Apparatus with valve for treating incontinence

• US 5,795,288 A
• Filed: 08/08/1996
• Issued: 08/18/1998
• Est. Priority Date: 08/08/1996
• Status: Expired due to Fees

• Current Assignee: Dennis J. Hanlon, Kenneth L. Cohen
• Original Assignee: Dennis J. Hanlon, Kenneth L. Cohen
• Inventors: Hanlon, Dennis J., Cohen, Kenneth L.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US08/694,331
• Time in Patent Office: 740 Days
• Field of Search: 600/29-32, 128/DIG. 25, 128/834, 128/835, 128/836, 604/327, 604/328, 604/329
• 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: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An apparatus for treating incontinence includes a substantially tubular body member having a first end and a second end and defining a flow passage, an internal seal member positioned at the first end of the body member, an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member, ratchet structure for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra, and a valve positioned in the flow passage for controlling flow through the flow passage.

Claims

1. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end of the body member wherein the first end terminates in the internal seal member and the second end terminates in the external retaining member so as to define a total length of the body member between the internal seal member and the external retaining member, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage.

2. An apparatus according to claim 1, wherein the internal seal member comprises an inflatable collar for sealingly engaging with an internal opening of the urethra.

3. An apparatus according to claim 2, further comprising means for inflating the collar with the tubular body member positioned in the urethra.

4. An apparatus according to claim 3, wherein the means for inflating comprises an inflation fluid passage associated with the tubular body member and communicated at one end with the collar and having means at the other end for communicating with a source of inflation fluid for inflating the collar.

5. An apparatus according to claim 4, wherein the inflation fluid passage comprises a tube running lengthwise along the tubular body member.

6. An apparatus according to claim 5, wherein the tube extends through the retaining member.

7. An apparatus according to claim 1, wherein the tubular body member comprises a first body portion defining the first end and a second body portion defining the second end, and wherein the first body portion is longitudinally moveable relative to the second body portion whereby spacing between the seal member and the retaining member is adjustable.

8. An apparatus according to claim 7, further comprising means for locking the first body portion relative to the second body portion at a desired spacing.

9. An apparatus according to claim 8, wherein the means for locking comprises ratchet means associated with the first portion and the second portion for permitting relative movement of the first portion toward the second portion and for preventing relative movement of the first portion away from the second portion.

10. An apparatus according to claim 9, wherein the first portion comprises a first tubular element having a first set of ratchet teeth, and the second portion comprises a second tubular element having a second set of ratchet teeth for engaging the first set of ratchet teeth.

11. An apparatus according to claim 10, wherein the first portion has a first diameter and the second portion has a second diameter, and wherein the first and second diameter are selected so that one portion slidably fits within the other portion.

12. An apparatus according to claim 7, further comprising grippable means associated with the first tubular portion for gripping with an elongate object whereby the first tubular portion can be held in place during positioning of the second tubular portion relative to the first tubular portion.

13. An apparatus according to claim 12, wherein the grippable means comprises a rod positioned across at least a portion of the first end.

14. An apparatus according to claim 1, wherein the valve means comprises means for releasably blocking flow through the flow passage.

15. An apparatus according to claim 7, wherein the valve means comprises means for releasably blocking flow through the flow passage.

16. An apparatus according to claim 15, wherein the valve means is mounted within the first tubular portion and further comprises grippable means associated with the first tubular portion for gripping from a remote position whereby the first tubular portion can be held in place during positioning of the second tubular portion relative to the first tubular portion.

17. An apparatus according to claim 16, wherein the grippable means comprises at least one rod member mounted within the first tubular portion downstream of the valve means.

18. An apparatus according to claim 1, wherein the valve means comprises a valve seat positioned in the flow passage, and a valve body movably associated with the valve seat between a closing position wherein the valve body substantially sealingly engages the valve seat, and a flow position wherein the valve body does not engage the valve seat.

19. An apparatus according to claim 18, wherein the valve body is biased toward the closing position.

20. An apparatus according to claim 19, wherein the valve body extends through the valve seat toward the second end whereby a collection member can be inserted into the tubular body member from the second end so as to bias the valve body into the flow position.

