CN109414317B - 混合型可调节人工晶状体组合件 - Google Patents

混合型可调节人工晶状体组合件 Download PDF

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CN109414317B
CN109414317B CN201780030330.7A CN201780030330A CN109414317B CN 109414317 B CN109414317 B CN 109414317B CN 201780030330 A CN201780030330 A CN 201780030330A CN 109414317 B CN109414317 B CN 109414317B
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约书亚·本纳
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Rayner Intraocular Lenses Ltd
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Abstract

混合型可调节人工晶状体(AIOL)组合件包括两个分离的元件部分，呈分离的基底部件和分离的晶状体单元形式，该分离的基底部件用于在空出的囊袋中初始植入，该分离的晶状体单元用于在空出的囊袋中随后植入用于锚定到该分离的基底部件。该晶状体单元包括晶状体光学器件，该晶状体光学器件具有至少两个从该晶状体光学器件向外径向延伸的晶状体触觉件。该基底部件包括具有零光学倍率的扁平的圆形的基底部件中心物。

Description

混合型可调节人工晶状体组合件
技术领域
本发明一般涉及调节的人工晶状体组合件(accommodating intraocular lensassemblages)，具体地说，涉及在袋中的调节的人工晶状体组合件。
背景技术
参照图1和图2，人眼的结构和手术在本发明的上下文中被描述了。图1和图2是人眼10的前面部分的截面图，人眼10在人体的轴平面中具有分别针对近视力和远视力的视轴VA。人眼10具有被称为角膜11的前面透明帽样结构，角膜11在它的圆周外围处连接到由结实的结缔组织(被称为巩膜12)组成的球形外部体(spherical exterior body)的环形的角膜缘13处。虹膜14在角膜缘13处从它的根部16向内延伸到人眼10中，以将人眼的前面部分划分为前房17和后房18。虹膜14是具有中心瞳孔的薄的环形的肌肉结构。虹膜14是被尤其是周围光照条件、针对近视力的聚焦，和针对瞳孔直径的间断变化的其它因素来激活。环形睫状体19与带状纤维21连接，带状纤维21转而与囊袋22的赤道边缘外围连接，囊袋22具有前囊(anterior capsule)23和后囊(a posterior capsule)24并且包含天然晶状体26。睫状体19的收缩允许晶状体26沿着视轴VA增厚到它的自然厚度T1，用于针对近视力的较大的正光学倍率(positive optical power)(参见图1)。睫状体19的放松拉紧带状纤维21，带状纤维21径向地向外拉囊袋22(如箭头A所示)用于沿着视轴VA压缩晶状体26以减少它的厚度到T2<T1，用于针对远视力的较小的正光学倍率(参见图2)。近视力被定义为在大约33cm到40cm的距离范围内并且需要超过最佳矫正的远视力在大约3个屈光度到2.5个屈光度之间的额外的正光学倍率。健康的人眼经历从远视力(对应于周围光照条件)的大约3mm到6mm的瞳孔直径到近视力的大约2mm的瞳孔直径的瞳孔瞳孔缩小。
白内障手术涉及在前囊23中的撕囊术用于实现天然的晶状体26的移除。撕囊术通常涉及在前囊23中制造大约4mm到大约5mm直径的圆孔以留下环形的前囊边缘27和完整的后囊24。图1和图2显示了由箭头B所示的圆孔的边界。囊袋的环形的前囊边缘27和它的完整的后囊24之间的间隔能够使囊上皮细胞(capsular epithelial cells)生长，该囊上皮细胞自然迁移到它的内部囊表面上导致后囊24浑浊(被缩写为PCO)和/或具有囊收缩的囊纤维化。虽然继发性白内障通过YAG激光器破裂以使视轴清晰并且恢复视力，囊收缩是无法医治的。
