Development of a Smart Shunt with ICP-feedback for the Treatment of Hydrocephalus

PROJECT SUMMARY Hydrocephalus is a devastating condition characterized by a buildup of cerebrospinal fluid (CSF) in the brain. The most utilized treatment for hydrocephalus is the CSF shunt in which a catheter diverts excess CSF from the ventricles of the brain through a one-way valve to an area in the body that can reabsorb the fluid (most commonly the peritoneal cavity). Despite technological advances in the 6 decades since the shunt was first introduced, nearly 40% of all shunts fail within one year of placement, and most fail within 3 years, requiring multiple revision surgeries per patient. This translates to recurring debilitating symptoms for the patient, unnecessary hospitalizations and surgery, and death, ultimately costing the healthcare system well over $2 billion annually. Although many shunts that exist on the market today have attempted to control for gravity and other variables researched, none of the current shunt systems works reliably enough to prevent shunt failure. We are developing a “smart shunt”, a comprehensive diagnostic and therapeutic shunt system that aims to maintain optimal ICP by monitoring and draining optimal amounts of CSF for each given patient, thus eliminating underdrainage/overdrainage, to eventually decrease the risk of shunt obstruction and long-term complications related to erratic drainage. The device is a multi-system technology composed of an ICP sensor, communication modules, and a valve. The sensor transmits instantaneous pressures inside the brain to a microcontroller, which transforms incoming pressures into a moving average. The moving average, in turn, excludes transient instantaneous ICP changes related to position (gravity) or activities of daily living (coughing, straining, etc.) When the average ICP exceeds a threshold, the microcontroller sends a signal to open the valve. As opposed to commercial valves, which open during any instance of elevated ICP (e.g., from a cough or sudden standing), our smart valve would open in a controlled fashion, eliminating erratic drainage. Our team has prototyped and shown proof-of-concept of each individual component of the shunt system. While some components need one more level of development to advance the readiness of the technology, a few key subsystems hold higher technical risk, which if overcome, would enable the integration and success of the overall shunt system to function safely and effectively. The completion of this device would mark the first-in-class “smart” shunt that effectively monitors ICP and appropriately drains CSF.