Structural analysis of a bileaflet mechanical heart valve prosthesis with curved leaflet

Structural analysis, especially the thickness effect on the structural strength, of a bileaflet mechanical heart valve prosthesis with curved leaflets is presented in this paper. Taking the wide variations of the blood flow pressure on the leaflet surface, the structural stresses inside the leaflet and deflections of the leaflet are investigated by adopting both linear and nonlinear structural analysis techniques for more accurate results comparison. The thickness of the curved leaflet also varies considerably from 0.50 mm to 0.75 mm by 0.05 mm. These are very useful for the design of the mechanical heart valve (MHV) prosthesis. Linear and nonlinear structural mechanic analyses for the leaflet of the MHV prosthesis are conducted to predict the structural strength variation of the leaflet as the leaflet thickness changes. Analysis results show that the structural strength of the leaflet decreases as the leaflet thickness becomes thinner and thinner, and the nonlinear structural behaviors of thin leaflets are very conspicuous for large applied blood pressures. Hence, these thin leaflets are not desirable for the in vivo use of the MHV prosthesis. This paper was recommended for publication in revised form by Associate Editor Young Eun Kim Young Joo Kwon received his B.S. and M.S. degrees in mechanical engineering from Seoul National University in year and year, respectively, and then obtained the Ph.D. degree from the Department of Aerospace Engineering at The University of Michigan. He served as an engineer at Analysis and Design Application Co., Ltd., country, and a manager at Engineering Mechanics Research Corporation, country, and is currently a senior researcher at Korea Institute of Science and Technology, Korea and a professor in the Department of Mechano-Informatics & Design Engineering at Hongik University.     

A structural analysis on the leaflet motion induced by the blood flow for design of a bileaflet mechanical heart valve prosthesis

This paper presents a structural analysis on the rigid and deformed motion of the leaflet induced by the blood flow required in the design of a bileaflet mechanical heart valve (MHV) prosthesis. In the study on the design and the mechanical characteristics of a bileaflet mechanical heart valve, the fluid mechanics analysis on the blood flow passing through leaflets, the kinetodynamics analysis on the rigid body motion of the leaflet induced by the pulsatile blood flow, and the structural mechanics analysis on the deformed motion of the leaflet are required sequentially and simultaneously. Fluid forces computed in the previous hemodynamics analysis on the blood flow are used in the kinetodynamics analysis on the rigid body motion of the leaflet. Thereafter, the structural mechanics analysis on the deformed motion of the leaflet follows to predict the structural strength variation of the leaflet as the leaflet thickness changes. Analysis results show that structural deformations and stresses increase as the fluid pressure increases and the leaflet thickness decreases. Analysis results also show that the leaflet becomes structurally weaker and weaker as the leaflet thickness becomes smaller than 0.6 mm.     

A numerical analysis on the curved bileaflet mechanical heart valve (mhv): leaflet motion and blood flow in an elastic blood vessel

In blood flow passing through the mechanical heart valve (MHV) and elastic blood vessel, hemolysis and platelet activation causing thrombus formation can be seen owing to the shear stress in the blood. Also, fracture and deformation of leaflets can be observed depending on the shape and material properties of the leaflets which is opened and closed in a cycle. Hence, comprehensive study is needed on the hemodynamics which is associated with the motion of leaflet and elastic blood vessel in terms of fluid-structure interaction. In this paper, a numerical analysis has been performed for a three-dimensional pulsatile blood flow associated with the elastic blood vessel and curved bileaflet for multiple cycles in light of fluid-structure interaction. From this analysis fluttering phenomenon and rebound of the leaflet have been observed and recirculation and regurgitation have been found in the flow fields of the blood. Also, the pressure distribution and the radial displacement of the elastic blood vessel have been obtained. The motion of the leaflet and flow fields of the blood have shown similar tendency compared with the previous experiments carried out in other studies. The present study can contribute to the design methodology for the curved bileaflet mechanical heart valve. Furthermore, the proposed fluid-structure interaction method will be effectively used in various fields where the interaction between fluid flow and structure are involved.     

