Urethral pressure catheter

• US 5,776,081 A
• Filed: 06/06/1995
• Issued: 07/07/1998
• Est. Priority Date: 06/06/1995
• Status: Expired due to Fees

• Current Assignee: Cystomedix, Inc.
• Original Assignee: University of Iowa Research Foundation
• Inventors: Kreder, Karl J.
• Primary Examiner(s): Hindenberg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/467,100
• Time in Patent Office: 1,127 Days
• Field of Search: 128/748, 128/762, 128/774, 128/673-675
• US Class Current: 600/593
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters

Abstract

Devices and methods for measuring the weakness of body lumens, and in particular, urethral sphincters and similar valves, are disclosed. In one embodiment of the invention, a catheter with a hollow fluted distal end can be inserted into a lumen. The hollow fluted distal end of the catheter is then expanded into an enlarged configuration. The measurement of resistance to withdrawal of the catheter in the enlarged configuration provides an indication of weakness of the lumen. In one aspect of the invention, the catheter is inserted into a bladder via the urethral sphincter and the weakness of the urethral sphincter is measured. In another aspect of the invention, a device for measuring weakness of a body lumen, such as a urethral sphincter and similar valves, can consist of a catheter with a hollow fluted distal end having of an array of wings, and an expanding means for radially expanding the wings into an enlarged configuration. Subsequent withdrawal of the catheter in the enlarged configuration encounter resistances which can be measured as an indication of the weakness of the body lumen, such as a urethral sphincter and similar valves. In still another aspect of the invention, a system for measuring weakness of a body lumen can consist of a catheter, a means for expanding a hollow fluted distal end of the catheter from a first configuration into a second enlarged configuration and means for measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of weakness of the body lumen, such as the urethral sphincter and similar valves.

Claims

1. A method for measuring the constrictive force of a wall of a body lumen comprising:

inserting a catheter into the body lumen;

expanding a hollow fluted distal end of the catheter into an enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

measuring a resistance to withdrawal of the catheter in the enlarged configuration as an indicator of the constrictive force of a wall of the body lumen.

2. The method of claim 1 wherein the step of inserting the catheter into the body lumen further comprises simultaneously inserting a retracting cable inside the catheter into the body lumen such that a plunger distal end of the retracting cable extends beyond the hollow fluted distal end of the catheter.

3. The method of claim 2 wherein the step of expanding the hollow fluted distal end of the catheter further comprises activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter.

4. The method of claim 3 wherein the step of activating the retracting cable further comprises activating the retracting cable to a pre-determined extent.

5. The method of claim 1 wherein the step of expanding the hollow fluted distal end of the catheter further comprises increasing the diameter of the hollow fluted distal end of the catheter to at least about 4 french.

6. The method of claim 1 wherein the step of measuring resistance further comprises measuring resistance with a resistance monitor.

7. The method of claim 1 wherein the step of measuring resistance further comprises withdrawing the catheter at a predetermined rate.

8. The method of claim 1, wherein the catheter in the inserting step is surrounded on the outside with a disposable plastic sheath prior to insertion of the catheter into the body lumen.

9. A method for measuring the constrictive force of a urethral sphincter comprising:

inserting a catheter into a bladder via the urethral sphincter;

expanding a hollow fluted distal end of the catheter into an enlarged configuration where the fluted distal end contacts the urethral sphincter; and

measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of the urethral sphincter.

10. The method of claim 9 wherein the step of inserting the catheter into the bladder further comprises simultaneously inserting a retracting cable inside the catheter into the bladder such that a plunger distal end of the retracting cable extends beyond the hollow fluted distal end of the catheter.

11. The method of claim 10 wherein the step of expanding the hollow fluted distal end of the catheter further comprises activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter.

12. The method of claim 11 wherein the step of activating the retracting cable from the catheter further comprises activating the retracting cable to a pre-determined extent.

13. The method of claim 9 wherein the step of expanding the hollow fluted distal end of the catheter further comprises increasing the diameter of the hollow fluted distal end of the catheter to at least about 4 french.

14. The method of claim 9 wherein the step of measuring resistance further comprises measuring resistance with a resistance monitor.

