Uterine manipulator

Abstract

To provide devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures.SOLUTION: A uterine manipulator device 100 includes: an elongated cannulated tube having proximal and distal ends, a cervical cup 23 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 an occluder assembly 18 comprising an occluder 19 positioned proximally from the cervical cup 23 on the elongated cannulated tube, the occluder having a body with at least one primary rib and at least two secondary ribs, where a diameter of at least one secondary rib is smaller than a diameter of the primary rib.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. priority application Ser. No. 15 / 899,427, entitled "UTERINE MANIPULATOR," filed Feb. 20, 2018.

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

[0003] Various conventional forms of uterine manipulators and cervical retractors are known. For example, U.S. Patent No. 5,209,754 describes a cervical retractor that generally consists of a half-length curved outer shaft (corresponding to the posterior pelvic curvature) and a straight proximal half connected to a handle, an inner cap positioned within the outer cap and a circular disk disposed at the distal end of an outer tube, and an inner plastic tube positioned through the outer tube and the circular disk, with the inner cap and outer cap (which may include a cervical cup of one of the conventional devices) having a balloon at the distal end. The cervical retractor is used to manipulate and visualize the uterus while maintaining a pneumoperitoneum during various medical diagnostic and laparoscopic procedures. Such diagnostic and procedures include laparoscopic total hysterectomy, laparoscopic partial hysterectomy, and colpotomy. A laparoscope can be inserted through a surgically made incision in the patient's abdominal wall to allow visualization of the abdominal cavity and uterus to assist in the hysterectomy, while the vaginal neck retractor manipulates the uterus during a laparoscopic hysterectomy, for example, by partially positioning and inflating a balloon within the uterine cavity, capturing the vaginal vault in an internal cup, and maintaining pneumoperitoneum by appropriately positioning a disk. Other conventional forms of uterine manipulators and vaginal neck retractors exist and include similar features.

[0004] However, some conventional uterine manipulators and vaginal neck retractors do not include mechanisms or structural configurations for adequately maintaining pneumoperitoneum during certain medical procedures (such as those described above). Furthermore, some conventional uterine manipulators and vaginal neck retractors do not include configurations for adequately fitting and holding a balloon at the distal end of the inner tube or manipulator tube. In fact, the balloons of such conventional uterine manipulators and vaginal neck retractors often gather in one place during assembly, implying certain potential safety and lack of sterility concerns during certain medical procedures. Furthermore, conventional uterine manipulators and vaginal neck retractors do not include mechanisms for passing dye other than through slits in the balloon, and use saline instead of gas to inflate the balloon.

[0005] Thus, there is a need in the art for improved devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures, including mechanisms or structural configurations to address these and other shortcomings of conventional devices.

[0006] Related Art Section Disclaimer Explanation: To the extent that certain patents / publications / products are discussed in this Background Art section description 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 sufficiently early, may not reflect subject matter developed early enough, and / or may not be sufficiently capable to amount to prior art for purposes of patent law. To the extent that certain patents / publications / products are discussed in this Background Art section description and / or throughout the application, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for purposes of patent law. As discussed above, the descriptions / disclosures thereof are hereby incorporated by reference in their entirety. Summary of the Invention

[0007] The present disclosure is directed to an inventive apparatus and method for manipulation of the uterus and cervix in surgical and diagnostic procedures that overcomes various problems (as described herein below) in conventional apparatus. A non-limiting specific purpose of the use of the embodiments herein is to provide an apparatus for manipulation of the uterus and fluid or gas insufflation during laparoscopic procedures such as laparoscopic 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 this disclosure), and for maintaining pneumoperitoneum by sealing the vagina during such procedures. In brief, the uterine manipulator apparatus of the embodiments allows medical personnel to more easily access key surgical targets within the pelvic cavity by creating clear visibility of surgical landmarks and excellent mobility of the uterus that maximizes safe surgical margins from the pelvic wall. The device may be structured and / or configured to displace the cervix away from the ureters, displace the bladder anteriorly, define the anatomical plane of the vaginal incision, and prevent loss of pneumoperitoneum during open surgery (as described above). Applicant recognizes and understands that it would be beneficial for medical practitioners to be able to approach such procedures with a high degree of confidence in performing consistent, predictable and repeatable procedures.

