Novel clip applicator for minimally invasive surgery.

BACKGROUND: Ligation clips are used ubiquitously throughout minimally invasive surgery for apposition of tissues. Their size limits their application beyond ligation of small tubular structures. A novel clip and clip applicator that allows for broad-area clamping and rotation has been developed by our team. The primary aim of this study is to provide preliminary data assessing tensile strength of the clip across apposed segments of bowel. METHODS: A comparative study evaluating the maximum load (N) held across two apposed tissues by (a) our novel broad-area clip and (b) a conventional commercial clip was performed. Two sections of porcine bowel were clamped together and the maximum load (N) was measured using a tensile strength material testing machine. A preliminary experiment comparing staple line leak pressures in a porcine model ± clip enforcement of staple line was also conducted. p < 0.05 determined statistical significance. RESULTS: Twenty-four samples (intervention = 15; control = 9) of porcine bowel annealed by surgical clips were tested. The mean maximum force withheld by the bowel and staples was greater for our novel clip design (2.043 ± 0.831 N) than the control clip (1.080 ± 0.466 N, p = 0.004). Ten staple line (intervention = 5; control = 5) pressures of porcine bowel were measured. There was no statistically significant difference between the leak pressures with clip reinforcement (84.8 mmHg; range 71.8-109.8 mmHg), or without (54.1 mmHg; range 26.3-98.9 mmHg). CONCLUSION: These preliminary results suggest that our novel clip is able to withstand higher tensile force across tissues compared to a leading commercial clip. A small preliminary trial of effect on leak pressures demonstrated no statistical significance; however, increasing reliability of staple line deformation may be a clinically important finding. Whilst further iteration of product design and clinical testing is required, this product may occupy an important clinical niche through staple line reinforcement, enterotomy closure and other applications

REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Kinetics of coupled Fe(II)-catalysed ferrihydrite transformation and U(VI) reduction

Antimony is released into the environment in some natural and man-induced processes. [1]. Yet, its impact on the transformation processes of heavy metal-adsorbing minerals remains poorly understood. In acid-mine drainage systems and shooting ranges, the adsorption of antimony by iron oxides such as ferrihydrite can play a major role. The poorly crystalline 2-line ferrihydrite represents one of the most common Fe oxides in these settings and can transform to goethite (,-FeOOH) or hematite (,-Fe2O3) with time [2]. The rate of transformation depends on the pH, temperature, and on the ions and molecules present during the transformation process [3]. This study focuses on the transformation of synthetic ferrihydrite to crystalline iron oxides in the presence of Sb(V). Transformations were carried out for 1-16 days at 70 ºC and at pH 4, 7 and 12, with different concentrations of Sb(V) (0.00, 0.23, 0.75, 2.25 and 6.00 mM Sb). Samples taken from aqueous suspensions were washed, dried, and characterized by X-ray diffraction (XRD) and atomic absorption spectroscopy (AAS). At pH 12, goethite (Sb concentrations up to 3.7 mg Sb/g) is favored and the transformation is completed after one day. Only a concentration of 6 mM Sb retarded the transformation, where even after 8 days only 50 % of the ferrihydrite was transformed into goethite. Transformations at pH 7 led to a mixture of 75 % hematite and 25 % goethite (4.3 mg Sb/g). However, at concentrations of 6 mM Sb, feroxyhyte (!- FeOOH) (9.1 mg Sb/g) was favored instead. At pH 4, hematite (32.3 mg Sb/g) was favored except for concentrations of 6 mM Sb, were again feroxyhyte (141.1 mg Sb/g) occurred. We assume that increased Sb concentrations favor feroxyhyte and indicate the incorporation of Sb into the structure of feroxyhyte. © The Author

Ferric iron geometry and coordination during hydrolysis and ferrihydrite precipitation

Definitive structural characterisation of ferrihydrite has challenged scientists primarily due to its nanosized particles and inherent long-range structural disorder which challenges analytical methodology (and modelling) typically employed to determine the structure of minerals. Here we report on the application of a synchrotron quick-scanning X-ray absorption spectroscopy (XAS) approach, which allows the collection of Extended X-ray Absorption Fine Structure (EXAFS) spectral data to k = 15 Å-1 in < 1 minute, to obtain unparalleled iron Kedge data on the hydrolysis of FeIII(H2O)6 and ferrihydrite precipitation. Modelling of the pre-edge and EXAFS data: 1) supports theoretical studies which have suggested the existence of a monomeric penta-coordinated FeIII hydrolysis species and; 2) corroborates recently proposed structural models of ferrihydrite that contain tetrahedral FeIII. Modelling results indicate that ferrihydrite consists of 15 to 25 % tetrahedral FeIII and suggest that this geometry must be included in any comprehensive structural model of ferrihydrite and, furthermore, should be considered when evaluating the reactivity, stability and other structure-property relationships of this mineral. © The Authors

