Kink-free spiral-wound catheter

• US 5,454,795 A
• Filed: 06/27/1994
• Issued: 10/03/1995
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Samson, Gene
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/266,540
• Time in Patent Office: 463 Days
• Field of Search: 604/280-283, 604/264, 128/657, 128/658, 128/4-6
• US Class Current: 604/526
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: C08L 23/06 Polyethene
• CPC Class Codes: C08L 23/12 Polypropene
• CPC Class Codes: C08L 27/06 Homopolymers or copolymers of vinyl chloride
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 77/00 Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 79/08 Polyimides; Polyester-imides; Polyamide-imides; Polyamide acids or similar polyimide precursors
• CPC Class Codes: C08L 81/06 Polysulfones; Polyethersulfones

Abstract

This invention is a surgical device. In particular, it is a catheter suitable for treating a tissue target within the body, which target is accessible through the vascular system. Central to the invention is the use of stiffener ribbons, typically metallic, wound within the catheter body in such a way as to create a catheter having controllable stiffness.

Claims

1. A catheter section comprising:

an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends,

said elongate tubular member comprising an inner tubular liner of a first liner material in coaxial relationship with an outer tubular cover comprising a first cover material, and at least a first ribbon stiffener having a handedness and spirally and coaxially wound exterior to said inner tubular liner and covered by said outer tubular cover, and the catheter section, in the region of the distal end, has a critical bend diameter of no more than 3.5 mm and a lateral flexibility of greater than 6500°

/in-lb.

2. The catheter section of claim 1 wherein the section has a lateral flexibility of greater than 8500°

/in-lb.

3. The catheter section of claim 1 wherein the where the liner material and cover material are miscible in melt form.

4. The catheter section of claim 3 where the liner material is admixed with the cover material in the coaxial region of the first ribbon stiffener.

5. The catheter section of claim 1 which is binderless between the inner tubular liner and the outer tubular cover.

6. The catheter section of claim 1 where the liner material and cover material are radiation sterilizable without substantial degradation of their physical attributes.

7. The catheter section of claim 1 where the first ribbon stiffener spirally and coaxially wound upon said inner tubular liner where the catheter section additionally comprises a second ribbon stiffener of opposite handedness to the first ribbon stiffener spirally and coaxially wound upon said first ribbon stiffener.

8. The catheter section of claim 1 additionally comprising at least one additional ribbon stiffener spirally and coaxially wound upon said inner tubular liner having the same handedness as the first ribbon stiffener.

9. The catheter section of claim 7 additionally comprising at least one additional ribbon stiffener spirally and coaxially wound upon said inner tubular liner having the same handedness as the first ribbon stiffener.

10. The catheter section of claim 7 additionally comprising at least one additional ribbon stiffener spirally and coaxially wound upon said first ribbon stiffener and having the same handedness as the second ribbon stiffener.

11. The catheter section of claim 10 additionally comprising at least one additional ribbon stiffener spirally and coaxially wound upon said first ribbon stiffener and having the same handedness as the second ribbon stiffener.

12. The catheter section of claim 1 where the elongate tubular member has at least one region of variable stiffness between the proximal end and the distal end.

13. The catheter section of claim 11 where the elongate tubular member has at least one region of variable stiffness between the proximal end and the distal end.

14. The catheter section of claim 1 where the first ribbon stiffener has a pitch which varies between the proximal end and distal end.

15. The catheter section of claim 9 where the first ribbon stiffener has a pitch which varies between the proximal end and distal end.

16. The catheter section of claim 7 where the second ribbon stiffener has a pitch which varies between the proximal end and distal end.

17. The catheter section of claim 8 where the second ribbon stiffener has a pitch which varies between the proximal end and distal end.

18. The catheter section of claim 1 where the cover materials are selected from polyimide, polyamides, polyethylene, polypropylene, polyvinylchloride, fluoropolymers including PTFE, FEP, vinylidene fluoride, and their mixtures, alloys, copolymers, and block copolymers, polysulfones or the like.

19. The catheter section of claim 1 where the liner and cover materials are selected from polyurethane, low density polyethylene (LDPE), polyvinylchloride, fluoropolymers including PTFE, FEP, vinylidene fluoride, and their mixtures, alloys, copolymers, and block copolymers.

20. The catheter section of claim 1 where the first ribbon stiffener comprises a ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.

21. The catheter section of claim 7 where the second ribbon stiffener comprises a ribbon having a thickness between 0.75 mil and 2.5 mils and a width between 2.5 and 8.0 mils.

22. The catheter of claim 1 where at least one of the liner and cover materials are radiopaque.

23. A catheter comprising:

an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends,

said elongate tubular member having;

a.) a relatively stiff proximal segment, and

b.) a relatively flexible distal segment, said distal segment being composed of an inner distal tubular liner comprising a distal liner material in coaxial relationship with an outer distal tubular cover comprising a distal cover material, and at least a first ribbon stiffener having a first handedness and spirally and coaxially wound upon said inner distal tubular liner and covered by said outer distal tubular cover, and the catheter, in the region of the distal end, has a critical bend diameter of no more than 3.5 mm and a lateral flexibility of greater than 6500°

/in-lb.

24. The catheter of claim 23 wherein the distal section has a lateral flexibility of greater than 8500°

/in-lb.

25. The catheter of claim 23 wherein the where the liner material and cover material are miscible in melt form.

26. The catheter of claim 23 where the proximal segment is composed of an inner proximal tubular liner comprising a proximal liner material in coaxial relationship with an outer proximal tubular cover comprising a proximal cover material, and said first ribbon stiffener spirally and coaxially wound upon said inner proximal tubular liner and covered by said outer proximal tubular cover.

