Methods of treating spinal injuries using injectable flowable compositions comprising organic materials

• US 20080058954A1
• Filed: 08/22/2006
• Published: 03/06/2008
• Est. Priority Date: 08/22/2006
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai
• Application Number:
  US11/507,682
• Publication Number:
  US 20080058954A1
• Time in Patent Office: Days
• US Class Current: 623/23.62
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30593 hollow
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• 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 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The instant invention discloses novel methods of treating vertebrae, intervertebral discs, and facet joints by administering to these areas or to the implants in these areas a flowable composition comprising an organic material capable of being cured or polymerized in vivo.

Claims

1. A method of treating a patient having a fractured vertebra comprising administering to said fractured vertebra a flowable composition comprising an organic material, capable of being cured or polymerized into a solid substance in vivo, said solid substance having an elastic modulus of at least about 100 MPa, wherein at least about 50% of said solid substance is bioresorbed or biodegraded within 10 years from the curing or polymerization.

2. The method of claim 1, wherein said flowable composition is capable of being administered through a delivery device comprising a channel having a cross-section not larger than about 8 G.

3. The method of claim 2, wherein the delivery device is a needle or a cannula.

4. The method of claim 1, wherein a fracture of the fractured vertebra is a compression fracture.

5. The method of claim 1, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, and tyrosin-polycarbonate.

6. The method of claim 1, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

7. The method of claim 1, wherein the flowable composition comprises at least two components.

8. The method of claim 7, wherein:

at least one of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, tyrosin-polycarbonate, and any combination thereof; and

at least a second of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

9. The method of claim 7, wherein said organic material comprises:

a monomer or an oligomer of lactic acid; and

a monomer or an oligomer of silicone or polyurethane.

10. The method of claim 7, wherein a mixing of the at least two components initiates curing.

11. The method of claim 7, wherein the at least two components of the flowable composition are mixed no more than about 2 minutes prior to administering the flowable composition.

12. The method of claim 1, wherein the curing or polymerizing of the organic material is activated by an application of energy.

13. The method of claim 12, wherein the energy is selected from the group consisting of light energy, heat energy, radiation energy, electrical energy, mechanical energy and any combination thereof.

14. The method of claim 13, wherein the energy is applied before, during, or after administering the flowable composition.

15. The method of claim 1, wherein the polymerization of the organic material has a peak temperature not higher than approximately 75°

C. per volume of the administered flowable composition.

16. The method of claim 1, wherein the flowable composition further comprises at least one additive.

17. The method of claim 16, wherein the at least one additive is selected from the group consisting of growth factors, analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, a biomaterial, and any combinations thereof.

18. The method of claim 17, wherein the at least one additive is selected from the group consisting of BMP-2 and LMP-1.

19. The method of claim 17, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

20. The method of claim 16, wherein the at least one additive is in a sustained-release formulation.

21. The method of claim 1, wherein the solid substance is porous.

22. A method of treating a patient having a back pain caused by a degenerative facet joint or a degenerative disc disease comprising administering into the degenerative facet joint or the degenerating disc a flowable composition comprising an organic material, capable of being cured or polymerized into a solid substance in vivo, said solid substance having an elastic modulus of at least about 1 MPa, wherein at least about 50% of said solid substance is bioresorbed or biodegraded within 10 years from the curing or polymerization.

23. The method of claim 22, wherein said flowable composition is administered by an injection.

24. The method of claim 23, wherein the injection is a percutaneous injection.

25. The method of claim 22, wherein said flowable composition is capable of being administered through a delivery device comprising a channel having a cross-section not larger than about 12 G.

26. The method of claim 25, wherein the delivery device is a needle or a cannula.

27. The method of claim 22, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, and tyrosin-polycarbonate.

28. The method of claim 22, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

29. The method of claim 22, wherein the flowable composition comprises at least two components.

30. The method of claim 29, wherein:

at least one of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, tyrosin-polycarbonate, and any combination thereof; and

at least a second of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

31. The method of claim 29, wherein said organic material comprises:

a monomer or an oligomer of lactic acid; and

a monomer or an oligomer of silicone or polyurethane.

32. The method of claim 29, wherein a mixing of the at least two components initiates curing.

33. The method of claim 29, wherein the at least two components of the flowable composition are mixed no more than about 2 minutes prior to administering the flowable composition.

34. The method of claim 22, wherein the curing or polymerizing of the organic material is activated by an application of energy.

35. The method of claim 34, wherein the energy is selected from the group consisting of light energy, heat energy, radiation energy, electrical energy, mechanical energy and any combination thereof.

36. The method of claim 34, wherein the energy is applied before, during, or after administering the flowable composition.

37. The method of claim 22, wherein the polymerization of the organic material has a peak temperature not higher than approximately 75°

C. per volume of the administered flowable composition.

38. The method of claim 22, wherein said flowable composition is administered for a non-fusion stabilization of the degenerative facet joint or the degenerating disc.

