Simplified Pump Oxygenator for Pediatric Use

描述(逐字摘自申请者摘要)：心肺 技术公司(CPT)已经开发出非常高效的活性混合膜 氧合器(弹药)，具有在输送气体时泵送血液的固有能力。 目前，该装置由0.18平方米的膜表面积和泵组成 每分钟3.0升的血液。CPT提议改变其目前的弹药设计，以满足 新生儿和婴儿大小(体重小于5公斤)患者的需要。 实验证据支持我们的设计标准的可行性 儿科装置，包括：膜表面积0.1M2，额定气体 输送速度为50ml/min，泵送能力为1.0LPM，预充量为25 这种装置的另一个优点是结合了高效的 氧合器单元内的冷却元件，从而进一步利用 主动混合概念，不再需要单独的加热器/冷却器 多方面的。此第一阶段计划旨在证明 我们的理念。 这项计划的目的是修改我们目前的设计，以满足 最小的病人，制造儿科大小的弹药单位，并执行 足够的体外和体内试验来评估系统的性能和 对预期用途的适宜性。如果成功，我们相信这项CPT 产品将在整个医疗过程中获得儿科输液师的接受 社区。 建议的商业应用： 儿科患者每年接受大量的心脏直视手术。 目前的氧合器是成人大小设备的微型版本，还没有 为这些患者进行了优化。该设备是专门为满足以下需求而设计的 作为第一台专门为这一人群设计的氧合器，加上 随着其效率的提高，应该会成为这个市场的主导设备。

DESCRIPTION (Verbatim from the Applicant's Abstract): Cardiopulmonary Technologies, Inc. (CPT) has developed very efficient Active Mixing Membrane Oxygenator (AMMO) with an inherent ability to pump blood as it transfers gases. Currently, this device consists of 0.18 M2 of membrane surface area and pumps 3.0 Lpm of blood. CPT is proposing to alter its current AMMO design to meet the needs of newborn and infant sized patients (less than 5 kg body weight). Experimental evidence supports the feasibility of our design criteria for a pediatric device that would include: membrane surface area of 0.1 M2, rated gas transfer of 50ml/min., pumping capability of 1.0 Lpm, and priming volume of 25 ml. Another advantage of this device will be the incorporation of efficient cooling elements within the oxygenator unit, thus taking further advantage of the active mixing concept and eliminating the need for a separate heater/cooler manifold. This Phase I program is designed to demonstrate the feasibility of our concept. The aims of this program are to modify our current design to meet the needs of the smallest patients, fabricate pediatric-sized AMMO units, and perform sufficient in vitro and in vivo trials to evaluate system performance and suitability for the intended use. If successful, we believe that this CPT product would gain acceptance by pediatric perfusionists throughout the medical community. PROPOSED COMMERCIAL APPLICATION: Pediatric patients represent a substantial number of open heart operations each year. Current oxygenators are miniaturized versions of adult sized devices that have not been optimized for these patients. This device is especially designed to meet the needs of small patients and as the first oxygenator designed specifically for this population, coupled with its increased efficiency, should become the dominant device in this market.