搏动辅助血泵专用的蝴蝶瓣离体性能测试

目的：对已设计制成的低成本搏动血泵专用瓣膜蝴蝶瓣（butterfly valve,B-Y)按ISO5840进行国际规范化的离体性能测试。方法：先对B－Y瓣进行物理性能测试，然后根据ISO5840的要求用特殊仪器对3枚B－Y瓣作静态及动脉性能测试，其均值与进行同样测试的2种美国进口植入型瓣膜Bjork-Shiley(B-S)瓣和Medtronic-Hall(M-H)瓣作比较。结果：B－Y瓣的物理性能符合临床要求，在静态测试中2枚B－Y瓣膜片过薄，在12mmHg（1kPa=7.5mmHg)水压下有下凹内翻产生较多静止泄漏量。动态测试方面无搏动流中B－Y瓣的跨瓣压力落差及搏动流时跨瓣正压压力阶差均较B－S瓣和M－H瓣膜略高，但其关闭回流量远较B－S瓣与M－H瓣为低，其舒张泄漏量与B－S瓣相仿，而明显低于M－H瓣。结论：B－Y瓣的水流阻力较进口瓣膜为高，但在临床允许范围以内。其总反流量（关闭回流量、舒张泄漏量）明显低于进口瓣膜，保证了瓣膜的效率和耐用性，潜在溶血程度亦因而轻微。B－Y瓣由于结构简单，成本低廉，却有与进口植入型瓣膜相仿的功能，是其主要特点，适合短期辅助循环的临床应用。

In Vitro Study of a Newly Designed Bicuspid Valve (Butterfly Valve) for PulsatileVentricular Assist Device

Objective To evaluate the in vitro performance of a simple bicuspid valve (butterfly valve) for pulsatile ventricular assist device according to the protocol of ISO5840. Methods A comparative study between the butterfly valve(B Y) and 2 reference valves[Bjork Shiley(B S) and Medtronic Hall(M H) valve] were conducted with different test devices. Results In static leakage test, the leakage was prominent in 2 of the B Y valves at a static water pressure of 120 mmHg as a result of faulty fabrication technic of the membrane. The pressure drop and mean transvalvular positive pressure gradiant of B Y valve in steady flow and pulsatile flow test respectively were higher than those of B S and M H valves. Its closing volume, however, was much lower than those of B S and M H valves, and the diastolic leakage, while approximating the B S valve, was again lower than that of the M H valve. Conclusion The bit higher resistance of B Y valve is acceptable for clinical application. The total regurgitation volume (closing volume and diastolic leakage) was substantially lower than that of the 2 imported valves, denoting that B Y valve was more durable and the potential of hemolysis was thus lessened. The cost of B Y valve could be surprisingly reduced owing to its simple structure. It could be effectively used in short term ventricular assist.