39. The method of claim 38, wherein the flowable composition further comprises at least one additive.

40. The method of claim 39, wherein the at least one additive is selected from the group consisting of analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, agents preventing cell motility, a biomaterial, and any combinations thereof.

41. The method of claim 40, wherein the at least one additive is selected from the group consisting of BMP-2 and LMP-1.

42. The method of claim 40, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

43. The method of claim 39, wherein the at least one additive is in a sustained-release formulation.

44. The method of claim 38, wherein the solid substance is essentially non-porous.

45. The method of claim 22, wherein said flowable composition is administered for a fusion stabilization of the degenerative facet joint or the vertebrae separated by the degenerating disc.

46. The method of claim 45, wherein the flowable composition further comprises at least one additive.

47. The method of claim 46, wherein the at least one additive is selected from the group consisting of growth factors, analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, a biomaterial, and any combinations thereof.

48. The method of claim 47, wherein the at least one additive is selected from the group consisting of BMP-2 and LMP-1.

49. The method of claim 47, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

50. The method of claim 45, wherein the solid substance is porous.

51. The method of claim 45, wherein the solid substance has a Young'"'"'s modulus of at least about 50 MPa.

52. The method of claim 22, wherein no tissue is removed prior to the administering of the composition.

53. A method of preventing an adhesion of a first tissue to at least a second tissue after a surgery comprising administering to the first tissue a flowable composition comprising an organic material, capable of being cured or polymerized into a film in vivo, said film having an elastic modulus of at least about 50 MPa, wherein at least about 50% of said film is bioresorbed or biodegraded within 10 years from the curing or polymerization.

54. The method of claim 53, wherein the first tissue is an implant.

55. The method of claim 53, wherein the flowable composition is administered by spraying, misting, aerosol-spraying, brushing, squirting, soaking or a combination thereof.

56. The method of claim 53, further comprising administering the flowable composition to the at least the second tissue.

57. The method of claim 53, wherein the film is non-porous or essentially non-porous.

58. The method of claim 53, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, and tyrosin-polycarbonate.

59. The method of claim 53, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

60. The method of claim 53, wherein the flowable composition comprises at least two components.

61. The method of claim 60, wherein:

at least one of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, tyrosin-polycarbonate, and any combination thereof; and

at least a second of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

62. The method of claim 60, wherein said organic material is wherein said organic material comprises:

a monomer or an oligomer of lactic acid; and

a monomer or an oligomer of silicone or polyurethane.

63. The method of claim 60, wherein a mixing of the at least two components initiates curing.

64. The method of claim 60, wherein the at least two components of the flowable composition are mixed no more than about 2 minutes prior to administering the flowable composition.

65. The method of claim 53, wherein the curing or polymerizing of the organic material is activated by an application of energy.

66. The method of claim 65, wherein the energy is selected from the group consisting of light energy, heat energy, radiation energy, electrical energy, mechanical energy and any combination thereof.

67. The method of claim 65, wherein the energy is applied before, during, or after administering the flowable composition.

68. The method of claim 53, wherein the polymerization of the organic material has a peak temperature not higher than approximately 75°

C. per volume of the administered flowable composition.

69. The method of claim 53, wherein the flowable composition further comprises at least one additive.

70. The method of claim 69, wherein the at least one additive is selected from the group consisting of growth factors, analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, a biomaterial, and any combinations thereof.

71. The method of claim 70, wherein the at least one additive is an anti-inflammatory agent.

72. The method of claim 70, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

73. The method of claim 69, wherein the at least one additive is in a sustained-release formulation.

74. A method of tissue augmentation comprising:

administering to a tissue in need thereof a flowable composition comprising an organic material, capable of being cured or polymerized into a solid substance in vivo, said solid substance having an elastic modulus of at least about 1 MPa, wherein at least about 50% of said solid substance is bioresorbed or biodegraded within 10 years from the curing or polymerization.

75. The method of claim 74, wherein the tissue in need of augmentation comprises a tissue void formed between an implant and walls of a surrounding tissue.

76. The method of claim 74, wherein the solid substance is porous.

77. The method of claim 74, wherein said flowable composition is capable of being administered through a delivery device comprising a channel having a cross-section not larger than about 12 G.

78. The method of claim 74, wherein the delivery device is a needle or a cannula.

79. The method of claim 74, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, and tyrosin-polycarbonate.

80. The method of claim 74, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

81. The method of claim 74, wherein the flowable composition comprises at least two components.

82. The method of claim 81, wherein:

at least one of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, tyrosin-polycarbonate, and any combination thereof; and

at least a second of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

83. The method of claim 81, wherein said organic material comprises:

a monomer or an oligomer of lactic acid; and

a monomer or an oligomer of silicone or polyurethane.

84. The method of claim 81, wherein a mixing of the at least two components initiates curing.

85. The method of claim 81, wherein the at least two components of the flowable composition are mixed no more than about 2 minutes prior to administering the flowable composition.

