Robust catheter tubing

• US 8,444,608 B2
• Filed: 06/05/2009
• Issued: 05/21/2013
• Est. Priority Date: 11/26/2008
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Haslinger, Thomas, Lee, Jeong S., Fernandez, Neftali, Simpson, John
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/478,929
• Publication Number:
  US 20100130925A1
• Time in Patent Office: 1,446 Days
• Field of Search: 604 9601-10314, 604/915, 604/264, 604/524
• US Class Current: 604/264
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• 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
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: C08L 23/06 Polyethene
• 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

Abstract

A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Claims

1. An elongate, flexible catheter, comprising:

a shaft having a proximal end, a distal end, and a lumen extending therein, the shaft having an inner layer comprising an amorphous polyamide having a Shore D durometer value of greater than 78, and an outer layer comprising a semi-crystalline polyamide or copolyamide having a Shore D durometer value of less than 76, wherein the outer layer is thinner than the inner layer, the shaft having an increased resistance to kinking as compared to a similar shaft of a single layer of the amorphous polyamide having a Shore D durometer value of greater than 78; and

a working device disposed on the distal end of the shaft.

2. The elongate, flexible catheter of claim 1 wherein the working device is an inflatable balloon.

3. The elongate, flexible catheter of claim 1 wherein the amorphous polyamide of the inner layer has a glass transition temperature of greater than 100°

C.

4. The elongate, flexible catheter of claim 1 wherein the polyamide or copolyamide of the outer layer has a glass transition temperature of less than 55°

C.

5. The elongate, flexible catheter of claim 1 wherein the amorphous polyamide of the inner layer and the polyamide or copolyamide of the outer layer have a common amide block.

6. The elongate, flexible catheter of claim 5 wherein the common amide block is selected from a group comprising nylon 12, nylon 11, nylon 6, and nylon 6,6.

7. The elongate, flexible catheter of claim 1 wherein the inner polyamide includes a cycloaliphatic segment.

8. The elongate, flexible catheter of claim 1 wherein the inner polyamide includes an aliphatic segment.

9. The elongate, flexible catheter of claim 1 wherein the inner polyamide includes an aromatic segment.

10. The elongate, flexible catheter of claim 1 wherein the inner polyamide comprises at least two segments of a group including aliphatic segments, aromatic segments, and cycloaliphatic segments.

11. The elongate, flexible catheter shaft of claim 1 wherein the inner and outer layers are formed by co-extrusion.

12. The elongate, flexible catheter shaft of claim 11 wherein the catheter shaft is tapered.

13. The elongate, flexible catheter shaft of claim 11 wherein the catheter shaft has a necked diameter portion.

14. The elongate, flexible catheter shaft of claim 1 wherein the outer layer is a polymer of nylon or a block copolymer of nylon.

15. The elongate, flexible catheter shaft of claim 14 wherein the nylon is nylon 11, nylon 12, nylon 6, nylon 6,6 or nylon 6,12.

16. The elongate, flexible catheter shaft of claim 14 wherein the block copolymer is a block copolymer of nylon and polytetramethylene oxide.

17. The elongate, flexible catheter shaft of claim 16 wherein the nylon is nylon 11, nylon 12, nylon 6, nylon 6,6 or nylon 6,12.

18. The elongate, flexible catheter of claim 1 wherein the outer layer comprises a block copolymer of nylon 12 and polytetramethylene oxide.

19. The elongate, flexible catheter of claim 1 wherein the shaft has an enhanced resistance to solvents as compared to a similar shaft of a single layer of the amorphous polyamide having a Shore D durometer value of greater than 78.

20. The elongate, flexible catheter of claim 1 wherein the outer layer is thinner than the inner layer along substantially an entire length of the shaft extending from the proximal end to the distal end.

21. An elongate, flexible catheter, comprising:

a shaft having a proximal end, a distal end, and a lumen extending therein, the shaft having an inner layer comprising high density polyethylene and an outer layer comprising a blend of two polymers, including a first polymer being an amorphous nylon having a Shore D durometer value of greater than 78 and a second polymer having a Shore D durometer value of no more than 76, wherein the inner layer is thicker than the outer layer, the shaft having an increased resistance to kinking as compared to a similar shaft having an inner layer of the high density polyethylene and an outer layer of the amorphous nylon having a Shore D durometer value of greater than 78; and

a working device disposed on the distal end of the shaft.

22. The elongate, flexible catheter of claim 21 further comprising an intermediate layer disposed between the inner layer and the outer layer, the intermediate layer serving as a bonding layer.

23. The elongate, flexible catheter of claim 21 wherein the first polymer and the second polymer have a common amide block.

24. The elongate, flexible catheter of claim 23 wherein the common amide block is selected from a group comprising nylon 12, nylon 11, nylon 6, and nylon 6,6.

25. The elongate, flexible catheter of claim 21 wherein the first polymer includes a cycloaliphatic segment.

26. The elongate, flexible catheter of claim 21 wherein the first polymer includes an aliphatic segment.

27. The elongate, flexible catheter of claim 21 wherein the first polymer includes an aromatic segment.

28. The elongate, flexible catheter of claim 21 wherein the first polymer comprises at least two segments of a group including aliphatic segments, aromatic segments, and cycloaliphatic segments.

29. The elongate, flexible catheter of claim 21 wherein the inner layer and outer layer are formed by co-extrusion.

30. The elongate, flexible catheter of claim 21 wherein the second polymer is a semi-crystalline polymer of nylon or a block copolymer of nylon.

31. The elongate, flexible catheter of claim 30 wherein the nylon is nylon 11, nylon 12, nylon 6, nylon 6,6 or nylon 6,12.

32. The elongate, flexible catheter of claim 21 wherein the block copolymer is a block copolymer of nylon and polytetramethylene oxide.

33. The elongate, flexible catheter of claim 21 wherein the shaft has an enhanced resistance to solvents as compared to a similar shaft having an inner layer of the high density polyethylene and an outer layer of the amorphous nylon having a Shore D durometer value of greater than 78.

34. The elongate, flexible catheter of claim 21 wherein the outer layer is thinner than the inner layer along substantially an entire length of the shaft extending from the proximal end to the distal end.