Diametrically adaptable encapsulated stent and methods for deployment thereof

• US 7,468,071 B2
• Filed: 06/21/2004
• Issued: 12/23/2008
• Est. Priority Date: 03/10/1995
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Banas, Christopher E., Edwin, Tarun J., McCrea, Brendan
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/873,085
• Publication Number:
  US 20040236400A1
• Time in Patent Office: 1,646 Days
• Field of Search: 623/1.13, 623/1.27, 623/23.7, 623/23.71, 623/1.11, 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

An implantable intraluminal device having a self-expanding stent encapsulated between a first and second seamless ePTFE tube. The implantable intraluminal device has a reduced first diametric dimension and an expanded second diametric dimension, and is adapted to be modeled to the in vivo profile of a receiving anatomical structure through radial expansion of at least a portion thereof to a third diametric dimension greater than the second diametric dimension.

Claims

1. An implantable intraluminal device, comprising a self-expanding stent encapsulated between a first seamless ePTFE tube and a second seamless ePTFE tube, at least one of the tubes being unsintered, an interlayer member comprising a pair of unsintered ePTFE rings disposed between an abluminal surface of the stent and the second ePTFE tube, the implantable intraluminal device having a reduced first diametric dimension and an expanded second diametric dimension, the implantable intraluminal device adapted to be modeled to the in vivo profile of a receiving anatomical structure through radial expansion of at least a portion thereof to a third diametric dimension greater than the second diametric dimension.

2. The implantable intraluminal device according to claim 1, wherein at least a portion of the first and second ePTFE tubes are plastically deformable between the second and third diametric dimensions.

3. The implantable intraluminal device according to claim 1, wherein the first and second ePTFE tubes, characterized by a node-fibril microstructure, contain fibrils having a parallel orientation with respect to a longitudinal axis of the implantable intraluminal device.

4. The implantable intraluminal device according to claim 1, wherein resiliency of the self-expanding stent enables the device to expand to the second diametric dimension.

5. The implantable intraluminal device according to claim 4, wherein resiliency of the self-expanding stent is due to the elastic behavior thereof.

6. The implantable intraluminal device according to claim 4, wherein resiliency of the self-expanding stent is due to the temperature induced martensitic behavior thereof.

7. The implantable intraluminal device according to claim 4, wherein resiliency of the self-expanding stent is due to the stress-induced martensitic behavior thereof.

8. The implantable intraluminal device according to claim 1, wherein pressure applied to a luminal surface of the first ePTFE tube enables the device to expand to the second diametric dimension.

9. The implantable intraluminal device according to claim 1, wherein the pair of ePTFE rings are disposed at each of the opposing ends of the self-expanding stent.

10. The implantable intraluminal device according to claim 9, wherein the pair of ePTFE rings have a node-fibril microstructure, the fibrils having a parallel orientation with respect to a longitudinal axis of the implantable intraluminal device.

11. A method for deploying the implantable intraluminal device of claim 1, wherein the self-expanding stent is encapsulated between the first and second ePTFE tubes at the first diametric dimension, preventing the stent from expanding to the second diametric dimension, comprising the steps of:

delivering the implantable intraluminal device to a predetermined site within a body lumen;

applying a first pressure to the implantable intraluminal device at the predetermined site, wherein the implantable intraluminal device is enabled to expand to the second diametric dimension; and

applying a second pressure to at least a portion of the implantable intraluminal device following expansion thereof to the second diametric dimension, wherein at least a portion of the implantable intraluminal device is enlarged to the third diametric dimension.

12. A method for deploying the implantable intraluminal device of claim 1, wherein an outside constraint maintains the implantable intraluminal device in the reduced first diametric dimension, comprising the steps of:

delivering the implantable intraluminal device to a predetermined site within a body lumen;

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

applying pressure to the implantable intraluminal device, wherein at least a portion of the implantable intraluminal device is enlarged to the third diametric dimension.

13. The implantable intraluminal device according to claim 1, wherein both of the first and second ePTFE tubes are unsintered.