Draining bodily fluid

• US 20030073978A1
• Filed: 11/19/2002
• Published: 04/17/2003
• Est. Priority Date: 05/16/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Rioux, Robert F., OʼKeefe, Christopher R.
• Granted Patent: US 6,972,040 B2
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022

Abstract

A urethral prosthesis with prostatic and bulbar segments connected by two types of ties allows the prosthesis to assume at least two configurations different with inter-segmental distances adapted to situations where the patient either has or does not have normal control of the external sphincter. This is particularly useful for a patient undergoing an anesthetic procedure that affects the external sphincter muscles. When the muscles are anesthetized, the prosthesis may provide constant urine voiding, and when the anesthetic effects wear off, the prosthesis may assume a different configuration to allow the sphincter to reassert control over urinary voiding.

Claims

1. A prosthesis for insertion into a patient'"'"'s urethra, comprising:

(a) a first segment including a distal portion and a proximal portion, the distal portion comprising a distal opening, the proximal portion comprising a proximal opening, the first segment defining a lumen extending from the distal opening to the proximal opening;

(b) a second segment connected to the first segment at an inter-segmental distance, the second segment including a distal portion and a proximal portion, the distal portion of the second segment comprising a distal opening, the proximal portion of the second segment comprising a proximal opening, the second segment defining a lumen extending from the distal opening of the second segment to the proximal opening of the second segment; and

(c) a tie connecting the proximal portion of the first segment and the distal portion of the second segment, wherein the tie adopts one of a plurality of configurations in which the tie has one of a plurality of inter-segmental lengths between the first and second segments, positioning the first and second segments at one of a plurality of inter-segmental distances.

2. The prosthesis of claim 1, wherein the tie is adjustable to adopt a compact configuration, positioning the proximal portion of the first segment in direct contact with the distal portion of the second segment.

3. The prosthesis of claim 1, wherein the tie is adjustable to adopt an extended configuration, in which the inter-segmental distance permits insertion of an object between the two segments such that the object intercepts fluid communication between the lumens of the first and second segments.

4. The prosthesis of claim 3, wherein the inter-segmental distance permits operation of an external sphincter muscle.

5. The prosthesis of claim 1, wherein the tie comprises a thread with two ends.

6. The prosthesis of claim 5, wherein the two ends of the thread are connected.

7. The prosthesis of claim 5, wherein the two ends of the thread are not connected.

8. The prosthesis of claim 5, wherein the thread forms at least one loop between the proximal portion of the first segment and the distal portion of the second segment.

9. The prosthesis of claim 8, wherein the thread forms a one-and-a-half loop between the proximal portion of the first segment and the distal portion of the second segment.

10. The prosthesis of claim 6, wherein the ends of the thread are knotted together.

11. The prosthesis of claim 1, further comprising a second tie also connecting the proximal portion of the first segment with the distal portion of the second segment, the second tie having a predetermined inter-segmental length between the first and second segments, the pre-determined inter-segmental length setting a maximum value for the plurality of inter-segmental distances.

12. The prosthesis of claim 11, wherein the maximum value for the plurality of inter-segmental distances permits insertion of an object between the two segments such that the object intercepts fluid communication between the lumens of the first and second segments.

13. The prosthesis of claim 12, wherein the maximum value for the plurality of inter-segmental distances permits operation of an external sphincter muscle.

14. The prosthesis of claim 1, wherein the first segment further comprises an inflatable balloon.

15. The prosthesis of claim 1, wherein the distal portion of the first segment further comprises a coude tip.

16. The prosthesis of claim 1, wherein the first and second segments comprise a biocompatible material.

17. The prosthesis of claim 16, wherein the biocompatible material comprises silicone.

18. The prosthesis of claim 1, further comprising a retrieval piece connected to the second segment.

19. The prosthesis of claim 18, wherein the retrieval piece comprises a thread.

20. The prosthesis of claim 1, further comprising a third segment including a distal portion comprising a distal opening, and a proximal portion comprising a proximal opening, the third segment defining a lumen extending from the distal portion of the third segment to the proximal portion of the third segment, the distal portion of the third segment being removably connected to the proximal portion of the second segment.

