fig. 24 is a top distal perspective view of an elastomeric cover that can be removably fit over a pre-existing colpotomy cup or cutting head;
  • FIG. 25 is a profile view of one embodiment of a suture shuttle for use in any of the hysterectomy systems of Figs. 1 , 11 , and 17;
  • FIGs. 26A-26E are plan views of different uses of the suture shuttle of Fig. 25 to introduce a suture through a vaginal-cervical junction of a female patient;
  • FIG. 27 is a profile view of another embodiment of a suture shuttle for use in any of the hysterectomy systems of Figs. 1 , 11 , and 17;
  • FIGs. 28A-28C are plan views of different uses of the suture shuttle of Fig. 27 to introduce a suture through a vaginal-cervical junction of a female patient;
  • Fig. 29 is a flow diagram illustrating one exemplary method of operating the hysterectomy system of Fig. 1 to perform a total laparoscopic hysterectomy (TLH) on a female patient;
  • TSH total laparoscopic hysterectomy
  • FIGs. 30A-30D are perspective views illustrating a colpotomy and suturing technique used in the method of Fig. 29;
  • FIG. 31 is a flow diagram illustrating another exemplary method of operating the hysterectomy system of Fig. 1 to perform a TLH on a female patient;
  • FIGS. 33A-32E are perspective views illustrating a colpotomy and suturing technique used in the method of Fig. 31 ;
  • Fig. 33 is a profile view of one embodiment of a tissue anchor for use in any of the hysterectomy systems of Figs. 1 , 11 , and 17;
  • Figs. 34A-34B are plan views of one manner of anchoring the tissue anchor of Fig. 33 in a vaginal-cervical junction of a female patient;
  • Fig. 35 is a profile view of another embodiment of a tissue anchor for use in any of the hysterectomy systems of Figs. 1 , 11 , and 17;
  • Figs. 36A-36B are distal perspective views of one manner of transitioning the tissue anchor of Fig. 35 from a low-profile state to a high-profile state;
  • Figs. 37A-37C are distal axial view of different tissue retention assemblies that can be used with the tissue anchor of Fig. 35 while in the high-profile state;
  • Figs. 38A-38B are plan views illustrating one manner of anchoring the tissue anchor of Fig. 35 in a vaginal-cervical junction of a female patient;
  • FIG. 39 is a top distal perspective view of one embodiment of a vaginal cuff closure tool for use in any of the hysterectomy systems of Figs. 1, 11 , and 17, particularly showing a carriage of the vaginal cuff closure tool in its most-distal position;
  • Fig. 40 is a top distal perspective view of the vaginal cuff closure tool of Fig.
  • Fig. 41 is a top distal perspective view of one embodiment of a connector device of the vaginal cuff closure tool of Fig. 39;
  • Fig. 42 is a top proximal perspective view of the vaginal cuff closure tool of Fig. 39;
  • Fig. 43 is a proximal axial view of the vaginal cuff closure tool of Fig. 39;
  • Fig. 44 is a distal perspective view of the carriage of the vaginal cuff closure tool of Fig. 39;
  • Fig. 45 is a top view of the vaginal cuff closure tool of Fig. 39;
  • Fig. 46 is a profile view of the vaginal cuff closure tool of Fig. 39;
  • Fig. 47 is a proximal axial view of a distal housing of the vaginal cuff closure tool of Fig. 39;
  • Fig. 48 is a distal axial view of the distal housing of Fig. 47;
  • Fig. 49 is a top view of the distal housing of Fig. 47, particularly showing a top half of the distal housing removed;
  • Fig. 50 is a top proximal perspective view of the vaginal cuff closure tool of Fig. 39, particularly showing the top half of the distal housing removed;
  • Fig. 51 is a cross-sectional view of the vaginal cuff closure tool of Fig. 39;
  • Fig. 52 is a top distal perspective view of a kit that can be assembled to create the vaginal cuff closure tool of Fig. 39;
  • Fig. 53 is a cross-sectional view of the carriage of Fig. 44;
  • Fig. 54 is a flow diagram illustrating one exemplary method of operating the hysterectomy system of Fig. 1 , with the vaginal cuff closure tool of Fig. 39, to perform a TLH on a female patient;
  • Figs. 55A-55E are perspective views illustrating a colpotomy and suturing technique used in the method of Fig. 54;
  • Figs. 56A-56C are plan views illustrating one manner of locating the distal housing of the vaginal cuff closure tool of Fig. 39 in the vaginal cavity of a female patient;
  • FIG. 57A-57F are perspective views illustrating the assembly of the vaginal tissue cuff closure kit of Fig. 52 and the connection of distally anchored tissue anchors to the assembled vaginal cuff closure tool;
  • Figs. 58A-58B respectively proximal perspective and proximal axial views of the relaxed tissue anchors distally anchored at the respective anchor points of the vaginal-cervical junction of the patient;
  • Figs. 59A-59B are respectively distal perspective and distal axial views of the tissue anchors distally anchored at the respective anchor points of the vaginal- cervical junction of the patient, while being tensioned by the vaginal cuff closure tool of Fig. 39;
  • Fig. 60 is a cross-sectional view along a horizontal plane of the vaginal cuff closure tool of Fig. 39, particularly showing the tensioned tissue anchors within the vaginal cuff closure tool of Fig. 39;
  • Fig. 61 is a cross-sectional view along a vertical plane of the vaginal cuff closure tool of Fig. 39, particularly showing the tensioned tissue anchors within the vaginal cuff closure tool of Fig. 39;
  • Fig. 61 A is a close-up view of the distal end of the vaginal cuff closure tool of Fig. 61.
  • FIG. 1 one embodiment of a hysterectomy system 10 capable of performing a colpotomy on a female patient P will now be described.
  • the hysterectomy system 10 simplifies the closure of the vaginal cuff by facilitating the strategic placement of sutures in the optimal location of the vaginal cuff prior to performing the colpotomy cut that severs the uterus U and cervix C from the vagina V of the female patient P.
  • the hysterectomy system 10 allows the suture or sutures to be placed at the optimal distance from edge of the vaginal cuff and at a consistent circumferential interval around the cuff. As a result of the significant improvement in suture placement, vaginal cuff complications may be reduced.
  • the hysterectomy system 10 particularly lends itself well for use in total laparoscopic hysterectomy (TLH) (i.e., the uterus U, along with the cervix C, is laparoscopically severed from the vagina V while the procedure is performed under laparoscopic guidance and visualization).
  • TH total laparoscopic hysterectomy
  • the use of the hysterectomy system 10 should not be so limited, and thus, may be used for other types of hysterectomy procedures, including a radical hysterectomy procedure where the ovaries and fallopian tubes of the patient P are to be severed and removed, either laparoscopically or transvaginally.
  • the hysterectomy system 10 generally comprises a conventional laparoscopic tissue cutting assembly 12 and an intravaginal colpotomy assembly 14.
  • the hysterectomy system 10 is specifically designed to be used in a TLH.
  • some or all of the components of either the laparoscopic tissue cutting assembly 12 and an intravaginal colpotomy assembly 14. may be disposable.
  • Some of the components of the laparoscopic tissue cutting assembly 12 and an intravaginal colpotomy assembly 14 may be removable from one another, so that disposable components can be uncoupled from permanent components and replaced with new disposable components.
  • the hysterectomy system 10 may additionally comprise monitors, a foot switch, an instrument table, and an operating table (all not shown) on which the patient P will be placed.
  • the laparoscopic tissue cutting assembly 12 is configured for performing the actual colpotomy cut by circumferentially incising the vaginal-cervical junction J (i.e., the region between the vagina V and cervix C), thereby transecting the uterus U and cervix C from the vagina V of the patient P.
  • the laparoscopic tissue cutting assembly 12 includes a tissue cutting instrument 16, and in this case a laparoscopic electrosurgical instrument, and a source of electrical energy 18, and in this case, an electrosurgical generator, e.g., a radio frequency (RF) generator, electrically coupled to the laparoscopic electrosurgical instrument 16 via an electrical cable 20.
  • RF radio frequency
  • the laparoscopic electrosurgical instrument 16 comprises a rigid shaft 22 sized to be inserted through a conventional laparoscopic port (not shown), a handle assembly 24 coupled to the proximal end 28 of the rigid shaft 22, and an end effector 26 coupled to the distal end 30 of the rigid shaft 22.
  • the handle assembly 24 includes a handle body 32 ergonomically shaped to be manually grasped, a radio frequency (RF) port 34 electrically coupled to the electrical cable 20, and an electrosurgical activation button 36 for controlling the transmission of electrical energy from the RF generator 18 to the end effector 26 for effecting the circumferential incision of the vaginal-cervical junction J of the patient P.
  • RF radio frequency
  • the electrosurgical activation button 36 may be located on the electrosurgical generator 18.
  • the laparoscopic electrosurgical instrument 16 may be bipolar or monopolar in nature.
  • the electrosurgical generator 18 may be a conventional RF power supply that operates at a suitable frequency (e.g., in the range of 200 KHz to 1 .25 MHz) with a conventional sinusoidal or non-sinusoidal wave form. Such power supplies are available from many commercial suppliers, such as Valleylab, Aspen, and Bovie.
  • the electrosurgical generator 18 will typically be operated at the lower end of the voltage and power capability (e.g., below 150 volts, usually between 50 volts and 100 volts, and at a power from 20 watts to 200 watts).
  • laparoscopic electrosurgical instruments are well known in the art, and that the hysterectomy system 10 illustrated in Fig. 1 may employ any laparoscopic electrosurgical instrument capable of circumferentially incising the vaginal-cervical junction J of the patient P via laparoscopic means.
  • the laparoscopic tissue cutting assembly 12 may employ a laparoscopic surgical device capable of mechanically severing the uterus U and cervix C from the vagina V of the patient P without the use of an electrical source of energy.
  • the intravaginal colpotomy assembly 14 is configured for gripping or manipulating the uterus U during the hysterectomy procedure, and to this extent, may also serve as a uterine manipulator, e.g., to move the intact uterus U around through engagement of the interior wall of the uterus U while performing adjunct laparoscopic functions, such as visualizing anatomical structures (e.g., the bladder or intestines), and/or dissecting tissue associated with the uterus U (e.g., connective tissue and blood vessels), and/or performing the colpotomy cut with the laparoscopic tissue cutting assembly 12.
  • adjunct laparoscopic functions such as visualizing anatomical structures (e.g., the bladder or intestines), and/or dissecting tissue associated with the uterus U (e.g., connective tissue and blood vessels), and/or performing the colpotomy cut with the laparoscopic tissue cutting assembly 12.
  • the intravaginal colpotomy assembly 14 may be configured for removing the severed uterus U, along with the cervix C, through the vaginal cavity VC.
  • the intravaginal colpotomy assembly 14 generally comprises a uterine manipulator 38, a colpotomy device 40 slidably disposed over the uterine manipulator 38, one or more elongate tissue-penetrating members 42 (only one shown in Fig. 1), and a pneumo-occlusion assembly 44 affixed to the colpotomy device 40.
  • a distal end of the uterine manipulator 38 can be secured within the uterus U of the patient P for manipulating the uterus U, while the distal end of the colpotomy device 40 may be secured within the vaginal cavity VC of the patient P relative to the uterine manipulator 38 for facilitating the colpotomy cut of the vaginal- cervical junction J made by the laparoscopic tissue cutting assembly 12, as well as facilitating suturing of the resulting vaginal cuff by distally advancing the distal end of each of the elongate tissue-penetrating members 42 through vaginal-cervical junction J prior to performing the colpotomy cut.
  • Each elongate tissue-penetrating member 42 may have a suitable diameter (e.g., in the range of 0.020” to 0.35”) that facilitates its distal advancement through tissue without unduly damaging the tissue.
  • Each elongate tissue-penetrating member 42 is preferably composed of a material (e.g., stainless steel) that provides the elongate tissue-penetrating member 42 with the necessary columnar strength to puncture through the vaginal-cervical junction J.
  • each of the elongate tissuepenetrating members 42 may, e.g., be a suture shuttle that can be used to introduce a suture through an optimally placed suture point in the vaginal-cervical junction J created by the suture shuttle, thereby facilitating subsequent suturing of the vaginal cuff, or a tissue anchor that can be manipulated after the colpotomy cut, but prior to suturing, to collapse the opposite ends of the vaginal cuff together, thereby facilitating subsequent suturing of the vaginal cuff.
  • the uterine manipulator 38 includes a rigid shaft 46 over which the colpotomy device 40 is slidably disposed, an intrauterine balloon 48 affixed to a distal end 54 of the rigid shaft 46, a handle assembly 50 affixed to a proximal end 56 of the rigid shaft 46, and a first source of fluid 52 (e.g., a syringe (filled with inflation gas or fluid, such as saline)) configured for inflating the intrauterine balloon 48.
  • a first source of fluid 52 e.g., a syringe (filled with inflation gas or fluid, such as saline)
  • the intrauterine balloon 48 is non-compliant, such that, when inflated, it can firmly engage the interior wall of the uterus U and facilitate pulling the separated uterus U and cervix C out of the patient P via the vaginal cavity VC without the use of a tenaculum.
  • the intrauterine balloon 48 is triangular in shape, thereby mimicking the interior contour of the uterus U of the patient P, as illustrated in Fig. 3
  • the rigid shaft 46 has an internal inflation lumen (not shown) in in fluid communication with the interior of the intrauterine balloon 48.
  • the handle assembly 50 comprises a handle body 58, a flexible fluid conduit 60 in fluid communication with the internal inflation lumen of the rigid shaft 46, and a proximal adapter 62 configured for being mated to the first source of fluid 52, such that the first source of fluid 52 can be placed in fluid communication with the inflation lumen of the rigid shaft 46, and thus, the interior region of the intrauterine balloon 48.
  • the handle body 58 is preferably shaped to be ergonomic for the physician while standing on the side the patient P and sitting or standing between the legs of the patient P. Further details describing one embodiment of the uterine manipulator 38 are set forth in U.S. Provisional Application Ser. No. 63/136,916, entitled “Surgical Device for Performing Colpotomy on Patient,” which is expressly incorporated herein by reference.
  • the colpotomy device 40 of the intravaginal colpotomy assembly 12 generally comprises a flexible shaft 64 having a distal end 70 and a proximal end 72, a colpotomy cup 66a affixed to the distal end 70 of the flexible shaft 64, and a handle assembly 68 affixed to the proximal end 72 of the flexible shaft 64.
  • the flexible shaft 64 comprises a lumen 74 (shown in phantom) through which the rigid shaft 46 of the uterine manipulator 38 is slidably disposed, such that the colpotomy cup 66a may be freely displaced along the rigid shaft 46 of the uterine manipulator 38 in either the distal direction or proximal direction until the locked, as will be described in further detail below.
  • the flexible shaft 64 may have any desired cross-sectional shape of a desired dimension, so long as it may be received within the vaginal cavity VC of the patient P.
  • the flexible shaft 64 may be composed of any suitable inert and biocompatible material that provides the necessary flexibility to the flexible shaft 64. As best shown in Fig.
  • the colpotomy cup 66a is configured for being positioned at the vaginal fornices VF (i.e. , the superior (or deepest) portions of the vagina V extending into the recesses created by the vaginal portion of the cervix C, which consist of the larger anterior fornix, the posterior fornix, and two lateral fornices) between the cervix C and the vagina V of the patient P, and being operated to circumferentially incise the vaginal-cervical junction J of the patient P.
  • VF vaginal fornices VF
  • the superior (or deepest) portions of the vagina V extending into the recesses created by the vaginal portion of the cervix C, which consist of the larger anterior fornix, the posterior fornix, and two lateral fornices
  • the handle assembly 68 comprises a handle body 69 and a uterine manipulator locking device 71 .
  • the handle body 69 is preferably shaped to be ergonomic for the physician from both a laparoscopic position and from a standing position or sitting position between the legs of the patient P. Alternatively, the handle body 69 may be shaped to be ergonomic for the physician from a standing position on the side of the patient P.
  • the uterine manipulator locking device 71 selectively locks or unlocks the colpotomy device 40 to the rigid shaft 46 of the uterine manipulator 38.
  • the colpotomy cup 66a is permanently affixed to the distal end 70 of the flexible shaft 64, although in alternative embodiments, the colpotomy cup 66a is detachable or disconnectable from the distal end 70 of the flexible shaft 64, such that the colpotomy cup 66a can be sterilized and re-used, removed from the distal end 70 of the flexible shaft 64 and be disposed, or be made to be interchangeable with other cutting heads in a variety of dimensions, such that the physician can select an appropriately sized colpotomy cup 66a to suit the size of the vaginal cavity VC of the patient P.
