镍钛合金支气管封堵器的研制及其实验应用

Development of bronchial occlusive device made of NiTi memory alloy and its application for bronchial closure in dogs

目的 :评价自行研制的镍钛合金支气管封堵器的有效性和安全性。方法 :以镍钛合金丝为原料按预先的设计编织成圆柱状、蘑菇状、哑铃状和朝鲜鼓状 4种形状的封堵器 ,尾部装有用于连接推送杆的螺帽 ;取健康犬 2 4只 ,随机分为 4组 (n=6 ) ,全麻下行气管切开术 ,分别置入金属气管套管 ;经气管套管插入纤维支气管镜 ,在确定封堵靶位后将 4种形状的封堵器分别置入各组动物靶支气管腔内 ,每只犬置入 2枚同形状的封堵器。分别于术后第 1、3、5及 8周时 ,观察封堵器的位置、封堵器周围的支气管组织结构、远端肺组织、全身重要器官及封堵器本身的变化。 结果 :4 8只镍钛合金支气管封堵器均一次成功置入。在为期 8周的观察中 ,4 8只不同形状的封堵器有 1 4只 (2 9.2 % )先后发生移位或脱落 ,其中圆柱状 2只、蘑菇状 7只、哑铃状 5只 ,而朝鲜鼓状封堵器无一发生移位或脱落。封堵器置入后 1周 ,局部呈急性炎症反应 ;3周时 ,局部炎症反应减弱 ,支气管黏膜上皮开始增殖 ;5周时 ,增殖的支气管上皮完全将封堵器覆盖 ,远端肺组织明显萎陷 ;8周时 ,局部炎症反应消失 ,远端肺组织完全萎陷。期间未出现明显封堵远端的阻塞性炎症。8周观察期结束 ,对取出的封堵器进行观察 ,未见明显变形、腐蚀和断裂。 结论 :自制镍钛合金支气?

Objective:To evaluate the efficiency and safety of self-developed bronchial occlusive device made of NiTi memory alloy after being implanted into dogs.Methods:The NiTi alloy wire was woven into various shapes,such as cast-like, mushroom-like,dumbbell-like and Korean drum-like shapes,and a screw was fixed at the end of each shape.Twenty-four healthy dogs were divided into4groups(n=6)and were inserted with metal tracheal cannulas.Fibrobronchoscope was insert-ed through the cannula.After the target location was determined,guiding wire was sent through the biopsy channel of the bronchoscope,and catheter was then sent along the guiding wire.Supervised with fluoroscopy and bronchoscopy,occlusive de-vices were sent to the target location through the catheter in4groups.The changes in the location of occlusive device,the ad-jacent and distal bronchial tissue,other key organs and the occlusive device themselves were observed on the first,third,fifth and eighth week.Results:Forty-eight pieces of occlusive device were implanted successfully into dogs at the first time.During 8weeks of observation,14pieces of occlusive device(29.2%)were displaced or shed;among them there were2cast-like,7mushroom-like,5dumbbell-like devices,while all the Korean drum-like occlusive devices had no displacement or shedding.Bronchial tissue around the occlusive device had acute inflammatory reaction on the first week and epithelia began to prolifer-ate on the third week.On the fifth week,epithelia covered the device totally and distal lung tissue collapsed obviously.On the eighth week,inflammation disappeared and distal lung tissue collapsed totally.There was no obvious obstructive pneumonia in the distal lung tissue during the observation period.After observation,shedding occlusive device was taken out,and no obvi-ous deformation,erosion or rupture was found.Conclusion:This self-developed bronchial occlusive device of NiTi memory al-loy and its implanting system are characterized by accurate localization and easy implantation.Among the4different shapes, the Korean drum-like one has the best effect and satisfactory histocompatibility .