Impra, Inc.,

Endomed, Inc.

C. R. Bard, Inc.

Bard Peripheral Vascular, Inc.

Impra, Inc., a Subsidiary of C.r. Bard, Inc.

William M Colone

Joseph B Sinnott

Kevin G Farl

William L Creer

Barbara L Teeter

Rajagopal R Kowligi

Linda V Della Corna

Robert C Farnan

Ramon Berguer

Peter Y Lee

Extruded, stretched, sintered tubular PTFE materials are produced which are suited for use in the medical field as liners and covers for expandable stents. The PTFE materials have an unusually low REC (Radial Expansion Coefficient) and RER (Radial Expansion Ratio).

Radially expandable polytetrafluoroethylene

A method is disclosed for making vascular prostheses from ePTFE said prostheses having a diameter which is larger, and a wall thickness which is smaller than previously achievable using ram extrusion techniques. The method consists of extruding a PTFE tube, finish processing the tube into an ePTFE tube, laterally dilating it by expansion in incremental steps, calendering the tube after each dilating step, while the tube is being maintained at an elevated temperature. Once the tube is dilated it can be sintered with another tube to form a laminate. Alternatively, a wire stent may be joined with one or more tubes, thereby biasing the laminate to a cylindrical configuration.

Method of making large diameter vascular prostheses and vascular prosthesis made by said method

Expandable vascular prosthesis

An intraluminal device such as a stent graft is formed of a conformable ePTFE tube and preferably a compressed self-expanding stent affixed to the tube. The conformable tube is made by a special process which insures that the tube is radially deformable up to a predetermined diameter without exceeding the plastic deformation limit of the tube. The stent has a relaxed diameter larger than the diameter of the expanded tube after insertion so that the tube is biased to a cylindrical shape. The process for making the tube involves progressively dilating a small diameter extruded tube until a desired diameter is achieved. The tube is then contracted on a small diameter mandrel by heating.

Balloon-assisted intraluminal stent graft

Method of making large diameter vascular prosteheses and a vascular prosthesis made by said method

A device for disposing a radially self-expanding endoprosthesis in a body lumen. The implantation device includes an elongated catheter having a distal end and an outer surface over which the endoprosthesis is placed a sheath disposed to releasably surround at least a portion of the endoprosthesis, holding the endoprosthesis on the catheter in a radially contracted state, and a flexible elongation release element cooperating with the sheath. The sheath is released, permitting the surrounded portion of the endoprosthesis to expand, by axial withdrawal of the release element.

Delivery system for self-expanding stents and grafts

A non-porous coated PTFE graft includes a PTFE tube having a conventional porous inner cylindrical wall and a non-porous elastomeric coating applied over at least a portion of the outer cylindrical wall of the PTFE tube to render such portion of the outer cylindrical wall non-porous. The elastomeric coating is made of polyurethane or another biocompatible non-porous elastomer and precludes tissue ingrowth into the outer cylindrical wall, minimizes suture hole bleeding, and increases suture retention strength, while reducing the incidence of serous weepage. The elastomeric coating is preferably applied by mounting the PTFE tube upon a mandrel of like diameter and either dip coating or spray coating all, or selected portions, of the PTFE tube with liquified polyurethane. After the polyurethane coating is completely dried, the non-porous vascular graft is removed form the mandrel and is ready for use.

Non-porous coated PTFE graft

A vascular patch for closing an incision in a blood vessel includes a base layer of expanded polytetrafluoroethylene (PTFE) having an outer coating of an elastomeric, biocompatible material such as polyurethane to minimize suture hole bleeding. Suture guidelines are formed upon the ablumenal side of the PTFE base layer prior to application of the elastomeric coating to facilitate proper and consistent placement of sutures. A colorant is added to the elastomeric coating to identify the ablumenal side of the vascular patch. The vascular patch is made by mounting an expanded PTFE tube upon a mandrel and applying a water based PTFE ink as a helical stripe about the outer surface of the PTFE tube to form the suture guidelines. The striped PTFE tube is then dip-coated or spray-coated with the elastomeric coating to which the colorant has been added. The PTFE tube is slit to form a flat sheet from which vascular patches are cut.

Blood vessel patch

A vascular patch for closing an incision in a blood vessel includes a base layer of expanded polytetrafluoroethylene (PTFE) having an outer coating of an elastomeric, biocompatible material such as polyurethane to minimize suture hole bleeding. Suture guidelines are formed upon the ablumenal side of the PFTE base layer prior to application of the elastomeric coating to facilitate proper and consistent placement of sutures. A colorant is added to the elastomeric coating to identify the ablumenal side of the vascular patch. The vascular patch is made by mounting an expanded PTFE tube upon a mandrel and applying a water based PFTE ink as a helical stripe about the outer surface of the PTFE tube to form the suture guidelines. The striped PTFE tube is then dip-coated or spray-coated with the elastomeric coating to which the colorant has been added. The PTFE tube is slit to form a flat sheet from which vascular patches are cut.

A longitudinally compliant PTFE graft is provided by compressing at least a portion of a porous PTFE tube along its longitudinal axis and coating at least the outer wall of the compressed portion of the PTFE tube with a biocompatible elastomer for allowing the compressed portion of the tube to be stretched along the longitudinal axis. The PTFE tube is compressed by pulling the tube over a cylindrical mandrel of like diameter and applying a compression force to the tube along its longitudinal axis. The compressed portion(s) is (are) secured against movement upon the mandrel, and a coating of liquified polyurethane or other biocompatible elastomer is then applied over at least the compressed portion(s) of the tube. The elastomeric coating may be applied by dip coating or spray coating techniques. After the elastomeric coating has dried, the completed graft is removed from the mandrel.

Longitudinally compliant vascular graft

A vascular access fistula includes a smooth, continuous PTFE tube having a hard sintered tube section integrally joined at its opposing ends with expanded PTFE tube sections. Inlet and outlet access port holes are formed in the hard sintered tube section to provide acute access to the fistula. A port collar surrounds the hard sintered tube section to facilitate the attachment of dual lumen tubing thereto. Following implantation of the access fistula, the dual lumen tubing temporarily extends through the skin to provide acute access while the access fistula heals. The port collar houses a slide valve which selectively couples the inlet and outlet access port holes to the dual lumen tubing for acute access. After the access fistula has healed, the slide valve is closed, the dual lumen tubing is cut off from the port collar, and chronic vascular access is provided by percutaneous cannulation of the implanted PTFE tube.

Growing community of inventors

Phoenix, AZ, United States of America

William M Colone