Temporarily Stiffened Mesh Prostheses

Abstract

The present invention relates to medical prostheses and methods of manufacturing those devices. In particular, the prostheses are temporarily stiffened meshes with particular coatings to provide initial stiffness and thereby permit easier surgical handling for treatment or reconstruction of soft tissue defects. Preferred embodiments include surgical meshes coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The devices of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use. By including biologically active agents and/or drugs in the coating, the devices provide prophylaxis for and can alleviate side effects or complications associated with the surgery or use of prostheses in general.

1 . A medical prosthesis comprising a mesh and one or more coatings which temporarily stiffen the mesh to at least 1.1 times its original stiffness; said mesh being formed to encapsulate an implantable device; and said one or more coatings comprising one or more biodegradable polymers and one or more drugs which, alone or in combination, are capable of providing pain relief, inhibiting scarring or fibrosis and/or inhibiting bacterial growth. 
     
     
         2 . A medical prosthesis comprising a mesh and one or more coatings, wherein said one or more coatings comprise one or more biodegradable polymers which act as a stiffening agent and coat filaments or fibers of said mesh to temporarily immobilize contact points of the filaments or fibers of said mesh; said mesh is formed to encapsulate an implantable device; and said one or more coatings further comprise one or more drugs which, alone or in combination, are capable of providing pain relief, inhibiting scarring or fibrosis and/or inhibiting bacterial growth. 
     
     
         3 . The medical prosthesis of  claim 1  or  2 , wherein said implantable device is a pacemaker, a defibrillator generator, an implantable access system or a neurostimulator. 
     
     
         4 . The medical prosthesis of  claim 2 , wherein said mesh remains porous when coated with said agent. 
     
     
         5 . The medical prosthesis of  claim 2 , wherein said agent selectively and/or partially coats said filaments or said fibers. 
     
     
         6 . The medical prosthesis of  claim 2 , wherein said contact points comprise the knots in a woven mesh. 
     
     
         7 . The medical prosthesis of  claim 1  or  2 , wherein said one or more coatings increases stiffness of said mesh by at least 1.1 to about 4.5 times its uncoated stiffness. 
     
     
         8 . The medical prosthesis of  claim 1  or  2 , wherein said mesh comprises woven polypropylene. 
     
     
         9 . The medical prosthesis of  claim 1  or  2 , wherein said one or more biodegradable polymers are selected from the group consisting of a polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide), polyglycolic acid, poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D, L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polyoxaester, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptide, maleic anhydride copolymer, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylate, tyrosine-derived polycarbonate, tyrosine-derived polyiminocarbonate, tyrosine-derived polyphosphonate, polyalkylene oxide, hydroxypropylmethylcellulose, polysaccharide, protein, and copolymers, terpolymers and blends of any thereof. 
     
     
         10 . The medical prosthesis of  claim 1  or  2 , wherein at least one of said biodegradable polymers comprise one or more tyrosine-derived diphenol monomer units. 
     
     
         11 . The medical prosthesis of  claim 10 , wherein said polymer is a polyarylate. 
     
     
         12 . The medical prosthesis of  claim 11 , wherein said polyarylate is DT-DTE succinate having from about 1% DT to about 30% DT. 
     
     
         13 . The medical prosthesis of  claim 11 , wherein said polyarylate is a random copolymer of desaminotyrosyl-tyrosine (DT) and an desaminotyrosyl-tyrosyl ester (DT ester), wherein said copolymer comprises from about 0.001% DT to about 80% DT and said ester moiety can be a branched or unbranched alkyl, alkylaryl, or alkylene ether group having up to 18 carbon atoms, any of group of which can, optionally have a polyalkylene oxide therein. 
     
     
         14 . The medical prosthesis of  claim 1  or  2 , wherein said one or more drugs are selected from the group consisting of antimicrobial agents, anesthetics, analgesics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents and leukotriene inhibitors. 
     
     
         15 . The medical prosthesis of  claim 14 , wherein said drug is an anesthetic. 
     
     
         16 . The medical prosthesis of  claim 15 , wherein said anesthetic is bupivacaine HCl. 
     
     
         17 . The medical prosthesis of  claim 14 , wherein said drug is an antimicrobial agent. 
     
     
         18 . The medical prosthesis of  claim 17 , wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, silver/chlorhexidine, vancomycin, a cephalosporin, gentamycin, triclosan and combinations thereof. 
     
     
         19 . The medical prosthesis of  claim 18 , wherein at least one of said coatings comprises rifampin in combination with minocycline, gentamycin or vancomycin. 
     
     
         20 . The medical prosthesis of  claim 19 , wherein at least one of said coatings comprises rifampin and minocycline HCl. 
     
     
         21 . The medical prosthesis of  claim 14 , wherein ate least one of said coatings comprises an anti-inflammatory agent selected from non-selective cox-1 and cox-2 inhibitors. 
     
     
         22 . The medical prosthesis of  claim 14  wherein at least one of said coatings comprises an anti-inflammatory agent selected from selective cox-1 or cox-2 inhibitors.