CN102834740A - 表现出理想的光学性与舒适性的瞳区光致变色接触镜片 - Google Patents
表现出理想的光学性与舒适性的瞳区光致变色接触镜片 Download PDFInfo
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Abstract
本发明涉及一种用于制备光致变色的水凝胶接触镜片的方法,其中包括:给前接触镜片模具提供第一镜片组合物,所述组合物含有接触镜片单体和光致变色材料;以及给所述接触镜片模具提供第二镜片组合物,其中所述第一组合物的粘度大于所述第二接触镜片组合物的粘度至少约1000厘泊,所述第二组合物的组成与所述第一组合物匹配,以减少所得镜片的组合物之间的应变。
Description
相关专利申请
本专利申请要求对提交于2010年4月13日的美国临时专利申请No.61/323,410和提交于2011年4月8日的美国专利申请Serial No.13/082,447的优先权。
技术领域
本发明涉及隐形眼镜,更具体地说,涉及佩戴时覆盖瞳区的具有光致变色染料的接触镜片,所述光致变色接触镜片具有改善的美容外观和改进的结构特性。本发明还涉及制造此类光致变色的接触镜片的方法和材料。
背景技术
早期的接触镜片已知有光致变色液保存在形成接触镜片的两种材料之间的储液池中,作为应对诸如核爆炸之类的强烈闪光的防护系统的一部分。
最近,研究工作已针对这样的光致变色接触镜片,所述光致变色接触镜片可以每天佩戴并且可利用能吸收特定波长范围的光的光致变色染料在有色和无色状态之间迅速转变。在一些实例中,染料被分配在能够在构成接触镜片的聚合物材料中呈现光致变色的镜片中,以优选地具有能够吸收光的单层。然而,在整个镜片区域(“边缘到边缘”)显示光致变色的接触镜片,由于美容原因而并不可取。
因此,已经努力研制出了仅在中央瞳区改变颜色的接触镜片,即“瞳区”接触镜片。
美国专利2003/0142267公开了仅在镜片的中央即瞳区具有光致变色材料的接触镜片。所述镜片通过在镜片模具中分配具有不同粘度的单体混合物而制备。所述接触镜片为不含水分的硬接触镜片。美国专利2003/0142267中公开的方法不制造具有理想的特性例如良好光学性和舒适性的软性水凝胶接触镜片。
需要一种改进的瞳区光致变色接触镜片(包括制造这种镜片的方法),所述镜片表现出降低的变形和光学畸变以及增强的舒适性、耐磨能力和美容外观。
附图说明
本发明参照附图进行公开,其中:
图1A和1B示意表示制造根据本发明的瞳区光致变色镜片的方法。
图2为按本发明的方法制备的示例性镜片。
图3表示根据本发明的接触镜片的干涉条纹图。
图4为根据本发明的示例性镜片。
图5-8为实例12、比较例1和2以及实例13的照片。
图9为所述实例中用来测量矢状深度对于设计矢状深度的偏差的装置的示意图。
具体实施方式
如文中所用,水凝胶为含水量在约20和约75%之间的水溶胀性聚合物。
如文中所用,反应混合物或单体混合物意指
如文中所用,膨胀系数或溶胀是在水合后水凝胶制品尺寸的变化。膨胀系数可以通过将在萃取和水合之前在模具中形成的镜片除以经水合镜片的直径并乘以100而算出。
如文中所用,矢状深度为接触镜片的高度,在镜片中心(顶点)处以在其底部直径处跨越镜片画出的弦为始点测量。可以用已知的测试方法来测量矢状深度,包括ISO 18369-3、使用超声仪器(第4.1.4.2.3节)。
一般而言,制造软性水凝胶镜片的一种方式是在塑料模具中模制接触镜片。通常有两个模具部分,它们在组装时形成腔体。反应混合物在该腔体内固化而形成接触镜片。通常,第一模具部件被分配反应混合物,第二模具部件放置在第一模具部件上,然后反应混合物被固化。反应混合物的反应一般是辐射激活的。反应混合物在腔体固化(例如聚合和/或交联)而形成接触镜片。然后从模具中取出固化的水凝胶接触镜片并置入溶剂中,以除去不需要的化学成分。镜片通常在此过程中溶胀。然后让镜片与水接触,以用水交换溶剂,并赋予水凝胶以其最终的稳定形状和大小。
