Medical device balloons containing thermoplastic elastomers

• US 7,781,038 B2
• Filed: 05/27/2004
• Issued: 08/24/2010
• Est. Priority Date: 10/01/1993
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Hamilton, Bruce, Sahatjian, Ronald A.
• Primary Examiner(s): Dye; Rena L
• Assistant Examiner(s): JACOBSON, MICHELE LYNN
• Application Number:
  US10/855,816
• Publication Number:
  US 20050186370A1
• Time in Patent Office: 2,280 Days
• Field of Search: 428/36.9, 428/36.91, 428/480, 604 96-103, 604/264, 604/280, 606191-200
• US Class Current: 428/36.9
• 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 wherein said blend is a homogeneous blend and comprises a ratio of about 30:

70 to about 60;

40, thermoplastic elastomer to non-compliant structural polymer.

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 an inner layer and an outer layer disposed upon an intermediate structural layer of said second non-compliant structural polymeric material.

6. 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.

7. A balloon in accordance with claim 1 wherein said blend comprises an elastomeric layer and said balloon further comprises a structural layer upon which said elastomeric layer is disposed.

8. 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, said blend is a homogeneous blend and comprises a ratio of about 30;

70 to about 60;

40, thermoplastic elastomer to non-compliant structural polymer.

9. A catheter in accordance with claim 8 wherein said thermoplastic elastomer is an engineering thermoplastic elastomer.

10. A catheter in accordance with claim 8 wherein said blend forms an outer layer disposed upon an inner structural layer of a second non-compliant structural polymeric material.

11. A catheter in accordance with claim 10 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.