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Frostbite Scanner

Description:

OBJECTIVE: A device to detect frostbite in a Warfighter during operations. The medic would use the device/system to detect whether a Warfighter has frostbite or the onset of frostbite. This device would detect frostbite remotely from a stand-off distance as a threshold requirement. In the early pre-frostbite phase, local vasoconstriction and ischemia occurs primarily in the feet, hands, face and ears. A local detection approach on a Warfighter that alerts the Warfighter of potential onset of frostbite and provides a mechanism to convey that information to the medic is the initial approach for a potential solution. Optimally, the system will notify the medic either automatically or by query from the medic. Ultimately, the objective requirement would be to detect the onset of frostbite before it actually occurs. Demonstration of the technology in arctic conditions would be the ultimate deciding factor for moving forward with advanced development. What would be required is to develop the technology needed or use commercial off the shelf technology that would allow this capability to work. It must be a hand-held device with limited range but would allow for a medic to carry it for ease of use. In addition, the approach would identify potential technologies that could be used for this or could this have be developed to provide a technical solution that could detect frostbite remotely. Are there alternative technologies for arctic conditions to investigate? For instance, could the Warfighter wear a sensor that the medic could query to detect the onset of frostbite? This would allow the Warfighter to notify the medic that a Warfighter has frostbite and inform leadership, that readiness is being impacted and needs to operational change the Warfighter’s health before increased damage takes place. DESCRIPTION: The Army is responsible for providing Arctic capable forces to support joint all-domain operations in defense from the region’s threats. The Army must also be able to provide and sustain Arctic-capable forces for employment outside of the region as necessary. The Army is an essential key to ensuring land dominance in support of the joint force in the all-domain environment. The Army’s ability to compete in the region delivers dilemmas to adversaries seeking an advantage in the Arctic. One of the major issues for Warfighters in the Arctic is frostbite. Frostbite is an injury caused by freezing of the skin and underlying tissues. Typical frostbite occurs in toes, fingers, face and ears, which are extremities that have the least protection to external temperatures in arctic conditions. First your skin becomes very cold and red, then numb, hard and pale. Frostbite is most common on the fingers, toes, nose, ears, cheeks and chin. Exposed skin in cold, windy weather is most vulnerable to frostbite. But frostbite can occur on skin covered by gloves or other clothing. Frostnip is a milder form of cold injury that doesn't cause permanent skin damage. You can treat Frostnip with first-aid measures, including rewarming the affected skin. All other frostbite requires medical attention because it can damage skin, tissues, muscle and bones. Possible complications of severe rostbite include infection and nerve damage. For Army operations to succeed, a frostbite scanner that a medic could use to detect the onset of this injury is needed. Is their technology available or an approach in operations that would allow a medic to determine a way to detect frostbite in a Warfighter without thorough examination? The need is for operational detection, during deployment. PHASE I: Phase I is a feasibility study that should demonstrate or determine if a frostbite scanner or remote methodology is possible to meet the scientific, technical, and commercial merit and feasibility of this concept. This would require a technical solution approach that determines if a frostbite scanner or remotely queried approach is possible. The vendor would need to identify and define the technical approach/s to solve this problem. Once an approach is defined, a design concept for meeting the frostbite detection requirement would be needed. Phase I deliverables will include a feasibility study that will demonstrate or determine the scientific, technical, and commercial merit and feasibility of a frostbite scanner or methodology that is remotely determined without thorough examination by the medic and initial prototype for showing proof of concept in a laboratory environment. Vendor would provide a plan for practical deployment of the proposed approach, to include how the prototype could be developed and demonstrated. This will include a design/develop approach for an innovative concept along with the limited testing of materials or solutions. Identification of concepts and methods to solve this problem which will include investigative processes and perform an analysis to validate the approach concept making a solution to this issue. This approach may focus on