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Patent
Bard Peripheral Vascular | Date: 2013-12-20

A drug coated inflatable balloon catheter (


Lin Z.,Abbott Laboratories | Pike K.,Abbott Laboratories | Schlun M.,Bard Peripheral Vascular | Zipse A.,Bard Peripheral Vascular | Draper J.,Safe Technology Ltd
Journal of Materials Engineering and Performance | Year: 2012

Nitinol fatigue testing results are presented for variable strain amplitude cycling. The results indicate that cycles smaller than the constant amplitude fatigue limit may contribute to significant fatigue damage when they occur in a repeating sequence of large and small amplitude cycles. The testing utilized two specimen types: stent-like diamond specimens and Z-shaped wire specimens. The diamond specimens were made from nitinol tubing with stent-like manufacturing processes and the Z-shaped wire specimens were made from heat set nitinol wire. The study explored the hypothesis that duty cycling can have an effect on nitinol fatigue life. Stent-like structures were subjected to different in vivo loadings in order to create more complex strain amplitudes. The main focus in this study was to determine whether a combination of small and large amplitudes causes additional damage that alters the fatigue life of a component. © ASM International. Source


Rebelo N.,Dassault Systemes | Zipse A.,Bard Peripheral Vascular | Schlun M.,Bard Peripheral Vascular | Dreher G.,Bard Peripheral Vascular
Journal of Materials Engineering and Performance | Year: 2011

The uniaxial behavior of Nitinol in different forms and at different temperatures has been well documented in the literature. Mathematical models for the three-dimensional behavior of this class of materials, covering superelasticity, plasticity, and shape memory effects have been previously developed. Phenomenological models embedded in FEA analysis are part of common practice today in the development of devices made out of Nitinol. In vivo loading of medical devices has cyclic characteristics. There have been some indications in the literature that cyclic loading of Nitinol modifies substantially its behavior. A consortium of several stent manufacturers, Safe Technology and Dassault Systèmes Simulia Corp., dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices, has conducted an extensive experimental study of the modifications in uniaxial behavior of both Nitinol wire and tubing due to cyclic loading. The Abaqus Nitinol material model has been extended to capture some of the phenomena observed and is described in this article. Namely, a preload beyond 6% strain alters the transformation plateaus; if the cyclic load amplitude is large enough, permanent deformations (residual martensite) are observed; the lower plateau increases; and the upper plateau changes. The modifications to the upper plateau are very interesting in the sense that it appears broken: its start stress gets lowered creating a new plateau up to the highest level of cyclic strain, followed by resuming the original plateau until full transformation. Since quite often the geometry of a device at the point at which it is subjected to cyclic loading is very much dependent on the manufacturing, deployment, and preloading sequence, it is important that analyses be conducted with the original material behavior up to that point, and then with the cyclic behavior thereafter. © ASM International. Source


Zipse A.,Bard Peripheral Vascular | Schlun M.,Bard Peripheral Vascular | Dreher G.,Bard Peripheral Vascular | Gahr J.Z.,Bard Peripheral Vascular | Rebelo N.,DS SIMULIA Corporation
Journal of Materials Engineering and Performance | Year: 2011

In this study, we investigated the fatigue behavior of stent-like diamond specimens with particular attention paid to the nature of the test specimen, the constitutive model for the finite element analyses and the displacement condition. A newly designed test rig did enhance the investigation and results with respect to the simulation of the expected in vivo displacement conditions. The excellent performance of the new test method presented within our study provides a good basis for future tests without risk of compromised results due to differing characteristics between test specimens and finished stents, inappropriate displacement conditions or constitutive material model and provides a high reliability and applicability of the results to actual stents. © ASM International. Source


Rebelo N.,SIMULIA Western Region | Radford R.,38366 Nebo Dr. | Zipse A.,Bard Peripheral Vascular | Schlun M.,Bard Peripheral Vascular | Dreher G.,Bard Peripheral Vascular
Journal of Medical Devices, Transactions of the ASME | Year: 2011

Finite Element Analysis (FEA) of Nitinol medical devices has become prevalent in the industry. The analysis methods have evolved in time with the knowledge about the material, the manufacturing processes, the testing or in vivo loading conditions, and the FEA technologies and computing power themselves. As a result, some common practices have developed. This paper presents a study in which some commonly made assumptions in FEA of Nitinol devices were challenged and their effect was ascertained. The base model pertains to the simulation of the fabrication of a diamond shape stent specimen, followed by cyclic loading. This specimen is being used by a consortium of several stent manufacturers dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices. The FEA models represent the geometry of the specimens built, for which geometrical tolerances were measured. These models use converged meshes, and all simulations were run in the FEA code Abaqus making use of its Nitinol material models. Uniaxial material properties were measured in dogbone specimens subjected to the same fabrication process as the diamond specimens. By convention, the study looked at computed geometry versus measured geometry and at the maximum principal strain amplitudes during cyclic loading. The first aspect studied was the effect of simulating a single expansion to the final diameter compared to a sequence of three partial expansions each followed by shape setting. The second aspect was to ascertain whether it was feasible to conduct the full analysis with a model based on the electropolished dimensions or should an electropolish layer be removed only at the end of fabrication, similar to the manufacturing process. Finally, the effect of dimensional tolerances was studied. For this particular geometry and loading, modeling of a single expansion made no discernable difference. The fabrication tolerances were so tight that the effect on the computed fatigue drivers was also very small. The timing of the removal of the electropolished layer showed an effect on the results. This may have been so, because the specimen studied is not completely periodic in the circumferential direction. © 2011 American Society of Mechanical Engineers. Source

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