SBIR Phase I: Smart Shunt Valve to Treat Hydrocephalus

Madison Scientific, Inc., Madison WI

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a smart cerebrospinal fluid (CSF) shunt system to improve the treatment of hydrocephalus, called “water on the brain”. Despite being the most common pediatric brain surgery performed worldwide, 40% of CSF shunts fail within the first year and nearly all fail within 10 years, leading to increased patient morbidity as well as unnecessary revision surgeries. In fact, adverse events related to shunts arguably account for the majority of pediatric neurosurgical complications. Further, multiple hospitalization and revision surgeries cost the global healthcare system at least $2 billion annually from intermittent emergency room admissions, imaging, care of complications, and other factors associated with failed shunts. The current solutions do not account for individual patient physiology and changing conditions. The proposed solution will intelligently sense intracranial pressure (ICP) and drain CSF as needed, improving patient care and associated health care costs. This Small Business Innovation Research (SBIR) Phase I project aims to develop a comprehensive shunt diagnostic and therapeutic system that senses ICP and customizes drainage in real time in an integrated modular system. An ICP sensor will collect and communicate real-time pressure signals to a processing microcontroller that can control a valve. The system will communicate with external receivers for physician/patient monitoring and control. The objectives of this project include developing the electrical (ICP + communication modules) and mechanical (valve systems) sub-systems of the device and demonstrating proof-of-concept of an integrated shunt system. To demonstrate feasibility, the device will undergo testing using an artificial human brain ventricle platform, developed to mimic ventricular physiology. 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.