SBIR/STTR Award attributes
In the United States alone, approximately 2.87 million people experience a traumatic brain injury (TBI), resulting in 2.53 million hospital visits, 288,000 hospitalizations and 56,800 deaths per year. This is a 53% increase since 2006 and is likely due to the increased awareness of the dangers of delayed medical treatment for concussions and other head injuries. TBI is a major public health problem among males ages 15 to 24, who account for two-thirds of childhood and adolescent head trauma patients. In addition, TBI is a severe problem among elderly people (age 75 years and older) of both sexes. Globally, there are over 27 million new cases of TBI every year. Rapid triage, diagnosis and treatment are critical in minimizing the adverse consequences of the more serious TBI cases. For patients with moderate-to-severe TBI in particular, diagnosis within the first hour (the “golden” hour) of the traumatic event is critical. With both open and closed head injuries, the most important factor determining whether or not a patient requires emergency surgery is the presence of an intracranial hematoma. Time is crucial as an expanding hematoma can cause death from brainstem compression or cause global ischemic injury. CT scans are the gold standard for identification and localization of traumatic intracranial hematomas. Near Infrared technology is a practical solution to address the problem in early identification of hematomas in the field using the unique light-absorbing properties of hemoglobin. The basic method for hematoma detection is based on the differential light absorption of the left versus right side of the brain. Under normal circumstances, the brain’s light absorption is symmetrical. When additional underlying extravascular blood is present, there is a greater local concentration of hemoglobin, and consequently the absorbance of the light is greater while the reflected component is proportionately less. InfraScan has developed the Infrascanner to provide a rapid evaluation of head trauma patients with possible intracranial hemorrhage. The technology is portable and noninvasive, allowing for repeated monitoring without concern for radiation dose. The Office of Naval Research (ONR), the United States Marine Corps (USMC) and the U.S. Army Medical Materiel Development Activity (USAMMDA) sponsored the development of the different generations of the Infrascanner. The objective of this proposal is to refine the design towards fielding an optimized hand-held miniaturized device (Infrascanner Model 2500) to detect brain hematomas resulting from head trauma on the battlefield. Under this proposal, the Infrascanner Model 2500 design will be refined to meet prior military users feedback and validated with military users. The specific aims of the project are: Development of beta prototype of Infrascanner Model 2500 1. Build 30 beta prototypes 2. System validation and safety testing with 10 units 3. Military Users evaluation with 20 of the beta prototypes
