CN106413634A - 双部件调节性人工晶状体设备 - Google Patents

双部件调节性人工晶状体设备 Download PDF

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CN106413634A
CN106413634A CN201480071996.3A CN201480071996A CN106413634A CN 106413634 A CN106413634 A CN 106413634A CN 201480071996 A CN201480071996 A CN 201480071996A CN 106413634 A CN106413634 A CN 106413634A
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crystalline lenses
crystalline
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focal power
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CN106413634B (zh
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D·布雷迪
T·希尔维斯托里尼
R·劳
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RAINESKEN Co
Lensgen Inc
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1635—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing shape
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/15—Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1682—Intraocular lenses having supporting structure for lens, e.g. haptics having mechanical force transfer mechanism to the lens, e.g. for accommodating lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/169—Surrounding optic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/16901—Supporting structure conforms to shape of capsular bag
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

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Abstract

本申请公开一种用于植入患者眼睛的囊袋内的双部件调节性人工晶状体(IOL)设备。IOL设备包含主晶状体组件和焦度变化晶状体。主晶状体组件包含固定晶状体和设置在外围的对中构件。对中构件具有周向远侧边缘和邻近周向远侧边缘的第一耦合表面。焦度变化晶状体具有封闭的并且填充有流体或凝胶的晶状体腔以及设置在晶状体腔外围的触觉系统。触觉系统具有被配置成接触囊袋的外围接合边缘和第二耦合表面。第一和第二耦合表面互相滑动接触以允许焦度变化晶状体相对于主晶状体组件移动并且还在焦度变化晶状体的径向压缩期间维持固定晶状体和晶状体腔之间的间隔关系。

Description

双部件调节性人工晶状体设备
技术领域
本发明总体涉及调节性人工晶状体设备，并且更具体地涉及被配置用以植入对象眼睛的晶状体囊中的调节性人工晶状体设备。
背景技术
当技术进步允许进行复杂的介入以解决各种眼科疾病时，对眼睛进行外科手术也在上升趋势。由于这种手术已经被证明总体安全并且可以产生显著改善患者生活质量的效果，所以在最近二十年病人接受者已经增加。
白内障外科手术仍然是最常见的外科手术之一，其中超过一千六百万白内障手术在全世界进行。随着平均寿命预期继续上升，可以预期该数量将会继续增加。白内障通常通过从眼睛移除晶状体并且在其位置植入人工晶状体(IOL)来治疗。因为常规的IOL设备主要对远距视力(distance vision)聚焦，所以它们不能矫正老视并且仍然需要老花镜。因此，虽然经历了标准的IOL植入的患者不再经受白内障的浑浊，但是他们不能从近到远、从远到近以及在之间的距离处调节或改变焦距。
矫正眼睛的屈光不正(refractive errors)的外科手术也变得非常普通，镭射视力矫正手术(LASIK)变得非常普及，其中每年进行超过700000例手术。鉴于屈光不正的高患病率和这种手术相对安全且有效，预期越来越多的人会转向LASIK或其他的外科手术，而不是常规的眼镜或隐形眼镜。尽管LASIK在治疗近视方面取得了成功，但是仍存在用于矫正老视的有效外科介入的未能满足的需要，其中老视不能通过常规的LASIK手术来治疗。
由于近来每个白内障患者还会遭受老视，所以治疗这些疾病存在收敛的市场需求。医生和患者普遍接受将可植入人工晶状体用于白内障的治疗，但是矫正老花眼的类似手术仅仅占了美国白内障市场的5％。因此，存在解决日渐老龄化人口中的眼科白内障和/或老视的需要。
发明内容
