Disposable sensor for on-line measure of urea clearance in effluent dialysate

描述(由申请人提供)：项目摘要/摘要：尿素监测的一个关键需求是一种简单的一次性设备，可以很容易地与现有的血液透析(HD)技术集成在一起。该方案旨在论证利用直接沉积在短长度标准透析管内表面上的纳米工程比色膜来准确在线监测尿素清除量的可行性。最终的应用将包括将一次性传感器插入含有用过的透析液的输出回路中，并使用廉价的光学设备来量化由于尿素水平而导致的纳米膜中的颜色偏移。为了测试这种方法的潜力，已经制定了3个具体目标。(1)。开发一种纳米组装工艺，在标准透析管的内壁上重复沉积稳定的pH感应膜和尿素酶。(2)。设计、构建和测试纳米膜传感器和原型读取器，测量并关联尿素生理(透析液)水平的pH变化。(3)。评估准备和存储过程，以生产具有长保质期的敏感、一次性设备。预计这项拟议的工作将导致一次性传感器的原型。制造的简易性和成本效益将非常适合需要一次性传感器并且所有步骤都可以放大的应用。AURA纳米技术将利用在纳米制造和光学传感器方面的丰富经验，同时与学术和临床合作伙伴合作实现这一目标。第一阶段项目的成功完成将使Aura Nanotech能够在第二阶段进行广泛的原型测试，包括有限的临床试验。项目简介：截至2002年12月31日，接受ESRD治疗的患者总数超过43万人。在这些患者中，大约有28万人正在接受HD；这是一个相当大的群体，他们的生活质量受到了影响，每周花8-13个小时接受治疗。尿素清除的实时评估将允许立即量化所提供的HD剂量，使临床医生和患者都能够在下一次透析之前，甚至可能在透析期间，识别出表现不佳并采取纠正措施。拟议的设备将具有重要意义，因为它将具有成本效益，使用简单，并易于与当前的透析过程相结合。

DESCRIPTION (provided by applicant): Project Summary/Abstract: A key need for urea monitoring is a simple and disposable device that can be easily integrated with existing hemodialysis (HD) technology. This proposal aims to demonstrate the feasibility of accurate on-line urea clearance monitoring using nanoengineered colorimetric films deposited directly on the inside surface of short lengths of standard dialysis tubing. The ultimate application will involve the insertion of the disposable sensor within the output loop containing spent dialysate, and using an inexpensive optical device to quantify color shifts in the nanofilms due to urea levels. To test the potential for this approach, 3 specific aims have been developed. (1). Develop a nanoassembly process to repeatably deposit a stable pH sensing film and urease on the inner wall of standard dialysis tubing. (2). Design, construct and test nanofilm sensor and prototype reader that measure and correlate pH changes at physiological (dialysate) levels of urea. (3). Assess preparation and storage processes to produce sensitive, disposable devices with long shelf-life. It is an anticipated that this proposed work will result in a prototype sensor that is disposable. The ease and cost-effectiveness of fabrication would be very well suited for an application where disposable sensors are required and all steps amenable to scale-up. Aura Nanotechnology will leverage extensive experience in nanofabrication and optical sensors, while working with academic and clinical partners to realize this goal. Successful completion of this Phase I project will put Aura Nanotechnology in a position to perform extensive prototype testing in Phase II, including limited clinical trials. Project Narrative: The total number of patients receiving ESRD therapy as of December 31, 2002 was over 430,000. Among these patients, approximately 280,000 were undergoing HD; a significant population of people that have a compromised quality of life and spend 8-13 hours per week receiving therapy. Real-time assessment of urea removal would allow immediate quantification of the delivered HD dose, allowing both clinicians and patients to identify inadequate performance and undertake corrective action prior to the next dialysis session, possibly even during the session. The proposed device would be significant, because it will be cost effective, simple to use, and easy to integrate with the current dialysis processes.