生物瓣膜瓣叶性能优化及瓣架成型加工方法研究
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摘要
自19世纪60年代以来人工心脏瓣膜被越来越多地用于治疗心脏瓣膜疾病。人工心脏瓣膜包括人工机械瓣膜和人工生物瓣膜(简称生物瓣膜或生物瓣)。生物瓣是由瓣叶和架体组成的一种人工心脏瓣膜。瓣叶是瓣膜开闭的可动部分,一般用牛或猪心包经化学处理后形成的稳定生物高分子组合材料制成。瓣架则起构型、支撑和承力的作用。生物瓣的形状与人体心瓣相似,其流型属中心流型,流场特性也接近人体心瓣。生物瓣的抗溶血和抗血栓形成的性能较好,但由于材料的原因(如产生钙化)和瓣型设计的不够合理,生物瓣只是部分地达到了改善人工心瓣性能的目的。而作为其核心部分瓣架的加工制作,还没有较为统一的标准,无论在设计还是加工制作上都还处于探索阶段。随着人心脏瓣膜流场理论和生物材料理论研究的不断深入,围绕着提高生物瓣使用寿命而展开的生物瓣膜瓣叶力学性能分析及瓣架精密成型加工方法研究表现出广阔的前景。
论文以心脏解剖学及心瓣动力学理论为依据详细讨论了心瓣各动力学参数对其启闭性能的影响。以接近或达到人体天然心瓣的性能为目的,将传统设计理论与现代设计方法相结合,探讨构建人工生物心脏瓣膜参数化模型的新方法。本研究以采集临床心瓣动态参数为基础,通过对人体心瓣自然形态的分析导引出生物瓣膜的基本雏形,即以生物瓣膜的钢丝支架取代乳突肌腱索;以基本几何回转曲面造型取代半月瓣;以生物瓣膜的缝合环代替纤维环。本文以薄壳理论为依据对圆柱面、圆球面、抛物面、椭球面四种曲面旋转壳体应力状况理论分析,结果可知:采用球面构型的生物瓣膜瓣叶与采用圆柱面相比,瓣膜受力均匀且周向应力较小,其受力情况优于圆柱面。对旋转抛物面和椭球面,二者两个应力并不恒定,随坐标变化而发生变化,因而在有限元分析时可着重注意圆球面、旋转抛物面和椭球面三种型面瓣叶的力学性能分析。
本文以CAD/CAM应用软件—Pro/E软件为工具对生物瓣膜的瓣叶、瓣架及缝合环进行基于特征的实体造型设计。在薄膜应力分析的基础上参考不同型面瓣叶,分别创建符合空间几何方程的圆柱面、圆球面、旋转抛物面和椭球面,随之依次与其对应的倒圆锥面相交确定边界线和重要点的空间位置,得到了一系列较为精确的尺寸参数,建立了瓣叶参数化模型,利用有限元分析软件对不同构型瓣叶进行应力分析。
有限元分析是目前人工心脏瓣膜力学性能分析普遍采用的方法,是人工心脏瓣膜抗疲劳、防钙化设计的关键步骤。而有限元软件自身存在着建模功能薄弱的不足,CAD方法的引入为人工生物瓣膜的参数化造型提供了极大的方便,并在保证建模效果的前提下进一步提高了各参数的准确性。结合生物瓣膜瓣叶有限元模型我们依次定义材料属性及边界条件、导入几何模型、划分网格、加载数据、求解和结果分析。对不同构型、不同厚度、不同倾角以及不同材料特性的生物瓣膜瓣叶参数化模型进行线性、非线性力学性能分析。通过比较各种不同型面瓣叶应力分布情况发现:以椭球型面为基本构型瓣叶的第一主应力峰值低于其他型面瓣叶第一主应力峰值且椭球型面瓣叶较其他型面瓣叶应力分布较为均匀合理。因此论文采用椭球面作为生物瓣膜瓣叶的基本构型并用于生物瓣膜瓣架的设计、加工。
生物瓣膜瓣架设计与加工是以生物瓣膜力学性能分析结果为依据并对生物瓣膜瓣架展开算法详细讨论而展开的。首先,我们完成了生物瓣膜支架平面成型模具、空间成型模具的设计。其次,用电火花线切割方法加工生物瓣膜支架平面成型模具并得到平面成型生物瓣膜支架;再次,用雕刻铣加工方法加工生物瓣膜支架空间成型凹凸模石墨电极;用电火花加工方法加工生物瓣膜支架空间成型凹凸模;最后,用补偿的方法预留生物瓣膜支架空间成型的回弹量,修正生物瓣膜支架空间成型凹凸模,解决生物瓣膜支架冲压成型后回弹变形问题并取得实际经验数据,最终得到与优化造型设计基本一致的生物瓣膜支架实体。生物瓣膜瓣架的构型来源于生物瓣膜瓣叶力学性能分析,而生物瓣膜瓣叶的造型取决于生物瓣膜瓣架的构型,因此生物瓣膜瓣架的精密成型与加工为延长生物瓣膜的使用寿命及更好地应用于临床奠定了良好的基础。
Prosthetic heart valve have become increasingly used in the treatment of cardiovalvular disease since their introduction in the early 1960s. These artificial heart valve may be either the mechanical heart valve or the bioprosthetic heart valve (BHV). The BHV that consists of valvular leaflets, supporting stent and sutural ring is a type of man- made heart valve. Valvular leaflets made by high molecular material of porcine or bovine pericardial can be opened or closed by ejected blood. Supporting stent not only act as supporting and bearing forces but also act as configuration function. The bioprosthetic heart valve is similar to human heart valve on flow field. Its flow pattern is central-like. Although its function is improved in antihemolysis and antithrombotic, the efficiencies in device design of the bioprosthetic heart valve is still not satisfied. The united manufacturing standard on the BHV stent hasn't been made. About the design and manufacture of the BHV, some problems have not been solven untill now. However, with the development of the flow field theory and the biomaterials theory, the research on the stress analysis on the BHV leaflet and the precision modeling on the BHV stent will give a great help to prolonging the lifetime of BHV.
