Patent
Methods and Apparatus for Manufacturing Plasma Based Plastics and Bioplastics Produced Therefrom
| العنوان: | Methods and Apparatus for Manufacturing Plasma Based Plastics and Bioplastics Produced Therefrom |
|---|---|
| Document Number: | 20080286329 |
| تاريخ النشر: | November 20, 2008 |
| Appl. No: | 12/104728 |
| Application Filed: | April 17, 2008 |
| مستخلص: | Blood-derived plastic articles prepared from compositions including blood and, in some embodiments, at least one crosslinking agent and/or at least one biological response modifier, that can be useful for biological applications such as wound repair and tissue grafts; methods of making and using the same; methods for assessing the concentration of a biological response modifier in an article; and systems for preparing blood-derived plastic articles are provided. |
| Inventors: | Campbell, Phil G. (Pittsburgh, PA, US); Burgess, James E. (Gibsonia, PA, US); Weiss, Lee E. (Pittsburgh, PA, US); Smith, Jason (Pittsburgh, PA, US) |
| Assignees: | CARNEGIE MELLON UNIVERSITY (Pittsburgh, PA, US), ALLEGHENY-SINGER RESEARCH INSTITUTE (Pittsburgh, PA, US), CARMELL, LLC (Pittsburgh, PA, US) |
| Claim: | 1. A blood-derived plastic article comprising at least one biological response modifier. |
| Claim: | 2. The blood-derived plastic article according to claim 1, wherein the article is prepared from a composition comprising blood. |
| Claim: | 3. The blood-derived plastic article according to claim 2, wherein the blood comprises the at least one biological response modifier. |
| Claim: | 4. The blood-derived plastic article according to claim 2, wherein the blood is obtained from an autologous donor. |
| Claim: | 5. The blood-derived plastic article according to claim 2, wherein the blood is obtained from allogeneic donors. |
| Claim: | 6. The blood-derived plastic article according to claim 2, wherein the blood is whole blood. |
| Claim: | 7. The blood-derived plastic article according to claim 2, wherein the blood is blood plasma. |
| Claim: | 8. The blood-derived plastic article according to claim 7, wherein the blood plasma is pre-treated prior to mixing with other components of the composition to increase the concentration of platelets compared to the concentration of platelets of the blood plasma prior to such treatment. |
| Claim: | 9. The blood-derived plastic article according to claim 2, wherein the blood is at least partially clotted. |
| Claim: | 10. The blood-derived plastic article according to claim 2, wherein the blood is at least partially dried. |
| Claim: | 11. The blood-derived plastic article according to claim 10, wherein the dried blood has a water content of about 5 to about 15 weight percent on a basis of total weight of the dried blood. |
| Claim: | 12. The blood-derived plastic article according to claim 10, wherein the average particle size of the at least partially dried blood is less than about 500 μm prior to mixing with other components of the composition. |
| Claim: | 13. The blood-derived plastic article according to claim 12, wherein the average particle size of the at least partially dried blood is less than about 150 μm prior to mixing with other components of the composition. |
| Claim: | 14. The blood-derived plastic article according to claim 13, wherein the average particle size of the at least partially dried blood is less than about 38 μm prior to mixing with other components of the composition. |
| Claim: | 15. The blood-derived plastic article according to claim 1, wherein the biological response modifier is a bioactive protein selected from the group consisting of hormones, growth factors, cytokines, extracellular matrix molecules and mixtures thereof. |
| Claim: | 16. The blood-derived plastic article according to claim 14, wherein the bioactive protein comprises at least one growth factor selected from the group consisting of platelet derived growth factors (PDGF), acidic and basic fibroblast growth factors, transformation growth factor beta (TGF-beta), insulin like growth factors (IGF), epidermal growth factors (EGF), platelet-derived angiogenesis factors (PDAF), platelet-derived endothelial growth factors (PDEGF), tumor necrosis factor-alpha (TNF-α), tumor necrosis factor-beta (TNF-β), vascular endothelial growth factors (VEGF), epithelial cell growth factors (ECGF), granulocyte-colony stimulating factors (G-CSF), granulocyte-macrophage colony stimulating factors (GM-CSF), nerve growth factors (NGF), neurotrophins, erythropoietin (EPO), thrombopoietin (TPO), myostatin (GDF-8), growth differentiation factor-9 (GDF9), hepatocyte growth factors (HGF), platelet factors, isoforms thereof and others and mixtures thereof. |
| Claim: | 17. The blood-derived plastic article according to claim 14, wherein the bioactive protein comprises at least one extracellular matrix molecule selected from the group consisting of osteocalcin, osteonectin, fibrinogen, vitronectin, fibronectin, thrombospondin 1 (TSP-1), bone sialoprotein (BSP), proteoglycans and mixtures thereof. |
| Claim: | 18. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one biological response modifier. |
| Claim: | 19. The blood-derived plastic article according to claim 18, wherein the at least one biological response modifier comprises about 1 picogram per grain of composition to about 20 milligrams per gram of composition. |
| Claim: | 20. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one plasticizer. |
| Claim: | 21. The blood-derived plastic article according to claim 20, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers and functionalized derivatives thereof, such as poly(ethylene glycol) diacrylate, water and mixtures thereof. |
| Claim: | 22. The blood-derived plastic article according to claim 21, wherein the at least one plasticizer is glycerol. |
| Claim: | 23. The blood-derived plastic article according to claim 20, wherein the at least one plasticizer comprises about 0.1 to about 80 weight percent of the components on a basis of total weight of the composition. |
| Claim: | 24. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one crosslinking agent. |
| Claim: | 25. The blood-derived plastic article according to claim 24, wherein the at least one crosslinking agent is selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins that are chemically different from the bioactive protein, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanadin, reuterin and mixtures thereof. |
| Claim: | 26. The blood-derived plastic article according to claim 25, wherein the iridoid derivative is genipin (Methyl (1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate). |
| Claim: | 27. The blood-derived plastic article according to claim 24, wherein the at least one crosslinking agent comprises about 0.01 to about 20 weight percent of the components on a basis of total weight of the components. |
| Claim: | 28. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one drug. |
| Claim: | 29. The blood-derived plastic article according to claim 28, wherein the drug is selected from the group consisting of analgesics; anti-infective agents such as antibiotics, antifungals and antivirals; antineoplastics such as antibiotics, antimetabolites, hormonal agonists/antagonists, androgens, immunomodulators, skin and mucous membrane agents and steroids; biologicals; blood modifiers such as anticoagulants, antiplatelet agents, colony stimulating factors, hematinics, hemorrheologic agents, hemostatics, thrombin inhibitors and thrombolytic agents; cardioprotective agents; cardiovascular agents such as adrenergic blockers, adrenergic stimulants, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, antiarrhythmics, antilipemic agents, beta adrenergic blocking agents, vasodilators, and vasopressors; cholinesterase inhibitors; hormones such as: anabolic steroids, androgens, estrogens and combinations, glucocorticoids and growth hormone; immunomodulators; immunosuppressives; ophthalmic preparations such as antibiotics, anti-infectives, anti-inflammatory agents and beta adrenergic blocking agents; respiratory agents such as anti-infective agents, anti-inflammatory agents, skin and mucous membrane agents such as analgesics, anti-infectives, antibiotics, antifungals, antivirals, antineoplastics, anti-cancer agents and mixtures thereof. |
| Claim: | 30. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one stabilizer. |
| Claim: | 31. The blood-derived plastic article according to claim 30, wherein the stabilizer is selected from the group consisting of glycogen, sorbitol, mannitol, trehalose, maltitol, xylitol, isomaltitol, erythritol, amylose, amylopectin, inositol hexasulfate, sulfated beta-cyclodextran, betaine, nontoxic polysaccharides represented by the formula Cn(H2O)n-1 where n is between 200 and 2500, antioxidants, and mixtures thereof. |