[0008] In general, in one aspect, a uterine manipulator device includes an elongated cannulated tube including a distal end and a proximal end, a cervical cup positioned on the elongated cannulated tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter, and a closure assembly positioned proximally from the cervical cup on the elongated cannulated tube including a closure stopper having a body having at least one primary rib and at least two secondary ribs, wherein a diameter of the at least one secondary rib is different from a diameter of the primary ribs.

[0009] According to another aspect, a uterine manipulator device includes an elongated cannulated tube including a distal end and a proximal end, with laser marked reference graduations positioned along an outer surface of the elongated cannulated tube, a cervical cup positioned on the elongated cannulated tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter, and an occluder assembly including an occluder having a body positioned proximally from the cervical cup on the elongated cannulated tube.

[0010] According to a further aspect, the uterine manipulator device includes an elongated cannula-like tube including a distal end and a proximal end, a cervical cup positioned on the elongated cannula-like tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter, and an intrauterine balloon including a distal end and a proximal end and positioned on the distal end of the elongated cannula-like tube, the distal end and the proximal end being secured to the elongated cannula-like tube by heat shrink material.

[0011] 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. [Brief description of the drawings]

[0012] The present invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the accompanying drawings, which depict only exemplary embodiments of the disclosed subject matter and are therefore intended to limit the scope of the disclosed subject matter, as other equally effective embodiments may be envisioned. It should not be regarded as something.

[0013] Reference will now be made briefly to the accompanying drawings, in which:

[0014] [Figure 1] FIG. 1 is a top perspective view of a fully assembled uterine manipulator apparatus, according to an embodiment. [Diagram 2]2 is a schematic cross-sectional view of a cervical cup of the uterine manipulator device along line A---A of FIG. 1, according to an embodiment. [Figure 3A] FIG. 3A is a side perspective view of an obturator of a uterine manipulator apparatus, according to an embodiment. [Figure 3B] FIG. 3B is a schematic cross-sectional side view of an occluder of a uterine manipulator apparatus, according to an embodiment. [Figure 3C] FIG. 3C is a schematic cross-sectional view of an occluder of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 3D] FIG. 3D is a perspective view of a uterine manipulator device according to an alternative embodiment. [Figure 3E] FIG. 3E is a side view of a uterine manipulator device according to an alternative embodiment. [Figure 3F] FIG. 3F is a side view of an obturator assembly of the uterine manipulator apparatus, according to an alternative embodiment. [Figure 4] FIG. 4 is an enlarged front view of a locking assembly of a uterine manipulator apparatus, according to an embodiment. [Diagram 5] FIG. 5 is an enlarged front view of the locking assembly of a uterine manipulator device with thumbscrews removed, according to an embodiment. [Figure 6A] FIG. 6A is a schematic cross-sectional view of a distal-most portion of a uterine manipulator device, according to an embodiment. [Figure 6B] FIG. 6B is a top view of the distal-most portion of a uterine manipulator device, according to an embodiment. [Figure 6C] FIG. 6C is an exploded view of a distal-most portion of a uterine manipulator device, according to an embodiment. [Figure 6D] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6E] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6F] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6G] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6H] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6I] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6J] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6K] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6L] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6M] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6N] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6O]6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6P] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6Q] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6R] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6S] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6T] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6U] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6V] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 6W] 6D-6W are various views (perspective, top, bottom, and side views) of an alternative embodiment of a cap of a uterine manipulator apparatus, according to an alternative embodiment. [Figure 7] FIG. 7 is an enlarged schematic view of a distal-most portion of a uterine manipulator device with the balloon removed, according to an embodiment. [Figure 8]FIG. 8 is a top side perspective view of a uterine manipulator device with the occluder removed, according to an embodiment. [Figure 9A] FIG. 9A is a schematic cross-sectional view of a handle of a uterine manipulator device, according to an embodiment. [Figure 9B] FIG. 9B is an enlarged perspective cross-sectional view of a handle of a uterine manipulator device, according to an embodiment.

