SBIR Phase I: Multimodal Diagnostic Microsensors for Monitoring Catheter-based Therapies

This SBIR Phase I project focuses on the development of a smart hydrocephalus shunt system. Senseer's sensor technology is widely applicable to implantable and external catheters for many clinical indications; however, the company's first target application is hydrocephalus, a life-long, incurable disease characterized by a buildup of CSF in the brain's ventricles. It is treatable by chronically implanting a shunt to divert CSF from the brain into the abdominal cavity. Around 90,000 shunts are implanted in the US each year. However, these shunts fail or become obstructed at alarming rates (40% after 1st year of use), quickly leading to permanent brain damage and death without clinical intervention, i.e., shunt replacement. Diagnosing shunt failure is difficult and involves a prolonged assessment period with costly imaging studies and invasive shunt taps. Patients and doctors alike seek an accurate, reliable method for the timely detection of shunt failure. Senseer's MultiSense shunt system, integrated with the company's patented impedimetric sensor technologies, will allow remote, on-demand measurement of shunt status, therapeutic efficacy, and patient health. To surpass the limitations of existing implantable sensors, Senseer has patented impedimetric sensors, which are designed to interact directly with physiological fluid and be chronically implanted in the human body. A combination of sensors (pressure, flow, catheter patency, temperature, and cerebral blood flow waveform) will generate an unprecedented diagnostic data set for data analytics. This will significantly advance the scientific/medical understanding of hydrocephalus, which is limited today by the paucity of data on cerebrospinal fluid (CSF) hydrodynamics over time. Senseer's system would include several significant first-to-market capabilities, include chronic repeated measurement of cerebrospinal fluid dynamics and automated wireless transduction from multiple sensors to a cloud-based database for analyses and disseminations. Scientific milestones include development of an integrated multi-sensor array for up to five biometric measurements; wireless electronics for inductive power and signal transmission for interrogating implantable sensors; miniaturized packaging with implantable form factor; software for sensor calibration, data storage, and data analysis; and a benchtop hydrocephalus model for system validation. 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.