In order to reach the function of a human being's heart valve, the geometrical parametric model of bioprosthetic heart valve is established based on the heart anatomy. Based on the traditional design theory and the modern design method, we get the model of the BHV by analyzing natural shape of human valve. The wire stent of BHV is used instead of the muscle papillaris and the revolving curved surface is applied to valvular leaflets. The sutural ring of BHV replaces the annulus fibrosus. The stress distribution of curved surface with different shapes is analyzed based on Membrane theory. It is showed that the stress distribution of the spherical surface is comparatively reasonable. While the stress distribution of cylindrical surface is not uniform. The stress of the paraboloidal surface and the ellipsoid surface change in accordance with the change of coordinate points. Therefore, the stress distribution of the paraboloidal surface, the ellipsoid surface and spherical surface has been discussed in detail by the Finite Element method.
The solid model of valvular leaflets, the supporting stent and the sutural ring of the BHV have been set up by Pro/ENGNEER software. We take turns to create the cylinder, sphere, paraboloid, ellipsoid surfaces and then make them to intersect with inverse conic surfaces to get satisfy boundary curves and important points. After constructing parametric models of BHV via Computer Aided Design, a series of accurate points are obtained. The stress distribution of leaflets with different shapes is analyzed by the Finite Element software.
The finite element method is often applied to stress analysis, which is also crucial to the design of anti-fatigue and anti-calcification of bioprosthetic heart valve, however it has some disadvantages in modeling function. The Computer Aided Design software provides a convenient method to create the parametric model of the BHV and improve the accuracy of parametric models. The properties of material of the valve leaflet with the Finite Element model is defined and geometrical model of the valve leaflet with the Finite Element feature are established. After the valve leaflet with the Finite Element feature has been loaded, the result of the Finite Element analysis can be got. Not only the linear stress but also the non-linear stress of leaflets with different shapes, different thickness, different inclination and different properties of material are analyzed. It is showed that the maximal primary stress of the valve leaflet with elliptic sphere is low than that of the other valve leaflet and the stress distribution of the valve leaflet with elliptic sphere is comparatively reasonable. So, the ellipsoid surface should be applied in the design and machining of the BHV stent.