Making the leap: the translation of innovative surgical devices from the laboratory to the operating room

MINI-ABSTRACT: A decade from publication, approximately one in ten surgical devices described in the literature made the leap from the laboratory to a first-in-human study. Clinical involvement was a significant predictor of translation; devices developed with clinical collaboration were over six times more likely to be translated than those without. STRUCTURED ABSTRACT: OBJECTIVE: To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation. SUMMARY BACKGROUND DATA: Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood. METHODS: All biomedical engineering journals, and the five basic science journals with the highest impact factor, were searched between January 1993 and January 2000 using the Boolean search term “surgery OR surgeon OR surgical”. Articles were included if they described the development of a new device and a surgical application was described. A recursive search of all citations to the article was performed using the Web of Science (Thompson-Reuters, New York, USA) to identify any associated first-in-human studies published by January 2015. Kaplan-Meier curves were constructed for the time first-in-human studies. Factors influencing translation were evaluated using Log Rank and Cox proportional hazards models. RESULTS: 8,297 articles were screened, and 205 publications describing unique devices identified. The probability of a first-in-human at 10 years was 9.8%. Clinical involvement was a significant predictor of a first-in-human study (p = 0.02); devices developed with early clinical collaboration were over six times more likely to be translated than those without (RR 6.5 [95% CI 0.9 - 48]). CONCLUSIONS: These findings support initiatives to increase clinical translation through improved interactions between basic, translational, and clinical researchers

Atomic-Scale Picture of the Composition, Decay, and Oxidation of Two-Dimensional Radioactive Films

Two-dimensional radioactive (125)I monolayers are a recent development that combines the fields of radiochemistry and nanoscience. These Au-supported monolayers show great promise for understanding the local interaction of radiation with 2D molecular layers, offer different directions for surface patterning, and enhance the emission of chemically and biologically relevant low-energy electrons. However, the elemental composition of these monolayers is in constant flux due to the nuclear transmutation of (125)I to (125)Te, and their precise composition and stability under ambient conditions has yet to be elucidated. Unlike I, which is stable and unreactive when bound to Au, the newly formed Te atoms would be expected to be more reactive. We have used electron emission and X-ray photoelectron spectroscopy (XPS) to quantify the emitted electron energies and to track the film composition in vacuum and the effect of exposure to ambient conditions. Our results reveal that the Auger electrons emitted during the ultrafast radioactive decay process have a kinetic energy corresponding to neutral Te. By combining XPS and scanning tunneling microscopy experiments with density functional theory, we are able to identify the reaction of newly formed Te to TeO2 and its subsequent dimerization. The fact that the Te2O4 units stay intact during major lateral rearrangement of the monolayer illustrates their stability. These results provide an atomic-scale picture of the composition and mobility of surface species in a radioactive monolayer as well as an understanding of the stability of the films under ambient conditions, which is a critical aspect in their future applications

Foot orthoses: how much customisation is necessary?

The relative merit of customised versus prefabricated foot orthoses continues to be the subject of passionate debate among foot health professionals. Although there is currently insufficient evidence to reach definitive conclusions, a growing body of research literature suggests that prefabricated foot orthoses may produce equivalent clinical outcomes to customised foot orthoses for some conditions. Consensus guidelines for the prescription of customised foot orthoses need to be developed so that the hypothesised benefits of these devices can be thoroughly evaluated

