Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration

Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs. We reviewed all Traditional 510(k) submissions for cervical IBFDs deemed substantially equivalent and cleared for marketing from 2007 through 2014. To reduce sources of variability in test methods and results, analysis was restricted to cervical IBFD designs without integrated fixation, coatings, or expandable features. Mechanical testing reports were analyzed and results were aggregated for seven commonly performed tests (static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267), and percentile distributions of performance measurements were calculated. Eighty-three (83) submissions met the criteria for inclusion in this analysis. The median device yield strength was 10,117 N for static axial compression, 3680 N for static compression-shear, and 8.6 N m for static torsion. Median runout load was 2600 N for dynamic axial compression, 1400 N for dynamic compression-shear, and ±1.5 N m for dynamic torsion. In subsidence testing, median block stiffness (Kp) was 424 N/mm. The mechanical performance data presented here will aid in the development of future cervical IBFDs by providing a means for comparison for design verification purposes.     

微生物铁蛋白的研究进展

铁蛋白作为一种重要的铁储存蛋白,在不同的微生物体中普遍存在.通过对典型的微生物铁蛋白分子(FTN)的结构及其功能的归纳分析发现,铁蛋白依赖其独特的结构特点,在铁的补充、转运、氧化、成核和储存中扮演着重要作用,也对生物体内的多种生物化学反应影响显著.同时借助基因工程技术对铁蛋白进行相应的分子改造,增加了其作为纳米载体的应...     

Effects of separation of resources on behaviour of high-, medium- and low-ranked hens in furnished cages

In our previous studies, we demonstrated that dominant hens had priority in using the dust bath, resulted in increased competition for the resource. It seemed that the problem was that the resource was placed on one side of the cage (‘localised’). Therefore, we designed a medium-sized furnished cage with a dust bath and nest box on both sides of the cage (‘separated’, MFS). To evaluate the effects of separation of these resources, we compared the behaviour of high-, medium- and low-ranked hens in MFS cage with that in small (SF) and medium furnished (MFL) cages with a localised resource. In total, 150 White Leghorn layers were used. At the age of 17 weeks, the hens were randomly divided into three groups and moved to small furnished cages (SF, 90 cm wide; five birds per cage) and two types of medium furnished cages (180 cm wide; 10 birds per cage) with a nest box and dust bath on both sides (MFS) and a nest box and dust bath on one side of the cage (MFL). The total dust bath and nest box areas per hen were same for the three cages. The dominance hierarchy was determined by observing the aggressive interactions and by this high-, medium- and low-ranked hens in each cage were identified. The behaviour, use of facilities and physical condition of these hens were measured. Data were analysed by using repeated measure ANOVA. A significant interaction between social order and cage design was found in the proportions of time spent in the dust bath and on performing dust-bathing (both P < 0.001), and these proportions tended to be higher in higher-ranked hens in SF and MFL. Conversely, the MFS low-ranked hens tended to use the dust bath more than the SF and MFL low-ranked hens. Thus, hens from each rank used the dust bath equally in MFS, though the MFS high-ranked hens tended to use the resource less than the SF and MFL high-ranked hens. While the frequency of pre-laying sitting was lower among low-ranked hens (P < 0.05), the proportion of time in the nest box was higher among low- than high-ranked hens (P < 0.01). The low-ranked hens spent more time performing escaping, moving and standing in the nest box. In conclusion, it is suggested that separation of the dust bath to two locations would be an effective arrangement to promote more equal usage of the dust bath by hens from each rank in the furnished cages. It was also confirmed in the present study that nest boxes were not only used for laying eggs but also as a refuge by lower ranked hens.     

Naturally occurring populations of Bemisia tabaci, biotype B and associated natural enemies in agro-ecosystem in northern China

The sweet potato whitefly, Bemisia tabaci (Gennadius) biotype B was first found in southern China in 1994 and has since then become a pest of increasing importance throughout the nation. The population dynamics of this invasive species and the effect of natural enemies on its population dynamics were studied in commercial cotton fields during the summers of 2003 through 2005 in Langfang, Hebei (northern China). The abundance of Bemisia tabaci was found to increase rapidly in late July, and reached its first peak in mid-August, then followed by the second peak in early September. Whitefly populations subsequently declined slowly to attain a plateau after mid-September. A total of 13 natural enemy species were discovered in association with B. tabaci in cotton fields, including dominant species such as Chrysopa sinica Tjeder, Leis axyridis Pallas, Propylaea japonica Thunberg, Orius similis Zheng, and Eretmocerus sp. Caged experiments on velvetleaf, Abutilon theophrasti Medic, one of the preferred host plants of the insect, indicated higher B. tabaci population densities in small-mesh cages with exclusion of all natural enemies versus those in medium- and large-mesh cages, and the uncaged plants retained the lowest population densities of B. tabaci. While no natural enemies were observed in the small-mesh cages, natural enemies like Misumenopos tricuspiaata, Eretmocerus sp., Encarsia formosa Orius similis, Deraeocoris punctulatus and Scolothrips takahashii were found in medium- and/or large-mesh cages. Findings from this study suggest that under open-field conditions, various indigenous natural enemies of different sizes may act in concert in the suppression of B. tabaci populations.     

