Dressing System

Abstract

The present invention relates to skin dressings that are useful in the treatment of conditions associated with tissue ischaemia and skin lesions including those that are infected, such as burns and surgical wounds and chronic wounds such as but not limited5 to diabetic foot ulcers and venous leg ulcers. The skin dressings are also useful to effect transdermal delivery of pharmaceutically active agents.

1 - 36 . (canceled) 
     
     
         37 . A system comprising:
 a layer containing a nitrite; and   a layer comprising a source of hydrogen ions, wherein the layer is not a hydrogel.   
     
     
         38 . The system according to  claim 37 , wherein the layer comprising the source of hydrogen ions is a carboxymethylcellulose, an alginate, or a gelling fibre, or a mixture thereof. 
     
     
         39 . The system according to  claim 37 , wherein the layer comprising the source of hydrogen ions is a superabsorbent dressing based on sodium polyacrylate. 
     
     
         40 . The system according to  claim 37 , wherein the layer comprising the source of hydrogen ions is a honey-based dressing. 
     
     
         41 . The system according to  claim 37 , wherein the layer containing the nitrite is a mesh. 
     
     
         42 . The system according to  claim 41 , wherein the mesh is formed of a polymer. 
     
     
         43 . The system according to  claim 42 , wherein the polymer is polypropylene. 
     
     
         44 . The system according to  claim 37 , wherein the layer containing the nitrite is a dissolvable film. 
     
     
         45 . The system according to  claim 44 , wherein the dissolvable film is formed of a polyvinyl alcohol, polyvinylpyrrolidone, a cellulose-based polymer, or cellulose. 
     
     
         46 . The system according to  claim 37 , wherein the nitrite is an alkaline metal nitrite or an alkaline earth metal nitrite. 
     
     
         47 . The system according to  claim 46 , wherein the nitrite is sodium nitrite. 
     
     
         48 . The system according to  claim 37 , wherein the system comprises a plurality of layers containing a nitrite. 
     
     
         49 . The system according to  claim 37 , wherein the nitrite is present as a nitrite solution. 
     
     
         50 . The system according to  claim 37 , wherein the pH of the layer comprising the source of hydrogen ions is below 5.5. 
     
     
         51 . The system according to  claim 37 , wherein the system does not contain a thiol or a reductant. 
     
     
         52 . The system according to  claim 37 , further comprising a pharmaceutically active agent. 
     
     
         53 . A method of treating a subject having a condition associated with tissue ischaemia or a wound, comprising administering the system according to  claim 37  to the subject in need thereof. 
     
     
         54 . A kit comprising:
 a layer containing a nitrite; and   a layer comprising a source of hydrogen ions, wherein the layer is not a hydrogel, as a combined preparation suitable for simultaneous, separate, or sequential use in treating a condition associated with tissue ischaemia or a wound.   
     
     
         55 . A method of treating a subject having a disease or medical condition, comprising administering the system according to  claim 52  to the subject in need thereof. 
     
     
         56 . A kit comprising:
 a layer containing a nitrite; and   a layer comprising a source of hydrogen ions, wherein the layer is not a hydrogel, as a combined preparation suitable for simultaneous, separate, or sequential use in treating a disease or condition, wherein the layer containing the nitrite and/or the layer comprising the source of hydrogen ions comprises a pharmaceutically active agent.   
     
     
         57 . The system according to  claim 37 , comprising:
 a layer containing a nitrite; and   a layer comprising a source of hydrogen ions, wherein the layer is not a hydrogel, in combination with an anaesthetic suitable for use in the treatment or prevention of pain.   
     
     
         58 . The system according to  claim 57 , wherein the system is designed for simultaneous, separate, or sequential administration with the anaesthetic. 
     
     
         59 . The system according to  claim 58 , wherein the anaesthetic is selected from the group consisting of lignocaine (lidocaine), amethocaine (tetracaine), xylocaine, bupivacaine, prilocaine, ropivacaine, benzocaine, mepivocaine, and cocaine, or a mixture thereof. 
     
     
         60 . A method of treating a condition associated with tissue ischaemia or a wound in a subject in need thereof, comprising administering to the subject an anaesthetic and a system according to  claim 37 . 
     
     
         61 . The method according to  claim 60 , wherein the wound is an ulcer. 
     
     
         62 . The method according to  claim 61 , wherein the ulcer is a leg ulcer, pressure ulcer, or diabetic ulcer. 
     
     
         63 . The method according to  claim 60 , wherein the wound is a skin donor site, a surgical wound, a burn, a laceration, or an abrasion. 
     
     
         64 . The method according to  claim 60 , wherein the condition associated with tissue ischaemia is Raynaud's syndrome, or tissue ischaemia caused by septic shock, irradiation, or a peripheral vascular disease. 
     
     
         65 . A system comprising:
 a layer containing a nitrite; and   a layer comprising a source of hydrogen ions, wherein the layer is:
 a gelling fibre, an alginate, or carboxymethylcellulose, or a mixture thereof; 
 a superabsorbent dressing based on sodium polyacrylate; or 
 a honey-based dressing. 
   
     
     
         66 . The system according to  claim 65 , wherein the layer comprising the source of hydrogen ions is not a hydrogel.