Catheter assembly

• US 20050059957A1
• Filed: 07/21/2004
• Published: 03/17/2005
• Est. Priority Date: 01/17/2003
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Campbell, Carey V., Vonesh, Michael J., Trapp, Benjamin M., Mann, James W., Eskaros, Sherif A.
• Application Number:
  US10/895,817
• Publication Number:
  US 20050059957A1
• Time in Patent Office: Days
• US Class Current: 604/524
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• 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

Novel catheter constructions comprising thin covering or wrapping materials such as polymer films. A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. Moreover, polymer film can be used in combination with one or more elements to produce novel catheter constructions.

Claims

1. Catheter comprising:

at least a first and a second essentially parallel, longitudinally extending elements each having an outer surface, a distal end and a proximal end;

at least one of the elements having a lumen extending for at least a portion therethrough; and

polymer film contacting the outer surface of each element.

2. The catheter of claim 1, wherein the at least first and second elements comprise a first tube and a second tube, each having a lumen extending for at least a portion therethrough.

3. The catheter of claim 2, wherein one of the lumens is a guidewire lumen and one of the lumens is an inflation lumen.

4. The catheter of claim 1, wherein the polymer film is wrapped about the outer surface of each element.

5. The catheter of claim 4, wherein the polymer film is helically wrapped about the outer surface of each element.

6. The catheter of claim 1, wherein the at least first element is a tube and the at least second element comprises a material selected from the group consisting of wires, chords, fibers, and filaments.

7. The catheter of claim 6, wherein the polymer film is wrapped about the outer surfaces of the at least first element and the at least second element.

8. The catheter of claim 7, wherein the polymer film is helically wrapped about the outer surfaces of the at least first element and the at least second element.

9. The catheter of claim 6, wherein an inflatable member is located on the distal end of the catheter.

10. The catheter of claim 2, wherein the first tube and the second tube are about the same length.

11. The catheter of claim 10, wherein the second tube is provided with a guidewire exit port that communicates with the lumen of the second tube and that is located at a point between the distal and proximal ends of the second tube.

12. The catheter of claim 2, wherein the first tube is longer than the second tube.

13. The catheter of claim 2, wherein an inflatable member is located on the distal end of the catheter.

14. The catheter of claim 13, wherein a stent is mounted on the inflatable member.

15. A catheter comprising:

a first element comprising a first longitudinally extending tube having an outer surface, a lumen extending for at least a portion therethrough, a distal end and a proximal end;

a second element in contact with the outer surface of the first element; and

polymer film in contact with the outer surface of the first element and the second element.

16. The catheter of claim 15, wherein the second element is a radiopaque material.

17. The catheter of claim 15, wherein the second element is indicia placed on the outer surface of the first element.

18. The catheter of claim 15, wherein the polymer film is wrapped about the outer surface of each element.

19. The catheter of claim 18, wherein the polymer film is helically wrapped about the outer surface of each element.

20. A catheter comprising:

a first longitudinally extending element having a lumen extending for at least a portion therethrough, an outer surface, a proximal region and a distal region;

a second longitudinally extending element having a lumen extending for at least a portion therethrough, an outer surface, a proximal region and a distal region;

the distal region of the first element joined to the proximal region of the second element;

wherein polymer film is in contact with the outer surface of the distal region of the first element and the proximal region of the second element.

21. The catheter of claim 20, wherein the first element and the second element are joined in abutting relationship.

22. The catheter of claim 20, wherein the first element and the second element are joined in an overlapping joint.

23. The catheter of claim 20, wherein the lumen of the first element and the lumen of the second element are in fluid communication.

24. The catheter of claim 20, wherein at least one of the first element and the second element further includes a second lumen extending for at least a portion therethrough.

25. The catheter of claim 24, wherein both of the first element and the second element further include a second lumen extending for at least a portion therethrough.

26. The catheter of claim 25, wherein the first and second lumen of the first element are in fluid communication with the first and second lumen of the second element, respectively.

27. The catheter of claim 20, wherein the polymer film is wrapped about the outer surface of each element.

28. The catheter of claim 27, wherein the polymer film is helically wrapped about the outer surface of each element.

29. A catheter comprising:

A longitudinally extending tube having at least one physical property varied from a proximal point on the catheter to a distal point on the catheter, the at least one physical property being varied by wrapping polymer film about at least a portion of the length of the catheter.

30. The catheter of claim 29, wherein the at least one varied physical property is selected from the group consisting of flexibility, column strength, tensile strength, crush resistance, burst strength, wall thickness and lubricity.

31. The catheter of claim 29, wherein the catheter has a wall thickness that varies from a proximal point to a distal point.

32. The catheter of claim 29, wherein the catheter has a tapered outer diameter.

33. The catheter of claim 29, wherein the catheter has a tapered inner diameter.

34. The catheter of claim 29, wherein the longitudinally extending tube is formed by the wrapped polymer film.

35. The catheter of claim 34, wherein the longitudinally extending tube has a wall thickness that varies from a proximal point to a distal point.

