SBIR-STTR Award

Each year, there are over 10,000 newborns diagnosed with hydrocephalus in the United States. Hydrocephalus, an excessive accumulation of cerebrospinal fluid (CSF) within the head, is a lifelong disease with no known cure. Fortunately, hydrocephalus can be managed with CSF shunts. Shunts redirect excessive CSF to another part of the body for absorption into the circulatory system. Unfortunately, 30-40% of shunts fail in the first year. Mechanical malfunctions are the most common cause of failure and can lead to recurrent complications of hydrocephalus. Therefore, to reduce the risk of sustaining permanent brain damage or blindness, rapid diagnosis of shunt failure is critically important. The current protocol for detecting shunt failure and its location is time-consuming and expensive since it relies on symptom diagnosis, brain scans, and percutaneous shunt tapping. Consequently, our ultimate objective is to develop an ambulatory system that can rapidly detect shunt failure and its location without brain scans and invasive procedures, thereby reducing patient risk and healthcare costs. To accomplish this, we propose the use of a distributed network of micro-miniature, wireless, battery-less pressure sensors which are strategically placed in the shunt and ventricular space. The Specific Aims for the Phase I feasibility study will be to develop the pressure sensor and to establish in vivo biocompatibility of the sensor materials. A Phase II project would involve in vivo implementation of the pressure sensors for monitoring of shunt functionality. The completion of the combined Phase I and Phase II project would give hydrocephalus sufferers and their families a sense of security by providing them with an ambulatory system that can rapidly detect shunt failures, thereby practically eliminating the risks of sustaining permanent brain damage, blindness, or even death

Each year, there are over 10,000 newborns diagnosed with hydrocephalus in the United States. Hydrocephalus, an excessive accumulation of cerebrospinal fluid (CSF) within the head, is a lifelong disease with no known cure. Fortunately, hydrocephalus can be managed with CSF shunts which redirect excessive CSF elsewhere in the body. Unfortunately, 30-40% of shunts fail in the first year and blockages are the most common cause. Therefore, to reduce the risk of sustaining permanent brain damage or blindness, rapid diagnosis of shunt failure is critically important. The current protocol for detecting shunt failure is time-consuming and expensive since it relies on symptom diagnosis, brain scans, and percutaneous shunt tapping. Consequently, our ultimate objective is to develop an ambulatory system that can rapidly detect shunt failure without brain scans and invasive procedures, thereby improving patient outcomes and reducing healthcare costs. To accomplish this, shunts will be mounted with micro-miniature pressure sensors that are implantable, communicate outside the body wirelessly, and require no batteries. The sensors are strategically placed in the shunt using innovative packaging techniques, thus requiring no additional invasive surgical procedures for implantation. Wireless communications are performed through a low-power (microwatt) mutual inductive coupling between a handheld reader and the sensor. Building upon the successful Phase I feasibility project, the Specific Aims of the proposed Phase II project are to: (1) Optimize the wireless pressure sensor and readout electronics for in vivo ambulatory use. Sensor enhancements will be implemented and verified through modeling, microfabrication, and performance characterization. (2) Establish biocompatibility of sensor materials. All constituent sensor and packaging materials will be examined for biocompatibility using an in vivo, statistically significant animal study. (3) Demonstrate accurate intracranial pressure (ICP) measurements and detection of shunt failure. Wireless sensors will be acutely and chronically tested against standard, commercially-available, wired ICP probes using an in vivo canine model. For demonstration of shunt failure detection, wireless sensors will be examined in both an in vitro setup and an in vivo canine model for 12 months. Successful completion of the Phase II project would provide a clear pathway for Phase III commercialization. The ultimate product implementation will give hydrocephalus sufferers and their families a sense of security by providing them with an ambulatory system that can rapidly detect current shunt failures and predict future ones.

