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

SBIR 第二阶段：用于监测导管治疗的多模式诊断微传感器

• 批准号: 2151744
• 负责人: Sascha Lee
• 金额: $ 99.91万
• 依托单位: SENSEER HEALTH INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2151744&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Multimodal; Diagnostic

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.

该小型企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力将是改善可植入器械故障的检测并实现预测。第一个目标应用是脑积水，这是一种终生无法治愈的疾病，其特征是脑室内脑脊液（CSF）积聚。脑积水可以通过长期植入分流器将CSF从大脑转移到腹腔来治疗。美国每年大约有9万个分流器被植入。然而，这些分流器以惊人的速度失败（在使用的第一年内为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。诊断分流失败是困难的，涉及到昂贵的成像研究和侵入性分流抽头延长的评估期。所提出的传感器模块可以与已经商业化的分流系统集成，并可以允许远程，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，同时降低整体治疗成本。这个小企业创新研究（SBIR）第二阶段项目将集中在各种微传感器的集成，以生成用于数据分析的诊断数据集。该数据集将显著推进对脑积水的科学/医学理解，目前由于缺乏随时间推移的CSF动力学数据而受到限制。该系统将包括几个首次上市的功能，包括CSF动态的长期重复测量和从多个传感器到基于云的数据库的自动无线转换，以进行分析和传播。智能分流系统将能够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实时定量和主动管理患者的疾病，从而提高他们的生活质量。该奖项反映了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。