特别参见图1,该图示意性地示出制造瞳区光致变色接触镜片的两种方法。在图1a所示的第一方法中,前曲面11a在步骤10a形成。前曲面11a是对合模具的一部分,为凹形,因此沉积的材料由于重力而保持在模具中心。在步骤12a,精确的小剂量含光致变色染料的单体混合物13a(或者说瞳区单体混合物)被施加或分配到前曲面半模11a的表面上,优选地在大致中央的位置,并且成大致圆形的构型。
在一个实施例中,含光致变色染料的单体混合物被分配到接触镜片视觉区内的中央圆形区域。该中央圆形区域可以与视觉区同大,在典型的接触镜片中其直径为等于或小于约9mm。在一个实施例中,中央圆形区域的直径为约4至约7mm之间,在另一个实施例中为约4至约6mm之间。
任选地,含光致变色染料的单体混合物可以在步骤12a通过受控的固化机制而至少部分地聚合。然后在步骤14a,一定剂量的透明单体混合物(其中不包含光致变色染料)15a被分配在含光致变色染料的单体混合物13a的顶部。该剂量的透明单体混合物15a按所需量填充凹进的前曲面11a,然后在步骤16a中设置底曲面17a,半模11a、17a被置入其最终固化位置,单体混合物被固化和/或聚合,完成成型过程。在聚合过程包括光聚合机制的情况下,辐射既可朝向前曲面半模也可朝向底曲面半模,或朝向两者。成型的镜片然后被萃取以除去不需要的化学成分,并被水合。
另一种方法示于图1b中,其中在步骤12b第一剂量的光致变色单体混合物13b被设置在前曲面模具11b的中央,然后在步骤14b透明的单体混合物的环形圈15b中被分配在前曲面模具11b的边缘处。所得的透明单体材料15b的环形圈被重力拖拽到前曲面的中央。然后加上底曲面模具17b并起始固化过程,该过程在步骤16b完成,继续进行萃取和水合步骤(s)(未图示),以形成最终的水凝胶接触镜片产品。
为了形成两个区域可接受的分离(打印质量)和低失真的水凝胶接触镜片,这一般根据集中的光致变色染料11的分布,已经发现(如美国专利2003/0142267所描述的),增加单体混合物13、15的粘度,特别是与透明的单体混合物15相比增加光致变色染料的单体混合物13的粘度,可降低单体13、15的分子扩散,从而保持中央区域中的光致变色染料。使用比透明单体混合物的粘度高的光致变色染料单体混合物,有助于减少两种单体混合物的界面处的剪切从而减少物理混合。斯托克斯-爱因斯坦方程的分析(如下所示)说明了影响材料扩散能力的参数:
式中,D是分子的扩散系数,k为玻尔兹曼常数,T为温度,μ为粘度,r为分子半径。在较低的温度下操作和使用较高粘度的单体,趋向于减少分子的扩散速率。在一个实施例中光致变色染料单体混合物的粘度比透明的即外围的单体混合物的粘度高至少约1000厘泊,在另一个实施例中高至少约1500厘泊。
然而,如在美国专利2003/0142267中公开的那样控制单体混合物的粘度,不足以形成具有合适的光学性和舒适性的水凝胶接触镜片。当固化到一起时,水凝胶单体混合物形成呈现变平的视觉区的接触镜片,而不是具有连续半径的镜片。这可以通过测量接触镜片的矢状深度来测量。本发明的水凝胶镜片具有偏离镜片的设计矢状深度不超过约100微米的矢状深度。在一个实施例中,与设计矢状深度的偏离从0(与设计矢状深度匹配)到-100微米,-100微米的偏差表示稍有偏离设计矢状深度的平坦化。
