CN105142886B - 制造具有嵌入式掩膜的人工晶状体的方法 - Google Patents

制造具有嵌入式掩膜的人工晶状体的方法 Download PDF

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CN105142886B
CN105142886B CN201480013291.6A CN201480013291A CN105142886B CN 105142886 B CN105142886 B CN 105142886B CN 201480013291 A CN201480013291 A CN 201480013291A CN 105142886 B CN105142886 B CN 105142886B
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crystalline lens
mask
lens material
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protrudent pin
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CN105142886A (zh
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亚当·C·勒布尔
帕特里克·H·本茨
R·凯尔·韦布
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/02—Artificial eyes from organic plastic material
    • B29D11/023—Implants for natural eyes
    • 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
    • A61F2/16—Intraocular lenses
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/12—Moulds or cores; Details thereof or accessories therefor with incorporated means for positioning inserts, e.g. labels
    • B29C33/123—Moulds or cores; Details thereof or accessories therefor with incorporated means for positioning inserts, e.g. labels for centering the inserts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/00009—Production of simple or compound lenses
    • B29D11/00432—Auxiliary operations, e.g. machines for filling the moulds
    • B29D11/00442—Curing the lens material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/00009—Production of simple or compound lenses
    • B29D11/0048—Moulds for lenses
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2627/00—Use of polyvinylhalogenides or derivatives thereof for preformed parts, e.g. for inserts
    • B29K2627/12—Use of polyvinylhalogenides or derivatives thereof for preformed parts, e.g. for inserts containing fluorine
    • B29K2627/16—PVDF, i.e. polyvinylidene fluoride
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B29K2995/0093—Other properties hydrophobic

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  • Ophthalmology & Optometry (AREA)
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Abstract

提供了眼内植入物和制造眼内植入物的方法。眼内植入物可包括适于增大焦深的掩膜。制造植入物的方法可包括将具有孔口的掩膜定位在定位模具部的突出销上。突出销可构造成使掩膜在人工晶状体中居中。

Description

制造具有嵌入式掩膜的人工晶状体的方法
技术领域
本申请总体上涉及眼内装置领域。更具体地，本申请涉及眼内植入物和晶状体(IOL)，该眼内植入物和晶状体具有孔口以增大焦深(例如“掩膜处理的”人工晶状体)，本申请还涉及制造眼内植入物和晶状体的方法。
背景技术
人眼用以通过下述方式来提供视觉：使光透射穿过被称为角膜的透明的外部部分并聚焦、并且进一步借助晶状体使图像精准聚焦到视网膜上。所聚焦的图像的质量取决于包括眼睛的尺寸和形状、晶状体和角膜的透明度的许多因素。
眼睛的屈光力由晶状体和角膜的屈光力决定。在正常的、健康的眼睛中，远距离物体的清晰图像形成在视网膜上(正常眼)。在许多眼睛中，远距离物体的图像或者由于眼睛不正常地长或者角膜不正常地陡而形成在视网膜前方(近视眼)，或者由于眼睛不正常地短或角膜不正常地平而形成在视网膜的后方(远视眼)。
