Supplemented and unsupplemented tissue sealants, methods of their production and use
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-038/48
A61K-038/43
A61K-009/70
A61L-015/16
출원번호
US-0465854
(2003-06-20)
발명자
/ 주소
MacPhee,Martin James
Drohan,William Nash
Liau,Gene
Nunez,Hernan
Burgess,Wilson H.
Maciag,Thomas
출원인 / 주소
American National Red Cross
대리인 / 주소
Sterne, Kessler, Goldstein &
인용정보
피인용 횟수 :
19인용 특허 :
88
초록▼
This invention provides supplemented tissue sealants, methods for their production and use thereof. Disclosed are tissue sealants supplemented with at least one cytotoxin or cell proliferation inhibiting composition. The composition may be further supplemented with, for example, one or more antibodi
This invention provides supplemented tissue sealants, methods for their production and use thereof. Disclosed are tissue sealants supplemented with at least one cytotoxin or cell proliferation inhibiting composition. The composition may be further supplemented with, for example, one or more antibodies, analgesics, anticoagulants, anti-inflammatory compounds, antimicrobial compositions, cytokines, drugs, growth factors, interferons, hormones, lipids, deminearlized bone or bone morphogenetic proteins, cartilage inducing factors, oligonucleotides polymers, polysaccharides, polypeptides, protease inhibitors, vasoconstrictors or vasodilators, vitamins, minerals, stabilizers and the like.
대표청구항▼
What is claimed is: 1. A biocompatible, supplemented tissue sealant composition comprising: (i) at least one supplement selected from the group consisting of an antibiotic, an anesthetic, an anticoagulant, a cardiovascular drug, an anti-inflammatory compound, a cytotoxin or cell proliferation inhib
What is claimed is: 1. A biocompatible, supplemented tissue sealant composition comprising: (i) at least one supplement selected from the group consisting of an antibiotic, an anesthetic, an anticoagulant, a cardiovascular drug, an anti-inflammatory compound, a cytotoxin or cell proliferation inhibiting compound, an osteogenic compound, a cartilage inducing compound, a protease inhibitor, a steroid, an analgesic, an antifungal, an antiangiogenin, an antifibrinolytic compound, an antimicrobial compound, an antiparsitic agent, an antiseptic, an antiviral compound, a chemotherapeutic drug, a lipid or liposome, an oligonucleotide or polynucleotide, an osteoconductive compound, a polysaccharide, a vascoconstrictor, a vasodilator, a vitamin, a nutritional supplement and a mineral; and (ii) fibrinogen in an amount which forms a fibrin matrix; wherein said fibrinogen forms a fibrin matrix when in the presence of thrombin and Ca++ and water, further wherein said supplement is released from said fibrin matrix into the external environment of use for a sustained period, further wherein the amount of said supplement in said composition is greater than the amount of said supplemented which is soluble in said fibrin matrix, and further wherein said sustained period is greater than then period obtained according to simple diffusion kinetics. 2. A biocompatible, supplemented tissue sealant composition comprising: (i) at least one supplement selected from the group consisting of an antiangiogenin, an antifibrinolytic protein, an antimicrobial protein, a cytokine, a hormone, an interferon, a proteoglycan, a polypeptide, a protease inhibitor, a cytotoxin or cell proliferation inhibiting protein, and a protein nutritional supplement, and (ii) fibrinogen in an amount which forms a fibrin matrix; wherein said fibrinogen will form a fibrin matrix when in the presence of thrombin and Ca++ and water, further wherein said supplement is released from said fibrin matrix into the external environment of use for a sustained period, and further wherein said sustained period is greater than then period obtained according to simple diffusion kinetics. 3. A biologically, supplemented tissue sealant composition comprising: (i) at least one supplement selected from the group consisting of a growth factor, an osteogenic protein, a cartilage inducing protein, an antibody, and an anticoagulant protein; and (ii) fibrinogen in an amount which forms a fibrin matrix; wherein said fibrinogen will form a fibrin matrix when in the presence of thrombin and Ca++ and water, further wherein said supplement is released from said fibrin matrix into the external environment of use for a sustained period, and further wherein said sustained period is greater than then period obtained according to simple diffusion kinetics. 4. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein said supplement is selected from the group consisting of an antibiotic, a chemotherapeutic drug, a protease inhibitor, and an antifibrinolytic compound and interacts with said fibrin matrix and so increases the longevity thereof in said environment of use. 5. