TY - JOUR
T1 - Advances in Design and Development of Lumi-Solve
T2 - A Novel Drug-Eluting Photo-Angioplasty Device
AU - Sangeetha Menon, Amarnath
AU - Subasic de Azevedo, Igor
AU - Choong, Kylie
AU - Bhatnagar, Dhruv
AU - Wang, Chen
AU - Sluka, Pavel
AU - Chisholm, David R.
AU - Pasic, Paul
AU - Thissen, Helmut
AU - Sama, Gopal
AU - Robinson, Andrea
AU - Rodda, Andrew
AU - Tria, Aldous
AU - Spiegel, Loren
AU - Dharma, Anak
AU - Kaipananickal, Harikrishnan
AU - Okabe, Jun
AU - El-Osta, Assam
AU - Mountford, Simon
AU - Thompson, Philip
AU - Dear, Anthony E.
N1 - Funding Information:
Open Access funding enabled and organized by CAUL and its Member Institutions. The study was supported by a research grant from the Eastern Health Foundation (EHF), (Robert C Bulley Surgical Research Grant) and an National Health and Medical Research Council (NH&MRC) Development Grant (2013899). The EHF and NH&MRC had no role in the design of the study, collection, analysis, and interpretation of data or in writing the manuscript.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/8
Y1 - 2023/8
N2 - Purpose: The Lumi-Solve photo-angioplasty drug eluting balloon catheter (DEBc) may afford safety advantages over current DEBc. Lumi-Solve utilises the guidewire (GW) port and lumen to deliver fibre-optic UV365nm light to the angioplasty balloon which may be problematic. We explore and evaluate alternative Lumi-Solve design options to circumvent fibre-optic use of the GW port and lumen which may enhance efficacy and clinical utility. Methods: Effects of guidewire shadowing (GWS) on visible and UV365nm light transmission were evaluated and modelled in-silico. To evaluate the effect of a dedicated intra-balloon fibre-optic port, modified angioplasty balloons and sections of translucent polyethylene terephthalate (PET) GW port tubing were utilised. Investigation of the effect of GWS on chemical and biological photo-activation of balloon surface drug was performed utilising LCMS analysis and inhibition of histone deacetylase activity (HDACi) was measured in human umbilical vein endothelial cells (HUVEC). Results: Parallel fibre-optic and GW port configurations generated a GWS of approximately 18.0% of the evaluable balloon surface area and attenuated both visible and UV light intensity by 20.0–25.0% and reduced chemical photo-activation of balloon surface drug and HDACi by at least 40–45%. Alternative fibre-optic port configurations including a spiral design significantly mitigated GWS effects on UV light transmission. Conclusions: To avoid use of the GW port and its associated complications a dedicated third port and lumen for the Lumi-Solve fibre-optic may be required. To maximize balloon surface chemical and biological photo-activation, non-parallel, intra-balloon, fibre-optic lumen trajectories, including a spiral design may be useful.
AB - Purpose: The Lumi-Solve photo-angioplasty drug eluting balloon catheter (DEBc) may afford safety advantages over current DEBc. Lumi-Solve utilises the guidewire (GW) port and lumen to deliver fibre-optic UV365nm light to the angioplasty balloon which may be problematic. We explore and evaluate alternative Lumi-Solve design options to circumvent fibre-optic use of the GW port and lumen which may enhance efficacy and clinical utility. Methods: Effects of guidewire shadowing (GWS) on visible and UV365nm light transmission were evaluated and modelled in-silico. To evaluate the effect of a dedicated intra-balloon fibre-optic port, modified angioplasty balloons and sections of translucent polyethylene terephthalate (PET) GW port tubing were utilised. Investigation of the effect of GWS on chemical and biological photo-activation of balloon surface drug was performed utilising LCMS analysis and inhibition of histone deacetylase activity (HDACi) was measured in human umbilical vein endothelial cells (HUVEC). Results: Parallel fibre-optic and GW port configurations generated a GWS of approximately 18.0% of the evaluable balloon surface area and attenuated both visible and UV light intensity by 20.0–25.0% and reduced chemical photo-activation of balloon surface drug and HDACi by at least 40–45%. Alternative fibre-optic port configurations including a spiral design significantly mitigated GWS effects on UV light transmission. Conclusions: To avoid use of the GW port and its associated complications a dedicated third port and lumen for the Lumi-Solve fibre-optic may be required. To maximize balloon surface chemical and biological photo-activation, non-parallel, intra-balloon, fibre-optic lumen trajectories, including a spiral design may be useful.
KW - Drug eluting balloon catheter
KW - Fibre-optic
KW - Guide wire shadow
KW - Neointimal hyperplasia
KW - Photo-activation
UR - https://www.scopus.com/pages/publications/85159144355
U2 - 10.1007/s13239-023-00668-0
DO - 10.1007/s13239-023-00668-0
M3 - Article
C2 - 37165253
AN - SCOPUS:85159144355
SN - 1869-408X
VL - 14
SP - 605
EP - 614
JO - Cardiovascular Engineering and Technology
JF - Cardiovascular Engineering and Technology
ER -