Fabrication and characterization of biodegradable Zn-Cu-Mn alloy micro-tubes and vascular stents: Microstructure, texture, mechanical properties and corrosion behavior.

Zinc (Zn) alloys are a promising biodegradable material for vascular stent applications. This study aimed to fabricate biodegradable Zn-2.0Cu-0.5Mn alloy micro-tubes and vascular stents with high dimensional accuracy and suitable mechanical properties, and to investigate their microstructure, texture, mechanical properties and corrosion behavior. The micro-tubes and vascular stents were successfully fabricated by a combined process of extrusion, drawing, laser cutting and electrochemical polishing. The microstructures of as-extruded and as-drawn micro-tubes consisted of Zn matrix with near-equiaxed grains (average grain size: ∼2 µm) and second phases of ε (CuZn) and MnZn with different sizes. The texture evolved from basal planes approximately paralleling to deformation direction for as-extruded micro-tube to approximately perpendicular to deformation direction for as-drawn micro-tube, because predominant deformation mechanisms changed from basal dislocation slip during tube extrusion to prismatic dislocation, pyramidal dislocations, and {101¯2} twins during tube drawing. As-drawn micro-tube exhibited suitable mechanical properties with an ultimate tensile strength of about 298 MPa and elongation of about 26% as a stent material. Moreover, the processed stent with a thickness of about 125 µm possessed sufficient radial strength of about 150 kPa and good balloon expandability. In addition, as-drawn tube exhibited an in vitro corrosion rate of about 158 µm/year with a basically uniform corrosion morphology. These results indicated that biodegradable Zn-2.0Cu-0.5Mn alloy is a promising vascular stent material candidate, and the procedure for processing the micro-tube and stent is practical and effective. STATEMENT OF SIGNIFICANCE: Fabrication of micro-tubes followed by laser cutting and polishing is a common way to prepare metallic vascular stents. However, it is quite challenging to fabricate Zn-based stents using this standard method, and there is a lack of studies reporting processing details in the past. Biodegradable Zn-2.0Cu-0.5Mn alloy micro-tubes and vascular stents with high dimensional accuracy and suitable mechanical properties were successfully fabricated by a combined process in this study. As-drawn micro-tube exhibited an ultimate tensile strength of about 298 MPa and elongation of about 26%. The stent possessed sufficient radial strength of about 150 kPa and good balloon expandability. We demonstrated a practical method to fabricate biodegradable Zn-based micro-tubes and stents with high dimensional accuracy and mechanical properties.