已经发现,通过平衡由光致变色染料单体混合物形成的聚合物和由透明单体混合物形成的聚合物的膨胀系数,可以产生具有所需的光学性和舒适性的水凝胶接触镜片。在一个实施例中,由各个单体混合物形成的聚合物的膨胀系数为约10%以内,在一些实施例中为约8%以内,在另一些实施例中为约5%以内。膨胀系数可以通过调控一些配方变量来调整,这些配方变量包括稀释剂的浓度、亲水性和疏水性组分的浓度和亲水性或疏水性、引发剂和交联剂的浓度、以及它们的组合。许多光致变色染料是高度疏水性的,并且在本发明中所使用的浓度条件下可以对含有它们的水凝胶的膨胀系数具有影响。在一个其中光致变色染料是疏水性的实施例中,光致变色染料取代同样数量的另一种疏水性组分加入配方中。同样地,如果光致变色化合物是亲水的,它将取代相同数量的另一种亲水性成分添加到配方中。在一些实施例中,例如在制成有机硅水凝胶接触镜片的实施例中,可能需要保持有机硅组分的浓度并替换亲水性组分之一的一部分。在这些实施例中,为达到所需的膨胀系数可能需要进行多种调整。
此外,可以修改其他的配方变量以达到所需的膨胀系数。在一些实施例中,改变亲水性组分的浓度、稀释剂的浓度和引发剂的浓度、以及它们的组合的浓度,对于形成具有所需的光学性和舒适性的光致变色接触镜片已表现出有效性。在一个实施例中,亲水性聚合物例如聚(乙烯基吡咯烷酮)(PVP)、甲基丙烯酸、聚二甲基或聚(乙烯基甲基乙酰胺)可以被添加到光致变色染料单体混合物中。
在一些实施例中,理想的是在光致变色染料混合物和透明单体混合物中使用相同的或相似的组分。例如,也许理想的是两个单体混合物都包含相同的亲水性组分。在这种情况下,亲水性组分的浓度之外的配方变量可以改变。这些例子进一步说明,配方变量可以如何进行平衡。
在一个其中采用单側固化的实施例中,膨胀系数用单体、稀释剂浓度和它们的组合加以匹配。在固化只从一侧(如在光固化过程中)进行的情况下,增加引发剂的浓度可能也是可取的。
本发明中可以采用的透明单体混合物15包括由HEMA型水凝胶或硅水凝胶制备的软接触镜片材料,其中包括但不限于硅水凝胶和含氟水凝胶(fluorohydrogels)材料。软性接触镜片配方的例子包括但不限于etafilcon A、genfilcon A、lenefilcon A、polymacon、acquafilcon A、balafilcon A、galyfilcon A、Senofilcon、narafilcon A、narafilcon B、comfilcon、filcon II 3、asmofilcon、单体A和lotrafilcon A、以及类似物。也可以采用在如下专利文献中公开的硅水凝胶配方:美国专利No.5,998,498;美国专利申请No.09/532,943和2000年8月30日提交的美国专利申请No.09/532,943的部分继续申请;以及美国专利No.6,087,415、U.S.6,087,415、U.S.5,760,100、U.S.5,776,999、U.S.5,789,461、U.S.5,849,811、U.S.5,965,631、US7,553,880、WO2008/061992、US2010/048847。这些专利据此因其中包含的水凝胶组分而以引用方式并入。在一个实施例中,接触镜片配方选自etafilcon A、balafilcon A、acquafilcon A、lotrafilcon A、galyfilcon A、senfilcon、comfilcon、narafilcon,单体A和硅水凝胶。
另外,合适的接触镜片可由包含至少一种含有机硅组分的反应混合物形成。含有机硅组分是一个在单体、大分子单体或预聚物中包含至少一个[--Si--O--Si]基团的组分。优选地,Si和所连接的O在含有机硅组分中存在的量大于20重量%,并且更优选地大于含有机硅组分的总分子量的30重量%。有用的含有机硅组分优选地包含可聚合官能团,例如丙烯酸酯、甲基丙烯酸酯、丙烯酰胺、甲基丙烯酰胺、N-乙烯基内酰胺、N-乙烯基酰胺和苯乙烯基官能团。可以被包括在硅水凝胶配方中的有机硅组分的例子包括但不限于聚有机硅大分子单体、预聚物和单体。有机硅大分子单体的例子包括但不限于带有侧链亲水性基团的甲基丙烯酸酯化的聚二甲基硅氧烷。
