The evaluation of blood compatibility of biomaterials is crucial for ensuring the clinical safety of implantable medical devices. To address the limitations of traditional testing methods in real-time monitoring and electrical property analysis, this study developed a portable electrical impedance tomography (EIT) system. The system uses a 16-electrode design, operates within a frequency range of 1 to 500 kHz, achieves a signal to noise ratio (SNR) of 69.54 dB at 50 kHz, and has a data collection speed of 20 frames per second. Experimental results show that the EIT system developed in this study is highly consistent with a microplate reader ( R ²=0.97) in detecting the hemolytic behavior of industrial-grade titanium (TA3) and titanium alloy-titanium 6 aluminum 4 vanadium (TC4) in anticoagulated bovine blood. Additionally, with the support of a multimodal image fusion Gauss-Newton one-step iterative algorithm, the system can accurately locate and monitor in real-time the dynamic changes in blood permeation and coagulation caused by TC4 in vivo. In conclusion, the EIT system developed in this study provides a new and effective method for evaluating the blood compatibility of biomaterials.
Electric Impedance ; Animals ; Tomography/instrumentation* ; Biocompatible Materials ; Materials Testing/instrumentation* ; Cattle ; Titanium ; Alloys ; Prostheses and Implants

OBJECTIVE: To compare the cyclic fatigue resistance of nickel-titanium files made by 3 new heat treatment in simulated S-shaped root canals at different temperatures. METHODS: Gold heat-treated nickel-titanium files TruNatomy (25 mm, tip size 26#/0.04) and ProTaper Gold (25 mm, tip size 25#/0.08) were selected as the experimental group, M wire technique nickel-titanium file ProTaper Next (25 mm, tip size 25#/0.06) was selected as the control group. It was speculated that the Gold technique used in TruNatomy nickel-titanium file was R phase separation technique, which included a complete intermediate R-phase, increasing its flexibility. ProTaper Gold was a CM wire nickel-titanium file and the increased phase transformation temperature by heat treatment introduced martensite at room temperature, while it underwent gold heat treatment on the surface, generating an intermediate R phase during phase transformation, providing hyperelastic. ProTaper Next used M wire technique, M wire included austenite at room temperature, where heat mechanical processing introduced hardened martensite, which was incapable of participating phase transformation. Because of the lower elastic modulus of hardened martensite than austenite, the flexibility of the file was increased. Twenty instruments of each nickel-titanium file were submitted to the cyclic fatigue test by using a simulated canal with double curvatures at room tem-perature (24 ℃) and 65 ℃, 10 instruments of each nickel-titanium file were selected at each temperature (n=10). At the same temperature, the number of cyclic fatigue (NCF) and fragment length were analyzed by using One-Way analysis of variance at a significance level of P < 0.05. NCF and fragment length of the same nickel-titanium file at room temperature and 65 ℃ were compared by paired sample t test and the significance level was α=0.05. Fractured surfaces were analyzed by using scanning electron microscope. RESULTS: In double-curved canals, all the failure of the files due to cyclic fatigue was first seen in the apical curvature before the coronal curvature. At room temperature, in the apical curvature, NCF of TruNatomy was 344.4±96.6, ProTaper Gold was 175.0±56.1, ProTaper Next was 133.3±39.7, NCF of Tru Natomy was the highest (P < 0.05). In the coronal curvature, NCF of TruNatomy was 618.3± 75.3, ProTaper Gold was 327.5±111.8, ProTaper Next was 376.6±67.9, NCF of TruNatomy was also the highest (P < 0.05). There was no significant difference among the apical and coronal fragment length of the 3 nickel-titanium files (P>0.05). At 65 ℃, in the apical curvature, NCF of TruNatomy was 289.6±65.8, ProTaper Gold was 187.5±75.4, ProTaper Next was 103.0±38.5, NCF of TruNatomy was the highest (P < 0.05). In the coronal curvature, NCF of TruNatomy was 454.2±45.4, ProTaper Gold was 268.3±31.4, ProTaper Next was 283.8±31.7, NCF of TruNatomy was also the highest (P < 0.05). The apical fragment length of ProTaper Next was the highest (P < 0.05), and there was no significant difference among coronal fragment length of the 3 nickel-titanium files (P>0.05). Compared with room temperature, at 65 ℃, in the coronal curvature, NCF of TruNatomy decreased significantly (P < 0.05). The fractured surfaces of the three nickel-titanium files demonstrated typical cyclic fatigue. CONCLUSION Gold heat-treated nickel-titanium file had better cyclic fatigue resistance than M wire nickel-titanium file in S-shaped root canals.
Nickel/chemistry* ; Titanium/chemistry* ; Hot Temperature ; Root Canal Preparation/methods* ; Humans ; Materials Testing ; Gold/chemistry* ; Dental Alloys/chemistry* ; Stress, Mechanical

