Method of forming a thin walled member by extrusion and medical device produced thereby

• US 6,224,803 B1
• Filed: 04/28/1999
• Issued: 05/01/2001
• Est. Priority Date: 04/28/1999
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Tiernan, Stephen J.
• Primary Examiner(s): Silbaugh, Jan H.
• Assistant Examiner(s): Eashoo, Mark
• Application Number:
  US09/301,151
• Time in Patent Office: 734 Days
• Field of Search: 264/166, 264/171.13, 264/173.16, 264/173.19, 264/177.17, 264/183, 264/209.3, 264/209.5, 264/288.4, 604/523
• US Class Current: 264/166
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: B29C 48/001 Combinations of extrusion moulding with other shaping operations
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/11 comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 48/335 Multiple annular extrusion nozzles in coaxial arrangement, e.g. for making multi-layered tubular articles
• CPC Class Codes: B29L 2023/007 Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A method of forming a thin-walled polymeric tubular member for an intralumenal device, and the member produced thereby. The thin-walled tubular member extruded using the method of the invention is suitable for use a sleeve for a catheter shaft or balloon. The thin-walled tubular member has a single wall thickness of not greater than about 0.003 inch (0.0076 cm). In the method of the invention, the thin-walled tubular member is formed by co-extruding a thin-walled first polymer layer with a removable second polymer layer, and the two layers are separated by dissolution or physical removal of the second layer, to leave the first layer, with the first polymer layer forming the thin-walled tubular member. Because the method of the invention involves co-extruding a removable second polymer layer along with the thin-walled first polymer layer, conventional tooling dimensions in the extruder may be used.

Claims

1. A method of forming a thin-walled tubular member for a medical device, comprising:

a) co-extruding a first polymer and a second polymer to form a multilayered extrudate having a first polymer layer and a second polymer layer, the second polymer layer surrounding the entire circumference of the first polymer layer along a length of the extrudate; and

b) separating the first polymer layer from the second polymer layer to form the thin-walled member having a substantially uniform annular thickness.

2. The method of claim 1 wherein the separation of the first and second polymer layers is by exposing the second polymer layer to a solvent to dissolve the second polymer layer.

3. The method of claim 1 wherein the separation of the first and second polymer layers is by peeling the second polymer layer away from the first polymer layer.

4. The method of claim 1 wherein the first polymer layer forming the thin-walled member has a wall thickness not greater than 0.0076 centimeters along the portion of the length of the extrudate.

5. The method of claim 1 further including the step of drawing down the multilayered extrudate prior to the separating step.

6. The method of claim 5 wherein the first polymer layer forming the thin-walled member has a wall thickness not greater than about 0.0076 centimeters.

7. The method of claim 1 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.00025 to about 0.0025 centimeters.

8. The method of claim 1 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.0013 to about 0.005 centimeters.

9. The method of claim 1 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.0013 to about 0.0076 centimeters.

10. A method of forming a thin-walled tubular member for a medical device, comprising:

a) co-extruding a first polymer and a second polymer to form a multilayered tubular extrudate having a first polymer layer and a second polymer layer, the second polymer layer surrounding the entire circumference of the first polymer layer along a length of the extrudate, the second polymer being soluble in a solvent and the first polymer being insoluble in the solvent; and

b) exposing the second polymer layer to the solvent to dissolve the second polymer layer, with the first polymer layer forming the thin-walled tubular member having a substantially uniform annular wall-thickness not greater than 0.0076 centimeters along the portion of the length of the extrudate.

11. A method of forming a thin-walled tubular member for a medical device, comprising:

a) co-extruding a first polymer and a second polymer to form a multilayered extrudate having a first polymer layer and a second polymer layer, the first polymer layer and the second polymer layer each having a substantially uniform annular thickness, and the second polymer layer surrounding the entire circumference of the first polymer layer along a length of the extrudate; and

b) separating the first polymer layer from the second polymer layer to form the thin-walled member having a substantially uniform annular thickness.

12. The method of claim 11 wherein the separation of the first and second polymer layers is by exposing the second polymer layer to a solvent to dissolve the second polymer layer.

13. The method of claim 11 wherein the separation of the first and second polymer layers is by peeling the second polymer layer away from the first polymer layer.

14. The method of claim 11 wherein the first polymer layer forming the thin-walled member has a wall thickness not greater than 0.0076 centimeters along the portion of the length of the extrudate.

15. The method of claim 11 further including the step of drawing down the multilayered extrudate prior to the separating step.

16. The method of claim 15 wherein the first polymer layer forming the thin-walled member has a wall thickness not greater than about 0.0076 centimeters.

17. The method of claim 11 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.00025 to about 0.0025 centimeters.

18. The method of claim 11 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.0013 to about 0.005 centimeters.

19. The method of claim 11 wherein the first polymer layer forming the thin-walled member has a wall thickness from about 0.0013 to about 0.0076 centimeters.