被设计放置在空出的囊袋(a vacated capsular bag)22中的调节的人工晶状体(AIOL)组合件被称为袋中AIOL组合件(in-the-bag AIOL assemblage)。目前设想的袋中AIOL组合件是自身庞大的大的一体的双重光学器件结构(large monolithic dual opticsstructures of inherent bulkiness)，该一体的双重光学器件结构需要大的角膜切口用于在人眼中植入并且恰当的放置在它的囊袋中，因为双重光学器件结构中的1个光学器件从它的视轴的稍微偏差导致光学畸变。再者，先前设想的袋中AIOL组合件并不适合与曲面透镜元件一起使用用于矫正散光，因为将囊袋内的庞大的双重光学器件结构拨动到矫正散光所需要的预定角度存在较大的撕开囊袋的风险。
需要改进的袋中AIOL组合件。
发明内容
本发明针对的是混合型可调节人工晶状体(AIOL)组合件，该混合型可调节人工晶状体组合件包括两个分离的元件部分，呈分离的基底部件(discrete base member)和分离的晶状体单元(discrete lens unit)形式，该分离的基底部件形式用于在空出的囊袋中初始植入，该分离的晶状体单元用于在空出的囊袋中随后植入用来在该空出的囊袋上锚定。该分离的晶状体单元包括晶状体光学器件(lens optics)，该晶状体光学器件具有至少两个从晶状体光学器件径向向外延伸的晶状体触觉件(lens haptics)。该分离的基底部件包括扁平的圆形的基底部件中心物(a flat circular base member centerpiece)。该晶状体光学器件和基底部件中心物都是由合适的可植入的生物兼容的透明的光学级材料制成并且必然具有相同的折光率。该晶状体光学器件和该基底部件中心物优选地是由相同的材料制成，但是可由不同的材料制成。
该晶状体光学器件具有用于远视力矫正的前面的晶状体光学器件表面和具有用于近视力矫正的中心圆形物的后面的晶状体光学器件表面。该后面的晶状体光学器件表面优选地具有围绕它的中心圆形物的环形的多焦点部分(multi-focal segment)，其经计算用于在植入的健康眼中提供良好的中间视力。或者，为了在受伤的视力眼中植入，降解的晶状体单元可具有由单焦点的晶状体光学器件表面构成的后面的晶状体光学器件表面。
基底部件中心物具有渗透性质，当对该基底部件中心物按压以建立单一的折射率光学连续区(a single refractive index optical continuum)时，该渗透性质能够使后面的晶状体光学器件表面深入地埋入它的前面的基底部件中心物表面。完全的睫状体放松导致该后面的晶状体光学器件表面完全埋入该前面的基底部件中心物表面，从而使该中心圆形物和它的周围的环形的多焦点部分的光学倍率无效，使得仅仅该前面的晶状体光学器件表面针对远视力是光学活性的。睫状体收缩导致该后面的晶状体光学器件表面与该前面的基底部件中心物表面完全轴向分离使得该前面的晶状体光学器件表面和该后面的晶状体光学器件表面的中心圆形物都针对近视力是光学活性的。在睫状体收缩和完全的睫状体放松之间的中间的睫状体状态中，该后面的晶状体光学器件表面的中心圆形物仅仅被埋入该前面的基底部件中心物表面，并且它的环形的多焦点部分连同该前面的晶状体光学器件表面一起针对中间视力是光学活性的。附图的简单说明
为了理解本发明并且明白在实践中如何实施它，仅仅借助非限制性实施例，参照附图，其中类似的部件被做了同样编号，现在优选的实施例被描述了，其中。
图1是在人体的轴平面在它的天生近视力的情况下人眼的前面部分的截面图；
图2是在人体的轴平面在它的天生远视力的情况下人眼的前面部分的截面图；
图3是混合型AIOL组合件的透视图，该混合型AIOL组合件包括在白内障手术期间用来在囊袋中原位组装的分离的晶状体单元和分离的基底部件；
图4是分离的晶状体单元的顶部俯视图；
图5是沿着图4中的线5-5的分离的晶状体单元的截面图；
图6是分离的基底部件的顶部俯视图；
图7是沿着图6中的线7-7的分离的基底部件的截面图；
图8是在手中组装的混合型AIOL组合件的截面图；
图9是另一个分离的基底部件的边的截面图；
图10是再一个分离的基底部件的边的截面图；
