UTERINE MANIPULATING DEVICES
Patent Information
- Application Number
- BR112022025994
- Authority / Receiving Office
- BR · BR
- Patent Type
- Patents
- Current Assignee / Owner
- Publication Date
- 2026-09-08
Smart Images
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Abstract
Description
[001] The present application claims priority to and benefit of U.S. Provisional Patent Application Number 63 / 040,824, filed June 18, 2020, the entirety of which is incorporated herein by reference. Field of Invention
[002] The present description refers generally to devices and methods for the manipulation of the uterus and cervix in surgical and diagnostic procedures. Background
[003] Several conventional forms of uterine manipulators with occluders are known. For example, U.S. Patent Application No. 15 / 617,299, designated to the Applicant, describes a uterine manipulator generally consisting of an elongated cannulated tube, comprising a proximal end and a distal end (for the medical professional using the device); a cervical dome having a proximal top portion of a first diameter and a distal base portion of a second smaller diameter, wherein the distal base portion includes an orifice formed in that place, having a perimeter including a distal end and a proximal end, the elongated cannulated tube is positioned through the orifice in the cervical dome; and a plastic or foam occluder is positioned close to the cervical dome, to maintain pneumoperitoneum for the procedure (see also U.S. Patent No. 10695092, designated to the Applicant).
[004] Uterine manipulators with occluders are used to maneuver and visualize the uterus during various medical examinations and laparoscopic procedures while maintaining pneumoperitoneum. Such examinations and procedures include a complete hysterectomy. Petition 870250084753, dated 09 / 19 / 2025, page 6 / 56 2 / 19 total laparoscopic, a partial laparoscopic hysterectomy and a colpotomy. Specifically, the occluder can form a seal to prevent pneumoperitoneum loss during colpotomy, and displaces the sigmoid colon out of the uterus. Other conventional forms of uterine manipulators with occluders exist and contain similar features.
[005] However, conventional uterine manipulators with occluders do not include a mechanism to allow the occluder to be removed or used independently of the uterine manipulator. In fact, conventional occluders are not capable of being used during both pre-colpotomy and post-colpotomy. Conventional occluders such as those made of foam or plastic can degrade over time. Furthermore, conventional devices are typically one size and do not allow for proper conformity to a patient's anatomy or manipulation.Additionally, some conventional uterine manipulators and occluders do not include a mechanism or structural configuration to reduce fatigue during use. Therefore, there is a need in the art for improved devices and methods for uterine manipulation and maintenance in surgical and diagnostic procedures, including a mechanism or structural configuration to address each of these and other shortcomings of conventional devices.
[006] Description of the Related Art Disclaimer: To the extent that specific patents / publications / products are discussed above in this Background Section or elsewhere in this Application, such discussions should not be taken as an admission that the patents / publications / products discussed are prior art for purposes of patent law. For example, some or all of the patents / publications / products discussed may not be sufficiently advanced in time, may not reflect the subject matter developed early enough in time, and / or may not be Petition 870250084753, dated 09 / 19 / 2025, page 7 / 56 3 / 19 sufficiently enabling in a manner to the extent of the prior art for purposes of patent law. To the extent that specific patents / publications / products are discussed above in this Background Section and / or throughout the application, the descriptions / disclosures thereof are all hereby incorporated by reference herein in their entirety. Summary of the Invention
[007] The present description is directed to inventive devices and methods for uterine manipulation and vaginal occlusion in surgical and diagnostic procedures, which overcome the various problems with conventional devices (as discussed herein and below). A particular non-limiting objective of use of the embodiments and implementations herein is to provide a device for uterine manipulation and injection of fluids or gases during laparoscopic procedures, such as laparoscopic-assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), minilap, laparoscopic tubal occlusion or diagnostic laparoscopy (and other similar procedures as shall be understood by a person of common knowledge in the art in conjunction with a review of this description), and for maintaining a pneumoperitoneum by sealing the vagina during such procedures.In summary, a uterine manipulation device of this type enables a medical professional to more easily conform and manipulate the uterus and seal the vagina during procedures, using an occlusive balloon. Specifically, to maintain pneumoperitoneum during use, the occluder contains an inflatable balloon for vaginal occlusion conforming to the patient's anatomy.
