Claims for Patent: 9,131,929

Summary for Patent: 9,131,929

Title:	Methods and dressings for sealing internal injuries
Abstract:	Disclosed are solid and frozen haemostatic materials and dressings consisting essentially of a fibrinogen component and a fibrinogen activator. Also disclosed are methods of treating internal wounded tissue in a mammal by applying one or more of these haemostatic materials and dressings.
Inventor(s):	MacPhee; Martin (Darnestown, MD), Kanellos; Jerry (Victoria, AU), Wilmer; Belinda (Martinsburg, WV), Beall; Dawson (Gaithersburg, MD)
Assignee:	STB, Ltd. (Bellevue, WA)
Application Number:	13/080,086
Patent Claims:	1. A device for treating wounded internal tissue in a mammal comprising: (a) an applicator; and (b) a haemostatically effective amount of a casted haemostatic material, wherein said casted haemostatic material consisting essentially of a substantially homogeneous mixture of a fibrinogen component and a fibrinogen activator, wherein said fibrinogen component is present in an amount between 26 to about 450 mg per square centimeter of the surface intended to contact the wounded internal tissue being treated and wherein the fibrinogen activator is employed between about 0.0087-1.000 mg fibrinogen component, and wherein said fibrinogen component and fibrinogen activator are cooled to about 4.degree. C.+/-2.degree. C. before casting. 2. The device of claim 1, wherein said applicator comprises a plunger or tamper. 3. The device of claim 1, wherein said applicator comprises a guide wire. 4. The device of claim 1, wherein said haemostatic material includes at least one support layer. 5. The device of claim 4, wherein said support layer comprises a backing material. 6. The device of claim 4, wherein said support layer comprises an internal support material. 7. The device of claim 4, wherein said support layer comprises a resorbable material. 8. The device of claim 4, wherein said support layer comprises a non-resorbable material. 9. The device of claim 8, wherein said non-resorbable material is selected from the group consisting of silicone polymers, paper, gauze, plastics, non-resorbable suture materials, and latexes. 10. The device of claim 4, further comprising at least one physiologically acceptable adhesive between said haemostatic material and said support layer. 11. The device of claim 7, wherein said resorbable material is selected from the group consisting of proteinaceous materials, carbohydrate substances and resorbable suture materials. 12. The device of claim 11, wherein said proteinaceous material is at least one substance selected from the group consisting of keratin, silk, fibrin, collagen, and gelatin. 13. The device of claim 11, wherein said carbohydrate substance is selected from the group consisting of alginic acid and salts thereof, chitin, chitosan, cellulose, n-acetyl glucosamine, proteoglycans, glycolic acid polymers, lactic acid polymers, glycolic acid/lactic acid co-polymers, and mixtures of two or more thereof. 14. The device of claim 1, wherein said haemostatic material also contains a fibrin crosslinker and/or a source of calcium ions. 15. The device of claim 1, wherein said haemostatic material also contains one or more of the following: at least one filler; at least one solubilizing agent; at least one foaming agent; and at least one release agent. 16. The device of claim 15, wherein said filler is selected from the group consisting of sucrose, lactose, maltose, keratin, silk, fibrin, collagen, gelatin, albumin, polysorbate, chitin, chitosan, alginic acid and salts thereof, cellulose, proteoglycans, glycolic acid polymers, lactic acid polymers, glycolic acid/lactic acid co-polymers, and mixtures of two or more thereof. 17. The device of claim 15, wherein said solubilizing agent is selected from the group consisting of sucrose, lactose, maltose, dextrose, mannose, trehalose, mannitol, sorbitol, albumin, sorbate, polysorbate, and mixtures of two or more thereof. 18. The device of claim 15, wherein said release agent is selected from the group consisting of gelatin, mannitol, sorbitol, polysorbate, sorbitan, lactose, maltose, trehalose, sorbate, glucose and mixtures of two or more thereof. 19. The device of claim 15, wherein said foaming agent is selected from the group consisting of mixtures of sodium bicarbonate/citric acid, sodium bicarbonate/acetic acid, calcium carbonate/citric acid and calcium carbonate/acetic acid. 20. The device of claim 1, wherein said haemostatic material also contains at least one therapeutic supplement selected from the group consisting of antibiotics, anticoagulants, steroids, cardiovascular drugs, growth factors, antibodies (poly and mono), chemoattractants, anesthetics, antiproliferatives/antitumor agents, antivirals, cytokines, colony stimulating factors, antifungals, antiparasitics, antiinflammatories, antiseptics, hormones, vitamins, glycoproteins, fibronectin, peptides, proteins, carbohydrates, proteoglycans, antiangiogenins, antigens, nucleotides, lipids, liposomes, fibrinolysis inhibitors, procoagulants, anticoagulants, vascular constrictors and gene therapy reagents. 21. The device of claim 20, wherein said therapeutic supplement is present in an amount equal to or greater than its solubility limit in fibrin. 22. The device of claim 1, wherein said haemostatic material further contains at least one binding agent in an amount effective to retain the physical integrity of said haemostatic material. 23. The device of claim 22, wherein said binding agent is selected from the group consisting of sucrose, mannitol, sorbitol, gelatin, maltose, povidone, chitosan, carb oxymethylcellulose and derivatives thereof. 24. The device of claim 1, wherein said haemostatic material has been subjected to at least one process selected from the group consisting of lyophilization, drying, spray-drying, vacuum drying and vitrification, and combinations of two or more thereof. 25. The device of claim 1, wherein said haemostatic material has moisture content of at least 6%. 26. The device of claim 1, wherein said haemostatic material has moisture content of less than 6%. 27. The device of claim 1, wherein said haemostatic material is frozen. 28. The device of claim 1, wherein said fibrinogen component is a mammalian fibrinogen. 29. The device of claim 28, wherein said mammalian fibrinogen is selected from the group consisting of bovine fibrinogen, porcine fibrinogen, ovine fibrinogen, equine fibrinogen, caprine fibrinogen, feline fibrinogen, canine fibrinogen, murine fibrinogen and human fibrinogen. 30. The device of claim 1, wherein said fibrinogen component is selected from the group consisting of bird fibrinogen and fish fibrinogen. 31. The device of claim 1, wherein said fibrinogen component is selected from the group consisting of human fibrinogen, human fibrin I, human fibrin II, human fibrinogen a chain, human fibrinogen .beta. chain, human fibrinogen .gamma. chain, and mixtures of two or more thereof. 32. The device of claim 28, wherein said mammalian fibrinogen is recombinantly produced fibrinogen. 33. The device of claim 1, wherein said fibrinogen activator is selected from the group consisting of thrombins, prothrombins, snake venoms, and mixtures of any two or more thereof. 34. The device of claim 33, wherein said thrombin is mammalian thrombin. 35. The device of claim 34, wherein said mammalian thrombin is selected from the group consisting of bovine thrombin, porcine thrombin, ovine thrombin, equine thrombin, caprine thrombin, feline thrombin, canine thrombin, murine thrombin and human thrombin. 36. The device of claim 33, wherein said thrombin is selected from the group consisting of bird thrombin and fish thrombin. 37. The device of claim 34 or 36, wherein said thrombin is recombinantly produced thrombin. 38. The device of claim 2, wherein said applicator further comprises a sheath or barrel.

Details for Patent 9,131,929

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	08/27/2007		2027-08-06
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247	09/17/2009		2027-08-06
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	01/16/2009		2027-08-06
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA, FIBRYNA	fibrinogen (human)	For Injection	125612	06/07/2017		2027-08-06