Urinary catheter and method with increased resistance to obstructions

• US 20050080399A1
• Filed: 08/18/2004
• Published: 04/14/2005
• Est. Priority Date: 09/17/2003
• Status: Abandoned Application

• Current Assignee: ProstaLund Operations AB (ProstaLund AB)
• Original Assignee: ProstaLund Operations AB (ProstaLund AB)
• Inventors: Schelin, Sonny, Bolmsjo, Magnus
• Application Number:
  US10/921,356
• Publication Number:
  US 20050080399A1
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2210/166 Prostate
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A catheter for draining urine from a bladder is made more resistant obstructions and blood clot accumulations by configurations of urine inlet openings into an interior urine drainage passageway. The inlet opening configurations include a whistle tip, a multiple opening tip, a couvelaire tip, and a beveled tip with a direct opening into the passageway. A low friction coating also resists blood clot accumulation. A single-use or multiple-use clearing device moves within the interior drainage passageway to contact, disintegrate, and facilitate movement of the accumulated clots and obstructions out of the urine inlet opening and interior passageway.

Claims

1. A catheter for insertion in a urinary tract to drain urine from a bladder to a location adjacent to an orifice in an external urinary sphincter muscle which controls urine flow into a urinary canal of the urinary tract, comprising:

a main body having a distal end, a proximal end and a length sufficient to position the distal end within the bladder and to position the proximal end adjacent to and distal of the orifice in the external urinary sphincter muscle, the main body defining an urine drainage interior passageway extending from the distal end to the proximal end, the interior passageway having a cross-sectional size;

a distal anchor attached to the distal end of the main body and expandable within the bladder to restrain the main body against proximal movement within the urinary tract from a use position in which the distal end of the main body is located in the bladder and the proximal end of the main body is located adjacent to and distal of the orifice in the external urinary sphincter muscle;

a proximal anchor attached to the proximal end of the main body to restrain the main body against distal movement in the urinary tract from the use position; and

at least one urine inlet opening extending through the distal end of the main body and into the interior passageway, each inlet opening having a cross sectional size, the cumulative cross-sectional size of all inlet openings in the distal end being greater than the cross-sectional size of the interior passageway to facilitate passing urine and blood clots from the bladder into the interior passageway while reducing an accumulation of blood clots within the inlet opening and the interior passageway.

2. A catheter as defined in claim 1, wherein:

the distal end includes a rounded tip;

a single inlet opening extends through the distal end of the main body;

the single inlet opening has a predetermined configuration; and

the predetermined configuration of the inlet opening is defined by the absence of a longitudinal half portion of the rounded tip and the distal end adjacent to the rounded tip, the longitudinal half portion defined substantially by a longitudinal bisection of the rounded tip and the portion of the distal end adjoining the rounded tip.

3. A catheter as defined in claim 2, wherein:

the single inlet opening and a remaining longitudinal half portion of the rounded tip and the distal end establish a whistle-tip shape of the distal end of the main body.

4. A catheter as defined in claim 1, wherein:

the distal end includes a rounded tip;

a plurality of inlet openings extend through the distal end of the main body; and

each of the inlet openings is longitudinally spaced from an adjacent inlet opening along the portion of the distal end adjacent to the rounded tip.

5. A catheter as defined in claim 4, wherein:

each of the inlet openings is also circumferentially spaced from an adjacent inlet opening along the portion of the distal end adjacent to the rounded tip.

6. A catheter as defined in claim 1, wherein:

the distal end includes a rounded tip;

two inlet openings extend through the distal end of the main body; and

the two inlet openings are positioned radially opposite one another on the distal portion of the main body adjacent to the rounded tip, each of the two inlet openings has a cross-sectional size, and the cross-sectional size of each of the two inlet openings is substantially greater than the cross-sectional size of the interior passageway.

7. A catheter as defined in claim 6, wherein:

each of the two inlet openings has a circumferential dimension greater than one-fourth of the circumferential distance around the main body.

8. A catheter as defined in claim 6, wherein:

each of the two inlet openings is elongated with a longer dimension of each elongated opening extending longitudinally along the distal end.

9. A catheter as defined in claim 6, wherein:

each of the two inlet openings defines a couvelaire tip configuration of the distal end of the main body.

10. A catheter as defined in claim 1, wherein:

the distal end includes a beveled surface which extends substantially transversely at an acute angle relative to a longitudinal axis through the distal end;

a single inlet opening extends through the distal end of the main body; and

the single inlet opening extends through the beveled surface substantially directly into the interior passageway of the main body.

11. A catheter as defined in claim 1, further comprising:

a low friction coating extending over the distal end, within each inlet opening, and along the interior passageway.

