Simplified Pump Oxygenator for Pediatric Use Phase II

描述（由申请人提供）：Ension，Inc.正在寻求完成一个集成的心肺转流系统，Ped- AMMO，这是专门设计用于新生儿和小尺寸的儿科患者，小于10公斤体重的发展。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，单个装置执行泵送和气体传输功能。我们的经营目标是：额定氧气输送量为100 cc/min，额定二氧化碳输送量为60 cc/min，泵送能力为2.0 L/min，使用的装置膜表面积小于0.2 m2，预充体积小于85 cc。该装置中集成了一个使用无孔聚丙烯纤维的热交换器。 该项目的其余目标是泵送和氧合功能的优化，从我们目前的200 cc/min/m2氧气输送（额定流量为2.0Lmin）到更高的气体输送速率（血液流速较低）。我们目前的主动热交换装置比同等的静态热交换装置效率高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，以满足这些小患者的需求。目前通过铸造制造的部件将使用注塑成型技术制造。将根据AAMI标准使用体外实验室试验确认器械功能，然后使用羔羊作为动物模型进行一系列离体实验。 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医生面临的两个主要问题。Ension器械通过非常有效的泵氧合器和加热器/冷却器解决了这些因素，使我们能够缩小整个CPB回路的尺寸，而不会伤害患者。如果成功，Ension相信该产品将很快被整个医学界的儿科灌注师接受。

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.