Medical device balloons containing thermoplastic elastomers

• US 20050186370A1
• Filed: 05/27/2004
• Published: 08/25/2005
• Est. Priority Date: 10/01/1993
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Hamilton, Bruce, Sahatjian, Ronald A.
• Granted Patent: US 7,781,038 B2
• Time in Patent Office: Days
• US Class Current: 428/35.200
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]

Abstract

A dilatation balloon and catheter for insertion into a bodily conduit. The catheter (10) includes shaft (12) and a dilatation balloon (24) at the distal end of the shaft. The balloon is inflated via a central lumen (14) in the shaft for delivery of a fluid inflation media. The balloon is fabricated from a combination of a thermoplastic elastomer (TPE), preferably an engineering thermoplastic elastomer (ETE), with a non-compliant structural polymeric material. The combination may be a blend of the non-compliant structural polymer and the TPE. Alternatively, the combination may be a layered balloon having, for example, a non-compliant structural polymer inner layer and a soft, abrasion resistant, elastomeric outer layer. Methods for fabricating the balloon from the combination of a TPE and a non-compliant structural polymer are also disclosed.

Claims

1. A dilatation balloon for use in a medical catheter device, said dilatation balloon comprising a thermoplastic elastomer in a blend with a non-compliant structural polymeric material.

2. A balloon in accordance with claim 1 wherein said thermoplastic elastomer comprises an engineering thermoplastic elastomer.

3. A balloon in accordance with claim 2 wherein said engineering thermoplastic elastomer is a polyether glycol/polybutylene terephthalate block copolymer.

4. A balloon in accordance with claim 1 wherein said blend forms an outer layer disposed upon an inner structural layer of a second non-compliant structural polymeric material.

5. A balloon in accordance with claim 4 wherein said blend forms both an inner layer and an outer layer disposed upon an intermediate structural layer of said second non-compliant structural polymeric material.

7. A balloon in accordance with claim 1 wherein said blend comprises a structural layer and said balloon further comprises an elastomeric layer disposed upon said structural layer, said elastomeric layer comprising a thermoplastic elastomer.

8. A balloon in accordance with claim 7 wherein said blend comprises a ratio of about 40:

60 to about 60;

40, thermoplastic elastomer to non-compliant structural polymeric material.

9. A balloon in accordance with claim 16 wherein said blend comprises an elastomeric layer and said balloon further comprises a structural layer upon which said elastomeric layer is disposed.

10. A balloon in accordance with claim 9 wherein said blend comprises a ratio of about 30:

70 to about 60;

40, thermoplastic elastomer to non-compliant structural polymeric material.

13. A catheter in accordance with claim 11 wherein said blend forms an outer layer disposed upon an inner structural layer of a second non-compliant structural polymeric material.

14. A catheter in accordance with claim 13 wherein said blend is both an inner layer and an outer layer disposed upon an intermediate structural layer of said second non-compliant structural polymeric material.

6. (canceled)

11. A catheter for insertion into a bodily conduit, said catheter comprising:

a shaft including a lumen internal to said shaft for delivery of fluid inflation media; and

a dilatation balloon bonded to said shaft and defining a chamber, said chamber being in fluid communication with said lumen to permit inflation of said chamber, wherein said dilatation balloon comprises a thermoplastic elastomer in a blend with a non-compliant structural polymeric material.

12. A catheter in accordance with claim 11 wherein said thermoplastic elastomer is an engineering thermoplastic elastomer.

15-22. -22. (canceled)