Endoluminal implantable stent-grafts

• US 7,641,680 B2
• Filed: 11/06/2002
• Issued: 01/05/2010
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Palmaz, Julio C., Wiseman, Roger W., Marton, Denes, Boyle, Christopher T.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/289,843
• Publication Number:
  US 20030130718A1
• Time in Patent Office: 2,617 Days
• Field of Search: 623/1.13, 623/1.18, 623/1.19, 623/1.32, 623/1.44, 623/1.46, 606/191, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/3679 Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
• 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 31/022 Metals or alloys
• CPC Class Codes: Y10T 29/49936 Surface interlocking

Abstract

An implantable endoluminal device that is fabricated from materials that present a blood or body fluid and tissue contact surface that has controlled heterogeneities in material constitution. An endoluminal stent-graft and web-stent that is made of an monolithic material deposited into a monolayer and etched into regions of structural members and web regions subtending interstitial regions between the structural members. An endoluminal graft is also provided which is made of a biocompatible metal or metal-like material. The endoluminal stent-graft is characterized by having controlled heterogeneities in the stent material along the blood flow surface of the stent and the method of fabricating the stent using vacuum deposition methods.

Claims

1. An implantable medical device for supporting an anatomical passageway, comprising a stent cover member and a stent member, wherein the stent cover member comprises a generally tubular biocompatible metallic stent cover member having a plurality of patterned microporous openings, each passing transversely through walls of the generally tubular stent cover, having a first contracted diameter for delivery within the anatomical passageway and a second expanded diameter for contacting the anatomical passageway, the tubular stent cover being biased to its enlarged condition;

and the stent member comprises a plurality of structural members contacting a luminal surface of the generally tubular stent cover member, supporting the stent cover member in its second expanded diameter and defining interstitial regions of the stent cover member between adjacent pairs of structural members.

2. The implantable medical device according to claim 1, wherein the stent cover member is fabricated of a shape memory material biased to the second expanded diameter.

3. The implantable medical device according to claim 1, wherein the plurality of structural members are fabricated of a shape memory material biased to the second diameter.

4. The implantable medical device according to claim 1, wherein the stent cover member and the plurality of structural members are both fabricated from at least one of a metal or metal-like materials exhibiting at least one of shape memory and superelastic properties.

5. The implantable medical device according to claim 1, wherein the plurality of microporous openings each have maximum dimension sufficient to permit cellular migration therethrough without permitting fluid flow therethrough.

6. The implantable medical device according to claim 5, wherein each of the plurality of microporous openings have maximum dimension of about 19 μ

m.

7. The implantable medical device according to claim 1, wherein the plurality of structural members comprises struts.

8. The implantable medical device according to claim 1, wherein the stent cover member and the plurality of structural members are both fabricated of nitinol.

9. An implantable medical device for supporting an anatomical passageway, comprising a stent and a stent cover wherein the stent comprises a plurality of structural members, the plurality of structural members spaced apart from each other to form a plurality of interstices in between adjacent structural members;

and wherein the stent cover comprises a web member having a plurality of patterned microporous openings, each of the openings passing transversely and completely through the web member, the web member being positioned adjacent the plurality of interstices and supported by the adjacent structural members defining the plurality of interstices in the stent, wherein the implantable medical device has a first contracted diameter for delivery to the anatomical passageway and a second expanded diameter for contacting the anatomical passageway and is biased to the second expanded diameter.

10. The implantable medical device according to claim 9, wherein the plurality of structural members and the web member are fabricated of at least one of a metal or metal-like material exhibiting at least one of shape memory and superelastic properties.

11. The implantable medical device according to claim 10, wherein the plurality of structural members and the web member are fabricated of nitinol.

12. The implantable medical device according to claim 9, wherein the plurality of microporous openings each have a maximum dimension sufficient to permit cellular migration therethrough without permitting fluid flow therethrough.

13. The implantable medical device according to claim 12, wherein each of the plurality of microporous openings have a maximum dimension of about 19 μ

m.

14. A method of fabricating an implantable medical device for supporting a physiological vessel, comprising the steps of:

a. providing a film of biocompatible metal or metal-like material exhibiting at least one of shape memory and superelastic properties;

b. removing portions of the film to form a plurality of thin-film regions and a plurality of structural support regions for the thin-film regions; and

c. etching a plurality of patterned microporous openings passing transversely through, in the thin-film regions.

15. The method of fabricating an implantable medical device according to claim 14, wherein the tubular film is fabricated of nitinol.