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，将循证医疗解决方案商业化。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，该设备基于乔治华盛顿大学(GW)合作伙伴发明的可弯曲和可伸缩的面片上实验室平台。2010年，尽管进行了教育和提高了认识，但仍有1.12亿人自称在驾驶汽车时受到损害，120万人因酒后驾车或吸毒被捕。负责任的成年人知道醉酒的风险，但仍然决定在受伤的情况下开车，而不知道他们实际的BAC。市面上也有可买到的产品，但价格在150美元之间。消费者通常可以使用随时可以在酒吧和餐馆使用的智能手机，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发送他们的BAC的实时通知。一种离散的、可弯曲的、可伸展的贴片实验室，集成了电化学酒精传感器/电子芯片、微流体通道和可伸展的电气互连的混合体，可实时监测乙醇和汗液中的代谢物，将是首个监测目标BAC的设备。原则证明 GW的数据显示在《自然》杂志2013年1月的《科学报告》中，报告了一种通过液态金属互连在柔性基板(PDMS)上集成半导体/CMOS传感器和电子与微流体的微型实验室技术。Zansors已经获得了GW技术的许可(正在申请美国专利13/715,110)，STTR的授予将有助于建立用于BAC水平筛选的乙醇实时监测的可行性。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，可以测量腋下附近的汗液酒精水平。设计了电化学燃料电池酒精传感器；设计和组装了信号放大电子器件；完成了微流控器件的设计和制造。具体目标2：适配和校准算法，根据汗液数据实时计算BAC，并开发移动应用程序来收集、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：与20名参与者进行开放标签临床研究，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.