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Last Updated: March 28, 2024

Claims for Patent: 7,189,410


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Summary for Patent: 7,189,410
Title:Supplemented and unsupplemented tissue sealants, methods of their production and use
Abstract: This invention provides a fibrin sealant bandage, wherein said fibrin sealant may be supplemented with at least one composition selected from, for example, one or more regulatory compounds, antibody, antimicrobial compositions, analgesics, anticoagulants, antiproliferatives, anti-inflammatory compounds, cytokines, cytotoxins, drugs, growth factors, interferons, hormones, lipids, demineralized bone or bone morphogenetic proteins, cartilage inducing factors, oligonucleotides polymers, polysaccharides, polypeptides, protease inhibitors, vasoconstrictors or vasodilators, vitamins, minerals, stabilizers and the like. Also disclosed are methods of preparing and/or using the unsupplemented or supplemented fibrin sealant bandage.
Inventor(s): Drohan; William N. (Springfield, VA), MacPhee; Martin J. (Gaithersburg, MD), Burgess; Wilson H. (Clifton, VA), Nunez; Hernan (Derwood, MD), Singh; Manish (San Diego, CA), Liau; Gene (Darnestown, MD), Maciag; Thomas (Freeport, ME)
Assignee: The American National Red Cross (Rockville, MD)
Application Number:08/474,078
Patent Claims:1. A fibrin sealant bandage for treating tissue of a patient, said bandage comprising: (i) a backing layer having at least one tissue-facing surface; and (ii) a hemostatic component layer on said at least one tissue-facing surface of said backing layer, said component layer comprising a hemostatically effective amount of fibrinogen; wherein said hemostatic component layer contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein said fibrinogen forms a hemostatically effective fibrin clot that covers and adheres to tissue of a patient when said bandage is applied to said tissue, thereby being capable of significantly diminishing fluid loss from said tissue.

2. The fibrin sealant bandage of claim 1, wherein said component layer further comprises at least one component selected from the group consisting of Factor XIII, thrombin, and Ca.sup.++.

3. The fibrin sealant bandage of claim 1, wherein said component layer further comprises at least two components selected from the group consisting of Factor XIII, thrombin, and Ca.sup.++.

4. The fibrin sealant bandage of claim 1, wherein said component layer further comprises Factor XIII, thrombin, and Ca.sup.++.

5. The fibrin sealant bandage of claim 1 which further comprises: (iii) a physiologically-acceptable adhesive layer affixed to the tissue-facing surface of said backing, wherein said component layer is affixed to the tissue-facing surface of said adhesive layer.

6. The fibrin sealant bandage of claim 5, wherein said adhesive layer comprises at least one material having a lower shear or tensile strength than that of said fibrin clot formed by said fibrinogen, thereby permitting removal of said backing without damage to said fibrin clot or to tissue.

7. The fibrin sealant bandage of claim 6, wherein said tissue-facing surface of said bandage has an inner region and an outer region and wherein said component layer is affixed to said inner region of said tissue-facing surface of said backing.

8. The fibrin sealant bandage of claim 7, wherein said adhesive layer extends beyond said component layer so that upon application of said bandage to a patient, a portion of said adhesive layer is affixed directly to tissue.

9. The fibrin sealant bandage of claim 6, wherein the adhesive capability of said adhesive layer after application to said tissue permits removal of said backing from said fibrin clot.

10. The fibrin sealant bandage of claim 1, wherein said backing also functions as a physiologically-acceptable adhesive layer to which said component layer is affixed on the tissue-facing surface.

11. The fibrin sealant bandage of claim 5, further comprising a removable, waterproof, protective film over said component layer and said adhesive layer.

12. The fibrin sealant bandage of claim 1, wherein at least one component of said component layer of said bandage is dry.

13. The fibrin sealant bandage of claim 12, wherein said dry component of said component layer of said bandage is capable of being hydrated by a physiologically-acceptable hydrating agent prior to, during or following application of said bandage to wounded tissue.

14. The fibrin sealant bandage of claim 12, wherein said dry component of said component layer of said bandage is capable of being hydrated during application of said bandage to tissue by endogenous fluids from said tissue.

15. The fibrin sealant bandage of claim 12, wherein said dry component of said component layer of said bandage is capable of being hydrated during application of said bandage to tissue by a physiologically-acceptable hydrating agent.

