Methods, devices, and preparations for intervertebral disc treatment

• US 20040010251A1
• Filed: 12/10/2002
• Published: 01/15/2004
• Est. Priority Date: 12/10/2001
• Status: Abandoned Application

• Current Assignee: Datum Biotech, Ltd.
• Original Assignee: Datum Biotech, Ltd.
• Inventors: Pitaru, Shahar, Noff, Matitiau
• Application Number:
  US10/315,220
• Publication Number:
  US 20040010251A1
• Time in Patent Office: Days
• US Class Current: 606/53
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/044 Collagen

Abstract

A therapeutic method for treating mammalian intervertebral discs. A preparation of cross-linked collagen is injected under pressure into the intra-discal space. The intervertebral distance in injected discs is immediately increased by the treatment. At least some mechanical properties of the treated vertebral column are preserved or partially restored. The method may be used to relieve back pain in patients, to increase patient height and to stabilized the spinal column. The therapeutic method may result in at least a partial regeneration of the nucleus pulposus, and/or development of cartilaginous or fibrocartilaginous tissues or dense fibrous tissues.

Claims

1. A method for treating a mammal with degenerative disc disease, the method comprises injecting into at least one intervertebral disc of said mammal a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar.

2. The method according to claim 1 wherein said the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

3. The method according to claim 1 wherein said injectable fluid is injected into said at least one intervertebral disc to reach an intra-discal pressure level within a range of 0.5-12 atmospheres.

4. The method according to claim 1 wherein said injectable fluid is injected into said at least one intervertebral disc to reach an intra-discal pressure level within a range of 5-8 atmospheres.

5. The method according to claim 1 wherein said reducing sugar is D(−

) ribose.

6. The method according to claim 1 wherein said collagen is reconstituted fibrillar atelopeptide collagen.

7. The method according to claim 1 wherein said mammal is a human patient and wherein said volume is within the range of 0.5-2.5 milliliter.

8. The method according to claim 1 wherein said mammal is a human patient and wherein said volume is within the range of 1.0-2.0 milliliter.

9. The method according to claim 1 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting through said needle said volume into the internal space within said disc to reach a pressure in said internal space in the range of 0.5-11 atmospheres.

10. The method according to claim 1 wherein the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

11. The method according to claim 1 wherein said cross-linked collagen comprises particles of fibrillar collagen.

12. A method for treating a mammal with degenerative disc disease, the method comprises pressure injecting into at least one intervertebral disc of said mammal a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar to reach a selected pressure level within said at least one disc.

13. The method according to claim 12 wherein said selected pressure level is within a range of 0.5-12 atmospheres.

14. The method according to claim 12 wherein said selected pressure level is within a range of 5-8 atmospheres.

15. The method according to claim 12 wherein said reducing sugar is D(−

) ribose.

16. The method according to claim 12 wherein said mammal is a human patient and wherein said volume is within the range of 0.5-2.5 milliliter.

17. The method according to claim 12 wherein said mammal is a human patient and wherein said volume is within the range of 1.0-2.0 milliliter.

18. The method according to claim 12 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting through said needle said volume into the internal space within said disc to reach a pressure in said internal space in the range of 0.5-12 atmospheres.

19. The method according to claim 12 wherein the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

20. A method for therapeutically preserving at least one mechanical property of a degenerative mammalian intervertebral disc, the method comprises pressure injecting into said disc a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar to reach a selected intra-discal pressure level within said at least one disc.

21. The method according to claim 20 wherein said selected intra-discal pressure level is within a range of 0.5-12 atmospheres.

22. The method according to claim 20 wherein said selected intra-discal pressure level is within a range of 5-8 atmospheres.

23. The method according to claim 20 wherein said reducing sugar is D(−

) ribose.

24. The method according to claim 20 wherein said mammalian disc is a human intervertebral disc and wherein said volume is within the range of 0.5-2.5 milliliter.

25. The method according to claim 20 wherein said mammalian disc is a human intervertebral disc and wherein said volume is within the range of 1.0-2.0 milliliter.

26. The method according to claim 20 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting through said needle said volume into the internal space within said disc to reach a pressure in said internal space in the range of 0.5-11 atmospheres.

27. The method according to claim 20 wherein said at least one mechanical property is selected from the spacing between the two vertebrae flanking said mammalian intervertebral disc, the flexional mechanical properties of said mammalian disc, and the torsional mechanical properties of said mammalian disc.