A new method for quantitative evaluation of perceived sounds from mechanical heart valve prostheses

Closing clicks from mechanical heart valve prostheses are transmitted to the patient's inner ear mainly in two different ways: as acoustically transmitted sound waves, and as vibrations transmitted through bones and vessels. The purpose of this study was to develop a method for quantifying what patients perceive as sound from their mechanical heart valve prostheses via these two routes. In this study, 34 patients with implanted mechanical bileaflet aortic and mitral valves (St Jude Medical and On-X) were included. Measurements were performed in a specially designed sound insulated chamber equipped with microphones, accelerometers, preamplifiers and a loudspeaker. The closing sounds measured with an accelerometer on the patient's chest were delayed 400 ms, amplified and played back to the patient through the loudspeaker. The patient adjusted the feedback sound to the same level as the 'real-time' clicks he or she perceived directly from his or her valve. In this way the feedback sound energy includes both the air- and the bone-transmitted energies. Sound pressure levels (SPLs) were quantified both in dB(A) and in the loudness unit sone according to ISO 532B (the Zwicker method). The mean air-transmitted SPL measured close to the patient's ear was 23 +/- 4 dB(A). The mean air- and bone-transmitted sounds and vibrations were perceived by the patients as an SPL of 34 +/- 5 dB(A). There was no statistically significant difference in the perceived sound from the two investigated bileaflet valves, and no difference between aortic and mitral valves. The study showed that the presented feedback method is capable of quantifying the perceived sounds and vibrations from mechanical heart valves, if the patient's hearing is not too impaired. Patients with implanted mechanical heart valve prostheses seem to perceive the sound from their valve two to three times higher than nearby persons, because of the additional bone-transmitted vibrations.     

Analysis of blood flow interacted with leaflets in MHV in view of fluid-structure interaction

Interaction of blood flow and leaflet behavior in a bileaflet mechanical heart valve was investigated using computational analysis. Blood flows of a Newtonian fluid and a non-Newtonian fluid with Carreau model were modeled as pulsatile, laminar, and incompressible. A finite volume computational fluid dynamics code and a finite element structure dynamics code were used concurrently to solve the flow and structure equations, respectively, where the two equations were strongly coupled. Physiologic ventricular and aortic pressure waveforms were used as flow boundary conditions. Flow fields, leaflet behaviors, and shear stresses with time were obtained for Newtonian and non-Newtonian fluid cases. At the fully opened phase three jets through the leaflets were found and large vortices were present in the sinus area. At the very final stage of the closing phase, the angular velocity of the leaflet was enormously large. Large shear stress was found on leaflet tips and in the orifice region between two leaflets at the final stage of closing phase. This method using fluid-structure interaction turned out to be a useful tool to analyze the different designs of existing and future bileaflet valves.     

The effects of the tilt angle of a bileaflet mechanical heart valve on blood flow and leaflet motion

Diseased heart valves can be replaced with bileaflet mechanical heart valves (BMHVs), which may be affected by complications such as hemolysis, platelet activation and device failure. These complications are closely related to the characteristics of blood flow through mechanical valves and leaflet dynamics, and can become worse with tilted implantation of BMHVs. This study simulated the interactions of blood flow and leaflet motion for BMHVs implanted at different tilt angles. A fluid-structure interaction (FSI) method was employed to solve the problems of blood flow and leaflet motion interactively. A validation of the present numerical methods was performed against data produced in a previous work, indicating that the method presented in this study is reliable. Our results reveal detailed blood flow and leaflet motion in an aorta caused by the systole and diastole of the ventricle. As the tilt angle increased, the degree of asymmetry of blood flow and the time delay in the motions of the two different leaflets also increased, which may cause worsening of complications.     

Nanocomposite biomaterial mimicking aortic heart valve leaflet mechanical behaviour

The main problem with polymeric heart valves (which are already biocompatible) is that they usually fail in the long term owing to tearing and calcification of the leaflets under high dynamic tensile bending stress and oxidative reactions with blood. To overcome this shortcoming, it is hypothesized that synthetic valve leaflets which mimic native valve leaflet structure fabricated from fibre-reinforced composite material will optimize leaflet stresses and decrease tears and perforations. The objective of this study is to develop a PVA-BC (polyvinyl alcohol-bacterial cellulose)-based hydrogel that mimics not only the non-linear mechanical properties displayed by porcine heart valves, but also their anisotropic behaviour. By applying a controlled strain to the PVA samples, while undergoing low-temperature thermal cycling, it was possible to create oriented mechanical properties in PVA hydrogels. The oriented stress-strain properties of porcine aortic valves were matched simultaneously by a PVA hydrogel (15 per cent PVA, 0.5 BC cycle 4, 75 per cent initial tensile strain). This novel technique allows the control of anisotropy to PVA hydrogel, and gives a broad range of control of its mechanical properties, for specific medical device applications.     

