Drug Eluting Balloon

Abstract

The present invention is an inflatable balloon which is enclosed by an expandable cover which becomes increasingly porous/permeable during expansion. The balloon is coated or enclosed with a matrix which contains a pharmaceutically active agent. During expansion of the balloon, the pharmaceutically active agent is released or extruded through the expandable cover into a body cavity such as an artery or vein. The present invention also provides for a method of treating a disease or condition by delivering the inflatable balloon to a particular body cavity.

1 . A medical device, comprising a balloon, a biocompatible matrix and a cover, wherein the balloon comprises a plurality of pleats, wherein the biocompatible matrix is disposed between the balloon and the cover, wherein the cover encloses the biocompatible matrix and the balloon, and wherein permeability of the cover when the balloon is inflated is greater than the permeability of the cover when the balloon is in an unexpanded state. 
     
     
         2 . The medical device of  claim 1 , wherein the biocompatible matrix comprises at least one pharmaceutical agent. 
     
     
         3 . The medical device of  claim 2 , wherein the pharmaceutical agent is encapsulated in a microsphere, liposome, nanoparticle, nanogel or mixture thereof. 
     
     
         4 . The medical device of  claim 2 , wherein the pharmaceutical agent comprises at least one anti-proliferative agents selected from the group consisting of everolimus, tacrolimus, zotarolimus, biolimus, rapamycin or mixtures thereof. 
     
     
         5 . The medical device of  claim 1 , wherein the biocompatible matrix encloses the pleats. 
     
     
         6 . The medical device of  claim 5 , wherein the biocompatible matrix is extruded through the cover on inflation of the balloon. 
     
     
         7 . The medical device of  claim 6 , wherein the balloon is compliant, semi-compliant or non-compliant. 
     
     
         8 . The medical device of  claim 6 , further comprising a plurality of holes, pores, slits, or combinations thereof in the cover. 
     
     
         9 . The medical device of  claim 8 , wherein the biocompatible matrix is extruded through the holes in the cover when the balloon is inflated. 
     
     
         10 . The medical device of  claim 1 , wherein the biocompatible matrix forms a tube enclosing the pleats. 
     
     
         11 . The medical device of  claim 2 , wherein total surface load of the pharmaceutical agent in the biocompatible matrix ranges from about 1 μg/mm 2 to about 200 μg/mm 2 . 
     
     
         12 . The medical device of  claim 11 , wherein less than about 10% (w/w) of the pharmaceutical agent is released after incubation of the medical device for about 10 minutes at 37° C. in an aqueous solution, when the balloon is not inflated. 
     
     
         13 . The medical device of  claim 11 , wherein greater than about 75% (w/w) of the pharmaceutical agent is released after incubation for about 10 minutes at 37° C. in an aqueous solution, when the balloon is inflated. 
     
     
         14 . The medical device of  claim 13 , wherein the pharmaceutical agent is released into the aqueous solution following zero-order kinetics. 
     
     
         15 . The medical device of  claim 1 , wherein thickness of the cover ranges from about 0.1 μm to about 300 μm. 
     
     
         16 . The medical device of  claim 1 , wherein the biocompatible matrix is a thin film. 
     
     
         17 . The medical device of  claim 2 , wherein the biocompatible matrix comprises dextran, alginate, amylose, amylopectin, carrageenan, carboxymethyl cellulose, gellan, guar gum, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, amylopectin, hyaluronic acid, xantan, xyloglucan, chitosan-based hydrogel, peptidoglycan, proteoglycans, glucose, polysaccharides, maltose, lactose, fructose, sucrose, galactose, glucosamine, galactosamine, muramic acid, glucuronate, gluconate, fucose, trehalose, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, propylene glycol, polyoxyethylene derivatives, elastin, polyvinyl amine or poly(L-lysine), carboxymethyl cellulose (CMC), hydroxypropylmethyl cellulose (HPMC), amylopectin, hyaluronic acid, pullulan or combinations thereof. 
     
     
         18 . The medical device of  claim 17 , further comprising a bioadhesive. 
     
     
         19 . The medical device of  claim 18 , wherein the biocompatible matrix is formed from pullulan. 
     
     
         20 . The medical device of  claim 19 , wherein biocompatible matrix is formed as a tape which is wrapped from 1 to 10 times around the pleats.