28. A therapeutic method for at least partially restoring at least one mechanical property of a degenerative mammalian spinal column or a part thereof, the method comprises pressure injecting into at least one intervertebral disc of said spinal column a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar to reach a selected pressure level within said at least one disc.

29. The method according to claim 28 wherein said at least one mechanical property is selected from the spacing between the two vertebrae flanking said at least one intervertebral disc, the flexional mechanical properties of said spinal column, and the torsional mechanical properties of said of said spinal column.

30. A method of therapeutically injecting a fluid comprising cross-linked collagen into a mammalian intervertebral disc, the method comprises injecting said fluid into the internal space of said disc using an injection pressure sufficient to elevate the intra-discal pressure to a selected pressure level.

31. The method according to claim 30 wherein said selected pressure level is in the range of 5.0-8.0 atmospheres.

32. The method according to claim 30 wherein said selected pressure level is in the range of 0.5-12.0 atmospheres.

33. The method according to claim 30 wherein said collagen is cross-linked with a reducing sugar.

34. The method according to claim 30 wherein said disc is a human intervertebral disc and wherein the volume of the injected fluid is within the range of 0.5-2.5 milliliter.

35. The method according to claim 30 wherein said disc is a human intervertebral disc and wherein the volume of the injected fluid is within the range of 1.0-2.0 milliliter.

36. The method according to claim 30 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said disc and injecting said fluid through said needle into the internal space within said disc to reach an intra-discal pressure in said internal space in the range of 0.5-12 atmospheres.

37. The method according to claim 30 wherein the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

38. An injectable preparation for injecting into an intervertebral disc for inducing fibrocartilage formation in vivo, the preparation comprising an injectable fluid comprising particles of collagen cross-linked with a reducing sugar.

39. The injectable preparation according to claim 38 wherein said reducing sugar is D(−

) ribose.

40. The injectable preparation according to claim 38 wherein the concentration of the cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable preparation.

41. A method for increasing the height of a patient having a hydrodynamic disc dysfunction in at least one intervertebral disc, the method comprises injecting into said at least one disc a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar to increase the distance between the two vertebrae attached to said at least one disc.

42. The method according to claim 41 wherein said increasing of height occurs during the injecting of said volume and is effective immediately after the injecting of said volume.

43. The method according to claim 41 wherein said injecting is performed to reach a selected intra-discal pressure level within a range of 0.5-12 atmospheres.

44. The method according to claim 41 wherein said injecting is performed to reach a selected intra-discal pressure level within a range of 5-8 atmospheres.

45. The method according to claim 41 wherein said reducing sugar is D(−

) ribose.

46. The method according to claim 41 wherein said volume is within the range of 0.5-2.5 milliliter.

47. The method according to claim 41 wherein said volume is within the range of 1.0-2.0 milliliter.

48. The method according to claim 41 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting through said needle said volume into the internal space within said disc to reach an intra-discal pressure level in the range of 0.5-12 atmospheres.

49. The method according to claim 41 wherein the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

50. A method for increasing the height of a patient having a hydrodynamic disc dysfunction in at least one intervertebral disc, the method comprises pressure injecting into said at least one disc a volume of an injectable fluid comprising collagen cross-linked with a reducing sugar to reach a selected intra-discal pressure level within said at least one disc.

51. The method according to claim 50 wherein said selected intra-discal pressure level within a range of 0.5-12 atmospheres.

52. The method according to claim 50 wherein said injecting is performed to reach a selected intra-discal pressure level within a range of 5-8 atmospheres.

53. The method according to claim 50 wherein said reducing sugar is D(−

) ribose.

54. The method according to claim 50 wherein said volume is within the range of 0.5-2.5 milliliter.

55. The method according to claim 50 wherein said volume is within the range of 1.0-2.0 milliliter.

56. The method according to claim 50 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting said volume through said needle into the internal space within said disc to reach an intra-discal pressure level in the range of 0.5-12 atmospheres.

57. The method according to claim 50 wherein the concentration of said cross-linked collagen is in the range of 35-90 milligrams per milliliter of said injectable fluid.

58. A method for relieving back pain resulting from degenerative disc disease in a patient, the method comprises injecting into at least one intervertebral disc of said patient a volume of an injectable preparation comprising a biocompatible biodurable material to increase the distance between the two vertebrae attached to said at least one disc.

