Therapeutic agent delivery device with controlled therapeutic agent release rates

摘要

A method for preparing an implantable medical device comprises providing an implantable medical device with a plurality of holes; loading into the plurality of holes an amount of a therapeutic agent, which amount is sufficient to form a therapeutic agent layer; loading into the plurality of holes an amount of a composition which amount is sufficient to liquify a portion of the therapeutic agent layer, thereby allowing a portion of the therapeutic agent layer to be disposed within a mixing layer wherein an amount of therapeutic agent contained within the mixing layer is smaller than an amount of therapeutic agent contained in the therapeutic agent layer; repeating the previous step sequentially at least once with a substantially identical composition, whereby the layers take on a concentration gradient in the plurality of holes. An implantable medical device comprises an implantable device body having a plurality of holes; a therapeutic agent provided in a therapeutic agent layer contained within the plurality of holes in the device body; and at least one mixing layer provided adjacent the therapeutic agent layer in the plurality of holes, wherein the at least one mixing layer comprises at least one pharmaceutically acceptable bioresorbable polymer for allowing the therapeutic agent to be released as the polymer is resorbed; wherein the therapeutic agent layer and the at least one mixing layer together contain a concentration gradient of said therapeutic agent for allowing for the controlled release of the therapeutic agent, and wherein the therapeutic agent layer comprises at least one pharmaceutically acceptable polymer different from the polymer of the mixing layer.