SBIR-STTR Award

The broader/commercial impact of this SBIR Phase I project outlines a development plan for a wireless, wearable sensor for noninvasive measurements in shunts in patients with hydrocephalus. Hydrocephalus is a common and costly condition caused by the accumulation of cerebrospinal fluid in the ventricles of the brain. It affects >1 million people in the US and is nearly always treated with the surgical implantation of a shunt to drain this excess fluid away from the brain. Unfortunately, shunts have extremely high failure rates (98% over ten years) and diagnosing shunt malfunction is confounded by its vague, nonspecific symptoms such as headaches and nausea. Additionally, there exists no direct way to measure flow through shunts. The proposed project would save the US healthcare system >$200 million annually in diagnostic costs and unnecessary hospital admissions. Moreover, it could be used to monitor shunt function at home, providing patients and their caregivers peace of mind. The materials science and mechanical engineering advances required to advance the project will fundamentally advance the development of wearable electronics for digital health.The proposed project relies on a set of concepts in materials science, mechanical engineering and fundamental studies of thermal transport phenomena to yield a soft, wireless, wearable device the thermal characterization of skin and soft tissue. Specifically, the integration of controlled, low-power thermal actuators and precise temperature sensors on a flexible circuit on the surface of the skin allows for the mapping of temperature and direction heat flow through near-surface epidermal layers. The flow of heat can be quantitatively correlated to both the presence and magnitude of underlying flow in a range of biological conduits, ranging from shunts to blood vessels. Moreover, the soft, silicone construction of the device presents a nonirritating, compliant interface to the surface of the skin. Quantitative measurements of thermal transport, in comparison to benchtop models and calculations will yield real-time flow rates, while a customized software application on a smartphone, communicating with a Bluetooth system-on-chip located on the device will collect store and analyze data in real-time, proving real-time feedback to physicians, patients and their caregivers.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.

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.