36. The catheter of claim 34, wherein the catheter has a tapered outer diameter.

37. The catheter of claim 34, wherein the catheter has a tapered inner diameter.

38. A medical device comprising:

a longitudinally extending tube having a wall portion and a lumen extending for at least a portion therethrough;

the tube having at least one fenestration extending through the wall portion; and

polymer film covering at least a portion of the at least one fenestration.

39. The medical device of claim 38, wherein the polymer film has at least one polymer film aperture overlaying at least a portion of the at least one fenestration.

40. The medical device of claim 38, wherein the polymer film is wrapped about the tube and has non-overlapping edges forming the at least one polymer film aperture.

41. The medical device of claim 38, wherein the tube fenestration is a longitudinally extending spiral cut through the wall portion.

42. The medical device of claim 38, wherein an inflatable member is located on the distal end of the tube and the lumen is in fluid communication with the interior of the inflatable member.

43. Catheter comprising a first longitudinally extending hollow polymer tube having a proximal end, a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end;

a channel located in the wall forming an opening in the outer surface of the wall and extending from the proximal end to the distal end; and

polymer film covering the channel from the proximal end to the distal end, thus covering the opening in the outer surface and forming a first wall lumen extending from the proximal end to the distal end.

44. The catheter of claim 43, further comprising a second longitudinally extending hollow tube having a proximal end and a distal end, a wall having an inner surface and an outer surface, and a centrally located lumen extending from the proximal end to the distal end, wherein the second longitudinally extending hollow tube is located inside the first longitudinally extending hollow tube with the inner surface of the first tube being in contact with the outer surface of the second tube.

45. The catheter of claim 44, wherein the first polymer tube encapsulates a metal braid material.

46. The catheter of claim 45 wherein the polymer material comprises polyamide.

47. The catheter of claim 46, wherein the polymer film comprises polytetrafluoroethylene.

48. The catheter of claim 44, wherein the second tube comprises polytetrafluoroethylene.

49. The catheter of claim 48, wherein the polytetrafluoroethylene is extruded polytetrafluoroethylene.

50. The catheter of claim 48, wherein the polytetrafluoroethylene is expanded polytetrafluoroethylene.

51. The catheter of claim 46, wherein the channel is formed by a laser.

52. The catheter of claim 46, wherein the polymer film is wrapped about the outer surface of the first longitudinally extending hollow tube.

53. The catheter of claim 52, wherein the polymer film is helically wrapped about the outer surface of the first longitudinally extending hollow tube.

54. The catheter of claim 43, wherein the channel is a longitudinally extending channel.

55. The catheter of claim 43, wherein the channel is a spirally extending channel.

56. The catheter of claim 43, wherein an inflatable member is located on the distal end of the catheter.

57. The catheter of claim 56, wherein the first wall lumen is in fluid communication with the inflatable member.

58. The catheter of claim 57, wherein a guidewire is in sliding relationship with the centrally located lumen of the first longitudinally extending hollow tube.

59. The catheter of claim 45, wherein an inflatable member is located on the distal end of the catheter and the first wall lumen is in fluid communication with the inflatable member.

60. The catheter of claim 58 wherein the inflatable member is an occlusion balloon.

61. The catheter of claim 43, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

62. The catheter of claim 60, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

63. The catheter of claim 44, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

64. The catheter of claim 56, wherein the catheter is sized to be capable of being advanced into a patient'"'"'s cerebral vasculature.

65. The catheter of claim 64, wherein the inflatable member is an occlusion balloon.

66. The catheter of claim 56, wherein the inflatable member is a dilatation balloon.

67. The catheter of claim 66, wherein a stent is mounted on the dilatation balloon.

68. The catheter of claim 43, further comprising at least a second channel located in the wall forming at least a second opening in the outer surface of the wall.

69. The catheter of claim 68, wherein the second channel extends from the proximal end to the distal end of the catheter.

70. The catheter of claim 68, wherein the polymer film covers the at least second opening in the outer surface of the wall, forming at least a second wall lumen.

71. The catheter of claim 70, wherein the second wall lumen extends from the proximal end to the distal end of the catheter.

72. The catheter of claim 44, wherein the channel is a longitudinally extending channel.

73. The catheter of claim 44, wherein the channel is a spirally extending channel.

74. The catheter of claim 44, wherein an inflatable member is located on the distal end of the catheter.

75. The catheter of claim 74, wherein the first wall lumen is in fluid communication with the inflatable member.

76. The catheter of claim 75, wherein a guidewire is in sliding relationship with the centrally located lumen of the first longitudinally extending hollow tube.

77. The catheter of claim 74, wherein the inflatable member is an occlusion balloon.

78. The catheter of claim 74, wherein the inflatable member is a dilatation balloon.

79. The catheter of claim 78, wherein a stent is mounted on the dilatation balloon.