Ocular Biocompatibility and Structural Integrity of Micro- and Nanostructured Poly(caprolactone) Films
Ocular Biocompatibility and Structural Integrity of Micro- and Nanostructured Poly(caprolactone) Films
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DOI：
10.1089/jop.2012.0152
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发表时间：
2013-03-01
影响因子：
2.3
通讯作者：
Desai, Tejal A.
中科院分区：
文献类型：
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作者：
Bernards, Daniel A.;Bhisitkul, Robert B.;Desai, Tejal A.
识别眼内耐受性良好的生物材料对于开发新的眼部给药装置和植入物非常重要，而微/纳米工程装置在生物医学治疗中的应用是基于非常小的功能设计元素在目标器官或组织内的长期保存。这项研究评估了注入或植入兔眼的微米和纳米结构生物聚合物薄膜的眼耐受性和持久性。将结构聚己内酯(PCL)薄膜放置在成年兔眼内进行存活研究，并进行为期6个月的连续眼科检查。通过组织学研究评价膜的形态异常和装置/组织反应，并用扫描电子显微镜(SEM)确定膜的结构完整性。结构PCL薄膜(20到40微米厚)是根据设计规格构造的，具有50微米的线性微槽或直径类似于30 nm的纳米孔阵列。在长达9个月的眼睛停留后，从眼睛取回的设备的扫描电子显微镜显示微结构和纳米结构特征保持不变。在超过6个月的眼安全性评估中，18只植入眼的系列检查显示没有慢性炎症、白内障形成或视网膜毒性的证据。术后1周内67%的眼出现炎症反应，1眼出现持续性角膜水肿。组织学检查未见眼部炎症或眼组织形态异常。未见薄膜/组织反应，如细胞反应、纤维化或表面生物沉积。微结构和纳米结构的PCL薄膜具有可接受的眼睛耐受性，并在驻留在眼睛内的同时保持了设计特征的结构完整性。薄膜微纳米结构的PCL有望成为眼内治疗的一种可行的生物材料。
The identification of biomaterials that are well tolerated in the eye is important for the development of new ocular drug delivery devices and implants, and the application of micro- and nanoengineered devices to biomedical treatments is predicated on the long-term preservation within the target organ or tissue of the very small functional design elements. This study assesses the ocular tolerance and durability of micro- and nanostructured biopolymer thin films injected or implanted into the rabbit eye. Structured poly(caprolactone) (PCL) thin films were placed in adult rabbit eyes for survival studies, with serial ophthalmic examinations over 6 months. Morphologic abnormalities and device/tissue reactions were evaluated by histologic studies, and scanning electron microscopy (SEM) of films was used to determine the structural integrity. Structured PCL thin films (20- to 40-mu m thick) were constructed to design specifications with 50-mu m linear microgrooves or arrays of nanopores with similar to 30-nm diameters. After up to 9 months of ocular residency, SEM on devices retrieved from the eye showed preservation of micro- and nanostructural features. In ocular safety evaluations carried out over 6 months, serial examinations in 18 implanted eyes showed no evidence of chronic inflammation, cataractogenesis, or retinal toxicity. Postoperative ocular inflammation was seen in 67% of eyes for 1 week, and persistent corneal edema occurred in 1 eye. Histology revealed no ocular inflammation or morphologic abnormalities of ocular tissues. Thin-film/tissue responses such as cellular reaction, fibrosis, or surface biodeposits were not seen. Micro- and nanostructured PCL thin films exhibited acceptable ocular tolerance and maintained the structural integrity of design features while residing in the eye. Thin-film micro- and nanostructured PCL appears to be a feasible biomaterial for intraocular therapeutic applications.