SBIR Phase II: Multimodal Diagnostic Microsensors for Monitoring Catheter-based Therapies

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力将是改进植入式设备故障的检测和预测。第一个目标应用是脑积水，这是一种以脑室中脑脊液（CSF）积聚为特征的终身无法治愈的疾病。脑积水可以通过长期植入分流器将脑脊液从大脑转移到腹腔来治疗。在美国，每年大约植入9万个分流器。然而，这些分流器失败率惊人（使用一年内40%），首先导致非特异性症状，如头痛和视力模糊，然后在没有临床干预的情况下导致永久性脑损伤和死亡。诊断分流故障是困难的，需要花费昂贵的影像学检查和有创的分流抽头来进行长时间的评估。所提出的传感器模块可以与已经商业化的分流系统集成，并可能允许远程，按需测量分流状态，治疗效果和患者健康，最终改善临床结果，同时降低总体治疗成本。这项小型企业创新研究（SBIR）第二阶段项目将重点关注各种微传感器的集成，以生成用于数据分析的诊断数据集。该数据集将显著促进对脑积水的科学/医学理解，目前由于缺乏脑脊液动态数据而受到限制。该系统将具备多项率先进入市场的能力，包括CSF动态的长期重复测量，以及从多个传感器到基于云的数据库进行分析和传播的自动无线转导。智能分流系统将实现远程、按需监测分流状态，为医生提供及时诊断和预测分流故障所需的数据。家庭电子分流监测将使医生能够定量和主动地实时管理患者的疾病，从而提高他们的生活质量。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 will be to improve detection and enable prediction of implantable device failure. The first target application is hydrocephalus, a life-long, incurable disease characterized by a buildup of cerebrospinal fluid (CSF) in the brain’s ventricles. Hydrocephalus is treatable by chronically implanting a shunt to divert CSF from the brain into the abdominal cavity. Around 90,000 shunts are implanted in the US each year. However, these shunts fail at alarming rates (40% within the 1st year of use), leading first to nonspecific symptoms such as headaches and blurred vision and then to permanent brain damage and death without clinical intervention. Diagnosing shunt failure is difficult and involves a prolonged assessment period with costly imaging studies and invasive shunt taps. The proposed sensor module can be integrated with already-commercialized shunt systems and may allow remote, on-demand measurement of shunt status, therapeutic efficacy, and patient health, ultimately improving clinical outcomes while reducing overall treatment costs.This Small Business Innovation Research (SBIR) Phase II project will focus on the integration of various microsensors to generate a diagnostic data set for data analytics. This data set will significantly advance the scientific/medical understanding of hydrocephalus, which is limited today by the paucity of data on CSF dynamics over time. The system would include several first-to-market capabilities, including chronic repeated measurement of CSF dynamics and automated wireless transduction from multiple sensors to a cloud-based database for analyses and dissemination. The smart shunt system will enable remote, on-demand monitoring of shunt status, giving physicians the data necessary for timely diagnosis and prediction of shunt failure. At-home electronic shunt monitoring will allow physicians to quantitatively and proactively manage patients’ disease in real-time, and thereby improve their quality of life.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.