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein said supplement is sufficiently insoluble in said environment of use to permit sustained-release of said supplement. 6. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein said supplement is present in said fibrin matrix in solid form. 7. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein said supplement is introduced into said composition prior to formation of the fibrin matrix as a solution of said supplement dissolved in a carrier liquid. 8. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein the mass of said supplement in said composition exceeds the amount which is soluble in the volume of the fibrin matrix formed when said fibrinogen is hydrated in the presence of thrombin and Ca++. 9. The supplemented tissue sealant composition of claim 1, 2 or 3, wherein said supplement is introduced into said composition prior to formation of the fibrin matrix as an emulsion of said supplement in a carrier liquid or component of said fibrin matrix. 10. The supplemented tissue sealant composition of claim 1, 2 or 3, further comprising an effective amount of at least one additional supplement selected from the group consisting of analgesics, anesthetics, antimicrobial compounds, antibiotics, antifibrinolytic agents, anti-inflammatory compounds, antibodies, anticoagulants, antifungal compounds, antiangiogenins, antiseptics, cardiovascular drugs, cytokines, cytotoxins or cell proliferation inhibiting compounds, chemotherapeutic drugs, interferons, growth factors, hormones, lipids or liposomes, oligonucleotides or polynucleotides, osteoinducers, cartilage-inducing compounds, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors, vasodilators, vitamins, nutritional supplements, minerals and stabilizers. 11. The supplemented tissue sealant composition of claim 1, or 2, further comprising an effective amount of at least one compound selected from the group consisting of inhibiting compounds and potentiating compounds, wherein said inhibiting compounds inhibit the activity of any agent present in said composition and/or said external environment of use that interferes with the biological activity of said supplement, while said potentiating compounds potentiate and/or mediate and/or enhance the biological activity of said supplement. 12. The supplemented tissue sealant composition of claim 11, wherein said compound inhibits the activity of any agent present in said composition that interferes with the biological activity of said supplement. 13. The supplemented tissue sealant composition of claim 11, wherein said compound potentiates or mediates or enhances the biological activity of said supplement. 14. The supplemented tissue sealant composition of claim 11, wherein said compound potentiates or mediates or enhances the biological activity of said supplement, while inhibiting the activity of any agent present in said composition that interferes with the activity of said supplement. 15. The supplemented tissue sealant composition of claim 11, wherein said compound is heparin. 16. The supplemented tissue sealant composition of claim 3, wherein said supplement is a growth factor selected from the group consisting of: fibroblast growth factors; platelet-derived growth factors; insulin-like growth factors; epidermal growth factors; transforming growth factors; cartilage-inducing factors; osteoid-inducing factors; osteogenin; bone growth factors; bone morphogenetic growth factors; collagen growth factors; heparin-binding growth factors; vascular endothelial growth factors; cytokines; interferons; and hormones. 17. The supplemented tissue sealant composition of claim 2, wherein said supplement is an antibody selected from the group consisting of polyclonal antibodies, monoclonal antibodies, chimeric antibodies, functional derivatives of said antibodies, fragments of said antibodies, and modified forms of said antibodies. 18. The supplemented tissue sealant composition of claim 1, wherein said supplement is a polynucleotide or oligonucleotide selected from the group consisting of RNA, DNA, and modified forms thereof. 19. The supplemented tissue sealant composition of claim 18, wherein said polynucleotide or oligonucleotide is sense or antisense. 20. The supplemented tissue sealant composition of claim 1, wherein said supplement is a cytotoxin or cell proliferation inhibiting compound. 21. The supplemented tissue sealant composition of claim 20, further comprising an effective amount of at least one additional supplement selected from the group consisting of an antibody, an antimicrobial compound, an anesthetic, an antiangiogenin, and a vasoconstrictor drug in an amount sufficient to effect localized vasoconstriction. 22. The supplemented tissue sealant composition of claim 1, wherein said supplement stabilizes said fibrin matrix. 