Methods of performing medical procedures which promote bone growth, compositions which promote bone growth, and methods of making such compositions

• US 20040127563A1
• Filed: 03/24/2003
• Published: 07/01/2004
• Est. Priority Date: 03/22/2002
• Status: Abandoned Application

• Current Assignee: Doctors Research Group, Inc. (Abyrx, Inc.)
• Original Assignee: Doctors Research Group, Inc. (Abyrx, Inc.)
• Inventors: Deslauriers, Richard J.
• Application Number:
  US10/395,001
• Publication Number:
  US 20040127563A1
• Time in Patent Office: Days
• US Class Current: 514/547
• CPC Class Codes: A61K 31/225 Polycarboxylic acids
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

In an exemplary embodiment of the present invention, a method of performing a medical procedure includes the step of applying a particular material to a portion of a bone of a mammal. The particular material includes at least one glyceride and stimulates bone growth. For example, cyclic adenosine monophosphate regulated lipases may metabolize the particular material after the particular material is applied to the bone. The at least one glyceride of the particular material and water within the mammal then may be converted into glycerol, fatty acid, and protons, which stimulates a conversion of osteoprogenitor cells into osteoblast cells. Subsequently, the glycerol and the fatty acid may be oxidized, and the oxidation may stimulate the conversion of adenosine diphosphate within the mammal into adenosine triphosphate. The osteoblast cells then may convert the adenosine triphosphate into adenosine diphosphate, such that energy is released. Moreover, the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal, which creates the bone growth.

Claims

1. A method of performing a medical procedure, comprising the step of applying a particular material to at least one portion of a bone of a mammal, wherein the particular material comprises at least one glyceride and stimulates bone growth.

2. The method of claim 1, wherein the particular material stimulates the conversion of at least one osteoprogenitor cell into an osteoblast cell.

3. The method of claim 1, wherein at least one portion of the particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the particular material is applied to the at least one portion of the bone.

4. The method of claim 3, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the particular material, the at least one glyceride of the particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

5. The method of claim 4, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

6. The method of claim 5, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

7. The method of claim 6, wherein the synthesis of the Type-I collagen proteins create bone.

8. The method of claim 1, wherein the particular material is each of adhesive and cohesive.

9. The method of claim 1, wherein the particular material is each of bacterial static and bactericidal.

10. The method of claim 1, wherein the at least one glyceride comprises a first glyceride, a second glyceride, and a third glyceride.

11. The method of claim 10, wherein the second glyceride is different than the first glyceride, and the third glyceride is different than each of the first glyceride and the second glyceride.

12. The method of claim 1, further comprising the step of combining a first material and a second material to generate the particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

13. The method of claim 12, wherein the combining step is performed before the applying step.

14. The method of claim 12, wherein at least one of the first material and the second material is partially polymerized.

15. The method of claim 12, wherein when the first material is combined with the second material to generate the particular material, the maximum reaction temperature of the particular material is less than a predetermined temperature.

16. The method of claim 15, wherein the predetermined temperature is about 45°

C.

17. The method of claim 1, wherein the particular material conforms to a shape of the at least one portion of the bone when the particular material is applied to the at least one portion of the bone.

18. The method of claim 1, wherein the particular material is a liquid and transforms into a solid after the applying step.

19. The method claim 1, further comprising the step of increasing a temperature of the particular material before or after the applying step.

20. The method claim 1, further comprising the step of decreasing a temperature of the particular material before or after the applying step.

21. The method of claim 1, wherein the particular material is osteoconductive.

22. The method of claim 1, wherein the particular material is osteoinductive.

23. The method of claim 1, further comprising the step of injecting at least one of air, gas, and a fluid inside the particular material.

24. The method of claim 23, wherein the injecting step is performed after the applying step.

25. The method of claim 24, wherein the combining step is performed before the applying step.

26. The method of claim 1, wherein the particular material further comprises at least one of calcium, calcium carbonate, calcium hydroxyapatite, calcium phosphate, barium sulfate, hydroxyapatite salt, and bone suspended within the particular material.

27. The method of claim 1, wherein the particular material is applied to the at least one portion of the bone by inserting a needle through a skin of the mammal.