Pulsatile blood flows through a bileaflet mechanical heart valve with different approach methods of numerical analysis; pulsatile flows with fixed leaflets and interacted with moving leaflets

Many researchers have investigated the blood flow characteristics through bileaflet mechanical heart valves using computational fluid dynamics (CFD) models. Their numerical approach methods can be classified into three types; steady flow analysis, pulsatile flow analysis with fixed leaflets, and pulsatile flow analysis with moving leaflets. The first and second methods have been generally employed for two-dimensional and three-dimensional calculations. The pulsatile flow analysis interacted with moving leaflets has been recently introduced and tried only in two-dimensional analysis because this approach method has difficulty in considering simultaneously two physics of blood flow and leaflet behavior interacted with blood flow. In this publication, numerical calculation for pulsatile flow with moving leaflets using a fluid-structure interaction method has been performed in a three-dimensional geometry. Also, pulsatile flow with fixed leaflets has been analyzed for comparison with the case with moving leaflets. The calculated results using the fluid-structure interaction model have shown good agreements with results visualized by previous experiments. In peak systole, calculations with the two approach methods have predicted similar flow fields. However, the model with fixed leaflets has not been able to predict the flow fields during opening and closing phases. Therefore, the model with moving leaflets is rigorously required for advanced analysis of flow fields.     

Mechanism for cavitation phenomenon in mechanical heart valves

Recently, cavitation on the surface of mechanical heart valve has been studied as a cause of fractures occurring in implanted Mechanical Heart Valves (MHVs). It has been conceived that the MHVs mounted in an artificial heart close much faster than in vivo sue, resulting in cavitation bubbles formation. In this study, six different kinds of monoleaflet and bileaflet valves were mounted in the mitral position in an Electro-Hydraulic Total Artificial Heart (EHTAH), and we investigated the mechanisms for MHV cavitation. The valve closing velocity and a high speed video camera were employed to investigate the mechanism for MHV cavitation. The closing velocity of the bileaflet valves was slower than that of the monoleaflet valves. Cavitation bubbles were concentrated on the edge of the valve stop and along the leaflet tip. It was established that squeeze flow holds the key to MHV cavitation in our study. Cavitation intensity increased with an increase in the valve closing velocity and the valve stop area. With regard to squeeze flow, the bileaflet valve with slow valve-closing velocity and small valve stop areas is better able to prevent blood cell damage than the monoleaflet valves.     

Leaflet geometry extraction and parametric representation of a pericardial artificial heart valve

Reverse engineering technology was used to reconstruct the complex leaflet geometry of a commercial pericardial valve in our study. Results show that the three-dimensional computer-aided design model of the leaflet surface can be rendered by fitting the surface either to cloud points or by a group of B-splines fitted to a set of cloud points that had been obtained by the process of laser-scanning digitizing. However, an acceptable smooth surface is usually not guaranteed and additional manipulation is required. An alternative method is introduced in this paper, which involves the fitting of an equation to the leaflet geometry to create a smooth surface. The geometrical profile of a pericardial artificial heart valve was scanned using a laser digitizing system. The leaflet profile is represented as a set of cloud points. A quadric surface is fitted to a set of unique points, which were located on the set of cloud points. A mathematical equation is obtained by solving a least-squares fit. The geometry of the fitted leaflet surface has been proven to be closely represented by an elliptical hyperboloid. The quadratic equations of the leaflet curvatures, calculated along both the circumferential and the radial directions, resulted in simple hyperbolic curvatures. The advantages of using elliptical hyperboloid geometry for the leaflet surface are discussed and compared with other types of conicoid geometries. The concepts of parametric representation of the leaflet geometry and parametric design for leaflets are discussed. A smooth surface without inflection points and with an adjustable surface area suitable for a series of stent sizes with incremented diameters is created by this method of a single parametric design. Finally, a generic method to apply the geometry extraction and parametric representation to most pericardial heart valve prostheses was discussed. The application to valves with natural shape was introduced, challenges were identified, and a technical solution was proposed.     

