阅读说明：本技术 子宫操纵器 (Uterus manipulator ) 是由 吴晓 格雷戈里·奥科涅夫斯基 艾希礼·霍尔布鲁克 于 2019-01-22 设计创作，主要内容包括：一种子宫操纵器装置,包括：细长空心管,所述细长空心管具有近侧端部和远侧端部；宫颈杯,所述宫颈杯定位在所述细长空心管上,所述宫颈杯包括具有第一直径的顶部远侧部分和具有第二较小直径的底部近侧部分；以及封堵器组件,所述封堵器组件包括定位在所述细长空心管上在所述宫颈杯近侧的封堵器,所述封堵器具有主体,所述主体具有至少一个主肋和至少两个副肋,其中至少一个副肋的直径小于所述主肋的直径。(A uterine manipulator device comprising: an elongated hollow tube having a proximal end and a distal end; a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and an occluder assembly comprising an occluder positioned on the elongated hollow tube proximal to the cervical cup, the occluder having a body with at least one primary rib and at least two secondary ribs, wherein the diameter of at least one secondary rib is less than the diameter of the primary rib.)

1. A uterine manipulator device comprising: an elongated hollow tube comprising a proximal end and a distal end; a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and an occluder assembly comprising an occluder having a proximal end and a distal end positioned on the elongated hollow tube proximal to the cervical cup, the occluder having a body with at least one primary rib and at least two secondary ribs, wherein at least one secondary rib has a diameter less than the diameter of the primary rib.

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

2. The device of claim 1, wherein the occluder is spherical 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.

3. The device of claim 1, wherein the occluder is comprised of an open cell foam.

4. The device of claim 1, wherein the body of the occluding device comprises an outer skin having a density that is different from a density of a remainder of the body.

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

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

7. The device of claim 7, wherein the occluder assembly further comprises a groove positioned within the body of the occluder, the groove having a diameter less than or equal to 50% of the rib having the smallest diameter.

8. The device of claim 7, wherein the occluder assembly further comprises a groove positioned within the body of the occluder, the groove having a diameter less than or equal to 25% of the rib having a smallest diameter.

9. The device of claim 1, wherein the occluder assembly further comprises a locking assembly positioned on the elongated hollow tube proximal to the occluder, wherein the locking assembly is configured to lock the cervical cup and the occluder against movement in at least one direction along the elongated hollow tube.

10. The device of claim 10, wherein the locking assembly comprises a thumbscrew having a plurality of threads, the thumbscrew configured to lock into a collar, wherein at least one thread is deformed compared to the other threads.

11. The device of claim 11, wherein the collar is comprised of nylon.

12. A uterine manipulator device comprising:

an elongated hollow tube comprising a proximal end and a distal end, wherein a laser marked reference scale is positioned along an outer surface of the elongated hollow tube;

a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and

an occluder assembly comprising an occluder having a body positioned on the elongated hollow tube proximal to the cervical cup.

13. The device of claim 13, wherein the laser marked reference scale extends proximally and distally along the elongated hollow tube from a location between the proximal and distal ends of the elongated hollow tube.

14. The apparatus of claim 13, wherein the reference scale is laser marked with a UV laser emitting at 355nm wavelength.

15. The device of claim 13, wherein the reference markings are laser marked on an acrylated polyolefin layer positioned over the surface of the elongated hollow tube.

16. A uterine manipulator device comprising:

an elongated hollow tube comprising a proximal end and a distal end;

a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and

an intrauterine balloon comprising a proximal end and a distal end and positioned over the distal end of the elongated hollow tube, wherein the proximal end and the distal end of the intrauterine balloon are secured to the elongated hollow tube by a heat shrinkable material.

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

18. The device of claim 18, further comprising an inflation valve positioned through the handle and communicatively coupled to a gas passage lumen in the elongated hollow tube.

19. The device of claim 19, further comprising a closed cavity positioned between the elongated hollow tube and the intrauterine balloon and communicatively connected to the gas passage lumen.