21. The prosthesis of claim 20, wherein the proximal portion of the third segment is connected to a drainage bag for collecting fluid passing through the lumen of the third segment.

22. A prosthesis for insertion into a patient'"'"'s urethra, comprising:

(a) a first segment including a distal portion and a proximal portion, the distal portion comprising a distal opening, the proximal portion comprising a proximal opening, the first segment defining a lumen extending from the distal opening to the proximal opening;

(b) a second segment connected to the first segment at an inter-segmental distance, the second segment including a distal portion and a proximal portion, the distal portion of the second segment comprising a distal opening, the proximal portion of the second segment comprising a proximal opening, the second segment defining a lumen extending from the distal opening of the second segment to the proximal opening of the second segment;

(c) a first tie engaging the first and the second segments by holding the segments in proximity to allow fluid communication between the lumens of the segments; and

(d) a second tic having a predetermined inter-segmental length between the first and the second segments, the second tie connecting the proximal portion of the first segment and the distal portion of the second segment at an inter-segmental distance upon disengagement of the first tic.

23. The prosthesis of claim 22, wherein the first tie holds the proximal portion of the first segment in direct contact with the distal portion of the second segment.

24. The prosthesis of claim 22, wherein the inter-segmental distance permits insertion of an object between the two segments such that the object intercepts fluid communication between the lumens of the first and second segments.

25. The prosthesis of claim 24, wherein the inter-segmental distance permits operation of an external sphincter muscle.

26. The prosthesis of claim 22, further comprising a third segment including a distal portion and a proximal portion, the distal portion of the third segment comprising a distal opening, the proximal portion of the third segment comprising a proximal opening, the third segment defining a lumen extending from the distal opening of the third segment to the proximal opening of the third segment, the distal portion of the third segment removably connected to the proximal portion of the second segment.

27. The prosthesis of claim 22, wherein the proximal portion of the third segment is connected to a drainage bag for collecting fluid passing through the lumen of third segment.

28. The prosthesis of claim 22, wherein the first tie comprises a loop connecting the first and second segments, a tape and an actuation thread, all connected at a junction.

29. The prosthesis of claim 28, wherein the tape comprises a perforated portion connected to the actuation thread at the junction, wherein the perforated portion tears from the tape upon pulling the actuation thread.

30. The prosthesis of claim 22, wherein the second tie comprises a thread.

31. The prosthesis of claim 22, wherein the first segment further comprises an inflatable balloon.

32. The prosthesis of claim 22, wherein the distal portion of the first segment further comprises a coude tip.

33. The prosthesis of claim 22, wherein the first and second segments comprise a biocompatible material.

34. The prosthesis of claim 33, wherein the biocompatible material comprises silicone.

35. The prosthesis of claim 22, further comprising a retrieval piece connected to the second segment.

36. The prosthesis of claim 35, wherein the retrieval piece comprises a thread.

37. A method of draining bodily fluid from a patient having an external sphincter situated for voluntary control over drainage of at least one bodily fluid, comprising the steps of:

(1) inserting a prosthesis into the urethra of a patient, the prosthesis comprising;

(a) a first segment including a distal portion and a proximal portion, the distal portion comprising a distal opening, the proximal portion comprising a proximal opening, the first segment defining a lumen extending from the distal opening to the proximal opening;

(b) a second segment connected to the first segment at an inter-segmental distance, the second segment including a distal portion and a proximal portion, the distal portion of the second segment comprising a distal opening, the proximal portion of the second segment comprising a proximal opening, the second segment defining a lumen extending from the distal opening of the second segment to the proximal opening of the second segment, and

(c) an adjustable tie connecting the proximal portion of the first segment and the distal portion of the second segment; and

(2) adjusting the adjustable tie to adopt the one of a plurality of inter-segmental lengths, thereby positioning the first and second segments at one of a plurality of inter-segmental distances, which allows or disallows insertion of an object between the two segments wherein the insertion intercepts fluid communication between the lumens of the first and second segments, thereby allowing or disallowing voluntary control over drainage of the at least one bodily fluid through the lumens of the two segments.

38. The method of claim 37, wherein one of a plurality of inter-segmental distances allows or disallows operation of the patient'"'"'s external sphincter muscle.