[0015] Where applicable, identical reference characters are used throughout the several figures unless otherwise indicated. In addition, the embodiments disclosed herein may include elements that appear in one or more of the figures or a combination of the figures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] 1, which is a schematic diagram of a uterine manipulator device 100 in one embodiment. Uterine manipulator device 100 may include (from proximal end 1 to distal end 3) a handle 5, a dye injection port 7 positioned within handle 5 (preferably through the proximal end and communicatively coupled to intrauterine balloon 25), an inflation valve 9 (preferably through the distal end) to which a syringe (e.g., a 10 cc syringe, not shown) is attached and a pilot balloon 11 is attached to handle 5, and a cannulated manipulator tube 13 (preferably through the distal end and communicatively coupled to intrauterine balloon 25). Cannulated manipulator tube 13 is curved at its distal end and straight at its proximal end for easy introduction of device 100 for manipulation of both retroverted and anteverted uteruses and for maintaining proper position of the uterus at the proximal end. A cannulated manipulator tube 13 is connected to the handle 5 (preferably at the distal end of the handle 5) and the dye injection port 7, inflation valve 9, and pilot balloon 11 through the handle 5. The manipulator tube 13 is configured to anatomically match the angle of the sacral curve and allow for easy manipulation of the uterus. The handle 5 (which may include grip / non-smooth surfaces such as multiple ridges, or other non-smooth surface features that will be understood by those of skill in the art in conjunction with a review of this disclosure) that is smooth (as shown) and generally fits the user's hand or provides for positioning all four fingers on one side and the thumb on the other side, allows for easy manipulation of the uterus upwards, downwards, and laterally.

[0017] The uterine manipulator device 100 incorporates a system of manipulation / elevation mechanisms that are positioned on the manipulator tube 13 to provide manipulation of the uterus and retraction and elevation of the cervix. These mechanisms may include a cervical cup 23, an occluder assembly 18 including an occluder 19, a stem 55, and a locking assembly 39, each including holes therethrough that facilitate movement along and positioning on the manipulator tube 13 (the occluder assembly 18 and cervical cup 23 can be locked and unlocked in place and prevented from moving proximally on the manipulator tube 13 with each use of the locking assembly 39, as shown and described in more detail below with respect to Figures 4-5). The cervical cup 23 is positioned adjacent to and on the distal end of the manipulator tube 13 and may include sites / holes for sutures positioned through the sides of the cervical cup 23. The cervical cup 23 can include a variety of volumes and diameters, examples of which are shown in Table 1 below.

[0018] [Table 1]

[0019] FIG. 2 is a schematic diagram of a cervical cup 23 taken along line A---A of FIG. 1 in one embodiment. 2. As shown, the cervical cup 23 tapers from a top distal portion having a first diameter to a bottom proximal portion having a smaller second diameter, including a central hole 85 with a perimeter 87. The perimeter may be chamfered / angled away from the longitudinal axis A at the proximal end 87B and may be straight / non-angled relative to the longitudinal axis A at the distal end 87A (the angulation may be the opposite). The chamfered perimeter aids in the movement of the cervical cup 23 along the manipulator tube 13. The straight / non-angled perimeter aids in increasing the retention of the cervical cup 23 on the manipulator tube 13 and in preventing separation of the cup from the manipulator tube 13. Additionally, the diameter of the hole 85 may be reduced (from 2.15 cm to 2.05 cm). The combination of the straight / non-angled perimeter and the narrowing of the diameter of the hole 85 significantly increases the retention of the cervical cup 23 on the manipulator tube 13.

[0020] 3A, a side view of an exemplary embodiment of the occluder plug 19 and stem 55 with the manipulator tube 13 positioned therethrough is shown. The purpose of the occluder plug 19 is to keep gas (e.g., insufflation gas) within the exposed cavity and maintain insufflation within the cavity. Thus, the occluder plug 19 is preferably relatively small (e.g., diameter less than 2.6″), easy to insert and remove, and impermeable to gas. In one embodiment, the occluder plug 19 may be constructed from an open cell foam having a “skin” layer 28 (i.e., outer layer) that allows the occluder plug 19 to be easily compressible for proper positioning, and that expands to return to its original shape after proper positioning during use of the uterine manipulator (as should be understood by those of skill in the art in conjunction with a review of this disclosure) but is also configured to prevent leakage through the open cell foam. In one embodiment, the inner open cell foam and the outer layer may be constructed from the same material. Alternatively, however, the outer skin layer may be of a different material and / or density (e.g., higher density) and / or may be a region of different permeability than the inner open cell foam. For example, varying the temperature of the mold for preparation of the closure plug 19 may provide a thicker, denser outer skin layer, resulting in increased impermeability (as opposed to porosity) of the outer skin layer.

