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Forward viewing catheter-delivered microbubble enhanced sonothrombolysis (FV-CAMUS)

前视导管微泡增强超声溶栓 (FV-CAMUS)

基本信息

批准号：
10219344
负责人：
Xiaoning Jiang
金额：
$ 52.24万
依托单位：
NORTH CAROLINA STATE UNIVERSITY RALEIGH
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-15 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10219344
关键词：
Acoustics Acute Affect Alteplase American Animals Basic Science Blood coagulation Caliber Catheters Cessation of life Clinical Coagulation Process Contrast Media Cytolysis Deep Vein Thrombosis Development Devices Disease Distal Drug Delivery Systems Embolism Endothelium Failure Family suidae Femoral vein Fibrinolysis Fibrinolytic Agents Focused Ultrasound Frequencies Functional disorder Goals Heating Hemorrhage Hour In Vitro Injections Injury Intravenous Leg Letters Lung Lytic Malignant Neoplasms Measures Mechanics Mediating Microbubbles Modeling Monitor Morbidity - disease rate Output Pain Particle Size Pathologic Patients Penetration Performance Peripheral Pharmaceutical Preparations Pharmacology Postphlebitic Syndrome Procedures Prognosis Pulmonary Embolism Quality of life Recurrence Research Residual state Risk Safety Side Source Survivors System Techniques Technology Testing Thrombectomy Thrombosis Thrombus Time Tissues Transducers Translation Process Tube Ulcer Ultrasonic Transducer Ultrasonography Validation Vascular Diseases Veins Venous Work base bone clinical translation clinically significant contrast enhanced deep vein design effective therapy improved in vivo in vivo evaluation innovation innovative technologies interest mortality nanoDroplet new technology novel novel strategies patient population phase change prototype thrombolysis tool

项目摘要

Forward viewing catheter-delivered microbubble enhanced sonothrombolysis (FV-CAMUS) Deep vein thrombosis (DVT) induced pulmonary embolism (PE) causes more than 0.1 million deaths annually in the US alone. Recent innovative treatment techniques for thrombolysis, such as pharmacological dissolution or fibrinolysis and mechanical fragmentation, have showed progressive results, yet still suffer from severe limitations such as low thrombolysis efficiency and long treatment times, frequent bleeding complications, high failure rate, vein injury associated with severe regional dysfunction, recurrence, and the relatively large particle size of residual clot debris which can result in distal embolism. This has led to great interest in sonothrombolysis, the use of focused ultrasound to disrupt clots, yet current commercial sonothrombolysis systems (e.g. EKOS) are still limited by long treatment times and peripheral tissue damage due to heating and excessive acoustic exposure. More recently, our group and others have demonstrated several advances which promise to improve the performance (significantly reduced treatment time) and safety of thrombolysis using a microbubble-mediated forward-looking dual frequency catheter based technology. We hypothesize that the development of a new approach for catheter sonothrombolysis combining multi-frequency tools as well as cavitation-enhancing agents can substantially improve the efficacy, safety, and impact of this approach. In this project, we develop innovative technologies from our collaborative group, each of which has shown notable advantages over current technology, and we hypothesize that together they can overcome existing challenges in the aforementioned acute embolism treatments. Specifically, a 4-French catheter will be integrated with dual acoustic sources - a small aperture dual frequency forward-looking ultrasound transducer, combined with a micro-tube for delivery of microbubbles and lytic agent (tissue-type plasminogen activator or t-PA), to achieve Forward Viewing CAtheter- delivered MicrobUbble enhanced Sonothrombolysis (FV-CAMUS). The FV-CAMUS catheter will be designed, prototyped and characterized, followed by in-vitro, ex-vivo and in-vivo thrombolysis tests in large animals. The proposed FV-CAMUS technology will provide a new tool enabling accurate, fast, and safe thrombus treatment.

前视导管递送微泡增强超声溶栓（FV-CAMUS）深静脉血栓形成（DVT）引起的肺栓塞（PE）每年导致超过10万人死亡仅在美国。最新的溶栓创新治疗技术，如药物溶解或纤维蛋白溶解和机械破碎，已显示出进展性结果，但仍患有严重的局限性，如溶栓效率低和治疗时间长，出血并发症频繁，失败率高，静脉损伤伴严重区域功能障碍，复发，且颗粒相对较大可能导致远端栓塞的残留凝块碎片尺寸。这引起了人们对超声溶栓的极大兴趣，使用聚焦超声破坏血栓，但目前的商业超声溶栓系统（例如EKOS）仍然受到长的治疗时间和由于加热和过度的声学而引起的外周组织损伤的限制 exposure.最近，我们的团队和其他人已经展示了一些进步，这些进步有望改善使用微泡介导的血栓溶解的性能（显著减少的治疗时间）和安全性前瞻性双频导管技术。我们假设一种新的结合多频工具和空化增强剂的导管超声溶栓方法可以大大提高这种方法的有效性、安全性和影响力。在这个项目中，我们开发了创新的技术，其中每一个都显示出显着的优势，比目前的技术，我们假设他们可以一起克服上述现有的挑战急性栓塞治疗。具体而言，4 Fr导管将与双声源集成- 小孔径双频前视超声换能器，与微管结合，用于输送微泡和溶解剂（组织型纤溶酶原激活剂或t-PA），以实现前视导管- 提供了微球增强超声溶栓（FV-CAMUS）。FV-CAMUS导管的设计，原型化和表征，然后在大动物中进行体外、离体和体内血栓溶解试验。的提出的FV-CAMUS技术将提供一种新的工具，能够实现准确、快速和安全的血栓治疗。