12. A catheter as defined in claim 1, further comprising:

a clearing device positioned within the interior passageway and including a contact element movable within the interior passageway past each inlet opening to contact and disintegrate and facilitate movement of blood clots and obstructions within each inlet opening and the interior passageway with the flow of urine through the interior passageway.

13. A catheter as defined in claim 12, wherein:

the contact element is normally positioned within the interior passageway in a stowed position between each inlet opening and a distal end of the interior passageway; and

the contact element is movable from the stowed position to a position proximal of each inlet opening in the interior passageway through the main body.

14. A catheter as defined in claim 13, further comprising:

an activation device connected to the contact element and extending through the urinary canal to a position outside an exterior opening of the urinary canal; and

wherein;

the contact element is selectively moved by manipulation of the activation device at the position outside the exterior opening of the urinary canal.

15. A catheter as defined in claim 14, further comprising in combination:

an insertion tool for inserting the catheter into the urinary tract to the use position, the insertion tool having a distal end for connecting with the proximal end of the main body and a proximal end that extends to a position outside the exterior opening of the urinary canal, the insertion tool having an interior channel extending from its distal end to its proximal end, the interior channel communicating with the interior passageway in the main body when the distal end of the insertion tool is connected to the proximal end of the main body; and

wherein;

the activation device extends through the interior channel of the insertion tool when the insertion tool is connected to the main body.

16. A catheter as defined in claim 1, wherein:

the distal anchor comprises a balloon attached to the distal end of the main body, the balloon is expandable in size when inflated within the bladder to maintain the distal end of the main body in the bladder and to restrain the main body against proximal movement from the use position; and

further comprising;

an inflation tube having a distal end, a proximal end and a length extending between the distal and proximal ends, the distal end of the inflation tube connected to the main body, the length of the inflation tube sufficient to extend from the main body through the orifice of the external urinary sphincter muscle and the urinary canal to a position outside of an exterior opening of the urinary canal, the inflation tube and the main body establishing an inflation passageway extending from the proximal end of the inflation tube to the balloon through which to deliver fluid to inflate the balloon.

17. A catheter as defined in claim 16, wherein:

the proximal anchor comprises a coiled section of the inflation tube located at a position adjacent to and proximal of the sphincter muscle when the main body is in the use position, the coiled section interacting with the external urinary sphincter muscle when constricted to restrain the main body against distal movement from the use position

18. A method of making an urinary catheter more resistant to obstructions from blood clots in a urine flowpath from a bladder through an interior passageway of the catheter, comprising:

locating at least one urine inlet opening within an end piece of the catheter to conduct urine from the bladder into the interior passageway when the end piece is located in the bladder; and

forming each inlet opening with a predetermined configuration and a cross-sectional size to facilitate passing urine and blood clots from the bladder into the interior passageway while reducing an accumulation of blood clots within the inlet opening and the interior passageway, the cumulative cross-sectional size of all inlet openings being greater than the cross-sectional size of the interior passageway.

19. A method as defined in claim 18, further comprising:

forming a single inlet opening in a configuration of a whistle tip.

20. A method as defined in claim 18, further comprising:

forming a single inlet opening in a configuration in which a substantially longitudinally bisectioned portion of the end piece is absent.

21. A method as defined in claim 18, further comprising:

forming a plurality of separate inlet openings each of which is longitudinally spaced from an adjacent separate opening along the end piece.

22. A method as defined in claim 18, further comprising:

forming a plurality of separate inlet openings each of which is circumferentially spaced from an adjacent separate opening around the end piece.

23. A method as defined in claim 18, further comprising:

forming a plurality of separate openings each of which is longitudinally and circumferentially spaced from an adjoining separate opening on the end piece.

24. A method as defined in claim 18, further comprising:

forming two separate openings at radially opposite positions on the end piece as a couvelaire tip.

25. A method as defined in claim 18, further comprising:

forming two separate openings at radially opposite positions on the end piece; and

forming each of the two separate openings with a greater longitudinal dimension than a circumferential dimension.

26. A method as defined in claim 18, further comprising:

creating a beveled portion on the end piece which extends at a more transverse rather than longitudinal angle relative to a longitudinal axis through the end piece;

forming a single inlet opening through the end piece; and

extending the single inlet opening through the beveled surface substantially directly into the interior passageway of the main body.

27. A method as defined in claim 18, further comprising:

coating the end piece, each inlet opening and the interior passageway with a low friction coating.