由于双部件调节性IOL设备的独立的双部件构造，本文公开的双部件调节性IOL设备提供了多个优点。植入IOL设备要求显著减小的切口尺寸，因为IOL设备的两个部件被分开植入并且因此显著地减小用于植入的递送轮廓。减小的切口尺寸提供了多个优点，包含避免对麻醉和用于闭合切口部位的缝合的需要以及改善的手术效果。
此外，在外科手术期间可以提供更多的控制以便调整IOL的尺寸和焦度。主要晶状体到晶状体囊的植入将会为医生提供患者晶状体囊的尺寸的印象，并且将会因此帮助确认将随后植入的焦度变化晶状体的矫正尺寸。
在一个实施例中，描述了用于植入患者的眼镜的囊袋内的双部件调节性人工晶状体(IOL)设备。IOL设备包括主晶状体组件和焦度变化晶状体组件。主晶状体组件包括固定晶状体和设置在固定晶状体外围的对中构件。对中构件具有周向远侧边缘和靠近周向远侧边缘的第一耦合表面。焦度变化晶状体包括封闭的且填充有流体或凝胶的晶状体腔和设置在晶状体腔外围的触觉系统。触觉系统具有被配置成接触囊袋的外围接合边缘和面对第一耦合表面并且邻近外围接合边缘定位的第二耦合表面。第一和第二耦合表面互相滑动接触以允许焦度变化晶状体相对于主晶状体组件移动。当焦度变化晶状体被径向压缩时，第一和第二耦合表面维持固定晶状体和晶状体腔之间的间隔关系。
根据第一方面，在没有径向压缩的情况下，焦度变化晶状体的直径d1大于主晶状体组件的直径d2。
根据第二方面，在调节期间，固定晶状体不会改变形状或曲率。
根据第三方面，在调节期间，晶状体腔改变形状和曲率两者。
根据第四方面，固定晶状体和晶状体腔是正焦度晶状体。
根据第五方面，填充有流体或凝胶的晶状体腔是双凸面的晶状体。
根据第六方面，固定晶状体组件包括在光学区之外绕着固定晶状体周向定位的直角边缘。
根据第七方面，对中构件和触觉系统的面对表面均包括互补且互锁对中的一个，互锁对分别绕着固定晶状体和焦度变化晶状体周向设置。
根据第八方面，外围接合边缘比周向远侧边缘更厚。
根据第九方面，周向远侧边缘与外围接合边缘的厚度比的范围在约1:5到约1:2。
根据第十方面，主晶状体组件具有比焦度变化晶状体更高的杨氏弹性模量。
根据第十一方面，对中构件和触觉系统中的至少一个包括多个开口。
根据第十二方面，焦度变化晶状体包括沿着外围边缘的径向力作用时互相远离移位的两个相对表面，两个相对表面具有中心区域和外围区域以及从外围区域到中心区域逐渐增加的厚度剖面。
在另一实施例中，描述了用于植入患者眼睛的囊袋内的双部件调节性人工晶状体(IOL)设备。IOL包括主晶状体组件和焦度变化晶状体组件。主晶状体组件包括固定晶状体和设置在固定晶状体外围的对中构件。对中构件具有径向可压缩的外围边缘，其具有被配置成接合患者眼睛的囊袋的外部周向表面和与外部周向表面径向向内间隔的内部周向表面。焦度变化晶状体包括封闭的且填充有流体或凝胶的晶状体腔和设置在晶状体腔外围的触觉系统。触觉系统具有被配置成接合内部周向表面的周向边缘。作用于外部周向表面的径向压缩引起曲率增加和晶状体腔直径减小中的至少一个，并且作用于外部周向表面的径向压缩不引起固定晶状体的曲率增加或其直径减小。
根据第一方面，对中构件还包括在固定晶状体和外围边缘之间的周向铰链，周向铰链被设置在对中构件的相对侧上。
根据第二方面，对中构件还包括在固定晶状体和外围边缘之间的单个周向铰链。
根据第三方面，周向铰链被设置在面对焦度变化晶状体的触觉件的内部表面上。
根据第四方面，触觉系统的周向边缘和外围边缘的内部周向表面具有互补的圆形表面，并且作用于外部周向表面的径向压缩引起外围边缘绕着周向铰链径向向内倾斜。
根据第五方面，焦度变化晶状体被整个包含在主晶状体组件的外围边缘内。
根据第六方面，焦度变化晶状体还包括从周向边缘的内表面径向向内设置的周向凸缘(lip)。
根据第七方面，焦度变化晶状体包括沿着外围边缘的径向力作用时互相远离移位的两个相对表面，两个相对表面具有中心区域和外围区域，其中中心区域的厚度是外围区域的厚度的至少两倍，优选至少三倍并且更优选地至少四倍。
在进一步实施例中，描述了将双部件IOL设备植入患者眼睛的囊袋内的方法。该方法包括首先通过位于角膜内的切口将主晶状体组件插入和安置患者眼睛的囊袋内，主晶状体具有固定晶状体和设置在固定晶状体外围的对中构件。下一步包括将焦度变化晶状体插入和安置到患者眼睛的囊袋内在主晶状体组件的前方，焦度变化晶状体包括封闭的并且填充有流体或凝胶的晶状体腔以及设置在晶状体腔外围的触觉系统，触觉系统具有被配置成接触囊袋的外围接合边缘。主晶状体组件接触囊袋的后部部分并且焦度变化晶状体在植入后接触囊袋的前部部分。固定晶状体和晶状体腔以光学轴线为中心。
根据第一方面，切口小于5mm，优选地小于4mm，并且更优选地小于3mm。
根据第二方面，两个插入步骤都通过切口进行。
根据第三方面，该方法还包括在将焦度变化晶状体插入和安置之前注射粘弹性材料。
所述优选实施例的其他目的、特征以及优点对于阅读以下具体实施方式的本领域技术人员来说是明显的。然而，将会理解的是，当提到本发明的优选实施例时，具体描述和特定示例通过说明而非限制的方式给出。可以做出本发明范围内的许多改变和修改而不偏离本发明的精神，并且本发明包含所有的这种修改。
附图说明
通过参考附图，本文描述了本公开的说明性实施例，其中：
图1是双部件调节性IOL的实施例的分解透视图。
图2是图1中的双部件调节性IOL的分解侧面截面图。
图3是图1中的双部件调节性IOL的组装侧视图，其中焦度变化晶状体和主晶状体互相滑动接触。
图4A到图4F是双部件调节性IOL的各种实施例的横截面图。
图5是双部件调节性IOL的实施例的分解透视图。
图6A和图6B是图5的双部件IOL的焦度变化晶状体的俯视平面图和侧视平面图。
图7A和图7B是图5的双部件IOL的主晶状体的俯视平面图和侧视平面图。
图8A和图8B是双部件调节性IOL的另一实施例的分解截面图和耦合截面图，其中焦度变化晶状体和主晶状体耦合到一起。
图9A和图9B是双部件调节性IOL的替代实施例的截面图，其中焦度变化晶状体和晶状体耦合到一起。
