Design a Novel Polymeric Heart Valve PHV-SH and Test the Feasibility Using in Vivo Pre-Clinical Non-inferiority Trial

Polymeric heart valves (PHVs) present a promising alternative to mechanical and bio-prosthetic valves, addressing critical issues such as durability and calcification. This study investigates poly(styrene-block-ethylene/butylene-block-styrene) (SEBS) block copolymers for PHV applications, focusing on material characterization, valve fabrication, in vitro durability testing, and in vivo bio-compatibility evaluation. Mechanical tests, including thermogravimetric analysis (TGA), dynamic mechanical analysis (DMA), differential scanning calorimetry (DSC), and hydrodynamic performance analysis demonstrated that SEBS offers excellent thermal stability, flexibility, and fatigue resistance. Bio-compatibility assessments conducted per ISO 10993 standards revealed minimal cytotoxicity, hemolysis, and adverse immune responses. The hydrodynamic performance tests showed favorable hemodynamics, with low transvalvular pressure gradients and effective orifice areas within acceptable limits. In vivo trials on animal models confirmed that SEBS valves maintained competent valve function, without significant structural degeneration or calcification, over the 140-day study period. Mild regurgitation, observed in a subset of models, is attributed to anatomical variations and surgical technique. These results suggest that SEBS-based PHVs are a durable, biocompatible alternative to traditional heart valves and hold promise for overcoming limitations associated with current mechanical and bioprosthetic designs.