Catheter having polymer stiffener rings and method of making the same

• US 20050004556A1
• Filed: 06/25/2004
• Published: 01/06/2005
• Est. Priority Date: 06/25/2003
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Pursley, Matt D.
• Granted Patent: US 7,815,975 B2
• Time in Patent Office: Days
• US Class Current: 604/529
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• 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 25/0054 with regions for increasing flexibility

Abstract

A catheter and method of making a catheter are disclosed in which the catheter is highly flexible and yet resistant to crushing and kinking. The catheter is made by applying rings of hard polymer material along the tubular shaft as the catheter is manufactured. The catheter thus has a plurality of hard polymer rings formed at spaced locations along its length, and soft segments between the hard polymer rings that allow the catheter to remain very flexible. The hard polymer rings improve the radial strength of the catheter and make the catheter resistant to crushing and kinking.

Claims

1. A catheter, comprising:

a tubular member formed of a soft, flexible polymer material; and

a plurality of hard polymer rings disposed at spaced locations along a length of the tubular member.

2. The catheter according to claim 1, wherein said soft, flexible polymer material has a hardness within a range of about 80 Shore A to 35 Shore D, and said hard polymer rings are formed of a polymer material having a hardness of greater than about 70 Shore D.

3. The catheter according to claim 1, wherein said hard polymer rings are concentric with the tubular member and are completely separated from each other.

4. The catheter according to claim 1, wherein said hard polymer rings cover approximately 30 to 80% of the length of the catheter.

5. The catheter according to claim 1, wherein said hard polymer rings are spaced apart from each other a distance within a range of about 0.1 to 1.0 times the diameter of the tubular member.

6. The catheter according to claim 1, wherein a spacing between said hard polymer rings varies over a length of the catheter.

7. The catheter according to claim 1, wherein said hard polymer rings have a width of about 0.010 to 0.050 inch.

8. The catheter according to claim 1, wherein said hard polymer rings are formed of a material selected from the group consisting of epoxies, cyanoacrylicates and acrylics.

9. The catheter according to claim 1, wherein said hard polymer rings have a thickness of less than about 0.001 inch.

10. The catheter according to claim 1, wherein said hard polymer rings include an opacifier material that makes the hard polymer rings readily visible by x-ray.

11. The catheter according to claim 1, further comprising a fibrous reinforcement layer, and said hard polymer rings are disposed over said fibrous reinforcement layer.

12. A method of making a catheter, comprising the steps of:

forming a tubular member of a soft, flexible polymer material; and

adding a plurality of hard polymer rings at spaced locations along a length of the tubular member.

13. The method of making a catheter according to claim 12, wherein said hard polymer rings are formed by applying a hard polymer material to an outer surface of the tubular member, and further comprising the step of applying a top coat over the hard polymer rings and the tubular member to create a seamless end product.

14. The method of making a catheter according to claim 12, wherein said step of forming the tubular member comprises extruding the tubular member using multiple layers of soft polymer material;

and

wherein said step of adding a plurality of hard polymer rings comprises laminating the hard polymer rings between two of said multiple layers.

15. The method of making a catheter according to claim 12, wherein said step of adding a plurality of hard polymer rings comprises applying a hard polymer in liquid form to an outer surface of the tubular member.

16. The method of making a catheter according to claim 12, wherein said hard polymer rings are formed of a polymer material having a hardness greater than about 70 Shore D, and said soft, flexible polymer material has a hardness of less than about 35 Shore D.

17. The method of making a catheter according to claim 12, wherein said hard polymer rings are formed concentric with the tubular member and are completely separated from each other.

18. The method of making a catheter according to claim 12, wherein said hard polymer rings are applied to cover approximately 30 to 80% of the length of the catheter.

19. The method of making a catheter according to claim 12, wherein said hard polymer rings are applied to the tubular member with a spacing between adjacent rings of about 0.1 to 1.0 times the diameter of the tubular member.

20. The method of making a catheter according to claim 12, wherein said hard polymer rings are applied to the tubular member with a spacing between adjacent rings that varies over a length of the catheter.

21. The method of making a catheter according to claim 12, wherein said hard polymer rings are formed on the tubular member with a width of about 0.010 to 0.050 inch.

22. The method of making a catheter according to claim 12, wherein said hard polymer rings are formed of a material selected from the group consisting of epoxies, cyanoacrylicates and acrylics.

23. The method of making a catheter according to claim 12, wherein at least one of said hard polymer rings is formed by mixing an opacifier material with a polymer material to make the at least one hard polymer ring readily visible by x-ray.

24. The method of making a catheter according to claim 12, further comprising the step of applying a fibrous reinforcement layer over the tubular member and then applying said hard polymer rings over said fibrous reinforcement layer.

25. A catheter that is highly flexible yet resistant to crushing and kinking, comprising:

a tubular member formed of a soft, flexible polymer material having a hardness within a range of about 80 Shore A to 35 Shore D; and

a plurality of hard polymer rings which are concentric with the tubular member and disposed at spaced locations completely separated from each other along a length of the tubular member, said hard polymer rings being formed of a polymer material having a hardness greater than about 70 Shore D and being spaced apart from each other a distance within a range of about 0.1 to 1.0 times the diameter of the tubular member.