图11是针对与图1对应的近视力的植入的混合型AIOL组合件的截面图；
图12是针对与图2对应的远视力的植入的混合型AIOL组合件的截面图；以及
图13是针对中间视力的植入的混合型AIOL组合件的截面图；
附图的详细描述
图3显示了混合型AIOL组合件30，混合型AIOL组合件30包括用于在白内障手术期间在囊袋中原位组装的分离的晶状体单元40和分离的基底部件60。分离的晶状体单元40包括晶状体光学器件41和至少两个从晶状体光学器件41径向向外延伸的平均间隔分布的晶状体触觉件42。分离的晶状体单元40优选地包括4个平均间隔分布的晶状体触觉件42。晶状体单元40可被制作为一体结构。或者，晶状体触觉件42可与晶状体光学器件41分开被制造，并且通过使用工业上已知的连接技术连接到晶状体光学器件41。分离的基底部件60具有基底部件中心线61并且包括扁平的圆形的基底部件中心物62和基底部件围绕物63。基底部件60可被制作为一体的结构。或者，基底部件围绕物63可与基底部件中心物62分开被制造，并且通过使用工业上已知的连接技术连接到基底部件中心物62。混合型AIOL组合件30完全是由可植入的生物兼容材料制成。晶状体光学器件41和基底部件中心物62是由光学级的透明材料制成并且具有相同的折射率。晶状体光学器件41和基底部件中心物62优选地是由相同的材料制成。
图4和图5显示了晶状体光学器件41具有用来与视轴VA同轴对齐的光学器件轴43。晶状体光学器件41具有前面的晶状体光学器件表面44、后面的晶状体光学器件表面46和晶状体光学边缘47。晶状体光学器件41具有与目前被用于白内障手术的标准IOLs类似的直径和厚度。前面的晶状体光学器件表面44提供主要的光学倍率，该主要的光学倍率经计算用于在植入的眼睛中最佳的远视力矫正。健康的眼睛需要在近距离和中间距离处良好的视力，因此，后面的光学晶状体表面46优选地具有多焦点光学梯度(multifocal opticalgradient)，该多焦点光学梯度从晶状体光学器件轴(lens optics axis)43处的最大的光学倍率朝向晶状体光学边缘47逐渐减小。相应地，后面的晶状体光学器件表面46包括中心圆形物48，中心圆形物48具有围绕晶状体光学器件轴43的大约2.5mm的直径，这对应于正常的阅读光照条件(normal reading illumination conditions)下的近视力瞳孔大小。中心圆形物48具有需要的额外的功率，用以针对打算植入的眼睛中的近视力的前面的晶状体光学器件表面44的原则距离矫正光学倍率(principle distance correction opticalpower)。中心圆形物48通常具有大约3.0屈光度的光学倍率。通过使用本领域已知的制作方法，从中心圆形物48的边界，光学倍率朝向晶状体光学边缘47逐渐减小。在用于植入受伤的视力眼睛中的分离的晶状体单元40的退化变体中，后面的晶状体光学器件表面46可由单个单焦点的晶状体光学器件表面构成，用来提供针对仅仅在打算植入的眼睛中的近视力的最佳矫正。
每个晶状体触觉件42具有晶状体触觉件自由端51，晶状体触觉件自由端51具有符合分离的基底部件60的锚定界面的曲率的晶状体触觉件弯曲边缘52。每个晶状体触觉件42优选地具有用于实现晶状体单元40相对于基底部件60的恰当放置的操作孔53。每个晶状体触觉件42优选地具有与晶状体光学器件41邻近的细长的前面的一对间隔物(an elongatedanterior spacer pair)54，该对间隔物用于将前囊边缘27与晶状体触觉件42间隔开，以实现前囊边缘27和晶状体单元40之间的眼房水循环。
然而，前面的晶状体光学器件表面44还被设计用于同时在打算植入的眼睛中矫正散光。因此，晶状体单元40被设置有光学器件轴标记56用于在植入期间帮助晶状体单元40相对于人视轴VA的矫正对齐。光学器件轴标记56优选地被放置在晶状体触觉件42上，而不妨碍视力。操作孔53被利用用来围绕晶状体光学器件轴43拨动恰当地放置的晶状体单元40，用于在需要的位置设置用于散光矫正。
