Device for the treatment of male and female urinary incontinence

• US 6,119,697 A
• Filed: 05/28/1997
• Issued: 09/19/2000
• Est. Priority Date: 05/28/1996
• Status: Expired due to Fees

• Current Assignee: Medi-Globe Vertriebs-GmbH
• Original Assignee: Medi-Globe Vertriebs-GmbH
• Inventors: Engel, Konrad, Engel, Kilian
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/864,367
• Time in Patent Office: 1,210 Days
• Field of Search: 128/885, 128/886, 128/DIG. 25, 600/29-31, 604/101
• US Class Current: 128/885
• CPC Class Codes: A61F 2/0027 inflatable
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A device for the treatment of human urinary incontinence with a catheter which can be inserted into the urethra and carries a balloon arrangement which can be filled with fluid to close off the urinary bladder and to hold the catheter in the lumen of the urethra. The fluid can be admitted to and discharged from this balloon arrangement via at least one closed channel running along the catheter wall which is closed off at the distal end of the catheter, and via a valve mounted at one proximal end section of the catheter in inserted condition. The length of the catheter is dimensioned such that its distal end in inserted condition lies within the urethra. A hydraulic actuating mechanism, also located in the lumen of the urinary bladder, is assigned to the self-closing valve. This hydraulic actuating mechanism can be hydraulically actuated by mechanical pressure exerted on an actuating balloon located at the distal end of the catheter which is filled with fluid and linked to the actuating mechanism via a connecting channel (FIG. 1).

Claims

1. A device for the treatment of human urinary incontinence comprising:

a catheter which is inserted into the urethra and carries a balloon arrangement which is filled with fluid to close off the urinary bladder and to hold the catheter in the lumen of the urethra, the fluid being admitted to and discharged from the balloon arrangement via at least one channel running along the catheter wall which is closed off at the distal end of the catheter, and via a valve mounted at one end section of the catheter located in the urinary bladder, whereby the length of the catheter is dimensioned such that its distal end in the inserted condition lies within the urethra and the valve is actuated by mechanical pressure exerted from outside the urethra on an actuating balloon located at the distal end of the catheter, characterized in that the valve is installed in the proximal end section which, with the catheter in the inserted condition, lies within the lumen of the urinary bladder, in that the proximal end section carries a hydraulic actuating mechanism for opening the valve and in that the actuating mechanism can be hydraulically pressurized by mechanical pressure exerted on the actuating balloon located on the distal end section of the catheter which is filled with fluid and connected to the actuating mechanism via a connecting channel.

2. The device in accordance with claim 1 wherein said valve is an elastically resilient flap valve which can be lifted from its valve seat by said actuating element of the actuating mechanism.

3. The device in accordance with claim 1 wherein said actuating mechanism further comprises a non-elastic traction element which is deflected by the actuating element.

4. The device in accordance with claim 3, characterized in that the actuating element is a hydraulically expandable membrane, one side of which can be hydraulically pressurized via the connecting channel and whose expansion deflects the spanned traction element.

5. The device in accordance with claim 3, characterized in that the traction element is a traction band tightly covering the expandable membrane, the ends of which are permanently connected to the areas of the proximal end section assigned to the sealing lips of the valve.

6. The device in accordance with claim 1 wherein said valve can be closed off by a resilient elastic section of the proximal end section.

7. The device in accordance with claim 6, characterized in that the resilient elastic section is formed by a flexible elastic baton located in the catheter wall.

8. The device in accordance with claim 1 wherein said actuating mechanism is surrounded by a protective membrane.

9. The device in accordance with claim 1, characterized in that the balloon can be filled with fluid via a closed channel at the distal end of the catheter.

10. The device in accordance with claim 1, characterized in that the balloon arrangement for closing off the urinal bladder and holding the catheter in the bladder lumen in the male device is formed by a first balloon at the proximal end and a second balloon located distally from the first balloon, which with the catheter in inserted condition, lies outside the bladder muscle.

11. The device in accordance with claim 1, characterized in that the balloon arrangement for closing off the urinal bladder and holding the catheter in the bladder lumen in the female device is formed by a first balloon at the proximal end and the actuating balloon.

12. The device in accordance with claim 11, characterized in that the actuating balloon has protrusions on its outer surface for fixing its position.

13. The device in accordance with claim 1, characterized in that the catheter consists of a proximal part and a distal part which are linked separably by a plugged connection and are held together by a tensile connection after separation of the plugged connected.

