CN103561684A - 调节性眼内透镜和植入方法 - Google Patents
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Abstract
一种适合于植入囊袋中的适应性眼内透镜(AIOL)包括外壳体、阀以及力传递组件。外壳体包括至少在外壳体的周边上的至少一个表面修饰以促进与囊袋的结合。阀配置成允许填充材料的注入。外壳体中的力传递组件适合于响应囊袋形状的变化传递来自囊袋的力以改变被填充的外壳体的形状。
Description
相关申请
本申请要求于2011年5月31日提交的、序列号为61/491819的美国临时申请的优先权,上述申请通过引用被合并于本文中。
技术领域
本申请总体上涉及眼内透镜(IOL)的领域,并且更特别地涉及调节性(accommodative)IOL。
背景技术
人眼的功能,简单来说是通过将光透射通过被称为角膜的透明外部分并且进一步通过晶状体将图像聚焦到视网膜上而提供视觉。聚焦图像的品质取决于许多因素,包括眼睛的尺寸和形状以及角膜和晶状体的透明度。晶状体由浸入在房水中、被称为囊袋或后囊的膜保持就位在眼睛的后房内。晶状体的形状和晶状体相对于房水的折射率决定光线聚焦到视网膜上的何处。
当年龄或疾病导致晶状体变得不太透明时,视力由于可以透射到视网膜的光减少而下降。眼睛的晶状体的该缺陷在医学上被称为白内障。用于该状况的可接受的治疗是手术摘除晶状体并且植入人工眼内透镜(IOL)。白内障晶状体常常通过被称为晶状体乳化的外科技术被摘除。在该程序期间,在囊袋(围绕天然晶状体的薄膜)的前侧中制造开口。将细晶状体乳化切割尖端插入病变晶状体中并且超声地振动。振动切割尖端液化或乳化晶状体使得晶状体可以从眼睛被吸出。一旦被摘除,用人工透镜替换病变晶状体。
在天然晶状体中,由被称为调节作用(accommodation)的机制提供远距和近距视力的多焦点性。在人生的早期,天然晶状体柔软并且包含在囊袋内。囊袋通过小带从睫状肌悬挂。睫状肌的松弛拉紧小带,并且拉伸囊袋。因此,天然晶状体倾向于展平。睫状肌的拉紧松弛小带上的张力,允许囊袋和天然晶状体呈现更圆的形状。以该方式,天然晶状体可以选择性地聚焦在近和远的物体上。当晶状体老化时,它变得较硬并且不太可能响应睫状肌的拉紧改变形状。这使晶状体更难以聚焦在近物体上,这种医学状况被称为老花眼。老花眼影响年龄超过45或50岁的几乎所有成人。
当白内障或其他疾病需要摘除天然晶状体并且用人工眼内透镜(“IOL”)替换时,用于替换天然晶状体的IOL常常是单焦点透镜。这些透镜不响应囊袋的运动而改变光学能力,看近物时需要患者使用眼镜或隐形眼镜。然而,在现有技术中有许多囊状或袋状眼内透镜的若干示例,其由填充有粘性凝胶的外挠性皮肤组成。由此产生的透镜完全填充囊袋并且很柔软和柔韧,很像天然晶状体。例如参见美国专利第4,373,218(Schachar)、4,585,457(Kalb)、4,685,921(Peyman)、4,693,717(Michelson)、5,275,623(Sarfarazi)、4,822,360(Deacon)、5,489,302(Skottum)和6,217,612(Woods)号。但是为了提供调节作用,睫状肌的运动必须通过囊袋充分地传递到透镜系统,并且这些参考文献中没有公开保证在囊袋和透镜系统之间有紧密连接或固定的机制。
所以,一直需要安全和稳定的调节性眼内透镜系统和植入方法,其提供在大且有用范围上的调节作用。
发明内容
一种适合于植入囊袋中的适应性(accommodating)眼内透镜(AIOL)包括外壳体、阀以及力传递组件。所述外壳体包括至少在所述外壳体的周边上的至少一个表面修饰以促进与囊袋的结合。所述阀配置成允许填充材料的注入。所述外壳体中的所述力传递组件适合于响应囊袋形状的变化传递来自囊袋的力以改变被填充的外壳体的形状。
附图说明
图1是根据本发明的特定实施例的透镜的放大横截面图;
图2是图1的透镜的放大横截面图,显示植入囊袋中的透镜;
图3是图1的透镜的放大横截面图,显示植入囊袋中的透镜,并且材料正注入透镜中以接近未调节状态;
图4是图1的透镜的放大横截面图,显示植入囊袋中的透镜,并且材料正从透镜被去除;
