Minimally Invasive Microsensor for Blood Alcohol Assay

用于准确测量血液酒精浓度的小型、不显眼的系统将在临床、研究和刑事司法目的的酒精消耗和新陈代谢监测方面有广泛的应用。理想的特征包括：灵敏、精确和准确的酒精分析方法；可靠的采样方法，并提供与血液中酒精浓度直接相关的结果；芯片功率和数据存储；以及明确的篡改迹象。基于两种技术的协同作用，一种独特的新设备可以满足这一需求--申请者实验室首创的用于无痛血液测试的硅微采样和分析芯片，以及集成的电化学酒精生物传感器。 该芯片包括一个比人类头发更细的微探头，可以可靠而无痛地穿透皮肤。利用MEMS(微电子机械系统)技术可以经济高效地生产一次性硅微芯片。这种包装的设备不需要专家的医疗干预来粘贴或移除，可以戴在皮肤上的任何地方。它由一个类似创可贴的胶带和一个两毫米长的硅微探头和伸入皮肤的电化学传感器组成，外加信号处理 电路和数据存储在一个集成的纽扣式外壳中。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目前由糖尿病血糖自检申请人制造的设备。

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.