Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly

• US 5,752,525 A
• Filed: 12/04/1995
• Issued: 05/19/1998
• Est. Priority Date: 12/31/1990
• Status: Expired due to Fees

• Current Assignee: UroMed Corporation
• Original Assignee: UroMed Corporation
• Inventors: Syad, Azhar, Felice, Leo C., Simon, John G., McLaughlin, Paul D., Joshi, Sharad
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/566,732
• Time in Patent Office: 897 Days
• Field of Search: 128/885, 128/DIG. 26, 604/329, 604/330, 604/346-353, 600/29-31
• 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: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 5/48 Devices for preventing wetting or pollution of the bed
• 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 novel urethral plug assembly having adhesive thereon, wherein the adhesive seals the plug assembly against an internal wall thereby arresting movement of the plug assembly while it functions in the urethra to block the flow of urine therefrom. The plug assembly may comprise a solid body which is of a sufficient diameter to occlude the urethra. Alternatively, the plug assembly may comprise a body which has the ability to change its shape from a compressed to an elongated condition so as to conform to the urethral wall and occlude the opening to the urethra. In one embodiment of the invention, the adhesive lies on the meatal plate of the plug assembly so as to secure the plug assembly against the meatus urinarius. In a second embodiment of the invention, the adhesive is on the body of the plug assembly so as to seal the plug assembly against the urethra, bladder neck or bladder wall. In a third embodiment of the invention, the adhesive is on a portion of the meatal plate so as to seal the plug assembly at the tissue surrounding the meatus urinarius. The adhesive seals the plug assembly in place until the wearer wishes to void, at which point, the seal may be broken by the exertion a downward, pulling force on the plug assembly.

Claims

1. A remove-to-void device for controlling urinary incontinence comprising:

a body having an expandable portion at one end, which is capable of expanding upon introduction of a fluid to form a plug and which, when placed in a urethra through the natural opening thereof, and expanded, provides a urine-impermeable barrier to the flow of urine, which can only permit the passage of urine from the bladder by removal of the device;

a meatal plate attached to another end of said body, said meatal plate having a layer of adhesive thereon to anchor said meatal plate to the urethral meatus when said body is placed in the urethra, bladder neck or bladder;

means for transmitting fluid into the interior of said expandable portion of said device, from a source external to said device, to enable said expandable portion to expand upon the introduction of the fluid from the source,

said expandable portion having a hollow interior, which hollow interior is in fluid communication with an opening in said body, on the end of the body opposite the end which has said expandable portion,

said body defining a lumen fluidly coupling the opening and the hollow interior;

a valve in the lumen preventing flow of the fluid from the expandable portion until flow of the fluid from the expandable portion is desired by the user; and

means for exerting a force on said valve to open said valve to allow deflation of the expandable portion when desired, and to enable the device to be removed in order to void.

2. The remove-to-void device according to claim 1, said adhesive comprising hydrogel adhesive.

3. The remove-to-void device according to claim 1, said body further having curved indentations on the periphery thereof.

4. 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 human;

a meatal plate attached to one end of said housing, said meatal plate having a layer of adhesive disposed thereon for anchoring said meatal plate to the urethral meatus when said housing is placed in the urethra, bladder neck or bladder;

means for mechanically changing the shape of said housing upon insertion of said housing into the natural opening; and

means for reversing the changing of the shape of said housing, so that the wearer may remove said housing from the natural urethral opening and effect bladder evacuation.

5. The plug assembly according to claim 4, said adhesive comprising hydrogel adhesive.

6. The plug assembly according to claim 4, said housing further having curved indentations on the periphery thereof.

7. A remove-to-void device for controlling urinary incontinence comprising:

an expandable member comprising a plastic polymer possessing

a first shape prior to insertion into a human body, said first shape being insufficient in size and volume to form a plug to block the flow of urine, and a

second shape following insertion into a human body, said second shape being in response to the environment of the urethra, bladder neck or bladder,

said second shape forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as to remain in place against the walls of the urethra, bladder neck, or bladder while blocking the flow of urine,

such that in said first shape said member is adapted to be configured in its non-expanded disposition and in said second shape said member is adapted to be configured in its expanded disposition,

said member further having a meatal plate attached at one end thereof, said meatal plate having a layer of adhesive disposed thereon so as to seal said meatal plate at the urethral meatus when said member is placed in the urethra, bladder neck or bladder.

8. The remove-to-void device according to claim 7, said adhesive comprising hydrogel adhesive.

9. The remove-to-void device according to claim 7, said member further having curved indentations on the periphery thereof.

10. A urethral plug having enhanced sealing capabilities comprising:

a body adapted to expand after insertion into a urethra of a human for internally occluding the urethra,

a meatal plate for anchoring said body to the urethral meatus, said meatal plate having a layer of adhesive disposed thereon,

whereby said adhesive anchors said meatal plate at the urethral meatus such that movement of the plug is arrested.

11. The urethral plug according to according to claim 10, said adhesive comprising hydrogel adhesive.

12. The urethral plug according to claim 10, said member further having curved indentations on the periphery thereof.

13. A method of using a urethral plug having enhanced sealing capabilities comprising the steps of:

providing a urethral plug including a body having an expandable portion adapted to expand in response to a stimulus external to said plug, said body further having a meatal plate at one end thereof, said meatal plate having a layer of adhesive disposed thereon to anchor said meatal plate at the urethral meatus when said body is placed in the urethra, bladder neck or bladder;

inserting said urethral plug into the urethra of a wearer;

sealing said meatal plate against the urethral meatus via said adhesive;

introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, thereby blocking the flow of urine; and

retaining said urethral plug in place without the movement or slippage thereof from said position until the wearer wishes to void.

14. The method according to claim 13, further comprising anchoring said urethral plug at the urethral meatus.

15. The method according to claim 13, further comprising removing said urethral plug to void the bladder.

16. The method according to claim 13, wherein said stimulus comprises the introduction of a fluid through said body to expand said expandable portion.

17. The method according to claim 13, wherein said stimulus comprises the introduction of a mechanical force on said body to expand said expandable portion.

18. A method of using a urethral plug having enhanced sealing capabilities comprising:

providing a urethral plug including a body having an expandable portion adapted to expand in response to a stimulus, said body further including a meatal plate at one end thereof, said meatal plate having a layer of adhesive disposed thereon for anchoring said meatal plate at the urethral meatus when said body is placed in the urethra, bladder neck or bladder;

inserting said urethral plug into the urethra of a wearer;

sealing said meatal plate against the urethral meatus via said adhesive;

introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, thereby blocking the flow of urine; and

retaining said urethral plug in place without the movement or slippage thereof from said position until the wearer wishes to void.

19. The method according to claim 18, further comprising anchoring said urethral plug at the urethral meatus.

20. The method according to claim 18, further comprising removing said urethral plug to void the bladder.

21. The method according to claim 18, wherein said stimulus is the introduction of a temperature greater than the temperature of said urethral plug, causing the expansion of said expandable portion.

22. The method according to claim 18, further comprising providing adhesive on said body of said urethral plug.

23. The method according to claim 22, further comprising sealing said body against the urethra, bladder neck, or bladder wall via said adhesive.