28. The method of claim 1, wherein the medical procedure is a surgical procedure.

52. The method of claim 23, wherein the injecting step is performed after the dispensing step.

53. The method of claim 24, wherein the combining step is performed before the dispensing step.

29. A method of performing a medical procedure, comprising the step of dispensing a particular material into an opening formed within or through at least one portion of a bone of a mammal, wherein the particular material comprises at least one glyceride and stimulates bone growth within the opening.

30. The method of claim 29, wherein the particular material stimulates the conversion of at least one osteoprogenitor cell into an osteoblast cell.

31. The method of claim 29, wherein at least one portion of the particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the particular material is dispensed within the opening.

32. The method of claim 31, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the particular material, the at least one glyceride of the particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

33. The method of claim 32, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

34. The method of claim 33, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

35. The method of claim 34, wherein the synthesis of the Type-I collagen proteins create the bone growth.

36. The method of claim 29, wherein the particular material is each of adhesive and cohesive.

37. The method of claim 29, wherein the particular material is each of bacterial static and bactericidal.

38. The method of claim 29, wherein the at least one glyceride comprises a first glyceride, a second glyceride, and a third glyceride.

39. The method of claim 38, wherein the second glyceride is different than the first glyceride, and the third glyceride is different than each of the first glyceride and the second glyceride.

40. The method of claim 29, further comprising the step of combining a first material and a second material to generate the particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

41. The method of claim 40, wherein the combining step is performed before the dispensing step.

42. The method of claim 40, wherein at least one of the first material and the second material is partially polymerized.

43. The method of claim 40, wherein when the first material is combined with the second material to generate the particular material, the maximum reaction temperature of the particular material is less than a predetermined temperature.

44. The method of claim 43, wherein the predetermined temperature is about 45°

C.

45. The method of claim 29, wherein the particular material conforms to a shape of the opening when the particular material is dispensed within the opening.

46. The method of claim 29, wherein the particular material is a liquid and transforms into a solid after the dispensing step.

47. The method claim 29, further comprising the step increasing a temperature of the particular material before or after the dispensing step.

48. The method claim 29, further comprising the step decreasing a temperature of the particular material before or after the dispensing step.

49. The method of claim 29, wherein the particular material is osteoconductive.

50. The method of claim 29, wherein the particular material is osteoinductive.

51. The method of claim 29, further comprising the step of injecting at least one of air, gas, and a fluid inside the particular material.

54. The method of claim 29, wherein the particular material further comprises at least one of calcium, calcium carbonate, calcium hydroxyapatite, calcium phosphate, barium sulfate, hydroxyapatite salt, and bone suspended within the particular material.

55. The method of claim 29, wherein the particular material is dispensed within the opening by inserting a needle through a skin of the mammal.

56. The method of claim 29, further comprising the step of applying a pressure to a skin of the mammal after a completion of the dispensing step, wherein applying the pressure altars a shape of the particular material within the opening.

57. The method of claim 29, wherein the medical procedure is a surgical procedure.

58. A method of performing a medical procedure, comprising the steps of:

forming a mold;

dispensing a liquid, particular material into the mold, wherein the particular material solidifies within the mold and comprises at least one glyceride;

removing the solidified, particular material from the mold; and

implanting the solidified, particular material into an opening formed within or through at least one portion of a bone of a mammal, wherein the implanted, particular material stimulates bone growth.

59. The method of claim 58, further comprising the step of obtaining a medical scan of the at least one portion of the bone, wherein the mold is formed based on the medical scan.

60. The method of claim 59, wherein the medical scan is at least one of an X-ray, a Magnetic Resonance Imaging, and a Computer Tomography.

61. The method of claim 58, wherein at least one portion of the solidified, particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the solidified, particular material is implanted within the opening.