有机硅和/或含氟大分子单体也可以使用。合适的有机硅单体包括:三(三甲基甲硅烷氧基)甲硅烷基丙基甲基丙烯酸酯;羟基官能化的含有机硅的单体,例如3-甲基丙烯酰氧基-2-羟基丙氧基)丙基双(三甲基甲硅烷氧基)甲基硅烷。
另外的合适的硅氧烷单体包括:TRIS的酰胺类似物、乙烯基碳酸酯或碳酸酯类似物、一甲基丙烯酰氧基丙基封端的聚二甲基硅氧烷、聚二甲基硅氧烷、3-甲基丙烯酰氧基丙基双(三甲基硅氧基)甲基硅烷、甲基丙烯酰氧基丙基五甲基二硅氧烷、以及它们的组合。
在一些实施例中可采用的示例性的光致变色材料可包括与接触镜片材料混合的染料或者自身为光致变色的可聚合单体。其他的示例性材料可包括以下所列材料中的一种或多种:可聚合的光致变色材料,例如可聚合萘并恶嗪;可聚合螺苯并吡喃;可聚合螺苯并吡喃和螺苯并硫吡喃(spirobenzothiopyrans);可聚合俘精酸酐;可聚合并四苯二酮(naphthacenediones);可聚合螺恶嗪;可聚合聚萘并吡喃;以及可聚合的光致变色化合物。
此外,在一些实施例中,光致变色材料可包括下列各类材料中的一种或多种:色烯,例如萘并吡喃、苯并吡喃、茚并萘并吡喃(indenonaphthopyrans)和菲并吡喃(phenanthropyrans);例如,螺吡喃、螺(苯并二氢吲哚)萘并吡喃、螺(二氢吲哚)苯并吡喃、螺(二氢吲哚)萘并吡喃、螺(二氢吲哚)喹啉吡喃(quinopyrans)和螺(二氢吲哚)吡喃;恶嗪,例如螺(二氢吲哚)萘恶嗪、螺(二氢吲哚)吡啶并苯并恶嗪、螺(苯并二氢吲哚)吡啶并苯并恶嗪、螺(苯并二氢吲哚)吩恶嗪和螺(二氢吲哚)苯并恶嗪;双硫腙汞(mercurydithizonates)、俘精酸酐、俘精酰亚胺(fulgimides)以及这类光致变色化合物的混合物。
在本发明中,可能是有用的其他光致变色材料包括:有机金属双硫腙盐,即(芳基偶氮)-硫代芳基双酰肼((arylazo)-thioformicarylhydrazidates),例如双硫腙汞;以及俘精酸酐和俘精酰亚胺,例如3-呋喃基和3-噻吩基俘精酸酐和俘精酰亚胺。合适的光致变色染料的非限制性实例包括:
式I
式II
式III
式IV
下面的实例和实验示出了本发明的某些方面,但它们并不界定或限制本发明。
实例
以下缩写在下列实例中使用:
单体混合物A
单体混合物A由列于表1的组分和稀释剂(D30)(77重量%组分:23重量%D30)形成。
表1
组分 | 重量% |
Sigma | 28 |
PVP(K90) | 7 |
DMA | 24 |
mPDMS | 31 |
HEMA | 6 |
Norbloc | 2 |
CGI 1850 | 0.48 |
TEGDMA | 1.5 |
Blue HEMA | 0.02 |
单体混合物B
单体混合物B由列于表1的55重量%的组分和45重量%的稀释剂(55重量%的TPME和45重量%的癸酸共稀释剂的混合物)形成。
表2:单体组分
单体混合物B制剂于分配前在环境温度、约600-700mm汞柱的气压下脱气约30分钟。
实例1
为了说明根据图1a所示方法获得瞳区接触镜片的可行性,将20mg圆珠笔油墨混入表2中列出的1g的单体B的单体混合物中,以模拟含染料的瞳区单体混合物中的单体和3mg的该单体混合物被分配到前曲面模具10c的中央。单体混合物的粘度为~3000CP。接着,80mg的单体A的单体混合物被分配到14c中所示的瞳区单体混合物的顶部。单体A的单体混合物的粘度为~300CP。然后堆积底曲面并且关闭模具,用1.2至1.8mW/cm2的Philips TL K 40W/03灯泡在约55±5℃下于氮气氛中照射25分钟。
。然后该组件被固化,结果得到16c所示的照片。如图2所示,观察到两个单体混合物的很清晰的边界。
实例2
在此实验中,使用了PPG工业公司生产的式I所示的光致变色染料。
式I