图10A和图10B是双部件调节性IOL的进一步实施例的分解截面图和耦合截面图，其中焦度变化晶状体和主晶状体耦合到一起。
图11A到图11F是主晶状体的各种替换实施例的俯视图。
相同的数字在附图的若干视图中指代相同的部件。
具体实施方式
本发明的具体的非限制实施例将参考附图来描述。应该认识到，这种实施例作为示例并且只说明本发明范围内的仅少数实施例。对本发明所属领域技术人员来说明显的各种改变和修改被视为在本发明所附权利要求进一步限定的精神、范围和意图内。
图1-3描绘了双部件调节性IOL设备100的实施例，其中焦度变化晶状体110和主晶状体120互相滑动接触。
焦度变化晶状体110被描绘为包括填充有流体或凝胶的晶状体室112和设置在填充有流体或凝胶的晶状体室112外围的触觉系统114。触觉系统114包括被配置以接合患者眼睛的囊袋的外围接合边缘116，外围接合边缘116通常处在其经由小带(zonules)附连至睫状肌的位置。多个通孔115可以沿着触觉系统114的周边设置以减小材料体积并且因此减小焦度变化晶状体110的递送轮廓(delivery profile)。
主晶状体120被描绘为包括固定焦度晶状体122和关于固定焦度晶状体对称设置的多个对中构件124。对中构件124包括远侧边缘126和通孔125以减小对囊袋施加的径向压缩的阻力。
焦度晶状体110内孔115的存在可以允许操纵其下的焦度晶状体110和主晶状体120两者。孔115也帮助减小焦度晶状体110的递送轮廓并且允许操纵焦度晶状体110和主晶状体120两者以在植入期间将其定心在囊袋内。孔115的存在还可以减小焦度晶状体的刚度。类似地，主晶状体120还具有孔125，孔125允许操纵和减小递送轮廓。主晶状体120的孔125被额外成形以便在主晶状体120已经被植入后当焦度变化晶状体110被植入到患者眼睛的囊袋时减小抓取焦度变化晶状体110的可能性。
焦度变化晶状体110和主晶状体120被配置成互相滑动接触，同时维持填充有流体或凝胶的晶状体室112和固定焦度晶状体122之间分离。在一个实施例中，该距离通过将触觉系统114和对中构件124中的任一者或两者朝向彼此成角度来维持。如图2和图3所示，焦度变化晶状体110和主晶状体120之间的滑动接触分别在第一和第二耦合表面118、128形成。
焦度变化晶状体110被设计大小并且被成形为承受并且响应沿着晶状体110的外围边缘116作用的径向向内的力。相反，主晶状体120不参与提供调节性响应并且因此被设计大小并且被成形为避免干扰或抵抗作用到焦度变化晶状体110的径向压缩力。这可以通过控制焦度变化晶状体110和主晶状体120的相对直径和厚度以便使作用到焦度变化晶状体110上的径向压缩力的程度最大并且使作用到主晶状体120上的这些力的程度最小来实现。
在优选的实施例中，如图2所描绘的，焦度变化晶状体110的外围接合边缘116的厚度t1比固定焦度晶状体122的远侧边缘126的厚度t2厚得多。在优选实施例中，t1与t2的厚度比为2:1，优选地为3:1，更优选地为4:1并且最优选地为5:1。在另一优选实施例中，如图3所示，焦度变化晶状体110的直径d1大于主晶状体120的直径d2。
在一个优选实施例中，晶状体室112的至少相对侧或壁由一种材料制成，该材料具有足够的机械强度以在植入期间承受物理操纵，而且具有足够低的杨氏模量以便使其对变形的阻力最小。在优选实施例中，晶状体室112的相对侧由具有100psi或更小的，优选为75psi或更小，并且最优选地为50psi或更小的杨氏模量的聚合物制成。在一个优选实施例中，IOL 100的其余部分具有的杨氏模量大于晶状体室112的杨氏模量。晶状体室112的壁可以是聚合物，优选为硅酮聚合物，并且更优选地为苯基硅氧烷，例如乙烯基封端的苯基硅氧烷(vinyl-terminated phenyl siloxane)或乙烯基封端的二苯基硅氧烷(vinyl-terminated diphenyl siloxane)。为了给予足够的机械强度，聚合物可以与填料交联、加强或两者。填料可以是被功能化以与聚合物反应的树脂或二氧化硅。
晶状体室112的壁限定了填充有流体或凝胶的封闭腔，流体或凝胶具有特定的物理和化学特性以增强调节期间由IOL提供的折射焦度(refractive power)的范围。流体或凝胶被选择使得其与焦度变化晶状体110配合以提供足够范围的调节，所述调节高达至少3屈光度、优选地高达至少5屈光度、优选地高达至少10屈光度并且最优选地高达至少15屈光度。在优选的实施例中，在将IOL100植入眼睛的囊袋40之前，封闭腔被填充有流体或凝胶，在更优选的实施例中，所述腔在IOL的制造期间就被填充有流体或凝胶。
图4A-4F和图8-10更清楚地描绘了焦度变化晶状体(210、310、410、510)内所含的流体或凝胶(213、313、413、513)的位置。在一个优选实施例中，晶状体室112的壁限定的封闭腔被填充有流体，例如气体或液体，该流体具有室温下的低粘度和高折射率。在优选实施例中，流体(213、313、413、513)是在23℃下具有1000cP或更小的粘度和至少1.46、1.47、1.48或1.49的折射率的液体。流体可以是聚合物，优选地为硅酮聚合物，并且更优选地为苯基硅氧烷聚合物，例如乙烯基封端的苯基硅氧烷或乙烯基封端的二苯基硅氧烷聚合物。优选地，在流体由聚合物制成的实施例中，聚合物优选地不被交联并且聚合物可以是线性的或含支链的。在流体是乙烯基封端的苯基硅氧烷聚合物或乙烯基封端的二苯基硅氧烷聚合物的情况下，乙烯基群可以反应以形成其他基团，所述其他基团不形成交联。
根据一个实施例，流体(213、313、413、513)可以是聚苯醚(“PPE”)，如Teledyne Licensing LLC的标题为“Variable Focus Liquid-Filled Lens UsingPolyphenyl Ethers”的美国专利US7256943中描述的，该专利的全部内容通过引用并入本文，如同本文全部阐述。
