Catheter-mounted Device for Measuring Intravascular Flow and Pressure

用于测量血管内流量和压力的导管安装装置

• 批准号: 8125373
• 负责人: John Blebea
• 金额: $ 49.1万
• 依托单位: DVX, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-16 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8125373
• 关键词: Advanced Development; Affect; American; Angiography; Animal Experiments; Animals; Balloon Angioplasty; Biocompatible Materials; Blood; Blood Pressure; Blood Vessels; Blood flow; Bypass; Caliber; Cardiology; Cardiovascular system; Caring; Catheters; Clinical; Clinical Trials; Coronary; Coronary Stenosis; Devices; Doppler Ultrasound; Equipment; Film; Flow-It; Goals; Heart; Human; Intervention; Knowledge; Lead; Legal patent; Life; Measurement; Measures; Outcome; Patient Care; Patients; Performance; Peripheral; Phase; Procedures; Progress Reports; Research; Safety; Stenosis; Stents; Structure; Techniques; Technology; Testing; Time; Tube; Ultrasonography; United States; Work; X ray visualization; base; clinically significant; commercialization; cost; electric impedance; improved; innovation; meetings; minimally invasive; new technology; outcome forecast; pressure; programs; sensor; skills; success; tool

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.

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。美国每年进行近一百万例此类手术。这些手术以 X 射线血管可视化、血管造影术为指导。经过几十年的研究，已经确定在血管造影的指导下添加功能测量（即血压和流量测量）可显着改善患者的治疗效果并降低成本。然而，当今大多数手术仍然仅使用血管造影术；目前，功能测量需要昂贵的专用装置和设备以及某些专业技能。 DVX 发明了一种新型血流测量多普勒超声传感器，该传感器价格低廉，可以直接安装在导管上。在该研究项目的第一阶段概念验证部分中，该传感器安装在虚拟导管上，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存在方向敏感性。在拟议的第二阶段中，压力和流量传感器将集成到手术导管上，例如用于球囊血管成形术或支架放置，并且该设备在指导手术中的安全性和实用性已在动物研究中得到证明。第二阶段的目标是推进导管安装设备的开发，使人体临床试验变得适当和理想。这些研究应导致功能测量在基于导管的手术中的广泛应用，改善患者的治疗结果并降低每年数百万患者的费用。 公众健康相关性：该计划的目标是提高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。