北京生物醫(yī)學(xué)工程

球囊翼片數(shù)目對裝配后球囊支架系統(tǒng)性能的影響

Effect of balloon wing number on the performance of the assembled balloon expandable stent

作者：艾澤琪谷雪蓮肖善社姜洪焱

單位：上海理工大學(xué)醫(yī)療器械與食品學(xué)院（上海 200093）; 上海微創(chuàng)醫(yī)療器械（集團(tuán)）有限公司（上海 201203）

關(guān)鍵詞： Pebax球囊；冠脈支架；球囊折疊數(shù)目；有限元法

分類號：R318.04

出版年·卷·期（頁碼）：2019·38·6（590-597）

摘要：

目的分析球囊翼片數(shù)目對裝配后球囊支架系統(tǒng)性能的影響，為球囊支架裝配工藝以及球囊支架的后續(xù)設(shè)計(jì)結(jié)構(gòu)優(yōu)化提供理論支持。方法首先對Pebax球囊材料樣本進(jìn)行拉伸試驗(yàn)，得到軸向與周向應(yīng)力應(yīng)變曲線。然后采用抗拉性能弱的球囊周向應(yīng)力應(yīng)變曲線，構(gòu)建基于Yeoh模型的球囊材料本構(gòu)方程。之后使用SolidWorks軟件建立二翼、三翼、五翼球囊以及支架模型，利用ABAQUS軟件對球囊支架進(jìn)行吹塑以及壓握模擬，以球囊表面應(yīng)力、支架最終直徑作為球囊支架系統(tǒng)性能評價(jià)參數(shù)。最后利用水壓爆破儀和游標(biāo)卡尺來檢測裝配后球囊支架系統(tǒng)的爆破壓和直徑，驗(yàn)證有限元模擬的準(zhǔn)確性。并根據(jù)有限元的分析結(jié)果優(yōu)選出三翼和五翼球囊支架進(jìn)行抗脫載力實(shí)驗(yàn)對比分析。結(jié)果仿真中球囊表面應(yīng)力集中在球囊褶皺位置，其中二翼球囊表面應(yīng)力最大。二翼、三翼、五翼球囊支架系統(tǒng)的最終直徑基本相同。實(shí)驗(yàn)結(jié)果與有限元模擬結(jié)果相一致。抗脫載力實(shí)驗(yàn)中五翼球囊支架抗脫載力較三翼球囊支架更大。結(jié)論球囊翼片數(shù)目對裝配后球囊支架系統(tǒng)的性能影響顯著，五翼球囊支架系統(tǒng)在綜合性能評價(jià)上表現(xiàn)出優(yōu)勢。本研究可以指導(dǎo)球囊與支架裝配參數(shù)的調(diào)試以及球囊支架結(jié)構(gòu)的優(yōu)化設(shè)計(jì)。

Objective To analyze the influence from the balloon wing numbers on the performance of the assembled balloon expandable stents, and to provide theoretical support for the balloon stent assembly process and the optimization design of the balloon expandable stent. Methods Firstly, stress-strain curves in axial and hoop directions were obtained through tensile experiments of Pebax balloon sample. Then the material constitutive equation of balloon was established in finite element based on the Yeoh model according to the stress-strain curve of the balloon with weaker tensile strength in hoop direction. Moreover, the stent and balloon models with two-wing, three-wing, five-wing were established by SolidWorks. The process of compression and expanding behavior were simulated in ABAQUS, the parameters such as balloon stress and final diameter of the stent were to evaluate the performance of different balloon expandable stent. Finally, the burst pressure of assembled balloon expandable stents was tested by hydraulic blasting apparatus and the diameters of assembled balloon expandable stents were measured by a caliper to verify the accuracy of the finite element simulation. Based on the results of both simulation and experiment, the balloon expandable stent of three-wing and five-wing were selected for comparison test of anti-dislodgement force experiment. Results The stress concentrated on the position of folded area on the balloon surface. The two-wing balloon had larger stress on balloon surface than others. The final diameters of the two-wing balloon expandable stent was similar to the others. The experimental results were consistent with simulation results. In the anti-dislodgement force test, five-wing balloon expandable stent was better than three-wing balloon expanded stent. Conclusions The balloon wing number has a significant influence on the performance of the assembled balloon expandable stent. The five-wing balloon expandable stent shows the best performance in certain tests. The study promotes the adjustment of balloon expandable stent assembly process parameters and optimization design of balloon stent structure.

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