Description:
RT&L FOCUS AREA(S): General Warfighting Requirements (GWR)
TECHNOLOGY AREA(S): Bio Medical
OBJECTIVE: To develop a preventive technology to reduce the risk of brain injury from blast that is relevant to operational and/or training settings. The technology developed should be portable, light-weight and have low footprint without additional burden/impedance to Warfighter operations/duties and comfort. The end-product should be easily worn/carried by the Warfighter and the device can be an active or passive system in nature.
DESCRIPTION: Injury to brain from blast related trauma has been a critical problem for Warfighter brain health and performance (e.g. traumatic brain injury). Although the current personal protective equipment, up to an extent, is designed to protect against shrapnel and projectiles from explosive events and low caliber ammunition, there is still risk stemming from the blast overexposure and technologies that provide protection/prevention against blast are highly desirable. The need to accelerate and develop these types of technologies, which can work as an either active/passive systems, has been further realized from the numerous traumatic brain injuries experienced by US forces following recent bombing of Ain al-Asad air base attack by adversaries (Military times, Feb 10, 2020). There is a likelihood that these issues could be further complicated due the new requirement of Maneuverability Center of Excellence to develop lighter weight personnel protective equipment to meet the demands of the Warfighter in future multi-domain operations 2028 (MDO). Unfortunately, there are no preventative technologies to reduce the risk of Warfighters’ brain health during combat and training operations. (Pratt NJ., 2017; Review of Department of Defense Test Protocols for Combat Helmets, 2014). Potentially injurious mechanical forces of blast include, but are not limited to, overpressure, accelerative forces, and impact forces on the subject from dislodging. Technologies that can mitigate the risk of injury by triggering preventive mechanisms from these forces associated with blast such as overpressure and/or impact are highly desired. Blast overpressure is in the order of nanoseconds for initial peak rise time with a total event time-scale less than 5-6 milliseconds for improvised explosive device (IED). This is a near instantaneous environmental exposures, thus any innovative technology should quickly respond to mitigate injury. Non-invasive innovative technologies that can either protect the brain by reducing the loading forces of blast or biologically insulating the brain from overpressure/accelerative forces for impact (secondary/tertiary blast) are highly desirable. The medical system or technology is highly desirable to integrate on to the Warfighter without compromising the performance of the individual and the other technologies/systems (e.g. GPS or communication equipment) carried by the Warfighter. The medical system or technology should be non-invasive, safe, wearable, non-pharmaceutical/nutraceutical, portable, light-weight, and user-friendly that can trigger physiological responses to make brain less susceptible to injury from the mechanical forces of blast. The medical system or protective technology is desired (but not required in Phase I) to perform well under field rugged conditions such as extreme temperatures, humidity and dust/wet conditions. Overall, this topic desires to develop/identify a technology and/or a medical system to mitigate the risk of blast related traumatic brain injury that can be accelerated towards fieldable use.
PHASE I: To develop/demonstrate the feasibility of the prototype under limited blast loading conditions (e.g. overpressure) to identify viable functionalities (activation/trigger of sensing systems) of the prototype. Blast loading conditions simulation should replicate ecologically valid “free-field” blast exposures from an IED-like blast exposure. WRAIR has an advanced blast simulator and the performer may coordinate with WRAIR to leverage blast simulation capabilities for prototype feasibility demonstration. A demonstration will be achieved by subjecting the prototypes to dynamic loading of blast overpressure exposure at different pressures (e.g. 4psi – 24 psi in steps of 4psi). At the end of the phase, a working prototype/device should demonstrate the feasibility/application of the system by providing a road-map or experimental plan for pre-clinical testing to test the efficacy of the system in laboratory setting. No animal and/or human studies are required during this phase.
PHASE II: An iterative process can be used to develop a prototype by sensing blast or blunt trauma and activating of the medical/preventive system against a biological organism (e.g. use of animal models). Blast and animal research capabilities at WRAIR may be leveraged to test the efficacy of the prototype. Consideration should be given to large animal models for prototype testing that may include pig, sheep, or non-human primates. Prototype should not significantly burden the soldier with weight and should be comfortable to wear. Prototype should be easy to use and operate. In addition, it should not interfere with any communication system used by the Warfighter. The efficacy of the technology requires testing in a pre-clinical setting against a wide range of blast overpressures (primary blast) and/or blast overpressure + impact scenario (tertiary blast). The technology should demonstrate protective-ness against blast related traumatic injury under the testing conditions in the laboratory. The prototype effectiveness can be shown through the assessment of injury reduction (e.g. reduction in brain hemorrhage, lesions, axonal injury and/or inflammation). Technology should also demonstrate that the prototype (s) can withstand the field rugged conditions such as extreme temperature, humidity and/or dry/wet environments in the laboratory. At the end of this phase, the prototype should demonstrate a clear path to show efficacy in pre-clinical testing and future readiness for testing in scaled human conditions to show the protectiveness of the product. An FDA regulatory plan will be provided during Phase II to illustrate the technology’s pathway as a medical device to protect against blast related traumatic brain injuries.
PHASE III DUAL USE APPLICATIONS: The performer should refine and implement their regulatory strategy for obtaining FDA approval (if necessary) based on the initial feedback from FDA (if necessary). The prototypes developed should provide protective efficacy and operational viability on Warfighters in the blast conditions where blast-induced performance deficits are expected/identified (e.g. breaching training) or conduct clinical trials to conclusive demonstrate protective capabilities of the product. The performer may coordinate with WRAIR/USAMRDC/USAMMDA for this objective for advanced development. The performer can seek additional funding from other government sources and/or private investors to commercialize the project. Plans for large-scale production, licensing and process for rapid deployment of devices without compromising the efficiency of the product are sought through the funding from government sources and/or private organizations. This technology can be used to prevent impact TBI that can occur in civilian populations such as sports concussive, blast exposure in law enforcement personnel, and bicycle/motorcycle accidents.
REFERENCES:
- Prat NJ, Daban JL, Voiglio EJ, Rongieras F. Wound ballistics and blast injuries. J Visc Surg. 154:S9-S12. (2017)
- Review of Department of Defense Test Protocols for Combat Helmets, Washington (DC): National Academies Press (US), ISBN-13: 978-0-309-29866-7, (2014).
- Military Times. 109 US troops diagnosed with TBI after Iran missile barrage says Pentagon in latest update. Feb 12, 2020.