| Claim: | 32. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one filler. |
| Claim: | 33. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one particulate selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium phosphate, calcium sulfate and mixtures thereof. |
| Claim: | 34. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one porogen. |
| Claim: | 35. The blood-derived plastic article according to claim 34, wherein the at least one porogen is soluble in an aqueous phase. |
| Claim: | 36. The blood-derived plastic article according to claim 35, wherein the at least one porogen is sodium chloride. |
| Claim: | 37. The blood-derived plastic article according to claim 34, wherein the at least one porogen is a sublimation porogen. |
| Claim: | 38. The blood-derived plastic article according to claim 37, wherein the sublimation porogen is selected from the group consisting of ammonium acetate, ammonium chloride, ammonium sulfate, ammonium bicarbonate, ammonium carbonate, pyridinium trifluoroacetate and mixtures thereof. |
| Claim: | 39. The blood-derived plastic article according to claim 1, wherein the article is at least partially coated with at least one biological response modifier. |
| Claim: | 40. The blood-derived plastic article according to claim 1, wherein the article is in the form of a film. |
| Claim: | 41. The blood-derived plastic article according to claim 1, wherein the article is in the form of a powder or granules. |
| Claim: | 42. The blood-derived plastic article according to claim 1, wherein the article comprises a laminated structure. |
| Claim: | 43. The blood-derived plastic article according to claim 42, wherein the laminated structure is in the form of a stack of sheets, a tubular roll, or combination thereof. |
| Claim: | 44. The blood-derived plastic article according to claim 1, wherein the article is in the form of a bone substitute, cartilage substitute, tendon substitute, ligament substitute, skin substitute, cornea substitute, stent, fixation plate, screw, suture or staple. |
| Claim: | 45. A blood-derived plastic article prepared from a composition comprising: (1) blood and (2) at least one crosslinking agent selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanidin, reuterin, and mixtures thereof. |
| Claim: | 46. The blood-derived plastic article according to claim 45, wherein the blood comprises at least one biological response modifier. |
| Claim: | 47. The blood-derived plastic article according to claim 46, wherein the at least one biological response modifier is a bioactive protein selected from the group consisting of hormones, growth factors, cytokines, extracellular matrix molecules and mixtures thereof. |
| Claim: | 48. The blood-derived plastic article according to claim 47, wherein the bioactive protein comprises at least one growth factor selected from the group consisting of platelet derived growth factors (PDGF), acidic and basic fibroblast growth factors, transformation growth factor beta (TGF-beta), insulin like growth factors (IGF), epidermal growth factors (EGF), platelet-derived angiogenesis factors (PDAF), platelet-derived endothelial growth factors (PDEGF), tumor necrosis factor-alpha (TNF-α), tumor necrosis factor-beta (TNF-J3), vascular endothelial growth factors (VEGF), epithelial cell growth factors (ECGF), granulocyte-colony stimulating factors (G-CSF), granulocyte-macrophage colony stimulating factors (GM-CSF), nerve growth factors (NGF), neurotrophins, erythropoietin (EPO), thrombopoietin (TPO), myostatin (GDF-8), growth differentiation factor-9 (GDF9), hepatocyte growth factors (HGF), platelet factors, isoforms thereof and others and mixtures thereof. |
| Claim: | 49. The blood-derived plastic article according to claim 45, wherein the blood is obtained from an autologous donor. |
| Claim: | 50. The blood-derived plastic article according to claim 45, wherein the blood is obtained from allogeneic donors. |
| Claim: | 51. The blood-derived plastic article according to claim 45, wherein the blood is whole blood. |
| Claim: | 52. The blood-derived plastic article according to claim 45, wherein the blood is blood plasma. |
| Claim: | 53. The blood-derived plastic article according to claim 52, wherein the blood plasma is pre-treated prior to mixing with other components of the composition to increase the concentration of platelets compared to the concentration of platelets of the blood plasma prior to such treatment. |
| Claim: | 54. The blood-derived plastic article according to claim 45, wherein the blood is at least partially clotted. |
| Claim: | 55. The blood-derived plastic article according to claim 45, wherein the blood is at least partially dried. |
| Claim: | 56. The blood-derived plastic article according to claim 55, wherein the dried blood has a water content of about 5 to about 15 weight percent on a basis of total weight of the dried blood. |
| Claim: | 57. The blood-derived plastic article according to claim 55, wherein the average particle size of the at least partially dried blood is less than about 500 μm prior to mixing with other components of the composition. |
| Claim: | 58. The blood-derived plastic article according to claim 57, wherein the average particle size of the at least partially dried blood is less than about 150 μm prior to mixing with other components of the composition. |
| Claim: | 59. The blood-derived plastic article according to claim 58, wherein the average particle size of the at least partially dried blood is less than about 38 μm prior to mixing with other components of the composition. |
| Claim: | 60. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one biological response modifier. |
| Claim: | 61. The blood-derived plastic article according to claim 60, wherein the at least one biological response modifier comprises about 1 picogram per gram of composition to about 20 milligrams per gram of composition. |
| Claim: | 62. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one plasticizer. |
| Claim: | 63. The blood-derived plastic article according to claim 62, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers and functionalized derivatives thereof, such as poly(ethylene glycol) diacrylate, water and mixtures thereof. |
| Claim: | 64. The blood-derived plastic article according to claim 63, wherein the at least one plasticizer is glycerol. |
| Claim: | 65. The blood-derived plastic article according to claim 62, wherein the at least one plasticizer comprises about 0.1 to about 80 weight percent of the components on a basis of total weight of the composition. |
| Claim: | 66. The blood-derived plastic article according to claim 45, wherein the iridoid derivative is genipin (Methyl (1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate). |
| Claim: | 67. The blood-derived plastic article according to claim 45, wherein the at least one crosslinking agent comprises about 0.01 to about 20 weight percent of the components on a basis of total weight of the components. |
| Claim: | 68. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one drug. |
| Claim: | 69. The blood-derived plastic article according to claim 68, wherein the drug is selected from the group consisting of analgesics; anti-infective agents such as antibiotics, antifungals and antivirals; antineoplastics such as antibiotics, antimetabolites, hormonal agonists/antagonists, androgens, immunomodulators, skin and mucous membrane agents and steroids; biologicals; blood modifiers such as anticoagulants, antiplatelet agents, colony stimulating factors, hematinics, hemorrheologic agents, hemostatics, thrombin inhibitors and thrombolytic agents; cardioprotective agents; cardiovascular agents such as adrenergic blockers, adrenergic stimulants, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, antiarrhythmics, antilipemic agents, beta adrenergic blocking agents, vasodilators, and vasopressors; cholinesterase inhibitors; hormones such as: anabolic steroids, androgens, estrogens and combinations, glucocorticoids and growth hormone; immunomodulators; immunosuppressives; ophthalmic preparations such as antibiotics, anti-infectives, anti-inflammatory agents and beta adrenergic blocking agents; respiratory agents such as anti-infective agents, anti-inflammatory agents, skin and mucous membrane agents such as analgesics, anti-infectives, antibiotics, antifungals, antivirals, antineoplastics, anti-cancer agents and mixtures thereof. |
| Claim: | 70. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one stabilizer. |
| Claim: | 71. The blood-derived plastic article according to claim 70, wherein the stabilizer is selected from the group consisting of glycogen, sorbitol, mannitol, trehalose, maltitol, xylitol, isomaltitol, erythritol, amylose, amylopectin, inositol hexasulfate, sulfated beta-cyclodextran, betaine, nontoxic polysaccharides represented by the formula Cn(H2O)n-1 where n is between 200 and 2500, antioxidants, and mixtures thereof. |
