左心耳封堵器体外疲劳耐久性试验方法

Experimental method of the left atrial appendage occluder fatigue durability in vitro

目的心房颤动是临床上常见的心律失常之一,左心耳封堵术是在传统药物治疗之外发展的通过微创介入封堵左心耳以达到预防血栓栓塞目的的新技术。左心耳封堵器在体内承受周期循环载荷可能会导致封堵器的固定盘发生疲劳断裂,威胁患者生命,并且血流对阻流膜的冲击造成阻流膜破裂导致封堵效果不佳。因此需要建立一种疲劳耐久性试验方法去评估封堵器在人体中的耐疲劳性能。方法首先根据医药行业标准YY 0808—2010确定疲劳试验采用直径控制法;然后确定在疲劳试验中左心耳封堵器的规格、振幅;最后进行疲劳试验获得封堵器在1900万次疲劳(内皮化时间点)和3.8亿次疲劳(10年疲劳时间点)后的状态。结果1900万次疲劳后,阻流膜无破损、缝合线无松脱掉落、金属部位无断裂,封堵器未移动;3.8亿次疲劳后,左心耳封堵器金属部位无断裂、无磨损。结论本研究可为研发和生产左心耳封堵器的企业及科研机构提供一种便捷、高效的疲劳耐久性评价方法。

Objective Atrial fibrillation is one of the most common arrhythmias in clinic.Left atrial appendage occlusion is a kind of new technology that is different from the development of traditional medicine with minimally invasive interventional auricle to prevent thromboembolism.LAA occluder in the body under a cycle load could lead to a fatigue fracture,which is life-threatening,and the rupture of the barrier film caused by the blood flow on the barrier film will lead to the poor sealing effect.Therefore,a kind of fatigue durability test to evaluate the fatigue resistance of occluder in human bodies needs to be established.Methods The research was conducted by first choosing the diameter control method for the fatigue test according to the pharmaceutical industry standard YY 0808—2010 and then determining the specification and amplitude of left atrial appendage in the fatigue test.Finally,the state of the occluder after 19 million fatigue(endothelialization time point)and 380 million fatigue(10 years fatigue time point)were obtained in accordance with the test steps.Results After the fatigue test of 19 million times,there was no damage to membrane,loosing of the suture line,breakage of the metal parts,or moving fatigue of the sealer.After the fatigue test of 380 million times,the metal parts of the left atrial appendage were free from fracture and wear.Conclusions A convenient and efficient method of fatigue durability evaluation can be provided for enterprises and scientific research institutions that study the left atrial appendage on the basis of the research.