SBIR Phase I: Integrating alignment angle sensors into limb prosthesis standard componentry

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is an improvement in how artificial limbs (prostheses) are fitted to the individual user. This promises better rehabilitation outcomes for people with limb loss, which lowers the risk of long-term health issues, such as accidental falls, back pain, or conditions that are associated with a sedentary lifestyle. All those risks can carry substantial direct and indirect costs for the individual and the society at large. There are approximately 2 million Americans who are living with limb loss, and who will potentially benefit from better prosthesis fit. Beyond the expected long-term benefits, these individuals will experience immediate benefits that include a more inconspicuous gait pattern, a reduction in skin and muscle soreness, and an increase in activity radius. The commercial impact of this research will extend to the industry of prosthetic componentry manufacturing. Currently, the structural elements of prostheses are mass-produced, strictly mechanical components. The proposed work will entail the integration of miniature sensors into those components, which will make them more valuable, and - along with the economical long-term benefits - justify higher unit prices and thereby a substantial growth potential for this $400M market. The proposed project is focused on optimizing the static alignment of limb prostheses. This alignment needs to be carefully fine-tuned to each individual user of a prosthesis. The associated work is the domain of the prosthetist, who depends on experience, patient feedback, and intuition to achieve acceptable results. There are currently no easy ways to measure and track alignment changes throughout this process and therefore no data-based approaches to improving it. In the proposed project, small scale sensors will be integrated into the conventional alignable prosthesis components. These will provide continuous, accurate real-time measurements of alignment changes. It is planned to make those measurements available to the prosthetist via smartphone or tablet PC, so that they can help streamline the alignment optimization process. In the future, if it is possible to analyze the so collected data from thousands of alignment procedures, scientific methods can be applied to solve the problem of imperfect prosthesis alignments. The proposed work will be focused on customizing the sensors and associated hardware to existing standard components without making them much heavier or more expensive. Preliminary tests of the device with a sample of prosthetists are part of the planned Phase 1 project as well.