Medical devices including metallic films

• US 7,854,760 B2
• Filed: 05/16/2005
• Issued: 12/21/2010
• Est. Priority Date: 05/16/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chin, Gregory D., Molaei, Masoud, Obara, Robert Z., Henry, William S.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/130,534
• Publication Number:
  US 20060259131A1
• Time in Patent Office: 2,045 Days
• Field of Search: 623 115- 148
• US Class Current: 623/1.38
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• 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 2230/0054 V-shaped

Abstract

Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a composite cover formed of a deposited metallic film and one or more polymer layers. The polymer layers contribute to mechanical or biological properties of the endoprosthesis.

Claims

1. An endoprosthesis, comprising:

first and second tubular frameworks spaced apart by a degradable central portion and defining an interior and an exterior, the tubular frameworks configured to, upon deployment within a body passage, exert a radially expansive force against the body passage sufficient to retain the endoprosthesis with respect to the body passage, the degradable central portion configured to, upon deployment within the body passage, initially reduce a flow of blood between the interior and exterior of the endoprosthesis and, subsequent to deployment, degrade over time providing increased flow of blood between the interior and exterior of the endoprosthesis; and

a deposited metallic film generally coextensive with at least a portion of at least one of the frameworks.

2. The endoprosthesis of claim 1, wherein the metallic film comprises nickel and titanium.

3. The endoprosthesis of claim 1, wherein the metallic film has a thickness of less than about 50 μ

m.

4. The endoprosthesis of claim 1, wherein a different deposited metallic film is generally coextensive with at least a portion of each of the first and second frameworks.

5. The endoprosthesis of claim 1, wherein the first and second frameworks are only connected by the degradable central portion.

6. The endoprosthesis of claim 1, further comprising a deposited metallic film connects the first and second frameworks.

17. The endoprosthesis of claim 1, wherein the metallic film has a thickness of about 4-35 μ

m.

20. The endoprosthesis of claim 1, wherein the first and second tubular frameworks each have a plurality of struts, and wherein at least some of the struts crimp about a portion of the central portion to attach the first and second tubular frameworks to the central portion.

21. The endoprosthesis of claim 1, further comprising a plurality of radiopaque markers configured to define boundaries between the central portion and the first and second tubular frameworks.

22. The endoprosthesis of claim 1, wherein the central portion comprises fenestrations.

23. The endoprosthesis of claim 1, wherein the central portion is configured to release a pharmaceutically active compound during degradation.

24. The endoprosthesis of claim 1, wherein the central portion comprises first and second portions, the first and second portions having different degradation lifetimes.

7. An endoprosthesis, comprising:

a generally tubular deposited metallic film comprising first and second ends and at least one fenestration located therebetween, the at least one fenestration having an area sufficient to pass a microcatheter; and

a degradable layer obstructing the fenestration, the degradable layer configured to, upon deployment of the endoprosthesis within a body passage, degrade thereby opening the fenestration to provide an area sufficient to allow passage of a microcatheter.

8. The endoprosthesis of claim 7, wherein the fenestration has an area of at least 2 mm².

9. The endoprosthesis of claim 7, wherein the fenestration has an area sufficient to pass a 1.7 french catheter.

10. The endoprosthesis of claim 7, wherein the metallic film comprises nickel and titanium.

11. The endoprosthesis of claim 10, wherein the metallic film has a thickness of less than about 50 μ

m.

18. The endoprosthesis of claim 10, wherein the metallic film has a thickness of about 4-35 μ

m.

25. The endoprosthesis of claim 7, wherein the endoprosthesis further includes markers configured to indicate an orientation of the plurality of fenestrations.

12. A generally tubular endoprosthesis defining an interior and an exterior, the endoprosthesis comprising:

a tubular framework;

a deposited metallic film covering the framework, the deposited metallic film comprising a plurality of fenestrations; and

a degradable polymer layer extending around one or both of the film and the framework, the degradable polymer layer configured to, upon deployment within a body passage, initially limit passage of liquid between the interior of the endoprosthesis and the exterior of the endoprosthesis along a path including the fenestrations.

13. The endoprosthesis of claim 12, wherein the metallic film comprises nickel and titanium.

14. The endoprosthesis of claim 12, wherein the metallic film has a thickness of less than about 50 μ

m.

15. The endoprosthesis of claim 12, wherein the film comprises at least about 100 fenestrations.

16. The endoprosthesis of claim 15, wherein the degradable layer is configured to, upon deployment of the endoprosthesis within the body passage, degrade thereby allowing increasing passage of fluid between the interior of the endoprosthesis and the exterior of the endoprosthesis along a path including the fenestrations.

19. The endoprosthesis of claim 13, wherein the metallic film has a thickness of about 4-35 μ

m.

26. The endoprosthesis of claim 16, wherein the degradable layer is configured to release therapeutic agents during degradation.