Uterine manipulator device

Abstract

Provided is a uterine manipulator device, comprising: an elongated tubular uterine manipulator tube comprising a proximal end and a distal end; a cervical cup having a proximal top portion of a first diameter and a distal bottom portion of a smaller second diameter, the distal bottom portion including a bore formed therein, the bore having a periphery including a distal end and a proximal end, the bore including a longitudinal axis therethrough, one of the proximal end and the distal end of the periphery is angled away from the longitudinal axis and the other is parallel to the longitudinal axis, the uterine manipulator tube passing through a hole in the cervical cup; a retention mechanism including a retention ring positioned on the uterine manipulator tube proximate the cervical cup, the retention ring configured to prevent detachment of the cervical cup from the uterine manipulator tube; and an intrauterine balloon positioned on the proximal portion of the uterine manipulator tube and having a proximal end positioned above the proximal end of the uterine manipulator device and a distal end positioned above the retention mechanism, and sufficiently mated and retained on the retention mechanism.

Description

[0001] This application is a divisional application of the application filed on June 8, 2017, with application number 201780035919.6 and invention title "Uterus Lifting Device".

[0002] Cross-reference to related applications

[0003] This application claims priority and benefit to U.S. Provisional Patent Application No. 62 / 347781, filed June 9, 2016, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to methods and apparatus for manipulating the uterus and cervix during surgical and diagnostic procedures. Background Technology

[0005] Various common forms of uterine manipulators and vaginal cervical retractors are known. For example, U.S. Patent No. 5,209,754 describes a vaginal cervical retractor that generally comprises: an outer shaft (corresponding to the curvature of the posterior pelvis) curved proximally (towards the patient) and a straight distal half connected to a handle; an inner cap positioned within an outer cap and a circular disc located at the proximal end of the outer tube; and a plastic inner tube positioned through the outer tube and the circular disc, the inner cap, and the outer cap (which, in some conventional devices, may include a cervical cup), the outer cap having an air bladder at its proximal end. Vaginal cervical retractors are used to manipulate and visualize the uterus while maintaining pneumoperitoneum during various medical examinations and laparoscopic procedures. Such examinations and procedures include full laparoscopic hysterectomy, laparoscopic partial hysterectomy, and vaginostomy. During a complete laparoscopic hysterectomy, vaginal and cervical retractors are used to manipulate the uterus, for example, by positioning and inflating a balloon within the uterine cavity, capturing the vaginal fornix within its inner lining, and maintaining pneumoperitoneum by appropriately positioning a disc-shaped component. A laparoscope can be inserted through a surgically created incision in the patient's abdominal wall to allow visualization of the peritoneal cavity and uterus, thus assisting in the hysterectomy. Other common forms of uterine manipulators and vaginal and cervical retractors exist and contain similar features.

[0006] However, some common uterine manipulators and vaginal cervical retractors do not include mechanisms or structures for adequately maintaining the cervical cup on the manipulator tube or inner tube during certain medical procedures (as described above). Furthermore, some common uterine manipulators and vaginal cervical retractors do not include structures for adequately engaging and holding the balloon on the proximal end of the manipulator tube or inner tube. In fact, due to certain potential safety concerns during certain medical procedures, the balloons of these common uterine manipulators and vaginal cervical retractors often clump together during assembly.

[0007] Therefore, 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 structures for adequately maintaining a cervical cup on a manipulator tube or inner tube, and structures for adequately engaging and maintaining a balloon on the proximal end of the manipulator tube or inner tube.

[0008] Description of the disclaimer regarding the relevant field: With regard to the specific patents / publications / products discussed in this Background section or other parts of this application, such discussions should not be construed as an admission that the patents / publications / products discussed are prior art for patent law purposes. For example, all or part of the patents / publications / products discussed may not be early enough, may not reflect research topics that were early enough, and / or may not adequately constitute prior art for patent law purposes. With regard to the specific patents / publications / products discussed in this Background section and / or throughout this application, their descriptions / disclosures are incorporated herein by reference in their entirety. Summary of the Invention

