CN106999507A - 用于调节人工晶状体的聚合材料 - Google Patents

用于调节人工晶状体的聚合材料 Download PDF

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CN106999507A
CN106999507A CN201580063249.XA CN201580063249A CN106999507A CN 106999507 A CN106999507 A CN 106999507A CN 201580063249 A CN201580063249 A CN 201580063249A CN 106999507 A CN106999507 A CN 106999507A
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T·希尔维斯托里尼
K·雅各布
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Lensgen Inc
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Abstract

本公开内容一般地涉及用于调节植入患者眼睛的晶状体室内的人工晶状体的聚合材料。本公开内容涉及包括氟硅氧烷聚合物和二氧化硅组分的聚合材料。目前公开的聚合材料既是光学透明的又具有足够低的杨氏模量，使得它可以有效地响应于眼睛的自然调节力并且因而可以用于调节人工晶状体。当用于制造人工晶状体时，本文公开的聚合材料保护晶状体的物理特性，这是因为氟硅氧烷聚合物增加的疏水性允许其有效地抑制来自眼睛的流体扩散和生物材料的粘附。

Description

用于调节人工晶状体的聚合材料
技术领域
本公开内容一般地涉及用于调节植入患者眼睛的晶状体室中的人工晶状体的聚合材料。
背景技术
眼外科手术一直在上升，因为技术进步允许复杂的干预以解决各种眼科病症。过去二十年来，患者接受度增加，因为这种手术被证明是普遍安全并且产生显著改进患者生活质量的结果。
白内障手术是最普通的外科手术之一，全世界进行了超过1600万白内障手术。可以预期的是，随着平均寿命预期继续上升，该数字将继续增加。通常通过从眼睛移除晶状体并且在其位置上植入人工晶状体(“IOL”)治疗白内障。由于常规的IOL装置主要关注远视力，它们未能矫正远视并且仍然需要阅读眼镜。因而，虽然经历标准IOL植入的患者不再经受白内障的模糊，但是他们不能够从近至远、从远至近以及之间距离调节或改变焦距。
矫正眼睛的屈光不正的手术也已经变得非常常见，其中LASIK享有相当大的知名度，其每年进行超过700,000个手术。鉴于屈光不正的高发病率以及该手术的相对安全性和有效性，与使用常规眼镜或隐形眼镜相比，预计越来越多的人会倾向于进行LASIK或其他外科手术。尽管LASIK在治疗近视中是成功的，但对于矫正远视的有效手术干预仍然存在未满足的需要，远视不能通过常规的LASIK手术治疗。
由于几乎每个白内障患者也患有远视，因此对于治疗这两种病症存在交汇的市场需求。虽然医师和在治疗白内障中具有可植入人工晶状体的患者普遍接受，但是矫正远视的类似手术仅占美国白内障市场的5％。因此，在日益老化的人口中，存在解决眼科白内障和/或远视二者的需要。
发明内容
本公开内容涉及包括氟硅氧烷聚合物和二氧化硅组分的聚合材料。目前公开的聚合材料是光学透明的并且具有足够低的杨氏模量，使得它可以有效地响应于眼睛的自然调节力并且因而可以被用于调节人工晶状体。当用于制造人工晶状体时，本文公开的聚合材料保护晶状体的物理特性，因为氟硅氧烷聚合物的增加的疏水性允许它有效地抑制来自眼睛的流体扩散和生物材料的粘附。
