An estimated one and half million individuals seek medical treatment for head trauma in the US each year, and annually about 10 million individuals seek treatment for head trauma worldwide. Intracranial hematomas resulting from a traumatic brain injury are a life-threatening, but treatable cause of secondary brain injury in patients who have sustained head trauma. But, successful treatment often relies upon timely diagnosis and intervention prior to the occurrence of brain damage. A computed tomography (CT) scan is the current clinical standard examination to detect this condition.
From the time a person experiences severe head trauma at the scene of an accident, paramedics and physicians have one “golden hour” to define what type of surgical intervention is needed to save the patient’s life. But, being transported to a hospital and getting a CT scan is not practical, or available in many cases, and requires transport to a CT scanner. While it’s vastly easier in most areas of the US to obtain one, the battlefield presents an entirely different scenario. Getting a wounded soldier in the field a CT scan quickly is simply not an option in most cases.
Enter the Infrascanner, a handheld device that uses nearinfrared (NIR) technology to detect intracranial bleeding, identifying those patients who would most benefit from immediate referral to a CT scan and neurosurgical intervention. The Infrascanner was introduced in Iraq and Afghanistan to address the critical need for a non-invasive and portable means for early detection of intracranial hematomas. During early field tests with the Marines, the lives of a US serviceman and an Afghan boy were saved because doctors were able to detect and treat severe head injuries with the device before further complications or brain damage occurred.
How It Works
The Infrascanner compares the left and right sides of the brain in four different areas. The sensor is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at selected wavelengths is recorded. Under normal circumstances, the brain’s absorption should be symmetrical when comparing left and right sides.
Extravascular blood absorbs NIR light more than intravascular blood since there is a greater concentration of hemoglobin in a hematoma than in the brain tissue where blood is contained within vessels. The absorbance of NIR light is on the side of the brain containing a hematoma, than on the uninjured side.
The unit includes a sensor and a cradle. The sensor includes an eye safe NIR diode laser and an optical detector. The light to and from the laser and detector are optically coupled to the patient’s head through two disposable light guides. The detector signal is digitized and analyzed by a single board computer (SBC) in the sensor that receives the data from the detector and automatically adjusts the settings to ensure good data quality. The data is further processed by the SBC and results are displayed on a display screen. The sensor can be powered either by a rechargeable NiMH battery pack or by four disposable AA batteries. The cradle is used to charge the rechargeable battery pack, and to copy the data from the sensor to a PC. (See Figure 1)
The device began in the lab of Dr. Britton Chance, professor emeritus in the University of Pennsylvania Department of Biochemistry and Biophysics, who developed the technology in collaboration with a leading neurosurgeon from Baylor College of Medicine, Dr. Claudia Robertson.
Using NIR technology, their device could detect the differential absorption of NIR between brain tissue not infused with hemoglobin, and injured brain tissue where blood is present or hematomas between the meninges.
Initial clinical trials to determine the device’s usefulness in identifying the presence of brain hematomas were carried out by Robertson and colleagues. But the technology might have languished in the laboratory without entrepreneur and medical optics specialist, Baruch Ben Dor who spent months working in Chance’s laboratory, learning about his technologies. After selecting the one technology that he felt had the most commercial potential, he teamed up with Banu Onaral, director of the School of Biomedical Engineering, Science & Health Systems, and colleagues at Drexel University.
Ben Dor entered the Wharton School at the University of Pennsylvania’s business plan competition with a prototype unit and won in April 2004. In March 2004, the company received a Phase 1 SBIR grant from the Office of Naval Research (ONR), followed by a Phase 2 award in 2005. Between 2004 and 2005, the fledgling company received a $500,000 investment from BioAdvance, which provides funding to startup life sciences companies in Southeastern Pennsylvania. In 2006, the Infrascanner began multicenter clinical trials. By 2007, an additional $100,000 in grants from a US Army SBIR, and $500,000 from the Ben Franklin Technology Partners, helped with the development of the device.
In February of 2008, the U.S. Marine Corps began a field evaluation in Iraq of the device. That year, InfraScan’s quality system received ISO 13845 certification, and the CE Mark. In 2010, the company received a Commercialization Pilot Program SBIR award from the Marine Corps System Command. And finally, in 2011, the FDA permitted its marketing in the US. Along the way, the device picked up numerous design and technology awards.
Where It Stands
In January 2013, the improved Infrascanner Model 2000 received FDA approval. The Model 2000 is based on the original Model 1000, following the specifications of the US Marine Corps. The new model include integration of the processing, display, and control functions of the separate PDA into the sensor; improved ruggedness of the system for better reliability; and the ability to use disposable AA batteries in addition to a rechargeable battery pack. Both models are currently available.
“FDA approval in the US allows InfraScan to offer an industry first, powerful tool for use by civilian and military medical professionals to quickly triage head trauma patients,” said Baruch Ben Dor, President and CEO of InfraScan, Inc. “Shortening the time to treatment through effective detection of intracranial bleeding can mean preserving brain function in a patient and even saving lives.”
InfraScan, Inc., Philadelphia, PA, is a medical device company specializing in developing, commercializing, and distributing hand-held diagnostic devices for brain injury. For more information, Click Here