Method and apparatus for treating diseased or fractured bone

• US 20070043440A1
• Filed: 09/17/2004
• Published: 02/22/2007
• Est. Priority Date: 09/19/2003
• Status: Abandoned Application

• Current Assignee: Synecor LLC
• Original Assignee: Synecor LLC
• Inventors: Holbrook, Kevin, Glenn, Richard, Stack, Richard, Smith, Jeffrey, William, Michael
• Application Number:
  US10/571,580
• Publication Number:
  US 20070043440A1
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

An apparatus according to the invention may comprise one or more expandable structural support pylons (140), means for deploying said one or more structural support pylons (138, 141), and one or more therapeutic substances. Structural support pylons (20) may comprise an elastomeric core (22), or may comprise one or more suitable metals, and may be deployed by shortening the length and increasing the height of the pylon. Alternatively, scaffold (200) may comprise a delivery configuration in which first unit (202) and second unit (204) he generally end to end, and a deployed configuration in which superior surfaces (216) and (218) exert an upward force and inferior surfaces (220) and (222) exert a downward force on superior and inferior vertebral surfaces respectively. A method according to the invention may comprise accessing an interior of a diseased or injured bone in a minimally invasive manner, creating a semi-circular path within said bone, deploying one or more structural support pylons within said interior, introducing structural reinforcement material, and if desired, repeating with one or more subsequent structural support pylons.

Claims

1. An endoprosthesis for use in the treatment of diseased or fractured bone, said endoprosthesis comprising an elastomeric core, a delivery configuration and a deployed configuration, wherein said delivery configuration comprises a first width and a first height, and said deployed configuration comprises a second, reduced width and a second, increased height a reduced diameter configuration and an expanded diameter configuration.

2. The endoprosthesis according to claim 1, said endoprosthesis comprising sufficient outward radial strength to resist multi-directional loads, said multi-directional loads comprising compressive loads of between 50N and 6000N.

3. The endoprosthesis according to claim 1, said endoprosthesis further comprising one or more therapeutic substances.

4. The endoprosthesis according to claim 3, wherein said one or more therapeutic substances comprises bone morphogenic protein.

5. The endoprosthesis according to claim 3, wherein said one or more therapeutic substances is disposed about said endoprosthesis using a solvent in a supercritical state.

6. The endoprosthesis according to claim 1, wherein said delivery configuration comprises a generally cylindrical configuration and said deployed configuration comprises a generally ellipsoidal or a generally spherical configuration.

7. The endoprosthesis according to claim 1, wherein said elastomeric core comprises a first hardness when said endoprosthesis is in said delivery configuration, and a second hardness when said endoprosthesis is in said deployed configuration, wherein said second hardness is greater than said first hardness.

8. The endoprosthesis according to claim 7, wherein said first hardness is in the range of less than 10 Shore A durometer and said second hardness is in the range of 20 to 70 Shore A durometer.

9. The endoprosthesis according to claim 1, wherein said elastomeric core comprises an aperture therethrough.

10. The endoprosthesis according to claim 9, wherein said aperture is disposed centrally within said elastomeric core.

11. The endoprosthesis according to claim 9, wherein said aperture is disposed eccentrically within said elastomeric core.

12. The endoprosthesis according to claim 6, wherein said generally cylindrical configuration comprises one or more flat sides.

13. The endoprosthesis according to claim 6, wherein said generally cylindrical configuration comprises a transverse axis, and a generally ovular cross section along said transverse axis.

14. The endoprosthesis according to claim 9, wherein said aperture comprises a threaded interior for engagement with a threaded member.

15. The endoprosthesis according to claim 9, wherein said aperture comprises a notched interior for engagement with a ratcheting member.

16. The endoprosthesis according to claim 9, wherein said aperture comprises a smooth surface for engagement with a smooth mandrel.

17. The endoprosthesis according to claim 1, wherein said expanded diameter configuration is between 1.1 and 10 times the greater than said reduced diameter configuration.

18. An endoprosthesis for use in repairing a diseased or fractured bone, said endoprosthesis comprising endoprosthesis members, a substantially hollow interior and endplates, and comprising a delivery configuration and a deployed configuration.

19. The endoprosthesis according to claim 18, said endoprosthesis comprising sufficient outward radial strength to resist multi-directional loads, said multi-directional loads comprising compressive loads of between 50N and 6000N.

