北京生物醫(yī)學(xué)工程

新型生物可吸收房間隔缺損封堵器的體外性能測(cè)試

Test of a new type of biodegradable septal defect occluder in vitro

作者：謝兆豐王樹水張智偉劉香東陳賢淼張貴張德元

單位：廣東省心血管病研究所,廣東省華南結(jié)構(gòu)性心臟病重點(diǎn)實(shí)驗(yàn)室,廣東省醫(yī)學(xué)科學(xué)院,廣東省人民醫(yī)院 (廣州510100)

分類號(hào)：R318.04

出版年·卷·期（頁碼）：2016·35·5（521-526）

摘要：

目的對(duì)自制聚左旋乳酸（poly-L-lactic acid,PLLA）房間隔缺損封堵器進(jìn)行材料及其相關(guān)性能的體外測(cè)試，為該封堵器的動(dòng)物實(shí)驗(yàn)提供依據(jù)。方法采用生物可吸收PLLA單絲網(wǎng)編織成雙盤狀封堵器框架，兩盤及腰部都縫有阻流膜，兩盤各縫兩個(gè)鉑銥點(diǎn)作為標(biāo)記。采用PLLA單絲拉伸性能測(cè)試、PLLA絲體外降解實(shí)驗(yàn)、PLLA封堵器主要尺寸測(cè)試、穩(wěn)定性測(cè)試、入鞘力測(cè)試、栓頭焊接強(qiáng)度測(cè)試、鞘管推送力測(cè)試及封堵器XA射線下可視性測(cè)試研究其體外性能。結(jié)果 PLLA房間隔缺損封堵器的體外性能測(cè)試均符合封堵器要求，在磷酸鹽緩沖液(PBS)模擬人體內(nèi)環(huán)境1月后，PLLA分子量下降至初始值的93.5%，2個(gè)月后下降至89.3%，至3個(gè)月時(shí)下降至78.9%。結(jié)論 PLLA房間隔封堵器體外性能測(cè)試良好，具有可降解性，可進(jìn)行下一步的動(dòng)物實(shí)驗(yàn)研究。

Objective To design an atrial septal defect (ASD) occluder made of biodegradable poly-L-lactic acid (PLLA) and to evaluate its mechanical properties and degradation in vitro. Methods The PLLA occluder is the first septal occluder with a biodegradable framework of PLLA, which is designed as “double-umbrella” framework. Two discs and waist are sewn with choked flow membrane while two discs are sewn with two platinum-iridium points respectively as a marker. The tensile properties of PLLA monofilament, PLLA degradation experiment, main dimensions of occluder, stability test, test of ability into the sheath, strength of the occluder, pushing force test of the occluder sheath, visibility test of PLLA occluder under X-rays are selected to test its properties in vitro. Results The properties of PLLA occluder in vitro meet the criterion of occluder. The molecular weight reduces to 93.5% of the initial value one month later, then decreases to 89.3% of the initial value 2 months later, and finally reaches 78.9% of the initial value 3 months later. Conclusions The PLLA occluder for ASD has qualified properties and degradation in vitro, which can be used for the future animal experiment.

參考文獻(xiàn)：

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