Newswise — From the time a person experiences severe head trauma at the scene of an accident paramedics and emergency room physicians have a total of 60 minutes—one "golden hour" —to define what type of surgical intervention is necessary to save the patient's life. Realizing the importance of finding hematoma as soon as possible after the injury, a team of Drexel University biomedical engineers has created the InfraScanner(tm), the first handheld device that medical professionals can use to detect brain hematoma at the accident scene.
The InfraScanner(tm) is about to begin multicenter clinical trials and pending FDA approval, it will be available in the U.S. as early as the end of 2006.
"The InfraScanner(tm) promises to be a fast, accurate and affordable traumatic brain injury screening solution," said Dr. Banu Onaral, director of Drexel's School of Biomedical Engineering, Science and Health Systems, who is leading the Drexel team. "The user-friendly device that maps out the location of the hematoma with graphics on a PDA screen can assist paramedics and emergency room personnel in attending to those injured in traffic and sports accidents, falls and on the battlefield."
In developed countries, moderate to severe traumatic brain injury (TBI) will be diagnosed in the ER by emergency physicians and neurosurgeons. Often a Computed Tomography (CT) scan is used to detect head trauma. However, because it's expensive, the CT scan is used on less than half of the patients that enter an ER with head trauma.
"The new device addresses the critical problem of detecting brain hematoma as early as possible," said Dr. Kambiz Pourrezaei, Drexel professor and director of strategic initiatives. "It can also solve the problem of how to find head trauma in children, who are brought to the ER after a crib fall or other injury, without having to wait to determine if a CT scan is needed."
The Drexel biomedical team is working with the patented work in near-infrared based optical brain imaging (fNIR) of pioneer Dr. Britton Chance, Drexel University
distinguished lecturer and Eldridge Reeves Johnson University Professor Emeritus at the University of Pennsylvania, to develop and market the medical technology that detects hematoma in the brain.
How it looks:The InfraScanner(tm) unit is a hand-held device based on a PDA platform with a wireless detector probe. The signal from the probe, which can be a hairbrush, is digitized and transmitted by a wireless link to the PDA. User interface in the PDA includes a graphic display and an audio feedback to ensure the paramedic's/operator's attention on the patient.
How it works:The InfraScanner(tm) detects hematoma based on the differential NIR light absorption of the bleeding versus the non-bleeding part of the brain. The unique light-absorbing property of the hemoglobin in the blood makes this possible.
Clinical Evidence:A pilot study using NIR technology at Baylor College of Medicine on 305 patients-to-date resulted in:"¢Sensitivity for extracerebral (epidural and subdural) hematomas: 100 percent."¢Sensitivity for intracerebral hematomas: 98 percent."¢No observed false positives. "¢93 percent of late onset lesions detected more rapidly than conventional monitoring.
Application Areas:"¢Pre-hospitalization screening: head injured patients can be diagnosed at the site of injury by emergency technicians."¢Hospital screening: patients can be screened in the ER to establish the need for a CT scan of the head. Using the InfraScanner? patients after surgery can also be monitored between CT scans."¢Post-hospitalization monitoring: Recovering patients can be monitored in physician offices during follow-up visits.
Marketing the Device:After successful trials are completed, the device will be the flagship product of InfraScan, a start-up company founded to further the clinical deployment and translational research of Drexel University's biomedical engineers. Under the management of Dr. Baruch Ben Dor, Drexel associate professor and president of InfraScan, the start-up was chosen as a recipient of BioAdvance Greenhouse funding. The funds will support further product development and testing.
National Institutes of Health (NIH) funded the pre-clinical trials while the initial prototype development was funded by the U.S. Army and Navy. During this year the business plan of InfraScan written by Ben Dor with Samonnoi Banerjee and Sandeep Naik, MBA students from Wharton, won the prestigious Wharton business plan competition and consequently the second place at the global business plan competition in Singapore.
"With the help of local funding from BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, we hope to launch the InfraScanner(tm) overseas by the end of this year," said Ben Dor. "By the end of 2006, we anticipate to launch the product in the U.S."
Additional Background:According to the Center for Disease Control and Prevention, more than two million people in the U.S. suffer from head injury each year and require medical care. About 1.7 million visit a hospital emergency room and more than 500,000 are diagnosed with Traumatic TBI and hospitalized. About 50,000 die annually as a result of head trauma.