Alan R. Pelton

Fatigue and durability of Nitinol stents

Nitinol self-expanding stents are effective in treating peripheral artery disease, including the superficial femoral, carotid, and renal arteries. However, fracture occurrences of up to 50% have been reported in some stents after one year. These stent fractures are likely due to in vivo cyclic displacements. As such, the cyclic fatigue and durability properties of Nitinol-based endovascular stents are discussed in terms of an engineering-based experimental testing program. In this paper, the combined effects of cardiac pulsatile fatigue and stent-vessel oversizing are evaluated for application to both stents and stent subcomponents. In particular, displacement-controlled fatigue tests were performed on stent-like specimens processed from Nitinol microtubing. Fatigue data were collected with combinations of simulated oversizing conditions and pulsatile cycles that were identified by computer modeling of the stent that mimic in vivo deformation conditions. These data are analyzed with non-linear finite element computations and are illustrated with strain-life and strain-based constant-life diagrams. The utility of this approach is demonstrated in conjunction with 10 million cycle pulsatile fatigue tests of Cordis SMART Control((R)) Nitinol self-expanding stents to calculate fatigue safety factors and thereby predict in vivo fatigue resistance. These results demonstrate the non-linear constant fatigue-life response of Nitinol stents, whereby, contrary to conventional engineering materials, the fatigue life of Nitinol is observed to increase with increasing mean strain.

Mechanical fatigue and fracture of Nitinol

Abstract Nitinol, a near equiatomic intermetallic of nickel and titanium, is the most widely known and used shape memory alloy. Owing to its capacity to undergo a thermal or stress induced martensitic phase transformation, Nitinol displays recoverable strains that are more than an order of magnitude greater than in traditional alloys, specifically as high as 10%. Since its discovery in the 1960s, Nitinol has been used for its shape memory properties for couplings and actuators, although its contemporary use has been in for medical devices. For these applications, the stress induced transformation (‘superelasticity’) has been used extensively for self-expanding implantable devices such as endovascular stents and vena cava filters, and for tools such as endodontic files. Most of these applications involve cyclically varying biomechanical stresses or strains that drive the need to fully understand the fatigue and fracture resistance of this alloy. Here we review the existing knowledge base on the fatigue of Nitinol, both in terms of their stress or strain life (total life) and damage tolerant (crack propagation) behaviour, together with their fracture toughness properties. We further discuss the application of such data to the fatigue design and life prediction methodologies for Nitinol implant devices used in the medical industry.

Rotary-bending fatigue characteristics of medical-grade Nitinol wire

The rotary bending fatigue properties of medical-grade Nitinol wires were investigated under conditions of 0.5-10% strain amplitudes to a maximum of 10(7) cycles. The results from this study provide insight into the behavior of Nitinol under fully reversed (εmin/εmax=-1) fatigue conditions for three compositions, two surface conditions and three test temperatures. For pseudoelastic conditions there are four distinct regions of the strain-cycle curves that are related to phases (austenite, stress-induced martensite, and R-Phase) and their respective strain accommodation mechanisms. In contrast, there are only two regions for the strain-cycle curves for thermal martensite. It was further observed that the strain amplitude to achieve 10(7)-cycles increases with both decreasing test temperature and increasing transformation temperature. Fatigue behavior was not, however, strongly influenced by wire surface condition. SEM of the fracture surfaces showed that the fatigue fracture area increased with decreasing strain amplitude. Finite element analysis was used to illustrate strain distributions across the wire as well as to calculate the tension-compression contributions to the rotary bending curves. The results from this investigation are discussed with respect to mechanisms of strain accommodation under cyclic tensile and compressive conditions.

Corrosion Resistance and Biocompatibility of Passivated NiTi

Equiatomic nickel-titanium (NiTi) or Nitinol possess a unique combination of properties, including superelasticity and shape memory, which are very attractive for biomedical applications. NiTi has been used in orthopedic and orthodontic implants for several decades and has contributed to significant improvements in these fields [1, 2]. This alloy is rapidly becoming the material of choice for selfexpanding stents, graft support systems, filters, baskets and various other devices for minimally invasive interventional procedures (Fig. 1) [1,3]. While the superior performance of NiTi over conventional engineering materials for implants is well documented [1,4,5], the high nickel content of the alloy (55 weight % Ni) and itspossible influence on biocompatibility continues to be an issue of concern. This concern is further complicated by the conflicting literature on corrosion resistance.

