Real-Time Monitoring Device for Vascular Signals

 描述(由申请人提供)： 长期透析的成功和成本取决于维持患者的血管通路，这是一个通过手术创建的动-静脉旁路区域，可以允许高血流量。在透析过程中，血液从通路动脉侧的针头中提取，由血液透析单元过滤，然后通过第二根下游针头返回患者。血管通路也被称为血液透析的“阿喀琉斯之跟”，因为保持高流量特性(通路通畅)是实现有效透析治疗的关键。对血管通路进行监测和监视，以确定可能导致通路堵塞(血栓形成)的内部狭窄(狭窄)。介入监测的目标是在血栓形成发生之前，通过常规手术程序先发制人地治疗狭窄。目前的准入监测依赖于熟练的操作员和专门的设备，由于血液透析护理标准中的经济现实，无法有效地应用于所有患者。我们建议进行临床实验，以展示和评估非侵入性筛选血液透析血管通畅的新方法。我们有兴趣研究使用数字听诊器和皮肤温度测量自主收集血管信号的可行性，以提供动静脉移植物通畅性的连续和实时测量。我们将继续进行这项研究，以回答关于这种非侵入性监测方法的重复性和可行性的假设，并展示使临床应用成为可能的创新技术。这项工作的第二个目标是将Steve Majerus培养成一名独立研究员，能够调查血管健康技术的未来方向。我们的研究计划将通过两个目标进行。目标1将在克利夫兰弗吉尼亚州中城血液透析中心进行一项临床研究，其中将使用数字听诊器和红外(IR)温度计来收集患者血管入口附近的非侵入性信号。这些信号已被证明是通道通畅性的准确指标；我们试图了解患者之间和慢性透析患者内部的信号特征和变异性。目标2将确定使用无线电子设备非侵入性测量血管声音和皮肤温度的可行性。这是一个重要的实验，以了解这种方法的重复性和可变性。为了在超负荷的透析诊所的现实中产生影响，测量方法必须方便使用，并且非医生使用时必须准确。将对拟议的无线方法的局限性进行评估，以确定原型的可行性和未来方向。这项研究旨在进行假设驱动的研究，同时在血管信号分析和无线、可穿戴传感器设计领域产生创新的平台技术。与血管通路狭窄程度和位置相关的心音血管造影和皮肤温度测量的综合分析尚未发表。已发表的无线筛查工具的例子依赖于通过熟练操作员进行的传统听诊。我们试图证明最先进的电子和传感器集成技术的可行性，适合临床部署。这项技术将是临床翻译的极佳候选者，因为它可以在独立的透析诊所的经济限制下，实现对血管通畅的简单筛查。

 DESCRIPTION (provided by applicant): Long-term dialysis success and cost is dependent on maintaining a patient's vascular access, a surgically- created artery-vein bypass region that can permit high blood flow. During dialysis, blood is drawn from a needle in the arterial side of the access, filtered by a hemodialysis unit, and then returned to the patient through a second downstream needle. The vascular access is also known as the "Achilles Heel" of hemodialysis, as maintaining the high flow characteristics (access patency) is critical to achieving efficient dialysis treatment. Vascular accesses are subjected to monitoring and surveillance to identify internal narrowing (stenosis) which can lead to access blockage (thrombosis). The goal of access monitoring is to pre- emptively treat stenosis with a routine surgical procedure before thrombosis occurs. Current access monitoring relies on skilled operators and specialized equipment and cannot be effectively applied to all patients due to economic realities within the hemodialysis standard-of-care. We propose clinical experiments to demonstrate and evaluate new approaches for non-invasive screening of hemodialysis vascular access patency. We are interested in studying the feasibility of autonomously gathering vascular signals using digital stethoscopes and skin temperature measurements to provide a continuous and real-time measure of arteriovenous graft patency. We will pursue this research to answer hypotheses regarding the reproducibility and feasibility of this non-invasive monitoring method, and to demonstrate innovative technology to enable clinical application. A second objective of this work is to train Steve Majerus to be an independent researcher capable of investigating future directions for vascular health technology. Our research plan will be conducted through two objectives. Objective 1 will conduct a clinical study at the Cleveland VA Midtown Hemodialysis Center in which digital stethoscopes and infrared (IR) thermometers will be used to gather non-invasive signals near patient's vascular accesses. These signals have been shown to be accurate indicators of access patency; we seek to understand the signal characteristics and variability across patients and within patients on chronic dialysis. Objective 2 will determine the feasibility of non-invasively measuring vascular sounds and skin temperatures using wireless electronics. This is an important experiment to understand the reproducibility and variability of this approach. To make an impact within the realities of over-loaded dialysis clinics, the measurement method must be convenient to use and accurate when used by a non-physician. The limitations of the proposed wireless approach will be assessed to determine prototype feasibility and future directions. This study aims to pursue hypothesis-driven research while producing innovative platform technologies in the fields of vascular signal analysis and wireless, wearable sensor design. A comprehensive analysis of phonoangiograms and skin temperature measurements relative to vascular access stenosis level and location has not yet been published. Published examples of wireless screening tools have relied on traditional auscultation via a skilled operator. We seek to demonstrate the feasibility of state-of-the-art electronics and sensor integration technology that is suitable for clinical deployment. This technology would be an excellent candidate for clinical translation as it could enable simple screening of vascular access patency within the economic constraints of freestanding dialysis clinics.