[0009] This disclosure relates to methods and apparatus for manipulating the uterus and cervix during surgical and diagnostic procedures. Various embodiments and implementations herein relate to uterine manipulator devices comprising a manipulator tube and a cervical cup having an aperture feature (preferably centrally located) at the bottom of the cervical cup through which the manipulator tube is positioned. The distal portion of the outer periphery of the aperture feature may (but is not required to) bevel (i.e., angled to the longitudinal axis through which the aperture is positioned) to facilitate sliding of the cup along the axis of the manipulator tube. Alternatively, the proximal portion of the outer periphery may be straight and not beveled / angled to the longitudinal axis to increase the retention force of the cup on the manipulator tube and to help prevent the cup from detaching from the manipulator tube. Other combinations of beveled and non-beveled structures are contemplated (as should be understood by those skilled in the art in conjunction with the comments of this disclosure). For example, the distal portion of a hole may be chamfered, and the proximal portion may be straight / not angled, or each of the distal and proximal portions may be partially chamfered (which may or may not be chamfered by the same amount).

[0010] Other embodiments and implementations of this document relate to a device including an airbag tapered (or angled away from the longitudinal axis) at its distal end to fully engage with a portion of a cup-shaped retention mechanism positioned on the proximal portion of the uterine device and to hold the airbag on the cup-shaped retention mechanism.

[0011] The specific, non-limiting objective of utilizing the embodiments and implementations herein is to provide a device for manipulating the uterus and injecting fluids or gases during hysteroscopic procedures such as hysteroscopic-assisted vaginal hysterectomy (LAVH), hysteroscopic total hysterectomy (TLH), minilap, hysteroscopic tubal obstruction or diagnostic laparoscopy (and other similar procedures that should be understood by those skilled in the art in conjunction with the comments of this disclosure), and maintaining pneumoperitoneum by sealing the vagina during these procedures. In short, the uterine manipulator device of the embodiments allows medical practitioners easier access to key surgical targets in the pelvic cavity by creating clearly visible surgical landmarks and excellent uterine mobility that maximizes the safe surgical boundaries from the pelvic wall. The device can be constructed and / or configured to move the cervix away from the uterus, anterriorily displace the bladder, define the anatomical plane of the vaginoplasty, and prevent loss of pneumoperitoneum during the vaginoplasty (as described above). The applicant has recognized and understands that what would be beneficial for healthcare practitioners is the ability to implement this process with greater confidence in executing a consistent, predictable, and repeatable process.

[0012] Typically, in one aspect, a uterine manipulator device includes: an elongated tubular tube comprising a proximal end and a distal end; a cervical cup having a proximal top portion of a first diameter and a distal bottom portion of a smaller second diameter, wherein: the distal bottom portion includes a hole formed therein, the hole having an outer periphery including the distal end and the proximal end, and the hole including a longitudinal axis positioned through the hole; one of the proximal end and the distal end of the outer periphery is angled away from the longitudinal axis, and the other of the proximal end and the distal end of the outer periphery is aligned with the longitudinal axis; and the elongated tubular tube is positioned through the hole in the cervical cup.

[0013] According to another aspect, the uterine manipulator device includes: an elongated tubular tube including a proximal end and a distal end; a cervical cup having a proximal top portion of a first diameter and a distal bottom portion of a smaller second diameter, wherein: the distal bottom portion includes a hole formed therein, the hole having a periphery including the distal and proximal portions and including a longitudinal axis positioned through the hole; the elongated tubular tube being positioned through the hole in the cervical cup; the uterine manipulator device further includes a retention mechanism positioned close to the cervical cup on the elongated tubular tube, wherein the retention mechanism is configured to prevent the cervical cup from detaching from the uterine manipulator tube; and the uterine manipulator device includes an intrauterine balloon positioned on the proximal end of the elongated tubular tube and having a proximal end and a distal end, wherein the distal end of the intrauterine balloon is angled away from the longitudinal axis.

[0014] As used herein for the purposes of this disclosure, the terms “distal” and “proximal” are used to describe the location of embodiments of the device from the patient’s perspective. Attached Figure Description

[0015] The invention will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings. The drawings illustrate only typical embodiments of the disclosed subject matter and should not be construed as limiting its scope, as the disclosed subject matter allows for other equally effective embodiments.

[0016] Now, please briefly refer to the attached diagram, in which:

[0017] Figure 1 This is a schematic diagram of a uterine lifting device according to an embodiment.

[0018] Figure 2A This is a schematic diagram of the proximal end of the uterine lifting device according to an embodiment.

[0019] Figure 2B It is along the embodiment Figure 1 A schematic diagram of the cervical cup-shaped component of the uterine lifting device, as shown in section A---A.

