Noninvasive Raman Monitoring of Urea During Hemodialysis

血液透析期间尿素的无创拉曼监测

• 批准号: 6760851
• 负责人: Richard H Clarke
• 金额: $ 31.57万
• 依托单位: RAMAN SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6760851
• 关键词: Raman spectrometry; biomedical equipment development; blood chemistry; clinical research; fiber optics; hemodialysis; human subject; noninvasive diagnosis; patient monitoring device; urea

DESCRIPTION (provided by applicant): It is the aim of the present Phase II research program to develop a continuous, noninvasive, on-line process for optically monitoring the levels of urea in a patient's blood during hemodialysis. The ultimate goal of such a process is to provide a direct and continuous measure of the efficiency of dialysis without having to wait for the drawing of a blood sample, thereby providing an assessment of whether dialysis at any point in time has reached an effective stopping point for the patient while still attached to the dialysis equipment. We propose to utilize low-resolution laser Raman scattering for the direct measurement of the urea levels in blood using the optical access provided by the dialysis tubing delivering the patient's blood to the dialyzer. Our Phase I SBIR results have shown that urea has a unique Raman spectroscopic signature in animal blood and can be identified and quantified against a whole blood background. Our Phase II program is designed to assess the capability of Raman to quantify the levels of urea in human blood samples with varying concentrations of urea present. After constructing a suitable multiple regression model for BUN, we will build out an appropriate low-resolution Raman module for attachment to a hemodialysis unit and expand the investigation to human blood analysis for BUN and URR during actual dialysis procedures in the clinical setting. If successful, a Raman measurement approach would allow, for the first time, real-time, direct and continuous monitoring of the progress of urea removal dudng the course of hemodialysis. This would permit more efficient timing of the dialysis procedure for the patient, as well as providing an ongoing readout of the effectiveness of the dialysis system during patient treatment. We anticipate that a commercially viable urea monitor might be produced rapidly, if the Phase II work is successful, by the adaptation for the clinical setting of the Company's present R-2001 Raman module for attachment by fiberoptic probe to existing renal dialysis equipment.

描述（由申请人提供）：目前II期研究项目的目的是开发一种连续的、无创的、在线的过程，用于光学监测血液透析期间患者血液中的尿素水平。该过程的最终目标是提供透析效率的直接和连续测量，而不必等待抽取血液样本，从而提供透析是否在任何时间点达到患者有效停止点的评估，同时仍然连接到透析设备。我们建议利用低分辨率激光拉曼散射直接测量血液中的尿素水平，使用透析管提供的光学通道，将患者的血液输送到透析器。我们的I期SBIR结果表明，尿素在动物血液中具有独特的拉曼光谱特征，可以在全血背景下进行识别和量化。我们的II期项目旨在评估拉曼在不同尿素浓度的人类血液样本中量化尿素水平的能力。在构建合适的BUN多元回归模型后，我们将构建合适的低分辨率拉曼模块，用于附着在血液透析装置上，并将研究扩展到临床实际透析过程中人体血液的BUN和URR分析。如果成功，拉曼测量方法将首次允许实时、直接和连续监测血液透析过程中尿素去除的进展。这将允许更有效地为患者安排透析程序，并在患者治疗期间提供透析系统有效性的持续读数。我们预计，如果第二阶段的工作成功，通过适应公司目前的R-2001拉曼模块的临床环境，通过光纤探针连接到现有的肾透析设备，商业上可行的尿素监测仪可能会很快生产出来。