Traumatic Brain Injury (TBI) is the signature injury of current conflicts accounting for approximately 20-25% combat casualties. Commercially, it is the primary cause of worldwide morbimortality in people under 45 years old. In the USA, TBI is estimated to be 1.5 million cases annually, resulting in over 50,000 deaths which is similar to European numbers. Today, a specific prehospital treatment remains lacking and clear clinical strategy is controversial. Cell damage is not only produced by the initial trauma itself but by a series of resultant pathophysiological mechanisms that are initiated almost immediately and perpetuate the damage caused by the initial trauma. This effort will design a hypothermic delivery system which includes nasopharyngeal PFC cooling with closed loop control in a lightweight, mobile package for first responders. Closed loop control will be based on non-invasive vital signs measurements. Technology today presents innovative methods to obtain a variety of efficacy measures available including heart rate complexity, cardiac output, EEG, EEG, r-SO2 and dynamic trending of state assessment. Connectivity between current USN/Marine wearable medical sensing platforms and a novel therapy for TBI suggest a pre-hospital solution specifically for the POI environment.
Benefit: Anticipated Benefits/ Potential Commercial Application of this R&D Commercialization of the Mobile Targeted Temperature Management (MT2M) system involves two key strategies. First, the development of a robust far forward miniaturized device implementing targeted PFC therapy. Secondly the development of the electronics to monitor both the device functionality and the patient response to that therapy. The clear anticipative benefit of this effort is each of these are standalone values to the military but together they are specifically targeted to TBI mitigation strategies of the future for far-forward critical care. These two values will be designed to run connected or wired and yet also allow wireless closed loop control with novel decision assist. These also allow a clear telecommunications strategy to provide casualty data as part of existing and developmental communications efforts tri-service for early data. The outcome of earlier data has clearly been shown to be improved outcomes. Although invasive monitoring of intracranial pressure (ICP) and perfusion remains the foundation for the care of brain-injured patients in the neuro-intensive care units, advanced non-invasive cerebral monitoring has been used increasingly in recent years to monitor brain oxygenation and cerebral blood flow (CBF). Most current monitoring technologies involve the placement of an invasive monitor in the brain parenchyma, with all the attendant risks. In the prehospital market where therapy is critically started early, this option is not practical. The most recent update of the Guidelines for the Management of Severe Traumatic Brain Injury providers recommended thresholds of brain oxygenation in patients with severe traumatic brain injury (TBI). The prehospital market is our core market commercialization target for both the military and commercial TBI victims which is based on non-invasive optical measurement techniques now evolving and a robust therapy device to target the injured brain quickly. Development of a noninvasive method to monitor cerebral status in a continuous and clinically useful fashion has long been a goal in neuro-critical care. The use of near-infrared optical spectroscopy to assess regional cerebral oxygenation and blood flow noninvasively, coupled to other measures is the cornerstone of a multimodal sensing platform. The monitor employs a near real time near-infrared spectroscopy (NIRS), leveraging the effect of therapy dynamically with trending and end point identification based on this programs clinical efficacy guidelines. This technology harnesses the ability of near-infrared light to measure regional oxygen saturation in combination with requisite metabolic parameters and neuro measurements such as EEG, NIBP, and SpO2. Together we believe we can chart a course for the therapy as well as monitor and adjust as needed to improve TBI outcomes pre-hospital. This capability does not currently exist on the market. The market is huge. As estimated by Center for Diseases Control and Prevention (CDC) every day 138 people in the U.S. die from TBI. According to the CDC, 2010 estimates in the U.S. approximately 2.5 million emergency department visits and hospitalization were associated with TBI cases (either alone or in combination with other injuries). Falls are leading cause of hospitalization in patients with TBI followed by accidents including motor, vehicle traffic injuries. In just North America, over 1.7 million people suffer annually from significant TBI and the consequent medical care costs exceed $70 billion in USD. According to WHO, the global incidence for TBI is close to 10 million people annually and a combined medical care cost projected to be over 400 billion! The brain has one of the least self-repair capabilities making it highly vulnerable to injuries and often leading to permanent loss or disability of motor functions which dramatically reduces the quality of life for any individual and significantly increases the cost of long term care on an annual basis. Long term cost of care is a volatile political issue right now as well as a medical issue in the literature. Positively impacting a reduction in secondary damage of only 10% of the annual incidents through the designed capability of this SBIR may result in a cost savings of about $40 billion in health care worldwide. Most neuronal damage occurs sometime after the injury takes place giving this program not only the obvious chance for a significant life-saving therapeutic intervention much earlier, but a clearer mitigation/reduction clinical guideline for secondary damage. Increasing incidences of TBI due to rising assaults, accidents, terrorism, and military combats over the world are expected to drive the continued growth of the market. The return on investment (ROI) opportunity there is awe-inspiring once the FDA embraces the technology. Our commercialization strategy focuses on a lower risk device concept yet it is based on decades of neuro-intensive care data showing clinical efficacy. Our strategy is also interesting in that it may complement the various alternative, drug focused TBI mitigation efforts currently underway. There is no clear drug available to mitigate secondary damage but a series of diuretics available to reduce brain swelling. A major challenge in developing some therapeutics for TBI lie in overcoming the blood-brain barrier while delivering some drugs. PFC hypothermic therapy likely does not interfere with any work we are aware of in this area. It could enhance drug performance through increasing cerebral blood flow and tissue perfusion while decreasing the metabolism in the region targeted. Since there are currently no FDA approved TBI therapeutic products, the arena remains widely open with opportunities for clinical treatment and even drug testing.
Keywords: medical sensing, medical sensing, closed loop control, Intracranial Pressure (ICP), Traumatic Brain Injury (TBI), Android, device, wireless connectivity, Perfluorocarbon (PFC)