根据另一实施例，流体(213、313、413、513)可以是含氟聚苯醚(“FPPE”)。FPPE具有独特的优点，其提供可调的折射率同时是具有色散属性的化学惰性生物兼容流体。可调性通过增加或降低聚合物的苯基和氟含量来提供。增加苯基含量将会有效增加FPPE的折射率，而增加氟含量将会降低FPPE的折射率同时降低FPPE流体通过晶状体室112的壁的渗透性。
在另一优选的实施例中，晶状体室112的壁限定的封闭腔被填充有凝胶(213、313、413、513)。凝胶(213、313、413、513)优选地具有至少1.46、1.47、1.48或1.49的折射率。凝胶也可以优选地具有20psi或更小、10psi或更小、4psi或更小、1psi或更小、0.5psi或更小、0.25psi或更小以及0.01psi或更小的杨氏模量。在优选的实施例中，凝胶(213、313、413、513)是交联的聚合物，优选地为交联硅酮聚合物，并且更优选地为交联苯基硅氧烷聚合物，例如乙烯基封端的苯基硅氧烷聚合物或乙烯基封端的二苯基硅氧烷聚合物。除了硅氧烷聚合物之外，其他光学透明的聚合物液体或凝胶也可以用于填充封闭腔并且这种聚合物可以是含支链的、不含支链的、交联的或不交联的或者前述的任何组合。
与大部分液体相比，凝胶具有扩大分子量交联、更加自粘结并且还可粘结到晶状体室112的壁或相对侧的优点。这使得凝胶不太可能通过焦度变化晶状体的壁泄露。为了获得焦度变化晶状体的可调节焦度与相对小的曲率变形的组合，凝胶(213、313、413、513)被选择以便具有高折射率，同时由特征是具有低杨氏模量的光学透明材料制成。因此，在优选实施例中，凝胶具有1.46或更大的折射率，优选地为1.47或更大，1.48或更大并且最优选地为1.49或更大的折射率。同时，凝胶优选地具有10psi或更小的杨氏模量，优选地为5psi或更小以及更优选地为1psi或更小的杨氏模量。在特定优选的实施例中，凝胶具有的杨氏模量为0.5psi或更小，优选地为0.25psi或更小并且最优选地为0.01psi或更小。应该理解的是，杨氏模量越低，对于给定的作用力单位，凝胶将表现出对变形的更小的阻力并且因此焦度变化晶状体110的变形更大。
在特定的优选实施例中，凝胶是基于以下四个公式之一产生的乙烯基封端的苯基硅氧烷：
公式1：
100份20-25摩尔％的乙烯基封端的二苯基硅氧烷-二甲基硅氧烷共聚物(Gelest PDV 2335)。
3ppm铂络合物催化剂
0.35pph的苯基硅氧烷氢化物交联剂(Nusil XL-106)
杨氏弹性模量＝0.0033psi
公式2：
100份20-25摩尔％乙烯基封端的二苯基硅氧烷-二甲基硅氧烷共聚物(Gelest PDV 2335)
3ppm铂络合物催化剂
0.4pph的苯基硅氧烷氢化物交联剂(Nusil XL-106)
杨氏弹性模量＝0.0086psi
公式3：
100份20-25摩尔％乙烯基封端的二苯基硅氧烷-二甲基硅氧烷共聚物(Gelest PDV 2335)
3ppm铂络合物催化剂
0.5pph的苯基硅氧烷氢化物交联剂(Nusil XL-106)
杨氏弹性模量＝0.0840psi
公式4：
100份20-25摩尔％乙烯基封端的二苯基硅氧烷-二甲基硅氧烷共聚物(Gelest PDV 2335)
3ppm铂络合物催化剂
0.6pph的苯基硅氧烷氢化物交联剂(Nusil XL-106)
杨氏弹性模量＝2.6psi
晶状体室的壁和腔内所含的流体或凝胶被优选选择从而防止或减小流体或凝胶迁移到晶状体室之外的可能性。因此，在优选实施例中，焦度变化晶状体和流体或凝胶(213、313、413、513)中的一者或两者选自生物兼容材料，所述生物兼容材料优化了对流体或凝胶穿过焦度变化晶状体的渗透性的阻力。
降低腔内所含的凝胶穿过焦度变化晶状体的渗透性的一个方法是提供交联的凝胶。然而，交联的度必须被选择并且被控制，从而使得一方面，焦度变化晶状体和凝胶具有足够低的杨氏模量以使焦度变化晶状体变形的阻力最小，另一方面，使凝胶穿过焦度变化晶状体的渗透性最小。因此，在优选实施例中，期望较长链的聚合物，其被轻度交联，例如硅酮凝胶所用的那些聚合物，这种聚合物起始于具有分子量大于35000道尔顿，优选地大于50000道尔顿并且最优选地至少70000道尔顿的单体。
在另一优选实施例中，使用具有低渗透性的萃取物的凝胶。这种凝胶可以通过使用含支链的长链聚合物来按配方制造。
在优选实施例中，晶状体室壁和凝胶中的一者或两者可以由苯基取代的硅酮的均聚合物或共聚合物制成。
对于晶状体室壁，交联的均聚合物或共聚合物优选地具有5-25mol％，优选地10-20mol％，并且更优选地15-18mol％的二苯基含量。可替代地，对于晶状体室壁，均聚合物或共聚合物优选地具有10-50mol％、优选地20-40mol％并且更优选地30-36mol％的苯基含量。
对于凝胶，均聚合物或共聚合物优选地具有10-35mol％，优选地15-30mol％并且更优选地25-25mol％的二苯基含量。可替换地，对于凝胶，均聚合物或共聚合物优选地具有20-70mol％、优选地30-60mol％并且更优选地为40-50mol％的苯基含量。
在特定优选实施例中，晶状体室的壁由交联的苯基硅氧烷制成，该苯基硅氧烷具有约15-18mol％的二苯基含量或约30-36mol％的苯基含量，并且凝胶由苯基硅氧烷制成，该苯基硅氧烷具有约20-25mol％的二苯基含量或者约40-50mol％的苯基含量。晶状体室的壁被理解为比凝胶更加交联。
在特定的优选实施例中，晶状体室壁由乙烯基封端的苯基硅氧烷制成，最优选由交联的乙烯基封端的苯基硅氧烷制成。例如二氧化硅的增强剂也可以被包含在内，其范围为10-70mol％，优选地为20-60mol％并且最优选地为30-50mol％。
