CN108210159B - 眼表治疗装置及其制备方法 - Google Patents
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Abstract
本发明提供了一种眼表治疗装置，包括：角膜固定环和固定在所述角膜固定环上的壳聚糖静电纺丝膜；所述壳聚糖静电纺丝膜设置有与眼表相配合的弧度。本发明还提供了一种眼表治疗装置的制备方法。本发明的眼表治疗装置使用时，角膜固定环与角膜紧密接触，从而使壳聚糖静电纺丝膜紧密贴附于眼表，从而免于缝合二次损伤角膜。壳聚糖具有良好的抑菌、抗炎、透气、透氧等性能，不会对眼表产生刺激，舒适性好，保湿效果好，能够对抗干眼等疾病对眼表造成的损伤，维持眼表微环境稳态。同时，壳聚糖静电纺丝膜具有纳米空间结构，能够吸附滴眼液、干细胞悬液等药物，随着壳聚糖的降解，药物实现缓慢释放，从而减少给药次数。
Description
技术领域
本发明涉及眼睛保健与治疗技术领域，尤其涉及一种眼表治疗装置及其制备方法。
背景技术
角膜位于眼球的最前部，长期暴露于空气中，角膜是由：上皮细胞层、前弹力层、基质层、后弹力层和内皮细胞层组成。角膜表面覆盖一层0.02-0.05毫微米的泪膜，泪膜主要由：黏蛋白层、水液层和脂质层组成，其主要的功能为保护角膜上皮处于一个良好的微环境中。泪膜与角膜共同构成了人眼第一道屈光系统，泪膜与角膜的损伤都会构成人眼的不适甚至影响视力。目前空气环境恶化、电子产品层出不穷、角膜接触的频繁佩戴等因素都会对眼表造成不同程度的损伤，如泪膜缺损、角膜炎、干眼、角膜上皮结膜化、角膜新生血管、角膜上皮糜烂等等。
目前临床针对角膜损伤疾病主要治疗方法有：1、药物治疗，干眼、角膜炎、结膜炎等疾病一般通过眼药水进行治疗。药物治疗可以较好的缓解眼部炎症等疾病，但是由于角膜长期暴露于空气中与泪膜的保护，药物角膜停留时间较短，频繁给药对角膜上皮细胞损伤较为严重；2、羊膜覆盖修复角膜损伤，针对于较严重的角膜损伤进行羊膜覆盖，如角膜溃疡、胬肉等疾病需要进行羊膜孵育治疗。羊膜作为胚胎最内层与人眼结膜组织结构相似的异体来源组织敷料，富含有大量不同的胶原与成纤维生长因子、干细胞生长因子等能够促进角膜的上皮的修复。但是由于羊膜为同种异体来源，生物来源有限。新鲜羊膜对眼表疾病的疗效较好，但是新鲜羊膜病菌等检测大多由医院自行完成，标准难以确定具有潜在传播疾病的风险，同时新鲜羊膜处理、保持、运输不便，不利于广泛应用。生物冻干羊膜疗效有限，同时来源有限，处理步骤繁琐，具有潜在的疾病传播风险。另外，由于生物羊膜来源个体不同，其疗效差异较大，不同批次的羊膜对患者的治疗效果相差较大，标准难于统一。
发明内容
本发明的目的在于提供一种眼表治疗装置及其制备方法，本发明提供的眼表治疗装置能够很好的与角膜接触，无需缝合即可实现保湿或药物缓释等功能，不会二次损伤角膜。
本发明提供了一种眼表治疗装置，包括：角膜固定环和固定在所述角膜固定环上的壳聚糖静电纺丝膜；所述壳聚糖静电纺丝膜设置有与眼表相配合的弧度。
本发明提供的眼表治疗装置包括角膜固定环，所述角膜固定环是可以与角膜紧密接触的环状装置，可以通过去除角膜接触镜中间部分得到。在本发明中，所述角膜固定环的材质为硅水凝胶、醋酸丁酸纤维素和聚甲基丙烯酸羟乙酯中的一种或多种。
本发明提供的眼表治疗装置包括固定在所述角膜固定环上的壳聚糖静电纺丝膜，所述壳聚糖静电纺丝膜设置有与眼表相配合的弧度。
