Wearable Device to Monitor Blood Alcohol Levels in Real Time

 描述(申请人提供)：酒精滥用与广泛的经济成本以及大量的伤害和死亡有关。据估计，2013年有1660万18岁及以上的成年人患有酒精使用障碍(其中只有一人是酒精中毒)，总计约246亿美元的医疗费用。此外，每年有近8.8万人死于与酒精有关的原因。酒精滥用是15-49岁人群过早死亡的头号主要风险因素，也是总体死亡的第五大主要风险因素。酗酒的高发生率(2013年18岁或以上的人中有24.6%)表明了潜在的问题。有鉴于此，有助于防止过度饮酒的工具在减少与酒精滥用相关的巨大人类和社会经济代价方面发挥了重要作用。负责任地亲自跟踪血液酒精浓度(BAC)水平的能力可以显著减少与酒精有关的伤害和死亡。此外，在定期监测和报告BAC方面，患者的依从性是酒精中毒治疗的主要关注和需要之一。目前，测量BAC最准确的方法是直接、有创地采集血液并进行检测，因此不利于广泛应用。呼气酒精浓度(BRAC)的非侵入性测量很流行，但很明显，其准确性值得怀疑(与真实BAC相差±50%)。有几种非侵入性的可穿戴设备可以测量经皮酒精浓度(TAC)。然而，TAC对BAC的反映很差，延迟了30-90分钟，而且试图检测进入皮肤的少量酒精容易出错。因此，有必要直接对生物量进行非侵入性测量。Lynntech提议开发一种可穿戴设备，可以准确且非侵入性地测量BAC。该设备将是可编程的，不引人注目，对佩戴者有吸引力，可以采取现代手表的形式，与移动设备通信，以实现反馈并保持用户沉醉的意识。我们假设，从高度成熟的脉搏血氧仪领域学到的经验教训，可以使用光谱学实现真正和直接的BAC测量。在第一阶段，我们设计了我们的目标，目标是开发一种原型非侵入性BAC测量设备。这些目标包括：1)开发BAC测量装置的硬件和软件；2)利用体外和体外模型优化BAC测量；3)展示准确、实时的体内BAC测量。将设计和编程一个使用高强度LED和适当的光电探测器的原型装置。组装好的装置将被用来演示通过猪皮样本测量血液中酒精含量的可行性。结果将用于优化设备设计、配置和操作。最后，将优化后的装置在小鼠模型上进行演示，以证明其完全可行。这一努力是更全面的技术的组成部分 《预算理由》中所述的发展计划。

 DESCRIPTION (provided by applicant): Alcohol misuse is linked to extensive economic costs as well as a large number of injuries and deaths. An estimated 16.6 million adults 18 and older had an alcohol use disorder (only one of which is Alcoholism) in 2013, amounting to ~$24.6 billion in healthcare costs. Additionally, nearly 88,000 deaths per year have been attributed to alcohol-related causes. Alcohol misuse is the number one leading risk factor for premature death for those aged 15-49, and the fifth leading risk factor for death overall. A high incidence o binge drinking (24.6% of people 18 or older in 2013) is indicative of the underlying problem. In light of this, tools that help to prevent excessive alcohol consumption serve an important role in reducing the enormous human and socio- economic costs associated with alcohol misuse. The ability to responsibly and personally track Blood Alcohol Concentration (BAC) levels could result in a significant reduction of alcohol related injuries and deaths. In addition, patient compliance n terms of regular monitoring and reporting of BAC is one of the major concerns and needs for the treatment of Alcoholism. Currently, the most accurate method for measuring BAC is to directly and invasively sample the blood and perform an assay, and is therefore not amenable to widespread use. Non-invasive measurement of Breath Alcohol Concentration (BrAC) is popular but conspicuous, and of questionable accuracy (variable by ±50% from true BAC). Several non-invasive, wearable devices are available that measure Transdermal Alcohol Concentration (TAC). However, TAC is a poor reflection of BAC, being delayed by 30-90 minutes and prone to error by attempting to detect the small amount of alcohol that makes it to the skin. There is therefore a need for non-invasive measuring of BAC directly. Lynntech proposes to develop a wearable device that accurately and non-invasively measures BAC. The device will be programmable, unobtrusive, appealing to the wearer, and can take the form of a modern wristwatch that communicates with a mobile device to enable feedback and maintain user intoxication awareness. We hypothesize that, with lessons learned from the highly mature field of pulse oximetry, a true and direct measurement of BAC can be achieved using spectroscopy. In the Phase I, we have designed our aims with the goal of developing a prototype non-invasive BAC measuring device. These aims include: 1) developing the BAC measurement device hardware and software; 2) optimizing the BAC measurement using in vitro and ex vivo models; and 3) demonstrating accurate, real-time BAC measurement in vivo. A prototype device using high intensity LEDs and appropriate photodetectors will be designed and programmed. The assembled device will be used to demonstrate the feasibility of measuring alcohol content in the blood through a sample of porcine skin. Results will be used to optimize device design, configuration, and operation. Finally, the optimized device will be demonstrated in a mouse model to prove full feasibility. This effort is an integral part of a more comprehensive Technology Development Plan that is described in the Budget Justification.