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.

A fracture-mechanics-based approach to fracture control in biomedical devices manufactured from superelastic Nitinol tube.

Several key fracture-mechanics parameters associated with the onset of subcritical and critical cracking, specifically the fracture toughness, crack-resistance curve, and fatigue threshold, have recently been reported for the superelastic alloy Nitinol, in the product form of the thin-walled tube that is used to manufacture several biomedical devices, most notably endovascular stents. In this study, we use these critical parameters to construct simple decision criteria for assessing the quantitative effect of crack-like defects in such Nitinol devices with respect to their resistance to failure by deformation or fracture. The criteria are based on the (equivalent) crack-initiation fracture toughness and fatigue threshold stress-intensity range, together with the general yield strength and fatigue endurance strength, and are used to construct a basis for design against single-event (overload) failures as well as for time-/cycle-delayed failures associated with fatigue.

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.

Fatigue-crack growth properties of thin-walled superelastic austenitic Nitinol tube for endovascular stents.

Over the past 10 years, the supereleastic nickel-titanium alloy Nitinol has found widespread application in the manufacture of small-scale biomedical devices, such as self-expanding endovascular stents. Although conventional stress/strain-life (S/N) analyses are invariably used as the primary method for design against fatigue loading and for predicting safe lifetimes, fracture mechanics-based methodologies provide a vital means of assessing the quantitative effect of defects on such lifetimes. Unfortunately, fracture mechanics studies on fatigue in Nitinol are scarce, and most results do not pertain to the (thin-walled tube) product forms that are typically used in the manufacture of endovascular stents. In the current work, we document the basic fatigue-crack growth properties of flattened thin-walled ( approximately 400 microm thick) Nitinol tubing in a 37 degrees C air environment. Crack-growth behavior is characterized over a wide range of growth rates ( approximately 6 orders of magnitude) and load ratios, that is, as a function of the alternating and maximum stress intensities, at 50 Hz. Limited experiments at both 5 and 50 Hz were also performed in 37 degrees C air and simulated body fluid to determine whether the cyclic frequency affects the fatigue behavior. Fatigue-crack growth-rate properties in such thin-walled Nitinol tube are found to be quite distinct from limited published data on other (mainly bulk) product forms of Nitinol, for example, bar and strip, both in terms of the relative fatigue thresholds and the variation in steady-state growth rates.

Crystallographic texture for tube and plate of the superelastic/shape-memory alloy Nitinol used for endovascular stents.

The superelastic/shape-memory material, Nitinol, an approximately equiatomic alloy of Ni and Ti, is rapidly becoming one of the most important metallic implant materials in the biomedical industry, in particular for the manufacture of endovascular stents. As such stents are invariably laser-machined from Nitinol tubes or sheets rolled into tubes, it is important to fully understand the physical phenomena that may affect the mechanical behavior of this material. With tubing and plate, one major issue is crystallographic texture, which can play a key role in influencing the mechanical properties of Nitinol. In this article, we present a study on how geometry and heat treatment can affect the texture of Nitinol, with specific quantification of the texture of Nitinol tube used for the production of endovascular stents.