Simplified Pump Oxygenator for Pediatric Use

儿童用简化泵式氧合器

• 批准号: 6337531
• 负责人: PHILIP LITWAK
• 金额: $ 10万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6337531
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood flow measurement; blood oxygenator; extracorporeal circulation; heart /lung bypass; hemodynamics; hemolysis; immature animal; miniature biomedical equipment; pediatrics; respiratory gas; respiratory gas analyzer; sheep; thermodynamics

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.

描述（来自申请人摘要的逐字记录）：心脏病 技术公司(CPT)开发了非常有效的主动混合膜 氧合器（AMMO）在输送气体时具有泵血的固有能力。 目前，该装置由0.18 M2的膜表面积和泵组成 3.0 Lpm的血液。CPT建议改变其目前的AMMO设计，以满足 新生儿和婴儿大小的患者（体重小于5 kg）的需求。 实验证据支持我们的设计标准的可行性， 儿科器械包括：膜表面积0.1 M2，额定气体 以50 ml/min的速度转移，泵送能力为1.0 Lpm，预充量为25 ml.该装置的另一个优点是结合了高效的 冷却氧合器单元内的元件，从而进一步利用 主动混合概念，无需单独的加热器/冷却器 歧管第一阶段计划旨在证明以下方面的可行性： 我们的概念。 该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AMMO单位，并执行 充分的体外和体内试验，以评价系统性能， 适用于预期用途。如果成功，我们相信这个CPT 产品将在整个医疗过程中获得儿科灌注师的认可， 社区 拟定商业应用： 儿科患者代表每年大量的心脏直视手术。 目前的氧合器是成人尺寸的装置的小型化版本， 为这些患者优化。 该设备是专门为满足以下需求而设计的： 作为第一个专门为这一人群设计的氧合器， 随着其效率的提高，应该成为这个市场上的主导设备。