MyoFit: A new approach to suspension for upper limb myoelectric prostheses

 描述（由申请人提供）：上肢肌电假肢的一种新的悬吊方法。我们的研究计划的总体目标是使上肢截肢者能够生产和独立。对于这些人来说，过去十年最有前途的发展之一是引入完全灵巧的终端设备。然而，一个有效的和直观的控制策略仍然难以捉摸。肌电控制（通常利用两个表面EMG电极）对于一个或两个自由度的设备工作良好，但是当处理大量的运动类别时（例如当试图区分“手张开”、“食指点”、“细捏”等时），它不是那么有效。因此，已经进行了重要的研究，使用来自大量表面EMG电极（通常为八对）的信号来解码截肢者的意图。然而，最佳性能取决于高质量的表面肌电信号采集。电极位置或电极与皮肤之间接触的微小变化会导致系统性能显著下降。一个主要原因是标准解剖学悬挂式假体的设计没有预见到假体技术的发展，以包括对高度稳定的多通道表面EMG信号采集的需求。因此，有必要从根本上重新考虑假肢设计的新机会，以实现灵巧的控制。具体来说，在这个快速通道的努力，我们建议MyoFit系统的发展，以取代标准的解剖悬挂假体。它包括一个滚涂硅凝胶衬垫，该衬垫被制造成包含八个柔性表面EMG电极。内衬（以及延伸的电极）通过两部分销锁系统与假体的承窝和框架连接。该系统能够实现稳定的电极-皮肤界面，包括当假体承受载荷时以及当假体被移动到工作空间中的各种位置时。在第一阶段，我们将开发并完成内衬和锁的工程验证。在第二阶段，我们将完成系统集成和FDA监管许可。我们还将开展一项临床研究，以评价MyoFit系统与标准解剖学悬吊假体相比的功能受益。MyoFit系统的最终目标是使上肢截肢者获得上级临床功能结果。

 DESCRIPTION (provided by applicant): A new approach to suspension for upper limb myoelectric prostheses. The overall goal of our research program is to empower upper limb amputees to be productive and independent. For these individuals, one of the most promising developments in the past decade has been the introduction of fully dexterous terminal devices. However, an effective and intuitive control strategy has remained elusive. Myoelectric control (typically utilizing two surface EMG electrodes) works well for one or two degree-of-freedom devices, but it is not as effective when dealing with a large number of movement classes (such as when attempting to discriminate amongst "hand open", "index finger point", "fine pinch", and so on). Thus significant research has been undertaken on decoding the amputee's intention using signals from a larger number of surface EMG electrodes - typically eight pairs. However, optimal performance is dependent on high- quality surface EMG signal acquisition. Small changes in electrode position or in contact between the electrode and the skin results in significant degradation in system performance. One primary reason is that the design of the standard anatomically suspended prosthesis did not anticipate the evolution of prosthesis technology to include this need for highly stable multichannel surface EMG signal acquisition. Thus there is a need to fundamentally rethink prosthesis design in light of the new opportunity to achieve dexterous control. Specifically, in this Fast Track effort we propose development of the MyoFit system to replace the standard anatomical suspended prosthesis. It includes a roll-on silicone gel liner which is fabricated to incorporate eight flexible surface EMG electrodes. The liner (and by extension the electrodes) interfaces with the socket and frame of the prosthesis via a two-part pin-lock system. The system enables a stable electrode-skin interface, including when the prosthesis is bearing load and when it is being moved to various positions in the workspace. During Phase I we will develop and complete engineering validation of the liner and the lock. In Phase II, we will complete system integration and FDA regulatory clearance. We will also undertake a clinical study to evaluate the functional benefits of the MyoFit system as compared to the standard anatomically suspended prosthesis. It is our ultimate goal for the MyoFit system to enable upper limb amputees to achieve a superior clinical functional outcome.