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Design and Prototyping of a Novel Triple Lumen Photo-Angioplasty Device: Lumi-Solve-T

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Cardiovascular Engineering and Technology Aims and scope Submit manuscript

Abstract

Purpose

A triple lumen iteration of the novel photo-angioplasty drug eluting balloon catheter (DEBc) Lumi-Solve may be compromised by guidewire shadow (GWS)-mediated attenuation of balloon surface drug activation. The current study aimed to design and evaluate a novel triple lumen prototype, designated Lumi-Solve-T, to circumvent these issues.

Methods

Effects of guidewire shadowing (GWS) on vascular smooth muscle cell (VSMC) proliferation was evaluated using the MTT assay. In-silico modelling of GWS in the novel triple lumen design was conducted. Computer-aided design (CAD) and finite element analysis (FEA) contributed to development of a novel triple lumen catheter. 3D printing of rudimentary and refined prototypes of the catheter together with assembly of a novel fibre-optic (FO) complex and ex-vivo evaluation of the triple lumen device, Lumi-Solve T, was also performed.

Results

GW insertion in a parallel triple lumen FO: GW port orientation demonstrated significantly reduced inhibition of VSMC proliferation after 7 days confirming the need for an alternative triple lumen design. In-silico analysis identified a multi-fibre FO sleeve design supported uniform, radial and uninterrupted UV365nm light transmission to the angioplasty balloon surface. FEA confirmed a multi-fibre FO ribbon design afforded a practical method of FO sleeve generation and facilitated a novel hub configuration able to afford a FO ribbon to sleeve transition. 3D printed prototypes demonstrated the utility of the novel design.

Conclusions

A dedicated third port and lumen for the Lumi-Solve FO is required for optimal balloon surface photo-activation. A novel triple lumen design, Lumi-Solve-T, incorporating a ribbon to sleeve FO transition and novel hub design offers a realistic solution to current device limitations.

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Data Availability

All data generated or analyzed during this study are included in this manuscript and its supplementary information files.

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Acknowledgements

Abbott and Medtronic Australasia Pty Ltd: Provision of plain angioplasty balloons.

Funding

National Health and Medical Research Council (NH&MRC) Development Grant (2013899). NH&MRC had no role in the design of the study, collection, analysis, and interpretation of data or in writing the manuscript.

Author information

Authors and Affiliations

  1. Monash Institute of Medical Engineering, Monash University, Melbourne, Australia

    Aldous Tria, Anak Dharma, Loren Spiegel & Andrew E. Rodda

  2. Eastern Health Clinical School, Monash University, Melbourne, Australia

    Asvini Allada, Pavel Sluka, Amarnath Sangeetha Menon, Ethan Prabaharan, Pulasthi V. Wettesinghe & Anthony E. Dear

  3. Department of Anatomy and Developmental Biology, Monash University, Melbourne, Australia

    Justin W. Adams

  4. Department of Radiology, Eastern Health, Box Hill Hospital, Melbourne, Australia

    Manfred Spanger

  5. Department of Vascular Surgery, Eastern Health, Box Hill Hospital, Melbourne, Australia

    Anthony E. Dear

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  1. Aldous Tria
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Corresponding author

Correspondence to Anthony E. Dear.

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For this type of study ethics approval is not required.

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For this type of study informed consent is not required.

Conflict of Interest

Authors Aldous Tria, Anak Dharma, Loren Spiegel, Andrew E Rodda and Anthony E Dear are inventors on Australian Provisional Patent Specification 2024901285, filed on behalf of Monash University, which relates to work presented in this manuscript.

Additional information

Communicated by Igor Efimov, Ph.D.

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Tria, A., Dharma, A., Spiegel, L. et al. Design and Prototyping of a Novel Triple Lumen Photo-Angioplasty Device: Lumi-Solve-T. Cardiovasc Eng Tech 16, 211–221 (2025). https://doi.org/10.1007/s13239-024-00768-5

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  • DOI: https://doi.org/10.1007/s13239-024-00768-5

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