Abstract
The potential of polymeric heart valves (PHV) prostheses is to combine the hemodynamic performances of biological valves with the durability of mechanical valves. The aim of this work is to design and develop a new tri-leaflet prosthetic heart valve (HV) made from styrenic block copolymers. A computational finite element model was implemented to optimize the thickness of the leaflets, to improve PHV mechanical and hydrodynamic performances. Based on the model outcomes, 8 prototypes of the designed valve were produced and tested in vitro under continuous and pulsatile flow conditions, as prescribed by ISO 5840 Standard. A specially designed pulse duplicator allowed testing the PHVs at different flow rates and frequency conditions. All the PHVs met the requirements specified in ISO 5840 Standard in terms of both regurgitation and effective orifice area (EOA), demonstrating their potential as HV prostheses.
Highlights
Two categories of heart valve (HV) prostheses are currently available to substitute severe insufficient or stenotic native valves: mechanical HV prostheses or biological HV prostheses.[1]
Polymeric heart valve (PHV) prostheses have been widely studied in the past due to their promising ability to replicate the function of native HVs; they are not currently used for clinical applications due to their lack of reliability.[2]
The computational model implemented in this study can be used as a tool for the optimization of the design of new polymeric heart valves (PHV): The automatic parametric CAD procedure allows a wide variety of leaflet designs to be investigated and the standardized finite element model procedure gives information about the mechanical response of the device before prototyping
Summary
Two categories of heart valve (HV) prostheses are currently available to substitute severe insufficient or stenotic native valves: mechanical HV prostheses (made from synthetic hard materials) or biological HV prostheses (made from animal or human tissues).[1]. New emerging material technologies allowed the development of novel polymeric materials with improved and tunable properties: styrenic block copolymer elastomers have a suitable morphology (i.e., stiff cylindrical micro-domains) which may mimic the function and the anisotropic structure of collagen and elastin in the native valve.[3,4,5]
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