28. A method as defined in claim 18, further comprising:

positioning a contact element within the interior passageway for movement within the interior passageway and relative to each inlet opening and the interior passageway; and

moving the contact element within the interior passageway to contact and disintegrate and facilitate movement of blood clots and obstructions within at least one inlet opening and the interior passageway with the flow of urine through the interior passageway.

29. A catheter for insertion in an urinary tract to drain urine from a bladder through a urinary canal and out of an exterior opening of the urinary canal, comprising:

a main body having a distal end and a length sufficient to position the distal end within the bladder, the main body defining an urine drainage interior passageway;

an urine inlet opening extending through the distal end into the interior passageway to pass urine from the bladder into the interior passageway; and

a clearing device comprising a contact element moveably positioned within the interior passageway for movement past the inlet opening and along the interior passageway to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway with the flow of urine through the interior passageway.

30. A catheter as defined in claim 29, further comprising:

an activation device connected to the contact element and extending through the interior passageway and extendable from the main body through the urinary canal to a position outside of the exterior opening of the urinary canal, the activation device moving the contact element by manipulation of the activation device at the position outside the exterior opening of the urinary canal.

31. A catheter as defined in claim 30, wherein:

the activation device comprises a tether connected to the contact element to move the contact element past the inlet opening and along the interior passageway upon pulling the tether at the position outside the exterior opening of the urinary canal.

32. A catheter as defined in claim 31, wherein:

the contact element is retained within the interior passageway for removal and transportation through the interior passageway and out of the main body by pulling the tether after moving the contact element past the inlet opening.

33. A catheter as defined in claim 30, further comprising:

a return element connected between the contact element and the main body to bias the contact element into an initial position from which the contact element commences movement; and

the return element moving the contact element back to approximately the initial position after the contact element has been moved past the inlet opening and along the interior passageway.

34. A catheter as defined in claim 33, wherein:

the return element comprises a spring.

35. A catheter as defined in claim 33, wherein:

the activation device comprises a tether connected to the contact element to move the contact element past the inlet opening and along the interior passageway upon pulling the tether at the position outside the exterior opening of the urinary canal.

36. A catheter as defined in claim 30, wherein:

the contact element is positioned within the interior passageway for removal out of the main body after the contact element has been moved past the inlet opening and along the interior passageway.

37. A catheter as defined in claim 36, wherein:

the activation device comprises a tether connected to the contact element to move the contact element past the inlet opening and along the interior passageway and remove the contact element out of the main body upon pulling the tether at the position outside the exterior opening of the urinary tract.

38. A catheter as defined in claim 29, wherein:

the contact element comprises a brush structure.

39. A catheter as defined in claim 38, wherein:

the brush structure includes a plurality of bristles.

40. A catheter as defined in claim 39, wherein:

the brush structure is maintained in the interior passageway by friction between the bristles and the interior passageway until the contact member is moved.

41. A catheter as defined in claim 29, wherein:

the contact element occupies an initial position within the interior passageway from which the contact element commences movement; and

the contact member is returned to the starting position by the application of fluid pressure through the interior passageway of the main body after the contact element has been moved past the inlet opening and along the interior passageway.

42. A catheter as defined in claim 29 wherein the catheter is of the partial-length indwelling type used to drain urine from the bladder to a location adjacent to an orifice in an external urinary sphincter muscle which controls urine flow into a urinary canal of the urinary tract, wherein:

the main body has a distal end, a proximal end and a length sufficient to position the distal end within the bladder and to position the proximal end adjacent to and distal of the orifice in the external urinary sphincter muscle when the catheter is in a use position.

43. A catheter as defined in claim 42, further comprising:

an activation device connected to the contact element and extending through the interior passageway and extendable from the main body through the orifice of the external urinary sphincter muscle and through the urinary canal to a position outside of the exterior opening of the urinary canal, the activation device moving the contact element by manipulation of the activation device at the position outside the exterior opening of the urinary canal.

44. A catheter as defined in claim 43, further comprising in combination:

an insertion tool for inserting the catheter into the urinary tract to the use position, the insertion tool having a distal end for connecting with the proximal end of the main body and a proximal end that extends to a position outside the exterior opening of the urinary canal, the insertion tool having an interior channel extending from its distal end to its proximal end, the interior channel communicating with the interior passageway in the main body when the distal end of the insertion tool is connected to the proximal end of the main body; and

wherein;

the activation device extends through the interior channel of the insertion tool when the insertion tool is connected to the main body.

