Adhesive composition for carrying therapeutic agents as delivery vehicle on coating applied to vascular grafts

Abstract

Water-soluble polymeric adhesive compositions and their use as delivery vehicles for carrying therapeutic agents on implantable devices, such as vascular grafts, are disclosed. Use of drug-coated vascular grafts is demonstrated for delivery of the therapeutic agents in vivo, thereby inhibiting restenosis or neointimal hyperplasia of the vascular graft and inhibiting infection at the vascular graft site. Methods of forming the adhesive and making the coated vascular grafts are also disclosed.

1 - 31 . (canceled) 
     
     
         32 . A composition comprising:
 a first hydrophilic monomer consisting of N-tolylglycine-glycidylmethacrylate;   a second hydrophilic monomer consisting of bisphenyldimethacrylate; and   a therapeutic agent,   
       wherein the composition is water soluble and is disassociated from the therapeutic agent when dissolved in water. 
     
     
         33 . The composition according to  claim 32 , wherein each of the first and second monomer components is present in an amount of between about 0.5 and about 20 percent by weight. 
     
     
         34 . The composition according to  claim 32 , wherein the first hydrophilic monomer is present in an amount of about 0.5 to about 3 weight percent and the second hydrophilic monomer is present in an amount of about 10 to about 20 weight percent. 
     
     
         35 . The composition according to  claim 32 , wherein the therapeutic agent is soluble in acetone or alcohol. 
     
     
         36 . The composition according to  claim 32 , wherein the therapeutic agent is rapamycin, an anti-inflammatory agent, an antimicrobial agent, an antibacterial agent, an antifungal agent, an anti-thrombogenic agent, an antiproliferative agent, or a combination thereof. 
     
     
         37 . The composition according to  claim 32 , further comprising a volatile solvent. 
     
     
         38 . The composition according to  claim 37 , wherein the volatile solvent is acetone, acetone in water, alcohol, alcohol in water, or a combination thereof. 
     
     
         39 . The composition according to  claim 32 , further comprising a polymerization initiator. 
     
     
         40 . The composition according to  claim 39 , wherein the polymerization initiator is a photoinitiator or a chemical initiator. 
     
     
         41 . A pharmaceutical composition for providing extended release of a therapeutic agent, comprising the composition according to  claim 32 . 
     
     
         42 . The pharmaceutical composition according to  claim 41 , wherein the therapeutic agent is soluble in acetone or alcohol. 
     
     
         43 . The pharmaceutical composition according to  claim 41 , wherein the therapeutic agent is rapamycin, an anti-inflammatory agent, an antimicrobial agent, an antibacterial agent, an antifungal agent, an anti-thrombogenic agent, an antiproliferative agent, or a combination thereof. 
     
     
         44 . The pharmaceutical composition according to  claim 41 , further comprising a volatile solvent. 
     
     
         45 . The pharmaceutical composition according to  claim 44 , wherein the volatile solvent is acetone, acetone in water, alcohol, alcohol in water, or a combination thereof. 
     
     
         46 . The pharmaceutical formulation according to  claim 41 , further comprising a polymerization initiator. 
     
     
         47 . The pharmaceutical composition according to  claim 46 , wherein the polymerization initiator is a photo initiator or a chemical initiator. 
     
     
         48 . A system for preparing the composition according to  claim 32 , the system comprising:
 a first solution comprising the first hydrophilic monomer dissolved in one or more volatile solvents; and   a second solution comprising the second hydrophilic monomer dissolved in one or more volatile solvents,   wherein:
 the first hydrophilic monomer is present in the first solution in an amount sufficient to form a water-soluble polymeric adhesive; or 
 the second hydrophilic monomer is present in the second solution in an amount sufficient to form a water-soluble polymeric adhesive; or 
 a combination thereof.