Edwards Lifesciences Corporation

Baxter International Inc.

Benny Tu

Chris Kuo

Donald T Shannon

John James McIntyre

Yizi Chu

Ronald L Clinkenbeard

Mike Randall

Don Shannon

A method of non-delaminably bonding a non-porous thermoplastic elastomer to a substrate by heating a bilayer of the elastomer and the substrate for a predetermined time and a product obtained by the method. Methods for producing non-delaminable conduits and non-delaminable kink-resistant conduits constructed of biocompatible elastomers and substrates, and products produced by these methods are taught. Methods, products, and articles of manufacture relating to non-delaminable monofilament supported kink-resistive conduits that may be used as inflow conduits in left ventricular assist devices for treatment of heart failure are also provided.

Method for substantially non-delaminable smooth ventricular assist device conduit and product from same

Stented tubular grafts of expanded, sintered polytetrafluoroethylene (PTFE). The stented PTFE grafts of the present invention include an integrally stented embodiment, an externally stented embodiment, and an internally stented embodiment. In each embodiment, the stent may be either self-expanding or pressure-expandable. Also, in each embodiment, the stent may be coated or covered with a plastic material capable of being affixed (e.g., heat fused) to PTFE. Manufacturing methods are also disclosed by the individual components of the stented grafts are preassembled on a mandrel and are subsequently heated to facilitate attachment of the PTFE layer(s) to one another and/or to the stent. Optionally, the stented graft may be post-flexed and post-expanded following it's removal from the mandrel to ensure that the stented graft will be freely radially expandable and/or radially contractible over it's full intended range of diameters.

Stented, radially expandable, tubular PTFE grafts

Stented tubular grafts of expanded, sintered polytetrafluoroethylene (PTFE). The stented PTFE grafts of the present invention include an integrally stented embodiment, an externally stented embodiment, and an internally stented embodiment. In each embodiment, the stent may be either self-expanding or pressure-expandable. Also, in each embodiment, the stent may be coated or covered with a plastic material capable of being affixed (e.g., heat fused) to PTFE. Manufacturing methods are also disclosed by the individual components of the stented grafts are preassembled on a mandrel and are subsequently heated to facilitate attachment of the PTFE layer(s) to one another and/or to the stent Optionally, the stented graft may be post-flexed and post-expanded following it's removal from the mandrel to ensure that the stented graft will be freely radially expandable and/or radially contractible over it's full intended range of diameters.

Radially expandable stented tubular PTFE grafts

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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Lake Forest, CA, United States of America

Benny Tu