20. The apparatus of claim 18, further comprising: a dye injection port positioned through the handle and communicatively coupled to the elongated hollow tube; and a cap positioned on the distal end of the elongated hollow tube.

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

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

23. The device of claim 17, wherein the intrauterine balloon is comprised of a thermoplastic elastomer.

24. The device of claim 21, wherein the cap includes a proximal end and a distal end, and at least one channel therethrough.

25. 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.

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.

27. The device of claim 27, wherein the at least one channel branches into at least one additional channel.

28. A method of manufacturing a uterine manipulator device comprising an elongate hollow tube having an outer surface, comprising the steps of:

applying a heat shrink layer to the outer surface of the elongated hollow tube, an

Applying a laser marked reference mark on the elongated hollow tube along the outer surface of the heat shrinkable layer.

29. The method of claim 29, wherein the laser marked reference scale is applied using a UV laser emitting at a 355nm wavelength.

30. The method of claim 29, wherein the heat-shrinkable layer comprises an acrylated polyolefin layer.

Technical Field

The present disclosure relates generally to devices and methods for manipulating the uterus and cervix during surgical and diagnostic procedures.

Background

Various conventional forms of uterine manipulator and vaginal cervical retractor are known. For example, U.S. patent No. 5,209,754 describes a vaginal cervical retractor generally consisting of a distal (to the practitioner using the device) semi-long curved outer shaft (corresponding to the curvature of the posterior pelvis) and a straight proximal half connected to a handle, an inner cover positioned within the outer cover and a disc at the distal end of the outer tube, and an inner plastic tube positioned through the outer tube and disc, the inner and outer covers (which in some conventional devices may include a cervical cup) having a balloon on the distal end. Vaginal cervical retractors are used to manipulate and visualize the uterus during various medical and laparoscopic procedures while maintaining pneumoperitoneum. Such examinations and procedures include full laparoscopic hysterectomies, partial laparoscopic hysterectomies, and colpotomies. When the vaginal cervical retractor manipulates the uterus during a complete, full-laparoscopic hysterectomy, for example, in part by positioning and inflating a balloon within the uterine cavity, capturing the vaginal vault in an inner cover, and maintaining the pneumoperitoneum by properly positioning the disc, a laparoscope may be inserted through a surgically created incision in the patient's abdominal wall to allow visualization of the peritoneal cavity and uterus, thereby facilitating the hysterectomy. Other conventional forms of uterine manipulator and vaginal cervical retractor exist and contain similar features.

However, some conventional uterine manipulators and vaginal cervical retractors do not include a mechanism or structural configuration sufficient to maintain pneumoperitoneum during a particular medical procedure (as described above). In addition, some conventional uterine manipulators and vaginal cervical retractors do not include a configuration that adequately fits and retains the balloon on the distal end of the inner tube or manipulator tube. Indeed, the balloons of such conventional uterine manipulators and vaginal cervical retractors often bunch up during assembly, which means certain potential safety and lack of sterility issues in certain medical procedures. In addition, conventional uterine manipulators and vaginal cervical retractors do not include a mechanism for passing dye other than through a slit in the balloon, and saline is used instead of gas to inflate the balloon.

Accordingly, there is a need in the art for improved devices and methods for manipulating the uterus and cervix during surgical and diagnostic procedures, including mechanisms or structural configurations for addressing each of these and other drawbacks of conventional devices.

Disclosure of Invention

The present disclosure is directed to inventive devices and methods for manipulating the uterus and cervix during surgical and diagnostic procedures that overcome various problems of conventional devices (as discussed herein and below). A particular non-limiting object utilizing the embodiments and implementations herein is to provide a device for manipulating the uterus and injecting fluids or gases during laparoscopic procedures, such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), full laparoscopic hysterectomy (TLH), small incisions, laparoscopic tubal occlusion or diagnostic laparoscopy (and other similar procedures as would be understood by one of ordinary skill in the art in connection with a review of this disclosure), and for maintaining pneumoperitoneum by sealing the vagina during these procedures. In short, the uterine manipulator device of embodiments maximizes safe operating margins from the pelvic wall by creating clear visibility of surgical landmarks and higher activity of the uterus, allowing the practitioner to more easily access critical surgical targets in the pelvic cavity. The results and configuration of the device can be designed to displace the cervix away from the ureter, displace the bladder forward, define the anatomical plane of the colpotomy and prevent loss of pneumoperitoneum during the colpotomy (as described above). Applicants have recognized and appreciated that it would be beneficial for a medical practitioner to be able to perform a consistent, predictable, and repeatable procedure with greater confidence.