| Claim: | 72. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one filler. |
| Claim: | 73. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one particulate selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium phosphate, calcium sulfate and mixtures thereof. |
| Claim: | 74. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one porogen. |
| Claim: | 75. The blood-derived plastic article according to claim 74, wherein the at least one porogen is soluble in an aqueous phase. |
| Claim: | 76. The blood-derived plastic article according to claim 75, wherein the at least one porogen is sodium chloride. |
| Claim: | 77. The blood-derived plastic article according to claim 74, wherein the at least one porogen is a sublimation porogen. |
| Claim: | 78. The blood-derived plastic article according to claim 77, wherein the sublimation porogen is selected from the group consisting of ammonium acetate, ammonium chloride, ammonium sulfate, ammonium bicarbonate, ammonium carbonate, pyridinium trifluoroacetate and mixtures thereof. |
| Claim: | 79. The blood-derived plastic article according to claim 45, wherein the article is at least partially coated with at least one biological response modifier. |
| Claim: | 80. The blood-derived plastic article according to claim 45, wherein the article is in the form of a film. |
| Claim: | 81. The blood-derived plastic article according to claim 45, wherein the article is in the form of a powder or granules. |
| Claim: | 82. The blood-derived plastic article according to claim 45, wherein the article comprises a laminated structure. |
| Claim: | 83. The blood-derived plastic article according to claim 82, wherein the laminated structure is in the form of a stack of sheets, a tubular roll, or combination thereof. |
| Claim: | 84. The blood-derived plastic article according to claim 45, wherein the article is in the form of a bone substitute, cartilage substitute, tendon substitute, ligament substitute, skin substitute, cornea substitute, stent, fixation plate, screw, suture or staple. |
| Claim: | 85. A blood-derived plastic bone tissue article having a Young's Modulus ranging from about 0.03 GPa to about 50 GPa measured according to ASTM Method No. D-638-03 and a compressive strength ranging from about 1 MPa to about 250 MPa according to ASTM Method No. D-695-02a, the Young's Modulus and compressive strength being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 86. A blood-derived plastic tendon tissue article having a Young's Modulus ranging from about 0.5 GPa to about 1.5 GPa measured according to ASTM Method No. D-638-03, a percent strain at failure ranging from about 8% to about 16% according to ASTM Method No. D-638-03, and a stiffness ranging from about 100 N/mm to about 5000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus, percent strain at failure and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 87. A blood-derived plastic ligament tissue article having a Young's Modulus ranging from about 100 MPa to about 1000 MPa measured according to ASTM Method No. D-638-03 and a stiffness ranging from about 50 N/mm to about 1000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 88. A blood-derived plastic cartilage tissue article having a Young's Modulus ranging from about 1 MPa to about 250 MPa measured according to ASTM Method No. D-638-03, a percent strain at failure ranging from about 0.1% to about 1% according to ASTM Method No. D-638-03, and a stiffness ranging from about 5 N/mm to about 4000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus, percent strain at failure and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 89. A blood-derived plastic skin tissue article comprising at least one biological response modifier, wherein the article has a Young's Modulus ranging from about 0.1 MPa to about 20 MPa measured according to the Skin Young's Modulus Test, and an elasticity ranging from about 50% to about 100% according to the Elasticity Test, the Young's Modulus and elasticity being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 90. A blood-derived plastic skin tissue article prepared from components comprising: (1) blood plasma and (2) at least one crosslinking agent selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanidin, reuterin and mixtures thereof, wherein the article has a Young's Modulus ranging from about 0.1 MPa to about 20 MPa measured according to the Skin Young's Modulus Test, and an elasticity ranging from about 50% to about 100% according to the Elasticity Test, the Young's Modulus and elasticity being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). |
| Claim: | 91. A method for assessing the concentration of a biological response modifier in an article comprising: (a) providing a range of acceptable concentrations of a pre-determined biological response modifier for a batch of blood to be used to prepare an article; (b) determining the concentration of a pre-determined biological response modifier in a blood batch to be used to prepare an article; and (c) comparing the concentration determined in (b) to the range of acceptable concentrations obtained from (a) to determine if the concentration determined in (b) is above or below the range of acceptable concentrations determined in step (a). |
| Claim: | 92. The method according to claim 91, wherein the method further comprises: adjusting the concentration of pre-determined biological response modifier determined in (b) to be within the range of acceptable concentrations determined in step (a) if the concentration determined in (b) is above or below the range of acceptable concentrations determined in step (a). |
| Claim: | 93. The method according to claim 91, wherein the method further comprises: (1) determining the concentration of the pre-determined biological response modifier for each of a plurality of blood batches; (2) determining the concentration of the biological response modifier for each of a plurality of blood-derived articles prepared from each of the respective blood batches of (1); (3) determining an acceptable range of concentrations of the biological response modifier for the blood-derived articles based upon the concentrations determined in (2); and (4) correlating the acceptable range of concentrations of the biological response modifier for the blood-derived plastic articles obtained from (3) with the concentrations of the biological response modifier for the blood batches obtained in (1) to determine a range of acceptable concentrations of the biological response modifier for the batch of blood of (a). |
| Claim: | 94. The method according to claim 91, wherein the blood is received from donors of about 18 to about 65 years of age. |
| Claim: | 95. A system for preparing blood-derived plastic articles, comprising: a) a dryer for at least partially drying blood; b) a powderizing device miller for milling the at least partially dried blood received from the dryer to form a blood powder; c) a mixer for mixing the blood powder received from the powder miller with at least one plasticizer to form a molding composition; and d) a compression molding apparatus comprising at least one mold for receiving the molding composition from the mixer and a vacuum degasser for removing gas from the molding composition during molding. |
| Claim: | 96. The system according to claim 95, wherein the system further comprises a centrifuge for separating blood plasma from whole blood. |
| Claim: | 97. A method for making a blood-derived plastic article comprising: a) collecting a quantity of blood; b) clotting said blood; c) drying said blood; and d) contacting a quantity of the clotted dried blood with at least one plasticizer to make a composition, and shaping and heating said composition to make a blood-derived plastic article. |
| Claim: | 98. The method according to claim 97, wherein the blood is blood plasma. |
| Claim: | 99. The method according to claim 97, wherein the at least one plasticizer is added to said quantity of blood either before or after the step of clotting said blood. |
| Claim: | 100. The method according to claim 97, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers, water and mixtures thereof. |
| Claim: | 101. The method according to claim 97, wherein a crosslinking agent is added to said quantity of blood either before or after the step of clotting said blood. |
| Claim: | 102. The method according to claim 97, wherein said quantity of blood is a pooled quantity of blood from a plurality of human donors. |
| Claim: | 103. The method according to claim 97, wherein said quantity of blood is collected from a single human donor. |
