WO2021142457A1

WO2021142457A1 - Advanced colpotomy system with uterine manipulator for total laparoscopic hysterectomy

Info

Publication number: WO2021142457A1
Application number: PCT/US2021/012991
Authority: WO
Inventors: Tarek AHMED NABIL ABOU EL KHEIR
Original assignee: Ahmed Nabil Abou El Kheir Tarek
Priority date: 2020-01-10
Filing date: 2021-01-11
Publication date: 2021-07-15

Abstract

A device for facilitating a total laparoscopic hysterectomy includes a cervical cup adapted to abut a cervicovaginal junction. An electrocautery/electrosurgery wire with an uninsulated portion is housed in the cervical cup, including a channel for housing and controlled releasing the uninsulated portion. An introducer coupled to the electrocautery/electrosurgery wire configured to penetrate the cervicovaginal junction introduces the electrocautery wire into the intra- abdominal cavity. A shaft secures the electrocautery/electrosurgery wire, and pulling the electrocautery/electrosurgery wire causes a controlled release of the uninsulated portion along a predetermined circumferential path around the cervix along the channel. Thus, the vagina is severed from the cervix along the circumference of the cervicovaginal junction.

Description

Non-Provisional Patent Application for

ADVANCED COLPOTOMY SYSTEM WITH UTERINE MANIPULATOR FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

RELATED APPLICATIONS

[0001] This application claims is a continuation in part of U.S. Patent Application Serial No. 15/985650, entitled “Colpotomy System with Uterine Manipulator and Electrocautery for Total Laparoscopic Hysterectomy,” which was filed on 21 May 2018 (attorney docket no. IPF18-133).

BACKGROUND

[0002] Total hysterectomy procedures involving the use of a colpotomy ring are known in the art, including the removal of the patient’s uterus and cervix. In such a procedure, the patient’s vagina is separated from the patient’s uterus and cervix prior to extraction. Performing that portion of the procedure is difficult because there currently exists no way of uniformly cutting around the patient’s cervicovaginal junction and vaginal fornix. Under current practices, several incisions must be made laparoscopically, which is time consuming and prone to error due to the difficulty in locating and manipulating the patient’s cervicovaginal junction and vaginal fomices, adjacent the uterus.

[0003] Hence, what is needed is a device for severing a patient’s vagina from the patient’s uterus and cervix in a minimally invasive and controlled manner. There is also a need for such a device that is installed on an otherwise conventional colpotomy ring and uterine sound assembly. Finally there is a need for such a device that uses limited electrosurgery and/or electrocautery to sever the patient’s uterus from the vagina without impacting the surrounding tissue, and which may be subsequently removed through a laparoscopy port or through the vagina.

SUMMARY

[0004] Electrosurgery and electrocautery terminologies (including the combined expression ‘electrosurgery/electrocautery’ are being used interchangeably throughout this document, and are meant to describe that in some embodiments of the invention ‘electrocautery’ (whether the wire, the energy, the energy generator, the activating element, etc.) may be used, while in other embodiments ‘ electrosurgery ’ (whether the wire, the energy, the energy generator, the activating element, etc.) may be used, or even another type of energy, such as electromagnetic, radiofrequency, heat, electric, etc. are contemplate.

[0005] A device is provided for facilitating a total laparoscopic hysterectomy including removing a patient’s uterus and cervix , when the uterus and a portion of the patient’s cervix are located inside an intra-abdominal cavity and a vagina is circumferentially attached to the cervix creating a cervicovaginal junction, wherein the cervix has a cervical canal, the uterus has an intrauterine cavity, and the intra-abdominal cavity includes a laparoscopic access installed through the anterior abdominal wall.

[0006] Among other features, the device includes a cervical cup having a cervical cup proximal end and a cervical cup distal end. The cervical cup distal end is adapted for embracing the cervix with the cervical cup distal end abutting the cervicovaginal junction, and the cervical cup proximal end extending away from the cervix. An electrosurgery/electrocautery wire having two electrosurgery/electrocautery wire proximal ends and two electrosurgery/electrocautery wire distal ends are included within the cervical cup, and the two electrosurgery/electrocautery wire distal ends each include a small uninsulated portion. The cervical cup distal end includes a channel for housing the uninsulated portion of the two electrosurgery/electrocautery wire distal ends, and the channel is configured for a controlled movement, including release of the uninsulated portion of the two electrosurgery/electrocautery wire distal ends.

[0007] An introducer is provided, having an introducer proximal end and an introducer distal end, the introducer proximal end is releasably coupled to the two electrosurgery/ electrocautery wire proximal ends, and the introducer is configured to penetrate the cervicovaginal junction upon activation of the introducer distal end, thereby introducing the electrosurgery/electrocautery wire proximal ends into the intra-abdominal cavity. A shaft is provided, the shaft having a shaft proximal end, and a shaft distal end, wherein the shaft distal end is configured for introduction into the intra-abdominal cavity through the access installed in the anterior abdominal wall.

[0008] The shaft is configured to secure the electrosurgery/electrocautery wire proximal ends through the shaft distal end and move the electrosurgery/electrocautery wire proximal ends through the shaft toward the shaft proximal end, thereby pulling the electrosurgery/electrocautery wire uninsulated portions in the channel and causing a controlled movement, including release of the uninsulated portion along a predetermined circumferential path around the cervix along the channel. Thus, the vagina is severed from the cervix along the circumference of the cervicovaginal junction. [0009] The apparatus preferably also includes two sliders (which may comprise sliders, balls, or rollers) inside the channel, with each slider configured to slide in one of two opposing 180 degree semi-circular tracks until the two sliders meet. In one new and improved embodiment of the invention, each of the uninsulated portions of the two distal ends of the electrosurgery/electrocautery wires ends in one of the sliders, respectively. Such an arrangement allows the uninsulated portions to be controllably moved along the channel aided by the smooth movement of the sliders through their respective portions of the channel. In a second new and improved embodiment of the invention, each of the sliders (i.e., sliders/balls/ rollers) preferably includes a duct having an inlet and an outlet, and the uninsulated portion of each of the two electrosurgery/electrocautery wire distal ends passes through the duct of each slider from the inlet to the outlet, emerging from each outlet toward the outside of the channel. A spring is located on the inlet side of each of the sliders inside the channel, the spring exerting counter traction on the other end of the uninsulated portion of each of the two electrosurgery/ electrocautery distal ends to pull it and keep it hidden inside the colpotomy channel to protect the patient tissue from the electric energy effect when the operator is not actively pulling on it and using the device. That arrangement allows the uninsulated portions to be released and moved along the channel and for the electrosurgery/electrocautery wires to disengage the cervical cup through the outlet of each duct and for the uninsulated portions of the electrosurgery/ electrocautery wires to be retracted into the colpotomy channel when not in use.

[0010] The apparatus preferably also includes an elongated curved stem having a stem proximal end, a stem distal end and a first curved axis, the stem distal end is adapted to be introduced through the cervical canal into the intrauterine cavity, thereby providing a means for manipulating the uterus, and the proximal end includes a handle. The device preferably includes an elongated curved cylinder having a proximal end, a distal end, with a duct along its length and a second curved axis matching the first curved axis. The elongated curved cylinder is preferably shorter in length than the elongated curved stem, and the distal end of the elongated cylinder is adapted to be coupled with the proximal end of the cervical cup. This allows them to move as one unit, wherein the elongated curved stem is configured for sliding through the duct of the elongated curved cylinder and adapted to be locked in place at a predetermined distance set by the operator.

[0011] The semicircular tracks of the channel at the cervical cup distal end are preferably tilted interiorly, thereby causing the sliders to be tilted interiorly along the track. This causes the angle of the exposed portion of the electrosurgery/electrocautery wires extending between each slider to be tilted interiorly closer to the cervix, thereby causing the cutting area severed by the uninsulated portion in the cervicovaginal junction to be closer to the cervix and away from other body organs. Additionally, a portion of the shaft may be flexible, a portion of the shaft may be bifurcated, and the shaft may be insulated.

[0012] In various alternative embodiments, an optical/light system terminating at the cervical cup. The shaft includes sliding bars configured to move the electrosurgery/ electrocautery wire proximal ends through the shaft. In various alternative embodiments, the device may also include a component selected from the group consisting of a monopolar energy generator, a bipolar wired electrosurgery energy generator, a monopolar battery operated electrosurgery energy generator, a bipolar battery operated electrosurgery energy generator, a pedal activating element, a manual activating element, and a button activating element, a monopolar wired electrocautery energy generator, a bipolar wired electrocautery energy generator, a monopolar batteries operated electrocautery energy generator, a bipolar batteries operated electrocautery energy generator, a pedal activating electrocautery , a manual activating electrocautery, and a button activating electrocautery, a gas seal vaginal element, a gas seal vaginal balloon occluder, a gas seal vaginal umbrella shape occluder, a shaft with a flexible portion, a shaft with bifurcated portion , an insulated shaft, and at least one apparatus chosen from the list of a handle, a uterine sound's intrauterine balloon, a uterine sound's anchoring element to the uterus and a uterine sound's anchoring folded arms shape element to the uterus, and a handle. The device further utilizes at least one type of energy selected from the group consisting of monopolar energy, bipolar energy, electrosurgery energy, monopolar electrosurgery energy, bipolar electrosurgery energy, monopolar electrocautery energy, bipolar electrocautery energy, radio-frequency energy, electromagnetic energy, heat energy, and electric energy.

