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带集成动脉管路过滤器的泰尔茂Capiox FX05中空纤维氧合器的临床评估。

Clinical evaluation of the Terumo Capiox FX05 hollow fiber oxygenator with integrated arterial line filter.

作者信息

Deptula Joseph, Valleley Melinda, Glogowski Kimberly, Detwiler John, Hammel James, Duncan Kim

机构信息

Department of Cardiothoracic and Vascular Surgery, Children's Hospital and Medical Center, Omaha, Nebraska, USA.

出版信息

J Extra Corpor Technol. 2009 Dec;41(4):220-5.

Abstract

Perfusion techniques and equipment in pediatric open heart surgery have continued to focus on decreasing prime volumes and lowering surface areas of the cardiopulmonary bypass circuit. While this has improved drastically over the last 20 years, greater demand is being placed on the perfusionist to reduce the deleterious effects of bypass without compromising safety or efficiency. Specifically, manufacturers of disposable perfusion equipment have focused on providing pediatric perfusionists with oxygenators that provide the smallest prime and surface area possible while attempting to maximize performance. Recently,Terumo Cardiovascular has introduced the Capiox FX05, a neonatal hollow fiber oxygenator that includes an integrated arterial line filter. The FX05 provides a blood flow range of 0.1-1.5 L/min and a low priming volume of 43 mL. Additionally, it is coated with X Coating, a biocompatible, hydrophilic polymer surface coating that reduces platelet adhesion and protein denaturation. The purpose of this study was to test the FX05 for gas transfer, blood path resistance, and blood handling characteristics in a standardized clinical setting. Heat exchange coefficients were also calculated during the cooling and warming period. Other data analyzed includes bypass circuit prime volumes and initial patient hematocrit along with the total operative homologous blood donor exposures. In summary, the FX05 offers good gas exchange capabilities and a low pressure drop during normal cardiopulmonary bypass parameters along with the safety of an integrated arterial line filter. Furthermore, the FX05 with integrated filter allows a reduction in overall bypass prime volume and surface area while promoting the reduction of homologous blood transfusions, optimizing hemostasis.

摘要

小儿心脏直视手术中的灌注技术和设备一直致力于减少预充量并降低体外循环回路的表面积。尽管在过去20年中这已取得了巨大进步,但对灌注师的要求越来越高,即在不影响安全性或效率的前提下减少体外循环的有害影响。具体而言,一次性灌注设备制造商专注于为小儿灌注师提供尽可能小的预充量和表面积同时试图最大化性能的氧合器。最近,泰尔茂心血管公司推出了Capiox FX05,一款新生儿中空纤维氧合器,其包括一个集成动脉管路过滤器。FX05的血流范围为0.1 - 1.5 L/分钟,预充量低至43 mL。此外,它涂有X涂层,一种生物相容性的亲水性聚合物表面涂层,可减少血小板粘附和蛋白质变性。本研究的目的是在标准化临床环境中测试FX05的气体交换、血路阻力和血液处理特性。在冷却和复温期间还计算了热交换系数。分析的其他数据包括体外循环回路预充量、初始患者血细胞比容以及总的术中同源供血暴露情况。总之,FX05在正常体外循环参数下具有良好的气体交换能力和低压降,同时具有集成动脉管路过滤器的安全性。此外,带有集成过滤器的FX05可减少整体体外循环预充量和表面积,同时促进同源输血的减少,优化止血效果。

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