14. The device in accordance with claim 13, characterized in that the plugged connection surrounds small pipes extending from the proximal face end of the distal part which can be inserted into the openings of the channels at the distal end of the proximal part and form a continuation of these channels to the distal end of the catheter.

15. The device in accordance with claim 13, characterized in that the tensile connection between the proximal part and the distal part is formed by a thread whose length permits the separation of the plugged connection.

16. The device in accordance with claim 13, characterized in that a hooking element is attached to the distal end of the distal part in which an extraction instrument can engage during extraction of the device.

17. The device in accordance with claim 16, characterized in that the hooking element is formed by a thread spanned cross-wise over the distal catheter opening which, at the same time, forms a contact element for an insertion device during insertion of the catheter.

18. The device in accordance with claim 13 further comprising an insertion device for insertion of a device into the male urethra, with a shaft which can be pushed onto the distal end of the distal part, characterized in that a nucleus shaped rod is shiftably located in the shaft, the front end of which can be pushed out of the shaft to contact the distal end of the catheter.

19. The device in accordance with claim 18 wherein the front end section of the nucleus can be inserted into the lumen of the catheter up to a stop and in inserted condition reinforcingly bridges a joint in the catheter consisting of a proximal part and a distal part.

20. The device in accordance with claim 19 wherein the cross-section of the front end section is smaller than that of the nucleus and that the stop is a shoulder.

21. The device in accordance with claim 18 wherein the rear end of the nucleus shaped rod protrudes from the shaft as an actuating end.

22. The device in accordance with claim 18 wherein the insertion device is, at the same time, designed as a filling device to allow the balloons to be filled with fluid in that the front end of the shaft is designed as a plug connection with canulae which can be pushed into puncture valves in the face end of the catheter part.

23. A device for the treatment of human urinary incontinence to be used by a human being having a bladder and a urethra, comprising:

a. a catheter having a proximal end with a tip and a distal end, which catheter is inserted into the urethra and is dimensioned such that its distal end in the inserted condition lies within the urethra and its proximal end in the inserted condition lies within the bladder;

b. said catheter including a balloon arrangement which is filled with fluid to close off the urinary bladder and to hold said catheter in the lumen of the urethra, the fluid being admitted to and discharged from the balloon arrangement through at least one channel which is closed off at said distal end of said catheter;

c. a valve mounted adjacent to said tip of said proximal end of said catheter and which is positioned inside the bladder to permit urine to be evacuated when the valve is opened; and

d. means for opening said valve to permit urine to be discharged from the bladder while said catheter remains within the human body and means for closing said valve after the urine has been evacuated from the bladder;

e. whereby said catheter can remain in the human body for the purposes of both closing of the flow of urine from the bladder and also permitting urine to be evacuated from the bladder while said catheter remains in its inserted condition.

24. The device in accordance with claim 23 wherein said balloon arrangement further comprises:

a. a first balloon located adjacent to said proximal end and a second balloon located distally from the first balloon;

b. means for inflating both balloons such that in the inflated condition said first and second balloons are located on opposite sides of the sphincter muscle and thereby maintain said catheter in the correct position.

25. The device in accordance with claim 24 wherein said means for inflating both balloons causes said first balloon to be inflated more rapidly than said second balloon.

26. The device in accordance with claim 25 wherein said means for inflating both balloons comprises at least one channel extending from said distal end of said catheter to a first opening located in said catheter and within said first balloon and a second opening located in said catheter, within said at least one channel and within said second balloon, where the first opening is larger than the second opening and said balloons are inflated through fluid entering from said distal end of said catheter, flowing through said at least one channel, and into the respective balloons through their respective openings.

27. The device in accordance with claim 25 wherein said means for inflating both balloons comprises a first channel extending from said distal end of said catheter to a first opening located in said catheter and within said first balloon, and a second channel extending from a second opening in said catheter and within said first balloon to a third opening located in said catheter and within said second balloon, where the second opening is larger than the third opening and said balloons are inflated through fluid entering from said distal end of said catheter into the first channel, flowing through the first channel into said first balloon from the first opening and then from the second opening into the second channel and into said second balloon through the third opening.

28. The device in accordance with claim 24 wherein said second balloon also functions as an actuating element.

29. The device in accordance with claim 28 wherein said means for inflating both balloons causes said first balloon to be inflated more rapidly than said second balloon.

