Anti-infective antimicrobial-containing biomaterials

Abstract

A biomaterial including a plurality of fatty acid chains cross-linked together and elemental silver metal formed within the material. Method(s) for forming the material are also included. The silver-containing biomaterial can be utilized alone or in combination with a medical device for the release and local delivery of one or more anti-infective agents.

1 - 17 . (canceled) 
     
     
         18 . A fatty-acid derived biomaterial incorporated with reduced silver, wherein the biomaterial is derived from a formulation comprising:
 an oil comprising a plurality of fatty acid chains;   a pre-cure of the oil, wherein the plurality of the fatty acid chains are at least partially cross-linked together; and   a silver solution, wherein the biomaterial results from oxidizing the formulation so that additional fatty acid chains have cross-linked and so that reduced silver metal forms within the biomaterial.   
     
     
         19 . The biomaterial of  claim 18 , wherein the silver solution comprises silver nitrate or silver acetate. 
     
     
         20 . The biomaterial of  claim 19 , wherein the silver solution is an aqueous solution. 
     
     
         21 . The biomaterial of  claim 18 , wherein the reduced silver metal formed within the biomaterial comprises nanoparticles of silver metal. 
     
     
         22 . The biomaterial of  claim 18 , wherein the fatty acid chains are omega-3 fatty acids and the oil is a fish oil. 
     
     
         23 . The biomaterial of  claim 22 , wherein the fish oil and pre-cured fish oil of the formulation are in a ratio of approximately 50:50 with each other. 
     
     
         24 . The biomaterial of  claim 18 , wherein the oil and the pre-cure of the oil are in a ratio of approximately 50:50 with each other. 
     
     
         25 . The biomaterial of  claim 18 , wherein further comprising an additional antimicrobial compound. 
     
     
         26 . The biomaterial of  claim 25 , wherein the antimicrobial compound is selected from the group consisting of triclosan, chlorhexidine and gentamicin. 
     
     
         27 . The biomaterial of  claim 18 , wherein FTIR analysis of the biomaterial does not possess a peak corresponding to the presence of fatty acid salts. 
     
     
         28 . The biomaterial of  claim 18 , wherein the biomaterial has a silver release profile in μg/cm 2  as shown in  FIG. 10 . 
     
     
         29 . The biomaterial of  claim 18 , wherein the biomaterial is a solid or a gel. 
     
     
         30 . A coating or film comprising the biomaterial of  claim 18  disposed on a medical device. 
     
     
         31 . The coating or film of  claim 30  having an additional antimicrobial compound applied to an outer surface of the coating or film. 
     
     
         32 . The coating or film of  claim 30 , wherein the medical device is a graft, a catheter balloon, or a stent. 
     
     
         33 . A method for forming the biomaterial of  claim 18 , wherein the method comprises the steps of:
 mixing the oil, the pre-cure of the oil and the silver solution with intermittent heating so as to form an emulsion;   thermally curing the emulsion so that additional fatty acid chain cross-linking occurs; and   oxidizing silver of the silver solution so that reduced silver metal forms within the biomaterial.   
     
     
         34 . The method of  claim 33 , wherein the silver solution mixed with the oil and the pre-cure of the oil is an aqueous silver acetate solution or an aqueous silver nitrate solution. 
     
     
         35 . The method of  claim 33 , wherein the pre-cure of the oil is formed by at least partially cross-linking fatty acids of the oil so that the pre-cure of the oil has a higher viscosity than the oil. 
     
     
         35 . The method of  claim 33 , wherein the silver solution is an aqueous silver solution, and thermally curing the emulsion includes forming hydroperoxides in the emulsion, and silver ions react with the hydroperoxides to form the reduced silver metal from the aqueous silver solution. 
     
     
         36 . The method of  claim 33 , further comprising the step of:
 casting the emulsion onto a medical device before thermally curing the emulsion on the medical device.   
     
     
         37 . The method of  claim 36 , wherein the medical device is a graft, a catheter balloon, or a stent.