[008] The occlusive balloon can be structured and / or configured to be removed or used independently of the uterine manipulator, enabling vaginal occlusion during both pre-colpotomy and post-colpotomy. The occlusive balloon is configured to be inflated and Petition 870250084753, dated 09 / 19 / 2025, page 8 / 56 4 / 19 emptied. Following colpotomy and subsequent removal of the device, the occlusive balloon component can be removed from the uterine manipulator. This independent occlusive balloon component can then be reinserted into the vaginal canal and inflated, acting as an occlusive device alone during vaginal cuff suturing following hysterectomy. The Applicant acknowledged and perceived that it would be beneficial for medical professionals to be able to approach such procedures with a higher degree of confidence in performing a consistent, predictable, and repeatable procedure.
[009] Additionally, according to one embodiment, the device can be configured to reduce hand fatigue during use, due to improved ergonomics in handling the device, and the presence of the low-profile silicone cap.
[0010] Generally, in one embodiment, a uterine manipulator device includes an elongated cannulated tube comprising a proximal end and a distal end; a handle (cube) positioned at the proximal end of the elongated cannulated tube; a cervical dome positioned on the elongated cannulated tube; an intrauterine balloon positioned at the distal end of the elongated cannulated tube; a stem positioned near the cervical dome on the elongated cannulated tube; and an occluding balloon assembly including an occluding balloon shaped to form an opening, the opening configured to allow passage through the entire elongated cannulated tube and cervical dome.
[0011] In one aspect, the occluding balloon assembly further comprises an inflation valve communicatively coupled to the occluding balloon through a gas passage lumen.
[0012] In an additional aspect, the occluding balloon is torus-shaped.
[0013] In an additional aspect, a key characteristic qua Petition 870250084753, dated 09 / 19 / 2025, page 9 / 56 5 / 19 of the force is in the handle, which directs an applied force in only one direction.
[0014] In a further aspect, the trunk comprises a locking assembly positioned close to the distal lip of the trunk, wherein the locking assembly is configured to block the trunk and the occluding balloon assembly from moving in at least one direction along the elongated cannulated tube.
[0015] In an additional aspect, the trunk comprises a plurality of striations positioned between a proximal lip and a distal lip, configured to limit the movement of the occlusive balloon assembly.
[0016] In an additional aspect, the opening of the occluding balloon is configured to allow passage through the entire distal lip of the trunk.
[0017] In a further aspect, the occluding balloon is communicatively coupled to a pilot balloon, configured to indicate balloon inflation.
[0018] Generally, in another embodiment, a uterine manipulator device comprises an elongated cannulated tube comprising a proximal end and a distal end, a trunk positioned along the elongated cannulated tube, the trunk comprising a plurality of striations (ribs) positioned between a proximal lip and a distal lip; and an occluding balloon assembly, comprising: a balloon shaped to form an opening, the opening configured to allow passage through the entire elongated cannulated tube and the distal lip of the trunk; and an inflation valve configured to change the occluding balloon between an inflated and a deflated state, the inflation valve being communicatively coupled to the balloon through a gas passage lumen.
[0019] In a further aspect, the trunk comprises a locking assembly positioned approximately from the distal lip, wherein the locking assembly is configured to lock the trunk and the Petition 870250084753, dated 09 / 19 / 2025, page 10 / 56 6 / 19 Occluder balloon assembly allows movement in at least one direction along the elongated cannulated tube.
[0020] In an additional aspect, a handle is positioned at the proximal end of the elongated cannulated tube.
[0021] In a further aspect, the occluder balloon assembly also comprises a pilot balloon configured to indicate balloon inflation.
[0022] In a further aspect, the balloon assembly is configured to be placed around the trunk striations.
[0023] In another embodiment, an occluding balloon comprises a torus-shaped balloon, configured to be changed from an empty state to an inflated state, and comprising an inner wall and an outer wall; and an inflation valve communicatively coupled to the balloon through a gas passage lumen.
[0024] In a further aspect, the device comprising a pilot balloon configured to indicate balloon inflation.
