Developing, Testing and Validating a Wearable Alcohol Biosensor

开发、测试和验证可穿戴酒精生物传感器

• 批准号: 9768931
• 负责人: John F Currie
• 金额: $ 74.98万
• 依托单位: CLINITECH, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-20 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768931
• 关键词: Accidents; Adhesives; Affect; Alcohol consumption; Alcohols; Appearance; Award; Back; Bandage; Behavioral; Biosensor; Biotechnology; Blood; Blood alcohol level measurement; Blood specimen; Bluetooth; Businesses; Calibration; Cellular Phone; Cessation of life; Collaborations; Collection; Computers; Consumption; Data; Development; Devices; Drug Kinetics; Elements; Exercise; Gas Chromatography; Health; Homicide; Hospitals; Human; Human Volunteers; Individual; Injury; Institutional Review Boards; Intercellular Fluid; Joint Ventures; Journals; Law Enforcement; Legal patent; Licensing; Marketing; Measures; Modeling; Monitor; Motor; Outcome; Penetration; Performance; Personal Satisfaction; Phase; Physiological; Population; Population Research; Preparation; Price; Private Sector; Process; Product Labeling; Product Packaging; Protocols documentation; Public Health; Publications; Reaction; Recommendation; Reporting; Research; Sample Size; Sampling; Scheme; Site; Skin; Skin Pigmentation; Small Business Innovation Research Grant; Sweat; Syndrome; Technology; Testing; Time; Tissues; Update; Wireless Technology; alcohol monitoring; alcohol testing; alcohol use disorder; assault; base; breath alcohol measurement; college; commercialization; design; drinking; experience; experimental study; fetal; field study; healthy volunteer; human subject; improved; innovation; interest; medical schools; miniaturize; monitoring device; nanosensors; novel; off-patent; performance tests; programs; prototype; real time monitoring; response; sensor; sex; sexual assault; smartphone Application; social; volunteer; wearable device; web site

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.

1项目概要 2此第二阶段SBIR奖的申请扩展了第一阶段的成功完成，并代表了 3 Clinitech，LLC和姆克林医院/哈佛医学院之间的合作， 4、研制可穿戴式生物传感器，用于检测人体组织液中的酒精。过度使用 5酒精占与酒精使用障碍有关的公共卫生负担的大部分，包括胎儿酒精 6综合征，致命的车祸，事故和凶杀案。仅在大学校园里，酒精的使用导致 每年有近2,000人死亡，10万起性侵犯，60万起受伤和70万起袭击事件。这些 8个数字证明了在许多层面上需要一个可穿戴设备，可以帮助跟踪个人的酒精 9消费在真实的时间。一个原型设备被开发出来，人体测试证明它匹配 10与血液酒精浓度非常好，从而提供了一个有价值的概念验证。当前的提议是 11旨在将设计改进为可穿戴贴片并实施商业化计划。所有专利和 Clinitech拥有12个许可证，姆克林医院团队拥有数十年的管理经验， 13酒精对人类志愿者，然后测量血液，呼吸和组织酒精浓度。因此 14两个地点是合作这个合资企业的理想选择，并准备以非常快的速度继续这个项目。 15步LabPatch-alcohol采用新型纳米传感器技术， 然后使用电化学反应来测量几个人体内的酒精浓度。 17秒ISF上级目前市场上基于呼吸和汗液的设备，因为它与血液平行。的 18器械不显眼，看起来像胶布绷带，不会造成损伤，并且可程控。的 最初的原型连接到计算机上，现在我们准备切换到自动制造 20最佳阵列的传感器和转换设备的无线补丁，与智能手机进行通信。 21我们已经确定了三个基本市场：私营部门，AUD治疗人群和研究 22，并预测价格点和市场渗透率，这将导致重大的积极影响， 23人类健康和福祉，同时也证明是一个成功的商业奋进。研究计划 24将使用相同的迭代方法，Clinitech将向姆克林提供用于人体测试的补丁。 将对25份ISF和血液的平行样本进行饮酒后酒精浓度检测，以将 图26这两个隔室中酒精的药代动力学曲线。第二阶段的主要里程碑包括： 27并对原型进行验证，开发无线功能，测试与性别和皮肤相关的差异， 28性能，测试锻炼的效果，并实施全面的商业化计划。