  • the colpotomy cup 66a may have any suitable shape, configuration, and/or dimension, such that the colpotomy cup 66a can be received in the vaginal cavity VC of the patient P.
  • the colpotomy cup 66a is hollow, and comprises an annular wall 76 and a central cavity 78 through which the rigid shaft 46 (shown in Fig. 4) of the uterine manipulator 38 is slidably disposed.
  • the colpotomy cup 66a may be solid, and thus, would not include a central cavity.
  • the colpotomy cup 66a is divided between a shaft coupling section 80, a member retention section 82 distal to the shaft coupling section 80, a transition section 84 located between the shaft coupling section 80 and member retention section 82, and a member deflection section 86 distal to the member retention section 82, as best shown in Figs. 4 and 5.
  • the distal end 70 of the flexible shaft 64 of the colpotomy device 40 is affixed to the shaft coupling section 80 of the colpotomy cup 66a in a suitable manner.
  • the distal end 70 of the flexible shaft 64 is disposed within the portion of the central cavity 78 extending through the shaft coupling section 80 of the colpotomy cup 66.
  • a sleeve 88 may be bonded over the shaft coupling section 80 of the colpotomy cup 66a and a portion of the flexible shaft 64 proximally extending from the shaft coupling section 80, thereby permanently affixing the flexible shaft 64 to the colpotomy cup 66.
  • the distal end 70 of the flexible shaft 64 may be bonded around the shaft coupling section 80 of the colpotomy cup 66.
  • the member retention section 82 is sized to be firmly retained within the vaginal cavity VC of the patient P.
  • the member retention section 82 may have a suitable diameter, e.g., in the range of 2.5 cm - 4.0 cm.
  • the member retention section 82 is cylindrical in nature (i.e. , the surface of the member retention section 82 is parallel to the longitudinal axis of the colpotomy cup 66), and the transition section 84 has a frusto-conical shape to transition the smaller diameter of the shaft coupling section 80 to the larger diameter member retention section 82.
  • the transition section 84 minimizes any trauma to the vagina V as the colpotomy cup 66a is proximally removed from the vaginal cavity VC of the patient P.
  • the member retention section 82 along with the transition section 84, has a frusto-conical shape.
  • the member retention section 82 has a frusto-conical shape that flares outward from the distal end of the shaft coupling section 80, such that a separate transition section is not needed. In this case, the flare of the member retention section 82 will minimize trauma to the vagina V as the colpotomy cup 66a is proximally removed from the vaginal cavity VC of the patient P.
  • the member retention section 82 includes a plurality of member lumens 90 (best shown in Fig. 4) longitudinally extending through the annular wall 76 from a proximal end 92 of the member retention section 82 to a distal end 94 of the member retention section 82.
  • Each of the member lumens 90 has a proximal entry port 96 into which a distal end of the elongate tissue-penetrating member 42 can be inserted, and a distal exit port 98 out which the distal end of the elongate tissuepenetrating member 42 can be deployed.
  • the proximal entry ports 96 of the member lumens 90 are disposed on the surface of the colpotomy cup 66, 66’ between the member retention section 82 and the transition section 84. Because the member lumens 90 are parallel to the longitudinal axis of the colpotomy cup 66, and it is assumed that the tissue-piercing elongate member(s) 42 will be introduced into the vaginal cavity VC of the patient P along the longitudinal axis of the colpotomy cup 66, the insertion force required to convey the distal end of each elongate tissuepenetrating member 42 through the respective member lumen 90 is minimized.
  • the proximal entry ports 96 of the member lumens 90 are disposed on the surface of the colpotomy cup 66c between the shaft coupling section 80 and the member retention section 82, although the proximal entry ports 96 may be disposed on the surface of the colpotomy cup 66c anywhere on the member retention section 82.
  • the number of member lumens 90 is at least six, and in the illustrated embodiment, the number of member lumens 90 equals twelve (only two shown in Fig. 4).
  • the member lumens 90 are circumferentially disposed about the member retention section 82 in an equi-distant manner, such that the orientation of the colpotomy cup 66a is agnostic to the placement of the elongate tissue-penetrating members 42, as will be described in further detail below.
  • the member deflection section 86 is configured for deflecting each elongate tissue-penetrating member 42 radially outward as the distal end of the elongate tissue-penetrating member 42 is deployed from the distal exit port 98 of the respective member lumen 90.
  • the distal end of each elongate tissuepenetrating member 42 will be oriented in a manner that it will pierce through the vaginal-cervical junction J at a puncture point (e.g., a suture point through which a suture may be subsequently introduced or an anchor point wherein opposite sides of the vaginal cuff may be collapsed together into the abdominal cavity AC of the patient P, as best illustrated in Fig. 3.
  • the puncture points will be located, such that the vaginal-cervical junction J can be circumferentially incised distal to the puncture points to create a vaginal cuff having the puncture points.
  • the consistent and equi-distant spacing between the distal exit ports 98 of the member lumens 90 allows these puncture points to be made with an equi-distant manner around the vaginal-cervical junction J in a repeatable manner.
  • the member deflection section 86 includes a member deflection surface 100 distal to the exit ports 98 of the member lumens 90.
  • the member deflection section 86 is configured for urging the distal end of each elongate tissue-penetrating member 42 radially outward (shown as arrow 101 in Fig. 5) as the elongate tissue-penetrating member 42 exits the distal exit port 98 and abuts the member deflection surface 100.
  • the member deflection section 86 includes an annular ring 102 affixed to the distal end of the member retention section 82.
  • the member deflection surface 100 of the annular ring 102 has a perimeter (in this case, a maximum diameter) greater than a perimeter of the distal exit ports 98 of the member lumens 90.
  • the maximum diameter of the annular ring 102 is equal to the outer diameter of the distal end of the member retention section 82.
  • the annular ring 102 has a radially inward tapering proximal surface 104 configured for non-traumatically contacting the cervix C of the patient P (see Fig. 3), and a radially inward tapering distal surface that forms the member deflection surface 100.
  • the member deflection surface 100 is convex in nature, such that as the distal end of each elongate tissue-penetrating member 42 contacts the member deflection surface 100, the distal end of the elongate tissue-penetrating member 42 naturally is deflected radially outward.
  • the intravaginal colpotomy assembly 14 may be further configured for occluding the vaginal cavity VC via the pneumoocclusion assembly 44 to prevent insufflation gas from escaping the abdominal cavity AC of the patient P, and thus preventing loss of pneumoperitoneum, as the vaginal-cervical junction J of the patient P is being circumferentially incised.
  • a vapor or gas e.g., carbon dioxide
  • the pneumo-occlusion assembly 44 comprises a pneumo-occluder 110, which, in the illustrated embodiment, takes the form of an inflatable balloon, a flexible fluid conduit 112 in fluid communication with the interior region of the pneumo-occluder 110, a second source of fluid 114 (e.g., a syringe (filled with inflation gas or fluid, such as saline)), and a proximal adapter 116 configured for being mated to the second source of fluid 114, such that the second source of fluid 114 can be placed in fluid communication with the flexible fluid conduit 112, and thus, the interior region of the pneumo-occluder 110 to facilitate occlusion of the vaginal cavity VC of the patient P.
  • a second source of fluid 114 e.g., a syringe (filled with inflation gas or fluid, such as saline)
  • a proximal adapter 116 configured for being mated to the second source of fluid 114, such that the second source of fluid
  • the pneumo-occluder 110 is disposed around the flexible shaft 64 of the colpotomy device 40 between the colpotomy cup 66a and the handle assembly 68.
  • the pneumo-occluder 110 is permanently affixed to the flexible shaft 64, e.g., at the distal end 70 of the flexible shaft 64 just proximal to the colpotomy cup 66.
  • the pneumo-occluder 110 may comprise any suitable geometric shape (e.g., a sphere, ovoid, cylinder, cone, tori (toroidal), bulb, ring, or wheel, but in the illustrated embodiment is toroidal or donut-shaped.
  • the pneumo-occluder 110 is preferably compliant, thereby facilitating a seal between the tissue colpotomy cup 66a and the wall of the vaginal cavity VC of the patient P, and as a result, minimizing the risk of losing pneumoperitoneum (i.e. , loss of insufflation via fluid communication between the abdominal cavity AC and the vaginal cavity VC of the patient P) during the hysterectomy procedure.
  • “compliant” means that the balloon, when fully inflated, is bendable, deformable, manipulatable, and soft to enable conforming to the contours of the vaginal cavity VC, while yet able to spring back into shape after bending, stretching or being compressed to conform to the vaginal cavity VC.
  • the hysterectomy system 10 has been described as having a tissue cutting device in the form of a laparoscopic tissue cutting assembly 12 that is mechanically separate from the intravaginal colpotomy assembly 14, it should be appreciated that a cutting device may be incorporated into the intravaginal colpotomy assembly 14, such that a separate cutting device is not needed to perform the colpotomy cut.
  • an alternative embodiment of a hysterectomy system 10’ is similar to the hysterectomy system 10 illustrated in Fig. 1 with the exception that, instead of having a separate laparoscopic tissue cutting assembly 12, the hysterectomy system 10’ comprises an intravaginal colpotomy assembly 14’ that is configured for circumferentially incising the vaginal-cervical junction J of the patient P via a suitable means, and in the illustrated embodiment, via electrocautery.
  • the hysterectomy system 10’ is specifically designed to be used in a total vaginal hysterectomy (TVH) (i.e.
  • the uterus U, along with the cervix C is severed from within the vagina V without the use of laparoscopy and removed through the vagina V) or a laparoscopically assisted vaginal hysterectomy (LAVH) (i.e., the uterus U, along with the cervix C, is severed from within the vagina V and removed through the vagina V, while the procedure is performed under laparoscopic guidance and visualization).
  • LAVH laparoscopically assisted vaginal hysterectomy
  • the intravaginal colpotomy assembly 14’ generally comprises the previously described uterine manipulator 38, tissue-piercing elongate member(s) 42 (only one shown in Fig. 1), and pneumo-occlusion assembly 44. Instead of a colpotomy device 40, the intravaginal colpotomy assembly 14’ comprises a colpotomy device 120 slidably disposed over the uterine manipulator 38.
  • the colpotomy device 120 is similar to the colpotomy device 40 in that its distal end may be secured within the vaginal cavity VC of the patient P relative to the uterine manipulator 38, and used to distally advance the distal end of each of the elongate tissue-penetrating members 42 through vaginal-cervical junction J prior to performing the colpotomy cut, thereby facilitating suturing of the resulting vaginal cuff after performing the colpotomy cut.
  • the colpotomy device 120 is additionally configured for actively performing the colpotomy cut of the vaginal-cervical junction J.
  • the colpotomy device 120 comprises a flexible shaft assembly 122 having a distal end 128 and a proximal end 130, a cutting head 124 affixed to the distal end 128 of the flexible shaft assembly 122, and a handle assembly 126 affixed to the proximal end 130 of the flexible shaft assembly 122.
  • the flexible shaft assembly 122 has a composite structure, and comprises an inner shaft 132 and an outer shaft 134 coaxially disposed around the inner shaft 132.
  • the inner shaft 132 is rotatably disposed within the outer shaft 134 about a longitudinal axis 136 of the flexible shaft assembly 122 to actuate the tissue cutting functionality of the colpotomy device 120.
  • the cutting head 124 is configured for being positioned at the vaginal fornices VF (i.e., the superior (or deepest) portions of the vagina V extending into the recesses created by the vaginal portion of the cervix C, and being operated to circumferentially incise the vaginal-cervical junction J of the patient P (shown in Fig. 13).
  • VF vaginal fornices VF
  • the superior (or deepest) portions of the vagina V extending into the recesses created by the vaginal portion of the cervix C
  • the cutting head 124 is configured for being positioned at the vaginal fornices VF (i.e., the superior (or deepest) portions of the vagina V extending into the recesses created by the vaginal portion of the cervix C, and being operated to circumferentially incise the vaginal-cervical junction J of the patient P (shown in Fig. 13).
  • the cutting head 124 generally comprises a colpotomy cup 66d and a cutting element 140 configured for puncturing through the vaginal-cervical junction J of the patient P after the cutting head 124 has been positioned at the vaginal fornices VF and rotated about the longitudinal axis 136 of the flexible shaft assembly 122, thereby creating a circumferential incision through the vaginal-cervical junction J and transecting the uterus U and cervix C from the vagina V of the patient P.
  • the colpotomy cup 66d may have any suitable shape, configuration, and/or dimension, such that the colpotomy cup 66d can be received in the vaginal cavity VC of the patient P.
  • the colpotomy cup 66d is sized to be firmly retained within the vaginal cavity VC of the patient P.
  • the colpotomy cup 66d may have a suitable diameter, e.g., in the range of 2.5 cm - 4.0 cm.
  • the cutting element 140 takes the form of a cutting electrode that is operated in a bipolar mode, and thus, the cutting head 124 further comprises a ground electrode 142 affixed to the colpotomy cup 66d adjacent to the cutting electrode 140.
  • the RF generator 18 is electrically coupled to the colpotomy device 120 via the electrical cable 20, such that RF ablation energy may be delivered between the cutting electrode 140 and ground electrode 142 to facilitate severing of the uterus U and cervix C from the vagina V.
  • the colpotomy cup 66d comprises an outer cup portion 144 and inner cup portion 146 disposed within the outer cup portion 144.
  • the inner cup portion 146 is rotatable relative to outer cup portion 144 about the longitudinal axis 136 of the flexible shaft assembly 122.
  • the inner shaft 132 of the flexible shaft assembly 122 (shown in Fig. 12) is affixed to the inner cup portion 146 of the colpotomy cup 66d, while the outer shaft 134 of the flexible shaft assembly 122 (shown in Fig.
  • the outer cup portion 144 of the colpotomy cup 66d is similar to the colpotomy cup 66a illustrated in Fig. 4-8 in that it comprises an annular wall 148 and a central cavity 149 in which the inner cup portion 146 is rotatable disposed.
  • the outer cup portion 144 of the colpotomy cup 66d is divided between a shaft coupling section 150, a member retention section 152 distal to the shaft coupling section 150, a transition section 154 located between the shaft coupling section 150 and member retention section 152, and a member deflection section 156 distal to the member retention section 152, as best shown in Figs. 14 and 15.
  • the inner cup portion 146 is hollow and comprises an annular wall 151 and a central cavity 153 through which the rigid shaft 46) of the uterine manipulator 38 is slidably disposed.
  • the inner cup portion 146 of the colpotomy cup 66d may be solid, and thus, would not include a central cavity.
  • the distal end 128 of the flexible shaft assembly 122 is affixed to the shaft coupling section 150 of the colpotomy cup 66d in a suitable manner.
  • the distal end of the outer shaft 134 of the flexible shaft assembly 122 is bonded over the shaft coupling section 150 of the outer cup portion 144 of the colpotomy cup 66d, and the distal end of the inner shaft 132 of the flexible shaft assembly 122 is bonded within the proximal end of the inner shaft 132 of the flexible shaft assembly 122, such that rotation of the inner shaft 132 within the outer shaft 134 oof the flexible shaft assembly 122 rotates the inner cup portion 146 within the outer cup portion 144 of the colpotomy cup 66d.
  • the member retention section 152 of the outer cup portion 144 of the colpotomy cup 66d includes a plurality of member lumens 90 longitudinally extending through the annular wall 148 from a proximal end 162 of the member retention section 152 to a distal end 164 of the member retention section 152, as best shown in Fig. 15.
  • Each of the member lumens 90 has a proximal entry port 96 into which a distal end of the elongate tissue-penetrating member 42 can be inserted, and a distal exit port 98 out which the distal end of the elongate tissue-penetrating member 42 can be deployed.
  • the outer cup portion 144 of the colpotomy cup 66d may be shaped in the same manner as the colpotomy cups 66’, 66” respectively illustrated in Figs. 9 and 10.
  • the member deflection section 156 of the outer cup portion 144 of the colpotomy cup 66d is configured for deflecting each elongate tissue-penetrating member 42 radially outward as the distal end of the elongate tissue-penetrating member 42 is deployed from the distal exit port 98 of the respective member lumen 90.
