Tria Aldous, Dharma Anak, Spiegel Loren, Rodda Andrew E, Allada Asvini, Sluka Pavel, Menon Amarnath Sangeetha, Prabaharan Ethan, Wettesinghe Pulasthi V, Adams Justin W, Spanger Manfred, Dear Anthony E
Monash Institute of Medical Engineering, Monash University, Melbourne, Australia.
Eastern Health Clinical School, Monash University, Melbourne, Australia.
Cardiovasc Eng Technol. 2025 Apr;16(2):211-221. doi: 10.1007/s13239-024-00768-5. Epub 2024 Dec 20.
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.
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.
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.
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.
新型光血管成形术药物洗脱球囊导管（DEBc）Lumi-Solve的三腔迭代可能会受到导丝阴影（GWS）介导的球囊表面药物激活衰减的影响。本研究旨在设计并评估一种新型三腔原型，即Lumi-Solve-T，以解决这些问题。
使用MTT法评估导丝阴影（GWS）对血管平滑肌细胞（VSMC）增殖的影响。对新型三腔设计中的GWS进行了计算机模拟建模。计算机辅助设计（CAD）和有限元分析（FEA）有助于开发一种新型三腔导管。还对导管的初步和改进原型进行了3D打印，同时组装了新型光纤（FO）复合体，并对三腔装置Lumi-Solve T进行了体外评估。
在平行三腔FO:GW端口方向插入导丝后，7天后VSMC增殖的抑制作用显著降低，这证实了需要一种替代的三腔设计。计算机模拟分析确定了一种多纤维FO套管设计，可支持向血管成形术球囊表面均匀、径向且不间断地传输UV365nm光。FEA证实多纤维FO带设计提供了一种生成FO套管的实用方法，并促进了一种新型的集线器配置，该配置能够实现FO带向套管的过渡。3D打印原型展示了这种新颖设计的实用性。
Lumi-Solve FO需要一个专用的第三端口和管腔，以实现最佳的球囊表面光激活。一种新型的三腔设计Lumi-Solve-T，结合了带向套管的FO过渡和新颖的集线器设计，为当前设备的局限性提供了一个切实可行的解决方案。