| Claim: | 104. The method according to claim 97, wherein the blood-derived plastic article is plasticized at a temperature between 50-65° C. |
| Claim: | 105. The method according to claim 97, wherein the blood-derived plastic article is plasticized at a temperature of no higher than 150° C. |
| Claim: | 106. The method according to claim 97, wherein the at least one plasticizer is selected from the group consisting of glycerol and water. |
| Claim: | 107. The method according to claim 97, wherein the clotted dried blood is crosslinked by adding genipin (((Methyl)1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate) as a powder to the clotted dried blood in an amount of about 2% by weight of the dried blood. |
| Claim: | 108. The method according to claim 107, wherein the genipin is solubilized in alcohol before adding the genipin to the composition. |
| Claim: | 109. The method according to claim 97, wherein the clotted dried blood is adjusted to water content by weight of 5-15% based upon total weight of the dried blood prior to mixing with other components of the composition. |
| Claim: | 110. The method according to claim 97, wherein a porogen compound is added to the composition prior to curing. |
| Claim: | 111. The method according to claim 97, wherein prior to curing, the composition is provided with a quantity of particulate ammonium acetate crystals, pre-sized to 150-250 microns, whereas, during curing, the ammonium acetate crystals sublimate to result in a controlled porous plastic with a pore size of 150-250 microns. |
| Claim: | 112. The method according to claim 97, wherein said quantify of blood is clotted, dried and comminuted to a particle size distribution of between 38-500 microns. |
| Claim: | 113. The method according to claim 97, wherein the composition is plasticized at a temperature between 55-150° C. |
| Claim: | 114. The method according to claim 113, wherein the composition is plasticized at a temperature between 100-140° C. |
| Claim: | 115. The method according to claim 97, wherein the composition is plasticized at a pressure between 9-25 kilopounds per square inch. |
| Claim: | 116. The method according to claim 97, wherein the composition is plasticized at a pressure of at least 10.7 kilopounds per square inch or higher. |
| Claim: | 117. The method according to claim 97, wherein prior to curing, up to 10% nanoparticulate tricalcium phosphate is added to the composition. |
| Claim: | 118. The method according to claim 97, wherein the dried blood is sterilized with an alcohol wash prior to admixing with the at least one plasticizer. |
| Claim: | 119. A method for promoting healing of a skin wound comprising: applying to the skin wound surface an effective amount of a blood-derived plastic article, wherein the blood-derived plastic article comprises at least one biological response modifier. |
| Claim: | 120. The method according to claim 119, wherein the article is a film. |
| Claim: | 121. A method for promoting healing of a tissue wound or defect comprising: applying to the tissue wound or defect an effective amount of a blood-derived plastic article, wherein the blood-derived plastic article comprises at least one biological response modifier. |
| Claim: | 122. A method for providing a resorbable graft to a graft position in a subject, comprising: inserting a blood-derived plastic article into a graft position in a subject, wherein the blood-derived plastic article comprises at least one biological response modifier. |
| Claim: | 123. A method for delivering stem cells to a tissue of a subject, comprising: contacting a blood-derived plastic article comprising stem cells with a tissue of a subject. |
| Claim: | 124. The method according to claim 123, wherein the article is a tissue substitute or support. |
| Claim: | 125. A method of connecting a first portion of a tissue with a second portion of a tissue, comprising: contacting at least one blood-derived plastic article selected from the group consisting of a suture, staple and barb with a first portion of a tissue with a second portion of a tissue such that the first portion of the tissue and the second portion of the tissue are connected. |
| Claim: | 126. A method for forming a blood-derived plastic film, comprising: (a) drying a blood-derived composition under vacuum to reduce the water content thereof and form an at least partially dried composition; and (b) shaping the at least partially dried composition into a film. |
| Claim: | 127. The method according to claim 126, further comprising applying pressure to at least a portion of the blood-derived composition during vacuum drying. |
| Claim: | 128. The method according to claim 126, wherein the blood-derived composition comprises at least one crosslinking agent. |
| Claim: | 129. The method according to claim 126, wherein the article comprises at least one biological response modifier. |
| Claim: | 130. A method for forming a blood-derived plastic article, comprising: (a) lyophilizing a blood-derived composition to reduce the water content thereof and form an at least partially dried composition; (b) mixing the at least partially dried composition with at least one plasticizer to form a mixture; and (c) shaping the mixture into a blood-derived plastic article. |
| Claim: | 131. The method according to claim 130, wherein the at least partially dried composition is powderized. |
| Claim: | 132. The method according to claim 130, wherein the mixture is shaped into the blood-derived plastic article by molding or extrusion. |
| Claim: | 133. The method according to claim 130, wherein the mixture is shaped into the blood-derived plastic article by compression molding. |
| Current U.S. Class: | 424/423 |
| Current International Class: | 61; 61; 61; 01; 61; 61; 61; 29 |
| رقم الانضمام: | edspap.20080286329 |
| قاعدة البيانات: | USPTO Patent Applications |
| ResultId |
1 |
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edspap USPTO Patent Applications edspap.20080286329 718 3 Patent patent 717.968383789063 |
| PLink |
https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edspap&AN=edspap.20080286329&custid=s6537998&authtype=sso |
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Array ( [Name] => DocumentID [Label] => Document Number [Group] => Patent [Data] => 20080286329 ) Array ( [Name] => DateEntry [Label] => Publication Date [Group] => Patent [Data] => November 20, 2008 ) Array ( [Name] => DocumentID [Label] => Appl. No [Group] => Patent [Data] => 12/104728 ) Array ( [Name] => DateFiled [Label] => Application Filed [Group] => Patent [Data] => April 17, 2008 ) Array ( [Name] => Abstract [Label] => Abstract [Group] => Ab [Data] => Blood-derived plastic articles prepared from compositions including blood and, in some embodiments, at least one crosslinking agent and/or at least one biological response modifier, that can be useful for biological applications such as wound repair and tissue grafts; methods of making and using the same; methods for assessing the concentration of a biological response modifier in an article; and systems for preparing blood-derived plastic articles are provided. ) Array ( [Name] => Author [Label] => Inventors [Group] => Patent [Data] => <searchLink fieldCode="ZA" term="%22Campbell%2C+Phil+G%2E%22">Campbell, Phil G.</searchLink> (Pittsburgh, PA, US); <searchLink fieldCode="ZA" term="%22Burgess%2C+James+E%2E%22">Burgess, James E.</searchLink> (Gibsonia, PA, US); <searchLink fieldCode="ZA" term="%22Weiss%2C+Lee+E%2E%22">Weiss, Lee E.</searchLink> (Pittsburgh, PA, US); <searchLink fieldCode="ZA" term="%22Smith%2C+Jason%22">Smith, Jason</searchLink> (Pittsburgh, PA, US) ) Array ( [Name] => OtherAuthors [Label] => Assignees [Group] => Patent [Data] => <searchLink fieldCode="ZS" term="%22CARNEGIE+MELLON+UNIVERSITY%22">CARNEGIE MELLON UNIVERSITY</searchLink> (Pittsburgh, PA, US), <searchLink fieldCode="ZS" term="%22ALLEGHENY-SINGER+RESEARCH+INSTITUTE%22">ALLEGHENY-SINGER RESEARCH INSTITUTE</searchLink> (Pittsburgh, PA, US), <searchLink fieldCode="ZS" term="%22CARMELL%2C+LLC%22">CARMELL, LLC</searchLink> (Pittsburgh, PA, US) ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 1. A blood-derived plastic article comprising at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 2. The blood-derived plastic article according to claim 1, wherein the article is prepared from a composition comprising blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 3. The blood-derived plastic article according to claim 2, wherein the blood comprises the at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 4. The blood-derived plastic article according to claim 2, wherein the blood is obtained from an autologous donor. