The purpose of this study was to investigate the cytotoxicity of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Seven cell lines were chosen. They were L929, h9c2(2-1), 293[HEK-293], hFOB1.19, THLE-3, H9 and IM-9 respectively. According to the principle of biological evaluation of medical devices, MTT method was chosen to test the cytotoxicity in different concentrations of nickel ion. For each cell line, the relative growth rate (RGR) was obtained and the cytotoxic grade was classified. Besides, IC50 values were calculated. As a result, it was found that the sensitivity was different among all cell lines. H9 was the most sensitive one, while the L929 was the most tolerant one. The concentration which is not above 1.25 mg/L was safe for all seven cell lines, because the cytotoxicity for all cells exposed in this concentration were not higher than grade 1. According to the criteria for medical devices, the concentrations not above 5 mg/L were safe for L929 cells. This result helps us to roughly assess the cytotoxicity and systematic toxicity caused by nickel contained in medical devices.
Cell Line ; Equipment and Supplies ; HEK293 Cells ; Humans ; Ions ; toxicity ; Nickel ; toxicity

The dissolution of nickel from nitinol alloy under different extraction conditions was investigated when biological tests of nitinol medical devices were carried out. It discussed the equivalence of these extraction conditions and found the best extraction conditions. In the experiment, two brands of nitinol were chosen and extracted under different extraction conditions according to GB/T 16886-12. Plasma emission spectrometer was used to analyse the concentration of nickel in extract liquid. The results show that there is no equivalence among these extraction conditions for nitinol materials. And it is suggested that (37 +/- 1) degree C, (72 +/- 2) h could be used as normal extraction condition and (70 +/- 2) degrees C, (24 +/- 2) h as accelerated extraction condition.
Alloys ; chemistry ; Biocompatible Materials ; Materials Testing ; Nickel ; chemistry ; Temperature ; Titanium

To investigate the clinical value of three-dimensional ultrasonography (3DUS) in obstetrics, various 3DUS rendering methods including surface mode, transparent mode and multiplanar mode were employed to scan 30 fetuses in second and third trimester by using the transabdominal volume transducer. The results showed that surface mode could vividly demonstrate the surface morphologic features of the fetuses, as well as the stereo-shape and the spatial relationship among the surface structures. The face, limbs, umbilical cord and outer genitalia of the fetus could be well displayed by surface mode. Transparent mode could reveal the bony structures under the surface, such as ribs, vertebrae, crania, etc. The result was not affected by the sophisticated curvature of these bony structures and the success rate was up to 100 %. When rendered by multiplanar mode, the region of interest (ROI) could be viewed from different directions. It should be concluded that 3DUS could serve as a supplement to two-dimensional ultrasonography (2DUS). 3DUS might play an important role in prenatal diagnosis and enhance the diagnostic confidence level of the physicians.

To investigate the clinical value of three-dimensional ultrasonography (3DUS) in obstetrics, various 3DUS rendering methods including surface mode, transparent mode and multiplanar mode were employed to scan 30 fetuses in second and third trimester by using the transabdominal volume transducer. The results showed that surface mode could vividly demonstrate the surface morphologic features of the fetuses, as well as the stereo-shape and the spatial relationship among the surface structures. The face, limbs, umbilical cord and outer genitalia of the fetus could be well displayed by surface mode. Transparent mode could reveal the bony structures under the surface, such as ribs, vertebrae, crania, etc. The result was not affected by the sophisticated curvature of these bony structures and the success rate was up to 100 %. When rendered by multiplanar mode, the region of interest (ROI) could be viewed from different directions. It should be concluded that 3DUS could serve as a supplement to two-dimensional ultrasonography (2DUS). 3DUS might play an important role in prenatal diagnosis and enhance the diagnostic confidence level of the physicians.

Currently, as the key raw material of artificial biological heart valve, bovine pericardium is mainly depend on import and has become a "bottleneck" challenge, greatly limiting the development of domestic biological heart valve. Therefore, the localization of bovine pericardium is extremely urgent. In this study, the pericardium of Sichuan yak was compared with that of Australian cattle in terms of fundamental properties and anti-calcification performance. The results demonstrated that the appearance and thickness of yak pericardium were more advantageous than the Australian one. Sichuan yak pericardium and Australian cattle pericardium had comparable performance in shrinkage temperature, mechanical test and anti-calcification test. This study preliminarily verifies the feasibility of substitution of Australian cattle pericardium by Sichuan yak pericardium and promotes the progression of bovine pericardium localization with data support.
Animals ; Australia ; Bioprosthesis ; Cattle ; Heart Valve Prosthesis ; Pericardium

The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 μg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
Animals ; Equipment and Supplies/adverse effects* ; Nickel/toxicity* ; No-Observed-Adverse-Effect Level ; Rats ; Rats, Sprague-Dawley ; Risk Assessment