球囊扩张式冠脉支架扩张变形机理的数值方法研究

通过非线性有限元方法,建立了球囊扩张式冠脉支架自由扩张和狭窄血管体内扩张的数值计算模型。针对两种不同联接筋结构的冠脉支架,分析了S型和N型支架的自由扩张性能和介入狭窄血管后的体内扩张性能,研究了支架结构对血管组织机械损伤的影响机理。数值模拟结果表明,在自由扩张阶段,S型和N型支架变形均匀,两种支架的径向回弹率和轴向短缩率趋于一致,并且具有良好的扩张均匀性与一致性,有利于支架扩张狭窄血管和在血管内的精确定位。在体内扩张阶段,由于狭窄血管的约束作用,S型和N型支架的径向回弹率均高于自由扩张阶段,轴向短缩率均低于自由扩张阶段;但是S型支架介入狭窄血管后的径向回弹率和轴向短缩率略高于N型支架,引起了更低的血管应力水平和应力梯度,减少了血管组织的机械损伤,降低了支架介入术后的血管内再狭窄率。综上,提出的计算模型对于冠脉支架的生物力学性能评估、结构优化设计与介入术后的血管损伤评价提供了重要的理论依据。     

狭窄血管内支架变形行为及力学性能模拟研究

狭窄率反映血管的堵塞程度,不同狭窄率对血管内支架力学性能的影响不同。利用有限元法对4种支架分别在30%,40%,50%的狭窄血管内进行力学性能模拟分析,研究狭窄率对支架变形行为和力学性能的影响。结果显示,狭窄率对支架的等效应力影响较小,而支架结构对血管内应力分布具有明显的影响,其中开环支架对血管内应力影响大于闭环支架;随着血管内狭窄率的升高,支架轴向缩短率呈减小的趋势、径向回弹率与扩张不均匀性呈增大的趋势,血管内等效应力具有增加的趋势;狭窄率对闭环支架径向回弹率与扩张不均匀性的影响比开环支架更显著。通过对狭窄率影响的分析,再现了不同堵塞程度血管对不同支架的影响,为支架的设计与植入提供理论依据。     

CoCr合金冠脉支架扩张变形的生物力学性能研究

通过非线性有限元方法研究了冠脉支架扩张过程的变形机理和生物力学性能。在不考虑血管壁和斑块的作用下,研究支架压握收缩、自由扩张和卸载过程中的有限元模型的网格划分、材料本构模型建立、边界条件、载荷定义和接触处理等关键技术。根据有限元计算结果得到了3种支架的轴向缩短率、扩张均匀性、径向反弹率、径向支撑力和柔顺性等生物力学性能参数,并与实验测试数据进行了分析比较,数值结果与扩张实验数据吻合较好。模拟方法为冠脉支架的优化设计及性能评估提供了科学的依据。     

不同扩张尺度对非对称椎动脉支架力学性能影响的研究

在临床治疗中,不同尺寸的狭窄血管所需要支架扩张的尺度也不同,而支架的扩张尺度对其力学性能有着重要影响。利用有限元方法仿真模拟分析了三款不同支架的体外扩张过程,主要研究了结构相同时不同扩张尺度对支架力学性能的影响。结果显示:随着支架扩张直径的增大,支架的最大等效应力、轴向短缩率、扩张不均匀性及柔顺性能呈递增趋势,支撑刚度和静安全系数呈递减趋势;支架的径向回弹主要受到其材料和结构影响,扩张尺度并不起决定性作用;通过与实验结果相比对,理论值与实验值结果吻合较好,误差在7%以内,验证了有限元模拟的准确性及合理性;利用动物实验对支架治疗效果进行验证,表明了支架的植入治疗是安全且有效的。综合考虑各因素影响,支架的治疗效果受支架扩张尺度的影响较大,这为临床治疗的顺利实施提供了良好的理论依据。     

不锈钢冠脉支架耦合扩张变形生物力学性能的模拟研究

利用非线性有限元方法仿真模拟不锈钢(SUS-316L)3种不同结构冠脉支架动静态耦合扩张过程和生物力学性能。研究支架在压握收缩、自由扩张、卸载过程以及脉流循环变应力持续作用过程中有限元模型的网格划分、材料本构模型建立、边界条件、载荷定义和接触处理等关键技术。根据有限元计算结果得到了3种支架在耦合扩张过程中最大等效应力为807.9MPa,最大塑性应变为0.208;3种支架的轴向缩短率、径向反弹率、扩张不均匀性都在13%以内,静态安全系数1.3,动态安全系数1.1;并与实验测试数据进行分析比较,理论分析与体外扩张实验结果吻合较好,误差在7%以内,验证了有限元模拟的准确性和合理性。本文的模拟方法为冠脉支架的优化设计、新产品开发以及临床评估提供了科学的依据。     

