Uterine Manipulator with Balloon Occluder

Abstract

To provide improved devices and methods for manipulating and maintaining the uterus in surgical and diagnostic procedures.SOLUTION: A uterine manipulator device includes: an elongated cannulated tube having proximal and distal ends; a cervical cup positioned on the elongated cannulated tube with a top distal portion of a first diameter and a base proximal portion of a second smaller diameter; and a balloon occluder assembly (20). The balloon occluder assembly can be used independently or positioned proximally from the cervical cup on the elongated cannulated tube.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 040,824, filed June 18, 2020, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE INVENTION The present disclosure relates generally to devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures. [Background technology]

[0003] background Various conventional forms of uterine manipulators with occluders are known. For example, commonly assigned U.S. patent application Ser. No. 15 / 617,299 describes a uterine manipulator generally consisting of an elongated cannula tube having a proximal end and a distal end (relative to the medical practitioner using the device), and a cervical cup having an upper proximal portion of a first diameter and a base distal portion of a second, smaller diameter, the base distal portion including a bore formed therein having a perimeter including the distal and proximal ends, the elongated cannula tube being positioned through the bore in the cervical cup, and a plastic or foam occluder being positioned proximally relative to the cervical cup to maintain pneumoperitoneum for the procedure (see also commonly assigned U.S. Patent No. 10,695,092).

[0004] Uterine manipulators with occluders are used to manipulate and visualize the uterus during various examinations and laparoscopic procedures while maintaining pneumoperitoneum. These examinations and procedures include total laparoscopic hysterectomy, partial laparoscopic hysterectomy, and colpotomy. Specifically, the occluder can form a seal to prevent loss of pneumoperitoneum during colpotomy and can also displace the sigmoid colon from the uterus. Other conventional forms of uterine manipulators with occluders exist and contain similar features.

[0005] However, conventional uterine manipulators with occluders do not include a mechanism that allows the occluder to be removed or used independently of the uterine manipulator. In fact, conventional occluders cannot be used during both the pre-colpostomy and post-colpostomy periods. Conventional occluders, such as those made from foam or plastic, can deteriorate over time. Furthermore, conventional devices are typically one size fits all and do not allow for proper fit to the patient's anatomy or operation. Additionally, some conventional uterine manipulators and occluders do not include mechanisms or structural features that reduce hand fatigue during use. Therefore, there is a need in the art for improved devices and methods for manipulating and maintaining the uterus during surgical and diagnostic procedures, including mechanisms or structural features that address each of these and other shortcomings of conventional devices.

[0006] Related Art Section Statement Disclaimer: To the extent that specific patents / publications / products are discussed in this Background section above or elsewhere in this application, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for purposes of patent law. For example, some or all of the discussed patents / publications / products may not be early enough, may not reflect subject matter developed early enough, and / or may not be sufficiently effective to constitute prior art under patent law. To the extent that a specific patent / publication / product is discussed above in this Background section and / or throughout the application, the description / disclosure thereof is hereby incorporated by reference in its entirety into this document. Summary of the Invention

[0007] The present disclosure is directed to inventive devices and methods for manipulating uterine and vaginal occlusion in surgical and diagnostic procedures that overcome various problems (as described herein and below) with conventional devices. A non-limiting specific objective of the use of embodiments and implementations herein is to provide a device for manipulating the uterus and injecting fluids or gases during laparoscopic procedures, such as laparoscopic total vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy (and other similar procedures that should be understood by those skilled in the art in conjunction with a review of this disclosure), as well as for maintaining pneumoperitoneum by sealing the vagina during such procedures. Briefly, the uterine manipulator device of the embodiments allows medical personnel to more easily conform and manipulate the uterus and seal the vagina during procedures by using a balloon occluder. Specifically, to maintain pneumoperitoneum during use, the occluder contains an inflatable balloon for vaginal occlusion by conforming to the patient's anatomy.

[0008] The balloon occluder can be structured and / or configured to be removed or used independently from the uterine manipulator, allowing for vaginal occlusion both pre- and post-colpotomy. The balloon occluder is configured to inflate and deflate. Following colpotomy and subsequent removal of the device, the balloon occluder component can be removed from the uterine manipulator. This independent balloon occluder component can then be reinserted into the vaginal canal and inflated to act as the sole occluder during suturing of the vaginal stump after a hysterectomy. Applicant recognizes and understands that it would be beneficial for medical professionals to be able to approach such procedures with greater confidence in performing consistent, predictable, and repeatable procedures.

