After surgical procedures such as coronary/peripheral bypass grafting or endarterectomy for the treatment of organ ischemia derived from atherosclerosis, intimal hyperplasia (IH) which leads to restenosis or occlusion at the site of graft anastomosis frequently occurs. In order to inhibit IH caused by abnormal growth of smooth muscle cells (SMCs) in tunica media, various perivascular drug delivery devices are reported for delivery of anti-proliferation drugs into vascular tissue. However, there still remain conflicting requirements such as local and unidirectional delivery vs device porosity, and conformal tight device installation vs pulsatile expansion and constriction of blood vessels. In this study, a biodegradable microneedle (MN) array is developed on a flexible woven surgical mesh using a transfer molding method. Mechanical properties of ‘wrappable’ MN meshes are investigated and compared to the properties of blood vessels. Ex vivo and in vivo animal studies demonstrate enhanced drug delivery efficiency, efficacy for IH reduction, and safety of MN mesh. In particular, MN mesh showed significantly reduced neointiamal formation (11.1%) compared to other competitive groups (23.7 and 22.2%) after 4-week in vivo animal study. Additionally, wrappable MN meshes effectively suppressed side effects such as IH due to mechanical constriction, loss of toxic drug to the surroundings, and cell death that were frequently observed with other previous perivascular drug delivery devices.

在进行诸如冠状动脉/外周动脉旁路移植术或动脉内膜切除术等外科手术以治疗源自动脉粥样硬化的器官缺血后，经常发生内膜增生（IH），该内膜增生导致移植物吻合处的再狭窄或闭塞。为了抑制由中膜中的平滑肌细胞（SMC）异常生长引起的IH ，已报道了各种血管周围药物递送装置，用于将抗增殖药物递送到血管组织中。但是，仍然存在相互冲突的要求，例如本地和单向交付与设备孔隙率，保形的紧密设备安装与设备孔隙率搏动性血管扩张和收缩。在这项研究中，可生物降解的微针（MN）阵列是使用传递模塑方法在柔性编织外科网上开发的。研究了“可包裹的” MN网格的机械性能，并将其与血管的性能进行了比较。体外和体内动物研究表明，药物的递送效率，降低IH的功效以及MN筛网的安全性均得到提高。特别是，与其他竞争组（23.7和22.2％）相比，在体内放置4周后，MN网片显示出新内膜形成的明显减少（11.1％）动物研究。另外，可包裹的MN网格有效地抑制了诸如机械收缩，有毒药物向周围环境损失以及细胞死亡等副作用，这些副作用是在其他先前的血管周围药物输送装置中经常观察到的。