15. The method of claim 9 wherein the step of measuring resistance further comprises withdrawing the catheter at a predetermined rate.

16. The method of claim 9, wherein the catheter in the inserting step is surrounded on the outside with a disposable plastic sheath prior to insertion of the catheter into the bladder.

17. A device for measuring the constrictive force of a wall of a body lumen comprising:

a catheter;

a hollow fluted distal end of the catheter with an array of wings radially disposed, the array of wings being closed in a first configuration and being radially expanded in a second enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

means for expanding the array of wings of the hollow fluted distal end into the second enlarged configuration such that subsequent withdrawal of the hollow fluted distal end in the second enlarged configuration encounters resistance which can be measured as an indication of the constrictive force of a wall of the body lumen.

18. The device of claim 17 wherein the means for expanding the array of wings of the hollow fluted distal end of the catheter further comprises:

a retracting cable disposed inside the catheter; and

a plunger distal end of the retracting cable extending beyond the hollow fluted distal end of the catheter.

19. The device of claim 18, further comprising:

means for activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands the wings of the hollow fluted distal end of the catheter into the second enlarged configuration.

20. The device of claim 19, further comprising:

restriction means disposed at a proximal end of the catheter for restricting the extent of the activation of the retracting cable to a pre-determined extent.

21. The device of claim 18 wherein the plunger distal end of the retracting cable further comprises a shape to facilitate insertion into the body lumen.

22. The device of claim 17, further comprising:

a resistance monitor for measuring the resistance of the withdrawal of the catheter.

23. The device of claim 17, further comprising:

a withdrawal means for withdrawing the catheter at a pre-determined rate.

24. The device of claim 17 wherein the device is disposable.

25. The device of claim 17, further comprising:

a disposable plastic sheath surrounding the outside of the device; and

a sterilizable catheter.

26. A system for measuring the constrictive force of a wall of a body lumen comprising:

a catheter;

a means for expanding a hollow fluted distal end or the catheter from a first configuration into a second enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

a means for measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of a wall of the body lumen.

27. The system of claim 26 wherein the means for expanding the hollow fluted distal end of the catheter further comprises:

a retracting cable disposed inside the catheter; and

a plunger distal end of the retracting cable extending beyond the hollow fluted distal end of the catheter.

28. The system of claim 27, further comprising:

a means for activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter into the second enlarged configuration.

29. The system of claim 28, further comprising:

restriction means disposed at a proximal end of the catheter for restricting the activation of the retracting cable to pre-determined extent.

30. The system of claim 27 wherein the plunger distal end of the retracting cable further comprises a shape to facilitate insertion into the body lumen.

31. The system of claim 26 wherein the hollow fluted distal end of the catheter further comprises an array of wings radially disposed, the array of wings being closed in the first configuration and being radially expanded in the second enlarged configuration.

32. The system of claim 26, further comprising:

a means for withdrawing the catheter at a predetermined rate.

33. The system of claim 26, further comprising:

a sterilizable catheter; and

a disposable plastic sheath surrounding the outside of the catheter.

34. A method for measuring constrictive force of a wall of a of a body lumen comprising:

inserting a catheter into the body lumen

inserting a retracting cable inside the catheter into the body lumen such that a plunger distal end of the retracting cable extends beyond a hollow fluted distal end of the catheter;

expanding the hollow fluted distal end of the catheter into an enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

measuring a resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of the wall of the body lumen.

35. The method of claim 34 wherein the step of expanding the hollow fluted distal end of the catheter further comprises activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter.

36. The method of claim 35 wherein the step of activating the retracting cable further comprises activating the retracting cable to a pre-determined extent.

37. A method for measuring constrictive force of wall of a body lumen comprising:

inserting a catheter into a body lumen, said catheter being surrounded on the outside with a disposable plastic sheath forming a surrounded catheter;

expanding a hollow fluted distal end of the surrounded catheter into an enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

measuring a resistance to withdrawal of the surrounded catheter in the enlarged configuration as an indicator of constrictive force of a wall of the body lumen.

