Multiple drug delivery from a balloon and a prosthesis

Abstract

System for treating vascular disease comprising a balloon having an outer surface for temporary contact with a vessel wall when in an expanded state, a coating disposed on at least a portion of the outer surface, the coating including an initial amount of a cytostatic agent selected from the group consisting of Zotarolimus (ABT578), everolimus, pimecrolimus, and a combination thereof, the coating being capable of maintaining a therapeutically effective amount of the cytostatic agent on the outer surface for delivery to a vessel wall, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall, and optionally, a stent disposed on the balloon.

What is claimed is: 
     
         1 . A system for treating vascular disease comprising:
 a balloon having an outer surface for temporary contact with a vessel wall when in an expanded state;   a coating disposed on at least a portion of the outer surface, the coating including an initial amount of a cytostatic agent selected from the group consisting of Zotarolimus (ABT578), everolimus, pimecrolimus, and a combination thereof, the coating being capable of maintaining a therapeutically effective amount of the cytostatic agent on the outer surface for delivery to a vessel wall, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall; and   optionally, a stent disposed on the balloon.   
     
     
         2 . The system of  claim 1 , wherein the cytostatic agent is zotarolimus. 
     
     
         3 . The system of  claim 2 , wherein the zotarolimus is disposed on the outer surface at a concentration of from about 3.7 μg/mm 2  to about 7.0 μg/mm 2 . 
     
     
         4 . The system of  claim 2 , wherein the coating further comprises ethanol, Iopromide and acetone. 
     
     
         5 . The system of  claim 2 , wherein the cytostatic agent is zotarolimus and the therapeutically effective amount of zotarolimus is effective to maintain at least about 35.7% of a vessel lumen diameter after delivery of the therapeutically effective amount of zotarolimus. 
     
     
         6 . The system of  claim 1 , wherein the coating further comprises binders, polymers, solvents, or combinations thereof. 
     
     
         7 . The system of  claim 6 , wherein the binder is selected from the group consisting of complex sugars, starches, collagens, and polymeric materials. 
     
     
         8 . The system of  claim 1 , wherein the stent is crimped onto the balloon. 
     
     
         9 . The system of  claim 1 , wherein the stent is a self-expanding stent. 
     
     
         10 . The system of  claim 1 , wherein the coating includes an additional beneficial agent. 
     
     
         11 . The system of  claim 1 , wherein the therapeutically effective amount of the cytostatic agent is effective to reduce neointimal formation after delivery of the cytostatic agent to the vessel wall. 
     
     
         12 . The system of  claim 1 , wherein the therapeutically effective amount of the cytostatic agent is delivered within about 60 seconds of contact between the balloon in an expanded condition and the vessel wall.