Early identification and prevention of acute compartment syndrome using a novel electrical impedance-based muscle-monitoring device

使用新型电阻抗肌肉监测装置早期识别和预防急性筋膜室综合征

• 批准号: 10325320
• 负责人: Elmer C Lupton
• 金额: $ 69.78万
• 依托单位: MYOLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325320
• 关键词: Acute; Albumins; Algorithms; Amputation; Amyotrophic Lateral Sclerosis; Analgesics; Animal Model; Animals; Anterior; Anterior Compartment Syndrome; Awareness; Bluetooth; Boston; Businesses; Compartment syndromes; Contralateral; Data; Data Collection; Databases; Detection; Development; Devices; Disease; Disease model; Dose; Early identification; Edema; Effectiveness; Electrodes; Emergency Care; Extracellular Space; Family suidae; Fracture; Frequencies; Funding; Health; Health Professional; Health Status; Home; Hospitals; Human; Infusion procedures; Injury; Interest Group; Investigation; Ions; Ischemia; Israel; Lead; Leg; Limb structure; Lower Extremity; Malpractice; Measurement; Measures; Medical; Medical center; Methods; Modeling; Monitor; Multicenter Studies; Muscle; Muscular Dystrophies; Musculoskeletal Diseases; Myography; Needles; Nerve; Orthopedics; Outcome; Pathway interactions; Patients; Perfusion; Persons; Phase; Positioning Attribute; Prevention; Procedures; Process; Provider; Rattus; Risk; Secure; Sensitivity and Specificity; Small Business Innovation Research Grant; Splint Device; Surface; Surgeon; System; Techniques; Technology; Technology Assessment; Testing; Tissues; Trauma; Trauma patient; Wireless Technology; Work; base; clinical practice; data exchange; data modeling; design; detector; electric impedance; healthy volunteer; human subject; improved; indexing; interest; ischemic injury; limb injury; monitoring device; novel; porcine model; pressure; prevent; prototype; sarcopenia; success; tertiary care; tool; voltage

Project Summary Acute compartment syndrome (ACS) remains one of the most devastating and readily overlooked traumatic musculoskeletal disorders in clinical practice. In this condition, pressure increases in one of the body’s space-limited compartments, due to direct trauma or bone fracture, resulting in injury to all of the compartment’s contents, including muscle and nerve. Once full-blown ACS develops, the consequences are uniformly catastrophic, with permanent tissue destruction, sometimes necessitating amputation. If caught early, procedures can be used to save the limb. A non-invasive technology that can monitor for the development of the condition both in and out of the hospital and even with the patient’s having a cast in place could serve a critical purpose for ACS prevention. One approach that holds substantial potential for this purpose is electrical impedance myography (EIM). In EIM, a weak electrical current is applied to a muscle or group of muscle and the consequent surface voltages measured, providing an index of myofiber health. Previous studies of impedance techniques have demonstrated high sensitivity to tissue ischemia and injury, including intracellular edema and reductions in extracellular space. Thus, we hypothesize that the application of EIM to muscle could serve as a sensitive method for assessing the onset of ACS. Myolex Inc, a Boston-based small business, has as its main interest the design and development of EIM technology for broad medical use. The company in conjunction with Beth Israel Deaconess Medical Center has studied the specific application of EIM technology for the assessment of ACS in a well-established rat model of this disorder. Data collected and analyses completed previously have demonstrated the sensitivity of EIM to the development of ACS. In this Phase 2 SBIR, we plan to extend the success of our early investigations by developing a self-contained, wireless, battery-powered, wearable ACS detector that can even work on a casted limb that we have called the Myolex® mAlertTM. In Specific Aim 1, building upon an already functioning early prototype, we will create a system, that can be placed on a person at risk for ACS to assess the development of the condition. The system will be wireless and small such that it can be applied prior to cast placement and be easily removable once the period of concern has passed. We will test basic functionality in a small group of healthy subjects. In Specific Aim 2, we will apply this system in a porcine model of ACS while simultaneously measuring tissue perfusion pressures and also preforming measurement on the contralateral limb. We anticipate showing the mAlert’s sensitivity to progressing muscle injury and to its improvement after fasciotomy. At the conclusion of this work, Myolex will be well-positioned to test the device in human subjects at risk for developing ACS and achieve ultimate FDA approval.

项目摘要 急性筋膜室综合征（ACS）仍然是最具破坏性和容易被忽视的 临床实践中的创伤性肌肉骨骼疾病。在这种情况下，压力增加，在一个身体的 由于直接创伤或骨折导致的空间有限的隔室，导致所有隔室的损伤 内容物，包括肌肉和神经。一旦ACS全面发展，其后果是一致的 灾难性的，永久性的组织破坏，有时需要截肢。如果及早发现， 手术可以用来保存肢体。一种非侵入性的技术，可以监测的发展， 医院内外的情况，甚至病人的石膏都可以起到关键的作用。 预防ACS的目的。一种具有实现这一目的的巨大潜力的方法是电 阻抗肌描记术（EIM）。在EIM中，弱电流被施加到肌肉或肌肉组， 随后测量表面电压，提供肌纤维健康指数。以往的研究 阻抗技术已经显示出对组织缺血和损伤的高灵敏度，包括细胞内的 水肿和细胞外空间减少。因此，我们假设EIM在肌肉中的应用可以 作为评估ACS发作的敏感方法。Myolex Inc是一家总部位于波士顿的小企业， 作为其主要兴趣的EIM技术的设计和开发，广泛的医疗用途。本公司 与贝斯以色列女执事医疗中心合作，研究了EIM技术的具体应用 用于在一个完善的ACS大鼠模型中评估这种疾病。收集的数据和分析 先前完成的研究已经证明了EIM对ACS发展的敏感性。在此阶段2 SBIR，我们计划通过开发一个独立的， 无线的，电池供电的，可穿戴的ACS探测器，甚至可以在我们的假肢上工作， 称为Myolex® mAlertTM。在具体目标1中，基于已经运行的早期原型，我们将 创建一个系统，可以放置在一个人在ACS的风险，以评估病情的发展。 该系统将是无线的和小型的，使得它可以在铸件放置之前应用，并且可以容易地被植入。 一旦关注期过去，就可以删除。我们将在一小群健康的人中测试基本功能。 科目在具体目标2中，我们将在猪ACS模型中应用该系统，同时 测量组织灌注压并且还在对侧肢体上执行测量。我们 预期显示mAlert对进行性肌肉损伤及其在筋膜切开术后的改善的敏感性。 在这项工作结束时，Myolex将能够在有以下风险的人类受试者中测试该器械： 开发ACS并最终获得FDA批准。