[0013] The device may also be characterized as a device to facilitate a total laparoscopic hysterectomy of a uterus, wherein the uterus and a portion of a cervix are inside an intra abdominal cavity and a vagina is circumferentially attached to the cervix creating a cervicovaginal junction, wherein the cervix has a cervical canal, the uterus has an intrauterine cavity, and the intra-abdominal cavity includes an access installed through the anterior abdominal wall. The device in this embodiment includes a cervical cup having a cervical cup distal end adapted to abut the cervicovaginal junction, and a cervical cup proximal end extending away from the cervix. An electrosurgery/electrocautery wire is provided having an insulated portion, and an uninsulated portion disposed in the cervical cup distal end.

[0014] The cervical cup distal end preferably includes a channel partially housing the uninsulated portion, the channel comprising a pair of sliders configured to move through the channel and control the movement and release of the uninsulated portion of the electrosurgery/ electrocautery wire. An introducer having an introducer proximal end and an introducer distal end is included, with the introducer proximal end releasably coupled to the electrosurgery/ electrocautery wire insulated portion, and the introducer slidable relative to the cervical cup, such that the proximal end is configured to penetrate the cervicovaginal junction upon activation of the introducer distal end, thereby introducing the electrosurgery/electrocautery wire insulated portion into the intra-abdominal cavity.

[0015] The device preferably also includes a shaft having a shaft proximal end, and a shaft distal end, wherein the shaft distal end is configured for introduction into the intra abdominal cavity through the access installed in the anterior abdominal wall. The shaft is further configured to secure the electrosurgery/electrocautery wire insulated portion through the shaft distal end and urge the electrosurgery/electrocautery wire through the shaft toward the shaft proximal end, thereby pulling the electrosurgery/electrocautery wire uninsulated portion through the sliders and around the channel, and thereby cause a controlled release and movement of the uninsulated portion along a predetermined circumferential path around the cervix.

[0016] A method is also provided for separating a patient’s cervix from the patient’s vagina at the cervicovaginal junction. The method includes the steps of providing a colpotomy cup assembly having a colpotomy ring, and providing an electrosurgery/electrocautery wire on the colpotomy cup assembly.

[0017] An introducer trocar is provided on the colpotomy cup assembly in a sliding relationship to the colpotomy ring, and the introducer trocar is anchored to the electrosurgery/electrocautery wire. The colpotomy ring is placed against the cervicovaginal junction, and the introducer urged through the cervicovaginal junction, thereby carrying the electrosurgery/electrocautery wire through the cervicovagional junction. The electrosurgery/ electrocautery wire is captured with a laparoscopic shaft assembly, placed under tension, and the electrosurgery/electrocautery wire is pulled causing the electrosurgery/electrocautery wire to travel around the colpotomy ring.

[0018] In various alternative embodiments of the method, two sliders are provided. The two sliders are configured to travel around two semi-circular portions of the colpotomy ring and control the movement and in some embodiments the movement and release of the electrosurgery/ electrocautery wire from the colpotomy ring. Additionally, a first handle may be provided on the laparoscopic shaft assembly for drawing the electrosurgery/electrocautery wire through the laparoscopic shaft and a movement/release system may be provided comprising a colpotomy cup and sliders/balls/rollers. When the electrosurgery/electrocautery wire is urged through the laparoscopic shaft such that the colpotomy cup sliders/balls/rollers travel around the colpotomy ring, a channel provided in the colpotomy ring is configured to allow the sliders/balls/rollers to pass therethrough. The method of further comprises the step of providing at least one type of energy to be utilized by the device to exert its effect on the tissue (such as cutting or cutting and coagulating the tissues, etc.) selected from the group consisting of monopolar energy, bipolar energy, electrosurgery energy, monopolar electrosurgery energy, bipolar electrosurgery energy, monopolar electrocautery energy, bipolar electrocautery energy, radio-frequency energy, electromagnetic energy, heat energy, and electric energy.

BRIEF DESCRIPTION OF THE FIGURES

[0019] FIG. 1 illustrates a perspective view of a uterine colpotomy system assembly;

[0020] FIG. 2a illustrates a perspective view of an accordion folded electrosurgery/ electrocautery wire and tensioner cable, including flexible insulated sheaths and a release system; [0021] FIG. 2b illustrates a perspective view of the accordion folded electrosurgery/ electrocautery wire and tensioner cable attached to an introducer trocar, including flexible insulated sheaths and a release system;

[0022] FIG. 3 illustrates a perspective view of the uterine colpotomy system assembly, with the electrosurgery/electrocautery wire and tensioner cable extending into a laparoscopy shaft assembly;

[0023] FIG. 4a illustrates a perspective view of the uterine colpotomy system assembly with the electrosurgery/electrocautery wire, tensioner cable, and flexible insulated sheaths extended.

[0024] FIG. 4b illustrates a perspective view of a uterine sound;

[0025] FIG. 4c illustrates a perspective view of a colpotomy cup assembly;

[0026] FIG. 4d illustrates the terminal ends of the electrosurgery/electrocautery wire and tensioner cable;

[0027] FIG. 5a illustrates a perspective view of the colpotomy cup assembly, including a colpotomy ring bearing the electrosurgery/electrocautery wire and release system in a channel;

[0028] FIG. 5b illustrates a perspective view of the release system;

[0029] FIG. 5c illustrates a partial cut-away perspective view of the release system;

[0030] FIG. 6a illustrates an enlarged view of the colpotomy ring;

[0031] FIG. 6b illustrates an enlarged view of the electrosurgery/electrocautery wire and release mechanism, including an electrocautery disc;

[0032] FIG. 7al illustrates a perspective view of a portion of the colpotomy ring and the release mechanism in a retracted configuration. [0033] FIG. 7b 1 illustrates a perspective view of a portion of the colpotomy ring and the release mechanism in a non-retracted configuration.

[0034] FIG. 7a2 illustrates a perspective view of the release mechanism in a retracted configuration.

[0035] FIG. 7b2 illustrates a perspective view of the release mechanism in a non- retracted configuration.

[0036] FIG. 7a3 illustrates a cut-away perspective view of the release mechanism in a retracted configuration.

[0037] FIG. 7b3 illustrates a cut-away perspective view of the release mechanism in a non-retracted configuration.

[0038] FIG. 8a illustrates a perspective view of the colpotomy ring;

[0039] FIG. 8b illustrates a close-up perspective view of the colpotomy ring;

[0040] FIG. 9a illustrates a perspective rear view of the colpotomy cup assembly;

[0041] FIG. 9b illustrates a perspective rear view of the colpotomy cup assembly, including a uterine sound;

[0042] FIG. 9c illustrates a perspective view of a locking mechanism for the uterine sound in the colpotomy cup assembly;

[0043] FIG. 9d illustrates a perspective view of the locking mechanism with the uterine sound in position for locking relative to the colpotomy cup assembly;

[0044] FIG. 10a illustrates a perspective view of electrosurgery/electrocautery wire and tensioner cable attachment portions of the laparoscopic shaft assembly, including sliding handles; [0045] FIG. 10b illustrates an exploded perspective view of the electrosurgery/ electrocautery wire and tensioner cable attachment portions;

[0046] FIG. 10c illustrates a perspective view of sliding attachments for the electrosurgery/electrocautery wire and tensioner cable with the electrosurgery/electrocautery wire and tensioner cable attached;

[0047] FIG. 1 la is a perspective view of the laparoscopic shaft assembly;

[0048] FIG. 1 lb is a perspective view of the electrosurgery/electrocautery wire and tensioner cable attachment portions, including a locking release button;

[0049] FIG. 12a is a perspective view of an electrosurgery/electrocautery machine attached to the laparoscopic shaft assembly and FIG. 12b is a close-up view of the laparoscopic shaft assembly handle;

[0050] FIG. 13a is a perspective view of an electrosurgery/electrocautery machine attached to an alternative embodiment laparoscopic shaft assembly;

[0051] FIG. 13b is a perspective view of a handle portion of the alternative embodiment laparoscopic shaft assembly;

[0052] FIG. 14 is a perspective view of the uterine colpotomy system assembly and the laparoscopic shaft assembly being used to cut through a cervicovaginal junction to separate a cervix from a vagina;

[0053] FIG. 15 illustrates a perspective view of an improved uterine colpotomy system assembly;