[0025] In a further aspect, the outer wall of the balloon still comprising a lumen door. Brief Description of the Drawings
[0026] The present invention will be more fully understood and appreciated by reading the Detailed Description below, together with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the subject described, and in this way are not considered to limit its scope, as other equally effective embodiments may be admitted for the subject described.
[0027] Reference is now made briefly to the accompanying drawings, where:
[0028] FIG. 1 is a side perspective view of a uterine manipulator with a balloon device according to an embodiment;
[0029] FIG. 2A is a side perspective view of a Petition 870250084753, dated 09 / 19 / 2025, p. 11 / 56 7 / 19 occlusive balloon assembly according to a modality;
[0030] FIG. 2B is a side perspective view of an occluding balloon assembly according to an embodiment;
[0031] FIG. 3A is a side perspective view of an occluder balloon assembly according to an embodiment;
[0032] FIG. 3B is a side perspective view of an occluding balloon assembly according to an embodiment;
[0033] FIG. 4 is a perspective view of a trunk according to a modality;
[0034] FIG. 5A is a schematic top sectional view of an occluding balloon along G—G of FIG. 5B, according to an embodiment;
[0035] FIG. 5B is a schematic side view of an occluding balloon, according to an embodiment;
[0036] FIG. 5C is a schematic bottom sectional view of an occluding balloon along D—D of FIG. 5B, according to one embodiment;
[0037] Where applicable, such as designated reference characters identical or corresponding components and units across all the various views, which are not to scale unless otherwise indicated. Furthermore, the embodiments described herein may include elements that appear in one or more of the various views, or in combinations of the various views. Detailed Description of the Modalities
[0038] Aspects of the present invention and certain features, advantages and details thereof are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and Petition 870250084753, dated 09 / 19 / 2025, page 12 / 56 8 / 19 The specific non-limiting examples, while indicating aspects of the invention, are given for illustrative purposes only and are not limiting. Various substitutions, modifications, additions and / or arrangements, within the spirit and / or scope of the underlying inventive concepts, will be apparent to those skilled in the art of this description.
[0039] As used herein for purposes of this description, the terms “distal” and “proximal” are used to describe device modality locations from the perspective of a medical professional using the device.
[0040] The uterine manipulator with balloon occlusion device (generally referred to by reference number 100) may include a uterine manipulator (generally referred to by reference number 1) and a balloon occlusion assembly (generally referred to by reference number 20). According to one embodiment, the uterine manipulator with balloon occlusion device 100 may comprise a cannulated manipulator tube having a proximal end 4 and a distal end 6, a crank 11 extending from the proximal end 4, and a balloon occlusion assembly 20 positioned distally from the crank 11 along the cannulated manipulator tube 5.
[0041] With reference to FIG. 1, a perspective view of a uterine manipulator with balloon occlusion device 100 in one embodiment is shown. As shown, the uterine manipulator with balloon occlusion device 100 comprises a uterine manipulator 1 having a crank 11 with a dye injection port cap 13 (preferably positioned across the proximal end of the crank 11), a cannulated manipulator tube 5 extending from the crank, a movable balloon occlusion assembly 20 positioned along the proximal portion of the cannulated manipulator tube 5, and a cervical cap 14 positioned along the tube 5 adjacent to the balloon occlusion assembly 20, extending from the distal end of the manipulator tube. Petition 870250084753, dated 09 / 19 / 2025, p. 13 / 56 9 / 19 cannulated balloon 5 has a proximal thermal contraction 9, an intrauterine balloon 7, a distal thermal contraction 10, and a cap 8. Additionally, coupled to the crank 11 is a lumen 15, a pilot balloon 3, and a check valve 2, all communicatively coupled to the intrauterine balloon 7. The occluding balloon assembly 20 may comprise an occluding balloon 22 communicatively coupled to the check valve 24 and the pilot balloon 26 through the lumen 28.
[0042] The crank 11, which may be soft (as shown) and conform to the user's hand as a whole, or provide for the positioning of all four fingers on one side, and the thumb on the opposite side (which may include an adhesive / non-smooth surface, such as a plurality of raised portions or other non-smooth surface structure, as shall be evidenced by a person skilled in the art in conjunction with a review of this description), enables easy manipulation of the uterus upwards, downwards and to the sides. The dye injection port cap 13 may be positioned on the crank in multiple locations, but preferably on the proximal portion of the crank 11, for example as shown.
