Concept of automatic development of polymer heart valve prosthesis

Aim: To validate an automated design algorithm for the leaflet apparatus of a polymeric heart valve prosthesis, focusing on achieving high hydrodynamic performance through design, prototyping, and in vitro testing. Material and Methods. The study employs a proprietary automated design algorithm based on computational modeling and numerical analysis of the hydrodynamic characteristics of heart valve prosthesis leaflets in computational modeling. The algorithm generated a large number of geometrical variants (over 16,000), which were subsequently evaluated for their functionality, including the effective orifice area, coaptation area, and stress distribution within the leaflet material. Based on the design algorithm's output, the optimal leaflet geometry was selected and prototyped using casting techniques to produce three samples. These prototypes were evaluated in vitro under simulated physiological flow conditions using a hydrodynamic testing system. Results. The geometries produced by the design algorithm exhibited a wide range of quantitative metrics for the targets: the mean effective orifice area was 38.85% (minimum 7.54%; maximum 85.78%); the coaptation area was 1.08% (0–1.88%); and the maximum stress was 0.47 MPa (0.25–1.43 MPa). The optimal leaflet geometry selected for prototyping demonstrated an effective orifice area of 85.75%, a coaptation area of 0.45%, and a maximum stress of 1.023 MPa. Prototyping and subsequent in vitro testing confirmed the high functional performance of the developed sample, although significant deviations in quantitative indicators from the results of numerical modeling were observed due to the specifics of prototyping. These discrepancies indicate the need for further refinement of the algorithm and improvements in the prototyping methodology. Conclusion. The study confirms the effectiveness of the proposed automated algorithm for the development and optimization of polymeric heart valve prostheses. The primary advantage of this methodology lies in its ability to rapidly generate and evaluate a large number of geometrical variants, thereby enhancing the accuracy and functionality of the final product. The results demonstrate the significant potential of automated design in biomedical engineering and pave the way for the development of more advanced medical devices. Future efforts should focus on improving the accuracy of numerical models and prototyping techniques to ensure even higher quality and durability of polymeric heart valve prostheses.