[0054] FIG. 16a illustrates a perspective view of the colpotomy ring;

[0055] FIG. 16b illustrates a close-up perspective view of the colpotomy ring with the new improved sliders/perforated balls; [0056] FIG. 16c illustrates a close-up perspective view of the new improved sliders/perforated balls;

[0057] FIG. 17a illustrates a perspective view of the colpotomy ring;

[0058] FIG. 17b illustrates a close-up perspective view of the colpotomy ring with the new improved sliders/balls/ rollers;

[0059] FIG. 17c illustrates a close-up perspective view of the new improved sliders/ balls/ rollers;

[0060] FIG. 18a is a perspective view of the laparoscopic shaft assembly;

[0061] FIG. 18b illustrates a close-up perspective view of electrosurgery/electrocautery wire attachment portion of the laparoscopic shaft assembly, including sliding bar;

[0062] FIG. 18c is a perspective view of the laparoscopic shaft sliding bar for electrosurgery/electrocautery wire hook up and constriction, which is an alternative to a sliding bar;

[0063] FIG. 18d is a perspective view of the external sheath of the laparoscopy shaft;

[0064] FIG. 19 illustrates a perspective view of an improved uterine colpotomy system assembly with improved handle and uterine sound intrauterine folding arms in open position;

[0065] FIG. 20a illustrates a close-up perspective view of uterine sound intrauterine folding arms (uterine sound’s intrauterine anchoring element) in closed position; and

[0066] FIG. 20b illustrates a close-up perspective view of uterine sound intrauterine folding arms (uterine sound’s intrauterine anchoring element) in open position. [0067] COMPONENT LISTING:

[0068] To assist with the detailed description of the claimed apparatus, the following listing of components as described and shown in the drawings is provided.

1. Uterine sound (Figs. 1, 3, 4a, 4b, 9b, and 14);

2. Uterine sound handle (see Figs. 1, 3, 4a, 4b, 9b, and 14);

3. Locking ring to adjust uterine sound intrauterine length (see Figs. 1, 3, 5a, 9a, 9b, 9c, 9d, and 14);

4. Colpotomy cup cylinder (see Figs. 1, 3, 4c, 9a, 9b, 9c, 9d, and 14);

5. Colpotomy cup (see Figs. 1, 3, 4a, 4c, 5a, 6a, 8a, 8b, 9a, and 9b);

6. Colpotomy cup channel (tilted interior) (see Figs. 1, 3, 5a, 6a, and 8b);

7. Colpotomy cup roller (see Figs. 2a, 3, 5b, 5c, 6a, 6b, 7a2, 7b2, 7a3, 7b3, and 8b);

8. Light optical system (see Figs. 1, 3, 4a, 4c, 5a, and 14);

9. Tensioner cable handling insulated flexible sheath (cable) which is attached permanently to one end of the flexible insulated sheath (11) (see Figs. 4a, 4d, 10c, 11a, and lib);

10. Electrosurgery/electrocautery wire (see Figs. 4a, 4d, 5b, 5c, 7a2, 7b2, 7a3, 7b3, 10c, 11a and lib);

11. Flexible insulated sheath (flexible sheath, insulated flexible sheath, insulated sheath, sheath) (see Figs. 3, and 14);

12. Introducer trocar that carries the electrosurgery/electrocautery wire (10) and the tensioner cable (9) through the cervicovaginal junction (see Figs. 1, 2b, 3, 4a, 4c, Fig. 5a, and 14);

13. Uterine sound intrauterine balloon or other uterine sound anchoring element to the uterus or intrauterine cavity (see Figs. 1, 3, and 4a);

14. Laparoscopy shaft (shaft) (see Figs. 10a, 11a, lib, 12a, 12b, 13a, 13b, and 14); Ball tips of the electrosurgery/electrocautery wire (10) (ball tips) (see Figs. 4a, 4d, and 10c); Horse shoe tip of the tensioner cable (9) handling the insulated flexible sheath (11) (see Figs. 4a, 4d, 10c, and 1 lb); Electrosurgery/electrocautery ball socket to receive the ball tips (15) of the electrosurgery/electrocautery wire (10) (see Figs. 10a, 10c, and lib); Sliding bar for electrosurgery/electrocautery wire (10) hook up and constriction (see Fig. 10a); Sliding bar for tensioner cable (9) handling insulated flexible sheath hook up and constriction (11) (see Figs. 10a, 10b, and lib); Groove in the sliding bar to hook up the horse shoe tip of the tensioner cable (9) handling the insulated Flexible sheath (11) (see Figs. 10a, 10b, and 1 lb); Cable attachment to electrosurgery/electrocautery machine (see Figs. 11a, 12a, 12b, 13a, 13b, and 14); Cover of the distal end of the laparoscopic shaft (see Figs. 3, 10a, 11a, 12a, 13a, and 14); Electrosurgery/electrocautery machine (see Figs. 12a and 13a); Electrosurgery/electrocautery machine pedal to activate electrosurgery/ electrocautery machine with alternative activation button on the laparoscopy shaft handle (33) (see Figs. 12a and 13a); Uterine sound projections (see Figs. 1, 3, 4a, 4b, 9b, 9d, and 14); Vaginal occluder balloon with alternative other gas seal vaginal elements (see Figs. 1, 3, and 14); Vaginal occluder balloon base (see Figs. 4b and 5a); Vaginal vault (see Fig. 14); Uterus (see Fig. 14); A cut in the vaginal vault made by the introducer (12) to sever vagina from cervix (see Fig. 14); Handle for sliding bar (18) for electrosurgery/electrocautery wire hook up and constriction (see Figs. 3, 10a, 10b, 11a, lib, and 14); Handle for sliding bar (19) for tensioner cable (9) handling insulated flexible sheath (11) hook up and constriction (see Figs. 10b, 10c, 11a, 1 lb, Fig. 12a, 13a, and 14); Handle for laparoscopy shaft (see Figs. 11a and 14); Release button for releasing locking system for sliding bar (19) for tensioner cable (9) handling insulated flexible sheath (11) (see Figs. 3, 11a, 1 lb, 12a, 13a, and 14); Release system of electrocautery wire at distal end of insulated flexible sheath (11) (see Figs. 1, 3, 5a, 5b, 6a, 6b, 7al, 7bl, 7a2, 7b2, 8b, and 14); Electrosurgery/electrocautery disc for supporting the electrocautery wire (10) with its folded configuration (43) and allows for both bipolar and monopolar electrosurgery/ electrocautery (see Figs. 1, 2a, 5a, 6a, 6b, and 8b); Spring (see Figs. 5c, 6a, 6b, 7al, 7bl, 7a3, 7b3, and 8b); The uninsulated portion of electrosurgery/electrocautery wire (10) in colpotomy cup channel (6) (see Figs. 2a, 5a, 5b, 5c, 6a, 6b, 7al, 7bl, 7b2, 7a3, 7b3, and 8b); LED (see Figs. 1, 5a, 6a, 7al, 7bl, and 8b); Alternative handle for manipulating sliding bar (18) for electrosurgery/ electrocautery wire (10) hook up and constriction (see Figs. 12a, 12b, 13a and 13b); Ridge on laparoscopy shaft to guide cover (22) at the distal end of the laparoscopic shaft (14) (see Fig. 10a); Folded tensioner cable handling insulated flexible sheath (tensioner cable (9) in accordion-folded configuration) (see Figs. 1 and 2a); Folded electrosurgery/electrocautery wire (electrosurgery/electrocautery wire (10) in accordion-folded configuration) (see Figs. 1 and 2a); Folded insulated flexible sheath (insulated flexible sheath (11) in accordion- folded configuration) (see Figs. 1, 2a, and 2b); A temporary attachment between the electrosurgery/electrocautery wire (10, 43), the cable (9, 42) and the introducer trocar (12) (see Figs. 1 and 2b); Roller rod (see Figs. 5b, 5c, 7a2, 7a3 and 7b3); Roller rod channel in release system (35) of electrosurgery/electrocautery wire (10) at distal end of insulated flexible sheath (11) (see Figs. 5c, 7a3, and 7b3); Electrosurgery/electrocautery duct in insulated flexible sheath (11) (see Figs. 5c, 7a3, and 7b3); Exposed portion of electrosurgery/electrocautery wire (10) (see Figs. 5b, 5c, 7a2, 7b2, 7a3, 7b3, and 8b); Top opening of the colpotomy cup channel (see Figs. 7al, 7bl, and 8b); Floor of the colpotomy cup channel (tilted interior) (see Figs. 7al, 7b 1, and 8b); Distal opening of the colpotomy cup cylinder (4) duct through which the uterine sound is housed when the device is in use (see Figs. 5a, 6a, and 14); Cut face of distal end of insulated flexible sheath (see Figs. 5c, 7a3, and 7b3); Groove for the introducer trocar (12) for electrosurgery/electrocautery wire (12) within the vaginal occluder balloon base (27) (see Figs. 1 and 5a); Proximal opening of the colpotomy cup cylinder (4) duct through which the uterine sound is housed when the device is in use (see Fig. 9a); Groove in the colpotomy cup cylinder through which uterine sound projections (25) can pass (see Figs. 9a and 9c); Slit opening in the locking ring (3) (see Fig. 9a); Groove in the locking ring (3) that encase the locked uterine sound projection when the locking ring (3) is turned (see Figs. 9c and 9d); Ridge on the colpotomy cup cylinder to guide the locking ring (see Figs. 9c, 9d); The introducer trocar (12) handle tab (see Figs. 1, 2b, 3, 4c, 5a, 9a, 9b, and 14); Introducer trocar (12) off-set portion (see Figs. 2b, 4c, and 5a); Introducer trocar 12 off-set face (see Figs. 3, 4c, 5a, and 14); Introducer trocar 12 pointing tip or a blade (see Figs. 1, 2b, 3, 4c, 5a, 6a, 7al, 7bl, and 8b); Colpotomy cup (5) opening for releasing colpotomy cup rollers (7) (see Figs. 5a, 6a, and 8b); Button activating electrosurgery/electrocautery (see Fig. 14); Umbrella vaginal gas occluding mechanism alternative to vaginal occluder (see Fig. 15); Ring with a handle that can open and close Umbrella vaginal gas occluding mechanism (see Fig. 15); Locking arm with ring alternative to Locking ring to adjust uterine sound intrauterine length (see Figs. 15 and 19); Spring controlling release of uninsulated portion of electrosurgery/electrocautery wire (see Figs. 16b and 16c); Slider/perforated ball/roller that control movement and release of electrosurgery/electrocautery wire along the colpotomy cup channel (6), the slider/bail has a hole/duct that allows electrosurgery/electrocautery wire to pass through (see Figs. 16b and 16c); End of uninsulated portion of electrosurgery/electrocautery wire (49) in colpotomy cup channel (6) (see Fig. 16c); Slider/ ball/roller that control movement of electrosurgery/electrocautery wire along the colpotomy cup channel (6), the electrosurgery/electrocautery wire ends and is attached to the inside of the slider/bail (see Figs. 17b and 17c); 73. Sliding bar for electrosurgery/electrocautery wire (10) hook up and constriction (alternative to sliding bar (18) (see Figs. 18a, 18b and 18c);