[0043] The cannulated manipulator tube 5 can be S-curved or bent 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 uteri, and to maintain the proper attitude of the uterus. The manipulator tube 5 is configured to anatomically conform to the angle of the sacral curve, and to allow easy manipulation of the uterus. The cannulated manipulator tube 5 is connected to the crank 11 and the dye injection port cap 13 (preferably at the distal portion of the crank 11), and the pilot balloon 3 via the crank 11. This cannulated manipulator tube 5 is cannulated to allow fluid injection through the dye injection port cap 13, for chromoperturbation and balloon inflation 7 via the balloon port. Petition 870250084753, dated 09 / 19 / 2025, page 14 / 56 10 / 19 pilot 3. According to one embodiment, the dye injection port cover 13 has a low-profile cover, which does not extend far from the crank body 11 when in place. Additionally, the cover 13 may be silicone or other similar material.
[0044] In one embodiment, the manipulator tube 5 may include repeated sets of reference graduations (e.g., 4 cm to 16 cm moving outward from either side of the cervical cap 14). The manipulator tube 5 may have any number of sets of markings, for example, the manipulator tube 5 may be marked with reference graduations from both the distal end 6 and the proximal end 4. The reference graduations provide a guide for comparison to a graduated uterine sound, and may help to achieve the appropriate insertion depth during use. In one embodiment, the reference graduations are laser-marked on the manipulator tube 5. In conventional devices, the reference graduations may be added to the manipulator tube 5 via the pad printing process. Pad printing may be done prior to the application of thermal contraction.Although laser marking is typically cheaper than pad printing, it is more accurate and permanent because, for example, pad printing may not have rubber. In one embodiment, a thermal shrink is first applied to the manipulator tube 5 before the reference graduations are laser-marked. It has been discovered and evaluated by the inventors that the acrylated thermal shrink enables an ultraviolet laser to mark the applied thermal shrink layer. As such, in one embodiment, an ultraviolet laser is used to successfully mark a thin layer of acrylated polyolefin on the manipulator tube 5. In such an embodiment, the UV laser emits a wavelength of 355 nm. It is considered that other wavelengths of the UV laser can be used to successfully create the reference graduations. Petition 870250084753, dated 09 / 19 / 2025, p. 15 / 56 11 / 19
[0045] The trunk 21 is configured to position and hold the occlusive balloon assembly 20 in place. According to one embodiment, the trunk 21 is cannulated and is placed around and along the manipulator tube 5. The trunk 21 may be positioned distally to the crank 11 and proximally to the cervical dome 14. The trunk 21 may be flexible enough to slide along the curves of the manipulator tube 5.
[0046] According to one embodiment, the occlusive balloon assembly is movable along the manipulator tube 5. The trunk 21 can be used to position the occlusive balloon assembly 20. Once in the desired position to block gas from exiting the exposed cavity (as should be understood by a person of common knowledge in the art in conjunction with a review of this description), the occlusive balloon assembly 20 and trunk 21 can be locked in place (which prevents proximal movement of the cervical cap 14). In the embodiment shown, the locking assembly is a finger screw 23 in the trunk 21. With conventional screws, the user does not know how deep the screw is in the collar and thus, when loosening the screw, the screw often falls out. To allow tightening and loosening of the screw without the risk of losing the screw, the finger screw can be used.The last thread in finger screw 23 can be overloaded, such that there is virtually no spacing between the last two threads. Because there is no space between the last two threads, the finger screw cannot be completely removed. In this way, although finger screw 23 can be loosened and tightened, it cannot be completely removed, preventing the loss of finger screw 23. The screw channel can be made of or over-molded with hard plastic, polycarbonate, or nylon to allow finger screw 23 to push against it while maintaining the shape of the molded trunk 21. Alternatively, other locking mechanisms (e.g., washing machine, etc.) can be used. Petition 870250084753, dated 09 / 19 / 2025, page 16 / 56 12 / 19 nut, plastic part, other screw deformation) that are larger than the hole in which the screw is positioned (or otherwise prevent the screw from exiting the hole) are considered.
