Intra-vaginal devices and methods for treating fecal incontinence

• US 9,289,278 B2
• Filed: 09/24/2012
• Issued: 03/22/2016
• Est. Priority Date: 03/16/2010
• Status: Active Grant

• Current Assignee: Pelvalon, Inc.
• Original Assignee: Pelvalon, Inc.
• Inventors: Rosen, Miles Harris, Herbowy, Steven Lawrence, Brenner, Jacob Samuel
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US13/625,683
• Publication Number:
  US 20130150661A1
• Time in Patent Office: 1,275 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/4225 Cervix uteri
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/0013 inflatable
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/0027 inflatable
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Devices and methods for intra-vaginal bowel control.

Claims

1. An intravaginal device for the control of stool passage of a female user, the device comprising:

an intravaginal stabilizing body extending in a longitudinal direction and in a lateral direction that is substantially perpendicular to the longitudinal direction, the stabilizing body having a laterally narrower portion and a laterally wider portion along a length of the stabilizing body; and

an expandable member supported by the stabilizing body in a manner such that a greatest lateral extent of the expandable member is positioned along the laterally narrower portion of the stabilizing body, the expandable member having an expanded state and a retracted state,

wherein the stabilizing body is sized and configured to fit entirely within a vaginal cavity of the user with the longitudinal extent of the stabilizing body extending substantially along a length of the vaginal cavity to hold the expandable member in contact with the user'"'"'s recto-vaginal septum to control the passage of stool through a rectum of the user.

2. The device of claim 1, wherein the expandable member has a width of 1-6 cm and a length of 1-6 cm.

3. The device of claim 2, wherein the expandable member has a width of 3-4 cm and a length of 2-5 cm.

4. The device of claim 1, wherein the device is adapted to prevent rotation about an axis extending from a proximal end to a distal end of the device during the expanded and retracted states.

5. The device of claim 1, wherein the stabilizing body has a lateral span that is narrower in proximity to the expandable member than in a region not in proximity to the expandable member.

6. The device of claim 1, wherein the expandable member is disposed along a proximal portion of the stabilizing body.

7. The device of claim 1, wherein the stabilizing body is generally planar, and the expandable member extends out of the plane of the stabilizing body.

8. The device of claim 1, wherein the expandable member comprises a supportive member adapted to prevent deflection of the expandable member.

9. The device of claim 1, wherein the device is configured to support the expandable member against the recto-vaginal septum above a perineal body of the user in the expanded and retracted states.

10. The device of claim 1, wherein the expandable member is foldable into the stabilizing body.

11. The device of claim 1, wherein the expandable member includes a spring adapted to expand the expandable member.

12. The device of claim 1, wherein the expandable member includes an electromagnetic system.

13. The device of claim 1, wherein the expandable member is selectively controllable by the user to transition between the expanded state and the retracted state.

14. The device of claim 1, wherein the laterally narrower portion of the stabilizing body comprises a proximal portion of the stabilizing body that is configured to be positioned in a superior portion of the vaginal cavity.

15. The device of claim 1, wherein the greatest lateral extent of the expandable member is supported by the laterally narrower portion of the stabilizing body.

16. The device of claim 1, wherein substantially an entire length of the expandable member is positioned along the laterally narrower portion of the stabilizing body.

17. The device of claim 1, wherein the device is sized and configured such that tension in the vaginal wall in a superior portion of the vagina is less than tension in the vaginal wall in an inferior portion of the vaginal cavity when the device is disposed in the vaginal cavity and the expandable member is in the retracted state.

18. The device of claim 1, wherein the expandable member is positioned along a proximal portion of the stabilizing body that is configured to be positioned in a superior portion of the vaginal cavity.

19. The device of claim 18, wherein the stabilizing body is substantially planar.

20. The device of claim 1, wherein the stabilizing body is in the form of one or more wire forms enclosed in tubing.

21. The device of claim 20, wherein the stabilizing body further comprises one or more springs.

22. The device of claim 1, wherein the stabilizing body includes a first wire form that extends along a first side of the stabilizing body, a second wire form that extends along a second side of the stabilizing body, and a spring that connects an end of the first wire form to an end of the second wire form.

23. The device of claim 22, wherein the spring is configured to allow the stabilizing body to be folded along a length of the device.

24. The device of claim 1, wherein the expandable member comprises a balloon.

25. The device of claim 1, wherein the device is sized and configured to fit entirely within the vaginal cavity of the user.

26. The device of claim 1, further comprising a cushioning portion secured to the stabilizing body, opposite the expandable member.