Percutaneously-Placed Blood Flow Measuring System

描述(申请人提供)：这项研究是为了开发一种微创的、经皮放置的系统，它将测量体内的血液流动。血液流动使组织保持活力。复杂的仪器，如双工多普勒、核磁共振或CT血管造影术，可以非侵入性地测量血流，但只能提供血流的“快照”。我们的目标是开发微创经皮置入设备，能够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上有意义的信息。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，可以通过手术在人工动脉中植入流量传感器，并通过皮下无线传输流量数据。在NIH赞助的另一个项目中，我们学习了如何制造特殊的柔性超声多普勒换能器系统。在第一阶段中，我们将把这些传感器放在带有支架的动脉内壁上测量流量，传感器的信号由沿壁放置的一条细而窄的条带携带。在第一阶段，“血管内铅”将离开动物身体进行信号处理。未来，对于长期测量，这些信号将连接到植入的装置进行经皮通信。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，并就经皮放置支架装置向团队提供建议。新血管内膜生长和组织反应对这些新成分的影响，以及这些成分对血管组织的任何影响，将通过30天的植入和随后的血管组织病理学检查来评估。在血流监测已经成为可能的地方，如在透析通路移植和腿部搭桥中，长期监测血流显著改善了患者的预后。该项目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，潜在地极大地改善数百万患者的预后。 公共卫生相关性：这项研究旨在开发一种微创植入式设备，能够提供短期和长期可靠、准确的血流监测，从而提供关于患者心血管系统的新的具有医学意义的信息。由于血液流动使组织保持活力，因此有可能防止血液流动衰竭，如心脏病发作，并将血流监测的好处带到循环系统的许多部分，显著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.