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      Effect of grain sizes on mechanical properties and biodegradation behavior of pure iron for cardiovascular stent application

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          Abstract

          Pure iron has been demonstrated as a potential candidate for biodegradable metal stents due to its appropriate biocompatibility, suitable mechanical properties and uniform biodegradation behavior. The competing parameters that control the safety and the performance of BMS include proper strength-ductility combination, biocompatibility along with matching rate of corrosion with healing rate of arteries. Being a micrometre-scale biomedical device, the mentioned variables have been found to be governed by the average grain size of the bulk material. Thermo-mechanical processing techniques of the cold rolling and annealing were used to grain-refine the pure iron. Pure Fe samples were unidirectionally cold rolled and then isochronally annealed at different temperatures with the intention of inducing different ranges of grain size. The effect of thermo-mechanical treatment on mechanical properties and corrosion rates of the samples were investigated, correspondingly. Mechanical properties of pure Fe samples improved significantly with decrease in grain size while the corrosion rate decreased marginally with decrease in the average grain sizes. These findings could lead to the optimization of the properties to attain an adequate biodegradation-strength-ductility balance.

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          Effect of Grain Size on Corrosion: A Review

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            Long-term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta.

            Currently there are no biodegradable stents available for treatment of vascular obstructions in patients with congenital heart defects. This study was performed to evaluate the safety of a corrodible stent produced from pure iron in a peripheral stent design (6-12mm diameter) in a slotted tube design similar to a commercially available 316-L stent which served as control. Both stents were implanted into the descending aorta of 29 minipigs with an overstretch injury without technical problems. Two animals died after the implantation not related to the iron stent. The remaining 27 minipigs were followed for 1-360 days. Histomorphometry and quantitative angiography showed no difference with regard to the amount of neointimal proliferation between 316-L and iron stents. Histopathological examination of heart, lung, spleen, liver, kidney and para-aortic lymphatic nodes demonstrated no signs of iron overload or iron-related organ toxicity. Adjacent to the iron stent struts, there was no evidence for local toxicity due to corrosion products. We conclude that iron is a suitable metal for the production of a large-size degradable stent with no local or systemic toxicity. A faster degradation rate, however, is desirable and further studies have to focus on the modification of the composition and design of the stent to expedite the degradation process.
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              A novel approach to temporary stenting: degradable cardiovascular stents produced from corrodible metal-results 6-18 months after implantation into New Zealand white rabbits.

              To determine whether corrodible materials may be safely used as biodegradable cardiovascular implants. Corrodible iron stents (> 99.8% iron) were produced from pure iron and laser cut with a stent design similar to a commercially available permanent stent (PUVA-AS16). A total of 16 NOR-I stents were implanted into the native descending aorta of 16 New Zealand white rabbits (mean luminal diameter at the implantation site 3.4 mm, balloon diameter to vessel diameter ratio 1.13). No thromboembolic complications and no adverse events occurred during the follow up of 6-18 months. All stents were patent at repeat angiography after 6 (n = 9), 12 (n = 5), and 18 months (n = 2) with no significant neointimal proliferation, no pronounced inflammatory response, and no systemic toxicity. This initial in vivo experience suggests that degradable iron stents can be safely implanted without significant obstruction of the stented vessel caused by inflammation, neointimal proliferation, or thrombotic events.
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                Author and article information

                Journal
                Biomatter
                Biomatter
                KBIM
                kbim20
                Biomatter
                Taylor & Francis
                2159-2527
                2159-2535
                2016
                30 October 2014
                30 October 2014
                : 6
                : 1
                : e959874
                Affiliations
                [a ]Department of Metallurgical & Materials Engineering, University of Nigeria , Nsukka, Nigeria
                [b ]Laboratory for Biomaterials and Bioengineering (CRC-I), Department of Materials Engineering & CHU de Quebec Research Centre, Laval University , Quebec City, Canada
                Author notes
                Article
                959874
                10.4161/21592527.2014.959874
                5055204
                25482336
                3eff8f02-04e0-41c3-a364-954ddc900c5c
                © 2016 The Author(s). Published with license by Taylor & Francis Group, LLC

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License http://creativecommons.org/licenses/by-nc/3.0/, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

                History
                : 14 February 2014
                : 7 July 2014
                : 29 July 2014
                Page count
                Figures: 3, Tables: 3, References: 33, Pages: 9
                Categories
                Report

                annealing,biodegradable metal,cold rolling,corrosion rate,iron stent,mechanical properties

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