Medical device balloons containing thermoplastic elastomers

• US 6,086,556 A
• Filed: 08/04/1998
• Issued: 07/11/2000
• Est. Priority Date: 10/01/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Hamilton, Bruce, Sahatjian, Ronald A.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Sadula, Jennifer R.
• Application Number:
  US09/129,029
• Time in Patent Office: 707 Days
• Field of Search: 604/96, 604/264, 604/280, 604/97-103, 606/191-200, 606/280-523
• US Class Current: 604/96.01
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/12 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• 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: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

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 device, the balloon having a structural layer which is a blend consisting essentially of polyethylene terephthalate (PET) as its major component and as a minor component a randomized block copolymer of polyether glycol and polybutylene terephthalate.

2. The balloon of claim 1 further comprising an elastomeric layer outside of the structural layer.

3. The balloon of claim 2 in which the elastomeric layer comprises a blend of an ETE with PET.

6. The balloon of claim 1, 4 or 5 in which the randomized block copolymer of polyether glycol and polybutylene terephthalate is HYTREL®

.

7. The balloon of claim 1, 4, or 5 in which the PET in the blend comprises modified PET.

8. The balloon of claim 7 in which the modified PET is SELAR®

.

4. A dilatation balloon for use in a medical device, the balloon comprising a structural layer which is a blend consisting essentially of polyethylene terephthalate (PET) as its major component and as a minor component a randomized block copolymer of polyether glycol and polybutylene terephthalate, the balloon further comprising an elastomeric layer outside of the structural layer, said balloon being made by a process which comprises coextruding the elastomeric layer and the structural layer.

5. A dilatation balloon for use in a medical device, the balloon having a structural layer which is a blend comprising at least two components:

a) polyethylene terephthalate (PET) as its major component; and

b) as a minor component a randomized block copolymer of polyether glycol and polybutylene terephthalate, said blend components not being covalently bound to other molecules.