有些人患有白内障，其中，晶状体丧失了透明度。在这种情况下，晶状体可以被移除并用人工晶状体(IOL)代替。然而，有些人工晶状体在患者的非远距离视力方面可能仍存在缺陷。
发明内容
该公开内容的某些方面涉及制造人工晶状体的方法。该方法可包括将第一量的晶状体材料添加至第一晶状体成型模具部。该方法可包括将具有孔口的掩膜定位在定位模具部的突出销上。突出销可构造成使掩膜位于人工晶状体的中央。该方法可包括将第一晶状体成型模具部与定位模具部接合。该方法可包括使第一量的人工晶状体材料部分地固化。该说明书中公开的模具特征、人工晶状体或掩膜特征、步骤或过程中的任一者可包括在任何实施方式中。
在上述方法方面中，晶状体材料可包括紫外线吸收剂和光敏引发剂。引发剂可构造成在暴露于具有紫外线吸收剂的吸收光谱之外的波长的光时使晶状体材料固化。在某些方面，引发剂可构造成由具有在从约380nm到约495nm范围中的波长的光激活。
在上述方法方面中的任一者中，将掩膜定位在突出销上可包括将掩膜与突出销的肩部相邻地定位，突出销的肩部的直径比掩膜的孔口的直径大。肩部可构造成控制掩膜在人工晶状体中的深度。
在上述方法方面中的任一者中，将第一晶状体成型模具部与定位模具部接合可使得晶状体材料流入掩膜的表面与定位模具部的内表面之间的空间中，从而使得掩膜在其两侧至少部分地被晶状体材料围绕，其中，突出销自定位模具部的内表面延伸。
在上述方法方面中的任一者中，使第一量的晶状体材料部分地固化可包括将光施用至第一晶状体成型模具部。
在上述方法方面中的任一者中，使第一量的晶状体材料部分地固化可包括使第一量的晶状体材料固化小于完全固化的50％，但固化至足以在移除定位模具部之后使掩膜与第一晶状体成型模具部保持在一起。
在上述方法方面中的任一者中，该方法可包括使第一晶状体成型模具部冷却。冷却工艺可有助于使模具组偏置，使得在将模具部分开时晶状体材料和掩膜保持在第一晶状体成型模具部中。使模具组偏置的其他方法可包括但不限于由比定位模具部材料更大程度地粘附至晶状体材料的材料制成第一晶状体成型模具部。
在上述方法方面中的任一者中，该方法可包括将定位模具部移除并将第一晶状体成型模具部与第二晶状体成型模具部接合。
在上述方法方面中的任一者中，该方法可包括将第二量的晶状体材料添加至第二晶状体成型模具部。在某些方面，该方法可包括通过暴露于光而使第二量的晶状体材料部分地固化小于完全固化的50％。在某些方面，该方法可包括在通过暴露于光而使第二量的晶状体材料部分地固化之后，对第二量的晶状体材料进行热固化。
在上述方法方面中的任一者中，该方法可包括使第一量的晶状体材料和第二量的晶状体材料的至少99％聚合。
在上述方法方面中的任一者中，晶状体材料可为疏水性材料。
在上述方法方面中的任一者中，该方法可包括将襻防护部与定位模具部接合，使得襻防护部防止晶状体材料在襻区域中聚合。
本公开的某些方面涉及用于制造人工晶状体的模具组，该人工晶状体具有悬置在人工晶状体内的掩膜。模具组可包括第一晶状体成型模具部，第一晶状体成型模具部构造成保持晶状体材料的至少一部分。模具组可包括定位模具部，定位模具部构造成将掩膜定位在晶状体材料内。定位模具部可构造成与第一晶状体成型模具部匹配。定位模具部可包括本体部和自本体部延伸的突出销。突出销的端部可具有第一直径，第一直径定尺寸成与掩膜中的孔口对应。突出销可构造成控制掩膜在人工晶状体材料内的居中定位。在某些方面，突出销可包括具有比第一直径大的第二直径的肩部。肩部可构造成控制掩膜在晶状体材料内的深度。该说明书中公开的模具特征、人工晶状体或掩膜特征、步骤或方法中的任一者可包括在任何实施方式中。
在上述模具方面中，突出销的长度可定尺寸成使得在定位模具部与第一晶状体成型模具接合时突出销的端部延伸在距第一晶状体成型模具部的晶状体成型表面0mm至0.2mm内。
在上述模具方面中的任一者中，突出销的长度可构造成使得在第一晶状体成型模具部与定位模具部匹配时人工晶状体的光学区基本没有晶状体材料。
在上述模具方面中的任一者中，肩部的第二直径可为掩膜的外直径的约50％。
在上述模具方面中的任一者中，肩部可构造成使得晶状体材料可在掩膜的表面与本体部之间流动。
在上述模具方面中的任一者中，模具可包括第二晶状体成型模具部，第二晶状体成型模具部构造成保持晶状体材料的另一部分并且与第一晶状体成型模具部接合。
在上述模具方面中的任一者中，第一晶状体成型模具可包括襻区域。在某些方面，模具可包括定位在定位模具部上的襻防护部，使得襻防护部阻挡固化光到达襻区域，从而防止晶状体材料在襻区域内聚合。
处于概括描述本公开的目的，已在文中描述了本发明的某些方面、优点和特征。应当理解的是，并非任意或所有这些优点都需结合根据文中公开的本发明的任何具体实施方式来实现。本公开的方面并非必必需或不可缺少。
附图说明
图1A示出了具有用于增大焦深的嵌入式掩膜的人工晶状体的示例实施方式的俯视图。
图1B示出了图1A的人工晶状体沿线1B-1B截取的截面图。
图2A是构造成增大焦深的掩膜的一个实施方式的立体图。
图2B是构造成增大焦深的大致平的的掩膜的实施方式的立体图。
图3A是构造成增大焦深的掩膜的另一个实施方式的俯视图。
图3B是图3A的视图的一部分的放大视图。
图3C是图3B的掩膜沿线3C-3C截取的截面图。
图4A至图4C示出了模具组的实施方式的截面图。
图5是示出了利用图4A和图4B中示出的模具组来制造人工晶状体的方法的实施方式的流程图。
图6是示出了利用图4A和图4B中示出的模具组来制造人工晶状体的方法的另一实施方式的流程图。
具体实施方式
如文中所论述的，经历了人工晶状体(IOL)植入手术的人可能在他们的非远距离视力方面仍存在不足之处。用于处理这种不足的一种技术为通过在IOL内包括掩膜(mask)来增大患者的焦深。文中描述的眼内植入物的实施方式包括掩膜，该掩膜适于提供较小的孔口，以用于使光穿过直至视网膜，从而增大焦深。穿过IOL内的掩膜的光线在视网膜上的单一焦点处聚集，而不能在视网膜上的单个焦点处聚集的光线则被掩膜阻挡。本公开描述了用于制造具有嵌入式掩膜的晶状体——例如IOL——的方法。
