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地改善截肢患者对动力假肢的控制，但是它们还没有商业化。Coapt，LLC，是一家初创阶段公司，已启动了一个控制的商业释放公关肌电控制上肢截肢者的利益。该控制器是基于芝加哥康复研究所仿生医学中心（RIC）完成的研究，并已广泛开发和测试经桡动脉和更高水平的截肢者。Coapt之前已经从RIC获得了宝贵的PR控制器技术和知识产权。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，市售的多功能假体现在是可用的，其为用户提供多个动力选项，但这些目前还不能通过PR控制实现。长期目标是为上肢截肢者提供更直观的选择来控制他们的外部动力假肢。该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，并将现场工程时间缩短到最低限度。Coapt的第一款产品是一款先进的PR微控制器系统，可以通过解释肌电（EMG）信号模式来“驱动”任何现有或未来的假肢系统。发展这种广泛接触方法的一个重要因素是接触尽可能多的截肢患者。为了获得消费者的认可，产品供应必须根据假肢从业者的需求和实践来实现。本申请包括以下三个具体目标：（1）开发一个临床重点软件包;（2）完成市售多功能臂系统的实验室测试;以及（3）评价关于装配过程的定量数据以及多个研究中心带回家使用的假体使用情况。在第一个目标下，系统配置软件的面向临床医生的元素将通过迭代临床评价来实现。根据第二个目标，PR控制器系统将被配置为增强对截肢者受试者的市售多功能手假肢的控制。第三个目标将提供有价值的信息，我们可以与传统控制使用的基准数据进行比较，这反过来又会为未来的设计决策提供信息。拟议的研究是重要的，因为它使一条途径，连接模式识别为基础的肌电控制与商业上可用的多功能假肢被采用。最终，这项研究将帮助上肢截肢者大大改善对假肢的控制，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.