74. Handle to sliding bar (73) (see Figs. 18a and 18c);

75. External sheath of Laparoscopy shaft (14) (see Figs. 18a and 18d);

76. Container on colpotomy cup that initially holds folded electrosurgery/ electrocautery wire (43) (see Figs. 15 and Fig. 19);

77. Cover for the container (76) on colpotomy cup that initially holds Folded electrosurgery/electrocautery wire (43) (see Figs. 15 and 19);

78. Ridges on uterine sound (1) that prevents Locking arm with ring (68) from sliding and slipping over uterine sound (1) (see Fig. 15);

79. Uterine sound handle trigger that deploy uterine sound intrauterine folding arms which are one of the anchoring elements to the uterus alternative to Uterine sound intrauterine balloon (13) (see Fig. 19);

80. Uterine sound intrauterine folding arms in open position which are one of the anchoring elements to the uterus alternative to Uterine sound intrauterine balloon (13) (see Figs. 19 and 20b); and

81. Uterine sound intrauterine folding arms in closed position which are one of the anchoring elements to the uterus alternative to Uterine sound intrauterine balloon (13) (see Fig. 20a).

DETAILED DESCRIPTION

[0069] The following description is presented to enable any person skilled in the art to make and use the invention, and is provided in the context of a particular application and its requirements. Various modifications to the disclosed embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Thus, the present invention is not limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein.

[0070] Referring to FIG. 1, a colpotomy system assembly is shown. The colpotomy system assembly includes a uterine sound 1 and a handle 2. A locking ring 3 is provided on the uterine sound 1, the locking ring 3 engaging one of a series of uterine sound projections 25 for adjusting and locking the uterine sound 1 in position relative to the a colpotomy cup 5 at the proper intrauterine length.

[0071] A colpotomy cup cylinder 4 surrounds the uterine sound 1 around a portion of its length, and supports the colpotomy cup 5. The colpotomy cup 5 has a forward facing toroidal profile and includes a colpotomy cup channel 6. The colpotomy cup channel 6 is disposed at a slightly inward angle along the toroidal colpotomy cup 5 surface. A light optical system 8 extends along the colpotomy cup cylinder 4, and extends to the colpotomy cup 5 to illuminate the area around the colpotomy cup 5, and may include one or more LEDs 39 to provide effective illumination of a vagina and vaginal fomices during the introduction of the colpotomy cup around a patient’s cervix and to transilluminate through the cervicovaginal junction and the surrounding tissue to help during the laparoscopic tissues dissection and avoid injury to blood vessels and surrounding organs.

[0072] An introducer trocar 12 is provided for introducing an electrosurgery/ electrocautery wire 10, shown here in an accordion-folded configuration 43, as well as a cable 9, also shown here in an accordion-folded configuration 42 from the vagina into the intrauterine cavity through the cervicovaginal junction, and allowing the electrosurgery/electrocautery wire 43 and cable 42 to be grasped by a regular laparoscopic grasper (not shown) and coupled to a laparoscopy shaft assembly (See, Figs. 3, 4a, 11a, 12 and 14). The electrosurgery/electrocautery wire 10 in one of the preferred embodiment of this invention has two proximal ends and two distal ends, each of the two distal ends have an uninsulated portion, such that when the the proximal ends are in communication with the energy generator while the two uninsulated portions of the two distal ends are exposed and in contact with the patient’s tissue at the cervicovaginal junction, a closed circuit is formed. At that time if the electrosurgery system is the system being used, the energy flows through the tissue and exert the desired effect or in other embodiment if the electrocautery system is being used the energy heats up the exposed uninsulated portions of the electrocautery wire which exert the desired effect on the tissue. The introducer trocar 12 extends through an introducer trocar groove 54 located in a vaginal occluder balloon base 27 which supports a vaginal occluder balloon 26. A uterine sound intrauterine balloon 13 is provided near a terminal end of the uterine sound 1 opposite the uterine sound handle 2 which help to stabilize and anchor the distal end of the uterine sound to the uterus and the uterine cavity.

[0073] Additional components of the colpotomy system assembly discussed in more detail below include release systems 35 for the electrosurgery/electrocautery wire 10, 43 located at a distal end of insulated flexible sheaths 11, 44. An electrosurgery/electrocautery disc 36 is provided for supporting the electrosurgery/electrocautery wire 10, 43 and allows for both bipolar and monopolar electrosurgery/electrocautery. A temporary attachment 45 is provided between the electrosurgery/electrocautery wire 43, the cable 42 and the introducer trocar 12.

[0074] Referring to Figs. 2a and 2b, the electrosurgery/electrocautery portions of the colpotomy system assembly are shown in more detail. Referring to FIG. 2a, the cable 42 and electrosurgery/electrocautery wire 43 are preferably accordion folded together. While the cable 9, 42 is attached to the proximal end of the insulated sheaths 44, the electrosurgery/ electrocautery wire 10, 43 extends through the insulated sheaths 44, continuing along roller rods 46 and through colpotomy cup rollers 7 before traveling around the colpotomy cup 5 in the colpotomy cup channel 6 (not shown). The electrosurgery/electrocautery wire 10, 43 includes an uninsulated portion 38 disposed in the colpotomy cup channel 6, which terminates at the electrosurgery/electrocautery disc 36.

[0075] In an alternative embodiment, the folded electrosurgery/electrocautery wire 43, the folded insulated flexible sheaths 44 and the folded cable 42 are enclosed in a sterile encasement (not shown) to protect them from being contaminated from the different microbes that are present in the vagina prior to their introduction into the intra-abdominal cavity.

[0076] Referring to Fig. 2b, The introducer trocar 12 is shown interfacing with the electrosurgery/electrocautery wire 43 and cable 42. The introducer trocar 12 includes a handle portion 60 for engagement by a surgeon, to push the introducer trocar 12 forward relative to the colpotomy cup 5 (not shown). Continued forward movement of the introducer trocar 12 may be arrested by providing a handle tab 60 configured to catch on the locking ring 3. The introducer trocar 12 also includes an off-set portion 61 allowing it to travel through the vaginal occluder balloon base 27 and not interfere with the vaginal occluder balloon 26 once inflated. The off-set portion 61 may include an off-set face 62 configured to abut the vaginal occluder balloon base 27 when the handle tab 60 engages the locking ring 3. The introducer trocar 12 also preferably includes a pointing tip or a blade 63 for piercing the vaginal fornix and the cervicovaginal junction tissue. The electrosurgery/electrocautery wire 43 and cable 42 are preferably semi permanently attached to the introducer trocar 12 such that they are carried from the vagina through the vaginal fornix and the cervicovaginal junction along with its tip 63 in order to be grasped by a regular laparoscopic grasper in the intra-abdominal side and manually or in a different embodiment automatically coupled with the laparoscopy shaft assembly.

