SBIR Phase II: Advanced Controlled-Impedance Transfemoral Knee/Ankle Prosthesis

这项小型企业创新研究（SBIR）第二阶段项目旨在开发一种经股骨假体，使佩戴者能够更平稳地行走和跑步，具有更大的稳定性和更少的努力。通常，经股截肢者难以实现自然步态，从而导致不适和更大的能量消耗。预计这种先进假肢的开发将大大提高截肢者的功能和舒适度，并为假肢行业带来新技术。在第一阶段的研究中，开发了一个独特的膝关节和踝关节工程模型，实现了气动顺应性（弹簧）和电控液压阻尼。在第二阶段，将开发微处理器控制的膝关节/踝关节假体的完整原型，具有以下特征：（a）合规（B）协调膝盖和脚踝阻抗以匹配期望的步行节奏，以及通过将弹簧刚度调整到自然频率来最小化能量消耗;和（c）膝阻抗的肌电控制。此外，高性能的功能将被集成到假肢设备中，包括自适应摆动阶段膝盖阻抗，和自动控制站立阶段阻抗。该项目的商业应用将在假肢设备领域，供膝盖和脚（经股）截肢的人使用。拟议的产品将允许截肢者佩戴假肢更长的时间，更少的努力和更安全，并在更崎岖和不平坦的地形上行走。该项目产生的收入估计数显示，销售总额从每年75万美元开始，5年后迅速增长到800万美元以上。

This Small Business Innovation Research (SBIR) Phase II project aims to develop a transfemoral prosthesis which will allow wearers to walk and run more smoothly, with greater stability and less effort. Typically, transfemoral amputees have difficulty achieving a natural gait, thus causing discomfort and greater energy expenditure. It is expected that the development of this advanced prosthesis will greatly enhance the function and comfort of amputees and bring new technology to the prosthetic industry. In Phase I research, a unique engineering model of the knee and the ankle was developed, implementing the pneumatic compliance (spring) and electrically-controlled hydraulic damping. In Phase II, complete prototypes of the microprocessor-controlled knee/ankle prosthesis will be developed, with the following features: (a) compliant (elastic, rather than stiff) knee flexion during stance phase, which will return energy to the wearer and improve comfort, (b) co-ordination of knee and ankle impedance to match desired walking cadence, and minimal energy expenditure by tuning the spring rate to the natural frequency; and (c) myoelectric control of knee impedance. In addition, high-performance features will be integrated into the prosthetic device, including adaptive swing phase knee impedance, and automatic control of stance phase impedance.The commercial application of this project will be in the area of prosthetic devices for use by people with knee and foot (transfemoral) amputation. The proposed product will allow the amputees to wear their prosthesis for a longer time period, with less effort and more safety, and to walk on more rugged and uneven terrain. Estimates of revenues resulting from this project show gross sales starting at $750,000 per year, growing rapidly after 5 years to over $8,000,000.