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 is a continuation of U.S. priority application Ser. No. 15 / 899,427, filed Feb. 20, 2018. Priority is claimed with respect to the publication number "UTERINE MANIPULATOR".

[0002] FIELD OF THEINVENTION The present disclosure generally relates to a method and apparatus for manipulating the uterus and cervix in surgical and diagnostic procedures. The present invention relates to an apparatus and a method. [Background technology]

[0003] Various conventional forms of uterine manipulators and cervical retractors are known. For example, U.S. Pat. No. 5,209,754 generally describes a curved outer shaft (rear The proximal half is connected to the handle (corresponding to the pelvic curvature of the pelvis) and the external an inner cap positioned within the cap and a circular disk disposed at the distal end of the outer tube; and an inner plastic tube positioned through the outer tube and the circular disk; An inner cap and an outer cap (which may include a cervical cup as in a conventional device) A vaginal cervix retractor is described that has a balloon at its distal end. Manipulate and visualize the uterus while maintaining pneumoperitoneum during a variety of medical diagnostic and laparoscopic procedures Such diagnostic and surgical procedures include laparoscopic total hysterectomy, laparoscopic hysterectomy, Partial hysterectomy, colpotomy, etc. If a vaginal cervical retractor is used during a laparoscopic total hysterectomy, e.g. A balloon is positioned partially within the uterine cavity and inflated to capture the vaginal vault in the internal cup. Manipulate the uterus by properly positioning the disc and maintaining pneumoperitoneum. During surgery, a laparoscope can be inserted through a surgically made incision in the patient's abdominal wall. It allows visualization of the abdominal cavity and uterus to assist in hysterectomy. Uterine manipulators and cervical retractors exist and contain similar features.

[0004] However, some conventional uterine manipulators and cervical retractors have A mechanism or structural configuration for adequately maintaining pneumoperitoneum during a medical procedure (such as those described above). In addition, some conventional uterine manipulators and cervical retractors do not include To adequately fit and hold the balloon at the distal end of the inner tube or manipulator tube. In fact, such conventional uterine manipulators and vaginal cervical retractors The balloons of the catheter often gather in one place during assembly and may become dislodged during certain medical procedures. This raises potential safety and sterility concerns. The balloon and the vaginal neck retractor have a mechanism for passing dye other than through the slit in the balloon. The balloon is inflated using saline instead of gas.

[0005] Accordingly, mechanisms or structural arrangements have been developed to address these and other shortcomings of conventional devices. Improved methods for manipulation of the uterus and cervix in surgical and diagnostic procedures, including the creation of There is a need in the art for such devices and methods.

[0006] Disclaimer in Related Art section: Certain patents / publications / products are not included in this Background Art section. To the extent that these are discussed in the description of the application or elsewhere in this application, as an admission that the patent / publication / product is prior art for purposes of patent law. For example, some or all of the patents / publications / products discussed may have been disclosed early enough. may not reflect sufficiently early-developed subject matter; and / or may not be sufficiently capable to amount to prior art for purposes of patent law. The following patents / publications / products are cited in this Background section and / or throughout the application: As discussed above, the descriptions / disclosures thereof are incorporated herein by reference in their entirety. . Summary of the Invention

[0007] The present disclosure overcomes various problems (as described herein below) in conventional devices. Apparatus of the invention for the manipulation of the uterus and cervix in surgical and diagnostic procedures The present invention is directed to a method and apparatus for performing laparoscopic procedures. Total lower vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), minilap, abdominal Laparoscopic tubal occlusion or diagnostic laparoscopy (and as will be understood by those of skill in the art in light of this disclosure) of the uterus and fluid or gas infusion during laparoscopic procedures such as endoscopic procedures (and other similar procedures that should be considered) Equipment for the operation and for maintaining pneumoperitoneum by sealing the vagina during such procedures. Briefly, the present invention provides a uterine manipulator according to an embodiment. The device provides clear visibility of surgical landmarks and safe surgical margins from the pelvic wall. By creating excellent mobility of the uterus that maximizes the The device provides easier access to the cervix, away from the ureter. It displaces the bladder anteriorly, defines the anatomical plane of the vaginal incision, and is used during the incision procedure. It may be structured and / or configured to prevent loss of pneumoperitoneum (as described above). , for healthcare professionals to perform procedures in a consistent, predictable and repeatable manner. It would be beneficial to be able to approach such procedures with a high degree of confidence. I recognize and understand that.

