Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens

Abstract

A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which is complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

1 - 20 . (canceled) 
     
     
         21 . A catheter assembly comprising:
 an expandable structure having an outer surface;   a non-durable coating comprising a polymer matrix complexed with iodine disposed on the outer surface of the expandable structure; and   an aqueous soluble therapeutic agent dispersed in the matrix which is complexed with the iodine.   
     
     
         22 . The catheter assembly of  claim 21 , wherein the polymer matrix is a continuous aggregate polymer matrix which is uniformly dissolvable and removable from the outer surface of the expandable structure in an aqueous solvent, and at least partially dissolvable in a non-aqueous solvent. 
     
     
         23 . The catheter assembly of  claim 22 , wherein the continuous aggregate polymer matrix comprises an amphiphilic polymer or co-polymer which is fully dissolvable in a solution having a range of 100% to 80% non-aqueous solvent, and 0% to 20% aqueous solvent. 
     
     
         24 . The catheter assembly of  claim 22 , wherein the continuous aggregate polymer matrix is uniformly dissolvable and removable from the outer surface in both aqueous solvent and non-aqueous solvent. 
     
     
         25 . A catheter assembly of  claim 21 , wherein said iodine is present in said coating at a weight ratio of 1-30% of said coating dry weight. 
     
     
         26 . The catheter assembly of  claim 21 , wherein said iodine is complexed with polyethylene glycol, polyvinyl pyrrolidone and hydroxypropyl cellulose. 
     
     
         27 . The catheter assembly of  claim 21 , wherein said iodine is complexed with methyl cellulose, hydroxypropyl methylcellulose, or a co-polymer of N-vinylpyrrolidone with a reactive double bond containing monomer. 
     
     
         28 . The catheter assembly of  claim 27 , wherein the reactive double bond containing monomer is selected from the group consisting of styrene, acrylic acid, vinyl acetate and vinyl caprolactam. 
     
     
         29 . The catheter assembly of  claim 21 , wherein said aqueous soluble therapeutic agent is selected from the group consisting of epothilones, anti-platelet agents, anti-thrombotic agents, thrombolytic agents, and recombinant antibodies for anti-platelet and anti-endothelin applications. 
     
     
         30 . The catheter assembly of  claim 21 , wherein the substantially aqueous soluble therapeutic agent is dispersed throughout the polymer matrix which is complexed with the iodine. 
     
     
         31 . A catheter assembly comprising:
 an expandable structure having an outer surface;   a non-durable coating comprising a polymer matrix disposed on the outer surface of the expandable structure; and   an aqueous soluble therapeutic agent and non-covalently bound iodine dispersed throughout the polymer matrix.   
     
     
         32 . The catheter assembly of  claim 31 , wherein the polymer matrix is a continuous aggregate polymer matrix which is dissolvable and removable from the outer surface of the expandable structure in an aqueous solvent, and at least partially dissolvable in a non-aqueous solvent. 
     
     
         33 . The catheter assembly of  claim 32 , wherein the continuous aggregate polymer matrix comprises an amphiphilic polymer or co-polymer which is fully dissolvable in a solution having a range of 100% to 80% non-aqueous solvent, and 0% to 20% aqueous solvent. 
     
     
         34 . The catheter assembly of  claim 31 , wherein the polymer matrix comprises a polymer selected from the group consisting of polyethylene glycol, polyvinyl pyrrolidone and hydroxypropyl cellulose. 
     
     
         35 . The catheter assembly of  claim 31 , wherein the aqueous soluble therapeutic agent is selected from the group consisting of Epothilone A, Epothilone B, Epothilone D, (Arg-Gly-Asp)-based peptides, heparin, heparin sulfate, low molecular weight heparins, synthetic oligosaccharides, urokinase, recombinant urokinase, pro-urokinase, recombinant pro-urokinase, tissue plasminogen activator, recombinant tissue plasminogen activator, and streptokinase. 
     
     
         36 . The catheter assembly of  claim 31 , wherein the iodine is present in the coating at a weight ratio of 1-30% of said coating dry weight. 
     
     
         37 . The catheter assembly of  claim 31 , wherein the polymer matrix comprises a polymer selected from the group consisting of methyl cellulose and hydroxypropyl methylcellulose, or a co-polymer of N-vinylpyrrolidone with a reactive double bond containing monomer. 
     
     
         38 . The catheter assembly of  claim 37 , wherein the reactive double bond containing monomer is selected from the group consisting of styrene, acrylic acid, vinyl acetate and vinyl caprolactam. 
     
     
         39 . The catheter assembly of  claim 31 , wherein the polymer matrix comprises polyethylene glycol.