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 5. The blood-derived plastic article according to claim 2, wherein the blood is obtained from allogeneic donors. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 6. The blood-derived plastic article according to claim 2, wherein the blood is whole blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 7. The blood-derived plastic article according to claim 2, wherein the blood is blood plasma. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 8. The blood-derived plastic article according to claim 7, wherein the blood plasma is pre-treated prior to mixing with other components of the composition to increase the concentration of platelets compared to the concentration of platelets of the blood plasma prior to such treatment. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 9. The blood-derived plastic article according to claim 2, wherein the blood is at least partially clotted. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 10. The blood-derived plastic article according to claim 2, wherein the blood is at least partially dried. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 11. The blood-derived plastic article according to claim 10, wherein the dried blood has a water content of about 5 to about 15 weight percent on a basis of total weight of the dried blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 12. The blood-derived plastic article according to claim 10, wherein the average particle size of the at least partially dried blood is less than about 500 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 13. The blood-derived plastic article according to claim 12, wherein the average particle size of the at least partially dried blood is less than about 150 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 14. The blood-derived plastic article according to claim 13, wherein the average particle size of the at least partially dried blood is less than about 38 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 15. The blood-derived plastic article according to claim 1, wherein the biological response modifier is a bioactive protein selected from the group consisting of hormones, growth factors, cytokines, extracellular matrix molecules and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 16. The blood-derived plastic article according to claim 14, wherein the bioactive protein comprises at least one growth factor selected from the group consisting of platelet derived growth factors (PDGF), acidic and basic fibroblast growth factors, transformation growth factor beta (TGF-beta), insulin like growth factors (IGF), epidermal growth factors (EGF), platelet-derived angiogenesis factors (PDAF), platelet-derived endothelial growth factors (PDEGF), tumor necrosis factor-alpha (TNF-α), tumor necrosis factor-beta (TNF-β), vascular endothelial growth factors (VEGF), epithelial cell growth factors (ECGF), granulocyte-colony stimulating factors (G-CSF), granulocyte-macrophage colony stimulating factors (GM-CSF), nerve growth factors (NGF), neurotrophins, erythropoietin (EPO), thrombopoietin (TPO), myostatin (GDF-8), growth differentiation factor-9 (GDF9), hepatocyte growth factors (HGF), platelet factors, isoforms thereof and others and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 17. The blood-derived plastic article according to claim 14, wherein the bioactive protein comprises at least one extracellular matrix molecule selected from the group consisting of osteocalcin, osteonectin, fibrinogen, vitronectin, fibronectin, thrombospondin 1 (TSP-1), bone sialoprotein (BSP), proteoglycans and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 18. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 19. The blood-derived plastic article according to claim 18, wherein the at least one biological response modifier comprises about 1 picogram per grain of composition to about 20 milligrams per gram of composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 20. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one plasticizer. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 21. The blood-derived plastic article according to claim 20, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers and functionalized derivatives thereof, such as poly(ethylene glycol) diacrylate, water and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 22. The blood-derived plastic article according to claim 21, wherein the at least one plasticizer is glycerol. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 23. The blood-derived plastic article according to claim 20, wherein the at least one plasticizer comprises about 0.1 to about 80 weight percent of the components on a basis of total weight of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 24. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one crosslinking agent. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 25. The blood-derived plastic article according to claim 24, wherein the at least one crosslinking agent is selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins that are chemically different from the bioactive protein, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanadin, reuterin and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 26. The blood-derived plastic article according to claim 25, wherein the iridoid derivative is genipin (Methyl (1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 27. The blood-derived plastic article according to claim 24, wherein the at least one crosslinking agent comprises about 0.01 to about 20 weight percent of the components on a basis of total weight of the components. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 28. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one drug. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 29. The blood-derived plastic article according to claim 28, wherein the drug is selected from the group consisting of analgesics; anti-infective agents such as antibiotics, antifungals and antivirals; antineoplastics such as antibiotics, antimetabolites, hormonal agonists/antagonists, androgens, immunomodulators, skin and mucous membrane agents and steroids; biologicals; blood modifiers such as anticoagulants, antiplatelet agents, colony stimulating factors, hematinics, hemorrheologic agents, hemostatics, thrombin inhibitors and thrombolytic agents; cardioprotective agents; cardiovascular agents such as adrenergic blockers, adrenergic stimulants, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, antiarrhythmics, antilipemic agents, beta adrenergic blocking agents, vasodilators, and vasopressors; cholinesterase inhibitors; hormones such as: anabolic steroids, androgens, estrogens and combinations, glucocorticoids and growth hormone; immunomodulators; immunosuppressives; ophthalmic preparations such as antibiotics, anti-infectives, anti-inflammatory agents and beta adrenergic blocking agents; respiratory agents such as anti-infective agents, anti-inflammatory agents, skin and mucous membrane agents such as analgesics, anti-infectives, antibiotics, antifungals, antivirals, antineoplastics, anti-cancer agents and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 30. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one stabilizer. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 31. The blood-derived plastic article according to claim 30, wherein the stabilizer is selected from the group consisting of glycogen, sorbitol, mannitol, trehalose, maltitol, xylitol, isomaltitol, erythritol, amylose, amylopectin, inositol hexasulfate, sulfated beta-cyclodextran, betaine, nontoxic polysaccharides represented by the formula Cn(H2O)n-1 where n is between 200 and 2500, antioxidants, and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 32. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one filler. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 33. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one particulate selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium phosphate, calcium sulfate and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 34. The blood-derived plastic article according to claim 2, wherein the composition further comprises at least one porogen. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 35. The blood-derived plastic article according to claim 34, wherein the at least one porogen is soluble in an aqueous phase. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 36. The blood-derived plastic article according to claim 35, wherein the at least one porogen is sodium chloride. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 37. The blood-derived plastic article according to claim 34, wherein the at least one porogen is a sublimation porogen. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 38. The blood-derived plastic article according to claim 37, wherein the sublimation porogen is selected from the group consisting of ammonium acetate, ammonium chloride, ammonium sulfate, ammonium bicarbonate, ammonium carbonate, pyridinium trifluoroacetate and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 39. The blood-derived plastic article according to claim 1, wherein the article is at least partially coated with at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 40. The blood-derived plastic article according to claim 1, wherein the article is in the form of a film. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 41. The blood-derived plastic article according to claim 1, wherein the article is in the form of a powder or granules. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 42. The blood-derived plastic article according to claim 1, wherein the article comprises a laminated structure. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 43. The blood-derived plastic article according to claim 42, wherein the laminated structure is in the form of a stack of sheets, a tubular roll, or combination thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 44. The blood-derived plastic article according to claim 1, wherein the article is in the form of a bone substitute, cartilage substitute, tendon substitute, ligament substitute, skin substitute, cornea substitute, stent, fixation plate, screw, suture or staple. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 45. A blood-derived plastic article prepared from a composition comprising: (1) blood and (2) at least one crosslinking agent selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanidin, reuterin, and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 46. The blood-derived plastic article according to claim 45, wherein the blood comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 47. The blood-derived plastic article according to claim 46, wherein the at least one biological response modifier is a bioactive protein selected from the group consisting of hormones, growth factors, cytokines, extracellular matrix molecules and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 48. The blood-derived plastic article according to claim 47, wherein the bioactive protein comprises at least one growth factor selected from the group consisting of platelet derived growth factors (PDGF), acidic and basic fibroblast growth factors, transformation growth factor beta (TGF-beta), insulin like growth factors (IGF), epidermal growth factors (EGF), platelet-derived angiogenesis factors (PDAF), platelet-derived endothelial growth factors (PDEGF), tumor necrosis factor-alpha (TNF-α), tumor necrosis factor-beta (TNF-J3), vascular endothelial growth factors (VEGF), epithelial cell growth factors (ECGF), granulocyte-colony stimulating factors (G-CSF), granulocyte-macrophage colony stimulating factors (GM-CSF), nerve growth factors (NGF), neurotrophins, erythropoietin (EPO), thrombopoietin (TPO), myostatin (GDF-8), growth differentiation factor-9 (GDF9), hepatocyte growth factors (HGF), platelet factors, isoforms thereof and others and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 49. The blood-derived plastic article according to claim 45, wherein the blood is obtained from an autologous donor. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 50. The blood-derived plastic article according to claim 45, wherein the blood is obtained from allogeneic donors. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 51. The blood-derived plastic article according to claim 45, wherein the blood is whole blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 52. The blood-derived plastic article according to claim 45, wherein the blood is blood plasma. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 53. The blood-derived plastic article according to claim 52, wherein the blood plasma is pre-treated prior to mixing with other components of the composition to increase the concentration of platelets compared to the concentration of platelets of the blood plasma prior to such treatment. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 54. The blood-derived plastic article according to claim 45, wherein the blood is at least partially clotted. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 55. The blood-derived plastic article according to claim 45, wherein the blood is at least partially dried. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 56. The blood-derived plastic article according to claim 55, wherein the dried blood has a water content of about 5 to about 15 weight percent on a basis of total weight of the dried blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 57. The blood-derived plastic article according to claim 55, wherein the average particle size of the at least partially dried blood is less than about 500 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 58. The blood-derived plastic article according to claim 57, wherein the average particle size of the at least partially dried blood is less than about 150 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 59. The blood-derived plastic article according to claim 58, wherein the average particle size of the at least partially dried blood is less than about 38 μm prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 60. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 61. The blood-derived plastic article according to claim 60, wherein the at least one biological response modifier comprises about 1 picogram per gram of composition to about 20 milligrams per gram of composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 62. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one plasticizer. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 63. The blood-derived plastic article according to claim 62, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers and functionalized derivatives thereof, such as poly(ethylene glycol) diacrylate, water and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 64. The blood-derived plastic article according to claim 63, wherein the at least one plasticizer is glycerol. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 65. The blood-derived plastic article according to claim 62, wherein the at least one plasticizer comprises about 0.1 to about 80 weight percent of the components on a basis of total weight of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 66. The blood-derived plastic article according to claim 45, wherein the iridoid derivative is genipin (Methyl (1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 67. The blood-derived plastic article according to claim 45, wherein the at least one crosslinking agent comprises about 0.01 to about 20 weight percent of the components on a basis of total weight of the components. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 68. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one drug. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 69. The blood-derived plastic article according to claim 68, wherein the drug is selected from the group consisting of analgesics; anti-infective agents such as antibiotics, antifungals and antivirals; antineoplastics such as antibiotics, antimetabolites, hormonal agonists/antagonists, androgens, immunomodulators, skin and mucous membrane agents and steroids; biologicals; blood modifiers such as anticoagulants, antiplatelet agents, colony stimulating factors, hematinics, hemorrheologic agents, hemostatics, thrombin inhibitors and thrombolytic agents; cardioprotective agents; cardiovascular agents such as adrenergic blockers, adrenergic stimulants, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, antiarrhythmics, antilipemic agents, beta adrenergic blocking agents, vasodilators, and vasopressors; cholinesterase inhibitors; hormones such as: anabolic steroids, androgens, estrogens and combinations, glucocorticoids and growth hormone; immunomodulators; immunosuppressives; ophthalmic preparations such as antibiotics, anti-infectives, anti-inflammatory agents and beta adrenergic blocking agents; respiratory agents such as anti-infective agents, anti-inflammatory agents, skin and mucous membrane agents such as analgesics, anti-infectives, antibiotics, antifungals, antivirals, antineoplastics, anti-cancer agents and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 70. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one stabilizer. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 71. The blood-derived plastic article according to claim 70, wherein the stabilizer is selected from the group consisting of glycogen, sorbitol, mannitol, trehalose, maltitol, xylitol, isomaltitol, erythritol, amylose, amylopectin, inositol hexasulfate, sulfated beta-cyclodextran, betaine, nontoxic polysaccharides represented by the formula Cn(H2O)n-1 where n is between 200 and 2500, antioxidants, and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 72. