Developing, Testing and Validating a Wearable Alcohol Biosensor

1个项目摘要 2本申请第二阶段SBIR奖延长了第一阶段的成功完成，并代表了 3 Clinitech、LLC和McLean医院/哈佛医学院之间的合作 4可穿戴式人体组织液酒精生物传感器的研制。过度使用 5酒精占与酒精使用障碍有关的公共健康负担的很大一部分，包括胎儿酒精 6综合症、致命的车祸、事故和凶杀。仅在大学校园里，饮酒就会导致 每年造成近2000人死亡，10万人性侵，60万人受伤，70万人性侵。这些 8个数字证明了在许多层面上需要一种可穿戴设备来帮助跟踪个人的酒精含量 9实时消费。开发了一个原型装置，人体试验证明它与 10与血液酒精浓度非常好，从而提供了有价值的概念证明。目前的建议是 11旨在将设计细化为可穿戴补丁，并实施商业化计划。所有专利和 Clinitech拥有12个许可证，McLean医院团队拥有数十年的管理经验 13名志愿者饮用酒精，然后测量血液、呼吸和组织酒精浓度。因此， 14这两个地点是在这个合资企业上进行合作的理想地点，并且已经做好了以非常快的速度继续这个项目的准备 15步。LabPatch-乙醇利用新的纳米传感器技术从 16在皮肤下，然后使用电化学反应来测量几个 17秒。ISF比目前市场上基于呼吸和汗水的设备更优越，因为它与血液相似。这个 18装置不显眼，看起来会像胶布一样，不会造成伤害，将是可编程的。这个 19最初的原型是连接到计算机上的，现在我们准备切换到自动制造一个 20最佳传感器阵列，并将设备转换为可与智能手机通信的无线补丁。 21我们已经确定了三个基本市场：私营部门、澳大利亚的治疗人群和研究 22并预测了价格点和市场渗透率，这将对 23人类健康和福祉，同时也被证明是一项成功的商业努力。研究计划 24将使用与Clinitech向McLean提供补丁进行人体测试相同的迭代方法。 25个平行的ISF和血液样本将在饮酒后进行酒精浓度测试，以便将 26酒精在这两个隔室中的药动学分布。第二阶段的主要里程碑包括：增强 27并将原型微型化，开发无线功能，测试与性别和皮肤相关的差异 28绩效，测试锻炼效果，实施全面商业化计划。

1 PROJECT SUMMARY 2 This application for a Phase II SBIR award extends the successful completion of Phase I and represents a 3 collaboration between Clinitech, LLC and McLean Hospital/Harvard Medical School to continue the 4 development of a wearable biosensor for detecting alcohol in the interstitial fluid of humans. Excessive use of 5 alcohol accounts for much of the public health burden related to alcohol use disorders, including fetal alcohol 6 syndrome, fatal motor crashes, accidents and homicides. On college campuses alone, alcohol use results 7 annually in almost 2,000 deaths, 100,000 sexual assaults, 600,000 injuries, and 700,000 assaults. These 8 figures justify the need at many levels to have a wearable device that can help track individual’s alcohol 9 consumption in real time. A prototype device was developed, and human subject testing proved that it matched 10 very well with blood alcohol concentrations, thus providing a valuable proof-of-concept. The current proposal is 11 aimed at refining the design into a wearable patch and implementing a Commercialization Plan. All patents and 12 licenses are in place at Clinitech and the McLean Hospital team has decades of experience in administering 13 alcohol to human volunteers and then measuring blood, breath and tissue alcohol concentrations. Thus, the 14 two sites are ideal to collaborate on this joint venture and are well poised to continue this project at a very rapid 15 pace. LabPatch-alcohol utilizes novel nanosensor technology that samples interstitial fluid (ISF) from just 16 underneath the skin and then uses an electrochemical reaction to measure alcohol concentration in a few 17 seconds. ISF is superior to breath and sweat-based devices currently on the market as it parallels blood. The 18 device is unobtrusive, will look like an adhesive bandage, causes no injury and will be programmable. The 19 initial prototype was wired to a computer and now we are ready to switch to automated fabrication of an 20 optimal array of sensors and convert the device to a wireless patch that communicates with a Smart-phone. 21 We have identified three fundamental markets: the private sector, AUD Treatment population, and research 22 and have projected price points and market penetrations that will result in a significant positive impact on 23 human health and well-being, while also proving to be a successful commercial endeavor. The research plan 24 will use the same iterative approach by which Clinitech will provide patches to McLean for human testing. 25 Parallel samples of ISF and blood will be tested for alcohol concentration after drinking in order to correlate the 26 pharmacokinetic profile of alcohol in these two compartments. Key milestones for Phase II include: enhance 27 and miniaturize the prototype, develop wireless capabilities, test for sex- and skin-related differences in 28 performance, test for the effects of exercise, and implement a comprehensive Commercialization Plan.