[0077] Referring to Fig. 3, the colpotomy system assembly is shown with cable 9, the electrosurgery/electrocautery wire 10, and the flexible sheaths 11 extended into the laparoscopy shaft assembly. The laparoscopy shaft assembly includes a cover 22 distal from the laparoscopy shaft handle 33. The laparoscopy shaft assembly also includes an electrosurgery/electrocautery wire sliding bar handle 31 pulling the electrosurgery/electrocautery wire 10 through the laparoscopy shaft assembly and a cable sliding bar handle 32 for pulling the cable/tensioner cable 9 through the laparoscopy shaft assembly. A release button 34 is provided for releasing the cable sliding bar handle 32. Also shown in this view, opposite the cover 22, the flexible sheaths 11 each comprise a release system 35 for controlling the exposure of the uninsulated portion of the electrosurgery/electrocautery wire to the cervicovaginal junction tissue.

[0078] Referring to Figs. 4a-4d, details of the colpotomy system assembly are shown, including the uterine sound 1 and uterine sound handle 2 disposed opposite the uterine sound intrauterine balloon 13. The colpotomy cup cylinder 4 is also shown, including the introducer trocar 12, vaginal occluder balloon base 27 and the colpotomy cup cylinder distal opening 52 through which the uterine sound 1 passes. In this view the cable/tensioner cable handling insulated flexible sheath 9 is shown along with the insulated electrosurgery/electrocautery wire 10. The insulated electrosurgery/electrocautery wire 10 includes ball tips 15 for engaging the laparoscopy shaft assembly, while the cable/tensioner cable handling insulated flexible sheath 9 ends in a horseshoe tip for the same purpose.

[0079] Referring to Figs. 5a-5c, the release systems 35 for the electrosurgery/ electrocautery wire 10 with its portion 38 located in colpotomy cup channel 6 are shown in more detail. As shown in FIGS. 5b and in the partial cross section in FIG. 5c, each release mechanism 35 includes a colpotomy cup roller 7 that travels around the colpotomy cup channel 6. Specifically, FIG. 5c shows a cut through the distal end of the insulated flexible sheath 53 that shows the cut face of the distal end of the insulated flexible sheath 53. A roller rod 46 extends from each colpotomy cup roller 7, extending into a roller rod channel 47. A spring 37 is housed in each roller rod channel 47, and an electrosurgery/electrocautery duct 48 is provided in each insulated flexible sheath 11 such that the exposed portion electrosurgery/electrocautery wire 49 can travel through the insulated flexible sheaths 11 and into the laparoscopy shaft assembly. The exposed portion electrosurgery/electrocautery wire 49 also extends through the colpotomy cup rollers 7, which guide its movement around the colpotomy cup 5.

[0080] Referring to Figs. 6a and 6b, the placement of the electrosurgery/electrocautery wire 38 in the colpotomy cup channel 6 is shown. The electrosurgery/electrocautery wire 38 terminates in an electrosurgery/electrocautery disc 36, thus allowing for bipolar electrosurgery/ electrocautery if the disc 36 prevents the transmission of electricity between the electrosurgery/ electrocautery wire on both sides of the disc 36, and alternatively, for monopolar electrosurgery/ electrocautery if it allows the transmission of electricity between the electrosurgery/ electrocautery wire on both sides of the disc 36. As shown in this view the introducer trocar 12 is located adjacent the release systems 35 in their starting positions. Once the colpotomy cup rollers 7 have travelled the circumference of the colpotomy cup channel 6 and reached the electrosurgery/electrocautery disc 36, the electrosurgery/electrocautery wire 10 and the cable 9 are uncoupled from the laparoscopy shaft assembly and the colpotomy system assembly will be removed from the vagina along with the severed cervix and the uterus, or in a different embodiment the colpotomy cup rollers 7 are released from the colpotomy cup 5 by an opening in the colpotomy cup channel 6 adjacent to the electrosurgery/electrocautery disc 36 and they are removed from the body through the laparoscopic port along with the electrosurgery/ electrocautery wire 10, the cable 9 and the laparoscopy shaft assembly.

[0081] Referring to Figs. 7al through 7b3, the release systems 35 are shown in their extended (7al, 7a2 and 7a3) and contracted (7b 1, 7b2 and 7b3) states. Referring to Figs. 7al and 7b 1, the uninsulated portion fo the electrosurgery/electrocautery wire 38 travels along a floor 51 of the colpotomy cup channel 50. Referring to Figs. 7bl, 7b2 and 7b3, when the cable handling insulated flexible sheath 9 is not under tension, the spring 37 causes the insulated sheath 11 to extend downward along the roller rod 46, substantially covering the exposed portion electrosurgery/electrocautery wire 49 in the process. When a user pulls the cable 9, the insulated sheaths 11 are pulled upward along the roller rods, compressing the spring 37 in each roller rod channel 47, and exposing the exposed portion electrosurgery/electrocautery wire 49 between the colpotomy cup rollers 7 in the colpotomy cup channel 6. The exposed portion electrosurgery/ electrocautery wire 49 is located in front of the roller rod 46 in the direction of travel of each colpotomy cup roller to facilitate cutting.

[0082] Referring to Figs. 8a and 8b, a detail of the colpotomy cup 5 is shown. In this view the release systems 35 are in their retracted state, exposing the electrosurgery/ electrocautery wire 38 between the insulated sheaths 11 and the colpotomy cup rollers. Also, as shown in this view, the colpotomy cup channel 6 comprises a semicircular channel having an opening 50 through which the electrosurgery/electrocautery wire 38, but not the colpotomy cup rollers 7 can pass. The opening is oriented slightly inward, angled more toward the cervix (not shown) and away from the surrounding organs (not shown) to decrease the risk of injury of the surrounding organs by the exposed electrosurgery/electrocautery wire 49. Also shown in this view is the electrosurgery/electrocautery disc 36, and adjacent spaces through which the colpotomy cup rollers 7 pass when disengaging from the colpotomy cup 5. Preferably, the channel 6 may comprise a translucent material such that the LEDs 39, or similar lighting system illuminate area adjacent the colpotomy cup 5.

[0083] Referring to Figs. 9a-9d, operation of the locking ring 3 to adjust the uterine sound intrauterine length is shown in detail. Fig. 9a shows the colpotomy cup cylinder 4 and colpotomy cup 5, including the proximal opening of the colpotomy cup cylinder duct 55 through which the uterine sound 1 extends when in use. The colpotomy cup cylinder 4 includes a groove 56 through which the uterine sound projections 25 can pass as the uterine sound 1 travels through the colpotomy cup cylinder 4. Additionally, the locking ring 3 includes a slit opening 57 coinciding with the groove 56. A ridge 59 on the colpotomy cup cylinder 4 guides the locking ring 3 with a groove 58 in the locking ring 3, enabling the uterine sound 1 to be locked in position using the uterine sound projections 25 as shown in Fig. 9d.

[0084] Referring to Figs. 10a- 10c, the proximal portion of the laparoscopy shaft assembly is shown. The laparoscopy shaft 14 includes a ridge 41 for guiding the cover 22 at the end of the laparoscopy shaft 14. A pair of electrosurgery/electrocautery ball sockets 17 are provided for receiving the ball tips 15 of the electrosurgery/electrocautery wire 10. A first sliding bar 18 is provided to connect and constrict the electrosurgery/electrocautery wire 10. A second sliding bar 19 is provided for connecting the cable 9 which is connected to the insulated sheaths 11. A groove 20 is provided in the second sliding bar 19 for receiving the horse shoe tip 16 of the cable 9 handling the insulated flexible sheaths 11. As shown in Fig. 10c, the horseshoe tip 16 of the cable 9 is installed in the groove 20, which may be manipulated by operating the cable sliding bar handle 32, while the electrosurgery/electrocautery wire sliding bar handles directly control the electrosurgery/electrocautery wire 10 using the ball tips 15.

[0085] Figs. 11a and 1 lb show an enlarged view of the laparoscopy shaft assembly controls. In particular, the release button 34 is shown enabling a user to release the cable sliding bar handle 32 after it has been pulled to take up all of the cable 9, such that the insulated flexible sheaths 11 are abutting the distal end of the laparoscopy shaft 14. The electrosurgery/ electrocautery ball sockets 17 and first sliding bar 18 are also shown, which are controlled by the electrosurgery/electrocautery wire sliding bar handle 31. The laparoscopy shaft handle 33 is connected to a cable attachment to an electrosurgery/electrocautery machine 23 (Fig. 12).