壳聚糖(chitosan)又称脱乙酰甲壳素，是由自然界广泛存在的几丁质(chitin)经过脱乙酰作用得到的，化学名称为聚葡萄糖胺(1-4)-2-氨基-B-D葡萄糖。这种天然高分子的生物官能性和相容性、血液相容性、安全性、微生物降解性等优良性能被各行各业广泛关注，在医药、食品、化工、化妆品、水处理、金属提取及回收、生化和生物医学工程等诸多领域的应用研究取得了重大进展。静电纺丝技术(electrostatic spinning，ES)是一种简单易行的新型组织工程多孔支架制备方法，静电纺丝材料具有独特的微观结构和适当的力学性能，为生物组织工程支架、缓释材料等的研发提供理想的平台。目前人们利静电纺丝技术成功的合成了人造皮肤、人造血管等生物材料，利用PLLA、壳聚糖、胶原、PLGA等生物材料制备外伤辅料止血、皮肤再生、定向药物缓释等功能的医用产品。壳聚糖基静电纺丝复合伤口辅料是利用不同的静电纺丝方法制备层次清晰的复合壳聚糖静电纺丝膜，纺丝膜具有持久的、广谱性的抗菌效果，具有良好的缓释抗菌和舒适性能，生物相容性好，并带有一定的植物芳香味，可以作为医用材料、纺织服装材料、抗菌材料等广泛应用于纺织工业、医药保健、生物医学等领域。
在本发明中，所述壳聚糖静电纺丝膜按照以下方法制备：
壳聚糖和明胶经过静电纺丝成膜后与戊二醛交联。
本发明以壳聚糖和明胶为原料制备静电纺丝膜，其中，所述壳聚糖和明胶的质量比为6～8:2～4，优选为7:3。所述壳聚糖的数均分子量为50w～150w。
本发明首先将壳聚糖和明胶溶解于三氟乙酸和二氯甲烷的混合溶液中，得到纺丝液，所述纺丝液的固含量为3％～5％。
采用KH-1103型静电纺丝设备对得到的纺丝液进行静电纺丝成膜，静电纺丝的参数为：注射器前端的针头直径为0.7mm；静电纺丝机正负电极之间的距离为7cm～12cm，正负电压差子为20kV～35kV，接收器的转速为100转/min～120转/min，静电纺丝针头的平移速度为0.2mm/s～0.5mm/s，纺丝空间温度为70℃～90℃，湿度为40RH～60RH。连续纺丝120min～180min即可获得纺丝膜。
获得纺丝膜后，将其与戊二醛交联，具体过程如下：
将所述纺丝膜与戊二醛溶液混合，在密闭、干燥的环境中进行交联，其中，戊二醛溶液的质量浓度为10％～25％，交联时间为1h～3h，交联温度为室温。交联完毕后，70℃～90℃真空条件下干燥2h～3h，然后采用蒸馏水反复清洗去掉多余的杂质，70～100℃真空干燥，得到壳聚糖静电纺丝膜。
将壳聚糖静电纺丝膜裁剪成15mm大小直径的薄片，利用压膜机将其制备成与眼表相配合的弧度的膜片，紫外灯照射24小时，消毒备用。
在本发明中，所述壳聚糖静电纺丝膜的厚度可以为20μm～50μm。
本发明提供的眼表治疗系统中，具有与眼表相配合弧度的壳聚糖静电纺丝膜固定在角膜固定环上，角膜固定环与角膜紧密接触，从而使得壳聚糖静电纺丝膜紧密贴附于眼表，从而免于缝合二次损伤角膜。在本发明中，所述壳聚糖静电纺丝膜通过生物胶固定在所述角膜固定环上，所述生物胶选自盛康医用胶、福爱乐或康派特医用胶。
在本发明提供的眼表治疗系统中，所述壳聚糖静电纺丝膜还可以负载有药物，如滴眼液、干细胞悬液等，通过壳聚糖静电纺丝膜实现药物在眼表的缓释，提高治疗效果。
本发明还提供了一种眼表治疗装置的制备方法，包括：
a)将壳聚糖静电纺丝膜加工成具有与眼表相配合的弧度的膜片；
去除角膜接触镜中间部分，得到角膜固定环；
b)将所述膜片固定于角膜固定环中，得到眼表治疗装置。
