Catheter-mounted Device for Measuring Intravascular Flow and Pressure

描述(申请人提供)：使用导管进行微创治疗纠正严重的心血管问题，使心血管护理发生了革命性的变化。在美国，每年有将近一百万例这样的手术。这些手术是由血管的X光可视化、血管造影术指导的。经过几十年的研究，已经确定，在血管造影术的指导下增加功能测量，即测量血压和血流，可以显著改善患者的预后并降低成本。然而，今天的大多数手术仍然只使用血管造影术；目前，功能测量需要昂贵的专门仪器和设备以及某些专门技能。DVX发明了一种新型的血流测量多普勒超声传感器，这种传感器价格低廉，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，这种安装在虚拟导管上的传感器在动物试验中被证明工作良好。DVX还确定了如何将微型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完成对血压和流量的全功能测量。台架测试证明，与以前的多普勒超声设备相比，该设备的高精度不受导管与血流角度的影响，以前的多普勒超声设备受到方位敏感性的影响。在拟议的第二阶段，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放置，并在动物实验中证明该设备在指导程序中的安全性和有效性。第二阶段的目标是将导管安装设备的开发推进到适合和希望在人体上进行临床试验的水平。这些研究应该会导致功能测量在基于导管的手术中的广泛应用，改善患者的结局，并降低每年数百万患者的成本。

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.