Novel Fluid Management System for Microfluidic Devices

描述（由申请人提供）：微流体学是一门研究微升和纳升体积流体的行为、精确控制和操作的科学分支。其应用包括血细胞分离、生化测定、化学合成、遗传分析（例如，基因芯片和蛋白质组学芯片）、药物筛选、电色谱等。将微流体产品推向市场的最困难的问题之一是缺乏准确转移和管理少量流体的适当方法。许多微流体装置依赖于相对复杂且昂贵的机械致动泵，其不适合于许多应用。内置于微流体装置中并通过电激活过程（例如电渗和压电）操作的技术通常不够可靠。因此，需要开发廉价且精确的流体管理系统和部件。该提议描述了一种用于流体管理的新颖的、低成本的微型泵，其基于电化学（即，电解和燃料电池）原理。它的好处是：（1）精确输送微升量的流体，（2）低制造成本（它基于单个移动部件），（3）如果需要，能够在非常高的背压下操作（>100 psi），以及（4）可缩放以满足各种用户应用（流速范围从微升/分钟到毫升/分钟）。在第一阶段，我们简化了微型泵组装技术，并展示了微型泵的工艺和成本优势。微型泵的实际用途进行了演示，如用于控制实验室比色酶反应的微流控诊断芯片。通过长期连续运行，验证了微泵的可靠性.微型泵的低成本、准确性和可靠性使其与竞争方法有很大的区别，使该微型泵独特地适合纳入大容量医疗产品（药筒和微加工流体芯片等）是一次性的这一点很重要，因为微流体领域正朝着这个方向发展。拟议的第二阶段项目涉及材料开发、工程设计、过程控制开发和微流体应用测试，如果成功，将使该技术在未来过渡到制造或产品环境。我们的计划包括与医疗设备制造商和法规事务专家合作。重点是利用微泵的独特功能，用于未来的药物输注系统。 公共卫生相关性拟议的技术将通过提供具有成本效益的系统组件，将下一代医疗保健产品和诊断测试推向市场，从而使公共卫生受益。具有成本效益的下一代医疗保健产品和诊断将使医生能够提供更好的和更个性化的患者治疗和护理。

DESCRIPTION (provided by applicant): Microfluidics is a branch of science dealing with the behavior, precise control and manipulation of microliter and nanoliter volumes of fluids. Its applications include blood-cell-separation, biochemical assays, chemical synthesis, genetic analysis (e.g., gene-chips and proteomics chips), drug screening, electrochromatography, etc. One of the most difficult problems in bringing microfluidic products to the market is the lack of appropriate methods to accurately transfer and manage small quantities of fluid. Many microfluidic devices rely on relatively complex and costly mechanically activated pumps that are unsuitable for many applications. Techniques that are built into the microfluidic device and operate by electrically activated processes, such as electroosmosis and piezoelectrics, are often insufficiently reliable. Thus, there is a need to develop cheap and accurate fluid management systems and components. This proposal describes a novel, low cost micropump for fluid management that is based on electrochemical (i.e., electrolysis & fuel cell) principles. Its benefits are: (1) accurate delivery of microliter quantities of fluids, (2) low cost of manufacture (it is based on a single moving part), (3) ability to operate at very high backpressures if required (>100 psi), and (4) scaleable to meet a variety of user applications (flow rates range from microliters per minute to milliliters per minute). In Phase I, we streamlined the micropump assembly techniques and demonstrated the micropump's process and cost advantages. Practical uses of the micropump were demonstrated, such as for controlling a laboratory colorimetric enzymatic reaction on a microfluidic diagnostic chip. The micropump's reliability was also demonstrated through long- term continuous operation. The low cost, accuracy, and reliability of the micropump strongly differentiates it from competing methods, making this micropump uniquely appropriate for inclusion into high volume medical products (cartridges and microfabricated fluidic chips etc.) that are designed to be disposable. This is important because the field of microfluidics is moving in this direction. The proposed Phase II project involves materials development, engineering design, process control development and microfluidics applications testing that, if successful, will position the technology for future transition into a manufacturing or product environment. Our program includes working with a medical equipment manufacturer and with regulatory affairs specialists. The focus is on exploiting the unique features of the micropump for use in future drug infusion systems. PUBLIC HEALTH RELEVANCE The proposed technology will benefit public health by providing cost-effective system components for bringing next generation health care products and diagnostic tests to the market place. Cost effective next generation health care products and diagnostics will allow physicians to provide improved and more individualized patient treatment and care.