Urethra control device

• US 6,027,442 A
• Filed: 11/26/1997
• Issued: 02/22/2000
• Est. Priority Date: 11/03/1994
• Status: Expired due to Fees

• Current Assignee: Uroscientific Incorporated
• Original Assignee: Uroscientific Incorporated
• Inventors: Von Iderstein, Irwin F.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/979,099
• Time in Patent Office: 818 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

A urethra control device has a control valve and is used for controlling fluid flow. The control valve is adapted to be inserted a short distance with the open distal end of the urethra of a subject. The control valve has a valve jacket to be positioned in the urethra and a valve within the valve jacket. A collar on the outer surface of the valve jacket engages an inner surface of the urethra to secure the valve jacket relative to the urethra.

Claims

1. A urethra control device comprising:

a valve jacket adapted to be positioned in the urethra to control fluid flow;

a valve within the valve jacket;

a collar on an outer surface of the valve jacket,

the collar adapted to engage an inner surface of the urethra to secure the valve jacket relative to the urethra.

2. The device of claim 1 further comprising a spring loaded ball valve within the valve jacket.

3. The device of claim 1 wherein the collar comprises an inflatable membrane.

4. The device of claim 1 wherein the valve jacket further comprising a fluid inlet and a fluid outlet.

5. The device of claim 1 further comprising a magnet that actuates the valve.

6. The device of claim 3 further comprising a pump that inflates the membrane.

7. A urethra control device comprising:

a control valve adapted to be inserted a short distance within the open distal end of the urethra of a subject, which valve comprises;

(i) a cylindrical jacket having an outlet end and an inlet end and an external diameter and surface that extends a short distance into the open distal end of the urethra of a subject;

(ii) a collar about the jacket to stabilize the jacket in position within and to the interior wall of the urethra, the collar moving between a radially outwardly extended, inflatable position to stabilize the jacket and a radially deflated position to permit the insertion into or removal from the urethra of the jacket;

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

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

(v) a chamber in the jacket to connect the valve with the collar;

(vi) a head secured to the outlet end of the jacket and having at least one fluid flow passageway to permit the flow of fluid externally from the subject; and

(vii) 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 position against a valve seat to prevent the flow of fluid 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 fluid from the inlet to the passageway;

by the external use of 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 when magnetically activated or to prevent the movement of the ball valve to the open position by sufficient bladder pressure of the subject.

8. The apparatus of claim 7 wherein the chamber comprises a generally longitudinal passageway in the jacket from the valve to the collar.

9. The apparatus of claim 7 wherein the tension-biased ball valve comprises a longitudinal spring within the jacket and a metal ball having a polymeric coating at one end of the spring.

10. The apparatus of claim 7 wherein the jacket includes a ball valve seat for the tension-biased ball valve about the inlet or outlet of the jacket.

11. The apparatus of claim 7 wherein the flange has a smooth, arcuate surface on the external surface adapted to fit the tissue contour surrounding the end of the urethra.

12. The apparatus of claim 7 wherein the collar is positioned toward the inlet end of the jacket.

13. The apparatus of claim 7 wherein the collar comprises a curved portion of the jacket surface and includes a flexible, radially movable membrane secured to the curved portion of the jacket surface.

14. The apparatus of claim 7 wherein the head is removably secured in the outlet of the jacket.

15. The apparatus of claim 7 wherein the head is threadably secured in the outlet of the jacket.

16. A method for controlling fluid flow comprising the steps of:

inserting a valve a short distance within a lumen from a distal end;

securing the valve in position within an interior wall of the lumen with a collar; and

operating the valve to control fluid flow in the lumen.

17. The method of claim 16 further comprising the steps of:

fitting a jacket about adjacent to the open distal end of the lumen, one radially extended flange having an external surface from one end of the jacket;

permitting the introduction of a fluid into the collar and permitting the release of fluid from the collar by a valve on the external surface of the flange;

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

securing a head to the outlet end of the jacket and having at least one fluid flow passageway permitting the flow of fluid externally from the lumen;

positioning a tension-biased, magnetically activated ball valve within the jacket, the ball valve moving generally longitudinally within the jacket between a tension-biased position against a valve seat preventing the flow of fluid 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 fluid from the inlet to the passageway by the external use of a magnet by a user, the ball valve having sufficient tension to be placed in the closed position, but insufficient to prevent the ball valve moving to the open position when magnetically activated or preventing the movement of the ball valve to the open position by sufficient fluid pressure in the lumen.

18. The method of claim 17 further comprising the steps of deflating periodically the collar by the valve to insert and remove the device from the lumen.

19. The method of claim 17 which includes inserting the device a short distance within the lumen of up to about one inch.

20. The method of claim 16 further comprising inflating the collar to frictionally engage an inner wall of the lumen.