Thermoplastic fluoropolymer-coated medical devices

Abstract

A medical device provided with at least a partial surface coating of a thermoplastic copolymer of tetrafluoroethylene and perfluoroalkylvinylether that is free of cross-linking monomers and curing agents. The fluoropolymer coating is preferably an amorphous thermoplastic, is highly inert and biocompatible, has elastomeric characteristics that provide desirable mechanical properties such as good flexibility and durability. These characteristics allow the coating to be considered “functionally transparent” because it withstands mechanical deformations required for the assembly, deployment, expansion, and placement of medical devices, without any adverse effect on the mechanical and biological functionality of the coated device. Further, its inertness, derived from the perfluorocarbon structure, contributes to its functionally transparent nature. The coating can be provided with various liquid or solid additives, can be loaded with large quantities of additives including a wide range of therapeutic agents, and has excellent drug elution characteristics when elutable additives are used.

The invention claimed is: 
     
         1 . A device comprising a medical device provided with a coating over at least a portion of a surface of the medical device, said coating comprising a thermoplastic copolymer of tetrafluoroethylene and perfluoropropylvinylether, said copolymer being free of cross-linking monomers and curing agents.