Balloon for a dilation catheter and method for manufacturing a balloon

• US 6,696,121 B2
• Filed: 07/27/2001
• Issued: 02/24/2004
• Est. Priority Date: 05/14/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Original Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Inventors: Roucher, Leo R. Jr., Jung, Eugene J. Jr.
• Primary Examiner(s): RAYFORD, SANDRA M
• Application Number:
  US09/918,684
• Publication Number:
  US 20020041940A1
• Time in Patent Office: 942 Days
• Field of Search: 428/35.7, 604/96, 604/192, 604/264, 604/280, 606/194
• US Class Current: 428/35.7
• 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
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1345 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]

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 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.

2. The dilation balloon of claim 1 wherein stretching and expanding the preform tube within the precondition mold occurs substantially simultaneously.

3. The dilation balloon of claim 1 wherein stretching and expanding the parison within the balloon mold occurs substantially simultaneously.

4. 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.

5. The dilation balloon of claim 4 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.

6. The dilation balloon of claim 4 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.

7. The dilation balloon of claim 4 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.

8. The dilation balloon of claim 4 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.

9. The dilation balloon of claim 4 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.

10. 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;

arid

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.

11. The balloon of claim 10 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.

12. The balloon of claim 10 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.

13. The balloon of claim 10 wherein the polyester block copolymer comprises a polybutylene terephthalate hard segment and a long chain polyether glycol soft segment.

14. 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;

stretching and expanding the parison in the balloon mold to form a balloon, the balloon having a balloon wall thickness, BWT, approximately 0.33PWT.