Stents with metallic covers and methods of making same

• US 10,172,730 B2
• Filed: 09/15/2008
• Issued: 01/08/2019
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Vactronix Scientific, LLC
• Inventors: Banas, Christopher E.
• Primary Examiner(s): Louis, Richard
• Application Number:
  US12/210,789
• Publication Number:
  US 20090132022A1
• Time in Patent Office: 3,767 Days
• Field of Search: 623 113, 623 118, 623 119, 623 132, 623 115, 623 111, 623 116, 623 138- 149, 606191-198, 427 224, 427 225
• 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 2002/072 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

All metal stent grafts and covered stents having either a single structural supporting stent member with concentrically positioned graft members on the luminal and abluminal surfaces of the stent member or a single graft member with concentrically positioned structural supporting stent members on the luminal and abluminal surfaces of the graft member are provided.

Claims

1. A tubular medical device having an inner luminal surface and outer abluminal surface, comprising:

a) a structural support member having first and second wall surfaces thereof, the structural support member having at least one open space passing through the first and second wall surfaces, and being comprised of at least one of a metallic and pseudometallic laminate material; and

b) at least one tubular cover member consisting of a coherent laminate film of at least one of a metallic and pseudometallic material, the at least one tubular cover member being positioned adjacent against at least a portion of both the luminal and abluminal surfaces of the medical device and covering the at least one open space of the structural support member.

2. The tubular medical device according to claim 1, wherein the laminate is 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, chromium-cobalt alloy, zirconium-titanium-tantalum alloy, nickel-titanium alloy, and stainless steel.

3. The tubular medical device according to claim 1, wherein the at least one metallic and pseudometallic laminate further comprises a pseudometallic material selected from the group consisting of ceramic, quartz, borosilicate, carbon fibers, boron fibers, boron carbide fibers, carbon nanotubes, carbon and graphite fibers, silicon carbide fibers, steel fibers, tungsten fibers, graphite/copper fibers, titanium fibers, and silicon carbide/titanium fibers.

4. The tubular medical device according to claim 1, wherein the at least one tubular cover member further comprises a plurality of openings passing through the tubular cover member.

5. The tubular medical device according to claim 4, wherein each of the plurality of openings has a pore size between about 0.1 μ

m to about 1000 μ

m in either an x-axis or a y-axis of the opening.

6. The tubular medical device according to claim 4, wherein the plurality of openings form a total open surface area in the tubular cover member between about 0.001 to about 90% of the area of one of a first or a second surface of the tubular cover member.

7. The tubular medical device according to claim 1, wherein the at least one tubular cover member is coupled to at least one of a proximal and distal end of the structural support member.

8. The tubular medical device according to claim 1, wherein the at least one tubular cover member and a second tubular cover member are coupled to each other through the at least one open space of the structural support member.

9. The tubular medical device according to claim 1, further comprising at least one affixation junction between the at least one tubular cover member and the structural support member or the at least one tubular cover member.

10. The tubular medical device according to claim 9, wherein the at least one affixation junction is selected from the group consisting a chemical, mechanical and thermal affixation junction.

11. The tubular medical device according to claim 10, wherein the mechanical affixation junction further comprises an interference fit.

12. The tubular medical device according to claim 10, wherein the mechanical affixation junction further comprises an interfacing detent and trough.

13. The tubular medical device according to claim 7, wherein the at least one tubular cover member is coupled to the at least one of a proximal and distal end of the structural support member by at least one of a chemical, thermal or mechanical junction.

14. The tubular medical device according to claim 8, wherein the first and second tubular cover members are attached to one another by at least one of a chemical, thermal and mechanical junction.

15. The tubular medical device according to claim 8, wherein the open space is capable of geometric deformation about the attachment between the first and second tubular cover members.

16. The tubular medical device according to claim 1, further comprising a defined junction region on each of the structural support member and the at least one tubular cover member in alignment with one another and a junction formed therebetween.

