SBIR Phase II: Development of a Noninvasive, Wireless Telemedicine Flow Sensor for Patients with Hydrocephalus

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力在于开发一套脑积水患者管理和护理技术。脑积水是一种常见疾病，影响着100万美国人，每1000个活产儿中就有1个以上。它是由脑室中脑脊液（CSF）的积累引起的，并且几乎总是通过外科植入管（称为分流管）来治疗，将多余的脑脊液从大脑中排出并进入体内的远端吸收部位。不幸的是，分流器的故障率极高，在10年内接近100%，由于各种原因、非特异性症状以及缺乏直接量化分流器通畅的技术，诊断分流器故障极具挑战性。因此，分流相关的手术和住院给患者、护理人员和医院带来了沉重的负担，每年花费美国医疗保健系统超过20亿美元。此外，无法在家中监测患者，再加上分流管失效的可能性和诊断的不确定性，破坏了患者的生活质量，并经常导致不必要的住院和影像学检查。该项目提出了一种无线、可穿戴传感器，可以无创地测量分流器的流量。这个小企业创新研究（SBIR）二期项目将推进一种用于分流器的新型传感器的翻译。该传感器基于柔软、灵活的电子技术的进步，依靠热传输的测量来检测通过底层皮肤层的流量。当放置在分流器上的皮肤上时，传感器将测量CSF流量的存在和大小，并将这些数据无线传输到接收器，如智能手机或平板电脑，在那里可以通过带有图形用户界面（GUI）的软件应用程序查看。该项目将专门针对开发家庭使用的技术，并将包括支持长期测量的功能，包括可充电电池、充电站和云数据支持。目前在家中常规监测脑积水患者的能力是不可用的，如果成功，我们的传感器将允许更深入地了解脑脊液流体动力学。这些数据将用于开发一种算法来检测长期趋势，以理解、预测并最终防止分流故障。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 is in developing a set of technologies for the management and care of patients with hydrocephalus. Hydrocephalus is a common condition, affecting 1 million Americans, and over 1 in 1,000 live births. It is caused by the accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain, and nearly always treated with the surgical implantation of a tube, known as a shunt, to drain this excess CSF away from the brain and into a distal absorptive site within the body. Unfortunately, shunts have extremely high failure rates, approaching 100% over 10 years, and diagnosing shunt malfunction is extremely challenging owing to a combination of varied causes, nonspecific symptoms, and the absence of a technology to directly quantify shunt patency. Consequently, shunt-related procedures and admissions significantly burden patients, their caregivers and hospitals, costing the U.S healthcare system over $2 billion annually. Additionally, the inability to monitor patients at home, coupled with the potential for shunt failure and the uncertainty surrounding its diagnosis disrupts patients’ quality of life, and frequently results in unnecessary hospital admission and imaging. This project advances a wireless, wearable sensor that can noninvasively measure flow through shunts.This Small Business Innovation Research (SBIR) Phase II project will advance translation of a new sensor for shunts. The sensor is based on advances in soft, flexible electronics and relies on measurements of thermal transport to detect flow through underlying skin layers. When placed on skin overlying a shunt, the sensor will measure both the presence and magnitude of flow of CSF, and transmit these data wirelessly to a receiver, such as a smartphone or tablet, where it can be viewed through a software application with a graphical user interface (GUI). The project will be specifically aimed at developing the technology for home use and will include features that support long-term measurements, including a rechargeable battery, charging station and cloud data support. The ability to routinely monitor patients with hydrocephalus at home is currently unavailable, and if successful, our sensor will allow for a deeper understanding of CSF hydrodynamics. These data will be used to develop an algorithm to detect long-term trends, with a view to understanding, predicting, and ultimately preventing shunt failure.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.