[0021] 3A, the occluder 19 is oval shaped and includes a number of ridges (or "ribs"). In the illustrated embodiment, the primary rib 27 having the largest diameter is located approximately in the center of the occluder 19, and the secondary ribs 29 are located on either side tapering away from the center such that the distal-most secondary rib 31 and the proximal-most secondary rib 33 have the smallest diameters (forming an essentially symmetrical design). This symmetrical design facilitates insertion and removal of the occluder 19 while still performing the essential blocking / occluding function of the occluder. In alternative embodiments, all secondary ribs 29 on either side of the primary rib 27 are smaller and / or sized equally with approximately the same diameter. In the illustrated embodiment, the secondary ribs 29 are configured to allow for best closure without interfering with the sealing ability of the primary ribs 27. Conventional sealing mechanisms are not symmetrical and are typically generally smooth (i.e., lacking ribs or ridges) and may be tapered without ribs.

[0022] 3B, the occluder 19 may also include anti-occluder migration features on its distal and / or proximal sides configured to prevent migration of the occluder 19 relative to the stem 55 in the distal and proximal directions. In the illustrated embodiment, the anti-migration features are "barbell" features 35. The barbell features 35 on the distal and proximal ends of the occluder 19 are constructed of a hard plastic and are structured to maintain an open cell foam therebetween. The occluder 19 may also include a series of internal grooves 37, which may have a diameter of 50% or less of the smallest rib diameter of the occluder 19, and preferably have a diameter of 25% or less of the smallest rib diameter of the occluder 19. The size of the internal grooves 37 aids in the compressibility of the occluder 19 while also preventing migration of the occluder 19 (as described above). The barbell features 35 are configured to prevent the occluder 19 from moving along its central axis. , while the internal groove 37 may (but need not be) configured to prevent the occluder 19 from moving freely, with or without additional structural features. The internal groove 37 may also have structural features that prevent the occluder 19 from rotating freely.

[0023] Referring to FIG. 3C, a schematic cross-sectional view of an occluder plug 19' is shown according to an alternative embodiment. The occluder plug 19' is shaped differently than the occluder plug 19 to perform certain functions described herein. For example, the front / distal tip section 91 is cone-shaped, narrow at the distal end and wide / thick at the proximal end near the secondary ribs 29' to allow for natural expansion of the anatomy (as should be understood by those skilled in the art in conjunction with a review of this disclosure). The primary rib 27' is centered between the two smaller secondary ribs 29', 29'. Each of the two or more secondary ribs 29', 29' may be of the same or different thickness than one or more of the other secondary ribs 29'. The primary rib 27' is spaced apart from each secondary rib 29', 29' to allow the primary rib 27' to at least partially fold proximally during insertion or distally upon removal. The primary rib 27' is of larger diameter / thickness compared to the secondary ribs 29', 29'. These secondary ribs 29', 29' on either side of the primary rib 27' are configured and constructed to provide additional sealing capability in the event that the primary rib 27' leaks or does not operate fully as required. However, the secondary ribs 29', 29' are also configured to provide additional support to the primary rib 27' such that the secondary ribs 29', 29' are configured and constructed to prevent the primary rib 27' from folding completely downward (also acting as a prop) and thus rendering the primary rib 27' ineffective.

[0024] Referring to Figure 3D, a perspective view of a fully assembled uterine manipulator apparatus 100' is shown according to an alternative embodiment. Figure 3E is a side perspective view of a fully assembled uterine manipulator apparatus 100' according to an alternative embodiment, and Figure 3F is a side perspective view of an occluder assembly 18' including an occluder 19'. Uterine manipulator apparatus 100' includes an occluder 19' as described above. All other elements of uterine manipulator apparatus 100' are the same or similar to uterine manipulator apparatus 100.