20. The endoprosthesis according to claim 18, said endoprosthesis further comprising one or more therapeutic substances.

21. The endoprosthesis according to claim 20, wherein said one or more therapeutic substances comprises bone morphogenic protein.

22. The endoprosthesis according to claim 20, wherein said one or more therapeutic substances is disposed about said endoprosthesis using a solvent in a supercritical state.

23. The endoprosthesis according to claim 18, wherein said endplates comprise a threaded interior for engagement with a threaded element.

24. The endoprosthesis according to claim 18, wherein said aperture comprises a notched interior for engagement with a ratcheting member.

25. The endoprosthesis according to claim 18, wherein said aperture comprises a smooth surface for engagement with a smooth mandrel.

26. The endoprosthesis according to claim 18, wherein said endoprosthesis members comprise preferential bending regions.

27. The endoprosthesis according to claim 18, wherein said delivery configuration is generally cylindrical and said deployed configuration is generally ellipsoidal or generally spherical.

28. The endoprosthesis according to claim 18, wherein said endoprosthesis comprises a central region and one or more end regions, and said deployed configuration is generally ellipsoidal or generally spherical about said central region, and generally cylindrical about said one or more end regions.

29. The endoprosthesis according to claim 18, wherein said deployed configuration is between 1.1 and 10 times greater than said delivery configuration.

30. An endoprosthesis for use in repairing a diseased or fractured bone, said endoprosthesis comprising a sleeve and one or more inverted end members and an interior, wherein said one or more inverted end members engage said sleeve within said interior, said endoprosthesis comprising a reduced profile configuration and an expanded profile configuration.

31. The endoprosthesis according to claim 30 wherein said inverted end members comprise a threaded interior for engagement with a threaded member.

32. An endoprosthesis for use in repairing diseased or fractured bone comprising a reduced profile delivery configuration and an expanded profile deployment configuration, said endoprosthesis comprising a superior end plate, an inferior endplate, and an expandable member disposed therebetween.

33. The endoprosthesis according to claim 32 wherein said expandable member comprises a threaded element.

34. The endoprosthesis according to claim 33 wherein said expandable member comprises a ratcheting element.

35. The endoprosthesis according to claim 33 wherein said expandable member is self-expanding.

36. An assembly for use in repairing diseased or injured bone, said assembly comprising one or more structural support pylons, wherein one or more of said structural support pylons comprises a delivery configuration and a deployed configuration, wherein said delivery configuration comprises a first width and a first height, and said deployed configuration comprises a second, reduced width and a second, increased height.

37. The assembly according to claim 36, wherein said assembly further comprises a structural reinforcement material.

38. The assembly according to claim 36, wherein said assembly further comprises a threaded element, wherein said plurality of structural support pylons are engaged with said threaded element.

39. The assembly according to claim 36, wherein said assembly further comprises a ratcheting element, and wherein said plurality of structural support pylons are engaged with said ratcheting element.

40. The assembly according to claim 36, wherein said assembly further comprises a smooth mandrel, and wherein said plurality of structural support pylons are engaged with said smooth mandrel.

41. The assembly according to claim 36, wherein said one or more of said plurality of structural support pylons are disposed at between 45 degree and 90 degree angles with respect to an adjacent structural support pylon.

42. An assembly for use in repairing diseased or fractured bone, said assembly comprising a plurality of structural support discs, wherein said assembly comprises a reduced profile delivery configuration and an expanded profile deployment configuration.

43. An endoprosthesis for use in repairing diseased or fractured bone, said endoprosthesis comprising a reduced profile delivery configuration and an expanded profile deployment configuration, wherein said endoprosthesis comprises an inverse layered braid configuration.

44. The endoprosthesis according to claim 43, wherein said endoprosthesis comprises means for locking said braid configuration.

45. An endoprosthesis for use in the treatment of diseased or fractured bone, said endoprosthesis comprising a delivery configuration and a deployed configuration, wherein said delivery configuration is generally cylindrical and said deployed configuration is generally ellipsoidal.

46. The endoprosthesis according to claim 45, wherein said endoprosthesis is deployed by mechanical means.

47. The endoprosthesis according to claim 46, wherein said mechanical means comprises a ratchet column.

48. The endoprosthesis according to claim 46, wherein said endoprosthesis comprises endplates, and wherein said mechanical means comprises a threaded element connecting said endplates.