16. The fibrin sealant bandage of claim 1, wherein at least one component of said component layer is a gel.

17. The fibrin sealant bandage of claim 1, wherein said component layer further comprises at least one supplement selected from the group consisting of: analgesics, anesthetics, antibiotics, antimicrobial compounds, antibodies, anticoagulants, antifungal agents, anti-inflammatory compositions, antiproliferatives, antiseptics, cartilage-inducing compounds, cardiovascular drugs, cells, cytokines, cytotoxins, chemotherapeutic drugs, growth factors, hormones, interferons, lipids, polynucleotides or oligonucleotides, osteoinducers, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors, vasodilators, vitamins, nutritional supplements, minerals and stabilizers.

18. The fibrin sealant bandage of claim 17, wherein said supplement is an antimicrobial compound.

19. The fibrin sealant bandage of claim 17, wherein said supplement is a growth factor.

20. The fibrin sealant bandage of claim 19, wherein said growth factor is 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; cells; osteoid-inducing factors; osteogenin and other bone growth factors; collagen growth factors; heparin-binding growth factors; cytokines; and interferon.

21. The fibrin sealant bandage of claim 19, wherein said component layer further comprises at least one compound selected from the group consisting of inhibiting compounds and potentiating compounds, wherein said inhibiting compounds inhibit agents that interfere with a biological function of said growth factor, while said potentiating compounds increase and/or mediate the ability of said growth factor to regulate or mediate cell proliferation, cell differentiation, cell migration, tissue regeneration, cell attraction, wound repair and/or any cell developmental or proliferative process.

22. The supplemented tissue sealant composition of claim 21, wherein said compound increases and/or mediates the ability of said growth factor supplement to regulate or mediate cell proliferation, cell differentiation, cell migration, tissue regeneration, cell attraction, wound repair and/or any cell developmental or proliferative process while also inhibiting agents that interfere with the activity of said growth factor.

23. The fibrin sealant bandage of claim 19, wherein said component layer further comprises at least one antibody and/or at least one antimicrobial compound.

24. The fibrin sealant bandage of claim 19, wherein said component layer further comprises at least one anaesthetic.

25. The fibrin sealant bandage of claim 17, wherein said component layer comprises at least one cytotoxin or cell proliferation inhibiting compound.

26. The fibrin sealant bandage of claim 25, wherein said cytotoxin or cell proliferation inhibiting compound is selected from the group consisting of alkylating agents, enzyme inhibitors, proliferation inhibitors, lytic agents, DNA synthesis inhibitors, membrane permeability modifiers, DNA intercalators, metabolites, protein production inhibitors, ribosome inhibitors, inducers of apoptosis, and neurotoxins.

27. The fibrin sealant bandage of claim 25, wherein said cytotoxin or cell proliferation inhibiting compound is selected from the group consisting of 5-fluorouracil, actinomycin D, adriamycin, azaribine, bleomycin, busulfan, carmustine, chlorambucil, cisplatin, cytarabine, dacarbazine, estrogen, hormone antagonists or mimics, insulins, hydroxyurea, L-asparaginase, lomustine, melphalan, mercaptopurine, methotrexate, mitomycin C, prednisilone, prednisone, procarbazine, steroids, streptozotocin, testosterone, thioguanine, thiotepa, vinblastine, vincristine, taxol, taxotere, gentamycin, carboplatin, cyclophosphamide, ifosphamide, maphosphamide, ricin, diptheria toxoid, and venoms.

28. The fibrin sealant bandage of claim 25, wherein said component layer further comprises at least one antibody and/or at least one antimicrobial compound.

29. The fibrin sealant bandage of claim 17, wherein said supplement is released from said fibrin clot long term.

30. The fibrin sealant bandage of claim 29, wherein said supplement is in solid form.

31. The fibrin sealant bandage of claim 30, wherein prior to application of said bandage to said tissue, said supplement is introduced into said component layer prior to formation of the fibrin clot as a solution of said supplement dissolved in a carrier, said carrier having a higher rate of diffusion or dissolution than said supplement contained therein, so that said supplement is deposited within the resulting fibrin clot as a solid precipitate.

32. The fibrin sealant bandage of claim 29, wherein said supplement interacts with said fibrin clot, thereby permitting localized, sustained-release of said supplement from said fibrin clot.

33. The fibrin sealant bandage of claim 29, wherein said supplement is of sufficiently low solubility to permit sustained-release of said supplement from said fibrin clot.

34. The fibrin sealant bandage of claim 29, wherein the mass of said supplement in said component layer exceeds the amount which is soluble in the volume of the fibrin clot formed during application of said bandage to said tissue, thereby permitting localized, sustained-release of said supplement from said fibrin clot.

