Female incontinence control device and method

• US 5,234,409 A
• Filed: 11/09/1992
• Issued: 08/10/1993
• Est. Priority Date: 07/07/1989
• Status: Expired due to Term

• Current Assignee: Urocath Corporation
• Original Assignee: Cabot Corporation
• Inventors: Goldberg, Jay R., Trick, Robert E., Chin, Rebecca Y., Barwick, Carl B.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Cermak, Adam
• Application Number:
  US07/973,225
• Time in Patent Office: 274 Days
• Field of Search: 600/29-31, 128/DIG. 25, 604/96, 604/99, 604/102, 604/246, 604/249, 604/247, 604/327-331
• US Class Current: 604/99.04
• CPC Class Codes: A61F 2/0013 inflatable
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A female incontinence control device includes a conduit having inlet and outlet openings for receiving, conducting and discharging urinary fluid. The device also includes structure for holding the conduit in position relative to the urethra such that the inlet opening is adapted to receive substantially all of the urinary fluids which drain from the bladder, and the outlet opening of the conduit is positioned outside the urethra. In one embodiment of the invention, the device can be entirely contained within the labia majora. In other embodiments of the invention the device extends through the urethra to the bladder. In all embodiments of the invention a drainage control valve is positioned within the conduit for location intermediate the urethral orifice and the labia majora for manual actuation to selectively control urinary flow through the conduit. The method of controlling female incontinence includes the steps of providing and positioning a conduit to receive the urinary fluid and manually actuating a valve in the conduit by squeezing the conduit, to allow accumulated urinary fluids to be drained from the urinary tract.

Claims

1. An incontinence device for a human female comprising a flexible conduit having inlet and outlet openings and a ball valve means for controlling flow of urine past the outlet opening, said ball valve means being shaped to be positioned within the labia majora of a female, with said conduit sealingly engaging the urinary tract of the female to receive substantially all of the urinary fluids which drain from the bladder, so that said ball valve means, when closed, permits accumulation or urinary fluids in the urinary tract and, when open, allows the urinary fluids to pass through the conduit for discharge from the outlet opening, and said ball valve means being selectively manually actuatable by squeezing said flexible conduit at said control ball valve means to allow accumulated urinary fluids to be drained from the urinary tract.

7. An incontinence device according to claim 1 wherein said conduit means is deformable at said valve means to permit manual deformation of said conduit means to actuate positioning of said valve means into a valve open position or a valve closed position.

8. An incontinence device according to claim 1 where, and said valve means comprises a ball valve having a ball axially moveable within said conduit means, between a valve-open position and a valve-closed position, upon manual manipulation of said conduit means.

9. An incontinence device according to claim 8 wherein said holding means for said valve means include detent means for holding said ball valve in said valve open position or said valve closed position.

10. An incontinence device according to claim 9 wherein said conduit means is deformable at said valve means to permit manual deformation of said conduit means to actuate positioning of said valve means into said valve open position or said valve closed position.

13. An incontinence device according to claim 7, including means carried by said conduit means adjacent said valve means for preventing migration of said valve means into the urethra, said migration preventing means permitting positioning of said inlet opening adjacent the externally communicating orifice.

14. An incontinence device according to claim 13 wherein said conduit means includes a conduit and a wall-forming member projecting from said conduit, said wall forming member having an end surface facing said inlet opening that surrounds said inlet opening, and wherein said holding means comprises an adhesive gel provided on the end surface for contact with the urethral meatus.

17. An incontinence device according to claim 1 wherein said conduit means includes a first conduit portion containing the inlet opening and an elongated portion adapted to extend through the urethra to position the first conduit portion within the bladder, and wherein said holding means includes an expansible diaphragm member carried by the first conduit portion adjacent said inlet opening and inflatable within the bladder to prevent withdrawal of the first conduit portion from the bladder.

18. An incontinence device according to claim 17 wherein said conduit means includes a second conduit portion containing the valve means and wherein said holding means includes means provided on said second conduit portion for preventing migration of said valve means into the urethra.

19. An incontinence device according to claim 18 wherein said migration preventing means comprises an enlarged portion of said conduit means, said enlarged portion being of a predetermined size greater than the size of the externally communicating urethral orifice.

20. An incontinence device according to claim 18 wherein said conduit means includes means for adjusting the distance between said enlarged portion of said conduit means and said expansible diaphragm.

