Method for manufacturing a balloon for a dilation catheter

• US 6,645,422 B2
• Filed: 07/27/2001
• Issued: 11/11/2003
• Est. Priority Date: 05/14/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Jomed Inc.
• Inventors: Roucher, Leo R. Jr., Jung, Eugene J. Jr.
• Primary Examiner(s): McDowell, Suzanne E.
• Application Number:
  US09/918,599
• Publication Number:
  US 20020041059A1
• Time in Patent Office: 837 Days
• Field of Search: 264/529, 264/531, 264/532, 264/535, 264/573, 264/235, 264/346, 428/35.7, 428/36.9, 428/36.91, 428/36.92, 604/96, 604/915, 606/191, 606/192, 606/194
• US Class Current: 264/530
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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: B29C 49/18 using several blowing steps B29C49/16 takes precedence

Abstract

A method for forming a balloon for a dilation catheter is provided herein. The method includes the steps of: (i) positioning a tube in a preconditioned mold; (ii) expanding the tube in a preconditioned mold to form a parison; (iii) positioning the parison in a balloon mold; and (iv) expanding the parison within the balloon mold to form the balloon. Thus, the tube is initially expanded into a parison in the preconditioned mold. Subsequently, the parison is expanded into a balloon in the balloon mold. Because of this unique manufacturing process, polyester block copolymers can be formed into balloons. Some of these polyester block copolymers could not be formed into a balloon using prior art blow molding processes. The resulting balloon exhibits superior characteristics, including relatively thin and consistent walls, soft texture, low uninflated crossing profile, expansion in a predictable fashion, and good tensile strength.

Claims

1. A method for forming a balloon, the method comprising:

providing a tube formed from a polyester block copolymer, said tube having a tube inner diameter and a tube outer diameter;

positioning the tube in a precondition mold, said precondition mold having a pair of opposed precondition mold openings;

expanding the tube within the precondition mold to form a parison, said parison having a parison outer diameter, said parison outer diameter being larger than said tube outer diameter;

positioning the parison in a balloon mold, the balloon mold having a balloon mold inner diameter which is larger than the precondition mold inner diameter, said balloon mold having a pair of opposed balloon mold openings; and

expanding the parison within the balloon mold to form the balloon.

2. The method for forming a balloon of claim 1 wherein during formation of the balloon, expanding the tube includes heating the tube and pressurizing a lumen of the tube to a first pressure, which is at least approximately five hundred (500) psi.

3. The method for forming a balloon of claim 1 wherein the tube has an initial diameter of D and expanding the tube includes radially expanding the tube so that the parison has a parison outer diameter between 1.5D and 2.5D.

4. The method for forming a balloon of claim 1 wherein the tube has an initial length of L and expanding the tube includes axially stretching the tube to a length between 1.5L and 2.5L.

5. The method for forming a balloon of claim 1 wherein expanding the tube includes radially expanding the parison so that the balloon has a balloon outer diameter which is at least approximately one and one-half (1.5) times larger than a parison outer diameter of the parison.

6. The method for forming a balloon of claim 1 wherein providing a tube formed from a polyester block copolymer comprises providing a tube formed from an aromatic polyester hard segment and an aliphatic polyester soft segment.

7. The method for forming a balloon of claim 1 wherein providing a tube formed from a polyester block copolymer comprises providing a tube formed from a polybutylene terephthalate hard segment and a long chain of polyether glycol soft segment.

8. A method for forming a balloon for a dilatation catheter, the method comprising:

providing a tube formed from a polyester block copolymer and having a tube outer diameter and a lumen;

positioning the tube in a precondition mold, said precondition mold having an inner diameter which is between approximately one and one-half and approximately two and one-half times larger than the tube outer diameter;

heating the tube;

forming a parison by pressurizing said lumen of said tube;

positioning the parison in a balloon mold, said balloon mold having a balloon mold diameter at least five times larger than said tube inner diameter;

heating the parison in the balloon mold; and

forming a balloon from the parison by pressurizing the lumen of the parison.

9. The method of claim 8 wherein forming a parison from the tube includes axially stretching the tube.

10. The method of claim 8 wherein forming a balloon from the parison includes axially stretching the parison.

11. The method of claim 8 wherein forming a balloon from the parison comprises pressurizing the lumen of the parison to at least approximately three hundred and fifty psi.

12. The method of claim 8 further comprising annealing the balloon in the balloon mold.

13. The method of claim 12 wherein annealing the balloon comprises annealing the balloon at a temperature at least approximately two hundred degrees Fahrenheit.

14. The method of claim 12 wherein annealing the balloon comprises annealing the balloon at a pressure of at least approximately two hundred psi.

15. The method of claim 8 wherein providing a tube formed from a polyester block copolymer comprises providing a tube formed from an aromatic polyester hard segment and an aliphatic polyester soft segment.

16. The method of claim 8 wherein providing a tube formed from a polyester block copolymer comprises providing a tube formed from a polybutylene terephthalate hard segment and a long chain of polyether glycol soft segment.