已开发出了对固定焦距IOL的各种替代方案，包括多焦点IOL和调节型IOL，从而尝试提供在近距离和远距离两者处清晰观看的能力。然而，调节型IOL太复杂，并且一些多焦点IOL在中间距离处表现不佳，从而导致与非聚焦光的出现相关联的夜视困难、炫目以及晕轮。该局限性可使得多焦点光学的设计人员选择针对每个焦点的光线的量、并且处理经常存在于任何图像中的非聚焦光的影响。为了使无限大(>6m)处和40cm(正常阅读距离)的重要距离处的敏锐度最大化，通常在中间距离处提供很少的聚焦光或在中间距离处不提供聚焦光，并且因此这些距离处的视力敏锐度较差。然而，通过包括用以增大焦深的孔口的掩膜，患者的中间距离的视力可显著提高。例如，与孔口相关联的散焦模糊度在中间距离处比在近距离处小。
图1A至图1B示出了具有用于增大焦深的嵌入式掩膜1008的人工晶状体的示例实施方式。人工晶状体1000包括用于将晶状体定位在眼睛内的襻(haptic)1004。晶状体本体1002的截面厚度总体上取决于人工晶状体1000的屈光力和晶状体本体1002的材料。具体地，晶状体本体1002的中央区域总体上为具有中心区域截面厚度1006的人工晶状体1000的最厚部段。用于减小人工晶状体的厚度的方法在2010年8月13日提交的美国公报NO.2011/0040376中进行了描述，该美国公报的全部内容通过参引并入本文。
人工晶状体和/或晶状体本体可以由一种或更多种材料制成。在某些实施方式中，人工晶状体的材料可包括疏水性材料和/或低粘性材料。例如，在某些实施方式中，晶状体材料可包括疏水性共聚物，例如在2006年6月27日提交的美国专利NO.7,067,602中所公开的疏水性共聚物，该美国专利的全部内容通过参引并入本文。在其他实施方式中，人工晶状体和/或晶状体本体可包括聚合物(例如PMMA(聚甲基丙烯酸甲酯)、PVDF(聚偏二氟乙烯)、聚丙烯、聚碳酸脂、PEEK(聚醚醚酮)、聚乙烯、丙烯酸共聚物、聚苯乙烯、PVC(聚氯乙烯)、聚砜)、水凝胶或硅树脂。
在某些实施方式中，晶状体材料可包括紫外线吸收剂以为眼睛提供保护。人工晶状体本体可构造成允许小于在370nm波长下的光透射的约10％、小于在370nm波长下的光透射的约5％、小于在370nm波长下的光透射的约1％，或者其他。
在某些实施方式中，人工晶状体可具有双凸面设计和/或可构造成具有从至少约12.5屈光度到小于等于约30屈光度的屈光力范围。在某些实施方式中，在589nm波长下的折光率可在约1.481和/或约1.487之间、在约1.481和/或约1.484之间、或为其它方式。在某些实施方式中，在546nm波长下的折光率可以在约1.483和/或约1.489之间、在约1.482和/或约1.484之间、或为其它方式。在某些实施方式中，晶状体本体可具有至少约90和/或小于等于约95的肖氏A硬度。在某些实施方式中，晶状体本体可以具有约93的肖氏A硬度。
文中讨论了可定位在植入物本体上或植入物本体内的掩膜的多种变型，并且也在美国专利No.7,628,810、美国专利公报No.2006/0113054、以及美国专利公报No.2006/0265058中进行了描述，所有前述的美国专利和美国专利公报的全部内容通过参引并入本文。图2A示出了掩膜2034a的一个实施方式。掩膜2034a可包括环形区域2036a，环形区域2036a围绕大致居中地定位在掩膜2034a上的孔口2038a。孔口2038a可大致绕文中被称作掩膜2034a的光轴的中心轴线2039a定位。孔口2038a可以为圆形。图2B示出了与图2A中示出的掩膜2034a类似的掩膜2034b的另一个实施方式。图2A的掩膜2034a的环形区域2036a具有从环形区域2036a的外周到内周的曲率，而图2B的掩膜2034b的环形区域2036b可以基本上是平的。
掩膜可具有构造成与植入物本体共同作用以提高患者视力的尺寸。例如，掩膜的厚度可根据掩膜相对于植入物本体的位置而改变。例如，在掩膜嵌入植入物本体内的情况下，掩膜可以具有比0大且比植入物本体的厚度小的厚度。替代性地，在掩膜联接至植入物本体的表面的情况下，掩膜可优选地具有不大于具有期望的不透明度所需的厚度，使得掩膜不给人工晶状体增加额外的厚度。
如下面论述的，掩膜可具有恒定的厚度。然而，在一些实施方式中，掩膜的厚度可以在内周边(孔口2038a、2038b的附近)与外周边之间改变。
环形区域2036a、2036b可至少部分不透明或可以完全不透明。环形区域2036a、2036b的不透明度可防止至少一些或基本上全部的光透射穿过掩膜2034a、2034b。环形区域2036a、2036b的不透明度可以若干不同方式中的任何一种实现。
例如，在一些实施方式中，用来制造掩膜2034a、2034b的材料可以是天然地不透明的。在一些实施方式中，用来制造掩膜2034a、2034b的材料可以是基本上透明的，但通过染色或其他色素沉着处理以使区域2036a、2036b基本上或完全不透明。在一些实施方式中，掩膜2034a、2034b的表面可以被物理地或化学地(例如通过蚀刻)处理以改变掩膜2034a、2034b的折射特性和透射特性，从而使掩膜较少地透射光。
掩膜2034a、2034b的材料可以例如是任何聚合材料。在掩膜2034a、2034b应用于眼内植入物的情况下，掩膜2034a、2034b的材料应当是生物相容性的。用于掩膜2034a、2034b的适合的材料的示例可包括但不限制于高度氟化的聚合物，例如PVDF(聚偏二氟乙烯)、水凝胶，或纤维材料，例如涤纶网。
在一些实施方式中，光致变色材料可以用作掩膜或添加至掩膜。在亮光条件下，光致变色材料可变暗，从而形成掩膜并且增强近视力。在弱光条件下，光致变色材料可变亮，从而允许更多的光穿过直至视网膜。在某些实施方式中，在弱光条件下，光致变色材料变亮以露出眼内植入物的光学件(optic)。光致变色材料的更多细节在2012年11月30日提交的美国专利申请No.13/691,625中公开，该美国专利申请的全部内容通过参引并入本文。
