Electrospraying Nanoparticle Coatings on Stents

描述(由申请人提供)： 这个SBIR第一阶段项目将开发一种将药物和聚合物纳米颗粒复合涂层应用于冠状动脉支架表面的工艺，并将其商业化。在可植入的医疗设备上使用性能增强涂层，如冠状动脉支架，已经开始改变设备市场，并拥有改善人类健康的巨大潜力。药物洗脱支架在冠状动脉疾病的非手术治疗方面取得了突破性进展。它们代表了使用表面修饰的医疗设备进行特定部位治疗的新机会中的第一波。这些支架早期版本的商业经验表明，涂层技术和材料的改进极大地影响了临床性能。 我们的初步原理验证实验表明，电子纳米技术可用于将药物和生物活性物质的纳米颗粒应用于支架的小表面，以及可用于控制这些物质释放的生物兼容和可生物降解的聚合物。电喷雾有几个关键优点：它的效率是标准喷雾技术的几倍，并且能够控制沉积，施加复杂的(两相)颗粒，设计涂层，并对支架的内表面和外表面进行差异化涂层。这些特性不仅提供了改进支架涂层的可能性，还提供了将治疗性和生物相容性涂层应用于各种植入式医疗设备的可能性。 其具体目标是(1)利用Nanocopeia的电子探针系统制造新型支架涂层并表征其物理性能，以及(2)确定涂层支架候选的药物洗脱性能曲线。将评估涂层的质量、表面特性、质量和一致性、转移效率、内外表面的非连线沉积以及附着力。涂层的性能将通过在人工动脉系统中进行疲劳测试来评估。将建立包衣变化的药代动力学曲线。

DESCRIPTION (provided by applicant): This SBIR Phase I project will develop and commercialize a process for applying nanoparticle composite coatings with drugs and polymers to the surfaces of coronary artery stents. The use of performance-enhancing coatings on implantable medical devices, such as coronary artery stents, has begun to transform the device market and holds tremendous potential for improving human health. Drug-eluting stents have created a breakthrough improvement in the non-surgical treatment of coronary artery disease. They represent the first wave in a new opportunity to use surface-modified medical devices for site-specific therapy. Commercial experience gained with the early versions of these stents showed that improvements in coating technique and materials dramatically impact clinical performance. Our preliminary proof-of-principle experiments have shown that electronanospray can be used to apply nanoparticles of both drug and bioactive substances to the small surface of the stent, together with biocompatible and biodegradable polymers that can be used to control release of those substances. Electrospray offers several key advantages: it is several-fold more efficient than standard spray techniques and provides the ability to control deposition, apply complex (two phase) particles, engineer the coating layers, and differentially coat the inner and outer surfaces of the stent. These features provide the potential not only to improve coatings for stents, but also to apply therapeutic and biocompatible coatings to a wide variety of implantable medical devices. The specific aims are to (1) produce novel stent coatings using Nanocopoeia's electronanospray system and characterize their physical properties, and (2) determine the drug-elution performance profiles of coated stent candidates. Coatings will be assessed for coating mass, surface characteristics, quality and consistency, transfer efficiency, non-line-of-site deposition on inner as well as outer surfaces, and adherence qualities. Performance of the coatings will be assessed using fatigue testing in an artificial artery system. Pharmacokinetic profiles will be established for coating variations.