Coating process for drug delivery balloons using heat-induced rewrap memory

摘要

A method of producing a drug coated balloon that comprises the steps of: subjecting a balloon catheter with a folded and wrapped balloon thereon to a pre-annealing step to induce a fold/wrap memory in the resulting pre-annealed balloon; unfolding the pre-annealed balloon sufficiently to expose the full circumferential surface of the balloon by application of an inflation pressure that retains said fold/wrap memory; applying a drug coating formulation to the unfolded balloon surface; releasing pressure to relax the balloon and induce creasing along fold memory; and evacuating the balloon slowly to induce refolding and rewrapping of the balloon. The method overcomes the need to use a folding apparatus to fold and wrap a drug coated balloon.

主权项

1. A method of producing a drug coated balloon that comprises the steps of:
subjecting a balloon catheter with a folded and wrapped balloon thereon to a pre-annealing step to induce a fold/wrap memory in the resulting pre-annealed balloon; unfolding the pre-annealed balloon sufficiently to expose the full circumferential surface of the balloon by application of an inflation pressure that retains said fold/wrap memory; applying a drug coating formulation to the unfolded balloon surface, the drug coating formulation comprising a drug, a solvent and optionally water; releasing pressure to relax the balloon and induce creasing along fold memory; and evacuating the balloon slowly to induce refolding and rewrapping of the balloon, wherein in said step of evacuating the balloon slowly, a balloon protector is concurrently gradually slid over the coated balloon and wherein an elapsed time between the step of applying the drug formulation and beginning to slide the balloon protector over the balloon is less than that needed to fully remove all solvent and/or water in the coating.