An Algorithm for Automatic Generation and Evaluation of Leaflet Apparatus Models for Heart Valve Prostheses.

Area of Science:

• Biomedical Engineering
• Computational Fluid Dynamics
• Prosthetic Device Design

Background:

• Designing prosthetic heart valves requires optimizing leaflet apparatus geometry for mechanical performance and flow characteristics.
• Accurate modeling is crucial for predicting stress distribution and orifice area, impacting device longevity and efficacy.
• Existing methods may lack efficiency in exploring a wide range of design parameters.

Purpose of the Study:

• To develop and validate an algorithm for the automated generation of leaflet apparatus models for prosthetic heart valves.
• To optimize model parameters for minimizing stress-strain states and maximizing the geometric orifice area.
• To facilitate research and development of novel prosthetic valve designs.

Main Methods:

• An algorithm comprising 'Generator', 'Modeling', and 'Analysis' blocks was developed.
• The 'Generator' block creates 3D leaflet models based on input parameters (height, radius, thickness, etc.).
• Finite element method (FEM) was used for numerical simulation of valve function, followed by statistical analysis of von Mises stresses and orifice area calculation.

Main Results:

• Algorithm verification against Trifecta bioprosthesis data showed lumen area deviations of 2.85% (19mm), 14.81% (21mm), and 23.17% (23mm).
• Leaflet thickness was identified as the primary factor influencing opening degree and stress levels.
• 1517 designs were generated; 278 met criteria (>80% opening, <4 MPa stress), with 3 optimal designs selected for each size, exhibiting high opening degrees and low stress.

Conclusions:

• The developed algorithm enables automated 3D model generation, FEM simulation, and analysis for prosthetic heart valve leaflet apparatus.
• Verification confirmed the algorithm's capability, despite material property data limitations.
• The algorithm is suitable for research, development, and optimization of prosthetic valve designs.