Contribution of computational model for assessment of heart tissue local stress caused by suture in LVAD implantation.

STUDY: Implantation of a Left Ventricular Assist Device (LVAD) may produce both excessive local tissue stress and resulting strain-induced tissue rupture that are potential iatrogenic factors influencing the success of the surgical attachment of the LVAD into the myocardium. By using a computational simulation compared to mechanical tests, we sought to investigate the characteristics of stress-induced suture material on porcine myocardium. METHODS: Tensile strength experiments (n = 8) were performed on bulk left myocardium to establish a hyperelastic reduced polynomial constitutive law. Simultaneously, suture strength tests on left myocardium (n = 6) were performed with a standard tensile test setup. Experiments were made on bulk ventricular wall with a single U-suture (polypropylene 3-0) and a PTFE pledget. Then, a Finite Element simulation of a LVAD suture case was performed. Strength versus displacement behavior was compared between mechanical and numerical experiments. Local stress fields in the model were thus analyzed. RESULTS: A strong correlation between the experimental and the numerical responses was observed, validating the relevance of the numerical model. A secure damage limit of 100 kPa on heart tissue was defined from mechanical suture testing and used to describe numerical results. The impact of suture on heart tissue could be accurately determined through new parameters of numerical data (stress diffusion, triaxiality stress). Finally, an ideal spacing between sutures of 2 mm was proposed. CONCLUSION: Our computational model showed a reliable ability to provide and predict various local tissue stresses created by suture penetration into the myocardium. In addition, this model contributed to providing valuable information useful to design less traumatic sutures for LVAD implantation. Therefore, our computational model is a promising tool to predict and optimize LVAD myocardial suture.

Synthesis and characterization of Ti-27.5Nb alloy made by CLAD® additive manufacturing process for biomedical applications.

Biocompatible beta-titanium alloys such as Ti-27.5(at.%)Nb are good candidates for implantology and arthroplasty applications as their particular mechanical properties, including low Young's modulus, could significantly reduce the stress-shielding phenomenon usually occurring after surgery. The CLAD® process is a powder blown additive manufacturing process that allows the manufacture of patient specific (i.e. custom) implants. Thus, the use of Ti-27.5(at.%)Nb alloy formed by CLAD® process for biomedical applications as a mean to increase cytocompatibility and mechanical biocompatibility was investigated in this study. The microstructural properties of the CLAD-deposited alloy were studied with optical microscopy and electron back-scattered diffraction (EBSD) analysis. The conservation of the mechanical properties of the Ti-27.5Nb material after the transformation steps (ingot-powder atomisation-CLAD) were verified with tensile tests and appear to remain close to those of reference material. Cytocompatibility of the material and subsequent cell viability tests showed that no cytotoxic elements are released in the medium and that viable cells proliferated well.

Mechanical stability of custom-made implants: Numerical study of anatomical device and low elastic Young's modulus alloy.

The advent of new manufacturing technologies such as additive manufacturing deeply impacts the approach for the design of medical devices. It is now possible to design custom-made implants based on medical imaging, with complex anatomic shape, and to manufacture them. In this study, two geometrical configurations of implant devices are studied, standard and anatomical. The comparison highlights the drawbacks of the standard configuration, which requires specific forming by plastic strain in order to be adapted to the patient's morphology and induces stress field in bones without mechanical load in the implant. The influence of low elastic modulus of the materials on stress distribution is investigated. Two biocompatible alloys having the ability to be used with SLM additive manufacturing are considered, commercial Ti-6Al-4V and Ti-26Nb. It is shown that beyond the geometrical aspect, mechanical compatibility between implants and bones can be significantly improved with the modulus of Ti-26Nb implants compared with the Ti-6Al-4V.

Fatigue performance evaluation of a Nickel-free titanium-based alloy for biomedical application - Effect of thermomechanical treatments.

In the present work, structural fatigue experiments were performed on a Ti-26Nb alloy subjected to different thermomechanical treatments: a severe cold rolling, a solution treatment and two aging treatments at low-temperature conducted after cold rolling in order to optimize the kinetics of precipitation. The aim is to investigate the effect of microstructural refinement obtained by these processes on fatigue performances. Preliminary tensile tests were performed on each state and analyzed in terms of the microstructure documented by using X-Ray diffraction and TEM analysis. These tests clearly promote the short-time-aged cold-rolled state with a fine α and ω phases precipitation. An interesting balance between mechanical properties such as high strength and low Young's modulus has been obtained. Cyclic bending tests were carried out in air at 0.5%, 1%, 2% and 3% imposed strain amplitudes. At low straining amplitude, where the fatigue performances are at their best, the cold-rolled state does not break at 3×106 cycles and the long-time aged precipitation hardened state seems to be a good competitor compared to the cold-rolled state. All failure characteristics are documented by Scanning Electron Microscopy (SEM) micrographs and analyzed in term of microstructure.

