Shape memory and superelasticity : advances in science and technology最新文献

Nitinol frames are often covered with polymer(s) in cardiovascular medical devices to direct blood flow or maintain structural integrity. Due to their insulating properties, coverings pose a challenge to accurately assess the corrosion resistance of the device. Potentiodynamic polarization testing was performed on electropolished and thermal oxide Nitinol stent rings with either an electrospun TPU, dip-coated silicone, or ePTFE/FEP covering to evaluate its impact on Nitinol corrosion resistance. Stent rings were tested fully covered, partially covered (no silicone group), and with the covering removed. For the silicone and ePTFE/FEP groups, uncovered stent rings with a simulated thermal history representative of their covering processes were also tested. The results indicated that breakdown potentials (E _b ) were similar between the different TPU groups within each surface finish. In contrast, the silicone group displayed lower E _b values for the covering removed and simulated thermal history compared to the as-manufactured electropolished rings. Substantial variability in electrochemical behavior was observed in the ePTFE-covered group, particularly in the covering removed group that possessed significantly lower E _b values compared to the as-manufactured electropolished stent rings. These findings highlight the importance of test article selection for pitting corrosion assessments of Nitinol medical products covered with a non-conductive polymer.

Nitinol implants, especially those used in cardiovascular applications, are typically expected to remain durable beyond 10⁸ cycles, yet literature on ultra-high cycle fatigue of nitinol remains relatively scarce and its mechanisms not well understood. To investigate nitinol fatigue behavior in this domain, we conducted a multifaceted evaluation of nitinol wire subjected to rotary bend fatigue that included detailed material characterization and finite element analysis as well as post hoc analyses of the resulting fatigue life data. Below approximately 10⁵ cycles, cyclic phase transformation, as predicted by computational simulations, was associated with fatigue failure. Between 10⁵ and 10⁸ cycles, fractures were relatively infrequent. Beyond 10⁸ cycles, fatigue fractures were relatively common depending on the load level and other factors including the size of non-metallic inclusions present and the number of loading cycles. Given observations of both low cycle and ultra-high cycle fatigue fractures, a two-failure model may be more appropriate than the standard Coffin-Manson equation for characterizing nitinol fatigue life beyond 10⁸ cycles. This work provides the first documented fatigue study of medical grade nitinol to 10⁹ cycles, and the observations and insights described will be of value as design engineers seek to improve durability for future nitinol implants.

Nitinol is a nickel-titanium alloy widely used in medical devices for its unique pseudoelastic and shape-memory properties. However, nitinol can release potentially hazardous amounts of nickel, depending on surface manufacturing yielding different oxide thicknesses and compositions. Furthermore, nitinol medical devices can be implanted throughout the body and exposed to extremes in pH and reactive oxygen species (ROS), but few tools exist for evaluating nickel release under such physiological conditions. Even in cardiovascular applications, where nitinol medical devices are relatively common and the blood environment is well understood, there is a lack of information on how local inflammatory conditions after implantation might affect nickel ion release. For this study, nickel release from nitinol wires of different finishes was measured in pH conditions and at ROS concentrations selected to encompass and exceed literature reports of extracellular pH and ROS. Results showed increased nickel release at levels of pH and ROS reported to be physiological, with decreasing pH and increasing concentrations of hydrogen peroxide and NaOCl/HOCl having the greatest effects. The results support the importance of considering the implantation site when designing studies to predict nickel release from nitinol and underscore the value of understanding the chemical milieu at the device-tissue interface.

Nitinol is used as a metallic biomaterial in medical devices due to its shape memory and pseudoelastic properties. The clinical performance of nitinol depends on factors which include the surface finish, the local environment, and the mechanical loads to which the device is subjected. Preclinical evaluations of device durability are performed with fatigue tests while electrochemical characterization methods such as ASTM F2129 are employed to evaluate corrosion susceptibility by determining the rest potential and breakdown potential. However, it is well established that the rest potential of a metal surface can vary with the local environment. Very little is known regarding the influence of voltage on fatigue life of nitinol. In this study, we developed a fatigue testing method in which an electrochemical system was integrated with a rotary bend wire fatigue tester. Samples were fatigued at various strain levels at electropotentials anodic and cathodic to the rest potential to determine if it could influence fatigue life. Wires at potentials negative to the rest potential had a significantly higher number of cycles to fracture than wires held at potentials above the breakdown potential. For wires for which no potential was applied, they had fatigue life similar to wires at negative potentials.