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Experimental Protocol and Phantom Design and Development for Performance Characterization of Conventional Devices for Peripheral Vascular Interventions

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Abstract

Conventional catheter-based interventions for treating peripheral artery disease suffer high failure and complication rates. The mechanical interactions with the anatomy constrain catheter controllability, while their length and flexibility limit their pushability. Also, the 2D X-ray fluoroscopy guiding these procedures fails to provide sufficient feedback about the device location relative to the anatomy. Our study aims to quantify the performance of conventional non-steerable (NS) and steerable (S) catheters in phantom and ex vivo experiments. In a 10 mm diameter, 30 cm long artery phantom model, with four operators, we evaluated the success rate and crossing time in accessing 1.25 mm target channels, the accessible workspace, and the force delivered through each catheter. For clinical relevance, we evaluated the success rate and crossing time in crossing ex vivo chronic total occlusions. For the S and NS catheters, respectively, users successfully accessed 69 and 31% of the targets, 68 and 45% of the cross-sectional area, and could deliver 14.2 and 10.2 g of mean force. Using a NS catheter, users crossed 0.0 and 9.5% of the fixed and fresh lesions, respectively. Overall, we quantified the limitations of conventional catheters (navigation, reachable workspace, and pushability) for peripheral interventions; this can serve as a basis for comparison with other devices.

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Conflict of interest

Some of the co-authors are inventors of the CathPilot technology, that aims to address the limitations of conventional interventional devices characterized in this manuscript. Some of the co-authors are co-founders of Magellan Biomedical, Inc. a company that pursues the commercialization of the CathPilot technology.

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Authors and Affiliations

  1. Faculty of Engineering and Architectural Science, Toronto Metropolitan University (Formerly Ryerson University), Toronto, ON, Canada

    Yara Alawneh, James J. Zhou, Alykhan Sewani, Mohammadmahdi Tahmasebi & M. Ali Tavallaei

  2. Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital, Houston, TX, USA

    Trisha L. Roy

  3. Weill Medical College, Cornell University, New York, NY, USA

    Trisha L. Roy

  4. Department of Vascular Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

    Ahmed Kayssi & Andrew D. Dueck

  5. University of Toronto, Toronto, ON, Canada

    Ahmed Kayssi, Andrew D. Dueck & Graham A. Wright

  6. Schulich Heart Research Program, Sunnybrook Research Institute, Toronto, ON, Canada

    Graham A. Wright & M. Ali Tavallaei

  7. Department of ECBE, Toronto Metropolitan University, 350 Victoria St., Toronto, ON, M5B 2K3, Canada

    M. Ali Tavallaei

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  1. Yara Alawneh
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Correspondence to M. Ali Tavallaei.

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Alawneh, Y., Zhou, J.J., Sewani, A. et al. Experimental Protocol and Phantom Design and Development for Performance Characterization of Conventional Devices for Peripheral Vascular Interventions. Ann Biomed Eng 51, 1547–1557 (2023). https://doi.org/10.1007/s10439-023-03160-x

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