39. The method of claim 37, wherein step (2) comprises shortening the inter-segmental length and thereby the inter-segmental distance to allow constant fluid communication between the lumens of the first and second segments, thereby disallowing the voluntary control.

40. The method of claim 39, wherein step (2) comprises adjusting the tie such that the poximal portion of the first segment directly contacts the distal portion of the second segment.

41. The method of claim 37, wherein step (2) further comprises lengthening the inter-segmental length and thereby the inter-segmental distance to allow the insertion, thereby allowing the voluntary control.

42. The method of claim 37, wherein the adjustable tie forms at least one loop between the proximal portion of the first segment and the distal portion of the second segment.

43. The method of claim 37, wherein the adjustable tie comprises a thread with two ends and wherein step (2) comprises pulling both ends of the thread.

44. The method of claim 43, wherein the ends of the thread are connected at a knot and pulling both ends of the thread comprises pulling the knot.

45. The method of claim 37, wherein the prosthesis further comprises a retrieval piece connected to the second segment, and wherein step (2) comprises pulling the retrieval piece substantially away from the first segment.

46. The method of claim 37, wherein the prosthesis further comprises a second tie also connecting the proximal portion of the first segment with the distal portion of the second segment, the second tie having a predetermined inter-segmental length between the first and the second segments;

and

wherein the method further comprises lengthening the inter-segmental distance to allow the insertion, the inter-segmental distance being limited by the pre-determined inter-segmental length of the second tie.

47. The method of claim 46, further comprising removing the adjustable tie from the urethra.

48. The method of claim 37, further comprising surrounding the patient'"'"'s penis with a condom catheter for receiving the at least one bodily fluid.

49. The method of claim 37, further comprising connecting the prosthesis to a drainage bag to collect the at least one bodily fluid passing through prosthesis.

50. A method of draining bodily fluid from a patient having an external sphincter situated for voluntary control over drainage of at least one bodily fluid, comprising the steps of:

(1) inserting a prosthesis into the urethra of a patient, the prosthesis comprising;

(a) a first segment including a distal portion and a proximal portion, the distal portion comprising a distal opening, the proximal portion comprising a proximal opening, the first segment defining a lumen extending from the distal opening to the proximal opening;

(b) a second segment connected to the first segment at an inter-segmental distance, the second segment including a distal portion and a proximal portion, the distal portion of the second segment comprising a distal opening, the proximal portion of the second segment comprising a proximal opening, the second segment defining a lumen extending from the distal opening of the second segment to the proximal opening of the second segment;

(c) a first tie engaging the first and the second segments by holding the segments in proximity to allow fluid communication between the lumens of the segments; and

(d) a second tie having a pre-determined inter-segmental length between the first and the second segments;

(2) constantly draining at least one bodily fluid through the lumens of the two segments held by the first tie; and

(3) when voluntary control over fluid drainage is desired, disengaging the first tie such that the first tie no longer affects the inter-segmental distance, thereby relying on the second tie for connecting the two segments at a predetermined inter-segmental distance sufficient for insertion of an object between the two segments to intercept the fluid drainage.

51. The method of claim 50, wherein the pre-determined inter-segmental distance permits operation of an external sphincter.

52. The method of claim 50, further comprising removing the disengaged first tie from the urethra while retaining at least a portion of the prosthesis inside the urethra,

53. The method of claim 50, wherein the first tie, before the disengagement, holds the proximal portion of the first segment in direct contact with the distal portion of the second segment.

54. The method of claim 50, further comprising surrounding the patient'"'"'s penis with a condom catheter for receiving the at least one bodily fluid.

55. The method of claim 50, further comprising connecting the prosthesis to a drainage bag to collect the at least one bodily fluid passing through the prosthesis.

56. The method of claim 50, wherein the first tie comprises a loop connecting the first and second segment, a tape and an actuation thread, all connected at a junction, the tape comprises a perforated portion connected to the actuation thread at the junction, and

the method further comprising pulling the actuation thread, thereby separating the perforated portion from the tape to disengage the first tie.

57. The method of claim 50, wherein the prosthesis further comprises a retrieval piece attached to the second segment, and wherein step (3) further comprises pulling the retrieval piece substantially away from the first segment.