5%的光致变色染料被溶入含有列于表2的组分和作为稀释剂45%的TPME的单体混合物。为了得到透明单体混合物,使用含有55%TPME作为稀释剂的单体B的单体混合物。该材料的粘度为~400CP。然后在0.5mW/cm2强度的飞利浦TLK 40W/03灯泡照射下,单体混合物在2%氧气的环境中在60℃下固化20分钟。然后取下底曲面模具,镜片留在前曲面模具中。镜片和前曲面模具组件被浸入90C去离子水15分钟以从模具中分离出镜片,然后对镜片作萃取和水合处理。镜片然后被置入玻璃小瓶中的包装溶液并在121℃温度下灭菌。
包装溶液在去离子水H2O中含有下列成分:0.18重量%的硼酸钠[1330-43-4],Mallinckrodt公司;0.91重量%的硼酸[10043-35-3],Mallinckrodt公司;1.4重量%的氯化钠,Sigma公司;0.005%甲醚纤维素[232-674-9],飞世尔科技公司(Fisher Scientific)。
图3示出了在本实施例2中产生的三个示例性镜片30、32和34的干涉图(interferrograms)。这些干涉图显示出跨越由两种单体混合物形成的镜片部分之间的交界处的平滑和连续的干扰条纹。因此,在所产生的镜片上未见有任何明显的物理变形。
实例3
在本实例中,透明单体外侧区域是表1的单体混合物A,而含有光致变色染料的瞳区单体混合物是基于单体混合物A并加入5%的额外的PVP(聚(N-乙烯基吡咯烷酮))K90以及6%的光致变色染料而形成的。额外的PVP K90使单体混合物A的粘度从~300CP转变到~1200CP,这足以保持含有光致变色染料的集中视觉区。
3mg的瞳区单体混合物被分配到Zeonor前曲面镜片模具的中央。接着,80mg的单体混合物A被分配到瞳区单体混合物的顶部。然后将聚丙烯底曲面堆积在前曲面模具上,并关闭模具。用飞利浦TL20W/03T荧光灯泡在镜片模具的上方和下方照射经填充的模具,并满足下列条件:在环境温度下以约1mW/sec2照射约1分钟,在80℃下以2mW/sec2照射约7分钟,并在80℃下以5.5.mW/sec2照射约4分钟。整个固化在N2气氛中完成。模具被打开,然后镜片被取出并放入70∶30(重量)的IPA和去离子H2O溶液,在环境温度下保持至少60分钟。IPA:去离子水溶液被更换两次,且每加一次更换在IPA:去离子水于环境温度下浸泡至少约30分钟,以除去残留的稀释剂和单体,再置入去离子H2O中约30分钟,然后在硼酸盐缓冲液中平衡至少约24小时,并在122℃下高压灭菌30分钟。
根据本实验的镜片40示出于图4。本实验的一项结果是,添加额外的PVP K90有助于使瞳区中的聚合物含水量向高处偏移,从而平衡因加入疏水性光致变色染料导致的含水量减少。因此,由含染料的单体混合物和透明单体混合物这二者形成的聚合物的水合度基本上一致。光学测量结果表明,使用这种方法产生的镜片具有改善的光学品质。
实例4
在本实验中,由单体B的单体混合物形成透明单体区域,并由含有光致变色染料的单体B的材料形成瞳区。然而,在本实验中,粘度通过将单体B的单体混合物的稀释剂组分的浓度改变到45%来调整。在透明区域的45%的稀释剂由40%的叔戊醇和60%的癸酸配成,而在瞳区单体混合物中的45%的稀释剂是100%的癸酸。通过修改本实验中的稀释剂,使光致变色瞳区的中心位置很好地容纳在视觉区中央。这种额外的改变使得粘度在内部(瞳区)和外部(透明区)之间能够有~1800cP的差异,同时还使得水合镜片的溶胀在这两个区域得以匹配,从而获得良好的光学性。
实例5
反应混合物由表3列出的组分和稀释剂(D30)(77重量%组分:23重量%D30)形成(反应混合物C)。
式1的光致变色染料(6重量%,按反应混合物C的反应组分的重量计)和另加的5%PVP溶入反应混合物C而形成含染料反应混合物。