掩膜可具有不同程度的不透明度。例如，掩膜可阻挡基本上所有的可见光或阻挡可见光的一部分。掩膜的不透明度还可在掩膜的不同区域中改变。在某些实施方式中，掩膜的外边缘和/或内边缘的不透明度可以小于掩膜的中心区域的不透明度。不同区域中的不透明度可突然转变或以渐变的方式转变。不透明度转变的其它示例可在美国专利5,662,706、5,905,561和5,965,330中找到，所有这些美国专利的全部内容通过参引并入本文。
掩膜的更多细节在1990年12月11日公布的美国专利No.4,976,732、2009年12月8日公布的美国专利No.7,628,810和2004年5月26日提交的美国专利申请No.10/854,032中公开，所有这些美国专利和美国专利申请的全部内容通过参引并入本文。
图3至图4示出了构造成增大患有远视眼的患者的眼睛焦深的掩膜2100的另一实施方式。除下面描述的不同之外，掩膜2100可与上文描述的掩膜类似。掩膜2100可由文中论述的材料、包括上文论述的材料制成。此外，掩膜2100可通过任何适合的工艺形成。掩膜2100可构造成应用于IOL和/或嵌入IOL。
在一些实施方式中，掩膜2100可包括本体2104，本体2104具有前表面2108和后表面2112。本体2104可由任何适合的材料制成，包括但不限于开孔泡沫材料、膨胀固体材料和/或基本不透明的材料中的至少一种。在一些实施方式中，用来制成本体2104的材料可具有相对高的含水量。在一些实施方式中，用来制成本体2104的材料可包括聚合物(例如，PMMA、PVDF、聚丙烯、聚碳酸脂、PEEK、聚乙烯、丙烯酸共聚物(例如疏水性或亲水性)、聚苯乙烯、PVC、聚砜)、水凝胶、硅树脂、金属、金属合金或碳(石墨烯或纯碳)。
在一些实施方式中，掩膜2100可包括孔结构2116。孔结构2116可包括多个孔2120。孔2120示出为仅位于掩膜2100的一部分上，但在一些实施方式中孔2120可位于整个本体2104上。掩膜2100可包括限定本体2104的外边缘的外周边2124。在一些实施方式中，掩膜2100可包括至少部分地由外周边2124围绕的孔口2128和定位在外周边2124与孔口2128之间的非透射部2132。
掩膜2100可以是对称的，例如关于掩膜轴线2136对称。在一些实施方式中，掩膜2100的外周边2124可为圆形。掩膜2100总体上可具有至少约3mm和/或小于约6mm的外直径。在一些实施方式中，掩膜为圆形并且可包括至少约3mm和/或小于等于约4mm的直径。在一些实施方式中，掩膜2100为圆形并且可以包括约3.2mm的直径。
在一些实施方式中，本体2104的前表面2108和后表面2112中的一者可以是基本上平的。在一些实施方式中，在整个平的表面上可测量到很小或测量不到一致的曲率。在一些实施方式中，前表面2108和后表面2112都可基本上是平的。总体上，掩膜2100的本体2104的厚度可在从大于0到约0.5mm的范围内、约1微米到约40微米的范围内、在从约5微米到约20微米的范围内或为其他情形。在一些实施方式中，掩膜2100的本体2104可包括至少约5微米和/或小于等于约20微米的厚度2138。在一些实施方式中，掩膜的本体2104可包括至少约5微米和/或小于等于约15微米的厚度2138。在某些实施方式中，厚度2138可为约15微米、约10微米、约8微米、约5微米或其他厚度。
基本上平的的掩膜与非平的的掩膜相比具有若干优点。例如，基本上平的的掩膜比需要成形成特定曲率的掩膜更容易制造。具体地，可以取消使掩膜2100具有曲率所涉及的处理步骤。
孔口2128可构造成透射沿着掩膜轴线2136的基本上所有的入射光。非透射部2132可围绕孔口2128的至少一部分并且基本上防止入射光在非透射部2132上的透射。如结合上面的掩膜所论述的，孔口2128可为本体2104中的通孔或为本体2104的基本上的光透射部(例如透明的)。掩膜2100的孔口2128可总体上限定在掩膜2100的外周边2124之内。孔口2128可采用任何适合的构型，例如上文描述的构型。
在一些实施方式中，孔口2128可大致为圆形并且可大致位于掩膜2100的中央。孔口2128的尺寸可为有利于增大患有远视眼的患者的眼睛焦深的任何尺寸。特别地，孔口2128的尺寸可取决于掩膜在眼睛内的位置(例如，距视网膜的距离)。在一些实施方式中，孔口2128可具有至少约0.85mm和/或小于等于约2.2mm的直径。在某些实施方式中，孔口2128的直径为小于约2mm。在一些实施方式中，孔口的直径为至少约1.1mm和/或小于等于约1.6mm。在一些实施方式中，孔口2128的直径为至少约1.3mm和/或小于等于约1.4mm。
非透射部2132可构造成防止可见光透射穿过掩膜2100。例如，在一些实施方式中，非透射部2132可防止基本上全部的或者至少部分的入射可见光光谱的穿过。在一些实施方式中，非透射部2132可构造成防止基本上所有的可见光、例如人眼可见的电磁频谱中的辐射能的透射。在一些实施方式中，非透射部2132可基本上防止人类可见范围以外的辐射能的透射。
如上面所论述的，防止光透射穿过非透射部2132可减小到达视网膜和小凹的不能在视网膜和小凹处聚集以形成清晰图像的光的量。如上面所论述的，孔口2128的尺寸为使得透射穿过孔口的光总体上在视网膜处或小凹处聚集。因此，与没有掩膜2100的其他情况相比，可在视网膜上呈现出更清晰的图像。
在一些实施方式中，非透射部2132可防止至少约90％的入射光的透射。在一些实施方式中，非透射部2132可防止所有入射光中的至少约95％的入射光的透射。掩膜2100的非透射部2132可构造成基本上是不透明的以防止光的透射。
在一些实施方式中，非透射部2132可透射不超过约5％的入射可见光。在一些实施方式中，非透射部2132可透射不超过约3％的入射可见光。在一些实施方式中，非透射部2132可透射不超过约2％的入射可见光。在一些实施方式中，本体2104的至少一部分构造成使得入射于其上的光的超过99％的部分都不能穿透。
如上面所论述的，非透射部2132可构造成防止光的透射而非吸收入射光。例如，掩膜2100可制成具有反射性或可制成以更复杂的方式与光相互作用，如在2003年4月29日公布的美国专利No.6,554,424中所讨论的，该专利的全部内容通过参引并入本文。
