Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies - Phase II

摘要 这第二阶段STTR应用代表了一个创新的，低成本的主要研究和开发工作。 专为新生儿和儿科体外心脏和心脏手术设计的磁悬浮电机， 心肺治疗我们的第一阶段工作证明了新型磁悬浮电机的可行性 从而实现无接触的血泵叶轮操作。非接触式操作消除了关键磨损区域 以及减少可导致溶血和血栓形成的热量产生。体外 儿科市场目前由单个磁悬浮血泵（Abbott PediMag）提供服务。如同 许多新生儿和儿科医疗产品，PediMag是成人血泵的缩小版 设计用于心切开术后支持（Abbott CentriMag）。虽然PediMag已被用于 在一系列心切开术后支持应用中取得了成功，但其更广泛的使用受到几个因素的限制 包括缺少专门为泵系统设计的辅助部件（例如，儿科血 氧合器和热交换器）、复杂的控制算法和高的一次性成本（大约 每个一次性PediMag泵头8000美元）。为了解决这些缺点，我们开发了一种创新的， 简化的磁悬浮马达，其从一次性的磁悬浮马达中消除了昂贵的稀土磁性元件， 将血液接触组件安装到可重复使用的电机定子上。我们的磁悬浮电机设计还允许 简化的控制算法，以提高鲁棒性并降低功率要求。悬浮电机 使用与目前Ension儿科产品中集成的叶轮和泵壳几何形状相同的叶轮和泵壳几何形状 心肺辅助系统（pCAS）的泵氧合器，并取代机械轴承，旋转 轴和血液接触密封件。我们保留当前pCAS泵几何结构的策略既降低了整体 开发成本，并允许使用现有的全面的体外和体内测试数据的性能 比较。在第一阶段，我们完成了两项急性和一项为期3天的慢性动物研究， 第一阶段的可行性，并确认第二阶段的努力是必要的。第二阶段的目标包括电机和控制器 优化、扩展与FDA质量体系一致的基于风险的设计历史文件（DHF） 法规（QSR），并进行一系列性能测试以确定安全性和可靠性。III期 商业化活动将包括转移到制造以及验证和确认测试， 支持监管备案，以支持在患有心脏和/或心肺疾病的儿科患者中进行的临床试验 功能障碍

Abstract This Phase II STTR application represents the main research and development effort for an innovative, low cost, magnetic levitation motor specifically designed for neonatal and pediatric extracorporeal cardiac and cardiopulmonary therapies. Our Phase I efforts demonstrated feasibility of a novel magnetic levitation motor enabling contact-free blood pump impeller operation. Contact-free operation eliminates critical areas of wear as well as reduces heat generation that can contribute to hemolysis and thrombosis. The extracorporeal pediatric market is currently served by a single magnetically levitated blood pump (Abbott PediMag). As with many neonatal and pediatric medical products, the PediMag is a scaled-down version of an adult blood pump that was designed for post-cardiotomy support (Abbott CentriMag). While PediMag has been used successfully in a range of post-cardiotomy support applications, broader usage is limited by several factors including lack of ancillary componentry designed specifically for the pump system (e.g., pediatric blood oxygenator and heat exchanger), complex control algorithms, and a high disposable cost (approximately $8000 per disposable PediMag pump head). To address these shortcomings, we developed an innovative and simplified magnetic levitation motor that eliminates the costly rare earth magnetic elements from the disposable blood-contacting component to the reusable motor stator. Our magnetic levitation motor design also permits simplified control algorithms for improved robustness and reduced power requirements. The levitation motor uses the same impeller and pump housing geometry as currently integrated in Ension’s pediatric cardiopulmonary assist system’s (pCAS) pump-oxygenator and replaces the mechanical bearings, rotating shaft, and blood contacting seal. Our strategy to retain the current pCAS pump geometry both lowers overall development costs and permits the use of existing comprehensive in vitro and in vivo test data for performance comparisons. In Phase I, we completed two acute and one 3-day chronic animal study that demonstrated Phase I feasibility and confirmed a Phase II effort is warranted. Goals in Phase II include motor and controller optimization, expansion of a risk-based design history file (DHF) consistent with FDA’s Quality System Regulation (QSR), and conduct of a range of performance testing to establish safety and reliability. Phase III commercialization activities will include a transfer to manufacturing and verification and validation testing to support a regulatory filing to support clinical trials in pediatric patients with cardiac and/or cardiopulmonary dysfunction.