改良小儿胸腔镜心脏手术股动静脉插管材料的血液相容性及毒理学研究

目的 通过对改良小儿胸腔镜心脏手术股动静脉插管材料进行血液相容性及毒理学研究,评价其临床应用的可行性.方法 分别进行溶血实验、皮内刺激实验及小鼠全身急性毒性实验,通过测定吸光度值计算溶血率,按照标准制备的材料浸提液注射到兔的皮下和小鼠体内,观察72h兔皮肤病理变化及小鼠的全身反应.结果 改良小儿胸腔镜心脏手术股动静脉插管材料溶血率为1.58%,低于国际标准(5%);实验组兔皮肤无红斑、水肿及坏死;实验组小鼠无死亡、体重下降及明显全身异常反应.结论 所用材料符合医用材料的要求,可用于临床.

Studies on blood compatibility and toxicology of modified femoral arterial and venous cannulae for children in thoracoscope-assisted cardiac surgery

Objective To evaluate clinical feasibility of using a modified bio-material of femoral arterial and bi-caval femoral venous cannulae for children by investigating the blood compatibility and toxicological characteristics of the bio-material of the cannula.Methods The evaluation tests including hemolysis test,skin irritative test were performed in rabbits,and systemic acute toxic test was performed in mice.First,the haemolysis rate of this modified cannula bio-material was calculated by determination of absorptance conducted in vitro;second,the extracts of this material were prepared according to the national evaluation standards of medical bio-materials,and then the extracts were injected subcutaneously in rabbits to observe the histological responses of skin 72h after injection;finally the prepared extracts were injected intravenously into mice to observe the systemic responses 72h after injection.Results Hemolysis test showed that the hemolysis rate of the novel cannula bio-material was 1.58%,which was much lower than the international standard(5%).The blood compatibility of this material was also satisfactory.Primary skin test in rabbits showed no erythema,necrosis or edema in skin.Furthermore,acute systemic toxic test in mice showed no death and no loss of body weight,and no obvious abnormal response was observed 72h after injection.Conclusion The novel bio-material for femoral arterial venous cannulae for children meets the requirements of medical material property,and it can be clinically used.