Not only size but also position of flow-diverting devices have a considerable impact on the intra-aneurysmal flow dynamics. The suggested evaluation criteria allowed a quantitative comparison of flow-diverting effect using syngo iFlow and could represent an efficient tool for predicting flow diversion pre-procedurally.

Particle image velocimetry (PIV) is a commonly used method for in vitro investigation of fluid dynamics in biomedical devices, such as flow diverters for intracranial aneurysm treatment. Since it is limited to transparent blood substituting fluids like water-glycerol mixture, the influence of coagulation and platelet aggregation is neglected. We aimed at the development and the application of a modified platelet rich plasma as a new PIV fluid with blood-like rheological and coagulation properties. In standardized intracranial aneurysm silicone models, the effect of this new PIV plasma on the fluid dynamics before and after flow diverter implantation was evaluated and compared with water-glycerol measurements. The flow diverting effect was strongly dependent on the used fluid, with considerably lower velocities achieved using PIV plasma, despite the same starting viscosity of both fluids. Moreover, triggering coagulation of PIV plasma allowed for intra-aneurysmal clot formation. We presented the first in vitro PIV investigation using a non-Newtonian, clottable PIV plasma, demonstrating a mismatch to a standard PIV fluid and allowing for thrombus formation.

Personalized medical devices adapted to the anatomy of the individual promise greater treatment success for patients, thus increasing the individual value of the product. In order to cater to individual adaptations, however, medical device companies need to be able to handle a wide range of internal processes and components. These are here referred to collectively as the personalization workload. Consequently, support is required in order to evaluate how best to target product personalization. Since the approaches presented in the literature are not able to sufficiently meet this demand, this paper introduces a new method that can be used to define an appropriate variety level for a product family taking into account standardized, variant, and personalized attributes. The new method enables the identification and evaluation of personalizable attributes within an existing product family. The method is based on established steps and tools from the field of variant-oriented product design, and is applied using a flow diverter—an implant for the treatment of aneurysm diseases—as an example product. The personalization relevance and adaptation workload for the product characteristics that constitute the differentiating product properties were analyzed and compared in order to determine a tradeoff between customer value and personalization workload. This will consequently help companies to employ targeted, deliberate personalization when designing their product families by enabling them to factor variety-induced complexity and customer value into their thinking at an early stage, thus allowing them to critically evaluate a personalization project.

Braiding of Nitinol micro wires is an established technology for the manufacturing of fine-meshed neurovascular implants for tortuous vessel geometries. Electropolishing of wires before the braiding process has the potential to improve the in vitro behaviour in terms of thrombogenicity and endothelial cell proliferation. In this study, we present the first in vitro investigation of braided electropolished/blue oxide Nitinol samples in a blood flow loop, showing a significantly lower activation of the coagulation pathway (represented by the TAT III marker) and a tendency towards reduced platelet adhesion. Furthermore, we applied the same surface treatment on flat disks and measured protein adhesion as well as endothelial cell proliferation. We compared our results to non-electropolished samples with a native oxide surface. While platelet deposition was reduced on electropolished/blue oxide surface, a significant increase of endothelial cell seeding was observed. Investigation of inflammatory marker expression in endothelial cells provided divergent results depending on the marker tested, demanding closer investigation. Surface analysis using Auger electron spectroscopy revealed a thin layer mainly consisting of titanium oxynitride or titanium oxide + titanium nitride as a potential cause of the improved biological performance. Translated to the clinical field of intracranial aneurysm treatment, the improved biocompatibility has the potential to increase both safety (low thrombogenicity) and effectiveness (aneurysm neck reconstruction).

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