晶状体室的壁和腔内所含的流体或凝胶还被优选地选择从而增加由晶状体室提供的可调节焦度的范围。在优选实施例中，晶状体室的壁由具有比封闭腔内所含的流体或凝胶更低的折射率的材料制成。在一个优选实施例中，晶状体室的壁的折射率为1.38，而其内所含凝胶或流体的折射率为1.49。
晶状体室壁和晶状体室内所含的凝胶或液体所提供的折射率差可以由晶状体室壁和凝胶或液体所用的材料或该材料的成分的不同来提供。
在一个实施例中，晶状体室壁和凝胶或液体两者都是由具有不同的二苯基或苯基含量的苯基硅氧烷制成。在优选实施例中，晶状体室壁具有的二苯基或苯基含量小于凝胶或液体的二苯基或苯基含量。在另一优选实施例中，晶状体室的壁可以由交联的乙烯基封端的苯基硅氧烷制成，所述交联的乙烯基封端的苯基硅氧烷具有约为15-18mol％的二苯基含量或者约为30-36mol％的苯基含量，而晶状体室壁内所含的凝胶可以由乙烯基封端的苯基硅氧烷制成，所述乙烯基封端的苯基硅氧烷具有20-25mol％的二苯基含量或者30-36mol％的苯基含量。
在另一实施例中，折射率差可以通过向晶状体室壁提供二苯基硅氧烷来提供，并且凝胶可以是具有高二苯基或苯基含量的苯基硅氧烷。在优选实施例中，二苯基含量至少为20mol％，至少为25mol％，至少30mol％，至少35mol％，以及至少为40mol％。可替换地，苯基含量至少为40mol％，至少50mol％，至少60mol％，至少70mol％以及至少80mol％。
在进一步的实施例中，折射率差可以通过交联的氟硅氧烷来提供，例如3,3,3-三氟丙基甲基硅氧烷(3,3,3-trifluoropropylmethyl siloxane)，并且凝胶可以是具有高二苯基或苯基含量的苯基硅氧烷。在优选实施例中，二苯基含量至少为20mol％，至少25mol％，至少30mol％，至少35mol％以及至少40mol％。可替换地，苯基含量至少为40mol％，至少50mol％，至少60mol％，至少70mol％以及至少80mol％。
图4A-4F描绘了双部件IOL设备200A-F的替代实施例，其中焦度变化晶状体210和主晶状体230的形状和配置变化。
在这些实施例中的每个实施例中，某些特征保持相同。焦度变化晶状体210被描绘为包括填充有流体或凝胶的晶状体室212和设置在该填充有流体或凝胶的晶状体室212外围的触觉系统214。晶状体室212包括两个相对表面，这两个相对表面被划分成围绕中心轴线A-A(见图1)的中心区域212a、212b和外围区域211a、211b。在优选实施例中，中心区域212a、212b具有从外围区域211a、211b径向朝着晶状体室212的中心逐渐增加的厚度。
在优选实施例中，中心区域211a、212b的中心点具有的厚度是外围区域211a、211b的厚度的两倍或更多倍，优选地为三倍或更多倍，并且最优选地为4倍或更多倍。流体或凝胶213被包含在相对表面之间。在另一优选实施例中，中心区域212a、212b最大厚度处的点与外围区域211a、211b最小厚度处的点的比率为2:1或更大，优选地为3:1或更大，并且最优选地为4:1或更大。在优选实施例中，中心区域212a、212b的光学轴线或中心处的厚度约为200微米，而外围区域211a、211b处的厚度约为50微米。在中心区域212a、212b内提供增加的厚度从而可以在晶状体室212响应于调节而变形时防止晶状体室212的相对表面弯曲。应理解，在图中所描绘的焦度晶状体的各实施例中，相对侧优选地具有如本文描述的和在图4A-4F描绘的厚度剖面。参考的光学轴线或在此作出的光学轴线A-A被理解为表示横贯IOL设备的中心的线，如图1所示。
当眼睛分别被不调节和调节时，晶状体室212的相对表面朝向彼此致动或彼此远离。触觉系统214包括外围接合边缘216和邻近外围接合边缘216的第一耦合表面218。主晶状体组件230包括固定晶状体232和围绕固定晶状体232设置的多个对中构件224。对中构件224包括远侧边缘236和与焦度变化晶状体210的第一接触表面218滑动接触的第二接触表面238。
在优选实施例中，当沿着光学轴线A-A测量时，主晶状体230比晶状体室212的相对侧中的一侧厚得多。在优选实施例中，晶状体室212的相对侧中的每侧沿着光学轴线A-A的厚度小于主晶状体230在中心光学轴线A-A处的厚度的1/2，优选地小于1/3，优选地小于1/4，并且最优选地小于1/5。因为主晶状体230比晶状体室212的相对侧中的任一侧厚得多，所以主晶状体230具有比室212的相对侧中任一侧的有效杨氏模量大得多的有效杨氏模量。
现在转向双部件IOL设备的各个区别特征，参考图4A中的IOL设备200A，其中主晶状体230被描绘为包括铰链240和成角度的或直角边缘239。铰链240被提供在对中构件224上以允许其响应于施加在囊袋上的可调节力而轴向弯曲、径向压缩或两者。因此，铰链240允许这些可调节力作用在焦度变化晶状体210的外围接合边缘216上以便互相远离或朝向彼此地致动相对表面212a、212b。直角边缘239被提供以帮助将主晶状体组件固定到囊袋并且还可以减小后囊混浊(PCO)发生的可能性。
图4B描绘了在许多方面与图4A类似的IOL设备200B，除了设置在对中构件224上的铰链242宽得多从而响应于施加在囊袋上并且因此施加到对中构件224的远侧边缘236上的可调节力而提供对弯曲、压缩或两者的较小阻力。应该理解的是，对于IOL设备200A、200B两者，铰链240被提供在背对焦度变化晶状体210的表面上，并且因此当径向压缩力被作用到远侧边缘236时，远侧边缘236沿着远离焦度变化晶状体210的方向枢转。
图4C描绘了IOL设备200C，其中主晶状体组件230包括绕着固定晶状体232外围的仅直角边缘239。因为主晶状体组件230不包含铰链，所以预期这种IOL设备200C将比在图4A和4B中分别描绘的IOL设备200A和200B的刚度大得多。