35. The fibrin sealant bandage of claim 34, wherein prior to application of said bandage to said tissue, said supplement is introduced into said component layer prior to formation of the fibrin clot as an emulsion.

36. The fibrin sealant bandage of claim 1, wherein said component layer further comprises at least one supplement selected from the group consisting of fibrin, collagen, gelatin and chitin.

37. The fibrin sealant bandage of claim 1, wherein said backing comprises a resorbable material.

38. The fibrin sealant bandage of claim 37, wherein said resorbable backing is selected from the group consisting of: fibrin, gelatin, chitin and chitosan.

39. A method of treating tissue in a patient by applying the fibrin sealant bandage of any one of claims 1 5 to said tissue.

40. A method of treating tissue in a patient by applying the fibrin sealant bandage of any one of claims 6 10 to said tissue.

41. A method of treating tissue in a patient using the fibrin sealant bandage of claim 11, said method comprising the steps of removing said film and applying said fibrin sealant bandage to said tissue.

42. A method of treating tissue in a patient by applying the fibrin sealant bandage of any one of claims 12 17 to said tissue.

43. A method of treating tissue in a patient by applying the fibrin sealant bandage of any one of claims 29 35 or 36 38 to said tissue.

44. A method of preparing a fibrin sealant bandage comprising layering (i) a backing layer, having at least one tissue-facing surface; and (ii) a hemostatic component layer on said at least one tissue-facing surface of said backing layer, said hemostatic component layer comprising a hemostatically effective amount of fibrinogen; wherein said hemostatic component layer contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein said fibrinogen is effective to form a fibrin clot that covers and adheres to tissue of a patient when said bandage is applied to said tissue.

45. The method of claim 44, further comprising layering (iii) a physiologically-acceptable adhesive layer.

46. The method of claim 44, wherein at least one component of said component layer of said bandage is dry.

47. The method of claim 44, wherein at least one component of said component layer of said bandage is a gel.

48. The method of claim 44, further comprising layering (iii) a removable, waterproof, protective film over said component layer.

49. The supplemented fibrin clot which is formed upon application of the fibrin sealant bandage of claim 17 to tissue.

50. The fibrin sealant bandage of claim 1, wherein said backing comprises a non-resorbable material.

51. The fibrin sealant bandage of claim 1, wherein said backing is an occlusive backing.

52. The fibrin sealant bandage of claim 17, wherein said supplement is an anesthetic.

53. The fibrin sealant bandage of claim 17, wherein said supplement is an anesthetic and an antimicrobial compound.

54. A method of treating tissue in a patient by applying the fibrin sealant bandage of any one of claims 18 28 to said tissue.

55. The method of claim 46, wherein said dry component of said component layer is lyophilized.

56. The method of claim 46, wherein a plurality of components of said component layer are dry.

57. The method of claim 56, wherein said dry components are lyophilized.

58. The method of claim 44, wherein said backing comprises a non-resorbable material.

59. The method of claim 44, wherein said backing is an occlusive backing.

60. The fibrin sealant bandage of claim 1, wherein said fibrinogen is recombinantly-produced human fibrinogen.

61. The method of claim 44, wherein said fibrinogen is recombinantly-produced human fibrinogen.

62. The fibrin sealant bandage of any one of claims 2 4, wherein said thrombin is recombinantly-produced human thrombin.

63. The fibrin sealant bandage of any one of claims 2 4, wherein said Factor XIII is recombinantly-produced human Factor XIII.

64. The fibrin sealant bandage of claim 8, wherein said portion of said adhesive layer further prevents fluid from entering or leaving said tissue.

65. The fibrin sealant bandage of claim 15, wherein said physiologically acceptable hydrating agent is contained within a separate layer of said bandage.

66. A bandage for treating tissue of a patient, said bandage comprising: (i) a backing; and (ii) a physiologically-acceptable adhesive layer on the tissue-facing surface of the backing; and (iii) a layer of materials comprising a hemostatically effective amount of fibrinogen wherein said fibrinogen is effective to form a fibrin matrix in the presence of thrombin, Ca.sup.++ and a hydrating agent; wherein the layer of materials contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein the layer of materials is adhesively affixed to the tissue-facing surface of the adhesive layer.

