Method of treating traumatic brain injury
Inventors
Bullock, M. Ross • Spiess, Bruce • Thompson, Deborah P.
Assignees
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Publication Number
US-8404752-B2
Publication Date
2013-03-26
Expiration Date
Abstract
This invention provides for methods of treating a subject suffering from central nervous system injury, including traumatic brain injury, comprising administering to the subject an amount of a perfluorocarbon. This invention also provides for use of a perfluorocarbon in the manufacture of a medicament for treating a subject suffering from central nervous system injury including traumatic brain injury. This invention further provides for a pharmaceutical composition comprising a perfluorocarbon for use in treating a subject suffering from central nervous system injury, including traumatic brain injury.
Core Innovation
The invention provides a method of treating a human subject suffering from traumatic central nervous system injury by administering an amount of a perfluorocarbon effective to treat the subject, wherein the perfluorocarbon is perfluoro-tert-butylcyclohexane. The disclosed context includes severe non-penetrating traumatic brain injury and traumatic injury affecting neuronal tissue.
The perfluoro-tert-butylcyclohexane is described as a perfluorocarbon/emulsion oxygen carrier, including embodiments using formulations such as Oxycyte®. The oxygen carrier is associated with increasing neuronal tissue oxygen tension (ptiO2/TiO2) and reducing ischemic or secondary ischemic damage, with monitoring including LICOX® brain oxygen sensor measurements.
The disclosure also addresses clinical evaluation and safety constraints in the treatment of traumatic central nervous system injury. Reported outcomes include functional outcomes using Glasgow Coma Scale (GCS) and Glasgow Outcome Scale-Extended (GOS-E), while safety discussion includes adverse events and monitoring for thrombocytopenia and free radical generation.
Claims Coverage
The independent claim set centers on administering an effective amount of perfluoro-tert-butylcyclohexane to treat traumatic central nervous system injury in a human subject. Related claims refine the inventive approach with treatment timing, administration route, formulation as an emulsion, administration rate, and a safety-related biological effect.
Treating traumatic central nervous system injury with perfluoro-tert-butylcyclohexane
A method of treating a human subject suffering from traumatic central nervous system injury by administering to the human subject an amount of a perfluorocarbon effective to treat the subject, wherein the perfluorocarbon is perfluoro-tert-butylcyclohexane.
Administration within 12 hours after central nervous system injury
The method wherein the perfluorocarbon is administered to the subject within 12 hours after a central nervous system injury.
Intrathecal administration of perfluoro-tert-butylcyclohexane
The method wherein the perfluorocarbon is administered intrathecally.
Perfluorocarbon as a perfluorocarbon emulsion
The method wherein the perfluorocarbon is present as a perfluorocarbon emulsion.
Perfluorocarbon administration rate of 6.0-12.0 g/min
The method wherein administering the perfluorocarbon is at a rate of 6.0-12.0 g/min.
No increase in free radical generation in neuronal tissue
The method wherein administering the perfluorocarbon does not increase free radical generation in a neuronal tissue of the subject.
Overall, the claim coverage focuses on the therapeutic use of perfluoro-tert-butylcyclohexane for traumatic central nervous system injury, with refinements covering treatment within 12 hours, intrathecal delivery, emulsion formulation, specified administration rate, and no increase in free radical generation in neuronal tissue.
Stated Advantages
Increased neuronal tissue oxygen tension (ptiO2/TiO2).
Reduced ischemic or secondary ischemic damage.
Improved functional outcomes using Glasgow Coma Scale (GCS) and Glasgow Outcome Scale-Extended (GOS-E).
Reported safety includes comparable severe adverse events to controls and monitoring for thrombocytopenia and free radical generation.
Documented Applications
Treatment of traumatic central nervous system injury in a human subject, including severe non-penetrating traumatic brain injury, using perfluoro-tert-butylcyclohexane as a perfluorocarbon/emulsion oxygen carrier.
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