21. An apparatus according to claim 1, wherein the valve means comprises a duck bill valve.

22. An apparatus according to claim 1 wherein the retaining member comprises a flange member arranged around the second end of the tubular body member.

23. An apparatus according to claim 1, further comprising means for releasably holding a collection member within the second end for receiving flow through the valve means.

24. An apparatus according to claim 1, wherein the tubular body portion is at least partially flexible whereby the tubular body portion can flex to adapt to a contour of the urethra.

25. An apparatus according to claim 1, wherein the valve means comprises a plug member releasably disposed within the flow passage.

26. A method for treating incontinence, comprising the steps of:

providing an apparatus comprising a substantially tubular body member having a first end and a second end and defining a urine flow passage, an internal seal member positioned at the first end, an external retaining member positioned at the second end of the body member, wherein the first end terminates in the internal seal member and the second end terminates in the external retaining member so as to define a total length of the body member between the internal seal member and the external retaining member, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member, means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra, and valve means positioned in the flow passage for controlling flow through the flow passage, wherein the internal seal member is positionable between a radially expanded position and a radially withdrawn position;

positioning the internal seal member in the radially withdrawn position;

inserting the apparatus into a urethra with the seal member extending beyond an internal opening of the urethra;

positioning the seal member in the radially expanded position;

moving the external retaining member relative to the seal member to an implanted position wherein the seal member substantially sealingly engages the internal opening of the urethra and the retaining member engages the external opening of the urethra;

securing the retaining member relative to the seal member in the implanted position; and

selectively operating the valve means for controlling flow through the flow passage.

27. A method according to claim 26, further comprising the step of holding the seal member in place during the moving step.

28. A method according to claim 27, wherein the holding step comprises providing grippable means associated with the seal member;

and

gripping the grippable means from a remote position during the step of moving the retaining member relative to the seal member.

29. A method according to claim 28, wherein the gripping step comprises inserting a substantially elongate member through the tubular body to grip the grippable means during the step of moving the retaining member.

30. A method according to claim 26, wherein the valve means comprises a valve seat mounted in the tubular body and a valve body movably mounted relative to the valve seat between a closing position wherein the valve body substantially sealing engages the valve seat, and a flow position wherein the valve body does not engage the valve seat and wherein the step of selectively operating comprises the steps of moving the valve body toward the flow position to allow flow through the valve means and allowing the valve body to return to the closing position.

31. A method according to claim 30, wherein the step of moving the valve body comprises inserting a flow collecting member into the tubular body so as to push the valve body out of engagement with the valve seat whereby flow through the valve means enters the flow collecting member;

and removing the flow collecting member from the tubular body whereby the valve body returns to the closing position.

32. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage, wherein the tubular body member comprises a first body portion defining the first end and a first portion of the flow passage, and a second body portion defining the second end and a second portion of the flow passage, and wherein the first body portion is longitudinally movable relative to the second body portion whereby spacing between the seal member and the retaining member is adjustable.

33. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage wherein the tubular body member comprises a first body portion defining the first end and a second body portion defining the second end, wherein the first body portion is longitudinally movable relative to the second body portion whereby spacing between the seal member and the retaining member is adjustable, and further comprising means for locking the first body portion relative to the second body portion at a desired spacing, said means for locking comprising a first set of ratchet teeth positioned on said first portion and skewed toward the first end, and a second set of ratchet teeth positioned on the second portion and skewed toward the second end, whereby relative movement of the first portion toward the second portion is permitted, and relative movement of the first portion away from the second portion is prevented.

34. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage, wherein the tubular body member comprises a first body portion defining the first end and a second body portion defining the second end, wherein the first body portion is longitudinally movable relative to the second body portion whereby spacing between the sealed member and the retaining member is adjustable, and further comprising grippable means within the first tubular portion for gripping with an elongate object whereby the first tubular portion can be held in place during positioning of the second tubular portion relative to the first tubular portion.

35. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage, wherein the tubular body member comprises a first body portion defining the first end and a second body portion defining the second end, and wherein the first body portion is longitudinally movable relative to the second body portion whereby spacing between the seal member and the retaining member is adjustable, wherein the valve means comprises means for releasably blocking flow through the flow passage mounted within the first tubular portion, and further comprising grippable means within the first tubular portion for gripping from a remote position whereby the first tubular portion can be held in place during positioning of the second tubular portion relative to the first tubular portion.

36. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra; and

valve means positioned in the flow passage for controlling flow through the flow passage, wherein the valve means comprises a valve seat positioned in the flow passage, and a valve body movably associated with the valve seat between a closing position wherein the valve body substantially sealingly engages the valve seat, and a flow position wherein the valve body does not engage the valve seat, the valve body being biased toward the closing position, and wherein the valve body extends through the valve seat toward the second end whereby a collection member can be inserted into the tubular member from the second end so as to bias the valve body into the flow position.

37. An apparatus for treating incontinence, comprising:

a substantially tubular body member having a first end and a second end and defining a urine flow passage;

an internal seal member positioned at the first end of the body member;

an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member;

means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra;

valve means positioned in the flow passage for controlling flow through the flow passage;

means for releasably holding a collection member within the second end for receiving flow through the valve means.

38. A method for treating incontinence, comprising the steps of:

providing an apparatus comprising a substantially tubular body member having a first end and a second end and defining a urine flow passage, an internal seal member positioned at the first end, grippable means fixedly associated with the seal member, and an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member, means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra, and valve means positioned in the flow passage for controlling flow through the flow passage, wherein the internal seal member is positionable between a radially expanded position and a radially withdrawn position;

positioning the internal seal member in the radially withdrawn position;

inserting the apparatus into a urethra with the seal member extending beyond an internal opening of the urethra;

positioning the seal member in the radially expanded position;

moving the external retaining member relative to the seal member to an implanted position wherein the seal member substantially sealingly engages the internal opening of the urethra and the retaining member engages the external opening of the urethra;

holding the seal member in place during the moving step by gripping the grippable means from a remote position during the step of moving the retaining member relative to the seal member;

securing the retaining member relative to the seal member in the implanted position; and

selectively operating the valve means for controlling flow through the flow passage.

39. A method for treating incontinence, comprising the steps of:

providing an apparatus comprising a substantially tubular body member having a first end and a second end and defining a urine flow passage, an internal seal member positioned at the first end, an external retaining member positioned at the second end, at least one member of the internal seal member and the external retaining member being moveable longitudinally with respect to the other member of the internal seal member and the retaining member, means for longitudinally securing the at least one member relative to the other member, whereby the tubular body member can be positioned in a urethra with the seal member substantially sealingly positioned in an interior opening of the urethra and with the retaining member positioned at an exterior opening of the urethra, and valve means positioned in the flow passage for controlling flow through the flow passage, wherein the internal seal member is positionable between a radially expanded position and a radially withdrawn position;

positioning the internal seal member in the radially withdrawn position;

inserting the apparatus into a urethra with the seal member extending beyond an internal opening of the urethra;

positioning the seal member in the radially expanded position;

moving the external retaining member relative to the seal member to an implanted position wherein the seal member substantially sealingly engages the internal opening of the urethra and the retaining member engages the external opening of the urethra;

securing the retaining member relative to the seal member in the implanted position; and

selectively operating the valve means for controlling flow through the flow passage, wherein the valve means comprising a valve seat mounted in the tubular body and a valve body movably mounted relative to the valve set between a closing position wherein the valve body substantially sealingly engages the valve seat, and a flow position wherein the valve body does not engage the valve seat, and wherein the step of selectively operating comprises the steps of moving the valve body toward the flow position to allow flow through the valve means and allowing the valve body to return to the closing position, and wherein the step of moving the valve body comprises inserting a flow collecting member into the tubular body so as to push the valve body out of engagement with the valve seat whereby flow through the valve means enters the flow collecting member, and removing the flow collecting member from the tubular body whereby the valve body returns to the closing position.