Painless Microsampling System for Total Hemoglobin and Hematocrit Monitoring

描述(申请人提供)：拟议的第一阶段工作的目标是开发一种无痛、微创采血和化验方法，通过消除与当前静脉采血技术相关的疼痛和样本量问题，尤其将使儿科和新生儿患者受益。这项新技术采用了一种一次性微量采样和分析设备，采用了电子行业中常见的硅微制造技术。这种一次性使用的微型设备有一个大小与人类头发相当的硅微针，可以无痛地刺入皮肤，并将亚微升容量的血液抽出到集成的微通道/试管中。第一阶段的工作将集中于微型采样装置的设计和制造，可能在一个装置中包含多个光学微管，以及开发完整的工程原型仪器。将开发和演示用于总血红蛋白和红细胞压积的直接光学分析方法。这两个独立的测量允许准确地确定平均红细胞血红蛋白浓度，这是贫血的一个指标。总血红蛋白和红细胞压积通常被用作许多情况的标志物，包括：贫血和红细胞增多症、脱水、大量出血、肝硬变、癌症和其他慢性病。这项工作的成功完成将导致开发一种新的血液测试系统，用于独立测量亚微升血液样本中的总血红蛋白和红细胞压积。这种仪器对儿科和新生儿患者特别有益，因为它没有疼痛，样本量小。它的易用性也将使其对疗养院、家庭保健和其他门诊护理点应用程序具有吸引力。

DESCRIPTION (provided by applicant): The goal of the proposed Phase I work is the development of a painless, mininimumly invasive method of blood sampling and assay that will especially benefit pediatric and neonatal patients by eliminating the problems of pain and sample volume associated with current phlebotomy techniques. This new technology employs a disposable microsampling and assay device made using silicon microfabrication techniques common in the electronics industry. This single-use microdevice has a silicon microneedle comparable in size to a human hair that can puncture the skin painlessly and withdraw a sub-microliter volume of blood into an integrated microchannel/cuvette. The Phase I work will focus on the design and fabrication of microsampling devices, possibly containing multiple optical microcuvettes in a single device, and the development of a complete engineering prototype instrument. Direct optical assays for total hemoglobin and hematicrit will be developed and demonstrated. These two independent measurements allow for the accurate determination of mean corpuscular hemoglobin concentration, an indicator of anemia. Total hemoglobin and hematocrit are commonly used as markers for many conditions, including: anemia and polycythemia, dehydration, excessive bleeding, cirrhosis, and certin cancers and other chronic illnesses. Successful completion of this work will lead to the development of a novel blood testing system for independent measurement of total hemoglobin and hematocrit in sub-microliter blood samples. This instrument will be of particular benefit to pediatric and neonatal patients because of its lack of pain and small sample volumes. Its ease of use will also make it attractive for nursing homes, home health care, and other out-patient point-of-care applications.