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

项目摘要 急性间隔室综合征(ACS)仍然是最具破坏性和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，身体的一个部位的压力会增加 空间有限的车厢，由于直接创伤或骨折，导致所有车厢的 内容物，包括肌肉和神经。一旦发展成熟的急性冠脉综合征，后果是一致的 灾难性的，具有永久性的组织破坏，有时需要截肢。如果及早被发现， 手术可以用来保全肢体。一种非侵入性技术，可以监测心脏疾病的发展 医院内外的情况，甚至患者的石膏已经到位，都可能是危重的 预防急性冠脉综合征的目的。一种具有很大潜力的方法是电气方法。 阻抗肌图(EIM)。在EIM中，弱电流被施加到一块或一组肌肉上，并 随后测量的表面电压，提供了肌纤维健康的指数。以前的研究 阻抗技术对组织缺血和损伤，包括细胞内的损伤表现出高度的敏感性。 水肿和细胞外间隙减少。因此，我们假设EIM在肌肉中的应用可能 可作为评估急性冠脉综合征发病的敏感方法。总部位于波士顿的小企业Myolex Inc. 其主要兴趣是设计和开发用于广泛医疗用途的EIM技术。该公司在 联合贝丝以色列女执事医疗中心研究了EIM技术的具体应用 用于在这种疾病的成熟大鼠模型中评估急性冠脉综合征。收集和分析的数据 之前完成的研究表明了EIM对ACS发展的敏感性。在此阶段2中 SBIR，我们计划通过开发一种独立的、 无线、电池供电、可穿戴的ACS探测器，甚至可以在我们现有的铸型肢体上工作 名为Myolex®mAlertTM。在具体目标1中，我们将在已经起作用的早期原型的基础上， 创建一个系统，该系统可以放在有风险的人身上，让ACS评估病情的发展。 该系统将是无线的和小的，以便它可以在演员安置之前应用，并且很容易 一旦关注期过去，就可以移除。我们将在一个健康的小团体中测试基本功能 研究对象。在特定的目标2中，我们将该系统应用于猪的急性冠脉综合征模型，同时 测量组织灌注压，并在对侧肢体上进行测量。我们 预计将显示mAlert对进行性肌肉损伤和筋膜切开后的改善的敏感性。 在这项工作结束时，Myolex将处于有利地位，可以在有风险的人类受试者身上测试该设备 开发ACS并获得FDA的最终批准。

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.