新型可降解食管支架的设计研究  

The Design Research on a New Novel Biodegradable Esophageal Stents

作　　者：高小龙 冷德嵘 刘春俊 胡洁 张岚 李常青 唐志 沈正华 

机构地区：[1]南京微创医学股份科技有限公司,南京210032

出　　处：《中国医疗器械信息》2016年第11期1-7,共7页China Medical Device Information

摘　　要：目前,良性食管狭窄的发病比例越来越高,对于复杂性食管良性狭窄的治疗方式主要为内镜下治疗支架置入。金属支架植入后由于粘膜增生,导致二次手术时支架不易回收,增加了病人的痛苦,而可降解支架在人体管腔内完成治疗使命后,支架不断降解,最终在体内降解消失,避免了长期异物影响带来的并发症,以及再取出支架的痛苦。本文通过比较目前不同可降解材料制备的可降解非血管支架的研究进展,如PLA、PLLA、PGA、PLGA、PDO等可降解支架,选用PDO作为可降解支架编织材料,同时设计了几种不同结构的支架,通过对比支架各方面的性能,发现分段式可降解支架,具有良好的支撑性能,且易于装载入输送装置;进一步通过动物实验研究发现,PDO丝材编织的分段式可降解支架,可以在动物体内以较高的力学性能持续维持6周,而不发生移位、结构破坏;8周以后,支架崩解,随后消失,而相应的粘膜增生恢复;因此,初步确认上述可降解支架在动物体内是安全的、有效的,具有良好的临床应用价值与市场前景。在此基础上,进一步对研究过程中发现的可降解支架的问题,以及改进方向做了相关阐述。At present, the incidence rate of benign esophageal stenosis has become more and more high. And the stent implantation under endoscopic has become the main treatment method for the complexity of benign esophageal stenosis. Unfortunately, due to the mucosal hyperplasia after Stent implantation, the stents is not easy to recover, and increase the pain of patients. However, the biodegradable stents continue to degrade until they finally disappear when the treatment mission is complete in the buman lumen. It avoids the complications caused by long-term foreign body effects, as well as the pain of removing the stent. Tiffs article through the comparison of the research progress of the biodegradable non vascular steuts by different degradable materials, Such as PLA, PLLA, PGA, PEGA, PDO and other biodegradable stents. PDO is selected as the biodegradable stent woven material. At the same time, several different structures were designed, it is show that the segmented degradable stent has good supporting performance by the comparison of different aspects perlbrmance of the stents, and is easy to be loaded into the delivery system. The lhrther animal experiments were also carried out. The higher mechanical properties of the segmented degradable stent can be sustained for 6 weeks without displacement and structural damage. After 8 weeks, the stent disintegrated and disappeared, and the corresponding mucosal hyperplasia recovered. It can be initially confirmed the degradable stent is sale and effective in vivo animal, and has clinical application value and good market prospects. In addition, the related problems and improvement direction of the degradable stent were further expounded.

关 键 词：良性食管狭窄 可降解支架 PLA PDO 动物实验 安全性评估 可降解 

分 类 号：R318[医药卫生—生物医学工程]