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Fremont, CA, United States

Runciman A.,University of California at Berkeley | Runciman A.,Lawrence Berkeley National Laboratory | Xu D.,University of California at Berkeley | Xu D.,Lawrence Berkeley National Laboratory | And 3 more authors.
Biomaterials | Year: 2011

Medical devices, particularly endovascular stents, manufactured from superelastic Nitinol, a near-equiatomic alloy of Ni and Ti, are subjected to complex mixed-mode loading conditions in vivo, including axial tension and compression, radial compression, pulsatile, bending and torsion. Fatigue lifetime prediction methodologies for Nitinol, however, are invariably based on uniaxial loading and thus fall short of accurately predicting the safe lifetime of stents under the complex multiaxial loading conditions experienced physiologically. While there is a considerable body of research documented on the cyclic fatigue of Nitinol in uniaxial tension or bending, there remains an almost total lack of comprehensive fatigue lifetime data for other loading conditions, such as torsion and tension/torsion. In this work, thin-walled Nitinol tubes were cycled in torsion at various mean and alternating strains to investigate the fatigue life behavior of Nitinol and results compared to equivalent fatigue data collected under uniaxial tensile/bending loads. Using these strain-life results for various loading modes and an equivalent referential (Lagrangian) strain approach, a strategy for normalizing these data is presented. Based on this strategy, a fatigue lifetime prediction model for the multiaxial loading of Nitinol is presented utilizing a modified Coffin-Manson approach where the number of cycles to failure is related to the equivalent alternating transformation strain. © 2011.

Kuo W.T.,Stanford University | Deso S.E.,Stanford University | Robertson S.W.,Nitinol Devices & Components
Journal of Vascular and Interventional Radiology | Year: 2013

A 48-year-old man presented with symptomatic inferior vena cava (IVC) occlusion from a chronically thrombosed and embedded Vena Tech LGM filter resulting in exercise intolerance from diminished cardiac preload and postthrombotic syndrome from chronic venous insufficiency. The patient was treated using a new PRIME technique - Piecemeal Removal by Intentional MEchanical fracture - to achieve successful filter retrieval 16 years after implantation. Removal of the obstructing filter permitted endovascular IVC recanalization with restoration of venous outflow and alleviation of venous obstructive symptoms. Cardiac preload was restored, allowing the patient to resume long-distance running, and he successfully completed a half-marathon 3 months after treatment. © 2013 SIR.

Kuo W.T.,Stanford University | Robertson S.W.,Nitinol Devices & Components | Odegaard J.I.,Stanford University | Hofmann L.V.,Stanford University
Journal of Vascular and Interventional Radiology | Year: 2013

Purpose: To evaluate clinical outcomes, characterize adherent tissue, and analyze inferior vena cava (IVC) filter fractures in patients undergoing complex retrieval for management of filter-related complications. To elucidate mechanisms of filter fracture by radiographic and electron microscopic (EM) evaluation. Materials and Methods: Over 2.5 years, 50 consecutive patients with fractured and/or penetrating filter components were prospectively enrolled into a single-center study. There were 19 men and 31 women (mean age, 42 y; range, 15-73 y). All patients underwent complex filter retrieval after failure of standard methods, and retrieval indications along with resultant clinical outcomes were evaluated. Specimens with adherent tissue underwent histologic analysis, and all fractured components were studied with EM. Results: Retrieval was successful in all 50 cases (mean implantation, 815 d; range, 20-2,599 d) among the following filters: G2X (n = 23),G2 (n = 9), Eclipse (n = 3), Recovery (n = 4), ALN (n = 1), Celect (n = 7), OptEase (n = 2), and Simon Nitinol (n = 1). Mean indwell time in fractured filters (n = 31) was 1,082 days, versus 408 days in nonfractured filters (n = 19; P =.00169). Neointimal hyperplasia/fibrosis was seen in 46 of 48 specimens with adherent tissue (96%). Among 61 fractured components from conical filters, 35 had extravascular penetration whereas 26 remained intravascular (11 free-floating in IVC, 15 embolized centrally), and EM revealed fracture modes of high-cycle fatigue (n = 53), overload (n = 6), and indeterminate (n = 2). Following retrieval, previously prescribed lifelong anticoagulation was discontinued in 30 of 31 patients (97%). Filter-related symptoms from IVC occlusion, component embolization, and penetration-induced abdominal pain, duodenal injury, and/or small-bowel volvulus were alleviated in all 26 cases (100%). There were no long-term complications at a mean follow-up of 371 days (range, 67-878 d). Conclusions: The risk of filter fracture increases after 408 days (ie,>1 y) of implantation and is associated with symptomatic extravascular penetration and/or intravascular embolization. Complex methods can be used to safely remove these devices, alleviate filter-related morbidity, and allow cessation of anticoagulation. © 2013 SIR.

Joner M.,CVPath Institute Inc. | Nakazawa G.,CVPath Institute Inc. | Bonsignore C.,Nitinol Devices & Components | Acampado E.,CVPath Institute Inc. | And 5 more authors.
EuroIntervention | Year: 2010

Aims: The histologic response to self-expanding stent implantation into advanced atherosclerotic lesions has not been systematically investigated. We tested the hypothesis of whether gradual expansion of advanced atherosclerotic plaques by self-expanding stents would be an appropriate method to seal atherosclerotic lesions without causing plaque disruption as is usually observed with balloon-expandable stents. Methods and results: Twelve New Zealand white rabbits were fed an atherogenic diet (1% cholesterol) followed by arterial denudation and injection of washed autologous erythrocytes. Nitinol self-expanding stents of two different stent designs and strengths (n=12 for SX and n=12 for Micro-SX) were implanted into the previously formed lesions within the abdominal aorta six weeks following injection of erythrocytes. Four weeks following stent implantation, animals were sacrificed, specimens harvested and processed for histology. Histomorphometry was performed on stented and adjacent non-stented regions. Atherosclerotic lesions were composed of foam cells, cholesterol clefts and necrotic plaque. While SX stents showed an unfavourable outcome with respect to vessel remodelling and the percentage of uncovered stent struts, Micro-SX stents had fewer uncovered stent struts, less positive remodelling and less plaque injury. Conclusions: Nitinol Micro-SX self-expanding stents might be a valuable approach to seal high risk atherosclerotic lesions. © Europa Edition. All rights reserved.

Nitinol Devices & Components | Date: 2012-11-30

Nitinol alloys; nitinol alloy materials, namely, sheets, tubes, wires, ingots, and bar stock made from nitinol alloys; nitinol alloys for industrial and consumer applications.

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