DEMINERALIZED CORTICAL BONE IMPLANTS

• US 20120116515A1
• Filed: 10/20/2011
• Published: 05/10/2012
• Est. Priority Date: 10/25/2010
• Status: Abandoned Application

• Current Assignee: Musculoskeletal Transplant Foundation, Spineology Incorporated
• Original Assignee: Spineology Incorporated
• Inventors: Semler, Eric J., Boylan, Clint, Roche, Karen
• Application Number:
  US13/277,703
• Publication Number:
  US 20120116515A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30252 quadric-shaped
• CPC Class Codes: A61F 2002/30253 ellipsoidal or ovoid
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30273 pyramidal
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/4646 Devices for cleaning bone graft
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2300/44 : Radioisotopes, radionuclides
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Implants comprising a plurality of separate cortical bone units, which have been at least partially demineralized and are osteoinductive, are described herein. The implants can be used in methods for treating bone. Also, disclosed are methods for treating spinal conditions using these implants. The spinal conditions include but are not limited to repairing damage to or defects in the spine, such as fractures in a vertebral body or degeneration of spinal discs.

Claims

1. An implant comprising a plurality of separate cortical bone units that are at least partially demineralized and osteoinductive,

wherein the cortical bone units have at least one dimension greater than about 1.0 mm, and

wherein when the cortical bone units are implanted into a cavity that has a volume, there are void spaces between the cortical bone units in the cavity.

2. The implant of claim 1, wherein the cavity is located in a patient.

3. The implant of claim 1, wherein the cortical bone units are implanted into an implantable container located within the cavity.

4. The implant of claim 1, wherein at least one of the cortical bone units has a cylindrical, spherical, pyramidal, ovoid, discoid, oblong, or cuboidal shape.

5. The implant of claim 1, wherein the cortical bone units have at least one dimension from about 1.5 mm to about 5.0 mm.

6. The implant of claim 1, wherein the implant includes less than or equal to about 5% by weight of cortical bone units having at least one dimension less than about 1.0 mm.

7. The implant of claim 1, wherein the cortical bone units are formed from human bone.

8. The implant of claim 1, wherein the implant includes less than or equal to about 1% by weight of cancellous bone.

9. The implant of claim 1, wherein the cortical bone units are fully demineralized.

10. The implant of claim 1, wherein the implant includes less than or equal to about 1% by weight of non-demineralized bone.

11. The implant of claim 1, further comprising a radiopaque marker.

12. The implant of claim 1, further comprising a carrier, wherein the carrier comprises saline, sodium hyaluronate or hyaluronic acid, and wherein the carrier is mixed with the cortical bone units.

13. The implant of claim 1, wherein the implant includes less than or equal to about 1% by weight of a carrier.

14. The implant of claim 3, wherein the cortical bone units occupy about 75% to about 99% of the volume of the cavity or implantable container.

15. The implant of claim 1, wherein when the implant is implanted in the cavity, the packing density of the cortical bone units in the cavity is of about 0.5 g/cc to about 1.0 glee based on dry weight of the cortical bone units.

16. A method of treating bone comprising:

(a) forming at least one cavity, having a volume and at least one opening, within the bone; and

(b) implanting into the cavity an implant comprising a plurality of separate cortical hone units that are at least partially demineralized and osteoinductive,

wherein the cortical bone units have at least one dimension greater than about 1.0 mm, and

wherein after the implant has been implanted in the cavity there are void spaces between the cortical bone units in the cavity.

17. The method of claim 16, further comprising the step of sealing the opening of the cavity after the implant has been implanted in the cavity.

18. The method of claim 16, further comprising the step of inserting an implantable container into the cavity prior to implanting the implant into the cavity so that when the implant is implanted into the cavity, the implant will be contained in the implantable container.

19. The method of claim 18, wherein the implantable container is a mesh bag.

20. The method of claim 16, wherein prior to implanting the implant in the cavity, the plurality of cortical bone units are contained in a delivery container which comprises a cannula, syringe, cartridge, hollow rod, hollow delivery tube, or fill tube.

21. The method of claim 16, wherein at least one of the cortical bone units has a cylindrical, spherical, pyramidal, ovoid, discoid, oblong or cuboidal shape.

