US-12616504-B2 - Uterine manipulator

US12616504B2US 12616504 B2US12616504 B2US 12616504B2US-12616504-B2

Abstract

A uterine manipulator device includes: an elongated cannulated tube having proximal and distal ends, a cervical cup 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 comprising an occluder positioned proximally from the cervical cup on the elongated cannulated tube, the occluder having a body with at least one primary rib and at least two secondary ribs, wherein a diameter of at least one secondary rib is smaller than the diameter of the primary rib.

Inventors

Xiao Wu
Gregory Okoniewski
Ashley Holbrooks

Assignees

CONMED CORPORATION

Dates

Publication Date: 20260505
Application Date: 20230717

Claims (15)

1 . A uterine manipulator device, comprising: an elongated cannulated tube comprising a proximal end and a distal end; a cervical cup positioned on the elongated cannulated tube having a top distal portion of a first diameter and a base proximal portion of a second smaller diameter; an intrauterine balloon comprising a proximal end and a distal end and being positioned on the distal end of the elongated cannulated tube, wherein the proximal end and the distal end of the intrauterine balloon are secured to the elongated cannulated tube with heat shrink material; a spheroid shaped occluder having a first side and a second side and positioned on a stem positioned proximally from the cervical cup on the elongated cannulated tube, wherein the spheroid shaped occluder includes an opening allowing passage therethrough of the elongated cannulated tube; and a first barrier rib positioned on the elongated cannulated tube and adjacent to the first side of the spheroid shaped occluder, and a second barrier rib positioned on the elongated cannulated tube and adjacent to the second side of the spheroid shaped occluder.
2 . The device of claim 1 , further comprising a handle positioned on the proximal end of the elongated cannulated tube.
3 . The device of claim 2 , further comprising an inflation valve positioned through the handle and communicatively coupled to a gas passage lumen in the elongated cannulated tube.
4 . The device of claim 2 , further comprising an enclosed cavity positioned between the elongated cannulated tube and the intrauterine balloon, and which communicatively connects to the gas passage lumen.
5 . 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 retaining feature configured to secure the cap to the elongated cannulated tube.
7 . The device of claim 5 , wherein the cap comprises a proximal end and a distal end, and at least one channel passing therethrough.
8 . The device of claim 7 , wherein the at least one channel extends through a side of the cap from the proximal end to the distal end of the cap.
9 . The device of claim 7 , 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.
10 . The device of claim 9 , wherein the at least one channel bifurcates into at least one additional channel.
11 . The device of claim 2 , further comprising a square key feature in the handle which directs an applied force in one direction only.
12 . The device of claim 1 , wherein the intrauterine balloon is composed of a thermoplastic elastomer.
13 . A method of manufacturing the uterine manipulator device of claim 1 , comprising the steps of: applying a layer of heat shrink to the outside surface of the elongated cannulated tube, and applying laser mark reference graduations along an outside surface of the heat shrink on the elongated cannulated tube.
14 . The method of claim 13 , wherein the laser mark reference graduations are applied using a UV laser emitting a wavelength of 355 nm.
15 . The method of claim 13 , wherein the heat shrink layer comprises an acrylated polyolefin layer.

Description

CROSS REFERENCE TO RELATED APPLICATION The present application is a continuation of U.S. patent application Ser. No. 16/910,311, filed Jun. 24, 2020, which claims priority to and the benefit of U.S. patent application Ser. No. 15/899,427, filed Feb. 20, 2018, now U.S. Pat. No. 10,695,092, the entirety of which is incorporated herein by reference. FIELD OF THE INVENTION The present disclosure relates generally to devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures. BACKGROUND Various conventional forms of uterine manipulators and vaginal cervical retractors are known. For example, U.S. Pat. No. 5,209,754 describes a vaginal cervical retractor generally consisting of a distal (to the medical practitioner using the device) half-length curved outer shaft (corresponding to the curve of the posterior pelvis) and a straight proximal half connected to a handle, an inner cap positioned within an outer cap and a circular disc located at the distal end of the outer tube, and an inner plastic tube positioned through the outer tube and the circular disc, inner cap and outer cap (which can include one cervical cup in certain conventional devices) with a balloon on the distal end. The vaginal cervical retractor is used to maneuver and visualize the uterus during various medical examinations and laparoscopic procedures while maintaining pneumoperitoneum. Such examinations and procedures include a complete, total laparoscopic hysterectomy, a partial laparoscopic hysterectomy, and a colpotomy. While the vaginal cervical retractor maneuvers the uterus during a complete, total laparoscopic hysterectomy, for example, by, in part, positioning and inflating the balloon within the uterine cavity, capturing the vaginal fornix in the inner cap, and maintaining the pneumoperitoneum by properly positioning the disc, a laparoscope can be inserted through a surgically formed incision in the wall of the patient's abdomen to allow for visualization of the peritoneal cavity and the uterus to assist with the hysterectomy. Other conventional forms of uterine manipulators and vaginal cervical retractors exist and contain similar features. However, some conventional uterine manipulators and vaginal cervical retractors do not include a mechanism or structural configuration to sufficiently maintain pneumoperitoneum during a particular medical procedure (as described above). Additionally, some conventional uterine manipulators and vaginal cervical retractors do not include a configuration to sufficiently fit and retain the balloon on the distal end of the inner or manipulator tube. Indeed, the balloon of such conventional uterine manipulators and vaginal cervical retractors often bunches up during assembly implicating certain potential safety and lack of sterilization concerns during the particular medical procedure. Moreover, conventional uterine manipulators and vaginal cervical retractors do not include a mechanism to pass dye other than through a slit in the balloon, and use saline instead of gas to inflate the balloon. Accordingly, there is a need in the art for improved devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures including a mechanism or structural configuration to address each of these and other short comings of conventional devices. Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Background Section or elsewhere in this Application, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Background Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies). SUMMARY OF THE INVENTION The present disclosure is directed to inventive devices and methods for manipulation of the uterus and cervix in surgical and diagnostic procedures, which overcome the various problems with conventional devices (as discussed herein and below). A particular non-limiting goal of utilization of the embodiments and implementations herein is to provide a device for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), minilap, laparoscopic tubal occlusion or diagnostic laparoscopy (and other similar procedures as should be understood by a person of ordinary skill in the art in conjunction with a revie