45. A catheter as defined in claim 42, further comprising:

a balloon attached to the distal end of the main body, the balloon is expandable in size when inflated within the bladder to maintain the distal end of the main body in the bladder and to restrain the main body against proximal movement from the use position; and

an inflation tube having a distal end, a proximal end and a length extending between the distal and proximal ends, the distal end of the inflation tube connected to the main body, the length of the inflation tube sufficient to extend from the main body through the orifice of the external urinary sphincter muscle and the urinary canal to a position outside of an exterior opening of the urinary canal, the inflation tube and the main body establishing an inflation passageway extending from the proximal end of the inflation tube to the balloon through which to deliver fluid to inflate the balloon.

46. A catheter as defined in claim 45, further comprising:

a proximal anchor connected to the proximal end of the main body and located at a position adjacent to and proximal of the external urinary sphincter muscle when the main body is in the use position, the proximal anchor interacting with the external urinary sphincter muscle when constricted to restrain the main body against distal movement from the use position.

47. A catheter as defined in claim 46, wherein:

the proximal anchor comprises a coiled section of the inflation tube formed at a position along the inflation tube to be adjacent to and proximal of the sphincter muscle when the main body is located in the use position.

48. A catheter as defined in claim 29, wherein:

the contact element is retained within the interior passageway in a stowed position at a distal end of the interior passageway;

the contact element when in the stowed position is substantially out of a urine drainage flow path through the inlet opening and the interior passageway; and

the contact element is returned to the stowed position after the contact element has been moved past the inlet opening and along the interior passageway.

49. A method of making an urinary catheter more resistant to obstructions from blood clots in a urine flowpath from a bladder through urinary tract, the catheter having a main body with an interior passageway for draining the urine through the catheter and an urine inlet opening formed through the main body and into the interior passageway at a distal end, comprising:

moving a clot clearing contact element positioned within the interior passageway past the inlet opening and along a portion of the interior passageway to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway with the flow of urine through the interior passageway.

50. A method as defined in claim 49, further comprising:

stowing the contact element in a stowed position substantially out of the urine flow path through the inlet opening and into the interior passageway before moving the contact element.

51. A method as defined in claim 49, further comprising:

positioning the contact element in a stowed position located at a distal end of the interior passageway before moving the contact element to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

52. A method as defined in claim 49, further comprising:

moving the contact element by transferring force to the contact element through an urinary canal of the urinary tract from a position outside of an exterior opening of the urinary canal to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

53. A method as defined in claim 52, further comprising:

extending a tether connected to the contact element from the contact element through the interior passageway and the urinary canal to the exterior opening of the urinary canal; and

pulling the tether to transfer force to move the contact element to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

54. A method as defined in claim 53, further comprising:

removing the contact element from the interior passageway by continuing to pull the tether after the contact element has been moved to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

55. A method as defined in claim 50, further comprising:

returning the contact element to the stowed position after having moved the contact element to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

56. A method as defined in claim 49, further comprising:

using a brush structure as the contact element to contact and disintegrate and facilitate movement of blood clots and obstructions within the inlet opening and the interior passageway.

57. A method as defined in claim 49 wherein the catheter is of the partial-length indwelling type used to drain urine from the bladder to a location adjacent to an orifice in an external urinary sphincter muscle which controls urine flow into a urinary canal of the urinary tract, further comprising:

positioning the distal end of the main body within the bladder when the catheter is in a use position; and

positioning a proximal end of the main body adjacent to and distal of the external urinary sphincter muscle when the catheter is in the use position.

58. A method as defined in claim 57, further comprising:

moving the contact element by transferring force to the contact element through the urinary canal and the orifice of the external urinary sphincter muscle from the position outside of the exterior opening of the urinary canal.

59. A method as defined in claim 57, further comprising:

connecting the proximal end of the main body to an insertion tool;

inserting the catheter through the urinary canal into the use position by movement imparted through the insertion tool; and

extending an activation device through an interior channel of the insertion tool to transfer force to the contact element through the urinary canal and the orifice of the external urinary sphincter muscle from the position outside of the exterior opening of the urinary canal.

60. A method as defined in claim 57, wherein the catheter is further of the type comprising a balloon attached to the distal end of the main body and an inflation tube communicating with an interior of the balloon and extending from the main body through the urinary canal to the position outside of the exterior opening of the urinary canal when the catheter is in the use position, the method further comprising:

delivering fluid through the inflation passageway to inflate the balloon within the bladder and restrain the main body against proximal movement from the use position.

61. A method as defined in claim 60, further comprising:

anchoring the catheter within the urinary canal adjacent to and proximal of the external urinary sphincter muscle to restrain the main body against distal movement from the use position.

62. A method as defined in claim 60, further comprising:

locating a coiled section of the inflation tube adjacent to and proximal of the external urinary sphincter muscle to restrain the main body against distal movement from the use position.