Anchoring fins of fully covered self-expandable metal stents affect pull-out force and stent migration.

BACKGROUND AND AIMS: Stent migration and subsequent adverse events are frequently observed in the use of fully covered self-expandable metal stents (FCSEMSs) for distal biliary stenosis. In this study, we identified predictors for stent migration based on biomechanical stent characteristics and associated these findings with clinical outcomes. METHODS: The migration resistance of FCSEMSs was quantified by measuring the pull-out force. We analyzed a single-center retrospective cohort of 178 FCSEMSs for treatment success and adverse events occurring during 180 days of follow-up. RESULTS: Biomechanical measurements revealed a 4-fold higher migration resistance of FCSEMSs with anchoring fins (AF-FCSEMSs; Fmax = 14.2 ± .1 N) compared with FCSEMSs with flared ends (FE-FCSEMSs; Fmax = 3.8 ± 1.0 N; P < .0001). Clinically, AF-FCSEMSs showed lower rates of migration compared with FE-FCSEMSs (5% vs 34%, P < .0001). Unscheduled ERCP procedures because of stent dysfunction were less frequent in the AF group compared with the FE group (15% vs 29%, P = .046). Cholangitis because of stent dysfunction was observed in 5% of the AF group compared with 19% in the FE group (P = .02). Stent patency rates at 1, 3, and 6 months were higher in the AF group (96%, 90%, and 80%, respectively) compared with the FE group (90%, 74%, and 66%; log-rank test: P = .03). CONCLUSIONS: The pull-out force as a biomechanical stent property predicts the migration resistance of FCSEMSs in distal biliary stenosis and may thus be used to classify stents for this application. AF-FCSEMSs showed a significantly lower rate of migration and adverse events compared with FE-FCSEMSs.

Design, simulation and experimental analysis of a monolithic bending section for enhanced maneuverability of single use laparoscopic devices.

Standard laparoscopes, which are widely used in minimally invasive surgery, have significant handling limitations due to their rigid design. This paper presents an approach for a bending section for laparoscopes based on a standard semi-finished tube made of Nitinol with laser-cut flexure hinges. Flexure hinges simply created from a semi-finished product are a key element for realizing low-cost compliant structures with minimal design space. Superelastic materials such as Nitinol allow the reversible strain required for this purpose while maintaining sufficient strength in abuse load cases. This paper focuses on the development of a bending section for single use laparoscopic devices (OD 10 mm) with a bending angle of 100°, which enables the application of 100 µm diameter Nitinol actuator wires. For this purpose, constructive measures to realise a required bending curvature and Finite Element Analysis for determining the strain distribution in the flexural region are applied and described for the design of the flexure hinges. In parallel, the influence of the laser-based manufacturing process on the microstructure is investigated and evaluated using micrographs. The deformation behavior of the bending section is experimentally determined using Digital Image Correlation. The required actuation forces and the failure load of the monolithic bending section is measured and compared to a state of the art riveted bending section made of stainless steel. With the developed monolothic bending section the actuation force could be reduced by 50% and the available inner diameter could be increased by 10% while avoiding the need of any assembly step.

Hygromechanical Behavior of Polyamide 6.6: Experiments and Modeling.

This paper investigates water absorption in polyamide 6.6 and the resulting hygroscopic swelling and changes in mechanical properties. First, sorption and swelling experiments on specimens from injection molded plates are presented. The observed swelling behavior is dependent on the melt flow direction of the injection molding process. Additionally, thermal analysis and mechanical tensile tests were performed for different conditioning states. The water sorption is accompanied by a decrease in the glass transition temperature and a significant reduction in stiffness and strength. Next, a sequentially coupled modeling approach is presented. A nonlinear diffusion model is followed by mechanical simulations accounting for swelling and concentration-dependent properties. For the mechanical properties, the notion of a "gap" temperature caused by the shift of the glass transition range due to water-induced plasticization is employed. This model enables the computation of local moisture concentration fields and the resultant swelling and changes in stress-strain behavior.

On the Resin Transfer Molding (RTM) Infiltration of Fiber-Reinforced Composites Made by Tailored Fiber Placement.

Tailored fiber placement (TFP) is a preform manufacturing process in which rovings made of fibrous material are stitched onto a base material, increasing the freedom for the placement of fibers. Due to the particular kinematics of the process, the infiltration of TFP preforms with resin transfer molding (RTM) is sensitive to multiple processes and material parameters, such as injection pressure, resin viscosity, and fiber architecture. An experimental study is conducted to investigate the influence of TFP manufacturing parameters on the infiltration process. A transparent RTM tool that enables visual tracking of the resin flow front was developed and constructed. Microsection evaluations were produced to observe the thickness of each part of the composite and evaluate the fiber volume content of that part. Qualitative results have shown that the infiltration process in TFP structures is strongly influenced by a top and bottom flow layer. The stitching points and the yarn also create channels for the resin to flow. Furthermore, the stitching creates some eye-like regions, which are resin-rich zones and are normally not taken into account during the infusion of TFP parts.

Structural Optimization through Biomimetic-Inspired Material-Specific Application of Plant-Based Natural Fiber-Reinforced Polymer Composites (NFRP) for Future Sustainable Lightweight Architecture.

Under normal conditions, the cross-sections of reinforced concrete in classic skeleton construction systems are often only partially loaded. This contributes to non-sustainable construction solutions due to an excess of material use. Novel cross-disciplinary workflows linking architects, engineers, material scientists and manufacturers could offer alternative means for more sustainable architectural applications with extra lightweight solutions. Through material-specific use of plant-based Natural Fiber-Reinforced Polymer Composites (NFRP), also named Biocomposites, a high-performance lightweight structure with topology optimized cross-sections has been here developed. The closed life cycle of NFRPs promotes sustainability in construction through energy recovery of the quickly generative biomass-based materials. The cooperative design resulted in a development that were verified through a 1:10 demonstrator, whose fibrous morphology was defined by biomimetically-inspired orthotropic tectonics, generated with by the fiber path optimization software tools, namely EdoStructure and EdoPath in combination with the appliance of the digital additive manufacturing technique: Tailored Fiber Placement (TFP).