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硅胶涂层聚丙烯中空纤维氧合器:实验评估与初步临床应用

Silicone-coated polypropylene hollow-fiber oxygenator: experimental evaluation and preliminary clinical use.

作者信息

Shimono T, Shomura Y, Hioki I, Shimamoto A, Tenpaku H, Maze Y, Onoda K, Takao M, Shimpo H, Yada I

机构信息

Department of Thoracic and Cardiovascular Surgery, Mie University School of Medicine, Tsu, Japan.

出版信息

Ann Thorac Surg. 1997 Jun;63(6):1730-6. doi: 10.1016/s0003-4975(97)00119-7.

DOI:10.1016/s0003-4975(97)00119-7
PMID:9205175
Abstract

BACKGROUND

A membrane oxygenator consisting of a microporous polypropylene hollow fiber with a 0.2-microm ultrathin silicone layer (cyclosiloxane) was developed. Animal experimental and preliminary clinical studies evaluated its reliability in bypass procedures.

METHODS

Five 24-hour venoarterial bypass periods were conducted on dogs using the oxygenator (group A). In 5 controls, bypass periods were conducted using the same oxygenator without silicone coating (group B). As a preliminary clinical study, 14 patients underwent cardiopulmonary bypass with the silicone-coated oxygenator.

RESULTS

Eight to 16 hours (mean, 12.2 hours) after initiation of bypass, plasma leakage occurred in all group B animals, but none in group A. The O2 and CO2 transfer rates after 24 hours in group A were significantly higher than at termination of bypass in group B (p < 0.005 and p < 0.03, respectively). Scanning electron microscopy of silicone-coated fibers after 24 hours of bypass revealed no damage to the silicone coating of the polypropylene hollow fibers. In the clinical study, the oxygenator showed good gas transfer, acceptable pressure loss, low hemolysis, and good durability.

CONCLUSIONS

This oxygenator is more durable and offers greater gas transfer capabilities than the previous generation of oxygenators.

摘要

背景

研发了一种由带有0.2微米超薄硅氧烷层(环硅氧烷)的微孔聚丙烯中空纤维组成的膜式氧合器。动物实验和初步临床研究评估了其在体外循环手术中的可靠性。

方法

使用该氧合器对犬进行了5次24小时的静脉-动脉体外循环(A组)。在5只对照犬中,使用未涂硅氧烷涂层的同一氧合器进行体外循环(B组)。作为初步临床研究,14例患者使用涂硅氧烷涂层的氧合器进行了心肺转流。

结果

体外循环开始后8至16小时(平均12.2小时),B组所有动物均发生血浆渗漏,而A组无渗漏。A组24小时后的氧和二氧化碳转运率显著高于B组体外循环结束时(分别为p<0.005和p<0.03)。体外循环24小时后对涂硅氧烷涂层纤维的扫描电子显微镜检查显示聚丙烯中空纤维的硅氧烷涂层无损伤。在临床研究中,该氧合器显示出良好的气体转运、可接受的压力损失、低溶血和良好的耐用性。

结论

与上一代氧合器相比,这种氧合器更耐用,气体转运能力更强。

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