图4D描绘了IOL设备200D，其类似于图4B中的IOL设备200B，除了铰链244现在位于面对焦度变化晶状体210的表面上。因此，当径向压缩力被作用到远侧边缘236时，远侧边缘236将沿朝向焦度变化晶状体210的方向枢转。
图4E描绘IOL设备200E在焦度变化晶状体210和固定晶状体组件230之间具有更大程度的接合。焦度变化晶状体210和固定晶状体组件230包括互补且互锁的钩状物250、260，所述钩状物250、260分别被设置在填充有流体或凝胶的晶状体室212和固定晶状体232外围。与图4A-4D中描绘的IOL设备不同，焦度变化晶状体210和固定晶状体组件230通过互锁钩状物250、260的接合互相耦连。
图4F描绘了IOL设备200F，其中焦度变化晶状体210包括外围接合边缘216下方的周向突出物246以将固定晶状体组件230的移动约束在周向部分246限定的边界内。结果，应该认识到固定晶状体组件230具有比周向突出物246限定的直径更小的直径。
图5-8描绘了双部件IOL设备300的另一实施例，其中焦度变化晶状体310被约束在固定晶状体组件350的边界内。如图5-6所示，焦度变化晶状体310具有大致盘形的外部表面并且包括封闭的填充有流体或凝胶的晶状体312、触觉系统314以及周向外围接合边缘316。焦度变化晶状体310进一步包括设置在封闭的填充有流体或凝胶的晶状体312外围的多个周向孔315。填充有流体或凝胶的晶状体312包括被划分成中心区域312a、312b和外围区域311a、311b的两个相对表面。在优选实施例中，中心区域312a、312b具有从外围区域311a、311b径向朝着填充有流体或凝胶的晶状体312的中心逐渐增加的厚度。在优选实施例中，中心区域312a、312b的中心点具有的厚度是外围区域311a、311b的厚度的两倍或更多，优选地为三倍或更多，并且最优选地为四倍或更多。流体或凝胶313被包含在相对表面之间。在另一优选实施例中，中心区域312a、312b内的最大厚度的点和外围区域311a、311b内的最小厚度的点的比为2:1或更大，优选地为3:1或更大，并且最优选地为4:1或更大。在优选实施例中，中心区域312a、312b的光学轴线或中心处的厚度约为200微米，而外围区域311a、311b处的厚度为50微米。在中心区域312a、312b内提供增加的厚度从而在填充有流体或凝胶的晶状体312响应于调节而变形时防止填充有流体或凝胶的晶状体312的相对表面弯曲。
固定晶状体组件350被配置成容纳并且接收焦度变化晶状体310。固定晶状体组件350包括设置在中心的固定晶状体352和由固定晶状体352、外围侧壁356以及多个径向伸出部358限定的内部腔，所述多个径向伸出部358从外围侧壁356的顶部向内突出。周向凹槽或铰链354围绕着固定晶状体352并且允许外围侧壁356径向向内枢转或压缩。多个周向孔359绕着固定晶状体352的外围被提供以允许房水流体(aqueous fluid)流过其中并且进入焦度变化晶状体310和固定晶状体组件350之间限定的腔375(图8B)内。孔359还减少了材料体积并且因此减小了固定晶状体组件350的递送轮廓。如图8B所示，空间375被限定在焦度变化晶状体310和固定晶状体组件350之间。
双部件IOL设备300的植入和组装遵循两个步骤。第一步，将固定晶状体组件350遵循囊水平轴(capsulhorexis)插入眼睛的囊袋。固定晶状体组件350被定中心使得外围侧壁356接合囊袋的周向区域，囊袋的周向区域被最紧密地连接到小带(zonule)，并且固定晶状体352以光学轴线为中心并且接触囊袋的后部部分。第二步，将焦度变化晶状体310插入囊袋并且安置在固定晶状体组件350的腔375内，从而使得外围接合边缘316接近或接触外围侧壁356的内部表面360。因此，作用到外围侧壁356的径向压缩被传递到焦度变化晶状体310的外围接合边缘316，从而使得填充有流体或凝胶的晶状体分别响应于眼睛的睫状肌的松弛和收缩而增加和减小曲率以提供调节。
图9-10是双部件IOL设备的各实施例的截面图。
图9A和图9B是双部件IOL设备400A、400B的两个替换实施例的截面图。在两个实施例中，双部件IOL设备包括焦度变化晶状体410和固定晶状体组件450。焦度变化晶状体410包括由相对表面限定的填充有流体或凝胶的晶状体室412和约束在其内的流体或凝胶413。具有接合边缘416的触觉件414被提供在晶状体室412的外围。固定晶状体组件450包括设置在中心的固定晶状体452和设置在晶状体452外围的铰链454。铰链454优选设置在固定晶状体组件450的面对焦度变化晶状体410的表面上，从而使得作用到周向外围456的径向压缩力引起其朝向焦度变化晶状体410枢转并且因此将径向压缩力传递到填充有流体或凝胶的晶状体412的接合边缘416上以实现填充有流体或凝胶的晶状体室412的相对侧的曲率改变。IOL设备400A和400B之间的区别在于设备400A内的接合边缘416与周向外围456的内部表面460是间隔关系，而设备400B内的接合边缘416在没有径向作用力时与周向外围456的内部表面460接触。
另外，IOL设备400A、400B在焦度变化晶状体410和固定晶状体组件450之间的接触点处被提供有弧形表面，以便促进焦度变化晶状体410和固定晶状体组件450之间滑动移动。因此，在优选实施例中，至少周向外围456、接合边缘416和周向外围456的内部表面460是弧形表面。
图10A和图10B描绘了双部件IOL设备500的另一实施例，其包括焦度变化晶状体510和固定晶状体组件550。焦度变化晶状体510包括由两个相对侧限定的封闭晶状体室512，封闭晶状体室512响应于作用到触觉件514的外围516的径向力而改变曲率。
