New nanostructural shape memory alloy (55.91 wt% of Ni and 44.03 wt% of Ti) for the production of minimally invasive implantation medical devices (stents) was tested for corrosion resistance under static conditions by dipping it into solutions with various acidities (pH from 1.68 to 9.18) for 2 years, for static mechanical properties and for biocompatibility. The material for investigations was 280-μm wires before and after thermal treatment at 450°C for 15 min in air and surface mechanical treatment. The characteristic image and size of grains were determined using the transmission electron microscope (TEM), and the phase composition; surface morphology; and the layer-bylayer composition were investigated using an X-ray diffractometer; a scanning electron microscope (SEM); and an Auger spectrometer. The nickel release from the investigated nanostructural nitinol is less in comparison with data for microstructural nitinol in a solution of any acidity. Dissolution in the alkali medium is absent. A significant retardation of the nickel ion release (and insignificant concentration as a whole) and the absence of titanium ion release in the weakly acidic and neutral solutions with polished samples are observed. A simultaneous 7-11% increase in strength and plasticity in comparison with microstructural nitinol was attained. Toxicity of samples has not been revealed.
The novelty of the study is the development, creation, and investigation of biodegradable polymeric membranes based on polylactide, that are capable of directed release of large molecular weight biomolecules, particularly, prourokinase protein (MW = 46 kDa). Prourokinase is a medication with significant thrombolytic activity. The created membranes possess the required mechanical properties (relative extension value from 2% to 10%, tensile strength from 40 to 85 MPa). The membranes are biodegradable, but in the absence of living cells in a water solution they decompose by less than 10% in half a year. The created membranes are capable of controlled prourokinase release into intercellular space, and the total enzymatic activity of prourokinase does not decrease by more than 12%. The daily release of prourokinase from one square centimeter of the membrane ranges from 1 to 40 μg per day depending on the technique of membrane preparation. The membranes have no acute toxic effect on cells accreting these surfaces de novo. The number of viable cells is at least 96%−97% of the overall cell count. The mitotic index of the cells growing on the surface of the polymeric films comprised around 1.5%. Histological examination did not reveal any disorders in tissues of the animals after the implantation of polymer membranes based on polylactide, both alone and as components of stent cover. Implantation of stents covered with prourokinase-containing polymers led to the formation of a mature connective tissue capsule that is thicker than in the case of uncovered stents. Thus, various polylactide-based biodegradable polymeric membranes possessing the required mechanical properties and capable of prolonged and directed release of prourokinase macromolecules are developed and investigated in the study.
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