2024 年第 2 期 第 0 卷

国产微型可植入式左心室辅助装置安全性和有效性的动物实验研究

Animal experimental study on the safety and effectiveness of domestically produced miniature implantable left ventricular assist device

作者：徐灿1杨光2王东进1廖云燕3余顺周3魏旭峰2

英文作者：Xu Can1 Yang Guang2 Wang Dongjin1 Liao Yunyan3 Yu Shunzhou3 Wei Xufeng2

单位：1南京中医药大学鼓楼临床医学院南京大学医学院附属鼓楼医院心脏外科，南京210008；2江苏省无锡明慈心血管病医院心血管外科，无锡214073；3深圳核心医疗科技有限公司，深圳518000

英文单位：1Department of Cardiovascular Surgery Drum Tower Clinical Medical College of Nanjing University of Chinese Medicine Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School Nanjing 210008 China; 2Department of Cardiovascular Surgery Wuxi Mingci Cardiovascular Hospital Jiangsu Province Wuxi 214073 China; 3Shenzhen Core Medical Technology Co. Ltd. Shenzhen 518000 China

关键词：心室辅助装置；心力衰竭；磁悬浮泵

英文关键词：Ventricularassistdevice;Heartfailure;Magneticlevitationpump

• 摘要：

• 目的  通过动物体内植入实验，测试研究一款自主研发的国产可植入式磁悬浮左心室机械循环辅助装置（Corheart 6）的安全性和有效性。方法  选取普通级雄性健康成年绵羊10只，常规全身麻醉后左侧第5肋间开胸，建立体外循环，植入Corheart 6，泵尺寸34 mm×26 mm，重量90 g。Corheart 6连接左心室及降主动脉进行左心室辅助。术后撤除体外循环，持续监测动物生命体征及Corheart 6运转情况。肝素静脉滴注维持活化凝血时间>500 s。观察动物整体存活情况、血液相容性情况并于实验终止时行心脏解剖病理分析。结果  10只绵羊术后心脏全部复跳，均能成功撤离体外循环辅助，8只动物术后正常存活到达预期实验终点（61～65 d），2只未到达实验终点，其中1只心肌组织意外进入血泵提前终止实验，另外1只于术后23 d死亡，死亡原因为肺部出血，与抗凝药物治疗有关。实验使用的Corheart 6泵运行良好，在整个实验过程中未出现自身原因导致的停机或其他运行故障。实验动物未发现有明显溶血，整体的血液指标都在正常范围内，未发现显著异常。8只存活至实验终点的羊，解剖取出的心脏大小和形态正常，且无明显的出血点与血栓形成，其余脏器也基本正常。血泵入口均无血栓形成，泵体内、泵出口也无明显的血栓形成与组织沉积，入口管与心尖顶环连接紧密无松动，血管保护套与泵出口连接良好，人工血管与主动脉段吻合良好。结论  在本动物实验研究中，Corheart 6表现了体积小、易于植入、性能稳定的特点，具有良好的血流动力学效果和良好的血液相容性。

• Objective  To test and study the safety and efficacy of a self-developed domestic implantable magnetic levitation left ventricular mechanical circulatory assist device(Corheart 6) through in vivo implantation experiments in animals. Methods  Ten normal level male healthy adult sheep were selected, and after conventional general anesthesia, the left side of the 5th intercostal space was opened to establish extracorporeal circulation and implanted with Corheart 6 with pump size 34 mm×26 mm and weight 90 g. Corheart 6 was connected to the left ventricle and descending aorta for left ventricular assist. Postoperatively, extracorporeal circulation was withdrawn and the animals were continuously monitored for vital signs and Corheart 6 operation status. Heparin intravenous infusion maintains activated coagulation time>500 s. The overall survival and blood compatibility of the animals were observed and cardiac anatomical and pathological analysis was conducted at the end of the experiment. Results  All 10 sheep resumed beating after surgery and were successfully withdrawn from the extracorporeal circulation. Eight animals survived normally to the expected experimental endpoint(61-65 d), 2 animals did not reach the experimental endpoint, including 1 case in which myocardial tissue accidentally entered the blood pump and terminated the experiment early, and 1 case died 23 d after surgery due to pulmonary hemorrhage, the cause of death was pulmonary hemorrhage, which was related to anticoagulant drugs. The Corheart 6 pump used in the experiment ran well, and there were no shutdowns or other operational failures caused by its own reasons throughout the entire experiment. No significant hemolysis was found in the experimental animals, and the overall blood indicators were within the normal range, with no significant abnormalities found. The dissected hearts of 8 surviving experimental sheep at the end of the experiment were of normal size and morphology, with no obvious bleeding points or thrombosis, and the other organs were also basically normal. There was no thrombus formation at the inlet of the blood pump, and there was no obvious thrombus formation or tissue deposition inside the pump body or at the pump outlet. The inlet pipe was tightly connected to the apical ring without looseness, and the vascular protective sleeve was well connected to the pump outlet. The artificial blood vessel was well aligned with the aortic segment. Conclusion  In this animal experimental study, Corheart 6 demonstrated small size, easy implantation, stable performance, good hemodynamic effect and good hemocompatibility.