62. The method of claim 61, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the solidified, particular material, the at least one glyceride of the solidified, particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

63. The method of claim 62, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

64. The method of claim 63, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

65. The method of claim 64, wherein the synthesis of the Type-I collagen proteins create the bone growth.

66. The method of claim 58, further comprising the step of combining a first material and a second material to generate the liquid, particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

67. The method of claim 66, wherein the combining step is performed before the dispensing step.

68. The method of claim 66, wherein at least one of the first material and the second material is partially polymerized.

69. The method of claim 58, wherein the medical procedure is a surgical procedure.

70. A method of performing a medical procedure, comprising the steps of:

forming a mold;

dispensing a liquid, particular material into the mold, wherein the particular material solidifies within the mold and comprises at least one glyceride;

removing the solidified, particular material from the mold; and

positioning the solidified, particular material on at least one portion of a bone of a mammal, wherein the positioned, particular material stimulates bone growth.

71. The method of claim 70, further comprising the step of obtaining a medical scan of the at least one portion of the bone, wherein the mold is formed based on the medical scan.

72. The method of claim 71, wherein the medical scan is at least one of an X-ray, a Magnetic Resonance Imaging, and a Computer Tomography.

73. The method of claim 70, wherein at least one portion of the solidified, particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the solidified, particular material is positioned on the at least one portion of the bone.

74. The method of claim 73, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the solidified, particular material, the at least one glyceride of the solidified, particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

75. The method of claim 74, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

76. The method of claim 75, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

77. The method of claim 76, wherein the synthesis of the Type-I collagen proteins create the bone growth.

78. The method of claim 70, further comprising the step of combining a first material and a second material to generate the liquid, particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

79. The method of claim 78, wherein the combining step is performed before the dispensing step.

80. The method of claim 78, wherein at least one of the first material and the second material is partially polymerized.

81. The method of claim 70, wherein the medical procedure is a surgical procedure.

82. A method of performing a medical procedure, comprising the step of injecting a particular material into a bone of a mammal, wherein the particular material comprises at least one glyceride and stimulates bone growth within the bone.

83. The method of claim 82, wherein the particular material is injected into the bone using a needle which is inserted into the bone to form an opening within the bone.

84. The method of claim 83, wherein the needle is inserted through a skin of the mammal before the needle is inserted into the bone.

85. The method of claim 82, wherein at least one portion of the particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the particular material is injected into the bone.

86. The method of claim 85, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the particular material, the at least one glyceride of the solidified, particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

87. The method of claim 86, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

88. The method of claim 87, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

89. The method of claim 88, wherein the synthesis of the Type-I collagen proteins create the bone growth.

90. The method of claim 82, further comprising the step of combining a first material and a second material to generate the particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

91. The method of claim 90, wherein the combining step is performed before the injecting step.

92. The method of claim 90, wherein at least one of the first material and the second material is partially polymerized.

93. The method of claim 82, wherein the medical procedure is a surgical procedure.

94. A method of performing a medical procedure, comprising the step of positioning a particular material between a first bone portion of a mammal and a second bone portion of the mammal, wherein the particular material comprises at least one glyceride and stimulates a growth of a third bone portion which fuses the first bone portion to the second bone portion.

95. The method of claim 94, wherein the positioning step comprises the substeps of:

injecting the particular material into a balloon; and

positioning the balloon between the first bone portion and the second bone portion.

96. The method of claim 94, wherein a particular bone comprises each of the first bone portion and the second bone portion.

97. The method of claim 94, wherein a particular bone comprises the first bone portion and a further bone comprises the second bone portion.

98. The method of claim 97, wherein the particular bone is a first vertebra of a spine of the mammal and the further bone is a second vertebra of the spine.

99. The method of claim 94, wherein at least one portion of the particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the particular material is positioned between the first bone portion and the second bone portion.

100. The method of claim 99, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the particular material, the at least one glyceride of the particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

101. The method of claim 100, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

102. The method of claim 101, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

103. The method of claim 102, wherein the synthesis of the Type-I collagen proteins create the growth of the third bone portion.

104. The method of claim 94, further comprising the step of combining a first material and a second material to generate the particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

105. The method of claim 104, wherein the combining step is performed before the positioning step.

106. The method of claim 104, wherein at least one of the first material and the second material is partially polymerized.

107. The method of claim 94, wherein the medical procedure is a surgical procedure.

108. A method of performing a medical procedure, comprising the steps of:

positioning at least one suture within an opening formed within or through at least one portion of a bone of a mammal; and

dispensing a particular material into the opening, wherein the particular material comprises at least one glyceride and stimulates bone growth within the opening.