[0047] The occlusive balloon assembly 20 is shown positioned on the distal portion of the trunk 21, the trunk 21 being positioned through the cannulated lumen 22-1 (or opening) of the occlusive balloon 22 (see FIG. 2B). As shown, the occlusive balloon assembly 20 is configured to allow the manipulator tube 5 to be positioned throughout the occlusive balloon 22. The occlusive balloon assembly 20 contains an inflatable occlusive balloon 22, which has an inflated and an uninflated state, for vaginal occlusion conforming to the patient's anatomy. Specifically, the occlusive balloon 22 is configured and positioned to retain gas (e.g., insufflation gas) in the exposed cavity to maintain cavity insufflation when in the inflated state. The occlusive balloon 22 can be inflated using a check valve assembly 24, pilot balloon 26, and lumen 28 as should be known in the art.
[0048] The cervical dome 14 is positioned on the manipulator tube 5 to provide manipulation of the uterus, and retraction and elevation of the cervix. The cervical dome 14 is optionally capable of being locked and unlocked in place, and prevented from moving around the manipulator tube 5. The cervical dome 14 is positioned on and adjacent to the proximal end 4 of the manipulator tube 5, and may include suture sites / holes positioned through the side of the cervical dome 14. The cervical dome 14 may include various volumes and diameters, examples of which are shown in Table 1 below: Table 1 Cervical Dome Volume Cervical Dome Diameter Cervical Dome Designation 9.7cm3 (0.59in3) 32mm (1.26in) S 14.3cm3 (0.87in3) 34mm (1.34in) M Petition 870250084753, dated 09 / 19 / 2025, page 17 / 56 13 / 19 20.7cm3(1.26in3) 37mm (1.46in) L 26.7cm3(1.63in3) 40mm (1.57in) XL
[0049] In the embodiment shown, the cervical dome 14 tapers from a distal top portion with a first diameter to a proximal base portion with a second, smaller diameter including a central orifice having a perimeter. The perimeter can be chamfered / angled outward from the longitudinal axis, and can be straight / non-angled with respect to the longitudinal axis (the angulation can be reversed). The chamfering of the perimeter aids in the movement of the cervical dome 14 along the manipulator tube 5. The straight / non-angled perimeter portion helps increase the retention force of the cervical dome 14 on the manipulator tube 5, and prevents separation of the dome from the manipulator tube 5. Additionally, the diameter of the orifice can be decreased (from 2.15 cm to 2.05 cm). The combination of the straight / non-angled perimeter portion and the narrowing of the orifice diameter significantly increases the retention force of the cervical dome 14 on the manipulator tube 5.The cervical dome contains a guide for performing colpotomy as well as suturing holes for tissue removal.
[0050] The intrauterine balloon 7 covers the manipulator tube 5 at its distal end. The intrauterine balloon 7 is shown positioned at the distal end 6 of the manipulator tube 5. The balloon 7, together 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 be held at 45cc of air. This allows for better manipulation of a larger uterus.
[0051] Balloon 7 may be a Thermoplastic Elastomer (TPE) balloon. In one embodiment, the TPE balloon is based on a styrene block copolymer, composed of SEBS. TPE balloons are similar to PVC balloons in strength and performance, and are composed and configured to maintain balloon inflation. Although a balloon 7 of Petition 870250084753, dated 09 / 19 / 2025, page 18 / 56 14 / 19 TPE balloons are shown and described in conjunction with uterine manipulator 1; a conventional silicone or urethane-based balloon can be used. However, TPE balloons are less permeable to gas compared to silicone balloons. Because silicone balloons are more permeable to gas, they can deflate. To combat deflation, saline solution is often used to inflate the silicone balloon as saline solution will not permeate. TPE balloons perform similarly when inflated with gas. Gas does not strain the bonds in the balloon as much as saline solution, thus gas is preferable if dilation can be maintained. However, TPE balloons can be used with saline solution at the user's choice.