In general, in one aspect, a uterine manipulator device comprises: an elongated hollow tube comprising a distal end and a proximal end; a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and an occluder assembly comprising an occluder positioned on the elongated hollow tube proximal to the cervical cup, the occluder having a body with at least one primary rib and at least two secondary ribs, wherein the diameter of at least one secondary rib is different from the diameter of the primary rib.

According to another aspect, a uterine manipulator device comprises: an elongated hollow tube comprising a distal end and a proximal end, wherein a laser marked reference scale is positioned along an outer surface of the elongated hollow tube; a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and an occluder assembly comprising an occluder having a body positioned on the elongated hollow tube proximal to the cervical cup.

According to another aspect, a uterine manipulator device comprises: an elongated hollow tube comprising a distal end and a proximal end; a cervical cup positioned on the elongated hollow tube, the cervical cup including a top distal portion having a first diameter and a bottom proximal portion having a second, smaller diameter; and an intrauterine balloon comprising a distal end and a proximal end and positioned over the distal end of the elongated hollow tube, wherein the distal end and the proximal end of the intrauterine balloon are secured to the elongated hollow tube with a heat shrink material.

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

Drawings

The invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the drawings. The drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments.

Referring now briefly to the drawings, wherein:

Fig. 1 is a top side perspective view of a fully assembled uterine manipulator device, according to one embodiment;

fig. 2 is a schematic cross-sectional view of a cervical cup of the uterine manipulator apparatus taken along line a-a of fig. 1, in accordance with one embodiment;

figure 3A is a side perspective view of an occluding device of a uterine manipulator device according to one embodiment;

figure 3B is a schematic side cross-sectional view of an occluder of a uterine manipulator device in accordance with one embodiment;

fig. 3C is a schematic cross-sectional view of an occluder of a uterine manipulator device in accordance with an alternative embodiment;

fig. 3D is a perspective view of a uterine manipulator device, according to an alternative embodiment;

fig. 3E is a side view of a uterine manipulator device, according to an alternative embodiment;

fig. 3F is a side view of an occluder assembly of a uterine manipulator device in accordance with an alternative embodiment;

fig. 4 is a close-up elevation view of a locking assembly of a uterine manipulator device, according to one embodiment;

fig. 5 is a close-up elevation view of a locking assembly of a uterine manipulator device with thumbscrews removed, according to one embodiment;

fig. 6A is a schematic cross-sectional view of a distal-most portion of a uterine manipulator device, according to one embodiment;

fig. 6B is a top view of a distal-most portion of a uterine manipulator device, according to one embodiment;

Fig. 6C is an exploded view of a distal-most portion of a uterine manipulator device, according to one embodiment;

fig. 6D-6W are various views (perspective, top, bottom, and side) of an alternative embodiment of a cover of a uterine manipulator device, according to an alternative embodiment;

fig. 7 is a close-up schematic view of a distal-most portion of a uterine manipulator device with a balloon removed, according to an embodiment;

figure 8 is a top side perspective view of the uterine manipulator device with the occluding device removed, according to one embodiment;

fig. 9A is a schematic cross-sectional view of a handle of a uterine manipulator device, according to one embodiment; and is

Fig. 9B is a close-up perspective cut-away view of a handle of a uterine manipulator device, according to one embodiment.

Where applicable, like reference numerals designate identical or corresponding parts and units throughout the several views, which are not drawn to scale unless otherwise indicated. Moreover, embodiments disclosed herein may include elements that appear in one or more of the several views or in a combination of the several views.