[0086] Referring to Fig. 12a and 12b, the electrosurgery/electrocautery machine 23 is shown, including an electrosurgery/electrocautery machine pedal 24. The electrosurgery/ electrocautery machine 23 is connected to the cable attachment 21 and laparoscopy shaft handle 33. With the electrosurgery/electrocautery machine 23 connected to the laparoscopy shaft assembly, and the cable sliding bar handle 32 retracted until the release button 34 catches it, the electrosurgery/electrocautery wire sliding bar handle 31 may be retracted, or otherwise manipulated, to pull the electrosurgery/electrocautery wire 10 with its uninsulated portion located in colpotomy cup channel 38 around the colpotomy cup 5.

[0087] Referring to Figs. 13a and 13b, an alternative laparoscopy shaft assembly is shown featuring an alternative handle 40 for manipulating the first sliding bar 18 and manipulating the electrosurgery/electrocautery wire. In this embodiment, compression of the alternative handle 40 against the laparoscopy shaft handle 33 causes tension in the first sliding bar 18 and ball tips 15 and thus pulls the electrosurgery/electrocautery wire 38 from the colpotomy cup channel 6. [0088] Fig. 14 shows the colpotomy system assembly and the laparoscopy shaft assembly in use separating a vagina at the vaginal vault, represented by cylinder 28, from a uterus, represented by sphere 29. In this view, the uterine sound assembly is inserted into the vagina such that the colpotomy ring 5 abuts the vaginal vault 28. This is done after sounding the uterus 29, and locking the uterine sound 1 in position using the uterine sound projections 25 and the locking ring 3. The vaginal occluder balloon 26 is inflated, although shown in a relatively smaller diameter in this view for illustration purposes.

[0089] Still referring to Fig. 14, the introducer trocar 12 has been pushed forward from the vagina through the vaginal vault 28 and the cervicovaginal junction, carrying with it, the ball tips 15 of the electrosurgery/electrocautery wire 10 in its folded state 43, and the horseshoe tip 16 of the cable 9 in its folded state 42. In the process the folded electrosurgery/electrocautery wire 43 and cable 42 have unfolded and travelled through the cut 30 in the vaginal fault 28 into the intra-abdominal side which are then grasped by a regular laparoscopic grasper (not shown) and manually coupled with the laparoscopy shaft assembly after bringing them out of the abdomen through the laparoscopy port (not shown) or in a different embodiment automatically coupled with the laparoscopy shaft assembly.

[0090] The user has moved the electrosurgery/electrocautery bar handle 31 and the cable sliding bar handle 32 back until the release button 34 has caught, preventing the cable sliding bar handle 32 from moving in a reverse direction. At which time the insulated flexible sheaths 11 are abutting the distal end of the laparoscopy shaft 14 and they both move as one unit. Pulling the laparoscopy shaft 14 causes pulling on the insulated flexible sheath which in turn cause the release systems 35 to be activated, exposing the electrosurgery/electrocautery wire 49. Once the electrosurgery/electrocautery machine 23 is activated, the exposed electrosurgery/electrocautery wire 49 will heat up and cut the vaginal vault 28/cervicovaginal junction if the electrocautery mechanism (electrocautery wire and electrocautery energy, etc...) is used or it causes the passage of high-frequency electrical current through the tissue to cut the vaginal vault 28/vaginal cervical junction when electrosurgery mechanism (electrosurgery wire and electrosurgery energy etc..) is used or uses other type of energy (electromagnetic, electrical, etc..) in order to achieve a specific surgical effect. As the electrosurgery/electrocautery wire sliding bar handle 31 is pulled, the electrosurgery/electrocautery wire 10 is pulled causing the uninsulated portion of the electrosurgery/electrocautery wire in the colpotomy channel 38 to shorten, causing the colpotomy cup rollers 7 to travel around the colpotomy cup channel 6 of the colpotomy cup 5, which is pressed against the vaginal vault 28, thereby severing it from the uterus 29.

[0091] Once the release systems 35 reach the electrosurgery/electrocautery disc 36, the electrosurgery/electrocautery wire 10 and the cable 9 are uncoupled from the laparoscopy shaft assembly and the colpotomy system assembly will be removed from the vagina along with the severed cervix and the uterus, or in a different embodiment, the colpotomy cup rollers 7 are released from the colpotomy cup 5 by an opening 64 in the colpotomy cup channel 6 adjacent the electrosurgery/electrocautery disc 36 and they are removed from the body through the laparoscopic port along with the electrosurgery/electrocautery wire 10, the cable 9 and the laparoscopy shaft assembly.

[0092] Referring to Fig. 15, an improved colpotomy system assembly is shown. The colpotomy system assembly includes a uterine sound 1 and a handle 2. A locking arm with ring 68 alternative to locking ring to adjust uterine sound intrauterine length and locking the uterine sound 1 in position relative to the a colpotomy cup 5 at the proper intrauterine length, with ridges 78 on uterine sound 1 that prevents locking arm with ring 68 from sliding and slipping over uterine sound when locked.

[0093] A colpotomy cup cylinder 4 surrounds the uterine sound 1 around a portion of its length, and supports the colpotomy cup 5. The colpotomy cup 5 has a forward facing toroidal profile and includes a colpotomy cup channel 6. The colpotomy cup channel 6 is disposed at a slightly inward angle along the toroidal surface. A light optical system 8 extends along the colpotomy cup cylinder 4, and extends to the colpotomy cup 5 to illuminate the area around the colpotomy cup 5, and may include one or more LEDs 39 to provide effective illumination of the vagina and vaginal fomices during the introduction of the colpotomy cup around the cervix and to trans illuminate through the cervicovaginal junction and the surrounding tissue to help during the laparoscopic tissues dissection and avoid injury to blood vessels and surrounding organs.

[0094] An introducer trocar 12 is provided for introducing an electrosurgery/ electrocautery wire 10 when in an accordion-folded configuration 43, from the vagina into the intrauterine cavity through the cervicovaginal junction, and allowing the electrosurgery/ electrocautery wire 43 to be grasped by a regular laparoscopic grasper (not shown) and coupled to a laparoscopy shaft assembly (See, Figs. 3, 4a, 11a, 12 and 14).

[0095] The shaft is configured to secure the electrosurgery/electrocautery wire proximal ends through the shaft distal end and move the electrosurgery/electrocautery wire proximal ends through the shaft toward the shaft proximal end, thereby pulling the electrosurgery/electrocautery wire uninsulated portions in the channel and causing a controlled movement/release of the uninsulated portions along a predetermined circumferential path around the cervix along the channel. Thus, the vagina is severed from the cervix along the circumference of the cervicovaginal junction. [0096] Cable 9 as well as flexible insulated sheath 11 are not needed in this improved colpotomy system configuration which decrease the space needed to hold them in their folded state on the colpotomy cup before their introduction into the abdominal cavity by the introducer 12 and reduce the amount of manipulation needed to be performed by the surgeon during the use of the device.

[0097] The reason they were needed in the prior configuration were to provide cover and insulation for the relatively longer uninsulated portion 38 of electrosurgery/electrocautery wire 10 that is laid along the whole length of the colpotomy cup channel 6 when pulled out and released from the colpotomy channel to sever the cervix from the vagina, so it keeps the exposed portion 49 of the electrosurgery/electrocautery wire relatively short so it does not touch and bum or cut any other body tissues.

[0098] In the new improved colpotomy system the length of the uninsulated portion of the electrosurgery/electrocautery wire 10 is much shorter, it either ends directly into the slider/ball/roller 72 (see Figs. 17a, 17b and 17c) or it goes through the slider/perforated ball/roller 70 and end shortly after in 71 (see Figs. 16a, 16b and 16c) so the exposed portion 49 of electrosurgery/electrocautery wire 10 remains relatively short at all time and the risk of harm or burn to other body tissues is minimized.

[0099] An umbrella vaginal gas occluding mechanism alternative to vaginal occluder balloon 26, having a ring with a handle 67 that can open and close it. A uterine sound intrauterine balloon 13 is provided near a terminal end of the uterine sound 1 opposite the uterine sound handle 2 which help to stabilize and anchor the distal end of the uterine sound to the uterus and the uterine cavity. [0100] Additional components of the colpotomy system assembly discussed in more detail below include the improved slider/perforated ball/roller 70 and the improved slider/ ball/roller 72 that control the movement of the electrosurgery/electrocautery wire 10 along the colpotomy cup channel 6 when activated and severing the cervix from the vagina.

