Medical devices comprising small fiber biomaterials, and methods of use

• US 20030171053A1
• Filed: 12/10/2002
• Published: 09/11/2003
• Est. Priority Date: 11/24/1999
• Status: Active Grant

• Current Assignee: University of Washington
• Original Assignee: University of Washington
• Inventors: Sanders, Joan E.
• Granted Patent: US 7,947,069 B2
• Time in Patent Office: Days
• US Class Current: 442/340
• CPC Class Codes: B32B 5/02 characterised by structural features of a fibrous or filamentary layer layer formed of metallic wires B32B15/02; layer formed of natural mineral fibres B32B19/02; layer formed of wood fibres B32B21/02
• CPC Class Codes: B32B 5/26 another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: Y10T 428/249962 Void-containing component has a continuous matrix of fibers only [e.g., porous paper, etc.]
• CPC Class Codes: Y10T 428/249964 Fibers of defined composition
• CPC Class Codes: Y10T 428/249979 Specified thickness of void-containing component [absolute or relative] or numerical cell dimension
• CPC Class Codes: Y10T 428/249981 Plural void-containing components
• CPC Class Codes: Y10T 428/2913 Rod, strand, filament or fiber
• CPC Class Codes: Y10T 442/102 Woven scrim
• CPC Class Codes: Y10T 442/107 Comprising at least two chemically different fibers
• CPC Class Codes: Y10T 442/184 Nonwoven scrim
• CPC Class Codes: Y10T 442/614 Strand or fiber material specified as having microdimensions [i.e., microfiber]
• CPC Class Codes: Y10T 442/615 Strand or fiber material is blended with another chemically different microfiber in the same layer
• CPC Class Codes: Y10T 442/62 Including another chemically different microfiber in a separate layer
• CPC Class Codes: Y10T 442/626 Microfiber is synthetic polymer

Abstract

In one aspect the present invention provides medical devices 10 that each include a plurality of fibers 22, substantially all of the plurality of fibers 22 each including a portion having a maximum diameter of at least five micrometers, wherein substantially all of fibers 22 form a layer on at least one external surface of medical device 10. In another aspect, the present invention provides methods of manufacturing medical devices 10, the methods including the steps of: (a) applying a layer comprising a plurality of fibers 22 to at least one surface of medical device 10; and (b) matching the value of the Young'"'"'s modulus of the layer to ±35% (in some embodiments to ±20%) of the value of the Young'"'"'s modulus of an animal tissue.

Claims

1. A medical device comprising a plurality of fibers, substantially all of said plurality of fibers each comprising a portion having a maximum diameter of at least five micrometers, wherein substantially all of said fibers form a layer on at least one external surface of the medical device.

2. The medical device of claim 1, wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 6 micrometers.

3. The medical device of claim 1, wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 7 micrometers.

4. The medical device of claim 1, wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 10 micrometers.

5. The medical device of claim 1, wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 15 micrometers.

6. The medical device of claim 1, wherein said portion extends for greater than 75% of the length of said fiber.

7. The medical device of claim 1, wherein said portion extends for greater than 90% of the length of said fiber.

8. The medical device of claim 1, wherein said portion extends for greater than 98% of the length of said fiber.

9. The medical device of claim 1, wherein each of said fibers comprise at least two portions each having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 75% of the length of said fiber.

10. The medical device of claim 1, wherein each of said fibers comprise at least two portions each having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 90% of the length of said fiber.

11. The medical device of claim 1, wherein each of said fibers comprise at least two portions each having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 98% of the length of said fiber.

12. The medical device of claim 1, wherein said layer is a mesh.

13. The medical device of claim 1, further comprising multiple layers of fibers disposed on at least one external surface of the medical device.

14. The medical device of claim 1, wherein said layer has a Young'"'"'s modulus of no more than 1.00 GPa.

15. The medical device of claim 1, wherein said layer has a Young'"'"'s modulus of no more than 0.5 GPa.

16. The medical device of claim 1, wherein said fibers consist essentially of a material selected from the group consisting of silicones, carbonized polyurethane, nylon, polypropylene, polyethylene, polyurethane, polyester, polytetrafluoroethylene, poly(lactic acid), poly(glycolic acid), polystyrene, polycarbonate, polyethylene glycol, fluoropolymers, poly(galactic acid), polyethylene terephthalate, poly(dioxanone), poly(trimethylene carbonate) copolymers, poly (ε

-caprolactone) homopolymers, poly (C-caprolactone) copolymers, polyanhydrides, polyorthoesters, collagen, elastin, protein, carbohydrate and glycosaminoglycan.

