SBIR Phase II: Development of a Noninvasive, Wireless Telemedicine Flow Sensor for Patients with Hydrocephalus

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in developing a set of technologies for the management and care of patients with hydrocephalus. Hydrocephalus is a common condition, affecting 1 million Americans, and over 1 in 1,000 live births. It is caused by the accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain, and nearly always treated with the surgical implantation of a tube, known as a shunt, to drain this excess CSF away from the brain and into a distal absorptive site within the body. Unfortunately, shunts have extremely high failure rates, approaching 100% over 10 years, and diagnosing shunt malfunction is extremely challenging owing to a combination of varied causes, nonspecific symptoms, and the absence of a technology to directly quantify shunt patency. Consequently, shunt-related procedures and admissions significantly burden patients, their caregivers and hospitals, costing the U.S healthcare system over $2 billion annually. Additionally, the inability to monitor patients at home, coupled with the potential for shunt failure and the uncertainty surrounding its diagnosis disrupts patients’ quality of life, and frequently results in unnecessary hospital admission and imaging. This project advances a wireless, wearable sensor that can noninvasively measure flow through shunts. This Small Business Innovation Research (SBIR) Phase II project will advance translation of a new sensor for shunts. The sensor is based on advances in soft, flexible electronics and relies on measurements of thermal transport to detect flow through underlying skin layers. When placed on skin overlying a shunt, the sensor will measure both the presence and magnitude of flow of CSF, and transmit these data wirelessly to a receiver, such as a smartphone or tablet, where it can be viewed through a software application with a graphical user interface (GUI). The project will be specifically aimed at developing the technology for home use and will include features that support long-term measurements, including a rechargeable battery, charging station and cloud data support. The ability to routinely monitor patients with hydrocephalus at home is currently unavailable, and if successful, our sensor will allow for a deeper understanding of CSF hydrodynamics. These data will be used to develop an algorithm to detect long-term trends, with a view to understanding, predicting, and ultimately preventing shunt failure. 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.