Public Health Relevance:
Each year in the U.S., there are over 10,000 newborns diagnosed with hydrocephalus ("water on the brain"), a lifelong disease with no known cure that can fortunately be treated with a shunt that redirects fluid in the brain to another location within the human body. The shunt, consisting of two catheters and a pressure regulated valve, however, are prone to malfunction, putting the hydrocephalic patient at risk of sustaining permanent brain injury. The ultimate goal of the proposed SBIR project is to apply novel technologies to develop a system which can monitor shunt functionality, resulting in better patient outcomes and lower healthcare costs.

Public Health Relevance Statement:
PROJECT NARRATIVE Each year in the U.S., there are over 10,000 newborns diagnosed with hydrocephalus ("water on the brain"), a lifelong disease with no known cure that can fortunately be treated with a shunt that redirects fluid in the brain to another location within the human body. The shunt, consisting of two catheters and a pressure regulated valve, however, are prone to malfunction, putting the hydrocephalic patient at risk of sustaining permanent brain injury. The ultimate goal of the proposed SBIR project is to apply novel technologies to develop a system which can monitor shunt functionality, resulting in better patient outcomes and lower healthcare costs.

Project Terms:
0-11 years old; 0-6 weeks old; Absorption; Acquired brain injury; Acute; Animal Model; Animal Models and Related Studies; Animals; Blindness; Body part; Brain; Brain Injuries; Brain imaging; Brain scan; CSF shunt; Canine Species; Canis familiaris; Cardiovascular; Cardiovascular Body System; Cardiovascular system; Cardiovascular system (all sites); Catheters; Cerebrospinal Fluid; Cerebrospinal Fluid Shunts; Cerebrospinal fluid shunt (CSF) procedure; Cerebrospinal fluid shunts procedure; Child; Child Youth; Children (0-21); Chronic; Common Rat Strains; Communication; Coupling; Detection; Diagnosis; Diagnostic Method; Diagnostic Procedure; Diagnostic Technique; Disease; Disorder; Dogs; Electronics; Encephalon; Encephalons; FLR; Failure (biologic function); Family; Figs; Figs - dietary; Future; Goals; Head; Health Care Costs; Health Costs; Healthcare Costs; Human Figure; Human body; Human, Child; Hydrocephalus; Hydrocephaly; Hydrogen Oxide; In Vitro; Infant, Newborn; Intracranial Pressure; Knowledge; Lead; Liquid substance; Location; Mammals, Dogs; Mammals, Rats; Measurement; Measures; Mechanics; Methods and Techniques; Methods, Other; Microfabrication; Modeling; Monitor; Needles; Nervous System, Brain; Neurosurgeon; Newborn Infant; Newborns; Operation; Operative Procedures; Operative Surgical Procedures; Organ System, Cardiovascular; Outcome; Palpation; Pathway interactions; Patients; Pb element; Performance; Phase; Pilot Projects; Pressure; Pressure- physical agent; Procedures; Process of absorption; Protocol; Protocols documentation; Rat; Rattus; Reader; Recurrence; Recurrent; Risk; SBIR; SBIRS (R43/44); Scanning; Security; Shunt; Shunt Device; Small Business Innovation Research; Small Business Innovation Research Grant; Subarachnoid Pressure; Surgical; Surgical Interventions; Surgical Procedure; Symptoms; System; System, LOINC Axis 4; Techniques; Technology; Testing; Time; United States; Vascular, Heart; Water; Wireless Technology; absorption; base; biocompatibility; biomaterial compatibility; brain damage; brain lesion (from injury); brain visualization; canine; children; circulatory system; commercialization; cost; design; designing; disease/disorder; domestic dog; experience; failure; fluid; heavy metal Pb; heavy metal lead; implantation; improved; in vivo; innovate; innovation; innovative; liquid; model organism; new technology; newborn human (0-6 weeks); packaging material; pathway; pilot study; pressure; public health relevance; rapid diagnosis; sensor; shunts; spinal fluid; success; surgeon, neuro-; surgery; wireless; youngster