[0008] In general, in one aspect, a uterine manipulator device includes an elongated catheter having a distal end and a proximal end. a cannula tube; and an upper distal portion of a first diameter positioned on the elongated cannula tube. and a cervical cup having a bottom proximal portion of a second smaller diameter; and an elongated cannula. At least one primary rib and a cervical cup positioned proximally on the cervical canal. and a closure having a body having at least two secondary ribs, and a closure assembly, the rib diameter being different than the primary rib diameter.

[0009] According to another aspect, the uterine manipulator device includes an elongated catheter having a distal end and a proximal end. A cannulated tube, the reference graduations being marked with a laser, is attached to the elongated cannulated tube. an elongated cannula-like tube positioned along an outer surface of the a top distal portion of a first diameter and a bottom proximal portion of a smaller second diameter. a cervical cup having a distal end and a proximal end of the cervical cup on an elongated cannula-like tube; and a closure assembly including a closure having a body positioned thereon.

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

[0011] As used herein for purposes of this disclosure, the terms "distal" and "proximal" refer to Used to describe the location of an embodiment of the 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 from the following detailed description taken in conjunction with the accompanying drawings, in which: It will be appreciated that the accompanying drawings depict only exemplary embodiments of the disclosed subject matter and are not intended to be limiting. Therefore, the disclosed subject matter may admit of other equally effective embodiments, and therefore should not be construed as limiting its scope. 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. or corresponding components and units, and are not to scale. The illustrated embodiment may be one or more of the figures, or a combination of the figures. It may include elements that result from a combination of DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Please refer to FIG. 1, which is a schematic diagram of a uterine manipulator device 100, in one embodiment. The uterine manipulator device 100 includes (from a proximal end 1 to a distal end 3) a handle 5. and positioned within the handle 5 (preferably through the proximal end and into the intrauterine balloon 25). A dye injection port 7 connected to the dye injection port 7 and a syringe (e.g., a 10 cc syringe, (not shown) is attached to the handle 5, and a pilot balloon 11 is attached to the handle 5 (preferably Preferably, through its distal end, an inflation valve 9 (communicatively coupled to the intrauterine balloon 25); , and a cannulated manipulator tube 13. 13 for manipulation of both retroverted and anteverted uteruses and for manipulation of the uterus at the proximal end. To maintain proper orientation of the device, the device 100 is curved at its distal end for easy introduction. At its proximal end, it is straight. The cannulated manipulator tube 13 is connected to the handle 5. (preferably at the distal end of the handle 5) and a dye injection port 7, an inflation valve 9, and a hand The manipulator tube 13 is connected to the pilot balloon 11 through the sacral Constructed to match the anatomical angle of the bone curve and allow for easy manipulation of the uterus It is smooth (as shown) and generally conforms to the user's hand; or Handles 5 (multiple) that provide for positioning of all four fingers on one side and thumb on the other grip / unsmooth surfaces, such as raised areas on the (which may include other non-smooth surface structures as understood by the arthritic surgeon) to guide the uterus upward, downward, and downward. This allows for easy sideways operation.

[0017] The uterine manipulator device 100 is positioned on the manipulator tube 13 to The system includes a manipulation / elevation mechanism that provides manipulation of the uterus and contraction and elevation of the cervix. These mechanisms include a cervical cup 23, an occluder assembly 18 including an occluder 19, and , stem 55, and lock assembly 39, each of which is connected to the manipulator tube. 13 and facilitating positioning on the manipulator tube 13, through which The closure assembly 18 and cervical cup 23 can be locked and unlocked in place. 4-5, as shown and described in more detail below. Each use of the lock assembly 39 prevents it from moving proximally on the manipulator tube 13. A cervical cup 23 is positioned adjacent to and on the distal end of the manipulator tube 13. 23 and includes 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 given below: As shown in Table 1.