[0009] Additionally, according to one embodiment, the device can be configured to reduce hand fatigue during use due to improved ergonomics of the device handle and the presence of a low-profile silicone cap.

[0010] Generally, in one embodiment, the uterine manipulator device includes an elongated cannulated tube having a proximal end and a distal end, a handle positioned on the proximal end of the elongated cannulated tube, a cervical cup positioned on the elongated cannulated tube, an intrauterine balloon positioned on the distal end of the elongated cannulated tube, a stem positioned proximally from the cervical cup on the elongated cannulated tube, and a balloon occluder assembly including a balloon occluder shaped to form an opening configured to allow passage of the elongated cannulated tube and cervical cup therethrough.

[0011] In one aspect, the balloon occluder assembly further comprises an inflation valve communicatively coupled to the balloon occluder via the gas passage lumen.

[0012] In a further aspect, the balloon occluder is toroidal in shape.

[0013] In a further aspect, there is a square key feature in the handle that directs applied force in only one direction.

[0014] In a further aspect, the stem includes a locking assembly positioned proximally from the distal lip of the stem. The stem and balloon occluder assembly include a locking assembly configured to lock the stem and balloon occluder assembly from movement in at least one direction along the elongated cannulated tube.

[0015] In a further aspect, the stem includes a plurality of ribs positioned between the proximal and distal lips configured to limit movement of the balloon occluder assembly.

[0016] In a further aspect, the opening in the balloon occluder is configured to allow passage of the distal lip of the stem therethrough.

[0017] In a further aspect, the balloon occluder is communicatively coupled to a pilot balloon configured to indicate balloon inflation.

[0018] In general, in another embodiment, a uterine manipulator device comprises an elongate cannula-like tube including a proximal end and a distal end; a stem positioned along the elongate cannula-like tube, the stem comprising a plurality of ribs positioned between a proximal lip and a distal lip; and a balloon occluder assembly comprising a balloon shaped to form an opening, the opening configured to allow passage of the elongate cannula-like tube and the distal lip of the stem therethrough; and an inflation valve configured to change between an inflated state and a deflated state, the inflation valve communicably coupled to the balloon occluder via a gas passage lumen.

[0019] In a further aspect, the stem includes a locking assembly positioned proximally from the distal lip, the locking assembly configured to lock the stem and balloon occluder assembly from movement in at least one direction along the elongated cannulated tube.

[0020] In a further aspect, the handle is positioned on the proximal end of the elongated cannulated tube.

[0021] In a further aspect, the balloon occluder assembly further comprises a pilot balloon configured to indicate balloon inflation.

[0022] In a further aspect, the balloon occluder assembly is configured to be placed around a rib of the stem.

[0023] In another embodiment, the balloon occluder comprises a toroidal shaped balloon configured to change from a deflated state to an inflated state and having an inner wall and an outer wall, and an inflation valve communicatively coupled to the balloon via a gas passage lumen.

[0024] In a further aspect, the device includes a pilot balloon configured to indicate balloon inflation.

[0025] In a further aspect, the outer wall of the balloon further comprises a lumen port. [Brief explanation of the drawings]

[0026] The present invention will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings, which illustrate only typical embodiments of the disclosed subject matter and therefore should not be considered as limiting the scope thereof, as the disclosed subject matter may admit of other equally effective embodiments.

[0027] Reference will now be made briefly to the accompanying drawings.

[0028] [Figure 1] FIG. 1 is a side perspective view of a uterine manipulator having a balloon occluder device according to one embodiment. [Figure 2A] FIG. 2A is a side perspective view of a balloon occluder assembly according to one embodiment. [Figure 2B] FIG. 2B is a side perspective view of a balloon occluder assembly according to one embodiment. [Figure 3A] FIG. 3A is a side perspective view of a balloon occluder assembly according to one embodiment. [Figure 3B] FIG. 3B is a side perspective view of a balloon occluder assembly according to one embodiment. [Figure 4] FIG. 4 is a perspective view of a stem according to one embodiment. [Figure 5A]FIG. 5A is a schematic cross-sectional top view of a balloon occluder along line GG of FIG. 5B according to one embodiment. [Figure 5B] FIG. 5B is a side schematic view of a balloon occluder according to one embodiment. [Figure 5C] 5C is a schematic cross-sectional view of the bottom of the balloon occluder along DD in FIG. 5B according to one embodiment.

