Medical devices with amorphous metals, and methods therefor

• US 8,057,530 B2
• Filed: 06/29/2007
• Issued: 11/15/2011
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Kravik, Rick, Kusleika, Richard S.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/771,890
• Publication Number:
  US 20080125848A1
• Time in Patent Office: 1,600 Days
• Field of Search: 623 111- 115, 148/421, 148/561
• US Class Current: 623/1.15
• CPC Class Codes: A61L 29/02 Inorganic materials
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

Medical devices made at least in part of amorphous metals or alloys are provided. Certain embodiments include filters, stents, guidewires, snares, and coils comprised of amorphous metal. Methods of forming the medical devices, including methods of shape setting amorphous metals or alloys into components of medical devices are also provided. Methods of using amorphous metal medical devices are also provided.

Claims

1. A medical device comprising an amorphous metal, wherein the medical device is a shape set medical device, the shape set medical device comprising between about 0.5 volume percent to about 75 volume percent crystalline portions formed from shape setting the medical device to partially convert amorphous metal into crystalline metal to impart crystalline properties to the medical device.

2. The medical device of claim 1, wherein the medical device is a stent.

3. The medical device of claim 2, wherein the stent is self expanding.

4. The medical device of claim 2, wherein the stent is balloon expandable.

5. The medical device of claim 1, wherein the medical device comprises one or more amorphous metal filaments having a diameter between about 0.010 inches (0.25 mm) and about 0.00050 inches (0.013 mm).

6. The medical device of claim 1, wherein the medical device further comprises a coating on at least a portion of the amorphous metal.

7. The medical device of claim 6, wherein the coating comprises one or more of a radiopaque coating, a drug coating, an active agent release coating, a biocompatible coating, or a lubricious coating.

8. The medical device of claim 1, wherein the medical device is sufficiently corrosion resistant to be internally biocompatible.

9. The medical device of claim 1, wherein the medical device is capable of imaging under MRI.

10. The medical device of claim 1, comprising between about 5 volume percent to about 75 volume percent crystalline metal.

21. The medical device of claim 1, wherein the shape set medical device comprises crystalline portions having a structure formed by annealing amorphous metal, the shape of the structure substantially maintained upon annealing.

22. The medical device of claim 1, wherein the shape set medical device is configured to maintain a desired shape upon annealing.

23. The medical device of claim 1, wherein the shape set medical device comprises crystalline portions having a structure formed by annealing amorphous metal in a desired shape of the medical device with an elastic yield limit value that is less than an otherwise identical medical device that is not shape set.

24. The medical device of claim 1, wherein the medical device is shape set to lower the elastic yield limit of said medical device.

25. The medical device of claim 1, wherein the shape set medical device comprises an annealed structure.

26. The medical device of claim 1, wherein the shape set medical device comprises an expanded structure.

27. The medical device of claim 1, wherein the crystalline portions are formed from shape setting the medical device to partially convert solidified amorphous metal to crystalline metal.

28. The medical device of claim 10, comprising between about 15 volume percent to about 40 volume percent crystalline metal.

38. The medical device of claim 1, wherein the medical device is a filter.

39. The medical device of claim 38, wherein the filter is a braided filter.

40. The medical device of claim 1, wherein the medical device is a stent delivery system.

41. The medical device of claim 1, wherein the medical device is a guidewire.

42. The medical device of claim 1, wherein the medical device is a snare.

43. The medical device of claim 1, wherein the medical device is a coil.

44. The medical device of claim 1, wherein the medical device is a catheter.

45. The medical device of claim 1, wherein the medical device is a septal defect closure device.

46. The medical device of claim 1, wherein the medical device is a left atrial appendage closure device.

47. The medical device of claim 1, wherein the medical device is a staple.

48. The medical device of claim 1, wherein the medical device is a clip.

58. The medical device of claim 38, wherein the filter is an embolic protection filter.

59. The medical device of claim 38, wherein the filter comprises a wire frame, at least a portion of the wire frame comprising an amorphous metal.

60. The medical device of claim 38, wherein the filter comprises a filter element comprising amorphous metal filaments.

61. The medical device of claim 60, wherein the filter element is braided.

62. The medical device of claim 60, wherein the filter has a pore size ranging from about 10 to about 1000 microns.

63. The medical device of claim 60, wherein the filter has a pore size ranging from about 20 to about 500 microns.

64. The medical device of claim 60, wherein the filter has a pore size ranging from about 30 to about 250 microns.

65. The medical device of claim 60, wherein the filter has a pore size ranging from about 40 to about 150 microns.

66. The medical device of claim 60, wherein the filter has a pore size ranging from about 50 to about 100 microns.

67. The medical device of claim 40, wherein the stent delivery system includes a stylet formed from an amorphous metal.

68. The medical device of claim 40, wherein the stent delivery system includes a reinforcing element formed from an amorphous metal.

