Catheter member with bondable layer

• US 6,010,521 A
• Filed: 11/25/1997
• Issued: 01/04/2000
• Est. Priority Date: 11/25/1997
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Lee, Jeong Soo, Wantink, Kenneth L., Tiernan, Stephen J., Tannier, Alan A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/977,815
• Time in Patent Office: 770 Days
• Field of Search: 606/194, 606/192, 606/198, 606/108, 604/96-103, 623/1, 623/12
• US Class Current: 606/194
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence

Abstract

The invention is directed to a catheter formed at least in part of a multilayered member having a first layer which is fusion bondable to another catheter component such as the skirt of an inflatable balloon and a second layer which is adjacent the first layer having a melting point greater than the first layer so that the multilayered member of the catheter is not deformed when the other catheter component is fusion bonded to the first layer of the multilayered member. The second layer is preferably lubricious in nature. In one embodiment of the invention, the multilayered member is a tubular element with the lubricious second layer defining an inner lumen extending within the tubular element. The outer layer of the tubular member may extend beyond the distal end of the inner layer and form a non-traumatic distal tip. Alternatively, a flexible non-traumatic distal tip may be fusion bonded to at least the outer layer of the multilayered tubular member.

Claims

1. An intraluminal catheter comprising:

a) an elongated shaft having proximal and distal ends, a port in the distal end and a guidewire lumen extending therein to and in fluid communication with the port in the distal end;

b) the guidewire lumen being defined at least in part by a multilayered tubular member having an inner layer formed of a lubricious polymeric material and an outer layer formed of a polyolefin polymerized with up to about 35% by weight of a polymer having reactive monomer groups, the outer layer having a melting point lower than that of the inner layer; and

c) a catheter part fusion bonded to the outer layer of the multilayered tubular layer.

2. The catheter of claim 1 wherein the catheter part is a distal skirt of a balloon.

3. The catheter of claim 1 wherein the inner layer of the multilayered tubular member has a static coefficient of friction of less than about 0.35.

4. The catheter of claim 1 wherein the inner layer of the multilayered tubular member has a static coefficient of friction of less than about 0.30.

5. The catheter of claim 1 wherein the outer layer is a polyolefin adhesive polymer.

6. The catheter of claim 5 wherein the polyolefin adhesive polymer is formed of a copolymer of a polyolefin and up to 30% by weight of a polymer with reactive monomer groups which facilitate fusion bonding to the catheter part.

7. The catheter of claim 6 wherein the reactive monomer groups include at least one component selected from the group consisting of carboxylic acid, acrylic acid, and maleic acid, and anhydrides thereof.

8. The catheter of claim 1 wherein the inner layer of the tubular member is thicker than the outer layer.

9. The catheter of claim 1 wherein the catheter part bonded to the outer layer is formed of a material selected from the group consisting of polyolefin, polyester, polyamide and copolymers thereof.

10. The catheter of claim 1 wherein the inner and outer layers of the multilayered tubular member are formed of compatible polymeric materials.

11. The catheter of claim 10 wherein the inner and outer layers are coextruded to form the multilayered tubular member, and the inner layer bonds to the outer layer.

12. The catheter of claim 1 wherein the reactive monomer groups bond to the catheter part.

13. The catheter of claim 1 wherein the inner layer is formed of high density polyethylene, and the polyolefin is a polyethylene.

14. The catheter of claim 1 wherein the outer layer is formed of an ethylene-acrylic acid copolymer.

15. The catheter of claim 1 having a strengthening layer bonded to an outer surface of the outer layer along a length thereof proximal to a section of the outer layer fusion bonded to the catheter part.

17. The catheter of claim 1 wherein the second polymer layer has a static coefficient of friction of less than about 0.35.

56. The catheter of claim 1 having a non-traumatic distal tip secured to the outer layer of the multilayered tubular member by fusion bonding.

