新型聚氨酯心脏瓣膜的组织相容性试验

Histocompatibility of a novel polyurethane material for construction of prosthetic heart valve

目的:评价由聚已二酸亚己酯(PDMS)与二甲基硅醚聚合物(PHMO)所构建的新型聚氨酯弹性体作为人工心脏瓣膜材料的可行性。方法:用此材料做致敏试验、全身急性毒性试验和致癌实验,评价其组织相容性。结果:此材料组织相容性良好,致敏试验提示新型聚氨酯材料较对照组有较明显的防止过敏的性能(P<0.05,P<0.01);全身急性毒性试验显示出明显的低毒性(P<0.01);致癌实验提示未见肿瘤样变化。结论:此种新型聚氨酯材料符合人工心脏瓣膜材料组织相容性的要求。

AIM： To evaluate the histocompatibility of a novel polyurethane material used for the construction of prosthetic heart valves. METHODS： Evaluations including hemolysis, stimulation and systemic acute toxicity tests were performed. Polyurethane extracts were injected subcutaneously （SC） in rabbits and intravenously （IV） in mice. Histological and animal responses after 72 h were studied. RESULTS： This material has displayed good histocompatibility. No toxicity was observed. Primary skin irritation test showed no erythema, eschar or edema. CONCLUSION： This novel polyurethane material meets the requirements for material characteristics used for the construction of prosthetic heart valves.