图5是图1的透镜的放大横截面图,显示植入囊袋中并且处于已调节状态的透镜;
图6是流程图,显示根据本发明的特定实施例的植入可膨胀适应性透镜的方法;
图7示出根据本发明的特定实施例的双光学适应性IOL;
图8A、8B和8C示出沿着光轴看到的根据本发明的特定实施例的双光学AIOL的各实施例;
图9是流程图,显示根据本发明的特定实施例的植入双光学AIOL的示例性方法;以及
图10示出可与本发明的各实施例结合使用的周围带。
具体实施方式
本发明的各实施例可以通过促进囊袋围绕适应性IOL的机械特征的附着力提供改善的适应性透镜。这提供袋和IOL之间的更稳定的机械连接以抵抗睫状肌的力允许袋的展平和松弛以便移动透镜。囊袋的形状的变化又用于变形透镜以产生光学能力变化(类似于天然晶状体的调节作用)或通过分离两个光学元件产生IOL光学能力的变化。
本发明的各实施例也包括用于将囊袋的运动所产生的力转变为产生透镜的变形或透镜的光学元件的分离的力的机械结构。通过将此与在沿着机械结构的特定点处囊袋与IOL的强附着结合,根据本发明的IOL的特定实施例有利地提供增加的机械效率和IOL的光学能力的更大程度的调节变化。
在图1中最佳地看到,根据本发明的特定实施例的透镜10大体上由限定包含内部填充材料14的内部空隙13的外壳体12组成。外壳体12优选地形成任何合适的总直径或长度,例如大约10毫米,以便植入眼睛的囊袋中。外壳体12优选地由固有地对后囊混浊(“PCO”)的形成具有抗性的柔性、可折叠材料(例如柔性丙烯酸树脂)制造。在某些实施例中,外壳体12的材料可以比囊袋相对更有弹性,使得外壳体12可以相对容易地由囊袋移动。外壳体12包含填充阀16,允许填充材料14注入空隙13中或从空隙13去除。
外壳体12也可以包括力传递结构,例如具有适当间隔(例如30°)的多个加强径向肋18,和/或可以附连到围绕透镜10的周围带(如下面更详细地所述)。在所示的实施例中,透镜10也包括在周边处的活动铰链21,从而便于表面的形状变化。在特定实施例中,周围带可以耦接到活动铰链组件以将来自囊袋的力传递为活动铰链的致动。外壳体12也可以包含尖锐的周围角20,其设计成防止透镜10的光学表面上的赤道细胞增殖,但是围绕透镜的周边处的铰链21的细胞附着优选地被促进以改善囊袋和透镜10之间的力传递的机械效率。
外壳体12的至少一部分涂覆有表面修饰22,其可以包括涂层、纹理或设计成促进蛋白附着的其他合适变化。这样的涂层的示例包括补体蛋白、囊袋的生长因子、在发出细胞生长条件的信号中使用的甲壳质或其他有机化学物质。用于形成透镜10的聚合物结构可以是蛋白质强化的,使得透镜材料自身具有促进蛋白结合的表面。其他合适的表面修饰包括纳米通道或允许细胞渗透进入透镜结构中的其他结构。这样的结构也可以包括涂层或处理以促进细胞生长和结合在渗透细胞/透镜网络内。另外的其他合适表面修饰包括生物相容粘合剂的使用。
填充材料14优选地是具有大于周围房水的折射率的液体、凝胶或低分子量聚合物。这样的材料可以包括(但不限于)硅油、普氟隆(perfluoron)以及交联或非交联聚合物凝胶。也优选的是最小化由于扩散引起的填充材料14的损失,因此外壳体12应当优选地相对不透填充材料14和周围房水。如图2中最佳地所见,透镜10可以在未填充状态下植入囊袋24中。如图3中所见,然后使用适当的器械,例如插管26,通过阀16用填充材料14填充内部空隙13,使得透镜10接近处于未调节状态的天然晶状体的形状,这导致外壳体12的前表面30比较平坦。在图2所示的实施例中,前表面30在调节期间明显地改变形状,而后表面在形状上保持相对不变,但是替代实施例可以使前和后表面都或多或少地改变形状。增厚后表面或使后表面相对更刚性的一个优点在于后表面可以相对固定以便更容易地允许在透镜10中使用非球面和/或环面校正。衍射和/或多焦点光学器件也可以包含到表面中。
当过度填充透镜10时,小带28处于松弛位置。透镜10留在该过度填充状态持续足以在外壳体12和囊袋24之间形成蛋白附着的一段时间,例如2-4周。如图4中最佳地所见,在蛋白附着已形成于外壳体12和囊袋24之间之后,通过透镜10的阀16从空隙13去除足够的填充材料14以采用未调节透镜的形状,如图5中最佳地所见,其中小带28张紧并且前表面30相对于过度填充状态具有更圆的形状,如箭头32所示。透镜10也可以朝着已调节状态机械地偏置,使得当囊袋松弛时,透镜10的缺省倾向是恢复到已调节状态。例如,活动铰链21可以具有倾向于将透镜30的前表面推动到已调节形状的弹簧作用。