[0025] 4, an enlarged front view of the locking assembly 39 is shown. Once the occluder 19 is in the desired position to block gas from escaping the exposed cavity (as should be understood by those skilled in the art in conjunction with a review of this disclosure), the occluder 19 should be locked in place (which also prevents proximal movement of the cervical cup 23). In the illustrated embodiment, the locking assembly 39 includes a thumbscrew 41 in the collar 43 for securing the occluder 19 in the desired position along the manipulator tube 13. With conventional screws, the screw often falls out when unscrewing because the user does not know how deep the screw is in the collar. The thumbscrew 41 in the illustrated embodiment is shown modified to allow for tightening and loosening the screw without risk of losing the screw. The thumbscrew 41 shown has a vertical feature up to the last two threads 45, 47. The intermediate threads 51 are spaced approximately equidistantly apart. However, the last thread 47 is over-torqued such that there is effectively no pitch between the last two threads 45 and 47. Because there is no space between the last two threads 45 and 47, the thumbscrew 41 cannot be completely removed from the collar 43. Thus, the thumbscrew 41 can be loosened and tightened, but cannot be completely removed from the collar 43, preventing loss of the thumbscrew 41. The thumbscrew 41 shown in FIG. 4 may be created by first placing the thumbscrew 41 into the collar 43 and then deforming the thumbscrew 41 using a cold work compression method (e.g., over-torquing the thumbscrew on an anvil). The collar 43 may then be placed onto the device 100. Alternatively, the thumbscrew 41 may be secured to the collar 43 using other blocking mechanisms (e.g., washers, nuts, plastics) that are larger than the hole through which the screw is positioned (or that do not allow the screw to back out of the hole). parts, and other threaded variations) are intended.

[0026] 5, an enlarged front view of the collar 43 of the lock assembly 39 is shown. Traditionally, the collar 43 has a threaded channel constructed from a soft Santoprene material. Santoprene material is very resilient and easily deforms so that it can be pushed down until the threaded bottom disengages. However, in the illustrated embodiment, the collar 43 has a hard plastic, polycarbonate, nylon ring 53, for example, overmolded onto the threaded channel. The hard plastic ring 53 maintains the shape of the one-piece closure stem 55 design while allowing the thumbscrew 41 to be compressed against it.

[0027] 6A-6C, there are shown various schematic views of the distal end 3 of the manipulator device 100. At the distal end 3 of the manipulator device 100 is the distal-most portion 57 of the manipulator tube 13. The distal-most portion 57 of the manipulator tube 13 preferably has a larger diameter than the diameter of the remainder of the manipulator tube 13 due to several features of the distal-most portion 57 of the manipulator tube 13 discussed below.

[0028] Turning first to FIG. 6A, a schematic cross-sectional (along the longitudinal axis) view of the distal end 3 of the manipulator device 100 is shown. An intrauterine balloon 25 is shown positioned on the most distal portion of the manipulator tube 13. The balloon 25 (e.g., a 10 cc inflatable balloon) is configured and positioned to reduce the risk of uterine perforation and is used to stabilize the manipulator tube 13 within the uterine cavity. The balloon 25 may be a thermoplastic elastomer (TPE) balloon. In one embodiment, the TPE balloon is based on a styrene block copolymer, a SEBS compound. The TPE balloon is similar in strength and performance to a PVC balloon and is configured to maintain the balloon inflation. Although the TPE balloon 25 is shown and described with the uterine manipulator device 100, a conventional silicone or urethane-based balloon may be used. However, TPE balloons are less permeable to gas compared to silicone balloons. Silicone balloons are more permeable to gas, and therefore may shrink. To address shrinkage, saline is often used to inflate the silicone, as saline is impermeable. TPE balloons achieve similar performance by inflating the balloon with a gas. Gas does not distort the bonds in the balloon as much as saline does, so gas is preferred when inflation can be maintained. However, TPE balloons may be used in conjunction with saline at the user's option.

[0029] With further reference to FIG. 6A, the intrauterine balloon 25 covers the manipulator tube 13 at its distal-most portion 57. In conventional uterine manipulator devices, the balloon is glued in place (or other similar adhesives are used) at both the proximal and distal ends of the balloon to seal the balloon to the metal tube. In the embodiment shown in FIG. 6A, heat shrink 59 is used to cover the balloon at both the proximal and distal ends of the balloon on the manipulator tube 13. Any commercially available heat shrink for insulating the tube may be used. In one embodiment, Insultab's HS-714 (acrylic polyolefin) heat shrink may be preferably used. The heat shrink may be colored to facilitate visibility of the laser scale markings. The heat shrink material adheres very well to itself and to the metal manipulator tube 13, making it a superior form of adhesion means over other conventional methods (e.g., adhesives). The inventors have discovered that heat shrink 59 has many manufacturing and reliability advantages over the use of conventional adhesives. For example, heat shrink 59 retains its properties better through the sterilization process compared to adhesives. If the adhesive deteriorates and weakens, the balloon may slide, exposing the patient to the adhesive and also leading to malfunction of the balloon itself.

