Variable stiffness balloon dilatation catheters

• US 5,499,973 A
• Filed: 09/08/1994
• Issued: 03/19/1996
• Est. Priority Date: 09/08/1994
• Status: Expired due to Term

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/302,267
• Time in Patent Office: 558 Days
• Field of Search: 604/96, 604/101, 604/282, 604/264, 606/194, 128/658
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A variable stiffness balloon dilatation catheter is disclosed in which one or more polymeric sleeves are heat-shrunk around portions of an inner tubular element so as to form stiffening bands that provide variable stiffness longitudinally along the catheter.

Claims

1. In a balloon dilatation catheter apparatus comprising generally concentric, coaxial, inner and outer polymeric tubular members, each having proximal and distal ends, and arranged so as to form an annular lumen therebetween in fluid communication with the interior of an inflatable balloon element sealed at its proximal end to said outer tubular member and at its distal end to said inner tubular member, the improvement comprising:

at least one heat-shrunk stiffening band surrounding at least some portion of the exterior of said inner tubular member so as to form a tubular sidewall having a first thickness along a first portion of said inner tubular member and at least a second, larger thickness along a second portion, further wherein at least one of said stiffening bands has a wall thickness substantially less than the wall thickness of said inner tubular member and consists essentially of a heat-shrunk polymeric material having a flexural modulus sufficiently greater than that of said inner tubular member such that the portion of said sidewall associated with said stiffening band has a flexural modulus substantially greater than that of said inner tubular member.

2. Apparatus according to claim 1 wherein said first portion of said inner tubular member begins at the distal end of said second portion and extends substantially to the distal end of said inner tubular member.

3. Apparatus according to claim 1 wherein said first portion of said inner tubular member begins at the distal end of said second portion and extends substantially to the distal end of said balloon element.

4. Apparatus according to claim 1 wherein said first portion of said inner tubular member begins at the distal end of said second portion and terminates before the proximal end of said balloon element.

5. Apparatus according to claim 1 wherein said first portion of said inner tubular member begins at the distal end of said second portion and terminates before the distal end of said outer tubular member.

6. Apparatus according to claim 1 further wherein said inner tubular member comprises at least an interior longitudinal lumen that runs the length of said inner tubular member.

7. Apparatus according to claim 1 wherein said inner tubular member comprises a first stiffening band heat-shrunk around said first and second portions of said inner tubular member, and a second stiffening band heat-shrunk around said first stiffening band along said second portion.

8. Apparatus according to claim 7 wherein said first stiffening band extends substantially to the distal end of said inner tubular member.

9. Apparatus according to claim 7 wherein said first stiffening band extends substantially to the distal end of said balloon element.

10. Apparatus according to claim 7 wherein said stiffening band terminates before the proximal end of said balloon element.

11. Apparatus according to claim 7 wherein said first stiffening band terminates before the distal end of said outer tubular member.

12. Apparatus according to claim 1 further wherein said inner tubular member comprises a third portion located proximally of said second portion and having a composite sidewall of a third thickness, said third thickness being larger than said second thickness.

13. Apparatus according to claim 12 wherein said inner tubular member comprises:

a first stiffening band heat-shrunk around said first, second and third portions of said inner tubular member;

a second stiffening band heat-shrunk around said first stiffening band along said second and third portions; and

, a third stiffening band heat-shrunk around said second stiffening band along said third portion.

14. Apparatus according to claim 13 wherein said first stiffening band extends substantially to the distal end of said inner tubular member.

15. Apparatus according to claim 13 wherein said first stiffening band extends substantially to the distal end of said balloon element.

16. Apparatus according to claim 13 wherein said first stiffening band terminates before the proximal end of said balloon element.

17. Apparatus according to claim 13 wherein said first stiffening band terminates before the distal end of said outer tubular member.

18. Apparatus according to claim 13 wherein said first, second and third stiffening bands consists essentially of the same material.

19. Apparatus according to claim 13 wherein at least two of said first, second and third stiffening bands consist essentially of different materials.

20. Apparatus according to claim 13 wherein said three stiffening bands consist essentially of different materials.

21. Apparatus according to claim 1 wherein said inner tubular member comprises a first stiffening band heat-shrunk around said first portion of said inner tubular member, and a second stiffening band, of larger thickness than said first stiffening band, heat-shrunk around said second portion.

22. Apparatus according to claim 21 wherein the proximal end of said first portion is substantially adjacent the distal end of said second portion.

23. Apparatus according to claim 22 wherein said first stiffening band extends substantially to the distal end of said inner tubular member.

24. Apparatus according to claim 22 wherein said first stiffening band extends substantially to the distal end of said balloon element.

25. Apparatus according to claim 22 wherein said first stiffening band terminates before the proximal end of said balloon element.

26. Apparatus according to claim 22 wherein said first stiffening band terminates before the distal end of said outer tubular member.

