Influence of the Manufacturing Process on the Corrosion and Mechanical Behavior of Esophageal Stents

Abstract

Esophageal nitinol stents are an established method for treating swallowing difficulties caused by obstructing cancer. This raesearch investigates the influence of different qualities of raw metal alloys in combination with production technology on corrosion resistance in standardized simulated gastric fluid (SGF). Four different international stent manufacturers produced samples of their standard stents from nitinol sourced from three different alloy manufacturers. The stents were subjected to a 6-week immersion in SGF. During the immersion, the surface was studied at specified intervals using microscopy. The surface of the samples was also studied by X-ray Photoelectron Spectroscopy and after immersion the released ions were analyzed. Results demonstrated that both raw material and certain steps in the manufacturing process negatively affect corrosion resistance. Analysis of the SGF showed that the amount of nickel released is proportional to the degree of corrosion attack. Finally, current accepted standard test methods are inadequate for assessing susceptibility to corrosion by gastric acid and should take the low pH of the implanted environment into account. Conversely, certain measures in the manufacturing process are able to reduce the impact of the base material on corrosion susceptibility.