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        Effect of sterilization on 3-point dynamic response to in vitro bending of an Mg implant

        Luis Humberto Campos Becerra,Marco Antonio Loudovic Hernández Rodríguez,Raúl Lesso Arroyo,Hugo Esquivel Solís,Alejandro Torres Castro 한국생체재료학회 2021 생체재료학회지 Vol.25 No.2

        Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results: As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank’s solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.

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        Development of Collagen/Poly(vinyl alcohol)/Chondroitin Sulfate and Collagen/Poly(vinyl alcohol)/HA Electrospun Scaffolds for Tissue Engineering

        Luis Humberto Delgado-Rangel,Julia Hernández-Vargas,Marymar Becerra-González,Ataúlfo Martínez-Torres,Evgen Prokhorov,J. Betzabe González Campos 한국섬유공학회 2019 Fibers and polymers Vol.20 No.12

        The combination of collagen (CG), chondroitin sulfate (CS), and hyaluronic acid (HA) with poly(vinyl alcohol)(PVA) was explored to produce 3D tri-component scaffolds with enhanced mechanical properties and potential use in tissueengineering. The CG/PVA/CS and CG/PVA/HA electrospun scaffolds were crosslinked with citric acid, a cytocompatiblecrosslinker, which induced improved mechanical properties in both dry and wet state, especially with large elongation atbreak in the wet state. Ultimate tensile stress under the dry and wet state are significantly higher than those previouslyreported about collagen based nanofibers. IR, DSC and dielectric analysis demonstrated homogenous blending without phaseseparation and strong interactions between components. All scaffolds had swelling pH-sensitive behavior, making thempromising materials for drug delivery systems. The nanofiber mats permitted adhesion and proliferation of human embryonickidney cells; this cell line formed clusters that adapted well to the mats’ surface, through which the cells extended theirprocesses.

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