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.

该SBIR I期项目的更广泛/商业影响概述了无线可穿戴传感器的开发计划，用于脑积水患者的分流器中无创测量。脑积水是由大脑心室中脑脊液的积累引起的常见且昂贵的状况。它影响了美国的100万人，几乎总是通过分流的手术植入来处理，以将这种多余的液体从大脑中排除。不幸的是，分流率具有极高的故障率（十年内为98％），并且诊断分流功能故障与其模糊，非特异性症状（如头痛和恶心）混淆。此外，没有直接的方法来测量通过分流的流动。拟议的项目将每年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医院入院。此外，它可用于监测家中的分流功能，使患者及其护理人员安心。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进可穿戴电子设备的可穿戴电子设备的开发。拟议的项目依赖于材料科学，机械工程和热运输现象的基本研究中的一系列概念，以产生柔软，无线，可磨损的设备，皮肤和软组织的热饰物。具体而言，在皮肤表面的柔性电路上的受控，低功率热执行器和精确温度传感器的整合使温度和方向热流穿过近地表表皮层。热量可以与一系列生物导管中的基础流的存在和幅度进行定量相关，从分流到血管。此外，该设备的柔软的硅酮结构为皮肤表面提供了不合格的，兼容的界面。与台式模型和计算相比，对热传输的定量测量将产生实时流速，而在智能手机上的定制软件应用程序与设备上的蓝牙系统进行沟通，将实时收集商店并分析数据，并通过对医师的奖励进行评估，并证明了实时的反馈。智力优点和更广泛的影响审查标准。