Degradable polymers incorporating gamma-butyrolactone

Abstract

Disclosed herein are implantable medical devices having controlled release biodegradable polymer coatings thereon wherein the polymer is formed from ring opening of γ-butyrolactone and at least one additional monomer selected from the group consisting of trimethylene carbonate, lactide, polyethylene glycol, glycolide, the monomers formed from ring opening of ε-caprolactone, 4-tert-butyl caprolactone, and N-acetyl caprolactone, and combinations thereof, and at least one drug releasable from the biodegradable polymer. Also disclosed are implantable medical devices form of the biodegradable polymers and processes for forming the polymers.

1 - 14 . (canceled) 
     
     
         15 : An implantable medical device comprising:
 a controlled release biodegradable polymer formed from γ-butyrolactone and trimethylene carbonate, and at least one additional monomer selected from the group consisting of lactide, polyethylene glycol, glycolide, ε-caprolactone, 4-tert-butyl caprolactone, p-dioxanone, N-acetyl caprolactone, and combinations thereof; and   at least one drug releasable from said biodegradable polymer.   
     
     
         16 : The implantable medical device of  claim 15  wherein the controlled release biodegradable polymer is in the form of a coating on the device. 
     
     
         17 : The implantable medical device of  claim 15  wherein said polymer is formed from γ-butyrolactone and trimethylene carbonate, and at least one additional monomer selected from the group consisting of lactide, polyethylene glycol, glycolide, and combinations thereof. 
     
     
         18 : The implantable medical device of  claim 17  wherein said polymer comprises the general structure of Formula 7: 
       
         
           
           
               
               
           
         
         and wherein a is an integer from 1 to about 20,000; b is an integer from about 2 to about 20,00, and c is an integer from about 1 to about 20,000 and the sum of a, b and c is at least 3. 
       
     
     
         19 : The implantable medical device of  claim 17  wherein said polymer comprises the general structure of Formula 8: 
       
         
           
           
               
               
           
         
         and wherein a is an integer from 1 to about 20,000; b is an integer from about 2 to about 20,000, and c is an integer from about 1 to about 20,000; d is an integer from about 1 to 20,000 and the sum of a, b and c is at least 4. 
       
     
     
         20 : The implantable medical device of  claim 17  wherein said polymer comprises the general structure of Formula 9: 
       
         
           
           
               
               
           
         
         and wherein a is an integer from 1 to about 20,000; b is an integer from about 2 to about 20,000, and c is an integer from about 1 to about 20,000; d is an integer from about 1 to 20,000 and the sum of a, b and c is at least 4. 
       
     
     
         21 : The implantable medical device of  claim 17  wherein said polymer comprises the general structure of Formula 10: 
       
         
           
           
               
               
           
         
         and wherein a is an integer from 1 to about 20,000; b is an integer from about 2 to about 20,000, and c is an integer from about 1 to about 20,000; d is an integer from about 1 to 20,000 and the sum of a, b and c is at least 4. 
       
     
     
         22 : The implantable medical device of  claim 15  wherein said at least one drug is selected from the group consisting of FKBP-12 binding agents, estrogens, chaperone inhibitors, protease inhibitors, protein-tyrosine kinase inhibitors, leptomycin B, peroxisome proliferator-activated receptor gamma ligands (PPARγ), hypothemycin, nitric oxide, bisphosphonates, epidermal growth factor inhibitors, antibodies, proteasome inhibitors, antibiotics, anti-inflammatories, anti-sense nucleotides and transforming nucleic acids. 
     
     
         23 : The implantable medical devices of  claim 21  wherein said drug comprises at least one compound selected from the group consisting of sirolimus, tacrolimus, everolimus, temsirolimus and zotarolimus. 
     
     
         24 : The implantable medical device of  claim 22  wherein said drug comprises zotarolimus. 
     
     
         25 : The implantable medical device of  claim 15  wherein said medical device is selected from the group consisting of vascular stents, stent grafts, urethral stents, bile duct stents, catheters, guide wires, pacemaker leads, bone screws, sutures and prosthetic heart valves. 
     
     
         26 : The implantable medical device of  claim 24  wherein said medical device is a vascular stent. 
     
     
         27 : The implantable medical device of either of  claim 15  wherein said medical device further comprises a cap coat.