21. An incontinence device according to claim 20 wherein said conduit means comprises a resilient material and said adjusting means comprises a plurality of axially spaced, circumferential ribs and depressions at said second conduit portion, and wherein said enlarged portion includes a deformable annular, flexible disk member having an internal diameter greater than the external diameter of said conduit means at said depressions but less than the diameter of said conduit means at said ribs to permit selective axial positioning of said disk member on said second conduit portion at an elected depression, to provide for adjustability of the length of the conduit means that is positioned between the expansible diaphragm and the disk member to correlate with the length of the urethra.

22. An incontinence device according to claim 18 wherein said migration preventing means comprises an expansible diaphragm member at said second conduit portion.

23. An incontinence device according to claim 18 wherein said second conduit portion is of a predetermined length to permit containment of said valve means intermediate the externally communicating urethral orifice and the labia majora.

2. An incontinence device comprising a conduit having an inlet opening for receiving urinary fluid from the bladder, an outlet opening for discharging urinary fluid, a longitudinal axis extending between said inlet and outlet openings, and a conductive section intermediate said inlet and outlet opening for conducting said urinary fluid from said inlet opening to said outlet opening;

means for holding said conduit in a predetermined position relative to the urethra, said holding means including a positioning member provided on said conduit for disposition of said holding means between the urethral orifice and the labia majora, said positioning member having a predetermined cross sectional magnitude greater than the magnitude of the urethral orifice to prevent migration of said conduit from said predetermined position toward said bladder;

an outlet section of said conduit being defined from said positioning member to said outlet opening;

valve means provided in said conduit at said outlet section for controlling the flow of urinary fluid through said conduit means for discharge through said outlet opening, said valve means being axially movable within said conduit and manually actuatable at said outlet section from a closed position to an open position by squeezing said conduit at said value means to selectively control discharge of urinary fluid from said outlet opening and holding means within said conduit for holding said valve means in said closed position or said open position.

3. The incontinence device according to claim 2 wherein said valve means is deformable and actuatable from said closed position to said open position by manually deforming the outlet section of said conduit.

4. A method of controlling female incontinence, comprising providing a conduit having inlet and outlet openings and a control valve for controlling flow of urine past the outlet opening, positioning at least the inlet opening and valve portion of the conduit within the labia majora of a female, with the inlet opening of the conduit sealingly engaging the urinary tract of the female to receive substantially all of the urinary fluids which drain from the bladder, so that the valve, when closed, permits accumulation of urinary fluids in the urinary tract and, when open, allows the urinary fluids to pass through the conduit for discharge from the outlet opening, and selectively manually opening the valve by squeezing the conduit at the control valve to allow accumulated urinary fluids to be drained from the urinary tract.

5. A method of controlling female incontinence according to claim 4, wherein the step of positioning at least portions of the conduit within the labia majora includes positioning the entire conduit within the labia majora so that when the valve is opened, urinary fluids pass out of the outlet opening of the conduit within the labia majora and then pass through the labia majora during their discharge from the urinary tract.

6. An incontinence device for a female, comprising:

(a) conduit means having inlet and outlet openings for receiving, conducting and discharging urinary fluids from the bladder; and

a longitudinal axis extending between said inlet and outlet openings;

(b) means secured to said conduit means for holding said conduit means in a predetermined position relative to the urethra such that said inlet opening is adapted to receive urinary fluid which drains from the bladder toward the urethra and such that said outlet opening is positioned outside the urethra;

(c) valve means provided within said conduit means and outside the urethra operable for manual activation reversibly between a closed position and an open position by squeezing said conduit means at said valve means for selectively controlling the flow of urinary fluid through said conduit means for discharge through said outlet opening, said valve means being axially movable within said conduit means; and

(d) holding means within said conduit means for holding said valve means in said closed position or said opening position.

11. An incontinence device according to claim 6 wherein said valve means comprises a ball valve having a ball radially movable within said conduit means between a valve open position and a valve closed position, upon manual manipulation of said conduit means.

12. An incontinence device according to claim 6, wherein said conduit means is of a predetermined size for entire self containment within the labia majora.

15. An incontinence device according to claim 12 wherein said holding means comprises a flange-like member contoured to fit between the urethral meatus and the labia minora to permit positioning of said inlet opening adjacent the urethral orifice.

16. An incontinence device according to claim 15 wherein said holding means further includes an adhesive gel provided on said flange-like member.