A model of the geometrical changes in aortic valve leaflets in response to leaflet extension and variable boundary conditions.

The function, deformation and performance of heart valve leaflets are dependent on the material properties and the geometry of the leaflet. As the leaflet acts as a constrained membrane the geometry is dependent on the boundary condition applied to the leaflet and any permanent extension of the leaflet. Both of these factors are varied during the preparation of frame-mounted porcine bioprosthetic heart valves and surgical insertion of free-sewn valves. This can result in abnormal geometry and function. A mathematical model has been developed which describes these changes in geometry of a cylindrical leaflet as a function of the diameter of the aortic root (boundary conditions) and the length (or permanent extension) of the leaflet. Both the angle of inclination and the radius of curvature of the cylindrical leaflet were reduced with increased leaflet length or decreased aortic diameter. Agreement was found between the model predictions and experimental observations in porcine bioprosthetic heart valves, where abnormal leaflet geometries are produced by non-physiological boundary conditions and permanent set of the leaflets by fixation with glutaraldehyde. The general solutions developed in this model allow leaflet geometries to be predicted for a range of conditions in free-sewn and frame-mounted valves.     

2D SIMPLIFIED SERVO VALVE

A novel pilot stage valve called simplified 2D valve, which utilizes both rotary and linear motions of a single spool, is presented. The rotary motion of the spool incorporating hydraulic resistance bridge, formed by a damper groove and a crescent overlap opening, is utilized as pilot to actuate linear motion of the spool. A criterion for stability is derived from the linear analysis of the valve. Special experiments are designed to acquire the mechanical stiffness, the pilot leakage and the step response. It is shown that the sectional size of the spiral groove affects the dynamic response and the stiffness contradictorily and is also very sensitive to the pilot leakage. Therefore, it is necessary to establish a balance between the static and dynamic characteristics in deciding the structural parameters. Nevertheless, it is possible to sustain the dynamic response at a fairly high level, while keeping the leakage of the pilot stage at an acceptable level.     

Functional and structural effects of percutaneous edge-to-edge double-orifice repair under cardiac cycle in comparison with suture repair

Percutaneous procedures for double-orifice mitral valve repair using the MitraClip device (clip) have been recently introduced as new treatment options as alternatives to medical management and open-heart surgery, especially for patients with high estimated operative risk. Similarly to the open-heart surgical technique, where suturing is used, the clip creates a double-orifice configuration that not only improves the closing function of the valve, but also significantly modifies its behaviour, particularly in the diastolic phase. While several clinical trials have been conducted, and are ongoing, in order to assess the safety and effectiveness of this technique, a deeper knowledge of the structural and functional effects on the valve, and of the cyclic loads transmitted to the clip itself, would allow a comparison with other repair techniques, and could serve as a foundation for possible further optimization of the clip design. The effects of the MitraClip device developed by Evalve Inc. were studied by means of a finite element model of the mitral valve, specifically developed to study the structural effects of the original, suture-based, edge-to-edge technique. A second model was developed in order to simulate the effects of a suture with similar extension from the leaflet edge in a direction to the annulus, in order to compare the two repair techniques. The mitral valve area and transvalvular pressure gradient predicted by the models for the clip and the suture are quite similar. Similar leaflet cyclic stresses, both in value and in location, were noted for the two mechanisms of linking the leaflets, while minor differences were found in the load transmitted to the suture and the clip, with slightly higher values for the clip. The model satisfactorily allowed functional parameters (valve area and transvalvular pressure gradient) and structural parameters (load, leaflet stress) to be determined. Overall, the structural effects of the clip and the suture are quite similar under the cyclic loading conditions imposed by the cardiac cycle.     