[0020] Figure 3A This is a schematic diagram of the proximal end of the uterine lifting device according to an embodiment.

[0021] Figure 3B It is along the embodiment Figure 3A A schematic diagram of the intrauterine air sac of the uterine lifting device, as shown in section A---A.

[0022] Figure 4 This is a schematic diagram illustrating the use of the uterine lifting device according to an embodiment.

[0023] Where applicable, the same reference numerals in several views indicate the same or corresponding parts and units, unless otherwise indicated, they are not to scale. Furthermore, the embodiments disclosed herein may include elements appearing in one or more views or in a combination of views. Detailed Implementation

[0024] refer to Figure 1The diagram below illustrates a uterine manipulator device 100 in one embodiment. The uterine manipulator device 100 may include (from distal end 1 to proximal end 3): a handle 5; a dye injection port 7 positioned within the handle 5 (preferably passing through the distal end and communicatively connected to an intrauterine balloon 25); an inflation valve 9 (communically connected to the intrauterine balloon 25), to which a syringe (e.g., a 10cc syringe, not shown) may be attached, and an indicator balloon 11 is attached to the handle 5 (preferably passing through the proximal end); and a cylindrical uterine manipulator tube 13. The cylindrical uterine manipulator tube 13 is curved at its proximal end and straight at its distal end to facilitate insertion of the device 100, to manipulate retroverted and anteverted uteri, and to maintain a proper uterine position at the distal end. The cylindrical uterine manipulator tube 13 is connected to the handle 5 (preferably at the proximal end of the handle 5) and passes through the handle 5 to the dye injection port 1, the inflation valve 9, and the indicator balloon 11. The uterine manipulator 13 is configured to anatomically conform to the angle of the sacral flexion and to allow for easy manipulation of the uterus. The uterine manipulator 13 may be marked with reference graduations (not shown) starting from the proximal end 3. These graduations may be scaled for comparison with a graduated uterine probe, and the graduations may help determine the appropriate insertion depth during use. The handle 5 may be configured for positioning all four fingers on one side and the thumb on the opposite side (it may include a gripping / non-smooth surface, such as multiple raised portions or other non-smooth surface structures, as should be understood by those skilled in the art in conjunction with the comments of this disclosure), and this handle allows for easy upward, downward, and lateral manipulation of the uterus.

[0025] The uterine manipulator device 100 includes a cup-shaped lifting system positioned on the manipulator tube 13 (positioned to pass through a hole formed at the bottom of each cup-shaped member) to provide manipulation of the uterus and lifting and withdrawal of the cervix. These cup-shaped lifting members may include a vaginal cup-shaped member 19 and a cervical cup-shaped member 23. The vaginal cup-shaped member 19 is tapered from a distal top portion having a first diameter to a proximal bottom portion having a smaller second diameter, and may include a cylindrical / tubular tail 21 positioned outside the manipulator tube 13. A locking assembly is positioned distal to the tubular tail 21 and includes a cylindrical portion 17 and a finger screw 15. The cervical cup-shaped member 23 is positioned on the proximal end of the manipulator tube 13 and may include a suture site / hole positioned through the side of the cervical cup-shaped member 23. Cervical cup-shaped members may include various volumes and diameters, examples of which are shown in Table 1 below.

[0026]

[0027] An intrauterine balloon 25 is also shown, positioned on the proximal portion of the uterine manipulator 13. This balloon (e.g., a 10cc inflatable balloon) is constructed and positioned to reduce the risk of uterine perforation and to stabilize the uterine manipulator 13 within the uterine cavity 303 during use (see [link]). Figure 4 ).

[0028] Go to Figure 2A In one embodiment, a schematic diagram of the proximal end 3 of the uterine manipulator device 100 is shown. The vaginal cup 19 and cervical cup 23 have been removed to show a retention mechanism for the cervical cup 23 positioned on the uterine manipulator tube 13. This retention mechanism includes a retention ring 27 laterally connected to heat-shrinkable tubing portions 29 and 31 (configured to retain the retention ring in its proper position on the uterine manipulator tube 13). In short, the retention ring 27, together with the heat-shrinkable portions 29 and 31, is positioned on the uterine manipulator tube 13 and configured to prevent the cervical cup 23 from detaching from the uterine manipulator tube 13. The intrauterine balloon 25 is also removed from FIG. 2, and by removing the intrauterine balloon 25, the proximal portion of the uterine manipulator tube 13 is exposed. This proximal portion includes an opening and a proximal end connected to the inflation valve tube 33 and an indicator balloon 11 for inflating the intrauterine balloon 25, leading to the dye injection port 7.

