Involuntary urine control apparatus, system and method

• US 5,624,374 A
• Filed: 11/03/1994
• Issued: 04/29/1997
• Est. Priority Date: 11/03/1994
• Status: Expired due to Fees

• Current Assignee: Uroscientific Incorporated
• Original Assignee: Irwin F. Von Iderstein
• Inventors: Von Iderstein, Irwin F.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US08/333,860
• Time in Patent Office: 908 Days
• Field of Search: 600/29-32, 128/DIG. 25
• US Class Current: 600/29
• 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 2/0018 magnetic
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An involuntary urine control valve apparatus, system and method comprising a urine control valve adapted to be inserted a short distance into the distal end of the urethra of a subject, the control valve including a jacket which is fitted within the distal end of the urethra. The ball valve is a tension-biased, magnetic ball valve subject to move between open and closed position by an externally held magnet held by the subject near the jacket. The jacket includes a inflatable-deflatable collar in which is radially inflatable to stabilize the outer jacket within the urethra. The outer jacket includes an outwardly-extending flange at the other end, which extends about the urethral opening. The system includes a finger operated pump for the inflation of the collar in the outer jacket, to stabilize the outer jacket within the urethra. The system also includes a measuring tool kit for measuring urethral size to determine the correct size of the control apparatus to be employed.

Claims

1. An involuntary urine control valve apparatus, which apparatus comprises:

a) a cylindrical jacket having a one outlet end and an other inlet end and an external diameter and surface adapted to fit slidably and comfortably in a snug fit and having a length to be inserted only a short distance into the open distal end of the urethra of a subject;

b) a collar chamber means extending circumferentially about the external diameter of and toward the other inlet end of the jacket;

c) a collar means about the collar chamber means to stabilize the jacket in position within and to the interior wall of the urethra, the collar means adapted to move between a radially outwardly extended, inflated position to stabilize the jacket against the internal wall of the urethra and a radially deflated position to permit the insertion into or removal from the urethra of the jacket;

d) a radially extended flange means having an external surface from the one end of the jacket adapted to fit about and adjacent the open distal end of the urethra;

e) a valve means on the external surface of the flange means to permit the introduction of a fluid into the collar means and to permit the release of the fluid from the collar means;

f) a valve chamber means in the jacket to connect the valve means with the collar means;

g) a head means secured to the outlet end of the jacket and having at least one urine flow passageway to permit the flow of urine externally from the subject;

h) a tension-biased, magnetically activated ball valve within the jacket, which ball valve is adapted to move generally longitudinally within the jacket between a tension-biased closed position against a valve seat to prevent the flow of urine through the jacket from the inlet to the passageway and a magnetically activated, open position with the ball valve removed from the valve seat to permit the flow of urine from the inlet to the passageway, by the external use of a magnet by the subject, the ball valve having sufficient tension to be placed in the closed position, but insufficient to prevent the ball valve to move to the open position unless magnetically activated.

2. The apparatus of claim 1 wherein the valve chamber means comprises a generally longitudinal passageway in the jacket from the valve means to the collar means.

3. The apparatus of claim 1 wherein the tension-biased ball valve comprises a longitudinal spring within the jacket and a metal ball valve having a polymeric coating and positioned at one end of the spring to move between a closed position and an open position.

4. The apparatus of claim 1 wherein the jacket includes a ball valve seat for the tension-biased ball valve about the inlet or outlet of the jacket.

5. The apparatus of claim 1 wherein the flange means comprises a smooth, arcuate surface on the external surface adapted to fit the tissue contour surrounding the end of the urethra.

6. The apparatus of claim 1 wherein the collar means is positioned toward the other inlet end of the jacket and in the deflated position the collar means has a diameter of about the external diameter of the jacket.

7. The apparatus of claim 1 wherein the collar chamber means comprises a portion of the jacket surface.

8. The apparatus of claim 1 wherein the head means is removably secured in the one outlet end of the jacket.

9. The apparatus of claim 8 wherein the head means is threadably secured in the one outlet end of the jacket.

10. The apparatus of claim 1 wherein the head means comprises a central urine flow passageway and a plurality of surrounding spaced-apart urine flow passageways.

11. The apparatus of claim 1 wherein the head means is removably secured within the one outlet end of the jacket and includes a plurality of inward, slightly tapered generally longitudinal spaced-apart guide fingers, within the jacket and about a spring-biased ball valve.

12. An involuntary urine control system which includes the urine control valve of claim 1, and which system includes an external magnet to be employed by a subject to activate the tension-biased ball valve to the open position.

13. The system of claim 12 which includes a finger operated pump to be employed by a subject to inflate the collar means and to stabilize the jacket in position within the urethra.

