Nitinol stent fractures in the superficial femoral artery: Incidence and clinical significance

Rocha‐Singh, Krishna; Scheer, Karen; Rutherford, Janiece

doi:10.1016/s0735-1097(03)80957-9

Cited by 2 publications

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“…However, there is a dearth of information in the literature regarding those responses and properties in a product form that is relevant to biomedical devices: Nitinol tube. Motivated by the cited failures of many hundreds of stents in vivo [78][79][80][81][82][83][84][85][86][87][88][89], as well as personal experience with investigation of failed biomedical devices, it is the primary goal of this research to determine the fracture and fatigue properties, and the relevant microstructural variables, that influence the failure of Nitinol tube.…”

Section: Objective Of This Workmentioning

confidence: 99%

On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

Robertson

2006

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This dissertation was motivated by the alarming number of biomedical device failures reported in the literature, coupled with the growing trend towards the use of Nitinol for endovascular stents. The research is aimed at addressing two of the primary failure modes in Nitinol endovascular stents: fatigue-crack growth and overload fracture. The small dimensions of stents, coupled with their complex geometries and variability among manufacturers, make it virtually impossible to determine generic material constants associated with specific devices. Instead, the research utilizes a hybrid of standard test techniques (fracture mechanics and x -ray micro-diffraction) and custom-designed testing apparatus for the determination of the fracture properties of specimens that are suitable representations of self-expanding Nitinol stents.Specifically, the role of texture (crystallographic alignment of atoms) and the austenite-to-martensite phase transformation on the propagation of cracks in Nitinol was evaluated under simulated 2 body conditions and over a multitude of stresses and strains. The results determined through this research were then used to create conservative safe operating and inspection criteria to be used by the biomedical community for the determination of specific device vulnerability to failure by fracture and/or fatigue.Professor Robert O. Ritchie Dissertation Committee Chair

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Section: Objective Of This Workmentioning

confidence: 99%

On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

Robertson

2006

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The Quest for Fatigue-Resistant Nitinol for Medical Implants

Pelton¹,

Pelton²,

Jörn³

et al. 2019

Fourth Symposium on Fatigue and Fracture of Metallic Medical Materials and Devices

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This article reviews the use of nitinol endovascular devices and the effects of biomechanics, design, and nitinol processing and microstructural purity on fatigue and fracture. Nitinol self-expanding stents have shown an improvement in the effectiveness of treatment of femoral arterial disease with a restenosis rate as low as 17.9 % and patency rates of more than 85 % at 18 months. Nevertheless, follow-up procedures show stent fracture rates of up to 52 % with some stent designs and nitinol source material. This article will review the improvements in nitinol stent technology due to: (1) better understanding of the in vivo biomechanical deformation dynamics and (2) ingenuity in stent design improvements in the understanding of nitinol fatigue, including effects of thermomechanical processing, prestrain, and “micropurity.”

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Nitinol stent fractures in the superficial femoral artery: Incidence and clinical significance

Cited by 2 publications

References 0 publications

On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

The Quest for Fatigue-Resistant Nitinol for Medical Implants

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