An Intuitive Prosthetic System for Upper Extremity Amputees

上肢截肢者直观的假肢系统

• 批准号: 8627657
• 负责人: Alexander W Dromerick
• 金额: $ 80万
• 依托单位: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8627657
• 关键词: Action Research; Adoption; Algorithms; Amputation; Amputees; Awareness; Boxing; Clinical; Clinical Research; Code; Communities; Complex; Computer software; Consumption; Data; Development; Devices; Electrodes; Electronics; Evaluation; Feedback; Focus Groups; Follow-Up Studies; Freedom; Gel; Goals; Grant; Hand; Hand functions; Home environment; Hospitals; Hour; Individual; Insurance; Laboratories; Life; Limb structure; Lithium; Marketing; Measures; Medical Device; Medicare; Movement; Occupational Therapy; Participant; Patients; Pattern Recognition; Peer Review; Performance; Persons; Phase; Polymers; Productivity; Prosthesis; Protocols documentation; Publications; Quality of life; Questionnaires; Radial; Rehabilitation therapy; Reporting; Research Design; Residual state; Silicones; Small Business Innovation Research Grant; Solutions; System; Technology; Testing; Textiles; Time; Training; United States; United States National Institutes of Health; Upper Extremity; Work; arm; base; cohort; cost effective; design; energy density; experience; flexibility; improved; innovation; innovative technologies; instrumentation; meetings; new technology; novel; product development; psychosocial; public health relevance; response; signal processing; verification and validation

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.

描述（由申请人提供）：当今美国有超过100，000人患有上肢缺失，每12例新截肢病例中就有1例是上肢截肢。失去上肢对一个人的生活质量、工作效率是毁灭性的，并带来许多心理社会挑战。虽然有令人兴奋的技术进步，承诺提供灵巧的假肢手，但在技术上的可能性和绝大多数截肢者所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具有成本效益的假体系统。作为直接回应，并根据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SBIR第IIB阶段努力开发这样一个系统，基于以下创新解决方案：1）MyoLiner：一种基于织物电极的系统，用于舒适地全天采集多通道“高清晰度”肌电图（HD-EMG）; 2）PRO-控制器：一种新的分类器算法和相关的电子硬件，用于解码协调的手部运动的意图;以及3）FlexCells：柔性高能量密度电池，其适形并适应肢体。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，创造出一种价格合理、功能强大的假肢--模式识别操作臂（PRO- Arm）。将在一项旨在客观评价性能以及从患者角度评价性能的研究中对系统进行测试。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，并获得了好评。其次，我们将在项目的第一年内准备MyoLiner系统的临床上市。第三，我们将以模块化的方式构建该系统，从而允许修复师将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一天中的真实世界性能，而不仅仅是实验室环境中的理想化性能。最后，第五，该系统将被出售给修复师以及在现有的医疗保险报销代码-因此，应该没有财务障碍，临床采用该技术。简而言之，我们相信，IIB期的资助将使我们能够使这个由NIH支持发起的项目取得合乎逻辑的结果。我们会把PRO Arm进入临床用途：是一种经济实惠的创新解决方案，为上肢截肢者提供了显著的益处。