W. L. Gore & Associates, Inc.

Gore Enterprise Holdings, Inc.

Wayne D. House

Edward H. Cully

Daniel B. Pond

Daniel B Pond

Edward H Cully

Carey V Campbell

Wayne D House

Alvaro J Laguna

James H Chastain

Larry J Kovach

A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer.

Method of making implantable devices with reduced needle puncture site leakage

A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer. Optionally, a middle layer of an elastomeric material may also be provided, joined to the inner and outer porous layers by the interpenetrating elastomeric adhesive. The device is preferably a vascular graft and more preferably a vascular graft for kidney dialysis.

Implantable devices with reduced needle puncture site leakage

A tube of porous PTFE having at least two first and at least two second regions wherein the at least two first regions have a greater density than the at least two second regions. For tubes of porous expanded PTFE having a microstructure of nodes interconnected by fibrils, the at least two first regions have a mean fibril length that is less than that of the at least two second regions. Preferably the regions are arranged in the form of ring-shaped segments of the tube wherein denser segments alternate along the length of the tube with less dense segments. Other arrangements between the different regions are possible; for example, the regions may be oriented in a spiral relationship with each other along the length of the tube. The porous PTFE tubes of the present invention have excellent radial compression resistance without requiring additional exterior reinforcing members due to the presence of the denser regions that are provided with a circumferential orientation. Tubes of this type are anticipated to be useful as vascular grafts and particularly as intraluminal vascular grafts. When provided as an intraluminal graft, the tube may also optionally be manufactured to be circumferentially distensible to a larger diameter up to a maximum diameter beyond which it will not distend during normal use; such a tube can also be made to recoil minimally on the release of the distending force. The tube may be used in in situ bypass procedures to hold venous valves open and to occlude tributary branches.

Method of insitu bypass to hold open venous valves

A tube of porous PTFE having at least two first and at least two second regions wherein the at least two first regions have a greater density than the at least two second regions. For tubes of porous expanded PTFE having a microstructure of nodes interconnected by fibrils, the at least two first regions have a mean fibril length that is less than that of the at least two second regions. Preferably the regions are arranged in the form of ring-shaped segments of the tube wherein denser segments alternate along the length of the tube with less dense segments. Other arrangements between the different regions are possible; for example, the regions may be oriented in a spiral relationship with each other along the length of the tube. The porous PTFE tubes of the present invention have excellent radial compression resistance without requiring additional exterior reinforcing members due to the presence of the denser regions that are provided with a circumferential orientation. Tubes of this type are anticipated to be useful as vascular grafts and particularly as intraluminal vascular grafts. When provided as an intraluminal graft, the tube may also optionally be manufactured to be circumferentially distensible to a larger diameter up to a maximum diameter beyond which it will not distend during normal use; such a tube can also be made to recoil minimally on the release of the distending force.

Radially supported polytetrafluoroethylene vascular graft

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Flagstaff, AZ, United States of America

Daniel B Pond