[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. As shown, the cervical cup 23 has an upper distal portion having a first diameter. from a bottom proximal portion having a second smaller diameter including a central bore 85 having a periphery 87; The periphery tapers away from the chamfer / longitudinal axis A at the proximal end 87B. at the distal end 87A at an angle relative to the linear / longitudinal axis A. The chamfer on the periphery may be removed from the manifold. Assists in moving the cervical cup 23 along the endoscopic tube 13. Straight / Angled The uncovered periphery is due to the increased retention of the cervical cup 23 on the manipulator tube 13 and This helps prevent separation of the cup from the manipulator tube 13. Additionally, the diameter of the hole 85 is reduced. (2.15cm to 2.05cm). Straight / non-angled perimeter, The combination of the narrowing of the diameter of the hole 85 and the narrowing of the cervical cannula on the manipulator tube 13 The holding force of the cup 23 is significantly increased.

[0020] 3A, with manipulator tube 13 positioned therethrough. A side view of an exemplary embodiment of the closure plug 19 and stem 55 is shown. The method includes the steps of: keeping a gas (e.g., an injection gas) in the exposed cavity and maintaining the injection of gas in the cavity; Thus, the closure plug 19 is relatively small (e.g., less than 2.6'' in diameter) and It is preferable that the device be easy to insert and remove, and impermeable to gas. In form, the closure plug 19 is an open cell foam having a "skin" layer 28 (i.e., outer layer). , which allows the occluder 19 to be easily compressed for proper positioning. The uterine manipulator can be used to position the uterus after it has been properly positioned. It will expand to return to its original shape (as will be understood by those of skill in the art in conjunction with a review of this disclosure). The foam may also be configured to prevent leakage through the open cell foam. In some embodiments, the inner open cell foam and the outer layer may be constructed from the same material. Alternatively, the outer skin layer may be made of a different material and / or density (e.g., high density). and / or may have areas of different permeability than the inner open cell foam. For example, by changing the temperature of the mold for preparing the closure plug 19, This provides a denser outer skin layer and reduces the impermeability (as opposed to porosity) of the outer skin layer. This may result in an increase.

[0021] With further reference to FIG. 3A, the occluder plug 19 is elliptical in shape and has a number of ridges (or "ribs"). In the illustrated embodiment, the primary rib 27 having the largest diameter is located at the closure plug 19. The secondary rib 29 is located approximately centrally between the distal-most secondary rib 31 and the proximal-most secondary rib 32. 33 is positioned on either side tapering away from the center so that it has a minimum diameter. (forming an essentially symmetrical design). This symmetrical design allows for the insertion and The present invention provides an improved method for the provision of an occluder that facilitates insertion and removal while still performing the essential blocking / occluding function of the occluder. In an alternative embodiment, all secondary ribs 29 on either side of the primary rib 27 may be smaller. The bins are equally sized, having approximately the same diameter. In this embodiment, the secondary ribs 29 are spaced apart so as not to interfere with the sealing ability of the primary ribs 27 and to allow for the best possible closure. Conventional sealing mechanisms are not symmetrical and are usually generally smooth ( ie, lacking ribs or ridges), or may be tapered without ribs.

[0022] Referring now to FIG. 3B, the occluder 19 also provides a stent for distal and proximal insertion. The distal and / or proximal ends of the occluder 19 may be configured to prevent movement of the occluder 19 relative to the cam 55. In the illustrated embodiment, the anti-migration feature is a "barbell" The barbell features 35 on the distal and proximal ends of the occluder 19 are rigid plastic. The closure is constructed of sticks that are structured to maintain open cell foam between them. The plug 19 may also include a series of internal grooves 37 that are spaced apart from the minimum rib diameter of the closure plug 19. 50% or less of the smallest rib diameter of the closure plug 19, and may have a diameter of 25% or less of the smallest rib diameter of the closure plug 19. The size of the internal groove 37 aids in the compressibility of the closure plug 19 while The barbell feature 35 also prevents the occluder 19 from moving around its axis (as described above). While allowing the closure plug 19 to rotate about its axis, the internal groove 37 provides an additional structural feature. may be configured to prevent free movement, with or without The internal groove 37 also need not be configured as a structural feature that prevents the closure plug 19 from freely rotating. may have:

