Post-crimping inspection of scaffolds mounted on scaffold delivery systems

摘要

A system for mounting a scaffold on a balloon catheter includes two positioning and alignment stations, which are used to prepare a scaffold and catheter for crimping using the same crimping head. The system is configured for automated assembly of the scaffold and catheter prior to crimping and performing post-crimping inspection for the crimped scaffold and prior to placing a restraining sheath over the crimped scaffold.

主权项

1. A method for crimping a scaffold to a balloon of a balloon catheter, comprising:
inserting the balloon and scaffold into a crimper head using an actuator including a carriage; performing a first crimping of the scaffold to the balloon to produce a pre-crimped scaffold; removing the pre-crimped scaffold from the crimper head, and collecting an image of the scaffold and the balloon to determine whether there is a misalignment between the pre-crimped scaffold and the balloon, whereupon detection of a misalignment a servo mechanism displaces one of the pre-crimped scaffold and the balloon relative to the other while a fork, cradle or arm is engaged with struts of the scaffold; returning the scaffold and balloon to the crimper head; and performing a second crimping of the scaffold to the balloon to produce a final crimped scaffold.