Methods and dressings for sealing internal injuries
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.
1. A method for treating wounded internal tissue in a mammal comprising applying to wounded internal tissue for a time sufficient to join or approximate said wounded tissue and/or to reduce the flow of fluid from said wounded tissue at least one haemostatically effective amount of a casted haemostatic material, wherein said casted haemostatic material consists essentially of a substantially homogenous 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° C.+/−2° C. before casting.
2. The method of claim 1 , wherein said haemostatic material includes at least one support layer.
3. The method of claim 2 , wherein said support layer comprises a backing material.
4. The method of claim 2 , wherein said support layer comprises an internal support material.
5. The method of claim 2 , wherein said support layer comprises a resorbable material.
6. The method of claim 2 , wherein said support layer comprises a non-resorbable material.
7. The method of claim 6 , wherein said non-resorbable material is selected from the group consisting of silicone polymers, paper, gauze, plastics, non-resorbable suture materials, latexes and suitable derivatives of thereof.
8. The method of claim 2 , further comprising at least one physiologically acceptable adhesive between said haemostatic material and said backing layer.
9. The method of claim 5 , wherein said resorbable material is selected from the group consisting of proteinaceous materials, carbohydrate substances and resorbable suture materials.
10. The method of claim 9 , wherein said proteinaceous material is at least one substance selected from the group consisting of keratin, silk, fibrin, collagen, and gelatin.
11. The method of claim 9 , 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.
12. The method of claim 1 , wherein said haemostatic material also contains a fibrin crosslinker and/or a source of calcium ions.
13. The method 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.
14. The method of claim 13 , 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.
15. The method of claim 13 , 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.
16. The method of claim 13 , 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.
17. The method of claim 13 , 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.
18. The method 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.