Simplified Pump Oxygenator for Pediatric Use Phase II

描述（由申请人提供）：Ension, Inc.正在寻求完成一种集成的体外循环系统Ped- AMMO的开发，该系统专门设计用于新生儿和体重小于10公斤的小儿科患者。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，一个装置同时执行泵送和气体传递功能。我们的经营目标是；氧气的额定传气量为l00cc/min，二氧化碳的额定传气量为60cc/min，泵送能力为2.0L/min，使用的装置膜表面积小于0.2m2，起吸体积小于85cc。集成在该装置中的是一个使用无孔聚丙烯纤维的热交换器。

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.