冠脉血管支架介入耦合系统力学行为数值模拟研究

针对冠脉支架植入术后引起的血管内再狭窄问题,开展了冠脉支架介入耦合系统力学行为的数值模拟研究。基于Ogden非线性弹性理论,构建了冠脉血管和动脉粥样硬化斑块的超弹性本构模型。通过非线性有限元法,建立了冠脉支架与狭窄血管的耦合作用模型,研究了冠脉支架在经历压握收缩、压握卸载、球囊扩张与球囊收缩等介入过程后的体内扩张性能,分析了冠脉支架的介入对狭窄血管损伤及再狭窄的力学影响因素。对比分析了S型支架和N型支架介入后狭窄冠脉血管的生物力学响应,数值计算结果表明:狭窄冠脉血管在支架支撑体波峰处存在较高的应力梯度,而且由于2种支架联接筋结构的类似性,血管内膜与斑块的应力分布规律一致。但是,N型支架的径向回弹率与轴向短缩率均小于S型支架,导致了更高的狭窄血管壁面峰值应力和应力梯度,更易于引起冠脉血管损伤造成血管内再狭窄。综上,该文提出的冠脉支架介入耦合系统力学模型,对于优化支架结构、抑制冠脉血管再狭窄问题,提供了重要的理论依据和临床参考。     

冠状动脉支架设计参数对支架弹性回弹性能的影响

冠状动脉支架作为经皮穿刺冠状动脉成形术中保持病变血管畅通的核心器件,其低的弹性回弹性能已作为新一代冠脉支架所应具有的重要力学特征。依据冠脉支架回弹性能的实际测试原型,建立了具有代表性的通用支架有限元模型,并利用此方法研究了冠脉支架设计参数对支架弹性回弹性能的影响。结果显示,支架波形环高度和花冠数在所有研究参数中对回弹性的影响最为显著,增加支架筋宽或者筋厚通常能够降低支架回弹率,但是,增加支架波形环高度或者波形环曲率半径通常会提高支架回弹率。此外,增加支架花冠数也会提高支架的回弹率。因此,有限元法对支架力学行为分析具有很大的帮助,为支架的临床选择及优化设计提供了重要指导。     

冷变形对00Cr18Mn15Mo2N0.9高氮无镍不锈钢摩擦磨损性能的影响EI北大核心CSCD

对新型00Cr18Mn15Mo2N0.9高氮无镍不锈钢进行不同变形量的冷轧处理,研究了高氮无镍不锈钢的冷变形性能以及冷变形对其摩擦磨损性能的影响。结果表明,高氮无镍不锈钢的奥氏体组织稳定,即使发生60%的冷变形也不产生形变马氏体;随着冷变形量的增加,高氮无镍不锈钢的强度、硬度提高,断后延伸率、加工硬化指数逐渐减小。在2、5和10 N载荷作用下,00Cr18Mn15Mo2N0.9高氮无镍不锈钢的磨损速率随着冷变形量的增加呈现先减小后增加的趋势,且载荷为2 N和5 N时在20%变形量处高氮无镍不锈钢具有最佳耐磨性,载荷为10 N时40%变形态高氮无镍不锈钢的耐磨性最佳。同时,随着冷变形程度和载荷的增加,00Cr18Mn15Mo2N0.9高氮无镍不锈钢的磨损机制逐渐由磨粒磨损、氧化磨损和脆性剥落转变为磨粒磨损和脆性剥落。     

不同材料冠状动脉支架膨胀行为分析

冠状动脉支架作为经皮穿刺冠状动脉成形术中保持病变血管畅通的核心器件,其在手术过程中受球囊作用的扩张特性以及球囊撤出后的反弹行为对支架植入术的成功有着重要的影响.利用有限元的方法系统,建立专有支架单独膨胀和血管支架膨胀模型,分析了316L不锈钢和L605钴铬合金两种材料支架筋尺寸和支架扩张尺度的变化及血管对其膨胀行为的影响.结果显示,支架所选材料是决定支架膨胀行为的主要因素,L605材料支架所需的临界内压力及反弹行为明显大于316L不锈钢支架;材料一定时,增加支架筋的宽度或厚度提高支架迅速扩张临界内压力;支架轴向长度的变化只与结构和最终膨胀状态相关.有限元模拟对支架性能的评价和设计有一定指导意义.     

