Development of a Clinically Viable Pattern Recognition Embedded System

描述（由申请人提供）：模式识别（PR）肌电控制系统可以显著改善截肢患者对动力假肢的控制，但尚未商业化。Coapt有限责任公司是一家初创阶段的公司，为上肢截肢者的利益发起了PR肌电控制的受控商业发布。该控制器是基于芝加哥康复研究所（RIC）仿生医学中心完成的研究，并已被广泛开发和测试，用于跨桡骨和更高水平的截肢者。Coapt之前从RIC获得了有价值的PR控制器技术和知识产权许可。上肢截肢者面临着严重的损伤，并且以前没有从PR控制技术的进步中受益。方便的是，商业上可用的多功能假肢现在可以为用户提供多种动力选择，但这些目前还没有启用PR控制。长期目标是为上肢截肢者提供一个更直观的选择来控制他们的外部动力假肢。此应用程序的目标是使最初发布的商业产品足够直观，以便它可以在各种站点和制造商之间可靠地工作，并且现场工程时间最少。Coapt的第一款产品是一款先进的PR微控制器系统，它可以通过解释肌电图（EMG）信号模式来“驱动”任何现有或未来的假肢系统。制定这种覆盖面广泛的方法的一个重要因素是尽可能多地接触到截肢患者。为了获得消费者的认可，产品的提供必须根据义肢从业者的需求和实践来实现。该申请包括以下三个具体目标：(1)开发临床重点软件包；(2)完成商用多功能臂系统的实验室测试；(3)评估关于在多个地点的装配过程和假体使用结果的定量数据。在第一个目标下，系统组态软件的面向临床的元素将通过反复的临床评估来实现。在第二个目标下，PR控制器系统将被配置为增强对商用多功能假肢的控制。第三个目标将提供有价值的信息，我们可以将其与传统控制使用的基准数据进行比较，这反过来将为未来的设计决策提供信息。这项研究具有重要意义，因为它为基于模式识别的肌电控制与商用多功能假肢的连接提供了一条途径。最终，这项研究将帮助上肢截肢者极大地改善对假肢的控制，从而提高生活质量，并在许多情况下促进重返工作岗位。

DESCRIPTION (provided by applicant): Pattern recognition (PR) myoelectric control systems can dramatically improve an amputee patient's control of a powered prosthesis, but they have not been made commercially available. Coapt, LLC, is a start-up stage company that has initiated a controlled commercial release of PR myoelectric control for the benefit of upper- limb amputees. The controller is based on research completed by the Center for Bionic Medicine at the Rehabilitation Institute of Chicago (RIC) and has been widely developed and tested with transradial and higher-level amputees. Coapt has previously licensed valuable PR controller technology and intellectual property from the RIC. Upper-limb amputees are faced with significant impairment and have not previously benefitted from the advances in PR control technology. Conveniently, commercially available multifunction prostheses are now available that offer users multiple powered options but these are not presently enabled with PR control. The long-term goal is to provide upper-limb amputees with a more intuitive option for controlling their externally powered prostheses. The objective of this application is to make the initially released commercial product intuitive enough that it can reliably work across a variety of sites and manufactures with minimal on-site engineering time. Coapt's first product is an advanced PR microcontroller system that can 'drive' any existing or future prosthetic arm system by interpreting electromyographic (EMG) signal patterns. An important factor in the development of such a broad reaching approach is reaching as many amputee patients as possible. To achieve consumer acceptance, the product offering must be realized according to the needs and practices of the prosthetic practitioner. This application comprises the following three specific aims: (1) develop a clinically focused software package; (2) complete in laboratory testing of commercially available multifunction arm systems; and (3) evaluate quantitative data regarding the fitting process and resulting prosthesis usage in take- home settings across multiple sites. Under the first aim the clinician-facing elements of the system's configuration software will be implemented with iterative clinical evaluations. Under the second aim, the PR controller system will be configured to enhance the control of commercially available multifunction hand prostheses on amputee subjects. The third aim will provide valuable information that we can compare against bench-mark data from conventional control usage, which in turn will inform future design decisions. The proposed research is significant because it enables a pathway to connect pattern recognition-based myoelectric control with commercially available multifunction prostheses from being adopted. Ultimately, this research will help upper-limb amputees to dramatically improve the control of their prostheses, allowing for an improved quality of life and promote return to work in many cases.