CA2575032A1

CA2575032A1 - Balloon for a dilation catheter and method for manufacturing a balloon

Info

Publication number: CA2575032A1
Application number: CA002575032A
Authority: CA
Inventors: Eugene J. Jung, Jr.; Leo R. Roucher, Jr.
Original assignee: Abbott Laboratories Vascular Enterprises Limited; Eugene J. Jung, Jr.; Leo R. Roucher, Jr.; Navius Corporation; Nantucket Acquisition Corporation; Endosonics Corporation; Jomed Inc.
Current assignee: Abbott Laboratories Vascular Enterprises Ltd
Priority date: 1997-05-14
Filing date: 1998-04-23
Publication date: 1998-11-14
Anticipated expiration: 2018-04-23
Also published as: CA2575032C

Abstract

A balloon for a dilation catheter, produced with a method that includes t he steps of: (i) positioning a tube in a preconditioned mold; (ii) expanding th e 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. The tube is initially expanded into a parison in the preconditioned mol d. Subsequently, the parison is expanded into a balloon in the balloon mold. Because of this unique manufacturing process, polyester block copolymers can be form ed 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, so ft texture, low uninflated crossing profile, expansion in a predictable fashion, and goo d tensile strength.

Claims

1. A balloon for a dilation catheter, the balloon being made from a polyester block copolymer.

2. The balloon of claim 1, wherein the polyester block copolymer consists of an aromatic polyester hard segment and an aliphatic polyester soft segment.

3. The balloon of claim 1, prepared by a process comprising the steps of:
providing a tube;
positioning the tube in a preconditioned mold, the precondition mold having a precondition mold inner diameter;
expanding the tube within the precondition mold to form a parison;
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;
and expanding the parison within the balloon mold to form the balloon.

4. A dilation balloon comprising a hard aromatic polyester segment and a soft aliphatic polyester segment and including a single layered block copolymer comprising:
polybutylene terephthalate segment; and a soft segment selected from the group consisting of polyether glycol or polyester, wherein the balloon is formed by:
positioning a preform tube in a precondition mold, the precondition mold having a precondition mold inner diameter;

stretching and expanding the preform tube within the precondition mold to form a uniformly reduced parison;
positioning the uniformly reduced parison in a balloon mold, the balloon mold having a balloon mold inner diameter which is larger than the precondition mold inner diameter; and stretching and expanding the parison within the balloon mold to form the balloon.

5. The dilation balloon of claim 4, wherein stretching and expanding the preform tube within the precondition mold occurs substantially simultaneously.

6. The dilation balloon of claim 4, wherein stretching and expanding the parison within the balloon mold occurs substantially simultaneously.

7. A dilation balloon comprising a hard aromatic polyester segment and a soft aliphatic polyester segment and including a single layered block copolymer comprising:
a polybutylene terephthalate segment; and a soft segment selected from the group consisting of polyether glycol or polyester, wherein the balloon is formed by:
providing a preform tube, the preform tube having a preform tube inner diameter and a preform tube outer diameter;
positioning the preform tube in a precondition mold, the precondition mold having a pair of opposed precondition mold openings;
stretching and expanding the preform tube within the precondition mold to form a parison, the parison having a parison outer diameter, the parison outer diameter being larger than the tube outer diameter;

preconditioning the tube within the precondition mold to form a parison by stretching and expanding the tube;
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, the balloon mold having a pair of opposed balloon mold openings;
and stretching and expanding the parison within the balloon mold to form the balloon.

8. The dilation balloon of claim 7, wherein stretching and expanding the preform tube further comprise heating the preform tube and pressurizing a lumen of the preform tube to a first pressure, which is at least approximately five hundred (500) psi.

9. The dilation balloon of claim 7, wherein the preform tube has an initial length of L and stretching the preform tube includes axially stretching the preform tube to a length between 1.5 L and 2.5 L.

10. The dilation balloon of claim 7, wherein the preform tube has an initial diameter of D and expanding the preform tube includes radially expanding the preform tube so that the parison has a parison outer diameter between 1.5 D
and 2.5 D.

11. The dilation balloon of claim 7, wherein stretching the parison includes axially stretching the parison to a length which is at least approximately one (1.0) times longer than the length of the parison.

12. The dilation balloon of claim 7, wherein expanding the parison includes radially expanding the parison so that the balloon has a balloon outer diameter which is at least approximately 1.5 to 2.5 times larger than a parison outer diameter of the parison.

13. A balloon for a dilation catheter, the balloon being prepared by a process comprising the steps of:
providing a tube consisting essentially of a single layered polyester block copolymer material having a tube outer diameter, the tube being made of a polyester block copolymer comprising a hard aromatic polyester segment and a soft aliphatic polyester segment;
expanding the tube to form a parison, the parison having a parison outer diameter which is between approximately one and one-half (1.5) to two and one-half (2.5) times larger than the tube outer diameter; and expanding the parison to form a balloon, the balloon having a balloon outer diameter which is between approximately one and one-half (1.5) to two and one-half (2.5) times larger than the parison outer diameter.

14. The balloon of claim 13, wherein the step of providing a tube consisting essentially of a single polyester block copolymer material includes providing a tube in which the polyester block copolymer consists of an aromatic hard segment arid an aliphatic polyester soft segment.

15. The balloon of claim 13, wherein the step of providing a tube consisting essentially of a single polyester block copolymer material includes providing a tube in which the polyester block copolymer is comprised of a polybutylene terephalate hard segment and a long chain of polyether glycol soft segment.

16. The balloon of claim 13, wherein the polyester block copolymer comprises a polybutylene terephthalate hard segment and a long chain polyether glycol soft segment.

17. A dilation balloon comprising a hard aromatic polyester segment and a soft aliphatic polyester segment and including a single layered block copolymer comprising:
polybutylene terephthalate segment; and a soft segment selected from the group consisting of polyether glycol or polyester, wherein the balloon is formed by:
positioning a single layered block copolymer preform tube in a precondition mold, the preform tube having a tube wall thickness of TWT;
stretching and expanding the tube in the precondition mold to form a work hardened parison, the parison having a parison wall thickness, PWT, approximately 0.25TWT;
positioning the uniformed reduced parison in a balloon mold; and stretching and expanding the parison in the balloon mold to form a balloon, the balloon having a balloon wall thickness, BWT, approximately 0.33PWT.