Choice of extraction media for Ni release risk evaluation on nickel-titanium alloys cardiovascular stents
10.3760/cma.j.cn121382-20240204-00208
- VernacularTitle:镍钛合金心血管产品镍释放风险评估浸提介质的选择
- Author:
Bin LIU
1
;
Yang QIN
;
Xiaoman ZHANG
;
Changyan WU
;
Dongwei WANG
;
Wenli LI
;
Cheng JIN
;
Yunfan DONG
;
Yiwei ZHAO
;
Lili LIU
;
Wei XIONG
Author Information
1. 山东省医疗器械和药品包装检验研究院，山东省医疗器械生物学评价重点实验室，国家食品药品监督管理局济南医疗器械质量监督检验中心，济南 250101
- Keywords:
Nickel release;
Safety evaluation;
Extraction media;
Ni-Ti alloys cardiovascular stents
- From:
International Journal of Biomedical Engineering
2024;47(2):156-161
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To determine the content of the released nickel ion through the 7 extraction media to extract the Ni-Ti wires and to plot the curve of the released nickel ion so as to identify a leaching medium that can be substituted for blood for in vitro Ni release evaluation. Methods:The release of Ni through microwave digestion/inductively coupled plasma mass spectrometry (ICP-MS) in the goat serum was determined. Because of the high content of Ni release, it could be determined by diluting the extraction medium, and other extraction media could be determined directly. Ni release standard curves were plotted by the release amount and different time point variables. Though the different extraction media Ni release curves confirm the specificity of extraction media instead of blood.Results:By analyzing the Ni release curves of seven leaching media, it was found that none of these seven extraction media was suitable for the evaluation of Ni release in in vitro leaching media. Considering the safety of the leaching medium and the simplicity of preparation, hydrochloric acid solution was chosen as the leaching medium, but the concentration needed to be diluted accordingly. Finally, a hydrochloric acid solution was created as an alternative to blood for the in vitro study of Ni release from Ni-Ti alloy cardiovascular products, with a volume fraction of 0.005%. Conclusions:The in vitro leaching medium that can replace blood was found to be hydrochloric acid for the time being, but its concentration was too high, resulting in too much Ni release as well, which deviated from the actual situation. Therefore, the hydrochloric acid solution was diluted step by step, and the Ni release curve was examined until it was close to the clinical release level, and the actual concentration was determined, thus laying a solid foundation for the subsequent evaluation of the safety and risk.
