SBIR-STTR Award

This Phase 1 SBIR will develop Continuous Real Time (CRT) ShuntCheck, the first portable, non- invasive device for real time, continuous monitoring of flow in CSF shunts. This device will result in improved clinical management of hydrocephalus by providing a rapid and non-invasive method for detecting 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. Shunts frequently malfunction, usually by obstruction, 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 radionuclide testing) and regular, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over drainage, for assessing the performance of specific shunt valves and siphon control devices and for streamlining the adjustment of programmable shunt valves). A new, non-invasive thermal dilution test for shunt flow, ShuntCheck, has reduced diagnostic specificity due to intermittent shunt flow - patent shunts do not flow continuously, leading to a high level of false positive readings. There are currently no non-invasive, non-radiologic technologies for assessing shunt function and malfunction. The goal of this Phase 1 project is to develop a prototype device which continuously monitors CSF flow via thermal dilution, and to verify it in a bench and validate it in an animal model of CSF flow. The program is based upon a breakthrough innovation in our thermal dilution technology which allows for long term, continuous CSF flow measurement (like a Holter test for CSF flow). Our Phase 2 goal will be to conduct a full scale clinical study to assess the diagnostic accuracy and utility of our non-invasive test in identifying shunt malfunction in hydrocephalus patients. An important additional outcome of this project will likely be a new tool for better understanding shunt and CSF flow behavior in hydrocephalus patients. Shunt malfunction and management testing constitute approximately 600,000 shunt flow tests annually in the United States alone. NeuroDx's business model for this product involves the generation of revenue primarily from the ongoing sale of single- use, disposable sensors for these tests. 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 proposal is responding. Our proposal directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function.

Public Health Relevance:
This proposal 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 portable, non-invasive device for continuous monitoring of flow in CSF shunts. 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 new tool will help neurosurgeons differentiate between intermittently flowing and obstructed shunts and will provide a valuable research tool for understanding shunt function.

Thesaurus Terms:
0-11 Years Old;Abbreviations;Abdomen;Abdominal;Accuracy Of Diagnosis;Acquired Brain Injury;Address;Affect;American;Animal Model;Animal Models And Related Studies;Behavior;Biological;Boston;Brain Dead;Brain Death;Brain Injuries;Brain Ventricle;Businesses;Cat Scan, X-Ray;Cat Scan;Csf Shunt;Ct X Ray;Ct Scan;Cephalalgia;Cephalgia;Cephalodynia;Cephalodynias;Cerebral Ventricles;Cerebrospinal Fluid;Cerebrospinal Fluid Shunts;Cerebrospinal Fluid Shunt (Csf) Procedure;Cerebrospinal Fluid Shunts Procedure;Child;Child Youth;Children (0-21);City Of Boston;Clinical;Clinical Management;Clinical Research;Clinical Study;Coma Depasse;Complex;Complication;Computed Tomography;Computerized Axial Tomography (Computerized Tomography);Computerized Tomography, X-Ray;Contracting Opportunities;Contracts;Cranial Pain;Data;Development;Device Or Instrument Development;Devices;Diagnosis;Diagnostic;Diagnostic Specificity;Drainage;Drainage Procedure;Emi Scan;Electronics;Exposure To;Flr;Failure (Biologic Function);Family Suidae;Generations;Goals;Hosp;Head Pain;Headache;Health Care Costs;Health Costs;Healthcare Costs;Holter Electrocardiography;Holtmon;Hospitals;Hour;Human;Human, Child;Human, General;Hydrocephalus;Hydrocephaly;Imaging Procedures;Imaging Techniques;Infection;Job Environment;Job Location;Job Place;Job Setting;Job Site;Legal Patent;Man (Taxonomy);Man, Modern;Manufacturer;Manufacturer Name;Marketing;Measurement;Medical Device;Methods;Modeling;Monitor;Monitoring, Holter;Nih;National Institutes Of Health;National Institutes Of Health (U.S.);Nausea;Neurosurgeon;Notification;Obstruction;Out-Patients;Outcome;Outpatients;Patents;Patient Monitoring;Patients;Performance;Phase;Pigs;Pilot Projects;Position;Positioning Attribute;Procedures;Programs (Pt);Programs [publication Type];Radiation;Radioactive Isotopes;Radioisotopes;Radionuclides;Reaction;Reading;Relative;Relative (Related Person);Research;Risk;Running;Sbir;Sbirs (R43/44);Sales;Science Of Neurosurgery;Series;Shunt;Shunt Device;Site;Skin;Small Business Innovation Research;Small Business Innovation Research Grant;Staging;Suidae;Swine;Symptoms;Technics, Imaging;Technology;Testing;Time;Tomodensitometry;Tomography, Xray Computed;United States;United States National Institutes Of Health;Work Location;Work Place;Work-Site;Workplace;Worksite;X-Ray Computed Tomography;Base;Brain Damage;Brain Injury;Brain Lesion (From Injury);Catscan;Cerebral Death;Children;Commercial Application;Computed Axial Tomography;Computerized Axial Tomography;Computerized Tomography;Design;Designing;Device Development;Diagnostic Accuracy;Experience;Failure;Improved;Innovate;Innovation;Innovative;Instrument Development;Model;Model Organism;Neurosurgery;New Diagnostics;Next Generation Diagnostics;Novel Diagnostics;Pilot Study;Porcine;Programs;Prototype;Rapid Method;Rapid Technique;Ray (Radiation);Sensor;Shunts;Spinal Fluid;Subcutaneous;Suid;Surgeon, Neuro-;Tool;Validation Studies;Work Environment;Work Setting;Work Site;Youngster