将壳聚糖静电纺丝膜加工成具有与眼表相配合的弧度的膜片的过程如上所述，角膜固定环的制备过程如下：
本发明利用角膜接触镜制备工艺制备壳聚糖静电纺丝膜眼表固定环。首先设计相应镜片成型的数据，电脑根据该数据控制数控机床，切割出完整接触镜内部弧度，再利用超细研磨膏抛光，使得眼表佩戴舒适。再将镜片蘸取一定量的蜡液，利用数控机床制备镜片外部的形态，利用超细研磨膏抛光。最后将制备好的角膜接触镜利用铣床去掉中间10mm范围内的组织，得到具有角膜固定环。
将角膜固定环放入半圆形模具中，固定环卡在模具的上半部，将生物胶(胜康医用胶、福爱乐、康派特医用胶等)涂抹于固定环的内表面，然后迅速将壳聚糖静电纺丝膜片放入到模具中，将壳聚糖静电纺丝膜片边缘与角膜固定环的边缘结合，待粘合紧密后，将得到的眼表治疗装置浸泡于保存液中。
本发明提供的眼表治疗装置包括角膜固定环和固定在所述角膜固定环上的壳聚糖静电纺丝膜；所述壳聚糖静电纺丝膜设置有与眼表相配合的弧度。使用时，角膜固定环与角膜紧密接触，从而使壳聚糖静电纺丝膜紧密贴附于眼表，从而免于缝合二次损伤角膜。壳聚糖具有良好的抑菌、抗炎、透气、透氧等性能，不会对眼表产生刺激，舒适性好，保湿效果好，能够对抗干眼等疾病对眼表造成的损伤，维持眼表微环境稳态。同时，壳聚糖静电纺丝膜具有纳米空间结构，能够吸附滴眼液、干细胞悬液等药物，随着壳聚糖的降解，药物实现缓慢释放，从而减少给药次数。
附图说明
图1是本发明实施例提供的眼表治疗装置的结构示意图；
图2是本发明实施例提供的眼表治疗装置中角膜固定环的结构示意图；
图3是本发明实施例提供的眼表治疗装置中壳聚糖静电纺丝膜的结构示意图。
具体实施方式
为了进一步说明本发明，下面结合实施例对本发明提供的眼表治疗装置及其制备方法进行详细地描述，但不能将它们理解为对本发明保护范围的限定。
实施例1
参见图1、图2和图3，图1是本发明实施例提供的眼表治疗装置的结构示意图，其中，1是角膜固定环，2是固定在角膜固定环上的壳聚糖静电纺丝膜；图2是本发明实施例提供的眼表治疗装置中角膜固定环的结构示意图，图3是本发明实施例提供的眼表治疗装置中壳聚糖静电纺丝膜的结构示意图。
本实施例提供的眼表治疗装置包括角膜固定环1和固定在角膜固定环1上的壳聚糖静电纺丝膜2，壳聚糖静电纺丝膜2设置有与眼表相配合的弧度。该眼表治疗装置制备过程如下：
(1)壳聚糖静电纺丝膜的制备
数均分子量为100万的壳聚糖和明胶按照质量比7:3溶解于质量比为7:3的三氟乙酸与二氯甲烷的混合溶液中，配置成4wt％的纺丝液。
采用KH-1103型静电纺丝设备对上述纺丝液进行纺丝，纺丝液装填于注射器中，注射器前端的针头直径为0.7mm，将壳聚糖注射器的针头连接静电纺丝机正电极，滚筒状接收器静电纺丝机负电极，调节静电纺丝机正负电极之间的距离为10cm，正负电压差子在30kv，接收器的转速设定为110转/min，壳聚糖静电纺丝针头的平移速度为0.3mm/s，纺丝空间温度为80℃，湿度为50RH，连续纺丝160min，获得厚度为30μm的膜；
将制备好的静电纺丝膜与质量浓度为20wt％的戊二醛水溶液置于密闭的干燥器皿中，利用戊二醛水溶液自然挥发蒸汽进行壳聚糖静电纺丝膜交联2h，80℃真空条件下干燥2.5h，蒸馏水反复清洗去掉多余的杂质，80℃真空干燥。真空干燥后将壳聚糖静电纺丝膜裁剪成15mm大小直径的薄片，采用压膜机将其制备成具有与眼表配合的弧度的膜片，紫外灯照射24小时，消毒备用，其结构如图3所示。
(2)角膜固定环的制备
