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

SBIR第一阶段项目的重点是开发智能脑积水分流系统。Senseer的传感器技术广泛适用于许多临床适应症的植入式和外部导管;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，其特征是脑脊液在脑室中积聚。通过长期植入分流器将脑脊液从大脑转移到腹腔是可以治疗的。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效或阻塞（使用第一年后为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，分流置换术。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。患者和医生都在寻求一种准确、可靠的方法来及时检测分流失败。Senseer的MultiSense分流系统集成了该公司的阻抗传感器专利技术，可远程按需测量分流状态、治疗效果和患者健康。为了超越现有植入式传感器的局限性，Senseer拥有阻抗传感器专利，该传感器可直接与生理液体相互作用，并可长期植入人体。传感器（压力、流量、导管通畅性、温度和脑血流波形）的组合将为数据分析生成前所未有的诊断数据集。这将大大推进脑积水的科学/医学理解，这是有限的，今天的数据缺乏脑脊液（CSF）流体动力学随着时间的推移。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长期重复测量，以及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。科学上的里程碑包括开发了一个集成的多传感器阵列，用于多达五个生物特征测量;用于感应电源和信号传输的无线电子器件，用于询问植入式传感器;具有植入式形状因子的小型化包装;用于传感器校准、数据存储和数据分析的软件;该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识产权进行评估来支持。优点和更广泛的影响审查标准。

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.