59. The method according to claim 58 wherein said injecting comprises injecting into said at least one disc a volume of said injectable preparation sufficient to cause said increase of said distance immediately after said volume is injected.

60. The method according to claim 58 wherein said injecting comprises injecting into said at least one disc a volume of said injectable preparation sufficient to cause at least a partial relief of back pain immediately after said volume is injected.

61. The method according to claim 58 wherein said injectable preparation comprises a substance selected from collagen and hyaluronic acid.

62. The method according to claim 61 wherein said collagen is a cross-linked collagen and said hyaluronic acid is a cross-linked hyaluronic acid.

63. The method according to claim 58 wherein said injecting comprises injecting said injectable preparation to reach an intra-discal pressure sufficient to cause at least a partial relief of back pain immediately after said volume is injected.

64. The method according to claim 58 wherein said injecting comprises injecting said injectable preparation into said at least one disc to reach an intra-discal pressure level sufficient to cause said increase of said distance immediately after said volume is injected.

65. A method for at least partially restoring or preserving at least one mechanical property of at least one degenerative disc in a patient, the method comprises injecting into said at least one intervertebral disc of said patient a volume of an injectable preparation comprising a biocompatible biodurable material to increase the distance between the two vertebrae attached to said at least one disc.

66. The method according to claim 65 wherein said injecting comprises injecting into said at least one disc a volume of said injectable preparation sufficient to cause said increase of said distance immediately after said volume is injected.

67. The method according to claim 65 wherein said volume is in the range of 0.5-2.5 milliliters

68. The method according to claim 65 wherein said injecting comprises injecting into said at least one disc a volume of said injectable preparation sufficient to cause said at least partial restoring immediately after said volume is injected.

69. The method according to claim 65 wherein said injectable preparation comprises a substance selected from collagen and hyaluronic acid.

70. The method according to claim 69 wherein said collagen is a cross-linked collagen and said hyaluronic acid is a cross-linked hyaluronic acid.

71. The method according to claim 65 wherein said injecting comprises injecting said injectable preparation to reach an intra-discal pressure said at least partial restoring immediately after said volume is injected.

72. The method according to claim 65 wherein said injecting comprises injecting said injectable preparation into said at least one disc to reach an intra-discal pressure level sufficient to cause at least a p[artial restoring of said at least one mechanical property immediately after said volume is injected.

73. A method for treating a mammal with degenerative disc disease, the method comprises pressure injecting into at least one intervertebral disc of said mammal a volume of an injectable preparation comprising collagen to reach a selected pressure level within said at least one disc.

74. The method according to claim 73 wherein said selected pressure level is within a range of 0.5-12 atmospheres.

75. The method according to claim 73 wherein said selected pressure level is within a range of 5-8 atmospheres.

76. The method according to claim 73 wherein said collagen is a cross-linked collagen.

77. The method according to claim 76 wherein said cross-linked collagen is cross-linked by a reducing sugar.

78. The method according to claim 77 wherein said reducing sugar is D(−

) ribose.

79. The method according to claim 73 wherein said mammal is a human patient and wherein said volume is within the range of 0.5-2.5 milliliter.

80. The method according to claim 73 wherein said mammal is a human patient and wherein said volume is within the range of 1.0-2.0 milliliter.

81. The method according to claim 73 wherein said injecting is performed by inserting a needle having a gauge in the range of 22G-31G through the annulus fibrosus of said at least one disc and injecting said volume of said preparation through said needle into the internal space within said disc to reach a pressure in said internal space in the range of 0.5-12 atmospheres.

82. The method according to claim 73 wherein the concentration of said collagen in said injectable preparation is in the range of 35-90 milligrams collagen per milliliter of said injectable preparation.

83. The method according to claim 73 wherein said injecting comprises injecting said injectable preparation into said at least one disc to reach an intra-discal pressure level sufficient to cause at least a partial restoring of at least one mechanical property of said at least one disc immediately after said volume is injected.

84. A method for inducing at least a partial regeneration of the nucleus pulposus, or development of cartilaginous tissue or fibrocartilaginous tissue or dense fibrous tissues in a degenerative mammalian intervertebral disc, the method comprising injecting into said disc an injectable preparation comprising collagen cross-linked with a reducing sugar.

85. The method according to claim 84 wherein said reducing sugar is D(−

) ribose.

86. The method according to claim 84 wherein said cross-linked collagen comprises particles of fibrillar reconstituted atelopeptide collagen.

87. The method according to claim 84 wherein said mammalian disc is a human disc.