I-Corps: Customer discovery for microsensor platforms in the management of hydrocephalus

该I-Corps项目的更广泛影响/商业化潜力涉及应用多传感器技术来改善对植入导管的患者的管理和治疗。导管堵塞和故障导致无效治疗，导致危及生命的症状。脑积水患者由于终生依赖植入导管而特别脆弱，并且由于植入失败率高（第1年为40%，十年内为80%）而遭受严重影响。目前有超过一百万的美国人患有脑积水，需要通过植入导管持续引流脑脊液。重复的成像研究和侵入性程序用于监测导管性能，但这些方法昂贵且不充分。MRI/CT成像可以在不到50%的病例中识别导管失效。即使与侵入性检查相结合，患者也经常被误诊并接受不必要的手术。对脑积水导管状态的无创监测可以消除昂贵的测试和不必要的手术，每年为美国医疗保健系统节省20亿美元，并大大提高患者的生活质量。心血管、泌尿和肾空间中的许多其他疾病也需要长期植入导管，并且将受益于无创导管监测。改进导管监测还将增加慢性疾病的科学知识，为研究和治疗开发提供重要工具。I-Corps项目探讨了可植入人体的多传感器导管的商业化潜力。市场上很少有传感器可以在人体内长时间工作。对于长期植入的导管，没有合适的传感器技术。该团队开发了一种基于微型电极的新传感器技术，该技术具有低轮廓，无需封装或保护以免受体内恶劣环境的影响。它们仅由惰性生物相容性材料制成，例如铂和Parylene C，这些材料长期以来一直用于FDA批准的医疗植入物。压力传感器通过监测微泡对压力变化的响应来操作。流量传感器使用微型加热器和电极来测量通过流动流体的热传递。传感器测量导管内外电极之间的电信号，以测量堵塞。这些传感器的临床测试目前正在进行中的儿童患者与外部脑室引流。这个奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用该基金会的智力价值和更广泛的影响审查标准。

The broader impact/commercialization potential of this I-Corps project involves the application of multi-sensor technologies to improve the management and treatment of patients with implanted catheters. Catheter blockage and failure results in ineffective treatment, leading to life-threatening symptoms. Hydrocephalus patients are particularly vulnerable due to their life-long dependence on implanted catheters and suffer significantly due to high implant failure rate (40% in year 1, 80% within a decade). Over one million Americans currently live with hydrocephalus, and require constant drainage of cerebrospinal fluid via implanted catheter. Repeated imaging studies and invasive procedures are used to monitor catheter performance, but these methods are expensive and inadequate. MRI/CT imaging can identify catheter failure in fewer than 50% of cases. Even when combined with invasive tests, patients are often misdiagnosed and undergo unnecessary surgery. Noninvasive monitoring of hydrocephalus catheter status could eliminate expensive tests and unnecessary operations, saving the US healthcare system $2 billion annually and immeasurably improve patient quality of life. Numerous other diseases in the cardiovascular, urinary, and renal spaces also require chronically implanted catheters and would benefit from noninvasive catheter monitoring. Improving catheter monitoring would also increase scientific knowledge of chronic diseases, providing an important tool for research and therapy development.This I-Corps project explores the commercialization potential for a multi-sensor catheter which can be implanted in the human body. Few sensors exist on the market that can operate for long periods in the human body. There are no suitable sensor technologies for chronically implanted catheters. This team developed a new sensor technology based on microscale electrodes that are low profile and eliminate the need for encapsulation or protection against the harsh environments found in vivo. They are made only of inert biocompatible materials, such as platinum and Parylene C, which have long been used in FDA approved medical implants. The pressure sensor operates by monitoring the response of a microbubble to changes in pressure. The flow sensor uses a microscopic heater and electrodes to measure heat transfer via flowing fluid. The sensor measures the electrical signal between electrodes inside and outside of a catheter to measure blockage. Clinical tests of these sensors are currently underway in pediatric patients with external ventricular drains.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.