SBIR Phase II: Compliant Nonlinear Quasi-Passive Orthotic Joint

这个小型企业创新研究(SBIR)第二阶段项目旨在创建一种腿部支架，以解决影响全球1.5亿人的轻度/中度步行功能障碍的根本原因。名为形态切换矫形关节的新型支撑元件将现场可调的非线性扭转弹簧与微处理器控制的离合器相结合，根据用户的步态动态改变支撑的机械状态。互联网可更新软件在多处理器、容错支架操作系统下执行，对支架的40个传感器进行采样，以监控腿部姿势并激活离合器状态转换。新颖的支具概念包括适应支具错位的软/柔性组织界面、与现有支具相比提供更大活动范围的关节配置以及具有自适应能力的装配方案。计划实现三个研究目标：在最大限度地减少对日常生活(ADL)活动的干扰的同时，优化支架设计的舒适度；建造/测试五个原型支架；以及在残疾志愿者中进行人体试验，以评估支架的安全性和益处。主要的生物力学好处包括动态适应使用者的腿部力量，以在所有膝关节角度提供完全支持，并在活动活动期间将膝关节上的总力减少高达一个数量级。该项目更广泛的影响/商业潜力源于创造了一种支架，它提供了大大超过现有设备的生物力学优势，而不会干扰非移动ADL。预期的好处包括：允许膝骨性关节炎(KOA)患者疼痛更少地行走；提高步行/下楼梯的安全性；适应用户首选的步长/步行速度；减少步行所需的工作量；以及允许一次电池充电进行全天的移动ADL(包括20英里步行)。这将对现有的腿部支架市场产生变革性的影响(仅每年卸载12万个支架)，并改善多达40%的世界上患有行动不便的人口的生活质量。对膝关节骨性关节炎患者的好处包括为多间隙或肥胖的膝关节骨性关节炎患者或不能接受膝关节置换手术的患者提供一种新的治疗选择。步行/楼梯下降安全的好处包括有可能减少跌倒的发生率。跌倒占意外死亡的三分之二，是美国老年人活动受限的主要原因；腿部无力的人跌倒的风险增加四到五倍；因此，直接解决腿部无力有可能延长寿命和减少医疗支出。

This Small Business Innovation Research (SBIR) Phase II project aims to create a leg brace that addresses the underlying causes of mild/moderate walking dysfunction affecting 150 million people worldwide. Novel brace elements called Morphologically Switched Orthotic Joints combine field-adjustable, non-linear torsion springs with microprocessor controlled clutches to change the brace's mechanical state dynamically according to the user's gait. Internet updatable software, executing under a multi-processor, fault tolerant brace operating system, samples the brace's 40 sensors to monitor leg posture and activate clutch state transitions. Novel brace concepts include soft/flexible tissue interfaces that adapt to brace misalignment, a joint configuration that provides greater range of motion compared with existing braces, and a fitting scheme with potential for self-fitting capability. Three research objectives are planned: optimize the brace design for comfort level while minimizing interference with Activities of Daily Living (ADL); build/test five prototype braces; and conduct human subjects testing with disabled volunteers to assess brace safety and benefits. Primary biomechanical benefits include dynamically adapting to the user's leg strength to provide full support at all knee angles and reducing the total force across the knee joint by up to an order of magnitude during mobility activities. The broader impact/commercial potential of this project stems from creating a brace that offers biomechanical benefits that substantially surpass those of existing devices without interfering with non-mobile ADL. Anticipated benefits include: allowing Knee Osteoarthritis (KOA) patients to walk with less pain; improving walking/stair-descent safety; adapting to the user's preferred step-length/walking-speed; reducing the effort needed to walk; and allowing a full day of mobile ADL (including a 20-mile walk) on a single battery charge. This will have a transformative effect on the existing leg brace market (120K offloading braces/yr alone) and improve Quality-of-Life for as much as 40% of the world's population suffering mobility dysfunction. The benefit for KOA patients includes a new treatment alternative for multicompartmental or obese KOA patients or for patients who cannot have knee replacement surgery. The benefit for walking/stair-descent safety includes potential for reducing the incidence of falls. Falling accounts for two thirds of accidental deaths and is the leading cause of restricted activity days amongst America's elderly; persons with leg weakness have a four- to fivefold increased risk for falls; directly addressing leg weakness therefore has potential to increase longevity and reduce healthcare spending.