婴幼儿罗叶泵聚氨酯瓣膜的制作及功能测试

背景：现有成人罗叶泵使用机械瓣,但机械瓣膜的尺寸较大,对血液破坏较大,不适于婴幼儿心室辅助泵,故设计和制作尺寸小、血栓形成低的高分子瓣膜是目前研究的热点。 目的：设计和制作20 mL婴幼儿罗叶泵的瓣膜,并进行基本功能测试和疲劳测试 方法：通过MASTERCAM软件设计瓣膜尺寸和形状,通过制作瓣膜模具和注塑获得聚氨酯瓣膜;根据ISO5840的要求测试聚氨酯瓣膜的静止泄露、跨瓣压差和耐疲劳性能。 结果与结论：制作了聚氨酯三叶瓣膜,但注塑失败率较高;所制作的三叶瓣膜的基本功能基本符合ISO 5840的要求;聚氨酯瓣膜在连续运行1.0×107次后,20 mL罗叶泵的搏出量的变化率为5.2%。两个聚氨酯瓣膜保持完整,瓣叶无变化。说明设计并成功制作了聚氨酯三叶瓣膜;所制备的聚氨酯瓣膜能满足20 mL罗叶泵的需要,已具备了临床试验的能力。

Production and functional testing of polyurethane valve of the pediatric Luo-Ye pump

BACKGROUND: The mechanical valves used in the adult Luo-Ye pump have a large size and great destruction to blood, which are not suitable for infant ventricular assist pump. Therefore, designing and producing a high molecular valve with small size and low incidence of thrombosis is a research hotspot. OBJECTIVE:To design and produce a valve of 20 mL infant Luo-Ye pump, and to test its basic functions and fatigue properties. METHODS: The size and shape of valve was designed with MASTERCAM software, polyurethane valve was obtained through producing the valve model and plastic injection; the static leakage, pressure drop and fatigue resistance of polyurethane valve were tested according to the ISO5840 requirements. RESULTS AND CONCLUSION:The polyurethane trefoil valve was produced, but the failure rate of plastic injection was high; the basic function of the trefoil valve met the ISO5840 requirements bascially; after continuously operated 1.0×107 times, stroke volume of 20 mL Luo-Ye pump was changed 5.2%, and two polyurethane valves and valve leaflets did not change and damage. Polyurethane trefoil valve was designed and produced successfully; polyurethane valves could meet the needs of 20 mL Luo-Ye pump, which already have the ability to clinical trials.