因此，在一方面，本文提供的是聚合材料，其包括氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分，其中二氧化硅组分具有至少大约280m2/g的表面积。
在另一方面，本文提供的是可植入的人工晶状体(IOL)，其包括包含氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分的聚合材料，其中二氧化硅组分具有至少大约280m2/g的表面积。
在仍另一方面，本文提供的是人工晶状体(IOL)装置，其包括氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分，其中二氧化硅组分具有至少大约280m2/g的表面积。在一方面，人工晶状体(IOL)装置包括：
(a)第一晶状体，其由氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分构成，其中二氧化硅组分具有至少大约280m2/g的表面积，其具有第一杨氏模量；
(b)沿着中心光轴与第一晶状体间隔开的第二晶状体；和
(c)围绕第一和第二晶状体的圆周部分，该圆周部分包括外围边缘；
其中第二晶状体的一部分和圆周部分的一部分的至少一个是由具有第二杨氏模量的材料制成；并且其中第一杨氏模量小于第二杨氏模量。
从以下具体实施方式，所公开的实施方式的其他目的、特征和优势将对本领域技术人员变得明显。然而，应当理解的是，详细描述和具体实例，虽然指示本发明的各种实施方式，但是通过说明而不是限制的方式给出。在本发明的范围内可以做出许多改变和更改而不脱离其精神，并且本发明包括所有这些更改。
具体实施方式
现在将参考以下附图描述本发明的具体的非限制性实施方式。应当理解的是，这些实施方式是通过实例的方式并且仅仅说明了在本发明的范围内的少数实施方式。如在所附的权利要求中所进一步限定，对本发明所属领域的技术人员显而易见的各种改变和更改被认为在本发明精神、范围和意图内。
聚合材料
本公开内容涉及聚合材料，其包括氟硅氧烷聚合物和二氧化硅组分，该聚合材料是光学透明的并且具有足够低的模量，使得它可以有效地响应于眼睛的自然调节力并且因而被用于调节人工晶状体。
在一个实施方式中，目前公开的聚合材料包括氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分。本文所述的氟硅氧烷聚合物是二烷基、二苯基或苯基烷基硅氧烷和氟化二烷基硅氧烷的交联共聚物。通常，氟硅氧烷聚合物是二烷基、二苯基或苯基烷基硅氧烷和三氟烷基(烷基)硅氧烷的交联共聚物，但可以是二苯基和/或苯基烷基硅氧烷、二烷基硅氧烷和三氟烷基(烷基)硅氧烷的三元共聚物或更高级聚合物。在某些实施方式中，氟硅氧烷聚合物是二烷基硅氧烷诸如二甲基硅氧烷和三氟烷基(烷基)硅氧烷诸如3,3,3-三氟丙基甲基硅氧烷的交联共聚物。可以调节二烷基硅氧烷和三氟烷基(烷基)硅氧烷的比率以调节氟硅氧烷聚合物的物理特性。例如，增加三氟烷基(烷基)硅氧烷可以增加所得氟硅氧烷聚合物的疏水性。在一些实施方式中，氟硅氧烷聚合物通常包括至少大约25摩尔％三氟烷基(烷基)硅氧烷，或大约25摩尔％三氟烷基(烷基)硅氧烷，或大约30摩尔％三氟烷基(烷基)硅氧烷，或大约35摩尔％三氟烷基(烷基)硅氧烷，或大约40摩尔％三氟烷基(烷基)硅氧烷，或大约50摩尔％三氟烷基(烷基)硅氧烷或从大约25摩尔％至大约50摩尔％，或从大约25摩尔％至大约40摩尔％三氟烷基(烷基)硅氧烷。
