In Vitro and In Vivo Testing of Zinc as a Biodegradable Material for Stents Fabricated by Photo-Chemical Etching

Abstract

There is an increasing interest in biodegradable metal implants made from magnesium (Mg), iron (Fe), zinc (Zn) and their alloys because they are well tolerated in vivo and have mechanical properties that approach those of non-degradable metals. In particular, Zn and its alloys show the potential to be the next generation of biodegradable materials for medical implants. However, Zn has not been as well-studied as Mg, especially for stent applications. Manufacturing stents by laser cutting has become an industry standard. Nevertheless, the use of this approach with Zn faces some challenges, such as generating thermal stress, dross sticking on the device, surface oxidation, and the need for expensive thin-walled Zn tubing and post-treatment. All of these challenges motivated us to employ photo-chemical etching for fabricating different designs of Zn (99.95% pure) stents. The stents were constructed with different strut patterns, made by photo-chemical etching, and mechanically tested to evaluate radial forces. Stents with rhombus design patterns showed a promising 0.167N/mm radial force, which was comparable to Mg-based stents. In vitro studies were conducted with uncoated Zn stents as control and Parylene C-coated Zn stents to determine corrosion rates. The Parylene C coating reduced the corrosion rate by 50% compared to uncoated stents. In vivo studies were carried out by implanting photo-chemically etched, uncoated Zn stent segments subcutaneously in a C57BL/6 mice model. Histological analyses provided favorable data about the surrounding tissue status, as well as nerve and blood vessel responses near the implant, providing insights into the in vivo degradation of the metal struts. All of these experiments confirmed that Zn has the potential for use in biodegradable stent applications.