Wireless, Batteryless Intracranial Sensors

ISSYS wireless medical products are being developed to monitor intracranial pressure due to clinical significance and market potential. One of the most important of intracranial applications is the monitoring of shunt pressure for the long-term management of hydrocephalus.

Hydrocephalus refers to an imbalance between the production and absorption of cerebrospinal fluid within the ventricular system of the brain. Affecting 1 in 1000 babies as well as adult-onset patients, or nearly 1.3 million patients in the U.S. alone, hydrocephalus is treated for the patient’s lifetime. Treatment usually is accomplished with a shunting system that diverts the flow of CSF from a site within the central nervous system (CNS) to another area of the body where it can be absorbed as part of the circulatory process.

Unfortunately, shunts are far from fail-safe; a full 40% of VP shunts fail within the first year of placement, and 5% fail per year after the first year. On average, hydrocephalus sufferers need to have their shunts surgically replaced every six years, with some needing replacements far more frequently. Shunts can overdrain and/or become clogged, causing discomfort, injury, or even death to a patient if not corrected. Currently, the only methods for evaluating intracranial pressure (ICP) are MRI or CT scans, which are costly, time-consuming, and not readily accessible on short notice. Furthermore, symptoms of shunt malfunction often include general moodiness and/or headaches; however, it is not practical to schedule an MRI every time such nonspecific symptoms appear.

By detecting blockage, overdrainage, and normal shunt pressures, ISSYS’ shunt monitor will minimize misdiagnoses and unnecessary replacement surgeries; reduce the number of neurologist visits, CAT scans and MRIs to diagnose shunt malfunction; and alleviate the uncertainty and emotional distress associated with shunt function. Based on conservative estimates, this technology has the potential to save nearly $1.3 billion per year in testing for the U.S. economy alone. In addition, this technology should be readily adaptable to the monitoring of intracranial pressure resulting from head trauma, thus addressing another clinical need for long-term, minimally invasive monitoring.

ISSYS Solution

ISSYS wireless pressure technology will provide safe, continuous intracranial pressure measurements, and supports the trend towards home health monitoring and improved in-patient diagnostic care, with the potential to revolutionize the way hydrocephalic and brain trauma patients are treated. The pressure monitoring system consists of two major parts: an implantable, batteryless, telemetric sensor and a companion hand-held reader. The miniature implantable micro-device contains a MEMS (MicroElectroMechanical System) pressure transducer along with custom electronics and a telemetry antenna. Using magnetic telemetry, the reader transmits power to the sensor and the sensed pressure is in turn transmitted back to the reader. Data collected by the sensor will be used by physicians to monitor brain pressure. For long-term hydrocephalous patients, data collection can be performed at the doctor's office or at home by the patient and submitted over the telephone or net.

There is a clear unmet need for shunt function testing that monitors the performance of the shunts that drain CSF. To address this need, ISSYS has developed a tiny, battery-less, wireless, implantable ICP monitor that can detect blockages, over drainage, and normal pressures using a hand-held readout unit. ISSYS's technology will alert patients, parents and practitioners to potential shunt failure, mitigating the uncertainty of present systems, reducing the risk of damage due to delays from misdiagnoses, and reducing the need for expensive testing procedures. A conventional shunt system that has been augmented with the proposed sensor can be implanted by a neurosurgeon using standard surgical procedures. At home, patients or parents can then check the CSF pressure as often as desired with a small, handheld testing unit. Readout units could give a simple pass/fail indication or be equipped with a digital display and complete data-logging capability for extended monitoring. In summary, the shunt monitor will:
  • Facilitate timely recognition of shunt failure
  • Eliminate uncertainty regarding shunt function, permitting more accurate diagnoses
  • Permit home monitoring, eliminating costly physician visits, CAT scans and MRIs
  • Lower overall treatment costs while improving disease management
ISSYS implantable sensors contribution to the field of intracranial will be tremendous since these wireless, batteryless, miniature implants can monitor pressure in a continuous, real-time, realiable fashion.

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