16. An intraluminal catheter, comprising:

a) an elongated catheter shaft having proximal and distal ends, a port in the distal end and a lumen extending therein;

b) a first catheter part having a first polymer layer with a desired melting point formed of a polyolefin copolymerized with up to about 35% by weight of a polymer having reactive monomer groups, and a second polymer layer with a melting point greater than the melting point of the first polymer layer; and

c) a second catheter part fusion bonded to the first polymer layer of the first catheter part.

18. The catheter of claim 16 wherein the second polymer layer has a static coefficient of friction of less than about 0.30.

19. The catheter of claim 16 wherein the first polymer layer is formed of a polyolefin adhesive polymer.

20. The catheter of claim 19 wherein the polyolefin adhesive polymer is a copolymer formed with up to 30% by weight of reactive monomer groups which facilitate fusion bonding to the second catheter part.

21. The catheter of claim 20 wherein the reactive monomer groups include at least one component selected from the group consisting of carboxylic acid, acrylic acid, and maleic acid, and anhydrides thereof.

22. The catheter of claim 16 wherein the second polymer layer of the tubular member is thicker than the first polymer layer.

23. The catheter of claim 16 wherein the second catheter part is formed of a material selected from the group consisting of polyolefin, polyester, polyamide and copolymers thereof.

24. A balloon dilatation catheter comprising:

a) an elongated shaft having proximal and distal ends, a port in the distal end and a guidewire lumen extending therein to and in fluid communication with the port in the distal end;

b) the guidewire lumen being defined at least in part by a multilayered tubular member having an inner layer formed of a lubricious polymeric material and an outer layer formed of a polyolefin polymerized with up to about 35% by weight of a polymer having reactive monomer groups, the outer layer having a melting point less than that of the lubricious polymeric material of the adjacent inner layer; and

c) a catheter part fusion bonded to the outer layer of the inner tubular layer.

25. The catheter of claim 24 wherein the catheter part is a distal skirt of a dilatation balloon.

26. The catheter of claim 24 wherein the inner layer has a static coefficient of friction of less than about 0.35.

27. The catheter of claim 24 wherein the inner layer has a static coefficient of friction of less than about 0.30.

28. The catheter of claim 24 wherein the outer layer is a polyolefin adhesive polymer.

29. The catheter of claim 28 wherein the polyolefin is a copolymer formed with up to 30% by weight of reactive monomer groups which facilitate fusion bonding of the outer layer to the catheter part.

30. The catheter of claim 29 wherein the reactive monomer groups include at least one component selected from the group consisting of carboxylic acid, acrylic acid, maleic acid and anhydrides thereof.

31. The catheter of claim 24 wherein the inner layer of the multilayered tubular member is thicker than the outer layer.

32. The catheter of claim 24 wherein the catheter part is formed of a material selected from the group consisting of polyolefin, polyester, polyamide and copolymers thereof.

33. An intraluminal catheter comprising:

a) an elongated shaft having proximal and distal ends, a port in the distal end and a guidewire lumen extending therein to and in fluid communication with the port in the distal end;

b) a multilayered tubular member having an inner layer formed of a lubricious polymeric material which defines in part the guidewire lumen and an outer layer formed of a polymeric material having a lower melting point than the melting point of the polymeric material of the inner layer; and

c) a non-traumatic distal tip on the distal end of the catheter formed by an extension of the outer layer of the multilayered tubular member.

34. The catheter of claim 33 wherein the extension of the outer layer of the multilayered tubular member forms the port in the distal end of the catheter.

35. An elongated catheter shaft, comprising:

a) a catheter wall defining at least in part a lumen extending therein;

b) an inner layer which defines at least in part the lumen extending within the shaft and which terminates at a location proximal to the distal end of the catheter; and

c) an outer layer which is more flexible than the inner layer and which extends distally beyond the location where the inner layer terminates, forming a non-traumatic distal end of the catheter shaft.