[0029] refer to Figure 2B In one embodiment, it is along Figure 1 A schematic diagram of the cervical cup-shaped member 23 cut from section A-A. As shown, the cervical cup-shaped member 23 is tapered from a proximal top portion having a first diameter to a distal bottom portion having a smaller second diameter, the distal bottom portion including a central hole 37 with a periphery 35. The periphery is chamfered / angled away from the longitudinal axis A at the distal end 35B, and is straight / not angled relative to the longitudinal axis A at the proximal end 35A. The chamfering of the periphery facilitates the movement of the cervical cup-shaped member 23 along the uterine manipulator tube 13. The straight / not angled periphery helps increase the retention force of the cervical cup-shaped member 23 on the uterine manipulator tube 13 and helps prevent the cup-shaped member from detaching from the uterine manipulator tube 13. In addition, the diameter of the hole 37 is reduced (from 2.15 cm to 2.05 cm). The combination of the straight / non-angled outer peripheral portion and the narrowing diameter of the orifice 37 significantly increases the retention force of the cervical cup 23 on the uterine manipulator tube 13.

[0030] Go to Figure 3A A schematic diagram of the proximal end 3 of the uterine manipulator device 100 in one embodiment is shown. The vaginal cup 19 and cervical cup 23 have been removed. An intrauterine balloon 25 is shown, having a proximal end 25A positioned on the proximal end 3 of the device 100 and a distal end 25B positioned on the retention mechanism.

[0031] refer to Figure 3B In one embodiment, it is along Figure 3A A schematic diagram of the cervical cup-shaped member 25 cut from section A---A. As shown, the distal end 25B of the intrauterine balloon 25 is bent out from the longitudinal axis by a certain amount to fully fit onto a portion of the retention mechanism and hold the intrauterine balloon 25 on the cup-shaped member retention mechanism. This structure and construction of the distal end 25B of the intrauterine balloon 25 facilitates the proper and neat assembly of the intrauterine balloon 25 on the device 100 (without clumping).

[0032] refer to Figure 4 The diagram illustrates the use of the uterine manipulator device 100 in one embodiment. The device is positioned through the vagina 305, with the intrauterine balloon 25 within the uterine cavity 303 and the vaginal fornix 301 positioned within the cervical cup 23. After the intrauterine balloon 25 is positioned within the uterine cavity 303, a syringe is attached to the inflation valve 9 to inflate the intrauterine balloon 25 (using, for example, 7 cc of air and up to, for example, 10 cc of air). The syringe is then removed to prevent the intrauterine balloon 25 from spontaneously deflating due to posterior pressure. The cervical cup 23 then slides proximally along the manipulator tube 13 until its outer edge surrounds the vaginal fornix 301 (as shown). Optionally, the cervical cup 23 can be sutured in place. The vaginal cup 19 then slides proximally along the uterine manipulator tube 13 until it meets the distal edge of the cervical cup 23 and is fully abutted against the vaginal wall 305 and configured, constructed, and / or positioned to ensure pneumoperitoneum is maintained as needed. The locking assembly slides proximally to meet the cylindrical / tubular tail 21 of the vaginal cup 19 and is secured in position by rotating a finger screw until it is tightened. Uterine manipulation can then be performed as necessary according to a specific procedure (as should be understood by one of ordinary skill in the art in conjunction with the comments of this disclosure), and various devices, including visualization and other surgical instruments (200, 201), can be inserted through an incision made in the patient's abdomen.

[0033] While embodiments of the invention have been specifically shown and described with reference to eight particular exemplary embodiments, those skilled in the art will understand that various changes in detail may be made without departing from the spirit and scope of the invention as defined by the claims supported by the written description and drawings. Furthermore, in the context of describing exemplary embodiments with reference to a specific number of elements, it will be understood that exemplary embodiments may be implemented using fewer or more than a certain number of elements.

