Multiple layer high strength balloon for dilatation catheter

• US 5,358,486 A
• Filed: 08/11/1992
• Issued: 10/25/1994
• Est. Priority Date: 01/09/1987
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Saab, Mark A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/928,135
• Time in Patent Office: 805 Days
• Field of Search: 604/96-103, 606/192-196, 128/207.15
• US Class Current: 604/103.13
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Abstract

A balloon for a dilatation catheter is formed to define relatively thin cone and neck segments at the opposite ends of the balloon by forming the balloon in a plurality of separate very thin layers. The balloon is built up from a plurality of layers including an inner layer which defines a complete balloon having a cylindrical midportion, cones at its ends and necks at the ends of the cones. Each successive outer layer is trimmed to be shorter than the next adjacent innermost layer, the trimming being effected in the region of the cones. The composite balloon thus formed has a staggered wall thickness in the region of the cones as to define a cone that is approximately uniform in wall thickness in a direction extending toward the neck region. The resulting balloon will be better adapted to collapse to a low profile about the catheter shaft on which it is mounted.

Claims

1. In an inelastic balloon for a dilatation catheter, the interior of the balloon being in fluid communication with an inflation lumen within the dilatation catheter when mounted on said dilatation catheter, the balloon being formed from polymeric material and having a cylindrical midportion, an outwardly tapering conical portion at each end of the midportion and a cylindrical neck portion at the ends of the conical portions, the improvement comprising the balloon being formed of at least two inelastic layers including an inner layer and an outer layer, the outer layer having first and second ends which terminate within the conical portions of the inner layer.

2. A balloon as defined in claim 1 wherein there are at least three layers with at least one intermediate layer being disposed between the inner layer and the outer layer, the intermediate layer being of a length between that of the inner and outer layers.

3. A balloon as defined in claims 1 or 2 wherein the layers are in intimate adhesive-free contact with each other.

4. A balloon as defined in claims 1 or 2 wherein the more inwardly disposed layers are of overall greater length than the more outwardly disposed layers.

5. A balloon dilatation catheter comprising an elongate flexible shaft having an inelastic dilatation balloon mounted at the distal end, the shaft having an inflation lumen therein and the interior of the balloon being in fluid communication with the inflation lumen, the balloon being formed from polymeric material and having a cylindrical midportion, an outwardly tapering conical portion at each end of the midportion and a cylindrical neck portion at the ends of the conical portions, the balloon being formed of at least two inelastic layers including an inner layer and an outer layer, the outer layer having first and second ends which terminate within the conical portions of the inner layer, the neck portions of the balloon being adhesively attached to the shaft.

6. A balloon dilatation catheter as defined in claim 5 wherein there are at least three layers with at least one intermediate layer being disposed between the inner layer and the outer layer, the intermediate layer being of a length between that of the inner and outer layers.

7. A balloon dilatation catheter as defined in claims 5 or 6 wherein the layers are in intimate adhesive-free contact with each other.