109. The method of claim 108, further comprising the steps of:

forming the opening before positioning the at least one suture within the opening; and

applying one of a liquid and a powder to the suture.

110. The method of claim 108, wherein at least one portion of the particular material is metabolized by cyclic adenosine monophosphate regulated lipases after the particular material is dispensed into the opening.

111. The method of claim 110, wherein when the cyclic adenosine monophosphate regulated lipase metabolizes the at least one portion of the particular material, the at least one glyceride of the particular material and water within the mammal is converted into glycerol, fatty acid, and protons, which stimulates a conversion of at least one osteoprogenitor cell into an osteoblast cell.

112. The method of claim 111, wherein after the conversion of the at least one glyceride of the particular material and the water within the mammal into glycerol, fatty acid, and protons, at least one of the glycerol and the fatty acid is oxidized, and the oxidation stimulates the conversion of adenosine diphosphate within the mammal into adenosine triphosphate.

113. The method of claim 112, wherein after the conversion of the adenosine diphosphate within the mammal into adenosine triphosphate, the osteoblast cells convert the adenosine triphosphate into adenosine diphosphate, such that energy is released and the osteoblast cells use the energy to synthesize at least Type-I collagen proteins within the mammal.

114. The method of claim 113, wherein the synthesis of the Type-I collagen proteins create the bone growth.

115. The method of claim 108, further comprising the step of combining a first material and a second material to generate the particular material, wherein the first material comprises:

a first amount of a hydroxyl functional group derived from a vegetable oil; and

a second amount of an isocyanate or a di-isocyanate, wherein a ratio between the second amount and the first amount is greater than a 1;

1 molar ratio, and wherein the second material comprises a molecule with two or more free hydroxyl functional groups in chain.

116. The method of claim 115, wherein the combining step is performed before the dispensing step.

117. The method of claim 115, wherein at least one of the first material and the second material is partially polymerized.

118. The method of claim 108, wherein the medical procedure is a surgical procedure.

119. A method of performing a medical procedure, comprising the steps of:

forming a mold;

dispensing a liquid, particular material into the mold, wherein the particular material solidifies within the mold and comprises at least one glyceride, and wherein the mold comprises at least one of a mold for a screw, a mold for a plate, and a mold for a prosthetic member;

removing the solidified, particular material from the mold; and

positioning the solidified, particular material one of on a bone of a mammal and within an opening formed within the bone, wherein the solidified, particular material stimulates bone growth.

120. A method of performing a medical procedure, comprising the step of positioning a particular material in the vicinity of a bone of a mammal, wherein the particular material comprises at least one glyceride.

121. The method of claim 120, wherein the positioning step comprises the substep of applying the particular material to at least one portion of the bone.

122. The method claim 121, wherein the positioning step comprises the substep of dispensing the particular material in an opening formed within or through the bone.

123. The method claim 121, wherein the positioning step comprises the substep of injecting the particular material into the bone.

124. A method of making a composition used in a medical procedure, comprising the steps of:

combining unsaturated vegetable oil ester with adipate to form a first composition; and

combining the first composition with vegetable oil polyols to form a second composition.

125. The method of claim 124, wherein the second composition stimulates bone growth when the second composition contacts or is positioned in the vicinity of a bone of a mammal.

126. The method of claim 124, wherein the first composition is formed using a recombinant DNA procedure

127. The method of claim 124, wherein the first composition is formed using an enzymatic reaction procedure.

128. The method of claim 124, wherein the first composition is formed using an isocyanate based organic synthesis reaction procedure.

129. A particular composition, comprising:

unsaturated vegetable oil ester;

adipate; and

vegetable oil polyols, wherein the unsaturated vegetable oil ester is combined with the adipate to form a further composition, and the further composition is combined with the vegetable oil polyols to form the particular composition.

130. The particular composition of claim 129, wherein the particular composition stimulates bone growth when the particular composition contacts or is positioned in the vicinity of a bone of a mammal.

131. The particular composition of claim 129, wherein the particular composition uniformly expands a predetermined amount of time after the further composition is combined with the vegetable oil polyols.