中国组织工程研究

中国组织工程研究 ›› 2018, Vol. 22 ›› Issue (10): 1547-1552.doi: 10.3969/j.issn.2095-4344.0714

• 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外评价实验

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:2018-01-30 出版日期:2018-04-08 发布日期:2018-04-08
  • 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“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 vitro 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. 1Vascular Surgery Department, Xuanwu Hospital, Capital Medical University, Beijing 100053, China; 2School of Materials Science & Engineering, Beijing Institute of Technology, Beijing 100081, China
  • Received:2018-01-30 Online:2018-04-08 Published:2018-04-08
  • Contact: Zhang Jian, Chief physician, Professor, Vascular Surgery Department, Xuanwu Hospital, Capital Medical University, Beijing 100053, China
  • About author:Gao Xi-xiang, M.D., Vascular Surgery Department, Xuanwu Hospital, Capital Medical University, Beijing 100053, China
  • Supported by:
    the National Natural Science Foundation of China, No. 30972944; National Key Rescarch and Development Program of China, No. 2017YFC1104100; the Top Talent Training Plan of Beijing Municipal Administration of Hospitals, No. DFL20150801; the Capital Health Development Research Projects, No. 2016-1-2012; Beijing Health System Plan and Discipline Backbone Training High-Level Health Technical Talent, No. 2014-3-059; Talent Training Plan of Xuanwu Hospital; Beijing Excellent Talent Project, No. 2016000020124G108; Beijing Municipal Administration of Hospitals Incubating Program, No. PX2018035; Beijing Chinese Medical Science and Technique Development Foundation Project, No. JJ2015-09; Capital Medical Research Project, No. 17QK10

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1

摘要：

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文题释义：
下腔静脉滤器：是通过捕捉脱落的静脉血栓以预防肺栓塞的过滤器。1967年Mobin-Uddin 滤器的产生，使得用腔内技术对下腔静脉进行干预成为现实，该装置能够容易地放置于肾下下腔静脉，在临床上应用广泛。1973年stainless steel Greenfield filter开始在临床应用，它能够有效预防肺栓塞，并且保持较高的下腔静脉通畅率。1983年真正意义上的可经皮穿刺放置的滤器——Bird's Nest device开始在临床上应用，而后出现的新一代的滤器放置便利，捕获血栓能力可靠，能够维持长期的下腔静脉通畅率。经过40多年的研究和创新改进及血管腔内介入等相关学科的发展，该方法日臻成熟。
理想的下腔静脉滤器：能够用较小的输送装置经多种途径容易地植入，展开安全，不倾斜；适合各种直径的下腔静脉；拦截所有栓子的同时保持下腔静脉完全通畅；不会造成移位、腔静穿孔及滤器断裂等情况；无磁性；如为可回收滤器，回收操作应简单、安全，并且不会对下腔静脉和滤器造成损害。
 
摘要
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：体外实验评价一种新型可自动变形腔静脉滤器的可变形性及捕栓效率。
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。在体外模型中(体外模型管路直径设置22，25，28 mm3种)植入15枚滤器(水平位和垂直位各植入1次)，测量释放后倾斜角度；通过脂肪酶溶液加速滤器可变形开关降解，评价滤器的可变形性；向体外模型中注入血栓栓子，评价滤器的血栓捕获效率。
结果与结论：①在3种不同直径管路中，无论垂直位还是水平位，所有滤器均成功植入，无滤器倾斜发生；②随着可降解开关的降解，15枚滤器均成功完成变形，变形过程中滤器结构未发生明显改变，无滤器倾斜和移位发生；滤器变形后，变形臂均完全回位，与管路内壁紧密接触；③不同管路直径和栓子大小及两种管路位置之间，可自动变形腔静脉滤器的栓子捕获效率差异均有显著性意义(P <0.001)；在所有情况中，可自动变形腔静脉滤器的平均栓子捕获效率为82.5%；随着管路直径增大、栓子大小的减小，以及管路位置由垂直位变为水平位，可自动变形腔静脉滤器的栓子捕获率降低；④结果表明可自动变形滤器设计可行，栓子捕获效率高。

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: Inferior vena cava filter is an effective way to prevent fatal pulmonary embolism. The existing filters have some shortcomings that limit the clinical application.
OBJECTIVE: To evaluate the feasibility and capture efficiency of a new self-convertible inferior vena cava filter (SCF) in vitro.
METHODS: The biodegradable switch was constructed of a copolymer of ε-caprolactone and L-lactide (75%/25%, PCLA75). The biodegradable switch bound together with the apices of the convertible struts to make the self-convertible filter. The deformability and capture efficiency of the filter were tested in an in-vitro flow model with three different diameters (22, 25, 28 mm). A total of 15 filters were implanted both in the vertical and horizontal positions, and the tilt angle of the filter was tested after release. To accelerate switch degradation, a lipase perfusate was injected into the flow model and refreshed every 8 hours until conversion.
RESULTS AND CONCLUSION: (1) All the filters were successfully implanted without tilting, both in the vertical and horizontal positions in the three different diameter models. (2) All the 15 SCFs were converted successfully without tilting, structural damage, and displacement. (3) The capture efficiency of the SCF had significant difference between the different diameter of the models, the size of the embolus and the position of the two models (P < 0.001). The mean capture efficiency was 82.5%, and the capture efficiency exhibited a downward trend with the increase of pipe diameter, the decrease of emboli size, and the position of pipeline changing from vertical to horizontal. All these results show that the SCF is feasible and highly efficient.

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

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