36. The catheter of claim 35 wherein an inner layer is formed of a lubricious polymeric material.

37. The catheter of claim 35 wherein the inner layer has a static coefficient of friction of less than about 0.3.

38. The catheter of claim 35 wherein the inner layer has a static coefficient of friction of less than about 0.30.

39. The catheter of claim 35 wherein the inner layer is formed of polymeric material having a desired melting point and the outer layer is formed of a polymeric material having a melting point of at least about 20°

C. less than the melting point of the inner layer.

40. The catheter of claim 35 wherein the inner layer is formed of polymeric material having a desired melting point and the outer layer is formed of a polymeric material having a melting point of at least about 30°

C. less than the melting point of the inner layer.

41. The catheter of claim 35 wherein the outer layer is a polyolefin adhesive polymer.

42. The catheter of claim 35 wherein the polyolefin adhesive polymer is a copolymer which has been formed with up to 30% by weight of a monomer with reactive groups which facilitate fusion forming of the distal end of the catheter.

43. The catheter of claim 42 wherein the monomer is selected from the group consisting of carboxylic acid, acrylic acid, maleic acid and anhydrides thereof.

44. The catheter of claim 35 wherein the inner layer is thicker than a section of the outer layer extending to a distal end of the inner layer.

45. An elongated catheter shaft, comprising:

a) a tubular member having a lumen, and having a port in an end of the tubular member in fluid communication with the lumen;

b) an inner layer of the tubular member which defines at least in part the lumen extending therein and which is formed of lubricious polymeric material having a desired melting point; and

c) an outer layer of the tubular member formed of a polymeric material which is more flexible than the inner layer polymeric material and which has a melting point at least 20°

C. less than the melting point of the inner layer.

46. The catheter shaft of claim 45 wherein the inner layer has a static coefficient of friction of less than about 0.35.

47. The catheter shaft of claim 46 wherein the inner layer has a static coefficient of friction of less than about 0.30.

48. The catheter shaft of claim 45 wherein the outer layer is a polyolefin adhesive polymer.

49. The catheter shaft of claim 48 wherein the polyolefin adhesive polymer is a copolymer formed of up to 30% by weight of a monomer with reactive groups.

50. The catheter shaft of claim 49 wherein the monomer is selected from the group consisting of carboxylic acid, acrylic acid, maleic acid and anhydrides thereof.

53. The intraluminal catheter part of claim 50 wherein the adjacent polymeric layer is formed of a polyolefin copolymerized with one or more components selected from the group consisting of carboxylic acid, acrylic acid and an anhydrides thereof.

51. An intralumenal catheter part comprising an elongated multilayered tubular member having an inner lubricious layer and an adjacent outermost polymeric layer formed of a polyolefin polymerized with up to about 35% by weight of a polymer having reactive monomer groups, the adjacent polymeric layer having a melting point of at least 20°

C. less than the inner layer.

52. The intralumenal catheter part of claim 51 wherein the polymeric layer adjacent the inner lubricious layer has a melting point of at least about 30°

C. less than the inner layer.

54. The intraluminal catheter part of claim 51 wherein the component with which the polyolefin is copolymerized is unsaturated.

55. An intraluminal catheter comprising:

a) an elongated shaft having proximal and distal ends, a port in the distal end and a guidewire lumen extending therein to and in fluid communication with the port in the distal end;

b) a multilayered tubular member having an inner layer formed of a lubricious polymeric material which defines in part the guidewire lumen and an outer layer formed of a polymeric material having a lower melting point than the melting point of the polymeric material of the inner layer; and

c) a non-traumatic distal tip on the distal end of the catheter formed by a tubular member formed of flexible polymeric material which is secured to the outer layer of the multilayered tubular member or the distal end thereof, the distal tip having an outer layer and an inner layer, the inner layer being formed of low melting point polymeric material to facilitate fusion bonding to the outer layer of the multilayered tubular member.

57. The catheter of claim 55 wherein the outer layer of the multilayered tubular member has a melting point of at least about 20°

C. less than the inner polymeric layer of the multilayered tubular member.

58. The catheter of claim 55 wherein the outer layer of the multilayered tubular member has a melting point of at least about 30°

C. less than the inner polymeric layer of the multilayered tubular member.