[0052] In conventional uterine manipulator devices, the balloon is placed in position at both the proximal and distal ends of the balloon (or other similar adhesive is used) to seal the balloon to the metal tube. In the embodiment shown, heat reducers 9 and 10 are used to cover the balloon at both the proximal and distal ends of the balloon over the manipulator tube 5. Any commercially available heat reducer for insulating a tube can be used. In one embodiment, Insultab's HS-714 heat reducer (acrylated polyolefin) may preferably be used. The heat reducer can be colored to facilitate visibility of laser graduation markers. The heat reducer material adheres to itself and to the metal manipulator tube 5 with or without silicone glue. The inventors found that a heat reducer 9 has many manufacturing and reliability advantages over the use of conventional adhesive.For example, heat reducers retain their properties better throughout the sterilization process compared to adhesives. When the adhesive degrades or weakens, the balloon can slip, exposing the patient to the adhesive, and can also lead to malfunction of the balloon itself.
[0053] Heat reduction 9 seals the intrauterine balloon 7 in a Petition 870250084753, dated 09 / 19 / 2025, page 19 / 56 15 / 19 first proximal position, and the heat reducer 10 seals the intrauterine balloon 7 in a second distal position, along the most distal portion of the manipulator tube 5 forming a pair of collars around the balloon 7. The heat reducers 9 and 10 can also be used to cover the entirety of the manipulator tube 5, in the collar position for isolation purposes when used in conjunction with electrosurgical accessories. A portion of the balloon 7 is not covered with the heat reducer, so that the balloon 7 can inflate. The uncovered portion of the balloon 7 can be adjacent to the substantially included cavity between the manipulator tube 5 and the balloon 7. According to one embodiment, the lumen 15 provides a pathway through the manipulator tube 5 to transport gas to the balloon 7. The lumen 15 provides a closed passage to the balloon 7 in order to facilitate inflation without introducing dye from the dye injection port cap 13 into the balloon 7.
[0054] The cap 8 is positioned in the most distal portion of the manipulator tube 5, and is configured to provide atraumatic insertion. According to one embodiment, the cap 8 may be approximately T-shaped, with a rounded portion and a trunk portion. The trunk portion of the cap 8 is positioned inside the manipulator tube 5. The rounded portion extends along the diameter of the most distal portion of the manipulator tube 5. Specifically, the diameter of the rounded portion of the cap 8 extends beyond the diameter of the manipulator tube 5 and outward by a similar diameter of the heat reduction 10.
[0055] According to one embodiment, the cap 8 may additionally be closed / sealed, but may alternatively include a shaped channel for the passage of dye, through both the rounded and trunk portions of the cap 8. The channel extends entirely through the cap 8 to facilitate the passage of dye throughout. The dye may be passed from a dye injection port cap 13, through the manipulator tube 5 and the cap 8 into the cavity. Petition 870250084753, dated 09 / 19 / 2025, p. 20 / 56 16 / 19 uterine. Conventional caps are closed and utilize a slit in the balloon to create a passage for the dye. The slit in the balloon may be opened during manufacturing and closed with a seal before balloon use. In some cases, the seal fails and the slit remains open, rendering the balloon inoperable. In other cases, the closed cap causes adhesive to clump at the tip of the manipulator tube 5. However, the balloon 7 in one embodiment is entirely separate from the manipulator tube 5. In particular, the dye can flow through the manipulator tube 5 and through the channel in the cap 8, while the gas is configured to be separately passed through the lumen 15 to expand the balloon 7. Alternative embodiments of the cap 8 include various structural configurations and numbers of molded channels passing through it.For example, one or more channels may pass through the center of cap 8, on either side of cap 8, and may include bifurcations into multiple additional channels (which may help with strategically distributing dye to certain anatomy, such as towards and through fallopian tubes).
[0056] The use of the uterine manipulator devices described herein is similar to the use of the uterine manipulator device described in US Pub. App. No. 20170354436 (see, for example, Fig. 4, and paragraph
[0028] ), as should be understood by a person of ordinary knowledge of the art, in conjunction with a review of this description.
