Cerebrospinal Fluid Monitor and Control System for Hydrocephalus

Period of Performance: 09/01/2011 - 08/31/2012


Phase 1 SBIR

Recipient Firm

Systems Science, Inc.
Oak Park, IL 60302
Principal Investigator


DESCRIPTION (provided by applicant): In patients suffering from hydrocephalus, cerebrospinal fluid volume accumulates abnormally in the brain. Hydrocephalus affects one in 1,000 births, or 70,000 patients a year. The most common method of treatment consists of implanting a shunt with a passive differential pressure valve to drain the excess fluid. The failure rate of this treatment is 50% for pediatric patients. On average, $1.4 billion is spent by hospitals on shunt related pediatric hydrocephalus care. Shunts often require revisions due to an inadequate pressure setting. Improper settings may lead to over- or under-drainage of the brain ventricles, which can lead to death if untreated. Another reason for shunt failure is due to obstruction, which blocks the diversion of fluid. These shortcomings call for a completely differ approach to treating this disease. The electrical properties of cerebrospinal fluid differ substantially from brain tissue. This large conductivity contrast can be exploited to measure ventricular size in-vivo based on the impedance technique. Systems Science Inc. will capitalize on existing intellectual property on a ventricular volume sensor developed by the investigators at UIC to develop a novel medical device by integrating the sensor with a digital controller and micro-pump. The feedback implementation will lead to better treatment options for hydrocephalus by overcoming shortcomings of passive shunts. The objective of aim 1 is to develop and test the catheter system consisting of multiple electrodes on bench-top models. We will assess the positional dependence of the sensor and explore active monitoring of shunt coagulation. The biocompatibility will be assessed by in-vitro and in-vivo analysis. In aim 2, we will develop a display as well as micro-pump integration. The monitor and control system will be tested on bench- top models. The systems performance will be validated in hydrocephalic animal models. The outcome of this phase-1 study is an acute system for short-term hospital use. For phase-2, Systems Science Inc. plans to develop an implantable device for novel clinical diversions for chronic patients. The vision of this project is to develop an active closed loop feedback system. PUBLIC HEALTH RELEVANCE: Hydrocephalus is a brain disease currently treated by diverting excess cerebrospinal fluid by an implanted differential pressure valve. These shunts frequently require surgical revisions, resulting in $1 billion per year in national healthcare costs. The idea of this translational project is to manufacture a ventricular volume monitor and feedback control system for patients with hydrocephalus. Systems Science Inc. will initially develop a bedside unit for acute patients. In phase-2, an implantable system for chronic treatment in patients will be developed.