Detailed Description

Referring to fig. 1, in one embodiment, this figure is a schematic view of a uterine manipulator device 100. The uterine manipulator device 100 can include (from proximal end 1 to distal end 3) a handle 5, a dye injection port 7 positioned in the handle 5 (preferably through the proximal end and communicatively coupled to the intrauterine balloon 25), an inflation valve 9 of an attachable syringe (e.g., a 10cc syringe, not shown) (communicatively coupled to the intrauterine balloon 25), a guide balloon 11 attached to the handle 5 (preferably through the distal end), and a hollow manipulator tube 13. The hollow manipulator tube 13 is curved at its distal end and straight at its proximal end for easy introduction of the device 100 for manipulating the retroverted and anteverted uterus and for maintaining the proper posture of the uterus at the proximal end. The hollow manipulator tube 13 is connected to the handle 5 (preferably at the distal end of the handle 5) and is connected to the dye injection port 7, the inflation valve 9 and the guide balloon 11 through the handle 5. The manipulator tube 13 is configured to anatomically conform to the angle of the sacral curvature and allows for easy manipulation of the uterus. The handle 5 may be smooth (as shown) and generally conform to the hand of a user, or for positioning all four fingers on one side and the thumb on the opposite side (which may include a gripping/non-smooth surface, such as a plurality of raised portions or other non-smooth surface structure as would be understood by one of skill in the art in view of a review of this disclosure), allowing for easy manipulation of the uterus up, down and laterally.

Uterine manipulator device 100 includes a manipulation/lifting mechanism system positioned on manipulator tube 13 to manipulate the uterus, retract and lift the cervix. These mechanisms may include cervical cup 23 and occluder assembly 18 which includes occluder 19, rod 55 and locking assembly 39, each of which includes a hole therethrough to facilitate movement along and positioning on manipulator tube 13 (occluder assembly 18 and cervical cup 23 can be locked and unlocked in place and prevented from moving proximally on manipulator tube 13 each time locking assembly 39 is used, as shown and described in more detail below with respect to fig. 4-5). Cervical cup 23 is positioned on and adjacent to the distal end of manipulator tube 13, and may include a location/hole for suturing positioned through the side of cervical cup 23. Cervical cup 23 may comprise a variety of volumes and diameters, examples of which are shown in table 1 below:

TABLE 1

Volume of cervical cup	Diameter of cervical cup	Name of cervical cup
			9.7cm3(0.59in3)	32mm(1.26in)	S
14.3cm3(0.87in3)	34mm(1.34in)	M
			20.7cm3(1.26in3)	37mm(1.46in)	L
26.7cm3(1.63in3)	40mm(1.57in)	XL

Referring to fig. 2, in one embodiment, this is a schematic view of cervical cup 23 taken along line a-a of fig. 1. As shown, cervical cup 23 tapers from a top distal portion having a first diameter to a bottom proximal portion having a second, smaller diameter, which includes a central bore 85 having a periphery 87. The perimeter may be chamfered/angled from longitudinal axis a at proximal end 87B and may be straight/non-angled relative to longitudinal axis a at distal end 87A (the angle may be reversed). The peripheral chamfer facilitates movement of cervical cup 23 along manipulator tube 13. The straight/non-angled peripheral portion helps to increase the retention force of cervical cup 23 on manipulator tube 13 and helps to prevent cup detachment from manipulator tube 13. In addition, the diameter of the aperture 85 may be reduced (from 2.15cm to 2.05 cm). The combination of the straight/non-angled peripheral portion and the narrowed diameter hole 85 significantly increases the holding force of cervical cup 23 on manipulator tube 13.