[0057] To maintain pneumoperitoneum during use, the occlusive balloon assembly 20 contains an inflatable occlusive balloon 22 for vaginal occlusion according to the patient's anatomy. The occlusive balloon assembly 20 is configured to be detached from the uterine manipulator 1 and to be used independently. With reference now to FIG 2A and FIG 2B, side perspective views of the independent occlusive balloon assembly 20 are shown, according to an embodiment in the non-vaginalized state. Petition 870250084753, dated 09 / 19 / 2025, page 21 / 56 17 / 19 inflated. Following colpotomy or similar procedure and subsequent removal of device 100, the occlusive balloon assembly 20 can be removed from the uterine manipulator 1 as described below. The occlusive balloon 22 of the occlusive balloon assembly 20 can then be reinserted into the vaginal canal to act as an occluder without the uterine manipulator 1.
[0058] Once the occlusive balloon assembly 20 is in place, the occlusive balloon 22 can be placed in an inflated state using the check valve 24 and the lumen 28. FIGS 3A and 3B show the occlusive balloon assembly 20 with the occlusive balloon 22 in an inflated state. The lumen 28 provides a pathway to transport air to the occlusive balloon 22 in order to facilitate inflation. According to one embodiment, the pilot balloon 26 fills with air and becomes less flexible after the occlusive balloon 22 is full as an indicator of inflation. The independent occlusive balloon assembly 20 can be particularly useful, for example, during vaginal cuff suturing following hysterectomy.
[0059] With reference now to FIG 4, in one embodiment the trunk comprises the finger screw 23 at its proximal end and a set of grooves 32 at its distal end. The occlusive balloon 22 is configured to be placed over the grooves 32 on the distal portion of the trunk 21. The grooves 32 may be of similar or varying sizes. In the embodiment shown there are five grooves 32, but there may be any number of grooves 32. Alternatively, the distal end of the trunk 21 may be soft, or the grooves 32 may be made by other means such as, but not limited to, shock absorbers, bumps (protrusions) or texture. The grooves 32 help to maintain and hold the occlusive balloon 22. In the embodiment shown, the grooves 32 are positioned between a proximal lip 32 and a distal lip 36, which may also help to keep the occlusive balloon 22 in place, and prevent movement of the occlusive balloon 22 along the cannulated tube 5.
[0060] To place the occlusive balloon 20 on the trunk 21, the user can Petition 870250084753, dated 09 / 19 / 2025, p. 22 / 56 18 / 19 Slide the distal end 6 of the uterine manipulator device 1 through the opening (or lumen 22-1) of the occlusive balloon 22. The occlusive balloon 22 can be slid down the cannulated tube 5 and extended over the cervical dome 14 and the distal lip 36 of the trunk 21. The occlusive balloon 22 can be seated and held in place between the proximal lip and the lip 34, 36 in the striations 32. To remove the occlusive balloon 20 from the uterine manipulator device 1, the occlusive balloon 22 can be slid over the distal lip 36 and the cervical dome 14, and out of the distal end 6 of the cannulated tube 5. The trunk 21 can remain in the uterine manipulator 1 after the occlusive balloon 20 assembly is removed.
[0061] The occlusive balloon 22 according to one embodiment is a torus- or cylindrical-shaped balloon, with an opening configured to slide over parts of the uterine manipulator 1.With reference now to FIG 5A-C, the occluding balloon 22, according to one embodiment, is composed of a flexible material such as silicone. Alternatively, the occluding balloon 22 may be a urethane- or TPE-based balloon, for example a styrene block copolymer-based TPE balloon, composed of SEBS. As shown, the occluding balloon 22 is designed to be constructed from a single molded silicone component, which is folded over itself and circumferentially sealed. With reference now to FIG 5B, section GG of the occluding balloon 22 is above, where the seal is located, and is only a single layer of the material. Section DD shows the two layers of the occluding balloon 22, which form the air pocket. This pocket within the layers can be inflated through the communicatively coupled check valve 24, pilot balloon 26, and lumen 28.In the embodiment shown, the occluding balloon 22 also comprises a lumen port 29, which can be formed in the body of the balloon 22 and coupled to the lumen 28 by a method such as overmolding. The occluding balloon 22 can be configured in other arrangements, as should be known in the art. The occluding balloon 22 can be made. Petition 870250084753, dated 09 / 19 / 2025, page 23 / 56 19 / 19 in a variety of shapes and sizes and inflated to any desired size.