在一个实施方式中，氟硅氧烷聚合物由式(I)表示：
其中：
n和m每个独立地是0至大约500；
t是大约100至大约1000；
每个R1独立地是烷基或芳基；
R2是卤代烷基；
R3是烷基或卤代烷基；
R4和R5独立地是烷基、卤代烷基或芳基；和
每个X是交联剂，其将式(I)的聚合物与式(I)的第二聚合物联接。
在一个实施方式中，n是大约50，或大约100，或大约125，或大约150，或大约200，或大约250，或大约300，或大约350，或大约400，或大约450，或大约500。在一个实施方式中，m是大约50，或大约100，或大约125，或大约150，或大约200，或大约250，或大约300，或大约350，或大约400，或大约450，或大约500。在另一个实施方式中，n是大约100，并且m是大约150。
在任一个实施方式中，t是大约100，或大约125，或大约150，或大约200，或大约250，或大约300，或大约350，或大约400，或大约450，或大约500，或大约550，或大约600，或大约650，或大约700，或大约750，或大约800，或大约850，或大约900，或大约950，或大约1000。
在一个实施方式中，每个R1是烷基。合适的烷基基团包括，但不限于，C1-C6烷基基团，诸如甲基，乙基，正丙基，异丙基，正丁基，叔丁基，正戊基，正己基等。在另一个实施方式中，每个R1是甲基。在一个实施方式中，R3是烷基，诸如对R1限定的。在另一个实施方式中，R3是甲基。在一个实施方式中，R4是烷基，诸如对R1限定的。在另一个实施方式中，R4是甲基。在一个实施方式中，R5是烷基，诸如对R1限定的。在另一个实施方式中，R5是甲基。在又另一个实施方式中，R4和R5是甲基。在仍另一个实施方式中，氟硅氧烷聚合物由式(IA)表示：
其中:
n是从1至大约500；
m是从0至大约500；
t是大约100至大约1000；
R2是卤代烷基；
R3是烷基或卤代烷基；和
每个X是交联剂，其将式(IA)的聚合物与式(IA)的第二聚合物联接。
在一个实施方式中，R2是卤代烷基基团，其包括1至3个卤基(条件是至少一个是氟)取代基。示例性的卤代烷基基团包括，但不限于，氟甲基，2-氟乙基，2,2-二氟乙基和3,3,3-三氟丙基。在一个实施方式中，R2是3,3,3-三氟丙基。
交联剂通常是甲基氢硅氧烷-二甲基硅氧烷共聚物，其具有大约30至大约70摩尔％的甲基-氢含量。在一些实施方式中，交联剂具有从大约5至大约30个重复Si单元(即，聚合度)的链长。
在某些实施方式中，本文提供的聚合材料具有从大约200至大约500，或从大约300至大约500，或大约400，或大约450的聚合度。
为了用作人工晶状体材料，本文所述的聚合材料应当是光学透明的。然而，氟硅氧烷聚合物和二氧化硅组分不是折射率匹配的。因而随着模量增加必须维持聚合材料的光学性能。有利地，可以独立于模量调节目前公开的聚合材料的光学性能。几种不同的因素有助于聚合材料的光学性能，其包括二氧化硅组分的量和颗粒尺寸。
由于氟硅氧烷聚合物的折射率低，考虑的是，二氧化硅组分的颗粒尺寸应当尽可能小以便获得优异的光学特性。在某些实施方式中，本文提供的聚合材料具有从大约1.35至大约1.40，或大约1.37至大约1.39，或大约1.38的折射率。因此，本文所使用的二氧化硅组分具有至少大约280m2/g，或至少大约300m2/g，或至少大约310m2/g，或至少大约320m2/g，或至少大约330m2/g，或至少大约340m2/g，或至少大约350m2/g的表面积。在某些实施方式中，二氧化硅组分具有小于大约11纳米的平均颗粒尺寸。具有直径大约7纳米的平均颗粒尺寸的热解法二氧化硅是特别合适的，因为小的颗粒尺寸不干扰可见光的波长并且有助于固化的组合物中提高的光学分辨率。具有低至7nm的颗粒尺寸的商业热解法二氧化硅是商业上可获得的(例如，CABOT和Sigma)。通常，二氧化硅组分以至多大约30重量％，或27重量％，或大约25重量％，或大约23重量％，或大约20重量％，或大约20至大约30重量％的量存在。