[0029] Where applicable, like reference characters refer to identical or corresponding components and units throughout the several figures, which are not drawn to scale unless otherwise indicated. Furthermore, embodiments disclosed herein may include elements that occur in more than one of the several figures or in a combination of several figures. DETAILED DESCRIPTION OF THE INVENTION

[0030] Aspects of the present invention and certain of its features, advantages, and details are described more fully below with reference to non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures have been omitted so as not to unnecessarily obscure the details of the invention. It should be understood, however, that the detailed description and specific non-limiting examples, while illustrating aspects of the invention, are given by way of illustration only, and not by way of limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the underlying inventive concept will be apparent to those skilled in the art from this disclosure.

[0031] As used herein for purposes of this disclosure, the terms "distal" and "proximal" are used to describe the location of an embodiment of a device from the perspective of a medical professional using the device.

[0032] The uterine manipulator with balloon occluder device (generally referred to as 100) can include a uterine manipulator (generally referred to as 1) and a balloon occluder assembly (generally referred to as 20). According to one embodiment, the uterine manipulator with balloon occluder device 100 can include a cannulated manipulator tube having a proximal end 4 and a distal end 6, a handle 11 extending from the proximal end 4, and a balloon occluder assembly 20 positioned distally from the handle 11 along the cannulated manipulator tube 5.

[0033] 1, a perspective view of a uterine manipulator with balloon occluder device 100 is shown in one embodiment. As shown, the uterine manipulator with balloon occluder device 100 includes a uterine manipulator 1 having a handle 11 with a dye injection port cap 13 (preferably positioned through the proximal end of the handle 11), a cannulated manipulator tube 5 extending from the handle, a balloon occluder assembly 20 movably positioned along a proximal portion of the cannulated manipulator tube 5, and a balloon occluder assembly 20 positioned along the tube 5 adjacent to the balloon occluder assembly 20. The handle 11 includes a cervical cap 14 attached to the handle 11. A proximal heat shrink 9, an intrauterine balloon 7, a distal heat shrink 10, and a cap 8 extend from the distal end of the cannulated manipulator tube 5. Additionally, a lumen 15, a pilot balloon 3, and a check valve 2 are attached to the handle 11, all fluidly connected to the intrauterine balloon 7. The balloon occluder assembly 20 can include a balloon occluder 22 fluidly attached to the check valve 24 and the pilot balloon 26 via a lumen 28.

[0034] Handle 11 (which may include gripping / non-smooth surfaces such as multiple ridges or other non-smooth surface structures, as will be understood by those skilled in the art in conjunction with a review of this disclosure) may be smooth (as shown) and may generally fit the user's hand or may provide for positioning all four fingers on one side and the thumb on the other, allowing for easy manipulation of the uterus above, below, and to the side. Dye injection port cap 13 may be positioned in multiple locations on the handle, but is preferably positioned on the proximal portion of handle 11, for example, as shown.

[0035] The cannulated manipulator tube 5 can be S-curved or curved at its proximal end 4 and straight at its distal end 6 for easy introduction of the device 10, for manipulation of both retroverted and anteverted uteruses, and for maintaining proper uterine positioning. The manipulator tube 5 is configured to anatomically match the angle of the sacral curve and allow for easy manipulation of the uterus. The cannulated manipulator tube 5 connects to the handle 11 and a dye injection port cap 13 (preferably on the distal portion of the handle 11) and through the handle 11 to the pilot balloon 3. The cannulated manipulator tube 5 is cannulated to allow injection of fluids through the dye injection port cap 13 for tubal dyeing and inflation of the balloon 7 through the pilot balloon 3. According to one embodiment, the dye injection port cap 13 has a low-profile cap that does not extend far from the body of the handle 11 when in place. Additionally, the cap 13 can be made of silicone or other similar materials.

