Intra-vaginal devices and methods for treating fecal incontinence

• US 9,707,067 B2
• Filed: 06/02/2014
• Issued: 07/18/2017
• Est. Priority Date: 03/16/2010
• Status: Active Grant

• Current Assignee: Pelvalon, Inc.
• Original Assignee: Pelvalon, Inc.
• Inventors: Brenner, Jacob Samuel, Rosen, Miles Harris, Herbowy, Steven Lawrence
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US14/293,365
• Publication Number:
  US 20140275746A1
• Time in Patent Office: 1,142 Days
• 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 2/005 with pressure applied to urethra by an element placed in the vagina

Abstract

Devices and methods for intra-vaginal bowel control.

Claims

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

an occluding portion; and

a stabilizing portion supporting the occluding portion, the stabilizing portion being sized and configured to maintain position and stability of the occluding portion in the user'"'"'s vagina during repeated extensions of the occluding portion within the user'"'"'s vagina, the occluding portion being configured to extend from the stabilizing portion in an extension direction within the user'"'"'s vagina to at least partially occlude the user'"'"'s rectum, the ratio of the thickness of the device in the extension direction in an extended state to the thickness of the device in the extension direction in an un-extended state being at least 2.0.

2. The intravaginal device of claim 1, wherein the occluding portion is configured to contact the user'"'"'s rectovaginal septum when the occluding portion is extended within the user'"'"'s vagina.

3. The intravaginal device of claim 1, wherein the device is sized and configured to maintain position and stability in the user'"'"'s vagina through engagement of internal vaginal anatomy during repeated extensions of the occluding portion within the user'"'"'s vagina.

4. The intravaginal device of claim 1, wherein at least a portion of the occluding portion has a lateral span less than the lateral span of the stabilizing portion.

5. The intravaginal device of claim 1, wherein the occluding portion has a lateral width of 20-60 mm.

6. The intravaginal device of claim 1, wherein the stabilizing portion includes tissue engagement surfaces and a lateral span of the tissue engagement surfaces of the stabilizing portion proximate to the occluding portion is less than a lateral span of the tissue engagement surfaces of the stabilizing portion not proximate to the occluding portion.

7. The intravaginal device of claim 1, wherein the occluding portion is disposed in a proximal region of the stabilizing portion.

8. The intravaginal device of claim 1, wherein the thickness in the extension direction of the stabilizing portion is less than the length in the extension direction of the occluding portion when the occluding portion is fully extended.

9. The intravaginal device of claim 8 wherein the thickness in the extension direction of the stabilizing portion region proximate to the occluding portion is less than the length in the extension direction of the occluding portion when the occluding portion is fully extended.

10. The intravaginal device of claim 1, wherein the thickness of the stabilizing portion in the extension direction is less than the width of the stabilizing portion in a direction perpendicular to the extension direction.

11. The intravaginal device of claim 1, wherein an anterior side of the stabilizing portion is planar.

12. The intravaginal device of claim 1, wherein the stabilizing portion comprises a structural perimeter surrounding a substantially open space.

13. The intravaginal device of claim 12 further comprising a support structure in the open space configured to support the occluding portion.

14. The intravaginal device of claim 1, further comprising a cushioning member configured to reduce trauma to the user'"'"'s vaginal tissue.

15. The intravaginal device of claim 14 wherein the cushioning member is disposed proximally on the device so as to be in the proximity of the cervix or vaginal cuff when the device is inserted into the user'"'"'s vagina.

16. The intravaginal device of claim 14, wherein the cushioning member is disposed opposite to the occluding portion.

17. The intravaginal device of claim 14, wherein the cushioning member comprises a part of the device that is more flexible than a part of the stabilizing portion.

18. The intravaginal device of claim 14, wherein the cushioning member comprises an outer layer of a material disposed over an inner gel or gel-like material.

19. The intravaginal device of claim 14, wherein the cushioning member comprises a part of the device that has a greater contact surface area than a part of the stabilizing portion.

20. The intravaginal device of claim 1, wherein the occluding portion is inflatable and has an inner inflatable chamber comprising a material that is less permeable to air than an outer material of the occluding portion.

21. The intravaginal device of claim 1, further comprising a fluid inflation device adapted to inflate the occluding portion, the fluid inflation device comprising a valve adapted to limit the force applied to the rectovaginal septum.

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

an occluding portion; and

a stabilizing portion supporting the occluding portion, the stabilizing portion being configured to hold the occluding portion in the user'"'"'s vagina, the occluding portion being configured to extend from the stabilizing portion in an extension direction within the user'"'"'s vagina to at least partially occlude the user'"'"'s rectum, the ratio of the thickness of the device in the extension direction in an extended state to the thickness of the device in the extension direction in an un-extended state being at least 2.0,

wherein the device is sized and configured to maintain position and stability in the user'"'"'s vagina through engagement of internal vaginal anatomy during repeated extensions of the occluding portion within the user'"'"'s vagina.

23. The intravaginal device of claim 22, wherein the occluding portion is configured to contact the user'"'"'s rectovaginal septum when the occluding portion is extended within the user'"'"'s vagina.

24. The intravaginal device of claim 22, wherein at least a portion of the occluding portion has a lateral span less than the lateral span of the stabilizing portion.

25. The intravaginal device of claim 22, wherein the stabilizing portion includes tissue engagement surfaces and a lateral span of the tissue engagement surfaces of the stabilizing portion proximate to the occluding portion is less than a lateral span of the tissue engagement surfaces of the stabilizing portion not proximate to the occluding portion.

26. The intravaginal device of claim 22, wherein the occluding portion is disposed in a proximal region of the stabilizing portion.