[0101] Referring to Figs. 16a and 16b, a detail of the colpotomy cup 5 is shown. In this view the colpotomy cup in transparent form is shown along with the improved slider/perforated ball/roller 70 of the improved colpotomy system with Fig. 16c showing an enlarged view of slider/perforated ball/roller 70 that control movement and release of electrosurgery/ electrocautery wire along the colpotomy cup channel 6, the slider/bail has a hole/duct that has an inlet and an outlet, and the uninsulated portion of each of the two electrosurgery/electrocautery wire distal ends passes through the duct of each slider from the inlet to the outlet, emerging from each outlet toward the outside of the channel. A spring is located on the inlet side of each of the sliders inside the channel exerts counter traction on the other end of the uninsulated portion of each of the two electrosurgery/electrocautery distal ends to pull it and keep it hidden inside the colpotomy channel to protect the patient tissue from the electric energy effect when the operator is not actively pulling on it and using the device. That arrangement allows the uninsulated portions to be released and moved along the channel and for the electrosurgery/electrocautery wire to disengage the cervical cup through the outlet of each duct and for the uninsulated portions of the electrosurgery/electrocautery wire to be retracted into the colpotomy channel when not in use.

[0102] Referring to Figs. 17a and 17b, a detail of the colpotomy cup 5 is shown. In this view the colpotomy cup in a transparent form is shown along with the improved slider/perforated ball/roller 72 of the improved colpotomy system with Fig. 17c showing an enlarged view of slider/ball/roller 72 that control movement of electrosurgery/electrocautery wire along the colpotomy cup channel 6, each of the uninsulated portion of the two distal ends of the electrosurgery/electrocautery wire ends in one of the sliders. That arrangement allows the uninsulated portions to be controllably moved along the channel aided by the smooth movement of the sliders through the channel, when the shaft secures the electrosurgery/electrocautery wire proximal ends through the shaft distal end and move the electrosurgery/electrocautery wire proximal ends through the shaft toward the shaft proximal end, thereby pulling the electrosurgery/electrocautery wire uninsulated portions in the channel and causing a controlled movement of the uninsulated portions along a predetermined circumferential path around the cervix along the channel. Thus, the vagina is severed from the cervix along the circumference of the cervicovaginal junction.

[0103] Figs. 18a, showing the laparoscopy shaft assembly 17 with the sliding bar 73 for electrosurgery/electrocautery wire 10 hook up and constriction (alternative to sliding bar 18) extending from its proximal to its distal end, covered by external sheath 75.

[0104] Referring to Fig. 18b showing a close-up of the electrosurgery/electrocautery wire attachment portion of the laparoscopic shaft assembly, showing the sliding bar 73 including a pair of electrosurgery/electrocautery ball sockets 17 are provided for receiving the ball tips 15 of the electrosurgery/electrocautery wire 10. The sliding bar 73 is provided to connect and constrict the electrosurgery/electrocautery wire 10. The handle 74 to sliding bar 73 directly control the electrosurgery/electrocautery wire 10 using the ball tips 15.

[0105] Referring to Fig. 18c the laparoscopic shaft sliding bar for electrosurgery/ electrocautery wire 10 hook up and constriction (alternative to sliding bar 18) is shown in its entirety. Referring to Fig. 18d the external sheath of the laparoscopy shaft that covers the sliding bar 73 is shown. Pulling the laparoscopy shaft Handle of the sliding bar 74 pulls the electrosurgery/electrocautery wire 10 which causes control movement and release of electrosurgery/electrocautery wire along the colpotomy cup channel 6 by slider/perforated ball/roller 70 or in a different embodiment, controlled movement of electrosurgery/electrocautery wire along the colpotomy cup channel 6 by slider/ball/roller 72. In the meanwhile the electrosurgery/electrocautery machine 23 is activated, the exposed electrosurgery/electrocautery wire 49 which is pressed against the vaginal vault/cervicovaginal junction 28 will heat up and cut the vaginal vault/cervicovaginal junction 28 if the electrocautery mechanism (electrocautery wire and electrocautery energy etc...) is used or it causes the passage of high-frequency electrical current through the tissue to cut the vaginal vault/cervicovaginal junction 28 if electrosurgery mechanism (electrosurgery wire and electrosurgery energy etc...) is used or uses other type of energy (electromagnetic, electrical, etc...) in order to achieve a specific surgical effect.

[0106] Referring to Fig. 19 showing an improved uterine colpotomy system assembly with improved handle and Uterine sound intrauterine folding arms in open position, showing container on colpotomy cup 76 that initially holds folded electrosurgery/electrocautery wire 43 (electrosurgery/electrocautery wire 10 in accordion-folded configuration) when initially placing the device through the vagina on the cervix, with its cover 77. It also shows the uterine sound handle trigger 79 that deploys uterine sound intrauterine folding arms which are one of the anchoring elements to the uterus alternative to uterine sound intrauterine balloon 13, which works by pulling on an internal rod (not shown) that runs through the inside of the uterine sound along its length that pulls on these folding arms that causes them to fold and take more space in the intrauterine cavity and anchor the uterine sound to the inside of the uterus or allow a spring mechanism (not shown) to push this rod(not shown) back into original position and unfold the folding arms so the uterine sound can be removed out of the uterus.

[0107] Referring to Fig. 20a showing a close-up perspective view of Uterine sound intrauterine folding arms (uterine sound’s intrauterine anchoring element) in closed/unfolded position.

[0108] Referring to Fig. 20b showing a close-up perspective view of Uterine sound intrauterine folding arms (uterine sound’s intrauterine anchoring element) in open/folded position.

[0109] The foregoing descriptions of embodiments of the present invention have been presented only for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the forms disclosed. Accordingly, many modifications and variations will be apparent to practitioners skilled in the art. Additionally, the above disclosure is not intended to limit the present invention. The scope of the present invention is defined by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A device to facilitate a total laparoscopic hysterectomy wherein a patient’s uterus and a portion of the patient’s cervix are inside the patient’s intra-abdominal cavity, with the patient’s vagina circumferentially attached to the cervix creating a cervicovaginal junction, and wherein the cervix has a cervical canal, the uterus has an intrauterine cavity, and the intra abdominal cavity includes an access installed through the anterior abdominal wall, the device comprising: a cervical cup having a cervical cup proximal end and a cervical cup distal end, the cervical cup distal end adapted to embrace the cervix with the cervical cup distal end abutting the cervicovaginal junction, and the cervical cup proximal end extending away from the cervix; an electrosurgery wire having two electrosurgery wire proximal ends and two electrosurgery wire distal ends, wherein the two electrosurgery wire distal ends each include an uninsulated portion; wherein the cervical cup distal end includes a channel, the channel housing the uninsulated portions of the electrosurgery wire distal ends, and wherein the channel is configured for a controlled release of the uninsulated portions of the electrosurgery wire distal ends from the channel; an introducer having an introducer proximal end and an introducer distal end, the introducer proximal end releasably coupled to the electrosurgery wire proximal ends; wherein the introducer is configured to penetrate the cervicovaginal junction upon activation, thereby introducing the electrosurgery wire proximal ends into the intra-abdominal cavity; the device further comprising a shaft having a shaft proximal end, and a shaft distal end, wherein the shaft distal end is configured for introduction into the intra-abdominal cavity through the access installed in the anterior abdominal wall; wherein the shaft is further configured to secure the electrosurgery wire proximal ends through the shaft distal end and move the electrosurgery wire proximal ends through the shaft toward the shaft proximal end, thereby pulling the electrosurgery wire uninsulated portions from the channel and causing the controlled release of the electrosurgery wire uninsulated portions along a predetermined circumferential path around the cervix along the channel; and wherein the vagina is thereby severed from the cervix along the circumference of the cervicovaginal junction.

2. The device of claim 1 further comprising two sliders inside the channel, wherein each slider is configured to slide in an opposing 180 degree path along semi-circular tracks until the two sliders meet, wherein each slider includes a duct having an inlet and an outlet, and wherein each electrosurgery wire uninsulated portion passes through the duct of each slider from the inlet to the outlet, emerging from each outlet toward an outside of the channel, thereby allowing the uninsulated portion to be released along the channel and the electrosurgery wire to disengage the cervical cup through the outlet of each duct.

3. The device of claim 2 further comprising two flexible insulated sheaths, wherein each flexible insulated sheath has a sheath proximal end and a sheath distal end, wherein each sheath distal end is individually coupled to a slider and configured such that each flexible insulated sheath may move a predetermined distance toward or away from each slider, wherein each flexible insulated sheath includes a duct having a duct proximal end and a duct distal end, wherein each duct distal end faces each slider and each duct proximal end is releasably coupled to the shaft distal end, wherein each of the ducts of each flexible insulated sheath houses a portion of the electrosurgery wire, with the electrosurgery wire extended from the duct distal end to the duct proximal end, and wherein the flexible insulated sheaths are configured such that pulling on the proximal end of the shaft with the shaft distal end coupled to each flexible insulated sheath causes each of the flexible insulated sheaths to move away from each slider for a predetermined distance exposing portion of the uninsulated electrosurgery wire, and wherein the electrosurgery wire is configured such that moving the proximal end through the long shaft causes the electrosurgery wire to move through the duct in a manner that the uninsulated portion extends only between a slider and a flexible insulated sheath, thereby causing the uninsulated portion to slide through a predetermined circular path around the cervix.