  • the distal end of each elongate tissue-penetrating member 42 will be oriented in a manner that it will pierce through the vaginal-cervical junction J at a puncture point into the abdominal cavity AC of the patient P, as best illustrated in Fig. 3.
  • the member deflection section 156 includes a member deflection surface 170 that urges each elongate tissue-penetrating member 42 radially outward (shown as arrow 171 in Fig. 15) as the elongate tissue-penetrating member 42 bears against the member deflection surface 170.
  • the member deflection section 156 includes an annular ring 172 affixed to the distal end of the member deflection section 156.
  • the annular ring 172 has a perimeter (in this case, a maximum diameter) greater than a perimeter of the distal exit ports 98 of the member lumens 90.
  • the maximum diameter of the annular ring 172 is equal to the outer diameter of the distal end of the member retention section 152.
  • the annular ring 172 has a radially inward tapering proximal surface 174 configured for non-traumatically contacting the cervix C of the patient P, and a radially inward tapering distal surface that forms the member deflection surface 170.
  • the member deflection surface 170 is convex in nature, such that as the distal end of each elongate tissue-penetrating member 42 contacts the member deflection surface 170, the distal end of the elongate tissue-penetrating member 42 naturally is deflected radially outward.
  • At least a portion of the cutting electrode 140 is disposed between the outer cup portion 144 and the inner cup portion 146, and is mechanically coupled to the inner cup portion 146, such that when inner cup portion 146 is rotated within the outer cup portion 144 about the longitudinal axis 136 of the flexible shaft assembly 122, the cutting electrode 140 rotates with the inner cup portion 146, thereby circumferentially incising the vaginal-cervical junction J (shown in Fig. 13).
  • the outer cup portion 144 remains stationary relative to the vagina V, while the inner cup portion 146, along with the cutting electrode 140, rotates within the inner cup portion 146 relative to the vagina V.
  • the cutting electrode 140 is slidably coupled to the inner cup portion 146 of the colpotomy cup 66d, such that the cutting electrode 140 is configured for being distally advanced from a stored position to a deployed position (shown in phantom in Fig. 17).
  • the ground electrode 142 is a surface electrode disposed on an inner surface 176 of the inner cup portion 146 and extends to a distal-facing surface 178 of the inner cup portion 146 adjacent to the cutting electrode 140.
  • the cutting electrode 140 in the exemplary embodiment, is an ablation electrode in a bipolar energy delivery with the ground electrode 142
  • monopolar electrical energy may be delivered to the cutting electrode 140, in which case, a ground electrode will not be located on the colpotomy cup 66d, but rather will take the form of a patch electrode (not shown) that can be affixed to the exterior of the patient P.
  • the handle assembly 126 not only provides the physician with the means of grasping the colpotomy device 120 and locking the cutting head 124 relative to the uterine manipulator 38 in a similar manner as with the handle assembly 68 of the colpotomy device 40 of the intravaginal colpotomy assembly 12 illustrated in Fig. 2, but is also configured for controlling the deployment/retraction of the cutting electrode 140, controlling the rotation of the cutting electrode 140, and enabling the cutting electrode 140 with electrical ablation energy.
  • the handle assembly 126 comprises a handle body 180, a uterine manipulator locking device 182, a cutting electrode deployment actuator 184, and an electrical ablation port 186.
  • the handle body 180 of the handle assembly 126 is preferably shaped to be ergonomic for the physician from both a laparoscopic position and from a standing position or sitting position between the legs of the patient P.
  • the handle body 69 may be shaped to be ergonomic for the physician from a standing position on the side of the patient.
  • the handle body 180 is affixed to the proximal end of the inner shaft 132 of the flexible shaft assembly 122, while being rotatably coupled to the proximal end of the outer shaft 134 of the flexible shaft assembly 122.
  • rotation of the handle body 180 relative to the outer shaft 134 of the flexible shaft assembly 122 causes the inner shaft 132 of the flexible shaft assembly 122 to rotate relative to the outer shaft 134 of the flexible shaft assembly 122 about the longitudinal axis 136 of the flexible shaft assembly 122, which in turn, causes the inner cup portion 146 of the colpotomy cup 66d, along with the cutting electrode 140, to rotate relative to the outer cup portion 144 of the colpotomy cup 66d about the longitudinal axis 136 of the flexible shaft assembly 122, such that the cutting electrode 140 can circumferentially incise the vaginal-cervical junction J of the patient P.
  • the uterine manipulator locking device 182 selectively locks or unlocks the colpotomy device 120 to the rigid shaft 46 of the uterine manipulator 38.
  • the cutting electrode deployment actuator 184 facilitates selective advancement of the cutting electrode 140 from the colpotomy cup 66d from its stored position to its deployed position (shown best in Figs. 15 and 16), and retracting the cutting electrode 140 into the colpotomy cup 66d from its deployed position to its stored position (shown best in Fig. 14), and allowing the physician to temporarily lock the cutting electrode 140 in the stored position or in different deployment positions.
  • the cutting electrode deployment actuator 184 is mechanically coupled to a linkage (which in the illustrated embodiment, comprises a sleeve 185 slidably disposed over the inner shaft 132 of the flexible shaft assembly 122 illustrated in Fig.
  • the electrical ablation port 186 electrically couples the RF generator 18 to the cutting electrode 140 via wires (not shown) extending through the flexible shaft assembly 122, thereby providing electrical ablation energy to the cutting electrode 140, and in the illustrated embodiment, bipolar electrical ablation energy between the cutting electrode 140 and the ground electrode 142 of the cutting head 124.
  • a hysterectomy system 10 is similar to the hysterectomy system 10 illustrated in Fig. 1 with the exception that, instead of having a laparoscopic tissue cutting assembly 12, the hysterectomy system 10” comprises conventional laparoscopic pliers 12’ configured for circumferentially incising the vaginal-cervical junction J of the patient P by pulling a cutting element associated with an intravaginal colpotomy assembly 14”.
  • the hysterectomy system 10’ is specifically designed to be used in an TLH (i.e., the uterus U, along with the cervix C, is laparoscopically severed from the vagina V while the procedure is performed under laparoscopic guidance and visualization).
  • the intravaginal colpotomy assembly 14 generally comprises the previously described uterine manipulator 38, tissue-piercing elongate member(s) 42 (only one shown in Fig. 1), and pneumo-occlusion assembly 44. Instead of a colpotomy device 40, the intravaginal colpotomy assembly 14’ comprises a colpotomy device 190 slidably disposed over the uterine manipulator 38.
  • the colpotomy device 190 is similar to the colpotomy device 40 in that its distal end may be secured within the vaginal cavity VC of the patient P relative to the uterine manipulator 38, and used to distally advance the distal end of each of the elongate tissue-penetrating members 42 through vaginal-cervical junction J prior to performing the colpotomy cut, thereby facilitating suturing of the resulting vaginal cuff after performing the colpotomy cut.
  • the colpotomy device 190 additionally comprises a cutting element designed to be pulled by the laparoscopic pliers 12’ to perform the colpotomy cut of the vaginal-cervical junction J.
  • the colpotomy device 190 comprises the flexible shaft 64, a cutting head 192 affixed to the distal end 70 of the flexible shaft 64, and the handle assembly 68 affixed to the proximal end 72 of the flexible shaft 64.
  • the cutting head 192 comprises a colpotomy cup 66e that is similar to the colpotomy cup 66a of the colpotomy device 40 illustrated in Fig. 4-8, with the exception that the colpotomy cup 66e comprises an annular groove 194 formed into the proximal surface 104 of the annular ring 102 of the colpotomy cup 66e.
  • the colpotomy device 190 further comprises a cutting element in the form of a tissue cutting wire 196 that is stored within the annular groove 194 of the colpotomy cup 66e.
  • one end of the tissue cutting wire 196 may be configured for puncturing through the vaginal-cervical junction J of the patient P after the cutting head 192 has been positioned at the vaginal fornices VF.
  • the laparoscopic pliers 12’ can then be employed to pull the cutting wire 196 out of the annular groove 194 of the colpotomy cup 66e, thereby creating a circumferential incision through the vaginal-cervical junction J and transecting the uterus U and cervix C from the vagina V of the patient P.
  • the cutting wire 196 may either cut the vaginal-cervical junction J “cold” (without electrical current) or with an electrical current, in which case, an RF generator may be electrically coupled to the cutting wire 196, while the laparoscopic pliers 12’ may be electrically coupled to ground, thereby allowing electrical energy to be conveyed to the cutting wire 196, through the tissue of the vaginal-cervical junction J, and back to ground through the laparoscopic pliers 12’. Further details discussing this technique are provided in U.S. Patent Application Ser. No. 16/368,457, entitled “Uterine Manipulator with Cutting Head,” which is expressly incorporated herein by reference.
  • the colpotomy cup 66f is similar to the colpotomy cup 66a illustrated in Figs. 4-8, with the exception that, instead of having a rigid, monolithic, annular wall 76 through which the member lumens 90 longitudinally extend, the colpotomy cup 66f has an inner, rigid, annular wall portion 76a, and an outer, elastomeric, annular wall portion 76b. In the illustrated embodiment, the entirety of the outer surface of the inner, rigid, annular wall portion 76a is covered by the outer, elastomeric, annular wall portion 76b. Furthermore, instead of the member lumens 90 longitudinally extending through the annular wall 76, the member lumens 90 longitudinally extend along an outer surface of the outer, elastomeric, annular wall portion 76b.
  • the colpotomy cup 66f comprises a plurality of elastomeric tubes 106 (in this case, four equi-distantly spaced tubes 106 shown in Fig. 22) suitably affixed to the outer surface of the inner, rigid, annular wall portion 76a (e.g., via bonding), and through which the member lumens 90, such that the member lumens 90 may collapse and conform to the vaginal cavity when the colpotomy cup 66f is introduced within the vagina.
  • elastomeric tubes 106 in this case, four equi-distantly spaced tubes 106 shown in Fig. 22
  • the member lumens 90 may collapse and conform to the vaginal cavity when the colpotomy cup 66f is introduced within the vagina.
  • each of the member lumens 90 is sized to receive an elongate tissue-penetrating member 42, and each has a proximal entry port 96 into which a distal end of the elongate tissue-penetrating member 42 can be inserted, and a distal exit port 98 out which the distal end of the elongate tissue-penetrating member 42 can be deployed. Due to the compliance of the elastomeric tubes 106, the diameters of the member lumens 90 may expand, if necessary, to accommodate the sizes of the elongate tissue-penetrating members 42.
  • the colpotomy cup 66f further comprises an enlarged elastomeric distal rim 108 disposed around the distal end of the outer, elastomeric, annular wall portion 76b.
  • the distal ends of the tubes 106 are suitably affixed over the enlarged elastomeric distal rim 108 (e.g., via bonding), such that the distal ends of the member lumens 90 are curved radially outward, essentially emulating the member deflection surface 100 of the colpotomy cup 66a illustrated in Figs. 5-6.
  • the distal end of the elongate tissue-penetrating members 42 is deflected radially outward when the distal end of the elongate tissue-penetrating member 42 is inserted from the proximal entry port 96 out of the distal exit port 98 of the respective member lumen 90.
  • the outer, elastomeric, annular wall portion 76b, plurality of tubes 106 (along with the member lumens 90), and enlarged elastomeric distal rim 108 may be formed as an elastomeric cover 198 configured for being removably fit over a pre-existing colpotomy cup 66 that was not previously enabled to distally advance elongate tissue-penetrating members 42 into the vaginal-cervical junction prior to performing a colpotomy cup for facilitating the suturing of a vaginal cuff after the colpotomy cup has been made.
  • the shape of the elastomeric, annular, wall of the elastomeric cover 198 preferably matches, but is smaller than the, the shape of the annular wall of the colpotomy cup 66 that the elastomeric cover 198 is intended to fit over, such that the elastomeric cover 198 conforms to, and fits snugly over, the colpotomy cup 66.
  • the elastomeric cover 198 comprises a pneumo-occluder 109, which may take the form of an inflatable ring- shaped balloon, to facilitate occlusion of the vaginal cavity VC of the patient P when inflated. In this case, a pneumo-occlusion assembly 44 illustrated in Figs. 1 , 11 , and 17 may not be needed.
  • each elongate tissue-penetrating member 42 may take the form of a suture shuttle that can be used to introduce a suture through an optimally placed suture point in the vaginal-cervical junction created by the suture shuttle, thereby facilitating subsequent suturing of the vaginal cuff.
  • Each suture shuttle may take any form that can penetrate from one side to the other side of the vaginal-cervical junction, thereby creating a suture point within the vaginal-cervical junction, while subsequently allowing a suture to be advanced through the suture point in the vaginal-cervical junction between the vaginal cavity and abdominal cavity of the patient.
  • the suture shuttle may be used, e.g., with any of the colpotomy cups 66a-66f.
  • a suture shuttle 42a’ comprises a twisted wire 204 having an eyelet or loop 206 through which a suture may be tied, and a tissue-penetrating distal tip 208 opposite the eyelet or loop 206.
  • the end of a suture 200 may be tied to the eyelet or loop 206 while the suture shuttle 42a’ extends through a suture point SP in the vaginal-cervical junction J between the vaginal cavity VC and abdominal cavity AC of the patient P.
  • the suture 200 may then be pulled, via the suture shuttle 42a’, through the suture point SP in the vaginal-cervical junction J.
  • the suture shuttle 42a’ is advanced from the abdominal cavity AC, through the vaginal-cervical junction J, and into the vaginal cavity VC of the patient P, such that the suture 200 is tied to the eyelet or loop 206 on the abdominal side of the vaginal-cervical junction J.
  • the suture 200 may then be pulled, via the suture shuttle 42a’, from the abdominal cavity AC, through the suture point SP in the vaginal-cervical junction J, and into the vaginal cavity VC of the patient P, as illustrated in Fig. 26B.
  • the suture shuttle 42a’ is advanced from the vaginal cavity VC, through the vaginal- cervical junction J, and into the abdominal cavity AC of the patient P, such that the suture 200 is tied to the eyelet or loop 206 on the vaginal side of the vaginal-cervical junction J, as illustrated in Fig. 26C.
  • the suture 200 may then be pulled, via the suture shuttle 42a’, from the vaginal cavity VC, through the suture point SP in the vaginal-cervical junction J, and into the abdominal cavity AC of the patient P, as illustrated in Fig. 26D.
  • the suture shuttle 42a’ may then be removed, leaving the suture 200 disposed through the suture point SP in place, as illustrated in Fig. 26E.
  • multiple suture points SP can be formed in the vaginal-cervical junction J using the foregoing techniques, after which the colpotomy cut can be made, and then the vaginal cuff sutured with the sutures 200 disposed through the suture points SP.
  • a suture shuttle 42a comprises a tube 210 having a lumen 212 configured for passing a suture 200.
  • the suture shuttle 42a” may also comprises a stylet 214 having a tissue-penetrating distal tip 216 that can be removably disposed within the lumen 212, such that the tissuepenetrating distal tip 216 extends from the end of the tube 210.
  • the suture shuttle 42a” with the stylet 214 is advanced from the abdominal cavity AC, through the vaginal-cervical junction J, and into the vaginal cavity VC of the patient P, or advanced from the vaginal cavity VC, through the vaginal-cervical junction J, and into the abdominal cavity AC of the patient P, as illustrated in Fig. 28A.
  • the stylet 214 can then be removed from the lumen 212, and the suture 200 may be passed from the abdominal cavity AC, through the lumen 212 of the tube 210, and into the vaginal cavity VC of the patient P, or passed from the vaginal cavity VC, through the lumen 212 of the tube 210, and into the abdominal cavity AC of the patient P, as illustrated in Fig.
  • suture shuttle 42a may then be removed, leaving the suture 200 disposed through the suture point SP in place, as illustrated in Fig. 28C.
  • multiple suture points SP can be formed in the vaginal-cervical junction J using the foregoing technique, after which the colpotomy cut can be made, and then the vaginal cuff sutured with the sutures 200 disposed through the suture points SP.
  • one end of the tube 210 may have a funnel or flared region to facilitate threading of the suture 200 within the lumen 212 of the tube 210.
  • a suture 200 is pre-loaded into the lumen 212 of the tube 210, e.g., by the manufacturer, such that the suture shuttle 42a”, along with the suture 200, may be concurrently introduced through the respective member lumen of the colpotomy cup, until the distal end of the tube 210, along with suture 200, traverses the suture point 200 in the vaginal-cervical junction
