Our Wireless Intracranial Pressure Monitor (WIPM) is the world’s most accurate and longest operating miniature implant. WIPM is designed with one purpose – to monitor intracranial pressure in subdural and intraparenchymal locations.
Suitable for use in both pediatric and adult patients, it is designed for ease of insertion and removal. It can be used chronically with accurate and high fidelity continuous operation. WIPM is battery free and wire free. It is not affected by patient external artifact or patient height.
What is hydrocephalus? How is it currently treated?
Hydrocephalus refers to an imbalance between the production and absorption of cerebrospinal fluid (CFS) within the ventricular system of the brain.
Affecting 1 in 1000 neonates, as well as adult-onset patients (nearly 1.3 million in the U.S. alone) hydrocephalus is chronic condition requiring treatment for the patient’s lifetime. This is usually accomplished with a surgically implanted shunt; a small passage which diverts the flow of CSF from the central nervous system (CNS) to another area of the body, where it can be reabsorbed as part of the circulatory process.
Often times shunts are used. Unfortunately, shunts are far from fail-safe:
- Fully 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 over drain 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.
Symptoms of shunt malfunction often include general moodiness and/or headaches, and it is not practical to schedule an MRI every time such nonspecific symptoms appear.
WIPM technology improves treatments requiring shunts:
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
Solution: Wireless, Batteryless Intracranial Sensors
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, batteryless, wireless, implantable ICP monitor that can detect blockages, over drainage, and normal pressures using a hand-held readout unit.
ISSYS wireless pressure technology provides 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.
By detecting blockage, over drainage, 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
- alleviate the uncertainty and emotional distress associated with shunt function
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 (Micro-ElectroMechanical 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 can 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 Internet.
ISSYS’s technology will alert patients 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, CSF pressure can then be monitored 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.