extremities but could expand to other areas. This Phase will demonstrate an initial working prototype for frostbite detection remotely/from a distance. The biggest risk is already getting frostbite. So detecting before it happens is the main purpose of this effort. PHASE II: Phase II is a prototype effort for operational demonstration to determine if a frostbite scanner or remote methodology is possible to meet the scientific, technical, and commercial merit and feasibility of this requirement. Building on phase I, the effort will focus on extending the benchtop prototype to an operational environment to show the technology will work in hostile environments. Produce prototype hardware based on Phase I work. This will require conducting life cycle and environmental testing. Building on the Phase I work, the vendor will implement the best approach into hardware and software solution that can be demonstrated in an operational environment using DOD Arctic exercises. The vendor will use Phase I modeling, design and develop this more mature prototype. This Phase will demonstrate the feasibility of producing a prototype for frostbite detection remotely/from a distance, either with a medic hand-held device or a query tool that would detect a sensor on the Warfighter that would detect onset of frostbite or already manifested frostbite that works to temperatures of -65oF. Required Phase II deliverables will include a validated operational working prototype that can demonstrate a battery powered device can meet this requirement. Since this is a prevention device, FDA registration as a Type 1 classification that is exempt from a 510k submission will need to be investigated vs simple registration. PHASE III DUAL USE APPLICATIONS: Phase III work will concentrate on technology transition to Acquisition Programs of Record and commercialization of the SBIR technology. The United States Army Medical Research and Development Command, United States Army Medical Development Activity, Warfighter, Health, Performance and Evacuation Project Management Office will work with joint services to support production and further testing. The Air Force and Navy will also be supporting arctic operations that will put Warfighters in harm’s way with frostbite. The strategy for the Department of Defense is to have a stronger influence to be able to operate in the arctic environments due to increased interest in the potential for pursuing oil reserves by competitive countries to the United States. Phase III shall provide production planning and marketing strategy for potential procurement from the US Army and other joint services. The final expectation of the Phase III is a working production device that can determine frostbite is occurring in a Warfighter during operational conditions in arctic weather. The device/system, should be able to notify the Warfighter that frostbite is starting to occur and provide that information to the medic, either automatically or by a remote medic query of Warfighter’s current status. The conditions for the success of the technology, are the arctic environmental conditions, in the -65oF or warmer conditions. In the future, Warfighters will be operating in very harsh temperatures, and a device that can help determine frostbite is a critical function for prevention of frostbite in the field. It must describe one or more specific Phase III military applications and/or supported S&T or acquisition program as well as the most likely path for transition of the SBIR from research to operational capability. Additionally, the technology will benefit the private sector as well in prevention of frostbite for other than Department of Defense applications, like oil exploration in the arctic regions of the world. If successful, such a system could impact so many people that operate in cold climates. With the current focus on finding new resources, there will be an increase of humans in arctic regions operating under severe conditions. If we could detect and prevent frostbite beforehand, it ultimately would be a great benefit to the Warfighter and the country. Finally, FDA registration and proper submissions for approvals will be needed to determine what is needed for final commercialization. REFERENCES: 1. Frostbite: Spectrum of Imaging Findings and Guidelines for Management John D. Millet Richard K. J. Brown, Benjamin Levi, Casey T. Kraft, Jon A. Jacobson, Milton D. Gross, Ka Kit Wong Author Affiliations Published Online:Aug 5 2016. doi: https://doi.org/10.1148/rg.2016160045 2. Frostbite Charles Handford 1 , Owen Thomas 2 , Christopher H E Imray 3 Affiliations PMID: 28411928 Emerg Med Clin North Am 2017 May;35(2):281-299. doi: https://doi.org/10.1016/j.emc.2016.12.006 3. Frostbite: pathogenesis and treatment J V Murphy 1 , P E Banwell, A H Roberts, D A McGrouther Affiliations PMID: 10647591 J Trauma 2000 Jan;48(1):171-8. doi: https://doi.org/10.1097/00005373-200001000-00036 4. https://www.medicinenet.com/frostbite/article.htm#what_should_i_know_about_frostbite
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