  • FIG. 29 one exemplary method 300 of operating the colpotomy system 10 (shown in Fig. 1 to perform a TLH on the patient P will now be described. It should be appreciated that modified methods similar to the exemplary method 300 illustrated in Fig. 29 may be used to operate the colpotomy system 10’ (shown in Fig. 11) to perform an LAVH on the patient P or the colpotomy system 10” (shown in Fig. 17) to perform a TVH on the patient P.
  • the patient P is prepared for surgery according to procedures that are well known in the surgical arts (step 302).
  • the patient P may be oriented in a supine-lithotomy position on an operating table, such that the legs of the patient P rest in raised stirrups.
  • a surgeon, anesthesiologist, and medical assistant may be present alongside the operating table.
  • Other healthcare personnel may be present well.
  • Insertion of the intravaginal colpotomy assembly 12 may begin by guiding the intrauterine manipulator 38 with one hand while holding the colpotomy device 40 (shown in Fig. 1) (or alternatively the colpotomy device 120 (shown in Fig. 11) or the colpotomy device 190 (shown in Fig. 17)) with the other hand.
  • the intrauterine balloon 48 of the uterine manipulator 38 while deflated, is inserted in the vaginal cavity VC, and guided through the cervix C into the uterus U of the patient P (step 306).
  • the intrauterine balloon 48 of the uterine manipulator 38 is inflated, thereby securing the intrauterine balloon 48 within the uterus U of the patient P (step 308).
  • this step is accomplished by conveying fluid from the first source of fluid 52, through the lumen of the rigid shaft 46, out into the interior region of the intrauterine balloon 48 (see Fig. 3 or alternatively Figs. 13 or 20).
  • the uterus U of the patient P may be manipulated by moving the rigid shaft 46 of the uterine manipulator 38 (step 310).
  • this step is accomplished by grasping the handle body 58 of the handle assembly 50 and moving it to accordingly move the rigid shaft 46 relative to the vagina V of the patient P, and thus, the inflated intrauterine balloon 48 within the uterus U of the patient P.
  • the colpotomy cup 66a of the colpotomy device 40 (shown in Fig. 1) (or alternatively the cutting head 124 of the colpotomy device 120 (shown in Fig. 13) or the cutting head 192 of the colpotomy device 190 (shown in Fig. 19)) is distally advanced over the rigid shaft 46 of the uterine manipulator 12 into the vaginal cavity VC of the patient P with one hand, while the other hand holds the handle body 58 of the uterine manipulator 38 (step 312).
  • the colpotomy device 40 (or alternatively the colpotomy device 120 or the colpotomy device 190) is distally advanced over the rigid shaft 46 of the uterine manipulator 12 to the apex of the vaginal cavity VC of the patient P until the colpotomy cup 66a (or alternatively the cutting head 124 or the cutting head 192) is positioned at, and in particular abuts against, the vaginal fornices VF and receives the cervix C of the patient P (step 314).
  • these steps are accomplished by grasping and distally displacing the handle body 69 of the colpotomy device 40 (or alternatively, the handle body 180 of the colpotomy device 120 or the handle body 69 of the colpotomy device 190) relative to the rigid shaft 46 of the uterine manipulator 14, such that the flexible shaft 64 and colpotomy cup 66a (or alternatively, the flexible shaft assembly 122 and cutting head 124 or the flexible shaft 64 and cutting head 192) is correspondingly distally displaced relative to the rigid shaft 46 of the uterine manipulator 14.
  • the colpotomy cup 66 when receiving the cervix C of the patient P aids in delineating the vaginal fornices VF from the other abdominal structures of the patient P prior to performing the colpotomy incision through the vaginal-cervical junction J, as will be described in further detail below.
  • the colpotomy device 40 (or alternatively the colpotomy device 120 or colpotomy device 190) is locked relative to the rigid shaft 46 of uterine manipulator 38 (step 316).
  • This step is accomplished by manipulating the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 1) (or alternatively the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 11) or the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 17) from its unlocked position to its locked position.
  • multiple laparoscopic ports are made in the abdomen of the patient P to facilitate the introduction of surgical and visualization instruments into the abdominal cavity AC of the patient P (step 318).
  • the abdominal cavity AC of the patient P is laparoscopically insufflated via one of the ports with a gas to create space and facilitate accessibility and visualization of the pelvic organs of the patient P (step 320), and laparoscopic surgical instruments may be inserted through the other ports into the abdominal cavity AC of the patient P to facilitate cutting of ligamentus structures and/or illuminate/visualize areas of interest (step 322).
  • the pneumo-occluder 110 of the colpotomy assembly 14 (shown in Fig. 1) (or alternatively the colpotomy assembly 14’ (shown in Fig. 11) or colpotomy assembly 14” (shown in Fig. 17)) is inflated, thereby sealing the vaginal cavity VC of the patient P prior to circumferentially incising the vaginal-cervical junction J of the patient P, thereby preventing insufflation gas, when the vaginal-cervical junction J of the patient P is circumferentially incised, from escaping the abdominal cavity AC through the vaginal cavity VC of the patient P (step 324).
  • this step is accomplished by conveying fluid from the second source of fluid 114, through the flexible fluid conduit 112, and into the interior region of the pneumo-occluder 110.
  • a plurality of suture shuttles 42a are respectively introduced (e.g., sequentially) through the member lumens 90 of the colpotomy cup 66a (see Figs. 4-8) (or alternatively, the colpotomy cup 66b (see Fig. 9), colpotomy cup 66c (see Fig. 10), the colpotomy cup 66d (see Figs. 14-16), colpotomy cup 66e (see Figs. 18-19), or colpotomy cup 66f (see Figs.
  • twelve suture shuttles 42a (only nine shown in Fig. 30A) can be respectively introduced through the twelve member lumens 90 of the colpotomy cup 66a.
  • six suture shuttles 42a can be respectively introduced through six of the twelve member lumens 90 (e.g., in an alternating fashion) of the colpotomy cup 66a.
  • the vaginal-cervical junction J of the patient P is circumferentially incised distal to the suture points SP, thereby transecting the uterus U and cervix C from the vagina V of the patient P, and creating a vaginal cuff VCU having the suture points SP, as illustrated in Fig. 30B (step 328).
  • the laparoscopic tissue cutting assembly 12 may be employed to laparoscopically incise the vaginal-cervical junction J of the patient P by conveying electrical energy from the RF generator 18 to the end effector 26 of the laparoscopic electrosurgical instrument 16 via operation of the electrosurgical activation button 36, while moving the end effector 26 around the vaginal-cervical junction J, which has been delineated from the other abdominal structures of the patient P by the colpotomy cup 66.
  • the vaginal-cervical junction J of the patient P is incised by first distally advancing the (unenergized) cutting electrode 140 of the cutting head 124 from its stored position in the colpotomy cup 66d to apply pressure to the vaginal-cervical junction J with the cutting electrode 140, such that the vaginal-cervical junction J tents within the abdominal cavity AC of the patient P.
  • this step is accomplished by displacing the cutting electrode deployment actuator 184 relative to the handle body 180 of the handle assembly 126 in the distal direction, such that the sleeve 185 slides distally along the longitudinal axis 136, thereby advancing the distal end of the cutting electrode 140 from the colpotomy cup 66d.
  • Tenting of vaginal-cervical junction J into the abdominal cavity AC of the patient P that the cutting electrode 140 is located at the proper location of the vaginal-cervical junction J is confirmed via laparoscopic visualization of the.
  • electrical ablation energy is applied between the cutting electrode 140 and the ground electrode 142 of the cutting head 124 in a bipolar manner, such as via a foot switch, while further distally advancing the cutting electrode 140 of the cutting head 124 from the colpotomy cup 66d to its deployed position, thereby puncturing the vaginal-cervical junction J with the cutting electrode 140.
  • this step is accomplished by operating the RF generator 18 to deliver the electrical ablation energy via the electrical ablation port 158 located on the handle body 180 of the handle assembly 126, while further displacing the cutting electrode deployment actuator 184 relative to the handle body 180 of the handle assembly 126 in the distal direction, such that the sleeve 185 slides distally along the longitudinal axis 136, thereby distally advancing the distal end of the cutting electrode 140 from the colpotomy cup 66d and puncturing through the vaginal- cervical junction J into the abdominal cavity AC of the patient P.
  • electrical ablation energy is applied between the cutting electrode 140 of the cutting head 124 and an external ground electrode (not shown) in a monopolar manner.
  • the inner cup portion 146 is rotated relative to the outer cup portion 144, along with the mechanically coupled cutting electrode 140.
  • Rotating the cutting electrode 140 relative to the vaginal cavity VC circumferentially incises the vaginal- cervical junction J, and transects the uterus U and cervix C from the vagina V of the patient P.
  • this step can be accomplished by rotating the handle body 180, such that the inner shaft 132 rotates within the outer shaft 134 of the flexible shaft assembly 122, thereby causing the inner cup portion 146 and the cutting electrode 140 to rotate about the longitudinal axis 136 of the flexible shaft assembly 122.
  • the cutting electrode 140 of the cutting head 124 is proximally retracted from its deployed position to its stored position within the colpotomy cup 66d.
  • this step is accomplished by displacing the cutting electrode deployment actuator 184 relative to the handle body 180 of the handle assembly 126 in the proximal direction, such that the sleeve 185 slides proximally along the longitudinal axis 136, thereby retracting the distal end of the cutting electrode 140 into the colpotomy cup 66d.
  • the conventional laparoscopic pliers 12’ may be employed to incise the vaginal-cervical junction J of the patient P by laparoscopically pull the cutting wire 196 from the annular groove 194 of the cutting head 192 and through the vaginal-cervical junction J of the patient P.
  • the colpotomy device 40 (or alternatively the colpotomy device 120 (shown in Fig. 11) or colpotomy device 190 (shown in Fig. 17)) is unlocked relative to the rigid shaft 46 of uterine manipulator 38 (step 330).
  • This step is accomplished by manipulating the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 1) (or alternatively the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 11) or the uterine manipulator locking device 71 located on the handle body 69 of the handle assembly 68 (shown in Fig. 17) from its locked position to its unlocked position.
  • the severed uterus U and cervix C are removed from the patient P (step 332).
  • the severed uterus U and cervix C is laparoscopically removed through the abdominal cavity AC of the patient P by cutting the uterus U and cervix C into small pieces and removing them through a laparoscopic port.
  • the colpotomy device 40 or alternatively the colpotomy device 120 (shown in Fig. 11) or the colpotomy device 190 (shown in Fig.
  • these steps are accomplished by grasping and proximally displacing the handle body 69 of the colpotomy device 40 (or alternatively, the handle body 180 of the colpotomy device 120 or the handle body 69 of the colpotomy device 190) relative to the rigid shaft 46 of the uterine manipulator 14, such that the flexible shaft 64 and colpotomy cup 66a (or alternatively, the flexible shaft assembly 122 and cutting head 124 or the flexible shaft 64 and cutting head 192) is correspondingly proximally displaced relative to the rigid shaft 46 of the uterine manipulator 14.
  • the inflated intrauterine balloon 48 is removed, along with the transected uterus U and cervix C, from the vaginal cavity VC of the patient P.
  • the pneumo-occluder 110 of the colpotomy assembly 14 (shown in Fig. 1) (or alternatively the colpotomy assembly 14’ (shown in Fig. 13) or colpotomy assembly 14” (shown in Fig. 19)) is deflated, thereby unsealing the vaginal cavity VC of the patient P (step 334). In the illustrated embodiment, this step is accomplished by withdrawing fluid from the interior region of the pneumo-occluder 110, back through the flexible fluid conduit 112, and into the second source of fluid 114. [194] Next, the colpotomy cup 66a of the colpotomy device 40 (shown in Fig.
  • step 336 1) (or alternatively the cutting head 124 of the colpotomy device 120 (shown in Fig. 11) or the cutting head 192 of the colpotomy device 190 (shown in Fig. 17)) is removed from the vaginal cavity VC of the patient P, leaving a vaginal cuff VCU with the suture placement shuttles 42 extending through the suture points SP in place (step 336).
  • the suture shuttles 42 While they traverse the suture points SP in the vaginal cuff VCU, are employed to thread a suture 200 through the suture points SP, as illustrated in Fig. 30C (step 338).
  • each of the suture shuttles 42a takes the form of a suture shuttle 42a’ comprising a twisted wire 204 having an eyelet or loop 206 (shown in Fig.
  • a suture may be tied to the eyelet or loop 206, and the twisted wire 204 may be grasped (either with a hand or a tool) and pulled through the respective suture point SP either from the abdominal cavity AC into the vaginal cavity VC of the patient P, or from the vaginal cavity VC into the abdominal cavity AC of the patient P, as illustrated in Figs. 26A-26E.
  • each of the suture shuttles 42a takes the form of a suture shuttle 42a” comprising a tube 210 having a lumen 212 (shown in Fig.
  • a suture may be passed through the lumen 212 (after the stylet 214 has been removed), and the end of the suture may be grasped (either with a hand or a tool) and pulled through the respective suture point SP either from the abdominal cavity AC into the vaginal cavity VC of the patient P, or from the vaginal cavity VC into the abdominal cavity AC of the patient P, as illustrated in Figs. 28A-28C.
  • one suture throw 200-1 may be created by threading one end of a suture through a first suture point SP (e.g., on one side of the vaginal cuff VCU) from the abdominal cavity AC into the vaginal cavity VC of the patient P via a first suture shuttle 42, and then threading the same end of the suture through a second suture point SP (e.g., on the other side of the vaginal cuff VCU) from the vaginal cavity VC into the abdominal cavity AC of the patient P via a second suture shuttle 42.
  • a first suture point SP e.g., on one side of the vaginal cuff VCU
  • a second suture point SP e.g., on the other side of the vaginal cuff VCU
  • the suture throw 200-1 may be created by threading one end of a suture through the second suture point SP from the vaginal cavity VC into the abdominal cavity AC of the patient P via the second suture shuttle 42, and then threading the same end of the suture through the first suture point SP from the abdominal cavity AC into the vaginal cavity VC of the patient P via the first suture shuttle 42.
  • Additional suture throws 200-2 to 198-6 may be created with the same suture 200 by employing additional different pairs of suture shuttles 42a to thread the end of the suture 200 through different suture points SP on opposite sides of the vaginal cuff VCU. As illustrated in Fig. 30C, six suture throws 200-1 to 198-6 are created.
  • suture 200 that has been passed through the suture points SP to create the suture throws 200-1 to 200-6 are tightened and tied off to create stiches 200-1 to 200-6, thereby closing the vaginal cuff VCU of the patient P (step 340), as illustrated in Fig. 30D.
  • FIG. 31 another exemplary method 300’ of operating the colpotomy system 10 (shown in Fig. 1) to perform a TLH hysterectomy on the patient P will now be described. It should be appreciated that modified methods similar to the exemplary method 300’ illustrated in Fig. 31 may be used to operate the colpotomy system 10’ (shown in Fig. 11) to perform an LAVH on the patient P or the colpotomy system 10” (shown in Fig. 17) to perform a TLH on the patient P.
  • the method 300’ is similar to the method 300 illustrated in Fig. 29, with the exception that a single suture shuttle 42a is employed to pass multiple sutures 200 through the respective suture points SP.
  • steps 302-324 may be performed in the same manner described above in the method 300 illustrated in Fig. 29.
  • a single suture shuttle 42a is sequentially introduced through each member lumen 90 of the colpotomy cup 66a (see Figs. 4-8) (or alternatively, the colpotomy cup 66b (see Fig. 9), colpotomy cup 66c (see Fig. 10), the colpotomy cup 66d (see Figs. 14-16), colpotomy cup 66e (see Figs. 18-19), or colpotomy cup 66f (see Figs.
  • each suture point SP in the vaginal-cervical junction J into an abdominal cavity AC of the patient P (step 326’).
  • the single suture shuttle 42a is introduced through a first member lumen 90 of the colpotomy cup 66a until the distal end of the single suture shuttle 42a is deflected by the member deflection surface 100 of the member deflection section 86 of the colpotomy cup 66a radially outward and pierces through a first suture point SP in the vaginal-cervical junction J into an abdominal cavity AC of the patient P, as shown in Fig. 32A; the single suture shuttle 42, while it traverses the first suture point SP in the vaginal cuff, is employed to thread a first suture through the first suture point SP, as shown in Fig.