本文所使用的二氧化硅组分是热解的或“活化的”二氧化硅，其已用硅氮烷处理。二氧化硅组分的量应当是使得聚合材料被充分增强，但仍然保持光学透明。用于进行热解法二氧化硅处理的合适的硅氮烷和方法包括小颗粒尺寸热解法二氧化硅的原位反应并且在本领域是公知的。在这些反应中，硅氮烷(例如，六甲基二硅氮烷)容易与热解法二氧化硅上的羟基官能团反应，形成涂布在二氧化硅表面上的三甲基硅氧烷。在某些实施方式中，本文提供的聚合材料具有大约10psi至大约150psi，或大约50psi至大约100psi，或大约70psi的杨氏模量。
也可以调制聚合材料的其他物理特性。在某些实施方式中，本文提供的聚合材料具有大约500psi至大约1200psi，或大约700psi至大约1000psi，或大约900psi的拉伸强度。在某些实施方式中，本文提供的聚合材料具有大约400％至大约1000％，或大约600％的伸长百分率。
本文还提供了制造以上所述聚合材料的方法。在某些实施方式中，方法包括以下步骤：
(a)将乙烯基封端的氟硅氧烷聚合物与至多大约30重量％的二氧化硅组分组合以获得氟硅氧烷基础组合物，其中二氧化硅组分具有至少大约280m2/g的表面积；
(b)添加交联剂和固化剂至氟硅氧烷基础组合物；并且
(c)固化氟硅氧烷基础组合物以获得聚合材料。
可以使用已知的方法由商业上可获得的或从商业来源购买的原材料合成乙烯基封端的氟硅氧烷聚合物。例如，乙烯基封端的三氟丙基甲基硅氧烷–二甲基硅氧烷共聚物，其具有大约25,000至大约35,000的分子量，是从Gelest可商业获得的。可选地，例如，也可以如实施例1中所述合成乙烯基封端的氟硅氧烷聚合物。合适的原材料包括，但不限于，烷基硅氧烷(例如，八甲基环四硅氧烷)，卤代烷基硅氧烷(例如，三氟丙基三甲基环硅氧烷)等。合适的乙烯基封端剂包括，但不限于，乙烯基封端的二甲基硅氧烷低聚物。
在一个实施方式中，氟硅氧烷聚合物具有长链长，具有大于35,000道尔顿，或大于50,000道尔顿以及或大于70,000道尔顿的分子量是期望的。
在一个实施方式中，氟硅氧烷聚合物是式(II)的化合物：
其中:
n和m每个独立地是0至大约500；
t是从大约100至大约1000；
每个R1独立地是烷基或芳基；
R2是卤代烷基；
R3是烷基或卤代烷基；和
R4和R5独立地是烷基、卤代烷基或芳基。
本文所述的聚合材料具有交联度，使得材料具有足够低的模量以最小化在其用作例如调节性人工晶状体期间施加的力引起的任何潜在的变形，但也足够坚固以最小化凝胶的渗透。在某些实施方式中，聚合材料是轻度交联的，具有小于每百份大约5份(pph)，或小于大约4pph，或小于大约2pph，或小于大约1pph，或大约1pph的交联剂。交联剂通常是具有大约30至大约70摩尔％的甲基-氢含量的甲基氢硅氧烷-二甲基硅氧烷共聚物。在一些实施方式中，交联剂具有大约5至大约30个重复Si单元(即，聚合度)的链长。
在一个实施方式中，固化步骤包括添加铂催化剂。铂族金属催化剂可以是任何相容的含铂族金属的催化剂，其已知催化硅氧烷-氢原子加成为硅键合乙烯基自由基。含铂族金属的催化剂可以是相容的任何已知的形式，诸如氯化铂，铂盐，氯铂酸和各种络合物，例如，具有含铂金属基团的硅氧烷络合物。含铂族金属的催化剂可以以任何催化量使用，诸如足以提供基于组合物的总重量至少大约0.1ppm重量的铂族金属(作为单质金属)的量。在某些实施方式中，使用按重量计至少大约10ppm，或至少大约20ppm，或至少30ppm，或至少大约40ppm的铂催化剂。