27. Apparatus according to claim 1 wherein at least one of said stiffening bands consists essentially of polyethylene terephthalate.

28. Apparatus according to claim 27 wherein said polyethylene terephthalate has been oriented in at least one direction.

29. Apparatus according to claim 27 wherein said polyethylene terephthalate has been biaxially oriented.

30. Apparatus according to claim 1 wherein each of said stiffening bands consists essentially of polyethylene terephthalate.

31. Apparatus according to claim 1 wherein the ratio of the thickness of said stiffening bands to the outside diameter of said inner tubular member is about 1:

5 or less.

32. Apparatus according to claim 1 wherein said inner tubular member consists essentially of a lubricous material that is not readily bondable to other polymeric materials.

33. Apparatus according to claim 1 wherein said inner tubular member consists essentially of a fluropolymer.

34. Apparatus according to claim 1 wherein each of said stiffening bands consists essentially of the same material.

35. Apparatus according to claim 1 wherein at least two of said stiffening bands consist essentially of different materials.

36. Apparatus according to claim 1 further wherein each of said stiffening bands has a wall thickness substantially less than the wall thickness of said inner tubular member and each portion of the sidewall associated with at least one of said stiffening bands has a flexural modulus at least about twice that of said inner tubular member.

37. Apparatus according to claim 1 further wherein each of said stiffening bands has a wall thickness less than about one-half the wall thickness of said inner tubular member.

38. Apparatus according to claim 1 further wherein each of said stiffening bands has a wall thickness less than about one-quarter the wall thickness of said inner tubular member.

39. Variable stiffness balloon dilatation catheter apparatus comprising:

(a) hollow inner and outer polymeric tubular members having different diameters, each with proximal and distal ends, said members being arranged concentrically such that an annular lumen is formed therebetween;

(b) a balloon element sealed at its proximal end to said outer tubular member and at its distal end to said inner tubular member so as to form a closed-ended, inflatable balloon interior in fluid communication with said annular lumen; and

(c) said inner tubular member further comprising regions of differing degrees of stiffness formed by heat-shrinking at least one relatively thin polymeric sleeve around a portion of a relatively thicker tubular element comprising a polymer different from said polymeric sleeve, wherein said polymeric sleeves consist essentially of material having a flexural modulus sufficiently greater than that of said tubular element such that the regions associated respectively with said polymeric sleeves have a flexural modulus substantially greater than that of said tubular element.

40. Apparatus according to claim 39 wherein said regions comprise at least first and second regions, said second region being located proximally of said first region and having a greater degree of stiffness than said first region.

41. Apparatus according to claim 40 wherein said first region comprises a section of said inner tubular member having a first polymeric sleeve heat-shrunk around its exterior wall, and said second region comprises a section of said inner tubular member having a second polymeric sleeve heat-shrunk around its exterior wall.

42. Apparatus according to claim 41 wherein said inner tubular member has a substantially uniform wall thickness along its length and further wherein said second polymeric sleeve is thicker than said first polymeric sleeve.

43. Apparatus according to claim 41 wherein said second polymeric sleeve has a greater flexural modulus than said first polymeric sleeve.

44. Apparatus according to claim 41 wherein said first polymeric sleeve extends substantially to the distal end of said inner tubular member.

45. Apparatus according to claim 41 wherein said first polymeric sleeve extends substantially to the distal end of said balloon element.

46. Apparatus according to claim 41 wherein said first polymeric sleeve terminates before the proximal end of said balloon element.

47. Apparatus according to claim 41 wherein said first polymeric sleeve terminates before the distal end of said outer tubular member.

48. Apparatus according to claim 40 wherein a section of said inner tubular member comprises a first polymeric sleeve heat-shrunk around the exterior wall of the inner tubular member, and wherein said second region comprises a section of said inner tubular member having a second polymeric sleeve heat-shrunk around the exterior of said first polymeric sleeve along a portion thereof, and said first region comprises the section of inner tubular member surrounded only by said first polymeric sleeve.

49. Apparatus according to claim 48 wherein said first polymeric sleeve extends substantially to the distal end of said inner tubular member.

50. Apparatus according to claim 48 wherein said first polymeric sleeve extends substantially to the distal end of said balloon element.

51. Apparatus according to claim 48 wherein said first polymeric sleeve terminates before the proximal ends of said balloon element.

52. Apparatus according to claim 48 wherein said first polymeric sleeve terminates before the distal end of said outer tubular member.

53. Apparatus according to claim 39 wherein said regions comprise first, second and third regions, said second region being located proximally of said first region and having a greater degree of stiffness than said first region, and said third region being located proximally of said second region and having a greater degree of stiffness than said second region.