[0036] In one embodiment, the manipulator tube 5 can include a set of repeating reference markings (e.g., moving 4 cm to 16 cm away from either side of the cervical cup 14). The manipulator tube 5 can have any number of sets of markings; for example, the manipulator tube 5 can be marked with reference markings from both the distal end 6 and the proximal end 4. The reference markings can provide a guide for comparison with a calibrated uterine sound and can assist in achieving the proper depth of insertion during use. In one embodiment, the reference markings are laser marked on the manipulator tube 5. In conventional devices, the reference markings can be added to the manipulator tube 5 through a pad printing process. Pad printing can be performed before the application of heat shrink. Laser marking is typically less expensive than pad printing, but is more accurate and more permanent, for example, since pad printing can rub off. In one embodiment, heat shrink is first applied to the manipulator tube 5, and then the reference markings are laser marked. It has been discovered and understood by the present inventors that acrylic heat shrink allows for an ultraviolet laser to mark the applied heat shrink layer. Therefore, in an embodiment, an ultraviolet laser is used to successfully mark the thin layer of acrylic polyolefin on the manipulator tube 5. In such an embodiment, the UV laser emits a wavelength of 355 nm. It is contemplated that other wavelengths from the UV laser may be used to successfully create the reference markings.

[0037] The stem 21 is configured to position and hold the balloon occluder assembly 20 in place. According to one embodiment, the stem 21 is cannulated and positioned around and along the manipulator tube 5. The stem 21 may be positioned distal to the handle 11 and proximal to the cervical cup 14. The stem 21 may be sufficiently flexible to slide along the curvature of the manipulator tube 5.

[0038] According to one embodiment, the balloon occluder assembly 20 is movable along the manipulator tube 5. The stem 21 can be used to position the balloon occluder assembly 20. Once in the desired position to block gas from exiting the exposed cavity (as should be understood by those skilled in the art in conjunction with a review of this disclosure), the balloon occluder assembly 20 and stem 21 can be locked in place (which also prevents proximal movement of the cervical cup 14). In the embodiment shown, the locking assembly is a thumbscrew 23 on the stem 21. With conventional screws, the user does not know how deep the screw is within the collar and, therefore, the screw often falls out when loosening. A thumbscrew can be used to allow the screw to be tightened and loosened without the risk of losing the screw. The last thread on the thumbscrew 23 can be over-torqued, as there is virtually no pitch between the last two threads. The thumbscrew cannot be completely removed because there is no space between the last two threads. Thus, thumbscrew 23 can be loosened and tightened but cannot be completely removed, preventing loss of thumbscrew 23. The screw channel can be constructed of or overmolded with hard plastic, polycarbonate, or nylon to allow thumbscrew 23 to be pressed against it while maintaining the shape of the stem 21 design. Alternatively, other locking mechanisms (e.g., washers, nuts, plastic pieces, other screw variations) that are larger than the hole through which the screw is positioned (or that do not otherwise allow the screw to back out of the hole) are contemplated.

[0039] The balloon occluder assembly 20 is shown positioned on a distal portion of the stem 21, which is positioned through the cannulated lumen 22-1 (or opening) of the balloon occluder 22 (see FIG. 2B). As shown, the balloon occluder assembly 20 is configured to allow a manipulator tube 5 to be positioned through the balloon occluder 22. The balloon occluder assembly 20 contains an inflatable balloon occluder 22 having an inflated state and an uninflated state for vaginal occlusion by conforming to the patient's anatomy. Specifically, the balloon occluder 22 is configured and positioned to retain gas (e.g., insufflation gas) within the exposed cavity when in the inflated state to maintain cavity ventilated. The balloon occluder 22 can be inflated using a check valve 24, pilot balloon 26, and lumen 28 assembly, as known in the art.

[0040] The cervical cup 14 is positioned on the manipulator tube 5 to provide manipulation of the uterus and retraction and elevation of the cervix. The cervical cup 14 can optionally be locked and unlocked in place and prevented from moving proximally on the manipulator tube 5. The cervical cup 14 is positioned on and adjacent the proximal end 4 of the manipulator tube 5 and can include sites / holes for sutures positioned through the sides of the cervical cup 14. The cervical cup 14 can include a variety of volumes and diameters, examples of which are shown in Table 1 below.

[0041] [Table 1]

[0042] In the embodiment shown, the cervical cup 14 tapers from an upper distal portion having a first diameter to a base proximal portion having a smaller second diameter, including a central bore with a periphery. The periphery can be chamfered / angled away from the longitudinal axis or straight / not angled relative to the longitudinal axis (the angulation can be reversed). The chamfered periphery aids in the movement of the cervical cup 14 along the manipulator tube 5. The straight / not angled periphery increases the retention of the cervical cup 14 on the manipulator tube 5 and helps prevent dislodgement of the cup from the manipulator tube 5. Additionally, the diameter of the bore can be reduced (from 2.15 cm to 2.05 cm). The combination of the straight / not angled periphery and the narrowing of the bore diameter significantly increases the retention of the cervical cup 14 on the manipulator tube 5. The cervical cup contains suture holes for tissue removal as well as a guide for performing the colpotomy.