可植入的人工晶状体(IOL)
植入在眼睛中的装置自然暴露于眼睛中的流体并且流体可以随着时间扩散穿过装置并且对装置的物理特性具有非意欲的和/或不期望的影响。已经尝试用阻挡层涂布眼科装置以防止这种扩散，但这些步骤可能是昂贵且费时的。此外，如果眼科装置在装置内含有室或通道，其含有流体，那么存在该流体可能扩散出其流体室并且进入聚合材料的风险。这导致可以被IOL利用的流体量减少，以及可能改变聚合材料的物理特性。含有氟碳的硅氧烷单体可以提高聚合物对流体扩散的阻力，并且如此，本文所述的聚合材料可以用在眼科装置中以抑制流体扩散到或扩散出装置。
使用已知的成型技术可以由所公开的聚合材料制造IOL，诸如一次性的或抛光的不锈钢模具，其具有材料正确折射光所需形状的模具腔。在实践中，未固化的氟硅氧烷基础组合物以涉及晶状体尺寸、折射率和结构的考虑所确定的量被引入到模具腔中，并且然后固化。可以采用几种使晶状体成型的方法，其包括注射成型、液体注射成型、压缩成型和传递成型。
人工晶状体(IOL)装置
目前公开的人工晶状体可以用在植入患者中的眼内装置中。这种装置在本领域是已知的，并且包括，例如，US7,662,180和US 7,875,661中描述的那些。
在某些实施方式中，目前公开的人工晶状体可以用作两部分调节性IOL装置中的折射率改变晶状体，其中在折射率改变晶状体和主晶状体在晶状体室内彼此滑动接触。在这些系统中，折射率改变晶状体的尺寸并且形状为承受并且响应于沿着晶状体的外围边缘施加的径向向内的力。相反，主晶状体不参与提供调节性响应并且因而尺寸并且形状为避免干涉或抑制施加至折射率改变晶状体的径向压缩力。这可以通过控制折射率改变晶状体和主晶状体的相对直径和厚度以最大化径向压缩力施加在折射率改变晶状体上的程度并且最小化这些力施加在主晶状体上的程度实现。
因此，在一个实施方式中，本文提供的是人工晶状体(IOL)装置，其包括：
(a)由具有第一杨氏模量的本文所描述的聚合材料组成的第一晶状体；
(b)沿着中心光轴与第一晶状体间隔开的第二晶状体；和
(c)围绕第一和第二晶状体的圆周部分，圆周部分包括外围边缘；
其中第二晶状体的一部分和圆周部分的一部分的至少一个由具有第二杨氏模量的材料制成；并且其中第一杨氏模量小于第二杨氏模量。
在实践中，第一晶状体(即，折射率改变晶状体)和第二晶状体(即，主晶状体)在晶状体室内彼此滑动接触。晶状体室填充有具有特定物理和化学特性的流体或凝胶以提高在调节期间由IOL提供的折射率范围。选择流体或凝胶使得它与折射率改变晶状体配合以提供上至至少3屈光度，优选地上至至少5屈光度，优选地上至至少10屈光度且最优选地上至至少15屈光度的足够范围的调节。
此外，由本文所述的聚合材料组成的晶状体在患者中从主晶状体接触而屈曲的可能性减小，因为表面比通常用于IOL的其他聚合物是显著更疏油的。
除了用在IOL中之外，本公开内容的聚合材料也可以用在其他眼科装置，诸如，但不限于，隐形眼镜、人工角膜、囊袋扩张环、角膜嵌体、角膜环、或其他眼科装置。示例性可选的用途将是在乳房植入领域中，使得聚合物可以用作外部壳样材料以防止内部材料的泄漏。
实施例
实施例1
根据本公开内容的示例性聚合材料制备如下。
乙烯基封端的40摩尔％氟硅氧烷聚合物