Based on the result of the stress analysis on the BHV, we finished the design and the manufacture of the BHV stent. Firstly, the unfolded algorithm of the BHV stent is discussed in detail. The casting mould of two dimensions and the casting mould of three dimensions are designed by the Pro/ENGNEER software. The casting mould of two dimensions is worked by the wire cut electrical discharge machine and the BHV stent of two dimensions was got. Secondly, the graphite electrode of three dimensions is machined by the carving miller and the casting mould of three dimensions was got by electric spark machining method. And then we solve the problem of the elastic deformation of the valvular stent and gain the experimental data by compensative method. Finally, we obtained the finished production the BHV stent which is consistent with the theoretical design. The manufacture of the BHV stent was based on the stress analysis on the BHV leaflet, on the other hand the shape of the BHV leaflet depends on the manufacture of the BHV stent. The precision modeling and machining of the BHV stent is very useful to prolong the lifetime of the BHV and to improve clinical practice of the BHV.
论文以心脏解剖学及心瓣动力学理论为依据详细讨论了心瓣各动力学参数对其启闭性能的影响。以接近或达到人体天然心瓣的性能为目的,将传统设计理论与现代设计方法相结合,探讨构建人工生物心脏瓣膜参数化模型的新方法。本研究以采集临床心瓣动态参数为基础,通过对人体心瓣自然形态的分析导引出生物瓣膜的基本雏形,即以生物瓣膜的钢丝支架取代乳突肌腱索;以基本几何回转曲面造型取代半月瓣;以生物瓣膜的缝合环代替纤维环。本文以薄壳理论为依据对圆柱面、圆球面、抛物面、椭球面四种曲面旋转壳体应力状况理论分析,结果可知:采用球面构型的生物瓣膜瓣叶与采用圆柱面相比,瓣膜受力均匀且周向应力较小,其受力情况优于圆柱面。对旋转抛物面和椭球面,二者两个应力并不恒定,随坐标变化而发生变化,因而在有限元分析时可着重注意圆球面、旋转抛物面和椭球面三种型面瓣叶的力学性能分析。
本文以CAD/CAM应用软件—Pro/E软件为工具对生物瓣膜的瓣叶、瓣架及缝合环进行基于特征的实体造型设计。在薄膜应力分析的基础上参考不同型面瓣叶,分别创建符合空间几何方程的圆柱面、圆球面、旋转抛物面和椭球面,随之依次与其对应的倒圆锥面相交确定边界线和重要点的空间位置,得到了一系列较为精确的尺寸参数,建立了瓣叶参数化模型,利用有限元分析软件对不同构型瓣叶进行应力分析。
有限元分析是目前人工心脏瓣膜力学性能分析普遍采用的方法,是人工心脏瓣膜抗疲劳、防钙化设计的关键步骤。而有限元软件自身存在着建模功能薄弱的不足,CAD方法的引入为人工生物瓣膜的参数化造型提供了极大的方便,并在保证建模效果的前提下进一步提高了各参数的准确性。结合生物瓣膜瓣叶有限元模型我们依次定义材料属性及边界条件、导入几何模型、划分网格、加载数据、求解和结果分析。对不同构型、不同厚度、不同倾角以及不同材料特性的生物瓣膜瓣叶参数化模型进行线性、非线性力学性能分析。通过比较各种不同型面瓣叶应力分布情况发现:以椭球型面为基本构型瓣叶的第一主应力峰值低于其他型面瓣叶第一主应力峰值且椭球型面瓣叶较其他型面瓣叶应力分布较为均匀合理。因此论文采用椭球面作为生物瓣膜瓣叶的基本构型并用于生物瓣膜瓣架的设计、加工。
生物瓣膜瓣架设计与加工是以生物瓣膜力学性能分析结果为依据并对生物瓣膜瓣架展开算法详细讨论而展开的。首先,我们完成了生物瓣膜支架平面成型模具、空间成型模具的设计。其次,用电火花线切割方法加工生物瓣膜支架平面成型模具并得到平面成型生物瓣膜支架;再次,用雕刻铣加工方法加工生物瓣膜支架空间成型凹凸模石墨电极;用电火花加工方法加工生物瓣膜支架空间成型凹凸模;最后,用补偿的方法预留生物瓣膜支架空间成型的回弹量,修正生物瓣膜支架空间成型凹凸模,解决生物瓣膜支架冲压成型后回弹变形问题并取得实际经验数据,最终得到与优化造型设计基本一致的生物瓣膜支架实体。生物瓣膜瓣架的构型来源于生物瓣膜瓣叶力学性能分析,而生物瓣膜瓣叶的造型取决于生物瓣膜瓣架的构型,因此生物瓣膜瓣架的精密成型与加工为延长生物瓣膜的使用寿命及更好地应用于临床奠定了良好的基础。
Prosthetic heart valve have become increasingly used in the treatment of cardiovalvular disease since their introduction in the early 1960s. These artificial heart valve may be either the mechanical heart valve or the bioprosthetic heart valve (BHV). The BHV that consists of valvular leaflets, supporting stent and sutural ring is a type of man- made heart valve. Valvular leaflets made by high molecular material of porcine or bovine pericardial can be opened or closed by ejected blood. Supporting stent not only act as supporting and bearing forces but also act as configuration function. The bioprosthetic heart valve is similar to human heart valve on flow field. Its flow pattern is central-like. Although its function is improved in antihemolysis and antithrombotic, the efficiencies in device design of the bioprosthetic heart valve is still not satisfied. The united manufacturing standard on the BHV stent hasn't been made. About the design and manufacture of the BHV, some problems have not been solven untill now. However, with the development of the flow field theory and the biomaterials theory, the research on the stress analysis on the BHV leaflet and the precision modeling on the BHV stent will give a great help to prolonging the lifetime of BHV.
