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Nitinol embolic protection filters: design investigation by finite element analysis

Michele Conti (UGent) , Matthieu De Beule (UGent) , Peter Mortier (UGent) , Denis Van Loo (UGent) , Pascal Verdonck (UGent) , Frank Vermassen (UGent) , Patrick Segers (UGent) , Ferdinando Auricchio and Benedict Verhegghe (UGent)
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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 (TM) 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.
Keywords
carotid artery stenting, embolic protection device, Angioguard (TM), finite element analysis, nitinol, wall apposition, STENT DESIGN, EMBOLIZATION, CEREBRAL PROTECTION, ENDARTERECTOMY, DEVICES

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Chicago
Conti, Michele, Matthieu De Beule, Peter Mortier, Denis Van Loo, Pascal Verdonck, Frank Vermassen, Patrick Segers, Ferdinando Auricchio, and Benedict Verhegghe. 2009. “Nitinol Embolic Protection Filters: Design Investigation by Finite Element Analysis.” Journal of Materials Engineering and Performance 18 (5-6): 787–792.
APA
Conti, M., De Beule, M., Mortier, P., Van Loo, D., Verdonck, P., Vermassen, F., Segers, P., et al. (2009). Nitinol embolic protection filters: design investigation by finite element analysis. JOURNAL OF MATERIALS ENGINEERING AND PERFORMANCE, 18(5-6), 787–792. Presented at the International Conference on Shape Memory and Superelastic Technologies.
Vancouver
1.
Conti M, De Beule M, Mortier P, Van Loo D, Verdonck P, Vermassen F, et al. Nitinol embolic protection filters: design investigation by finite element analysis. JOURNAL OF MATERIALS ENGINEERING AND PERFORMANCE. 2009;18(5-6):787–92.
MLA
Conti, Michele et al. “Nitinol Embolic Protection Filters: Design Investigation by Finite Element Analysis.” JOURNAL OF MATERIALS ENGINEERING AND PERFORMANCE 18.5-6 (2009): 787–792. Print.
@article{990864,
  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 (TM) 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.},
  author       = {Conti, Michele and De Beule, Matthieu and Mortier, Peter and Van Loo, Denis and Verdonck, Pascal and Vermassen, Frank and Segers, Patrick and Auricchio, Ferdinando and Verhegghe, Benedict},
  issn         = {1059-9495},
  journal      = {JOURNAL OF MATERIALS ENGINEERING AND PERFORMANCE},
  language     = {eng},
  location     = {Stresa, Italy},
  number       = {5-6},
  pages        = {787--792},
  title        = {Nitinol embolic protection filters: design investigation by finite element analysis},
  url          = {http://dx.doi.org/10.1007/s11665-009-9408-8},
  volume       = {18},
  year         = {2009},
}

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