In situ elaboration of a binary Ti-26Nb alloy by selective laser melting of elemental titanium and niobium mixed powders.

Ti-Nb alloys are excellent candidates for biomedical applications such as implantology and joint replacement because of their very low elastic modulus, their excellent biocompatibility and their high strength. A low elastic modulus, close to that of the cortical bone minimizes the stress shielding effect that appears subsequent to the insertion of an implant. The objective of this study is to investigate the microstructural and mechanical properties of a Ti-Nb alloy elaborated by selective laser melting on powder bed of a mixture of Ti and Nb elemental powders (26 at.%). The influence of operating parameters on porosity of manufactured samples and on efficacy of dissolving Nb particles in Ti was studied. The results obtained by optical microscopy, SEM analysis and X-ray microtomography show that the laser energy has a significant effect on the compactness and homogeneity of the manufactured parts. Homogeneous and compact samples were obtained for high energy levels. Microstructure of these samples has been further characterized. Their mechanical properties were assessed by ultrasonic measures and the Young's modulus found is close to that of classically elaborated Ti-26 Nbingot.

Interaction of bone-dental implant with new ultra low modulus alloy using a numerical approach.

Although mechanical stress is known as being a significant factor in bone remodeling, most implants are still made using materials that have a higher elastic stiffness than that of bones. Load transfer between the implant and the surrounding bones is much detrimental, and osteoporosis is often a consequence of such mechanical mismatch. The concept of mechanical biocompatibility has now been considered for more than a decade. However, it is limited by the choice of materials, mainly Ti-based alloys whose elastic properties are still too far from cortical bone. We have suggested using a bulk material in relation with the development of a new beta titanium-based alloy. Titanium is a much suitable biocompatible metal, and beta-titanium alloys such as metastable TiNb exhibit a very low apparent elastic modulus related to the presence of an orthorhombic martensite. The purpose of the present work has been to investigate the interaction that occurs between the dental implants and the cortical bone. 3D finite element models have been adopted to analyze the behavior of the bone-implant system depending on the elastic properties of the implant, different types of implant geometry, friction force, and loading condition. The geometry of the bone has been adopted from a mandibular incisor and the surrounding bone. Occlusal static forces have been applied to the implants, and their effects on the bone-metal implant interface region have been assessed and compared with a cortical bone/bone implant configuration. This work has shown that the low modulus implant induces a stress distribution closer to the actual physiological phenomenon, together with a better stress jump along the bone implant interface, regardless of the implant design.

Effects of thermomechanical process on the microstructure and mechanical properties of a fully martensitic titanium-based biomedical alloy.

Thermomechanical treatments have been proved to be an efficient way to improve superelastic properties of metastable ß type titanium alloys through several studies. In this paper, this treatment routes, already performed on superelastic alloys, are applied to the Ti-24Nb alloy (at%) consisting of a pure martensite α'' microstructure. By short-time annealing treatments performed on the heavily deformed material, an interesting combination of a large recoverable strain of about 2.5%, a low elastic modulus (35 GPa) and a high strength (900 MPa) was achieved. These properties are shown to be due to a complex microstructure consisting of the precipitation of nanoscale (α+ω) phases in ultra-fine ß grains. This microstructure allows a superelastic behavior through stress-induced α'' martensitic transformation. In this study, the microstructures were characterized by X-ray diffraction and transmission electron microscopy and the evolution of the elastic modulus and the strain recovery as a function of the applied strain was investigated through loading-unloading tensile tests.

Microstructure and mechanical behavior of superelastic Ti-24Nb-0.5O and Ti-24Nb-0.5N biomedical alloys.

In this study, the microstructure and the mechanical properties of two new biocompatible superelastic alloys, Ti-24Nb-0.5O and Ti-24Nb-0.5N (at.%), were investigated. Special attention was focused on the role of O and N addition on α(″) formation, supereleastic recovery and mechanical strength by comparison with the Ti-24Nb and Ti-26Nb (at.%) alloy compositions taken as references. Microstructures were characterized by optical microscopy, X-ray diffraction and transmission electron microscopy before and after deformation. The mechanical properties and the superelastic behavior were evaluated by conventional and cyclic tensile tests. High tensile strength, low Young's modulus, rather high superelastic recovery and excellent ductility were observed for both superelastic Ti-24Nb-0.5O and Ti-24Nb-0.5N alloys. Deformation twinning was shown to accommodate the plastic deformation in these alloys and only the {332}<113> twinning system was observed to be activated by electron backscattered diffraction analyses.

