Rapid patency assessment of dialysis vascular access

透析血管通路的快速通畅评估

基本信息

批准号：
6443644
负责人：
HANSEN A MANSY
金额：
$ 10万
依托单位：
BIOMEDICAL ACOUSTICS RESEARCH COMPANY
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-08-05 至 2005-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6443644
关键词：
biomedical equipment development cardiovascular injury clinical research dialysis therapy human subject intravenous administration microprocessor /microchip patient monitoring device sound vibration

项目摘要

DESCRIPTION (provided by applicant): Vascular access for renal dialysis is a lifeline for about 120,000 patients in the United States. Detection of access compromise is critical for optimal management. The proposed seeks to develop a new method for early and accurate detection of decreased access patency. The essential hypothesis is that vascular compromise alters blood flow turbulence resulting in diagnostic vibration ("acoustic") changes detectable at the skin surface. The proposed technology is based on computerized analysis of signals from "electronic stethoscopes" placed on the patient?s forearm. This is not an imaging technology. Rather, it is a much less expensive, yet potentially powerful method for immediate and safe diagnosis. Phase 1 research will test feasibility by studying fifteen human subjects before and after vascular access angioplasty. If successful, the novel device would have significant commercial potential with purchase by renal dialysis units and radiology departments. A much larger potential market may exist as the knowledge garnered in this effort is later applied to other vascular applications such as stroke prevention, renal artery stenosis detection, femoral-popliteal bypass graft salvage, and to early diagnosis of abdominal aortic aneurysms. PROPOSED COMMERCIAL APPLICATION: If this technology proves successful, it is anticipated that the device would become standard equipment in renal hemodialysis units world-wide with potential estimated sales in the order $30,000,000. Annual sales of disposable sensors are estimated to total an additional $25 million. A much larger potential market may exist as the knowledge garnered in this effort is later applied to other vascular applications such as stroke prevention, renal knowledge garnered in this effort is later applied to other vascular applications such as stroke prevention, renal artery stenosis detection, femoral-popliteal bypass graft salvage, and to early diagnosis of abdominal aortic aneurysms.

描述（由申请人提供）：肾透析的血管通路是一种美国约 120,000 名患者的生命线。检测访问妥协对于最佳管理至关重要。该提案旨在开发一个及早准确检测通路通畅率下降的新方法。这基本假设是血管受损会改变血流湍流导致皮肤上可检测到的诊断性振动（“声学”）变化表面。所提出的技术基于信号的计算机分析来自放置在患者前臂上的“电子听诊器”。这不是一个成像技术。相反，它的价格便宜得多，但有潜力即时、安全诊断的有力方法。第一阶段研究将测试通过研究血管通路前后的 15 名人类受试者的可行性血管成形术。如果成功，这种新颖的设备将具有重大的商业价值肾透析单位和放射科购买的潜力。一个随着在这项工作中获得的知识，可能存在更大的潜在市场后来被应用于其他血管应用，例如中风预防，肾动脉狭窄检测、股腘旁路移植术抢救以及腹主动脉瘤的早期诊断。拟议的商业应用：如果这项技术被证明是成功的，预计该设备将成为全球肾血液透析装置的标准设备，潜在的估计销售额约为 30,000,000 美元。一次性传感器的年销售额预计将额外增加 2500 万美元。可能存在更大的潜在市场，因为在此努力中获得的知识随后应用于其他血管应用，例如中风预防，在此努力中获得的肾脏知识随后应用于其他血管应用，例如中风预防、肾动脉狭窄检测、股动脉狭窄-腘动脉搭桥术的挽救，以及腹主动脉瘤的早期诊断。