Mechanically actuated urethral plug assembly and method for controlling urinary incontinence

• US 5,483,976 A
• Filed: 05/17/1993
• Issued: 01/16/1996
• Est. Priority Date: 12/31/1990
• Status: Expired due to Fees

• Current Assignee: UroMed Corporation
• Original Assignee: UroMed Corporation
• Inventors: Simon, John, McLaughlin, Paul D., Joshi, Sharad, Syad, Azhar
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/062,592
• Time in Patent Office: 974 Days
• Field of Search: 128/885, 128/886, 128/DIG. 25, 600/29, 600/30, 600/31
• US Class Current: 128/885
• 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: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A urethral plug assembly having a cooperating housing and inner member, the plug assembly possessing a contracted diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder. A larger diameter is achieved by mechanical deployment of the inner member, which results in the expansion of the housing, or in another embodiment, which results in the expansion of the inner member. A balloon is additionally expanded, thus sealing the plug assembly to the urethral, bladder neck and bladder wall. The plug assembly further has a meatal plate for anchoring the plug assembly in the urethra, preventing migration of the plug assembly into the bladder. Removal of the plug assembly for bladder evacuation, is easily accomplished by pulling a cord causing the contraction of the expanded housing or inner member, and grasping a tab associated with said meatal plate. In accordance with a further feature of the invention, there is provided a method for controlling incontinence in humans.

Claims

1. A remove-to-void plug assembly for use in the urethra to control urinary incontinence, comprising:

a housing adapted to be inserted into the natural urethral opening of a wearer,

a solid element coupled with said housing, which solid element directly impacts on said housing so as to mechanically change the shape of said housing causing at least a portion of said housing to expand outwardly to contact the walls of the urethra, bladder neck or bladder, wherein the mechanical change in shape is effectuated by the wearer after insertion of said housing into the natural urethral opening, said at least a portion of said housing thereby forming a seal with the walls to block the flow of urine without the formation of a passageway through said housing, and

means for reversing the change in shape of said housing to return said housing to its non-expanded state, thereby enabling the wearer to remove said housing from the natural urethra opening and effect bladder evacuation.

2. The plug assembly according to claim 1, said means for reversing the changing of the shape of said housing being integrally connected to the plug assembly.

3. The plug assembly according to claim 1, said housing further comprising an expandable tube having a membrane mounted thereon.

4. The plug assembly according to claim 1, said solid element for changing the shape of said housing comprising a rod positioned within said housing and movable within said housing to cause said changing of the shape of said housing.

5. The plug assembly according to claim 4, said rod having a bulk, fixed thereon, whereby movement of said rod causes said bulb to exert a force on said housing causing said changing of the shape of said housing.

6. The plug assembly of claim 4, said means for reversing the changing of the shape of said housing comprising a cord fixed to said rod and extending from said housing, whereby manipulation of said cord causes said movement of said rod in said housing.

7. The plug assembly of claim 6, wherein said assembly further comprises means for securing said housing in an expanded state.

8. The plug assembly of claim 7, wherein said means for securing said housing in said expanded state comprises means for retaining a portion of said cord in a non-movable state.

9. The plug assembly of claim 8, said means for retaining a portion of said cord comprising a socket.

10. The plug assembly of claim 9, said portion of said cord comprising a knot.

11. The plug assembly of claim 1 wherein said housing has a groove therein, and said solid element for mechanically changing the shape of said housing comprises a rod having a flange disposed thereon, said groove adapted to receive said flange so as to maintain the housing in an expanded state.

12. The plug assembly of claim 1, said housing further comprising a meatal plate.

13. The plug assembly of claim 12, said meatal plate further comprising a tab extending from a distal end of said housing, lying substantially normal to said housing.

14. The plug assembly of claim 1, said housing comprising a braided mesh.

15. The plug assembly of claim 1, said housing having curved indentations on the periphery thereof.

16. The plug assembly of claim 1, said housing comprising an outer tube having a plurality of apertures therein.

17. The plug assembly of claim 16, said solid element for mechanically changing the shape of said housing comprising an inner tube having a plurality of elongated segments.

