CN101505684B - 液压可调节型人工晶状体 - Google Patents

液压可调节型人工晶状体 Download PDF

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CN101505684B
CN101505684B CN200780027538XA CN200780027538A CN101505684B CN 101505684 B CN101505684 B CN 101505684B CN 200780027538X A CN200780027538X A CN 200780027538XA CN 200780027538 A CN200780027538 A CN 200780027538A CN 101505684 B CN101505684 B CN 101505684B
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J·斯图尔特·卡明
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Abstract

一种可调节型人工晶状体，其具有由固态硅酮和液态硅酮形成的光学部，所述光学部是圆形的并且具有固态硅酮的居中后部，该后部通过环形膜延伸至厚度大于所述环形膜的固态硅酮的周向环部，形成从所述光学部的周向后侧延伸至前侧的外径部；所述光学部还包括固态且居中的前部，该前部延伸至所述周向环部的前侧而且包括有单膜，该膜比所述后侧的环形膜薄并能够变形，所述光学部内的液态硅酮通过上述多个固态部和膜保持在其中，所述光学部设计为使得当玻璃体腔施加在固态的所述后部上的压力增大时，所述前部的较薄的膜的曲率半径能够发生改变。

Description

液压可调节型人工晶状体
背景技术
多年来，人工晶状体一直沿用的设计是包括单个光学部和附接至所述光学部从而使晶状体居中并将晶状体固定在人晶状体的空囊袋中的环。在80年代中期出现了板式晶状体，其包括具有6毫米的光学部且长度为10.5毫米的硅酮晶状体。这些晶状体能够折叠但却不能很好地固定在囊袋中，而是居于前囊膜和后囊膜之间的凹穴中。第一代可折叠晶状体完全由硅酮制成。在20世纪90年代中期提出了将丙烯酸树脂材料作为晶状体光学部的材料。丙烯酸树脂晶状体包括具有直边的双凸面光学部，环插置于其中以使晶状体在眼中居中并将晶状体固定在囊袋内。
最近市场上出现了可调节型人工晶状体，这种晶状体总体上为经过改型的襻(haptic)板式晶状体，并且和硅酮襻板式晶状体一样在板和光学部的后表面的连接处之间没有明显的分界。襻板式晶状体可以定义为具有两个或更多个襻板的人工晶状体，所述襻板与光学部接合。
柔性丙烯酸树脂材料明显受到眼科医生的青睐。以2003年为例，超过50％的植入人工晶状体具有丙烯酸树脂的光学部。目前也出现了水凝胶晶状体。丙烯酸树脂材料和水凝胶材料都不能在多次弯曲后不发生碎裂。
通过反复弯曲以沿眼轴移动而起作用的可调节型晶状体的出现在某种程度上限制了能够制成晶状体的材料。硅酮是理想的材料，因为它是柔性的并且能够弯曲大概几百万次而不会出现任何损坏。另外，在所述板上邻近光学部的地方可以贯穿地设置槽或铰链，其作为晶状体设计的一部分有助于光学部相对于襻的外端移动。另一方面，丙烯酸树脂材料如果被反复弯曲将会发生断裂。
在J.Stuart Cumming署名的美国专利No.6,387,126以及其它专利中公开了这种类型的可调节型晶状体的示例。
发明内容
本发明提供了一种可调节型人工晶状体，其具有由固态硅酮和液态硅酮形成的光学部，
所述光学部是圆形的并且具有固态硅酮的居中后部，该后部通过环形膜延伸至厚度大于所述环形膜的固态硅酮的周向环部，形成从所述光学部的周向后侧延伸至前侧的外径部；所述光学部还包括固态且居中的前部，该前部延伸至所述周向环部的前侧而且包括有单膜，该膜比所述后侧的环形膜薄并能够变形，所述光学部内的液态硅酮通过上述多个固态部和膜保持在其中，所述光学部设计为使得当玻璃体腔施加在固态的所述后部上的压力增大时，所述前部的较薄的膜的曲率半径能够发生改变。
本发明的另一方面提供了一种可调节型人工晶状体，其中光学部包括：
一体式居中光学系统，其由固态的、半径固定的、具有柔性环形周边的光学部件支撑；
居中的前光学部件，其包括可变形的薄膜，
居中的液态光学材料，其位于所述晶状体内，
后部居中的固态柔性光学部，其通过环形膜悬置于固态的环形支撑件上，该环形膜比所述薄的前膜厚并且比所述薄的前膜的弹性小，
所述后光学部设计为能够在睫状肌收缩使得玻璃体腔压力增大时向前移动并压缩所述居中的液态光学材料从而使所述薄的前膜向前凸出，进而导致其曲率半径减小并且光焦度增大，以及
襻件，其将所述光学系统支撑在眼睛内。
根据本发明的优选实施方式，一种可调节型晶状体包括具有柔性固态光学部和内部液态光学部的晶状体，所述晶状体优选地具有两个或更多个从固态光学部开始延伸的延伸部，该延伸部可以是能够多次弯曲而不会断裂的襻板，优选地襻板的远端处设置有固定和对中的构件。在延伸部的邻近光学部的地方贯穿地设置有铰链或槽以便于光学部相对于延伸部的外端向前和向后移动。另一方面，光学部可刚性地附接至襻。同样，襻也可以省略。
