The most common treatment for hydrocephalus is placement of a cerebrospinal fluid shunt to supplement or replace lost drainage capacity. Shunts are life-saving devices but are notorious for high failure rates, difficulty of diagnosing failure, and limited control options. Shunt designs have changed little since their introduction in 1950s, and the few changes introduced have had little to no impact on these long-standing problems. For decades, the community has envisioned a “smart shunt” that could provide advanced control, diagnostics, and communication based on implanted sensors, feedback control, and telemetry. The most emphasized contribution of smart shunts is the potential for advanced control algorithms, such as weaning from shunt dependency and personalized control. With sensor-based control comes the opportunity to provide data to the physician on patient condition and shunt function, perhaps even by a smart phone. An often ignored but highly valuable contribution would be designs that correct the high failure rates of existing shunts. Despite the long history and increasing development activity in the past decade, patients are yet to see a commercialized smart shunt. Most smart shunt development focuses on concepts or on isolated technical features, but successful smart shunt designs will be a balance between technical feasibility, economic viability, and acceptable regulatory risk. Here, we present the status of this effort and a framework for understanding the challenges and opportunities that will guide introduction of smart shunts into patient care.

OBJECTIVE The surgical placement of a shunt designed to resolve the brain's impaired ability to drain excess CSF is one of the most common treatments for hydrocephalus. The use of a dynamic testing platform is an important part of shunt testing that can faithfully reproduce the physiological environment of the implanted shunts. METHODS A simulation-based framework that serves as a proof of concept for enabling the application of virtual intracranial pressure (ICP) and CSF models to a physical shunt-testing system was engineered. This was achieved by designing hardware and software that enabled the application of dynamic model-driven inlet and outlet pressures to a shunt and the subsequent measurement of the resulting drainage rate. RESULTS A set of common physiological scenarios was simulated, including oscillations in ICP due to respiratory and cardiac cycles, changes in baseline ICP due to changes in patient posture, and transient ICP spikes caused by activities such as exercise, coughing, sneezing, and the Valsalva maneuver. The behavior of the Strata valve under a few of these physiological conditions is also demonstrated. CONCLUSIONS Testing shunts with dynamic ICP and CSF simulations can facilitate the optimization of shunts to be more failure resistant and better suited to patient physiology.

No abstract