Between 1 and 2 in 1000 newborns in the U.S. are affected by congenital hydrocephalus, an excessive build-up of cerebrospinal fluid (CSF) inside the head. Hydrocephalus, if not treated, can cause permanent brain damage, blindness, and eventually death. There is currently no known cure, but fortunately it can be managed with surgical intervention. The most common management technique is the use of a pressure-driven shunt to drain CSF to another area of the body for absorption. However, usage of shunts is accompanied by a large complication rate. The most common complications of CSF shunts are infection and mechanical malfunction. Minimizing the time lapse between when failure occurs and when it is corrected is vital to the patient’s well-being.
The current method of determining shunt failure is inadequate because of its indirect approach which relies on assessing and quantifying patient symptoms. In other words, when the patient presents certain symptoms, shunt failure is anticipated. In the case of a shunted infant, when symptoms such as vomiting, irritability, and papilledema (swelling of the optic disk) are observed, positive predictive values of 80% or higher for shunt failure have been demonstrated. However, in the same prospective study, some 20% of such patients required shunt revisions without one of the particular symptoms. The difficulty in predicting shunt failure in infants is further compounded by challenges of communication with the infant. This reliance on symptoms can make it difficult to distinguish between effects of shunt failure and other, normal childhood growing pains like viral infections, ear infections, or teething. Upon suspected failure, the infant is typically subjected to a brain scan via computed tomography (CT) or magnetic resonance imaging (MRI). This is used to determine if the ventricles within the brain are enlarged due to excessive CSF. If abnormal ventricle size is observed, the patient typically undergoes a percutaneous procedure using a syringe to determine the general failure site. Subsequently, immediate surgery is performed. This failure detection technique is not only poor in terms of the time lapse between first symptoms and treatment, it is also expensive. This expense is especially unnecessary for patients that go through imaging and do not have a failure. Consequently, early and accurate knowledge of the shunt failure is important because it would guide the subsequent interventional procedure.
The Intracranial Pressure Sensor is a telemetric pressure sensor to wirelessly monitor intracranial pressure in vivo and detect the onset of shunt failure. This pressure sensor provides patients with a precise diagnosis with minimal discomfort and helps to determine how patients will react to a particular therapy.
APDC seed grant funding will be used to support final product design and assembly, and animal testing.