Catheter shaft tubes and methods of making

• US 20060030835A1
• Filed: 07/27/2005
• Published: 02/09/2006
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Slazas, Robert R., Sherman, Darren R.
• Application Number:
  US11/191,636
• Publication Number:
  US 20060030835A1
• Time in Patent Office: Days
• US Class Current: 604/526
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• 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 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• 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

Abstract

Catheter shaft tubes and methods for making them are described, in which a tubular member has two or more polymer layers, with some kind of reinforcement between at least two of the polymer layers. An inner polymer layer has a lower melting temperature than an outer polymer layer.

Claims

1. A catheter for medically treating a patient, comprising:

a flexible shaft having a proximal and distal end;

the shaft extending between the proximal and distal ends and defining a lumen extending from a proximal port to a distal port;

at least a portion of the shaft including a tubular body having an inner and outer polymer layer;

at least a portion of the tubular body being reinforced by one or more reinforcing members extending between the inner and outer polymer layers;

wherein the inner polymer layer has a lower melting temperature than the outer polymer layer.

2. The catheter of claim 1, wherein the reinforcing member is a helical coil.

3. The catheter of claim 1, wherein reinforcing members are arranged in a braid pattern.

4. The catheter of claim 1, wherein the reinforcing members are selected from the group of:

braids, coils, hoops, woven members, and longitudinal members.

5. The catheter of claim 1, wherein the reinforcing members are of materials selected from the group of:

stainless steel, nitinol, Kevlar, Dyneema, metals, and glass fibers.

6. The catheter of claim 1, wherein the polymer layers are selected from the group of:

polyamides, nylons, polyimides, polyethylenes, polyurethanes, polyether block amides.

7. The catheter of claim 1, wherein the catheter shaft further comprises one or more additional tubular bodies.

8. The catheter of claim 1, wherein the tubular body further comprises one or more additional polymer layers.

9. The catheter of claim 1, wherein the inner and outer layers are of different polymer materials, the inner layer being lubricious.

10. The catheter of claim 1, wherein the tubular body has a braided reinforcement extending between the inner and outer layers, and an amount of braid per longitudinal distance changes from a proximal position to a distal position.

11. The catheter of claim 1, wherein the outer layer is a nylon.

12. The catheter of claim 1, wherein the outer layer is a polyether block amide.

13. The catheter of claim 1, wherein the inner layer is high-density polyethylene.

14. The catheter of claim 1, wherein portions of the outer layer have different flexibilities.

15. The catheter of claim 1, wherein the tubular body is coextruded.

16. A method of making a tubular body for a catheter shaft, comprising the steps of:

a. providing a core wire;

b. coating the core wire with a thermally insulating material;

c. applying an inner polymer layer having an inner melting temperature onto the coated core wire;

d. applying one or more reinforcing members to an outer surface of the inner polymer layer; and

e. apply an outer polymer layer around an outer surface of the inner polymer layer and reinforcement member;

the outer polymer layer having an outer melting temperature that is higher than the inner melting temperature;

wherein the inner and outer polymer layers and the reinforcement form a tubular assembly around the coated core wire;

f. releasing and removing the coated core wire from inside the inner polymer layer, such that the remainder forms a catheter shaft tube.

17. The method of claim 16, wherein said steps c and e of applying polymer layers are performed by extrusion.

18. The method of claim 16, wherein said steps c-e are performed during a continuous extrusion process.

19. The method of claim 16, wherein the inner polymer layer is high-density polyethylene, and the outer polymer layer is a polyether block amide.

20. A method of making a tubular body for a catheter shaft by a continuous extrusion process, comprising the steps of:

a. forming an inner polymer layer having an inner melting temperature;

b. applying one or more reinforcing members to an outer surface of the inner polymer layer; and

c. applying an outer polymer layer around an outer surface of the inner polymer layer and reinforcement member;

the outer polymer layer having an outer melting temperature that is higher than the inner melting temperature.