两个相对表面被划分成中心区域512a、512b和外围区域511a、511b。在优选实施例中，中心区域512a、512b具有从外围区域511a、511b径向朝着封闭晶状体室512的中心逐渐增加的厚度。在优选实施例中，中心区域512a、512b的中心点处的厚度是外围区域511a、511b的厚度的两倍或更多，优选地为三倍或更多，并且最优选地为四倍或更多。流体或凝胶213被约束在相对表面之间。在另一优选实施例中，中心区域512a、512b内的最大厚度的点和外围区域511a、511b内的最小厚度的点的比为2:1或更大，优选地为3:1或更大，并且最优选地为4:1或更大。在优选实施例中，中心区域512a、512b的光学轴线或中心处的厚度约为200微米，而外围区域511a、511b处的厚度约为50微米。在中心区域512a、512b内提供增加的厚度从而在封闭晶状体室512响应于调节而变形时防止封闭晶状体室512的相对表面弯曲。应该认识到在附图所描绘的焦度晶状体的各个实施例中，相对侧优选地具有如本文描述的和图4A-4F描绘的厚度剖面。
固定晶状体组件550包括形状或曲率不改变的固定晶状体552。内部腔由固定晶状体552和周向侧壁560来限定。周向铰链554被提供在固定晶状体组件550上固定晶状体552的外围。铰链554绕着固定晶状体554设置并且因此允许外围侧壁556沿着箭头B的方向被径向向内压缩以在接触外围516处压缩焦度变化晶状体510。进而，这使得相对侧512a、512b互相远离地成弧形。当径向力不再作用时，固定晶状体组件弹性偏置到扩展和未调节状态，并且外围侧壁沿着箭头A所示的方向扩展。
图11A-11F描绘了固定晶状体组件600A-F的各个替换实施例，其可以结合本文所述的任一固定晶状体组件一起使用以形成图1-3所述类型的双部件IOL设备。如图11A-11F中的每幅图所示，触觉件614A-F以对称方式设置从而确保焦度变化晶状体的对中。图11A描绘了固定晶状体组件600A，其具有被四个对称设置的凸出部614A围绕的晶状体612A。每个凸出部包括孔口615A和被配置成接合患者眼睛的囊袋的接合边缘616A。图11B描绘了四个触觉件614B的类似布置，除了每个触觉件均具有圆边616B并且触觉件对互相指向对方。图11C描绘了四个触觉件614C的布置，其也具有圆边616C，其中触觉件指向相同的方向。
图11D描绘了固定晶状体组件600D，其包括晶状体612D和多个触觉件614D，每个触觉件具有贯穿设置的孔口615D。触觉件614D还包括定尺寸的指状物620，指状物620从外部接合边缘616D突出。双部件IOL设备的植入一般要求首先植入固定晶状体组件。在固定晶状体组件被植入并且安置之后，晶状体囊壁可以压缩接合边缘616D并且将定尺寸的指状物620朝向晶状体612D移位。定尺寸的指状物620朝向晶状体612D移位的程度提供了患者晶状体囊的尺寸的指示从而允许选择尺寸合适的焦度变化晶状体，所述尺寸合适的焦度变化晶状体随后被植入到患者的晶状体囊内。
图11E描绘了另一个固定晶状体组件600E，其包括四个触觉凸出部614E，每个触觉凸出部包括三角形形状的孔口615E和外围接合边缘616E。三角形形状的孔口615E的意义在于减小植入期间划破(snag)焦度变化晶状体的部分的风险。
图11F描绘了固定晶状体组件600F的进一步实施例，其包括晶状体612F和从晶状体突出的三个板触觉件614F。因为板触觉件614的构造提供更硬的触觉件，所以固定晶状体组件600F相对于晶状体囊优选地尺寸较小。
本文描述的和要求保护的发明不限于在此公开的特定优选实施例的范围，因为这些实施例旨在说明本发明的几个方面。事实上，除了本文所示和所述的这些实施例之外的本发明的各种修改对于阅读了前述描述的本领域技术人员来说是明显的。这种修改也被预期落入所附权利要求的范围内。

Claims (30)

1.一种用于植入患者眼睛的囊袋内的双部件调节性人工晶状体设备即IOL设备，所述IOL设备包括：
主晶状体组件，其包括固定晶状体和设置在所述固定晶状体的外围的对中构件，所述对中构件具有周向远侧边缘和邻近所述周向远侧边缘的第一耦合表面；以及
焦度变化晶状体，其包括封闭的且填充有流体或凝胶的晶状体腔和设置在所述晶状体腔的外围的触觉系统，所述触觉系统具有被配置成接触所述囊袋的外围接合边缘和面对所述第一耦合表面并且邻近所述外围接合边缘定位的第二耦合表面；
其中所述第一和第二耦合表面互相滑动接触以允许所述焦度变化晶状体相对于所述主晶状体组件移动；以及
其中所述第一和第二耦合表面在所述焦度变化晶状体被径向压缩时维持所述固定晶状体和所述晶状体腔之间的间隔关系。
2.根据权利要求1所述的双部件IOL设备，其中在没有径向压缩时所述焦度变化晶状体的直径d1大于所述主晶状体组件的直径d2。
3.根据权利要求1所述的双部件IOL设备，其中所述固定晶状体在调节期间不改变形状或曲率。
4.根据权利要求1所述的双部件IOL设备，其中所述晶状体腔在调节期间改变形状和曲率两者。
5.根据权利要求1所述的双部件IOL设备，其中所述固定晶状体和所述晶状体腔是正焦度晶状体。
6.根据权利要求1所述的双部件IOL设备，其中所述填充有流体或凝胶的晶状体腔是双凸面的晶状体。
7.根据权利要求1所述的双部件IOL设备，其中所述固定晶状体组件包括绕着光学区外侧的所述固定晶状体周向定位的直角边缘。
8.根据权利要求1所述的双部件IOL设备，其中所述对中构件和所述触觉系统的面对表面均包括互补且互锁对中的一个，所述互锁对分别绕着所述固定晶状体和所述焦度变化晶状体周向设置。
9.根据权利要求1所述的双部件IOL设备，其中所述外围接合边缘比所述周向远侧边缘更厚。
10.根据权利要求9所述的双部件IOL设备，其中所述周向远侧边缘与所述外围接合边缘的厚度比的范围在约1∶5到约1∶2.