This Phase II SBIR will develop Continuous Real Time (CRT) ShuntCheck, the first portable, non- invasive device for real time, continuous monitoring of changes in flow in CSF shunts. This device will result in improved clinical management of hydrocephalus by providing a non-invasive method for monitoring and researching shunt function. 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. Shunts frequently malfunction, usually by obstruction, 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 radionuclide testing). Additionally, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over drainage, for assessing the performance of specific shunt valves and siphon control devices and for streamlining the adjustment of programmable shunt valves). NeuroDx's existing device, ShuntCheck-Micro-Pumper, is a shunt obstruction detector and addresses the need for a non-invasive test for shunt malfunction. While this makes it a valuable tool for the Emergency Dept, the short duration of the test limits its utility for shunt valve adjustment, investigating suspected shunt over drainage, etc. A non-invasive, non-radiologic device which can track changes in CSF flow rate would address many ongoing clinical management needs and become a valuable tool for the neurosurgery clinic. In our Phase I studies, we developed a laboratory prototype CRT based upon a breakthrough innovation in our thermal dilution technology and validated its safety and accuracy in bench and animal studies. CRT can reliably differentiate between no, low and robust shunt flow and can track changes in shunt flow rates over extended time periods. The goal of this Phase II project is to refine CRT ShuntCheck from a laboratory prototype to a production-ready device, validate its safety and accuracy in bench and animal testing, and complete a 510k submission for FDA clearance. Post-Phase II clinical studies will demonstrate the clinical utility and cost effectiveness of CRT ShuntCheck for streamlining valve adjustment in pediatric and in adult NPH patients. NeuroDx's business model for this product involves the generation of revenue primarily from the ongoing sale of single-use, disposable sensors for these tests. Shunt management testing constitutes approximately 105,000 shunt flow tests annually in the United States alone. 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 quantitatively determine shun function.

Public Health Relevance Statement:


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 portable, non-invasive device for continuous real time monitoring of changes in flow in CSF shunts. Ongoing clinical management of shunted patients is complex due to a lack of tools for investigating CSF over drainage, for assessing the performance of specific shunt valves and siphon control devices and for streamlining the adjustment of programmable shunt valves. This new device will address many ongoing clinical management needs and become a valuable tool for the neurosurgery clinic.

Project Terms:
Abbreviations; Abdomen; Address; Adult; Affect; American; Animal Model; Animal Testing; Animals; base; Brain Death; Brain Injuries; Businesses; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Childhood; Clinic; Clinical; Clinical Management; Clinical Research; Complex; Computers; Contracts; cost effectiveness; Data Security; design; detector; Device or Instrument Development; Devices; Diagnosis; Diagnostic; digital; Drainage procedure; Electronics; Emergency Situation; ergonomics; exhaust; experience; Exposure to; Failure (biologic function); Foundations; Generations; Goals; Headache; Health Care Costs; Heating; Holter Electrocardiography; Hospitals; Human; Hydrocephalus; improved; Infection; innovation; journal article; Laboratories; Link; Manufacturer Name; Marketing; Medical Device; meetings; Methods; Modeling; Monitor; Nausea; neurosurgery; Normal Pressure Hydrocephalus; novel diagnostics; Obstruction; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; phase 1 study; Procedures; Production; prototype; public health relevance; Pump; Radiation; Radioisotopes; Reporting; Research; Risk; Running; Safety; Sales; sensor; Shunt Device; Small Business Innovation Research Grant; Symptoms; System; Tablets; Technology; Testing; Time; tool; United States; United States National Institutes of Health; user friendly software; Wireless Technology; Work; X-Ray Computed Tomography