IMPLANTABLE GRAFT AND METHODS OF MAKING SAME

• US 20180010230A1
• Filed: 02/01/2016
• Published: 01/11/2018
• Est. Priority Date: 09/26/2002
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: BOYLE, Christopher T., BANAS, Christopher E., MARTON, Denes
• Granted Patent: US 10,465,274 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0042 differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C23C 14/0005 Separation of the coating from the substrate
• CPC Class Codes: C23C 14/165 by cathodic sputtering

Abstract

The present invention relates to an implantable endoluminal graft comprised of a microporous thin-film metal covering having a plurality of openings and a structural support element underlying and physically attached to the microporous thin-film metal covering, the microporous thin-film metal covering having shape memory properties.

Claims

1. An endoluminal covered-stent, comprising:

a) a radially expandable stent having a proximal end, a distal end and an intermediate region, the radially expandable stent being comprised of a plurality of interconnected structural members defining a generally tubular stent member having a plurality of stent fenestrations and a plurality of attachment members associated with some of the plurality of interconnected structure members at one or more of the proximal end, distal end and intermediate region of the stent; and

b) a generally tubular thin film metal cover member having a plurality of microporous openings, wherein each of the plurality of microporous openings has an open surface area less than an open surface area of each of the plurality of stent fenestrations, the generally tubular thin film metal cover member is concentrically joined to at least one of a luminal surface or an abluminal surface of the stent and coupled to the stent only at the plurality of attachment members, such that the generally tubular thin film metal cover member at least partially occludes the plurality of stent fenestrations,

c) wherein the joined radially expandable stent and the generally tubular thin film metal cover member are capable of radial expansion together with one another.

2. The endoluminal covered-stent of claim 1, wherein the radially expandable stent and the generally tubular thin film metal cover member have compatible degrees of foreshortening upon radial expansion of the stent and generally tubular thin film metal cover.

3. The endoluminal covered-stent of claim 1, wherein the generally tubular thin film cover has a thickness between about 0.1μ

to about 20μ

.

4. The endoluminal covered-stent of claim 1, wherein the stent and the generally tubular thin film metal cover are each composed of at least one material selected from the group consisting of:

titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nickel-titanium alloys, cobalt-chromium alloys and stainless steel.

5. The endoluminal covered-stent of claim 3, wherein the generally tubular thin film metal cover is coupled to the plurality of attachment members by thermal welds.

6. The endoluminal covered-stent of claim 5, wherein the thermal welds are passivated.

7. The endoluminal covered-stent of claim 3, wherein the generally tubular thin film metal cover metal cover has a transition temperature between about 60 and about 100 degrees Centigrade.

8. The endoluminal covered-stent of claim 1, wherein the stent has a transition temperature less than body temperature.

9. The endoluminal covered-stent of claim 1, wherein the plurality of microporous openings in the generally tubular thin film metal cover further comprising at least one circumferential region of microporous openings configured to allow longitudinal expansion and compression of the at least one circumferential region of microporous openings during longitudinal flexing of the generally tubular thin film metal cover.

10. The endoluminal covered-stent of claim 1, wherein the plurality of microporous openings further comprise microporous openings configured to allow for diametric expansion of the generally tubular thin film metal cover.

11. The endoluminal covered-stent of claim 9, wherein the plurality of microporous openings further comprise microporous openings configured to allow for diametric expansion of the generally tubular thin film metal cover.

12. The endoluminal covered-stent of claim 1, wherein the plurality of microporous openings are arranged in a regular pattern in the generally tubular thin film metal cover.

13. The endoluminal covered-stent of claim 1, wherein the plurality of microporous openings are arranged in an irregular pattern in the generally tubular thin film metal cover.

14. The endoluminal covered-stent of claim 1 further comprising an outer diameter catheter sheath, a pusher member, a guidewire shaft, and an atraumatic tip, wherein the endoluminal covered-stent is partially contained within the catheter sheath, the atraumatic tip is affixed to the distal end of the guidewire shaft, and the atraumatic tip abuts with the distal end of the catheter sheath thereby enclosing the endoluminal covered-stent within the catheter sheath.

16. The endoluminal covered-stent of claim 14, wherein the stent and the metal cover have compatible degrees of foreshortening upon radial expansion of the joined covered-stent.

17. The endoluminal medical device of claim 14, wherein the stent and the metal cover member are each formed of at least one material selected from the group consisting of:

titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nickel-titanium alloys, cobalt-chromium alloys and stainless steel.

18. The endoluminal covered-stent of claim 16, wherein the first join and said second join further comprise welds.

19. The endoluminal covered-stent of claim 14, wherein the plurality of openings are arranged in a non-regular pattern.

20. The endoluminal covered-stent of claim 14, wherein the proximal and distal junction points include a substantially planar surface area including a curvature along the y-axis.

21. The endoluminal covered-stent of claim 14, wherein the at least one enlarged proximal member and the at least one enlarged distal member include a generally quadrilateral shape in the X-Y axis of the luminal surface of the stent cover.

15. An endoluminal covered-stent, comprising:

a) a radially expandable stent having a plurality of circumferential structural members longitudinally interconnected by a plurality of interconnecting members and a plurality of stent fenestrations bounded by circumferential structural members and interconnecting members, and a plurality of attachment members coupled to at least one of the plurality of circumferential structural members or at least one of the plurality of interconnecting members; and

b) a radially expandable tubular thin film metal cover member having a plurality of openings passing through wall surfaces thereof, wherein each of the plurality of openings has an open surface area less than an open surface area of each of the plurality of stent fenestrations, the tubular thin film cover member being positioned to cover at least one of a luminal surface or an abluminal surface of the stent such that the generally tubular metal cover member at least partially occludes the plurality of stent fenestrations and wherein the generally tubular thin film metal cover member is thermally joined only to at least some of the plurality of attachment members.