Biodegradable stents (BRS) offer enormous potential but first they must meet five specific requirements: (i) their manufacturing process must be precise; (ii) degradation should have minimal toxicity; (iii) the rate of degradation should match the recovery rate of vascular tissue; (iv) ideally, they should induce rapid endothelialization to restore the functions of vascular tissue, but at the same time reduce the risk of restenosis; and (v) their mechanical behavior should comply with medical requirements, namely, the flexibility required to facilitate placement but also sufficient radial rigidity to support the vessel. Although the first three requirements have been comprehensively studied, the last two have been overlooked. One possible way of addressing these issues would be to fabricate composite stents using materials that have different mechanical, biological, or medical properties, for instance, Polylactide Acid (PLA) or Polycaprolactone (PCL). However, fashioning such stents using the traditional stent manufacturing process known as laser cutting would be impossible. Our work, therefore, aims to produce PCL/PLA composite stents using a novel 3D tubular printer based on Fused Deposition Modelling (FDM). The cell geometry (shape and area) and the materials (PCL and PLA) of the stents were analyzed and correlated with 3T3 cell proliferation, degradation rates, dynamic mechanical and radial expansion tests to determine the best parameters for a stent that will satisfy the five strict BRS requirements. Results proved that the 3D-printing process was highly suitable for producing composite stents (approximately 85–95% accuracy). Both PCL and PLA demonstrated their biocompatibility with PCL stents presenting an average cell proliferation of 12.46% and PLA 8.28% after only 3 days. Furthermore, the PCL/PLA composite stents demonstrated their potential in degradation, dynamic mechanical and expansion tests. Moreover, and regardless of the order of the layers, the composite stents showed (virtually) medium levels of degradation rates and mechanical modulus. Radially, they exhibited the virtues of PCL in the expansion step (elasticity) and those of PLA in the recoil step (rigidity). Results have clearly demonstrated that composite PCL/PLA stents are a highly promising solution to fulfilling the rigorous BRS requirements.
Bioresorbable stents (BRS) offer the potential to improve long-term patency rates by providing support just long enough for the artery to heal itself. While manufacturing methods to produce BRS using the appropriate architecture, material and mechanical studies, etc., have received much attention, the effects subsequent sterilization methods have on BRS properties are overlooked. Sterilization process can change a device's properties. This work presents the effects ethanol, ultraviolet light (UV), and antibiotic sterilization processes at 0.5, 1, 2, 4, 8, and 16 hours have on a novel 3D-printed polycaprolactone stent. The stents were analysed using sterility tests, scanning electron microscopy, differential scanning calorimetry, thermogravimetric analysis, mass spectrometry, for molecular weight, and degradation tests. Results have shown ethanol to be an effective sterilization treatment as it barely affected the material's properties. On the other hand, UV had a considerable influence (mainly produced by the photodegradation of UV irradiation) on crystallinity and molecular weight. Lastly, while antibiotic sterilization did not affect crystallinity to the same degree, it did substantially reduce the molecular weight of the samples. Ethanol results in being the best sterilization method for the high material requirements that medical devices such as stents have.
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