冷变形对00Cr18Mn15Mo2N0.9高氮无镍不锈钢摩擦磨损性能的影响

对新型00Cr18Mn15Mo2N0.9高氮无镍不锈钢进行不同变形量的冷轧处理,研究了高氮无镍不锈钢的冷变形性能以及冷变形对其摩擦磨损性能的影响。结果表明,高氮无镍不锈钢的奥氏体组织稳定,即使发生60%的冷变形也不产生形变马氏体;随着冷变形量的增加,高氮无镍不锈钢的强度、硬度提高,断后延伸率、加工硬化指数逐渐减小。在2、5和10 N载荷作用下,00Cr18Mn15Mo2N0.9高氮无镍不锈钢的磨损速率随着冷变形量的增加呈现先减小后增加的趋势,且载荷为2 N和5 N时在20%变形量处高氮无镍不锈钢具有最佳耐磨性,载荷为10 N时40%变形态高氮无镍不锈钢的耐磨性最佳。同时,随着冷变形程度和载荷的增加,00Cr18Mn15Mo2N0.9高氮无镍不锈钢的磨损机制逐渐由磨粒磨损、氧化磨损和脆性剥落转变为磨粒磨损和脆性剥落。     

A computational study of crimping and expansion of bioresorbable polymeric stents

This paper studied the mechanical performance of four bioresorbable PLLA stents, i.e., Absorb, Elixir, Igaki–Tamai and RevaMedical, during crimping and expansion using the finite element method. Abaqus CAE was used to create the geometrical models for the four stents. A tri-folded balloon was created using NX software. For the stents, elastic–plastic behaviour was used, with hardening implemented by considering the increase of yield stress with the plastic strain. The tri-folded balloon was treated as linear elastic. To simulate the crimping of stents, a set of 12 rigid plates were generated around the stents with a radially enforced displacement. During crimping, the stents were compressed from a diameter of 3 mm to 1.2 mm, with the maximum stress developed at both inner and outer sides of the U-bends. During expansion, the stent inner diameter increased to 3 mm at the peak pressure and then recoiled to different final diameters after balloon deflation due to different stent designs. The maximum stress was found again at the U-bends of stents. Diameter change, recoiling effect and radial strength/stiffness were also compared for the four stents to assess the effect of design variation on stent performance. The effect of loading rate on stent deformation was also simulated by considering the time-dependent plastic behaviour of polymeric material.     

医用高氮无镍奥氏体不锈钢的制备与生物相容性研究

主要探讨不同含氮量的无镍奥氏体不锈钢材料对血管内皮细胞及血小板粘附的影响。通过溶血率和血小板粘附试验考察不同含氮量的无镍奥氏体不锈钢材料的血液相容性;通过MTT试验和细胞粘附试验考察不同含氮量的无镍奥氏体不锈钢材料的细胞相容性。结果表明不同含氮量的无镍奥氏体不锈钢材料的溶血率都低于国家标准的5%,对血小板粘附的影响不显著;粘附在高氮无镍奥氏体不锈钢材料表面的血管内皮细胞数量均多于钛合金材料,且细胞生长状态良好;细胞毒性试验表明,不同含氮量的高氮无镍奥氏体不锈钢材料和对照组钛合金材料对血管内皮细胞没有产生明显的毒副作用。     

Analysis of Magnetism in High Nitrogen Austenitic Stainless Steel and Its Elimination by High Temperature Gas Nitriding

Stable austenitic structure in medical stainless steels is basically required for surgical implantation. A weak magnetism was found in a high nitrogen nickel-free austenitic stainless steel for cardiovascular stent application. This magnetic behavior in high nitrogen stainless steel was investigated by optical microscopy, X-ray diffraction (XRD), electron probe microanalysis (EPMA) and superconducting quantum interference device (SQUID). The results showed that the magnetism came from the composition segregation of ferrite formation elements such as Cr and Mo in the steel and some δ-ferrites were locally formed during the pressurized electroslag remelting process. The magnetism of high nitrogen stainless steel could be eliminated by a proper high temperature gas nitriding (HTGN).     

In vitro study of platelet adhesion on medical nickel-free stainless steel surface

A new nickel-free austenitic stainless steel, named BIOSSN4, has been recently developed to avoid the sensitivity to Ni ions. In the present study, the blood compatibility of the nickel-free stainless steel was evaluated in vitro by the platelet-rich plasma adhesion test with comparison to 316L stainless steel. The result shows that the nickel-free stainless steel only causes less activation of platelets, which was indicated by their morphology and low spreading. The result suggests that the nickel-free stainless steel should have better blood compatibility compared with 316L stainless steel and, as a bio-material, it should have obvious advantage and potential applications.     

