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Innovative Vascular Balloon Coating Strategies For Below-the-knee Peripheral Arterial Disease
Antonio Martino, MS, Minh Q. Duong, BS, Blake C. Fallon, BS, Vy C. Dang, MD, Richard C. Willson, PhD, Carly S. Filgueira, PhD, Maham Rahimi, MD, PhD.
Houston Methodist Research Institute, Houston, TX, USA.
INTRODUCTION: Peripheral arterial disease (PAD) affects over 200 million individuals worldwide. Current endovascular treatments, including stenting, balloon angioplasty, and drug-eluting technologies, aim to mitigate PAD but often require re-intervention within six months due to vessel dissection, acute thrombosis, occlusion, and restenosis. While multilayer coated balloons present a promising solution to some of these issues, commercially available balloons face challenges, such as lack of customization as they are preloaded with fixed amounts and types of drugs. These balloons may not address the complex nature of PAD, where multiple therapeutic agents or tailored release profiles might be necessary. Therefore, the high prevalence and serious complications associated with PAD, underscore the need for more effective and adaptable therapeutic strategies.
METHODS: Paclitaxel and/or Blue #1 dye was incorporated into hydrogel formulations consisting of sodium alginate, calcium carbonate, and D-(+)-gluconic acid δ-lactone at varying concentrations. The drug-loaded hydrogel was used to coat a peripheral vascular balloon. To evaluate balloon performance, it underwent inflation/deflation cycles and macro and microscopic examination to assess material integrity and structural stability. This comprehensive approach ensures successful coating loading and release (UV-Vis measurements), evaluation of mechanical properties (Rheometry), and performance characterization.
Hydrogel formulation created uniform coatings with predetermined thickness, supported multilayered coatings (Fig 1. A,B), and facilitated encapsulation of various agents. Release studies were conducted for up to 120 h (Fig. 1C) and the addition of PVA significantly enhanced mechanical properties, increasing the viscoelastic transition from 27.9% to 264.3% (Fig. 1D).
CONCLUSIONS: Drug release showed an initial burst followed by sustained release for up to 120 hours, with distinct release patterns from each layer. Addition of PVA to the coating formulation significantly enhanced mechanical properties, increasing the viscoelastic transition. Future improvements will focus on imaging the hydrogel coating's surface and cross-section for morphology and structure, assessing coating degradation and swelling during release, testing biocompatibility, and optimizing the formulation for improved mechanical properties and customizable release patterns. Additionally, the formulation's performance will be evaluated in a mock vessel environment to assess adhesion efficiency, drug loss, and washout rates, along with testing the encapsulation and efficiency of more agents.
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