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

该I-Corps项目的更广泛影响/商业潜力是开发可重复使用的管理系统和一次性管路，可降低当前成本，同时通过减少患者不适、减少与脑室外和腰椎引流使用相关的医疗错误以及减少护理管理时间来提高护理标准。在美国，每年约有60，000例患者使用脑室外和腰椎引流系统，2021年的市场规模为10.4亿美元。研究小组对神经外科医生和ICU护士进行了发现访谈，证实了对可定制引流控制和提高管理效率的需求。脑室外引流管和腰椎引流管的术后管理主要由护理人员负责，包括每小时检查和患者改变体位时手动重新定位。传统脑室外引流的使用显著增加了护士的工作量，特别是因为他们必须确保密切监督，护士与患者的比例为1：2。为了提高最先进的技术水平，该技术需要连续的压力测量，补偿患者的运动，以最大限度地减少患者的不适和伤害，从过度或引流不足，提供更可定制的控制患者优化，并使用更便宜的一次性。这个I-Corps项目是基于外部脑脊液引流系统的开发，为神经外科医生提供可定制的引流控制，需要较少的护士干预，并使脑脊液引流对患者更安全。开发中的器械用于通过脑室外引流管从大脑中引流脑脊液，或通过腰椎引流管从脊柱中引流脑脊液，并辅助诊断和治疗颅内压升高。最先进的引流系统连接到由神经外科医生放置的现有脑室或腰椎导管，以引流脑脊液并使用医院现有的标准压力传感器测量压力。该技术的一次性管路连接到现有的脑和脊柱导管和压力传感器使用行业标准鲁尔锁。这项技术及其一次性部件从未被置于人体内。无菌一次性管路手动固定到该技术的控制器系统外部。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.