北京生物醫(yī)學工程

左心耳封堵器體外疲勞耐久性試驗方法

Research on the left atrial appendage occluder fatigue durability test in vitro

作者：羅婷湯京龍劉艷文李曉玲劉攀攀胡君源呂原原

單位：先健科技（深圳）有限公司（深圳518063）；中國食品藥品檢定研究院（北京100050）

關鍵詞：左心耳封堵器；疲勞耐久性；直徑控制法；心房顫動；腦卒中

分類號：R318.04； R197.39

出版年·卷·期（頁碼）：2021·40·1（91-94）

摘要：

目的心房顫動（房顫）是臨床上常見的心律失常之一，左心耳封堵術是在傳統(tǒng)藥物治療之外發(fā)展的通過微創(chuàng)介入封堵左心耳以達到預防血栓栓塞目的的新技術。左心耳封堵器在體內(nèi)承受周期循環(huán)載荷可能會導致封堵器的固定盤發(fā)生疲勞斷裂，威脅患者生命，并且血流對阻流膜的沖擊造成阻流膜破裂導致封堵效果不佳。因此需要建立一種疲勞耐久性試驗方法去評估封堵器在人體中的耐疲勞性能。方法首先根據(jù)醫(yī)藥行業(yè)標準YY 0808-2010確定疲勞試驗采用直徑控制法；然后確定在疲勞試驗中左心耳封堵器的規(guī)格、振幅；最后進行疲勞試驗獲得封堵器在1900萬次疲勞（內(nèi)皮化時間點）和3.8億次疲勞（10年疲勞時間點）后的狀態(tài)。結果 1900萬次疲勞后，阻流膜無破損、縫合線無松脫掉落、金屬部位無斷裂，封堵器未移動；3.8億次疲勞后，左心耳封堵器金屬部位無斷裂無磨損。結論本研究可為研發(fā)和生產(chǎn)左心耳封堵器的企業(yè)及科研機構提供一種便捷、高效的疲勞耐久性評價方法。

Objective Atrial fibrillation (af) is one of the most common arrhythmias in clinic. Left atrial appendage occlusion is a kind of new technology that is different from the development of traditional medicine with minimally invasive interventional auricle to prevent thromboembolism. LAA occluder?in the body under a cycle load could lead to a fatigue fracture, which is life-threatening, and the rupture of the barrier film caused by the blood flow on the barrier film will lead to the poor sealing effect. Therefore, a kind of fatigue durability test to evaluate?the fatigue resistance of occluder?in human bodies needs to be established. Methods The research was conducted by first choosing the diameter control method for the fatigue test according to the pharmaceutical industry standard YY 0808-2010 and then determining the specification and amplitude of left atrial appendage in the fatigue test. Finally, the state of the occluder after 19 million fatigue (endothelialization time point) and 380 million fatigue (10 years fatigue time point) were obtained in accordance with the test steps. Results After the fatigue test of 19 million times, there was no damage to membrane, loosing of the suture line, breakage of the metal parts, or moving fatigue of the sealer. After the fatigue test of 380 million times, the metal parts of the left atrial appendage were free from fracture and wear. Conclusion A convenient and efficient method of fatigue durability evaluation can be provided for enterprises and scientific research institutions that study the left atrial appendage on the basis of the research.

參考文獻：

[1] Panjabi MM. Cervical spine models for biomechanical reserch [J]. Spine,1988(12):2648-2699.

[2] 張松,王振,姚瑤，等.新型左心耳封堵器初步設計[J].中國醫(yī)療器械雜志，2018,42（5）：335-338.

Zhang S，Wang Z，Yao Y，et al. New design of left atrial appendage closure [J]. Chinese Journal of Medical Instrumentation，2018,42（5）：335-338.

[3] 王良意，陳德玉，郭永飛，等.前路減壓不同撐開高度影響頸椎穩(wěn)定性的生物力學評價[J].中國矯形外科雜志,2004,12（23）：1846-1848.

Wang LY，Chen DY，Guo YF，et al. Biomechanical analysis of the effect of different distracting height on the cervical stability after anterior decompression[J]. Orthopedic Journal of China,2004,12（23）：1846-1848.

[4] 尚鵬,劉偉強,吳劍,等.頸椎植入ACP后的三維運動實驗測試研究[J].中國醫(yī)療器械雜志,2007,31(3):163-167.

Shang P，Liu WQ,Wu Jian,et al. An in vitro

experimental study for 3d motion analysis of the cevrical spine with the ACP[J]. Chinese Journal of Medical Instrumentation,2007,31(3):163-167.

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