图6和图7显示了分离的基底部件60具有具有扁平的圆形的前面的基底部件中心物表面(flat circular anterior base member centerpiece surface)64和扁平的圆形的后面的基底部件中心物表面(flat circular posterior base member centerpiecesurface)66的扁平的圆形的基底部件中心物(flat circular base member centerpiece)62。扁平的前面的和后面的基底部件中心物表面64和66具有零光学倍率。基底部件围绕物63与升高的圆周保持物67一起形成，用来形成具有前面的基底部件中心物表面64的圆周凹槽68，用来接收晶状体触觉件自由端51，用于在分离的基底部件60上锚定分离的晶状体单元40。基底部件围绕物63优选地具有直角横截面用于防止上皮细胞迁移到囊的外围。图8显示了将晶状体单元40安装在基底部件60上时的组装的混合型AIOL组合件30，通过晶状体触觉件自由端51被弯曲进入圆周凹槽68中使得晶状体触觉件42推动后面的晶状体光学器件表面46远离前面的基底部件中心物表面64。
囊袋大小可以在数个毫米范围内改变。混合型AIOL组合件30经设计使得相同的分离的晶状体单元40可以被植入到不同大小的人囊袋中。这是通过提供分离的基底部件60实现的，分离的基底部件60在相对基底部件中心线61的相同半径R处具有他们的圆周凹槽68并且通过基底部件围绕物63和升高的圆周保持物67的径向向外延伸弥补囊大小的差别，这点可以从图9和图7的比较看出。图10显示了替代的呈柔韧的边69形式的升高的圆周保持物67，柔韧的边69被设计为通过前囊边缘27朝向前面的基底部件中心物表面64弯曲(如箭头C所示)，以改进前囊边缘27和晶状体触觉件42之间的机械界面。柔韧的边69被布置在距离基底部件中心线61的相同半径R处，并且囊大小差别通过基底部件围绕物63相对于基底部件中心线61的径向向外延伸弥补。
图11显示了在对应图1的手术近视力状态中的植入的混合型AIOL组合件30。完全睫状体收缩伴随着虹膜收缩到大约2.5mm直径的瞳孔大小。图11显示了前面囊边缘27接触前面的晶状体光学器件表面44和/或触觉件间隔物(haptics spacers)54，但是并没有朝向基底部件中心物62推动晶状体光学器件41使得后面的晶状体光学器件表面46与前面的基底部件中心物表面64间隔开。因此，混合型AIOL组合件30提供了前面的晶状体光学器件表面44的组合光学倍率和中心圆形物48的光学倍率以实现近视力。
图12显示了在对应图2的手术远视力状态的植入的混合型AIOL组合件30。图12显示了前囊边缘27向下压在前面的晶状体光学器件表面44和/或触觉间隔物54上，用于推动晶状体光学器件41朝向基底部件中心物62。后面的晶状体光学器件表面46完全深入地埋入前面的基底部件中心物表面64使得后面的晶状体光学器件表面46和前面的基底部件中心物表面64建立零光学倍率的单一折射率光连续区，从而混合型AIOL组合件30凭借前面的晶状体光学器件表面44提供光学倍率，该光学倍率经适当地确定用于打算植入的眼睛的最佳远视力。
图13显示了在手术中间视力状态的植入的混合型AIOL组合件30。该中间视力涉及比针对近视力小得多的睫状体收缩，导致后面的晶状体光学器件表面46部分地深入地埋入前面的基底部件中心线表面64。如图所示，只有中心圆形物48和前面的基底部件中心物表面64建立零光学倍率的单一折射率光连续区。环形的多焦点部分(annular multi-focalsegment)49与前面的基底部件中心物表面64间隔开，从而提供针对中间视力的需要的额外的光学倍率。
虽然本发明描述了有限数量的实施例，会理解，本发明的许多变化、修改以及其它应用可在所附的权利要求书的范围内做出。

Claims (9)

1.一种混合型可调节人工晶状体组合件，所述混合型可调节人工晶状体组合件用于植入撕囊术后的人眼中，所述人眼具有视轴、环形的睫状体和空出的囊袋，所述囊袋具有环形的前囊边缘和完整的后囊，
所述睫状体具有针对远视力的放松的睫状体状态和针对近视力的收缩的睫状体状态，所述睫状体在从它的收缩的睫状体状态到它的放松的睫状体状态的它的放松时从外围拉紧所述囊袋，所述混合型可调节人工晶状体组合件包括：
(a)分离的基底部件，所述分离的基底部件具有基底部件中心线并且包括扁平的圆形的基底部件中心物和外围的基底部件围绕物，
