【摘要】 目的通过体外实验和动物实验,检测自主研发的一种用于临床心血管急危重症的经皮植入左心辅助装置的血液相容性、流量及可植入性。方法利用自制体外测量装置,在16 V电压下以37°甘油水作为驱动介质运转72 h,测定左心辅助装置流量,观察左心辅助装置流量及有无衰减,左心辅助装置表面温度有无上升;通过对健康成年狗1条行辅助循环,验证左心辅助装置的可植入性,通过超声测量左心辅助装置的流量,检测术前、术后动物血常规变化,并计算溶血指数(normalized index of hemolysis,NIH)以评估血细胞破坏程度。结果左心辅助装置在体外37°甘油水浴中,在16 V电压下运转流量维持在(2.3±0.06)L/min,间隔30 min测量左心辅助装置表面温度无明显变化情况,温度升高(1.41±0.054)℃;直至左心辅助装置连续运行72 h,左心辅助装置无机械损耗,左心辅助装置表面温度无持续升高。左心辅助装置通过股动脉植入,在X光透视下证实左心辅助装置出入水口分别位于主动脉瓣两侧,植入过程顺利,导管无折断;左心辅助装置在额定电压下运转,在动物体内能提供(1.885±0.563)L/min的流量,NIH为(0.054±0.008)g/100 L。左心辅助装置在额定电压范围内,持续在动物体内运转6 h,左心辅助装置无机械损耗。结论本课题组所研制的一种经皮植入式左心辅助装置可通过股动脉顺利植入动物体内,并在动物体内正常运转,稳定性好,有希望成为一种可用于临床上心血管急危重症抢救的左心辅助装置。更多还原

【Abstract】 Objectives To investigate the hemocompatibility, flow and implantation possibility of a domestic percutaneous left ventricular assist device through in vitro and animal experiments. Methods We tested the flow, changes of temperature and performance of the domestic percutaneous left ventricular assist device in 37℃ glycerin-water mixtures for 72 hours by a simple measuring device under the voltage of 16. We also evaluated the hemocompatibility by normalized index of hemolysis(NIH) and implantation possibility by assisting circulation to a healthy dog. Results In 37℃ glycerin-water mixtures, the flow of the percutaneous left ventricular assist device under the voltage of 16 was(2.3 ±0.06) L / min and the temperature showed no significant changes with an increase of(1.41±0.054)℃ every 30 minutes..The percutaneous left ventricular assist device maintained efficient for 72 hours and the temperature didn’t increase continuously..We successfully implanted the percutaneous left ventricular assist device through the femoral artery. Digital subtraction angiography confirmed that the device was located in the ventricular, with the outlet and inlet separately locating across the valve, without sheath ruptures.The flow from percutaneous left ventricular assist device was(1.885±0.563)L / min in the body. NIH was(0.054±0.0082)g /100 L.The percutaneous left ventricular assist device has effectively worked for 6 hours(at least) in the body and showed a good performance. Conclusions We have manufactured a percutaneous left ventricular assist device which can be implanted in the body through femoral artery with a stable and effective performance. It can be a satisfactory assist ventricular device to rescue patients with severe acute cardiovascular diseases in the future.更多还原