[0030] The heat shrink shown in FIG. 6B and FIG. 6C moves the intrauterine balloon 25 to a first position and to a manipulator position. 6A and 6C, heat shrink is also used to cover the entire manipulator tube 13 at the location of the collar 61 for sterilization purposes. A portion 63 of the balloon 25 is not covered with the heat shrink 59 so that the balloon 25 may be inflated. With further brief reference to FIG. 6A, the uncovered portion 63 of the balloon 25 is adjacent to a substantially sealed cavity 65 between the manipulator tube 13 and the balloon 25. A lumen 67 provides a path for gas to be conveyed through the manipulator tube 13 and through the cavity 65 to the balloon 25. The lumen 67 provides a closed passageway for the balloon 25 to facilitate inflation without introducing dye from the dye injection port 7 into the balloon 25.

[0031] Additionally, FIGS. 6A-6C show a cap 69 on the distal most portion 57 of the manipulator tube 13. FIG. 6C shows that the cap 69 is generally T-shaped and has a rounded portion 71 and a stem portion 73. FIG. 6A shows that the stem portion 73 of the cap 69 is positioned within the manipulator tube 13. The rounded portion 71 extends across the diameter of the distal most portion 57 of the manipulator tube 13. Specifically, the diameter of the rounded portion 71 of the cap 69 extends beyond the diameter of the manipulator tube 13 to a similar diameter of the heat shrink collar 61. In the illustrated embodiment, a gap 75 is shown between the heat shrink collar 61 and the manipulator tube 13. However, when the heat shrink 59 is applied to the manipulator tube 13, the heat shrink 59 deforms and fills the gap 75.

[0032] Returning to FIG. 6C, the cap 69 additionally includes a molded channel 77 for the passage of dye through both the rounded portion 71 and the stem portion 73 of the cap 69. The channel 77 extends through the entire cap 69 to facilitate the passage of dye therethrough. Dye may pass from the dye injection port 7 at the proximal end 1 through the manipulator tube 13 and the cap 69 to the uterine cavity. A conventional cap is closed and utilizes a slit in the balloon to create a passage for the dye. The slit in the balloon is open during manufacture and closed via a seal prior to use of the balloon. In some instances, the seal fails and the slit remains open, rendering the balloon inoperable. In other instances, the closed cap causes the adhesive to collect at the tip of the manipulator tube. However, the balloon 25 in the embodiment shown in FIG. 6A is completely separated from the manipulator tube 13 by the lumen 67. In particular, dye is configured to flow through the manipulator tube 13 and through a channel 77 in the cap 69 while gas is configured to pass separately through the lumen 67 to inflate the balloon 25 .

[0033] 6D-6W, various views (perspective, top, bottom, and side views) of alternative embodiments of cap 69 are shown. These alternative embodiments of cap 69 include various structural configurations and multiple molded channels therethrough. For example, one or more channels may pass through the center of cap 69 on either side of cap 69 and may include branching into additional multiple channels (which may aid in strategically distributing dye to specific anatomical structures, such as to and through the fallopian tubes).

[0034] 6D-6G, various views of cap 69 are shown with multiple channels 77-1, 77-2, and 77-3 passing separately therethrough.

[0035] 6H-6K, various views of cap 69 are shown with a main channel 77-1 that branches into two additional channels 77-2 and 77-3.

[0036] 6L-6O, various views of cap 69 are shown with a main channel 77-1 that branches into four separate channels 77-2, 77-3, 77-4 and 77-5.

[0037] 6P-6S, various views of cap 69 are shown with a main channel 77-1 that branches into two additional open channels 77-2 and 77-3 on the top surface of cap 69.

[0038] 6T-6W, various views of cap 69 are shown with a main open side channel 77-1, which, in use, the proximal end of cap 69 fits within (and is at least partially sealed by) cannulated tube 13.