[0043] An intrauterine balloon 7 covers the manipulator tube 5 at its distal portion. The intrauterine balloon 7 is shown positioned at the distal end 6 of the manipulator tube 5. The balloon 7, in conjunction with the cap 8, is configured and positioned to reduce the risk of uterine perforation and is used to stabilize the manipulator tube 5 within the uterine cavity. The balloon 7 is configured to hold up to 45 cc of air, which allows for better manipulation of larger uteri.

[0044] Balloon 7 can be a thermoplastic elastomer (TPE) balloon. In one embodiment, the TPE balloon is based on a styrene block copolymer, SEBS, compound. TPE balloons are similar in strength and performance to PVC balloons and are designed and constructed to maintain inflation. While TPE balloon 7 is shown and described in conjunction with uterine manipulator 1, traditional silicone or urethane-based balloons may also be used. However, TPE balloons are less permeable to gas than silicone balloons. Because silicone balloons are more permeable to gas, they may shrink. Because saline is impermeable, saline is often used to inflate silicone balloons to counteract shrinkage. TPE balloons achieve similar performance by inflating the balloon with gas. Gas does not distort the bonds within the balloon as much as saline, so gas is preferred when inflation can be maintained. However, TPE balloons may be used with saline at the user's option.

[0045] In conventional uterine manipulator devices, the balloon is glued in place (or other similar adhesive is used) at both the proximal and distal ends of the balloon to seal the balloon to the metal tube. In the embodiment shown, heat shrink 9 and 10 are used to cover the balloon on the outside of the manipulator tube 5 at both the proximal and distal ends of the balloon. Any commercially available heat shrink for insulating the tube can be used. In embodiments, Insultab's HS-714 (acrylic polyolefin) heat shrink is preferably used. The heat shrink can be colored to facilitate visibility of the laser scale markings. The heat shrink material adheres to itself and to the metal manipulator tube 5 with or without silicone glue. The inventors have discovered that heat shrink 9 offers numerous manufacturing and reliability advantages over the use of traditional adhesives. For example, heat shrink retains its properties better through the sterilization process compared to adhesives. If the adhesive weakens, the balloon may slide, exposing the patient to the adhesive and potentially leading to malfunction of the balloon itself.

[0046] Heat shrink 9 seals intrauterine balloon 7 at a first proximal location, and heat shrink 10 seals intrauterine balloon 7 at a second distal location along the distal-most portion of manipulator tube 5, forming a pair of collars around balloon 7. Heat shrink 9 and 10 can also be used to cover the entire manipulator tube 5 at the collar location for insulation purposes when used in conjunction with electrosurgical accessories. A portion of balloon 7 is not covered by heat shrink so that balloon 7 may inflate. The uncovered portion of balloon 7 can be adjacent to a substantially enclosed cavity between manipulator tube 5 and balloon 7. According to one embodiment, lumen 15 provides a path for transporting gas through manipulator tube 5 to balloon 7. Lumen 15 provides a closed passageway to balloon 7 to facilitate inflation without introducing dye into balloon 7 through dye injection port cap 13.

[0047] The cap 8 is positioned at the distal-most portion of the manipulator tube 5 and is configured to provide an atraumatic insertion. According to one embodiment, the cap 8 can be generally T-shaped, having a rounded portion and a stem portion. The stem portion of the cap 8 is positioned within the manipulator tube 5. The rounded portion extends across the diameter of the distal-most portion of the manipulator tube 5. Specifically, the diameter of the rounded portion of the cap 8 exceeds the diameter of the manipulator tube 5 and extends to a similar diameter of the outer heat shrink 10.

