CN111565675A - 提高角膜植入物粘附性的处理 - Google Patents

提高角膜植入物粘附性的处理 Download PDF

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CN111565675A
CN111565675A CN201980007520.6A CN201980007520A CN111565675A CN 111565675 A CN111565675 A CN 111565675A CN 201980007520 A CN201980007520 A CN 201980007520A CN 111565675 A CN111565675 A CN 111565675A
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奥弗尔·达夫纳
纳胡姆·费列埃拉
德米特里·杜布森
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Abstract

本发明描述一种通过在眼植入物(10)上形成植入物粘附层(14)来提高所述眼植入物(10)与角膜组织的粘附的方法，所述植入物粘附层(14)比所述植入物(10)的其余部分具有更大的粘附强度。这通过在所述植入物(10)的前表面上进行化学和/或物理改变使得所述植入物粘附层(14)比所述植入物(10)的其余部分更具粘附性来实现。

Description

提高角膜植入物粘附性的处理
技术领域
本发明总的来说涉及用于例如治疗角膜水分过多、水肿的角膜植入物，并且具体来说涉及在所述植入物和/或角膜组织上产生粘附层，以提高所述植入物与所述角膜组织的粘附。
背景技术
Daphna的美国专利8109997和8500803描述了使用粘合剂将疏水的假内皮植入物粘合到角膜的邻近房水的后部。所述植入物充当能够使角膜脱水的防水层，并且可用于治疗角膜水肿。
在不使用缝合线或机械紧固件的情况下将植入物与角膜组织粘附是一种挑战。所述粘附材料必须与眼环境相容，并且还必须长时间提供良好的粘附而不会降低眼的视觉品质。
发明内容
正如在下文中更详细描述的，本发明涉及一种方法，该方法处理表面以在角膜植入物和/或角膜组织上产生粘附层，提高所述植入物与所述角膜组织的粘附。
本发明使用激光处理、化学处理、热处理、等离子体处理、电晕处理、火焰处理或其他处理来制备所述植入物和/或角膜组织的表面，以产生薄的粘附层或具有粘附性大于所述植入物的其余部分的层，或者在处理角膜的层的情况下具有粘附性大于所述角膜的其余部分的层。
根据本发明的实施方案，提供了一种提高所述眼植入物与角膜组织的粘附的方法，该方法通过在眼植入物上形成植入物粘附层(所述植入物粘附层比所述植入物的其余部分具有更大的粘附强度)或通过在角膜组织的后部的后表面上形成角膜粘附层(所述角膜粘附层比所述角膜组织的其余部分具有更大的粘附强度)来实现。
附图说明
从下面的详细描述并结合附图，本发明将被更充分地理解和认识，在所述附图中：
图1和2是根据本发明的实施方案构造和手术的角膜植入物分别在冠状和横断面上的简化示意图；并且
图3A和3B是所述角膜植入物的简化前视图和侧视图。
具体实施方式
现在参考图1和图2，它们示出了根据本发明的实施方案构造和手术的角膜植入物10。植入物10可以是疏水的假内皮植入物，其可用于在DSEK(后弹力层剥离内皮角膜移植术)或DMEK(后弹力层膜内皮角膜移植术)手术中代替来自于捐献者的植入物。植入物10充当能够使角膜脱水的防水层。
植入物10可以由澄清透明的生物相容性材料构造而成，所述材料例如但不限于聚甲基丙烯酸甲酯(PMMA)、硅酮、硅橡胶、胶原蛋白、透明质酸(包括其钠盐、钾盐和其他盐)、水凝胶例如丙烯酸系或甲基丙烯酸系水凝胶如甲基丙烯酸羟乙酯或甲基丙烯酸共聚物/部分水解的聚甲基丙烯酸-2-羟乙酯(被称为PolyHEMA)、聚砜、热不稳定性材料和其他相对硬或相对软且柔性的生物惰性的光学材料，或此类材料的任何组合，例如被包封在聚合物中的凝胶。因此，植入物10可以是例如刚性、半刚性或可折叠的。
正如在图3A和图3B中看到的，角膜植入物10是圆顶形的，具有前表面13和后表面15(前和后被定义为对应于眼的前-后轴11)。可以在前表面13或后表面15上形成袋、凹陷或突起17，以帮助植入物10的正确定位。
在将植入物10粘合到角膜的后部之前，如在PLK(后板层角膜移植术)或DSEK中那样，可以从患者的眼的角膜除去基质组织的薄的后部或小扁豆体(连同后弹力层的膜和附着的内皮细胞)。或者，如在后弹力层剥离内皮角膜移植术中那样，仅仅除去后弹力层的膜和内皮细胞。或者，可以将所述植入物粘附到角膜的内皮而没有任何后表面剥离。
在一个实施方案中，利用在植入物10的前表面上形成的植入物粘附层14，将植入物10粘合到角膜12的后部。在另一个实施方案中，利用在角膜12的后部的后表面上形成的角膜粘附层16，将植入物10粘合到角膜12的后部。在又一个实施方案中，利用在植入物10的前表面上形成的粘附层14并利用在角膜12的后部的后表面上形成的粘附层16，将植入物10粘合到角膜12的后部。
不受任何特定理论限制，粘附是不同表面彼此粘贴的趋势。粘附可以通过粘附功(J/m)来度量，其是分离1平方米结合材料所需的能量；或者它可以通过剥离力(N/m)来度量，其是撕下1米宽的材料条所需的力。注意，粘附功不依赖于表面张力并且与其不成比例。表面张力在两种结合材料的粘附中仅发挥次要作用，但表面张力和润湿对引发粘附来说可能是重要的。
存在不同的粘附力：
1.机械粘附：胶黏剂流入基材的开口或孔眼中，并与基材的微孔互锁。
2.静电粘附：当两种材料发生接触并交换电子时会形成双电层。这在所述两种材料之间产生吸引性静电力或库仑力。
3.特异性粘附：两个粘附表面的原子/分子形成特异性键例如氢键。
4.化学粘附：两种粘附材料的原子/分子形成可以是离子特征或共价特征的化学键。
可以如下制造粘附层14：在植入物10的前表面上进行化学和/或物理改变，以使粘附层14比植入物10的其余部分具有更高粘附性，例如在粘附层14与角膜组织之间产生静电粘附、特异性粘附或化学粘附。同样地，可以如下制造粘附层16：在角膜12的后部的后表面上进行化学和/或物理改变，以使粘附层16比角膜12的其余部分具有更高的粘附性，例如在粘附层16与植入物10之间产生静电粘附、特异性粘附或化学粘附。
例如，通过在植入物10的前表面上施加激光能或施加化学品或热处理，可在植入物10的聚合物内产生化学变化(例如产生共价键)，其提高层14的粘附。作为另一个实例，使用飞秒激光器(例如被动锁模固态体激光器、二极管泵浦激光器、钛蓝宝石激光器，超快光纤激光器等)、Nd:YAG(掺钕钇铝石榴石)激光器、Yb:KGW(掺镱钨酸钾钆)激光器或Yb:KYW(掺镱钨酸钾钇)激光器和其他激光器(脉冲或连续激光器)在角膜12后部的后表面上进行化学和/或物理改变，以使粘附层16比角膜12的其余部分更具粘附性。
等离子体处理可用于通过产生粘附层14来提高所述植入物的粘附。在等离子体处理中，在气隙中产生高压放电，导致始终存在于空气中的自由电子加速并电离所述气隙中的气体。当所述放电非常强时，高速电子与气体分子的碰撞不会导致动量损失，并且会发生电子雪崩。当将植入物10(由塑料例如PMMA制成)放置在放电路径中时，放电中产生的电子以破坏所述植入物的撞击表面(其变成层14)上的分子键的能量撞击所述植入物的表面。这种撞击产生了非常活泼的自由基，其在氧气存在下可以快速反应，在植入物的表面(层14)上形成各种不同的化学官能团，从而提高表面能和粘附能力。
电晕处理可用于通过产生粘附层14来提高所述植入物的粘附。在电晕放电处理过程中，电子被加速到所述植入物的表面中，导致长链断裂，产生多个开放末端并形成自由价，从而提高表面能和粘附能力。电晕仅改变厚度为0.00001微米的顶部分子链。
火焰处理可用于通过产生粘附层14来提高所述植入物的粘附。通过对植入物10的表面快速施加强热，分子链断裂，并添加了极性官能团。火焰处理还烧掉灰尘、纤维、油和其他表面污染物。
层14和/或16的粘附性的提高有助于在所述植入物与角膜组织之间产生粘合，而不需施加外部胶黏性物质。
下表提供了用于产生将植入物10粘合到角膜12的后部的粘附层的可能的处理方法的列表。在该表中列出了一些与被添加胶黏性材料一起使用的处理方法，但是设想了即使没有所述被添加胶黏性材料，粘附性也可能被增强。
Figure BDA0002572609060000051

