Development of a 3D-printed silicone-based biocompatible pulmonary heart valve prosthesis with optimized structural design
D A E W O N KimAbstract
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.