[0023] Referring to FIG. 3C, a schematic cross-sectional view of a closure plug 19' is shown in accordance with an alternative embodiment. The occluder 19' is configured to function in a similar manner to the occluder 19 in order to perform the specific functions described herein. For example, the forward / distal tip section 91 is cone-shaped and the distal Narrow at the end and wide / thick at the proximal end near the secondary rib 29' to allow for natural expansion of the anatomy (As should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure). The secondary rib 29' is located in the center between two small secondary ribs 29' and 29'. There may be more than one secondary rib. Each of the secondary ribs 29', 29' has the same thickness or thickness as one or more of the other secondary ribs 29'. The primary ribs 27' may be of different thicknesses. The primary ribs 27' are spaced apart from each of the secondary ribs 29', 29'. and the primary rib 27' is at least partially proximally during insertion or distally during removal. The primary ribs 27' are spaced apart from the secondary ribs 29', 29' to allow the folding. These secondary ribs 29' on either side of the primary rib 27' have a large diameter / thickness. , 29' is provided in the event that the primary rib 27' leaks or does not operate completely as required. , are configured and constructed to provide additional sealing capabilities. 9', 29' also have secondary ribs 29', 29' that fold completely downwardly when primary rib 27' is folded down. Rare (also acts as a prop), thus preventing the primary rib 27' from becoming ineffective and configured to provide additional support to primary rib 27'. It is composed of.

[0024] Referring to FIG. 3D, a fully assembled uterine manipulator according to an alternative embodiment. FIG. 3E shows a perspective view of a rotor device 100' according to an alternative embodiment. FIG. 3F is a side perspective view of a fully assembled uterine manipulator apparatus 100'; FIG. 1 is a side perspective view of the closure assembly 18' including the closure plug 19'. 100' includes the occluder plug 19' described above. All other components of the uterine manipulator device 100' All elements are the same or similar to uterine manipulator device 100.

[0025] 4, an enlarged front view of the lock assembly 39 is shown. Once in the desired position to block gas from escaping from the exposed cavity (this As should be understood by those skilled in the art in conjunction with the review of the above, the closure plug 19 is locked in place. (This also prevents proximal migration of the cervical cup 23). In the illustrated embodiment, the locking assembly 39 is closed at a desired position along the manipulator tube 13. A thumbscrew 41 is included in the collar 43 for securing the stopper 19. The user does not know how deep the screw is in the collar, so when loosening the screw Screws often fall out. Tighten and loosen screws without risk of losing the screw To allow for this, the thumbscrew 41 in the illustrated embodiment is shown modified. The thumbscrew 41 has vertical features up to the last two threads 45, 47. 51 are spaced approximately equidistantly. However, the last thread 47 is spaced apart from the last two threads. It has been over-torqued so that there is effectively no pitch between threads 45 and 47. There is no space between the last two threads 45 and 47, so thumbscrew 41 can be fully removed from collar 43. Therefore, the thumbscrew 41 can only be loosened and tightened. but cannot be completely removed from collar 43 to prevent loss of thumbscrew 41 The thumbscrew 41 shown in FIG. 4 is first placed in the collar 43 and then cold worked. The thumbscrew 41 is changed using a compression method (e.g., by overtorquing the thumbscrew on the anvil). The collar 43 can then be placed on the device 100. Or it may be larger than the hole through which the screw is placed (or the screw may back out of the hole). other blocking mechanisms (e.g., washers, nuts, plastics, etc.) that do not allow parts, and other threaded variations) are intended.

[0026] 5, an enlarged front view of collar 43 of lock assembly 39 is shown. Conventionally, the collar 43 has a threaded channel constructed from a soft Santoprene material. The Santoprene material is very elastic and can be easily pressed down until the screw bottom comes off. However, in the illustrated embodiment, the collar 43 is deformed into, for example, a threaded channel. 5 rings of hard plastic, polycarbonate and nylon overmolded into 3. The hard plastic ring 53 is shaped to fit the one-piece closure stem 55 design. 4, while allowing the thumbscrew 41 to be pressed against it.

