Method and apparatus for valving body fluids

• US 5,112,306 A
• Filed: 12/27/1989
• Issued: 05/12/1992
• Est. Priority Date: 03/25/1986
• Status: Expired due to Term

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Berg, Eric P., Scott, Frank B., Burton, John H., Staehle, Bradford G.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/457,423
• Time in Patent Office: 867 Days
• Field of Search: 604/54, 604/96, 604/101, 604/246, 604/247, 604/280, 600/29-31, 128/DIG. 25
• US Class Current: 604/101.02
• CPC Class Codes: A61F 2/0027 inflatable
• CPC Class Codes: A61M 25/0075 Valve means
• 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 method and apparatus for valving body fluids involving a flexible tubular body with a drainage canal therethrough, including collapsible means for blocking the passageway and thereby preventing the flow of urine. The length of the device is such that one end protrudes into the bladder and the other end terminates interior of the meatus. The device includes a means for anchoring to secure it in place and a plug device for deflating and releasing the anchoring means and for collapsing the blocking means to facilitate removal of the device from the body. The device is manually actuable to an open position and means are provided to delay the closing of the device for a sufficient period of time to allow voiding of the bladder. The collapsible and expandable nature of the device facilitates its insertion and removal, particularly while passing through areas of restricted diameter.

Claims

1. An indwelling valving device, comprising:

a flexible tubular body having distal and proximal ends and defining a longitudinal passageway therethrough;

anchoring means for securing said body in place; and

collapsible blocking means for blocking said passageway, said blocking means operable to collapse by manual pressure to allow fluid flow through said passageway and operable to expand by gradual pressure equalization to again block said passageway when the desired fluid flow is completed.

2. An indwelling valving device of claim 1, further comprising releasing means operable to release said anchoring means and enable said device to be removed from the urethra.

3. An indwelling valving device of claim 1, further comprising pressure equalizing bleed-back means for delayed closing of said blocking means after said blocking means has been actuated to an unblocking position.

4. An indwelling valving device of claim 1 wherein said anchoring means further comprises first and second anchoring means.

5. An indwelling valving device of claim 4 wherein said first anchoring means secures said tubular body adjacent the bladder and said second anchoring means anchors said tubular body adjacent the proximal urethra.

6. An indwelling valving device of claim 4 wherein said first and second anchoring means comprise inflatable members.

7. An indwelling valving device of claim 6, further comprising valve means for inflating said inflatable members from said distal end.

8. An indwelling urinary continence device, comprising:

a flexible tubular body having distal and proximal ends and having a first passageway extending longitudinally therethrough;

a first fixation means secured to the exterior surface of said proximal end of said body;

a second fixation means secured to the exterior surface of said body; and

an inflatable member secured within said first passageway, said inflatable member inflatable to close said first passageway and manually compressible to open said first passageway.

9. An indwelling urinary continence device as in claim 8, wherein said first fixation means is inflatable.

10. An indwelling urinary continence device as in claim 9, further comprising:

a second passageway extending from the interior of said inflatable member to the interior of said first fixation means; and

differential pressure flow controller means in said second passageway enabling rapid balancing of pressures between said first fixation means and said inflatable member when the pressure in said inflatable member exceeds the pressure in said first fixation means, and enabling a time-delayed balancing of pressures when the pressure in the first fixation means exceeds the pressure in the inflatable member.

11. An indwelling urinary continence device comprising:

a tubular body adapted to be inserted in the urethra with one end extending into the bladder and the opposite end spaced inwardly of the meatus, said tubular body having upper and lower portions and said lower portion defining an annular space when positioned within the urethra;

a first inflatable member secured to the exterior surface of said upper portion of said tubular body and positioned to be within the bladder upon inflation;

a second inflatable member secured to the exterior surface of said upper portion of said tubular body and positioned to engage the urethra upon inflation;

a third inflatable member secured to the exterior surface of said lower portion of said tubular body; and

a first passageway in said tubular body to drain said bladder into said annular space between the urethra and said lower portion of said tubular body.

12. The indwelling urinary continence device of claim 11, further comprising:

a second passageway in said tubular body extending from the interior of said third inflatable member to said first inflatable member; and

differential pressure flow controller means in said second passageway for enabling rapid balancing of pressures between said first and third inflatable members when the pressure in said third inflatable member exceeds the pressure in said first inflatable member, said controller means including means for enabling a time-delayed balancing of pressures when the pressure in said first inflatable member exceeds the pressure in said third inflatable member.

13. The device of claim 11 including a collapsible sheath attached along its upper periphery to the periphery of the lower end of said upper portion of said tubular body, said sheath surrounding said third inflatable member so as to be collapsible upon insertion of said device but expandable to full diameter when properly positioned.

14. The device of claim 11 including:

a valve chamber in the lower end of said tubular body vented to provide fluid communication between said valve chamber and each said inflatable member, and between said valve chamber and said urethra; and

a valve member operable in said valve chamber between a first position in which said vents are all open and a second position in which all said vents are closed.

