CREARE LLC — Department of Defense STTR Phase II: DHA22B-001

Description

Blast-induced Traumatic Brain Injury (TBI) is a major threat to the health of military personnel serving in modern theaters. TBI incidence rates in Operation Enduring Freedom and Operation Iraqi Freedom approached 3% of all deployed personnel. Indeed, TBI has become known as the “signature” injury of these conflicts. Blast overpressure can also damage the lungs, eardrums, and eyes. Development and evaluation of personal protective equipment (PPE) to protect the warfighter from blast injury requires human surrogates. Today’s surrogates are either anatomically inaccurate (and fit PPE poorly) or are prohibitively expensive. Our warfighters deserve a better solution. In this STTR program, Creare, working with our partners at the Wake Forest University (WFU) Center for Injury Biomechanics, is developing the Modular Instrumented Torso and Head Surrogate (MITHS). The MITHS will provide a low-cost (<$5,000), biofidelic, and modular solution for evaluating blast injury risk and personal protective equipment performance. The MITHS features biofidelic and modular head and torso surrogates with biofidelic and replaceable brain, lung, eye, and ear phantoms, low-cost blast-relevant instrumentation, injury risk prediction software, and robust data acquisition. To date in Phase I, we developed a proof-of-concept MITHS complete with biofidelic lung, brain, eye, ear, and skeletal phantoms; demonstrated performance against a shock tube insult; developed a high-level design and manufacturing procedure for a fully modular MITHS; identified and characterized low-cost (<$100) blast-relevant pressure and acceleration sensors; established a baseline cost (<$3,000) and price (<$5,000) for the Phase III MITHS; and identified a commercialization partner eager to manufacture and market the MITHS as a product. Before the conclusion of Phase I, we will have demonstrated the proof-of-concept MITHS against blast insults exceeding 25 psi peak overpressure. In Phase II, we will conduct a final instrumentation down select; validate our approaches for replacing the brain, eye, ear, and lung phantoms; develop a detailed design with modular and replaceable components, using validated biofidelic geometry as a starting point; fabricate prototype surrogates using cost-conscious manufacturing approaches; demonstrate surrogate performance against repeated blast insults up to 75 psi without PPE and 135 psi with PPE; develop software to estimate injury risk using MITHS data; and continue to refine and execute our transition and commercialization plan.