[0048] According to one embodiment, the cap 8 can additionally be closed / sealed, or alternatively, can include a molded channel for passage of dye through both the rounded and stem portions of the cap 8. The channel extends throughout the entire cap 8 to facilitate passage of dye therethrough. Dye can pass from the dye injection port cap 13 through the manipulator tube 5 and cap 8 into the uterine cavity. Conventional caps are closed and utilize a slit in the balloon to create a passage for the dye. The slit in the balloon can be open during manufacturing and closed via a seal before use of the balloon. In some cases, the seal fails and the slit remains open, rendering the balloon inoperable. In other cases, a closed cap causes adhesive to collect at the tip of the manipulator tube 5. However, in one embodiment, the balloon 7 is completely separate from the manipulator tube 5. Specifically, dye can flow through the manipulator tube 5 and through a channel in the cap 8, while gas is configured to separately pass through the lumen 15 to inflate the balloon 7. Alternative embodiments of the cap 8 include various structural configurations and numerous molded channels therethrough. For example, one or more channels can pass through the center of the cap 8 on either side of the cap 8 and can include branches into additional channels (which can aid in strategically distributing dye to certain anatomical structures, such as to and through the fallopian tubes).

[0049] As will be appreciated by those skilled in the art in conjunction with a review of the present disclosure, the uterine mucosa described herein may be used in combination with other methods. Use of the manipulator device is similar to use of the uterine manipulator device described in U.S. Patent Application Publication No. 20170354436 (see, e.g., FIG. 4 and paragraph

[0028] ).

[0050] To maintain pneumoperitoneum during use, balloon occluder assembly 20 contains an inflatable balloon occluder 22 for vaginal occlusion by conforming to the patient's anatomy. Balloon occluder assembly 20 is configured to be detached from uterine manipulator 1 and used independently. Referring now to FIGS. 2A and 2B, a side perspective view of balloon occluder assembly 20 according to one embodiment is shown in an uninflated state. After colpotomy or similar procedure and subsequent removal of device 100, balloon occluder assembly 20 can be removed from uterine manipulator 1 as described below. Balloon occluder 22 of independent balloon occluder assembly 20 can then be reinserted into the vaginal canal to act as an occluder without uterine manipulator 1.

[0051] Once the balloon occluder assembly 20 is in place, the balloon occluder 22 can be placed into an inflated state using the check valve 24 and lumen 28. Figures 3A and 3B show the balloon occluder assembly 20 with the balloon occluder 22 in an inflated state. The lumen 28 provides a path for air to be transported to the balloon occluder 22 to facilitate inflation. According to one embodiment, the pilot balloon 26 is filled with air and the balloon occluder 22 becomes less flexible after it is full as an indication of inflation. The freestanding balloon occluder assembly 20 can be particularly useful, for example, during suturing of the vaginal stump following a hysterectomy.

[0052] Referring now to FIG. 4 , in one embodiment, the stem 21 includes a thumbscrew 23 on its proximal end and a set of ribs 32 on its distal end. The balloon occluder 22 is configured to be positioned outside the ribs 32 on the distal portion of the stem 21. The ribs 32 can be of similar size or of various sizes. In the embodiment shown, there are five ribs 32, but any number of ribs 32 can be used. Alternatively, the distal end of the stem 21 can be smooth, or the ribs 32 can be achieved by other means, such as, but not limited to, protrusions, bumps, or texture. The ribs 32 help to retain and secure the balloon occluder 22. In the embodiment shown, the ribs 32 are positioned between the proximal lip 32 and the distal lip 36, which can also help to hold the balloon occluder 22 in place and prevent movement of the balloon occluder 22 along the cannulated tube 5.

[0053] To place the balloon occluder 20 on the stem 21, the user can slide the distal end 6 of the uterine manipulator apparatus 1 through the opening (or lumen 22-1) in the balloon occluder 22. The balloon occluder 22 can be slid down the cannulated tube 5 and stretched over the cervical cup 14 and the distal lip 36 of the stem 21. The balloon occluder 22 can be seated and held in place between the proximal and distal lips 34, 36 on the ribs 32. To remove the balloon occluder 20 from the uterine manipulator apparatus 1, the balloon occluder 22 can be slid over the distal lip 36 and the cervical cup 14 and off the distal end 6 of the tubular tube 5. The stem 21 can remain on the uterine manipulator 1 after the balloon occluder assembly 20 is removed.