17. A covered stent device, comprising:

a) a diametrically expandable stent having a luminal and an abluminal wall surface and a wall thickness therebetween, and at least one open space passing through the luminal and abluminal wall surfaces; and

b) at least one tubular cover member consisting of a thin metallic laminate film having a plurality of openings passing therethrough, and positioned concentrically adjacent to and covering an entire circumferential aspect of the diametrically expandable stent and covering the at least one open space of the diametrically expandable stent and the at least one tubular cover member being radially-expandable, wherein each of the plurality of openings are smaller than the at least one open space of the diametrically expandable stent.

18. The covered stent device, according to claim 17, wherein the thin metallic laminate film is 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, such as chromium-cobalt alloy, zirconium-titanium-tantalum alloys, nickel-titanium alloy, and stainless steel.

19. The covered stent device according to claim 17, wherein at least a portion of the at least one tubular cover member is concentrically carried adjacent each of the luminal and abluminal wall surfaces of the diametrically expandable stent, wherein the portion of the at least one tubular cover member adjacent the luminal wall surface is coupled to the portion of the at least one tubular cover member adjacent the abluminal wall surface through the at least one open space of the diametrically expandable stent in such a manner as to permit geometric deformation of the at least one open space.

20. The covered stent device according to claim 17, wherein the at least one tubular cover member is coupled to at least one of a proximal and a distal end of the diametrically expandable stent.

21. The covered stent device according to claim 19, wherein the coupling further comprises at least one of a chemical, thermal or mechanical junction.

22. The covered stent device according to claim 20, wherein the coupling further comprises at least one of a chemical, thermal and mechanical junction.

23. The covered stent according to claim 21, wherein each of the plurality of openings of the at least one tubular cover member has a pore size between about 0.01 μ

m to about 1000 μ

m.

24. The covered stent according to claim 17, wherein the plurality of openings of the at least one tubular cover member form a total open surface area of the tubular cover member between about 0.001 to about 90% of the area of one of an abluminal or luminal surface of the tubular cover member.

25. The covered stent device according to claim 17, further comprising a polymeric material capable of releasing a pharmacologically active agent therefrom disposed on at least one of the diametrically expandable stent or the at least one tubular cover member, whereby the polymeric material does not subtend the openings in the at least one tubular cover member or the at least one open space of the diametrically expandable stent.

26. A medical device, comprising:

a) A body member consisting of a metallic or pseudometallic laminate film having a first and a second wall surface and thereof;

b) at least two structural support members, the first structural support member being positioned concentrically adjacent the first wall surface of the body member and the second structural support member being positioned concentrically adjacent the second wall surface of the body member, wherein the body member is bound between the first and second structural members is bound between the first and second structural members; and

c) wherein the structural support members each comprise a stent having a first wall surface, a second wall surface, and at least one open space passing through the first and second wall surfaces, the at least one open space subtended by a wall surface of the body member.

27. The medical device according to claim 26, wherein the metallic or pseudometallic laminate film is 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, chromium-cobalt alloy, zirconium-titanium-tantalum alloy, nickel-titanium alloy, and stainless steel.

28. The medical device according to claim 26, wherein the laminate film comprised of at least one of a metallic and pseudometallic material further comprises a thin film laminate comprised of a pseudometallic material selected from the group consisting of ceramic, quartz, borosilicate, carbon fibers, boron fibers, boron carbide fibers, carbon and graphite fibers, carbon nanotubes, silicon carbide fibers, steel fibers, tungsten fibers, graphite/copper fibers, titanium fibers, and silicon carbide/titanium fibers.

29. The medical device according to claim 26, wherein the body member further comprises a plurality of openings passing through the first and second wall surfaces of the body member.

30. The medical device according to claim 26, wherein at least one of the two structural support members is coupled to the body member at least at one of a proximal and distal end of the body member.

31. The medical device according to claim 29, wherein each of the plurality of openings of the body member has a dimension between about 0.1 μ

m to 1000 μ

m in either of an x-axis or y-axis of the opening.

32. The medical device according to claim 29, wherein the plurality of openings of the body member form a total open surface area in the body member between about 0.001 to about 90% of the surface area of the body member.

33. The medical device according to claim 26, wherein the body member has a thickness between about 0.3 μ

m and 125 μ

m.