54. Apparatus according to claim 53 wherein a section of said inner tubular member comprises a first polymeric sleeve heat-shrunk around the exterior wall of the inner tubular member, further wherein a portion of said first polymeric sleeve has a second polymeric sleeve heat-shrunk around its exterior, and wherein said third region comprises a section of said inner tubular member having a third polymeric sleeve heat-shrunk around the exterior of said second polymeric sleeve along a portion thereof, said second region comprises the section of inner tubular member surrounded only by said first and second polymeric sleeves, and said first region comprises the section of inner tubular member surrounded only by said first polymeric sleeve.

55. Apparatus according to claim 54 wherein said first polymeric sleeve extends substantially to the distal end of said inner tubular member.

56. Apparatus according to claim 54 wherein said first polymeric sleeve extends substantially to the distal end of said balloon element.

57. Apparatus according to claim 54 wherein said first polymeric sleeve terminates before the proximal end of said balloon element.

58. Apparatus according to claim 54 wherein said first polymeric sleeve terminates before the distal end of said outer tubular member.

59. Apparatus according to claim 54 wherein said first, second and third polymeric sleeves consist essentially of the same material.

60. Apparatus according to claim 54 wherein at least two of said first, second and third polymeric sleeves consist essentially of different materials.

61. Apparatus according to claim 54 wherein said three polymeric sleeves consist essentially of different materials.

62. Apparatus according to claim 39 wherein at least one of said polymeric sleeves consists essentially of polyethylene terephthalate.

63. Apparatus according to claim 62 wherein said polyethylene terephthalate has been oriented in at least one direction.

64. Apparatus according to claim 62 wherein said polyethylene terephthalate has been biaxially oriented.

65. Apparatus according to claim 39 wherein each of said polymeric sleeves consists essentially of polyethylene terephthalate.

66. Apparatus according to claim 39 wherein the ratio of the thickness of said polymeric sleeves to the outside diameter of said inner tubular member is about 1:

5 or less.

67. Apparatus according to claim 39 wherein said inner tubular member consists essentially of a lubricous material that is not readily bondable to other polymeric materials.

68. Apparatus according to claim 39 wherein said inner tubular member consists essentially of a fluropolymer.

69. Apparatus according to claim 39 wherein each of said polymeric sleeves consists essentially of the same material.

70. Apparatus according to claim 39 wherein at least two of said polymeric sleeves consist essentially of different materials.

71. Apparatus according to claim 39 further wherein each of said polymeric sleeves has a wall thickness less than about one-half the wall thickness of said tubular element.

72. Apparatus according to claim 39 further wherein each of said polymeric sleeves has a wall thickness less than about one-quarter the wall thickness of said tubular element.

73. Variable stiffness catheter member comprising elongated polymeric tubing having regions of differing degrees of stiffness formed by heat-shrinking at least one relatively thin polymeric sleeve around a portion of a relatively thicker tubular element comprising a polymer different from said polymeric sleeve, wherein said polymeric sleeves consist essentially of material having a flexural modulus sufficiently greater than that of said tubular element such that the regions associated respectively with said polymeric sleeves have a flexural modulus substantially greater than that of said tubular element.

74. Catheter member according to claim 73 wherein said regions comprise first, second and third regions, said second region having a greater degree of stiffness than said first region, and said third region having a greater degree of stiffness than said second region.

75. Catheter member according to claim 74 wherein a section of said member comprises a first polymeric sleeve heat-shrunk around the exterior wall of said tubing, further wherein a portion of said first polymeric sleeve has a second polymeric sleeve heat-shrunk around its exterior, and wherein said third region comprises a section of said member having a third polymeric sleeve heat-shrunk around the exterior of said second polymeric sleeve along a portion thereof, said second region comprises the section of said member surrounded only by said first and second polymeric sleeves, and said first region comprises the section of said member surrounded only by said first polymeric sleeve.

76. Catheter member according to claim 73 wherein said regions comprise at least first and second regions, said second region having a greater degree of stiffness than said first region.

77. Catheter member according to claim 76 wherein said first region comprises a section of tubing having a first polymeric sleeve heat-shrunk around its exterior wall, and said second region comprises a section of said tubing having a second polymeric sleeve heat-shrunk around its exterior wall.

78. Catheter member according to claim 77 wherein said tubing has a substantially uniform wall thickness along its length and further wherein said second polymeric sleeve is thicker than said first polymeric sleeve.

79. Catheter member according to claim 77 wherein said second polymeric sleeve has a greater flexural modulus than said first polymeric sleeve.

80. Catheter member according to claim 76 wherein a section of said member comprises a first polymeric sleeve heat-shrunk around the exterior wall of said tubing, and wherein said second region comprises a section of said member having a second polymeric sleeve heat-shrunk around the exterior of said first polymeric sleeve along a portion thereof, and said first region comprises the section of said member surrounded only by said first polymeric sleeve.

81. Catheter member according to claim 73 further wherein each of said polymeric sleeves has a wall thickness less than about one-half the wall thickness of said tubular element.

82. Catheter member according to claim 73 further wherein each of said polymeric sleeves has a wall thickness less than about one-quarter the wall thickness of said tubular element.