Urine control device

• US 6,105,580 A
• Filed: 02/25/1998
• Issued: 08/22/2000
• Est. Priority Date: 11/03/1994
• Status: Expired due to Fees

• Current Assignee: Uroscientific Incorporated
• Original Assignee: Uroscientific Incorporated
• Inventors: Cheng, Gordon C., Von Iderstein, Irwin F.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/030,186
• Time in Patent Office: 909 Days
• Field of Search: 128/885, 128/886, 128/DIG. 25, 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 2/0018 magnetic
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An involuntary urine control device (IUCD) having an inflatable collar membrane. The IUCD is inserted a short distance into the distal end of the urethra of a subject user. The IUCD includes the collar membrane which comprises an open ended tube of inflatable membrane material, typically about 30% to 90% of the length of the device. The collar membrane, in its inflated state, serves the purpose of providing sealing between the periphery of the urine control device and the urethra wall. The collar membrane is inflated to move radially outward once the urine control device is inserted into the distal end of the urethra of a patient by the external supply of a fluid. The collar membrane in its deflated state, namely with the inflating fluid removed, is substantially flush with the external diameters of the outer jacket of the urine control device to accommodate the thickness of the collar membrane.

Claims

1. An inflatable collar for a urethra insertion device, the collar comprising:

a cylindrical tube having a first end and a second end, the cylindrical tube being formed of an inflatable material wherein the thickness of the material of the cylindrical tube varies by at least 50 percent; and

a sealing element at each end of the cylindrical tube that seals the tube to the insertion device.

2. The inflatable collar of claim 1 wherein the material of the cylindrical tube narrows in thickness between the sealing element from one end of the cylindrical tube to the other end of the cylindrical tube.

3. The inflatable collar of claim 1 wherein the material of the cylindrical tube has at least two areas with reduced thickness between the sealing element at each end of the cylindrical tube.

4. The inflatable collar of claim 1 wherein the sealing element is an O-ring adapted to be received in a groove in the insertion device.

5. The inflatable collar of claim 4 wherein the inner diameter of the O-rings is smaller than the inner diameter of the groove.

6. An urine control valve apparatus comprising

a cylindrical jacket having an outlet end and an inlet end;

the cylindrical jacket having a pair of grooves around the outer diameter;

an inflatable collar membrane having a cylindrical tube having a pair of open ends and a sealing ring at each end of the cylindrical tube for securing within the grooves on the outer diameter of the cylindrical jacket, the cylindrical tube formed of an inflatable material of varying thickness.

7. The urine control valve apparatus of claim 6 wherein the cylindrical jacket has a smaller diameter between the grooves by the thickness of the inflatable collar such that the inflatable collar when in a deflated position is flush with the cylindrical jacket.

8. The urine control valve apparatus of claim 7 further comprising a radially extended flange having an external surface from the one end of the jacket adapted to fit about and adjacent the open distal end of the urethra.

9. The urine control valve apparatus of claim 6 further comprising a passageway between the inlet end and the outlet end and a valve in the passageway for limiting the flow through the passageway.

10. The urine control valve apparatus of claim 9 wherein the valve comprises a ball moveable between two positions and biased by a spring to a closed position.

11. The urine control valve apparatus of claim 9 further comprising a finger operated pump to be employed by a subject to inflate the collar membrane and to stabilize the jacket in position within the urethra.

12. The urine control valve apparatus of claim 6 wherein the cylindrical tube of the collar having varying thickness.

13. The urine control valve apparatus of claim 12 wherein the cylindrical tube of the collar narrows in thickness as it moves from the sealing rings.

14. The urine control valve apparatus of claim 13 wherein the thickness of the inflatable collar membrane varies from greater than 0.01 inches at the sealing rings to less than 0.002 inches at the midpoint between the sealing rings.

15. The urine control valve apparatus of claim 12 wherein the material of the cylindrical tube has at least two areas with reduced thickness between the sealing rings.

16. The urine control valve apparatus of claim 6 wherein the inflatable collar membrane extends over between 30 and 90 percent of the cylindrical jacket.

17. The urine control valve apparatus of claim 6 wherein the sealing ring is an O-ring and the inner diameter of the O-rings is smaller than the inner diameter of the groove.

18. A method of positioning an urine control device in a urethra comprising the following steps:

providing the urine control device having a cylindrical jacket having an outlet end and an inlet end, the cylindrical jacket having a pair of grooves around the outer diameter and an inflatable collar membrane having a cylindrical tube having a pair of open ends and a sealing ring at each end of the cylindrical tube for securing within the grooves on the outer diameter of the cylindrical jacket, the cylindrical tube formed of an inflatable material of varying thickness;

slideably inserting the urine control device into the open distal end of the urethra;

positioning a flange of the urine control device adjacent to the open distal end of the urethra; and

inflating the inflatable collar membrane to retain the urine control device in the urethra.

19. The method of claim 18 wherein the urethra has a cylindrical shape and the inflatable collar membrane has a plurality of sinusoidal waves.

20. The method of claim 18 wherein the urethra has an olive shape and the inflatable collar membrane has a complementary shape.

21. The method of claim 18 further comprising the step of deflating the inflatable collar membrane for removal of the urine control device from the urethra.

22. The method of claim 18 wherein the inflating step is done with a hand operated pump.

23. The method of claim 18 further comprising the step of tailoring the thickness of the inflatable collar membrane such that upon inflation the collar membrane complements the shape of the urethra.