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

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是开发一套用于脑积水患者管理和护理的技术。脑积水是一种常见疾病，影响100万美国人，每1,000名活产婴儿中就有1人以上。它是由脑脊液（CSF）在脑室中的积聚引起的，并且几乎总是通过手术植入管（称为分流器）来治疗，以将多余的CSF从大脑中排出并进入体内的远端吸收部位。不幸的是，分流系统的故障率极高，10年内接近100%，由于各种原因、非特异性症状和缺乏直接量化分流通畅性的技术，诊断分流系统故障极具挑战性。因此，分流相关的程序和入院给患者、他们的护理人员和医院带来了沉重的负担，每年使美国医疗保健系统花费超过20亿美元。此外，无法在家监测患者，加上分流失败的可能性及其诊断的不确定性，扰乱了患者的生活质量，并经常导致不必要的住院和成像。该项目推进了一种无线的可穿戴传感器，可以无创地测量通过分流器的流量。这个小企业创新研究（SBIR）第二阶段项目将推进分流器的新传感器的翻译。该传感器基于柔软、灵活的电子产品的进步，并依赖于对热传输的测量来检测通过底层皮肤层的流量。当放置在覆盖分流器的皮肤上时，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，例如智能手机或平板电脑，在那里可以通过具有图形用户界面（GUI）的软件应用程序查看数据。该项目将专门针对开发家用技术，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。目前无法在家中常规监测脑积水患者，如果成功，我们的传感器将允许更深入地了解CSF流体动力学。这些数据将被用于开发一种算法，以检测长期趋势，以期了解，预测，并最终防止分流失败。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。

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.