Edwards Lifesciences Corporation

Cardiopolymers, Inc.

Don Shannon

Chris Kuo

Benny Tu

Frank Ahmann

A vascular access graft that is radially supported and self-sealing upon puncture with, for example, a dialysis needle. The graft has at least one access segment that is formed by an inner layer, an intermediate layer, and outer layer. The intermediate layer has, in longitudinal cross-section, regions of different densities. Radial support members within the intermediate layer prevent collapse of vascular access graft and may be formed of a material that has a lower melting temperature than the other components of the graft. A porous or low-density material is provided between the radial support members to permit blood seepage therein, and the graft is formed by heating to cause the radial support members to melt slightly into the interstitial spaces of the low-density material. The radial support members may be individual turns of a helical coil of FEP, and the low-density material may be compressed PTFE &ldquo;cotton&rdquo;. The inner and outer layers may also be formed of PTFE. An adhesive layer of FEP may be provided closely surrounding the inner layer to further anchor the various components of the graft during the step of heating. The inner layer extends on either side of the access segment to provide junction segments that can be cleanly trimmed to size, and which can be used for graft cannulation in lieu of the access segment after suitable tissue ingrowth. A method of manufacture of the vascular access graft is also provided.

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Mission Viejo, CA, United States of America

Don Shannon