Polymer scaffold with multi-pleated balloon

摘要

A medical device includes a polymer scaffold crimped to a balloon. The balloon is formed with between 6 and 15 pleats to provide a uniform expansion of the scaffold when the balloon is inflated. Also provided are methods for crimping a scaffold to a multi-pleated balloon and methods for making a multi-pleated balloon.

主权项

1. A method for making a medical device, comprising the steps of:
providing a polymer scaffold having a longitudinal axis, pre-crimp diameter and a pair of ring elements connected to each other by at least two linking elements; placing the scaffold having the pre-crimp diameter over a balloon having at least six pleats to increase a uniformity of expansion of the scaffold; and crimping the scaffold to the balloon, including:
placing the scaffold and balloon in a crimping mechanism,reducing the scaffold diameter from the pre-crimp diameter to a first diameter, wherein the balloon is not inflated prior to the scaffold diameter being reduced to the first diameter,
maintaining the scaffold at the first diameter for a dwell period, andreducing the scaffold diameter to a final crimp diameter that is less than the first diameter.