This Phase I SBIR will develop ICPCheck, the first long term implantable, non-invasively readable intracranial pressure (ICP) monitor for hydrocephalus patients. This device will result in improved clinical management of hydrocephalus by providing a rapid and non-invasive method for detecting elevated ICP due to CSF shunt obstruction in symptomatic patients, and for monitoring and researching shunt function in asymptomatic patients. Hydrocephalus, a common condition in which CSF accumulates in the brain ventricles, is corrected by placing a VP shunt that drains excess CSF to the abdomen, maintaining ICP within normal levels. Shunts frequently malfunction, usually by obstruction, leading to a life-threatening elevation of intraventricular ICP. But the symptoms of shunt failure are unspecific - headache, nausea. Diagnosis of shunt malfunction is expensive and presents risks (exposure to radiation from CT scans, risk of infection from shunt taps and radionuclide testing) and regular, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over-drainage and for assessing the performance of specific shunt valves and siphon control devices). There are currently no non-invasive, non-radiologic technologies for detecting elevated intraventricular ICP caused by shunt malfunction. A long-term implantable intraventricular ICP monitor which can be placed during shunt surgery and which can be interrogated non-invasively thereafter would address this need - identifying malfunction where CT scan cannot (slit ventricles) and, in conjunction with the neurosurgeon's judgment, potentially ruling out malfunction and avoiding an unnecessary CT scan. The goal of this Phase I project is to develop a prototype device and to validate it in a bench model of ICP. The program will be a collaboration between NeuroDx Development (developer of ShuntCheck) and Millar Instruments (the premier cardiac and neurosurgical pressure transducer manufacturer) and is based upon two breakthrough innovations - a technology for long term drift control developed by Millar and a technology for recalibration developed by NeuroDx. Our Phase II goal will be to convert our proof-of-concept prototype into a MEMS device and to conduct full scale preclinical and clinical studies to assess the diagnostic accuracy and utility o the device in identifying elevated ICP due to shunt malfunction in hydrocephalus patients. The need for new diagnostic tools for managing hydrocephalus patients is highlighted by the NIH announcement "Advanced Tools and Technologies for Cerebrospinal Fluid Shunts" (PA-09-206), to which this application is responding. Our application directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitativey determine shunt function.
Public Health Relevance: This application addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by providing the first long term implantable, non- invasively readable intracranial pressure (intraventricular ICP) monitor for hydrocephalus patients. Obstruction of CSF shunts, a common complication in hydrocephalus, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. This device, which can be implanted during shunt surgery and which can be interrogated non-invasively thereafter, will help neurosurgeons detect elevated intraventricular ICP due to shunt malfunction and will provide a valuable research tool for understanding shunt function.
Public Health Relevance Statement: This application addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by providing the first long term implantable, non- invasively readable intracranial pressure (intraventricular ICP) monitor for hydrocephalus patients. Obstruction of CSF shunts, a common complication in hydrocephalus, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. This device, which can be implanted during shunt surgery and which can be interrogated non-invasively thereafter, will help neurosurgeons detect elevated intraventricular ICP due to shunt malfunction and will provide a valuable research tool for understanding shunt function.
NIH Spending Category: Assistive Technology; Bioengineering; Brain Disorders; Hydrocephalus; Injury (total) Accidents/Adverse Effects; Injury - Trauma - (Head and Spine); Neurosciences
Project Terms: Abbreviations; Abdomen; Address; Affect; Algorithms; American; Animal Model; Animals; base; Brain Death; Brain Injuries; Calibration; Cardiac; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Clinical; Clinical Management; Clinical Research; Collaborations; commercial application; Complex; Complication; Data; design; Development; Devices; Diagnosis; Diagnostic; diagnostic accuracy; Drainage procedure; Exposure to; Failure (biologic function); Family suidae; Financial compensation; Funding; Goals; Headache; Health Care Costs; Hospitals; human study; Hydrocephalus; Imaging Techniques; Implant; improved; Infection; innovation; instrument; International; Intracranial Hypertension; Intracranial Pressure; Intraventricular; Judgment; Life; Manufacturer Name; Marketing; Measurement; Medical Device; Membrane; Methods; miniaturize; Modeling; Monitor; Nausea; Neurosurgeon; Notification; novel diagnostics; Obstruction; Operative Surgical Procedures; Outpatients; Patient Monitoring; Patients; Performance; Phase; pre-clinical; preclinical study; pressure; Pressure Transducers; Procedures; programs; prototype; Radiation; Radioisotopes; rapid technique; Reading; Research; research study; response; Risk; sensor; Shunt Device; Side; Signal Transduction; Site; Small Business Innovation Research Grant; Speed (motion); Staging; Symptoms; System; Technology; Testing; Time; tool; United States National Institutes of Health; Work; X-Ray Computed Tomography
