W. L. Gore & Assoc. Inc.

Charles M Inman

Donald Jesse Stone

A percutaneous implant device is provided which is stable, biocompatible, substantially infection-free and provides a long-term port of entry into the body, the device having an easy-to-use, effective, contamination-resistant capping and valving system for the exchange of fluids into and out of the body. The device comprises a nonporous biocompatible conduit having an attached flange, the flange having a top and a bottom. In the preferred embodiment, at the top of the flange, where the flange and conduit connect, the conduit emerges from the flange, necks inwardly and then flares outwardly forming an hourglass configuration. Above this neck the conduit forms substantially a right-angle bend, the conduit then extending substantially parallel to the skin. The device is implanted in the body such that the flange is below the surface of the skin. The flange preferably is covered with a porous, biologically inert material which permits growth of connective tissue and vascularization. Within the neck portion of the device, the inside diameter of the conduit is increased resulting in a decrease of the conduit wall thickness in the neck region creating a point of flexion which acts as a cushion to absorb forces that could otherwise disrupt the skin/device interface. By reason of the bend in the conduit, the conduit can be grasped and held firmly while pressure is applied parallel to the skin surface to insert a needle into or apply a cover cap to the conduit. Removable protective cap means and blunt insertion needle assembly means are provided, as well as suitable valving and connector means, providing a connection between the bottom of the flange and any internal conduit.

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Flagstaff, AZ, United States of America

Charles M Inman