67. A method of using a bandage for treating tissue of a patient, said method comprising applying said bandage to said tissue, said bandage comprising: (i) a backing; and (ii) a physiologically-acceptable adhesive layer on the tissue-facing surface of the backing; and (iii) a layer of materials comprising a hemostatically effective amount of fibrinogen wherein said fibrinogen is effective to form a fibrin matrix in the presence of thrombin, Ca.sup.++ and hydrating agent; wherein the layer of materials contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein the layer of materials is adhesively affixed to the tissue-facing surface of the adhesive layer.

68. A bandage for treating tissue of a patient, said bandage comprising: (i) a backing; and (ii) a layer of dry materials comprising a hemostatically effective amount of fibrinogen; wherein said layer of dry materials contains no fibrinolysis inhibitor and wherein said layer of dry materials is adhesively affixed to said backing; wherein said backing contains no collagen; and wherein said fibrinogen is effective to form a fibrin matrix in the presence of thrombin, Ca.sup.++ and a hydrating agent.

69. A bandage for treating tissue of a patient, wherein said bandage is produced by a process comprising: (i) providing a backing layer having at least one tissue-facing surface; and (ii) layering a hemostatic component on at least one tissue-facing surface of said backing layer, said component layer comprising a hemostatically effective amount of fibrinogen; wherein said hemostatic component layer contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein said fibrinogen is effective to form a fibrin clot that covers and adheres to tissue of a patient when said bandage is applied to said tissue.

70. The bandage of claim 69, wherein said component layer comprises at least one supplement selected from the group consisting of: analgesics, anesthetics, antibiotics, antimicrobial compounds, antibodies, anticoagulants, antifungal agents, anti-inflammatory compositions, antiproliferatives, antiseptics, cartilage-inducing compounds, cardiovascular drugs, cells, cytokines, cytotoxins, chemotherapeutic drugs, growth factors, hormones, interferons, lipids, polynucleotides or oligonucleotides, osteoinducers, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors, vasodilators, vitamins, nutritional supplements, minerals and stabilizers.

71. A bandage for treating tissue of a patient, wherein said bandage is produced by a process comprising: (i) providing a backing; (ii) layering a physiologically-acceptable adhesive on the tissue-facing surface of said backing; and (iii) adhesively affixing a layer of material to the tissue-facing surface of the adhesive layer, wherein said layer of materials comprises a hemostatically effective amount of fibrinogen; wherein said layer of materials contains no added fibrinolysis inhibitor; wherein said backing layer contains no collagen; and wherein said fibrinogen is effective to form a fibrin matrix in the presence of thrombin, Ca.sup.++ and a hydrating agent.

72. The bandage of claim 71, wherein said layer of material comprises at least one supplement selected from the group consisting of: analgesics, anesthetics, antibiotics, antimicrobial compounds, antibodies, anticoagulants, antifungal agents, anti-inflammatory compositions, antiproliferatives, antiseptics, cartilage-inducing compounds, cardiovascular drugs, cells, cytokines, cytotoxins, chemotherapeutic drugs, growth factors, hormones, interferons, lipids, polynucleotides or oligonucleotides, osteoinducers, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors, vasodilators, vitamins, nutritional supplements, minerals and stabilizers.

73. A bandage for treating tissue of a patient, wherein said bandage is produced by a process comprising: (i) providing a backing; and (ii) adhesively affixing a layer of dry material to said backing, wherein said dry material comprises a hemostatically effective amount of fibrinogen; wherein said fibrinogen is effective to form a fibrin matrix in the presence of thrombin, Ca.sup.++ and a hydrating agent; wherein said backing contains no collagen; and wherein said dry material contains no added fibrinolysis inhibitor.

74. The bandage of claim 73, wherein said layer of dry material comprises at least one supplement selected from the group consisting of: analgesics, anesthetics, antibiotics, antimicrobial compounds, antibodies, anticoagulants, antifungal agents, anti-inflammatory compositions, antiproliferatives, antiseptics, cartilage-inducing compounds, cardiovascular drugs, cells, cytokines, cytotoxins, chemotherapeutic drugs, growth factors, hormones, interferons, lipids, polynucleotides or oligonucleotides, osteoinducers, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors, vasodilators, vitamins, nutritional supplements, minerals and stabilizers.

75. The fibrin sealant bandage of claim 1, wherein said component layer is in direct contact with the backing layer.

76. The fibrin sealant bandage of claim 1, wherein said component layer is in indirect contact with the backing layer.

77. The method of claim 44, wherein the component layer is layered in direct contact with the backing layer.

78. The method of claim 44, wherein the component layer is layered in indirect contact with the backing layer.

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