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.

Ension 儿科心肺辅助系统 (pCAS) 被设计和开发为下一代体外膜氧合 (ECMO)（也称为体外生命支持 (ECLS)）系统，可提供增强的功能和血液相容性。 pCAS 的预期用途是使用单个一次性血液接触泵氧合器为 2 公斤至 25 公斤的患者提供部分或完全心肺支持，持续时间长达两周。该系统经过专门设计，可通过快速更换泵氧合器来提供超过两周的扩展支持，整个过程可在五分钟内完成。与现有系统相比，该系统具有显着的优势，特别是改善了血液相容性、更小的表面积和灌注量、快速部署以及有利于亲子关系和患者转运的紧凑配置。 pCAS 系统由泵氧合器、控制台以及包括静脉和动脉插管以及气泡捕集器在内的辅助组件组成。 pCAS 泵氧合器是一种紧凑型设备，由通过旋转扩散器直接与血液氧合器集成的离心叶轮组成。该充氧器由中空纤维膜（Celgard 聚丙烯微孔针织阵列）组成，结合了专门为增强血液相容性而设计的基于肝素的工程表面。 pCAS 控制台功能包括调节泵速、显示所有操作参数、监控故障情况、显示警报以及控制供应至血液密封件的吹扫流体。控制台配有内部备用电池，如果交流电源丢失或在患者运输过程中，能够连续运行两个多小时。 在 pCAS 项目的开发阶段（主要由 NIH 儿科循环中心支持），原型 pCAS 泵氧合器和控制台已被制造并进行了广泛测试 支持合同 HHSN268200448189C 从 2004 年 4 月开始并持续进行）。集成泵氧合器和控制台的候选设计以及后续改进以功能、生物相容性、临床和成本要求以及测试数据、正式危害分析、人为因素评估、计算流体动力学 (CFD) 为指导分析和可靠性考虑。作为产品开发和原型生产流程的一部分，制造流程已得到建立、完善和验证。 Ension 准备在符合 ISO 13485 以及 21 CFR 820.30 中阐明的设计控制法规的质量体系下组装和测试所有必要的 pCAS 系统组件。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经过广泛的体外和体内测试。体外数据证明 pCAS 泵氧合器能够达到所需的血液流速和压力以及交换氧气和二氧化碳。其他体外数据已证实血液损伤极小，表现为红细胞、白细胞和血小板消耗水平较低，与目前可用的中空纤维膜氧合器相比，血浆渗漏显着改善，并且血液相容性得到改善。 Ension 已在仔猪中进行了体内系统测试，证明 pCAS 系统为目标人群中的小型患者和犊牛提供了适当的血流动力学支持，从而证明了设备的长期功能和血液相容性。