Referring now to figure 3A, a side view of an illustrative embodiment of the occluding device 19 and a rod 55 through which the manipulator tube 13 is positioned is shown. The purpose of the stopper 19 is to keep gas (e.g. insufflation gas) in the exposed cavity to keep the cavity insufflated. Thus, the occluding device 19 should preferably be relatively small (e.g., less than 2.6 "in diameter), easy to insert and remove, and air-tight. In one embodiment, the occluding device 19 may be comprised of an open cell foam with a thin "skin" layer 28 (i.e., an outer layer) that allows the occluding device 19 to be easily compressed for proper positioning and configured to expand back to its original shape after being properly positioned during use of the uterine manipulator (as will be understood by one of ordinary skill in the art in view of a review of this disclosure), and also prevents leakage through the open cell foam. In one embodiment, the inner open-cell foam and the outer layer may be composed of the same material. However, the outer skin layer may alternatively have a different material and/or density (e.g., a higher density) and/or may be a region having a different permeability than the inner open-cell foam. For example, changing the temperature of the mold to make the stopper 19 may provide a thickened and denser outer skin layer, which may result in an increased impermeability (not porous) of the outer skin layer.

Still referring to fig. 3A, the occluding device 19 is spherical and includes a plurality of ridges (or "ribs"). In the depicted embodiment, the primary rib 27 with the largest diameter is located approximately at the center of the occluding device 19, and the secondary ribs 29 on either side taper in diameter away from the center so that the most distal secondary rib 31 and the most proximal secondary rib 33 have the smallest diameters (resulting in a substantially symmetrical design). This symmetrical design makes the occluding device 19 easier to insert and remove while still performing the basic occluding/occluding function of the occluding device. In an alternative embodiment, all of the secondary ribs 29 on either side of the primary rib 27 are smaller and/or equal in size, having approximately the same diameter. In the depicted embodiment, the secondary ribs 29 are configured so as not to interrupt the sealing capability of the primary ribs 27 and allow for an optimal plug closure. Conventional sealing mechanisms are not symmetrical and are generally completely smooth (i.e., without ribs or ridges) and may taper without ribs.

Turning now to fig. 3B, the occluding device 19 may further comprise an anti-airlock migration feature on a distal and/or proximal side thereof configured to prevent movement of the occluding device 19 in the distal and proximal directions relative to the shaft 55. In the depicted embodiment, the anti-migration feature is a "barbell" feature 35. Barbell features 35 on the distal and proximal ends of occluder 19 may be constructed of hard plastic and configured to hold open-cell foam therebetween. The occluder 19 may also comprise a series of internal grooves 37 which may have a diameter of less than or equal to 50%, preferably not more than 25%, of the minimum rib diameter of the occluder 19. The dimensions of the internal recess 37 contribute to the compressibility of the occluding device 19 while also preventing migration of the occluding device 19 (as described above). The barbell feature 35 allows the occluder 19 to rotate about its central axis, while the internal groove 37 may be (but need not be) configured to prevent the occluder 19 from migrating freely with or without additional structural features. The internal groove 37 may also have structural features that prevent the occluding device 19 from rotating freely.

Referring to fig. 3C, a schematic cross-sectional view of an occluding device 19' according to an alternative embodiment is shown. The occluding device 19' is shaped differently than the occluding device 19 in order to perform certain functions described herein. For example, the anterior/distal guide section 91 is conically shaped, narrower at the distal end and wider/thicker at the proximal end near the secondary rib 29', allowing for natural expansion of the anatomy (as will be understood by those of ordinary skill in the art in light of this disclosure). The main rib 27 ' is centered between the two smaller secondary ribs 29 ', 29 '. Each of the sub-ribs 29 ', 29 ' may have two or more, and may have the same thickness or different thicknesses from one or more other sub-ribs 29 '. The primary rib 27 'is spaced from each secondary rib 29', 29 'to allow the primary rib 27' to at least partially collapse proximally during insertion or distally upon removal. The primary ribs 27 ' are of greater diameter/thickness than the secondary ribs 29 ', 29 '. The configuration and structure of these secondary ribs 29 ', 29' present on either side of the primary rib 27 'are designed to provide additional sealing capability as may be needed in the event that the primary rib 27' leaks or otherwise does not function fully. However, the secondary ribs 29 ', 29 ' are also configured to provide additional support to the primary rib 27 ', such that the configuration and structure of the secondary ribs 29 ', 29 ' is designed to not allow the primary rib 27 ' to fully collapse (also referred to as acting as a strut), thereby preventing failure of the primary rib 27 '.

