In the context of successful product development, continuous validation plays a central role in matching customer requirements and product characteristics. However, the early phase of product development in particular is characterised by special challenges, which are due to a high degree of uncertainty and a lack of resources, such as a lack of prototypes. Additive Tooling (AT) offers a quick and cost-effective way of producing injection moulded products and high fidelity prototypes using the injection moulding process and provides a promising approach for addressing these challenges. Furthermore, it allows different product variants to be tested early in the development process, thus generating meaningful insights into product properties and the necessary production system. As part of the validation process, AT is embedded into a complex process environment. In many cases, the use of AT in product development practice is not target-oriented as it also lacks methodological support. This paper presents a method for supporting the application of AT-based validation environments in integrated product development. Based on a case study, relevant process steps, activities and possible barriers in the realisation of an injection-moulded product are identified and analysed. The practical example essentially shows the need for verification of the AT application. Based on the identified requirements and sub-activities, a systematic for Additive Tooling is then derived and described. The aim of the AT-systematic is to support the targetoriented application of Additive Tooling to obtain physical prototypes at an early stage and to shorten validation cycles. Finally, it is shown how the AT-systematic is located in the integrated Product engineering Model (iPeM).
The visualization of heart rhythm disturbance and atrial fibrillation therapy allows the optimization of new cardiac catheter ablations. With the simulation software CST (Computer Simulation Technology, Darmstadt) electromagnetic and thermal simulations can be carried out to analyze and optimize different heart rhythm disturbance and cardiac catheters for pulmonary vein isolation. Another form of visualization is provided by haptic, three-dimensional print models. These models can be produced using an additive manufacturing method, such as a 3d printer. The aim of the study was to produce a 3d print of the Offenburg heart rhythm model with a representation of an atrial fibrillation ablation procedure to improve the visualization of simulation of cardiac catheter ablation. The basis of 3d printing was the Offenburg heart rhythm model and the associated simulation of cryoablation of the pulmonary vein. The thermal simulation shows the pulmonary vein isolation of the left inferior pulmonary vein with the cryoballoon catheter Arctic Front AdvanceTM from Medtronic. After running through the simulation, the thermal propagation during the procedure was shown in the form of different colors. The three-dimensional print models were constructed on the base of the described simulation in a CAD program. Four different 3d printers are available for this purpose in a rapid prototyping laboratory at the University of Applied Science Offenburg. Two different printing processes were used and a final print model with additional representation of the esophagus and internal esophagus catheter was also prepared for printing. With the help of the thermal simulation results and the subsequent evaluation, it was possible to draw a conclusion about the propagation of the cold emanating from the catheter in the myocardium and the surrounding tissue. It was measured that just 3 mm from the balloon surface into the myocardium the temperature dropped to 25 °C. The simulation model was printed using two 3d printing methods. Both methods, as well as the different printing materials offer different advantages and disadvantages. All relevant parts, especially the balloon catheter and the conduction, are realistically represented. Only the thermal propagation in the form of different colors is not shown on this model. Three-dimensional heart rhythm models as well as virtual simulations allow very clear visualization of complex cardiac rhythm therapy and atrial fibrillation treatment methods. The printed models can be used for optimization and demonstration of cryoballoon catheter ablation in patients with atrial fibrillation.
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