An innovative occluder for cardiac defect: 3D printing and a biocompatibility research based on self-developed bioabsorbable material—LA-GA-TMC
An innovative occluder for cardiac defect: 3D printing and a biocompatibility research based on self-developed bioabsorbable material—LA-GA-TMC
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创新型心脏缺损封堵器：基于自主研发生物可吸收材料的3D打印及生物相容性研究——LA-GA-TMC
DOI：
10.1002/jbm.b.34550
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发表时间：
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通讯作者：
Xing Quansheng
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作者：
Sun Yiming;Xia Yinghui;Xu Hanlin;Yi Tengfei;Zhang Xingjian;Li Wenjing;Xing Quansheng
本研究采用自主研发的最新生物可吸收材料乳酸-乙醇酸-1，3-三亚甲基碳酸酯（LA-GA-TMC），应用三维（3D）打印技术制造心脏间隔缺损封堵器，实现心脏间隔缺损的个体化治疗。同时对其生物安全性进行评价，为今后大规模动物实验和临床试验奠定基础。对传统的“一锅法”进行了改进，采用“两步法”合成LA-GA-TMC，丙交酯：乙交酯：三亚甲基碳酸酯的比例为6：1：1.7。然后，以合成的聚乙二醇为原料，采用3D打印技术制作封堵器模型。然后从细胞相容性、血液相容性和组织相容性等方面综合评价其生物相容性。LA-GA-TMC 3D打印制作的封堵器具有良好的延展性和可恢复性，并具有控温特性，在不同浓度浸提液中的相对细胞增殖率均> 70%，具有良好的细胞相容性。溶血实验表明其溶血率<5%，动态凝血实验表明其对凝血有一定的激活作用，具有良好的血液相容性。此外，体内植入实验表明，其组织相容性上级传统镍钛合金和新兴的聚左旋乳酸。基于生物相容性良好的新型可吸收材料LA-GA-TMC，通过3D打印技术制造心脏间隔缺损封堵器是完全可行的，在大规模动物实验和临床试验中具有广阔的前景。
This study adopted the latest self‐developed bioabsorbable material lactide–glycolide–1,3‐trimethylene carbonate (LA–GA–TMC) and applied the three‐dimensional (3D) printing technique to manufacture the occluder for cardiac septal defects, so as to realize the individualized treatment of cardiac septal defects. At the same time, its biosafety was evaluated, with an aim to establish foundation for futural large‐scale animal experiment and clinical trial. The traditional “one‐pot synthesis” was modified, and the “two‐step synthesis method” was utilized to synthesize the LA–GA–TMC terpolymer at the lactide: glycolide: trimethylene carbonate ratio of 6:1:1.7. Afterward, the synthesized terpolymer was used as the raw material to fabricate the occluder model via using 3D printing technique. Then, its biocompatibility was comprehensively evaluated through cytocompatibility, blood compatibility, and histocompatibility. The occluder made from LA–GA–TMC 3D printing had favorable ductility and recoverability; besides, it possessed the temperature‐control feature, and the relative cell proliferation rates in extract liquids at various concentrations were all >70%, suggesting that it had favorable cytocompatibility. Moreover, hemolytic experiment revealed that its hemolytic rate was <5%, dynamic blood coagulation experiment demonstrated that the sample material moderately activated the blood coagulation, and the above findings suggested that it had good blood compatibility. In addition, implanting experiment in vivo revealed that its histocompatibility was superior to the traditional nitinol and the emerging poly‐l‐lactic acid. It is completely feasible to manufacture the cardiac septal defects occluder based on the novel absorbable material LA–GA–TMC, which has favorable biocompatibility, through 3D printing technique and it possesses broad prospects in large‐scale animal experiment and clinical trial.