Turning to fig. 3D, a perspective view of a fully assembled uterine manipulator device 100' is shown, in accordance with an alternative embodiment. Fig. 3E is a side perspective view of a fully assembled uterine manipulator device 100 ' according to an alternative embodiment, and fig. 3F is a side perspective view of an occluder assembly 18 ' including an occluder 19 '. The uterine manipulator device 100 'comprises the occluder 19' described above. All other elements of uterine manipulator device 100' are the same as or similar to uterine manipulator device 100.

Turning now to fig. 4, a close-up elevation view of the locking assembly 39 is shown. Once the occluding device 19 is in a desired position to block gas from exiting the exposed cavity (as will be understood by those of ordinary skill in the art in light of a review of this disclosure), the occluding device 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 a collar 43 to secure the occluding device 19 in a desired position along the manipulator tube 13. With conventional screws, the depth of the screw in the collar is not known to use and therefore, when the screw is loosened, the screw often falls out. In order to allow tightening and loosening of the screws without risk of losing the screws, in the embodiment shown, the thumbscrews 41 are shown deformed. The illustrated thumbscrew 41 has the normal characteristics up to the last two threads 45, 47. The intermediate lines 51 are substantially equally spaced apart. However, the last thread 47 is over-twisted so that there is virtually no pitch between the last two threads 45, 47. The thumbscrew 41 cannot be completely removed from the collar 43 because there is no clearance between the last two threads 45, 47. Thus, although the thumbscrew 41 can be loosened and tightened, it cannot be completely removed from the collar 43, thereby preventing loss of the thumbscrew 41. The thumbscrew 41 shown in fig. 4 may be formed by first placing the thumbscrew 41 in a 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, other blocking mechanisms (e.g., washers, nuts, plastic pieces, other deformations of the screw) larger than the hole through which the screw is positioned (otherwise not allowing the screw to come out of the hole) may be considered.

Referring now to fig. 5, a close-up elevation view of collar 43 of locking assembly 39 is shown. Conventionally, collar 43 has a screw channel composed of soft santoprene (santoprene) material. The santoprene material has high elasticity and is easy to deform, so that the santoprene material can be pressed downwards until the screw is bottomed. However, in the depicted embodiment, the collar 43 has a ring 53, for example made of rigid plastic, polycarbonate, nylon, that is overmolded into the screw channel. The rigid plastic ring 53 allows the thumbscrew 41 to push against it while maintaining the shape of the integrated occluder rod 55 design.

Referring now to fig. 6A-6C, there are shown various views of a schematic of the distal end 3 of the manipulator device 100. The distal end 3 of the manipulator device 100 is the distal-most portion 57 of the manipulator tube 13. Due to several features of 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 remainder of the manipulator tube 13, as discussed below.

Turning first to fig. 6A, a cutaway (along the longitudinal axis) schematic view of the distal end 3 of the manipulator device 100 is shown. The intrauterine balloon 25 is shown positioned on the distal most portion of the manipulator tube 13. Balloon 25 (e.g., a 10cc inflatable balloon) is configured and positioned to reduce the risk of uterine perforation and to stabilize 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 SEBS compound. TPE balloons are similar in strength and performance to PVC balloons, and are designed in composition and configuration to maintain inflation of the balloon. Although TPE balloon 25 is shown and described in connection with uterine manipulator device 100, conventional silicone or urethane based balloons may also be used. However, TPE balloons are less permeable to gases than silicone balloons. Silicone balloons can shrink due to their higher permeability to gas. To resist shrinkage, saline is typically used to inflate the silicone balloon since saline does not penetrate. TPE balloons achieve similar performance by inflating the balloon with gas. The gas does not strain the keys in the balloon as saline does, so a gas is preferred if inflation can be maintained. However, TPE balloons can be used with saline at the option of the user.