如上面所论述的，掩膜2100可包括多个孔2120。在掩膜2100形成为嵌入在晶状体本体中时，晶状体本体可至少部分地延伸穿过孔，从而在掩膜的两侧上的晶状体本体之间形成连结(例如材料“桥”)。关于材料“桥”的更多公开内容可在2010年8月13日提交的美国公报No.2011/0040376中找到，该公报的全部内容通过参引并入本文。
图3A中示出的掩膜2100的孔2120可定位在掩膜2100上的任何位置。在一些实施方式中，基本上所有的孔都位于掩膜的一个或更多个区域中。图3A的孔2120至少部分地在掩膜2100的前表面2108与后表面2120之间延伸。在一些实施方式中，孔2120中的每个孔均包括孔入口2160和孔出口2164。孔入口2160与掩膜2100的前表面2108相邻地定位。孔出口2164与掩膜2100的后表面2112相邻地定位。在一些实施方式中，孔2120中的每个孔均延伸了在掩膜2100的前表面2108与后表面2120之间的整个距离。关于可能的孔的模式的更多细节在2010年8月13日提交的WO 2011/020074中描述，该专利文献的全部内容通过参引并入本文。
在一些实施方式中，掩膜2100可包括靠近掩膜的外周边2124的不具有孔的环形区域。在某些实施方式中，在掩膜2100的外周边2124的0.1mm内没有孔。
在一些实施方式中，掩膜可包括围绕掩膜的内周边的不具有孔的环形区域。在某些实施方式中，在孔口2128的0.1mm内没有孔。
在一些实施方式中，孔2120均具有相同的直径。在某些实施方式中，孔2120可包括一个或更多个不同的直径。在一些实施方式中，任何单独的孔2120的直径为至少约0.01mm和/或小于等于约0.02mm。在一些实施方式中，孔2120的直径可包括一个或更多个下述孔直径：0.010mm、0.013mm、0.016mm和/或0.019mm。在一些实施方式中，不同直径的孔遍及掩膜2100的至少一部分而分布。在一些实施方式中，孔遍及掩膜2100的至少一部分分布在不规则的位置处。
在一些实施方式中，具有至少约1000个孔和/或小于等于约2000个孔。在一些实施方式中，具有至少约1000个孔和/或小于等于约1100个孔。在一些实施方式中，具有约1040个孔。在一些实施方式中，各直径的孔的数量相同。在一些实施方式中，各直径的孔的数量不同。
在一些实施方式中，孔遍及掩膜2100的至少一部分分布在不规则的位置处。在一些实施方式中，不同直径的孔遍及掩膜2100的至少一部分均匀地分布。例如，掩膜2100可包括多个非重叠的孔区域。多个非重叠的孔区域的表面积的总和可等于掩膜的整个孔区域的总表面积。多个区域中的每个区域均可包括许多孔。孔中的每个孔均具有不同直径。每个区域中的孔的数量可等于整个孔区域中不同的孔尺寸的数量。
图4A和图4B示出了模具组4000的截面图，模具组4000具有第一晶状体成型模具部4002、第二晶状体成型模具部(未示出)、定位模具部4008和/或襻防护部4018。模具组部件中的每一者均可利用包括但不限于注射模制技术的任何适合的技术来制造。在一些实施方式中，多个这种模具组4000可结合为能够大致同时制造具有嵌入式掩膜的多个晶状体的模具组件中。
第一晶状体成型模具部4002可包括内晶状体成型表面4004、外表面4006、用于接纳晶状体材料的腔4024和/或襻区域4026。第一晶状体成型模具部4002可包括构造成与第二晶状体成型模具部和/或定位模具部4008接合的外边缘部4022。
腔4024可定尺寸为人工晶状体的尺寸。例如，腔4024可包括至少约5mm和/或小于等于约6.5mm的直径。在某些实施方式中，腔4024可包括约6.0mm的直径。包括腔4024和襻区域4026的区域的直径可为至少约10mm和/或小于等于约20mm。在某些实施方式中，包括腔4024和襻区域4026的区域的直径可为约13.4mm。
第二晶状体成型模具部可与第一晶状体成型模具部4002基本上类似但互补，并且第二晶状体成型模具部可包括襻区域和/或用于接纳晶状体材料的腔。第二晶状体成型模具部可包括构造成与第一晶状体成型模具部4002的外边缘部4022接合的外边缘部。在第二晶状体成型模具部与第一晶状体成型模具部4002接合时，第一晶状体成型模具部和第二晶状体成型模具部构成晶状体模具。第一晶状体成型模具部和第二人晶状体成型模具部的具体的形状、大小和表面可设计成制造具有期望的形状和尺寸的晶状体。
定位模具部4008可包括构造成与第一晶状体成型模具部4002的外边缘部4022接合的外边缘部4020。定位模具部4008可包括内表面4010和外表面4012。内表面可包括从定位模具部4008的内表面4010延伸的突出部4014，例如突出销4014。突出销4014可包括具有扩大的直径的肩部4016，突出销4014的肩部4016从定位模具部4008的内表面4010延伸。环形掩膜4028——例如文中所描述的——可在定位模具部4008与第一晶状体成型模具部4002接合之前装到突出销4014上。突出销4014可横向地位于空腔4024的中央，以控制环形掩膜4028在人工晶状体内的x-y位置，同时肩部4016可构造成控制环形掩膜4028在人工晶状体内的深度。
如图4B中所示出的，突出销4014的端部可包括直径D1。直径D1可与环形掩膜4028的内直径基本对应。例如，突出销4014的端部的直径D1可以在环形掩膜4028的内直径的约10微米内或可以在环形掩膜4028的内直径的约5微米内。在直径D1太小的情况下，由于在环形掩膜4028与突出销4014之间可能出现过量游隙，因此环形掩膜4028可能不沿x-y维度适当地位于人工晶状体的中央。在直径D1太大的情况下，在将定位模具部4008移除时由于环形掩膜4028与突出销4014配合的太紧密，可能难以将环形掩膜4028与突出销4014分开。在一些实施方式中，直径D1可至少约1.1mm和/或小于等于约1.6mm。在一些实施方式中，直径D1可至少约1.3mm和/或小于等于约1.4mm。
