Rapid patency assessment of dialysis vascular access

描述(由申请人提供)：肾透析的血管通路是 为美国约12万名患者提供生命线。访问检测 妥协是实现最佳管理的关键。拟议的建议旨在制定一项 早期、准确检测通道通畅性降低的新方法。这个 基本假设是血管受损会改变血液流动紊乱 导致可在皮肤检测到的诊断性振动(声学)变化 浮出水面。建议的技术是基于对信号的计算机分析 从放在病人身上的“电子听诊器”？S的前臂。这不是一个 成像技术。相反，它的成本要低得多，但有可能 快速、安全诊断的有力手段。第一阶段研究将测试 15名受试者血管通路前后的可行性研究 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 有可能被肾透析单位和放射科购买。一个 更大的潜在市场可能存在，因为在这一努力中获得的知识 后来被应用于其他血管应用，如中风预防， 肾动脉狭窄的检测、股-静脉旁路移植的挽救和 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，预计该设备将成为世界各地肾脏血液透析设备的标准设备，潜在销售额估计在3000万美元左右。据估计，一次性传感器的年销售额将增加2500万美元。随着在这项工作中获得的知识后来被应用于其他血管应用，如中风预防，在这一努力中获得的肾脏知识随后被应用于其他血管应用，如中风预防、肾动脉狭窄检测、股-窝旁路移植挽救，以及腹主动脉瘤的早期诊断，可能存在更大的潜在市场。

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.