Edwards Lifesciences Corporation

Baxter International Inc.

Other

Chris Kuo

Donald T Shannon

John James McIntyre

Robert C Peterson

Chris McCollam

Benny Tu

Yizi Chu

Ronald L Clinkenbeard

Mike Randall

Edwin Wang

Roger H Tu

Cary Hata

Benita Tu

Don Shannon

Robert Peterson

John Mcintyre

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

A tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. The graft includes a base graft and a reinforcing tape applied thereto. The tape may be spirally wrapped about the graft or spirally wrapped into a tube about a cylindrical mandrel and then applied to the exterior of the graft. Radial shrinkage of the combined base graft and tape, or of the reinforcing tape tube, renders the vascular graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel. Alternatively, radially enlargeable grafts of the present invention may be implanted by way of traditional surgical graft implantation techniques, without any radial enlargement of the graft at the time of implantation, so as to take advantage of the improved strength properties and suture-holding properties of the radially-shrunken tape-reinforced grafts of the present invention.

Radially-expandable PTFE tape-reinforced vascular grafts

An improved inflow conduit for an implantable ventricular assist device comprising covering the flexible porous tubular graft body of the conduit with an attached non-porous polymer to produce a non-porous conduit. The flexible conduit has an upstream end and a downstream end, a ventricular attachment structure to which the upstream end of the body connects; and a coupling fitting on the downstream end of the body. Also taught is a combination of the improved inflow conduit with an implantable ventricular assist device. A method for the treatment of congestive heart failure, comprising implanting the implantable ventricular assist device in a patient in need of such treatment, as well as an article of manufacture, comprising packaging material and the implantable ventricular assist device contained within the packaging material are also provided.

Non-porous smooth ventricular assist device conduit

A tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. The graft includes a base graft and a reinforcing tape applied thereto. The tape may be spirally wrapped about the graft or spirally wrapped into a tube about a cylindrical mandrel and then applied to the exterior of The graft. Radial shrinkage of the combined base graft and tape, or of the reinforcing tape tube, renders the vascular graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel. Alternatively, radially enlargeable grafts of the present invention may be implanted by way of traditional surgical graft implantation techniques, without any radial enlargement of the graft at the time of implantation, so as to take advantage of the improved strength properties and suture-holding properties of the radially-shrunken tape-reinforced grafts of the present invention.

Radially expandable tape-reinforced vascular 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.

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.

Laminated self-sealing vascular access graft

A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel. Alternatively, radially enlargeable grafts of the present invention may be implanted by way of traditional surgical graft implantation techniques, without any radial enlargement of the graft at the time of implantation, so as to take advantage of the improved strength properties and suture-holding properties of the radially-shrunken tape-reinforced grafts of the present invention.

Process of manufacturing a radially expandable PTFE tape-reinforced vascular graft

Porous fluoropolymer films, such as PTFE films, formed by a method including the steps of (a) forming a fluoropolymer (e.g., PTFE) paste, (b) extruding, calendaring, or otherwise processing the paste to form a film extrudate, (c) causing the film extrudate to be calendared in a first directional axis, (d) subsequently calendaring the film extrudate in a second directional axis which is different from the first directional axis, (e) subsequently calendaring the film extrudate in at least one additional directional axis which is different from said first and second directional axes, thereby forming a multiaxially calendared film extrudate, (f) drying the multiaxially calendared film extrudate, and (g) radially expanding the multiaxially calendared film extrudate to form a radially oriented fluoropolymer (e.g., PTFE) film. The porous fluoropolymer films formed by this method are multiaxially oriented and exhibit isotropic strength properties.

Methods of manufacture of multiaxially oriented fluoropolymer films

An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.

Method of forming an externally supported tape reinforced vascular graft

Radially-enlargeable PTFE tape-reinforced vascular grafts and their

Method of manufacturing a radially-enlargeable PTFE tape-reinforced

A method for preparing thin fluoropolymer (PTFE) films, said method generally having the steps of: a) providing an unsintered fluoropolymer film; b) pre-sintering expansion of the film; c) sintering the expanded film with dimensional restraint to prevent shrinkage; and d) post-sintering stretching of the film to a final thickness preferably less than 0.002 inches. The post-sintering stretching of the film in step d may be accomplished in a single step, or may include a series of post-sintering stretching steps. Steps b and c of the method may be carried out bypassing the calendared film through a machine direction orienter device and, thereafter, step d of the method may be accomplished by subsequently repassing the sintered film through the machine direction orienter device, one or more additional times.

Growing community of inventors

Orange, CA, United States of America

Chris Kuo