COMPOSITIONS HAVING CYLINDRICAL VOLUME, METHODS, AND APPLICATORS FOR SEALING INJURIES
Disclosed are solid and frozen haemostatic materials having a rod shape and suitable applicators and plungers for application of such dressings to wounded tissue wherein said 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, particularly for the treatment of injured tissue via endoscopic or minimally-invasive surgical techniques.
1 . A haemostatic material for treating wounded internal tissue in a mammal comprising a cylindrical haemostatic material consisting essentially of a fibrinogen component and a fibrinogen activator wherein said cylindrical haemostaic material is made by combining liquid fibrinogen and liquid fibrinogen at about 12° C. to 0° C. and preferable between 4° C.+/−2° C. into a cylindrical mold, freezing and thereafter lyophilizing said material, wherein said fibrinogen component is present in an amount between 1 mg/cm 2 and 75 mg/cm 2 and said fibrinogen activator is present in an amount between about 0.01 to about 1.0 U/mg fibrinogen component; wherein said liquid combination is thereafter frozen and lyophilized.
2 . A method for treating wounded internal tissue in a mammal comprising applying to wounded internal tissue at least one cylindrical haemostatic material consisting essentially of a fibrinogen component and a fibrinogen activator for a time sufficient to reduce the flow of fluid from said wounded tissue and/or join or approximate said wounded tissue, wherein said haemostatic material is cast or formed from a single aqueous solution containing the fibrinogen component and the fibrinogen activator, wherein said fibrinogen component is present in an amount between 1 mg/ml and 37.5 mg/ml and said fibrinogen activator is present in an amount between about 0.01 to about 1.0 U/mg fibrinogen component; wherein said liquid combination is thereafter frozen and lyophilized.
3 . The haemostatic material in claim 1 wherein said haemostatic material includes at least one support layer.
4 . The haemostatic material of claim 3 , wherein said support layer comprises a backing material.
5 . The haemostatic material of claim 3 , wherein said support layer comprises an internal support material.
6 . The haemostatic material of claim 3 , wherein said support layer comprises a resorbable material.
7 . The haemostatic material of claim 3 , wherein said support layer comprises a nonresorbable material.
8 . The haemostatic material of claim 7 , 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.
9 . The haemostatic material of claim 4 , further comprising at least one physiologically acceptable adhesive between said haemostatic material and said backing layer.
10 . The haemostatic material of claim 6 , wherein said resorbable material is selected from the group consisting of proteinaceous materials, carbohydrate substances and resorbable suture materials.
11 . The haemostatic material of claim 10 , wherein said proteinaceous material is at least one substance selected from the group consisting of keratin, silk, fibrin, collagen, gelatin and suitable derivatives thereof.
12 . The haemostatic material of claim 10 , 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, suitable derivatives thereof and mixtures of two or more thereof.
13 . The haemostatic material of claim 1 , wherein said haemostatic material also contains a fibrin cross-linker and/or a source of calcium ions.
14 . The haemostatic material 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.
15 . The haemostatic material of claim 14 , 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.
16 . The haemostatic material of claim 14 , 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.
17 . The haemostatic material of claim 14 , 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.
18 . The haemostatic material of claim 14 , 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.
19 . The haemostatic material 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.
20 . The haemostatic material of claim 19 , wherein said therapeutic supplement is present in an amount equal to or greater than its solubility limit in fibrin.
21 - 44 . (canceled)