Still referring to fig. 6A, intrauterine balloon 25 covers manipulator tube 13 on its distal-most portion 57. In conventional uterine manipulator devices, the balloon is glued in place on 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 in fig. 6A, a heat shrink 59 is used to cover the balloon over the manipulator tube 13 on both the proximal and distal ends of the balloon. Any commercially available heat shrink for insulating the tube may be used. In one embodiment, HS-714 (acrylated polyolefin) heat shrink from Insultab may be preferably used. The heat shrink may be colored to facilitate visibility of the laser scale markings. The heat shrinkable material adheres well to itself and to the metal manipulator tube 13, which makes it an excellent way of adhesion relative to other conventional methods (e.g., adhesives). The inventors have found that heat shrink 59 has many manufacturing and reliability advantages over conventionally used adhesives. For example, heat shrink 59 retains its properties better than an adhesive throughout the sterilization process. As the adhesive degrades and weakens, the balloon may slide, causing the patient to come into contact with the adhesive, and may also cause the balloon itself to fail.

The heat shrink shown in fig. 6B and 6C seals intrauterine balloon 25 at a first position and a second position along distal-most portion 57 of manipulator tube 13, forming a pair of loops 61 around balloon 25. As shown in fig. 6A and 6C, the heat shrink also serves to cover the entire manipulator tube 13 at the location of the collar 61 for sterilization purposes. A portion 63 of balloon 25 is not covered by heat-shrink 59 so that balloon 25 can be inflated. Turning briefly back to fig. 6A, uncovered portion 63 of balloon 25 is adjacent to substantially enclosed cavity 65 between manipulator tube 13 and balloon 25. Lumen 67 provides a path through manipulator tube 13 to deliver gas to balloon 25 through lumen 65. Lumen 67 provides a closed channel to balloon 25 to facilitate inflation without introducing dye from dye injection port 7 into balloon 25.

Also shown in fig. 6A-6C is a cover 69 at the distal-most portion 57 of the manipulator tube 13. Fig. 6C shows that the cover 69 is generally T-shaped, having a circular portion 71 and a stem portion 73. Fig. 6A shows the rod portion 73 of the cap 69 positioned within the steerer tube 13. The circular portion 71 extends across the diameter of the distal-most portion 57 of the manipulator tube 13. Specifically, the diameter of the circular portion 71 of the cap 69 extends beyond the diameter of the steerer tube 13 and out to a similar diameter of the heat shrink sleeve 61. In the embodiment shown, a gap 75 is shown between the heat shrink sleeve 61 and the manipulator tube 13. However, when the heat shrink 59 is applied to the manipulator tube 13, the heat shrink 59 will deform and fill in the gap 75.

Returning to FIG. 6C, the cover 69 also includes molded channels 77 for dye to pass through the circular portion of the cover 69 and the stem portions 71, 73. The channel 77 extends completely through the cover 69 to facilitate passage of dye therethrough. Dye may enter the uterine cavity from dye injection port 7 at proximal end 1 through manipulator tube 13 and cap 69. Conventional caps are closed and utilize slits in the balloon to form channels for the dye. The slits in the balloon are open during manufacture and are closed by a seal prior to use of the balloon. In some cases, the seal is not functional and the slit remains open, which renders the balloon inoperable. In other cases, the closed cap causes 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 due to the lumen 67. In particular, the dye flows through the manipulator tube 13 and through the channel 77 in the cap 69, while the gas is configured to flow solely through the lumen 67 to inflate the balloon 25.

Turning to fig. 6D-6W, various views (perspective, top, bottom, and side) of an alternative embodiment of the cover 69 are shown. These alternative embodiments of the lid 69 include a variety of structural configurations and a number of molded channels therethrough. For example, one or more channels may pass through the center of the cap 69 on either side of the cap 69, and may include bifurcations into additional channels (which may help strategically distribute dye to certain anatomical structures, such as to and through the fallopian tubes).

