Intra-vaginal devices and methods for treating fecal incontinence

• US 9,999,490 B2
• Filed: 02/14/2014
• Issued: 06/19/2018
• Est. Priority Date: 02/14/2013
• Status: Active Grant

• Current Assignee: Pelvalon, Inc.
• Original Assignee: Pelvalon, Inc.
• Inventors: Rosen, Miles Harris, Herbowy, Steven Lawrence, Goor, Jared, Brooks, Narvel M.
• Primary Examiner(s): Kuhlman, Catherine B
• Application Number:
  US14/181,569
• Publication Number:
  US 20140275743A1
• Time in Patent Office: 1,586 Days
• Field of Search: 600 29, 600 31, 128834, 128836
• 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 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Disclosed herein are devices and methods for intra-vaginal bowel control.

Claims

1. An intravaginal device for the control of stool passage, the device comprising

an expandable occluding body;

a stabilizing body supporting the occluding body to maintain position and stability of the occluding body in the user'"'"'s vagina during repeated expansions of the occluding body in an extension direction to contact the user'"'"'s recto-vaginal septum to at least partially occlude the rectum, the stabilizing body comprising first and second segments that are moveable along an axis relative to one another, and the stabilizing body having first and second states, a perimeter of the device in the first state of the stabilizing body being greater than the perimeter of the device in the second state of the stabilizing body, the first and second segments defining a portion of the perimeter, the perimeter measured in a plane including the axis of the first and second segments; and

wherein the first segment defines a recess, the second segment comprises a locking feature configured to be disposed in the recess to hold the first and second segments in a fixed position along the axis relative to one another, and the locking feature of the second segment is moveable out of the recess to allow the first and second segments to be moved along the axis relative to one another.

2. The device of claim 1, wherein a width of the stabilizing body and length of the stabilizing body can be adjusted separately between the first and second state.

3. The device of claim 1, wherein a portion of the stabilizing body to which the occluding body is attached does not change size between the first and second state.

4. The device of claim 1, wherein the first and second segments of the stabilizing body form an arm that is longer in the first state than in the second state.

5. The device of claim 4, wherein the arm is longer in the first state than in the second state due the stabilizing body being extended in the same plane as the plane that defines the perimeter.

6. The device of claim 1, wherein the stabilizing body comprises a plurality of arms.

7. The device of claim 6, wherein the stabilizing body comprises 4 arms.

8. The device of claim 6, wherein at least two of the plurality of arms are connected by a hinge.

9. The device of claim 8, wherein the hinge constrains the arms to rotational motion in the plane of the stabilizing body.

10. The device of claim 8, wherein the hinge allows angular changes between the two arms.

11. The device of claim 10, wherein the stabilizing body comprising a locking mechanism configured to maintain the two arms and the hinge in a particular angular configuration.

12. The device of claim 6, wherein all of the arms are interconnected by hinges to form a loop.

13. The device of claim 6, wherein at least one of the plurality of arms is extendible.

14. The device of claim 13, wherein all of the arms are extendible.

15. The device of claim 13, wherein the at least one extendible arm is configured to be extended by changing an amount of overlap of segments comprising the arm.

16. The device of claim 1, wherein the stabilizing body is configured to be collapsible.

17. The device of claim 1, comprising an adjustment mechanism comprising a linkage configured to expand or contract the overall perimeter of the stabilizing body.

18. The device of claim 1, wherein the first and second segments are overlapping segments configured to be pulled apart or pushed together.

19. The device of claim 1, wherein the first and second segments are configured to slide past one another.

20. The device of claim 1, wherein the stabilizing body comprises a cover.

21. The device of claim 1, wherein the occluding body is connected to the cover.

22. The device of claim 1, further comprising:

an arch member having a first end region and a second end region, the first end region being attached to one of the first and second segments of the stabilizing body; and

a ramp attached to the other of the first and second segments of the stabilizing body, the ramp and the arch member being configured such that the second end region of the arch member slides along the ramp when the first and second segments of the stabilizing body are moved axially relative to one another to provide the perimeter of the device with a rounded profile, wherein the arch forms a part of the perimeter of the device.

23. The device of claim 22, wherein one of the first and second segments is an inner segment and the other of the first and second segments is an outer segment, and the first and second segments are configured to slide relative to one another.

24. The device of claim 22, wherein a radial distance between a central region of the arch member and the one of the first and second segments to which the first end region of the arch member is attached changes as the first segment is moved axially relative to the second segment.

25. A method of selectively occluding a rectum to inhibit stool passage, comprising

inserting an intravaginal device into a user'"'"'s vagina, the device comprising a stabilizing body and an occluding body, the stabilizing body comprising first and second segments that are moveable relative to one another, the first segment defining a recess, the second segment comprising a locking feature configured to be disposed in the recess to hold the first and second segments in a fixed position along an axis relative to one another, and the locking feature of the second segment being moveable out of the recess to allow the first and second segments to be moved along an axis relative to one another;

adjusting a perimeter of the stabilizing body from a first state to a second state by moving the first and second segments along an axis relative to one another, the first and second segments defining a portion of the perimeter;

engaging vaginal anatomy with the stabilizing body to stably support the occluding body; and

extending the occluding body against a recto-vaginal septum of the user to at least partially occlude the rectum.

26. The method of claim 25, wherein adjusting the perimeter of the stabilizing body comprises adjusting a distance from the occluding body to a distal portion of the device.

27. The method of claim 25, wherein adjusting the perimeter of the stabilizing body comprises adjusting the stabilizing body to position the occluding body so that it engages the recto-vaginal septum while the stabilizing body is engaging the vaginal anatomy.

28. The method of claim 25, wherein a position of the occluding body relative to a portion of the stabilizing body to which the occluding body is attached remains constant during the adjusting step.

29. The method of claim 25, wherein the device further comprises an arch member having a first end region attached to one of the first and second segments of the stabilizing body and a second end region configured to slide along a ramp attached to the other of the first and second segments of the stabilizing body, and the second end region of the arch member slides along the ramp when the first and second segments of the stabilizing body are moved axially relative to one another to provide a perimeter of the device with a rounded profile.

30. The method of claim 29, wherein one of the first and second segments is an inner segment and the other of the first and second segments is an outer segment, and adjusting the perimeter of the stabilizing body comprises sliding the first and second segments relative to one another.

31. The method of claim 29, wherein a radial distance between a central region of the arch member and the one of the first and second segments to which the first end region of the arch member is attached changes as the first segment is moved axially relative to the second segment.