Percutaneously-Placed Blood Flow Measuring System

描述（由申请人提供）：本研究旨在开发一种微创、经皮放置的系统，用于测量体内的血流量。血流使组织存活。复杂的仪器，如双多普勒、核磁共振或CT血管造影，可以无创地测量血流，但只能提供血流的“快照”。我们的目标是开发微创经皮放置设备，可以提供急性和长期可靠，准确的血流监测，从而提供关于患者心血管系统的新的医学重要信息。在美国国立卫生研究院的赞助下，我们之前已经开发了一种植入装置，用于在人工动脉中操作手术植入的流量传感器，并通过皮肤无线传输流量数据。在另一个由美国国立卫生研究院赞助的项目中，我们学会了如何制造特殊的柔性超声多普勒换能器系统。在第一阶段，我们将用支架将这些换能器固定在动脉内壁上来测量流量，换能器的信号由一根细而窄的条带沿着动脉壁传递。在第一阶段，“血管内导联”将离开动物身体进行信号处理。在未来，对于长期测量，这些信号将连接到一个植入式装置进行经皮通信。与我们合作的是一位杰出的心脏外科医生和介入心脏病专家，他将进行外科研究并为团队提供经皮放置支架装置的建议。新内膜生长和组织对这些新成分的反应的影响，以及这些成分对血管组织的任何影响，将通过30天的植入和血管的组织病理学检查来评估。在有可能进行血流监测的地方，如透析通道移植物和腿部旁路移植物，长期监测血流可显著改善患者预后。该计划的目标是证明一种新的经皮血流测量系统的概念，将血流监测的好处带到循环系统的许多部分，可能极大地改善数百万患者的预后。

DESCRIPTION (provided by applicant): This research is to develop a minimally invasive, percutaneously-placed system that will measure blood flow in the body. Blood flow keeps tissue alive. Sophisticated instruments, such as duplex Doppler, MRI or CT angiography, can measure blood flow noninvasively, but provide only a "snapshot" of the flow. Our goal is to develop minimally invasive percutaneously-placed devices that can provide both acute and long-term reliable, accurate monitoring of blood flow, thus providing new medically significant information about patients' cardiovascular systems. We have previously developed, under NIH sponsorship, an implant unit to operate a surgically implanted flow sensor in an artificial artery, and wirelessly transmit the flow data transcutaneously. Under another NIH-sponsored program, we have learned how to make special flexible ultrasound Doppler transducer systems. In this Phase I, we will measure flow by holding these transducers against the inside wall of an artery with a stent, with signals to and from the transducers carried by a thin, narrow strip lying along the wall. In Phase I, the "intravascular lead" will exit the animal body for signal processing. In the future, for long-term measurements, these signals will connect to an implanted unit for transcutaneous communication. Collaborating with us are an outstanding cardiac surgeon and interventional cardiologist who will perform the surgical studies and advise the team on percutaneously placing stent-devices. The effects of neointimal growth and tissue response on these new components, and any effects of these components on vessel tissue, will be evaluated by a 30-day implant followed by histopathological examination of the vessel. Where flow monitoring has been possible, as in dialysis access grafts and leg bypass grafts, long-term monitoring of flow has significantly improved patient outcomes. The goals of this program are to prove the concept of a new percutaneously placed blood flow measuring system to bring the benefits of flow monitoring to many parts of the circulatory system, potentially greatly improving outcomes for millions of patients. PUBLIC HEALTH RELEVANCE: This research is to develop a minimally invasive implantable device that can provide both short and long-term reliable, accurate monitoring of blood flow, thus providing new medically significant information about a patient's cardiovascular system. Since blood flow keeps tissue alive, it may be possible to prevent failures of blood flow, such as heart attacks, and bring the benefits of flow monitoring to many parts of the circulatory system, significantly improving outcomes for millions of patients.