Development of a 3D-printed silicone-based biocompatible pulmonary heart valve prosthesis with optimized structural design

Background Conventional prosthetic valves face limitations, including structural degradation and the necessity for reoperations, particularly in growing pediatric patients. This study presents the development and validation of a novel 3D-printed silicone-based pulmonary heart valve prosthesis featuring an optimized structural design to achieve superior durability and hydrodynamic performance. Method The valve utilizes medical-grade silicone elastomer, fabricated via 3D printing for precise geometric control . Key structural optimizations were implemented based on native valve biomechanics, including strategically thickened leaflet edges, a propeller-like (helical) geometry, and integrated leaflet tips attached to the main body to enhance resistance against backflow pressure. Result Performance testing confirmed compliance with the acceptance criteria of ISO 5840, 3 regarding the Mean Peak-to-Peak Difference (PPD_Mean, mmHg) and regurgitation volume ratio (RVR, %). The valve demonstrated stable under pulmonary pressures ranging from 20 mmHg (normal) function (PPD_Mean ; 15.4 mmHg and 14.3 mmHg , sample 1 and 2 under 20mmHg 70 beat 5L) to 50 (hypertension) mmHg (PPD_Mean ; 14.1 mmHg and 16.4 mmHg , sample 1 and 2 under 50mmHg 70 beat 5L), with the RVR (11.8% and 8%, sample 1 and 2 under 70 beat 5L at 20mmHg ; 15.8% and 13%, %, sample 1 and 2 under 70 beat 5L at 50mmHg) remaining well below the 20% threshold. Furthermore, cytotoxicity tests confirmed the material's basic biocompatibility. Conclusion These findings demonstrate that the combination of 3D printing technology and specific structural modifications in silicone elastomers yields a mechanically robust and functionally stable pulmonary valve prototype. This approach provides a significant advancement toward developing durable, next-generation heart valve solutions.