Compositions and treatment method for brain and spinal cord injuries

Abstract

Cerebral edema is the final common pathway for all CNS tissue injuries. The CSF is the major player for cerebral edema and the resultant blood perfusion deficit. A composition and method for treating injured central nervous tissue, or preventing injury to central nervous system tissue is provided. The composition includes two washing solutions, a first solution comprising an emulsion of oil, water, at least one osmotic agent and at least one emulsifier; the second solution comprising a pre-emulsion comprising water, oil, at least one osmotic agent, and at least one emulsifier. The method provides for withdrawing a volume of cerebrospinal fluid from the subarachnoid space and flushing the subarachnoid space with one or both washing solutions. Other materials may be added to the solutions to treat or prevent injury to nerve tissue resulting from injury or interruption of circulation.

What is claimed is:  
     
         1 . A neuroprotective medicament composition for protecting the central nervous system of a mammal comprising of at least one emulsifier, at least one osmotic agent, water, oil and at least one active ingredient know to treat stroke or other neurological deficiencies selected from the group consisting of calcium channel blockers, potassium channel blockers; free radical scavengers, GABA agonists, GABA receptor antagonists, glutamate antagonists, AMPA antagonists, NMDA antagonists, NMDA channel blockers, Glycine site antagonists, and adenosine receptor antagonists in an emulsion.  
     
     
         2 . A neuroprotective medicament composition for protecting the central nervous system of a mammal comprising at least one emulsifier, at least one osmotic agent, water, oil and an active ingredient know to suppress CSF production in an emulsion.  
     
     
         3 . A neuroprotective medicament composition for protecting the central nervous system of a mammal according to  claim 2  wherein each of said at least one osmotic agents is selected from the group consisting of: glucose, mannitol, glycerin, saccharide, polysaccharide, starch, and protein.  
     
     
         4 . A neuroprotective medicament composition according to  claim 1  and  2  wherein said oil is selected from the group consisting of hydrocarbon oils from animal, vegetable, and mineral sources, such as soybean oil, mineral oil, cod liver oil, peanut oil, silicone oil, and Vitamin E oil.  
     
     
         5 . A neuroprotective medicament composition according to  claim 1  and  2  wherein said at least one emulsifier is selected from the group consisting of, phospholipids, phosphoglycerides, sphingomyelin, glycolipids, cholesterol, cholesterol hemisuccinate, sphingolipids, and cerebrosides.  
     
     
         6 . A neuroprotective medicament composition according to  claim 5  wherein the at least one emulsifier is lecithin and Tween-80.  
     
     
         7 . A neuroprotective medicament composition for protecting the central nervous system of a mammal comprising an emulsion solution of at least one osmotic agent, at least one emulsifier, water, and at least 31% oil.  
     
     
         8 . A neuroprotective medicament composition for protecting the central nervous system of a mammal consisting of a pre-emulsion solution of at least one emulsifier in oil.  
     
     
         9 . A neuroprotective medicament composition according to  claim 7  or  8  wherein the oil is selected from the group consisting of hydrocarbon oils from animal, vegetable, and mineral sources, such as soybean oil, mineral oil, cod liver oil, peanut oil, and silicone oil.  
     
     
         10 . A neuroprotective medicament composition according to  claim 9  wherein the oil is soybean oil.  
     
     
         11 . A neuroprotective medicament composition according to  claim 7  and  8  wherein each of said at least one emulsifier is selected from the group consisting of, amphipathic lipids or surface active agents such as phospholipids, phosphoglycerides, sphingomyelin, glycolipids, cholesterol, cholesterol hemisuccinate, sphingolipids, and cerebrosides, tween, span, and triton.  
     
     
         12 . A neuroprotective medicament composition according to  claim 7  and  8  wherein said at least one emulsifier comprises lecithin and Tween 80.  
     