  • the single suture shuttle 42a is introduced through a second member lumen 90 of the colpotomy cup 66a until the distal end of the single suture shuttle 42a is deflected by the member deflection surface 100 of the member deflection section 86 of the colpotomy cup 66a radially outward and pierces through a second suture point SP in the vaginal-cervical junction J into an abdominal cavity AC of the patient P, as shown in Fig. 32C; the single suture shuttle 42, while it traverses the second suture point SP in the vaginal cuff, is employed to thread a second suture 200 through the second suture point SP, as shown in Fig. 32D; and so forth until the sutures 200 are threaded through all of the desired suture points SP, as shown in Fig. 32E.
  • steps 328- 336 and 340 are performed in the same manner described above with respect to the method 300.
  • each suture shuttle 42a may be a tissue anchor that can be manipulated after the colpotomy cut, but prior to suturing, to bring opposite ends of the vaginal cuff together, thereby facilitating subsequent suturing of the vaginal cuff.
  • Each tissue anchor may take any form that can penetrate from one side to the other side of the vaginal-cervical junction, thereby creating an anchor point within the vaginal-cervical junction, while subsequently being configured to be retained on the other side of the vaginal-cervical junction when the tissue anchor is pulled.
  • the tissue anchor may be used, e.g., with any of the colpotomy cups 66a- 66f.
  • tissue anchor 42b’ comprises an elongate shaft 218 having a tissue-penetrating distal tip 220 configured for piercing through a first side of tissue at an anchor point and exiting out of a second side of tissue opposite the first side of tissue when the tissue anchor 42b’ is distally advanced.
  • the tissue anchor 42b’ further comprises a tissue retention assembly in the form of one or more barbs 222 (only two shown) affixed to the elongate shaft 218 proximal to the tissue-penetrating distal tip 220 and being configured for passing from the first side of tissue and exiting out of the second side of tissue behind the tissue-penetrating distal tip 220, and engaging the second side of tissue when the tissue anchor 42b’ is proximally retracted, thereby retaining the tissue-penetrating distal tip 220 on the second side of the tissue.
  • a tissue retention assembly in the form of one or more barbs 222 (only two shown) affixed to the elongate shaft 218 proximal to the tissue-penetrating distal tip 220 and being configured for passing from the first side of tissue and exiting out of the second side of tissue behind the tissue-penetrating distal tip 220, and engaging the second side of tissue when the tissue anchor 42b’ is proximally retracted, thereby
  • the tissue anchor 42b’ is distally advanced from the vaginal cavity VC, through the vaginal-cervical junction J at an anchor point AP, and into the abdominal cavity AC of the patient P, such that the tissue-penetrating distal tip 220 pierces through the vaginal side of the vaginal-cervical junction J and exits out the abdominal side of the vaginal-cervical junction J at the anchor point AP, while the barbs 222 likewise passes from the vaginal side of the vaginal-cervical junction J and exits out the abdominal side of the vaginal-cervical junction J at the anchor point AP behind the tissue-penetrating distal tip 220 (see Fig. 34A).
  • the tissue anchor 42b’ may then be proximally retracted, such that the barbs 222 engage the abdominal side of the vaginal-cervical junction J at the anchor point AP, thereby retaining the tissue-penetrating distal tip 220 on the abdominal side of the vaginal-cervical junction J when a relatively small tensile force is continually applied to the elongate member 218 (see Fig. 34B).
  • multiple anchor points AP can be formed in the vaginal-cervical junction J using the foregoing technique, after which the colpotomy cut can be made, and then the opposite sides of the vaginal cuff may be collapsed together by pulling on the anchor points with the tissue anchors 42b’ and then sutured.
  • tissue anchor 42b is similar to the tissue anchor 42b’ in that it comprises an elongate shaft 218 having a tissue-penetrating distal tip 220 configured for piercing through a first side of tissue and exiting out of a second side of tissue opposite the first side of tissue when the tissue anchor 42b’ is distally advanced.
  • the tissue anchor 42b” differs from the tissue anchor 42b’ in that it further comprises a tissue retention assembly 224 configured for being dynamically activated to assume a high-profile state for engaging the second side of tissue, thereby retaining the tissue-penetrating distal tip 220 on the second side of the tissue when the tissue anchor 42b” is proximally retracted, and dynamically deactivated to assume a low-profile state for disengaging the second side of tissue when the tissue anchor 42b” is proximally retracted, thereby allowing the tissue-penetrating distal tip 220 to be proximally retracted from the second side of tissue.
  • the dynamic activation/deactivation of the tissue anchor 42b” provides for a more stable anchoring point within tissue, while minimizing tissue trauma when the tissue anchor 42b” is removed from the tissue.
  • the tissue retention assembly 224 comprises a plurality of cross-bars 226 (in this case, only two cross-bars 226), each having a distal end 228a stably affixed to the elongate shaft 218, and a proximal end 228b slidably disposed relative to the elongate shaft 218.
  • each of the cross-bars 226 takes the form of a resilient wire.
  • the tissue retention assembly 224 further comprises a ring 230 to which the proximal ends 228b of the cross-bars 226 are affixed.
  • the ring 230 is slidably disposed around the elongate shaft 218, such that the ring 230 may be distally displaced (shown by arrow) relative to the elongate shaft 218 to linearly translate the proximal ends 228b of the cross-bars 226 respectively towards the distal ends 228a of the cross-bars 226, thereby laterally bending the cross-bars 226 to place the tissue retention assembly 224 into its high-profile state (Fig.
  • the ring 230 may be proximally displaced (shown by arrow) relative to the elongate shaft 218 to linearly translate the proximal ends 228b of the cross-bars 226 respectively away from the distal ends 228a of the cross-bars 226, thereby laterally straightening the cross-bars 226 to place the tissue retention assembly 224 into its low-profile state (Fig. 36A)
  • the two cross-bars 226 are clocked 180° from each other, such that the two cross-bars 226 form a single line when viewed along a longitudinal axis of the elongate shaft 218 (shown in Fig. 37A).
  • the two cross-bars 226 are clocked 90° from each other, such that the two cross-bars 226 form an L-shape when viewed along a longitudinal axis of the elongate shaft 218 (shown in Fig. 37B).
  • the tissue retention assembly 224 comprises four cross-bars 226 that are clocked 90° from each other, such that the four cross-bars 226 form a cross-shape when viewed along a longitudinal axis of the elongate shaft 218 (shown in Fig. 37C).
  • the tissue retention assembly 224 further comprises a hub 234 stably affixed to the elongate shaft 218 distal to the ring 230.
  • the hub 234 is sized to be interference fit with the ring 230 to lock the tissue retention assembly 224 in the high profile state when the ring 230 is distally displaced relative to the elongate shaft 218 into firm contact with the hub 234.
  • the tissue anchor 42b is distally advanced from the vaginal cavity VC, through the vaginal-cervical junction J at an anchor point AP, and into the abdominal cavity AC of the patient P, such that the tissue-penetrating distal tip 220 pierces through the vaginal side of the vaginal-cervical junction J and exits out the abdominal side of the vaginal-cervical junction J at the anchor point AP, while the tissue retention assembly 224, in its low profile state, likewise passes from the vaginal side of the vaginal-cervical junction J and exits out the abdominal side of the vaginal-cervical junction J at the anchor point AP behind the tissue-penetrating distal tip 220 (see Fig.
  • the tissue anchor 42b’ may then be proximally retracted, such that the ring 230 abuts the anchor point AP and is proximally displaced relative to the elongate shaft 218 to linearly translate the proximal ends 228b of the crossbars 226 respectively toward the distal ends 228a of the cross-bars 226 (shown in Fig. 36B), thereby laterally bending the cross-bars 226 to place the tissue retention assembly 224 into its high-profile state and retaining the tissue-penetrating distal tip 220 on the abdominal side of the vaginal-cervical junction J (see Fig. 38B).
  • the hub 234 may be interference fit with the ring 230 to lock the tissue retention assembly 224 in the high profile state.
  • multiple anchor points AP can be formed in the vaginal-cervical junction J with multiple tissue anchors 42b” using the foregoing technique, after which the colpotomy cut can be made, and then the opposite sides of the vaginal cuff may be collapsed together by pulling on the anchor points with the tissue anchors 42b” and then sutured.
  • vaginal cuff closure tool 240 that can be used in any of the hysterectomy system 10 illustrated in Fig. 1 , the hysterectomy system 10’ illustrated in Fig. 11 , or the hysterectomy system 10” illustrated in Fig. 17 will now be described.
  • the vaginal cuff closure tool 240 may be used to tension (or pull) the tissue anchors 42b to collapsing the opposite ends of the vaginal cuff together, thereby facilitating subsequent suturing of the vaginal cuff.
  • the vaginal cuff closure tool 240 may be provided as a kit that can be quickly assembled by the user to facilitate connection of the tissue anchors 42b to the vaginal cuff closure tool 240 while the tissue anchors 42b are distally anchored in the vaginal-cervical junction of the patient.
  • the vaginal cuff closure tool 240 generally comprises a connector device 242, a carriage 244, and a distal housing 246.
  • the connector device 242 is affixed to the carriage 244 and is configured for engaging the proximal ends of the tissue anchors 42b.
  • the connector device 242 comprises a connector block 248 and a plurality of the connectors 250 to which the proximal ends of the tissue anchors 42b are affixed.
  • the connector device 242 comprises six connectors 250-1 to 250-6, and thus, the proximal ends of six tissue anchors 42b can be potentially affixed to the connector device 242.
  • the connector device 242 may comprise any plural number of connectors 250, e.g., two connectors 250, four connectors 250, eight connectors 250, etc.
  • the connectors 250 are arranged as a top row of three connectors 250-1 to 250-3 and a bottom row of three connectors 250-4 to 250-6.
  • the proximal ends of the tissue anchors 42b that are anchored to the top hemi-circle of the vaginal-cervical junction J may be respectively connected to the upper row of connectors 250-1 to 250-3, whereas the proximal ends of the tissue anchors 42b that are anchored to the bottom hemi-circle of the vaginal-cervical junction J may be respectively connected to the lower row of connectors 250-4 to 250-6, thereby facilitating, proper alignment of the opposite sides of the vaginal cuff (after the colpotomy cut has been made) when collapsed and subsequently sutured.
  • the connector device 242 and tissue anchors 42b comprise features that allow the proximal ends of the tissue anchors 42b to be removably affixed to the connector device 242.
  • the carriage 244 is configured for being slidably engaged with a proximal end of the distal housing 246, such that proximal translation of the carriage 244 from a distal position (distal-most position illustrated in Fig. 39) to a proximal position (proximal-most position illustrated in Fig.
  • the carriage 244 comprises a shaft 252 configured for being slidably disposed within the proximal end of the distal housing 246 (best shown in Fig. 50), and a handle 254 affixed to the proximal end of the shaft 252 for being ergonomically grasped by the user to proximally translate the carriage 244 relative to the distal housing 246.
  • the handle 254 takes the form of a boss monolithically disposed on the proximal end of the shaft 252, and has a cross- sectional shape and size that matches the cross-sectional shape and size of the proximal end of the distal housing 246, such that outer surface of the vaginal cuff closure tool 240 is continuous.
  • the carriage 244 further comprises a bore 256 longitudinally extending through the shaft 252.
  • the connector device 242 is affixed within the bore 256, while the tissue anchors 42b (not shown in Figs. 39-40, 42-44, and 50) distally pass from the connector device 242, out through the bore 256 of the carriage 244, and into the distal housing 246.
  • the connector device 242 and carriage 244 comprise additional features that allow the connector device 242, with the proximal ends of the tissue anchors 42b, to be removably affixed within the bore 256 of the carriage 244.
  • the distal housing 246 is sized to snugly fit within a vaginal cavity of a patient, and is configured for guiding the tissue anchors 42b laterally inward towards a plane from the anchor points of the vaginal-cervical junction of the patient to which the distal ends of the tissue anchors 42b are respectively anchored, and proximally back to the connector device 242 affixed to the carriage 244 (shown in Fig. 42). As best illustrated in Figs.
  • the distal housing 246 comprises an insertion portion 258 designed to be inserted into the vaginal cavity of the patient.
  • the distal housing 246 further comprises a marker 260 in the form of an annular indentation for gauging the depth that the distal housing 246 has been inserted into the vaginal cavity of the patient.
  • laparoscopic visualization may be used to ensure that the distal housing 246 is properly positioned within the vaginal cavity of the patient.
  • the distal housing 246 comprises a closed wall 262, a bore 264 longitudinally extending through the closed wall 262, a planar cavity 266 in which the bore 264 distally terminates, and a distal aperture 268 located at the distal tip of the closed wall 262 and at which the planar cavity 266 terminates.
  • the bore 264 comprises an enlarged proximal bore portion 264a in which the shaft 252 of the carriage 244 (shown in Fig. 50) is slidably disposed, and a reduced distal bore portion 264b through which the tissue anchors 42b (not shown in Figs. 47-51) from the bore 256 of the carriage 244 distally pass to the distal aperture 268, and a tapered bore portion 264c that transitions the enlarged proximal bore portion 264a down to the reduced distal bore portion 264b.
  • the cross-sectional shape of the bore 264 is circular along the length of the bore 264, although other cross-sectional shapes are contemplated, e.g., ellipsoidal or oval.
  • the cross-sectional size and shape of the enlarged proximal bore portion 264a matches the cross-sectional size and shape of the shaft 252 of the carriage 244, such that the shaft 252 may snugly slide within the enlarged proximal bore portion 264a.
  • the tapered bore portion 264c transitions the enlarged proximal bore portion 264a down to the narrower reduced distal bore portion 264.
  • the planar cavity 266 is configured for arranging the tissue anchors 42b exiting the reduced distal bore portion 264b into a plane.
  • the width w1 of the planar cavity 266 is substantially greater than the width w2 (in this case, the diameter) of the reduced distal bore portion 264b (e.g., at least twice, and preferably at least three times), while the height hi of the planar cavity 266 is substantially less than the height h2 of the reduced distal bore portion 264b (e.g., less than one-half, and preferably less than one-quarter), as best illustrated in Figs. 49 and 51.
  • the planar cavity 266 may, e.g., have width-to-height aspect ratio that is greater than 2:1 , preferably greater than 5:1 , and most preferably, greater than 10:1.
  • the width of the spatial arrangement of the tissue anchors 42b when disposed within the planar cavity 266 is substantially increased relative to the width of the spatial arrangement of the tissue anchors 42b when disposed within the reduced distal bore portion 264b, while the height of the spatial arrangement of the tissue anchors 42b when disposed within the planar cavity 266 is substantially decreased relative to the height of the spatial arrangement of the tissue anchors 42b when disposed within the reduced distal bore portion 264b.
  • the distal housing 246 has a pair of top and bottom proximally facing bearing surfaces 270a, 270b for guiding the tissue anchors 42b from the broader height h2 of the reduced distal bore portion 264b into the narrower height hi of the planar cavity 266, and a pair of opposing bearing surfaces 272a, 272b for guiding the tissue anchors 42b from the narrower width w2 of the reduced distal bore portion 264b into the broader width w1 of the planar cavity 266.
  • the planar cavity 266 distally terminates at the distal aperture 268.
  • the distal aperture 268 comprises opposing top and bottom edges 274a, 274b, which serve to translate at least a portion of longitudinal tensile forces applied to the proximal ends of the tissue anchors 42b along a plane by the connector device 242 into lateral tensile forces that are applied to the distal ends of the tissue anchors 42b orthogonal to the plane, thereby facilitating the collapse of the vaginal cuff.
  • the distal aperture 268 is substantially rectangular, with the top and bottom edges 274a, 274b being rectilinear, thereby facilitating the displacement of the opposite ends of the vaginal cuff together along a plane.
  • the width-to-height aspect ratio of the distal aperture 268 is greater than 2:1 , preferably greater than 5:1 , and most preferably, greater than 10:1.
  • the dimensions of the distal aperture 268 exactly match the corresponding dimensions of the planar cavity 266, and thus, the height h3 of the distal aperture 268 equals the hi of the planar cavity 266, and the width w3 of the distal aperture 268 equals the w1 of the planar cavity 266.