49. The endoprosthesis according to claim 46, wherein said threaded member is disposed in the interior of said endoprosthesis.

50. An endoprosthesis for use in the treatment of diseased or fractured bone, said endoprosthesis comprising a delivery configuration and a deployed configuration, wherein said delivery configuration comprises a first width and a first height, and said deployed configuration comprises a second, reduced width and a second, increased height.

51. The endoprosthesis according to claim 50, wherein said second, increased height is between one and one tenth and ten times said first height.

52. The endoprosthesis according to claim 50, wherein said endoprosthesis comprises a plurality of folded discs when in said delivery configuration and a plurality of unfolded discs when in said deployed configuration.

53. The endoprosthesis according to claim 50, wherein said endoprosthesis comprises a superior surface, an inferior surface, and two or more side portions, wherein when in its delivery configuration, one or more of said side portions lie substantially in the same plane as the superior surface, and one or more of said side portions lie substantially in the same plane as the inferior surface, and when in its deployed configuration, one or more said side portions lie in a plane substantially perpendicular to said superior surface and one or more said side portions lie in a plane substantially perpendicular to said inferior surface.

54. The endoprosthesis according to claim 53, wherein one or more of said superior surface and inferior surface comprises means for engaging the interior of a vertebral body.

55. The endoprosthesis according to claim 54, wherein said means comprises a roughened surface.

56. The endoprosthesis according to claim 54, wherein said means comprises one or more protrusions.

57. The endoprosthesis according to claim 54, wherein said means comprises one or more adhesives.

58. The endoprosthesis according to claim 54, wherein said means comprises chemical means.

59. The endoprosthesis according to claim 54, wherein said means comprises one or more barbs.

60. An assembly for use in repairing diseased or fractured bone, said assembly comprising one or more structural support pylons and an actuating arm for the deployment of said one or more structural support pylons.

61. The assembly according to claim 60, wherein said assembly further comprises a structural reinforcement material.

62. The assembly according to claim 60, wherein said actuating arm is smooth.

63. The assembly according to claim 60, wherein said actuating arm is threaded.

64. The assembly according to claim 60, wherein said actuating arm is ratcheted.

65. The assembly according to claim 60, said assembly further comprising one or more washers.

66. A minimally invasive method for repairing diseased or fractured bone, said method comprising:

percutaneously introducing an endoprosthesis within the interior of said injured bone, said endoprosthesis comprising a delivery configuration and a deployed configuration, wherein said delivery configuration comprises a first width and a first height, and said deployed configuration comprises a second, reduced width and a second, increased height.

67. The method according to claim 66, wherein a generally semi-circular path is created within said bone prior to introducing said endoprosthesis.

68. The method according to claim 67, wherein said generally semi-circular path is oriented vertically within said bone.

69. The method according to claim 67, wherein said generally semi-circular path is oriented laterally within said bone.

70. The method according to claim 66, wherein said endoprosthesis is generally cylindrical, comprises an interior, and said step of deploying said generally cylindrical endoprosthesis comprises pulling a tapered plug through said interior.

71. The method according to claim 66, said method further comprising the step of administering a therapeutic within said diseased or fractured bone.

72. The method according to claim 66, said method further comprising the step of introducing a structural support material within said diseased or injured bone.

73. The method according to claim 66, wherein said endoprosthesis comprises first and second ends, wherein said first and second ends are at a first distance apart when said endoprosthesis is in its delivery configuration, and at a second, lesser distance apart when said endoprosthesis is in its deployed configuration, and wherein said step of deploying said endoprosthesis comprises decreasing said first distance.

74. The method according to claim 66, wherein said endoprosthesis comprises endoprosthesis members and voids therebetween, and wherein said endoprosthesis members comprise one or more preferential bending regions.

75. The method according to claim 74, wherein said endoprosthesis comprises a threaded member engaging said first and second ends, and said step of decreasing said first distance comprises advancing one of said first and second ends over said threaded member.

76. The method according to claim 75, wherein said endoprosthesis comprises an interior, and said threaded member is disposed within said interior.

77. The method according to claim 74, wherein said endoprosthesis comprises a ratchet column, and said step of decreasing said first and second distance comprises actuating said ratchet column.

78. The method according to claim 74, wherein said endoprosthesis comprises a smooth mandrel engaging said first and second ends, and said step of decreasing said first distance comprises advancing said of said first and second ends over said smooth mandrel.