利用硅水凝胶、醋酸丁酸纤维素RGP和聚甲基丙烯酸羟乙酯作为原材料，利用角膜接触镜制备工艺，制备角膜固定环。首先设计相应镜片成型的数据，电脑根据该数据控制数控机床切割出完整接触镜内部弧度，再利用超细研磨膏抛光，使得眼表佩戴舒适。再将镜片蘸取一定量的蜡液，利用数控机床制备镜片外部的形态，利用超细研磨膏抛光。最后将制备好的角膜接触镜利用铣床去掉中间10mm范围内的组织，得到具有接触完好的角膜固定环，其结构如图2所示。
(3)壳聚糖静电纺丝膜与角膜固定环相互结合
将角膜固定环放入半圆形模具中，角膜固定环卡在模具的上半部，将胜康医用胶小心的涂抹于角膜固定环的内表面，迅速将壳聚糖静电纺丝膜放入到模具中，将壳聚糖静电纺丝膜边缘与角膜固定环的内表面结合，利用生物胶粘合角膜固定环与壳聚糖静电纺丝膜，制备得到眼表治疗装置，待角膜固定环与壳聚糖静电纺丝膜粘合紧密后，将所述眼表治疗装置浸泡于保存液中。
本发明提供的眼表治疗装置按照以下方法使用：
将角膜固定环与角膜紧密接触，从而使得壳聚糖静电纺丝膜紧密贴附于眼表，壳聚糖具有抑菌、抗炎、透气、透氧等性能，不会对眼表产生刺激，舒适性好，保湿效果好，能够对抗干眼等疾病对眼表造成的损伤，维持眼表微环境稳态。
实施例2
与实施例1的差别在于在壳聚糖静电纺丝膜上负载药物，例如滴眼液或者干细胞悬液，通过壳聚糖的降解实现药物的缓释，减少给药次数。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (4)
1.一种眼表治疗装置，其特征在于，包括：角膜固定环和固定在所述角膜固定环上的厚度为20μm～50μm、直径为15mm的壳聚糖静电纺丝膜；
所述壳聚糖静电纺丝膜的边缘通过生物胶固定在角膜固定环的内表面；
所述壳聚糖静电纺丝膜设置有与眼表相配合的弧度；
所述壳聚糖静电纺丝膜按照以下方法制备：
壳聚糖和明胶经过静电纺丝成膜后与质量浓度为10％～25％的戊二醛交联，交联时间为1h～3h，交联温度为室温；交联完毕后，70℃～90℃真空条件下干燥2h～3h，然后采用蒸馏水清洗，70℃～100℃真空干燥得到壳聚糖静电纺丝膜；所述壳聚糖的数均分子量为50万～150万；所述壳聚糖和明胶的质量比为7～8:3～4；
所述角膜固定环按照以下方法制备：
去除角膜接触镜中间10mm范围内的组织，得到角膜固定环。
2.根据权利要求1所述的眼表治疗装置，其特征在于，所述角膜固定环的材质为硅水凝胶、醋酸丁酸纤维素和聚甲基丙烯酸羟乙酯中的一种或多种。
3.根据权利要求1所述的眼表治疗装置，其特征在于，所述生物胶选自盛康医用胶、福爱乐或康派特医用胶。
4.一种眼表治疗装置的制备方法，包括：
a)将厚度为20μm～50μm、直径为15mm的壳聚糖静电纺丝膜加工成具有与眼表相配合的弧度的膜片；
去除角膜接触镜中间10mm范围内的组织，得到角膜固定环；
所述壳聚糖静电纺丝膜按照以下方法制备：
壳聚糖和明胶经过静电纺丝成膜后与质量浓度为10％～25％的戊二醛交联，交联时间为1h～3h，交联温度为室温；交联完毕后，70℃～90℃真空条件下干燥2h～3h，然后采用蒸馏水清洗，70℃～100℃真空干燥得到壳聚糖静电纺丝膜；
所述壳聚糖的数均分子量为50万～150万；
所述壳聚糖和明胶的质量比为7～8:3～4；
b)将所述膜片的边缘通过生物胶固定于角膜固定环的内表面中，得到眼表治疗装置。
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