Compared with total knee arthroplasty, unicondylar knee replacement has the advantage of preserving the knee tissue structure and motor function to the greatest extent. Pre-clinical in-vitro test is an important tool to evaluate the safety and effectiveness of unicondylar knee prostheses, and it is also a key focus of the product registration process. Through collection, comparison, and analysis of current regulations, technical standards, guidelines, and related research literature, this paper expounds on the relevant research methods for the pre-clinical in-vitrotesting of unicondylar knee prostheses. At the same time, in conjunction with current evaluation requirements and experience, the study discusses the focus of pre-clinical performance research for unicondylar knee prostheses during the registration process to clarify the performance evaluation requirements of this product category. This aims to provide a reference for the pre-clinical performance research of unicondylar knee prostheses and to standardize industry testing standards.
Knee Prosthesis ; Arthroplasty, Replacement, Knee ; Humans ; Prosthesis Design ; Materials Testing

In this paper, a preliminary stress/strain analysis of the design structure of a nickel-titanium alloy patent foramen ovale occluder is conducted with the finite element simulation analysis method. In the analysis, solid structure modeling is carried out on three different specifications of domestic patent foramen ovale occluders. Referring to the test method of fatigue performance in inspection standard YY/T 1553-2017, an initial installation deformation is applied to the model, and then the fatigue displacement of 2 mm is applied to the sample to make the model fatigue deformation. The fatigue safety factors of each type of occluder are obtained by strain simulation analysis. The results indicate that the minimum fatigue safety factors of the three specifications of domestic patent foramen ovale occluders are 2.09, 2.35 and 2.06 respectively, which all meet the design of fatigue safety factor greater than 1. Among them, 1818 and 3030 specifications of patent foramen ovale occluders have close values in minimum fatigue safety factors, and both are lower than that of 1825 model. Therefore, it is recommended to carry out physical fatigue tests on both 1818 and 3030 specifications to further verify the fatigue performance of the products.
Finite Element Analysis ; Titanium ; Nickel ; Alloys ; Foramen Ovale, Patent ; Materials Testing ; Septal Occluder Device ; Stress, Mechanical

OBJECTIVES: This study aims to use 3D prin-ting technology based on the principle of stereo lithography apparatus (SLA) to shape dental lithium disilicate ceramics and study the effects of different slurry proportions on the microstructure and properties of heat-treated samples. METHODS: The experimental group comprised lithium disilicate ceramics manufactured through SLA 3D printing, and the control group comprised lithium disilicate ceramics (IPS e.max CAD) fabricated through commercial milling. An array of different particle sizes of lithium disilicate ceramic powder materials (nano and micron) was selected for mixing with photocurable acrylate resin. The proportion of experimental raw materials was adjusted to prepare five groups of ceramic slurries for 3D printing (Groups S1-S5) on the basis of rheological properties, stability, and other factors. Printing, debonding, and sintering were conducted on the experimental group with the optimal ratio, followed by measurements of microstructure, crystallographic information, shrinkage, and mechanical properties. RESULTS: Five groups of lithium disilicate ceramic slurries were prepared, of which two groups with high solid content (75%) (Groups S2 and S3) were selected for 3D printing. X-ray diffraction and scanning electron microscopy results showed that lithium disilicate was the main crystalline phase in Groups S2 and S3, and its microstructure was slender, uniform, and compact. The average grain sizes of Groups S2 and S3 were (559.79±84.58) nm and (388.26±61.49) nm, respectively (P<0.05). Energy spectroscopy revealed that the samples in the two groups contained a high proportion of Si and O elements. After heat treatment, the shrinkage rate of the two groups of ceramic samples was 18.00%-20.71%. Test results revealed no statistical difference in all mechanical properties between Groups S2 and S3 (P>0.05). The flexural strengths of Groups S2 and S3 were (231.79±21.71) MPa and (214.86±46.64) MPa, respectively, which were lower than that of the IPS e.max CAD group (P<0.05). The elasticity modulus of Groups S2 and S3 were (87.40±12.99) GPa and (92.87±19.76) GPa, respectively, which did not significantly differ from that of the IPS e.max CAD group (P>0.05). The Vickers hardness values of Groups S2 and S3 were (6.53±0.19) GPa and (6.25±0.12) GPa, respectively, which were higher than that of the IPS e.max CAD group (P<0.05). The fracture toughness values of Groups S2 and S3 were (1.57±0.28) MPa·m^0.5 and (1.38±0.17) MPa·m^0.5, respectively, which did not significantly differ from that of the IPS e.max CAD group (P>0.05). CONCLUSIONS The combination of lithium disilicate ceramic powders with different particle sizes can yield a slurry with high solid content (75%) and suitable viscosity and stability. The dental lithium disilicate ceramic material is successfully prepared by using 3D printing technology. The 3D-printed samples show a small shrinkage rate after heat treatment. Their microstructure conforms to the crystal phase of lithium disilicate ceramics, and their mechanical properties are close to those of milled lithium disilicate ceramics.
Printing, Three-Dimensional ; Dental Porcelain/chemistry* ; Ceramics/chemistry* ; Materials Testing ; Particle Size

