Painless Microsampling System for Total Hemoglobin and Hematocrit Monitoring

用于总血红蛋白和血细胞比容监测的无痛微量采样系统

• 批准号: 7272199
• 负责人: BRIAN J SULLIVAN
• 金额: $ 10.01万
• 依托单位: KUMETRIX, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7272199
• 关键词: Accounting; Adult; Age; Algorithms; Anemia; Bedside Testings; Benchmarking; Bilirubin; Biological Assay; Blood; Blood Glucose; Blood Tests; Blood Volume; Blood specimen; Calculi; Childhood; Chronic Disease; Cirrhosis; Companions; Condition; Dehydration Polycythemia; Development; Device or Instrument Development; Devices; Elderly; Electronics; Engineering; Erythrocytes; Facility Construction Funding Category; Goals; Hair; Hand; Hematocrit procedure; Hemoglobin; Hemorrhage; Home Care Services; Human; Individual; Industry; Infant; Invasive; Lead; Malignant Neoplasms; Manuals; Mean corpuscular hemoglobin concentration determination; Measurement; Measures; Methods; Microfabrication; Microprocessor; Monitor; Neonatal; Nursing Homes; Operative Surgical Procedures; Optics; Outpatients; Pain; Painless; Patients; Phase; Phase I Clinical Trials; Plasma; Puncture procedure; Reporting; Research Personnel; Sampling; Silicon; Skin; Standards of Weights and Measures; System; Techniques; Technology; Testing; Universities; Validation; Venous blood sampling; Whole Blood; Work; clinical application; concept; design; diabetic; glucose monitor; human subject; instrument; instrumentation; medical schools; milliliter; miniaturize; nanolitre; neonate; new technology; novel; point of care; programs; prototype; research and development; size; technological innovation; tissue trauma

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.

描述（由申请人提供）：拟定的I期工作的目标是开发一种无痛、微创的血液采样和分析方法，通过消除与当前放血技术相关的疼痛和样本量问题，该方法将特别有益于儿科和新生儿患者。这项新技术采用了一种一次性的微量取样和测定装置，该装置使用电子工业中常见的硅微加工技术制成。这种一次性微型装置具有一根与人的头发大小相当的硅微针，可以无痛地刺穿皮肤，并将亚微升体积的血液抽取到集成的微通道/试管中。第一阶段的工作将集中在微量取样装置的设计和制造，可能包含在一个单一的设备，并开发一个完整的工程原型仪器多个光学微量比色皿。将开发和演示总血红蛋白和红细胞压积的直接光学测定。这两个独立的测量值可以准确确定平均红细胞血红蛋白浓度（贫血的指标）。总血红蛋白和红细胞压积通常用作许多疾病的标志物，包括：贫血和红细胞增多症，脱水，出血过多，肝硬化和某些癌症和其他慢性疾病。这项工作的成功完成将导致一种新的血液检测系统的开发，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。该仪器将特别有利于儿科和新生儿患者，因为它没有疼痛和小样本量。它的易用性也将使其对养老院，家庭医疗保健和其他门诊点护理应用具有吸引力。