Perfusion System for In Utero Cardiac Surgery

宫内心脏手术灌注系统

• 批准号: 7154274
• 负责人: SARAH E MONTAG
• 金额: $ 47.19万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-01-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7154274
• 关键词: bioengineering /biomedical engineering; biomaterial compatibility; biomedical equipment development; blood oxygenator; congenital heart disorder; embryo /fetus; embryo /fetus surgery; extracorporeal circulation; fluidity; heart /lung bypass; heart surgery; hemodynamics; mathematical model; miniature biomedical equipment; pregnancy circulation; respiratory gas; sheep

DESCRIPTION (provided by applicant): Due to advances in fetal echocardiography, fetal cardiac surgery is an increasingly viable strategy to prevent simple cardiac lesions from progressing into serious defects requiring multiple corrective surgeries after birth. A significant obstacle to successful fetal cardiac bypass is placental dysfunction; hypothesized causes include blood contact with extracorporeal surfaces, priming fluids, and increased placental vascular resistance. The overall goal of this Phase II proposal is to complete development of a novel fetal cardiac bypass circuit designed to minimize placental dysfunction by minimizing priming volume, delivering pulsatile flow, and providing adequate gas exchange when the placenta is excluded from the fetal circulation. We believe this fetal perfusion system will serve as key "enabling technology" to facilitate wider adoption of in utero cardiac surgery. The specific aims of this Phase II proposal include: 1) utilizing computational fluid dynamics (CFD) techniques to optimize and subsequently freeze the designs of the fetal blood pump and miniature oxygenator developed during our Phase I work, 2) fabricating a sufficient number of prototype pumps and oxygenators for in vitro and in vivo testing and producing final Phase II componentry using plastic injection molding, 3) moving from the LabView-based controller used in Phase I to a hardware-based stand-alone control unit capable of operating the pump in both continuous and pulsatile flow modes and containing the alarms and other functionality needed for clinical use, 4) performing in vitro testing of circuit with lamb blood to evaluate hemodynamic, gas transfer, and biocompatibility performance, and 5) performing acute and chronic in vivo testing of circuit in a pregnant ewe model. Ultimately, we anticipate that our Phase II fetal perfusion system will advance the field of in utero surgery by allowing clinicians to more safely perform fetal cardiac surgery by avoiding placental dysfunction and, as a result, reduce if not eliminate the multiple, complicated post-birth surgical corrections currently required by these patients. Project Narrative: The overall goal of this Phase II proposal is to complete development of a novel fetal cardiac bypass circuit specifically designed to mitigate placental dysfunction by minimizing priming volume, delivering pulsatile flow, and providing adequate gas exchange when the placenta is excluded from the fetal circulation. Ultimately, this Phase II fetal perfusion system will advance the field of in utero surgery by enabling clinicians to more safely perform fetal cardiac surgery by avoiding placental dysfunction and, as a result, reduce if not eliminate the multiple, complicated post-birth surgical corrections currently required by these patients.

描述（由申请人提供）：由于胎儿超声心动图的进步，胎儿心脏手术是一种越来越可行的策略，可防止简单的心脏病变发展为出生后需要多次矫正手术的严重缺陷。成功进行胎儿心脏搭桥手术的一个重要障碍是胎盘功能障碍。假设的原因包括血液与体外表面的接触、预充液和胎盘血管阻力增加。该第二阶段提案的总体目标是完成新型胎儿心脏旁路回路的开发，该回路旨在通过最小化预充量、提供脉动流量以及在胎盘被排除在胎儿循环之外时提供足够的气体交换来最大程度地减少胎盘功能障碍。我们相信，这种胎儿灌注系统将作为关键的“使能技术”，促进子宫内心脏手术的更广泛采用。该第二阶段提案的具体目标包括：1）利用计算流体动力学（CFD）技术来优化并随后冻结我们在第一阶段工作中开发的胎儿血泵和微型氧合器的设计，2）制造足够数量的原型用于体外和体内测试的泵和氧合器，并使用塑料注射成型生产最终的第二阶段组件，3) 从第一阶段使用的基于 LabView 的控制器转向能够在以下情况下操作泵的基于硬件的独立控制单元连续式和脉动式流动模式并包含临床使用所需的警报和其他功能，4) 使用羔羊血对回路进行体外测试，以评估血流动力学、气体传输和生物相容性性能，以及 5) 在实验室中对回路进行急性和慢性体内测试怀孕母羊模型。最终，我们预计我们的 II 期胎儿灌注系统将推动子宫内手术领域的发展，让临床医生能够更安全地进行胎儿心脏手术，避免胎盘功能障碍，从而减少（如果不能消除）多种复杂的产后并发症。这些患者目前需要手术矫正。 项目叙述：第二阶段提案的总体目标是完成新型胎儿心脏旁路回路的开发，该回路专门设计用于通过最大限度地减少预充量、提供脉动流量以及在胎盘被排除在胎儿之外时提供足够的气体交换来减轻胎盘功能障碍。循环。最终，这个二期胎儿灌注系统将推动子宫内手术领域的发展，使临床医生能够通过避免胎盘功能障碍更安全地进行胎儿心脏手术，从而减少（如果不能消除）目前多重、复杂的产后手术矫正这些患者所需要的。