A thermo-mechanical treatment to improve the superelastic performances of biomedical Ti-26Nb and Ti-20Nb-6Zr (at.%) alloys.

A flash-thermal treatment technique has been developed very recently to improve both the critical stress to induce the martensitic transformation (MT) and the recoverable deformation of the metastable ß type titanium alloys. In this paper, this strategy is applied to both Ti-26Nb and Ti-20Nb-6Zr (at.%) alloys. Since both alloys have identical martensite start (Ms) temperature, it makes possible to investigate the effect of Zr on mechanical properties after the flash-thermal treatment. It is clearly shown that a flash treatment of 360 s at 873 K on heavily cold-rolled samples results in good balance between the tensile strength, the ductility and the recoverable strains. Such contribution is more significant in the ternary alloy in which balanced properties combining high martensitic critical stress over 400 MPa and the large fully recoverable strains up to 3.0% can be achieved. These improvements are due to the flash treatment effects, resulting in ultra-fine ß grains with sizes 1-2 µm with nano-sized α and ω phases precipitation in the ß matrix.

Mechanical properties of low modulus beta titanium alloys designed from the electronic approach.

Titanium alloys dedicated to biomedical applications may display both clinical and mechanical biocompatibility. Based on nontoxic elements such as Ti, Zr, Nb, Ta, they should combine high mechanical resistance with a low elastic modulus close to the bone elasticity (E=20 GPa) to significantly improve bone remodelling and osseointegration processes. These elastic properties can be reached using both lowering of the intrinsic modulus by specific chemical alloying and superelasticity effects associated with a stress-induced phase transformation from the BCC metastable beta phase to the orthorhombic alpha(″) martensite. It is shown that the stability of the beta phase can be triggered using a chemical formulation strategy based on the electronic design method initially developed by Morinaga. This method is based on the calculation of two electronic parameters respectively called the bond order (B(o)) and the d orbital level (M(d)) for each alloy. By this method, two titanium alloys with various tantalum contents, Ti-29Nb-11Ta-5Zr and Ti-29Nb-6Ta-5Zr (wt%) were prepared. In this paper, the effect of the tantalum content on the elastic modulus/yield strength balance has been investigated and discussed regarding the deformation modes. The martensitic transformation beta-->alpha(″) has been observed on Ti-29Nb-6Ta-5Zr in contrast to Ti-29Nb-11Ta-5Zr highlighting the chemical influence of the Ta element on the initial beta phase stability. A formulation strategy is discussed regarding the as-mentioned electronic parameters. Respective influence of cold rolling and flash thermal treatments (in the isothermal omega phase precipitation domain) on the tensile properties has been investigated.

Improvement of pseudoelasticity and ductility of Beta III titanium alloy--application to orthodontic wires.

The pseudoelasticity of metastable Beta III titanium alloy (TMAtrade mark) used for orthodontic applications is obtained by cold wiredrawing. This wire has higher rigidity than cold-drawn NiTi (Nitinoltrade mark, superelastic NiTi SE) and lower recoverable deformation. The low ductility value of Beta III is due to the deformation imposed by wiredrawing. The aim of this research was to improve the behaviour of this alloy by modifying the microstructural parameters to decrease the rigidity and increase the recoverable deformation and ductility of the alloy. The effects of second phase precipitate, grain size, and deformation on the wire mechanical properties were also examined. The isothermal precipitation of alpha (alpha) or omega (omega(isoth)) phases precludes the expression of the pseudoelastic effect. The presence of an omega(isoth) phase considerably increases fracture strength, whereas the alpha phase strongly decreases the ductility and adversely affects the strain recovery (epsilon(r)). To control the grain size, the growth of the recrystallized grains was studied by considering several parameters, which are known to have an influence on grain size, including the cold rolled strain, the temperature, the time of annealing, and the initial grain size. A structure with coarse grains, quenched from a temperature higher than the beta transus (T(beta)), associated with a plastic pre-deformation, contributed to an improved pseudoelastic behaviour, due to the presence of a reversible martensite phase (alpha'') induced by the pre-deformation.