Diametrically adaptable encapsulated stent and methods for deployment thereof

• US 6,758,858 B2
• Filed: 10/24/2001
• Issued: 07/06/2004
• Est. Priority Date: 03/10/1995
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: McCrea, Brendan J., Edwin, Tarun J., Banas, Christopher E.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US10/000,583
• Publication Number:
  US 20020038143A1
• Time in Patent Office: 986 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 606/108, 623/1.13, 623/1.27, 623/23.7, 623/23.71, 623/1.11
• 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 polytetrafluorethylene (“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 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, having an essentially tubular configuration with a central longitudinal lumen, wherein the stent has a luminal surface and an abluminal surface; and

a first seamless tube comprised of expanded polytetrafluoroethylene, covering at least a portion of the luminal surface, and a second seamless tube comprised of expanded polytetrafluoroethylene layer, covering at least a portion of the abluminal surface, wherein the stent is encapsulated between said first and second tubes;

wherein the encapsulated stent has a reduced first diametric dimension and an expanded second diametric dimension, and wherein the encapsulated stent is adapted to be enlarged to a third diametric dimension;

wherein the expanded polytetrafluoroethylene is plastically deformed between the second and third diametric dimensions.

2. The endoluminal prosthesis according to claim 1, wherein resiliency of the stent enables the prosthesis to expand to the second diametric dimension.

3. The endoluminal prosthesis according to claim 1, wherein pressure applied to a luminal surface of the prosthesis enables the prosthesis to expand to the third diametric dimension.

4. The endoluminal prosthesis according to claim 1, wherein the self-expanding stent is comprised of a shape-memory alloy.

5. The endoluminal prosthesis according to claim 1, wherein the expanded polytetrafluoroethylene layer has a node-fibril microstructure, the fibrils having a parallel orientation with respect to the central longitudinal lumen of the stent.

6. The endoluminal prosthesis according to claim 1, further comprising an interlayer member disposed between the abluminal layer of the stent and the expanded polytetrafluoroethylene covering.

7. The endoluminal prosthesis according to claim 6, wherein the interlayer member comprises a pair of unsintered expanded polytetrafluoroethylene rings.

8. The endoluminal prosthesis according to claim 7, wherein the rings are disposed at each of the opposing ends of the stent.

9. The endoluminal prosthesis according to claim 7, wherein the expand polytetrafluoroethylene rings have a node-fibril microstructure, the fibrils having a parallel orientation with respect to the central longitudinal lumen of the stent.

10. A method for deploying the endoluminal prosthesis of claim 1, wherein a constraint maintains the prosthesis in the reduced first diametric dimension for endoluminal delivery, comprising the steps of:

delivering the endoluminal prosthesis to a predetermined site within a body lumen;

removing the constraint from the prosthesis at the predetermined site, enabling the prosthesis to expand to the second diametric dimension; and

applying pressure to the prosthesis, wherein the prosthesis is enlarged to the third diametric dimension.

11. The endoluminal prosthesis according to claim 2, wherein resiliency of the stent is due to the elastic behavior thereof.

12. The endoluminal prosthesis according to claim 2, wherein resiliency of the stent is due to the temperature induced martensitic behavior thereof.

13. The endoluminal prosthesis according to claim 2, wherein resiliency of the stent is due to the stress-induced martensitic behavior thereof.