Smart EVD System “External Ventricular Drain”
An EVD or external ventricular drain, is a device used in neurosurgery to relieve intracranial pressure (ICP) resulting from a disturbance in cerebrospinal fluid (CSF) drainage due to tumors, cysts, bleeding, infection, hydrocephalus, and trauma. Existing EVD’s are manually assembled so as to insure appropriate drainage and ICP. Unfortunately, these systems are labor intensive and require full time monitoring by the medical staff.
Using today’s electronic devices and sensors, we have designed an EVD that can provide a completely autonomous solution while providing accuracy and repeatability.
The Problem
An external ventricular drain (EVD) is a device used in neurosurgery to relieve intracranial pressure (ICP) resulting from a disturbance in cerebrospinal fluid (CSF) drainage due to tumors, cysts, bleeding, infection, hydrocephalus, and trauma. Current EVD’s consist of a catheter inserted into the ventricle, a collection bag and tubing manually leveled with the ventricle in such a way, as to produce the desired ICP through a hydrostatic column. EVD position with respect to the patient must be closely monitored to avoid over-drainage and underdrainage of the CSF. Over-drainage can result in irreversible damage to the brain in a matter of a few seconds. It can result in a collapse of the brain away from the inner surface of the skull, with the risk of bleeding.
The Solution
Our solution enables real-time monitoring of the CSF flow and ICP patterns in external ventricular drains using an ultra-sensitive flow sensor. The flow-sensor along with a motion detector (accelerometer) and pressure sensors will be used to create the first-generation of a “smart” EVD drain, where data from the first 24-hrs of EVD use will be used as a baseline for subsequent monitoring and generation of automatic alarms due to patient motion or suspected over-drainage. The system is not a completely autonomous EVD system. It will however enable the necessary baseline data for the development of such a solution with a commercial partner.
The Opportunity
The global intracranial hemorrhage market has experienced substantial growth in recent years. According to research analysis, the intracranial hemorrhage market was valued at over $1.59B USD in 2021 and is expected to continue growing at a CAGR of about 6.5% until 2030.
Status
The ultra-sensitive external flow sensor for CSF has a resolution of 0.4 ml/hr in the 0-40 mL/hr flow rate and an accuracy of 2 mL/ 24-hr period. It utilizes Near-Field Charging (NFC) and readout circuitry, enabling wireless operation. The design separates the flow channel from the electronics, so that single-use sterilized inserts can be used with the electronics.
Additionally, the device contains a temperature sensor used for cancellation of thermal drift and to report the actual temperature of the CSF. The response to a nominal flow rate of 20 mL/hr shows excellent repeatability and rapid response. A user-friendly package has been developed and is operated by a single push button.
Meet the Team
Eniko Enikov PhD
Center for Biomedical Informatics & Biostatistics
Steven Wood MS, MBA
Tech Launch Arizona