A Tissue-Compliant Shape-Memory Composite Membrane for Cardiac Occluders

Ventricular septal defect (VSD) occluders commonly rely on permanent nitinol frameworks, which may contribute to long-term mechanical mismatch and late complications. Here, we developed a tissue-compliant composite membrane by embedding a 3D-printed poly(vinyl alcohol) (PVA) grid within a shape-memory poly(glycerol dodecanedioate) (PGD) matrix. Grid spacing was varied from 0.1 to 0.5 mm to tune reinforcement density. FTIR indicated that PVA was incorporated mainly through physical interlocking rather than new covalent bonding. The composite preserved near-body-temperature shape recovery. In water at 37 °C, PVA reinforcement increased tensile modulus and fracture strength, although swelling also increased. Finite-element analysis and benchtop occlusion testing consistently showed lower deformation, less strain localization, and smaller bulge height for PGD-PVA than for PGD alone. In vitro assays showed low cytotoxicity, low hemolysis, and prolonged plasma recalcification time. A 12-week pilot degradation study showed that the faster mass loss observed in initial samples was mainly caused by exposed PVA cut edges; after switching to a fully encapsulated design, static mass loss became similar across groups, and dynamic PBS agitation produced about 10% mass loss at 12 weeks. These results support PGD-PVA as a reinforced membrane strategy for polymeric occluders.