22. The method of claim 16 wherein at least one of the cortical bone units have at least one dimension from about 1.5 mm to about 5.0 mm.

23. The method of claim 16, wherein the implant includes less than or equal to about 5% by weight of cortical bone units having at least one dimension less than about 1.0 mm.

24. The method of claim 16, wherein the cortical bone units are formed from human hone.

25. The method of claim 16, wherein the implant includes less than or equal to about 1% by weight of cancellous bone.

26. The method of claim 16, wherein the cortical bone units are fully demineralized.

27. The method of claim 16, wherein the implant includes less than or equal to about 1% by weight of non-demineralized bone.

28. The method of claim 16, further comprising a radiopaque marker.

29. The method of claim 16, further comprising a carrier, wherein the carrier comprises saline, sodium hyaluronate or hyaluronic acid, and wherein the carrier is mixed with the cortical bone units.

30. The method of claim 16, wherein the implant includes less than or equal to about 1% by weight of a carrier.

31. The method of claim 18, wherein the cortical bone units occupy about 75% to about 99% of the volume of the cavity or implantable container.

32. The method of claim 16, wherein when the implant is implanted into the cavity, the packing density of the cortical bone units in the cavity is of about 0.5 g/cc to about 1.0 g/cc based on dry weight of the cortical bone units.

33. A method of treating a vertebral body in a patient comprising:

(a) forming at least one cavity, having a volume and at least one opening, within the vertebral body; and

(b) implanting into the cavity an implant comprising a plurality of separate cortical bone units that are at least partially demineralized and osteoinductive,

wherein the cortical bone units have at least one dimension greater than about 1.0 mm, and

wherein after the implant has been implanted in the cavity there are void spaces between the cortical bone units in the cavity.

34. The method of claim 33, wherein the vertebral body is fractured and the method is for treating the fractured vertebral body.

35. The method of claim 33, further comprising the step of sealing the opening of the cavity after the implant has been implanted in the cavity.

36. The method of claim 33, further comprising the step of inserting an implantable container into the cavity prior to implanting the implant into the cavity so that when the implant is implanted into the cavity, the implant will be contained in the implantable container.

37. The method of claim 36, wherein the implantable container is a mesh bag.

38. The method of claim 33, wherein prior to implanting the implant in the cavity, the plurality of cortical bone units are contained in a delivery container which comprises a cannula, syringe, cartridge, hollow rod, hollow delivery tube, or fill tube.

39. The method of claim 33, wherein at least one of the cortical bone units has a cylindrical, spherical, pyramidal, ovoid, discoid, oblong or cuboidal shape.

40. The method of claim 33, wherein at least one of the cortical bone units have at least one dimension from about 1.5 mm to about 5.0 mm.

41. The method of claim 33, wherein the implant includes less than or equal to about 5% by weight of cortical bone units having at least one dimension less than about 1.0 mm.

42. The method of claim 33, wherein the cortical bone units are formed from human bone.

43. The method of claim 33, wherein the implant includes less than or equal to about 1% by weight of cancellous bone.

44. The method of claim 33, wherein the cortical bone units are fully demineralized.

45. The method of claim 33, wherein the implant includes less than or equal to about 1% by weight of non-demineralized bone.

46. The method of claim 33, further comprising a radiopaque marker.

47. The method of claim 33, further comprising a carrier, wherein the carrier comprises saline, sodium hyaluronate or hyaluronic acid, and wherein the carrier is mixed with the cortical bone units.

48. The method of claim 33, wherein the implant includes less than or equal to about 1% by weight of a carrier.

49. The method of claim 36, wherein the cortical bone units occupy about 75% to about 99% of the volume of the cavity or implantable container.

50. The method of claim 33, wherein when the implant is implanted into the cavity, the packing density of the cortical bone units in the cavity is of about 0.5 g/cc to about 1.0 g/cc based on dry weight of the cortical bone units.

51. A method of treating a spinal disc in a patient comprising:

(a) forming at least one cavity, having a volume and at least one opening, herein the cavity is located between two adjacent vertebral bodies; and

(b) implanting into the cavity an implant comprising a plurality of separate cortical bone units that are at least partially demineralized and osteoinductive,

wherein the cortical bone units have at least one dimension greater than about 1.0 mm, and

wherein after the implant has been implanted in the cavity there are void spaces between the cortical bone units in the cavity.

