A Hybrid In Silico & In Vitro Approach To Study Coating Transfer In Drug-Coated Balloon Angioplasty

Drug-Coated Balloons (DCBs) have shown great promise as a minimally invasive therapeutic option for the treatment of stenotic arteries. However, recent animal studies have highlighted the challenge of limited coating transfer onto the arterial lumen short after the treatment. On this basis, studies have shown that the local transfer of the coating is highly influenced by the interaction between the balloon and the arterial endoluminal surface during balloon inflation. This sheds light on the significance of developing ex vivo strategies for the investigation of coating transfer efficiency. Therefore, this work aimed to propose a hybrid computational and experimental methodology to assess how the Contact Pressure (CP) and concurrent Balloon Stretch (BS) conditions may affect the coating delivery to the artery during the DCB inflation. On one hand, numerical simulations of a generic angioplasty balloon were implemented to study the CP at the balloon-artery interface and simultaneous BS. On the other hand, benchtop experiments of in-house and commercial DCBs were developed to study the effectiveness of local coating delivery after compression with pig aortic endothelium under the range of pressure and stretch values estimated from the numerical simulations. Coupling the effective or non-effective delivery of the coating under specific CP and BS conditions, the numerical simulations may predict the coating transfer maps under various procedure conditions. This approach is expected to provide significant insights for manufacturers of DCBs in terms of coating formulations and angioplasty platform devices.