Wearable Intracranial Pressure Monitoring Implant System

Elevated intracranial pressure (ICP) is a critical condition resulting from severe head injuries and various neurological disorders, potentially leading to serious outcomes, including death. Monitoring ICP is crucial in neurosurgical care for both acute events like traumatic brain injury (TBI), subarachnoid hemorrhage, and intracerebral hematoma, as well as chronic conditions such as hydrocephalus and benign intracranial hypertension. Current ICP monitoring systems typically involve a surgical procedure in which an intracranial probe is inserted through the skin and skull, connecting to an external monitor. While this method provides valuable data, it comes with significant risks, including a high chance of brain infection, especially during extended monitoring periods. Furthermore, the system's wired nature limits patient mobility, creating challenges, particularly for children and elderly patients who often require prolonged monitoring. In response to these limitations, we have developed a wireless ICP monitoring solution initially at Imperial College over 12 years, backed by £5 million in research funding from the Department of Health and Social Care and the Wellcome Trust. The research and development work, mainly supported by InnovateUK, have been taking place in Reco in the past 4 years. Our innovative system uses a wireless, implantable quartz sensor that is highly stable and can be read by a wearable reader, thereby eliminating the risk of transcutaneous infection. This advanced technology includes a compact implant, a reader, and an external antenna, designed for patient comfort and mobility. The light weight battery-powered reader can continuously monitor ICP for up to 12 hours on a single charge. It is equipped with Bluetooth, WiFi, and GSM interfaces, allowing seamless data transmission to smart devices and healthcare servers. Real-time data can be streamed to the Cloud, enabling clinicians to monitor patients 24/7 and receive immediate alerts in case of abnormal pressure levels. Our system not only minimizes infection risk and enhances patient comfort but also has the potential to reduce healthcare costs by approximately £6,000 per patient compared to existing wired systems. With support from InnovateUK through the BMC program, we have achieved ISO 13485 certification and continue to develop the ICP-Sense components in line with FDA510(k) Class II regulatory requirements to enter the U.S. market. This 18-month follow-up BMC project will enable us to adapt our system for the 865MHz band to target the European market, conduct essential pre-clinical testing, and lay the foundation for First-In-Human (FIH) trials and UKCA/CE approval, ultimately benefiting patients and healthcare systems.