血管栓塞用明胶海绵微球的制备及表征  

Preparation and Characterization of Gelatin Sponge Microspheres for Vascular Embolization

作　　者：谭奕勋 云晓 王春曼 吴芬敏 杨顶建 TAN Yi-xun;YUN Xiao;WANG Chun-man;WU Fen-min;YANG Ding-jian(Hainan Biomedical Device Co,.Ltd.,Hainan Dingan 571200)

机构地区：[1]海南百迈科医疗科技股份有限公司,海南定安571200

出　　处：《中国医疗器械信息》2024年第7期25-28,37,共5页China Medical Device Information

摘　　要：目的:制备一种可用于血管栓塞的明胶海绵微球,表征其理化性能,并通过动物试验初步验证其用于体内栓塞的安全性和有效性。方法:在制备明胶海绵微球时,将含有明胶的水相,添加到含有乳化剂的油相中,构建油包水的乳化体系,随后加入交联剂固化得到明胶海绵微球;对制得的微球开展了包括显微外观、粒径、溶胀率、弹性在内的理化性能表征;将制得的明胶海绵微球通过微导管注入猪肾脏血管,观察栓塞效果以及术后的并发症等情况以验证微球用于体内栓塞的安全性和有效性。结果:以此法制得的明胶海绵微球,表面光滑,呈规则球形;溶胀后的粒径呈类正态分布,粒径范围50~2000μm,平均溶胀率为355%,通过质构仪对微球施加粒径50%的压缩形变后,微球不破碎,不变形;猪肾脏栓塞动物试验表明,微球能够有效栓塞靶血管,引起靶组织的缺血梗死,体内降解时长约为28d,降解后血管可复通,试验过程中未见与明胶海绵微球相关的并发症。结论:该方法制得的明胶海绵微球呈完整球形,形状规则,粒径分布范围广,经筛分后具有可用于不同尺寸血管栓塞的潜力。微球具有适中的溶胀率与良好的弹性,便于在术中通过导管进行输送并能够与靶血管紧密嵌合;猪肾脏栓塞动物试验的结果亦表明制得的明胶海绵微球安全性和有效性良好,降解时长适中,运用于血管栓塞具有较大的市场前景。Objective:To prepare a gelatin sponge microsphere for vascular embolization and characterize its physicochemical properties.Its safety and efficacy for embolization was preliminarily verified through in vivo test.Methods:In the preparation of gelatin sponge microspheres,aqueous phase containing gelatin was added into the oil phase containing emulsifying agent,resulting in an oil-in-water emulsion system.Then by adding crosslinking agent,the emulsion system were solidified and transformed into gelatin sponge microspheres.The physical and chemical properties of the prepared microspheres were characterized,including microscopic appearance,particle size,swelling rate and elasticity.The prepared gelatin sponge microspheres were injected into pig renal vessels through microcatheter,and the embolization efficacy and postoperative complications were observed to verify the safety and effectiveness of microspheres for in vivo embolization.Results:The gelatin sponge microspheres obtained by this method were with smooth surface and spherical in shape.After swelling,the particle size conformed normal distribution,the particle size range was basically between 50-2000μm,and the average swelling rate was 355%.Being compressed to around 50%of the diameter through texture analyzer,the microsphere did not break or deform plasticly.In vivo test of pig kidney embolization showed that the microspheres could effectively embolize the target vessels and cause ischemic infarction of the target tissues.Microspheres completely degraded in vivo in 28 days,and the blood vessels were recanalized then.No complications related to gelatin sponge microspheres were observed during the experiment.Conclusion:The gelatin sponge microspheres prepared by this method are spherical with regular shape and wide particle size distribution,and have the potential to be used for vascular embolization for different levels.The microspheres have moderate swelling rate and good elasticity,which are easy to be delivered through the catheter during the operation and

关 键 词：明胶海绵 微球 血管栓塞 猪肾脏 动物试验 

分 类 号：TB324[一般工业技术—材料科学与工程]