Multi-layered poly(tetrafluoroethylene)/elastomer materials...

A - Human Necessities – 61 – L

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A61L 27/00 (2006.01) A61F 2/06 (2006.01) A61L 27/16 (2006.01) A61L 27/26 (2006.01) A61L 27/50 (2006.01) B29C 55/00 (2006.01) A61F 2/00 (2006.01)

Patent

CA 1302897

ABSTRACT Biologically compatible materials capable of being formed into implants, comprising layers of poly(tetrafluoro- ethylene) and mixtures of poly(tetrafluoroethylene) and elastomer, having excellent compliance, strength, elasticity and suturability are disclosed. The materials are preferably prepared as implants or vascular grafts by co-extruding a relatively thin luminal layer of poly(tetrafluoroethylene) having a distinct fibral nodal microstructure within a layer of a mixture of poly(tetrafluoroethylene) and elastomer to impart elasticity to the implant. A preferred embodiment comprises a radially asymmetric composite vascular graft having a luminal layer of poly(tetrafluoroethylene), a second layer of poly(tetrafluoroethylene)/elastomer mixture, a third layer of elastomer, and a fourth layer of a monomer fibrous elastomer matrix with each layer having a distinctive pore size, pore shape and porosity to promote tissue ingrowth and periprosthetic tissue anchoring.

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