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目的:评估蛋白涂层金属支架植入冠状动脉的生物相容性和致血栓性,并通过造影及病理学检查以确定其对动脉壁的影响。方法:金属支架由316L医用不锈钢丝编织而成,将该支架浸入含有交联剂的明胶溶液一定时间后,经干燥制成蛋白涂层。将蛋白涂层支架固定在3.0mm经皮冠状动脉腔内成形术(PTCA)球囊上,通过8F大腔引导导管植入13只小型猪冠状动脉前降支中段。结果:11只动物支架被成功植入前降支中段,2只动物支架植入前死于心室颤动。支架植入后3天及7天造影证实管腔通畅,无血栓形成、充盈缺损、夹层、栓塞、支架移位或血管痉挛。扫描电镜显示3天时有少量血小板沉积和纤维蛋白形成,且部分内皮化。7天时完全内皮化。4只动物在28天造影时管腔通畅。支架植入节段的所有管腔狭窄直径均<50.0%,平均狭窄直径为(30.0±7.2)%,无闭塞发生。组织病理学检查显示:所有支架植入节段完全内皮化,有不同程度的新生内膜增生,无异物巨细胞聚集,局部管壁完整,无中层坏死。平均新生内膜厚度为0.33±0.17mm,平均新生内膜面积为0.41±0.31mm2,平均百分狭窄面积为(32.0±21.0)%。结论:在小型猪冠状动脉模型中,通过球囊导管系统植入蛋?
OBJECTIVE: To assess the biocompatibility and thrombosis of coronary arteries implanted with protein-coated metal stents and to determine their effect on the arterial wall by angiography and pathology. Methods: The metal stent was braided by 316L medical stainless steel wire. The stent was immersed in a gelatin solution containing a crosslinking agent for a certain period of time and then dried to form a protein coating. The protein-coated scaffolds were mounted on a 3.0 mm PTCA balloon and implanted into the middle of the anterior descending coronary artery of 13 miniature pigs through an 8F lumen guide catheter. Results: Eleven animals were successfully implanted in the middle of the anterior descending artery, and two animals died of ventricular fibrillation before implantation. Stent 3 and 7 days after stent implantation confirmed lumen patency, no thrombosis, filling defect, dissection, embolism, stent displacement or vasospasm. Scanning electron microscopy revealed a small amount of platelet deposition and fibrin formation at 3 days, with partial endothelialization. Complete endothelialization at 7 days. Four animals had lumen patency at 28 days of contrast. All stent stenosis diameters were less than 50.0% and mean stenosis diameter was (30.0 ± 7.2)%. No occlusion occurred. Histopathological examination showed that all stents were completely endothelialized, with different degrees of neointimal hyperplasia, no foreign body giant cells aggregated, partial wall integrity, and no middle necrosis. The average neointimal thickness was 0.33 ± 0.17mm, the average neointimal area was 0.41 ± 0.31mm2, and the average percent stenosis area was (32.0 ± 21.0)%. CONCLUSIONS: In the mini-swine model of coronary arteries, is the balloon catheterized by the balloon catheter system?