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Nitinol Embolic Protection Filters: Design Investigation by Finite Element Analysis

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Abstract

The widespread acceptance of carotid artery stenting (CAS) to treat carotid artery stenosis and its effectiveness compared with surgical counterpart, carotid endarterectomy (CEA), is still a matter of debate. Transient or permanent neurological deficits may develop in patients undergoing CAS due to distal embolization or hemodynamic changes. Design, development, and usage of embolic protection devices (EPDs), such as embolic protection filters, appear to have a significant impact on the success of CAS. Unfortunately, some drawbacks, such as filtering failure, inability to cross tortuous high-grade stenoses, malpositioning and vessel injury, still remain and require design improvement. Currently, many different designs of such devices are available on the rapidly growing dedicated market. In spite of such a growing commercial interest, there is a significant need for design tools as well as for careful engineering investigations and design analyses of such nitinol devices. The present study aims to investigate the embolic protection filter design by finite element analysis. We first developed a parametrical computer-aided design model of an embolic filter based on micro-CT scans of the Angioguard™ XP (Cordis Endovascular, FL) EPD by means of the open source pyFormex software. Subsequently, we used the finite element method to simulate the deployment of the nitinol filter as it exits the delivery sheath. Comparison of the simulations with micro-CT images of the real device exiting the catheter showed excellent correspondence with our simulations. Finally, we evaluated circumferential basket-vessel wall apposition of a 4 mm size filter in a straight vessel of different sizes and shape. We conclude that the proposed methodology offers a useful tool to evaluate and to compare current or new designs of EPDs. Further simulations will investigate vessel wall apposition in a realistic tortuous anatomy.

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Notes

  1. Ovality being defined as the change in cross section roundness and defined as O = b/a, where a is cross section semi-major axis length and b is cross section semi-minor axis length.

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Authors and Affiliations

  1. Universitá degli Studi di Pavia, Pavia, Italy

    Michele Conti & Ferdinando Auricchio

  2. IBiTech, Institute of Biomedical Technology, Ghent University, Ghent, Belgium

    Matthieu De Beule, Peter Mortier, Pascal Verdonck, Patrick Segers & Benedict Verhegghe

  3. UGCT, Center for X-ray Tomography, Ghent University, Ghent, Belgium

    Denis Van Loo

  4. Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium

    Frank Vermassen

Authors
  1. Michele Conti
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  2. Matthieu De Beule
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  3. Peter Mortier
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  4. Denis Van Loo
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  5. Pascal Verdonck
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  6. Frank Vermassen
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  7. Patrick Segers
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  8. Ferdinando Auricchio
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  9. Benedict Verhegghe
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Corresponding author

Correspondence to Michele Conti.

Additional information

This article is an invited paper selected from presentations at Shape Memory and Superelastic Technologies 2008, held September 21-25, 2008, in Stresa, Italy, and has been expanded from the original presentation.

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Conti, M., De Beule, M., Mortier, P. et al. Nitinol Embolic Protection Filters: Design Investigation by Finite Element Analysis. J. of Materi Eng and Perform 18, 787–792 (2009). https://doi.org/10.1007/s11665-009-9408-8

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  • DOI: https://doi.org/10.1007/s11665-009-9408-8

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