Use of domesticated pigs by Mesolithic hunter-gatherers in northwestern Europe

Acknowledgements We thank the Archaeological State Museum Schleswig-Holstein, the Archaeological State Offices of Brandenburg, Lower Saxony and Saxony and the following individuals who provided sample material: Betty Arndt, Jo¨rg Ewersen, Frederick Feulner, Susanne Hanik, Ru¨diger Krause, Jochen Reinhard, Uwe Reuter, Karl-Heinz Ro¨hrig, Maguerita Scha¨fer, Jo¨rg Schibler, Reinhold Schoon, Regina Smolnik, Thomas Terberger and Ingrid Ulbricht. We are grateful to Ulrich Schmo¨lcke, Michael Forster, Peter Forster and Aikaterini Glykou for their support and comments on the manuscript. We also thank many institutions and individuals that provided sample material and access to collections, especially the curators of the Museum fu¨r Naturkunde, Berlin; Muse´um National d0 Histoire Naturelle, Paris; Smithsonian Institution, National Museum of Natural History, Washington D.C.; Zoologische Staatssammlung, Mu¨nchen; Museum fu¨r Haustierkunde, Halle; the American Museum of Natural History, New-York. This work was funded by the Graduate School ‘Human Development in Landscapes’ at Kiel University (CAU) and supported by NERC project Grant NE/F003382/1. Radiocarbon dating was carried out at the Leibniz Laboratory, CAU. This work is licensed under a Creative Commons AttributionNonCommercial-NoDerivs 3.0 Unported License.Peer reviewedPublisher PD

Electronic structure of superconducting graphite intercalate compounds: The role of the interlayer state

Although not an intrinsic superconductor, it has been long--known that, when intercalated with certain dopants, graphite is capable of exhibiting superconductivity. Of the family of graphite--based materials which are known to superconduct, perhaps the most well--studied are the alkali metal--graphite intercalation compounds (GIC) and, of these, the most easily fabricated is the C${}_8$K system which exhibits a transition temperature $\bm{T_c\simeq 0.14}$K. By increasing the alkali metal concentration (through high pressure fabrication techniques), the transition temperature has been shown to increase to as much as $\bm 5$K in C${}_2$Na. Lately, in an important recent development, Weller \emph{et al.} have shown that, at ambient conditions, the intercalated compounds \cyb and \cca exhibit superconductivity with transition temperatures $\bm{T_c\simeq 6.5}$K and $\bm{11.5}$K respectively, in excess of that presently reported for other graphite--based compounds. We explore the architecture of the states near the Fermi level and identify characteristics of the electronic band structure generic to GICs. As expected, we find that charge transfer from the intercalant atoms to the graphene sheets results in the occupation of the $\bm\pi$--bands. Yet, remarkably, in all those -- and only those -- compounds that superconduct, we find that an interlayer state, which is well separated from the carbon sheets, also becomes occupied. We show that the energy of the interlayer band is controlled by a combination of its occupancy and the separation between the carbon layers.Comment: 4 Figures. Please see accompanying experimental manuscript "Superconductivity in the Intercalated Graphite Compounds C6Yb and C6Ca" by Weller et a

Mammography screening: views from women and primary care physicians in Crete

Background: Breast cancer is the most commonly diagnosed cancer among women and a leading cause of death from cancer in women in Europe. Although breast cancer incidence is on the rise worldwide, breast cancer mortality over the past 25 years has been stable or decreasing in some countries and a fall in breast cancer mortality rates in most European countries in the 1990s was reported by several studies, in contrast, in Greece have not reported these favourable trends. In Greece, the age-standardised incidence and mortality rate for breast cancer per 100.000 in 2006 was 81,8 and 21,7 and although it is lower than most other countries in Europe, the fall in breast cancer mortality that observed has not been as great as in other European countries. There is no national strategy for screening in this country. This study reports on the use of mammography among middleaged women in rural Crete and investigates barriers to mammography screening encountered by women and their primary care physicians. Methods: Design: Semi-structured individual interviews. Setting and participants: Thirty women between 45–65 years of age, with a mean age of 54,6 years, and standard deviation 6,8 from rural areas of Crete and 28 qualified primary care physicians, with a mean age of 44,7 years and standard deviation 7,0 serving this rural population. Main outcome measure: Qualitative thematic analysis. Results: Most women identified several reasons for not using mammography. These included poor knowledge of the benefits and indications for mammography screening, fear of pain during the procedure, fear of a serious diagnosis, embarrassment, stress while anticipating the results, cost and lack of physician recommendation. Physicians identified difficulties in scheduling an appointment as one reason women did not use mammography and both women and physicians identified distance from the screening site, transportation problems and the absence of symptoms as reasons for non-use. Conclusion: Women are inhibited from participating in mammography screening in rural Crete. The provision of more accessible screening services may improve this. However physician recommendation is important in overcoming women's inhibitions. Primary care physicians serving rural areas need to be aware of barriers preventing women from attending mammography screening and provide women with information and advice in a sensitive way so women can make informed decisions regarding breast caner screening