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one filler. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 73. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one particulate selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium phosphate, calcium sulfate and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 74. The blood-derived plastic article according to claim 45, wherein the composition further comprises at least one porogen. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 75. The blood-derived plastic article according to claim 74, wherein the at least one porogen is soluble in an aqueous phase. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 76. The blood-derived plastic article according to claim 75, wherein the at least one porogen is sodium chloride. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 77. The blood-derived plastic article according to claim 74, wherein the at least one porogen is a sublimation porogen. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 78. The blood-derived plastic article according to claim 77, wherein the sublimation porogen is selected from the group consisting of ammonium acetate, ammonium chloride, ammonium sulfate, ammonium bicarbonate, ammonium carbonate, pyridinium trifluoroacetate and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 79. The blood-derived plastic article according to claim 45, wherein the article is at least partially coated with at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 80. The blood-derived plastic article according to claim 45, wherein the article is in the form of a film. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 81. The blood-derived plastic article according to claim 45, wherein the article is in the form of a powder or granules. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 82. The blood-derived plastic article according to claim 45, wherein the article comprises a laminated structure. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 83. The blood-derived plastic article according to claim 82, wherein the laminated structure is in the form of a stack of sheets, a tubular roll, or combination thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 84. The blood-derived plastic article according to claim 45, wherein the article is in the form of a bone substitute, cartilage substitute, tendon substitute, ligament substitute, skin substitute, cornea substitute, stent, fixation plate, screw, suture or staple. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 85. A blood-derived plastic bone tissue article having a Young's Modulus ranging from about 0.03 GPa to about 50 GPa measured according to ASTM Method No. D-638-03 and a compressive strength ranging from about 1 MPa to about 250 MPa according to ASTM Method No. D-695-02a, the Young's Modulus and compressive strength being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 86. A blood-derived plastic tendon tissue article having a Young's Modulus ranging from about 0.5 GPa to about 1.5 GPa measured according to ASTM Method No. D-638-03, a percent strain at failure ranging from about 8% to about 16% according to ASTM Method No. D-638-03, and a stiffness ranging from about 100 N/mm to about 5000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus, percent strain at failure and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 87. A blood-derived plastic ligament tissue article having a Young's Modulus ranging from about 100 MPa to about 1000 MPa measured according to ASTM Method No. D-638-03 and a stiffness ranging from about 50 N/mm to about 1000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 88. A blood-derived plastic cartilage tissue article having a Young's Modulus ranging from about 1 MPa to about 250 MPa measured according to ASTM Method No. D-638-03, a percent strain at failure ranging from about 0.1% to about 1% according to ASTM Method No. D-638-03, and a stiffness ranging from about 5 N/mm to about 4000 N/mm according to ASTM Method No. D-638-03, the Young's Modulus, percent strain at failure and stiffness being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 89. A blood-derived plastic skin tissue article comprising at least one biological response modifier, wherein the article has a Young's Modulus ranging from about 0.1 MPa to about 20 MPa measured according to the Skin Young's Modulus Test, and an elasticity ranging from about 50% to about 100% according to the Elasticity Test, the Young's Modulus and elasticity being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 90. A blood-derived plastic skin tissue article prepared from components comprising: (1) blood plasma and (2) at least one crosslinking agent selected from the group consisting of iridoid derivatives, diimidates, diones, carbodiimides, acrylamides, sugars, proteins, dimethylsuberimidates, aldehydes, Factor XIII, dihomo bifunctional NHS esters, carbonyldiimide, glyoxyls, dimethylsuberimide, proanthocyanidin, reuterin and mixtures thereof, wherein the article has a Young's Modulus ranging from about 0.1 MPa to about 20 MPa measured according to the Skin Young's Modulus Test, and an elasticity ranging from about 50% to about 100% according to the Elasticity Test, the Young's Modulus and elasticity being determined at a temperature of about 25° C. and a pressure of about 101 KPa (about 1 atm). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 91. A method for assessing the concentration of a biological response modifier in an article comprising: (a) providing a range of acceptable concentrations of a pre-determined biological response modifier for a batch of blood to be used to prepare an article; (b) determining the concentration of a pre-determined biological response modifier in a blood batch to be used to prepare an article; and (c) comparing the concentration determined in (b) to the range of acceptable concentrations obtained from (a) to determine if the concentration determined in (b) is above or below the range of acceptable concentrations determined in step (a). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 92. The method according to claim 91, wherein the method further comprises: adjusting the concentration of pre-determined biological response modifier determined in (b) to be within the range of acceptable concentrations determined in step (a) if the concentration determined in (b) is above or below the range of acceptable concentrations determined in step (a). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 93. The method according to claim 91, wherein the method further comprises: (1) determining the concentration of the pre-determined biological response modifier for each of a plurality of blood batches; (2) determining the concentration of the biological response modifier for each of a plurality of blood-derived articles prepared from each of the respective blood batches of (1); (3) determining an acceptable range of concentrations of the biological response modifier for the blood-derived articles based upon the concentrations determined in (2); and (4) correlating the acceptable range of concentrations of the biological response modifier for the blood-derived plastic articles obtained from (3) with the concentrations of the biological response modifier for the blood batches obtained in (1) to determine a range of acceptable concentrations of the biological response modifier for the batch of blood of (a). ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 94. The method according to claim 91, wherein the blood is received from donors of about 18 to about 65 years of age. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 95. A system for preparing blood-derived plastic articles, comprising: a) a dryer for at least partially drying blood; b) a powderizing device miller for milling the at least partially dried blood received from the dryer to form a blood powder; c) a mixer for mixing the blood powder received from the powder miller with at least one plasticizer to form a molding composition; and d) a compression molding apparatus comprising at least one mold for receiving the molding composition from the mixer and a vacuum degasser for removing gas from the molding composition during molding. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 96. The system according to claim 95, wherein the system further comprises a centrifuge for separating blood plasma from whole blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 97. A method for making a blood-derived plastic article comprising: a) collecting a quantity of blood; b) clotting said blood; c) drying said blood; and d) contacting a quantity of the clotted dried blood with at least one plasticizer to make a composition, and shaping and heating said composition to make a blood-derived plastic article. