Endoprosthesis having a fiber meshwork disposed thereon

• US 8,048,150 B2
• Filed: 04/12/2006
• Issued: 11/01/2011
• Est. Priority Date: 04/12/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Feng, James Q., Weber, Jan, Atanasoska, Liliana
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/403,344
• Publication Number:
  US 20070244569A1
• Time in Patent Office: 2,029 Days
• Field of Search: 623/1.15, 623 138- 154
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

The present invention comprises a medical device having an underlying structure on which is disposed a fiber meshwork composed of one or more fibers of substantially uniform diameter. The fiber meshwork may optionally have a multi-layer structure disposed upon it. Either or both of the fiber meshwork or the multi-layer structure may have one or more therapeutic agents absorbed within it. The fiber meshwork is permeable to body fluids and thereby permits body fluids to contact the underlying structure to facilitate its controlled disintegration. The fiber meshwork degrades more slowly than the underlying structure thereby permitting release of the therapeutic agent over a timescale longer than that of the lifetime of the underlying structure, while also ensuring that the support function of the underlying structure is not abrogated by the disintegration of the underlying structure.

Claims

1. A medical device for implantation into an organism, comprising:

an underlying structure comprising a metal framework, wherein the underlying structure is biodisintegrable; and

a fiber meshwork disposed upon the underlying structure, wherein the fiber meshwork comprises nano-fibers or micro-fibers, wherein the fiber meshwork is configured to ensure steady biodisintegration of the underlying structure over a first period of time inside the organism, wherein the fiber meshwork additionally effects controlled release of a pharmaceutically active agent absorbed therein over a second period of time inside the organism, wherein the first period of time is less than the second period of time.

2. The medical device of claim 1 wherein the framework is made of a metal selected from the group consisting of:

alkali metals, alkaline earth metals, iron, zinc, and aluminum.

3. The medical device of claim 2 wherein the metal is magnesium.

4. A The medical device of claim 1,

wherein the metal is iron.

5. The medical device of claim 1, wherein the framework comprises a metal alloy.

6. The medical device of claim 5, wherein the framework comprises a magnesium alloy.

7. A The medical device of claim 1, comprising:

wherein the framework comprises an iron alloy.

8. The medical device of claim 1, wherein the framework comprises a first metal selected from the group consisting of magnesium, titanium, zirconium, niobium, tantalum, zinc, and silicon, and a second metal selected from the group consisting of lithium, sodium, potassium, calcium, iron, and manganese.

9. The medical device of claim 1 wherein the fiber meshwork comprises a polymeric material.

10. The medical device of claim 1 wherein the fiber meshwork comprises two or more non-contiguous fibers.

11. The medical device of claim 1 wherein the fiber meshwork comprises an electro-spun polymeric material.

12. The medical device of claim 11 wherein the fiber meshwork is electro-spun by FFESS.

13. The medical device of claim 1 wherein the fiber meshwork comprises one or more fibers, wherein each of said one or more fibers has a diameter in the range 50 nm-500 nm.

14. The medical device of claim 13 wherein the fiber meshwork comprises at least two fibers, including a first fiber of a first type of material, and a second fiber of a second type of material.

15. The medical device of claim 14 wherein the first type of material has a first pharmaceutically active ingredient absorbed within it, and the second type of material has a second pharmaceutically active ingredient absorbed within it.

16. The medical device of claim 1 wherein the fiber meshwork comprises one or more fibers, wherein each of said one or more fibers has a diameter <

1 μ

m.

17. The medical device of claim 16 wherein each of said one or more fibers has a uniform diameter along its length.

18. The medical device of claim 1, wherein the fiber meshwork comprises a composition selected from the group consisting of:

poly(D,L-lactide-co-glycolide);

magnesium;

iron, or zinc.

19. The medical device of claim 1 further comprising a layer-by-layer coating situated on the fiber meshwork.

20. The medical device of claim 19, wherein the layer-by-layer coating comprises a first layer of a first polyelectrolyte, and a second layer of a second polyelectrolyte.

21. The medical device of claim 20, wherein the first polyelectrolyte is positively charged and the second polyelectrolyte is negatively charged, or vice versa.

22. The medical device of claim 19, wherein the layer-by-layer coating comprises at least 10 layers.

23. The medical device of claim 19, wherein the layer-by-layer coating comprises at most 300 layers.

24. The medical device of claim 19, wherein the layer-by-layer coating further comprises a therapeutic agent.

25. The medical device of claim 19, wherein the layer-by-layer coating further comprises nanoparticles.

26. The medical device of claim 1, wherein the underlying structure is generally tubular in shape.

27. The medical device of claim 26 wherein the first ring is made of a first material and wherein the second ring is made of a second material, and wherein the first material and the second material are different from a material of which the fiber meshwork is comprised.

28. The medical device of claim 1, wherein the underlying structure comprises a first ring and a second ring, wherein the first ring and the second ring are connected to one another by the fiber meshwork.

29. The medical device of claim 28 wherein the first material and the second material are each independently selected from the group consisting of:

nitinol, magnesium, and steel.

30. The medical device of claim 1 wherein the first period of time is between about 60 days and about 1,000 days.

31. The medical device of claim 1 wherein the first period of time is between about 120 days and about 750 days.

32. The medical device of claim 1 wherein the first period of time is between about 180 days and about 600 days.

33. The medical device of claim 1 wherein the biodisintegration comprises a mass reduction of at least about 50% of the structure.

34. The medical device of claim 1 wherein the second period of time is between about 60 days and about 1,000 days.

35. The medical device of claim 1 wherein the second period of time is between about 120 days and about 750 days.

36. The medical device of claim 1 wherein the second period of time is between about 180 days and about 600 days.

37. The medical device according to claim 1, further comprising a multi-layer structure disposed upon the fiber meshwork.

38. The medical device according to claim 37 wherein the multi-layer structure comprises alternating layers formed of molecules having opposite charges to one another.

39. The medical device of claim 1, wherein the device is an endoprosthesis.