Wearable Lab-on-a-patch for non-invasive Alcohol Sensing in Sweat

 描述（由申请人提供）：Zansors是一家生物传感器公司，拥有多个研究和产品领域，以商业化基于证据的医疗保健解决方案。这项拟议的研究旨在通过提供一种可穿戴的实时酒精生物传感设备来实现对血液酒精浓度（BAC）的客观评估，该设备基于合作伙伴乔治华盛顿大学（GW）发明的可弯曲和可拉伸的贴片实验室平台。2010年，尽管开展了教育和宣传，但仍有1.12亿人自报在驾驶车辆时受到损害，120万人因在酒精或毒品影响下驾驶而被捕。负责任的成年人了解醉酒的风险，但仍然决定在不知道他们实际的BAC的情况下驾驶。市场上有售的产品，但价格可能在150美元以上。消费者通常可以访问在酒吧和餐馆随时可用并使用的智能手机，因此通过无线通信将离散传感设备连接到智能手机上的应用程序可以提供其BAC的实时通知。一个离散的，可弯曲的，可拉伸的实验室贴片，集成了电化学酒精传感器/电子芯片，微流体通道和可拉伸的电互连的混合体，提供对汗液中乙醇和代谢物的实时监测，将是第一种监测目标BAC的设备。原理证明 GW的数据显示在2013年1月的《自然科学报告》中，报告了一种小型化的贴片实验室技术，该技术通过液态金属互连将半导体/CMOS传感器和电子器件与柔性衬底（PDMS）上的微流体集成在一起。Zansors已获得GW技术（美国专利申请中的13/715，110）的许可，STTR赠款将有助于建立实时监测乙醇以筛选BAC水平的可行性。具体目标1：设计和制造一种可穿戴的无线芯片实验室贴片，用于测量腋下附近的汗液酒精含量。设计电化学燃料电池酒精传感器;设计和组装信号放大电路;完成微流控器件的设计和制作。具体目标二：调整和校准算法，以实时从汗液数据计算BAC，并开发一个移动的应用程序，以收集、处理、分析和存储来自设备的数据，并与远程医疗和数字健康云系统进行通信。具体目标3：进行一项有20名参与者的开放标签临床研究，以评估无线生物传感器的初步工程性能特征。

 DESCRIPTION (provided by applicant): Zansors is a biosensor company with several research and product areas to commercialize evidence-based healthcare solutions. This proposed research is aimed at achieving objective assessment of blood alcohol concentration (BAC) by offering a wearable real-time alcohol bio-sensing device based on a bendable and stretchable lab-on-a-patch platform invented by partner, George Washington University (GW). In 2010, despite education and awareness, 112 million individuals self-reported being impaired while driving their vehicle and 1.2 million individuals were arrested for driving under the influence of alcohol or narcotics. Responsible adults understand the risks of intoxication, but stil make the decision to drive while impaired, not knowing their actual BAC. Commercially available products are available, but can cost between >$150. Consumers typically have access to smartphones that are readily available and used at bars and restaurants so connecting a discrete sensing device through wireless communication to an application on a smartphone could deliver real-time notifications of their BAC. A discrete, bendable, stretchable lab-on-a-patch that integrates a hybrid of electrochemical alcohol sensors/electronics chip, microfluidic channels, and stretchable electrical interconnects that offer real-time monitoring of ethanol and metabolites in sweat will be a first-in-kind device that monitors objective BAC. Proof-of-principle data by GW was shown in Nature's Scientific Reports Jan. 2013 reporting a miniaturized lab-on-a-patch technology integrating semiconductor/CMOS sensors and electronics with microfluidics on a flexible substrate (PDMS) via liquid metal interconnects. Zansors has licensed the GW technology (US patent-pending 13/715,110) and a STTR grant will help establish feasibility for real-time monitoring of ethanol for BAC levels screening. Specific Aim 1: Design and fabricate a wearable, wireless lab- on-a-chip patch that measures sweat alcohol level near underarm. Design electrochemical fuel cell alcohol sensors; Design and assemble signal amplification electronics; and finish the microfluidic device design and fabrication. Specific Aim 2: Adapt and calibrate the algorithm to compute BAC from sweat data in real-time, and develop a mobile app to collect, process, analyze and store data from the device and communicate with a telemedicine and digital health cloud system. Specific Aim 3: Conduct an open-label clinical study with 20 participants to assess the preliminary engineering performance characteristics of the wireless biosensor.