PumpKIN PreClinical

PumpKIN 临床前

• 批准号: 8607095
• 负责人: Mark Gartner
• 金额: $ 36.85万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-15 至 2014-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8607095
• 关键词: Area; Blood; Blood Platelets; Blood flow; Cannulas; Carbon Dioxide; Cardiopulmonary; Child; Childhood; Clinical; Clinical Trials; Clinical trial protocol document; Consumption; Data; Development; Devices; Engineering; Ensure; Erythrocytes; Evaluation; Extracorporeal Membrane Oxygenation; Extravasation; Fiber; Freezing; Heparin; Hour; Human; In Vitro; Leukocytes; Life Support Systems; Liquid substance; Membrane; Membrane Oxygenators; Monitor; Oxygen; Oxygenators; Parents; Patients; Phase; Plasma; Polypropylenes; Procedures; Process; Production; Pump; Regulation; Risk; Speed; Sterilization; Support Contracts; Surface; System; Systems Development; Target Populations; Testing; United States National Institutes of Health; Venous; Work; base; biomaterial compatibility; blood oxygenator; cost; design; hazard; hemodynamics; improved; in vitro testing; in vivo; manufacturing process; meetings; next generation; operation; pre-clinical; pressure; product development; protocol development; prototype; purge; seal

The Ension pediatric cardiopulmonary assist system (pCAS) has been designed and developed as a next-generation extracorporeal membrane oxygenation (ECMO) - also called extracorporeal life support (ECLS) - system that provides increased functionality and blood compatibility. The intended use of the pCAS is to provide partial or complete cardiopulmonary support to patients from 2 kg to 25 kg for periods of up to two weeks using a single disposable blood-contacting pump-oxygenator. The system has been specifically designed to accommodate extended support beyond this two-week period by rapid change-out of the pump-oxygenator in a procedure that can be completed in less than five minutes. The system offers key advantages over currently available systems, specifically improved blood compatibility, smaller surface area and priming volume, rapid deployment, and a compact configuration that facilitates parent-child bonding and patient transport. The pCAS system consists of a pump-oxygenator, a control console, and ancillary components that include venous and arterial cannulae and a bubble trap. The pCAS pump-oxygenator is a compact device consisting of a centrifugal impeller directly integrated with a blood oxygenator via a turning diffuser. The oxygenator is comprised of hollow fiber membranes (Celgard polypropylene microporous knitted array) incorporating a heparin-based engineered surface specifically designed to enhance blood compatibility. The pCAS control console functionality includes regulation of pump speed, display of all operational parameters, monitoring for fault conditions, display of alarms, and control of purge fluid supplied to the blood seal. The control console incorporates an internal backup battery capable of providing over two hours of continuous operation should AC power be lost or during patient transport. Prototype pCAS pump-oxygenators and control consoles have been fabricated and tested extensively during the development phase of the pCAS project (primarily supported by NIH Pediatric Circulatory Support contract HHSN268200448189C beginning in April 2004 and ongoing). Candidate designs for the integrated pump-oxygenator and control console, as well as subsequent refinements, were guided by functionality, biocompatibility, clinical, and cost requirements as well as test data, formal hazards analysis, human factors evaluations, computational fluid dynamics (CFD) analyses, and reliability considerations. Manufacturing processes have been established, refined, and validated as part of the product development and prototype production processes. Ension is prepared to assemble and test all necessary pCAS system components under a Quality System compliant with ISO 13485 as well as the design control regulations articulated in 21 CFR 820.30. This includes the continued use of in-depth risk and reliability analysis, management, and mitigation. Ension's pCAS system has been extensively tested in vitro and in vivo during development. In vitro data have demonstrated the pCAS pump-oxygenator's ability to achieve required blood flow rates and pressures and to exchange oxygen and carbon dioxide. Additional in vitro data have confirmed minimal blood damage as evidenced by low levels of red cell, white cell, and platelet consumption, significant improvement in plasma leakage over currently available hollow fiber membrane oxygenators, and improvement in blood compatibility. Ension has conducted in vivo system testing in piglets demonstrating that the pCAS system provides appropriate hemodynamic support for the small patients in the target population and in calves demonstrating longer-term device functionality and blood compatibility.

替代小儿心肺辅助系统（PCAS）已被设计和开发为下一代体外膜氧合（ECMO）（ECMO），也称为体外生命支持（ECLS） - 提供了增加功能性和血液兼容性的系统。 PCA的预期用途是使用单个一次性血液接触式泵关蛋白为2 kg至25 kg的患者提供部分或完整的心肺支持。该系统是专门设计的，可通过在不到五分钟的时间内完成的过程中快速更换泵氧气，以在为期两周的时间内适应扩展的支撑。该系统比当前可用的系统提供了关键的优势，特别改善了血液兼容性，较小的表面积和启动量，快速部署以及紧凑的配置，可促进亲子粘合和患者的运输。 PCAS系统由泵氧合机，控制控制台和辅助组件组成，其中包括静脉和动脉插管以及一个气泡陷阱。 PCAS泵 - 氧合器是一种紧凑的装置，由离心叶轮组成，直接通过转动扩散器直接与血液充氧合整合在一起。氧合剂由空心纤维膜（Celgard聚丙烯微孔针织阵列）组成，这些阵列融合了基于肝素的工程表面，专门设计用于增强血液兼容性。 PCAS控制控制台功能包括调节泵速度，显示所有操作参数，监视故障条件，显示警报以及提供给血液密封的吹扫液的控制。控制控制台结合了内部备用电池，能够在损失AC电源或患者运输过程中提供两个小时的连续操作。 在PCAS项目的开发阶段，PCAS PCAS泵氧合器和控制控制台已经进行了广泛的制造和测试（主要由NIH儿科循环系统支持 支持合同HHSN268200448189C从2004年4月开始，一直持续）。综合泵热和控制控制台以及随后的改进的候选设计受到功能，生物相容性，临床和成本需求以及测试数据，正式危害分析，人为因素评估，计算流体动力学（CFD）分析和可靠性考虑因素的指导。作为产品开发和原型生产过程的一部分，已经建立，完善和验证了制造过程。 insion准备在符合ISO 13485的质量系统下组装和测试所有必要的PCAS系统组件以及在21 CFR 820.30中阐明的设计控制法规。这包括继续使用深入的风险和可靠性分析，管理和缓解措施。 ension的PCAS系统在开发过程中已在体外和体内进行了广泛的测试。体外数据证明了PCAS泵 - 氧合机能够达到所需的血流和压力以及交换氧气和二氧化碳的能力。额外的体外数据已经证实了最小的血液损害，因此低水平的红细胞，白细胞和血小板消耗，血浆泄漏的显着改善，与当前可用的空心纤维膜氧合剂相比，血浆泄漏以及血液兼容性的改善。恩森（Ension）在小猪中进行了体内系统测试，表明PCAS系统为目标人群中的小型患者和犊牛提供了适当的血液动力学支持，这些患者表现出长期的装置功能和血液兼容性。