根据本发明，光学部是具有液态硅酮内核的可折叠柔性硅酮、丙烯酸树脂或水凝胶材料，并且襻是能够经得住多次折叠而不会损坏的可折叠材料，比如硅酮。优选地，襻板的端部具有T形固定装置而且该襻铰接至光学部。
本发明的晶状体由固态硅酮和液态硅酮制成，固态硅酮和液态硅酮的折射率相同，而且固态硅酮和液态硅酮的比重与自然人眼的水溶液的比重相同或非常近似。晶状体的光焦度(power)在植入人眼之前可以通过下列方式改变：(1)改变光学部的后部的半径；和/或(2)在制造过程中改变晶状体的光学部中的液态硅酮的体积，或者在植入之后通过将相同或不同折射率的液态硅酮注入晶状体的空腔中来改变晶状体的光焦度。在适应睫状肌收缩以及玻璃体腔的压力增大的过程中，晶状体的固态硅酮后部的后表面被向前推动，这是因为其被硅酮膜所包围。这导致较薄的前膜凸出，从而增大了其曲率，因而为近视者减小了晶状体的前表面的半径。前薄膜可以在其周边稍厚一些，使得晶状体内的压力的增大将导致膜的中间部分凸出。这种结构模拟的是人体晶状体的前囊层的结构和功能。后固态居中光学部可具有附加的单个或多个的球形部件或者可在其一个或两个表面上是非球面的。同样，玻璃体空腔的压力增大会使晶状体倾斜从而更容易进行调节。
因此，本发明的特征在于提供一种由固态硅酮和液态硅酮形成的改进形式的可调节型晶状体。
附图说明
图1是本发明的晶状体的优选实施方式的侧视截面图。
图2是从后侧观察的该晶状体的俯视图。
图3是从前侧观察的该晶状体的俯视图。
图4是类似于图1的该晶状体的截面图，但其中示出的是晶状体的前部凸出或曲率增大的情形。
[14a]图5和6示出的是截面的变型。
[14b]图7-10示出的是具有不同形式的襻的本发明的晶状体。
具体实施方式
下面参照附图，图中详细示出了优选实施方式，其中包括具有光学部10和襻16的人工晶状体。光学部10由两个部件形成，即优选由硅酮、丙烯酸树脂或水凝胶制成的柔性固态部12(12a-12d)和内部的液态硅酮部14。固态部12a和12b足够坚硬以防止光学部10在植入人眼的纤维性组织的囊袋时发生变形。柔性延伸部16可以是能够多次弯曲而不会损坏的襻板，而且柔性延伸部16由例如硅酮形成。光学部10和襻16优选是共平面的，两个或更多襻16从光学部10的相反侧向远处延伸。襻16的外端可包括诸如Cumming的美国专利No.6,387,126中公开的柔性指状部17。光学部的边缘24优选地是360°的直角边缘。
晶状体10包括固态硅酮部12a、12b和12d，其中固态部12c大体上比较薄，而12d甚至比12c更薄，从而具备能够在图1和图4的对比中看到的柔度。内部14是液态硅酮的。已知的是，用于这种晶状体的硅酮的比重与人眼中的水溶液的比重相同或近似。这导致晶状体的液态部不会因重力而发生变形或者所发生的变形可忽略不计。液态硅酮14的折射率与固态部件12的折射率相同或相近。固态部12a的后部半径防止后折射面发生变形。在制造过程中能够对固态部12a或12b的半径进行改变以便给晶状体选择期望的光焦度。同样，在制造过程中，能够通过改变晶状体光学部10中的液态硅酮14的体积来改变光焦度。
在调节过程中，通过睫状肌收缩对玻璃体腔施压而将后表面部12a向前推(图1和4中向左)。前部12d由于曲率增大而凸出，也就是说前部12d的半径减小，如图4中所示。
图1中固态部12b的从D至D的总体直径的示例性尺寸是4.5至10.5毫米，固态部12d的直径至多达5毫米，而图1中的厚度(从右至左)是3至6毫米。固态硅酮部12a和12b的典型厚度在0.5毫米至1.5毫米之间。前膜12d的厚度非常小，优选大约为玩具气球的厚度，而环形部12c的厚度大约是上述厚度的两倍从而为固态后部晶状体提供足够的柔度。铰链区域18的厚度可以是0.1毫米。铰链区域18可以是如图所示的“V”形，也可以是方槽形。同样，铰链部22优选地设置在12c与12a之间以便于后光学部12a向前运动。
此外，本晶状体的光焦度在通过注入或除去光学部10中的液态硅酮而在植入人眼以后可能会发生改变。
固态部12d的直径以及其面积可以小于或大于后部12a的直径和面积，这取决于所设计的晶状体的期望的折射率范围。
[20a]下面参照图5至6的实施方式，应当指出，前部12d的中间部分较薄，在玻璃体压力增大的情况下，如图6中所示该中间部分的凸出幅度将更大。
本领域中众所周知的是，在去除天然晶状体之后将人工晶状体植入人眼的囊袋中。通过在人体晶状体的前囊袋中切出大体上为圆形的开口以及通过角膜或巩膜中的小开口将晶状体插入囊袋中。襻的外端或环定位于囊袋的盲管(cul-de-sac)中。襻的外端或环处于囊袋的盲管附近，而且不管环的形式如何，该环都是弯曲(deffected)的。可以在环的外端部上设置球形突出物以通过与纤维化组织接合来改善其在囊袋或盲管中的稳固性，在手术切除前囊袋的中央部分以后该纤维化组织在囊袋中得以产生。
如上所述，襻16在邻近光学部处贯穿其表面设置有形成铰链的空间或薄区域18。这有助于光学部相对于襻的外端向前和向后移动。
因此，已经图示和描述了一种晶状体，其包括固态和液态硅酮的光学部以及襻环或襻板，优选地在每个襻的端部具有固定和/或对中突出物。
对于本领域普通技术人员来说，在结合附图和权利要求参阅了本说明书以后，本发明的各种修改、改型、变型以及其它用途和应用将变得显而易见。没有背离本发明的精神和范围的所有这些修改、改型、变型以及其它用途和应用都将落入所附权利要求的范围内。

