Detecting Impending Dialysis Access Graft Failure

检测即将发生的透析通路移植失败

• 批准号: 6550557
• 负责人: David Vilkomerson
• 金额: $ 9.99万
• 依托单位: DVX, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-15 至 2003-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6550557
• 关键词: biomaterial development /preparation; biomaterial interface interaction; biomedical equipment development; clinical research; hemodialysis; histocompatibility; human subject; transplantation immunology; ultrasound; ultrasound blood flow measurement

DESCRIPTION (provided by applicant): The aim of this program is to develop a low-cost, easy-to-use instrument to measure the blood flow in artificial dialysis access grafts. With such an instrument, these grafts could be monitored at frequent enough intervals to detect the falling flow levels that predict graft failure. Such graft failure is a major medical problem for the 250,000 Americans who undergo hemodialysis. The proposed instrument will utilize a new kind of ultrasound transducer, the diffraction-grating transducer, in a special Doppler technique that eliminates the need for imaging the graft during measurement, and is especially suitable for by minimally skilled operators. An early version of this instrument has shown promise in measuring dialysis access graft flow, and has proven that the range of normal physiological variation in graft flow is small enough that the proposed flow measurements should reveal impending graft failure. In the Proposed Phase I of this project, a prototype of the desired instrument will be constructed and its accuracy and ease of use validated in clinical use by comparison with standard flow techniques in a small number of hemodialysis patients. With the feasibility of the instrument so demonstrated, Phase II would continue with construction of a number of such instruments to be used in a multi-center trial to prove that their use can extend the life of artificial dialysis grafts. The economic benefit of such graft life extension can approach a billion dollars a year, ensuringcommercialization of the instrument.

描述(由申请人提供)：该项目的目的是开发一种低成本、易用的仪器来测量人工透析通路移植物的血流量。有了这样的仪器，这些移植物可以以足够频繁的间隔进行监测，以检测预测移植物失败的下降流量水平。对于25万接受血液透析的美国人来说，这种移植物失败是一个主要的医疗问题。 该仪器将利用一种新的超声换能器--衍射-光栅换能器，采用一种特殊的多普勒技术，在测量过程中消除对移植物成像的需要，特别适合于技能最低的操作员。该仪器的早期版本在测量透析通路移植物流量方面显示出前景，并已证明移植物流量的正常生理变化范围足够小，建议的流量测量应能显示即将发生的移植物衰竭。 在该项目的拟议第一阶段中，将构建所需仪器的原型，并通过在少数血液透析患者中与标准流动技术进行比较，在临床使用中验证其准确性和易用性。随着这种仪器的可行性得到证明，第二阶段将继续建造一些这样的仪器，用于多中心试验，以证明它们的使用可以延长人工透析移植物的寿命。 这种移植物寿命延长的经济效益每年可接近10亿美元，确保了该仪器的商业化。