SBIR Phase I: Smart Shunt Valve to Treat Hydrocephalus

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是开发一种智能脑脊液(CSF)分流系统，以改善被称为“脑上的水”的脑积水的治疗。尽管是世界上最常见的儿科脑外科手术，但40%的脑脊液分流术在第一年内失败，几乎所有手术都在10年内失败，导致患者发病率增加，以及不必要的翻修手术。事实上，与分流相关的不良事件可以说是儿科神经外科并发症的主要原因。此外，由于间歇性的急诊室入院、成像、并发症的护理以及与失败的分流相关的其他因素，多次住院和翻修手术每年给全球医疗系统造成至少20亿美元的损失。目前的解决方案没有考虑到个别患者的生理和不断变化的情况。建议的解决方案将智能地感知颅内压(ICP)并根据需要排出脑脊液，从而改善患者护理和相关的医疗成本。这个小型企业创新研究(SBIR)第一阶段项目旨在开发一种全面的分流诊断和治疗系统，该系统能够在集成的模块化系统中实时感知颅内压并定制引流。电感耦合等离子体传感器将采集实时压力信号，并将其传递给可以控制阀门的处理微控制器。该系统将与外部接收器进行通信，以进行医生/患者的监测和控制。该项目的目标包括开发该装置的电气(ICP+通信模块)和机械(阀门系统)子系统，并演示综合分流系统的概念验证。为了证明可行性，该设备将使用人造人类脑室平台进行测试，该平台是为模拟脑室生理学而开发的。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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 Small Business Innovation Research (SBIR) Phase I project is to develop a smart cerebrospinal fluid (CSF) shunt system to improve the treatment of hydrocephalus, called “water on the brain”. Despite being the most common pediatric brain surgery performed worldwide, 40% of CSF shunts fail within the first year and nearly all fail within 10 years, leading to increased patient morbidity as well as unnecessary revision surgeries. In fact, adverse events related to shunts arguably account for the majority of pediatric neurosurgical complications. Further, multiple hospitalization and revision surgeries cost the global healthcare system at least $2 billion annually from intermittent emergency room admissions, imaging, care of complications, and other factors associated with failed shunts. The current solutions do not account for individual patient physiology and changing conditions. The proposed solution will intelligently sense intracranial pressure (ICP) and drain CSF as needed, improving patient care and associated health care costs. This Small Business Innovation Research (SBIR) Phase I project aims to develop a comprehensive shunt diagnostic and therapeutic system that senses ICP and customizes drainage in real time in an integrated modular system. An ICP sensor will collect and communicate real-time pressure signals to a processing microcontroller that can control a valve. The system will communicate with external receivers for physician/patient monitoring and control. The objectives of this project include developing the electrical (ICP + communication modules) and mechanical (valve systems) sub-systems of the device and demonstrating proof-of-concept of an integrated shunt system. To demonstrate feasibility, the device will undergo testing using an artificial human brain ventricle platform, developed to mimic ventricular physiology.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.