[0027] 6A-6C, various schematics of the distal end 3 of the manipulator device 100 are shown. A schematic diagram is shown. At the distal end 3 of the manipulator device 100, a manipulator tube 13. The distal-most portion 57 of the manipulator tube 13 is the distal-most portion 57 of the manipulator tube 13, as discussed below. Several features of the distal most portion 57 of the manipulator tube 13 allow the manipulator It is preferred that the outer periphery of the inner periphery of the tube 13 has a diameter larger than that of the remainder of the tube 13 .

[0028] Looking first at FIG. 6A, a schematic cross-section (longitudinal axis) of the distal end 3 of the manipulator device 100 is shown. The intrauterine balloon 25 is located at the most distal end of the manipulator tube 13. A balloon 25 (e.g., a 10 cc inflatable balloon) is shown positioned on the The manipulator is configured and positioned to reduce the risk of uterine perforation. The balloon 25 is used to stabilize the catheter tube 13 within the uterine cavity. In one embodiment, the TPE balloon may be a styrene-butadiene (TPE) balloon. Based on the SEBS compound, a lock copolymer, TPE balloons offer superior strength and performance. Similar to a PVC balloon, it is constructed to maintain the balloon's inflation. Although the loon 25 is shown and described in conjunction with the uterine manipulator device 100, it is not intended to be construed as limiting the scope of the present invention. Conventional silicone or urethane balloons may be used. However, TPE balloons are Loon has a lower gas permeability than silicone balloons. Polypropylene is highly permeable to gases and may shrink. To counter this shrinkage, Saline is often used to expand the silicone since it is impermeable to saline. TPE balloons achieve similar performance by inflating the balloon with a gas. Gas is preferred if inflation can be maintained as it does not distort the bonds within the balloon as much as saline. However, at the user's option, the TPE balloon may be used in combination with saline. Good too.

[0029] With further reference to FIG. 6A, the intrauterine balloon 25 is connected to the manipulator tube 13 at its end. The balloon is covered with a distal portion 57. In conventional uterine manipulator devices, the balloon Glued in place (or other similar adhesive may be used) at both the proximal and distal ends In the embodiment shown in FIG. 6A, heat shrink 59 is used to seal the balloon to the metal tube. 2. Then, 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 tubing may be used. Preferably, TAB's HS-714 (acrylic polyolefin) heat shrink is 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 and other This makes it a superior form of adhesion means to traditional methods (e.g., adhesives). Heat shrink 59 offers many manufacturing and reliability advantages over the use of traditional adhesives. For example, heat shrink59 retains its properties throughout the sterilization process compared to adhesives. If the adhesive deteriorates and weakens, the balloon may slide and the patient may be This can lead to exposure to adhesive and 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. 3, the balloon 25 is sealed at a second location along the distal-most portion 57 of the rafter tube 13. 6A and 6C, the heat shrink also forms a mating collar 61 for sterilization purposes. It is also used to cover the entire manipulator tube 13 at the position of the collar 61 for A portion 63 of the balloon 25 is not covered with heat shrink 59 so that the balloon 25 can expand. With more brief reference to FIG. 6A, the uncovered portion 63 of the balloon 25 is adjacent to the substantially sealed cavity 65 between the pump tube 13 and the balloon 25. The lumen 67 allows gas to pass 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 and allows for dye injection. Inflation is facilitated without the introduction of dye into balloon 25 through port 7.

[0031] 6A-6C also show a cap 69 of the distal most portion 57 of the manipulator tube 13. FIG. 6C shows that the cap 69 is generally T-shaped, with a rounded portion 71 and a stem. FIG. 6A shows that the stem portion 73 of the cap 69 is connected to the manipulator. The rounded portion 71 is shown positioned within the manipulator tube 13. Extending across the diameter of the distal most portion 57 of the turret 13. Specifically, the radius of the cap 69 The diameter of the portion 71 extends beyond the diameter of the manipulator tube 13 and is fitted with a heat shrink collar. In the illustrated embodiment, the heat shrink collar 61 and the manipulator A gap 75 is shown between the manipulator tube 13. However, the heat shrink 59 When applied to the raterator tube 13 , the heat shrink 59 deforms and fills the gap 75 .