Referring to fig. 6D-6G, various views of the cover 69 with a plurality of channels 77-1, 77-2, and 77-3 individually passing therethrough are shown.

Referring to fig. 6H through 6K, various views of the cover 69 are shown with a main channel 77-1 that branches into two additional channels 77-2 and 77-3.

Referring to fig. 6L-6O, various views of the lid 69 are shown with a main channel 77-1 that branches into four separate channels 77-2, 77-3, 77-4, and 77-5.

Referring to fig. 6P-6S, various views of the lid 69 are shown with a main channel 77-1 that bifurcates into two additional open channels 77-2 and 77-3 on the top surface of the lid 69.

Referring to fig. 6T-6W, various views of the cap 69 are shown with the main open side channel 77-1, the side channel 77-1 being at least partially closed by the hollow tube 13 (into which the proximal end of the cap 69 fits) when in use.

Referring now to fig. 7, there is shown a cover 69 at 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 the lid 69. In the depicted embodiment, retention feature 57 is positioned between cover 69 and balloon 25. In the embodiment shown in fig. 7, the retention feature 79 is a laser cut "W" feature or recessed protrusion in the manipulator tube 13. The "W" feature 79 captures the cover 69 inside the steerer tube 13 (as shown in figure 6A). Conventionally, an adhesive such as a gel adhesive is used to fix the cover. However, the adhesive may deteriorate, and the cap may fall off and be lost in the patient. According to one embodiment, an adhesive may be used with the "W" feature to aid in mechanical retention as described above.

Turning now to fig. 8, a side perspective view of the uterine manipulator device 100 is shown with the occluder assembly 18 removed to show features of the manipulator tube 13. As shown in the depicted embodiment, manipulator tube 13 has a repeating set of reference scales 81 (e.g., moving 4cm to 16cm away from either side of cervical cup 23). Manipulator tube 13 may be marked with reference graduations 81 from both distal end 3 and proximal end 1. The reference scale 81 provides guidance for comparison with a scaled uterine sound and may help to obtain the correct insertion depth during use.

In conventional devices, the reference scale is added to the handling tube by a pad printing process. Pad printing may be performed prior to applying the heat shrink. Although laser marking is generally less expensive than pad printing, it is more accurate and more durable because, for example, pad printing can be wiped 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) described as part of the embodiments herein are not capable of laser marking heat shrinkable members. However, in fig. 8, the reference scale 81 is laser marked on the manipulator tube 13. In one embodiment, heat shrink 59 is first applied to manipulator tube 13 before reference scale 81 is laser marked. The inventors have discovered and recognized that acrylated heat shrink allows the uv laser to mark the applied heat shrink. Thus, in one embodiment, a thin layer of acrylated polyolefin is successfully marked on the manipulator tube 13 using an ultraviolet laser. In such embodiments, the UV laser emits a wavelength of 355 nm. It is contemplated that other wavelengths from the UV laser may be used to successfully create the reference scale 81.

Turning now to fig. 9A-9B, a schematic and perspective view of handle 5 of uterine manipulator device 100 is shown. The handle 5 has an anti-rotation feature that prevents the handle from twisting to allow manipulation. In the depicted embodiment, the anti-rotation feature is a square overmolded key feature 83. Traditionally, the anti-rotation feature is a hexagonal key feature. The hexagonal shape points the forces in both the X and Y directions within the handle. Thus, both facets of the hexagonal key feature are visible at the same time. In the case of forces in both the X and Y directions, the hexagonal key features are more likely to split the handle when twisted. In the embodiment shown, the square overmolded key features 83 direct some force only in the X-direction or Y-direction, rather than in both directions. Thus, the square overmolded key feature 83 is less likely to crack the handle 5.

The use of the uterine manipulator device described herein is similar to the use of the uterine manipulator device described in U.S. patent application No. 20170354436 (see, e.g., fig. 4, and paragraph [0028 ]).

While embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by the claims that may be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements, it will be understood that exemplary embodiments may be practiced with fewer or greater than the certain number of elements.