Enhancing Healthcare Delivery and Patient Outcomes: Noninvasive Wireless Sensors to Improve Ventricular Shunt Monitoring, Reduce Imaging, and Alleviate the Burden on Providers, Patients, and Families

ABSTRACT Hydrocephalus is a common and costly neurological condition caused by cerebrospinal fluid (CSF) buildup in the ventricles of the brain. It affects >1 million American and occurs in 1-5 of every 1,000 live births worldwide. While there is no cure for hydrocephalus, it is typically treated via the surgical implantation of a shunt, a pressure-regulated tube that drains excess CSF away from the ventricles to a distal absorptive site, most often the peritoneal cavity. Unfortunately, shunts are highly failure prone, with >50% of shunt recipients requiring surgical revision or replacement within a decade of implantation. Indeed, surgeries related to hydrocephalus are the most common neurosurgical procedures performed in children. More challenging, however, is the nature of shunt malfunctions: early symptoms are clinically non-specific and include headaches, nausea, and fatigue. As a result, accurately diagnosing shunt malfunction is difficult and regularly leads to unnecessary emergency department (ED) visits, frequent invasive testing, and a significant mental and physical burden for patients and their families. Moreover, long-term surveillance of implanted shunts currently requires routine imaging and creates a significant healthcare cost burden for patients and families. FlowSense, a flexible, wearable medical device, allows for a non-invasive, radiation-free, reliable, and fast assessment of CSF flow in under 10 minutes by utilizing the principle of thermal anisotropy. The flow information gathered by the device aims to be highly clinically useful as an aid to shunt malfunction diagnosis. The proposed work in this grant follows the successful completion of Phase I (Feasibility, Technical Development) and Phase II (Regulatory, Clinical Safety and Effectiveness) work. We aim to drive clinical adoption of FlowSense by improving device manufacturability and establishing clinical utility in both the ED and outpatient setting with the goal of improving clinical workflow, reducing unnecessary and time-consuming diagnostic testing, and decreasing the disease burden on patients and families.