Clinical Validation of Myoelectric Implant for Intuitive Prosthesis Control

用于直观假肢控制的肌电植入物的临床验证

• 批准号: 10290697
• 负责人: Scott Hiatt
• 金额: $ 72.82万
• 依托单位: RIPPLE, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10290697
• 关键词: Activities of Daily Living; Adoption; Algorithms; Amputation; Animals; Artificial Arm; Back; Clinical; Clinical Protocols; Clinical Trials; Complex; Coupled; Coupling; Data; Device Safety; Devices; Documentation; Electrodes; Enrollment; Evaluation; Feasibility Studies; Forearm; Freedom; Funding; Gel; Goals; Hand; Home; Implant; Implanted Electrodes; Individual; Intramuscular; Intuition; Joints; Learning; Limb Prosthesis; Link; Methods; Movement; Muscle; Noise; Operative Surgical Procedures; Outcome; Outcome Measure; Persons; Phase; Preclinical Testing; Prosthesis; Quality of life; Questionnaires; Residual state; Safety; Serious Adverse Event; Signal Transduction; Skin; Small Business Innovation Research Grant; Software Validation; Specificity; Surface; System; Telemetry; Testing; Time; United States National Institutes of Health; Universities; Upper Extremity; Vacuum; Validation; Work; Wrist; arm; design; implantable device; implantation; improved; joint mobilization; limb amputation; limb loss; primary outcome; programs; prosthesis control; prosthesis wearer; prosthetic hand; prosthetic socket; prototype; recruit; residual limb; secondary outcome; sensor; tool; translational goal; usability; verification and validation; wireless; wireless transmission

Abstract The goal of this translational NIH SBIR program is to evaluate a small, implantable system for recording myoelectric signals from residual muscles of individuals with forearm amputations. The signals will be wirelessly coupled to an external transceiver for controlling a prosthesis. Compared to conventional surface electrodes, this system will provide: • more channels for prosthesis control from a larger number of muscles in the residual limb, • improved specificity and repeatability for recording from individual muscles and muscle groups, • higher reliability and quality for the recorded signals under different socket conditions, • selective, consistent signals from deep muscles, and • the ability to use gel, vacuum, and other prosthesis socket lining systems that do not easily accommodate surface electrodes. These multichannel recordings will enable users to generate simultaneous multi-axis movements with a more natural feel of control than existing myocontrollers that only actuate a single joint axis at a time. In Phase I, we will complete upgrades and testing of the external transceiver to eliminate the need of the belt-worn processor. In Phase II, we will conduct an early feasibility IDE study in conjunction with the University of Pittsburgh. We will coordinate nationwide recruitment along with Advanced Arm Dynamics to enroll a sufficient number of subjects to implant 5 subjects with the myoelectric implant for a 1-year study. Subjects will be implanted and undergo quarterly evaluation at the University of Pittsburgh throughout the 1-year take-home study. The implant will be evaluated for safety and efficacy for controlling a multi-articulating prosthetic limb.

摘要 这个翻译NIH SBIR计划的目标是评估一个小型的，可植入的记录系统， 来自前臂截肢者的残余肌肉的肌电信号。信号将通过无线方式 其耦合到外部收发器以用于控制假体。与传统的表面电极相比， 该系统将提供： ·来自残肢中大量肌肉的用于假肢控制的更多通道， ·改善了从单个肌肉和肌肉群记录的特异性和可重复性， ·在不同插座条件下记录信号的可靠性和质量更高， ·来自深层肌肉的选择性、一致性信号，以及 ·能够使用凝胶、真空和其他不容易适应的假肢接受腔内衬系统 表面电极 这些多通道记录将使用户能够产生同步的多轴运动， 与现有的一次仅致动单个关节轴的肌控制器相比，在第一阶段，我们 将完成外部收发器的升级和测试，以消除对腰带磨损处理器的需要。 在第二阶段，我们将与匹兹堡大学合作进行早期的IDE可行性研究。我们将 沿着Advanced Arm Dynamics协调全国范围的招募，以招募足够数量的受试者 对5名受试者植入肌电植入物进行为期1年的研究。受试者将接受植入并接受 在匹兹堡大学进行的为期1年的带回家研究中进行季度评估。植入物将 评估了控制多关节假肢的安全性和有效性。