An Intuitive Prosthetic System for Upper Extremity Amputees

描述(申请人提供)：今天，美国有超过10万人患有上肢缺失，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，并带来了许多心理社会挑战。虽然已经有了令人兴奋的技术进步，保证了灵巧的假手的可获得性，但在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，需要一种能够可靠地控制多个自由度的集成的高性价比假肢系统。作为直接的回应，并按照PA-11-135有关复杂仪器开发和集成的范围，我们现在提出SBIR第IIB阶段工作，以开发这样一个系统，基于下列创新解决方案：1)MyoLiner：一种基于纺织电极的系统，可舒适地全天候获取多通道“高清晰度”肌电(HD-EMG)；2)PRO-控制器：用于解码意图的新型分类器算法和相关电子硬件；以及3)FlexCells：灵活的高能量密度电池，可共形且适合肢体。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，创造出一种负担得起、功能强大的假肢--模式识别操作手臂(PRO-ARM)。该系统将在一项旨在客观评估性能以及从患者角度进行评估的研究中进行测试。值得注意的是，我们的目标是在项目结束之前就开始产生重大的临床影响。首先，我们已经向市场推出了FlexCells，它们受到了好评。其次，我们将在项目的第一年内为临床推出MyoLiner系统做准备。第三，我们将以模块化的方式构建系统，从而允许修复师将这些部件与其他公司的产品一起使用。第四，算法开发和培训的重点是一天中的真实性能，而不仅仅是实验室环境中的理想化性能。最后，第五，该系统将出售给符合现有医疗保险报销代码的修复师--因此，临床采用该技术不应存在任何财务障碍。简而言之，我们相信，这笔第二阶段的赠款将使我们能够完成这个由NIH支持发起的项目，这是合乎逻辑的。我们会带来专业的 ARM进入临床应用：一种负担得起但创新的解决方案，为上肢截肢者提供了显著的好处。

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.