MEMS Based Continuous Alcohol Monitoring Device

描述（由申请人提供）： 这个为期两年的第一阶段项目将联合收割机结合电化学生物传感器技术与独特的硅微针体外监测技术，生产低成本的MEMS（微机电系统），用于连续监测血液酒精水平。我们建议使用硅微针对皮肤进行微侵蚀，以获得自由流动的组织间液（ISF）。然后用硅基生物传感器离体分析ISF中的酒精水平。这项工作中的分析物将是乙醇，但该技术也适用于许多其他分析物，包括糖尿病患者的葡萄糖连续监测。糖尿病血糖自我检测是目前最大的现有生物传感器市场机会。在第一年，电化学生物传感器将被集成到硅微针中，以制造用于体外测量的一次性用品。将使用含血清蛋白的缓冲液评价与液体连续流过器械相关的问题。第二年的工作重点是延长这些设备的使用寿命，使其成为用于连续监测乙醇浓度的一次性设备。将进行动物研究，以评价微针穿透角质层的强度，并确定连续监测ISF酒精的可行性。一旦该系统在动物模型中得到验证，人类受试者测试将在布朗大学的Robert Swift博士的监督下进行。SBIR第二阶段项目的目标是，将硅生物传感器微芯片与遥测芯片封装在一起，制成一个小型按钮状设备，可以不显眼地附着在皮肤上，连续测量酒精浓度并传输此数据。我们的方法的优势在于用生物传感器离体监测体液，从而避免了与皮下植入体内生物传感器相关的问题。皮下植入体内生物传感器的主要挑战是灵敏度的损失、传感器随时间的污染和体内校准。我们相信，通过尝试使用集成的生物传感器硅微针在体外进行测量，可能会导致商业上可行的连续监测设备的发展。

DESCRIPTION (provided by applicant): This two year Phase I project will combine the electrochemical biosensor technology with the unique silicon microneedle based ex-vivo monitoring technology, to produce low cost MEMS (MicroElectroMechanicalSystems) for continuous monitoring of blood alcohol levels. We propose to create mini-erosion of the skin with the silicon microneedles to obtain free flowing interstitial fluid (ISF). The alcohol level in the ISF will then be analyzed ex-vivo with the silicon based biosensor. The analyte in this work will be ethyl alcohol, but the technology is also applicable to many other analytes including continuous monitoring of glucose by diabetics. Diabetic glucose self-testing is currently the largest existing biosensor market opportunity. In the first year, electrochemical biosensors will be integrated into silicon microneedles to fabricate disposables for in vitro measurement. Issues related to continuous flow of fluids through the device will be evaluated using buffer solutions with serum proteins. The work of the second year will focus on extending the operating lifetime of these devices toward disposables for monitoring ethyl alcohol concentration continuously. Animal studies will be conducted to evaluate the strength of the microneedle for penetrating the stratum corneum as well as to establish feasibility of continuously monitoring ISF alcohol. Once the system is validated in animal models, human subject testing will be conducted under the supervision of Dr. Robert Swift at Brown University. A silicon biosensor microchip packaged with a telemetry chip to make a small button-like device which can be attached to the skin unobtrusively to measure alcohol concentration continuously and transmit this data will be the goal of a SBIR Phase II project. The strength of our approach lies in the ex-vivo monitoring of body fluid with a biosensor and thus avoid the problems associated with subcutaneously implanted in-vivo biosensors. The major challenges of subcutaneously implanted in-vivo biosensors are loss of sensitivity, fouling of the sensor over time and in-vivo calibration. We believe that by attempting to make the measurement outside the body with an integrated biosensor silicon microneedle could lead to the development of commercially viable continuous monitoring device.