Nitinol Release of Nickel under Physiological Conditions: Effects of Surface Oxide, pH, Hydrogen Peroxide, and Sodium Hypochlorite

Sussman, Eric M.; Shi, Huiyu; Turner, Paul; Saylor, David M.; Weaver, Jason D.; Simon, David A.; Takmakov, Pavel; Sivan, Shiril; Shin, Hainsworth Y.; Prima, Matthew Di; Godar, Dianne E.

doi:10.1007/s40830-022-00364-3

Cited by 3 publications

(1 citation statement)

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“…Consequently, even though these tests facilitate easy comparisons between devices, the degree to which in vitro performance aligns with in vivo corrosion behavior remains uncertain. Interestingly, Nagaraja et al 28 highlighted the impact of fatigue loading on uniform corrosion for different nitinol stent surfaces, while Sussman et al 29 demonstrated increased Ni release from nitinol devices exposed to different physiological environments characterized by the level of pH and reactive oxygen species (ROS). These findings emphasize the significance of taking the implantation site into account when designing studies to predict nickel release from medical implants and underscore the importance of the biomechanochemical environment at the device–tissue interface.…”

Section: Introductionmentioning

confidence: 99%

A Predictive Toxicokinetic Model for Nickel Leaching from Vascular Stents

Giakoumi,

Stephanou,

Kokkinidou

et al. 2024

ACS Biomater. Sci. Eng.

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In vitro testing methods offer valuable insights into the corrosion vulnerability of metal implants and enable prompt comparison between devices. However, they fall short in predicting the extent of leaching and the biodistribution of implant byproducts under in vivo conditions. Physiologically based toxicokinetic (PBTK) models are capable of quantitatively establishing such correlations and therefore provide a powerful tool in advancing nonclinical methods to test medical implants and assess patient exposure to implant debris. In this study, we present a multicompartment PBTK model and a simulation engine for toxicological risk assessment of vascular stents. The mathematical model consists of a detailed set of constitutive equations that describe the transfer of nickel ions from the device to peri-implant tissue and circulation and the nickel mass exchange between blood and the various tissues/organs and excreta. Model parameterization was performed using (1) in-house-produced data from immersion testing to compute the device-specific diffusion parameters and (2) full-scale animal in situ implantation studies to extract the mammalian-specific biokinetic functions that characterize the timedependent biodistribution of the released ions. The PBTK model was put to the test using a simulation engine to estimate the concentration−time profiles, along with confidence intervals through probabilistic Monte Carlo, of nickel ions leaching from the implanted devices and determine if permissible exposure limits are exceeded. The model-derived output demonstrated prognostic conformity with reported experimental data, indicating that it may provide the basis for the broader use of modeling and simulation tools to guide the optimal design of implantable devices in compliance with exposure limits and other regulatory requirements.

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Section: Introductionmentioning

confidence: 99%