Minimally Invasive Microsensor for Blood Alcohol Assay

一个小型的，不显眼的系统，用于准确测量血液酒精浓度将有广泛的应用，在监测酒精消费和代谢的临床，研究和刑事司法目的。理想的功能包括：灵敏、精确和准确的酒精测定方法;可靠并提供与血液中酒精浓度直接相关的结果的采样方法;片上电源和数据存储;以及明确的篡改指示。这一需求可以通过一种独特的新设备来满足，该设备基于两种技术的协同作用--申请人实验室首创的用于无痛血液检测的硅微取样和测定芯片，以及集成的电化学酒精生物传感器。 该芯片包括一个比人的头发还细的微探针，可以可靠地无痛地穿透皮肤。利用MEMS（微机电系统）技术可以低成本地生产一次性硅微芯片。包装好的设备不需要专业的医疗干预来固定或移除，并且可以佩戴在皮肤上的任何地方。它由一个类似创可贴的胶带组成，带有两毫米长的硅微探针，带有伸入皮肤的电化学传感器，加上信号处理 电路和数据存储在一个集成的按钮状外壳中。用于执行采样步骤和电化学读数的硅微芯片和电子仪器将改编自申请人目前生产的用于糖尿病葡萄糖自测的器械。

A small, unobtrusive system for accurate measurement of blood alcohol concentration would have wide application in monitoring alcohol consumption and metabolism for clinical, research, and criminal justice purposes. Desirable features include: an alcohol assay method that is sensitive, precise, and accurate; a sampling method that is reliable and provides results directly linked to the alcohol concentration in the blood; on-chip power and data storage; and a clear indication of tampering. This need can be met with a unique new device based on the synergy of two technologies-- the silicon microsampling and assay chip pioneered in the applicant's laboratory for painless blood testing, and an integrated electrochemical alcohol biosensor. The chip includes a microprobe finer than a human hair that can penetrate skin reliably and painlessly. The disposable silicon microchip can be cost-effectively produced by MEMS (microelectromechanical systems) technology. The packaged device does not require expert medical intervention to affix or remove, and can be worn anywhere on the skin. It consists of an adhesive strip resembling a Band-Aid with a two-millimeter long silicon microprobe with electrochemical sensor that protrudes into the skin, plus signal processing circuitry and data storage in an integrated button-like housing. The silicon microchips and electronic instrumentation to perform the sampling step and electrochemical readout will be adapted from devices currently being made by the applicant for diabetic glucose self-testing.