上海交通大学学报（医学版）

›› 2010, Vol. 30 ›› Issue (10): 1307-.doi: 10.3969/j.issn.1674-8115.2010.10.030

• 技术与方法 • 上一篇    下一篇

经皮肺动脉内血栓清除导管的研制与效果评估

樊济海1, 顾秀莲1, 巢胜吾1, 张 鹏1, 陈跃光2, 宓志才3   

  1. 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
  • 出版日期:2010-10-25 发布日期:2010-10-27
  • 作者简介:樊济海（1963—）, 男, 主任医师, 硕士；电子信箱: fanjihai2010@hotmail.com。
  • 基金资助:

    上海市长宁区卫生局项目（20074Y16001）

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

FAN Ji-hai1, GU Xiu-lian1, CHAO Sheng-wu1, ZHANG Peng1, CHEN Yue-guang2, MI Zhi-cai3   

  1. 1.Department of Cardiology, the 455th Hospital of People's Liberation Army, Shanghai 200052, China；2.Department of Cardiology, Minhang Branch of Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201100, China；3.Kangge Medical Equipments Limited Company, Shanghai 200052, China
  • Online:2010-10-25 Published:2010-10-27
  • Supported by:

    Foundation of Changning District Health Bureau of Shanghai, 20074Y16001

PDF (PC)

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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。

关键词: 急性肺血栓栓塞症；血栓清除术, 导管技术, 介入治疗

Abstract:

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.

Key words: acute pulmonary thromboembolism, thrombectomy, catheterization, interventional therapy