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 98. The method according to claim 97, wherein the blood is blood plasma. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 99. The method according to claim 97, wherein the at least one plasticizer is added to said quantity of blood either before or after the step of clotting said blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 100. The method according to claim 97, wherein the at least one plasticizer is selected from the group consisting of phthalate plasticizers, adipate plasticizers, trimellitate plasticizers, maleate plasticizers, sebacate plasticizers, benzoate plasticizers, plant oils, animal oils, mineral oils, sulfonamide plasticizers, phosphate plasticizers, water, polyalcohols, glycols, glycerol, polyethers, acetylated monoglycerides, alkyl citrates, polymeric plasticizers, water and mixtures thereof. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 101. The method according to claim 97, wherein a crosslinking agent is added to said quantity of blood either before or after the step of clotting said blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 102. The method according to claim 97, wherein said quantity of blood is a pooled quantity of blood from a plurality of human donors. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 103. The method according to claim 97, wherein said quantity of blood is collected from a single human donor. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 104. The method according to claim 97, wherein the blood-derived plastic article is plasticized at a temperature between 50-65° C. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 105. The method according to claim 97, wherein the blood-derived plastic article is plasticized at a temperature of no higher than 150° C. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 106. The method according to claim 97, wherein the at least one plasticizer is selected from the group consisting of glycerol and water. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 107. The method according to claim 97, wherein the clotted dried blood is crosslinked by adding genipin (((Methyl)1R,2R,6S)-2-hydroxy-9-(hydroxymethyl)-3-oxabicyclo[4.3.0]nona-4,8-diene-5-carboxylate) as a powder to the clotted dried blood in an amount of about 2% by weight of the dried blood. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 108. The method according to claim 107, wherein the genipin is solubilized in alcohol before adding the genipin to the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 109. The method according to claim 97, wherein the clotted dried blood is adjusted to water content by weight of 5-15% based upon total weight of the dried blood prior to mixing with other components of the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 110. The method according to claim 97, wherein a porogen compound is added to the composition prior to curing. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 111. The method according to claim 97, wherein prior to curing, the composition is provided with a quantity of particulate ammonium acetate crystals, pre-sized to 150-250 microns, whereas, during curing, the ammonium acetate crystals sublimate to result in a controlled porous plastic with a pore size of 150-250 microns. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 112. The method according to claim 97, wherein said quantify of blood is clotted, dried and comminuted to a particle size distribution of between 38-500 microns. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 113. The method according to claim 97, wherein the composition is plasticized at a temperature between 55-150° C. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 114. The method according to claim 113, wherein the composition is plasticized at a temperature between 100-140° C. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 115. The method according to claim 97, wherein the composition is plasticized at a pressure between 9-25 kilopounds per square inch. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 116. The method according to claim 97, wherein the composition is plasticized at a pressure of at least 10.7 kilopounds per square inch or higher. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 117. The method according to claim 97, wherein prior to curing, up to 10% nanoparticulate tricalcium phosphate is added to the composition. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 118. The method according to claim 97, wherein the dried blood is sterilized with an alcohol wash prior to admixing with the at least one plasticizer. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 119. A method for promoting healing of a skin wound comprising: applying to the skin wound surface an effective amount of a blood-derived plastic article, wherein the blood-derived plastic article comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 120. The method according to claim 119, wherein the article is a film. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 121. A method for promoting healing of a tissue wound or defect comprising: applying to the tissue wound or defect an effective amount of a blood-derived plastic article, wherein the blood-derived plastic article comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 122. A method for providing a resorbable graft to a graft position in a subject, comprising: inserting a blood-derived plastic article into a graft position in a subject, wherein the blood-derived plastic article comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 123. A method for delivering stem cells to a tissue of a subject, comprising: contacting a blood-derived plastic article comprising stem cells with a tissue of a subject. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 124. The method according to claim 123, wherein the article is a tissue substitute or support. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 125. A method of connecting a first portion of a tissue with a second portion of a tissue, comprising: contacting at least one blood-derived plastic article selected from the group consisting of a suture, staple and barb with a first portion of a tissue with a second portion of a tissue such that the first portion of the tissue and the second portion of the tissue are connected. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 126. A method for forming a blood-derived plastic film, comprising: (a) drying a blood-derived composition under vacuum to reduce the water content thereof and form an at least partially dried composition; and (b) shaping the at least partially dried composition into a film. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 127. The method according to claim 126, further comprising applying pressure to at least a portion of the blood-derived composition during vacuum drying. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 128. The method according to claim 126, wherein the blood-derived composition comprises at least one crosslinking agent. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 129. The method according to claim 126, wherein the article comprises at least one biological response modifier. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 130. A method for forming a blood-derived plastic article, comprising: (a) lyophilizing a blood-derived composition to reduce the water content thereof and form an at least partially dried composition; (b) mixing the at least partially dried composition with at least one plasticizer to form a mixture; and (c) shaping the mixture into a blood-derived plastic article. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 131. The method according to claim 130, wherein the at least partially dried composition is powderized. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 132. The method according to claim 130, wherein the mixture is shaped into the blood-derived plastic article by molding or extrusion. ) Array ( [Name] => Comment [Label] => Claim [Group] => Patent [Data] => 133. The method according to claim 130, wherein the mixture is shaped into the blood-derived plastic article by compression molding. ) Array ( [Name] => CodeClass [Label] => Current U.S. Class [Group] => Patent [Data] => 424/423 ) Array ( [Name] => CodeClass [Label] => Current International Class [Group] => Patent [Data] => 61; 61; 61; 01; 61; 61; 61; 29 ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edspap.20080286329 ) |
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