SBIR Phase I: Hardware and Software Development for Noninvasive, Wireless Flow Sensors for Patients with Hydrocephalus

SBIR 第一阶段：脑积水患者无创无线流量传感器的硬件和软件开发

• 批准号: 1938472
• 负责人: Anna Somera
• 金额: $ 22.5万
• 依托单位: RHAEOS, INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938472&HistoricalAwards=false
• 关键词: SBIR; Phase; Hardware; Software; Development

The broader/commercial impact of this SBIR Phase I project outlines a development plan for a wireless, wearable sensor for noninvasive measurements in shunts in patients with hydrocephalus. Hydrocephalus is a common and costly condition caused by the accumulation of cerebrospinal fluid in the ventricles of the brain. It affects 1 million people in the US and is nearly always treated with the surgical implantation of a shunt to drain this excess fluid away from the brain. Unfortunately, shunts have extremely high failure rates (98% over ten years) and diagnosing shunt malfunction is confounded by its vague, nonspecific symptoms such as headaches and nausea. Additionally, there exists no direct way to measure flow through shunts. The proposed project would save the US healthcare system $200 million annually in diagnostic costs and unnecessary hospital admissions. Moreover, it could be used to monitor shunt function at home, providing patients and their caregivers peace of mind. The materials science and mechanical engineering advances required to advance the project will fundamentally advance the development of wearable electronics for digital health.The proposed project relies on a set of concepts in materials science, mechanical engineering and fundamental studies of thermal transport phenomena to yield a soft, wireless, wearable device the thermal characterization of skin and soft tissue. Specifically, the integration of controlled, low-power thermal actuators and precise temperature sensors on a flexible circuit on the surface of the skin allows for the mapping of temperature and direction heat flow through near-surface epidermal layers. The flow of heat can be quantitatively correlated to both the presence and magnitude of underlying flow in a range of biological conduits, ranging from shunts to blood vessels. Moreover, the soft, silicone construction of the device presents a nonirritating, compliant interface to the surface of the skin. Quantitative measurements of thermal transport, in comparison to benchtop models and calculations will yield real-time flow rates, while a customized software application on a smartphone, communicating with a Bluetooth system-on-chip located on the device will collect store and analyze data in real-time, proving real-time feedback to physicians, patients and their caregivers.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.

SBIR一期项目的广泛/商业影响概述了一种无线、可穿戴传感器的开发计划，用于脑积水患者分流术的无创测量。脑积水是脑脊液在脑室积聚引起的一种常见且昂贵的疾病。在美国，它影响着100万人，几乎总是通过手术植入分流器来将多余的液体从大脑中排出。不幸的是，分流有极高的故障率（超过十年98%），并且诊断分流故障被其模糊的、非特异性的症状（如头痛和恶心）所混淆。此外，没有直接的方法来测量通过分流的流量。拟议中的项目每年将为美国医疗保健系统节省2亿美元的诊断费用和不必要的住院费用。此外，它还可以用于监测家中的分流功能，为患者和他们的护理人员提供安心。推进该项目所需的材料科学和机械工程进步将从根本上推动数字健康可穿戴电子产品的发展。拟议的项目依赖于材料科学、机械工程和热传输现象基础研究中的一系列概念，以产生一种柔软、无线、可穿戴的皮肤和软组织热表征设备。具体来说，在皮肤表面的柔性电路上集成了可控的低功耗热致动器和精确的温度传感器，可以绘制通过近表面表皮层的温度和方向热流。热流可以定量地与一系列生物导管（从分流管到血管）中潜在流的存在和大小相关联。此外，该装置的柔软硅胶结构呈现出与皮肤表面无刺激性、柔顺的界面。与台式模型和计算相比，热传输的定量测量将产生实时流量，而智能手机上的定制软件应用程序与设备上的蓝牙芯片系统通信，将实时收集、存储和分析数据，向医生、患者及其护理人员提供实时反馈。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。