[0054] The balloon occluder 22, according to one embodiment, is a toroidal or cylindrical balloon with an opening configured to slide over the outside of a portion of the uterine manipulator 1. Referring now to Figures 5A-5C, the balloon occluder 22, according to one embodiment, is a syringe. The balloon occluder 22 is constructed from a flexible material such as silicone. Alternatively, the balloon occluder 22 can be a urethane-based balloon or a TPE balloon based on a TPE, e.g., a styrene block copolymer, SEBS compound. As shown, the balloon occluder 22 is designed to be constructed from a single silicone-molded component that is folded over itself and circumferentially sealed. Referring now to FIG. 5B, cross section G-G of the balloon occluder 22 is a cross section in which the seal, above, is a single layer of material, and only a single layer of material. Cross sections D-D show the two layers of the balloon occluder 22, forming a pocket for air. This pocket within the layers can be inflated through the communicatively connected check valve 24, pilot balloon 26, and lumen 28. In the embodiment shown, the balloon occluder 22 also includes a lumen port 29 that can be formed into the body of the balloon 22 and attached to the lumen 28 by methods such as overmolding. The balloon occluder 22 can be configured in other configurations as would be known in the art. The balloon occluder 22 can be made in a variety of shapes and sizes and can be inflated to any desired size.

[0055] While embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, those skilled in the art will understand that various changes in detail may be made therein without departing from the spirit and scope of the invention as defined by the claims, which may be supported by the written description and drawings. Furthermore, when exemplary embodiments are described with reference to a certain number of elements, it will be understood that the exemplary embodiments can be practiced utilizing either more or fewer elements than the certain number of elements.

Claims

1. 1. A uterine manipulator device comprising: an elongated cannulated tube (5) having a proximal end (4) and a distal end (6); a handle (11) positioned on the proximal end (4) of the elongated cannula-like tube (5); a cervical cup (14) positioned on said elongated cannula-like tube (5); an intrauterine balloon (7) positioned on the distal end (6) of the elongated cannula-like tube (5); a stem (21) positioned proximally from the cervical cup (14) on the elongated cannula-like tube (5); a balloon occluder (22) positioned on the stem (21) and shaped to form an opening, wherein the cervical cup (14) is configured to move separately from the balloon occluder (22) along the elongated cannula-like tube (5); An apparatus comprising:

2. 2. The device of claim 1, wherein the balloon occluder (22) is communicatively coupled to an inflation valve (24) via a gas passage lumen (28).

3. The device of claim 1 , wherein the balloon occluder (22) is toroidal in shape.

4. 2. The device of claim 1, wherein the stem (21) further comprises a locking assembly, the locking assembly configured to lock the stem (21) and the balloon occluder (22) from movement in at least one direction along the elongated cannulated tube (5).

5. 2. The device of claim 1, wherein the stem (21) comprises a plurality of ribs (32) positioned between a proximal lip (34) and a distal lip (36), outside of which the balloon occluder (22) is positioned and configured to limit movement of the balloon occluder (22).

6. 6. The device of claim 5, wherein the opening in the balloon occluder (22) is configured to allow passage of the distal lip (36) of the stem (21) therethrough.

7. 10. The device of claim 1, wherein the balloon occluder (22) is communicatively coupled to a pilot balloon (26) configured to indicate balloon inflation.

8. 1. A uterine manipulator device comprising: an elongated cannulated tube (5) having a proximal end (4) and a distal end (6); a stem (21) positioned along the elongated cannulated tube (5), the stem (21) comprising a plurality of ribs (32) positioned between a proximal lip (34) and a distal lip (36); a balloon occluder assembly (20); Equipped with The balloon occluder assembly (20) comprises: a balloon occluder (22) shaped to form an opening and formed from a single formed component, wherein a cervical cup (14) is positioned on said elongated cannula-like tube (5) distal to said balloon occluder (22) and configured to move separately from said balloon occluder (22) along said elongated cannula-like tube (5); an inflation valve (24) configured to change the balloon occluder (22) between an inflated state and a deflated state, the inflation valve (24) being communicatively coupled to the balloon occluder (22) via a gas passage lumen (28).

9. 9. The device of claim 8, wherein the stem (21) comprises a locking assembly positioned proximally from the distal lip (36), the locking assembly configured to lock the stem (21) and the balloon occluder assembly (20) from movement in at least one direction along the elongated cannulated tube (5).

10. 9. The device of claim 8, further comprising a handle (11) positioned on the proximal end (4) of the elongated cannulated tube (5).

11. 9. The apparatus of claim 8, wherein the balloon occluder assembly (20) further comprises a pilot balloon (26) configured to indicate balloon inflation.

12. The device of claim 8, wherein the balloon occluder (22) is configured to be positioned around the plurality of ribs (32) of the stem (21).

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