Abbott Cardiovascular Systems, Inc.

Sarah A Nelson

John Arthur Simpson

Jonathan P Durcan

Multilayer balloon for a catheter comprises a first layer of a first elastomeric polymeric material, and a second layer of a second elastomeric polymeric material having a lower maximum blow up ratio (BUR) than the first elastomeric polymeric material and being an outer layer relative to the first layer. The multilayer balloon is formed by blow-molding such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, wherein an area draw-down ratio (ADDR) of 2.0 for the multilayer balloon is targeted.

Method for forming catheter balloon

Method of making a balloon catheter includes providing an elongated shaft having a proximal end and a distal end and an inflation lumen extending therein, providing a multilayer tube, forming a multilayer balloon by blow-molding the multilayer tube such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, and securing the multilayer balloon on a distal section of the shaft with an interior of the multilayer balloon in fluid communication with the inflation lumen. The ADDR of the multilayer balloon after formation is approximately 2.0.

A catheter balloon and method involves extruded tubing with multiple layers of different durometer values, selected such that the blow up ratio (BUR) at the balloon's inner surface is increased. In one method a two stage blow mold process uses a small radius initial stage where radial growth is limited, followed by a second stage to a final dimension. A single stage blow mold process is also disclosed where the materials and processing are selected to approach the elongation to failure limit of the material. The single stage approach is preferably followed by a modified post-expansion heat set treatment to promote greater axial strength, leading to a preferred failure mode in the axial rather than radial direction.

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New Haven, CT, United States of America

Sarah A Nelson