Catheter shaft and method of its manufacture

Patent metadata

Field	Value
Publication number	US-9352116-B2
Application number	US-201313795647-A
Country	US
Kind code	B2
Filing date	Mar 12, 2013
Priority date	Dec 30, 2007
Publication date	May 31, 2016
Grant date	May 31, 2016

Abstract

A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

First claim

What is claimed is:

1. A method of manufacturing a catheter shaft, comprising the steps of:
forming a layer of a first melt-processable polymer;
forming a plait matrix layer adjacent the first melt-processable polymer layer and extending continuously along a length of the first melt-processable polymer layer, the plait matrix layer including a braided wire mesh embedded in a matrix material comprising a second melt-processable polymer; and
forming a layer of a third melt-processable polymer adjacent the plait matrix layer,
wherein the second melt-processable polymer has a lower flexural modulus and a higher yield strain than at least one of the first melt-processable polymer and the third melt-processable polymer, and
wherein at least one of the first melt-processable polymer, the second melt-processable polymer, and the third melt-processable polymer comprises a particulate radiopaque filler material.

2. The method according to claim 1 , wherein the step of forming a plait matrix layer comprises:
braiding the wire mesh about the first melt-processable polymer layer to form a reinforced layer; and
extruding the matrix material about the reinforced layer to form the plait matrix layer.

3. The method according to claim 2 , wherein forming a layer of a third melt-processable polymer comprises extruding the third melt-processable polymer layer about the plait matrix layer.

4. The method according to claim 3 , wherein extruding the matrix material layer and extruding the third melt-processable polymer layer comprise co-extruding the matrix material layer and the third melt-processable polymer layer.

5. The method according to claim 1 , further comprising heating the first melt-processable polymer layer, the braided wire mesh, the matrix material layer, and the third melt-processable polymer layer to bond the first melt-processable polymer layer, the braided wire mesh, the matrix material layer, and the third melt-processable polymer layer together.

6. The method according to claim 5 , further comprising introducing a heat-shrink tube adjacent the third melt-processable polymer layer prior to the heating step.

7. The method according to claim 1 , wherein the first melt-processable polymer is the same as the third melt-processable polymer.

8. The method according to claim 1 , wherein the second melt-processable polymer has a lower flexural modulus and a higher yield strain than both the first melt-processable polymer and the third melt-processable polymer.

9. The method according to claim 1 , wherein the second melt-processable polymer has a lower flexural modulus and a higher yield strain than the first melt-processable polymer.

10. The method according to claim 1 , wherein the second melt-processable polymer is selected from the group consisting of: styrenic block copolymers, functionalized thermoplastic olefins, thermoplastic elastomeric alloys, thermoplastic polyurethanes, polyamide-based thermoplastic elastomers, polyester-based thermoplastic elastomers, ionomeric thermoplastic elastomers, and any combinations thereof.

11. The method according to claim 1 , wherein the second melt-processable polymer is a poly(ether-block-amide) copolymer resin selected from the group consisting of Pebax®, Grilflex®, Grilamid® ELY, Vestamid® E, and any combinations thereof.

12. The method according to claim 1 , wherein the second melt-processable polymer is an ionomeric thermoplastic elastomer.

13. The method according to claim 1 , wherein a yield strain of the second melt-processable polymer is between about 3% and about 100%.

14. The method according to claim 13 , wherein the yield strain of the second melt-processable polymer is between about 5% and about 50%.

15. The method according to claim 1 , wherein a Shore hardness of the second melt-processable polymer is between about 10D to about 85D.

16. The method according to claim 15 , wherein the Shore hardness is between about 20D and about 70D.

17. The method according to claim 1 , further comprising the step of coating the braided wire mesh with silicone.

18. A catheter shaft formed according to a method comprising the steps of:
forming a layer of a first melt-processable polymer;
forming a continuous plait matrix layer adjacent the layer of a first melt-processable polymer, the plait matrix layer including a braided wire mesh embedded in a matrix material comprising a second melt-processable polymer; and
forming a layer of a third melt-processable polymer adjacent the plait matrix layer,
wherein the second melt-processable polymer has a lower flexural modulus and a higher yield strain than at least one of the first melt-processable polymer and the third melt-processable polymer, and
wherein at least one of the first melt-processable polymer, the second melt-processable polymer, and the third melt-processable polymer comprises a particulate radiopaque filler material.

19. A catheter shaft, comprising:
an inner layer of a first polymeric material; and
a plait matrix layer bonded to the inner layer, the plait matrix layer including a braided wire mesh embedded in a second polymeric material that extends continuously along a length of the inner layer,
wherein the second polymeric material has a lower flexural modulus and a higher yield strain than the first polymeric material, and
wherein at least one of the first polymeric material and the second polymeric material comprises a particulate radiopaque filler material.

20. The catheter shaft according to claim 19 , wherein the braided wire mesh is fully embedded within the second polymeric material.

21. The catheter shaft according to claim 19 , further comprising a layer of a third polymeric material bonded to the plait matrix layer.

22. The catheter shaft according to claim 19 , wherein the second polymeric material is selected from the group consisting of: functionalized styrenic block copolymers, functionalized thermoplastic olefins, functionalized elastomeric alloys, thermoplastic polyurethanes, polyamide-based thermoplastic elastomers, polyester-based thermoplastic elastomers, ionomeric thermoplastic elastomers, and any combinations thereof.

23. The catheter shaft according to claim 21 , wherein the first polymeric material is the same as the third polymeric material.

Assignees

• Guo Xiaoping
• Stehr Richard E
• St Jude Medical Atrial Fibrill

Inventors

• Guo Xiaoping
• Stehr Richard E

Classifications

• A61M25/0043 Primary

  characterised by structural features · CPC title

• A61M25/005 Primary

  with embedded materials for reinforcement, e.g. wires, coils, braids · CPC title

• A61M25/0045

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61M2025/0059

  having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking · CPC title

• B29D23/001

  Pipes; Pipe joints (pleated hoses B29D23/18) · CPC title