Female incontinence control device with magnetically operable valve and method

• US 5,030,199 A
• Filed: 12/11/1989
• Issued: 07/09/1991
• Est. Priority Date: 12/11/1989
• Status: Expired due to Term

• Current Assignee: Urocath Corporation
• Original Assignee: Medical Engineering Corporation
• Inventors: Chin, Rebecca Y., Barwick, Carl B.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US07/448,496
• Time in Patent Office: 575 Days
• Field of Search: 600/29-30, 604/54, 604/93, 604/96-99, 604/117, 604/246, 604/247, 251/65, 128/DIG. 25
• US Class Current: 600/29
• CPC Class Codes: A61F 2/0018 magnetic
• 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 stabilizing structure, which can be adjustable, for holding the conduit in its installed position relative to the urethra and bladder such that a drainage inlet opening can receive fluid from the bladder, and the outlet discharge opening is positioned outside the urethra. The conduit includes a magnetically actuatable drainage control valve adapted to be positioned between the urethral orifice and the labia majora. Magnetic actuation of the valve from a normally closed position to an open position is thus easily accomplished by manipulating a portable magnet at a distal end of the conduit outside the urethral opening 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 magnetically actuating the valve in the conduit by manipulating a magnet proximal the conduit in the vicinity of the valve to open the valve and allow accumulated urinary fluids to be drained through the outlet opening. Removal of the magnet permits the valve to automatically close.

Claims

1. An incontinence device for a female, comprising conduit means for receiving, conducting, and discharging urinary fluids from the bladder, said conduit means including a conduit member having opposing inlet and outlet openings, means for holding said conduit member in a predetermined position relative to the urethra such that said inlet opening is received in the bladder and said outlet opening is positioned outside the urethra, and magnetically actuatable valve means having a normally closed position, said valve means being positioned within said conduit means proximate the outlet opening such that said valve means is positioned outside the urethra for magnetic actuation from outside said urethra from said closed position to an open position for selectively controlling the flow of urinary fluid through said conduit means for discharge through said outlet opening.

2. The incontinence device as claimed in claim 1 wherein said valve means includes a magnetically actuatable member normally positioned to maintain said valve means in said closed position.

3. The incontinence device as claimed in claim 1 wherein said valve means includes a valve member normally maintained in said closed position, said valve member being releasable from said closed position by magnetic actuation of said valve means to permit movement of said valve member from said closed position to said open condition to permit flow of urinary fluid through said conduit means for discharge through said outlet opening.

4. The incontinence device as claimed in claim 3 wherein said valve means further includes means for urging said valve member in said normally closed position.

5. The incontinence device as claimed in claim 3 wherein said valve means further includes a magnetically actuatable member engagable with said valve member to maintain said valve member in said closed position, said valve member being releasable from said closed position upon magnetic actuation of said magnetically actuatable member away from said valve member.

6. The incontinence device as claimed in claim 5 wherein said magnetically actuatable member is spring biased against said valve member.

7. The incontinence device as claimed in claim 1 wherein said valve means includes a valve member normally maintained in said closed position, said valve member being movable to said open condition by magnetic actuation of said valve means to permit flow of urinary fluid through said conduit means for discharge through said outlet opening.

8. The incontinence device as claimed in claim 7 wherein said valve member is formed of magnetically actuatable material and is movable from said closed position to said open position by magnetic actuation of said magnetically actuatable material.

9. The incontinence device as claimed in claim 7 wherein said valve means further includes means for urging said valve member in said normally closed position.

10. The incontinence device as claimed in claim 8 wherein said valve means comprises a valve member having a displaceable sealing surface, said valve member being axially movable within said conduit means, between a valve member open condition upon actuation of said valve means and a valve member normally closed position.

11. The incontinence device as claimed in claim 10 wherein said displaceable sealing surface is formed as part of a sphere.

12. The incontinence device as claimed in claim 10 wherein said displaceable sealing surface is formed as part of a hemisphere.

13. The incontinence device as claimed in claim 10 wherein said displaceable sealing surface is formed as part of a poppet valve member.

14. The incontinence device as claimed in claim 1 wherein said valve means includes a magnetically actuatable member, a valve chamber for accommodating displacement of said magnetically actuatable member and a resilient diaphragm for sealing a portion of said valve chamber, and wherein magnetic actuation of said magnetically actuatable member places said valve means in said open condition and causes movement of said magnetically actuatable member toward said resilient diaphragm to deflect said resilient diaphragm to take up a predetermined movement of said magnetically actuatable member.

