High Intensity Ultrasonic Device for Mitigating Neonatal Perioperative Bleeding

用于减轻新生儿围手术期出血的高强度超声装置

基本信息

批准号：
8780172
负责人：
Stuart B Mitchell
金额：
$ 22.41万
依托单位：
BIODESIGN RESEARCH & DEVELOPMENT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-15 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8780172
关键词：
Acoustics Acute Address Anatomy Animal Model Animals Aorta Aortic Valve Stenosis Benign Biological Blood Vessels Bypass Caliber Cardiac Cardiac Surgery procedures Child Childhood Clinical Clinical effectiveness Coagulation Process Collaborations Common Ventricle Complex Complication Congenital Heart Defects Devices Diagnostic Imaging Effectiveness Emergency Medicine Ensure Focused Ultrasound Therapy Hand Heart Heating Hemorrhage Hemostatic Agents Hemostatic function Histology Hospital Departments In Vitro Intervention Laboratories Left Lesion Life Live Birth Lung Methods Modality Modeling Morbidity - disease rate Nature Neonatal Operative Surgical Procedures Organ Patients Pediatric Hospitals Pediatric Surgical Procedures Perinatal Perioperative Phase Physics Preparation Pulmonary artery structure Regimen Repair Complex Reporting Research Safety Series Severities Solid Surgeon Surgical sutures System Testing Therapeutic Tissues Transposition of Great Vessels Ultrasonic Therapy Ultrasonic Transducer Ultrasonics Ultrasonography Universities Washington aortic arch base clinical application congenital heart disorder design instrumentation mortality novel strategies operation phase 2 study prototype public health relevance reconstruction repaired research and development research clinical testing research study success tissue phantom

项目摘要

DESCRIPTION (provided by applicant): Congenital heart disease (CHD) ranges from benign lesions to life-threatening structural abnormalities. While benign lesions may resolve without intervention, severe structural lesions require complex pediatric cardiac surgery. The reconstruction of the aortic arch in children is a complex repair in which perioperative bleeding i a significant, important and frequent complication. Moderate to severe Congenital Heart Disease (CHD) occurs in about 6/1,000 live births. Severe structural lesions that require complex pediatric surgeries have been reported as about 1/1,000 of live births; too many of these children die as a result of perioperative bleeding and the lack of more effective methods to stop bleeding. The reconstruction of the aortic arch in children with severe congenital heart disease often requires transection of the great vessels, significant augmentation, and then suture repair using very small caliber sutures placed extremely close together to ensure repair integrity. However, due to the complex nature of the repair, the anatomy of the neonatal arch, and the anti-coagulation regimen that is required during the cardio-pulmonary bypass, perioperative bleeding is a significant, important and frequent complication. There is a critical, unmet clinical need for an effective method to effect perioperative hemostasis in such patients. High Intensity Focused Ultrasound (HIFU) provides a novel approach for treating perioperative bleeding. HIFU has been demonstrated qualitatively to effectively induce hemostasis. Our overarching research objective is to mitigate the effects of perioperative bleeding in surgically reconstructed great vessels, thus reducing the perinatal morbidity and mortality associated with surgical procedures. The objectives of this proposal is to establish the feasibility and required parameters such that HIFU can be used safely and effectively to mitigate perioperative bleeding (Aim 1), develop a clinical hand-held HIFU system for treating perioperative bleeding (Aim 2), and conduct in vitro and ex vivo experiments in preparations for Phase II studies in an animal model (Aim 3). This collaboration brings together acoustics and instrumentation expertise at BioDesign Research & Development, acoustic bioeffects expertise at the University of Washington, and pediatric surgeons at Seattle's Children's Hospital to develop a device for mitigating perioperative bleeding of surgically reconstructed neonatal great vessels. This Phase I application proposed to conduct the necessary safety and efficacy studies to develop an indication specific device. Phase II of this project will be to evaluate the device in acute and survival animal models. We project Phase II would require approximately 1 million dollars to produce a device ready for clinical evaluation.

描述（由申请人提供）：先天性心脏病（CHD）范围从良性病变到危及生命的结构异常。虽然良性病变无需干预即可消退，但严重的结构性病变则需要复杂的小儿心脏手术。儿童主动脉弓重建是一项复杂的修复工作，其中围手术期出血是一个重要且常见的并发症。大约 6/1,000 活产婴儿患有中度至重度先天性心脏病 (CHD)。据报道，约 1/1,000 的活产婴儿患有严重的结构性病变，需要进行复杂的儿科手术；这些儿童中有太多人因围手术期出血和缺乏更有效的止血方法而死亡。患有严重先天性心脏病的儿童的主动脉弓重建通常需要横断大血管，进行显着增强，然后使用非常小口径的缝合线进行缝合修复，这些缝合线放置得非常紧密，以确保修复的完整性。然而，由于修复的复杂性、新生儿弓的解剖结构以及体外循环期间所需的抗凝方案，围手术期出血是一种重要且常见的并发症。对于此类患者围手术期止血的有效方法存在着迫切的、未得到满足的临床需求。高强度聚焦超声（HIFU）为治疗围手术期出血提供了一种新方法。 HIFU 已被定性证明可以有效诱导止血。我们的总体研究目标是减轻手术重建大血管围手术期出血的影响，从而降低与手术相关的围产期发病率和死亡率。该提案的目标是建立可行性和所需参数，以便安全有效地使用 HIFU 来减少围手术期出血（目标 1），开发用于治疗围手术期出血的临床手持式 HIFU 系统（目标 2），并进行动物模型 II 期研究准备中的体外和离体实验（目标 3）。此次合作汇集了 BioDesign Research & Development 的声学和仪器专业知识、华盛顿大学的声学生物效应专业知识以及西雅图儿童医院的儿科外科医生，开发一种用于减轻手术重建新生儿大血管围手术期出血的设备。该第一阶段申请建议进行必要的安全性和有效性研究，以开发适应症特定的设备。该项目的第二阶段将在急性和生存动物模型中评估该装置。我们预计第二阶段将需要大约 100 万美元来生产可供临床评估的设备。