图6是流程图100,显示根据本发明的特定实施例的示例性植入方法。在步骤102,提供具有表面修饰的可膨胀适应性透镜(“AIOL”)以促进与囊袋的蛋白附着。在步骤104,在未填充状态下植入AIOL。在步骤106,过度填充AIOL以便于与囊袋接触。在步骤109,允许囊袋围绕AIOL愈合足够的时间以允许囊袋和AIOL之间的结合。在步骤110,从AIOL去除填充材料以达到AIOL的未调节状态。
图7是根据本发明的另一实施例的双光学AIOL200的横截面图。为了本说明书的目的,“双光学”表示AIOL包括至少两个光学元件,但是这样的双光学AIOL也可以包括附加的光学元件。双光学AIOL200包括前光学元件202和后光学元件204。优选地,光学元件202或后光学元件204中的一个具有正光学能力,并且另一个具有负光学能力,从而光学能力之间的差异较大并且光学元件202和204之间的间隔的变化产生总体光学能力的显著变化。一个或两个表面也可以包括非球面、环面、衍射和/或多焦点校正。尽管两个光学元件202和204显示为在囊袋内,但是AIOL200可以包括沟固定前光学元件202乃至。
AIOL200也包括光学元件202和204之间的互锁特征206。互锁特征206围绕光学元件202和204在周边定位,并且互锁特征206也包括表面修饰,例如上述的表面修饰,以促进囊袋结合到互锁特征206。互锁特征206可以一体地形成,使得整个AIOL200是单个件,或者它们可以替代地是附连到它们的相应光学元件202和204的互补特征,使得在植入之前或期间互锁特征206彼此连接。尽管在整合活动铰链配置中示出互锁特征206,但是其他布置也可以合适地起作用,包括使用钩环或铰链销的布置。在所示的实施例中,互锁特征206配置成在未调节状态下保持光学元件202和204彼此间隔开以防止附着。
由于囊袋紧紧地附连到互锁特征206,因此当展平时囊袋向外牵引互锁特征206。互锁特征206成形为使得当向外牵引互锁特征206时光学元件202和204被牵引在一起。当光学元件202和204被牵引在一起时,互锁特征206也成形为储存机械能。例如,互锁特征206可以包括通过向外牵引互锁特征206扭转的弹簧绕组。因此,当囊袋展平时,AIOL200将被牵引到未调节(低光学能力)状态。当囊袋松弛时,互锁特征206释放储存的机械能以使光学元件202和204分开,从而增加AIOL200的光学能力以提供调节。
为了使囊袋具有足够的张力以牵引互锁特征206,囊袋应当在未调节状态下紧紧地结合到互锁特征206。为了便于该结合,AIOL200可以包括保持特征,例如夹子,其将光学元件202和204保持在未调节状态,其中机械能储存在互锁特征206中。保持特征可以留在原位持续两周或以上,此时发生囊袋的术后愈合和结合。在结合过程之后,保持特征可以被去除或以另外方式禁用,例如通过引导激光脉冲以切除保持特征。保持特征也可以被制造成是可生物降解的,使得在囊袋结合完好之后它们随着时间腐蚀并且最后溶解。一旦保持特征不再将光学元件202和204保持在一起,当囊袋上的张力释放时储存在弹簧元件中的机械能可以释放,从而提供如上所述的调节。
图8A、8B和8C示出沿着光轴看到的互锁特征206的若干不同实施例。在图8A所示的实施例中,互锁特征206形成在AIOL200的周边处具有表面修饰的连续圆以便于附连到囊袋。在图8B所示的实施例中,互锁特征206包括窗口以便于囊细胞渗透进入互锁特征206。在图8C所示的实施例中,互锁特征206在六个T形接合部处连接,所述接合部具有表面修饰以促进囊细胞生长和结合到互锁特征206。所示的实施例仅仅是示例,并且具有适合于促进与囊袋的结合的表面修饰的、能够储存机械能的任何结构可以适合于互锁特征206。