[0032] Returning to FIG. 6C, the cap 69 is formed by a rounded portion 71 and a stem portion The chamber 73 additionally includes a molded channel 77 for the passage of dye through both chambers 73. The proximal end 1 extends through the cap 69 to facilitate passage of the dye therethrough. from the dye injection port 7 through the manipulator tube 13 and cap 69 into the uterine cavity. Conventional caps are closed and utilize a slit in the balloon to allow dye to pass through. The slits in the balloon are open during manufacturing to create a passage for the material. The slit is closed via a seal prior to use. In some instances, the seal fails and the slit opens. In other instances, the closed cap However, in the experiment shown in Figure 6A, the adhesive was concentrated at the tip of the manipulator tube. The balloon 25 of the embodiment is completely separated from the manipulator tube 13 by the lumen 67. In particular, the dye passes through manipulator tube 13 and through channel 77 in cap 69. While gas flows through lumen 67, gas passes separately to inflate balloon 25. It is structured as follows.

[0033] 6D-6W, various views (perspective, top view) of an alternative embodiment of cap 69 are shown. These alternative embodiments of the cap 69 are shown in FIG. The embodiments include various structural configurations and multiple molded channels passing therethrough. For example, one or more The upper channel may pass through the center of the cap 69 on either side of the cap 69. , may contain branches into additional channels (which may be used to deliver dye to and from the oviduct). (which may aid in strategic distribution to specific anatomical structures, such as through

[0034] 6D-6G, various views of the cap 69 are shown having separate passages therethrough. Shown with multiple channels 77-1, 77-2, and 77-3.

[0035] 6H-6K, various views of the cap 69 show two additional channels 77. 77-3.

[0036] 6L-6O, various views of the cap 69 show four separate channels 77- 7, with a main channel 77-1 branching into 77-2, 77-3, 77-4 and 77-5. do.

[0037] 6P-6S, various views of the cap 69 are shown with respect to two portions on the top surface of the cap 69. 1, with a main channel 77-1 branching into additional open channels 77-2 and 77-3. It has been done.

[0038] 6T-6W, various views of the cap 69 are shown with the main open side channel 77-1 and 1, which shows that in use, the side channel 77-1 is connected to the cannulated tube 13 ( 5, a proximal end of a cap 69 fits within the interior of the housing 62 which is at least partially sealed by the proximal end of the cap 69.

[0039] 7, cap 69 is shown attached to the manipulator prior to application of heat shrink 59. The manipulator tube 13 is shown at its distal most portion 57 in the cap 69. In the illustrated embodiment, the retention feature 57 is adjacent the cap 6 9 and balloon 25. In the embodiment shown in FIG. Laser cut "W" feature or dimpled tab on manipulator tube 13 The "W" feature 79 captures the cap 69 inside the manipulator tube 13 ( As shown in Figure 6A. Conventionally, an adhesive such as a gel adhesive is used to fix the cap. However, the adhesive can deteriorate, causing the cap to become unsealed. According to one embodiment, the adhesive provides mechanical protection as described above. It can be used in conjunction with the "W" feature to assist in retention.

[0040] Referring now to FIG. 8, a side perspective view of uterine manipulator device 100 is shown. 1 and 2, with the closure assembly 18 removed to reveal the features of the manipulator tube 13. As shown in the illustrated embodiment, the manipulator tube 13 has a repeating reference scale 81. Set the cervical cup 23 so that it is 4 to 16 cm away from either side. The manipulator tube 13 is connected to the reference point from both the distal end 3 and the proximal end 1. The reference scale 81 is used to compare the calibrated uterine sounds. It may provide a guide for and assist in achieving the proper depth of insertion during use.

