Coated Stent and Method of Making the Same

Abstract

A coated implantable medical device and a method of coating an implantable medical device is disclosed, the method includes applying a composition onto the device and drying the composition at elevated temperature in an environment having increased relative humidity. A pre-screening method for a manufacturing lot of coated stents to determine the number of drug coating layers for a desired drug release rate is disclosed. The method including coating and testing small groups of stents, and applying the results of the tests to determine the number of drug coating layers to apply to the manufacturing lot of stents.

What is claimed is: 
     
         1 . A method of coating a stent comprising:
 providing a stent body;   applying a coating composition comprising a lactide polymer, a solvent, and novolimus added thereto to the stent body; and   drying the stent body in about 20% to about 100% relative humidity, temperature of 30 deg. C. to 110 deg. C., and for 10 minutes to 240 minutes;   wherein after the act of drying, a coating is formed that has a residual solvent level less than [(stent length (mm))×(2.634)]−(36.08) as measured in μg.