Wireless Intracranial Pressure Monitoring System

颅内压监测是创伤性脑损伤（TBI）、蛛网膜下腔出血、颅内血肿等急性事件以及脑积水、良性颅内高压等慢性疾病的神经外科护理中极其重要的组成部分。目前的有线ICP监测系统包括外科手术，通过皮肤和头骨引入颅内探头，而外部端连接到监视器。该系统的好处被严重的、可能危及生命的经皮脑感染的重大风险所抵消，特别是当ICP记录时间延长时。它需要限制行动，对儿童和老年患者尤其困难；两组通常需要长期ICP监测。在过去的12年里，我们在帝国理工学院开发了一种革命性的可穿戴/无线传感技术，得到了卫生与社会保障部和威康信托基金500万英镑的研究资金支持。我们的ICP监测解决方案消除了经皮感染的风险，因为它得益于无线植入式传感器，可以通过可穿戴读取器进行查询。这种可植入的传感器由高度稳定的晶体石英和其他生物相容性材料制成，这些材料已在植入物中使用多年。该传感器配备了一个薄天线，具有最小的复杂性风险，并在欧洲，美国，中国和大多数国家的免许可证频段工作。这些技术的独特组合允许一个小型植入物、读取器和外部天线。该阅读器重量轻（120g），由电池供电，一次充电可连续监测12小时的ICP。它配备了蓝牙和GSM无线接口，用于向智能设备和医疗保健服务器传输数据。患者的实时数据可以无缝地传输到云端，使临床医生可以全天候使用这些数据，并在出现异常压力时发出警报。与现有的有线系统相比，Reco的系统具有最小的感染风险，为患者在医院或家中提供了机动性/舒适性，并且可以为每位患者减少约6000英镑的医疗成本。Reco Medical于2020年获得InnovateUK 50万英镑的智能资助，用于构建QMS，在可扩展的环境中制造传感器，执行必要的体外和临床前测试，并在2022年准备好临床试验应用，随后在2023年进行临床试验，在2024年获得UKCA， CE和FDA批准，并在2025年进入市场，为患者和医疗保健系统带来好处。

Intracranial Pressure (ICP) monitoring is an extremely important part of neurosurgical care for both acute events such as traumatic brain injury (TBI), subarachnoid hemorrhage and intracerebral hematoma as well as chronic diseases such as hydrocephalus or benign intracranial hypertension. Current wired ICP monitoring systems involve a surgical procedure, introducing an intracranial probe through the skin and skull while the external end is connected to a monitor. The benefits of this system are offset by the significant risks of serious, potentially life-threatening, transcutaneous infection of the brain, particularly when the ICP recording is prolonged. It necessitates restricting mobility, particularly difficult for children and elderly patients; two groups commonly requiring prolonged ICP monitoring.We have developed, a revolutionary wearable/wireless sensing technology at Imperial College, over 12 years, supported by £5million research funding from the Department of Health and Social Care and Wellcome Trust. Our ICP monitoring solution eliminates the risk of transcutaneous infection, as it benefits from a wireless implantable sensor that can be interrogated by a wearable reader. The implantable sensor is made from highly stable crystal quartz and other biocompatible materials, used in implants for years. The sensor is equipped with a thin antenna with minimal risk of complication and works in a licence-free band available in Europe, USA, China and most countries. The unique combination of the technologies allows for a small implant, reader and external antenna. The reader is lightweight (120g), battery-powered and designed for 12 hours of continuous ICP monitoring on a single charge. It is equipped with Bluetooth and GSM wireless interfaces for data transmission to smart devices as well as healthcare servers. Patients' real-time data can be seamlessly streamed to the Cloud, making it available to clinicians 24/7 and raising alarm when abnormal pressure occurs. Reco's system has minimal infection risk, offers patient mobility/comfort in hospital or at home and can decrease healthcare costs by ~ £6000/patient compared with existing wired systems.Reco Medical was awarded InnovateUK £500K Smart grant in 2020 to build the QMS, fabricate sensors in a scalable setting, perform the necessary in vitro and pre-clinical tests, and be ready for clinical trial application by 2022, followed by a clinical trial in 2023, UKCA, CE and FDA approvals in 2024 and enter the market in 2025, to bring benefits to patients and healthcare systems.