3mg的含染料反应混合物被分配进Zeonor前曲面镜片模具的中央。接着,80mg的反应混合物C被分配到含染料反应混合物的顶部。然后沉积出聚丙烯底曲面,并关闭模具。用飞利浦TL 20W/03T荧光灯泡在镜片模具的上方和下方照射经填充的模具,并满足下列条件:在约1mW/sec2和环境温度下照射约1分钟,在2mW/sec2和80℃下照射约7分钟,并在5.5.mW/sec2和80℃下照射约4分钟。整个固化在N2气氛中完成。模具被打开,然后镜片被取出并放入70∶30(重量)的IPA和去离子H2O溶液,在环境温度下保持至少60分钟。IPA:去离子水溶液被更换两次,且每加一次更换在IPA:去离子水于环境温度下浸泡至少约30分钟,以除去残留的稀释剂和单体,再置入去离子H2O中约30分钟,然后在硼酸盐缓冲液中平衡至少约24小时,并在122℃下高压灭菌30分钟。
表3
组分 | 重量% |
Sigma | 28 |
PVP(K90) | 7 |
DMA | 24 |
mPDMS | 31 |
HEMA | 6 |
Norbloc | 2 |
CGI 1850 | 0.48 |
TEGDMA | 1.5 |
Blue HEMA | 0.02 |
制备了具有不同焦强的镜片。具有较薄中心厚度(-1.00,90微米和-1.75,120微米)的镜片表现出平滑的曲率半径、良好的光学性和舒适性。然而,较厚的镜片(>120微米,-6.00屈光度)呈现平坦的顶部,该镜片的光学性差。
实例6-11
式II的光致变色染料
式II
(6重量%,按反应混合物的反应组分的重量计)溶入表4中所示的反应混合物而形成实例6-11的含染料的反应混合物。D30作为稀释剂加入表4中列出的量(按反应组分和稀释剂的量计。
表4
Ex# | 6 | 7 | 8 | 9 | 10 | 11 |
DMA | 24 | 23.89 | 23.77 | 23.77 | 23.6 | 23.45 |
TEGDMA | 1 | 1 | 1 | 1 | 1 | 1 |
HEMA | 9.55 | 9.55 | 9.55 | 9.55 | 9.55 | 9.55 |
mPDMS | 12.5 | 12.5 | 12/5 | 12.5 | 12.5 | 12.5 |
SiMMA | 36 | 36 | 36 | 36 | 36 | 36 |
Norbloc | 1.7 | 1.7 | 1.7 | 1.7 | 1.7 | 1.7 |
Irgacure 819 | 0.25 | 0.36 | 0.48 | 0.48 | 0.65 | 0.8 |
PVP | 15 | 15 | 15 | 15 | 15 | 15 |
%稀释剂 | 29 | 29 | 29 | 35 | 35 | 35 |
3mg的含染料反应混合物被分配进Zeonor前曲面镜片模具的中央。接着,80mg的反应混合物1被分配到含染料反应混合物的顶部。然后堆积聚丙烯底曲面,并且关闭模具。在80℃恒温下,使用飞利浦TL20W/03T荧光灯泡(包括在区域(A&B)和区域2A内的紫外滤光片)及区域2A)在镜片模具的上方照射经填充的模具,并满足下列条件:以约2.2mW/sec2(区域1(A&B)和2A)照射约7.5分钟,并且以5.5mW/sec2(区域2B和3(A&B))照射约7.5分钟。整个固化在N2气氛中完成。模具被打开,然后镜片被取出并放入70∶30(重量)的IPA和去离子H2O溶液,在环境温度下保持至少60分钟。IPA:去离子水溶液被更换两次,且每加一次更换在IPA:去离子水于环境温度下浸泡至少约30分钟,以除去残留的稀释剂和单体,再置入去离子H2O中约30分钟,然后在硼酸盐缓冲液中平衡至少约24小时,并在122℃下高压灭菌30分钟。
在每个实例中测定镜片的中心处的矢状深度,并用以下步骤与计算的理想矢状深度或设计矢状深度作比较。