Solution structure of the twelfth cysteine-rich ligand-binding repeat in rat megalin

Megalin, an approx. 600 kDa transmembrane glycoprotein that acts as multi-ligand transporter, is a member of the low density lipoprotein receptor gene family. Several cysteine-rich repeats, each consisting of about 40 residues, are responsible for the multispecific binding of ligands. The solution structure of the twelfth cysteine-rich ligand-binding repeat with class A motif found in megalin features two short beta-strands and two helical turns, yielding the typical fold with a I-III, II-V and IV-VI disulfide bridge connectivity pattern and a calcium coordination site at the C-terminal end. The resulting differences in electrostatic surface potential compared to other ligand-binding modules of this gene family, however, may be responsible for the functional divergence.     

Biodistribution studies of protein cage nanoparticles demonstrate broad tissue distribution and rapid clearance in vivo

Protein cage nanoparticles have the potential to serve as multifunctional cell targeted, imaging and therapeutic platforms for broad applications in medicine. However, before they find applications in medicine, their biocompatibility in vivo needs to be demonstrated. We provide here baseline biodistribution information of two different spherical protein cage nanoplatforms, the 28 nm viral Cowpea chlorotic mottle virus (CCMV) and the 12 nm heat shock protein (Hsp) cage. In naive and immunized mice both nanoplatforms show similar broad distribution and movement throughout most tissues and organs, rapid excretion, the absence of long-term persistence within mice tissue and organs, and no overt toxicity after a single injection. These results suggest that protein cage based nanoparticles may serve as safe, biocompatible, nanoplatforms for applications in medicine.     

Reorganization of a novel vimentin-associated protein in 3T3-L1 cells during adipose conversion

We have found that the antibody A2, a marker for the capsule of steroidogenic lipid droplets, reacts with an intermediate filament-associated protein, P₂₀₀, in 3T3-L1 preadipocytes. Supporting evidence came from the colocalization pattern of P₂₀₀ with vimentin in double label experiments. The association of P₂₀₀ with vimentin was further confirmed by its copurification with vimentin after high salt extraction and colocalization of these two proteins in high salt-extracted and vinblastine-treated cells. In preadipocytes this protein was distributed on the vimentin filament network. At the early stage of adipose conversion, this protein was found to encircle nascent lipid droplets ranging from 0.1 to 0.2 μm, accompanied with a decreased distribution on the vimentin filament system. This infers a possible translocation of P₂₀₀ from the vimentin filaments to the droplet surface. Meanwhile, the vimentin filaments remained in a normal distribution in the cytoplasm and were apparently not associated with the nascent droplet. The association of vimentin filaments to droplet surfaces became prominent in lipid droplets larger than 0.2 μm, forming a typical vimentin cage. Immunogold staining also confirmed the translocation of P₂₀₀ immunoreactivity from the droplet surface to the vimentin cage. The relocation of P₂₀₀ from the cytoplasmic vimentin filaments to the droplet surface prior to the formation of the vimentin cage, as well as the reorganization of this protein in the vimentin cage, suggests a stabilizing role in the lipid droplet formation and an inducing function of this protein in the formation of the vimentin cage. J. Cell. Biochem. 67:84–91, 1997. © 1997 Wiley-Liss, Inc.     

Instrumental neutron activation analysis of rib bone samples and of bone reference materials

The instrumental neutron activation analysis method was used for the determination of trace elements in rib bone samples taken from autopsies of accident victims. The elements Br, Ca, Cl, Cr, Fe, Mg, Mn, Na, P, Sr, Rb, and Zn were determined in cortical tissues by using short and long irradiations with thermal neutron flux of the IEA-R1m nuclear reactor. The reference materials NIST SRM 1400 Bone Ash and NIST SRM 1486 Bone Meal were also analyzed in order to evaluate the precision and the accuracy of the results. It was verified that lyophilization is the most convenient process for drying bone samples because it does not cause any element losses. Comparisons were made between the results obtained for rib samples and the literature values as well as between the results obtained for different ribs from a single individual and for bones from different individuals.     

The potential of three native insect predators to control the rosy apple aphid, Dysaphis plantaginea

The potential of three aphidophagous predators, Adalia bipunctata, Aphidoletes aphidimyza, and Episyrphus balteatus to control the rosy apple aphid, Dysaphis plantaginea Pass., a major pest on apple in Europe, was assessed by means of laboratory and field cage experiments in Northern Switzerland. Under laboratory conditions, all three predators efficiently preyed upon D. plantaginea on apple seedlings. The searching success of larvae of A. bipunctata for individual aphids was not dependent on the size of branches of apple trees varying in leaf surface area from 150 cm² to 960 cm². Fifty and 70% of individual aphids were found and killed 6 hours and 48 hours, respectively, after release of single second instar larva of A. bipunctata. In a first field cage experiment in 1996, A. bipunctata, and to a lesser extent E. balteatus, proved to be effective and consistent predators of D. plantaginea during spring conditions, being little affected by cool temperatures and wet weather. In a subsequent field cage experiment in 1997, larvae of A. bipunctata and E. balteatus were released singly and in combination on aphid infested apple seedlings to study interactions between these two promising control agents. Both species had a significant negative effect on aphid population increase. The two species did not significantly interact and thus, their joint effect is best explained by an additive model. Combined releases of the two predator species reduced aphid densities to 5% of the control. This indicates the potential for augmentative releases of these native aphid predators to control D. plantaginea.