SBIR Phase II: Smart Shunt to Treat Hydrocephalus

SBIR 第二阶段：治疗脑积水的智能分流器

• 批准号: 2322905
• 负责人: Tyler Wanke
• 金额: $ 100万
• 依托单位: MADISON SCIENTIFIC, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2322905&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Smart; Shunt

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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力是开发先进的机电脑脊液（CSF）分流系统，用于处理和监测脑积水。脑积水是由大脑内发生的CSF积累引起的，通常会导致头骨内部的压力增加。大多数用于消除这种压力的分流器在安置的几年内失败，通常会出现严重的诊断不确定性，这既导致患者的结果较差，并且较高，通常数十亿美元的医疗保健费用。更适当地排除CSF和监控功能的智能分流的发展可能会降低分流故障率和诊断不确定性，从而降低医疗保健成本并改善患者的结果。这II阶段II阶段项目促进CSF排水智能分流器的开发。基于电子的控制可能会改善分流引流的缺点，因为当前使用的阀容易受到重力，高度，活性水平和腹部压力波动的影响。拟议的多系统技术旨在（1）测量颅内压（ICP），以确定分流何时需要排水，并且（2）准确而智能地感知到瞬态压力尖峰与持续，升高的ICP之间的差异，并适当地响应（例如，分别保持封闭的与排水管CSF）。这项新技术将进一步允许患者和医师的互动获得按需ICP读数，监视CSF动力学和非侵入性调整阀门设置。在此II阶段项目中，将进行最终开发测试，将验证系统绩效和安全性，并将分析医师和患者的可用性。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子评估和更广泛的影响来通过评估来支持的。