Claims (7)

1.一种方法，该方法包括：
通过在眼植入物(10)上形成植入物粘附层(14)来提高所述眼植入物(10)与角膜组织(12)的粘附，所述植入物粘附层(14)比所述植入物(10)的其余部分具有更大的粘附强度，其中通过在所述植入物(10)的前表面上进行化学和/或物理改变来形成所述植入物粘附层(14)，使得所述植入物粘附层(14)比所述植入物(10)的其余部分更具粘附性。
2.根据权利要求1所述的方法，其中通过在所述植入物(10)的前表面上施加激光能来形成所述植入物粘附层(14)。
3.根据权利要求1所述的方法，其中通过在所述植入物(10)的前表面上施加化学品来形成所述植入物粘附层(14)。
4.根据权利要求1所述的方法，其中通过在所述植入物(10)的前表面上施加热处理来形成所述植入物粘附层(14)。
5.根据权利要求1所述的方法，其中通过所述植入物(10)的前表面的等离子体处理来形成所述植入物粘附层(14)。
6.根据权利要求1所述的方法，其中通过所述植入物(10)的前表面的电晕处理来形成所述植入物粘附层(14)。
7.根据权利要求1所述的方法，其中通过所述植入物(10)的前表面的火焰处理来形成所述植入物粘附层(14)。
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