SBIR Phase II: Smart Shunt to Treat Hydrocephalus

Madison Scientific, Inc., Madison WI

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of an advanced electromechanical cerebrospinal fluid (CSF) shunt system for the treatment and monitoring of hydrocephalus. Hydrocephalus is caused by an accumulation of CSF occurs within the brain, often causing an increased pressure inside the skull. Most shunts used to remove this pressure fail within a few years of placement, often with significant diagnostic uncertainty, which leads to both poorer patient outcomes and higher, often multi-billion dollar healthcare costs. The development of a smart shunt that more appropriately drains CSF and monitors function may reduce shunt failure rates and diagnostic uncertainty, thus reducing healthcare costs and improving patient outcomes. This Small Business Innovation Research (SBIR) Phase II project advances the development of a smart shunt for CSF drainage. Electronic-based control may improve shortcomings in shunt drainage as the currently used valves are vulnerable to gravity, altitude, activity level, and abdominal pressure fluctuations. The proposed multi-system technology is designed to (1) measure intercranial pressure (ICP) to determine when shunts require drainage, and (2) accurately and intelligently perceives the difference between transient pressure spikes vs. sustained, elevated ICP and respond appropriately (e.g., remain closed vs. drain CSF, respectively). The new technology will further allow patient and physician interaction to obtain on-demand ICP readings, monitor CSF dynamics, and non-invasively adjust valve settings. In this Phase II project, final development testing will be conducted, system performance and safety will be verified, and physician and patient usability will be analyzed. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.