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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是改进如何为个人用户安装假肢（假体）。这为肢体丧失的人带来了更好的康复效果，降低了长期健康问题的风险，比如意外跌倒、背部疼痛或与久坐生活方式相关的疾病。所有这些风险都可能给个人和整个社会带来巨大的直接和间接成本。大约有200万美国人失去了肢体，他们可能会从更好的假肢中受益。除了预期的长期益处之外，这些人还将体验到直接的益处，包括更不明显的步态模式，皮肤和肌肉酸痛的减少，以及活动半径的增加。这项研究的商业影响将扩展到假肢部件制造行业。目前，义肢的结构部件是大量生产的，严格来说是机械部件。拟议的工作将需要将微型传感器集成到这些组件中，这将使它们更有价值，并且-伴随着经济上的长期利益-证明更高的单价，从而为这个4亿美元的市场带来巨大的增长潜力。本课题主要研究假肢的静态对齐优化问题。这种对齐需要仔细调整，以适应每个假体使用者。相关的工作是义肢专家的领域，他们依靠经验、患者反馈和直觉来获得可接受的结果。目前没有简单的方法来测量和跟踪整个过程中的校准变化，因此没有基于数据的方法来改进它。在拟议的项目中，小型传感器将集成到传统的可校准假体组件中。这些将提供连续，准确的实时测量对准变化。计划通过智能手机或平板电脑将这些测量结果提供给义肢医生，这样他们就可以帮助简化对齐优化过程。在未来，如果有可能对收集到的数千次假体对准过程的数据进行分析，可以应用科学的方法来解决假体对准不完美的问题。拟议的工作将侧重于定制传感器和相关硬件，使其符合现有的标准组件，而不会使它们变得更重或更昂贵。假肢专家样本对该设备的初步测试也是计划中的第一阶段项目的一部分。

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.