Rapid patency assessment of dialysis vascular access

透析血管通路的快速通畅评估

• 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
• 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

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）：用于肾透析的血管通路是一种 美国约12万名患者的生命线。检测访问 妥协对于优化管理至关重要。建议的目的是制定一个 早期准确检测通路通畅性降低的新方法。的 一个基本假设是血管损伤改变了血流湍流 导致在皮肤处可检测到的诊断振动（“声学”）变化 面所提出的技术是基于对信号的计算机分析 “电子听诊器”的声音吗的前臂。这不是一个 成像技术相反，它是一个便宜得多，但潜在的 快速、安全的诊断方法。第一阶段研究将测试 通过研究15名受试者在血管通路前后的可行性 血管成形术如果成功，这种新型设备将具有重大的商业价值。 肾透析单位和放射科可能购买。一 随着在这一努力中获得的知识，可能存在更大的潜在市场 随后应用于其他血管应用，例如中风预防， 肾动脉狭窄检测，股腘旁路移植物挽救，以及 腹主动脉瘤的早期诊断 拟定商业应用：如果这项技术被证明是成功的，预计该设备将成为世界范围内肾血液透析单位的标准设备，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估计将增加2500万美元。 可能存在更大的潜在市场，因为在这项工作中获得的知识后来应用于其他血管应用，如中风预防，在这项工作中获得的肾脏知识后来应用于其他血管应用，如中风预防，肾动脉狭窄检测，股腘旁路移植物抢救，以及腹主动脉瘤的早期诊断。