RT&L FOCUS AREA(S): General Warfighting Requirements (GWR) TECHNOLOGY AREA(S): Bio Medical OBJECTIVE: To develop a lightweight device that generates medical grade oxygen for deployed medical facilities and personnel. DESCRIPTION: The ability to deliver oxygen to patients requiring supplemental oxygen is an essential capability for deployed medical facilities that provide treatment primarily to combat casualties who incur traumatic injuries. The Army based its current oxygen generating capabilities on the American College of Surgeons trauma treatment guidelines, which recommended that all trauma patients receive oxygen at a rate of at least 10 liters per minute (L/m).1 To meet this high demand for oxygen, the Army developed its current centralized oxygen generating and distribution system that is extremely heavy, maintenance intensive and requires large dedicated generators to operate. These characteristics limit the organizations' mobility to support combat operations, and are incompatible with the austere, far-forward battlefield anticipated in multi-domain operations. Multiple studies strongly suggest that the actual oxygen requirements for trauma patients is much less that the 15 L/m previously recommended; they indicate that the majority of trauma patients may not need any supplemental oxygen to sustain adequate blood oxygen levels,2,3 and patients with TBI may be significantly harmed by hyperoxia.4 Therefore, the Army plans to replace the current centralized oxygen production and delivery system with a system of individual oxygen generators that are distributed to individual patients throughout the facility. These devices would be lightweight devices that produce oxygen at a variable rate up to 5-6 L/m and would operate on standard 110/220 VAC power with an internal battery back-up that would enable the device to operate up to 4 hours without external power. The outflow of oxygen from two of these devices could be merged (stackable) to provide higher flows of oxygen for the 12-15% of trauma casualties and other patients whose oxygen requirements are above 6 L/m.5 PHASE I: Phase I will consist of designing schematics and diagrams along with limited testing of a prototype for a lightweight oxygen generating device that will produce a 90-95% purity medical grade oxygen at a continuous, variable rate of up to 6 L/m from ambient air. The device will be designed to operate effectively in a deployed setting that will include static, dismounted medical units as well as medical transport vehicles (ground and rotary-wing ambulances). Specific emphasis will be placed on portability, reliability, and design for the particular challenges of the battlefield environment (to include no- or low-light, loud or noise-discipline conditions, cramped space, extreme temperature environments, elevation, etc.) and use by all providers to include the combat medic. While the size, weight, power, and performance constraints will not be as rigid for a Phase I prototype, the ultimate goals for Phase II should be considered and attainable. Long-term need for stacking capability will be considered. Though water has been shown a viable feedstock for oxygen generation, water of adequate purity is a logistical constraint in the prolonged field care environment. However, possible alternative non-liquid feedstocks to transiently supplement the fundamental oxygen delivery capacity of the device are not excluded nor required (any hazardous byproducts must be mitigated). An argument for the approach chosen, to include recognized open questions in the literature, will be included. PHASE II: This phase will consist of further development of a portable oxygen generating device demonstrating its utility, and validating the prototype(s) through relevant testing. During the first year, the prototype(s) will be tested in simulated environments (>40oC, <0oC, humidity > 90%, 10,000 ft elevation) in order to determine practical viability. The second year will involve refinement and more rigorous testing of the chosen design in contractor-arranged laboratory studies to determine purity of the oxygen produced and accuracy of flow rates. Testing and refinement will involve the device's adherence to battlefield constraints; the device must be portable, lightweight (~2 kg), self-contained, have low power requirements (i.e. can operate continuously for 4 hours on a single battery), quiet (<45db), have stacking capability, and perform to all needed parameters concurrently. The phase II commercialization plans should include a regulatory plan for FDA clearance. The contractor would ideally identify appropriate potential commercialization partners (manufacturing, marketing, etc.) to facilitate technology transition. PHASE III DUAL USE APPLICATIONS: The technology developed under this SBIR effort will have applicability to both civilian and military emergency medicine; for military application the contractor will coordinate with the US Army Medical Material Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment Office to maximize capability gap mitigation. Phase III will consist of finalizing the device design and delivering manufactured devices (in their final form) for military-relevant testing such as airworthiness/performance testing (e.g. Joint Enroute Care Equipment Test Standards [JECETS], AR 70-62) and FDA-related testing (e.g. oxygen purity, accuracy of flow rates, etc.) under design freeze. The device will be functional for use by medics, physician assistants, nurses, and physicians in far forward environments (roles 1-3 of care and ambulances). Phase III will also include developing and finalizing training methods and protocols for the new device. In addition, the regulatory package should be in its final form ready for submission to the FDA, including all relevant test data. REFERENCES: American College of Surgeons, and Committee on Trauma. Advanced Trauma Life Support: Student Course Manual. 2018. Stockinger ZT, McSwain Jr NE. Prehospital supplemental oxygen in trauma patients: its efficacy and implications for military medical care. Military medicine. 2004 Aug 1;169(8):609-12. Douin DJ, Schauer SG, Anderson EL, Jones J, DeSanto K, Cunningham CW, Bebarta VS, Ginde AA. Systematic review of oxygenation and clinical outcomes to inform oxygen targets in critically ill trauma patients. J Trauma Acute Care Surg. 2019 Oct 1;87(4):961-77. Davis DP, Meade Jr W, Sise MJ, Kennedy F, Simon F, Tominaga G, Steele J, Coimbra R. Both hypoxemia and extreme hyperoxemia may be detrimental in patients with severe traumatic brain injury. J Neurotrauma. 2009 Dec 1;26(12):2217-23. McMullan J, Hart KW, Barczak C, Lindsell CJ, Branson R. Supplemental oxygen requirements of critically injured adults: an observational trial. Military medicine. 2016 Aug 1;181(8):767-72.
