A biokinetic model for nickel released from cardiovascular devices

Area of Science:

• Biomedical Engineering
• Toxicology
• Materials Science

Background:

• Cardiovascular devices often contain nickel alloys, posing health risks if nickel is released.
• Current in-vitro tests may not accurately reflect in-vivo nickel release rates from implanted devices.

Purpose of the Study:

• To develop a novel biokinetic model for estimating in-vivo nickel release from implanted cardiovascular devices.
• To link in-vitro nickel release data to serum nickel concentrations for in-vivo estimations.

Main Methods:

• Combined a toxicokinetic compartment model with a physics-based model.
• Parameterized the model using literature data on nitinol in-vitro release and human serum nickel.
• Validated and optimized the model using serum nickel data from patients with nitinol atrial occluders.

Main Results:

• The model accurately reflects nickel levels in serum and urine of patients post-implantation.
• Optimized model parameters were found to be physiologically plausible.
• Demonstrated consistency between in-vitro release data and in-vivo nickel concentrations.

Conclusions:

• The developed biokinetic model provides a framework for interpreting nickel biomonitoring data.
• Enables estimation of in-vivo nickel release from implanted devices using in-vitro immersion test data.
• Enhances the assessment of nickel-related health risks associated with cardiovascular devices.