69. The medical device of claim 40, wherein the stent delivery system is an over the wire system.

70. The medical device of claim 40, wherein the stent delivery system is a rapid exchange system.

71. The medical device of claim 40, wherein the stent delivery system is a fixed wire system.

72. The medical device of claim 40, wherein the stent delivery system comprises a self expanding stent or a balloon expandable stent.

73. The medical device of claim 72, wherein the self expanding stent or the balloon expandable stent comprises amorphous metal.

74. The medical device of claim 72, wherein the self expanding stent or the balloon expandable stent comprises a shape set amorphous metal.

75. The medical device of claim 41, wherein the guidewire is monofilament, wherein the monofilament comprises amorphous metal.

76. The medical device of claim 41, wherein the guidewire is multi-stranded, wherein one or more of a strand or filament of the multi-stranded guidewire comprises amorphous metal.

11. A medical device comprising amorphous metal portions and crystalline metal portions, wherein the crystalline metal portions have a structure formed by shape setting an amorphous metal to convert said amorphous metal into partially crystalline metal, wherein between about 0.5 volume percent to about 75 volume percent of the amorphous metal is converted to crystalline metal.

12. The medical device of claim 11, wherein the medical device is a filter.

13. The medical device of claim 12, wherein the filter is a braided filter.

14. The medical device of claim 11, wherein the medical device is a stent.

15. The medical device of claim 14, wherein the stent is self expanding.

16. The medical device of claim 14, wherein the stent is balloon expandable.

29. The medical device of claim 11, wherein the crystalline metal portions are formed by shape setting a solidified amorphous metal to convert the solidified amorphous metal to partially crystalline metal.

30. The medical device of claim 11, wherein between about 5 volume percent to about 75 volume percent of the amorphous metal is converted to crystalline metal.

31. The medical device of claim 30, wherein between about 15 volume percent to about 40 volume percent of the amorphous metal is converted to crystalline metal.

49. The medical device of claim 11, wherein the medical device is a stent delivery system.

50. The medical device of claim 11, wherein the medical device is a guidewire.

51. The medical device of claim 11, wherein the medical device is a snare.

52. The medical device of claim 11, wherein the medical device is a coil.

53. The medical device of claim 11, wherein the medical device is a catheter.

54. The medical device of claim 11, wherein the medical device is a septal defect closure device.

55. The medical device of claim 11, wherein the medical device is a left atrial appendage closure device.

56. The medical device of claim 11, wherein the medical device is a staple.

57. The medical device of claim 11, wherein the medical device is a clip.

17. A medical device comprising an at least partially amorphous metal surface, wherein the at least partially amorphous metal surface has improved corrosion resistance when the at least partially amorphous metal surface is compared to a more crystalline metal surface, wherein the medical device is a stent, the at least partially amorphous metal surface comprising crystalline portions formed by shape setting at least a portion of the medical device, the crystalline portions comprising between about 0.5 volume percent to about 75 volume percent of the surface.

32. The medical device of claim 17, wherein the crystalline portions comprise between about 5 volume percent to about 75 volume percent of the surface.

33. The medical device of claim 32, wherein the crystalline portions comprise between about 15 volume percent to about 40 volume percent of the surface.

18. A medical device comprising a structure comprising amorphous metal, wherein the structure has one or more of improved MRI safety or improved MRI compatibility when compared to a more crystalline metal structure, wherein the medical device is a stent, the amorphous metal comprising crystalline portions formed by shape setting at least a portion of the medical device, the crystalline portions comprising between about 0.5 volume percent to about 75 volume percent of the structure.

34. The medical device of claim 18, wherein the crystalline portions comprise between about 5 volume percent to about 75 volume percent of the structure.

35. The medical device of claim 34, wherein the crystalline portions comprise between about 15 volume percent to about 40 volume percent of the structure.

19. A medical device comprising an amorphous metal structure, wherein the medical device is coated with one or more selected from the group consisting of a radiopaque coating and a lubricious coating, the amorphous metal structure comprising crystalline portions formed by shape setting at least a portion of the medical device, the crystalline portions comprising between about 0.5 volume percent to about 75 volume percent of the structure.

20. The medical device of claim 19, wherein the medical device is a stent.

36. The medical device of claim 19, wherein the crystalline portions comprise between about 5 volume percent to about 75 volume percent of the structure.

37. The medical device of claim 36, wherein the crystalline portions comprise between about 15 volume percent to about 40 volume percent of the structure.