突出销4014可具有使得在定位模具部4008接合至第一晶状体成型模具部时突出销4014的端部距离第一晶状体成型模具部4002的内表面4004在X2内的长度。在某些实施方式中，X2可为小于等于约0.3mm、小于等于约0.2mm、或小于等于约0.1mm。在某些实施方式中，X2可为约0.1mm。在某些实施方式中，从突出销4014的基部到第一晶状体成型模具部4002的内表面4004的距离X1可为小于等于约0.7mm、小于等于约0.6mm、小于等于约0.5mm、或小于等于约0.4mm。在某些实施方式中，距离X1可为约0.5mm。突出销4014的自肩部4016起的长度可等于X1与X2的差值(X1－X2)。在某些实施方式中，突出销4014的自肩部4016起的长度可为至少约0.2mm和/或小于等于约0.6mm。在某些实施方式中，突出销4014的自肩部4016起的长度可为约0.4mm。然而，应当理解的是，突出销4014的具体尺寸可取决于包括IOL的设计和IOL的屈光力的多种因素。
肩部4016的直径可比环形掩膜4028的内径大并且可构造成为环形掩膜4028提供支承以及还允许充足量的晶状体材料在环形掩膜4028的后面流动。在环形掩膜4028后面流动的晶状体材料可在将定位模具部4008移除时聚合并有助于使环形掩膜4028稳固，如在下文中所进一步论述的。
肩部4016可包括基本一致的直径或不同的直径。如图4A和图4B中示出的，肩部4016可包括总体上圆形的侧部并可包括比端部直径D2大的基部直径D3。肩部4016的任何部分都可包括在至少约1.5mm和/或小于等于约2.5mm的范围内的直径。在一些实施方式中，直径D3可为至少约1.5mm和/或小于等于约2.5mm。在某些实施方式中，直径D3可为至少约2.0mm和/或小于等于约2.5mm。在某些实施方式中，直径D3可为约2.1mm。在一些实施方式中，D2可为至少约1.5mm和/或小于等于约1.75mm。在一些实施方式中，D2可为环形掩膜4028的外直径的至少约40％和/或小于等于环形掩膜4028的外直径的约60％。在某些实施方式中，D2可为环形掩膜4028的外直径的约50％。在一些实施方式中，突出销4014的端部的直径D1与肩部4016的直径D2的差值可为小于等于约0.4mm、小于等于约0.2mm或其他数值。
肩部4016的长度X3可构造成控制环形掩膜4028在人工晶状体内的深度。在一些实施方式中，长度X3设计成使得环形掩膜4028沿晶状体的纵向轴线基本上位于已完成的晶状体的中央。在一些实施方式中，肩部4016可包括至少约0.15mm和/或小于等于约0.35mm的长度X3。在某些实施方式中，长度X3可为约0.25mm。然而，应当理解的是，肩部4016的具体尺寸可取决于包括IOL的设计和屈光力的多种因素。
第一晶状体成型模具部4002与定位模具部4008可通过例如将一个模具部放置在另一个模具部之上而接合在一起。在一些实施方式中，襻防护部4018可构造成接合定位模具部4008或第一晶状体成型模具部4002。襻防护部4018可构造成在制造过程的光固化阶段期间阻挡光进入模具的襻区域4026。在一些情况下，在将多重剂量的晶状体材料添加至模具并且在过程的不同阶段使晶状体材料至少部分地光固化的情况下，由于后添加的剂量的未固化的晶状体材料会导致先前聚合的晶状体材料隆起和褶皱，因此可能理想的是在至少部分的固化过程期间阻挡光进入襻区域。如图4A和图4B中示出的，襻防护部4018可包括定位在定位模具部4008和第一晶状体成型模具部4002的外边缘部分4020、4022上的本体部。该针对襻防护部4018的构型可在例如固化光被提供在组件的定位模具侧上的情况下使用。图4C示出了定位在第一晶状体成型模具部4002上的襻防护部4018(与图4A和图4B中的方位相比第一晶状体成型模具部是翻转的)。该针对襻防护部4018的构型可在例如固化光被提供在组件的第一晶状体成型模具侧上的情况下使用。在一些实施方式中，模具组4000可包括支承架4030。如图4C中所示出的，支承架4030可包括第一台阶状区域4032和第二台阶状区域4034，第一台阶状区域4032和第二台阶状区域4034构造成支承定位模具部4008和/或襻防护部4018中的相应的一者。
图5和图6是示出了制造人工晶状体的方法的流程图。该方法可用来将环形掩膜嵌入人工晶状体内并确保环形掩膜在人工晶状体中适当的对中和深度。除非另作说明，否则所公开的方法的任何步骤都不应当被理解为必不可少的或不可缺少的，并且任一方法可包括额外的制造步骤。
图5示出了利用图4A和图4B中示出的模具组4000制造具有嵌入式环形掩膜的人工晶状体的方法5000。该方法可包括将第一量的晶状体材料预先配至第一晶状体成型模具部4002(框5002)。该方法可包括将包括文中描述的任意环形掩膜的环形掩膜装到定位模具部4008的突出销4014上(框5004)。该方法5000可包括将第一晶状体成型模具部4002与定位模具部4008接合(框5006)，并且使第一量的晶状体材料至少部分地固化(框5008)。在使第一量的晶状体材料部分地固化之后，可移除定位模具部4008(框5010)，留下至少部分地嵌入晶状体材料的环形掩膜。这些方法步骤中的每个步骤的方面将结合图6更详细地描述。
图6示出了使用图4A和图4B中示出的模具组4000制造具有嵌入式环形掩膜的人工晶状体的方法6000。该方法可包括将第一量的晶状体材料预先配至第一晶状体成型模具部4002(框6002)。晶状体材料可包括文中描述的包括但不限于上面公开的疏水性材料的任何晶状体材料。
在某些实施方式中，第一量的晶状体材料可等于完全填充空腔4024并且使得晶状体材料在环形掩膜4028与定位模具部4008之间流动所需的材料的量。以这种方式，环形掩膜4028的两侧至少部分地嵌入晶状体材料，从而可以有助于在第一晶状体成型模具部4002与定位模具部4008分开时避免环形掩膜4028的纵向运动。在没有充足的晶状体材料填充空腔4024的情况下，模具中可能留存有氧气，从而由于氧气可阻止聚合而难以使材料固化。在某些实施方式中，第一量的晶状体材料可为至少约100微升和/或小于等于约150微升。
