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.

抽象的 NIH SBIR 转化项目的目标是评估小型植入式记录系统 来自前臂截肢者残余肌肉的肌电信号 这些信号将以无线方式传输。 与传统的表面电极相比，连接到外部收发器来控制假体， 该系统将提供： • 残肢中更多肌肉的更多假肢控制通道， • 提高了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具有更高的可靠性和质量， • 来自深层肌肉的选择性、一致的信号，以及 • 能够使用凝胶、真空和其他不易容纳的假肢接受腔衬里系统 表面电极。 这些多通道记录将使用户能够以更多的方式生成同步多轴运动。 与一次仅驱动单个关节轴的现有肌肉控制器相比，我们有更自然的控制感。 将完成外部收发器的升级和测试，以消除对皮带佩戴式处理器的需要。 在第二阶段，我们将与匹兹堡大学合作进行早期可行性 IDE 研究。 与 Advanced Arm Dynamics 协调全国招募，以招收足够数量的受试者 为 5 名受试者植入肌电植入物，进行为期 1 年的研究。受试者将被植入并接受治疗。 匹兹堡大学在为期一年的带回家研究中进行季度评估。 评估控制多关节假肢的安全性和有效性。