Image-guided Non-invasive Ultrasonic Thrombolysis Using Histotripsy

使用组织解剖学进行图像引导的无创超声溶栓

基本信息

  • 批准号:
    8755293
  • 负责人:
  • 金额:
    $ 49.47万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2008
  • 资助国家:
    美国
  • 起止时间:
    2008-09-30 至 2018-06-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Deep vein thrombosis (DVT) is a condition characterized by the formation a blood clot in the deep veins of the legs and affects nearly two million Americans per year. Clinical treatments for DVT include thrombolytic drugs and catheter-based surgical procedures, both of which have significant drawbacks, such as invasiveness and risks of bleeding and infection. Guided by ultrasound imaging, histotripsy is a cavitation-based ultrasound therapy that fractionates tissue. Using our laboratory prototype, histotripsy fractionated in vitro clots into debris smaller than red blood cells at a speed fifty-fold faster tan current clinical thrombolysis methods. Using an in vivo porcine DVT model, histotripsy non-invasively eradicated the thrombus in 10 of 12 cases. By eliminating thrombolytic drugs and catheters, shortening the treatment time, and maintaining or possibly increasing the efficacy for clot removal, histotripsy has the potential to truly change the landscape of thrombosis therapy. The goal of this proposal is to advance the clinical translation of histotripsy thrombolysis. To achieve this goal, we propose the following three specific aims. 1) Design and build an integrated image-guided histotripsy thrombolysis system for DVT patients. 2) Develop two technical innovations (microtripsy and bubble-induced color Doppler feedback) to further improve the safety and efficacy of histotripsy thrombolysis. 3) Determine the in vivo safety and efficacy of the clinically designed histotripsy thrombolysis system through a comprehensive pre-clinical study in the porcine DVT model. These aims are designed to obtain results that are crucial towards achieving approval from the United States Food and Drug Administration (FDA) to inaugurate the first clinical trial of histotripsy thrombolysis. In addition, our proposed comprehensive preclinical in vivo safety study will quantitatively measure all the possible adverse effects of cavitation, which will be essential for clinical translation of all cavitation-bsed thrombolysis techniques including histotripsy. While we are currently studying DVT, there are many other diseases which could benefit from this revolutionary new thrombolysis technique, including stroke, myocardial infarction, superficial vein thrombosis, and peripheral arterial and graft thrombosis. Each poses a significant clinical problem where histotripsy thrombolysis may improve upon current treatment methods.
描述(申请人提供):深静脉血栓形成(DVT)是一种疾病,其特征是在腿部深静脉形成血栓,每年影响近200万美国人。DVT的临床治疗包括溶栓药物和基于导管的外科手术,这两种方法都有明显的缺点,如侵袭性和出血和感染的风险。在超声成像的指导下,组织摩擦是一种基于空化的超声治疗,它将组织分割。使用我们的实验室原型,组织摩擦在体外将凝块分离成比红细胞更小的碎片,速度比目前的临床溶栓方法快50倍。在活体猪深静脉血栓模型中,12例中有10例无创地清除了血栓。通过取消溶栓药物和导管,缩短治疗时间,并保持或可能增加血栓清除的有效性,组织碎石术有可能真正改变血栓治疗的格局。这项建议的目的是促进组织旅行溶栓治疗的临床翻译。为实现这一目标,我们提出了以下三个具体目标。1)设计并构建了一套完整的DVT患者组织学溶栓系统。2)发展两项技术创新(显微碎石术和气泡诱导彩色多普勒反馈),进一步提高组织碎石术溶栓的安全性和有效性。3)通过对猪深静脉血栓模型的临床前综合研究,确定临床设计的组织学溶栓系统的体内安全性和有效性。这些目标的目的是为了获得对获得美国食品和药物管理局(FDA)批准启动组织试验溶栓治疗的第一个临床试验至关重要的结果。此外,我们提议的全面的临床前活体安全性研究将定量测量空化的所有可能的不良影响,这将是所有空化溶栓技术(包括组织摩擦学)的临床翻译所必需的。虽然我们目前正在研究DVT,但还有许多其他疾病可以受益于这一革命性的新溶栓技术,包括中风、心肌梗死、浅静脉血栓形成以及外周动脉和移植物血栓形成。每一种都构成了一个重大的临床问题,其中组织学溶栓可能会改善目前的治疗方法。

项目成果

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Zhen Xu其他文献

Zhen Xu的其他文献

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{{ truncateString('Zhen Xu', 18)}}的其他基金

Ultrasound-guided Ultra-steerable Histotripsy Array System for Non-invasive treatment of Soft Tissue Sarcoma
超声引导超可控组织解剖阵列系统用于软组织肉瘤的无创治疗
  • 批准号:
    10649994
  • 财政年份:
    2023
  • 资助金额:
    $ 49.47万
  • 项目类别:
The Role of Podosomes in Cerebrovascular Integrity and Intracranial Aneurysm
足体在脑血管完整性和颅内动脉瘤中的作用
  • 批准号:
    10586672
  • 财政年份:
    2023
  • 资助金额:
    $ 49.47万
  • 项目类别:
Transcranial Magnetic Resonance guided Histotripsy (tcMRgHt)
经颅磁共振引导组织解剖 (tcMRgHt)
  • 批准号:
    10396108
  • 财政年份:
    2019
  • 资助金额:
    $ 49.47万
  • 项目类别:
Transcranial Magnetic Resonance guided Histotripsy (tcMRgHt)
经颅磁共振引导组织解剖 (tcMRgHt)
  • 批准号:
    10183248
  • 财政年份:
    2019
  • 资助金额:
    $ 49.47万
  • 项目类别:
Novel, Noninvasive, Rapid Tumor Ablation Technology using Histotripsy
使用组织解剖学的新型、无创、快速肿瘤消融技术
  • 批准号:
    10322649
  • 财政年份:
    2018
  • 资助金额:
    $ 49.47万
  • 项目类别:
Image-Guided Non-Invasive Ultrasonic Thrombolysis Using Histotripsy
使用组织解剖学进行图像引导无创超声溶栓
  • 批准号:
    7690225
  • 财政年份:
    2008
  • 资助金额:
    $ 49.47万
  • 项目类别:
Image-Guided Non-Invasive Ultrasonic Thrombolysis Using Histotripsy
使用组织解剖学进行图像引导无创超声溶栓
  • 批准号:
    7559042
  • 财政年份:
    2008
  • 资助金额:
    $ 49.47万
  • 项目类别:
Image-Guided Non-Invasive Ultrasonic Thrombolysis Using Histotripsy
使用组织解剖学进行图像引导无创超声溶栓
  • 批准号:
    8125002
  • 财政年份:
    2008
  • 资助金额:
    $ 49.47万
  • 项目类别:
Image-Guided Non-Invasive Ultrasonic Thrombolysis Using Histotripsy
使用组织解剖学进行图像引导无创超声溶栓
  • 批准号:
    7899949
  • 财政年份:
    2008
  • 资助金额:
    $ 49.47万
  • 项目类别:
Image-guided Non-invasive Ultrasonic Thrombolysis Using Histotripsy
使用组织解剖学进行图像引导的无创超声溶栓
  • 批准号:
    8875679
  • 财政年份:
    2008
  • 资助金额:
    $ 49.47万
  • 项目类别:

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