Implantable graft and methods of making same

• US 9,284,637 B2
• Filed: 01/12/2010
• Issued: 03/15/2016
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Boyle, Christopher T., Marton, Denes, Banas, Christopher E.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US12/686,350
• Publication Number:
  US 20100217373A1
• Time in Patent Office: 2,254 Days
• Field of Search: 623/1.18, 623/1.11, 623 115- 116, 623 13- 131, 623 134- 136
• US Class Current: 1/1
• 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 having a microporous thin-film covering with a plurality of openings and a structural support element underlying and physically attached to the microporous thin-film covering, the microporous thin-film covering having shape memory properties.

Claims

1. An implantable covered-stent, comprising:

a) a stent including a plurality of cylindrical elements and a plurality of strut members, each fixedly attached to at least one of the plurality of cylindrical elements, wherein at least one of the plurality of strut members is fixedly attached to and interconnects two adjacent cylindrical elements, the stent having a proximal end having at least one enlarged proximal member projecting beyond the proximal end from a first strut member of the plurality of strut members, a distal end having at least one enlarged distal member projecting beyond the distal end from a second strut member of the plurality of strut members, and at least one fenestration disposed between the at least one enlarged proximal member and the at least one enlarged distal member; and

b) a metal cover member having a proximal end region, a distal end region, wall surfaces and a plurality of micro-openings passing through the wall surfaces and having an open surface area within the range of 0.5 μ

m to 150 μ

m, wherein each of the plurality of micro-openings has an open surface area less than an open surface area of the at least one fenestration, and wherein the proximal end region of said metal cover is fixedly attached by a first thermal method in a first join to the at least one enlarged proximal member, and the distal end region of the metal cover is fixedly attached by a second thermal method in a second join to the at least one enlarged distal member, wherein said metal cover is fixedly attached to the stent only at the enlarged members, wherein the stent and the metal cover member are formed of the same biocompatible metal, and wherein the metal cover at least partially occludes the at least one fenestration to form the implantable covered-stent.

2. The implantable covered-stent of claim 1, wherein the stent and the metal cover have compatible degrees of foreshortening.

3. The implantable covered-stent of claim 1, wherein said stent and said metal cover are each composed of at least one biocompatible metal 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.

4. The implantable covered-stent of claim 3, wherein the first join and said second join further comprise welds.

5. The implantable covered-stent of claim 4, wherein the welds are passivated.

6. The implantable covered-stent of claim 3, wherein the metal cover has a transition temperature between about 60 and about 100 degrees Centigrade.

7. The implantable covered-stent of claim 6, wherein the proximal and distal ends of the stent flare at room temperature.

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

9. The implantable covered-stent of claim 1 adapted to be used with a catheter and guidewire comprising a constant outer diameter catheter sheath and a guidewire sheath.

10. The implantable covered-stent of claim 1 adapted to be used with a catheter and guidewire comprising a tapered catheter sheath and a guidewire sheath.

11. The implantable covered-stent of claim 1 adapted to be used with a catheter and guidewire comprising an outer diameter catheter sheath, a pusher member, a guidewire shaft, and an atraumatic tip, wherein the implantable covered-stent is partially contained within the catheter sheath, the guidewire shaft is co-axially coupled through the central lumen of the pusher member and the central lumen of the implantable covered-stent to the atraumatic tip, 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 implantable covered-stent within the catheter sheath.

12. The implantable covered-stent of claim 1, wherein the proximal and distal ends include at least two junction points connecting the at least one enlarged proximal member and the at least one enlarged distal member, wherein the junction points include a substantially planar surface area including a curvature along a y-axis.

13. The implantable covered-stent of claim 1, wherein at least a portion of the at least one enlarged proximal member and the at least one enlarged distal member includes a generally rounded shape in an X-Y axis of a luminal surface of the metal cover.

14. An implantable covered-stent, comprising:

a) a stent including a plurality of cylindrical elements and a plurality of strut members, each fixedly attached to at least one of the plurality of cylindrical elements, wherein at least one of the plurality of strut members is fixedly attached to and interconnects two adjacent cylindrical members, the stent having a proximal end having at least one enlarged proximal member projecting beyond the proximal end from a first strut member of the plurality of strut members, a distal end having at least one enlarged distal member projecting beyond the distal end from a second strut member of the plurality of strut members, and at least one fenestration disposed between the at least one enlarged proximal member and the at least one enlarged distal member; and

b) a cover member having a proximal end region, a distal end region, wall surfaces and a plurality of micro-openings passing through the wall surfaces and having an open surface area within the range of 0.5 μ

m 150 μ

m, wherein each of the plurality of micro-openings has an open surface area less than an open surface area of the at least one fenestration, and wherein the proximal end region of said cover is fixedly attached by a first thermal method including a first interlayer material in a first join to the at least one enlarged proximal member, and the distal end region of the cover is fixedly attached by a second thermal method including a second interlayer material in a second join to the at least one enlarged distal member, wherein said cover is fixedly attached to the stent only at the enlarged members, wherein the stent and the cover member are formed of dissimilar materials, and wherein the cover at least partially occludes the at least one fenestration to form the implantable covered-stent.

15. The implantable covered-stent of claim 14, wherein the stent and the cover have compatible degrees of foreshortening.

16. The implantable medical device of claim 14, wherein the stent and the 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.

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

18. The implantable covered-stent of claim 14, wherein the proximal and distal ends include at least two junction points connecting the at least one enlarged proximal member and the at least one enlarged distal member, wherein the junction points include a substantially planar surface area including a curvature along a y-axis.

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

20. The implantable covered-stent of claim 14, wherein the cover member is formed of a material selected from the group consisting of:

pseudometallic materials, composite materials, ceramics, quartz, borosilicate, and matrix materials reinforced with fibers made from ceramics, metals, or polymers.