用于氟硅氧烷基础化合物的乙烯基封端的40摩尔％氟硅氧烷聚合物制备如下。140份八甲基环四硅氧烷(D4环状物)、100份三氟丙基三甲基环硅氧烷(D3氟环状物)，3.2份乙烯基封端的二甲基硅氧烷低聚物(乙烯基封端剂)和0.1份硅醇钾(potassiumsiloxanolate)催化剂在聚合容器中搅拌并且加热至大约150℃。在150℃，将硅醇钾催化剂添加至聚合容器。一旦通过增加的黏度视觉上观察到聚合，聚合继续大约3小时。
在大约3小时之后，通过用CO2吹扫聚合物1小时使催化剂失活并且在大约150℃至大约180℃的温度下将聚合物暴露于减小的压力(最小27”Hg真空)，直到挥发物含量达到低于大约3％的量。
氟硅氧烷基础化合物
100份的乙烯基封端的40摩尔％氟硅氧烷聚合物、9份六甲基二硅氮烷(HMDZ)和3份水被添加至混合容器(例如，sigma叶片搅拌机)。一旦混合，60份活化的二氧化硅(Tokuyama QS-30C热解法二氧化硅)被分多次添加，直到二氧化硅完全混合到氟硅氧烷聚合物。组合物在80℃下混合大约30分钟，此时混合容器被在真空下加热至大约150℃持续大约3小时。
在大约3小时之后，移除加热和真空。虽然氟硅氧烷基础化合物仍然很热，但是将另外的氟硅氧烷聚合物缓慢添加至聚合容器，直到二氧化硅含量减小至大约25份。然后将氟硅氧烷基础化合物分散在氯化溶剂(即四氯乙烯)中至大约30％固体含量，通过1微米介质过滤器过滤并且经受加热和抽真空以去除溶剂。
包括氟硅氧烷聚合物的聚合材料
将等份的A和B(表1)混合在一起，真空脱气，并且在302°F下在ASTM测试板模具中加压固化大约10分钟。固化的测试板允许在室温下平衡最少3小时。
表1
部分A 部分B
100份氟硅氧烷基础化合物 100份硅氧烷基础化合物
5-15ppm铂催化剂 2份甲基氢硅氧烷交联剂
0.3pph甲基乙烯基环硅氧烷抑制剂
氟硅氧烷聚合物的机械性能在表2中显示。令人惊讶地，当与非氟化硅氧烷聚合物相比时本文所述的氟硅氧烷聚合物展现提高的拉伸强度同时维持低模量。此外，考虑的是，由于低二氧化硅含量，本文所述的氟硅氧烷聚合物保持合适的光学清晰度。
氟硅氧烷聚合物 非氟化硅氧烷聚合物
硬度(肖氏A) 20 20
拉伸强度 900psi 475psi
伸长％ 600％ 300％
100％模量 70psi 65psi
本文描述和要求保护的发明在范围上不受本文公开的具体优选实施方式的限制，因为这些实施方式旨在说明本发明的几个方面。实际上，从前面的描述，除了本文显示和描述的那些之外的本发明的各种更改对本领域技术人员而言将是显示意见。这种更改也旨在落入所附权利要求的范围内。

Claims (26)

1.一种包括氟硅氧烷聚合物和至多大约30重量％的二氧化硅组分的聚合材料，其中所述二氧化硅组分具有至少大约280m2/g的表面积。
2.根据权利要求1所述的聚合材料，其中所述二氧化硅组分具有大约280m2/g至大约350m2/g的表面积。
3.根据权利要求1所述的聚合材料，其包括大约27％、或大约25％、或大约23％、或大约20％的所述二氧化硅组分。
4.根据权利要求1所述的聚合材料，其中所述氟硅氧烷聚合物包括式(I)的聚合物：
其中：
n和m每个独立地是0至大约500；
t是大约100至大约1000；
每个R1独立地是烷基或芳基；
R2是卤代烷基；
R3是烷基或卤代烷基；
R4和R5独立地是烷基、卤代烷基或芳基；并且
每个X是将式(I)的聚合物和式(I)的第二聚合物联接的交联剂。
5.根据权利要求3所述的聚合材料，其中式(I)的氟硅氧烷聚合物以下式(IA)表示：
其中：
n是1至大约500；
m是0至大约500；
t是大约100至大约1000；
R2是卤代烷基；
R3是烷基或卤代烷基；并且
