Implantable graft and methods of making same

• US 7,704,274 B2
• Filed: 09/26/2003
• Issued: 04/27/2010
• 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
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Prone; Christopher D
• Application Number:
  US10/672,695
• Publication Number:
  US 20040098094A1
• Time in Patent Office: 2,405 Days
• Field of Search: 623/1.13
• US Class Current: 623/1.13
• 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 covering having 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 endoluminal graft, comprising:

(a) a microporous metal thin film covering having a pattern of microporous openings passing therethrough;

(b) a metal structural support element having at least one affixation member, a pattern of openings passing through the metal structural support element and underlying the microporous metal thin film covering comprised of a metallic material; and

(c) wherein the metal structural support element is attached to the microporous metal thin film covering only at the at least one affixation member.

2. The implantable endoluminal graft of claim 1, wherein the affixation member is positioned near either a proximal end or distal end of the microporous metal thin film covering and a corresponding end of the metal structural support element.

3. The implantable endoluminal graft of claim 1, wherein the affixation member is near a distal end of the microporous metal thin film covering and metal structural support element.

4. The implantable endoluminal graft according to claim 1, wherein the at least one affixation member is positioned near a terminal end of the metal structural support element.

5. The implantable endoluminal graft of claim 4, wherein the microporous metal thin film covering is attached to the at least one affixation member.

6. The implantable endoluminal graft according to claim 4, wherein the metal structural support element further comprises a plurality of cylindrical elements and interconnecting elements, the cylindrical elements adopting a sinusoidal pattern with alternating peaks and valleys and the at least one affixation member extends longitudinally from at least one of a peak or a valley at a terminal end of the metal structural support element.

7. The implantable endoluminal graft of claim 6, wherein the microporous metal thin film covering exhibits a uniform pattern of openings throughout the surface of the microporous metal thin film covering.

8. The implantable endoluminal graft of claim 7, wherein the microporous metal thin film covering and the metal structural support element are fabricated from nitinol.

9. The implantable endoluminal graft of claim 8, wherein the microporous metal thin film covering maintains a martensite crystalline structure throughout a temperature transition from room temperature to body temperature and behaves martensitically in vivo.

10. The implantable endoluminal graft of claim 8, wherein the metal structural support element undergoes a martensite to austenite phase transition, during a temperature transition from room temperature to body temperature and behaves austenitically in vivo.

11. The implantable endoluminal graft of claim 8, further comprising a microporous metal thin film covering that maintains an austenite crystalline structure throughout a temperature transition from room temperature to body temperature and behaves austenitically in vivo.

12. The implantable endoluminal graft of claim 8, further comprising a microporous metal thin film covering that undergoes a phase transition, from martensite to austenite crystal structure, during a temperature transition from room temperature to body temperature and behaves austenitically in vivo.

13. The implantable endoluminal graft of claim 1, wherein the metal structural support element has a sinusoidal pattern with alternating peaks and valleys.

14. The implantable endoluminal graft of claim 1, wherein the at least one affixation member comprises a projection projecting proximally or distally from a cylindrical element at a terminal end of the structural support member.

15. An implantable endoluminal graft, comprising:

(a) a microporous metal thin film covering comprised of a shape memory alloy having an austenite phase transition start temperature greater than 37°

C. and the microporous metal thin film covering having a pattern of microporous openings passing therethrough; and

(b) a structural support element underlying the microporous covering comprised of at least a pair of cylindrical elements and interconnecting members joining adjacent cylindrical elements, the structural support element further comprised of a shape memory alloy having an austenite phase transition start temperature less than 0°

C.;

(c) the structural support element being attached to the microporous metal thin film covering at least one point of attachment including an at least one affixation member between the microporous metal thin film covering and the structural support element.

16. The implantable endoluminal graft of claim 15, wherein the shape memory alloy is nitinol.

17. The implantable endoluminal graft of claim 15, wherein the microporous metal thin film covering maintains a martensite crystalline structure throughout the temperature transition from room temperature to body temperature.

18. The implantable endoluminal graft of claim 15, further comprising a structural support member that undergoes a phase transition, from martensite to austenite crystal structure, during the temperature transition from room temperature to body temperature.

19. The implantable endoluminal graft of claim 15, wherein the at least one affixation member is located at either near a proximal end or distal end of the microporous metal thin film covering and corresponding end of the structural support element.

20. The implantable endoluminal graft of claim 15, wherein the at least one affixation member is located at near a distal end of the microporous metal thin film covering and structural support element.

21. The implantable endoluminal graft of claim 15, wherein the cylindrical elements adopt a sinusoidal pattern with alternating peaks and valleys.

22. The implantable endoluminal graft of claim 15, wherein the pattern of microporous openings exhibits a uniform pattern of openings throughout the surface of the microporous metal thin film covering.

23. The implantable endoluminal graft of claim 15, wherein the at least one affixation member is on a terminal end of a terminal interconnecting member.

24. An implantable endoluminal graft, comprising:

a. a microporous metal thin film covering comprised of nitinol; and

b. a structural support element underlying the microporous covering comprised of at least a pair of undulating cylindrical elements having a plurality of peaks and valleys and interconnecting members joining adjacent cylindrical elements at either the peaks or the valleys and having at least one projection extending longitudinally from a terminal cylindrical element, the structural support element being comprised of nitinol,

c. the structural support element being joined to the microporous metal thin film covering at the at least one projection.

25. The implantable endoluminal graft of claim 24, wherein the microporous metal thin film covering maintains a martensite crystalline structure throughout the temperature transition from room temperature to body temperature.

26. The implantable endoluminal graft of claim 24, wherein the structural support member that undergoes a phase transition, from martensite to austenite crystal structure, during the temperature transition from room temperature to body temperature.

27. The implantable endoluminal graft of claim 24, further comprising a microporous metal thin film covering that maintains an austenite crystalline structure throughout a temperature transition from room temperature to body temperature and behaves austenitically in vivo.

28. The implantable endoluminal graft of claim 24, further comprising a microporous metal thin film covering that undergoes a phase transition, from martensite to austenite crystal structure, during a temperature transition from room temperature to body temperature and behaves austenitically in vivo.

29. The implantable endoluminal graft of claim 24, wherein the microporous metal thin film covering exhibits a regular pattern of openings throughout a surface of the microporous metal thin film covering.

30. The implantable endoluminal graft of claim 29, wherein the regular pattern of openings further comprises a plurality of elongate slots arrayed in circumferentially adjacent and longitudinally offset rows, each of the plurality of elongate slots being parallel to a longitudinal axis of the endoluminal graft and capable of opening under the influence of a circumferentially expansive force.