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

用于儿科心脏和心肺治疗的磁悬浮电机 - II 期

• 批准号: 10192796
• 负责人: Patrick Thomas Cahalan
• 金额: $ 65.25万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10192796
• 关键词: Acute; Address; Adult; Algorithms; Amplifiers; Animals; Area; Automobile Driving; Blood; Blood Platelets; Boston; Cardiac; Cardiopulmonary; Characteristics; Childhood; Chronic; Clinical Trials; Complex; Consumption; Data; Development; Documentation; Electromagnetics; Elements; Evaluation; Functional disorder; Future; Generations; Geometry; Goals; Head; Hemolysis; Housing; In Vitro; Individual; Leukocytes; Life; Magnetism; Mechanics; Medical; Motor; Neonatal; Oxygenators; Pediatric Hospitals; Performance; Phase; Planet Earth; Production; Protocols documentation; Publishing; Pump; Readiness; Recording of previous events; Regulation; Risk; Rotation; Safety; Slice; Small Business Technology Transfer Research; Steel; Support System; Surgeon; Suspensions; System; Techniques; Technology; Testing; Therapeutic; Thrombosis; Work; base; biomaterial compatibility; blood oxygenator; blood pump; commercialization; cost; design; heat exchanger; hemodynamics; improved; in vitro testing; in vivo; in vivo evaluation; innovation; instrument; lamb model; manufacturability; motor control; neonatal patient; novel; operation; patient population; pediatric patients; performance tests; phase 1 designs; prototype; research and development; seal; sensor; verification and validation

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.

抽象的 该 II 期 STTR 应用代表了创新、低功耗的主要研究和开发工作。 成本，磁悬浮电机专为新生儿和儿童体外心脏和 我们的第一阶段工作证明了新型磁悬浮电机的可行性。 实现无接触式血泵叶轮操作 无接触式操作消除了关键磨损区域。 以及减少可能导致溶血和血栓形成的热量产生。 儿科市场目前由单个磁悬浮血泵（Abbott PediMag）提供服务。 在许多新生儿和儿科医疗产品中，PediMag 是成人血泵的缩小版 专为心脏切开术后支持而设计（Abbott CentriMag），而 PediMag 已被使用。 在一系列心脏切开术后支持应用中取得成功，但更广泛的使用受到几个因素的限制 包括缺乏专门为泵系统设计的辅助部件（例如儿科血液 氧合器和热交换器）、复杂的控制算法以及高昂的一次性成本（大约 每个一次性 PediMag 泵头售价 8000 美元。为了解决这些缺点，我们开发了一种创新型的泵头。 简化的磁悬浮电机，消除了一次性产品中昂贵的稀土磁性元件 我们的磁悬浮电机设计也允许将血液接触部件连接到可重复使用的电机定子上。 简化的控制算法可提高鲁棒性并降低功耗要求。 使用与当前 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) 泵氧合器并取代机械轴承、旋转 我们保留当前 pCAS 泵几何形状的策略都降低了整体。 开发成本并允许使用现有的综合体外和体内测试数据来衡量性能 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，证明了这一点。 第一阶段的可行性并确认第二阶段的努力是有必要的。第二阶段的目标包括电机和控制器。 优化、扩展基于风险的设计历史文件 (DHF)，符合 FDA 的质量体系 监管（QSR），并进行一系列性能测试以确定安全性和可靠性。 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，以支持患有心脏病和/或心肺疾病的儿科患者的临床试验 功能障碍。