A Newly Developed Tri-Leaflet Polymeric Heart Valve Prosthesis.

Area of Science:

• Biomaterials Science
• Biomedical Engineering
• Cardiovascular Research

Background:

• Polymeric heart valves (PHV) aim to integrate the hemodynamic benefits of biological valves with the longevity of mechanical valves.
• Current prosthetic heart valves (HV) face challenges in balancing performance and durability.

Purpose of the Study:

• To design and develop a novel tri-leaflet prosthetic heart valve (HV) using styrenic block copolymers.
• To optimize the mechanical and hydrodynamic performance of the PHV through computational modeling.

Main Methods:

• A finite element model was utilized to optimize leaflet thickness for improved performance.
• Eight PHV prototypes were manufactured based on model predictions.
• In vitro testing was conducted using a pulse duplicator under continuous and pulsatile flow, adhering to ISO 5840 standards.

Main Results:

• All developed PHV prototypes successfully met the ISO 5840 Standard requirements.
• Key performance metrics, including regurgitation and effective orifice area (EOA), were within acceptable limits.
• The study validated the design through rigorous in vitro testing.

Conclusions:

• The designed tri-leaflet polymeric heart valve (PHV) demonstrates significant potential as a durable and effective heart valve (HV) prosthesis.
• The findings support the use of styrenic block copolymers in developing advanced cardiovascular devices.
• The study successfully translated computational design into functional prototypes meeting international standards.