18. A plug assembly adapted to be inserted in the urethra for controlling urinary incontinence, comprising;

a housing having a plurality of apertures therein,

a member having a plurality of expandable segments, said member cooperating with said housing such that said segments project through said apertures when a force is applied to said member.

19. The plug assembly of claim 18, said housing further comprising means for maintaining said segments in a projected configuration.

20. The plug assembly of claim 19, said means for maintaining said segments in said projected configuration comprising a groove in said housing and a flange on said member adapted to form a snap-fit with said groove.

21. The plug assembly of claim 20, said member further comprising a flange adapted to form a snap-fit with said groove.

22. The plug assembly of claim 18, said housing having curved indentations on the periphery thereof.

23. The plug assembly of claim 18, said housing further comprising a meatal plate.

24. The plug assembly of claim 23, said meatal plate having a thickness sufficient to withstand compression by the urethra.

25. The plug assembly of claim 18, said housing further comprising a membrane.

26. The plug assembly of claim 18, further comprising means for reversing the projection of said segments.

27. The plug assembly of claim 26, wherein said means for reversing the expansion comprises a cord.

28. A method for controlling urinary incontinence comprising:

a) providing a remove-to-void urethral plug assembly having an expandable housing and a solid element for mechanically expanding said housing,

b) inserting said plug assembly into the natural opening of the urethra,

c) exerting a force on said solid element for mechanically expanding said housing, wherein the force exerted is imposed by a wearer of the urethral plug assembly,

d) mechanically expanding said housing via the force on said solid element impacting on said housing, until the flow of urine is blocked,

e) reversing the mechanically expanded housing to return said housing to its non-expanded state, whereby said reversing is effectuated by the wearer, and

f) removing the plug assembly from the natural opening of the urethra to allow the wearer to void the bladder.

29. The method of claim 28, further comprising;

expanding a sealing membrane while mechanically expanding said housing, whereby said solid element enables said sealing membrane to remain expanded notwithstanding a rupture of said sealing membrane.

30. The method of claim 28, further comprising;

manipulating a member coupled to said means for mechanically expanding said housing, for retraction of said expandable housing and removal of said plug assembly.

31. A method for controlling urinary incontinence comprising:

a) providing a urethral plug assembly comprising a housing having apertures therein, and a solid element for mechanically expanding segments within said housing,

b) inserting said plug assembly into the natural opening of the urethra, and

c) exerting a force on said solid element for mechanically expanding said segments, so as to mechanically expand said segments through said apertures in said housing until the flow of urine is blocked.

32. The method according to claim 31, further comprising;

expanding a sealing membrane while mechanically expanding said segments.

33. The method of claim 31, further comprising:

manipulating means for reversing the expansion of said elongated segments for removal of said plug assembly.

34. A plug assembly for use in the urethra to control urinary incontinence comprising:

a housing comprising a member having curved indentations on the periphery thereof to effect improved sealing of said housing with a wall of the urethra,

a solid element for changing the shape of said member, means for reversing the changing of the shape of said member.

35. A plug assembly for use in the urethra to control urinary incontinence comprising:

a housing adapted to be inserted into the natural opening of the urethra, including a meatal plate adapted to abut the urethral meatus, having a thickness sufficient to withstand compression by the urethra,

a solid element for mechanically changing the shape of said housing,

means for reversing the changing of the shape of said housing.

36. The plug assembly of claim 35, said meatal plate having a thickness of at least one millimeter.

37. A plug assembly for use in the urethra to control urinary incontinence, comprising:

a housing adapted to be inserted into the natural urethral opening of a wearer,

a solid element for mechanically changing the shape of said housing, comprising a rod positioned within said housing and moveable within said housing to change the shape of said housing,

means for reversing the changing of the shape of said housing.