Numerical investigation of influence of number of stent cells and type of link on expansion and haemodynamic behaviour of balloon-expandable coronary stent

Coronary stents are tubular, mesh-like structures used to force open clogged artery. Mounted on an inflatable balloon, stent compresses calcified plaque inside atherosclerotic artery with an inflating device, which transfers the load through the compliant balloon, thus maintaining the patency of lumen. One of the contributors for success of angioplasty is type of stents, which mainly differs in its geometrical design. A clinician recommends a stent based on comparative advantages. An ideal stent should be flexible to manoeuver through tortuous artery, easy to expand, provide good scaffolding to the vessel, have less radial recoil and foreshortening, possess uniformity in expansion and induce minimum alteration in physiological blood flow dynamics. In a stent these parameters are in competition with each other and are optimized by trade-offs. The present work tries to sequentially investigate the effect of number of stent cells and type of links on the expansion and haemodynamics behaviour through computational analysis based on finite element and finite volume techniques. The study compares performance within same classes of designs rather than comparing the designs that are completely different form each other. Results show that more number of stent cells in longitudinal direction considerably decrease the radial recoil, but increase the foreshortening effect. Restenosis-prone zones are localized around the stent struts and are predominant during end of systolic phase of cardiac cycle. Shorter links are preferred for better recoil and favourable distribution of wall shear stress while longer links are preferred for favourable foreshortening.     

Nickel-free austenitic stainless steels for medical applications

Abstract

The adverse effects of nickel ions being released into the human body have prompted the development of high-nitrogen nickel-free austenitic stainless steels for medical applications. Nitrogen not only replaces nickel for austenitic structure stability but also much improves steel properties. Here we review the harmful effects associated with nickel in medical stainless steels, the advantages of nitrogen in stainless steels, and emphatically, the development of high-nitrogen nickel-free stainless steels for medical applications. By combining the benefits of stable austenitic structure, high strength and good plasticity, better corrosion and wear resistances, and superior biocompatibility compared to the currently used 316L stainless steel, the newly developed high-nitrogen nickel-free stainless steel is a reliable substitute for the conventional medical stainless steels.     

A review on nickel-free nitrogen containing austenitic stainless steels for biomedical applications

The field of biomaterials has become a vital area, as these materials can enhance the quality and longevity of human life. Metallic materials are often used as biomaterials to replace structural components of the human body. Stainless steels, cobalt–chromium alloys, commercially pure titanium and its alloys are typical metallic biomaterials that are being used for implant devices. Stainless steels have been widely used as biomaterials because of their very low cost as compared to other metallic materials, good mechanical and corrosion resistant properties and adequate biocompatibility. However, the adverse effects of nickel ions being released into the human body have promoted the development of “nickel-free nitrogen containing austenitic stainless steels” for medical applications. Nitrogen not only replaces nickel for austenitic structure stability but also much improves steel properties. Here we review the harmful effects associated with nickel and emphatically the advantages of nitrogen in stainless steel, as well as the development of nickel-free nitrogen containing stainless steels for medical applications. By combining the benefits of stable austenitic structure, high strength, better corrosion and wear resistance and superior biocompatibility in comparison to the currently used austenitic stainless steel (e.g. 316L), the newly developed nickel-free high nitrogen austenitic stainless steel is a reliable substitute for the conventionally used medical stainless steels.     

Effect of cold deformation on corrosion fatigue behavior of nickel-free high nitrogen austenitic stainless steel for coronary stent application

Due to the excellent mechanical properties, good corrosion resistance, high biocompatibility and nickel-free character, the high nitrogen nickel-free austenitic stainless steel (HNASS) becomes an ideally alternative material for coronary stents. Stent implantation works in harsh blood environment after a balloon dilatation, i.e., the material is used in a corrosive environment with a permanent deformation. The present study attempts to investigate effects of pre-straining on high-cycle fatigue behavior and corrosion fatigue behavior of HNASS in Hank’s solution and the relevant mechanism for coronary stents application. It is found that higher pre-straining on HNASS results in higher strength and maintains almost same corrosion resistance. Fatigue limit of 0% HNASS is 550 MPa, while corrosion fatigue limit is 475 MPa. And improvement in fatigue limit of 20% and 35% pre-strained HNASS is in comparison with the 0% HNASS, while corrosion would undermine the fatigue behavior of HNASS. In a suitable range, the pre-straining had a beneficial effect on corrosion fatigue strength of HNASS, such as nearly 300 MPa improved with 20% cold deformation. This result provides a good reference for predicting the life of HNASS stent and as well its design.