图9是流程图300,示出用于植入双光学AIOL的示例性方法,该双光学AIOL与图7中所示的类似。在步骤302,提供具有互锁特征的双光学AIOL,所述互锁特征具有表面修饰以促进结合到囊袋。在步骤304,提供将AIOL200保持在未调节状态的保持特征。在步骤306,植入AIOL。在步骤308,允许囊袋愈合并且结合到AIOL。在步骤310,禁用保持特征以允许AIOL200响应囊袋的运动自由地移动。
图10示出适合用于上述的任何前述实施例的周围带400,但是它特别地示出用于图1的透镜10。当囊袋围绕透镜10愈合时,周围带400用于通过保留前和后小带中的张力而改善与囊袋的机械连接。适应性IOL通常产生的一个困难在于AIOL会比天然晶状体略微平坦。与它们围绕天然晶状体相比,当囊袋围绕IOL愈合时,这导致更多的前和后小带受到更大张力。周围带400具有足够的宽度以跨越小带所附连的囊袋的区域,因此防止囊袋在该区域中展平并且保留小带张力。这有利地改善来自囊袋的力传递。周围带400也可以附连到例如在图1中示出的活动铰链21以提供用于囊袋力的附加杠杆作用从而改变透镜10的形状。周围带400也可以由朝着已调节状态机械地偏置的弹性材料制造,从而当囊袋中的张力松弛时允许透镜10更容易地恢复到已调节位置。
与上述的其他实施例一样,周围带400具有促进囊袋结合到周围带400的表面修饰。周围带400机械地连接到透镜10或双光学AIOL200的互锁特征206,从而保留囊袋和AIOL的运动之间的稳健机械连接。例如可以通过将周围带400尺寸确定成使得它贴合地围绕AIOL配合,通过使用粘合剂将周围带400粘合到AIOL,或通过共聚合或以另外方式使周围带400与AIOL一体地形成而实现该机械连接。周围带400也可以包括用于预防PCO的尖锐角。
已提供本发明的各实施例,其包括促进结合到囊袋并且便于AIOL对囊袋的变化的机械响应以便产生调节作用的AIOL的示例。该描述仅仅为了图示和解释而给出。相关领域的技术人员将显而易见可以对上述的本发明进行变化和修改而不脱离如权利要求所述的本发明的范围。这样的修改例如包括使任何所述的实施例适合于药物输送或将诸如周围带的特征修改为减小正或负眩光。
Claims (28)
1.一种适合于植入囊袋中的适应性眼内透镜(AIOL),其包括:
外壳体,所述外壳体包括至少在所述外壳体的周边上的至少一个表面修饰以促进与囊袋的结合;
阀,所述阀配置成允许填充材料的注入;以及
在所述外壳体中的力传递组件,所述力传递组件适合于响应囊袋形状的变化传递来自囊袋的力以改变被填充的外壳体的形状。
2.根据权利要求1所述的AIOL,其还包括至少一个锐缘,所述至少一个锐缘成形为保持囊袋以减小后囊混浊。
3.根据权利要求1所述的AIOL,其还包括在所述AIOL的周边处的至少一个活动铰链。
4.根据权利要求1所述的AIOL,其中所述外壳体的不具有所述至少一个表面修饰的一部分被处理以防止囊袋的细胞生长。
5.根据权利要求1所述的AIOL,其中所述力传递组件包括多个加强肋。
6.根据权利要求1所述的AIOL,其中所述填充材料包括聚合物凝胶。
7.根据权利要求1所述的AIOL,其中所述外壳体还包括周围带,并且其中所述至少一个表面修饰在所述周围带上。
8.根据权利要求1所述的AIOL,其中所述至少一个表面修饰包括纳米纹理。
9.根据权利要求1所述的AIOL,其中所述至少一个表面修饰包括涂层,所述涂层包括用于囊袋的生长因子。
10.一种适合于植入囊袋中的双光学适应性眼内透镜(AIOL),其包括:
前光学器件;
后光学器件;以及
将所述前光学器件连接到所述后光学器件的互锁特征,所述互锁特征具有至少一个表面修饰以促进囊袋结合到所述互锁特征,其中所述互锁特征适合于在由被结合的囊袋向外牵引时储存机械能,并且其中所述互锁特征包括弹簧绕组。
11.根据权利要求10所述的双光学AIOL,其中所述互锁特征包括活动铰链。
12.根据权利要求10所述的双光学AIOL,其中所述至少一个表面修饰包括纳米纹理。
13.根据权利要求10所述的双光学AIOL,其中所述至少一个表面修饰包括涂层,所述涂层包括用于囊袋的生长因子。
14.根据权利要求10所述的双光学AIOL,其还包括连接到所述互锁特征的周围带。
15.根据权利要求10所述的双光学AIOL,其还包括保持特征,所述保持特征将机械能储存在所述互锁特征中以允许所述互锁特征结合到囊袋。
