| 主权项 |
1. A process for making a folded composition-eluting balloon catheter having a proximal end and a distal end, comprising an elongated catheter tube with an inflation lumen extending therewithin and at least one inflatable balloon having a central longitudinal balloon axis towards the distal end in fluid communication with the inflation lumen, wherein the balloon in an uninflated condition is configured as one or more foldable wings, wherein the balloon in a folded condition comprises a relief structure comprising at least one groove on the outside of the one or more foldable wings, configured to substantially reduce in depth in an inflated condition of the balloon, wherein the at least one groove crosses an outer edge of at least one of the one or more foldable wings, the process comprising the steps of:
a) coating one or both surfaces of the one or more foldable wings with a hydrophilic coating such that one or both surfaces of the one or more foldable wings are provided with a coated surface; b) applying a composition as a coating on the coated surface from step a), such that the composition is provided within a fold of the one or more foldable wings; and c) after step b), folding the one or more foldable wings around the central longitudinal balloon axis, thereby providing a folded composition-eluting balloon, wherein the relief structure seals the composition between the fold of the one or more foldable wings to prevent and/or reduce a release of the composition until after an inflation of the balloon of the composition-eluting balloon catheter. |
