可携带^(125)I粒子的胆道引流导管的研制报告

The preparation of self-designed biliary drainage catheter carrying ^(125)I seeds: preliminary study

目的设计一种经皮经肝途径置入可携带放射性粒子的胆道引流导管,以达到胆汁引流和胆道腔内放疗的双重效果,用于治疗恶性胆道梗阻。方法利用常用的导管制作材料聚氨酯,通过铸型加热拉管技术,形成具有3腔结构的导管,导管外径8~10 F,3个腔内径分别为0.75 mm、0.75 mm和≥1 mm,其中≥1 mm内径的管腔作为胆汁引流的通道,2个0.75 mm的管腔做为承载125I粒子的通道。对导管尾端进行特殊设计,便于粒子的置入及引流袋的连接。结果开发研制的胆道粒子引流导管结构合理,125I粒子假源能顺利送入导管的粒子腔道内,电视透视观察粒子能连续排列形成粒子链,并保持不移位;导管引流腔道与尾端引流接口相通,能够保证胆汁的顺利流出。结论本研究研制的导管具有较好的引流效果同时可携带125I粒子,拟对呈线形排列的粒子链的剂量学及生物效应进行计算,通过动物实验进一步探索其介入操作可行性及安全性。

Objective To design a biliary drainage catheter carrying125 I seeds to be used in percutaneous transhepatic procedure for the treatment of malignant biliary obstruction as it carries dual therapeutic effect of intra-biliary radiotherapy as well as bile drainage. Methods The polyurethane material was obtained from conventional catheter. Using heating, elongation and casting techniques, a catheter with three-cavity structure was formed. The outer diameter of this catheter was 8-10 F and the three-cavity inner diameters were 0.75 mm, 0.75 mm and ≥ 1.0 mm respectively. The ≥ 1.0 mm lumen was used as bile drainage channel, while the other two lumens of 0.75 mm were used to load125 I seeds. The end of the catheter was specially designed in order to facilitate the placement of125 I seeds and the connection with drainage bag.Results This self-developed biliary drainage catheter carrying125 I seeds had reasonable structure, the125 I seeds could be smoothly inserted into its lumen. Under fluoroscopic observation, the125 I seeds arranged in rows and the seeds remained stable in the position without shifting. The draining lumen of the catheter was well connected with the drainage interface, which ensured a fluent bile flow. Conclusion This self-developed biliary drainage catheter has good drainage effect, besides the125 I seeds that the catheter carries have radiotherapy effect. The radiation dose and biological effect of the line-arranged125 I seeds need to be further determined. More animal experiments on the feasibility and safety of this procedure are needed.