  • the carriage 244 is ratcheted with the distal housing 246, such that the carriage 244 may be selectively locked into a plurality of different positions relative to the distal housing 246 when the carriage 244 is proximally translated relative to the distal housing 246 to properly tension the tissue anchors 42b (by proximally translating the carriage 244 while holding the distal housing 246 in position, or by distally translating the distal housing 246 while holding the carriage 244 in position, or both).
  • the carriage 244 may be manually unlocked at any time, such that carriage 244 may be distally translated relative to the distal housing 246 to relax the tissue anchors 42b.
  • the distal housing 246 comprises at least one row of teeth 276 (in the illustrated embodiment, two rows of opposing teeth 276) longitudinally extending along the enlarged proximal bore portion 264a of the distal housing 246, while the shaft 252 of the carriage 244 comprises at least one cantilevered cog 278 (in the illustrated embodiment, two cogs 278) . Due to their resiliency, the cantilevered cogs 278 are urged to incrementally engage the series of teeth 276 as the carriage 244 is proximally translated within the enlarged proximal bore portion 264a of the distal housing 246.
  • the cantilevered cogs 278 takes the form of a cantilevered tab having a proximally facing chamfered surface (not shown) that allows the cantilevered cogs 278 to slide along the series of teeth 276 of the distal housing 246 as the carriage 244 is proximally translated within the enlarged proximal bore portion 264a of the distal housing 246.
  • the cantilevered cogs 278 will engage the current one of the series of teeth 276 to prevent the carriage 244 from being distally translated within the enlarged proximal bore portion 264a of the distal housing 246.
  • the cogs 278 may be disengaged from the series of teeth 276 by rotating the carriage 244 relative to the distal housing 246 about the longitudinal axis of the proximal bore portion 264a.
  • the tissue anchors 42b are configured for being quickly connected to the vaginal cuff closure tool 240 prior to initiation of the suturing procedure, and quickly disconnected from the vaginal cuff closure tool 240 subsequent to completion of the suturing procedure. Because the tissue anchors 42b will be preferably delivered through the lumens 90 of any of the colpotomy cups 66a-66f described above, with the distal ends of the tissue anchors 42 being anchored to the anchor points of the vaginal junction of the patient, connection of the proximal ends of the tissue anchors 42b to an already fully assembled vaginal cuff closure tool 240 may be tedious.
  • the vaginal cuff closure tool 240 may be provided as a kit that is then assembled by the user, with the connection of the proximal ends of the tissue anchors 42b to the connector device 242 being part of the assembly process, and subsequent to completion of the suturing process, the vaginal cuff closure tool 240 may be disassembled by the user, with the disconnection of the proximal ends of the tissue anchors 42b from the connector device 242 being part of the disassembly process.
  • a kit 240’ comprising the connector device 242, carriage 244, and distal housing 246 may be provided as separate components that can then be coupled to each other during the assembly process to create the vaginal cuff closure tool 240, and decoupled from each other during the disassembly process.
  • the proximal ends of the tissue anchors 42b are may be affixed to the connector device 242 (when not coupled to the carriage 244) while the distal ends of the tissue anchors 42b are anchored to the vaginal- cervical junction of the patient; the connector device 242, along with the distally anchored tissue anchors 42b, may then be removably affixed to the carriage 244; and the distal housing 246 may then be affixed to the carriage 244, along with the connector device 242 and distally anchored tissue anchors 42b.
  • the distal housing 246 may be removed from the carriage 244, then the connector device 242, along with the distally anchored tissue anchors 42b may be removed from the carriage, and then the proximal ends of the distally anchored tissue anchors 42b may be removed from the connector device 242.
  • the connectors 250 take the form of female connectors (sockets) to which corresponding male connectors (plugs) 251 permanently affixed to the proximal ends of the tissue anchors 42b may be removably mated.
  • each socket 250 of the connector device 242 comprises a slot 280 and a clasp mechanism 282 opposing the respective slot 280.
  • Each of the clasp mechanism 282 comprises a cantilevered tab 284 opposing the slot 280.
  • the plug 286 of each tissue anchor 42b comprises a block 253 sized to fit within the slot 280 of the corresponding socket 250 of the connector device 242.
  • each tissue anchor 42b further comprises a cantilevered tab 255 configured for being captured by the clasp mechanism 282 when the block 253 is inserted into the slot 280 of the corresponding socket 250 of the connector device 242. That is, the cantilevered tab 255 has a chamfered surface 257 that bears against the bottom surface of the clasp mechanism 282, and then, once the cantilevered tab 255 passes the tab 284 of the clasp mechanism 282, the cantilevered tab 255 springs up (with respect to the top row of sockets 250-1 to 250- 3) or down (with respect to the bottom row of sockets 250-4 to 250-6), thereby being captured by the clasp mechanism 282.
  • each tissue anchor 42b may be snap fit into the corresponding socket 250 of the connector device 242.
  • the plug 286 of each tissue anchor 42b may be removed from the corresponding socket 250 by manually moving the cantilevered tab 284 towards the block 253 of the plug 251 , and pulling the plug 251 out of the socket 250.
  • the means for connecting the tissue anchors 42b to the vaginal cuff closure tool 240 has been described as a specific plug and socket arrangement, other means of removably connecting the tissue anchors 42b to the vaginal cuff closure tool 240 are contemplated.
  • the connector device 242 may be removably affixed within the bore 256 of the shaft 276 of the carriage 244, while the distally anchored tissue anchors 42b may distally pass from the connector device 242, out through the bore 256.
  • the connector block 248 of the connector device 242 has a cross-section and size that is capable of being received within the carriage 244.
  • the cross-sectional shape and size of the connector block 248 matches the cross-sectional size and shape of the bore 256 within the shaft 252, such that the connector device 242 may be inserted into, and snugly slid within, the bore 256 and affixed therein.
  • the corresponding cross-sectional shapes of the connector block 248 and bore 256 are generally circular, although other cross-sectional shapes are contemplated.
  • the connector device 242 comprises a pair of cantilevered detents 278 disposed on the connector block 248, while the carriage 244 comprises a corresponding pair of apertures 290 formed through the wall of the proximal end of the shaft 252, such that, as the connector device 242 is slid within the bore 256 of the carriage 244, the pair of cantilevered detents 288 disposed on the connector block 248 will eventually engage the pair of apertures 290 formed through the wall of the shaft 252, thereby affixing the connector device 242 within the bore 256.
  • Each of the cantilevered detents 288 has proximally facing chamfered surface 292 that, as the connector device 242 is inserted into the bore 256, bears against the distal edge of the bore 256 to displace the cantilevered detents 288 inward.
  • the cantilevered detents 288 slide along the bore 256 until the cantilevered detents 288 coincide with the pair of apertures 290, at which point the cantilevered detents 288 spring outward into the pair of apertures 290, thereby being captured by the pair of apertures 290 in a snap fit arrangement.
  • the connector device 242 is keyed with the shaft 252, such that the connector device 242 is prevented from rotating within the bore 256, thereby maintaining the proximal ends of the connected tissue anchors 42b in the proper orientation (relative to the orientation of the anchor points on the vaginal-cervical junction), as well as rotationally aligning the pair of cantilevered detents 288 of the connector device 242 with the pair of apertures 290 formed through the wall of the shaft 252.
  • the connector device 242 comprises a pair of open channels 294 formed into the outer surface of the connector block 248, while the carriage 244 comprises a corresponding pair of ridges 296 formed into the inner surface of the shaft 252, such that the pair of ridges 296 are slidably engaged within the pair of channels 294 as the connector device 242 is slid within the bore 256.
  • the pair of channels 294 may be formed within the inner surface of the shaft 252, while the pair of ridges 296 may be formed on the outer surface of the connector block 248.
  • the carriage 244 further comprises a pair of access ports 297 (only one shown in Fig. 42) formed through the handle 254 in respective communication with the pair of apertures 290 formed through the wall of the shaft 252, and in which the pair of cantilevered detents 278 are engaged.
  • a pair of members may be respectively inserted into the pair of access ports 297 to push the pair of cantilevered detents 278 radially inward, thus disengaging the pair of cantilevered detents 278 from the pair of apertures 290, such that the connector device 242, with the tissue anchors 42b, may be removed from the carriage 244 by distally sliding the connector device 242 within the bore 256 and out through the distal end of the shaft 252.
  • the distal housing 246 takes the form a clam-shell arrangement comprising a top distal housing half 246a and a bottom distal housing half 246b (best shown in Fig. 52).
  • the top distal housing half 246a includes the top halves of the closed wall 262, bore 264, planar cavity 266, and distal aperture 268, while the bottom distal housing half 246b includes the bottom halves of the closed wall 262, bore 264, planar cavity 266, and distal aperture 268.
  • the top and bottom distal housing halves 246a, 246b may be mated to each other over the shaft 252 of the carriage 244.
  • the flat surfaces of the top and bottom distal housing halves 246a, 246b may be matched with the flat surfaces of the handle 254 (best shown in Fig. 43), such that the connector device 242 affixed within the bore 256 of the carriage 244 is properly oriented relative to the planar contour of the distal end of the distal housing 246.
  • the top and bottom distal housing halves 246a, 246b have complementary mating features.
  • the top distal housing half 246a comprises a ridge 298a (shown only in Fig. 52) and an open channel (not shown) formed on opposite sides of a bottom mating surface 295a of the top distal housing half 246a
  • the bottom distal housing half 246b comprises a ridge 298b and an open channel 299b formed on opposite sides of a top mating surface 295b of the bottom distal housing half 246b.
  • top and bottom distal housing halves 246a, 246b may be snap fit together to complete the distal housing 256.
  • the top distal housing half 246a and bottom distal housing half 246b may be removed from each other by pulling the top distal housing half 246a and bottom distal housing half 246b away from each other, such that the ridge 298a and open channel 299b de-mate from each other, and the open channel and ridge 298b de-mate from each other.
  • FIG. 54 another exemplary method 300” of operating the colpotomy system 10 (shown in Fig. 1) with the vaginal cuff closure tool 240, including assembly the vaginal cuff closure kit 240’ into the vaginal cuff closure tool 240, to perform a TLH hysterectomy on the patient P will now be described. It should be appreciated that modified methods similar to the exemplary method 300” illustrated in Fig. 31 may be used to operate the colpotomy system 10’ (shown in Fig. 11) to perform an LAVH on the patient P or the colpotomy system 10” (shown in Fig. 17) to perform a TLH on the patient P.
  • modified methods similar to the exemplary method 300” illustrated in Fig. 31 may be used to operate the colpotomy system 10’ (shown in Fig. 11) to perform an LAVH on the patient P or the colpotomy system 10” (shown in Fig. 17) to perform a TLH on the patient P.
  • the method 300 is similar to the method 300 illustrated in Fig. 29, with the exception that, instead of using suture shuttles 42a to pass sutures 200 through respective suture points of a vaginal- cervical junction, tissue anchors 42b are introduced through anchor points located on the vaginal cervical junction , and manipulated, after the colpotomy cut has been made, to collapse the vaginal cuff, after which a conventional laparoscopic suturing procedure may be employed to suture the collapsed vaginal cuff.
  • steps 302-324 may be performed in the same manner described above in the method 300 illustrated in Fig. 29.
  • a plurality of tissue anchors 42b are respectively introduced through the member lumens 90 of the colpotomy cup 66a (see Figs. 4-8) (or alternatively, the colpotomy cup 66b (see Fig. 9), colpotomy cup 66c (see Fig. 10), the colpotomy cup 66d (see Figs. 14-16), colpotomy cup 66e (see Figs. 18-19), or colpotomy cup 66f (see Figs.
  • tissue anchors 42b may then be proximally retracted to anchor the distal ends of the tissue anchors 42b at the anchor points AP on the vaginal-cervical junction J (step 327).
  • each of the tissue anchors 42b takes the form of a tissue anchor 42b’ having a tissue retention assembly in the form of one or more barbs 222 (shown in Fig. 33)
  • the tissue anchors 42b’ may be distally advanced until the barbs 222 respectively pass through the anchor points AP in the vaginal-cervical junction J and exit into the abdominal cavity AC of the patient P, as illustrated in Fig. 34A, and then the tissue anchors 42b’ may be proximally retracted to respectively anchor the barbs 222 at the anchor points AP in the vaginal-cervical junction J, as illustrated in Fig. 34B.
  • each of the tissue anchors 42b takes the for of a tissue anchor 42b” having a dynamically activated tissue retention assembly 224 (shown in Fig. 35)
  • the tissue anchors 42b” may be distally advanced until the tissue retention assemblies 224 (while in their low-profile states) respectively pass through the anchor points AP in the vaginal-cervical junction J and exit into the abdominal cavity AC of the patient P, as illustrated in Fig. 36A, and then the tissue anchors 42b’ may be proximally retracted to respectively anchor the tissue retention assemblies 224 (while in their high-profile states) at the anchor points AP in the vaginal-cervical junction J, as illustrated in Fig. 36B.
  • the distal ends of six tissue anchors 42b-1 to 42b-6 can be anchored respectively at six different anchor points AP on the vaginal- cervical junction J, with a top set of left, center, and right tissue anchors 42b-1 to 42b-3 anchored respectively at the anchor points AP1-AP3 located on the lateral center and lateral sides (left and right) of the top half (anterior half) of the vaginal- cervical junction J1 , and a bottom set of tissue left, center, and right anchors 42b-4 to 42b-6 respectively anchored to the anchor points AP4-AP6 located on the lateral center and lateral sides (left and right) of the bottom half (posterior half) of the vaginal-cervical junction J2.
  • vaginal-cervical junction J is idealized as a circle in Fig. 55A, the vaginal-cervical junction J may not form a perfect circle.
  • the vaginal-cervical junction J may take the shape of an oval.
  • vaginal-cervical junction J is shaped, it is desirable for one set of the anchor points AP1-AP3 to be located on one half of the vaginal-cervical junction J, and another set of the anchor points AP4-AP6 to be located on the other half of the vaginal-cervical junction J, so that after the colpotomy cut is made, the first set of anchor points AP1- AP3 will be located one side of the vaginal cuff, and the second set of anchor points AP4-AP6 will be located on the other side of the vaginal cuff.
  • first set of anchor points AP1- AP3 are described as being located on the top half (anterior half) J1 and the second set of anchor points AP4-AP6 as being located on the bottom half (posterior half) J2 of the vaginal-cervical junction
  • the respective sets of anchor points AP1-AP6 may be located on any of the halves of the vaginal-cervical junction J, e.g., the left half and right half on the lateral sides of the mid-sagittal plane of the vaginal-cervical junction J.
  • the orientation of the first set of anchor points AP1-AP3 and the second set of anchor points AP4-AP6 on the vaginal-cervical junction J will depend on the orientation of the plane dividing the opposite sides of the vaginal cuff that will be collapsed together and sutured.
  • such plane is the frontal plane FP, although other planes are contemplated, e.g., the mid- sagittal plane.
  • the distal ends of six tissue anchors 42b-1 to 42b-6 can be anchored respectively at six different anchor points AP1-AP6 on the vaginal-cervical junction J, with a left set of tissue anchors 42b-1 to 42b-3 anchored to anchor points AP1-AP3 located on the left lateral half of the vaginal-cervical junction J1 , and a right set of tissue anchors 42b-4 to 42b-6 anchored to anchor points AP4-AP6 located on the right lateral half of the vaginal- cervical junction J2, as illustrated in Fig. 56A, the distally anchored tissue anchors 42b-1 to 42b-6 will proximally extend from the respective anchor points AP1-AP6 in the vaginal-cervical junction J and out of the vaginal cavity VC of the patient P.
  • the vaginal-cervical junction J of the patient P is circumferentially incised distal to the anchor points SP, thereby transecting the uterus U and cervix C from the vagina V of the patient P, and creating a vaginal cuff VCU having the anchor points AP, as illustrated in Fig. 55C (step 328’).
