SBIR Phase II: Smart Shunt to Treat Hydrocephalus

这一小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是开发用于治疗和监测脑积水的先进机电脑脊液（CSF）分流系统。脑积水是由脑内发生的CSF积聚引起的，通常会导致颅骨内的压力增加。大多数用于消除这种压力的分流器在放置后几年内就会失效，通常具有显著的诊断不确定性，这导致患者结局较差，并且通常数十亿美元的医疗费用更高。智能分流器的开发，更适当地引流CSF和监测功能，可以降低分流器故障率和诊断的不确定性，从而降低医疗成本和改善患者的结局。这个小企业创新研究（SBIR）第二阶段项目推进了智能分流器的开发，用于CSF引流。基于电子的控制可以改善分流引流的缺点，因为目前使用的阀容易受到重力、海拔、活动水平和腹压波动的影响。所提出的多系统技术被设计为（1）测量颅内压（ICP），以确定何时需要引流分流，以及（2）准确且智能地感知瞬时压力峰值与持续升高的ICP之间的差异，并适当地做出响应（例如，分别保持关闭与引流CSF）。新技术将进一步允许患者和医生互动，以获得按需ICP读数，监测CSF动态，并无创调整阀门设置。在这个第二阶段的项目中，将进行最终的开发测试，系统的性能和安全性将得到验证，医生和患者的可用性将得到分析。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of an advanced electromechanical cerebrospinal fluid (CSF) shunt system for the treatment and monitoring of hydrocephalus. Hydrocephalus is caused by an accumulation of CSF occurs within the brain, often causing an increased pressure inside the skull. Most shunts used to remove this pressure fail within a few years of placement, often with significant diagnostic uncertainty, which leads to both poorer patient outcomes and higher, often multi-billion dollar healthcare costs. The development of a smart shunt that more appropriately drains CSF and monitors function may reduce shunt failure rates and diagnostic uncertainty, thus reducing healthcare costs and improving patient outcomes.This Small Business Innovation Research (SBIR) Phase II project advances the development of a smart shunt for CSF drainage. Electronic-based control may improve shortcomings in shunt drainage as the currently used valves are vulnerable to gravity, altitude, activity level, and abdominal pressure fluctuations. The proposed multi-system technology is designed to (1) measure intercranial pressure (ICP) to determine when shunts require drainage, and (2) accurately and intelligently perceives the difference between transient pressure spikes vs. sustained, elevated ICP and respond appropriately (e.g., remain closed vs. drain CSF, respectively). The new technology will further allow patient and physician interaction to obtain on-demand ICP readings, monitor CSF dynamics, and non-invasively adjust valve settings. In this Phase II project, final development testing will be conducted, system performance and safety will be verified, and physician and patient usability will be analyzed.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.