US 5,928,279 AGranted

Stented, radially expandable, tubular PTFE grafts

AssigneeBaxter International Inc.

InventorsDonald T. Shannon, Chris Kuo, John McIntyre, Ronald L. Clinkenbeard, Yizi Chu, Benny Tu

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Abstract

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.

Claims45

Dependent claims

A tubular stented graft which is alternately deployable in a radially compact configuration having a first diameter and a radially expanded configuration having a second diameter, said stented graft comprising:

a) a stent comprising:
i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;
ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft;
and,
iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;
b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising:
i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft;
and,
ii) a tubular outer layer formed of expanded, sintered PTFE tape which has a width of less than about 1 inch, said tape having been wound about the outer surface of said stent to create said tubular outer layer thereon, such that said stent is captured between said outer layer and said tubular base graft;
said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

7 more elements

a) a stent comprising:
i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;
ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft;
and,
iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;
b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising:
i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft;
and,
ii) a tubular outer layer formed of expanded, sintered PTFE tape which has a thickness of less than 0.015 inches, said tape being wrapped about the outer surface of said stent in overlapping fashion so as to form said tubular outer layer, such that said stent is captured between said outer layer and said tubular base graft;
c) said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

7 more elements

a) a stent comprising:
i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;
ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft;
and,
iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;
b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising:
i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft;
and,
ii) a tubular outer layer formed of expanded, sintered PTFE, said outer layer being disposed about the outer surface of said stent such that said stent is captured between said outer layer and said tubular base graft;
and,
c) polymer particles deposited between said inner base graft and said outer tubular later and subsequently melted to promote attachment of said tubular base graft to said tubular outer layer;
said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

9 more elements

a) a stent formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface, the stent having an initially radially collapsed state with a diameter which is substantially equal to said first diameter, and a radially expanded state with a diameter which is substantially equal to said second diameter, and wherein a plurality of lateral openings are formed in said stent in its radially expanded state;
b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising:
i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft;
and,
ii) a tubular outer layer formed of expanded, sintered PTFE, said outer layer being disposed about the outer surface of said stent such that said stent is captured between said outer layer and said tubular base graft;
and,
c) PTFE particles deposited between said inner base graft and said outer tubular later and subsequently melted to promote attachment of said tubular base graft to said tubular outer layer;
said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

5 more elements

Dependencies are inferred from the claim text.