所述扁平的圆形的基底部件中心物具有基底部件中心物折射率、前面的基底部件中心物表面和后面的基底部件中心物表面，
所述基底部件具有限定圆周凹槽的升高的圆周保持物，所述圆周凹槽具有所述前面的基底部件中心物表面；以及
(b)分离的晶状体单元，所述分离的晶状体单元具有
i)晶状体光学器件，所述晶状体光学器件具有晶状体光学器件折射率、用于与所述视轴同轴对齐的晶状体光学器件轴、具有针对远视力的主要的光学倍率的前面的晶状体光学器件表面和具有中心圆形物的后面的晶状体光学器件表面，所述中心圆形物具有针对所述主要的光学倍率的额外的光学倍率，用于近视力，以及
ii)至少两个间隔开的弹性地易弯曲的晶状体触觉件，所述至少两个间隔开的弹性地易弯曲的晶状体触觉件从所述晶状体光学器件径向地延伸，用于插入所述圆周凹槽中用来在所述分离的基底部件上锚定所述分离的晶状体单元，用来推动所述晶状体光学器件远离所述分离的基底部件，用来将所述后面的晶状体光学器件表面与所述前面的基底部件中心物表面分开，所述至少两个间隔开的弹性地易弯曲的晶状体触觉件各自具有远离所述晶状体光学器件的自由端，所述升高的圆周保持物被配置为覆盖所述自由端用来在所述分离的基底部件上锚定所述分离的晶状体光学器件，并且能够将所述分离的晶状体单元相对于固定在所述撕囊术后的人眼中的所述分离的基底部件旋转到预定位置，以及
其中所述基底部件中心物和所述晶状体光学器件具有相同的折射率，于是，依照所述分离的基底部件在所述空出的囊袋中的初始植入和所述分离的晶状体单元在所述空出的囊袋中在所述基底部件和所述前囊边缘之间的随后植入，
在放松的睫状体状态中，所述空出的囊袋朝向彼此推动所述晶状体光学器件和所述基底部件使得所述后面的晶状体光学器件表面被深入地埋入所述前面的基底部件中心物表面用于建立单一折射率的光学连续区，该单一折射率的光学连续区使所述后面的晶状体光学器件表面的光学倍率无效，于是，所述混合型可调节人工晶状体组合件具有仅仅针对远视力的光学倍率，以及
在收缩的睫状体状态中，所述空出的囊袋能够使得所述至少两个间隔开的弹性地易弯曲的晶状体触觉件用以间隔开所述晶状体光学器件和所述基底部件，使得所述后面的晶状体光学器件表面与所述前面的基底部件中心物表面是间隔开的用于针对所述前面的晶状体光学器件表面的主要的光学倍率增加所述中心圆形物的额外的光学倍率，于是，所述混合型可调节人工晶状体组合件具有组合的光学倍率，用于近视力。
2.根据权利要求1所述的组合件，其中所述后面的晶状体光学器件表面包括围绕所述中心圆形物的环形的多焦点部分，具有从所述晶状体光学器件轴朝向所述至少两个间隔开的弹性地可弯曲的晶状体触觉件的逐渐减小的光学倍率，用于中间视力矫正，
于是，在放松的睫状体状态和收缩的睫状体状态之间的中间的睫状体状态，所述中心圆形物被深入地埋入所述前面的基底部件中心物表面用于建立使所述中心圆形物的光学倍率无效的单一的折射率光学连续区，并且所述环形的多焦点部分与所述前面的基底部件中心物表面是间隔开的，用于中间视力。
3.根据权利要求1所述的组合件，其中所述后面的晶状体光学器件表面从所述晶状体光学器件轴到所述至少两个间隔开的弹性地可弯曲的晶状体触觉件是单焦点的晶状体光学器件表面。
4.根据权利要求1到3任一项所述的组合件，其中所述至少两个晶状体触觉件的每个晶状体触觉件都包括至少一个前面的间隔物，所述至少一个前面的间隔物用于在所述分离的晶状体单元在空出的囊袋中的所述随后植入时间隔所述前囊边缘与所述晶状体触觉件。
5.根据权利要求1到3任一项所述的组合件，其中所述外围的基底部件围绕物具有横截面是直角的截面。
6.根据权利要求1到3任一项所述的组合件，其中所述升高的圆周保持物是由柔韧的边构成的。
7.根据权利要求1到3任一项所述的组合件，其中所述前面的晶状体光学器件表面与复曲面光学设计结合用于矫正散光，并且所述分离的晶状体单元包括光学器件轴标记用于在所述分离的晶状体单元的植入期间帮助所述分离的晶状体单元相对所述视轴对齐。
8.一种分离的晶状体单元，其用于根据权利要求1到7任一项所述的混合型可调节人工晶状体组合件。
9.一种分离的基底部件，其用于根据权利要求1到7任一项所述的混合型可调节人工晶状体组合件。
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