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

Autor: Tria A; Monash Institute of Medical Engineering, Monash University, Melbourne, Australia., Dharma A; Monash Institute of Medical Engineering, Monash University, Melbourne, Australia., Spiegel L; Monash Institute of Medical Engineering, Monash University, Melbourne, Australia., Rodda AE; Monash Institute of Medical Engineering, Monash University, Melbourne, Australia., Allada A; Eastern Health Clinical School, Monash University, Melbourne, Australia., Sluka P; Eastern Health Clinical School, Monash University, Melbourne, Australia., Menon AS; Eastern Health Clinical School, Monash University, Melbourne, Australia., Prabaharan E; Eastern Health Clinical School, Monash University, Melbourne, Australia., Wettesinghe PV; Eastern Health Clinical School, Monash University, Melbourne, Australia., Adams JW; Department of Anatomy and Developmental Biology, Monash University, Melbourne, Australia., Spanger M; Department of Radiology, Eastern Health, Box Hill Hospital, Melbourne, Australia., Dear AE; Eastern Health Clinical School, Monash University, Melbourne, Australia. Anthony.dear@monash.edu.; Department of Vascular Surgery, Eastern Health, Box Hill Hospital, Melbourne, Australia. Anthony.dear@monash.edu.
Jazyk: angličtina
Zdroj: Cardiovascular engineering and technology [Cardiovasc Eng Technol] 2024 Dec 20. Date of Electronic Publication: 2024 Dec 20.
DOI: 10.1007/s13239-024-00768-5
Abstrakt: 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.
Competing Interests: Declarations. Ethical Approval: For this type of study ethics approval is not required. Consent for Publication: For this type of study consent for publication is not required. Informed Consent: 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.
(© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)
Databáze: MEDLINE
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