[0062] Although embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by a person skilled in the art that various changes in detail may be effected herein without departing from the spirit and scope of the invention as defined by the claims, which may be supported by the written description and the drawings. Furthermore, where exemplary embodiments are described with reference to a certain number of elements, it will be understood that exemplary embodiments may be practiced using either fewer than or more than the certain number of elements.
Claims
1. Uterine manipulator device (100) comprising: an elongated cannulated tube (5) comprising a proximal end (4) and a distal end (6); a crank (11) positioned at the proximal end (4) of the elongated cannulated tube (5); a cervical dome (14) positioned on the elongated cannulated tube (5); an intrauterine balloon (7) positioned at the distal end (6) of the elongated cannulated tube (5); a trunk (21) positioned approximately from the cervical dome (14) on the elongated cannulated tube (5); and an occluding balloon (22) positioned on the trunk (21) and shaped to form an opening (22-1), characterized in that the opening (22-1) is configured to allow passage through the entire elongated cannulated tube (5) and the cervical dome (14).
2. Device according to claim 1, characterized in that the occluding balloon (22) is communicatively coupled to an inflation valve (24) through a gas passage lumen (28).
3. Device of claim 1, characterized in that the occluding balloon (22) has the shape of a torus.
4. Device according to claim 1, characterized in that the trunk (21) further comprises a locking assembly, wherein the locking assembly (23) is configured to lock the trunk (21) and the occluding balloon (22) from movement, in at least one direction along the elongated cannulated tube (5).
5. Device according to claim 1, characterized in that the trunk (21) comprises a plurality of grooves Petition 870250084753, dated 09 / 19 / 2025, page 25 / 56 2 / 3 (32) positioned between a proximal lip (34) and a distal lip (36) over which the occluding balloon (22) is positioned and configured to limit the movement of the occluding balloon assembly (20).
6. Device according to claim 5, characterized in that the opening (22-1) of the occluding balloon (22) is configured to allow passage through the entire distal lip (36) of the trunk (21).
7. Device according to claim 1, characterized in that the occluding balloon (22) is communicatively coupled to a pilot balloon (26) configured to indicate balloon inflation.
8. Uterine manipulator device (100) comprising: an elongated cannulated tube (5) comprising a proximal end (4) and a distal end (6); a trunk (21) positioned along the elongated cannulated tube (5); and an occluding balloon assembly (20), comprising: an occluding balloon (22) shaped to form an opening (22-1); and an inflation valve (24) configured for changing the balloon (22) between an inflated and an emptied state, the inflation valve (24) being communicatively coupled to the balloon (22) through a gas passage lumen (28), characterized in that the trunk (21) comprises a plurality of grooves (32) positioned between a proximal lip (34) and a distal lip (36), and the opening (22-1) is configured to allow passage through the entire elongated cannulated tube (5) and the distal lip (36) of the trunk (21).
9. Device according to claim 8, characterized in that the trunk (21) comprises a locking assembly positioned approximately from the distal lip (36), wherein the locking assembly is configured to lock the trunk (21) and the balloon assembly (20) from movement in at least one direction along the elongated cannulated tube (5).
10. Device according to claim 8, characterized in that it further comprises a crank (11) positioned at the proximal end (4) of the elongated cannulated tube (5).
11. Device according to claim 8, characterized in that the occluding balloon assembly (20) further comprises a pilot balloon (26) configured to indicate balloon inflation.
12. Device according to claim 8, characterized in that the balloon (22) is configured to be placed around the grooves (32) of the trunk (21).
13. Device according to claim 8, characterized in that the occluding balloon is a torus-shaped occluding balloon (22) comprising an inner wall and an outer wall.
14. Device according to claim 13, characterized in that the occluding balloon assembly (20) further comprises a pilot balloon (26) configured to indicate balloon inflation.
15. Device according to claim 13, characterized in that the outer wall of the balloon (22) further comprises a lumen port (29).