38. A method for measuring constrictive force of a urethral sphincter comprising:

inserting a catheter into a bladder via the urethral sphincter;

inserting a retracting cable inside the catheter into the bladder such that a plunger distal end of the retracting cable extends beyond a hollow fluted distal end of the catheter;

expanding a hollow fluted distal end of the catheter into an enlarged configuration where the fluted distal end contacts the urethral sphincter; and

measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of the urethral sphincter.

39. The method of claim 38 wherein the step of expanding the hollow fluted distal end of the catheter further comprises activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter.

40. The method of claim 39 wherein the step of activating the retracting cable from the catheter further comprises activating the retracting cable to a pre-determined extent.

41. A method for measuring weakness of a urethral sphincter comprising:

inserting a catheter into a bladder via the urethral sphincter, said catheter being surrounded on the outside with a disposable plastic sheath forming a surrounded catheter;

expanding a hollow fluted distal end of the surrounded catheter into an enlarged configuration; and

measuring resistance to withdrawal of the surrounded catheter in the enlarged configuration as an indicator of weakness of the urethral sphincter.

42. A device for measuring constrictive force of a wall of a body lumen comprising:

a catheter;

a hollow fluted distal end of the catheter with an array of wings radially disposed, the array of wings being closed in a first configuration and being radially expanded in a second enlarged configuration where the fluted distal end contacts the wall of the body lumen; and

means for expanding the array of wings of the hollow fluted distal end into the second enlarged configuration such that subsequent withdrawal of the hollow fluted distal end in the second enlarged configuration encounters resistance which can be measured as an indication of weakness of the body lumen, wherein the means for expanding comprises a retracting cable disposed inside the catheter and a plunger distal end of the retracting cable extending beyond the hollow fluted distal end of the catheter.

43. The device of claim 42, further comprising:

means for activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands the wings of the hollow fluted distal end of the catheter into the second enlarged configuration.

44. The device of claim 43, further comprising:

restriction means disposed at a proximal end of the catheter for restricting the extent of the activation of the retracting cable to a predetermined extent.

45. The device of claim 42 wherein the plunger distal end of the retracting cable further comprises a shape to facilitate insertion into the body lumen.

46. A device for measuring constrictive force of a wall of a body lumen comprising:

a sterilizable catheter;

a hollow fluted distal end of the catheter with an array of wings radially disposed, the array of wings being closed in a first configuration and being radially expanded in a second enlarged configuration where the fluted distal end contacts the wall of the body lumen;

means for expanding the array of wings of the hollow fluted distal end into the second enlarged configuration such that subsequent withdrawal of the hollow fluted distal end in the second enlarged configuration encounters resistance for indicating constrictive force of the wall of the body lumen; and

a disposable plastic sheath surrounding the outside of the device.

47. A system for measuring constrictive force of a wall of a body lumen comprising:

a catheter;

a means for expanding a hollow fluted distal end of the catheter from a first configuration into a second enlarged configuration where the fluted distal end contacts the wall of the body lumen;

wherein the means for expanding comprises a retracting cable disposed inside the catheter and a plunger distal end of the retracting cable extending beyond the hollow fluted distal end of the catheter; and

a means for measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of a wall of the body lumen.

48. The system of claim 47, further comprising:

a means for activating the retracting cable such that the plunger distal end of the retracting cable is drawn into and expands a plurality of wings disposed at the hollow fluted distal end of the catheter into the second enlarged configuration.

49. The system of claim 48, further comprising:

restriction means disposed at a proximal end of the catheter for restricting the activation of the retracting cable to pre-determined extent.

50. The system of claim 47 wherein the plunger distal end of the retracting cable further comprises a shape to facilitate insertion into the body lumen.

51. A system for measuring constrictive force of a wall of a body lumen comprising:

a sterilizable catheter;

a disposable plastic sheath surrounding the outside of the catheter,

a means for expanding a hollow fluted distal end of the catheter from a first configuration where the fluted distal end contacts the wall of the body lumen into a second enlarged configuration; and

a means for measuring resistance to withdrawal of the catheter in the enlarged configuration as an indicator of constrictive force of a wall of the body lumen.