SBIR Phase II: Smart Shunt to Treat Hydrocephalus

这个小型企业创新研究(SBIR)第二阶段项目的更广泛影响/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。脑积水是由脑内积聚的脑脊液引起的，通常会导致颅骨内压力增加。大多数用于消除这种压力的分流器在放置后几年内失败，通常具有显著的诊断不确定性，这既导致患者预后较差，又导致更高的医疗成本，通常是数十亿美元。开发一种更适合引流脑脊液和监测功能的智能分流装置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。这项小型企业创新研究(SBIR)第二阶段项目推动了用于脑脊液引流的智能分流装置的开发。由于目前使用的瓣膜容易受到重力、海拔、活动水平和腹部压力波动的影响，基于电子的控制可能会改善分流引流方面的缺点。拟议的多系统技术旨在(1)测量颅间压(ICP)以确定分流管何时需要引流，以及(2)准确和智能地感知瞬时压力峰值与持续升高的颅内压之间的差异，并做出适当的反应(例如，分别保持关闭和引流脑脊液)。这项新技术将进一步允许患者和医生进行互动，以获得按需的颅内压读数，监测脑脊液动力学，并非侵入性地调整瓣膜设置。在这个第二阶段的项目中，将进行最终开发测试，将验证系统性能和安全性，并将分析医生和患者的可用性。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 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.