Apparatus and methods for enzymatic escharotomy in burn induced compartment syndrome

Abstract

Apparatus suitable for use in the prevention and treatment of burn induced compartment syndrome facilitates the rapid and efficient deployment of enzymatic compositions to the affected limb or limbs of a burn victim suffering from a circumferential burn. The apparatus includes a flexible, water-impermeable generally cylindrical covering layer. The covering layer has an inner surface facing the limb and an outer surface. The covering layer has a proximal sealable open end through which the burned limb is inserted and a distal closed end. An enzymatic escharotomy agent is contained within the covering layer. The covering layer retains the enzymatic escharotomy agent in close proximity to the burned limb, and the apparatus is enclosed within a sterile sealed package evacuated from moisture. In use, the burned limb is enclosed within the apparatus, and the enzymatic escharotomy agent is activated in situ by contacting the agent with hydrating fluid, thereby inducing enzymatic escharotomy of the circumferential burn.

1 . A method for treating Burn Induced Compartment Syndrome in a burned limb which comprises:
 enclosing the limb within an enzymatic escharotomy apparatus, the apparatus comprising:   a flexible, water-impermeable covering member having an inner surface for facing the limb and an outer surface, and further having a proximal sealable open end and a distal closed end; and   a lyophilized powder within the covering member, wherein the lyophilized powder comprises at least one enzymatic escharotomy agent and wherein the lyophilized powder further comprises excipients including at least one viscosity enhancing agent capable of forming a viscous solution or suspension from the lyophilized powder upon the addition of hydrating means;   
       wherein the burned limb is inserted through said proximal sealable open end of said apparatus such that the covering member surrounds the limb; and
 activating the enzymatic escharotomy agent in situ by contacting the enzymatic escharotomy agent with hydrating means; 
 wherein the covering member is capable of retaining the powder and viscous solution or suspension in close proximity to the burned limb; 
 thereby treating Burn Induced Compartment Syndrome in the burned limb. 
 
     
     
         2 . The method of  claim 1 , comprising inducing enzymatic escharotomy of the limb so as to relieve the Burn Induced Compartment Syndrome. 
     
     
         3 . The method of  claim 1 , wherein the affected limb is enclosed within the apparatus very early after initial trauma. 
     
     
         4 . The method of  claim 1  wherein the covering member has a generally cylindrical or tube shape. 
     
     
         5 . The method of  claim 1  wherein the powder is stored within the covering member to facilitate application to the burned limb. 
     
     
         6 . The method of  claim 5 , wherein the lyophilized powder is contained within an adsorbent layer adjacent to the inner surface of the covering member. 
     
     
         7 . The method of  claim 1 , wherein said enzymatic escharotomy agent is in the form of lyophilized powder prior to activation with the hydrating means and is also stored within the covering member to facilitate application to the burned limb. 
     
     
         8 . The method of  claim 1 , wherein the one or more excipients are selected such that the viscous solution or suspension is formed as an emulsion after contact with the hydrating means. 
     
     
         9 . The method of  claim 1 , wherein the enzymatic escharotomy agent is a proteolytic enzyme selected from the group consisting of: bromelain, debridase, collagenase, papain, streptokinase, sutilains, fibrinolysin, fibrinolysin-deoxyribonuclease, a proteolytic enzyme derived from krill, trypsin and combinations thereof. 
     
     
         10 . The method of  claim 1 , wherein the enzymatic escharotomy agent is a proteolytic enzyme derived from pineapple and is selected from the group consisting of bromelain and debridase. 
     
     
         11 . The method of  claim 1 , wherein the viscosity enhancing agent is selected from the group consisting of synthetic polymers, natural polymers and any combinations thereof 
     
     
         12 . The method of  claim 1 , wherein the hydrating means is physiological saline or sterile water. 
     
     
         13 . The method of  claim 1 , wherein the hydrating means is heated to 34 to 38° C. prior to contacting the enzymatic escharotomy agent. 
     
     
         14 . The method of  claim 1 , wherein the hydrating means further comprises a chemical debriding agent. 
     
     
         15 . The method of  claim 13 , wherein the chemical debriding agent is selected from the group consisting of acetic acid, pyruvic acid, phosphoric acid, salicylic acid, benzoic acid and malic acid. 
     
     
         16 . The method of  claim 1 , wherein the apparatus further comprises an external dressing layer adjacent or attached to the outer surface of the covering layer, with the external layer comprising at least one of a heat retaining cover, an elastic net or a pressure bandage. 
     
     
         17 . The method of  claim 1 , wherein the apparatus is enclosed within a sterile sealed package evacuated from moisture prior to enclosing the burned limb therein. 
     
     
         18 . The method of  claim 1 , wherein the burned limb has a circumferential burn and the method reduces development of Burn Induced Compartment Syndrome in the burned limb. 
     
     
         19 . The method of  claim 1 , wherein the burned limb is enclosed within the apparatus prior to hospitalization. 
     
     
         20 . The method of  claim 1 , further comprising determining the compartmental pressure in the burned limb prior to and following enclosing the burned limb within the enzymatic escharotomy apparatus.