Search Results (8)

Understanding the mechanical behavior of valve materials and the hemodynamic characteristics of blood flow is important for improving prosthetic heart valve design. In this study, a comprehensive computational investigation was conducted to evaluate the biomechanical and hemodynamic behavior of a three-dimensional tricuspid valve model constructed from reported prosthetic valve geometries. The structural response of the valve was evaluated using linear elastic, viscoelastic, and hyperelastic constitutive models for four different materials: pyrolytic carbon, polyurethane, porcine tissue, and bovine tissue. The results demonstrated clear material-dependent trends. Pyrolytic carbon exhibited negligible deformation (1.7166 × 10⁻⁸ m), confirming its rigid mechanical behavior, whereas biological tissues showed greater compliance, with the largest deformation observed for the bovine hyperelastic model (9.6837 × 10⁻⁵ m). Hyperelastic tissue models produced lower peak von Mises stresses (1.3951 × 10⁴–1.8603 × 10⁴ Pa) than the corresponding linear elastic tissue models (2.6842 × 10⁴–2.7017 × 10⁴ Pa), indicating improved stress redistribution under nonlinear deformation. Polyurethane showed intermediate mechanical behavior, with moderate deformation and lower stress under viscoelastic modeling than under the linear elastic assumption, suggesting its potential as a polymeric alternative to traditional valve materials. The Computational Fluid Dynamics (CFD) analysis of the rigid open valve geometry revealed a central velocity jet with a peak velocity of approximately 0.092 m/s, localized vortex formation with a maximum vorticity magnitude of about 177 s⁻¹ and a peak instantaneous wall shear stress of 1.32 Pa near the leaflet edges and valve opening. Overall, the results highlight the trade-off between rigidity, compliance, and durability among prosthetic valve materials and suggest that polyurethane may provide a balanced alternative for tricuspid valve replacement. Full article

Polyurethane-based implantable devices (PUIDs) delivered via catheter are increasingly used in structural heart interventions; however, limited in vivo data exist regarding their long-term biostability and biological safety. This study evaluated a balloon-shaped implant made of Pellethane^®, a polyether-based polyurethane, designed as a three-dimensional intracardiac spacer and deployed via percutaneous femoral vein access. The device was chronically positioned adjacent to the tricuspid valve annulus in seven pigs for 24 weeks. Explanted devices and surrounding tissues were evaluated through material characterization (SEM, GPC, FT-IR, and ¹H-NMR) and histological analysis. SEM and FT-IR confirmed preserved surface morphology and chemical bonds, GPC showed stable molecular weight, and ¹H-NMR revealed intact urethane and ether linkages. Materials characterization revealed no evidence of hydrolytic or oxidative degradation, indicating structural stability of the devices. Histological analysis showed stable device positioning with minimal thrombosis or inflammatory response. Biocompatibility was confirmed via ISO 10993-1:2018 Standard (International Organization for Standardization (ISO): Geneva, Switzerland, 2018), and extractable substances were evaluated under exhaustive extraction conditions specified by ISO 10993-18:2020 (International Organization for Standardization (ISO): Geneva, Switzerland, 2020), with no toxicologically significant findings. These findings support the long-term biostability and biological safety of the PUIDs in dynamic cardiac environments, informing future design criteria for catheter-delivered cardiovascular devices. Full article

Abnormal heart valve function is a major cause of heart disease and is often associated with high rates of morbidity and mortality from heart disease. Focusing on the field of valve replacement, tissue-engineered heart valves are becoming popular and attracting more attention. In this work, an artificial heart valve scaffold based on polycaprolactone/polyurethane (PCL/PU) three-layer composite fibers was prepared by 3D printing and electrospinning, including an inner PCL layer, a middle PCL/PU layer, and an outer PCL layer. The obtained valve scaffold had strong circumferential mechanical properties when PCL/PU = 1:2, and its elastic modulus was 14.7 MPa, similar to that of natural valve. The heart valve scaffold had good cytocompatibility, and the final cell survival rate was 99.8% after 14 days of cell culture. The layered structure makes the artificial heart valve more similar to the natural structure of the mammalian heart, which is conducive to cell proliferation and differentiation, and provides a reference solution for interventional treatment of heart valves. Full article

It is costly and time-consuming to design and manufacture functional polyurethane heart valve prototypes, to evaluate and comprehend their hemodynamic behaviour. To enhance the rapid and effective design of replacement heart valves, to meet the minimum criteria of FDA and ISO regulations and specifications, and to reduce the length of required clinical testing, computational fluid dynamics (CFD) and finite element analysis (FEA) were used. The results revealed that when the flexibility of the stent was taken into consideration with a uniform leaflet thickness, stress concentration regions that were present close to the commissural attachment were greatly diminished. Furthermore, it was found that the stress on the leaflets was directly impacted by the effect of reducing the post height on both rigid and flexible stents. When varying the leaflet thickness was considered, the high-stress distribution close to the commissures appeared to reduce at thicker leaflet regions. However, thicker leaflets may result in a stiffer valve with a corresponding increase in pressure drop. It was concluded that a leaflet with predefined varying thickness may be a better option. Full article