每个X是将式(IA)的聚合物与式(IA)的第二聚合物联接的交联剂。
6.根据权利要求4所述的聚合材料，其中R2是3,3,3-三氟丙基。
7.根据权利要求6所述的聚合材料，其包括至少大约25摩尔％的三氟丙基含量。
8.根据权利要求1所述的聚合材料，其具有大约1.35至大约1.40，或大约1.37至大约1.39，或大约1.38的折射率。
9.根据权利要求1所述的聚合材料，其具有大约500psi至大约1200psi，或大约700psi至大约1000psi，或大约900psi的拉伸强度。
10.根据权利要求1所述的聚合材料，其具有大约400％至大约1000％，或大约600％的伸长百分率。
11.根据权利要求1所述的聚合材料，其具有大约200至大约500，或大约400的聚合度。
12.根据权利要求1所述的聚合材料，其具有大约10psi至大约150psi，或大约50psi至大约100psi，或大约70psi的杨氏模量。
13.一种聚合材料，其包括交联的二烷基硅氧烷-三氟烷基(烷基)硅氧烷共聚物，和至多大约30重量％的二氧化硅组分，其中所述二氧化硅组分具有至少大约280m2/g的表面积。
14.一种聚合材料，其包括交联的二甲基硅氧烷-3,3,3-三氟丙基甲基硅氧烷共聚物和至多大约30重量％的二氧化硅组分，其中所述二氧化硅组分具有至少大约280m2/g的表面积。
15.根据权利要求1-14任一项所述的聚合材料，其中所述交联剂是甲基氢硅氧烷-二甲基硅氧烷共聚物。
16.根据权利要求15所述的聚合材料，其中所述交联剂具有大约5至大约30个重复Si单元的链长。
17.根据权利要求15所述的聚合材料，其中所述交联剂具有大约30至大约70摩尔％的甲基-氢含量。
18.一种可植入的人工晶状体(IOL)，其包括前述权利要求任一项所述的聚合材料。
19.一种制造权利要求1所述的聚合材料的方法，其包括以下步骤：
(a)将乙烯基封端的氟硅氧烷聚合物与至多大约30重量％的二氧化硅组分组合以获得氟硅氧烷基础组合物，其中所述二氧化硅组分具有至少大约280m2/g的表面积
(b)将交联剂和固化剂添加至所述氟硅氧烷基础组合物；和
(c)固化所述氟硅氧烷基础组合物以获得所述聚合材料。
20.根据权利要求19所述的方法，其中步骤b)包括：
添加所述交联剂至步骤a)的所述氟硅氧烷基础组合物的第一部分，并且添加所述固化剂至步骤a)的所述氟硅氧烷基础组合物的第二部分，并且
在步骤c)之前将所述第一部分和所述第二部分混合。
21.根据权利要求19或20所述的方法，其中所述氟硅氧烷基础组合物的第一部分进一步包括抑制剂。
22.根据权利要求19-21任一项所述的方法，其中所述固化剂是铂催化剂。
23.根据权利要求19-22任一项所述的方法，其中所述二氧化硅组分具有大约280m2/g至大约350m2/g的表面积。
24.根据权利要求19-23任一项所述的方法，其中通过将二氧化硅与六甲基二硅氮烷和水接触提供所述二氧化硅组分。
25.一种人工晶状体(IOL)装置，其包括由权利要求1-17任一项所述的聚合材料构成的晶状体。
26.一种人工晶状体(IOL)装置，其包括：
(a)由权利要求1-17任一项所述的聚合材料构成的第一晶状体，其具有第一杨氏模量。
(b)沿着中心光轴与所述第一晶状体间隔开的第二晶状体；和
(c)围绕所述第一和第二晶状体的圆周部分，所述圆周部分包括外围边缘；
其中所述第二晶状体的一部分和所述圆周部分的一部分的至少一个由具有第二杨氏模量的材料制造；并且
其中所述第一杨氏模量小于所述第二杨氏模量。
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