23. The supplemented tissue sealant composition of claim 3, wherein said supplement is an osteogenic protein or cartilage inducing protein selected from the group consisting of: osteoid-inducing factors; osteogenic; bone growth factors which modulate the attraction, migration and/or proliferation of progenitor bone cells; bone morphogenetic growth factors; demineralized bone matrix; and cartilage-inducing factors. 24. The supplemented tissue sealant composition of claim 3, wherein said supplement is a growth factor selected from the group consisting of bone morphogenetic growth factors 1-8; cartilage derived growth factors and cartilage inducing growth factors; heparin binding growth factors; fibroblast growth factors; and transforming growth factors. 25. The supplemented tissue sealant composition of claim 1, wherein said supplement is an analgesic. 26. The supplemented tissue sealant composition of claim 1, wherein said supplement is an antibiotic. 27. The supplemented tissue sealant composition of claim 1, wherein said supplement is an anticoagulant. 28. The supplemented tissue sealant composition of claim 1, wherein said supplement is an anti-inflammatory compound. 29. The supplemented tissue sealant composition of claim 1, wherein said supplement is an antiparasitic agent. 30. The supplemented tissue sealant composition of claim 1, wherein said supplement is an antiviral compound. 31. The supplemented tissue sealant composition of claim 2, wherein said supplement is a cytokine. 32. The supplemented tissue sealant composition of claim 1, wherein said supplement is a chemotherapeutic drug. 33. The supplemented tissue sealant composition of claim 2, wherein said supplement is a hormone. 34. The supplemented tissue sealant composition of claim 2, wherein said supplement is an interferon. 35. The supplemented tissue sealant composition of claim 1, wherein said supplement is a lipid or liposome. 36. The supplemented tissue sealant composition of claim 1, wherein said supplement is a polysaccharide. 37. The supplemented tissue sealant composition of claim 1 or 2, wherein said supplement is a protease inhibitor. 38. The supplemented tissue sealant composition of claim 2, wherein said supplement is a proteolglycan. 39. The supplemented tissue sealant composition of claim 2, wherein said supplement is a polypeptide. 40. The supplemented tissue sealant composition of claim 1, wherein said supplement is a steroid. 41. The supplemented tissue sealant composition of claim 1, wherein said supplement is a vasoconstrictor. 42. The supplemented tissue sealant composition of claim 1, wherein said supplement is a vasodilator. 43. The supplemented tissue sealant composition of claim 1, wherein said supplement is a vitamin, nutritional supplement or a mineral. 44. The supplemented tissue sealant composition of claim 1 or 2, further comprising thrombin. 45. The supplemented tissue sealant composition of claim 1 or 2, further comprising Factor XIII. 46. The supplemented tissue sealant composition of claim 1 or 2, further comprising Ca++. 47. The supplemented tissue sealant composition of claim 1 or 2, wherein said fibrinogen is recombinantly-produced human fibrinogen. 48. The supplemented tissue sealant composition of claim 1, wherein said supplement is an anesthetic. 49. The supplemented tissue sealant composition of claim 44, wherein said thrombin is recombinantly-produced human thrombin. 50. The supplemented tissue sealant composition of claim 45, wherein said Factor XIII is a recombinantly-produced human Factor XIII. 51. The supplemented tissue sealant composition of claim 2, wherein said supplement is an antifibrinolytic agent. 52. The supplemented tissue sealant composition of claim 7, wherein said carrier liquid dissolves or diffuses through said fibrin matrix at a faster rate than said supplement contained therein, so that said supplement is deposited within said fibrin matrix at a solid precipitate. 53. The supplemented tissue sealant composition of claim 7, wherein said carrier is a non-aqueous carrier. 54. The supplemented tissue sealant composition of claim 53, wherein said non-aqueous carrier liquid is a liquid or liposome. 55. The supplemented tissue sealant composition of claim 1 or 2, wherein said composition contains substantially no collagen or viscosity-enhancing polymers. 56. The supplemented tissue sealant composition of claim 1, 2 or 3, further comprising at least one agent selected from the group consisting of an antibiotic, a chemotherapeutic drug, a protease inhibitor, and an antifibrinolytic compound that stabilizes said fibrin matrix and so increases the longevity thereof in said environment of use. 57. The supplemented tissue sealant composition of claim 56, wherein said agent is selected from the group consisting of tetracycline free base and ciprofloxacin hydrochloride.
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