I-Corps: Digital Device to Improve the Safety of Extraventricular and Lumbar Cerebral Spinal Fluid Drainage

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The broader impact/commercial potential of this I-Corps project is the development of a reusable management system and disposable tubing that may cut current costs while improving the standard of care by reducing patient discomfort, reducing medical errors associated with extraventricular and lumbar drain use, and reducing nursing management time. Extraventricular and lumbar drain systems are used in approximately 60,000 patients annually in the US with a market of $1.04B in 2021. The research team has performed discovery interviews with neurosurgeons and ICU nurses, which have validated the need for customizable drainage control and improved management efficiency. The postoperative management of extraventricular and lumbar drains is primarily a nursing responsibility, consisting of hourly checks and manual releveling whenever patients change position. The use of conventional extraventricular drains add significantly to a nurse’s workload, especially since they are mandated to ensure close supervision with a nurse-to-patient ratio of 1:2. To improve the state-of-the-art, this technology takes continuous pressure measurements, compensates for patient movement to minimize discomfort and harm to patients from over or underdrainage, provides far more customizable control for patient optimization, and uses a much less expensive disposable.This I-Corps project is based on the development of an external cerebrospinal fluid drainage system that provides customizable drainage control for neurosurgeons, requires less intervention by nurses, and makes cerebrospinal fluid drainage safer for patients. The device in development is used to drain cerebrospinal fluid from the brain via an extraventricular drain or from the spine via a lumbar drain, and to aid in the diagnosis and treatment of elevated intracranial pressure. State-of-the art drainage systems connect to an existing ventricular or lumbar catheter that has been placed by a neurosurgeon to drain cerebrospinal fluid and measure pressure using a hospital’s existing standard pressure transducer. This technology’s disposable tubing line connects to existing brain and spine catheters and pressure transducers using industry standard Luer locks. The technology and its disposable parts are never placed inside humans. The sterile disposable tubing is manually secured to the technology’s controller system externally. The closed drainage system is not disrupted, limiting infection risk to the patient.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.