  • Steps 330-336 are then performed in the same manner described above with respect to the method 300.
  • the vaginal cuff closure kit 240’ (shown in Fig. 52) is assembled into the vaginal cuff closure tool 240, with connection of the proximal ends of the tissue anchors 42b to the vaginal cuff closure tool 240 being part of the assembly process.
  • the proximal ends of the distally anchored tissue anchors 42b extending from the vagina V of the patient P are first coupled to the connector device 242 (see Figs. 57A-57B) (step 342).
  • Connection between the proximal ends of the distally anchored tissue anchors 42b and the connector device 242 can be made, e.g., using the plug and socket arrangement illustrated in Fig. 41.
  • the top set of left, center, and right tissue anchors 42b-1 to 42b-3 that are distally anchored to the top half of the vaginal-cervical junction J1 are respectively affixed to the top row of connectors 250-1 to 250-3 (i.e.
  • the tissue anchor 42b-1 distally anchored to the anchor point AP1 at the top left of the vaginal-cervical junction J is connected to the top left connector 250-1 of the connector device 242
  • the tissue anchor 42b-2 distally anchored to the anchor point AP2 at the top center of the vaginal-cervical junction J is connected to the top center connector 250-2 of the connector device 242
  • the tissue anchor 42b-3 distally anchored to the anchor point AP3 at the top right of the vaginal-cervical junction J is connected to the top right connector 250-3 of the connector device 242)
  • the bottom set of left, center, and right tissue anchors 42b-4 to 42b-6 that are distally anchored to the bottom half of the vaginal-cervical junction J2 are respectively affixed to the bottom row of connectors 250-4 to 250-6 (i.e., the tissue anchor 42b-4 distally anchored to the anchor point AP1 at the top bottom of the vaginal-cervical junction J is connected to the
  • the proximal ends of the tissue anchors 42b-1 to 42b-6 are uniquely marked to ensure that the tissue anchors 42b-1 to 42b-6 are respectively connected to the corresponding connectors 250-1 to 250-6 of the connector device 242.
  • the connector device 242 with the distally anchored tissue anchors 42b, is coupled to the carriage 244, and in particular, affixed within the bore 256 of the carriage 244, such that the tissue anchors 42b extend out from the bore 256 at the proximal end of the shaft 252 (see Figs. 57C-57D) (step 344).
  • this can be accomplished by inserting the connector device 242 into the bore 256 at the distal end of the shaft 252, while the pair of open channels 294 of the connector device 242 are properly oriented (clocked) with the pair of ridges 296 in the shaft 252 (see Fig.
  • an elongated tool (not shown) can be employed to proximally slide the connector device 242 within the bore 256 of the carriage 244.
  • top and bottom distal housing halves 246a, 246b are laterally mated to together over the shaft 252 of the carriage 244 (see Fig. 57E) to fully form vaginal cuff closure tool 240, with the shaft 252 being housed within the distal housing 246, and the distally anchored tissue anchors 42b extending through the distal housing 246 (see Fig. 57F) (step 346).
  • this is accomplished by laterally disposing the shaft 252 of the carriage 244 within the bottom half of the enlarged proximal bore portion 264a of the bore 264 of the bottom distal housing half 246b, and laterally disposing the tissue anchors 42b exiting the bore 256 of the carriage 244 within the bottom halves of the tapered bore portion 264a, reduced distal bore portion 264b, and planar cavity 266 and out through the bottom half of the distal aperture 268, of the bottom distal housing half 246b (see Fig.
  • the vaginal cuff closure tool 240 having the closed wall 262, bore 264, planar cavity half 266, and distal aperture 268, with the shaft 252 being disposed within the fully formed enlarged proximal bore portion 264a, and the tissue anchors 42b being disposed within the fully formed tapered bore portion 264c, reduced bore portion 264b, and planar cavity 266, and exiting out the fully formed distal aperture 268 (see Fig. 57F).
  • the distal housing 246 is distally advanced into the vaginal cavity VC of the patient P until the distal housing 246 is positioned at, and in particular abuts against, the vaginal fornices VF and receives the cervix C of the patient P (e.g., from a proximal position illustrated in Fig. 56B to a distal position illustrated in Fig. 56C) (step 348), and the carriage 244 is proximally translated relative to the distal housing 246, thereby tensioning distally anchored tissue anchors 42b-1 to 42b-6 (which were previously relaxed, as illustrated in Figs. 58A-58B) and collapsing the opposite ends of the vaginal cuff VCU together, as illustrated in Fig. 55D (step 350).
  • the distal housing 246 is distally advanced into the vaginal cavity VC of the patient P without translating the carriage 244 and distal housing 246 relative to each other, and once the distal housing 246 abuts against the vaginal fornices VF and receives the cervix C of the patient P, the handle 254 of the carriage 244 is grasped with one hand and pulled in the proximal direction while the distal housing 246 is grasped with the other hand and held in place, thereby proximally translating the carriage 244 relative to the distal housing 246 (i.e.
  • the distal housing 246 is distally advanced into the vaginal cavity VC of the patient P by grasping the distal housing 246 with one hand and distally pushing the distal housing 246, while simultaneously proximally translating the carriage 244 relative to the distal housing 246 (i.e., proximally sliding the shaft 252 of the carriage 244 within the bore 256 of the carriage 244) by grasping the handle 254 of the carriage 244 with the other hand and either holding the carriage 244 in place or proximally pulling the carriage 244, thereby taking up the slack in the distally anchored tissue anchors 42b-1 to 42b-6.
  • any remaining slack in the distally anchored tissue anchors 42b-1 to 42b-6 may be taken up by continuing to translate the carriage 244 relative to the distal housing 246 (i.e., proximally sliding the shaft 252 of the carriage 244 within the bore 256 of the carriage 244), thereby applying the tension to the proximal ends of the distally anchored tissue anchors 42b-1 to 42b-6 and bringing the opposite ends of the vaginal cuff VCU together to collapse the vaginal cuff VCU.
  • the guide features within the vaginal cuff enclosure tool 240 help ensure that the distally anchored tissue anchors 42b-1 to 42b-6 extend between the respective anchor points AP1-AP6 in the vaginal-cervical junction J and the proper locations of the distal aperture 268, as illustrated in Figs. 59A-59B.
  • the top and bottom left tissue anchors 42b-1 , 42b-4 and the top and bottom right tissue anchors 42b-3, 42b-6 when tensioned, are spatially constrained in the horizontal plane (the plane of the drawing in Fig. 60).
  • the reduced distal bore portion 264b such that the top and bottom left tissue anchors 42b-1 , 42b-4 and the top and bottom right tissue anchors 42b-3, 42b- 6 distally extend at an inward angle toward each other (as projected onto the horizontal plane) from the left connectors 250-1 , 250-4 and the right connectors 250- 3 and 250-6 of the connector device 242, through the bore 256 of the shaft 254 of the carriage 244, and then through the enlarged proximal bore portion 264a and tapered bore portion 264c of the distal housing 246, and then distally extend straight (as projected onto the horizontal plane) through the reduced distal bore portion 264b of the distal housing 246, while the top center tissue anchor 42b-2 and bottom center tissue anchor 42b-4, are not spatially constrained in the horizontal plane, such that the tissue anchors 42b-2, 42b-4 distally extend straight (as projected onto the horizontal plane) from the center connectors 250-2, 250-5 of the connector device 242, through the bore 256 of the shaft
  • top and bottom left tissue anchors 42b-1 , 42b-4 and the top and bottom right tissue anchors 42b-3, 42b-6 are then spatially expanded in the horizontal plane from the width w1 of the reduced distal bore portion 264b to the width w2 of the planar cavity 266, such that the top and bottom left tissue anchors 42b-1 , 42b-4 and the top and bottom right tissue anchors 42b-3, 42b-6 distally extend at an outward angle away from each other (as projected onto the horizontal plane) from the reduced distal bore portion 264a of the distal housing 246 through the planar cavity 266 as the tissue anchors 42b-1 , 42b-4 bear against the left bearing surface 272a, and the tissue anchors 42b-3, 42b-6 bear against the right bearing surface 272b, while the top center tissue anchor 42b-2 and bottom center tissue anchor 42b-4 are not spatially expanded in the horizontal plane from the width w1 of the reduced distal bore portion 264b to the width w2 of the planar cavity 266, such that
  • top and bottom left tissue anchors 42b-1 , 42b-4 and the top and bottom right tissue anchors 42b-3, 42b- 6 then distally extend (straight or at an outward angle) (as projected onto the horizontal plane) from the distal aperture 268 to the respective anchor points AP1 , AP4 at the top half of the vaginal-cervical junction J1 and the anchor points AP3, AP6 at the bottom half of the vaginal-cervical junction J2, while the top and bottom center tissue anchors 42b-2, 42b-5 distally extend straight (as projected onto the horizontal plane) from the distal aperture 268 to the respective anchor point AP2 at the top half of the vaginal-cervical junction J1 and the anchor point AP5 at the bottom half of the vaginal-cervical junction J2, as illustrated in Figs. 59A-59B.
  • top bearing surface 270a and the bottom bearing surface 270b respectively by the top bearing surface 270a and the bottom bearing surface 270b, such that the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 distally extend at an inward angle toward each other (as projected onto the vertical plane) from the top connectors 250-1 to 250-3 and the bottom connectors 250-4 to 250-6, through the bore 256 of the shaft 254 of the carriage 244, and then through the enlarged proximal bore portion 264a, tapered bore portion 264c, and reduced distal bore portion 264b of the distal housing 246, as the top set of tissue anchors 42b-1 to 42b-3 bear against the top bearing surface 274a, and the bottom set of tissue anchors 42b-4 to 42b-6 bear against the bottom bearing surface 274a.
  • top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 are then spatially constrained along vertical plane from the height hi of the reduced distal bore portion 264b to the height h2 of the planar cavity 266, such that the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 distally extend straight (as projected onto the vertical plane) through the planar cavity 266.
  • top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 then distally extend at an outward angle (as projected onto the vertical plane) from the distal aperture 268 to the anchor points AP1-AP3 at the top half of the vaginal-cervical junction J1 and the bottom half of the vaginal-cervical junction J2, as the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 respectively bear against the top edge 274a and bottom edge 274b of the distal aperture 268, as illustrated in Figs. 59A-59B.
  • the top edge 274a and bottom edge 274b of the distal aperture 268 essentially serve to at least partially translate or convert the longitudinal tensile forces applied at the proximal ends of the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 by the top row of connectors 250-1 to 250-3 of the connector device 242 and the bottom row of connectors 250-4 to 250-6 along the horizontal plane (or frontal plane FP extending between the opposite sides of the vaginal cuff VCU) to lateral tensile forces applied orthogonal to the horizontal plane to the distal ends of the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 by the anchor points AP1-AP3 at the top half of the vaginal-cervical junction J1 and the by the anchor points AP4- AP6 at the bottom half of the vaginal-cervical junction J2.
  • the outward angle (as projected onto the vertical plane) that the top set of tissue anchors 42b-1 to 42b-3 and the bottom set of tissue anchors 42b-4 to 42b-6 extend away from each other is as greater as possible (e.g., greater than 90 degrees) in order to maximize the tensile force used to collapse the vaginal cuff VCU.
  • the carriage 244 will be locked to the distal housing 246 simply by releasing the carriage 244 (e.g., by releasing grip of the handle 254 of the carriage 244), such that the tensile forces applied to the distally anchored tissue anchors 42b cause the manually released carriage 244 to slightly be displaced distally relative to the distal housing 246 to cause the cantilevered cogs 278 to fully engage the tooth of the series of teeth 276 of the distal housing 246 that is immediately distal to the cantilevered cogs 278 when the carriage 244 is released.
  • one or more sutures 200 are then used to suture the collapsed vaginal cuff VCU in a conventional manner, e.g., laparoscopically, as illustrated in Fig. 55E (step 354).
  • the carriage 244 is unlocked from the distal housing 246, such that the carriage 244 may be distally translated relative to the distal housing 246 (step 356).
  • Unlocking of the carriage 244 from the distal housing 246 may be accomplished by radially rotating the carriage 244 relative to the distal housing 246 (e.g., by grasping the handle 254 of the carriage 244 and the distal housing 246 and rotating them in opposite directions), thereby disengaging the cantilevered cogs 278 from the series of teeth 276, such that the carriage 244 may be freely translated distally relative to the distal housing 246 as long as the cantilevered cogs 274 are displaced away from the series of teeth 276.
  • the carriage 244 is distally translated relative to the distal housing 246, thereby relaxing the distally anchored tissue anchors 42b-1 to 42b-6 (step 358), and the distal housing 246 is proximally retracted from vaginal cavity VC of the patient P, while leaving the distal ends of the tissue anchors 42b-1 to 42b-6 respectively anchored to the anchored points AP1-AP6 of the vaginal-cervical junction J of the patient P (e.g., from a distal position illustrated in Fig. 56C to a proximal position illustrated in Fig. 56B) (step 360).
  • the portion of the distal housing 246 extending from the vaginal cavity VC of the patient P is grasped with one hand and held in place, while the handle 254 of the carriage 244 is grasped with the other hand and pulled in the distal direction, thereby distally translating the carriage 244 relative to the distal housing 246 (i.e., distally sliding the shaft 252 of the carriage 244 within the bore 256 of the carriage 244), thereby relaxing the proximal ends of the distally anchored tissue anchors 42b-1 to 42b-6, and then the distal housing 246 is proximally retracted from the vaginal cavity VC of the patient P while leaving the distal ends of the slackened tissue anchors 42b-1 to 42b-6 respectively anchored to the anchored points AP1-AP6 of the vaginal-cervical junction J of the patient P.
  • the carriage 244 is distally translated relative to the distal housing 246 (i.e., distally sliding the shaft 252 of the carriage 244 within the bore 256 of the carriage 244) by grasping the handle 254 of the carriage 244 with one hand and distally pushing the carriage 244, thereby slackening the distally anchored tissue anchors 42b, while simultaneously proximally retracting the distal housing 246 from the vaginal cavity VC of the patient P by grasping the portion of the distal housing 246 extending from the vaginal cavity VC of the patient P with the other hand and proximally pulling the distal housing 246 while leaving the distal ends of the slackened tissue anchors 42b-1 to 42b-6 respectively anchored to the anchored points AP1-AP6 of the vaginal-cervical junction J of the patient P.
  • vaginal cuff closure 240 is disassembled, with disconnection of the proximal ends of the tissue anchors 42b from the vaginal cuff closure tool 240 being part of the disassembly process.
  • top and bottom distal housing halves 246a, 246b of the full formed vaginal cuff closure tool 240 are laterally de-mated from each other (see Fig. 57E), and the shaft 252 of the carriage 244, along with the distally anchored tissue anchors 42b removed (see Fig. 57D) (step 362).
  • the connector device 242 with the distally anchored tissue anchors 42b is decoupled from the carriage 244, and in particular, removed from the bore 256 of the carriage 244 (see Figs. 57C-57D) (step 364).
  • this can be accomplished by inserting a pair of tools (not shown) into the pair of access ports 297 on the handle 254 of the carriage 244 to push the pair of cantilevered detents 288 of the connector device 242 radially inward, thus disengaging the pair of cantilevered detents 288 from the pair of apertures 290 formed through the wall of the shaft 252 (see Figs. 42 and 53), and proximally sliding the connector device 242 within the bore 256 and out of the proximal end of the shaft 252. Then, the proximal ends of the distally anchored tissue anchors 42b are decoupled from the connector device 242 (see Figs. 57A-57B) (step 366).
  • tissue anchors 42b are removed from the vaginal-cervical junction J of the patient (step 368). This can be accomplished, e.g., laparoscopically by grasping the tissue retention assemblies (e.g., the barbs 222 in the case that the tissue anchors 42b’ illustrated in Fig. 33 are used, or the cross-bars 226 in the case that the tissue anchors 42b” illustrated in Fig. 35 are used) of the tissue anchors 42b with pliers and pulling them into the abdominal cavity AC, and then out of the laparoscopic ports.
  • tissue retention assemblies e.g., the barbs 222 in the case that the tissue anchors 42b’ illustrated in Fig. 33 are used, or the cross-bars 226 in the case that the tissue anchors 42b” illustrated in Fig. 35 are used