52. The method of claim 51, wherein the spinal disc is degenerated and the method is for treating the degenerated spinal disc.

53. The method of claim 51, wherein the implant is used to create a fusion between the two adjacent vertebral bodies.

54. The method of claim 51, wherein at least one of the vertebral bodies has an endplate and the method further comprises decorticating the endplate prior to implanting the implant into the cavity.

55. The method of claim 51, wherein the cavity is located within the spinal disc.

56. The method of claim 51, further comprising the step of sealing the opening of the cavity after the implant has been implanted into the cavity.

57. The method of claim 51, further comprising the step of inserting an implantable container into the cavity prior to implanting the implant into the cavity so that when the implant is implanted into the cavity, the implant will be contained in the implantable container.

58. The method of claim 57, wherein the implantable container is a mesh bag.

59. The method of claim 51, wherein prior to insertion of the implant in the cavity, the plurality of cortical bone units are contained in a delivery container which comprises a cannula, syringe, cartridge, hollow rod, hollow delivery tube, or fill tube.

60. The method of claim 51, wherein at least one of the cortical bone units has a cylindrical, spherical, pyramidal, ovoid, discoid, oblong, or cuboidal shape.

61. The method of claim 51, wherein the cortical bone units have at least one dimension from about 1.5 mm to about 5.0 mm.

62. The method of claim 51, wherein the implant includes less than or equal to about 5% by weight of cortical bone units having at least one dimension less than about 1.0 mm.

63. The method of claim 51, wherein the cortical bone units are formed from human bone.

64. The method of claim 51, wherein the implant includes less than or equal to about 1% by weight of cancellous bone.

65. The method of claim 51, wherein the cortical bone units are fully demineralized.

66. The method of claim 51, wherein the implant includes less than or equal to about 1% by weight of non-demineralized bone.

67. The method of claim 51, further comprising a radiopaque marker.

68. The method of claim 51, further comprising a carrier, wherein the carrier comprises saline, sodium hyaluronate or hyaluronic acid, and wherein the carrier is mixed with the cortical bone units.

69. The method of claim 51, wherein the implant includes less than or equal to about 1% by weight of a carrier.

70. The method of claim 57, wherein the cortical bone units occupy about 75% to about 99% of the volume of the cavity or implantable container.

71. The method of claim 51, wherein when the implant is implanted into the cavity, the packing density of the cortical bone units in the cavity is of about 0.5 g/cc to about 1.0 g/cc based on dry weight of the cortical bone units.

72. A method of treating a spinal disc in a patient comprising:

(a) forming at least one cavity, having a volume and at least one opening, wherein the cavity is located within the spinal disc; and

(b) implanting into the cavity an implant comprising a plurality of separate cortical bone units that are at least partially demineralized and non-osteoinductive,

wherein the cortical bone units have at least one dimension greater than about 1.0 mm, and

wherein after the implant has been implanted in the cavity there are void spaces between the cortical bone units in the cavity.

73. The method of claim 72, further comprising the step of inserting an implantable container into the cavity prior to implanting the implant into the cavity so that when the implant is implanted into the cavity, the implant will be contained in the implantable container

74. The method of claim 72, wherein the cortical bone units have at least one dimension from about 1.5 mm to about 5.0 mm.

75. The method of claim 72, wherein the implant includes less than or equal to about 5% by weight of cortical bone units having at least one dimension less than about 1.0 mM.

76. The method of claim 73 wherein the cortical bone units are formed from human bone.

77. The method of claim 72, wherein the cortical bone units are fully demineralized.

78. The method of claim 72, wherein the implant includes less than or equal to about 1% by weight of non-demineralized bone.

79. The method of claim 73, wherein the cortical bone units occupy about 75% to about 99% of the volume of the cavity or implantable container.

80. The method of claim 72, wherein when the implant is implanted into the cavity, the packing density of the cortical bone units in the cavity is of about 0.5 g/cc to about 1.0 g/cc based on dry weight of the cortical bone units.