Catheter-mounted Device for Measuring Intravascular Flow and Pressure

描述（由申请人提供）：使用导管进行微创治疗来纠正严重的心血管问题已经彻底改变了心血管护理。在美国，每年有近100万例这样的手术。这些手术是由x线血管成像指导的。经过几十年的研究，已经确定在血管造影指导下增加功能测量，即血压和流量的测量，可以显著改善患者的预后并降低成本。然而，今天大多数手术仍然只使用血管造影；目前，功能测量需要昂贵的专用仪器和设备以及一定的专业技能。DVX发明了一种新型的血流测量多普勒超声传感器，价格低廉，可以直接安装在导管上。在研究计划的第一阶段概念验证部分，这种传感器安装在假导管上，在动物试验中表现良好。DVX还确定了如何将一个微小的芯片压力传感器安装在流量传感器旁边，以便通过安装在导管上的设备来完成血压和流量的全功能测量。台架测试证明，该设备的高精度不受导管与血流角度的影响，而之前的多普勒超声设备则受到方向敏感性的影响。在拟议的第二阶段中，压力和流量传感器将集成到程序导管上，例如用于球囊血管成形术或支架置入，并且该设备在指导程序中的安全性和有效性已在动物研究中得到证明。II期的目标是推进导管安装设备的发展，使人体临床试验成为合适和可取的。这些研究将导致功能测量在基于导管的手术中的广泛应用，改善患者的预后，并减少每年数百万患者的费用。

DESCRIPTION (provided by applicant): Minimally invasive treatments using catheters to correct a serious cardiovascular problem has revolutionized cardiovascular care. Almost a million such procedures take place each year in the United States. These procedures are guided by X-ray visualization of the vessels, angiography. After several decades of research, it has been established that adding functional measurements, i.e. measures of blood pressure and flow, to guidance by angiography significantly improves patients' outcomes and reduces costs. However, most procedures today still use only angiography; currently, functional measurement requires expensive specialized devices and equipment and certain specialized skills. DVX has invented a new kind of blood flow measuring Doppler ultrasound sensor that is inexpensive and can be mounted directly on a catheter. In the Phase I proof-of-concept portion of the research program, this sensor, mounted on a dummy catheter, was shown to work well in animal trials. DVX also determined how a tiny chip pressure sensor could be mounted alongside of the flow sensor so that full functional measurement of blood pressure and flow could be accomplished by a device mounted on a catheter. Bench tests proved the device's high accuracy was not affected by the angle of the catheter to the blood flow, in contrast to previous Doppler ultrasound devices that suffered from orientation sensitivity. In the proposed Phase II, the pressure and flow sensors will be integrated onto procedural catheters, such as for balloon angioplasty or stent placement, and the safety and usefulness of the device in guiding procedures demonstrated in animal studies. It is the goal of Phase II to advance the development of the catheter-mounted device to where clinical trials on humans will be appropriate and desirable. These studies should lead to widespread application of functional measurement in catheter-based procedures, improving patient outcome and reducing costs for millions of patients per year. PUBLIC HEALTH RELEVANCE: The goal of this program is to improve the performance of catheter-based procedures in the circulatory system. By adding an innovative ultrasound device to catheters, the catheters will provide more accurate treatment, leading to better patient care at reduced cost.