SBIR Phase II: Smart Shunt to Treat Hydrocephalus

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力是开发一种先进的机电脑脊液（CSF）分流系统，用于治疗和监测脑积水。脑积水是由脑脊液在大脑内积聚引起的，通常会引起颅骨内压力增加。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，这不仅会导致患者预后较差，还会导致医疗费用增加，通常高达数十亿美元。开发一种更合适地引流脑脊液并监测功能的智能分流器可能会降低分流失败率和诊断不确定性，从而降低医疗成本并改善患者预后。这个小型企业创新研究（SBIR）二期项目推进了脑脊液引流智能分流器的开发。电子控制可以改善分流引流的缺点，因为目前使用的阀门容易受到重力、海拔、活动水平和腹压波动的影响。所提出的多系统技术旨在(1)测量颅间压（ICP），以确定何时分流需要引流；(2)准确智能地感知瞬时压力峰值与持续升高的ICP之间的差异，并做出适当的反应（例如，分别保持闭合与引流脑脊液）。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，并无创地调整阀门设置。在该二期项目中，将进行最终的开发测试，验证系统性能和安全性，并分析医生和患者的可用性。该奖项反映了美国国家科学基金会的法定使命，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 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.