Coatings with tunable molecular architecture for drug-coated balloon

Abstract

A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, wherein the cytostatic therapeutic agent and the at least one excipient have a weight ratio of about 20:1 to about 1:20, and further wherein the coating provides increased efficiency of therapeutic transfer to a body lumen.

What is claimed is: 
     
         1 . A method of coating a medical device having an outer surface, the method comprising:
 selecting a cytostatic therapeutic agent;   selecting at least one excipient;   blending the cytostatic agent and excipient to define a coating; and   applying the coating to the outer surface of the medical device, wherein the cytostatic therapeutic agent and the at least one excipient have a weight ratio of about 20:1 to about 1:20, and further wherein the coating provides increased efficiency of therapeutic transfer to a body lumen.   
     
     
         2 . The method of  claim 1 , further including:
 blending a plasticizer with the cytostatic therapeutic agent and the excipient.   
     
     
         3 . The method of  claim 2 , wherein the excipient to plasticizer weight ratio is from about 20:1 to about 1:20. 
     
     
         4 . The method of  claim 1 , wherein the cytostatic therapeutic agent and the at least one excipient has a weight ratio of about 2:1 to about 1:2. 
     
     
         5 . The method of  claim 1 , wherein the cytostatic therapeutic agent is zotarolimus. 
     
     
         6 . The method of  claim 1 , wherein the excipient is poly(vinylpyrrolidone). 
     
     
         7 . The method of  claim 2 , wherein the plasticizer is glycerol. 
     
     
         8 . The method of  claim 1 , wherein the coating is applied to the outer surface of the medical device by direct fluid application. 
     
     
         9 . The method of  claim 1 , further including applying heat to the coated medical device to dry the coating. 
     
     
         10 . The method of  claim 1 , wherein the medical device is a balloon catheter. 
     
     
         11 . A method of coating a medical device having an outer surface, the method comprising:
 selecting a cytostatic therapeutic agent;   selecting at least one polymeric excipient;   blending the cytostatic therapeutic agent and at least one polymeric excipient to define a coating; and   applying the coating to at least one length of the outer surface of the medical device, wherein the at least one polymeric excipient has a polydispersity index from about 1.05 to about 10 and provides increased efficiency of therapeutic transfer to a body lumen.   
     
     
         12 . The method of  claim 11 , further including:
 blending a plasticizer with the cytostatic therapeutic agent and excipient.   
     
     
         13 . The method of  claim 11 , wherein cytostatic therapeutic agent is zotarolimus. 
     
     
         14 . The method of  claim 11 , wherein the excipient is poly(vinylpyrrolidone). 
     
     
         15 . The method of  claim 12 , wherein the plasticizer is glycerol. 
     
     
         16 . The method of  claim 11 , wherein the medical device is a balloon catheter. 
     
     
         17 . A method of coating a medical device having an outer surface, the method comprising:
 selecting a cytostatic therapeutic agent;   selecting at least one excipient;   blending the cytostatic therapeutic agent and at least one excipient to define a coating;   applying the coating to at least one length of the outer surface of the medical device; and   inserting or implanting the coated medical device in a body lumen, wherein the coating has a dissolution rate of about 10 seconds to about 1 hour and provides an increased efficiency of therapeutic transfer to a body lumen.   
     
     
         18 . The method of  claim 17 , further including:
 blending a plasticizer with the cytostatic therapeutic agent and excipient.   
     
     
         19 . The method of  claim 17 , wherein cytostatic therapeutic agent is zotarolimus. 
     
     
         20 . The method of  claim 17 , wherein the excipient is poly(vinylpyrrolidone).