SBIR Phase I: Smart Shunt Valve to Treat Hydrocephalus

SBIR 第一阶段：治疗脑积水的智能分流阀

• 批准号: 2036695
• 负责人: Tyler Wanke
• 金额: $ 25.6万
• 依托单位: MADISON SCIENTIFIC, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2036695&HistoricalAwards=false
• 关键词: SBIR; Phase; Smart; Shunt; Valve

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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是开发智能脑脊液（CSF）分流系统，以改善脑积水的处理，称为“大脑上的水”。尽管是全球进行的最常见的小儿脑外科手术，但在第一年内，有40％的CSF分流器失败，几乎全部在10年内失败，导致患者的发病率增加以及不必要的修订手术。实际上，与分流有关的不利事件可以说是大多数儿科神经外科并发症。此外，多次住院和修订手术使全球医疗保健系统每年至少从间歇性急诊室入院，成像，并发症的护理以及与失败失败有关的其他因素中造成至少20亿美元。当前的解决方案不能说明个体的患者生理和不断变化的状况。拟议的解决方案将根据需要智能地感知颅内压（ICP）并排干CSF，从而提高患者护理和相关的医疗保健费用。这项小型企业创新研究（SBIR）I期项目旨在开发全面的分流诊断和治疗系统，该系统在集成的模块化系统中实时感知ICP并实时自定义排水。 ICP传感器将收集和通信实时压力信号与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，以进行物理/患者监测和控制。该项目的目标包括开发设备的电动（ICP +通信模块）和机械（阀系统）子系统，并证明集成分流系统的概念证明。为了证明可行性，该设备将使用人为的人脑心室平台进行测试，该平台开发为模仿心室生理学。该奖项反映了NSF的法定任务，并通过使用基金会的智力优点和更广泛的影响来评估NSF的法定任务。