30. The device in accordance with claim 29 wherein said means for inflating both balloons comprises at least one channel extending from said distal end of said catheter to a first opening located in said catheter and within said first balloon and a second opening located in said catheter, within the at least one channel and within said second balloon, where the first opening is larger than the second opening and said balloons are inflated through fluid entering from said distal end of said catheter, flowing through the at least one channel, and into the respective balloons through their respective openings.

31. The device in accordance with claim 23 wherein said valve is formed by a diagonal cut on said proximal end of said catheter.

32. The device in accordance with claim 23 wherein said means for opening said valve to permit urine to be discharged from the bladder further comprises:

a. an actuating element located adjacent to said distal end of said catheter;

b. at least one channel extending from said actuating element to a semi-balloon located adjacent to said tip of said proximal end of said catheter; and

c. a tissue element covering a portion of said semi-balloon;

d. whereby said actuating element causes said semi-balloon to inflate which in turn moves said tissue element which causes said valve to open.

33. The device in accordance with claim 32 wherein said actuating element is a balloon which is inflated by fluid and which is actuated by a force exerted on said balloon which causes the fluid to flow through said at least one channel, and into said semi-balloon to inflate said semi-balloon.

34. The device in accordance with claim 32 further comprising ribs molded into the surface of said balloon of said actuating element.

35. The device in accordance with claim 23 wherein said catheter further comprises a proximal part having the proximal end and a distal part having the distal end, wherein said proximal part and said distal part are separable and are held together by connecting means and when pulled apart still maintain a loose connection through thread means attached to the respective parts.

36. The device in accordance with claim 23 wherein said catheter has a lumen running from said proximal end to said distal end and said distal end further comprises a transverse thread means within the lumen to facilitate insertion and removal of said catheter.

37. A male device for the treatment of human urinary incontinence to be used by a human being having a bladder, a urethra, a sphincter muscle, and a penis, comprising:

a. a catheter having a proximal end with a tip and a distal end with the length of the catheter dimensioned such that in its inserted condition, the distal end lies within the urethra and the tip of the proximal end lies within the bladder;

b. a balloon arrangement including a first balloon located adjacent to said proximal end, a second balloon located distally from the first balloon, and means for inflating both balloons such that in the inflated condition the first and second balloons are located on opposite sides of the sphincter muscle;

c. a valve located adjacent to said proximal end of said catheter and situated closer to said tip of said proximal end than said first balloon, with the valve situated within the bladder such that urine can be evacuated from the bladder when the valve is opened;

d. said valve communicating with a lumen within said catheter which permits urine to flow from the opened valve, through the lumen and into the urethra;

e. urine is prevented from evacuating the bladder when said first balloon is in the inflated condition and said valve is closed; and

f. valve actuating means located adjacent to said distal end of said catheter and positioned within the urethra such that the valve actuating means is actuated through external pressure on the penis which is transmitted through the urethral wall to the valve actuating means to open said valve and permit urine to be evacuated;

g. whereby said catheter remains within the human body both during the period that urine is prevented from being evacuated from the bladder by the inflated first balloon and during the period that urine is evacuated from the bladder by exiting through the opened valve.

38. The male device in accordance with claim 37 wherein said means for inflating said first balloon and said second balloon such that said first balloon is inflated more rapidly than said second balloon.

39. The male device in accordance with claim 38 wherein said means for inflating both balloons comprises at least one channel extending from said distal end of said catheter to a first opening located in said catheter and within said first balloon and a second opening located in said catheter, within the at least one channel and within said second balloon, where the first opening is larger than the second opening and said balloons are inflated through fluid entering from said distal end of said catheter, flowing through the at least one channel, and into the respective balloons through their respective openings.

40. The male device in accordance with claim 38 wherein said means for inflating both balloons comprises a first channel extending from said distal end of said catheter to a first opening located in said catheter and within said first balloon, and a second channel extending from a second opening in said catheter and within said first balloon to a third opening located in said catheter and within said second balloon, where the second opening is larger than the third opening and said balloons are inflated through fluid entering from said distal end of said catheter into the first channel, flowing through the first channel into said first balloon from the first opening and then from the second opening into the second channel and into said second balloon through the third opening.

41. The male device in accordance with claim 37 wherein said valve is formed by a diagonal cut on said proximal end of said catheter.

