Multi-lumen extrusion tubing

• US 6,540,734 B1
• Filed: 02/16/2000
• Issued: 04/01/2003
• Est. Priority Date: 02/16/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Newton, Mark, Chiu, Jessica, Reiss, Paul, Peterson, Eric D.
• Primary Examiner(s): JACYNA, J CASIMER
• Application Number:
  US09/505,616
• Time in Patent Office: 1,140 Days
• Field of Search: 604/93.01, 604/508, 604/523
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A multi-lumen balloon for use in a fluted balloon centering catheter and method for providing the same. The multi-lumen balloon maintains a radiation source at the center of a cardiovascular artery, has improved blood perfusion capability, and has improved balloon refolding characteristics. The method of fabricating a multi-lumen balloon designed for a radiation centering catheter uses an improved extrusion process that allows the manufacture of the multi-lumen balloon sub-assembly to be done separately from the catheter shaft assembly.

Claims

1. A method for making multi-lumen tubing, the method comprising:

pushing a molten resin material through a tip and die assembly such that a plurality of resin material shafts are formed, the tip and die assembly including an extrusion die and a plurality of mandrels, wherein the extrusion die has at least one outer exit hole disposed adjacent to a central exit hole;

applying a pressurized medium to the plurality of resin material shafts so as to maintain a lumen running lengthwise along the plurality of resin material shafts; and

pulling the plurality of resin material shafts away from the extrusion die so as to cause the plurality of resin material shafts to fuse together lengthwise into the multi-lumen extrusion tubing having a central lumen and at least one outer lumen disposed adjacent to the central lumen.

2. The method of claim 1, wherein the at least one outer exit hole has a substantially flat shape across a part of a periphery where the at least one outer exit hole is disposed adjacent to the central exit hole.

3. The method of claim 1, wherein the central exit hole has a substantially flat shape across a part of a periphery where the central exit hole is disposed adjacent to the at least outer exit hole.

4. The method of claim 1 wherein said pulling the plurality of resin material shafts away from the extrusion die is done while the resin material is at a melt temperature in the range of about 370°

F. to 440°

F.

5. The method of claim 1 wherein said pulling the plurality of resin material shafts away from the extrusion die is done while the resin material is at a melt temperature in the range of about 380°

F. to 410°

F.

6. The method of claim 1 wherein the resin material is nylon.

7. The method of claim 1 wherein the resin material is polyethylene.

8. The method of claim 1 wherein the resin material is polyester.

9. The method of claim 1 wherein the pressurized medium comprises a pressurized gas.

10. The method of claim 9 wherein the pressurized gas applied to the plurality of resin material shafts is applied at a pressure of in a range of approximately 0-30 inches of water.

11. The method of claim 9 wherein the pressurized gas applied to the plurality of resin material shafts is applied at a pressure of 2 inches of water.

12. The method of claim 1 wherein the pressurized medium comprises air.

13. The method of claim 1 wherein said pushing a molten resin material through an extrusion die and said applying a pressurized fluid to the plurality of resin material shafts so as to maintain a lumen are performed concurrently.

14. The method of claim 1 wherein said pulling the plurality of resin material shafts away from the extrusion die is done at a pulling rate of about 25-100 feet per minute.

15. The method of claim 1 wherein said pulling the plurality of resin material shafts away from the extrusion die is done at a pulling rate of about 45-65 feet per minute.

16. The method of claim 1 wherein the at least one outer lumen has an outer lumen wall thickness in a range of approximately 0.0035-0.006 in.

17. The method of claim 1 wherein the multi-lumen tubing has an overall diameter in a range of approximately {fraction (34/1000)} in. to {fraction (48/1000)} in.