Drug Delivery Medical Device

Abstract

Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

1 . A method comprising the steps of:
 providing a device comprising a balloon; and a coating on at least a portion of the balloon, wherein the coating comprises an active agent, a polymer and a cationic binding agent, wherein the active agent includes a plurality of macrolide immunosuppressive drug particles in crystalline form, some of the particles having a portion uncovered by the polymer and some of the particles being fully encapsulated in the polymer;   inflating the balloon of the device in vivo; and   transferring at least 3% of the active agent and at least a portion of the polymer to a treatment site upon expansion of the balloon in vivo,   wherein the binding agent comprises at least one of: Polyarginine, Polyarginine 9-L-pArg, DEAE-Dextran (Diethylaminoethyl cellulose-Dextran), DMAB (Didodecyldimethylammonium bromide), PEI (Polyethyleneimine), TAB (Tetradodecylammonium bromide), and DMTAB (Dimethylditetradecylammonium bromide).