In order to reach the function of a human being's heart valve, the geometrical parametric model of bioprosthetic heart valve is established based on the heart anatomy. Based on the traditional design theory and the modern design method, we get the model of the BHV by analyzing natural shape of human valve. The wire stent of BHV is used instead of the muscle papillaris and the revolving curved surface is applied to valvular leaflets. The sutural ring of BHV replaces the annulus fibrosus. The stress distribution of curved surface with different shapes is analyzed based on Membrane theory. It is showed that the stress distribution of the spherical surface is comparatively reasonable. While the stress distribution of cylindrical surface is not uniform. The stress of the paraboloidal surface and the ellipsoid surface change in accordance with the change of coordinate points. Therefore, the stress distribution of the paraboloidal surface, the ellipsoid surface and spherical surface has been discussed in detail by the Finite Element method.
The solid model of valvular leaflets, the supporting stent and the sutural ring of the BHV have been set up by Pro/ENGNEER software. We take turns to create the cylinder, sphere, paraboloid, ellipsoid surfaces and then make them to intersect with inverse conic surfaces to get satisfy boundary curves and important points. After constructing parametric models of BHV via Computer Aided Design, a series of accurate points are obtained. The stress distribution of leaflets with different shapes is analyzed by the Finite Element software.
The finite element method is often applied to stress analysis, which is also crucial to the design of anti-fatigue and anti-calcification of bioprosthetic heart valve, however it has some disadvantages in modeling function. The Computer Aided Design software provides a convenient method to create the parametric model of the BHV and improve the accuracy of parametric models. The properties of material of the valve leaflet with the Finite Element model is defined and geometrical model of the valve leaflet with the Finite Element feature are established. After the valve leaflet with the Finite Element feature has been loaded, the result of the Finite Element analysis can be got. Not only the linear stress but also the non-linear stress of leaflets with different shapes, different thickness, different inclination and different properties of material are analyzed. It is showed that the maximal primary stress of the valve leaflet with elliptic sphere is low than that of the other valve leaflet and the stress distribution of the valve leaflet with elliptic sphere is comparatively reasonable. So, the ellipsoid surface should be applied in the design and machining of the BHV stent.
Based on the result of the stress analysis on the BHV, we finished the design and the manufacture of the BHV stent. Firstly, the unfolded algorithm of the BHV stent is discussed in detail. The casting mould of two dimensions and the casting mould of three dimensions are designed by the Pro/ENGNEER software. The casting mould of two dimensions is worked by the wire cut electrical discharge machine and the BHV stent of two dimensions was got. Secondly, the graphite electrode of three dimensions is machined by the carving miller and the casting mould of three dimensions was got by electric spark machining method. And then we solve the problem of the elastic deformation of the valvular stent and gain the experimental data by compensative method. Finally, we obtained the finished production the BHV stent which is consistent with the theoretical design. The manufacture of the BHV stent was based on the stress analysis on the BHV leaflet, on the other hand the shape of the BHV leaflet depends on the manufacture of the BHV stent. The precision modeling and machining of the BHV stent is very useful to prolong the lifetime of the BHV and to improve clinical practice of the BHV.
引文
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