4. The device of claim 1 further comprising an elongated curved stem having a stem proximal end, a stem distal end and a first curved axis, the stem distal end adapted to be introduced through the cervical canal into the intrauterine cavity thereby providing a means for manipulating the uterus, the proximal end having a handle, the device further comprising an elongated curved cylinder having a proximal end, a distal end, a duct along its length and a second curved axis matching the first curved axis, the elongated curved cylinder being shorter in length than the elongated curved stem, and wherein the distal end of the elongated cylinder is adapted to be coupled with the proximal end of the cervical cup thereby allowing them to move as one unit, wherein the elongated curved stem is configured for sliding through the duct of the elongated curved cylinder and adapted to be locked in place at a predetermined distance set by the operator.

5. The device of claim 1 further comprising a cable having a cable proximal end and a cable distal end, the cable distal end attached to the flexible insulated sheath proximal end and the cable proximal end configured for releasably coupling to the shaft distal end, thereby facilitating temporary coupling of the shaft with the insulated flexible sheath, and allowing them to move as a single unit; wherein the cable proximal end is configured to be releasably coupled to the introducer proximal end alongside the electrosurgery wire proximal end, and wherein actuating the introducer distal end is configured to push the introducer forward, thereby penetrating a small portion of the cervicovaginal junction, and thereby introducing both the cable proximal end and the electrosurgery wire proximal ends to the inside of the intra-abdominal cavity.

6. The device of claim 1 wherein the shaft includes at least one sliding bar configured to move wires through the shaft.

7. The device of claim 1 wherein the uninsulated portion of the electrosurgery wire distal ends are coupled together, thereby allowing the electrosurgery wire to function using a monopolar electrosurgery technique.

8 The device of claim 1 wherein the device comprises an electrocautery wire in place of an electrosurgery wire.

9. The device of claim 1 wherein the distal end of the colpotomy cup is configured for controlled movement of the uninsulated portion of the electrosurgery wire.

10. The device of claim 1 further comprising a component selected from the group consisting of a monopolar energy generator, a bipolar energy generator, a monopolar batteries operated energy generator, a bipolar batteries operated energy generator, a pedal activating element, a manual activating element, a button activating element, a gas seal vaginal element, a gas seal vaginal balloon occluder, a gas seal vaginal umbrella shape occluder, an optical/light system terminating at the cervical cup, a shaft with a flexible portion, a shaft with bifurcated portion, an insulated shaft, and at least one apparatus chosen from the list of a handle, a uterine sound's intrauterine balloon, a uterine sound's anchoring element to the uterus and a uterine sound's anchoring folded arms shape element to the uterus.

11. The device of claim 1 wherein the electrosurgery wire utilizes at least one type of energy selected from the group consisting of monopolar energy, bipolar energy, electrosurgery energy, monopolar electrosurgery energy, bipolar electrosurgery energy, monopolar electrocautery energy, bipolar electrocautery energy, radio-frequency energy, electromagnetic energy, heat energy, and electric energy.

12. A device to facilitate a total laparoscopic hysterectomy, wherein a uterus and a portion of a cervix are inside an intra-abdominal cavity and a vagina circumferentially attached to the cervix creating a cervicovaginal junction, wherein the cervix has a cervical canal, the uterus has an intrauterine cavity, and the intra-abdominal cavity includes an access installed through the anterior abdominal wall, the device comprising: a cervical cup with a cervical cup proximal end and a cervical cup distal end, the cervical cup distal end adapted to adjoin the cervix with the cervical cup distal end abutting the cervicovaginal junction, and the cervical cup proximal end extending away from the cervix; an electrosurgery wire having two electrosurgery wire proximal ends and two electrosurgery wire distal ends, wherein each of the electrosurgery wire distal ends includes an uninsulated portion; the cervical cup distal end having a channel, the channel partially housing the uninsulated portions, the channel further configured for controlled movement of the uninsulated portions of the electrosurgery wire distal ends; an introducer having an introducer proximal end and an introducer distal end, the introducer proximal end releasably coupled to the electrosurgery wire proximal ends; wherein the introducer is configured to penetrate the cervicovaginal junction upon activation, thereby introducing the electrosurgery wire proximal ends into the intra-abdominal cavity; the device further comprising a shaft having a shaft proximal end, and a shaft distal end, wherein the shaft distal end is configured for introduction into the intra-abdominal cavity through the access installed in the anterior abdominal wall; wherein the shaft is further configured to secure the electrosurgery wire proximal ends through the shaft distal end and move the electrosurgery wire proximal ends through the shaft toward the shaft proximal end, thereby pulling the electrosurgery wire uninsulated portions and causing a controlled movement of the uninsulated portions along a predetermined circumferential path around the cervix along the channel; and wherein the vagina is severed from the cervix along the circumference of the cervicovaginal junction.

13. The device of claim 12 further comprising two sliders, wherein each of the two sliders is coupled to one of the two electrosurgery wire distal ends, and are further configured to travel along with the electrosurgery wire distal ends around two semi-circular portions of the cervical cup distal end, thereby controlling the electrosurgery wire movement along the cervical cup distal end.

14. The device of claim 12 further comprising two sliders, wherein each of the two sliders includes a duct having an inlet and an outlet, wherein the uninsulated portion of each of the two electrosurgery wire distal ends passes through the duct of each slider from the inlet to the outlet, and is configured to emerge from each outlet toward the outside of the channel, wherein a spring is coupled to the duct inlet of each of the sliders, the spring configured to exert counter traction on the uninsulated portion of each of the two electrosurgery distal ends distal to each duct inlet, thereby retracting the uninsulated portion into the colpotomy channel when not in use, and wherein the sliders coupled with the springs are also configured to travel along with the electrosugery wire distal ends around two semi-circular portions of the cervical cup distal end thereby controlling the movement and release of the electrosurgery wire uninsulated portions along the cervical cup distal end.

15. The device of claim 12 further comprising an elongated curved stem having a stem proximal end, a stem distal end and a first curved axis, the stem distal end adapted to be introduced through the cervical canal into the intrauterine cavity thereby providing a means for manipulating the uterus, the proximal end having a handle; the device further comprising an elongated curved cylinder having a proximal end, a distal end, a duct along its length and a second curved axis matching the first curved axis, the elongated curved cylinder being shorter in length than the elongated curved stem, and wherein the distal end of the elongated cylinder is adapted to be coupled with the proximal end of the cervical cup thereby allowing them to move as one unit, wherein the elongated curved stem is configured for sliding through the duct of the elongated curved cylinder and adapted to be locked in place at a predetermined distance set by the operator.

16. The device of claim 12 wherein the device uses at least one type of energy selected from the group consisting of monopolar energy, bipolar energy, electrosurgery energy, monopolar electrosurgery energy, bipolar electrosurgery energy, monopolar electrocautery energy, bipolar electrocautery energy, radio-frequency energy, electromagnetic energy, heat energy, and electric energy.

17. The device of claim 12 further comprising a component selected from the group consisting of a monopolar energy generator, a bipolar energy generator, a monopolar battery operated energy generator, a bipolar battery operated energy generator, a pedal activating element, a manual activating element, a button activating element, a gas seal vaginal element, a gas seal vaginal balloon occluder, a gas seal vaginal umbrella shape occluder, an optical/light system terminating at the cervical cup, a shaft with a flexible portion, a shaft with bifurcated portion, an insulated shaft, and at least one apparatus chosen from the list of a handle, a uterine sound's intrauterine balloon, a uterine sound's anchoring element to the uterus and a uterine sound's anchoring folded arms shape element to the uterus.

18. A method of separating a patient's cervix from the patient's vagina at the cervicovaginal junction, the method comprising the steps of: providing a colpotomy cup assembly having a colpotomy ring; providing an electrosurgery wire on the colpotomy cup assembly; providing an introducer trocar on the colpotomy cup assembly in a sliding relationship to the colpotomy ring; anchoring the electrosurgery wire to the introducer trocar; placing the colpotomy ring against the cervicovaginal junction; urging the introducer trocar through the cervicovaginal junction, thereby carrying the electrosurgery wire through the cervicovaginal junction; capturing the electrosurgery wire with a laparoscopic shaft assembly; placing the electrosurgery wire under tension; and pulling the electrosurgery wire through the laparoscopic shaft assembly while activating and causing the electrosurgery wire to travel around the colpotomy ring.

19. The method of claim 18 further comprising the step of providing two sliders coupled to the distal end of the electrosurgery wire, the two sliders configured to travel with the distal end of the electrosurgery wire around two semi-circular portions of the colpotomy ring and control the movement of the electrosurgery wire along the colpotomy ring.

20. The method of claim 18 further comprising the step of providing at least one type of energy to be utilized selected from the group consisting of monopolar energy, bipolar energy, electrosurgery energy, monopolar electrosurgery energy, bipolar electrosurgery energy, monopolar electrocautery energy, bipolar electrocautery energy, radio-frequency energy, electromagnetic energy, heat energy, electric energy.