Influence of microstructural purity on the bending fatigue behavior of VAR-melted superelastic Nitinol

The bending fatigue resistance of commercially-available Standard versus High Purity Nitinol was evaluated at 3% mean strain and a range of strain amplitudes with the simple wire Z-specimen geometry. The Standard grade Nitinol demonstrated a 10(7)-cycle fatigue strain limit of 0.50% alternating strain, comparable to results reported elsewhere in the literature. Conversely, the High Purity grade VAR Nitinol demonstrated a 5-fold improvement in fatigue resistance with an impressive 10(7)-cycle fatigue strain limit of 2.5% alternating strain. The High Purity Nitinol has an oxygen+nitrogen content of 60wppm, maximum wrought-material inclusion length of 17µm, and inclusion volume fraction of 0.28%, all substantially less than industry standards. With all processing variables held constant except for inclusion content, it is clear that this marked fatigue superiority is due exclusively to the reduction in both size and area fraction of inclusions.

Impact of Thermomechanical Texture on the Superelastic Response of Nitinol Implants

The phenomenon of superelasticity in near-equiatomic NiTi, which originates from a first-order martensitic phase transition, is exploited in an increasing number of biomedical devices, most importantly endovascular stents. These stents are often manufactured from microtubing, which is shown to be highly textured crystallographically. Synchrotron X-ray microdiffraction provided microstructural, phase, and strain analysis from Nitinol tube sections that were deformed in situ along longitudinal, circumferential, and transverse orientations. We show that the large variation in the superelastic response of NiTi in these three tube directions is strongly influenced by the path that the martensitic transformation follows through the microstructure. Specifically, in severely worked NiTi, bands of [100] grains occur whose orientation deviates markedly from the surrounding matrix; these bands have an unusually large impact on the initiation and the propagation of martensite, and hence on the mechanical response. Understanding the impact of these local microstructural effects on global mechanical response, as shown here, leads to a much fuller understanding of the causes of deviation of the mechanical response from predictions and unforeseen fracture in NiTi biomedical devices.

High compressive pre-strains reduce the bending fatigue life of nitinol wire

Prior to implantation, Nitinol-based transcatheter endovascular devices are subject to a complex thermo-mechanical pre-strain associated with constraint onto a delivery catheter, device sterilization, and final deployment. Though such large thermo-mechanical excursions are known to impact the microstructural and mechanical properties of Nitinol, their effect on fatigue properties is still not well understood. The present study investigated the effects of large thermo-mechanical pre-strains on the fatigue of pseudoelastic Nitinol wire using fully reversed rotary bend fatigue (RBF) experiments. Electropolished Nitinol wires were subjected to a 0%, 8% or 10% bending pre-strain and RBF testing at 0.3-1.5% strain amplitudes for up to 10(8) cycles. The imposition of 8% or 10% bending pre-strain resulted in residual set in the wire. Large pre-strains also significantly reduced the fatigue life of Nitinol wires below 0.8% strain amplitude. While 0% and 8% pre-strain wires exhibited distinct low-cycle and high-cycle fatigue regions, reaching run out at 10(8) cycles at 0.6% and 0.4% strain amplitude, respectively, 10% pre-strain wires continued to fracture at less than 10(5) cycles, even at 0.3% strain amplitude. Furthermore, over 70% fatigue cracks were found to initiate on the compressive pre-strain surface in pre-strained wires. In light of the texture-dependent tension-compression asymmetry in Nitinol, this reduction in fatigue life and preferential crack initiation in pre-strained wires is thought to be attributed to compressive pre-strain-induced plasticity and tensile residual stresses as well as the formation of martensite variants. Despite differences in fatigue life, SEM revealed that the size, shape and morphology of the fatigue fracture surfaces were comparable across the pre-strain levels. Further, the mechanisms underlying fatigue were found to be similar; despite large differences in cycles to failure across strain amplitudes and pre-strain levels, cracks initiated from surface inclusions in nearly all wires. Compressive pre-strain-induced damage may accelerate such crack initiation, thereby reducing fatigue life. The results of the present study indicate that large compressive pre-strains are detrimental to the fatigue properties of Nitinol, and, taken together, the findings underscore the importance of accounting for thermo-mechanical history in the design and testing of wire-based percutaneous implants.