An Intuitive Prosthetic System for Upper Extremity Amputees

描述（由申请人提供）：今天在美国有超过10万人患有上肢丧失，每12例新截肢中就有1例是上肢截肢。失去上肢对一个人的生活质量和工作效率都是毁灭性的，并带来许多社会心理挑战。虽然已经有了令人兴奋的技术进步，灵巧的假肢手有望实现，但技术上的可能性与绝大多数截肢者面临的现实之间存在着巨大的鸿沟。简而言之，需要一种集成的经济高效的假肢系统，能够可靠地控制多个自由度。作为直接回应，根据PA-11-135与复杂仪器的开发和集成相关的范围，我们现在提出了SBIR IIB阶段的努力，以开发这样一个系统，基于以下创新解决方案：1)MyoLiner：一种基于纺织品电极的系统，用于全天舒适地获取多通道“高清”肌电图（HD-EMG）；2) PRO-Controller：一种新的分类算法和相关的电子硬件，用于解码手部协调运动的意向性；3)柔性电池：可弯曲的高能量密度电池，具有保形和适应性。这些技术将首次与我们的商业合作伙伴的灵巧手技术相结合，创造出一种经济实惠、功能强大的假肢，即模式识别操作臂（PRO- Arm）。该系统将在一项研究中进行测试，该研究旨在客观地评估患者的表现。值得注意的是，我们的目标是在项目结束之前产生显著的临床影响。首先，我们已经向市场推出了FlexCells，并获得了良好的反响。其次，我们将在项目的第一年为临床推出MyoLiner系统做准备。第三，我们将以模块化的方式构建系统，从而允许义肢医生将这些组件与其他公司的产品一起使用。第四，算法开发和训练的重点是在一天中的实际表现，而不仅仅是在实验室环境中的理想表现。最后，第五，该系统将在现有的医疗保险报销代码范围内出售给假肢医生，因此，临床采用该技术应该没有经济障碍。简而言之，我们相信这笔iii期ib拨款将使我们能够使这个由NIH支持发起的项目得到合乎逻辑的结论。我们会带上PRO

DESCRIPTION (provided by applicant): There are well over 100,000 people living with upper limb loss in the United States today and 1 in 12 new amputations are of the upper limb. The loss of an upper limb is devastating to a person's quality of life, their work productivity and it bring about many psychosocial challenges. While there have been exciting technological advances which promise the availability of dexterous prosthetic hands, there is a wide gulf between what is technically possible and the reality faced by the overwhelming majority of amputees. In short, there is a need for an integrated cost-effective prosthetic system which can reliably control multiple degrees of freedom. In a direct response, and in accordance with the scope of PA-11-135 as related to the development and integration of complex instrumentation, we now propose an SBIR Phase IIB effort to develop such a system, based on the following innovative solutions: 1) the MyoLiner: a textile-electrode based system for comfortable all-day acquisition of multichannel "high- definition" electromyograms (HD-EMG); 2) the PRO-Controller: a novel classifier algorithm and associated electronic hardware for decoding intentionality of coordinated hand movements; and 3) FlexCells: flexible high energy-density batteries that are conformal and adaptive to the limb. These technologies will be integrated for the first time with dexterous hand technology from our commercial partner to create an affordable, highly functional prosthesis, the Pattern-Recognition-Operated Arm (PRO- Arm). The system will be tested in a study designed to evaluate performance on an objective basis as well as from the standpoint of the patient. Of note, our goal is to have significant clinical impact, starting far before the end of the project. First, we have already launched FlexCells into the market and they have been well received. Second, we will prepare the MyoLiner system for clinical launch within the first year of the project. Third, we will build the system in a modular fashion, thereby allowing prosthetists to utilize the components with other companies' products. Fourth, the algorithm development and training is focused on real-world performance over the course of the day, not just idealized performance in the lab setting. And finally, fifth, the system will be sold to prosthetists well wihin the existing Medicare reimbursement codes - thus, there should be no financial impediments to clinical adoption of the technology. In short, we believe that this Phase IIB grant will enable us o bring this project, initiated through NIH support, to its logical conclusion. We will bring the PRO Arm into clinical use: an affordable but innovative solution, providing significant benefits to uppr extremity amputees.