[0039] Referring now to FIG. 7, the cap 69 is shown on the distal most portion 57 of the manipulator tube 13 prior to application of the heat shrink 59. The manipulator tube 13 includes a mechanical retention feature 79 adjacent to the cap 69. In the illustrated embodiment, the retention feature 57 is positioned between the cap 69 and the balloon 25. In the embodiment shown in FIG. 7, the retention feature 79 is a laser cut "W" feature or dimpled tab on the manipulator tube 13. The "W" feature 79 captures the cap 69 inside the manipulator tube 13 (as shown in FIG. 6A). Traditionally, an adhesive, such as a gel adhesive, is used to secure the cap. However, the adhesive may degrade and may be lost within the patient without the cap being attached. According to one embodiment, an adhesive may be used in conjunction with the "W" feature to aid in mechanical retention as described above.

[0040] 8, a side perspective view of the uterine manipulator device 100 is shown with the obturator assembly 18 removed to show the features of the manipulator tube 13. As shown in the illustrated embodiment, the manipulator tube 13 has a repeating set of reference graduations 81 (e.g., travelling 4cm to 16cm away from either side of the cervical cup 23). The manipulator tube 13 may be marked with reference graduations 81 from both the distal end 3 and the proximal end 1. The reference graduations 81 may provide a guide for comparison to the calibrated uterine sounds and assist in achieving the proper depth of insertion during use.

[0041] In conventional devices, the reference graduations are added to the manipulator tube via a process of pad printing. Pad printing may be done prior to application of the heat shrink. Laser marking is generally less expensive than pad printing, but is more accurate and more permanent, for example, because pad printing can be rubbed off. Despite its advantages, laser marking has not been used on conventional uterine manipulator devices because conventional lasers, such as conventional fiber lasers or hybrid lasers, cannot laser mark the heat shrink described as part of the embodiments herein. However, in FIG. 8, the reference graduations 81 are laser marked on the manipulator tube 13. In one embodiment, the heat shrink 59 is first applied to the manipulator tube 13 before the reference graduations 81 are laser marked. It has been found and understood by the inventors that the acrylic heat shrink allows the ultraviolet laser to mark the applied heat shrink layer. Thus, in an embodiment, an ultraviolet laser is used to successfully mark the thin layer of acrylic polyolefin on the manipulator tube 13. In such an embodiment, the UV laser emits a wavelength of 355 nm. It is contemplated that other wavelengths from a UV laser may be used successfully to create the reference scale 81.

[0042] 9A-9B, there is shown a schematic and perspective view of the handle 5 of the uterine manipulator device 100. The handle 5 has an anti-rotation feature that prevents the handle from being torqued and allowed to be manipulated. In the embodiment shown, the anti-rotation feature is a square overmolded key feature 83. Conventionally, the anti-rotation feature is a hexagonal shaped key feature. The hexagonal shape directs forces in both the X and Y directions within the handle. Thus, two faces of the hexagonal shaped key feature may be seen at once. Forces are directed in both the X and Y directions. , a hexagonal shaped key feature would be more likely to tear the handle when torque is applied. In the illustrated embodiment, the square overmolded key feature 83 directs some force in only one of the X or Y directions, but not both. Thus, the square overmolded key feature 83 is less likely to tear the handle 5.

[0043] Use of the uterine manipulator device described in this specification 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] ).

[0044] Although embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by those skilled in the art that various changes in details 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. Moreover, when an exemplary embodiment is described with reference to a particular number of elements, it will be understood that the exemplary embodiment may be implemented utilizing any of the particular number of elements or less.

Claims

1. 1. A uterine manipulator device comprising: an elongated cannula-like tube including a proximal end and a distal end; a cervical cup positioned on the elongated cannulated tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter; and a closure assembly including a closure stopper having a proximal end and a distal end positioned proximally from the cervical cup on the elongated cannula-like tube, the closure stopper having a body having at least one primary rib and at least two secondary ribs, the diameter of at least one secondary rib being smaller than the diameter of the primary rib.

2. The device of claim 1 , wherein at least a portion of the occluder is conically shaped with a taper extending from one of the secondary ribs to the distal end of the occluder.

3. The device of claim 1 , wherein the occluder is elliptical in shape such that one of the secondary ribs is positioned proximal to the primary rib and one of the secondary ribs is positioned distal to the primary rib.

4. The device of claim 1 , wherein the occluder is constructed from open cell foam.

5. The device of claim 1 , wherein the body of the occluder includes an outer skin layer having a different density than the remainder of the body.

