Novel Ultrasonic Technique for the Treatment of Hemorrhagic Stroke

治疗出血性中风的新型超声波技术

基本信息

批准号：
9791355
负责人：
Aditya S Pandey
金额：
$ 50.87万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
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：
2018-09-30 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9791355
关键词：
3-Dimensional 3D ultrasound Acoustics Address Aftercare Anatomy Autopsy Axon Blood Vessels Blood coagulation Brain Brain Injuries Brain hemorrhage Brain scan Cadaver Catheters Cerebral hemisphere hemorrhage Cerebral perfusion pressure Cerebrum Clinical Clinical Treatment Clinical Trials Coagulation Process Craniotomy Devices Diagnostic radiologic examination Drainage procedure Edema Elements Ensure Family suidae Feedback Fibrinolytic Agents Focused Ultrasound Future Goals Grant Hematoma Hemoglobin Hemorrhage Histologic Histopathology Hour Human Injury Intracranial Pressure Iron Lead Learning Length Location Magnetic Resonance Imaging Maps Mechanics Medical Methodology Methods Modeling Nervous System Trauma Neurons Neurosurgeon Operative Surgical Procedures Outcome Patients Physiologic pulse Positioning Attribute Precision therapeutics Randomized Clinical Trials Risk Rupture Safety Secondary Prevention Secondary to Stroke Surface Survival Rate Survivors System Techniques Time Tissues Training Trephine hole Ultrasonics Ultrasonography Ventriculostomy X-Ray Computed Tomography base blood product clinical translation cranium design and construction frontal lobe improved improved outcome in vivo injured innovation minimally invasive mortality novel portability preclinical study pressure prevent safety and feasibility

项目摘要

Project Summary Intracerebral hemorrhage (ICH) is the most common type of hemorrhagic stroke with 4 million annual cases worldwide. Evacuation of the ICH leads to reduction in intracranial pressure (ICP) as well as prevention of secondary cerebral injuries. Current strategy for removing ICH requires an invasive craniotomy and the need for traversing normal brain. Minimally invasive methods include: 1) craniopuncture/tPA method which requires days for evacuation of ICH and risk of rehemorrhage; 2) endoscopic ultrasonic aspiration has the force to injure cerebral tissue as well as the need for learning endoscopic techniques. There is a clear unmet clinical need for a minimally invasive method that can safely, effectively, and rapidly reduce the ICH volume without using thrombolytic drugs and be applied with the simplest methodology. We propose histotripsy as a novel ultrasonic technique that can fully address this unmet clinical need. Histotripsy uses microsecond duration, high-pressure ultrasound pulses applied from outside the skull and focused inside the ICH to produce cavitation to liquefy the ICH without causing brain injury. The liquefied ICH can be immediately drained via a small bore catheter. We have used histotripsy with electronic focal steering to achieve rapid transcranial ICH liquefaction (~40 mL in 10 min) and drainage through excised human skulls. We have developed a miniature hydrophone integrated within the catheter to precisely focus the ultrasound through excised human skulls and the catheter can also be used for drainage of the liquefied ICH. We have also demonstrated the in vivo feasibility and safety in a porcine ICH model. We propose three specific aims toward developing Histotripsy as a novel technique for safely evacuating ICH and improving outcomes. 1) Design and construct a portable histotripsy ICH system with real- time 3D feedback that can transcranially liquefy and drain ICH with high precision and efficacy. 2) Validate the targeting precision, treatment location profile, and efficacy of the transcranial histotripsy ICH system in human ICH phantom and fresh human cadaver. 3) Validate the safety and efficacy of the transcranial histotripsy ICH system in an established in vivo porcine ICH model. If these aims are successfully completed, we will establish a portable histotripsy ICH system suitable for clinical use and proceed towards a clinical trial.

项目摘要脑内出血（ICH）是最常见的出血性中风类型，有400万全球年度案件。 ICH的疏散导致颅内压（ICP）降低以及预防继发脑损伤。当前删除ICH的策略需要侵袭性颅骨切开术，并且需要穿越正常大脑。微创方法包括：1）颅骨/TPA方法，需要撤离ICH的天数和风险重新出现； 2）内窥镜超声抽吸也有损害脑组织的力作为学习内窥镜技术的需求。明显未满足的临床需求最小的侵入性方法，可以安全，有效，迅速减少ICH体积不使用溶栓药，并使用最简单的方法应用。我们提出组织疗法作为一种新型的超声技术，可以完全解决这种未定的临床需求。 Histototys使用微秒持续时间，高压超声脉冲应用从头骨外面，集中在ICH内部，生产空化，以液化ICH，而无需引起脑损伤。液化的ICH可以立即通过小孔导管排出。我们已经使用了带有电子局灶性转向的组织疗法来实现快速的经颅液化液化（在10分钟内约40毫升），并通过切除的人头骨排水。我们已经开发了一个微型集成在导管内的水文，以精确聚焦超声通过切除人头骨和导管也可以用于排水液化液。我们也有在猪ICH模型中证明了体内可行性和安全性。我们提出了三个开发组织疗法作为一种安全撤离ICH的新技术的具体目的并改善结果。 1）设计和构建一个可移植的组织智能ICH系统时间3D反馈可以通过高精度和功效进行经颅液化并排出ICH。 2）验证靶向精度，治疗位置轮廓和经颅的功效人类ICH幻影和新鲜人类尸体中的组织疗法系统。 3）验证安全性在既定的体内猪ICH模型中，经颅组织疗法ICH系统的功效。如果这些目标成功完成，我们将建立一个便携式的Histoty ICH系统适用于临床使用，并进行临床试验。