Gore Enterprise Holdings, Inc.

W. L. Gore & Associates, Inc.

James W Chang

Edward H Cully

Michael J Vonesh

Huey Shen Wu

Robert L Cleek

Jack J Hegenbarth

Jon P Moseley

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.

Thermoplastic fluoropolymer-coated medical devices

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 desirable mechanical characteristics are surprising given the absence of cross-linking monomers and curing agents that would otherwise render such materials inadequately biocompatible. The perfluoroalkylvinylether may be perfluoromethylvinylether, perfluoroethylvinylether or perfluoropropylvinylether.

An improved elastomeric material is described comprising an essentially noncross-linkable amorphous copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE) which is both a thermoplastic and exhibits exceptional mechanical properties. This material is particularly suitable for use in ultra-clean environments, and particularly for use in an implantable device, since it does not contain contaminants that previous thermoset TFE/PMVE copolymers have required. Among the improved properties of the present invention are excellent biocompatibility, high matrix tensile strength, high clarity, high abrasion resistance, high purity, adequate elasticity, and ease of processing due to the thermoplastic, and noncross-linkable structure of the copolymer. The material of the present invention is also a high strength bonding agent particularly suited for bonding porous PTFE to itself or to other porous substances at room or elevated temperatures.

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Flagstaff, AZ, United States of America

James W Chang