Intra-vaginal device for fecal incontinence

• US 9,072,578 B2
• Filed: 03/16/2011
• Issued: 07/07/2015
• Est. Priority Date: 03/16/2010
• Status: Active Grant

• Current Assignee: Pelvalon, Inc.
• Original Assignee: Pelvalon, Inc.
• Inventors: Herbowy, Steven Lawrence, Rosen, Miles Harris, Brenner, Jacob Samuel
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US13/635,598
• Publication Number:
  US 20130012764A1
• Time in Patent Office: 1,574 Days
• Field of Search: 600 29- 32, 600/37, 128/830, 128834-836, 128/885, 128/DIG.25
• US Class Current: 1/1
• 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 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion

Abstract

An intra-vaginal device for the control of stool passage, including a body mechanism for securing the device around the area of the pubic notch and in the area of the posterior fornix, the body mechanism including a force applying mechanism for reversibly applying a force to a posterior portion of the vagina to occlude the rectum. A method of controlling the passage of stool in a patient, by inserting an intra-vaginal device into the patient'"'"'s vagina such that an anterior end rests around the pubic notch and a posterior end rests in the posterior fornix, exerting a force towards the posterior side of the vagina, moving an anterior wall of the patient'"'"'s rectum towards the posterior wall of the rectum with the force applying portion, impeding the passage of stool, and removing the force, allowing stool to pass.

Claims

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

a reversibly extendable force applying portion having an extended state and a nonextended state; and

an intravaginal stabilizing body supporting the force applying portion, the 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, and the greatest lateral extent of the force applying portion being narrower than the greatest lateral extent of the stabilizing body,

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 force applying portion 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 device comprises a first engagement surface adapted to engage the vagina in the area of the pubic notch and a second engagement surface adapted to engage the vagina in the area of the posterior fornix.

3. The intravaginal device of claim 2 wherein the device is adapted to securely engage the pubic symphysis and the posterior fornix.

4. The device of claim 2, wherein the force applying portion is adapted to contact the recto-vaginal septum above the perineal body when the first engagement surface engages the vagina in the area of the pubic notch and the second engagement surface engages the vagina in the area of the posterior fornix.

5. The device of claim 2 wherein the stabilizing body comprises a ring, the first engagement surface being disposed on a first end of the ring and the second engagement surface being disposed on a second end of the ring opposite the first side.

6. The device of claim 1 wherein the force applying portion has a width of 1-6 cm and a length of 1-6 cm.

7. The device of claim 6 wherein the force applying portion has a width of 3-4 cm and a length of 2-5 cm.

8. The device of claim 1 wherein the device is adapted to prevent rotation about an axis extending from an anterior end to a posterior end of the device during the extended and non-extended states.

9. The device of claim 1 wherein the stabilizing body has a lateral span that is narrower in proximity to the force applying portion than in a region not in proximity to the force applying portion.

10. The device of claim 1 wherein the force applying portion is disposed in a proximal portion of the stabilizing body.

11. The device of claim 1 wherein the stabilizing body is generally planar, the force applying portion extending out of the plane of the stabilizing body.

12. The device of claim 1 wherein the force applying portion comprises a supportive member adapted to prevent deflection of the force applying portion.

13. The device of claim 1 wherein the device is configured to support the force applying portion against the recto-vaginal septum above the perineal body in the extended and non-extended states.

14. The device of claim 1, wherein the force applying portion is foldable into the stabilizing body.

15. The device of claim 1, wherein the force applying portion includes a spring adapted to expand the force applying portion.

16. The device of claim 1, wherein the device comprises a portion adapted to accommodate a cervix.

17. The device of claim 1, wherein the device includes suction features adapted to stabilize the device within the vagina.

18. The device of claim 1, wherein the force applying portion includes an electromagnetic system.

19. The device of claim 1, wherein the force applying portion is positioned along the laterally narrower portion of the stabilizing body.

20. The device of claim 19, 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.

21. The device of claim 19, wherein the greatest lateral extent of the force applying portion is supported by the laterally narrower portion of the stabilizing body.

22. The device of claim 19, wherein substantially the entire force applying portion is positioned along the laterally narrower portion of the stabilizing body.

23. 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 force applying portion is in the nonextended state.

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

25. The device of claim 24, wherein the stabilizing body is substantially planar.

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

27. The device of claim 26, wherein the stabilizing body further comprises one or more springs.

28. 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.

29. The device of claim 28, wherein the spring is configured to allow the stabilizing body to be folded along a length of the device.

30. The device of claim 1, wherein the force applying portion comprises a balloon.

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

32. A method of selectively occluding a rectum to inhibit stool passage in a female user, the method comprising:

inserting an intra-vaginal device into the user'"'"'s vagina;

stably supporting a force applying portion of the device against a recto-vaginal septum of the user while the force applying portion is in a nonextended state and slack is maintained in a region of a vaginal wall of the user adjacent the nonextended force applying portion;

extending the force applying portion to an extended state to apply a force with the force applying portion against the recto-vaginal septum while stably supporting the force applying portion against the recto-vaginal septum to impede passage of stool through the rectum of the user; and

after extending the force applying portion to the extended state to apply the force with the force applying portion against the recto-vaginal septum, reducing the force sufficiently to permit stool to pass through the rectum.

33. The method of claim 32 wherein the device further comprises a stabilizing body, and stably supporting the force applying portion of the device against the recto-vaginal septum comprises engaging the stabilizing body with the vagina in the area of the pubic notch and in the area of the posterior fornix.

34. The method of claim 32 further comprising, after reducing the force sufficiently to permit stool to pass through the rectum, maintaining the force applying portion against the recto-vaginal septum above the perineal body.

35. The method of claim 32, wherein the device comprises an intravaginal stabilizing body having a laterally narrower portion and a laterally wider portion, and the force applying portion is positioned along the laterally narrower portion of the stabilizing body.

36. The method of claim 35, 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.

37. The method of claim 35, wherein the greatest lateral extent of the force applying portion is supported by the laterally narrower portion of the stabilizing body.

38. The method of claim 35, wherein substantially the entire force applying portion is positioned along the laterally narrower portion of the stabilizing body.

39. The method of claim 32, wherein the stabilizing body is substantially planar.

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

a reversibly extendable force applying portion having an extended state and a nonextended state; and

an intravaginal stabilizing body supporting the force applying portion, the stabilizing body having a laterally narrower portion and a laterally wider portion, and the greatest lateral extent of the force applying portion being narrower than the greatest lateral extent of the stabilizing body,

wherein the stabilizing body has a lateral span that is narrower in proximity to the force applying portion than in a region not in proximity to the force applying portion, and the stabilizing body is sized and configured to fit entirely within a vaginal cavity of the user to hold the force applying portion in contact with the user'"'"'s recto-vaginal septum to control the passage of stool through a rectum of the user.

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

a reversibly extendable force applying portion having an extended state and a nonextended state; and

an intravaginal stabilizing body supporting the force applying portion, the stabilizing body having a laterally narrower portion and a laterally wider portion, and the greatest lateral extent of the force applying portion being narrower than the greatest lateral extent of the stabilizing body,

wherein the stabilizing body is sized and configured to fit entirely within a vaginal cavity of the user to hold the force applying portion in contact with the user'"'"'s recto-vaginal septum to control the passage of stool through a rectum of the user, and 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 force applying portion is in the nonextended state.