Synthetic biomaterials play a crucial role in developing tissue-engineered heart valves (TEHVs) due to their versatile mechanical properties. Achieving the right balance between mechanical strength and manufacturability is essential. Thermoplastic polyurethanes (TPUs) and elastomers (TPEs) garner significant attention for TEHV applications due to their notable stability, fatigue resistance, and customizable properties such as shear strength and elasticity. This study explores the additive manufacturing technique of selective laser sintering (SLS) for TPUs and TPEs to optimize process parameters to balance flexibility and strength, mimicking aortic valve tissue properties. Additionally, it aims to assess the feasibility of printing aortic valve models with submillimeter membranes. The results demonstrate that the SLS-TPU/TPE technique can produce micrometric valve structures with soft shape memory properties, resembling aortic tissue in strength, flexibility, and fineness. These models show promise for surgical training and manipulation, display intriguing echogenicity properties, and can potentially be personalized to shape biocompatible valve substitutes. Full article

Minimizing of the life-threatening thrombo-emboli formation in pulsatile heart assist devices by a new biomimetic heart valve design is presently one of the most important problems in medicine. As part of this work, an original valve structure was proposed intended for pneumatic, extracorporeal ventricular assist devices. The valve design allows for direct integration with other parts of the pulsating blood pump. Strengthening in the form of the titanium or steel frame has been introduced into the polyurethane lagging, which allows for maintaining material continuity and eliminating the risk of blood clotting. The prototype of the valve was made by the injection molding method assisted by numerical simulation of this process. The prototype was introduced into a modified pulsating, extracorporeal heart assist pump ReligaHeart EXT (developed for tilting disc valves) and examined in-vitro using the “artificial patient” model in order to determine hydrodynamic properties of the valve in the environment similar to physiological conditions. Fundamental blood tests, like hemolysis and thrombogenicity have been carried out. Very low backflow through the closed valve was observed despite their slight distortion due to pressure. On the basis of immunofluorescence tests, only slight activation of platelets was found on the inlet valve and slight increased risk of clotting of the outlet valve commissures as a result of poor valve leaflets assembling in the prototype device. No blood hemolysis was observed. Few of the clots formed only in places where the valve surfaces were not smooth enough. Full article

Valvular dysfunction as the prominent reason of heart failure may causes morbidity and mortality around the world. The inability of human body to regenerate the defected heart valves necessitates the development of the artificial prosthesis to be replaced. Besides, the lack of capacity to grow, repair or remodel of an artificial valves and biological difficulty such as infection or inflammation make the development of tissue engineering heart valve (TEHV) concept. This research presented the use of compound of poly-l-lactic acid (PLLA), thermoplastic polyurethane (TPU) and maghemite nanoparticle (γ-Fe₂O₃) as the potential biomaterials to develop three-dimensional (3D) aortic heart valve scaffold. Electrospinning was used for fabricating the 3D scaffold. The steepest ascent followed by the response surface methodology was used to optimize the electrospinning parameters involved in terms of elastic modulus. The structural and porosity properties of fabricated scaffold were characterized using FE-SEM and liquid displacement technique, respectively. The 3D scaffold was then seeded with aortic smooth muscle cells (AOSMCs) and biological behavior in terms of cell attachment and proliferation during 34 days of incubation was characterized using MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay and confocal laser microscopy. Furthermore, the mechanical properties in terms of elastic modulus and stiffness were investigated after cell seeding through macro-indentation test. The analysis indicated the formation of ultrafine quality of nanofibers with diameter distribution of 178 ± 45 nm and 90.72% porosity. In terms of cell proliferation, the results exhibited desirable proliferation (109.32 ± 3.22% compared to the control) of cells over the 3D scaffold in 34 days of incubation. The elastic modulus and stiffness index after cell seeding were founded to be 22.78 ± 2.12 MPa and 1490.9 ± 12 Nmm², respectively. Overall, the fabricated 3D scaffold exhibits desirable structural, biological and mechanical properties and has the potential to be used in vivo. Full article

Pathologic calcification leads to structural deterioration of implant materials via stiffening, stress cracking, and other structural disintegration mechanisms, and the effect can be critical for implants intended for long-term or permanent implantation. This study demonstrates the potential of using specific metal ions (MI)s for inhibiting pathological calcification in polyurethane (PU) implants. The hypothesis of using MIs as anti-calcification agents was based on the natural calcium-antagonist role of Mg²⁺ ions in human body, and the anti-calcification effect of Fe³⁺ ions in bio-prosthetic heart valves has previously been confirmed. In vitro calcification results indicated that a protective covering mesh of MI-doped PU can prevent calcification by preventing hydroxyapatite crystal growth. However, microstructure and mechanical characterisation revealed oxidative degradation effects from Fe³⁺ ions on the mechanical properties of the PU matrix. Therefore, from both a mechanical and anti-calcification effects point of view, Mg²⁺ ions are more promising candidates than Fe³⁺ ions. The in vitro MI release experiments demonstrated that PU microphase separation and the structural design of PU-MI matrices were important determinants of release kinetics. Increased phase separation in doped PU assisted in consistent long-term release of dissolved MIs from both hard and soft segments of the PU. The use of a composite-sandwich mesh design prevented an initial burst release which improved the late (>20 days) release rate of MIs from the matrix. Full article