15. The incontinence device as claimed in claim 1 wherein said holding means include means for preventing migration of said valve means into the urethra, said migration preventing means permitting positioning of said outlet opening outside the urethral orifice.

16. An incontinence device according to claim 15 wberein said migration preventing means includes a flange member projecting from said conduit member, said flange member being of predetermined size for self containment within the labia majora.

17. An incontinence device according to claim 1 wherein said conduit means includes a distal end portion containing said outlet opening and said valve means and wherein said holding means includes means provided on said distal end portion for preventing migration of said valve means into the urethra.

18. An incontinence device according to claim 17 wherein said means for preventing migration comprises a flange-like member on said conduit member contoured to fit between the urethral meatus and the labia majora to permit positioning of said outlet opening outside the urethral orifice.

19. An incontinence device according to claim 17 wherein said conduit member has a proximal end portion containing the inlet opening, said conduit member having a predetermined longitudinal extent to extend through the urethra to position the outlet opening outside said urethra, and wherein said holding means include a bladder engaging member carried by the proximal end portion to prevent withdrawal of the conduit means from the urethra.

20. An incontinence device according to claim 19 wherein said migration preventing means comprises flange means at the distal end portion of said conduit means.

21. An incontinence device according to claim 20 wherein said conduit member includes a lumen having an inlet opening at the distal end portion of said conduit and an outlet opening a predetermined distance from said flange means to communicate with said urethra to permit infusion of an antimicrobial agent through said lumen into said urethra.

22. An incontinence device according to claim 19 wherein said migration preventing means includes a flange member at the distal end portion of said conduit means, and means for adjusting the distance between said flange member and said bladder engaging member.

23. An incontinence device according to claim 22 wherein said adjusting means comprises a plurality of axially spaced, circumferential ribs and depressions formed on said conduit member, and said flange member is a deformable annular flexible member having an internal diameter greater than the external diameter of said conduit member at said depressions but less than the external diameter of said conduit member at said ribs, to permit selective axial positioning of said flange member on said conduit member at a selected depression to provide for adjustability of the length of the conduit that is positioned between the bladder engaging member and the flange member to correlate with the length of the urethra.

24. An incontinence device comprising a conduit having a proximal end portion with an inlet opening for receipt in the bladder, a distal end portion with an outlet opening for discharging urinary fluid, and a passageway 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 at said distal end portion of said conduit for disposition 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 proximal migration of said conduit, valve means provided at said distal end portion for controlling the discharge of urinary fluid through said outlet opening, said valve means being magnetically actuatable at said distal end portion from a closed position to an open condition to selectively control discharge of urinary fluid from said outlet opening.

25. The incontinence device according to claim 24 wherein said valve means includes a magnetic member actuatable with a portable manually manipulable magnet to move said valve means from said closed position to said open condition.

26. An incontinence device according to claim 24 wherein said conduit means includes a bladder engaging member at said proximal end portion and a lumen having a lumen inlet opening extending from the distal end portion of said conduit and a lumen outlet opening intermediate said bladder engaging member and said positioning member to permit infusion of an antimicrobial agent through said lumen to flush the urethral passage with said antimicrobial agent.

27. A method of controlling female incontinence comprising providing a conduit predeterminedly dimensioned to be partly positionable in the female urethra, said conduit having opposing inlet and outlet openings with a connecting passageway therebetween and a magnetically actuatable control valve for controlling flow of urine through the passageway past the outlet opening, positioning the outlet opening and the control valve proximal the labia majora of a female, positioning the inlet opening of the conduit to receive substantially all of the urinary fluids which drain from the bladder, so that the control valve, when closed, permits accumulation of urinary fluids, when open, allows the urinary fluids to pass through the conduit for discharge from the outlet opening, and selectively opening the control valve by manipulating a portable magnet at the control valve to magnetically actuate the valve into an open condition and allow the accumulated urinary fluids to discharge through the outlet opening.

28. The method of claim 27, wherein the step of manipulating a magnet includes holding a magnet proximal the labia majora adjacent the conduit in the vicinity of the control valve to cause the valve to open and removing the magnet from proximity to the labia majora to enable the control valve to automatically close when magnetic actuation is removed.