86. The method of claim 74, wherein the curing or polymerizing of the organic material is activated by an application of energy.

87. The method of claim 86, wherein the energy is selected from the group consisting of light energy, heat energy, radiation energy, electrical energy, mechanical energy and any combination thereof.

88. The method of claim 86, wherein the energy is applied before, during, or after administering the flowable composition.

89. The method of claim 74, wherein the polymerization of the organic material has a peak temperature not higher than approximately 75°

C. per volume of the administered flowable composition.

90. The method of claim 74, wherein the flowable composition further comprises at least one additive.

91. The method of claim 90, wherein the at least one additive is selected from the group consisting of growth factors, analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, a biomaterial, and any combinations thereof.

92. The method of claim 91, wherein the at least one additive is selected from the group consisting of BMP-2 and LMP-1.

93. The method of claim 91, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

94. The method of claim 90, wherein the at least one additive is in a sustained-release formulation.

95. The method of claim 75, wherein the implant comprises a device selected from the group consisting of cages, bladders, balloons, pouches, nucleus pulposus implants, intervertebral disc implants, corpectomy devices, cervical plates, lumbar plates, anterior spinal rods, posterior spinal rods, screws, pins, intervertebral spacers, interspinous spacers, and facet implants.

96. The method of claim 74, wherein the tissue in need of augmentation is a soft tissue.

97. The method of claim 74, wherein the tissue in need of augmentation is a hard tissue.

98. The method of claim 97, wherein the Young'"'"'s modulus of the solid structure is at least about 50 MPa.

99. A method of treating a tissue defect comprising:

inserting an inflatable device into the tissue defect;

inflating the inflatable device with a flowable composition comprising an organic material, capable of being cured or polymerized into a solid substance in vivo, said solid substance having an elastic modulus of at least about 5 MPa, wherein at least about 50% of said solid substance is bioresorbed or biodegraded within 10 years from the curing or polymerization.

100. The method of claim 99, wherein the inflating of the inflatable device is performed after inserting the inflatable device into the tissue defect.

101. The method of claim 99, wherein the inflatable device is selected from the group consisting of cages, bladders, balloons, pouches, nucleus pulposus implants, intervertebral disc implants, corpectomy devices, cervical plates, lumbar plates, anterior spinal rods, posterior spinal rods, screws, pins, intervertebral spacers, interspinous spacers, and facet implants.

102. The method of claim 99, wherein the inflatable device comprises a semi-permeable outer shell.

103. The method of claim 99, wherein the outer shell of the inflatable device is bioresorbable.

104. The method of claim 99, wherein said flowable composition is capable of being administered through a delivery device comprising a channel having a cross-section not larger than about 12 G.

105. The method of claim 104, wherein the delivery device is a needle or a cannula.

106. The method of claim 99, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, and tyrosin-polycarbonate.

107. The method of claim 99, wherein the flowable composition comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

108. The method of claim 99, wherein the flowable composition comprises at least two components.

109. The method of claim 108, wherein:

at least one of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of lactic acid, glycolic acid, lactide-co-glycolides, anhydrides, orthoesters, caprolactone, tyrosin-polycarbonate, and any combination thereof; and

at least a second of the at least two components comprises a monomer, an oligomer, a polymer, or a combination thereof of any member of the group consisting of an isocyanate-containing compound, an aldehydes-containing compound, a vinyl alcohol-containing compound, a polyol-containing compound, polyurethane, silicone, acrylic acid, cyanoacrylate, methacrylate, epoxy, and any combination thereof.

110. The method of claim 108, wherein said organic material comprises:

a monomer or an oligomer of lactic acid; and

a monomer or an oligomer of silicone or polyurethane.

111. The method of claim 108, wherein a mixing of the at least two components initiates curing.

112. The method of claim 108, wherein the at least two components of the flowable composition are mixed no more than about 2 minutes prior to administering the flowable composition.

113. The method of claim 99, wherein the curing or polymerizing of the organic material is activated by an application of energy.

114. The method of claim 113, wherein the energy is selected from the group consisting of light energy, heat energy, radiation energy, electrical energy, mechanical energy and any combination thereof.

115. The method of claim 113, wherein the energy is applied before, during, or after administering the flowable composition.

116. The method of claim 99, wherein the polymerization of the organic material has a peak temperature not higher than approximately 75°

C. per volume of the administered flowable composition.

117. The method of claim 99, wherein the flowable composition further comprises at least one additive.

118. The method of claim 117, wherein the at least one additive is selected from the group consisting of growth factors, analgetics, anesthetics, antibiotics, anti-inflammatory agents, radiocontrast agents, a biomaterial, and any combinations thereof.

119. The method of claim 118, wherein the at least one additive is selected from the group consisting of BMP-2 and LMP-1.

120. The method of claim 118, wherein the radiocontrast agent is a gadodiamine based radiocontrast agent.

121. The method of claim 117, wherein the at least one additive is in a sustained-release formulation.