11.根据权利要求1所述的双部件IOL设备，其中所述主晶状体组件具有比所述焦度变化晶状体更高的杨氏弹性模量。
12.根据权利要求1所述的双部件IOL设备，其中所述对中构件和所述触觉系统中至少一个包括多个开口。
13.根据权利要求1所述的双部件IOL设备，其中所述主晶状体包括定尺寸的设备，所述定尺寸的设备提供了所述囊袋的直径的近似值。
14.根据权利要求1所述的双部件IOL设备，其中所述定尺寸的设备是一个或多个径向伸出部。
15.根据权利要求1所述的双部件IOL设备，其中所述焦度变化晶状体包括沿着外围边缘的径向力作用时互相远离移位的两个相对表面，所述两个相对表面具有中心区域和外围区域并且具有从所述外围区域到所述中心区域逐渐增加的厚度剖面。
16.一种用于植入患者眼睛的囊袋内的双部件调节性人工晶状体(IOL)设备，所述IOL设备包括：
主晶状体组件，包括固定晶状体和设置在所述固定晶状体的外围的对中构件，所述对中构件具有可径向压缩的外围边缘，所述外围边缘具有被配置成接合所述患者眼睛的所述囊袋的外部周向表面和与所述外部周向表面径向向内间隔的内部周向表面；以及
焦度变化晶状体，其包括封闭的且填充有流体或凝胶的晶状体腔和设置在所述晶状体腔的外围的触觉系统，所述触觉系统具有被配置成接合所述内部周向表面的周向边缘；
其中作用到所述外部周向表面的径向压缩引起所述晶状体腔的曲率增加和直径减小中的至少一个；以及
其中作用到所述外部周向表面的径向压缩不引起所述固定晶状体的曲率增加或直径减小。
17.根据权利要求16所述的双部件IOL设备，其中所述对中构件进一步包括在所述固定晶状体和所述外围边缘之间的周向铰链，所述周向铰链被设置在所述对中构件的相对侧上。
18.根据权利要求16所述的双部件IOL设备，其中所述对中构件进一步包括在所述固定晶状体和所述外围边缘之间的单个周向铰链。
19.根据权利要求18所述的双部件IOL设备，其中所述周向铰链被设置在所述触觉件面对所述焦度变化晶状体的内部表面上。
20.根据权利要求18所述的双部件IOL设备，其中所述触觉系统的所述周向边缘和所述外围边缘的所述内部周向表面具有互补的圆形表面，并且其中作用到所述外部周向表面的径向压缩引起所述外围边缘绕着所述周向铰链径向向内倾斜。
21.根据权利要求16所述的双部件IOL设备，其中所述焦度变化晶状体被完全包含在所述主晶状体组件的所述外围边缘内。
22.根据权利要求21所述的双部件IOL设备，其进一步包括从所述周向边缘的所述内表面径向向内设置的周向凸缘。
23.根据权利要求16所述的双部件IOL设备，其中所述主晶状体包括定尺寸的设备，所述定尺寸的设备提供了所述囊袋的直径的近似值。
24.根据权利要求16所述的双部件IOL设备，其中所述焦度变化晶状体包括沿着外围边缘的径向力作用时互相远离移位的两个相对表面，所述两个相对表面具有中心区域和外围区域，所述中心区域的厚度是所述外围区域的厚度的至少两倍，优选地至少三倍，并且最优选地至少四倍。
25.一种将双部件IOL设备植入患者眼睛的囊袋内的方法，该方法包括：
首先通过位于角膜内的切口将主晶状体组件插入并且安置到所述患者眼睛的所述囊袋内，所述主晶状体具有固定晶状体和设置在所述固定晶状体的外围的对中构件；
然后将焦度变化晶状体插入并且安置到所述患者眼睛的所述囊袋内在所述主晶状体组件的前方，所述焦度变化晶状体包括封闭的且填充有流体或凝胶的晶状体腔和设置在所述晶状体腔的外围的触觉系统，所述触觉系统具有被配置成接触所述囊袋的外围接合边缘；
其中所述主晶状体组件接触所述囊袋的后部部分；
其中所述焦度变化晶状体接触所述囊袋的所述前部部分；以及
其中所述固定晶状体和所述晶状体腔以光学轴线为中心。
26.根据权利要求25所述的方法，其中所述切口小于5mm，优选地小于4mm。
27.根据权利要求26所述的方法，其中两个所述插入步骤通过所述切口进行。
28.根据权利要求25所述的方法，其进一步包括在所述焦度变化晶状体的插入和安置之前注射粘弹性材料。
29.根据权利要求25所述的方法，其中所述主晶状体组件包括定尺寸的设备，其在所述插入和安置之后提供所述囊袋的直径的近似值，并且所述方法进一步包括在所述插入和安置之后确定所述囊袋的所述直径。
30.根据权利要求29所述的双部件IOL设备，其中所述定尺寸设备是一个或多个径向伸出部。
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