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

• US 6,692,511 B2
• Filed: 02/02/2001
• Issued: 02/17/2004
• Est. Priority Date: 04/28/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Tiernan, Stephen J.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/776,068
• Publication Number:
  US 20010004703A1
• Time in Patent Office: 1,110 Days
• Field of Search: 606/194, 606/191-193, 606/171, 606/169, 606/159, 604/22, 604/20, 604/524, 623/1.11
• US Class Current: 606/194
• 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. An intraluminal device comprising an elongated shaft having a tubular proximal portion, a tubular distal portion, and an extruded polymeric thin-walled tubular member with a wall thickness of about 0.00025 to about 0.0025 cm, the thin-walled tubular member being free of melt fracture and being disposed about and supporting a junction of the proximal and distal portions at which said proximal and distal portions are directly joined to one another.

2. The intraluminal device of claim 1 wherein the elongated tubular shaft is formed at least in part by a metallic tubular member having the thin-walled tubular member disposed on at least a length of the elongated tubular shaft.

3. The intraluminal device of claim 1 wherein the thin-walled tubular member has a wall thickness of about 0.0013 to about 0.0025 centimeters.

4. The intraluminal device of claim 1 wherein the thin-walled tubular member is disposed about and fixes a distal extremity of the shaft proximal portion and a proximal extremity of the shaft distal portion.

5. The intraluminal device of claim 1 wherein thin-walled tubular member has a length of about 1 to about 40 centimeters.

6. The intraluminal device of claim 1 wherein said proximal and distal portions are directly joined to one another by heat fusion.

7. The intraluminal device of claim 1 wherein said proximal and distal portions are directly joined to one another by laser fusion.

8. The intraluminal device of claim 1 wherein said proximal and distal portions are directly joined to one another with the use of an adhesive.

9. The intraluminal device of claim 1 wherein said proximal and distal portions are joined to one another in an interlocking configuration.

10. The intraluminal device of claim 9, wherein said interlocking configuration comprises a lap joint.

11. The intraluminal device of claim 1 wherein the thin-walled tubular member is an outer sleeve extending from a location proximal to the junction to a location distal to the junction, and the wall thickness of the thin-walled tubular member is uniform along its length.

12. An intraluminal device comprising an elongated shaft having a tubular proximal portion, a tubular distal portion, and an extruded polymeric thin-walled tubular member with a wall thickness of about 0.00025 to about 0.0025 centimeters disposed about and supporting a junction of the proximal and distal portions, the wall thickness of the thin-walled tubular member being uniform along its length.

13. An intraluminal device comprising an elongated shaft having a tubular proximal portion, a tubular distal portion, and an extruded polymeric thin-walled tubular member with a wall thickness of about 0.00025 to about 0.0025 cm, the thin-walled tubular member being disposed about and supporting a junction of the proximal and distal portions at which said proximal and distal portions are directly joined to one another, and being formed by a process comprising coextruding the thin-walled tubular member as a first layer of a multilayered coextrudate having a second layer, and separating the thin-walled tubular member from the coextruded second polymer layer to form the thin-walled member having a smooth outer surface.