Catheter-mounted Device for Measuring Intravascular Flow and Pressure

描述（由申请人提供）：使用导管纠正严重心血管问题的微创治疗彻底改变了心血管护理。在美国，每年有近100万例此类手术。这些手术由血管的X射线可视化、血管造影术引导。经过几十年的研究，已经确定在血管造影引导中增加功能测量，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，今天的大多数程序仍然只使用血管造影术;目前，功能测量需要昂贵的专用设备和设备以及某些专业技能。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，这种安装在假导管上的传感器在动物试验中表现良好。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的角度的影响，与以前的多普勒超声设备相比，该设备具有方向敏感性。在拟议的第二阶段，压力和流量传感器将被集成到手术导管上，例如用于球囊血管成形术或支架置入，并且该器械在动物研究中证明了引导手术的安全性和有效性。II期的目标是推进导管安装器械的开发，以便在人体上进行适当和理想的临床试验。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，改善患者的预后并降低每年数百万患者的成本。 公共卫生相关性：该项目的目标是改善循环系统中基于导管的手术的性能。通过在导管中添加创新的超声设备，导管将提供更准确的治疗，从而以更低的成本提供更好的患者护理。

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.