BACKGROUND: Owing to shortage of surgical and N95 filtering facepiece respirators (FFRs) during the COVID-2019 pandemic, various masks were developed to prevent infection. This study aimed to examine the inward leakage rate (ILR) of sealed face masks and modified surgical masks using a quantitative fit test and compared it with the ILR of unmodified N95 FFRs. METHODS: We conducted paired comparisons of ILRs of bent nose-fit wire masks, double masks, and N95 FFRs from October to December 2021. To measure the protective effectiveness of masks, participants wore masks, and the number of particles outside and inside the mask were measured. The ILR was based on the percentage of particles entering the mask using a fit tester. RESULTS: We enrolled 54 participants (20 men and 34 women) in this study. The median ILR for surgical masks without and with a W-shaped bend in the nose-fit wire were 96.44% and 50.82%, respectively. The nose-fit wire adjustment reduced the ILR of surgical masks by a mean of 28.57%, which was significantly lower than the ILR without adjustment (P < 0.001). For double masks, with surgical or polyurethane masks on top of the W-shaped mask, the ILR did not differ significantly from that of N95. Although the filtration performance of double surgical masks matched that of N95 masks, their ILR was notably higher, indicating that double masks do not provide equivalent protection. CONCLUSIONS Wearing N95 masks alone is effective in many cases. However, surgical mask modifications do not guarantee consistent effectiveness. Properly selected, sealed masks with a good fit overcome leakage, emphasizing their crucial role. Without evidence, mask-wearing may lead to unexpected infections. Education based on quantitative data is crucial for preventing adverse outcomes.
Male ; Humans ; Female ; N95 Respirators ; COVID-19/epidemiology* ; Masks ; Pandemics/prevention & control* ; Respiratory Protective Devices ; Materials Testing ; Equipment Design ; Occupational Exposure/prevention & control*

OBJECTIVE: To investigate the influence of 135° and 90° cavity design on quality of margin and marginal adaptation and microleakage of all-ceramic computer aided design/computer aided manufacturing (CAD/CAM) inlays. METHODS: One hundred extracted human molars were prepared by criteria of buccal occlusal (BO) inlay. On the buccal, the mesial margin was prepared as 135° bevel while the distal margin was prepared as butt-joint. All-ceramic restorations were made in the Sirona CEREC AC CAD/CAM system with VitaBlocs Mark Ⅱ, Upcera UP.CAD, IPS e.max CAD, Upcera Hyramic and Lava Ultimate. The gaps between each inlay's mesial margin-abutment and distal margin-abutment were recorded under an optical microscope. Each inlay was adhered to the abutment and aged by thermal cycling for 10 000 times. Each specimen was cut into 3 slices after staining. Dye penetration was evaluated under an optical microscope for mesial and distal margins. RESULTS: Mean marginal integrity rate, mean marginal gap value and mean depth of microleakage of 135° margin of Group Upcera Hyramic and Lava Ultimate were significantly better than those of Group VitaBlocs Mark Ⅱ, Upcera UP.CAD and IPS e.max CAD(P < 0.05). Mean marginal gap value, mean depth of microleakage and scale of mean depth of microleakage of 90° margin of Group Upcera Hyramic and Lava Ultimate were significantly better than those of Group Upcera UP.CAD and IPS e.max CAD (P < 0.05) while mean marginal integrity rate was not significantly different (P>0.05). Mean marginal integrity rate of 90° margin was significantly better than that of 135° margin in each group (P < 0.05) while mean depth of microleakage between different margins was not significantly different in each group (P>0.05). Mean marginal gap value of 90° margin of Group VitaBlocs Mark Ⅱ and IPS e.max CAD was significantly better than that of 135° margin (P < 0.05) while there was not significant difference in other 3 groups between 90° and 135° margin (P>0.05). Scale of mean depth of microleakage of 135° margin of Group Upcera Hyramic and Lava Ultimate was significant better than that of 90° margin (P < 0.05) while there was not significantly different in other 3 groups between 90° and 135° margin (P>0.05). CONCLUSION The mesial and distal margins of abutement of all-ceramic inlay should be prepared as butt-joint.
Humans ; Aged ; Molar ; Ceramics ; Computer-Aided Design ; Dental Porcelain ; Materials Testing