     
         13 . A neuroprotective medicament composition according to  claim 7  wherein each of said at least one osmotic agent is selected from the following: glucose, mannitol, glycerin, saccharide, polysaccharide, starch, and protein.  
     
     
         14 . A neuroprotective medicament composition according to  claim 13  wherein said at least one osmotic agent is glucose.  
     
     
         15 . A method for protecting Central Nervous System tissue in need of such protection in a mammal, comprising the steps of: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space in spinal canal and or cranium if protection is needed for Central Nervous System tissue,    b) Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a neuroprotective medicament composition for protecting the central nervous system of a mammal comprising at least one emulsifier, at least one osmotic agent, water, oil and at least one active ingredient know to treat stroke or other neurological deficiencies selected from the group consisting of calcium channel blockers, potassium channel blockers; free radical scavengers, GABA agonists, GABA receptor antagonists, glutamate antagonists, AMPA antagonists, NMDA antagonists, NMDA channel blockers, Glycine site antagonists, and adenosine receptor antagonists in an emulsion.    
     
     
         16 . A method for protecting Central Nervous System tissue in need of such protection in a mammal, comprising the steps of: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space in spinal canal and or cranium if protection is needed for Central Nervous System tissue,    b) Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a neuroprotective medicament composition for protecting the central nervous system of a mammal comprising at least one emulsifier, at least one osmotic agent, water, oil and an active ingredient know to suppress CSF production in an emulsion.    
     
     
         17 . A method for protecting Central Nervous System tissue in need of such protection in a mammal, comprising the steps of: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space in spinal canal and or cranium if protection is needed for Central Nervous System tissue,    b) Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a neuroprotective medicament composition for protecting the central nervous system of a mammal comprising a emulsion solution of at least one osmotic agent, at least one emulsifier, water, and at least 31% oil.    
     
     
         18 . A method for protecting Central Nervous System tissue in need of such protection in a mammal, comprising the steps of: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space in spinal canal and or cranium if protection is needed for Central Nervous System tissue,    b) Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a neuroprotective medicament composition for protecting the central nervous system of a mammal consisting of a pre-emulsion solution of at least one emulsifier in oil.    
     
     
         19 . A method for protecting Central Nervous System tissue in need of such protection in a mammal according to  claim 15 ,  16  or  17 , comprising the an added step of: 
 Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a neuroprotective medicament composition for protecting the central nervous system of a mammal consisting of a pre-emulsion solution of at least one emulsifier in oil.  
 
     
     
         20 . A neuroprotective medicament composition for protecting the central nervous system of a mammal according to  claim 2  wherein the ingredient know to suppress CSF production is selected from the group consisting of diuretics: including furosemide, acetazolamide, mersalyl, thiaxides, spironolactone, and triamterene.  
     
     
         21 . A neuroprotective medicament composition for protecting the central nervous system of a mammal according to  claim 2  wherein the ingredient to suppress CSF production is furosemide.  
     
     
         22 . A neuroprotective medicament composition for protecting the central nervous system of a mammal according to  claim 2  wherein the ingredient to suppress CSF production is acetazolamide.  
     
     
         23 . A method for treating stroke in a mammal requiring such treatment comprising: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space in spinal canal and or cranium if protection is needed for Central Nervous System tissue,    b) Washing the Central Nervous System tissue by repeatedly injecting and withdrawing or flushing a volume of a said neuroprotective medicament composition according to  claim 1 ,  2  or  claim 7 .    c) administering a thrombolytic agent to said mammal in an amount effective to restore blood flow to central nervous system tissue.    
     
     
         24 . A method according to  claim 23  wherein said thrombolytic agent includes recombinant tissue plasminogen activator (rt-PA).  
     
     
         25 . A method for treating a central nervous system injury in a mammal requiring such treatment comprising: 
 a) Withdrawing a volume of cerebrospinal fluid from the subarachnoid space of the central nervous system of the mammal,    b) Injecting a volume of an intralipid solution into said subarachnoid space.