A Novel Hydrogel Colorimetric Urea Sensor for Dialysis

一种用于透析的新型水凝胶比色尿素传感器

• 批准号: 7150865
• 负责人: ANJAL C SHARMA
• 金额: $ 14.93万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-10 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7150865
• 关键词: automated data processing; bioengineering /biomedical engineering; biomedical equipment development; biosensor device; biotechnology; colorimetry; gel; hemodialysis; medical complication; monitoring device; technology /technique development; therapy adverse effect; urea; urease

DESCRIPTION (provided by applicant): Project Summary/Abstract: This Phase I proposal addresses the dire need for continuous on-line monitoring of urea concentration within dialysate fluid to gauge dialysis adequacy. At present, patients are dialyzed for a fixed amount of time. However, if the waste concentration within the patient's body is very high, the fixed dialysis time may result in underdialysis. On the other hand, if the patient has lower waste concentration within the body, the fixed dialysis time may result in overdialysis. Either scenario may result in several health problems, such as widespread organ failure due to consistently high toxin levels (underdialysis) or dangerously low electrolyte concentration (overdialysis). These health problems lead to increased morbidity and mortality amongst the dialysis population. Urea is a sensitive marker of waste level within the patient's body. By measuring the urea level continuously during the dialysis session, a sound judgment may be made as to the optimal dialysis time. In order to continuously monitor the urea levels within the dialysate, we propose to demonstrate colorimetric soft hydrogel films, which will change color with change in urea concentration. These novel colorimetric materials promise to be rugged, reliable, inexpensive, easy to mass produce and use for on-line continuous dialysis adequacy monitoring. During the Phase I effort, we will perform feasibility studies to prove that our colorimetric gels can reversibly and reproducibly monitor changing urea levels in a simulated dialysate fluid, using a pre-prototype device which we will assemble during Phase I. During Phase II of this effort, we will optimize the dynamic urea response range and longevity of the urea sensor in actual dialysate fluid. During Phase II, we will also prepare an actual prototype urea profiler which will automatically provide urea clearance profiles and other parameters of dialysis adequacy such as CB Equil and Kt/V. The prototype will be capable of being directly hooked up to existing dialysis lines and will be an independent stand-alone and miniature device for actual dialysis adequacy measurement to maximize the productivity of each dialysis session. We will team up with Nephrology centers nationwide, during and beyond Phase II to test and validate our on-line urea monitor in actual dialysis clinics. If successful, this technology, in the long term, will be of great benefit to the patient population relying on dialysis. Project Narrative: Our proposed on-line urea profiler for dialysis will directly benefit the hundreds of thousands of patients who rely on routine dialysis to survive. By maximizing the productivity of every dialysis session, the proposed urea monitor will ensure improved long-term health and length of life of renal failure patients. Clinicians will also benefit from this new user-friendly, inexpensive and fully automated technology to greatly improve the way in which they manage their dialysis patients.

描述（由申请人提供）： 项目摘要/摘要：该第一阶段提案解决了连续在线监测透析液中尿素浓度以衡量透析充分性的迫切需求。目前，患者的透析时间是固定的。然而，如果患者体内废物浓度很高，固定的透析时间可能会导致透析不足。另一方面，如果患者体内废物浓度较低，固定的透析时间可能会导致过度透析。这两种情况都可能导致多种健康问题，例如由于持续高毒素水平（透析不足）或危险的低电解质浓度（过度透析）而导致广泛的器官衰竭。这些健康问题导致透析人群发病率和死亡率增加。尿素是患者体内废物水平的敏感标志。通过在透析过程中连续测量尿素水平，可以对最佳透析时间做出合理的判断。为了持续监测透析液中的尿素水平，我们建议展示比色软水凝胶薄膜，该薄膜会随着尿素浓度的变化而改变颜色。这些新型比色材料具有坚固、可靠、廉价、易于批量生产和用于在线连续透析充分性监测的特点。在第一阶段的工作中，我们将进行可行性研究，以证明我们的比色凝胶可以使用我们将在第一阶段组装的预原型设备可逆地、可重复地监测模拟透析液中尿素水平的变化。我们将努力优化尿素传感器在实际透析液中的动态尿素响应范围和寿命。在第二阶段，我们还将准备一个实际的原型尿素分析仪，它将自动提供尿素清除率曲线和透析充分性的其他参数，例如 CB Equil 和 Kt/V。该原型将能够直接连接到现有的透析线，并将成为一个独立的微型设备，用于实际透析充分性测量，以最大限度地提高每次透析的生产率。我们将在第二阶段期间及之后与全国肾脏病中心合作，在实际的透析诊所中测试和验证我们的在线尿素监测仪。如果成功，从长远来看，这项技术将为依赖透析的患者群体带来巨大好处。项目叙述：我们提出的用于透析的在线尿素分析仪将直接使数十万依赖常规透析生存的患者受益。通过最大限度地提高每次透析的效率，所提出的尿素监测仪将确保改善肾衰竭患者的长期健康状况和寿命。临床医生还将受益于这种用户友好、廉价且全自动的新技术，从而大大改善他们管理透析患者的方式。