The composite material PLGA compounded with β-tricalcium phosphate (β-TCP) was prepared by melt blending method, and the absorbable interface screw was prepared by injection molding process. Prepare PBS buffer that simulates human body, conduct in vitro degradation experiments on interface screws according to relevant national and industry standards, then test and characterize interface screws at different time points for degradation of intrinsic viscosity, average molecular weight distribution, mass loss, mechanical properties and thermal properties. According to the degradation performance-time curve, determine the time node at which the interface screw loses the mechanical properties. In this paper, the in vitro degradation behavior of interfacial screws prepared from PLGA and β-TCP composites was studied in detail, providing a reference and basis for the degradation behavior of absorbable products prepared from PLGA and β-TCP composites.
Humans ; Polyesters ; Materials Testing ; Calcium Phosphates ; Absorbable Implants

OBJECTIVE: To study the mechanical properties related to the typical functional failure modes of non-absorbable suture anchor in clinical use, and to support product design, development and verification. METHODS: By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers. RESULTS: The typical functional failure modes of non-absorbable suture anchor include anchor failure, suture failure, fix loosening, inserter failure, which are related to the mechanical properties of products, such as screw-in torque and break torque of screw-in anchors, insertion force of knock-in anchors, suture strength, pull-out force before and after system fatigue test and elongation of sutures after fatigue test. CONCLUSIONS Enterprises should pay attention to improving the mechanical performance level of products through material, structural design and the suture weaving process to ensure the safety and effectiveness of products.
Suture Anchors ; Suture Techniques ; Sutures ; Absorbable Implants ; Biomechanical Phenomena ; Materials Testing

OBJECTIVE: To explore the influence of the thickness of mixed cardboard on the compressive strength of glass ionomer cement and the associated factors. METHODS: Three different types of glass ionomer cements were mixed on the top of 60, 40, 20 and 1 pieces of paper (P60, P40, P20 and P1), respectively. The compressive strength of the materials was tested after solidification, and the bubble rate was calculated with the assistance of scanning electron microscope. RESULTS: (1) Compressive strength: ① ChemFil Superior glass ionomer (CF): The average compressive strength of P1 group was the highest, which was significantly different from that of P40 and P60 groups (P values were 0.041 and 0.032 respectively); ② To Fuji IX GP glass ionomer (IX): The average compressive strength of P1 group was the highest, which was statistically different from that of P40 and P60 groups (P values were 0.042 and 0.038 respectively); ③ Glaslonomer FX-Ⅱ glass ionomer cement (FX): The average compressive strength of P1 group was the highest, which was statistically different from that of P20, P40 and P60 groups (P values were 0.031, 0.040 and 0.041 respectively), but there was no statistical difference among the other groups. All the three materials showed that the compressive strength of glass ions gradually increased with the decrease of the thickness of the blended paperboard, and the two materials had a highly linear negative correlation, the correlation coefficients of which were CF-0.927, IX-0.989, FX-0.892, respectively. (2) Scanning electron microscope: P1 group had the least bubbles among the three materials. CONCLUSION It indicates that the thickness of mixed cardboard has a negative correlation with the compressive strength of glass ions. The thicker the mixed cardboard is, the greater the elasticity is. Excessive elasticity will accelerate the mixing speed when the grinding glass ions. Studies have shown that the faster the speed of artificial mixing is, the more bubbles is produced.The thicker ther mixed cardboard is, the more bubblesn are generated by glass ionomer cement, and the higher the compressive strength is. Using one piece of paper board to mix glass ionomer cement has the least bubbles and can obtain higher compressive strength.
Compressive Strength ; Materials Testing ; Glass Ionomer Cements ; Silicon Dioxide