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

SBIR 第二阶段：为脑积水患者开发无创无线远程医疗流量传感器

• 批准号: 2037171
• 负责人: Anna Somera
• 金额: $ 97.86万
• 依托单位: RHAEOS, INC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2037171&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; Noninvasive

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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力在于开发一套用于管理和护理脑积水患者的技术。脑积水是一种常见的状况，影响了100万美国人，而有1000名活产的100万人。它是由脑脊液（CSF）在大脑心室中的积累引起的，几乎总是用管子的手术植入（称为分流器）进行治疗，以将这些多余的CSF排除在大脑中，并进入体内不吸收的部位。不幸的是，分流器的故障率极高，在10年内接近100％，并且诊断分流功能故障对各种原因，非特异性症状以及缺乏直接量化分流通路的技术的组合极为挑战。因此，与分流相关的程序和入院术大大烧毁了患者，他们的护理人员和医院，每年耗资超过20亿美元的医疗保健系统。此外，无法监测家里的患者，再加上分流故障的可能性以及围绕其诊断性的不确定性会破坏患者的生活质量，并且经常导致不必要的医院入院和成像。该项目推进了一个无线可穿戴的传感器，该传感器可以非侵入性地测量通过分流的流动。这项小型企业创新研究（SBIR）II期项目将推动转换新传感器的转换。该传感器基于柔软，柔性电子设备的进步，并依赖于测量热传输以检测通过下层皮肤层的流动。当放置在分流的皮肤上时，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，在其中可以通过具有图形用户界面（GUI）的软件应用程序查看。该项目将专门旨在开发用于家庭使用的技术，并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。目前无法使用常规监测脑积水患者的能力，如果成功的话，我们的传感器将使人们对CSF流体动力学有更深入的了解。这些数据将用于开发一种算法来检测长期趋势，以期理解，预测并最终防止分流失败。该奖项反映了NSF的法定任务，并被认为是通过基金会的智力优点和更广泛影响的评估来通过评估来获得的支持。