Solid dressing for treating wounded tissue

Abstract

Disclosed are solid dressings for treated wounded tissue in mammalian patients, such as a human, comprising a haemostatic layer consisting essentially of a fibrinogen component and thrombin, wherein the thrombin is present in an amount between 0.250 Units/mg of fibrinogen component and 0.062 Units/mg of fibrinogen component. Also disclosed are methods for treating wounded tissue.

1 . A solid dressing for treating wounded tissue in a mammal comprising at least one haemostatic layer conisisting essentially of thrombin and a fibrinogen component, wherein said thrombin is present an amount between about 0.250 Units/mg of fibrinogen component and 0.062 Units/mg of fibrinogen component. 
     
     
         2 . The solid dressing of  claim 1 , further comprising at least one support layer. 
     
     
         3 . The solid dressing of  claim 2 , wherein said support layer comprises a hacking material. 
     
     
         4 . The solid dressing of  claim 2 , wherein said support layer comprises an internal support material. 
     
     
         5 . The solid dressing of  claim 2 , wherein said support layer comprises a resorbable material. 
     
     
         6 . The solid dressing of  claim 2 , wherein said support layer comprises a non-resorbable material. 
     
     
         7 . (canceled) 
     
     
         8 . The solid dressing of  claim 3 , further comprising at least physiologically acceptable adhesive between said haemostatic layer and said backing layer. 
     
     
         9 - 11 . (canceled) 
     
     
         12 . The solid dressing of  claim 1 , wherein said haemostatic layer also contains a fibrin crosslinker and/ or a source of calcium ions. 
     
     
         13 . The solid dressing of  claim 1 , wherein said haemostatic layer 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 - 17 . (canceled) 
     
     
         18 . The solid dressing of  claim 1 , wherein said haemostatic layer 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 and gene therapy reagents. 
     
     
         19 . The solid dressing of  claim 1 , wherein said haemostatic layer is made from a single aqueous solution containing a mixture of said fibrinogen component and said thrombin. 
     
     
         20 . The solid dressing of  claim 1 , wherein said haemostatic layer is cast as a single piece. 
     
     
         21 . The solid dressing of  claim 1 , wherein said haemostatic layer is substantially homogeneous throughout. 
     
     
         22 . The solid dressing of  claim 1 , wherein said haemostatic layer is composed of a plurality of particles, each of said particles consisting essentially of fibrinogen and thrombin. 
     
     
         23 . The solid dressing of  claim 22 , wherein said haemostatic layer further contains at least one binding agent in an amount effective to improve the adherence of said particles to one another. 
     
     
         24 . (canceled) 
     
     
         25 . The solid dressing of  claim 1 , wherein said haemostatic layer is a monolith. 
     
     
         26 - 28 . (canceled) 
     
     
         29 . The solid dressing of  claim 1 , Wherein said fibrinogen component is a mammalian fibrinogen. 
     
     
         30 - 33 . (canceled) 
     
     
         34 . The solid dressing of  claim 29 , wherein said mammalian fibrinogen is present in an amount between 1.5 mg/cm2 of the wound-facing surface of said dressing and 13.0 mg/cm2 of the woundfacing surface of said dressing. 
     
     
         35 - 38 . (canceled) 
     
     
         39 . The solid dressing of  claim 19 , wherein said therapeutic supplement is present an amount equal to or greater than its solubility limit in fibrin. 
     
     
         40 . A method of treating wounded tissue in a mammal, comprising placing a solid dressing of  claim 1  to said wounded tissue and applying sufficient pressure to said dressing for a sufficient time for enough fibrin to form to reduce the loss of blood and/ or other fluid from said wounded tissue.