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: 10490448
• 负责人: David P. Dickinson
• 金额: $ 98万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10490448
• 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; 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; wireless

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.

项目概要 急性筋膜室综合征 (ACS) 仍然是最具破坏性且容易被忽视的疾病之一 临床实践中的创伤性肌肉骨骼疾病在这种情况下，身体某一部位的压力会增加。 空间有限的隔间，由于直接外伤或骨折，导致隔间所有部位受伤 一旦发生全面的 ACS，后果将是一致的。 灾难性的，会造成永久性组织破坏，如果及早发现，有时需要截肢 可以使用一种非侵入性技术来挽救肢体，该技术可以监测肢体的发育情况。 无论是在医院内还是在医院外，即使患者已打好石膏，情况也可能会危及生命 预防 ACS 的一种具有巨大潜力的方法是电气方法。 阻抗肌电图 (EIM) 在 EIM 中，将弱电流施加到肌肉或肌肉群上。 随后测量的表面电压，提供了肌纤维健康状况的指数。 阻抗技术已证明对组织缺血和损伤（包括细胞内损伤）具有高度敏感性 因此，我们发现将 EIM 应用于肌肉可以。 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。 该公司的主要兴趣是设计和开发用于广泛医疗用途的 EIM 技术。 联合贝斯以色列女执事医疗中心研究了EIM技术的具体应用 用于在完善的大鼠模型中评估 ACS 的数据收集和分析。 先前完成的研究已经证明了 EIM 对 ACS 发展的敏感性。第二阶段。 SBIR，我们计划通过开发一个独立的、 无线、电池供电、可穿戴 ACS 探测器，甚至可以在我们拥有的铸造肢体上工作 在特定目标 1 中，我们将在已经运行的早期原型的基础上，将其称为 Myolex® mAlertTM。 创建一个系统，可以放置在有 ACS 风险的人身上，以评估病情的发展。 该系统将是无线的且体积小，因此可以在石膏放置之前应用并轻松安装 一旦过了关注期，我们将在一小群健康人中测试基本功能。 在具体目标 2 中，我们将同时将该系统应用于 ACS 猪模型。 测量组织灌注压并对对侧肢体进行测量。 预计显示 mAert 对进展性肌肉损伤及其在筋膜切开术后改善的敏感性。 这项工作结束后，Myolex 将能够在有以下风险的人类受试者中测试该设备： 开发 ACS 并获得 FDA 最终批准。