# US 6,719,783 B2 · PTFE vascular graft and method of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,719,783 B2 - Document ID: US6719783B2 - Status: Granted - Kind: B2 - Application number: 10/212,609 - Filed: 2002-08-05 - Published: 2003-01-02 - Granted: 2004-04-13 - Earliest claimed: 1996-01-22 - Assignees: SciMed Life Systems, Inc. - Inventors: David Lentz; Jamie Henderson; Edward Dormier; Richard Zdrahala; Gary Loomis; Ronald Rakos; Krzysztof Sowinski - Web page: https://patentgrep.com/patent/US6719783B2 ## CPC - A61L 27/56: Porous materials, {e.g. foams or sponges} - A61F 2/06: Blood vessels - A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds - A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)} - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization, tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube. ## Claims ### Claim 1 A multi-layered ePTFE graft comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is selected from the group consisting of sheet, film, yarn, thread, mono-filament wrap, multi-filament wrap, tube, solvent-spun elastomeric fibers, helically-wound tape, and combinations thereof. ### Claim 2 (depends on 1) A multi-layered graft according to claim 1 wherein said first porosity is greater than said second porosity. ### Claim 3 (depends on 1) A multi-layered graft according to claim 1 wherein said self-sealing material is selected from the group consisting of thermoplastic elastomers, silicones, silicone rubbers, synthetic rubbers, polyurethanes, polyethers, polyesters, polyamides, fluoropolymers and combinations thereof. ### Claim 4 (depends on 1) A multi-layered graft according to claim 1 wherein said self-sealing material comprises a single layer having resealable properties. ### Claim 5 (depends on 1) A multi-layered graft according to claim 1 wherein said self-sealing material comprises an elastomeric polymer layer. ### Claim 6 (depends on 5) A multi-layered graft according to claim 5 wherein said self-sealing elastomeric polymer layer adheres to said first and second ePTFE tubular structures. ### Claim 7 (depends on 6) A multi-layered graft according to claim 6, wherein said adherence is by chemical means, mechanical means or a combination thereof. ### Claim 8 (depends on 5) A multi-layered graft according to claim 5 wherein said elastomeric polymer layer comprises an intemodal distance sufficient to promote cell endothelization and/or tissue ingrowth. ### Claim 9 (depends on 5) A multi-layered graft according to claim 5 wherein said elastomeric polymer layer comprises an internodal distance sufficient to promote enhanced strength and handling characteristics of the graft. ### Claim 10 (depends on 5) A multi-layered graft according to claim 5 wherein said elastomeric polymer layer is impregnated with a gel to enhance sealing properties thereof. ### Claim 11 (depends on 1) A multi-layered graft according to claim 1 wherein said solvent-spun elastomeric fibers form a woven or non-woven layer. ### Claim 12 (depends on 1) A multi-layered graft according to claim 1 wherein said solvent-spun elastomeric fibers have sufficient fiber density to form a sealing layer while allowing a puncturing member to penetrate between said solvent-spun elastomeric fibers. ### Claim 13 (depends on 1) A multi-layered graft according to claim 1 wherein said solvent-spun elastomeric fibers comprise solvent-spun polyurethane. ### Claim 14 (depends on 1) A multi-layered graft according to claim 1 wherein said self-sealing material is flowable. ### Claim 15 A multi-layered ePTFE graft comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material comprises multiple layers having resealable properties. ### Claim 16 A multi-layered ePTFE graft comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is augmented with a pre-sintered fluoropolymer bead wrap. ### Claim 17 A multi-layered ePTFE graft comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is augmented with a wire support coil. ### Claim 18 A multi-layered ePTFE graft comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is a self-sustained tubular structure. ### Claim 19 (depends on 18) A multi-layered graft according to claim 18 wherein said self-sustained tubular structure is a thermoplastic elastomer tube or a fluoropolymer tube. ### Claim 20 A multi-layered ePTFE vascular graft useful for repeated hemoaccess comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is selected from the group consisting of sheet, film, yarn, thread, mono-filament wrap, multi-filament wrap, tube, solvent-spun elastomeric fibers, helically-wound tape, and combinations thereof. ### Claim 21 (depends on 20) A multi-layered graft according to claim 20 wherein said first porosity is greater than said second porosity. ### Claim 22 A multi-layered ePTFE vascular graft useful for repeated hemoaccess comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is selected from the group consisting of thermoplastic elastomers, silicones, silicone rubbers, synthetic rubbers, polyurethanes, polyethers, polyesters, polyamides, fluoropolymers and combinations thereof. ### Claim 23 A multi-layered ePTFE vascular graft useful for repeated hemoaccess comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material is a self-sustained tubular structure. ### Claim 24 (depends on 23) A multi-layered graft according to claim 23 wherein said self-sealing material comprises a single layer having resealable properties. ### Claim 25 A multi-layered ePTFE vascular graft useful for repeated hemoaccess comprising: a first ePTFE tubular structure having a first porosity; a second ePTFE tubular structure having a different porosity than said first porosity, said second ePTFE tubular structure being disposed externally about said first ePTFE tubular structure; and a self-sealing material interposed between said first and second ePTFE tubular structures, wherein said self-sealing material comprises multiple layers having resealable properties.