DEVELOPMENT OF CONCEPTS FOR PRIMARY HEART VALVE REPLACEMENT

Highlights

• Average cycle stress for the developed concepts was 413.6–528.0 MPa.
• Hydrodynamic tests were successful – effective orifice area was 3.41 ± 0.08 and 3.52 ± 0.07 cm².
• Two frame concepts were unsuitable, and the third requires geometric optimization.

Aim. To develop and analyze concepts of support frames for transcatheter aortic valves based on numerical modeling methods in order to evaluate their mechanical characteristics, strength properties and hydrodynamic efficiency.

Methods. The study used three-dimensional models of the support frames created using SolidWorks software (Dassault Systemes, France). The mechanical characteristics were assessed in the Abaqus/CAE environment (Dassault Systèmes, France) using the finite element method. The study included an analysis of the stress-strain state, fatigue strength, and radial forces arising during crimping and implantation of the prosthesis. The hydrodynamic characteristics were assessed using the Pulse Duplicator II stand (Vivitro Labs, Canada), which simulates the operating conditions of the prosthesis in the left ventricle of the heart.

Results. Numerical modeling analysis showed that two of the three concepts studied demonstrated exceedance of the material strength limit, which makes them unsuitable for further use. One of the concepts demonstrated lower stress levels, but some areas of the design require further refinement. Radial stability tests revealed a predictable pattern of material deformation, which confirms the stability of the design under physiological conditions. Hydrodynamic tests showed compliance of the valve operation with established standards, the absence of critical turbulence zones and acceptable regurgitation levels.

Conclusion. The obtained results indicate the need for further optimization of the geometry of the supporting frame of the developed device to reduce local stresses, as well as improvement of the surface finishing technology to improve the roughness index. The manufactured prototypes of the prosthesis have satisfactory hydrodynamic characteristics.

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