在一些实施方式中，晶状体材料可包括紫外线吸收剂以保护眼睛免受紫外线辐射。晶状体材料还可包括光敏引发剂以允许晶状体材料通过暴露于光而进行光固化。光敏引发剂可包括各种生物相容的引发剂，包括但不限于酰基氧化膦引发剂例如819。尽管紫外线吸收剂是人工晶状体的一些实施方式的期望特征，但一些光敏引发剂与紫外线起反应。然而，紫外线吸收剂的存在可防止这样的光敏引发剂在光固化过程中生效。因此，添加到晶状体材料的引发剂可为在暴露于具有紫外线吸收剂的吸收光谱之外的波长的光时被激活的引发剂(例如可见光范围、紫蓝色光范围或其他范围)。在某些方面，引发剂可由具有在从约380nm到约495nm范围内的波长的光激活。在某些方面，吸收剂可由具有约420nm波长的光激活。在某些方面，光吸收剂的总量可小于等于约晶状体本体材料总量的0.25％。
在框6006中，第一晶状体成型模具部4002可与定位模具部4008接合在一起，例如图4A和图4B中所示。在某些实施方式中，肩部4016可构造成使得晶状体材料能够在模具部4002与模具部4008接合在一起时在环形掩膜4028的表面与定位模具部4008之间流动。在一些实施方式中，在将模具部4002与模具部4008接合之前，可排出过多的晶状体材料。
在一些实施方式中，襻防护部4018可接合至第一晶状体成型模具部4002和/或定位模具部4008，使得襻防护部4018在制造过程的特定固化阶段期间阻挡光到达襻区域4026并且防止晶状体材料在襻区域4026内聚合。在一些实施方式中，襻防护部4018可接合模具部4002和4008中的一者或两者的外边缘部4020、4022。襻防护部4018可沿定位模具部4008的外表面4012定位或沿第一晶状体成型模具部4002的外表面4006定位。在某些实施方式中，襻防护部4018可构造成嵌入模具部4002和模具部4008中的一者内或可定位在襻区域4026内。
在模具部4002与模具部4008接合之后，可以使晶状体材料至少部分地固化(框6010)。例如，可以使晶状体材料固化小于完全固化的量，例如为完全的单体转化率的至少约10％和/或小于约50％。晶状体材料可固化到足够的程度，使得在将定位模具部移除之后环形掩膜4028仍与第一晶状体成型模具部保持在一起。此外，环形掩膜4028与定位模具部4008之间的部分地固化的晶状体材料可有助于在将定位模具部移除之后将环形掩膜4028保持就位。
在一些实施方式中，可利用光、例如利用420nm的LED或文中描述的任何其他适合波长的光进行固化。由于可允许对固化过程进行更好地控制，因此在制造过程的该阶段光固化可优于热固化。例如，可根据指令打开或关闭固化光，从而允许对固化过程进行精细的控制，而热固化具有更延缓的响应时间。在一些实施方式中，光强度可为至少约0.5毫瓦/平方厘米和/或小于等于约10毫瓦/平方厘米。在一些实施方式中，光强度可为约2毫瓦/平方厘米。在一些实施方式中，部分地固化可进行小于约10分钟、小于约6分钟、小于约5分钟或其他时间。
在一些情况下，光可施用于定位模具部4008。然而，在环形掩膜4028包括紫外线吸收剂的情况下，环形掩膜4028可防止紫外线到达晶状体材料，从而阻止该部分的固化过程。在一些实施方式中，模具组4000可在该部分的固化过程之前翻转或可进行其他构造，使得光可应用于第一晶状体成型模具部4002(其可由相对于固化光基本为透明的材料制成)。
在使晶状体材料部分地固化之后，可使至少第一晶状体成型模具部4002冷却(框6012)。冷却过程可增大晶状体材料至第一晶状体成型模具部4002的粘附和/或使部分地固化的晶状体材料变硬，从而有助于确保在将定位模具部4008和/或襻防护部4018移除时晶状体材料和环形掩膜4028与第一晶状体成型模具部4002保持在一起(框6014)。在一些实施方式中，冷却过程可用来使第一晶状体成型模具部4002冷却至少20℃。在某些实施方式中，冷却过程可利用低温流体例如液态氮进行。
在一些实施方式中，模具部4002和模具部4008可利用机械操作的工艺来分开，以确保模具部4002和模具部4008垂直地移位而不干扰环形掩膜4028的位置。
模具组4000的材料还可构造成有助于在将定位模具部4002移除时使环形掩膜4028与第一晶状体成型模具部4002保持在一起。例如，第一晶状体成型模具部4002可包括更大程度地粘附至晶状体材料的材料，并且定位模具部4008可包括更容易地释放晶状体材料和/或环形掩膜4028的材料。在某些实施方式中，第一晶状体成型模具部4002可包括树脂。
当将定位模具部4008移除时，突出销4014可留下基本上没有任何晶状体材料的空处。该空处可在添加第二量的晶状体材料时通过未固化的晶状体材料来填充。由突出销4014留下的空处位于晶状体光轴线的区域中并且延伸至接近第一晶状体成型模具部4002的内晶状体成型表面4004或延伸至第一晶状体成型模具部4002的内晶状体成型表面4004处的深度。由于大致围绕晶状体的光轴线的容积仅通过第二量的晶状体材料填充，因此完成的光学件中可包括光学区中的均匀的光学材料。
在将定位模具部4008和/或襻防护部4018移除之后，可将第二量的晶状体材料添加至第一晶状体成型模具部4002和/或第二晶状体成型模具部(框6016)，并且可将第一晶状体成型模具部与第二晶状体成型模具部接合在一起(框6018)。在一些实施方式中，第二量的晶状体材料足以完全地填充第一晶状体成型模具部与第二晶状体成型模具部之间的容积。在某些实施方式中，第二量的晶状体材料可为至少约100微升和/或小于等于约150微升。在某些实施方式中，第二量的晶状体材料为约150微升。在将第一晶状体成型模具部与第二晶状体成型模具部接合之后，可允许第二量的晶状体材料扩散通过部分地固化的第一量的晶状体材料一段时间(框6020)。
在扩散阶段之后，可使第一量的晶状体材料与第二量的晶状体材料至少部分地固化(框6022)。第一量的晶状体材料与第二量的晶状体材料可固化单体到聚合物的完全转化的至少约10％和/或小于约50％。该部分的固化过程有助于在最终固化之前稳固环形掩膜4028的位置。在一些实施方式中，固化采用利用例如420nm的LED或文中描述的任何其他适合波长的光的光固化进行。在一些实施方式中，光强度可为至少约0.5毫瓦/平方厘米和/或小于等于约10毫瓦/平方厘米。在一些实施方式中，光强度可为约2毫瓦/平方厘米。在一些实施方式中，光固化过程可持续小于第一次部分的固化的时间(框6010)。在一些实施方式中，光强度可施用小于约5分钟、小于约3分钟或其他时间。