The stability of the femoral component of a minimal invasive total hip replacement system

In this study, the initial stability of the femoral component of a minimal invasive total hip replacement was biomechanically evaluated during simulated normal walking and chair rising. A 20 mm diameter canal was created in the femoral necks of five fresh frozen human cadaver bones and the femoral heads were resected at the smallest cross-sectional area of the neck. The relatively short, polished, taper-shaped prostheses were cemented centrally in this canal according to a standardized procedure. A servohydraulic testing machine was used to apply dynamic loads to the prosthetic head. Radiostereophotogrammetric analysis was used to measure rotations and translations between the prosthesis and bone. In addition, the reconstructions were loaded until failure in a static, displacement-controlled test. During the dynamic experiments, the femoral necks did not fail and no macroscopical damage was detected. Maximal values were found for normal walking with a mean rotation of about 0.2 degrees and a mean translation of about 120 microm. These motions stabilized during testing. The mean static failure load was 4714 N. The results obtained in this study are promising and warrant further development of this type of minimal invasive hip prosthesis.     

2D DIGITAL SIMPLIFIED FLOW VALVE

The 2D digital simplified flow valve is composed of a pilot-operated valve designed withboth rotary and linear motions of a single spool, and a stepper motor under continual control. How thestructural parameters affect the static and dynamic characteristics of the valve is first clarified and acriterion for stability is presented. Experiments are designed to test the performance of the valve. It isnecessny to establish a balance between the static and dynamic characteristics in deciding thestructural parameters. Nevertheless, it is possible to maintain the dynamic response at a fairly highlevel, while keeping the leakage of the pilot stage at an acceptable level. One of the features of thedigital valve is stage control. In stage control the nonlinearities, such as electromagnetic saturation andhysteresis, are greatly reduced. To a large extent the dynamic response of the valve is decided by theexecuting cycle of the control algorithm.     

计及动力刚化的柔体动力学

提出两种计及动力刚化影响的动力学建模方法；有限段方法和一致线性化动力学方法。分析了这两种动力不主动力刚化的机理，有限段方法将柔体动力学问题转化为带有柔性的多刚体体系统动力学问题，计及了几何非线性的影响，适合于解决梁式结构的动力学问题；一致线性化动力学方法将变形场描述成为变形广义坐标的非线性形式，在适当的阶段线性化，可得到一致线性化动力学方程，自然计及了动力刚化项，适合于柔体的小变形问题。     

一种新型液压保护装置的卸荷规律研究

研究一种采用先导阀结构的、用于机械压力机滑块行程调节的新型液压超载保护装置,分析其工作原理,根据液压流体力学理论,建立卸载过程中液压系统的分析模型及先导阀芯运动规律模型,可进行液压系统仿真和结构参数设计优化。     

复杂曲面卧式数控抛光机床结构设计及分析

我国机械制造业的快速发展,亟需开发高精度、自动化复杂曲面抛光设备以提高抛光效率。根据抛光加工需求,提出了一种用于复杂曲面表面抛光的卧式抛光机床的设计方案。利用有限元分析软件,对机床整机模态特性及瞬态动力学特性进行了仿真,并对机床传动主轴进行了谐响应分析,得到了整机及关键零部件的固有特性及校核结果。     

低噪声溢流阀的研究

本文从理论和实践相结合的角度,叙述了溢流阀噪声产生的原因,降低溢流阀噪声的途径,低噪声溢流阀的结构原理及其计算机辅助设计。本文还提供了低噪声溢流阀的声功率、声压级和其他主要性能指标。这种低噪声溢流阀的噪声指标达到目前国际同类产品的先进水平。     

一种用于自动变速器的比例电磁阀研究

介绍一种用于自动变速器的比例电磁阀结构,研究比例电磁阀的分析、设计方法及其稳态和动态特性。在结构分析的基础上,分析其工作原理,将比例电磁阀分为电场、磁场、机械和流体四部分,分析这四部分的内在耦合关系。建立各个部分的动态特性数学模型并进行耦合仿真分析,对比例电磁阀电磁特性进行研究,通过与试验结果对比,初步验证耦合仿真模型的正确性。 通过计算分析电磁阀内部参量的动态变化特性,为优化电磁阀设计奠定基础。在液压部分中,进油口采用球阀,排油口采用喷嘴挡板阀,通过控制排油口的开度可以进行流量控制,间接控制油压输出。在比例电磁阀开启时,电磁力与弹簧力的总和与球阀的液压力相平衡的工作模式,使该比例电磁阀具有开关响应快、输入电流与输出油压线性关系好的特点。研究结果表明,该比例电磁阀阀芯位移0.2 mm ,开启响应时间在2 ms以内,油压建立在4 ms以内,适用于自动变速器换挡执行回路中。