Wound Dressing, Methods and Apparatus For Making Same and Storage and Use Thereof

Abstract

Provided is a wound dressing prepared from whole blood that is clotted ex vivo to form a sheet of clotted blood that is applied onto the skin over a sight of skin injury.

1 . A kit or assembly for preparing a dressing to be applied onto a skin injury, comprising one or more hardware components for processing a volume of liquid whole blood to form a sheet of clotted blood. 
     
     
         2 . A kit according to  claim 1 , wherein said sheet is of a defined thickness. 
     
     
         3 . A kit or assembly according to  claim 1  or  2 , comprising one or more of:
 one or more blood withdrawal devices; 
 one or more blood collection receptacles; 
 one or more receptacles for receiving the blood and forming a clot thereon; 
 one or more support matrices for the formed blood clot; 
 an anticoagulant, optionally already included in the in the blood withdrawal or blood collection devices; and 
 an anti-anticoagulant for inducing clot formation. 
 
     
     
         4 . A kit for preparation of a wound dressing, the kit comprising:
 (a) a sterile container adapted to receive a volume of blood;   (b) anticoagulant;   (c) anti-anticoagulant;   (d) a tray for receiving and spreading said volume of blood to a desired thickness and for clotting whole blood therein; and   (e) forming a wound dressing comprising the clot.   
     
     
         5 . A kit according to  claim 4 , wherein said tray contains a support structure upon which the clot forms. 
     
     
         6 . A kit or assembly according to any one of  claims 3 - 5 , wherein said anticoagulant includes at least one substance selected from the group consisting of EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate. 
     
     
         7 . A kit or assembly according to any one of  claims 3 - 6 , wherein said anti-anticoagulant is selected from Ca 2+ , Mg 2+ , Kaolin, negatively charged phospholipid (PL) and protamine sulfate. 
     
     
         8 . A method of preparing a wound dressing, the method comprising:
 (a) collecting a volume of blood;   (b) clotting said blood to form a clot ex vivo; and   (c) forming a wound dressing comprising the clot.   
     
     
         9 . A method according to  claim 8 , comprising cutting a portion of said clot to dimensions suitable for dressing a specific wound. 
     
     
         10 . A method according to  claim 8 , comprising providing a support structure upon which said clot forms. 
     
     
         11 . Use of whole blood in manufacture of a wound dressing. 
     
     
         12 . Use of whole blood in preparation of a wound dressing. 
     
     
         13 . A method of treatment comprising:
 (a) preparing a sheet of clotted whole blood; and   (b) applying said sheet to an area of skin of a subject in need thereof.   
     
     
         14 . A method according to  claim 13 , comprising associating a support matrix with said sheet. 
     
     
         15 . A method according to  claim 13  or  14 , comprising embedding a mesh within said sheet. 
     
     
         16 . A method according to any one of  claims 13  to  15 , wherein said area of skin comprises a wound. 
     
     
         17 . A method according to any of  claims 13  to  16 , comprising covering said sheet with a conventional dressing. 
     
     
         18 . A method of producing a biological dressing comprising,
 a) spreading a unit of whole blood to cover an area; and   b) allowing the blood to clot to thereby form a clotted blood sheet.   
     
     
         19 . A method according to  claim 18 , comprising adding a coagulation initiator prior to said spreading. 
     
     
         20 . A method according to  claim 19 , wherein said coagulation initiator is selected to neutralize an activity of an anticoagulant in said unit. 
     
     
         21 . A method according to any one of  claims 18  to  20 , wherein said spreading is on a mesh which becomes embedded in said clot. 
     
     
         22 . A method according to any one of  claims 18  to  20 , wherein said clot is adhered to a support matrix. 
     
     
         23 . A bank of biological dressings, the bank comprising:
 (a) a plurality of sterile sheets of clotted whole blood; and   (b) cross compatibility information for each of said sheets.   
     
     
         24 . A device for clotting whole blood ex-vivo, the device comprising:
 (a) an inlet comprising a channel of fluid communication to an interior of the device;   (b) a sample receptacle adapted to spread a sample provided therein to produce a uniform layer; and   (c) at least one support structure deployed in said receptacle so that said uniform layer forms on said structure.   
     
     
         25 . A device according to  claim 24 , wherein the support structure is adapted to become wholly or partially embedded in said layer. 
     
     
         26 . A device according to  claim 24  or  25 , wherein the support structure is constructed of a material which adheres to a blood clot formed thereupon. 
     
     
         27 . A device according to any one of  claims 24  to  26 , wherein said receptacle contains an amount of an anti-anti-coagulant sufficient to cause coagulation of blood comprising said sample. 
     
     
         28 . A device for clotting whole blood ex-vivo, the device comprising:
 (a) at least one inlet comprising a channel of fluid communication to an interior of the device;   (b) a plurality of sample receptacles interconnected to allow concurrent inflow from a common source, each of said receptacles adapted to spread a sample provided therein to produce a uniform sheet;   (c) a sterility guard adapted to maintain sterility of said sheet in each of said receptacles.   
     
     
         29 . A device according to  claim 28 , comprising a support structure deployed in each of said receptacles so that said sheet forms on said support structure. 
     
     
         30 . A device according to  claim 29 , wherein the support structure comprises an external layer constructed of a material which adheres to a blood clot formed thereupon. 
     
     
         31 . A device according to  claim 28  or  29 , wherein the support structure comprises a mesh embedded in said sheet. 
     
     
         32 . A method of treatment comprising:
 (a) providing an absorbent matrix adapted for covering an area of skin of a subject in need of treatment;   (b) permitting an amount of whole blood to clot onto said covering to form a sheet of clotted whole blood thereon, to thereby form a clotted blood-containing dressing; and   (c) applying the clotted blood-containing dressing on a skin injury.   
     
     
         33 . A method according to  claim 32 , wherein said blood is autologous. 
     
     
         34 . A method according to any of  claims 32 - 33 , wherein said matrix comprises a mesh. 
     
     
         35 . A method according to  claim 34 , wherein said mesh comprises gauze. 
     
     
         36 . A method according to any of  claims 32  to  35 , for the treatment of non-bleeding wound. 
     
     
         37 . A method according to any of  claims 32  to  36 , comprising covering the clotted blood containing dressing with a conventional dressing. 
     
     
         38 . A method for preparing sheets of clotted whole blood, the method comprising:
 (a) providing a block of clotted whole blood; and   (b) cutting sheets from said block.   
     
     
         39 . Use of whole blood for the preparation of a dressing for a skin injury. 
     
     
         40 . Use according to  claim 39 , wherein the blood is clotted to form a sheet of clotted blood. 
     
     
         41 . Use according to  claim 38  or  39 , wherein the sheet of clotted blood is made to be associated with a support structure.