42. The male device in accordance with claim 37 wherein said valve actuating means for opening said valve to permit urine to be discharged from the bladder further comprises:

a. an actuating element located adjacent to said distal end of said catheter;

b. at least one channel extending from said actuating element to a semi-balloon located adjacent to said tip of said proximal end of said catheter; and

c. a tissue element covering a portion of said semi-balloon;

d. whereby said actuating element causes said semi-balloon to inflate which in turn moves said tissue element which causes said valve to open.

43. The male device in accordance with claim 42 wherein said actuating element is a balloon which is inflated by fluid and which is actuated by a force exerted on said balloon which causes the fluid to flow through said at least one channel, and into said semi-balloon to inflate said semi-balloon.

44. The male device in accordance with claim 37 wherein said catheter further comprises a proximal part having the proximal end and a distal part having the distal end, wherein said proximal part and said distal part are separable and are held together by connecting means and when pulled apart still maintain a loose connection through thread means attached to the respective parts.

45. The male device in accordance with claim 37 wherein said catheter has a lumen running from said proximal end to said distal end and said distal end further comprises a transverse thread means within the lumen to facilitate insertion and removal of said catheter.

46. A female device for the treatment of human urinary incontinence to be used by a human being having a bladder, a urethra, a sphincter muscle, a vagina and a symphysis, comprising:

a. a catheter having a proximal end with a tip and a distal end with the length of the catheter dimensioned such that in its inserted condition, the distal end lies within the urethra and the tip of the proximal end lies within the bladder;

b. an arrangement including a balloon located adjacent to said proximal end, valve actuating means located distally from the balloon, and means for inflating both the balloon and the valve actuating means such that in the inflated condition the balloon and the valve actuating means are located on opposite sides of the sphincter muscle;

c. a valve located adjacent to said proximal end of said catheter and situated closer to said tip of said proximal end than said balloon, with the valve situated within the bladder such that urine can be evacuated from the bladder when the valve is opened;

d. said valve communicating with a lumen within said catheter which permits urine to flow from the opened valve, through the lumen and into the urethra;

e. urine is prevented from evacuating the bladder when said balloon is in the inflated condition and said valve is closed; and

f. said valve actuating means located adjacent to the symphysis and positioned such that pressure from a finger inserted into the vagina and pressing against said valve actuating means to force it against the symphysis causes said valve to open and permit urine to be evacuated;

g. whereby said catheter remains within the human body both during the period that urine is prevented from being evacuated from the bladder and during the period that urine is evacuated from the bladder by exiting through the opened valve.

47. The female device in accordance with claim 46 wherein said means for inflating both said balloon and said valve actuating means causes said balloon to be inflated more rapidly than said valve actuating means.

48. The female device in accordance with claim 47 wherein said means for inflating the balloon and said valve actuating means comprises at least one channel extending from said distal end of said catheter to a first opening located in said catheter and within said balloon and a second opening located in said catheter, within the at least one channel and within said valve actuating means, where the first opening is larger than the second opening and said balloon and said valve actuating means are inflated through fluid entering from said distal end of said catheter, flowing through the at least one channel, and into the respective balloon and valve actuating means through their respective openings.

49. The female device in accordance with claim 46 wherein said valve is formed by a diagonal cut on said proximal end of said catheter.

50. The female device in accordance with claim 46 wherein said means for opening said valve to permit urine to be discharged from the bladder further comprises:

a. an actuating element located adjacent to said distal end of said catheter;

b. at least one channel extending from said actuating element to a semi-balloon located adjacent to said tip of said proximal end of said catheter; and

c. a tissue element covering a portion of said semi-balloon;

d. whereby said actuating element causes said semi-balloon to inflate which in turn moves said tissue element which causes valve to open.

51. The female device in accordance with claim 50 wherein said actuating element is a balloon which is inflated by fluid and which is actuated by a force exerted on said balloon which causes the fluid to flow through said at least one channel, and into said semi-balloon to inflate said semi-balloon.

52. The female device in accordance with claim 51 further comprising ribs molded into the surface of said balloon of said actuating element.

53. The female device in accordance with claim 46 wherein said catheter further comprises a proximal part having the proximal end and a distal part having the distal end, wherein said proximal part and said distal part are separable and are held together by connecting means and when pulled apart still maintain a loose connection through thread means attached to the respective parts.

54. The female device in accordance with claim 46 wherein said catheter has a lumen running from said proximal end to said distal end and said distal end further comprises a transverse thread means within the lumen to facilitate insertion and removal of said catheter.

55. The female device in accordance with claim 46 wherein said valve actuating means also functions as a second balloon to maintain said catheter in the correct position within the body.