15. The device of claim 11 in which said inflatable members are balloons.

16. The device of claim 11 in which said third inflatable member is positioned to be adjacent the perineum so as to be easily compressible from the exterior surface of the body.

17. An indwelling urethral device comprising:

a tubular body adapted to be inserted into the urethra and extend from an upper end in communication with the bladder to a lower end spaced above the lower end of the urethra;

a first balloon at the upper end of said tubular body inflatable from the lower end of said tubular body to expand into an anchoring position within the bladder;

a second balloon at and inflatable from the lower end of said tubular body to seal against the wall of the urethra;

a first lumen in said tubular body communicating between said balloons;

flow control means in said first lumen operable to promptly relieve differential pressures above a preselected value from said second balloon to said first balloon; and

time delay means for the gradual release of said differential pressures from said first balloon to said second balloon.

18. The device of claim 17, including:

an anchor on said tubular body between said balloons pneumatically actuable from said lower end of said tubular body to anchor said device within said urethra.

19. The device of claim 17, including:

a second lumen in said tubular body adapted to drain the bladder into the urethra above said second balloon.

20. The device of claim 19, including:

a valve chamber in the lower end of said tubular body vented to communicate with said balloons and said anchor for the passage of fluid therebetween; and

a valve operable in said chamber between a first position opening such vents and a second position closing such vents.

21. An indwelling valving device for use in a body passageway comprising:

an elongated member defining a first longitudinal passageway and adapted to be inserted into said body passageway, said member defining an annulus with the body passageway;

a first expansible member on said elongated member toward a first end of said elongated member of a character upon expansion to seal the annulus between said elongated member and said body passageway;

an inflatable member on said elongated member spaced longitudinally from said expansible member toward the second end of said elongated member to block said first passageway upon inflation, and palpable to expel fluid contained in said inflatable member;

an inflatable chamber to receive said expelled fluid; and

differential flow control means interconnecting said inflatable member and said inflatable chamber to enable said expelled fluid to flow rapidly from said inflatable member to said inflatable chamber and to enable fluid to flow more gradually from said inflatable chamber into said inflatable member.

22. The indwelling valving device of claim 21 in which said inflatable chamber is disposed within said first expansible member.

23. The indwelling valving device of claim 21 in which said flow control means comprises pressure relief means to enable said expelled fluid to flow to said inflatable chamber and flow restriction means to enable fluid to flow from said inflatable chamber to said inflatable member.

24. The indwelling valving device of claim 21 in which said first passageway includes a first section extending internally of said elongated member from said first end to bypass said expansible member and a second section comprising said annulus whereby said second section bypasses said inflatable member upon said expulsion of fluid from said inflatable member.

25. An indwelling valve assembly for controlling the flow of fluid through a body passageway, comprising:

a valve comprising a sheath operative to expand from a collapsed state to increase the flow area through the valve;

actuator means for selectively opening said valve; and

control means for delayed gradual closing of said valve,

said valve assembly operative to allow collapse of said sheath while passing though areas of restricted diameter.

26. A valve assembly as in claim 25, further comprising a valve member inflatable to close said valve.

27. A valve assembly as in claim 26, wherein said valve member comprises a receptor for receiving fluid.

28. A valve assembly as in claim 27, further comprising:

a reservoir; and

a passageway extending from said valve member to said reservoir.

29. A valve assembly as in claim 28 wherein said reservoir is expandable to receive fluid from said valve member.

30. A valve assembly as in claim 28, wherein said control means is responsive to said actuator means to allow fluid in said receptor to flow to said reservoir and responsive to pressure on said reservoir to yieldably resist flow of fluid from said reservoir to said receptor.

31. A device for insertion into the urethra, comprising:

a fixation means for engagement with the bladder;

a valve for substantially preventing the flow of urine through the urethra; and

an interconnecting member for interconnecting said fixation means and said valve,

said valve including a sheath operative to collapse upon passage of the device through areas of restricted diameter and expand upon proper positioning in the urethra to increase the flow area through said valve.

32. A urethral valving device, comprising:

a valve operable to collapse upon insertion into or withdrawal from the urethra and expand while in a position within the urethra; and

means for selectively opening said valve from a point external of the body.

33. The device of claim 32, further comprising:

means for automatic delayed closing of said valve after said valve has been opened.

34. The device of claim 32, further comprising:

a chamber vented to provide fluid communication between said chamber and said valve and between said chamber and said urethra; and

a plug operable in said chamber between a first position in which said vents are open and a second position in which said vents are closed.

35. An intraurethral valving device, comprising:

a flexible tubular body having distal and proximal ends and defining a longitudinal passageway therethrough;

anchoring means for securing said body in place;

blocking means for blocking said passageway;

a valve chamber in said distal end of said body having vents to provide fluid communication between said valve chamber and said anchoring means, between said valve chamber and said blocking means, and between said valve chamber and said urethra; and

a valve member operable in said valve chamber between a first position in which said vents are all open and a second position in which said vents are all closed.