Claims

1. An uterine manipulator device comprising: an elongated, tubular uterine manipulator tube including a proximal end and a distal end; a cervical cup having a proximal top portion of a first diameter and a distal bottom portion of a second, smaller diameter, wherein: the distal bottom portion includes a bore formed therein, the bore having an outer periphery including a distal end and a proximal end, and the bore including a longitudinal axis positioned therethrough; the proximal end of the outer periphery is angled away from the longitudinal axis and the distal end of the outer periphery is parallel to the longitudinal axis; and the elongated, tubular uterine manipulator tube is positioned through the bore in the cervical cup; a retention mechanism including a retention ring positioned on the elongated, tubular uterine manipulator tube proximal to the cervical cup, wherein the retention ring is configured to prevent the cervical cup from disengaging from the uterine manipulator tube; and an intrauterine balloon positioned on a proximal most portion of the elongated, tubular uterine manipulator tube and having a proximal end positioned superior to the proximal end of the uterine manipulator device and a distal end positioned superior to the retention mechanism, the intrauterine balloon fitting over and retained by the retention mechanism.

2. The apparatus of claim 1, wherein, the proximal end of the elongated, tubular uterine manipulator tube is non-linear.

3. The apparatus of claim 1, further comprising a vaginal cup positioned on said elongated tubular uterine manipulator tube distally from the cervical cup, wherein, the vaginal cup includes a distal top portion having a first diameter and a proximal bottom portion having a second, smaller diameter, and the vaginal cup is configured to maintain pneumoperitoneum during use.

4. The device of claim 3, further comprising a locking assembly positioned distal to the vaginal cup, the locking assembly configured to lock the cervical cup and vaginal cup in their positions during use.

5. The apparatus of claim 1, wherein, the retention mechanism further includes a heat-shrunk ring positioned on the elongated, tubular uterine manipulator tube proximal to the retention ring.

6. The apparatus of claim 1, wherein, the distal end of the intrauterine balloon is angled away from the longitudinal axis.

7. The device of claim 6, further comprising a handle positioned on the distal end of the elongated, tubular uterine manipulator tube.

8. The device of claim 7, further comprising an inflation valve positioned through the handle and communicatively coupled to the intrauterine balloon.

9. The device of claim 7, further comprising a dye injection port positioned through the handle and communicatively coupled to the intrauterine balloon.

10. An uterine manipulator device comprising: an elongated, tubular uterine manipulator tube including a proximal end and a distal end; a cervical cup having a proximal top portion of a first diameter and a distal bottom portion of a second, smaller diameter, wherein: the distal bottom portion includes a bore formed therein, the bore having an outer periphery including a distal end and a proximal end, and the bore including a longitudinal axis positioned therethrough; one of the proximal end of the outer perimeter and the distal end of the outer perimeter is angled away from the longitudinal axis, and the other of the proximal end of the outer perimeter and the distal end of the outer perimeter is parallel to the longitudinal axis; and the elongated tubular uterine manipulator tube is positioned through the hole in the cervical cup; a retention mechanism positioned on the elongated tubular uterine manipulator tube proximal to the cervical cup, wherein the retention mechanism is configured to prevent the cervical cup from disengaging from the uterine manipulator tube; and an intrauterine balloon positioned on a proximal-most portion of the elongated tubular uterine manipulator tube and having a proximal end positioned above a proximal end of the uterine manipulator device and a distal end positioned above the retention mechanism, the intrauterine balloon fitting over and retained on the retention mechanism, wherein the distal end of the intrauterine balloon is angled away from the longitudinal axis.

11. The apparatus of claim 10, wherein, the proximal end of the elongated tubular uterine manipulator tube is non-linear.

12. The apparatus of claim 10, further comprising a vaginal cup positioned on said elongated tubular uterine manipulator tube distally from said cervical cup, wherein, the vaginal cup includes a distal top portion having a first diameter and a proximal bottom portion having a second, smaller diameter, and the vaginal cup is configured to maintain pneumoperitoneum during use.

13. The device of claim 12, further comprising a locking assembly positioned distally from the vaginal cup, the locking assembly configured to lock the cervical cup and the vaginal cup in position during use.

14. The apparatus of claim 10, wherein, the retention mechanism includes a retention ring.

15. The apparatus of claim 14, wherein, the retention mechanism further includes a heat-shrunk ring positioned on the elongated tubular uterine manipulator tube proximal to the retention ring.

16. The device of claim 10, further comprising a handle positioned on the distal end of the elongated tubular uterine manipulator tube.

17. The device of claim 16, further comprising an inflation valve positioned through the handle and communicatively coupled to the intrauterine balloon.

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