16.一种周围带,所述周围带适合于耦接到囊袋内的适应性眼内透镜(AIOL),囊袋在附连区域附连到多个小带,所述周围带具有至少一个表面修饰以促进结合到囊袋,所述周围带具有跨越囊袋的附连区域的宽度。
17.根据权利要求16所述的周围带,其中所述周围带被尺寸确定成围绕所述AIOL贴合地配合以将来自囊袋的力传递到所述AIOL。
18.根据权利要求16所述的周围带,其中所述周围带用粘合剂结合到所述AIOL。
19.根据权利要求16所述的周围带,其中所述周围带与所述AIOL一体地形成。
20.根据权利要求16所述的周围带,其中所述至少一个表面修饰包括纳米纹理。
21.根据权利要求16所述的周围带,其中所述至少一个表面修饰包括涂层,所述涂层包括用于囊袋的生长因子。
22.一种将适应性眼内透镜(AIOL)植入囊袋中的方法,其包括:
提供AIOL,所述AIOL包括:外壳体,所述外壳体包括至少在所述外壳体的周边上的至少一个表面修饰以促进与囊袋的结合;阀,所述阀配置成允许填充材料的注入;以及在所述外壳体中的力传递组件,所述力传递组件适合于响应囊袋形状的变化传递来自囊袋的力以改变被填充的外壳体的形状;
使用填充材料过度填充所述AIOL;
允许囊袋结合到所述AIOL的所述外壳体;以及
从所述AIOL去除填充材料以将所述AIOL置于未调节状态。
23.根据权利要求22所述的方法,其中所述填充材料包括聚合物凝胶。
24.根据权利要求22所述的方法,其中所述至少一个表面修饰包括纳米纹理。
25.根据权利要求22所述的方法,其中所述至少一个表面修饰包括涂层,所述涂层包括用于囊袋的生长因子。
26.一种植入双光学适应性眼内透镜(AIOL)的方法,其包括:
提供双光学AIOL,所述双光学AIOL包括:前光学器件;后光学器件;以及将所述前光学器件连接到所述后光学器件的互锁特征;以及保持特征,所述互锁特征具有至少一个表面修饰以促进囊袋结合到所述互锁特征,其中所述互锁特征适合于在由被结合的囊袋向外牵引时在弹簧绕组中储存机械能,并且所述保持特征适合于将机械能储存在所述互锁特征中以允许所述互锁特征结合到囊袋;
将所述双光学AIOL植入囊袋中;
允许囊袋结合到所述双光学AIOL;以及
释放所述保持特征。
27.根据权利要求26所述的方法,其中释放所述保持特征包括去除所述保持特征。
28.根据权利要求26所述的方法,其中释放所述保持特征包括用激光切除所述保持特征。
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RU2610545C2 (ru) | 2017-02-13 |
RU2013157799A (ru) | 2015-07-10 |
CA2833317C (en) | 2019-06-11 |
WO2012166435A1 (en) | 2012-12-06 |
AU2012262814A1 (en) | 2013-10-31 |
TW201300089A (zh) | 2013-01-01 |
TWI549665B (zh) | 2016-09-21 |
JP2014521394A (ja) | 2014-08-28 |
US20120310343A1 (en) | 2012-12-06 |
EP2685935B1 (en) | 2016-11-30 |
AU2012262814B2 (en) | 2016-07-07 |
CN103561684B (zh) | 2016-11-09 |
CA2833317A1 (en) | 2012-12-06 |
ES2615747T3 (es) | 2017-06-08 |
EP2685935A4 (en) | 2015-05-13 |
BR112013028038A2 (pt) | 2020-08-25 |
EP2685935A1 (en) | 2014-01-22 |
JP6023182B2 (ja) | 2016-11-09 |
AR086619A1 (es) | 2014-01-08 |
US9186243B2 (en) | 2015-11-17 |
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