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

SBIR一期项目的重点是开发一种智能脑积水分流系统。Senseer的传感器技术广泛应用于多种临床适应症的植入和外置导管；然而，该公司的第一个目标应用是脑积水，这是一种终身无法治愈的疾病，其特征是脑室中脑脊液的积聚。它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，这些分流管失效或阻塞的发生率惊人（使用一年后为40%），在没有临床干预的情况下，迅速导致永久性脑损伤和死亡，即更换分流管。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。患者和医生都在寻求一种准确、可靠的方法来及时发现分流失败。Senseer的MultiSense分流系统集成了该公司的阻抗传感器专利技术，将允许远程、按需测量分流状态、治疗效果和患者健康状况。为了超越现有植入式传感器的局限性，Senseer已经获得了阻抗传感器的专利，这种传感器被设计成直接与生理液体相互作用，并长期植入人体。传感器的组合（压力、流量、导管通畅、温度和脑血流波形）将为数据分析产生前所未有的诊断数据集。这将大大提高对脑积水的科学/医学认识，目前由于缺乏长期以来的脑脊液流体动力学数据，这方面的认识受到限制。Senseer的系统将包括几个重要的首次上市功能，包括脑脊液动力学的慢性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导，用于分析和传播。科学里程碑包括开发集成多传感器阵列，最多可进行五种生物测量；用于感应电源和询问可植入传感器的信号传输的无线电子器件；具有可植入外形因素的小型化封装；传感器校准、数据存储和数据分析软件；以及一个用于系统验证的台式脑积水模型。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。

This SBIR Phase I project focuses on the development of a smart hydrocephalus shunt system. Senseer's sensor technology is widely applicable to implantable and external catheters for many clinical indications; however, the company's first target application is hydrocephalus, a life-long, incurable disease characterized by a buildup of CSF in the brain's ventricles. It 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 or become obstructed at alarming rates (40% after 1st year of use), quickly leading to permanent brain damage and death without clinical intervention, i.e., shunt replacement. Diagnosing shunt failure is difficult and involves a prolonged assessment period with costly imaging studies and invasive shunt taps. Patients and doctors alike seek an accurate, reliable method for the timely detection of shunt failure. Senseer's MultiSense shunt system, integrated with the company's patented impedimetric sensor technologies, will allow remote, on-demand measurement of shunt status, therapeutic efficacy, and patient health.To surpass the limitations of existing implantable sensors, Senseer has patented impedimetric sensors, which are designed to interact directly with physiological fluid and be chronically implanted in the human body. A combination of sensors (pressure, flow, catheter patency, temperature, and cerebral blood flow waveform) will generate an unprecedented diagnostic data set for data analytics. This will significantly advance the scientific/medical understanding of hydrocephalus, which is limited today by the paucity of data on cerebrospinal fluid (CSF) hydrodynamics over time. Senseer's system would include several significant first-to-market capabilities, include chronic repeated measurement of cerebrospinal fluid dynamics and automated wireless transduction from multiple sensors to a cloud-based database for analyses and disseminations. Scientific milestones include development of an integrated multi-sensor array for up to five biometric measurements; wireless electronics for inductive power and signal transmission for interrogating implantable sensors; miniaturized packaging with implantable form factor; software for sensor calibration, data storage, and data analysis; and a benchtop hydrocephalus model for system validation.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.