6. 6. The device of claim 5, wherein the outer skin layer has a first gas permeability and the remainder of the body has a second gas permeability.

7. The device of claim 1 , wherein the occluder assembly further comprises an anti-occluder migration feature on at least one of a proximal side and a distal side of the occluder.

8. 8. The device of claim 7, wherein said closure assembly further comprises a groove positioned within said body of said closure and having a diameter no greater than 50% of said rib having a minimum diameter.

9. 8. The device of claim 7, wherein said closure assembly further comprises a groove positioned within said body of said closure and having a diameter no greater than 25% of said rib having said minimum diameter.

10. 2. The device of claim 1, wherein the occluder assembly further comprises a locking assembly positioned proximally from the occluder on the elongated cannulated tube, the locking assembly configured to lock the cervical cup and the occluder from movement in at least one direction along the elongated cannulated tube.

11. 11. The device of claim 10, wherein the locking assembly includes a thumbscrew having a plurality of threads configured to lock into a collar, at least one thread being deformed relative to the other threads.

12. The device of claim 11 , wherein the collar is constructed from nylon.

13. 1. A uterine manipulator device comprising: an elongated cannulated tube including a proximal end and a distal end, wherein laser marked reference marks are located along an exterior surface of the elongated cannulated tube; A nodular tube; a cervical cup positioned on the elongated cannulated tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter; and an occluder assembly including an occluder having a body positioned proximally from the cervical cup on the elongated cannula tube.

14. 14. The device of claim 13, wherein the laser marked reference graduations extend both proximally and distally along the elongated cannulated tube from a location between the proximal and distal ends of the elongated cannulated tube.

15. 14. The apparatus of claim 13, wherein the reference graduations are laser marked by a UV laser emitting a wavelength of 355 nm.

16. 14. The apparatus of claim 13, wherein the reference graduations are laser marked on an acrylated polyolefin layer positioned on the elongated cannulated tube.

17. 1. A uterine manipulator device comprising: an elongated cannula-like tube including a proximal end and a distal end; a cervical cup positioned on the elongated cannulated tube and having a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter; an intrauterine balloon including a proximal end and a distal end and positioned on the distal end of the elongated cannula-like tube, the proximal and distal ends of the intrauterine balloon being secured to the elongated cannula-like tube by heat shrink material.

18. 20. The device of claim 17, further comprising a handle positioned on the proximal end of the elongated cannulated tube.

19. 20. The apparatus of claim 18, further comprising an inflation valve positioned through the handle and communicatively coupled to a gas passage lumen of the elongated cannular tube.

20. 20. The apparatus of claim 19, further comprising a sealed cavity positioned between the elongated cannulated tube and the intrauterine balloon and communicatively connected to the gas passage lumen.

21. 20. The device of claim 18, further comprising a dye injection port positioned through the handle and communicatively coupled to the elongated cannulated tube and a cap positioned on the distal end of the elongated cannulated tube.

22. 22. The device of claim 21, wherein the elongated cannulated tube further comprises a mechanical retention feature configured to secure the cap to the elongated cannulated tube.

23. 20. The device of claim 18, further comprising a square key feature in the handle that directs applied force in only one direction.

24. 20. The device of claim 17, wherein the intrauterine balloon is constructed from a thermoplastic elastomer.

25. The device of claim 21 , wherein the cap includes proximal and distal ends and at least one channel therethrough.

26. 26. The device of claim 25, wherein the at least one channel extends through a side of the cap from the proximal end to the distal end of the cap.

27. 26. The device of claim 25, wherein the at least one channel is centrally positioned within the cap and extends between the distal end and the proximal end of the cap.

28. 30. The apparatus of claim 27, wherein the at least one channel branches into at least one additional channel.

29. 1. A method of manufacturing a uterine manipulator device comprising an elongated cannula-like tube having an outer surface, the method comprising: applying a layer of heat shrink to the exterior surface of the elongated cannular tube; applying laser marked fiducials along an exterior surface of the heat shrink on the elongated cannulated tube.

30. 30. The method of claim 29, wherein the laser marked fiducials are applied using a UV laser emitting a wavelength of 355 nm.

31. 30. The method of claim 29, wherein the heat shrink layer comprises a polyolefin acrylate layer.

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