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Surgical Instruments (AREA)

Abstract

Ensemble colpotomie comprenant un arbre allongé, un ensemble poignée couplé à une extrémité proximale de l'arbre allongé et une coupelle de colpotomie couplée à une extrémité distale de l'arbre allongé. La coupelle de colpotomie comprend une section de retenue comprenant une paroi de coupelle et une pluralité de lumières d'élément qui s'étendent longitudinalement le long de la paroi de coupelle. Chacune des lumières d'élément a un orifice d'entrée proximal et un orifice de sortie distal. La coupelle de colpotomie comprend en outre une surface de déviation agencée de manière distale par rapport à la section de retenue. La surface de déviation est conçue pour dévier une extrémité distale d'un élément de pénétration de tissu radialement vers l'extérieur lorsque l'extrémité distale de l'élément de pénétration de tissu est insérée à partir du port d'entrée proximal hors du port de sortie distal.
PCT/US2022/081551 2021-12-16 2022-12-14 Coupelle de colpotomie pour faciliter la suture d'un manchon vaginal WO2023114840A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163290245P 2021-12-16 2021-12-16
US63/290,245 2021-12-16

Publications (1)

Publication Number Publication Date
WO2023114840A1 true WO2023114840A1 (fr) 2023-06-22

Family

ID=85037124

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/081551 WO2023114840A1 (fr) 2021-12-16 2022-12-14 Coupelle de colpotomie pour faciliter la suture d'un manchon vaginal

Country Status (1)

Country Link
WO (1) WO2023114840A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080294001A1 (en) * 2007-05-25 2008-11-27 Wilson-Cook Medical Inc. Medical devices, systems and methods for closing perforations
US8323278B2 (en) 2010-12-06 2012-12-04 Soulor Surgical, Inc. Apparatus for treating a portion of a reproductive system and related methods of use
US20190380700A1 (en) * 2018-06-14 2019-12-19 Covidien Lp Trans-vaginal cuff anchor and method of deploying same
US20210282836A1 (en) * 2020-03-11 2021-09-16 Covidien Lp Robotic colpotomy systems

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080294001A1 (en) * 2007-05-25 2008-11-27 Wilson-Cook Medical Inc. Medical devices, systems and methods for closing perforations
US8323278B2 (en) 2010-12-06 2012-12-04 Soulor Surgical, Inc. Apparatus for treating a portion of a reproductive system and related methods of use
US20190380700A1 (en) * 2018-06-14 2019-12-19 Covidien Lp Trans-vaginal cuff anchor and method of deploying same
US20210282836A1 (en) * 2020-03-11 2021-09-16 Covidien Lp Robotic colpotomy systems

Similar Documents

Publication Publication Date Title
US11413069B2 (en) Functional uterine manipulator
US8529563B2 (en) Electrical ablation devices
US9333029B2 (en) Method and devices for performing minimally invasive surgery
US5718703A (en) Method and apparatus for small needle electrocautery
CA2483735C (fr) Appareil d'insertion d'un dispositif de fixation a deploiement automatique pour la realisation d'une anastomose avec acces a une seule lumiere
US20220104850A1 (en) Uterine manipulator with detachable cup and locking occluder
US20230081890A1 (en) Uterine manipulator with cutting head
JP2011015969A (ja) 経膣外科手術のための装置および方法
JP2005507268A (ja) 多重軸の子宮動脈識別、特徴化、および閉塞回転装置および方法
US11344292B2 (en) Trans-vaginal cuff anchor and method of deploying same
US9271712B2 (en) Retraction device for laparoscopy
US20230200816A1 (en) Surgical device for performing colpotomy on patient
WO2023114840A1 (fr) Coupelle de colpotomie pour faciliter la suture d'un manchon vaginal
JP2000023989A (ja) ミニループレトラクタ
Shrivastava et al. The Vattikuti Institute prostatectomy.
WO2021105870A1 (fr) Dispositif d'aide au fonctionnement d'une agrafeuse chirurgicale circulaire, mécanique, et kit de chirurgie au moyen d'une agrafeuse chirurgicale circulaire, mécanique
Tang et al. Aseptic and Tumor-Free Operation and Other Key Techniques Sharing on NOSES

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22847387

Country of ref document: EP

Kind code of ref document: A1