17. The medical device of claim 1, wherein said plurality of fibers includes a mixture of fibers made from different materials.

18. The medical device of claim 13, wherein said layer comprises a gradient of fiber diameters.

19. The medical device of claim 18, wherein said gradient includes a maximum fiber diameter and a minimum fiber diameter and at least 75% of fibers possessing said maximum diameter are disposed adjacent said medical device external surface.

20. The medical device of claim 1, wherein said layer comprises pores defined by said fibers, said pores having a mean diameter of between 10 μ

m and 120 μ

m.

21. The medical device of claim 1, wherein said layer comprises pores defined by said fibers, said pores having a mean diameter of between 50 μ

m and 100 μ

m.

22. A method of manufacturing a medical device comprising the steps of:

(a) applying a layer comprising a plurality of fibers to at least one surface of a medical device; and

(b) matching the value of the Young'"'"'s modulus of the layer to ±

35% of the value of the Yotung'"'"'s modulus of an animal tissue.

23. The method of claim 22 wherein the value of the Young'"'"'s modulus of the layer is matched to ±

20% of the value of the Young'"'"'s modulus of an animal tissue.

24. The method of claim 22 wherein the value of the Young'"'"'s modulus of the animal tissue is no greater than 1.0 GPa.

25. The method of claim 22 wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least five micrometers.

26. The method of claim 22 wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 6 micrometers.

27. The method of claim 22 wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 7 micrometers.

28. The method of claim 22 wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 10 micrometers.

29. The method of claim 22 wherein substantially all of said plurality of fibers each comprise a portion having a maximum diameter of at least 15 micrometers.

30. The method of claim 22 wherein said portion extends for greater than 75% of the length of said fiber.

31. The method of claim 22 wherein said portion extends for greater than 90% of the length of said fiber.

32. The method of claim 22 wherein said portion extends for greater than 98% of the length of said fiber.

33. The method of claim 22 wherein each of said fibers comprises at least two portions, each portion having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 75% of the length of said fiber.

34. The method of claim 22 wherein each of said fibers comprises at least two portions, each portion having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 90% of the length of said fiber.

35. The method of claim 22 wherein each of said fibers comprises at least two portions, each of said portions having a maximum diameter of at least five micrometers, wherein said portions cumulatively extend for greater than 98% of the length of said fiber.

36. The method of claim 22 wherein said layer is a mesh.

37. The method of claim 22 further comprising multiple layers of fibers disposed on at least one external surface of the medical device.

38. The method of claim 22 wherein said layer has a Young'"'"'s modulus of no more than 1.00 GPa.

39. The method of claim 22 wherein said layer has a Young'"'"'s modulus of no more than 0.5 GPa.

40. The method of claim 22 wherein said fibers consist essentially of a material selected from the group consisting of silicones, carbonized polyurethane, nylon, polypropylene, polyethylene, polyurethane, polyester, polytetrafluoroethylene, poly(lactic acid), poly(glycolic acid), polystyrene, polycarbonate, polyethylene glycol, fluoropolymers, poly(galactic acid), polyethylene terephthalate, poly(dioxanone), poly(trimethylene carbonate) copolymers, poly (C-caprolactone) homopolymers, poly (F-caprolactone) copolymers, polyanhydrides, polyorthoesters, collagen, elastin, protein, carbohydrate and glycosaminoglycan.

41. The method of claim 22 wherein said plurality of fibers includes a mixture of fibers made from different materials.

42. The method of claim 22 wherein said layer comprises a gradient of fiber diameters.

43. The method of claim 42, wherein said gradient includes a maximum fiber diameter and a minimum fiber diameter and at least 75% of fibers possessing said maximum diameter are disposed adjacent said medical device external surface.

44. The method of claim 22 wherein said layer comprises pores defined by said fibers, said pores having a mean diameter of between 10 μ

m and 120 μ

m.

45. The method of claim 22 wherein said layer comprises pores defined by said fibers, said pores having a mean diameter of between 50 μ

m and 100 μ

m.