Aldous Tria, Anak Dharma, Loren Spiegel, Andrew E Rodda, Asvini Allada, Pavel Sluka, Amarnath Sangeetha Menon, Ethan Prabaharan, Pulasthi V Wettesinghe, Justin W Adams, Manfred Spanger, Anthony E Dear
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引用次数: 0
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.
期刊介绍：
Cardiovascular Engineering and Technology is a journal publishing the spectrum of basic to translational research in all aspects of cardiovascular physiology and medical treatment. It is the forum for academic and industrial investigators to disseminate research that utilizes engineering principles and methods to advance fundamental knowledge and technological solutions related to the cardiovascular system. Manuscripts spanning from subcellular to systems level topics are invited, including but not limited to implantable medical devices, hemodynamics and tissue biomechanics, functional imaging, surgical devices, electrophysiology, tissue engineering and regenerative medicine, diagnostic instruments, transport and delivery of biologics, and sensors. In addition to manuscripts describing the original publication of research, manuscripts reviewing developments in these topics or their state-of-art are also invited.
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