3D-printed flexible polymer stents for potential applications in inoperable esophageal malignancies

Palliation therapy for dysphagia using esophageal stents is the current treatment of choice for those patients with inoperable esophageal malignancies. However, the metallic and plastic stents currently used in the clinical setting may cause complications, such as tumor ingrowth and stent migration into the stomach. To effectively reduce/overcome these complications, we designed a tubular, flexible polymer stent with spirals. The parameters of the spirals were computationally optimized by using a finite element analysis. The designed polymer stents with optimized spirals were then printed by a 3D printing technique. 3D-printed tubular polymer stents without spirals served as controls. The self-expansion and anti-migration properties of the printed stent were characterized in an ex vivo normal porcine esophagus. The biodegradability test of the stent was performed in a neutral buffer and acidic gastric buffer. The cytotoxicity of the new stent was examined through the viability test of human esophagus epithelial cells. Results showed the self-expansion force of the 3D-printed polymer stent with spirals was higher than the stent without spirals. The anti-migration force of the 3D-printed stent with spirals was significantly higher than that of the stent without spirals. Furthermore, the stent with spirals significantly decreased the migration distance compared to the non-spiral 3D-printed polymer stent. Degradation study showed that the polymer materials started to degrade after six weeks and the compressive strength of the stent was not significantly decreased with time. In vitro cell viability results further indicated that the polymer stent does not have any cytotoxicity. Together, these results showed that the 3D-printed stent with spirals has potential applications in the treatment of inoperable esophageal malignancies. STATEMENT OF SIGNIFICANCE: In this study, we developed a new 3D-printed flexible tubular polymeric stent with spirals. The mechanical properties of the 3D-printed polymer stent are modulated by changing the ratios of PLA to TPU. The stent is flexible enough to be compressed in a clinically available stent delivery system, and can self-expand after it is released. The self-expansion force of the stent with spirals is higher than that of non-spiral stents. The spirals on the outside of the stent significantly increased the anti-migration force compared to non-spiral stents in an ex vivo normal pig esophagus. Together, the 3D-printed stent with spirals will bring promising potential in the treatment of inoperable esophagus malignancies or benign strictures.