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A Predictive Toxicokinetic Model for Nickel Leaching from Vascular Stents.
Giakoumi, Matheos; Stephanou, Pavlos S; Kokkinidou, Despoina; Papastefanou, Chara; Anayiotos, Andreas; Kapnisis, Konstantinos.
Afiliação
  • Giakoumi M; Department of Mechanical Engineering and Materials Science and Engineering, Cyprus University of Technology, Limassol 3036, Cyprus.
  • Stephanou PS; Department of Chemical Engineering, Cyprus University of Technology, Limassol 3036, Cyprus.
  • Kokkinidou D; Department of Mechanical Engineering and Materials Science and Engineering, Cyprus University of Technology, Limassol 3036, Cyprus.
  • Papastefanou C; Cp Foodlab Ltd, Nicosia 2326, Cyprus.
  • Anayiotos A; Department of Mechanical Engineering and Materials Science and Engineering, Cyprus University of Technology, Limassol 3036, Cyprus.
  • Kapnisis K; Department of Mechanical Engineering and Materials Science and Engineering, Cyprus University of Technology, Limassol 3036, Cyprus.
ACS Biomater Sci Eng ; 10(4): 2534-2551, 2024 04 08.
Article em En | MEDLINE | ID: mdl-38525821
ABSTRACT
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 time-dependent 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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Texto completo: 1 Coleções: 01-internacional Temas: Agentes_cancerigenos Base de dados: MEDLINE Assunto principal: Modelos Biológicos / Níquel Limite: Animals / Humans Idioma: En Revista: ACS Biomater Sci Eng Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Chipre

Texto completo: 1 Coleções: 01-internacional Temas: Agentes_cancerigenos Base de dados: MEDLINE Assunto principal: Modelos Biológicos / Níquel Limite: Animals / Humans Idioma: En Revista: ACS Biomater Sci Eng Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Chipre