14. The apparatus of claim 1 wherein the jacket has a length of up to about one inch.

15. The apparatus of claim 14 wherein the one outlet end and the other inlet end are longitudinally aligned and the jacket includes opposite spaced-apart tapered surfaces or valve ball seats internally to permit the ball valve to move between said seats in the closed and open position.

16. The apparatus of claim 1 wherein the collar chamber means defines a circumferential chamber with opposite spaced-apart outer edges on the external diameter of the jacket and the collar means comprises a membrane material extending across the chamber and secured to said opposite outer edges.

17. An involuntary urine control valve apparatus, which apparatus comprises:

a) a cylindrical jacket having a one outlet end and an other inlet end longitudinally aligned and an external diameter and surface adapted to fit slidably and comfortably in a snug fit and having a length to be inserted only a short distance into the open distal end of the urethra of a subject;

b) a collar chamber means extending circumferentially about the external diameter of and toward the other inlet end of the jacket;

c) a collar means about and secured to the collar chamber means to stabilize the jacket in position within and to the interior wall of the urethra, the collar means adapted to move between a radially outwardly extended, inflated position to stabilize the jacket against the internal wall of the urethra and a radially deflated position to permit the insertion into or removal from the urethra of the jacket;

d) a radially extended flange means having an external surface and a smooth, internal surface, from the one end of the jacket adapted to fit about in a contoured manner and adjacent the open distal end of the urethra;

e) a valve means on the external surface of the flange means to permit the introduction of a fluid into the collar means to stabilize the jacket in position within the urethra and a further means to permit the release of the fluid from the collar means;

f) a valve chamber means comprising a generally longitudinal passageway in the jacket to connect the valve means with the collar means;

g) a head means threadably and removably secured to the one outlet end of the jacket and having a plurality of surrounding, spaced-apart urine flow passageways to permit the flow of urine externally from the subject;

h) a tension-biased, magnetically activated ball valve comprised of a metal ball having a thin polymeric coating, which ball valve is adapted to move generally longitudinally within the jacket between a tension-biased closed position against a ball valve seat to prevent the flow of urine through the jacket from the inlet to the passageway and a magnetically activated, open position with the ball valve removed from the valve seat to permit the flow of urine from the inlet to the passageway, by the external use of a magnet by the subject, the ball valve having sufficient tension to be placed in the closed position, but insufficient to prevent the ball valve to move to the open position unless magnetically activated.

18. An involuntary urine control system to control the flow of urine from a subject which includes the apparatus of claim 17, and which system includes:

a) an external magnet to be employed by the subject to activate the tension-biased ball valve to the open position; and

b) a finger operated pump to be employed by the subject to inflate the collar means and to stabilize the jacket in position within the urethra.

19. An involuntary urine control valve method, which method comprises:

a) inserting a cylindrical jacket, having a one outlet end and an other inlet end and an external diameter and surface, slidably and comfortably in a snug fit a short distance into the open distal end of the urethra of a subject;

b) stabilizing the jacket in position within and against the interior wall of the urethra with a collar means about the jacket, the collar means moving between a radially outwardly extended, deflated position against the internal wall of the urethra to stabilize the jacket in a use position in the urethra and a radially deflated position of about the external diameter of the jacket to permit the insertion into or removal from the urethra of the jacket by a subject;

c) fitting about and adjacent to the open distal end of the urethra one radially extending flange means having an external surface extending from the one outlet end of the jacket;

d) introducing a fluid into the collar means and permitting the release of fluid from the collar means by a valve means on the external surface of the flange means;

e) connecting the valve means to the collar means with a fluid chamber means in the jacket;

f) securing a head means to the one outlet end of the jacket and having at least one urine flow passageway therein to permit the flow of urine externally from the subject;

g) positioning a tension-biased, magnetically activated ball valve within the jacket, the ball valve adapted to move generally longitudinally within the jacket between a tension-biased closed position against a ball valve seat in the jacket to prevent the flow of urine through the jacket from the inlet to the passageway and a magnetically activated, open position with the ball valve removed from the valve seat permitting the flow of urine from the inlet to the passageway by the external use of a magnet by the subject; and

h) employing an external magnet means by a user to move the ball valve between a closed position and an open position.

20. The method of claim 19 which includes periodically deflating the collar means to the deflated position by the valve means to permit the subject to insert or remove the device from the urethra.

21. The method of claim 19 which includes inserting the device a short distance within the urethra of up to about one inch.

22. The method of claim 19 which method includes:

a) providing a central longitudinally aligned urine flow passageway in the head means; and

b) providing a plurality of spaced-apart urine flower passageways in the head means about said central urine flow passageway.

23. The method of claim 19 which includes inflating and deflating the collar means positioned in and from a chamber collar means which extends circumferentially about the external diameter of the jacket toward the other inlet end.