27. The catheter of claim 26 further comprising at least one intermediate segment defining a passageway between the relatively stiff proximal segment and the relatively flexible distal segment, said at least one intermediate segment being composed of an extension of the inner proximal tubular liner in coaxial relationship with an extension of the outer distal tubular cover, and said first ribbon stiffener spirally and coaxially wound around said inner proximal tubular liner and covered by said outer distal tubular cover.

28. The catheter of claim 26 where the distal liner material is admixed with the distal cover material in the coaxial region of the first ribbon stiffener.

29. The catheter of claim 28 which is binderless between the distal inner tubular liner and the distal outer tubular cover.

30. The catheter of claim 23 where the proximal and distal liner materials and proximal and distal cover materials are radiation sterilizable without substantial degradation of their physical attributes.

31. The catheter of claim 23 where the catheter additionally comprises a second ribbon stiffener of opposite handedness to the first ribbon stiffener and is spirally and coaxially wound about said first ribbon stiffener.

32. The catheter of claim 23 where at least one of the distal, intermediate, and proximal segments are of constant stiffness.

33. The catheter of claim 27 where at least one of the distal, intermediate, and proximal segments are of constant stiffness.

34. The catheter of claim 27 where at least one of the distal, intermediate, and proximal segments are of variable stiffness.

35. The catheter of claim 31 where at least one of the distal, intermediate, and proximal segments are of variable stiffness.

36. The catheter section of claim 23 where the cover materials are selected from polyimide, polyamides, polyethylene, polypropylene, polyvinylchloride, fluoropolymers including PTFE, FEP, vinylidene fluoride, and their mixtures, alloys, copolymers, and block copolymers, polysulfones or the like.

37. The catheter section of claim 23 where the liner and cover materials are selected from polyurethane, low density polyethylene (LDPE), polyvinylchloride, fluoropolymers including PTFE, FEP, vinylidene fluoride, and their mixtures, alloys, copolymers, and block copolymers.

38. The catheter of claim 23 where the first ribbon stiffener comprises a ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.

39. The catheter of claim 31 where the second ribbon stiffener comprises a ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.

40. The catheter of claim 23 where at least one of the liner and cover materials are radiopaque.

41. A catheter comprising:

an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends,

said elongate tubular member having;

a.) a relatively stiff proximal segment, said proximal segment composed of an inner proximal tubular liner comprising a proximal liner material in coaxial relationship with an outer proximal tubular cover comprising a proximal cover material, a first ribbon stiffener having a handedness and spirally and coaxially wound upon said inner proximal tubular liner covered by said outer proximal tubular cover and

b.) a relatively flexible distal segment, said distal segment being composed of an inner distal tubular liner comprising a distal liner material in coaxial relationship with an outer distal tubular cover comprising a distal cover material, and said first ribbon stiffener spirally and coaxially wound upon said inner distal tubular liner and covered by said outer distal tubular cover, and the catheter, in the region of the distal end, has a critical bend diameter of no more than 3.5 mm and a lateral flexibility of greater than 6500°

/in-lb. and the second ribbon stiffener is spirally and coaxially wound about said first ribbon stiffener, and

c.) at least one intermediate segment defining a passageway between the relatively stiff proximal segment and the relatively flexible distal segment, said at least one intermediate segment being composed of an extension of the inner proximal tubular liner in coaxial relationship with an extension of the outer distal tubular cover, and said first ribbon stiffener spirally and coaxially wound between said inner proximal tubular liner and said outer distal tubular cover and the second ribbon stiffener is spirally and coaxially wound about said first ribbon stiffener.

42. The catheter of claim 41 where the first ribbon stiffener comprises a metallic ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.

43. The catheter of claim 42 where the first ribbon stiffener comprises a ribbon having a thickness of about 1.0 mil and a width of about 3.0 mil.

44. The catheter of claim 42 where the second ribbon stiffener comprises a metallic ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.

45. The catheter of claim 44 where the first ribbon stiffener comprises a ribbon having a thickness of about 1.0 mil and a width of about 3.0 mil.

46. A catheter section comprising:

an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends, said elongate tubular member comprising an outer tubular liner in coaxial relationship with at least a first ribbon stiffener having a handedness and spirally and coaxially wound and covered by said outer tubular cover, and the catheter section, in the region of the distal end, has a critical bend diameter of no more than 3.5 mm and a lateral flexibility of greater than 6500°

/in-lb.

47. The catheter section of claim 46 wherein the section has a lateral flexibility of greater than 8500°

/in-lb.

48. The catheter section of claim 46 where the cover material is radiation sterilizable without substantial degradation of its physical attributes.

49. The catheter section of claim 46 where the catheter section additionally comprises a second ribbon stiffener of opposite handedness to the first ribbon stiffener spirally and coaxially wound upon said first ribbon stiffener.

50. The catheter section of claim 46 additionally comprising at least one additional ribbon stiffener having the same handedness as the first ribbon stiffener.

51. The catheter section of claim 46 where the elongate tubular member has at least one region of variable stiffness between the proximal end and the distal end.

52. The catheter section of claim 46 where the first ribbon stiffener has a pitch which varies between the proximal end and distal end.

53. The catheter section of claim 49 where the second ribbon stiffener has a pitch which varies between the proximal end and distal end.

54. The catheter section of claim 46 where the cover materials are selected from polyimide, polyamides, polyethylene, polypropylene, polyvinylchloride, fluoropolymers including PTFE, FEP, vinylidene fluoride, and their mixtures, alloys, copolymers, and block copolymers, polysulfones or the like.

55. The catheter section of claim 46 where the first ribbon stiffener comprises a ribbon having a thickness between 0.75 mil and 2.5 mil and a width between 2.5 and 8.0 mil.