Encapsulated intraluminal stent-graft and methods of making same

• US 6,451,047 B2
• Filed: 04/09/1997
• Issued: 09/17/2002
• Est. Priority Date: 03/10/1995
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: McCrea, Brendan J., Banas, Christopher E., Edwin, Tarun J.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/833,797
• Publication Number:
  US 20010039446A1
• Time in Patent Office: 1,987 Days
• Field of Search: 623/1, 623/12, 623/1.13, 623/1.27, 623/1.44, 623/230.7, 623/23.71, 606/191, 606/194, 606/195, 606/198, 606/108
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: B29C 55/005 characterised by the choice of materials
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Claims

1. An endoluminal prosthesis comprising:

a self-expanding stent, characterized by having substantially the same longitudinal length in a radially contracted and expanded state;

a seamless expanded polytetrafluoroethylene covering, exhibiting a node and fibril microstructure with fibrils oriented in a generally uniaxial direction, the covering comprising extruded luminal and abluminal tubular layers of expanded polytetrafluoroethylene intimately joined to one another through the walls of the stent; and

an interlayer member disposed between the abluminal tubular layer of expanded polytetrafluoroethylene and the stent, comprising a pair of unsintered expanded polytetrafluoroethylene rings;

wherein the prosthesis has a contracted first diametrical dimension and an expanded second diametrical dimension, the prosthesis being adapted to expand from the first diametrical dimension to the second diametrical dimension without plastically deforming the expanded polytetrafluoroethylene covering.

2. The endoluminal prosthesis according to claim 1, wherein the endoluminal stent is comprised of shape memory material.

3. The endoluminal prosthesis according to claim 2, wherein the shape memory material further comprises a nickel-titanium alloy.

4. The endoluminal prosthesis according to claim 1, wherein the endoluminal stent is comprised of a material with elastic spring tension.

5. The endoluminal prosthesis according to claim 1, wherein at least one of the extruded luminal and abluminal tubular layers of expanded polytetrafluoroethylene is unsintered.

6. The endoluminal prosthesis according to claim 1, wherein said pair of rings are disposed at each of the opposing ends of the stent.

7. The endoluminal prosthesis according to claim 6, wherein the expanded polytetrafluoroethylene rings have a node-fibril microstructure, the fibrils oriented in a generally uniaxial direction.