Sheaths reducing recoil and loss of retention for polymer scaffolds crimped to balloons

摘要

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A single piece sheath is placed over the scaffold immediately following crimping of the scaffold to the balloon. The single piece sheath is replaced by a two-piece sheath, which is removed prior to performing a medical procedure using the medical device.

主权项

1. A method for assembling a medical device, comprising:
providing a catheter including a shaft and a balloon having distal and proximal ends; disposing a temporary sheath on the catheter shaft; crimping a polymer scaffold to the balloon while the sheath is disposed on the catheter shaft; advancing the temporary sheath from the balloon proximal end towards the balloon distal end to radially constrain the crimped scaffold; inspecting the crimped scaffold and/or balloon within the temporary sheath; removing the temporary sheath from the crimped scaffold; and placing a final sheath over the crimped scaffold.