Wireless Intracranial Pressure Monitoring System

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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.