经皮肺动脉内血栓清除导管的研制与效果评估  

Assessment of effect and development of percutaneous pulmonary artery thrombus clear catheter

作　　者：樊济海[1] 顾秀莲[1] 巢胜吾[1] 张鹏[1] 陈跃光[2] 宓志才 

机构地区：[1]中国人民解放军第四五五医院心内科,上海200052 [2]上海交通大学医学院附属瑞金医院闵行分院心内科,上海201100 [3]上海康鸽医疗器械股份有限公司,上海200052

出　　处：《上海交通大学学报（医学版）》2010年第10期1307-1311,共5页Journal of Shanghai Jiao tong University:Medical Science

基　　金：上海市长宁区卫生局项目(20074Y16001)~~

摘　　要：目的研制一款专用于大块急性肺血栓栓塞症(APTE)的经皮肺动脉内血栓抽吸装置,并评价其效果。方法选用临床常用的导管材料,采用超声焊接、涂膜工艺、热加工等技术,制作镍钛合金自膨胀伞形开口的负压吸引导管系统。通过体外实验及绵羊体内建立APTE模型(n=10),确证该吸栓导管的安全性、有效性及可操控性等。结果经反复改良导管制作成功,体外及体内实验均显示,该吸栓导管能有效清除血栓,实现栓塞肺动脉血流再通,改善了肺动脉压、外周动脉压、动脉血氧分压及心率等血流动力学指标。结论自制的经皮肺动脉内血栓吸除导管用于动物APTE模型安全有效。Objective To develop a percutaneous pulmonary artery thrombus clear catheter used in patients with acute pulmonary thromboembolism（APTE） and to assess its effect. Methods The commonly used clinical catheter materials were selected under ultrasound welding,film coating,and the hot working technologies to make a self-expandable nitinol umbrella mounted at a catheter-tip to suck thrombus.In vitro and in vivo tests were completed on the established sheep APTE models（n=10） for testing the safety,efficiency,and operability of the device. Results The device were made successfully along with iterative improvements.The tests revealed that thrombus could be extracted perfectly followed by partial recanalizations of pulmonary artery and significant improvements of hemodynamic parameters,such as pulmonary artery pressure,peripheral artery pressure,arterial partial pressure of oxygen,and heart rate. Conclusion The device is safe and feasible in sheep APTE models,and it is confident to have a clinical trial with further improvements of the device.

关 键 词：急性肺血栓栓塞症 血栓清除术 导管技术 介入治疗 

分 类 号：R563.5[医药卫生—呼吸系统] R-332[医药卫生—内科学]