中国组织工程研究

中国组织工程研究 ›› 2018, Vol. 22 ›› Issue (14): 2215-2220.doi: 10.3969/j.issn.2095-4344.0842

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

一种可自动变形腔静脉滤器的体内评价实验

高喜翔1，张 建1，谷涌泉1，郭连瑞1，佟 铸1，李立强1，李建新1，冯增国2   

  1. 1首都医科大学宣武医院血管外科，北京市 100053；  2北京理工大学材料科学与工程学院，北京市 100081
  • 收稿日期:2018-02-12 出版日期:2018-05-18 发布日期:2018-05-18
  • 通讯作者: 张建，主任医师，教授，首都医科大学宣武医院血管外科，北京市 100053
  • 作者简介:高喜翔，男，1981年生，汉族，博士，主要从事高分子材料在血管外科的应用研究。
  • 基金资助:

    国家自然科学基金资助项目(30972944)；科技部国家重点研发计划(2017YFC1104100)；北京市医院管理局临床技术创新项目(扬帆计划XMLX201610)；北京市医院管理局“登峰”人才培养计划(DFL20150801)；首都卫生发展科研专项项目(首发2016-1-2012)；北京市卫生系统高层次卫生技术人才培养计划学科骨干(2014-3-059)；宣武医院“英才培养计划”；北京市优秀人才培养青年骨干个人项目(2016000020124G108)；北京市属医院科研培育计划(PX2018035)；北京中医药科技发展资金项目(JJ2015-09)；首都全科医学研究专项(17QK10)

A new self-convertible inferior vena cava filter: in vivo experimental evaluation

Gao Xi-xiang1, Zhang Jian1, Gu Yong-quan1, Guo Lian-rui1, Tong Zhu1, Li Li-qiang1, Li Jian-xin1, Feng Zeng-guo2   

  1. 1Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China; 2School of Materials Science & Engineering, Beijing Institute of Technology, Beijing 100081, China
  • Received:2018-02-12 Online:2018-05-18 Published:2018-05-18
  • Contact: Zhang Jian, Chief physician, Professor, Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China
  • About author:Gao Xi-xiang, M.D., Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China

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摘要：

文章快速阅读：

 

文题释义：
可自动变形腔静脉滤器：下腔静脉滤器是通过捕捉脱落的静脉血栓以预防肺栓塞，现有滤器存在着一些不足，限制了其临床应用。在临床医疗实践和前期基础研究成果的基础上，将生物可降解材料与当前临床上广泛应用的金属滤器相结合，设计并制备了可自动变形腔静脉滤器。该滤器有一个可降解材料制成的变形开关，滤器在植入体内后随着可降解变形开关被降解，滤器发生自动变形，滤过作用解除，避免了二次手术操作创伤，降低了治疗费用。
可自动变形腔静脉滤器的特点：①固定臂与静脉腔面相吻合，确保滤器位置居中，有效避免倾斜；②变形动作可控，具有定时段拦截栓子功能；③变形后转换为血管支架，以支架形式留存体内，可以在局部起到支撑作用，同时最大程度避免了滤器移位、脱落甚至造成静脉穿孔等并发症；④最大限度地保留腔静脉横断面积、维持局部血液动力状态；⑤避免临时滤器的二次手术创伤，降低治疗费用。
 
 
背景：下腔静脉滤器是预防致命性肺栓塞的有效手段，现有滤器存在着一些不足，限制了其临床应用。
目的：体内实验评价一种新型可自动变形腔静脉滤器的可变形性。
方法：将L-丙交酯、ε-己内酯进行融合聚合，作为滤器的可降解变形开关；采用医用不锈钢丝作为滤器的金属结构部分，将可降解变形开关与金属结构结合，制成可自动变形腔静脉滤器。将8枚可自动变形腔静脉滤器分别植入8只成年比格犬肾下下腔静脉后，行下腔静脉造影，评估滤器的释放、形态和位置。2周后行静脉造影检查评价滤器的形态和位置、下腔静脉通畅情况，以及尸检是否发生肺动脉栓塞及其他并发症。

结果与结论：①8枚可自动变形腔静脉滤器均成功植入，定位准确，无倾斜发生；②术后2周静脉造影证实，8枚可自动变形腔静脉均已成功变形，其中1枚发生了明显移位，移位至下腔静脉入右心房口处，并在该处造成无症状的下腔静脉阻塞；另外7枚可自动变形腔静脉滤器变形后形态位置正常，无倾斜，下腔静脉局部无狭窄及阻塞；肺动脉造影显示肺动脉主干未见明显充盈缺损；尸检发现滤器臂已被内皮化，与滤器臂接触的下腔静脉局部无明显狭窄；在滤器臂的底部有轻度内膜增生，其厚度小于1 mm，未造成管腔的明显狭窄；未发现腔静脉穿孔、腹膜后出血及周围脏器的损伤；③结果说明，可自动变形腔静脉滤器设计可行。

ORCID: 0000-0003-4251-079X(张建)

关键词: 下腔静脉滤器, 肺栓塞, 生物可降解材料, 生物材料, 国家自然科学基金

Abstract:

BACKGROUND: An inferior vena cava filter is an effective tool to prevent fatal pulmonary embolism. The existing filters have some shortcomings that limit their clinical application.

OBJECTIVE: To evaluate the feasibility and capture efficiency of a new self-convertible inferior vena cava filter (SCF) in vivo.
METHODS: L-lactide and ε-caprolactone were fused and polymerized to act as a degradable deformable switch of the filter. Medical stainless steel wire as the metal structure of the filter was combined with the degradable deformable switch to make the SCF. Eight SCFs were implanted into the inferior vena cava of eight adult Beagle dogs. The inferior vena cava angiography was performed to evaluate the release process, morphology and location of the filter. Venous angiography was performed 2 weeks later to evaluate the morphology and location of the filter and inferior vena cava patency. Detection of pulmonary embolism or other complications was performed at autopsy.

RESULTS AND CONCLUSION: Eight SCFs were successfully implanted and positioned accurately with no tilt, and they were converted successfully at 2 weeks after the implantation, as assessed by the venous angiography. One of the eight SCFs migrated to the orifice of the right atrium, and caused asymptomatic inferior vena cava obstruction. The remaining SCFs were normally positioned with no tilt and local lesion or obstruction after deformation. No marked filling defect in the trunk of the pulmonary artery was shown by the pulmonary artery angiography. The autopsy report revealed that the filter arm had been endothelialized, and the inferior vena cava that was in contact with the filter arm had no obvious stenosis. Mild intimal hyperplasia, less than 1 mm in thickness, was found in the bottom of the filter arm, but it did not cause a stenosis in the lumen. No vena cava perforation, retroperitoneal hemorrhage, and injury of the surrounding viscera were found. Overall, the design of the SCF is feasible.

Key words: Vena Cava Filters, Pulmonary Embolism, Animal Experimentation, Tissue Engineering

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