Claims (20)

1.一种可调节型人工晶状体，其具有由固态硅酮和液态硅酮形成的光学部，
所述光学部是圆形的并且具有固态硅酮的居中后部，该后部通过环形膜延伸至厚度大于所述环形膜的固态硅酮的周向环部，形成从所述光学部的周向后侧延伸至前侧的外径部；所述光学部还包括固态且居中的前部，该前部延伸至所述周向环部的前侧而且包括有单膜，该膜比所述后侧的环形膜薄并能够变形，所述光学部内的液态硅酮通过上述多个固态部和膜保持在其中，所述光学部设计为使得当玻璃体腔施加在固态的所述后部上的压力增大时，所述前部的较薄的单膜的曲率半径能够发生改变。
2.如权利要求1所述的晶状体，其还包括从所述光学部的边缘开始延伸的延伸部，所述延伸部有助于将所述晶状体置入眼中。
3.如权利要求2所述的晶状体，其中，所述延伸部是襻件。
4.如权利要求2所述的晶状体，其中，所述延伸部是襻板。
5.如权利要求2所述的晶状体，其中，所述光学部能够相对于所述延伸部的外端向前和向后移动。
6.如权利要求1所述的晶状体，其中，所述固态硅酮和所述液态硅酮的比重与人眼的水溶液的比重大致相等。
7.如权利要求1所述的晶状体，其设计为使得玻璃体压力引起的对所述后部的后表面的压缩能够导致所述前部的前表面对称凸出。
8.如权利要求1所述的晶状体，其中，所述光学部的固态部和液态部的折射率大致相等。
9.如权利要求1所述的晶状体，其中，当睫状肌放松时，所述光学部的曲率半径使植入所述晶状体的患者屈光正常。
10.如权利要求1所述的晶状体，其中，在制造过程中可以对所述后部或所述前部的后固态表面或前固态表面的曲率半径进行改变，从而使指定的人眼屈光正常。
11.如权利要求1所述的晶状体，其中，在植入以后所述光学部的光焦度可以通过改变所述光学部中的液态硅酮的量而改变。
12.如权利要求1所述的晶状体，其中，所述薄的前部的面积小于所述居中的后部的面积。
13.如权利要求1所述的晶状体，其中，所述薄的前部的面积大于所述居中的后部的面积。
14.如权利要求1所述的晶状体，其中，所述薄的前部的直径小于所述居中的后部的直径。
15.如权利要求3所述的晶状体，其中，所述襻件具有邻近所述光学部的铰链。
16.如权利要求1所述的晶状体，其中，在所述光学部的后表面上设置有360度的直角边缘。
17.如权利要求1所述的晶状体，其中，所述后部具有固定的中心半径，而所述前部的半径是可变形的。
18.如权利要求1所述的晶状体，其中，玻璃体腔压力的增大能够导致所述晶状体的光学部倾斜从而有助于进行调节。
19.一种可调节型人工晶状体，其中光学部包括：
一体式居中光学系统，其由固态的、半径固定的、具有柔性环形周边的光学部件支撑；
居中的前光学部件，其包括可变形的薄膜，
居中的液态光学材料，其位于所述晶状体内，
后部居中的固态柔性光学部，其通过环形膜悬置于固态的环形支撑件上，该环形膜比所述居中的前光学部件的可变形的薄膜厚并且比所述居中的前光学部件的可变形的薄膜的弹性小，
所述后光学部设计为能够在睫状肌收缩使得玻璃体腔压力增大时向前移动并压缩所述居中的液态光学材料从而使所述居中的前光学部件的可变形的薄膜向前凸出，进而导致其曲率半径减小并且光焦度增大，以及
襻件，其将所述光学系统支撑在眼睛内。
20.如权利要求19所述的晶状体，其包括位于所述襻件的远端上的固定装置。
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