Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness

项目摘要/摘要 该项目的目标是开发一种闭环式肌肉电刺激(CL-EMS)系统，以减轻ICU 获得性弱点(ICUAW)。病因多因素(卧床时间延长，急性炎症状态， 暴露于多种药理制剂，如神经肌肉阻滞剂、抗生素和皮质类固醇)， ICUAW在ICU入院后几个小时内开始，影响四肢，特别是下肢以及 呼吸肌阻碍撤机，导致住院时间延长和 最终会出现短期和长期的功能损害和生活质量下降。目前，没有有效的 存在对ICUAW的治疗，重点主要是早期活动预防措施。当前提早 活动计划是通过物理治疗执行的，需要患者配合，无法执行 危重病人/机械通气病人入住ICU后即刻。因此，有很高的 对能够通过非意志性锻炼策略进行早期干预的兴趣。其中一个很有希望的策略是 “电肌肉刺激”(EMS)。EMS使用皮肤表面电极被动激活肌肉和 电脉冲。文献中的临床数据支持使用EMS作为早期康复的工具。 然而，技术限制阻碍了EMS在ICU中的广泛采用：(1)没有开发EMS设备 对于ICU使用，提出与心脏监护的电磁干扰(EMI)相关的安全问题 系统以及维持生命的设备，如心脏植入的电子设备和外部 除颤器；(2)熟练的操作员持续到场安装除颤器 监测治疗过程(通过评估患者的生理反馈并进行调整) 增加干预的工作量和成本。我们推断，具有低电气噪声的EMS设备可以 降低EMI风险。此外，我们认为，使用实时肌肉生物电反馈来应对 电刺激可以为闭合循环系统创造基础。一种低噪声EMS系统显示出良好的前景 结果用心电系统进行测试。此外，我们发现实时生物电反馈的使用是 可靠地检测肌肉对电刺激的反应。因此，在这个项目中，我们将集成一个 具有低噪声急救装置的生物电反馈装置，以创建可在重症监护病房安全使用的CL-急救α版本 布景。在第一阶段，与闭环系统原型系统的电气设计集成相关的研发工作将 才能完成。将建造一个α版本的CL-EMS系统，并对其安全性和有效性进行测试 有效的肌肉收缩。验证过程将包括IEC测试和健康志愿者测试。

Project Summary/Abstract The goal of the project is to develop a closed loop electrical muscle stimulation (CL-EMS) system to mitigate ICU acquired weakness (ICUAW). Multifactorial in origin (extended period of bed rest, acute inflammatory state, exposure to multiple pharmacological agents such as neuromuscular blockers, antibiotics, and corticosteroids), ICUAW starts within few hours of ICU admission, affects the limbs, particularly the lower extremities as well as the respiratory muscles impeding weaning from mechanical ventilation, leading to prolonged hospitalization and eventual short-term and long-term functional impairment and reduced quality of life. Currently, no effective treatment exists for ICUAW, and the focus is primarily on early mobility preventive measures. Current early mobility program is executed by physical therapy and requires patient’s cooperation and could not be performed immediately after ICU admission in critically ill/mechanically ventilated patients. Therefore, there is high interest in being able to intervene early via non-volitional exercise strategies. One such promising strategy is “Electrical Muscle Stimulation” (EMS). EMS passively activates muscles using skin-surface electrodes and electrical pulses. Clinical data from the literature support the use of EMS as a tool for early rehabilitation. However, technical limitations prevented widespread adoption of EMS in ICUs: (1) no EMS device is developed for ICU use raising safety questions related to electromagnetic interference (EMI) with cardiac monitoring systems as well as life sustaining equipment such as cardiac implanted electronic devices and external defibrillators; (2) the continuous presence of a skilled operator on site to set up the device and continuously monitor the treatment session (by assessing physiological feedback from the patient and making adjustments) increase the workload and cost of the intervention. We reasoned that an EMS device with low electric noise could reduce the risk of EMI. Additionally, we reasoned that using real-time muscle bioelectric feedback in response to electric stimulation could create the basis for a closed loop system. A low noise EMS system showed promising results when tested with an ECG system. In addition, we find that the use of real-time bioelectric feedback is reliable in detecting muscle response to electrical stimulation. Therefore, in this project we will integrate a bioelectric feedback device with a low noise EMS device to create a CL-EMS α-version that is safe for use in ICU setting. In phase 1 R&D work related to the electrical design integration of the closed loop prototype system will be completed. An α-version of the CL-EMS system will be built and tested for safety and efficacy in inducing an effective muscle contraction. The validation process will include IEC testing and testing in healthy volunteers.