Simplified Pump Oxygenator for Pediatric Use Phase II

描述(申请人提供)：Ension，Inc.正在寻求完成一种集成的体外循环系统PED-AMMO的开发，该系统专门为体重低于10公斤的新生儿和小儿科患者设计。Ension系统不需要集成单独的组件来执行其传质和泵送功能。PED-AMMO的新颖设计允许制造第一个真正的血泵-氧合器。也就是说，单个设备同时执行泵送和气体传输功能。我们的操作目标是：额定氧气传输量为100cc/min，额定二氧化碳气体传输量为60cc/min，泵送能力为2.0L/min，使用的设备膜表面积小于0.2m2，启动体积小于85cc。集成在该设备中的是使用无孔聚丙烯纤维的热交换器。 该项目的剩余目标是优化泵和氧合功能，从我们目前在额定流量为2.0Lmin时的200cc/min/m2氧气传输，到在较低血流速度下更高的气体传输速率。我们目前的有源热交换单元比同等的静态热交换单元效率高25%，需要直接集成到泵-氧合器模块上。目前的Model 1控制器和电机需要优化，以满足这些微小患者的需求。目前由铸造制造的部件将使用注塑技术制造。该装置的功能将通过AAMI标准的体外台架测试来确认，然后在一系列以羔羊为动物模型的体外实验中得到确认。 市场研究表明，预充量和异物表面积是儿科心血管外科医生和灌注师面临的两个主要问题。Ension设备通过非常高效的泵式氧合器和加热器/冷却器解决了这些因素，使我们能够在不损害患者的情况下缩小整个CPB电路的尺寸。如果成功，Ension相信这种产品将很快被整个医学界的儿科输液师接受。

DESCRIPTION (provided by applicant): Ension, Inc. is seeking to complete the development of an integrated cardiopulmonary bypass system, Ped- AMMO, that is specifically designed for use in neonatal and small-sized pediatric patients, less than 10 kg body weight. The Ension system does not require integration of separate components to perform its mass transfer and pumping functions. Ped-AMMO'S novel design permits fabrication of the first true blood pump- oxygenator. That is, a single device performing both pumping and gas transfer functions. Our operating goals are; rated oxygen gas transfer of l00cc/min, rated carbon dioxide gas transfer of 60cc/min, and a pumping capability of 2.0L/min, using devices with less than 0.2m2 membrane surface area with a priming volume of less than 85cc. Integrated in this device will be a heat exchanger using non-porous polypropylene fibers. The remaining goals for this project are the optimization of pumping and oxygenation functions, from our current 200cc/min/m2 oxygen transfer at a rated flow of 2.0Lmin to higher gas transfer rates at lower blood flow rates. Our current active heat exchange unit, which is 25 % more efficient than an equivalent static heat exchange unit, requires integration directly onto the pump-oxygenator module. The current Model 1 controller and motor require optimization to meet the needs of these tiny patients. Components that are currently made by casting will be made using injection molding techniques. Device function will be confirmed using in vitro bench tests per AAMI standards and then in a series of ex vivo experiments using lambs as the animal model. Market research indicates that priming volume and foreign surface area are two of the major concerns facing pediatric cardiovascular surgeons and perfusionists. The Ension device addresses these factors with a very efficient pump-oxygenator and heater/cooler that enables us to downsize the entire CPB circuit without harming the patient. If successful, Ension believes that this product would receive quick acceptance by pediatric perfusionists throughout the medical community.