最终固化过程可利用热固化实施(框6024)。在最终固化之后，在一些实施方式中，剩余的单体量可小于晶状体材料总量的5％、小于晶状体材料总量的1％、小于晶状体材料总量的0.5％或为其它，使得剩余的单体不需要排出。在某些实施方式中，在最终固化之后仅保留剩余的单体的约0.3％。
在最终固化过程之后，人工晶状体可利用盐溶液进行水结合。如上面所描述的，晶状体材料可包括疏水性材料，疏水性晶状体材料可能是有利的，因为与由亲水性材料制成的晶状体相比，完成的晶状体在盐溶液中进行水结合时吸收(take up)较少的水。在晶状体本体吸收太多水的情况下，晶状体本体会隆起并破坏掩膜的位置和/或损坏嵌入在人工晶状体内的掩膜。在某些实施方式中，人工晶状体材料可包括小于约4％或小于约3％的含水量。在某些实施方式中，人工晶状体材料可包括约2.5％的含水量。
在一些实施方式中，在将晶状体从模具组移除之后，可在晶状体的任一侧或两侧上进行机加工。例如，可将一侧切割成适合的形状，并且随后可对两侧进行磨光。在一些实施方式中，晶状体的待切割的侧为通过第二晶状体成型模具部成型的那一侧。
上面已描述了不同的实施方式。尽管已结合这些具体的实施方式对本发明进行了描述，但该描述意为说明性而非意为限定性。对于本领域技术人员而言在未背离如在所附权利要求中限定的本发明的范围和实质精神的情况下可进行各种改变和应用。

Claims (22)

1.一种制造人工晶状体的方法，所述方法包括：
将第一量的晶状体材料添加至第一晶状体成型模具部；
将具有孔口的掩膜定位在定位模具部的突出销上，所述突出销构造成使掩膜在所述人工晶状体中居中；
将所述第一晶状体成型模具部与所述定位模具部接合；以及
使所述第一量的所述晶状体材料部分地固化，
其中，将所述掩膜定位在所述突出销上包括将所述掩膜与所述突出销的肩部相邻地定位，其中所述肩部具有比所述掩膜的所述孔口的直径大的直径，所述肩部构造成控制所述掩膜在所述人工晶状体中的深度。
2.根据权利要求1所述的方法，其中，所述晶状体材料包括紫外线吸收剂和光敏引发剂，所述引发剂构造成在暴露于具有在所述紫外线吸收剂的吸收光谱之外的波长的光时使所述晶状体材料固化。
3.根据权利要求2所述的方法，其中，所述引发剂构造成由具有在从约380nm至约495nm范围中的波长的光激活。
4.根据权利要求1所述的方法，其中，将所述第一晶状体成型模具部与所述定位模具部接合使得晶状体材料流入所述掩膜的表面与所述定位模具部的内表面之间的空间中，从而使得所述掩膜在其两侧至少部分地以晶状体材料围绕，其中，所述突出销自所述定位模具部的所述内表面延伸。
5.根据权利要求1所述的方法，其中，使所述第一量的晶状体材料部分地固化包括将光施用至所述第一晶状体成型模具部。
6.根据权利要求1所述的方法，其中，使所述第一量的晶状体材料部分地固化包括使所述第一量的晶状体材料固化小于完全固化的50％、但达到足以在移除所述定位模具部之后使得所述掩膜与所述第一晶状体成型模具部保持在一起的程度。
7.根据权利要求1所述的方法，还包括：使所述第一晶状体成型模具部冷却。
8.根据权利要求1所述的方法，还包括：将所述定位模具部移除并且将所述第一晶状体成型模具部与第二晶状体成型模具部接合。
9.根据权利要求8所述的方法，还包括：将第二量的晶状体材料添加至所述第二晶状体成型模具部。
10.根据权利要求9所述的方法，还包括：通过暴露于光而使所述第二量的晶状体材料部分地固化小于完全固化的50％。
11.根据权利要求10所述的方法，还包括：在通过暴露于光而使所述第二量的晶状体材料部分地固化之后，使所述第二量的晶状体材料热固化。
12.根据权利要求11所述的方法，还包括：使所述第一量的晶状体材料与所述第二量的晶状体材料的至少99％聚合。
13.根据权利要求1所述的方法，其中，所述晶状体材料为疏水性材料。
14.根据权利要求1所述的方法，还包括：将襻防护部与所述定位模具部接合，使得所述襻防护部防止所述晶状体材料在襻区域中聚合。
15.一种用于制造人工晶状体的模具组，所述人工晶状体具有悬置在所述人工晶状体内的掩膜，所述模具组包括：
第一晶状体成型模具部，所述第一晶状体成型模具部构造成保持晶状体材料的至少一部分；
定位模具部，所述定位模具部构造成将所述掩膜定位在晶状体材料内，所述定位模具部构造成与所述第一晶状体成型模具部匹配，所述定位模具部包括：
本体部；以及
突出销，所述突出销从所述本体部延伸，所述突出销的端部具有第一直径，所述第一直径定尺寸成与所述掩膜中的孔口对应，所述突出销构造成控制所述掩膜在所述晶状体材料内的居中定位，所述突出销还包括肩部，所述肩部具有比所述第一直径大的第二直径，所述肩部构造成与所述掩膜相邻地定位从而控制所述掩膜在晶状体材料内的深度。
16.根据权利要求15所述的模具组，其中，所述突出销的长度定尺寸成使得在所述定位模具部与所述第一晶状体成型模具部接合时所述突出销的所述端部延伸在距所述第一晶状体成型模具部的晶状体成型表面0mm到0.2mm内。
17.根据权利要求15所述的模具组，其中，所述突出销的长度构造成使得在所述第一模具部与所述定位模具部匹配时所述人工晶状体的光学区基本上没有晶状体材料。
18.根据权利要求15所述的模具组，其中，所述肩部的所述第二直径为所述掩膜的外直径的约50％。
19.根据权利要求15所述的模具组，其中，所述肩部构造成使得晶状体材料能够在所述掩膜的表面与所述本体部之间流动。
20.根据权利要求15所述的模具组，还包括第二晶状体成型模具部，所述第二晶状体成型模具部构造成保持晶状体材料的另一部分并且与所述第一晶状体成型模具部接合。
21.根据权利要求15所述的模具组，其中，所述第一晶状体成型模具部包括襻区域。
22.根据权利要求21所述的模具组，还包括襻防护部，所述襻防护部在所述定位模具部上定位成使得所述襻防护部阻挡固化光到达所述襻区域，从而防止晶状体材料在所述襻区域内聚合。
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