Wireless Intracranial Pressure Monitoring System

颅内压升高是由严重头部损伤和多种其他神经系统疾病引起的一种危险状况，可导致包括死亡在内的严重神经系统后果。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、可能危及生命的脑感染的重大风险所抵消，特别是当ICP记录时间延长时。它限制了行动，对儿童/老年患者尤其困难；两组通常需要长期ICP监测。我们在帝国理工学院开发了一种可穿戴/无线传感技术，在12年的时间里，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的支持。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。该读卡器重量轻（180克），由电池供电，一次充电可进行12小时连续ICP监测。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。在2020年InnovateUK Smart资助的支持下，Reco在可扩展的环境中制造传感器，根据ISO 13485建立质量管理体系，并成功完成了急性动物研究。该项目将通过设计冻结、临床前测试、FDA 510k申请和英国首次人体试验申请来推进该系统。Reco计划在2026年推出该产品，为患者和医疗保健系统带来好处。

Elevated intracranial pressure (ICP) is a dangerous condition caused by severe head injuries and multiple other neurological conditions that can lead to severe neurological outcomes, including death. ICP monitoring is an extremely important part of neurosurgical care for both acute events such as traumatic brain injury (TBI), subarachnoid haemorrhage and intracerebral haematoma 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, brain infection, particularly when the ICP recording is prolonged. It restricts mobility, particularly difficult for children/elderly patients; two groups commonly requiring prolonged ICP monitoring.We have developed, a wearable/wireless sensing technology at Imperial College, over 12-years, supported by £5million research-funding from the Department of Health and Social Care and the Wellcome Trust. Our ICP montitoring solution eleminates 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 (180g), battery-powered and designed for 12 hours 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. Patient's 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 cost by ~ £6000/patient compared with existing wired systems.With the support from InnovateUK Smart grant in 2020, Reco fabricated sensors in a scalable setting, built QMS according to ISO 13485 and successfully completed an acute animal study. The project will advance the system through the design freeze, pre-clinical tests, FDA 510k application and first-in-human trial application in UK. Reco is planning to launch the product in 2026 to bring benefits to patients and healthcare systems.