[0041] In conventional devices, the fiducials are added to the manipulator tube via a pad printing process. Pad printing can be done before application of heat shrink. Laser marking is typically It is cheaper than pad printing, but has the advantage that pad printing can be rubbed off, for example. Despite its advantages, laser marking is still more precise and permanent than traditional marking. Conventional lasers, such as fiber lasers or hybrid lasers, may be used in the practice of this invention. The heat shrink described as part of the embodiment cannot be laser marked, making it difficult to use conventional uterine mastectomy. However, in FIG. 8, the reference scale 81 is not used on the manipulator device. The heat shrink 59 is laser marked on the inserter tube 13. , the reference scale 81 is first applied to the manipulator tube 13 before being marked with a laser. Acrylic heat shrink allows a UV laser to mark the applied heat shrink layer. It has been found and understood by the present inventors that it is possible to achieve the above. successfully marks a thin layer of acrylate polyolefin on the manipulator tube 13. In such an embodiment, the UV laser is 355 nm. Other wavelengths from UV lasers can be used to successfully measure the reference scale 81. It is contemplated that such a method may be used.

[0042] 9A-9B, a schematic diagram of the handle 5 of the uterine manipulator device 100 is shown. The handle 5 is operated by applying a torque to the handle. In the illustrated embodiment, the anti-rotation feature is a square The anti-rotation features are overmolded key features 83 in a hexagonal shape. The hexagonal shape directs the force in both the X and Y directions within the handle. Thus, two faces of a hexagonal shaped key feature can be seen at once. In some cases, the hexagonal shaped key feature is more likely to split the handle when torque is applied. In the illustrated embodiment, the square overmolded key feature 83 is Instead of a square, it will only direct some force in one direction, either X or Y. The shaped overmolded key feature 83 is less likely to tear the handle 5 .

[0043] Use of the uterine manipulator devices described herein may be accomplished in accordance with U.S. Patent Application Publication No. 20170 No. 354436 (see, e.g., FIG. 4 and paragraph

[0028] ) Use of the uterine manipulator device is similar.

[0044] Although embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, The spirit of the invention is defined by the claims which may be supported by the written description and drawings. and that various changes in detail may be made without departing from the scope It will be appreciated by those skilled in the art that, even if the exemplary embodiments refer to a particular number of elements, As described, example embodiments may be implemented using any of the following specific numbers of elements: It will be understood that one can obtain

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; an intrauterine balloon including a proximal end and a distal end and positioned on the distal end of the elongated cannular tube, the proximal end and the distal end of the intrauterine balloon being secured to the elongated cannular tube by a layer of heat shrink material; A uterine manipulator device, wherein said layer of heat shrink material comprises a polyolefin acrylate layer.

2. The device of claim 1 , further comprising a handle positioned on the proximal end of the elongated cannulated tube.

3. 3. The apparatus of claim 2, further comprising an inflation valve positioned through said handle and communicatively coupled to a gas passage lumen of said elongated cannular tube.

4. 4. The apparatus of claim 3, further comprising a sealed cavity positioned between the elongated cannula tube and the intrauterine balloon and communicatively connected to the gas passage lumen.

5. 3. The device of claim 2, 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.

6. The device of claim 5 , wherein the elongated cannulated tube further comprises a mechanical retention feature configured to secure the cap to the elongated cannulated tube.

7. The device of claim 2 , further comprising a square key feature in the handle that directs applied force in only one direction.

8. The device of claim 1 , wherein the intrauterine balloon is constructed from a thermoplastic elastomer.

9. The device of claim 5 , wherein the cap includes proximal and distal ends and at least one channel therethrough.

10. The device of claim 9 , wherein the at least one channel extends through a side of the cap from the proximal end to the distal end of the cap.

11. The device of claim 9 , 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.

12. The apparatus of claim 11 , wherein the at least one channel branches into at least one additional channel.

13. 10. A method of manufacturing a uterine manipulator device as claimed in claim 1, comprising an elongated cannula-like tube having an outer surface, the method comprising: applying a layer of heat shrink material to the exterior surface of the elongated cannular tube; applying laser marked reference indicia along an exterior surface of the layer of heat shrink material on the elongated cannulated tube.

14. 14. The method of claim 13, wherein the laser marked fiducials are applied using a UV laser emitting a wavelength of 355 nm.

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