Optimization of biological heart valve prosthesis "Uniline": new tools for improving function

According to various estimates, in 2020, more than 9,000 artificial heart valve implants were performed in specialized medical centers in the territory of the Russian Federation, and 19.1 % of them were based on animal tissues. Such devices have high biocompatibility, but after 10-15 years from one third to one half require reoperation due to the development of various dysfunctions. Despite the advantages of biological prosthetic heart valves and the prevalence of their use in the clinic, there is a need for their optimization and refinement to improve postoperative hemodynamics and increase service life. In this work, we applied an improved method to create the geometry of a leaflets and its evaluation to the commercial prosthesis «UniLine» (Kemerovo, CJSC «NeoKor») 23 standard sizes. An approach is demonstrated that includes a screening study of a large number of geometries ( N = 6766) and detailed modeling ( N = 4) of selected designs as part of the final product, taking into account interaction with the composite frame. The results obtained demonstrate the ability of the proposed method to optimize existing commercial models of prosthetic heart valves. An expanded set of construction parameters allowed us to select a design with peak maximum principal stresses of 1.89 and 0.68 MPa, as well as providing an open area of 233.08 and 267.34 mm2 with a maximum possible 314 mm2 for detailed and screening studies, respectively. At the same time, the area of the lumen in the diastolic phase in the prosthesis does not exceed 0.4 mm2 for the models shown. The presented results show the possibility of the method to create and evaluate "optimal" designs of flap devices according to a number of critical metrics for ensuring better hemo- and biomechanics - stresses occurring during the cardiac cycle, the presence of a twisting effect in the diastolic phase, as well as the ability to ensure maximum clearance and locking quality.