An innovative occluder for cardiac defect: 3D printing and a biocompatibility research based on self-developed bioabsorbable material-LA-GA-TMC.

Abstract

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.