使用SMZ1500型尼康显微镜,其组件型号为P-BERG(目镜)、P-IBSS(分光镜相机端口)、DS-Fi1(相机)、P-FMD(支架)、1XWD54(镜头),并包括底座。相邻于水浴槽布置了LED背光源,在NikonScope 1X镜头下设置有45°反射镜,使得从LED背光源射出的光通过水浴槽照射45°反射镜而反射进显微镜。参见图9。
所述显微镜以及NIS Elements D软件被设为0.75X。接触镜片放入水浴槽中,底曲面侧朝下。接触镜片和显微镜被调整成接触镜片在PC上位于焦点处。照明被调整成使得底曲面和前曲面可见。
利用NIS Elements D软件中的曲率测量(Radius)工具,在每一侧选择沿着底曲面的三个点,使得示出接触镜片底曲面的“理想”曲率的外接圆得以生成。
利用长度测量工具,通过在接触镜片的中央测量接触镜片的实际底曲面和“理想的”曲率之间的距离来确定中央光致变色区域的偏差。在中央光致变色区域中的底曲面的可见性受限的地方,产生代表底曲面的位置的点。代表底曲面的点可以通过测定从前曲面贯穿接触镜片而达到与接触镜片的中心厚度相等的距离而生成。这种设置也被用于拍摄图5-8中示出的镜片。
与理想值的偏差在下面的表5中列出。
表5
Ex# | [CGI 819] | [稀释剂] | 平均偏差(mm) |
6 | 0.25 | 29% | -0.109 |
7 | 0.36 | 29% | -0.014 |
8 | 0.48 | 29% | 0.057 |
9 | 0.48 | 36% | -0.04 |
10 | 0.65 | 36% | 0.0016 |
11 | 0.8 | 36% | -0.0038 |
实例12以及比较例1和2
镜片根据实例6制备,使用表6中所列的染料单体混合物。
表6
实例 | 12 | 比较例1 | 比较例2 |
DMA | 23.87 | 24 | 22.21 |
TEGDMA | 1 | 1.25 | 1.5 |
HEMA | 9.55 | 9.8 | 5.55 |
mPDMS | 12.5 | 12 | 28 |
SiMMA | 36 | 36 | 25.41 |
Norbloc | 1.7 | 1.7 | 1.85 |
Irgacure 819 | 0.36 | 0.23 | 0 |
Irgacure 1850 | 0 | 0 | 0.48 |
Blue HEMA | 0.02 | 0.02 | 0 |
PVP | 15 | 15 | 15 |
%稀释剂 | 31 | 27 | 27 |
在实例12以及比较例1和2中制成的镜片均被拍摄了照片。这些照片示出于图5-7。从图5中可以看出,实例12的镜片成形良好,在整个镜片表面上具有连续的曲面。五个镜片的底曲面的平均百分偏差是-4.5%。
比较例1和比较例2(分别如图6和7所示)的镜片显示扁平的顶部,其从设计矢状深度不可取地偏离。在图6中,设计曲面用轻淡的白线画出,并且镜片中心处的设计矢状高度用白色小块表示。图6和图7与图5(实例6)的比较表明,使用本发明可取得水凝胶镜片形状的显著改善。测定的比较例2的平均偏差是-0.397mm,这是实例6(-0.109mm)中镜片呈现的偏差的三倍以上。
实例13
镜片按实例6制备,但使用下表7中第2和第3栏中列出的光致变色单体混合物和透明单体混合物。光致变色单体混合物中含有6重量%的式II的光致变色化合物和45重量%的癸酸作为稀释剂。
表7
组分 | PMM(重量%) | CMM(重量%) |
Blue HEMA | 0.02 | 0.02 |
DMA | 18.9 | 18.9 |
Norbloc | 2.2 | 2.2 |
OH-mPDMS | 41.5 | 41.5 |
PVP K-90 | 12 | 12 |
TEGDMA | 3 | 3 |
HEMA | 22.13 | 22.13 |
CGI 819 | 0.25 | 0.25 |
癸酸(稀释剂) | 45 | |
60%叔戊醇/40%癸酸 | 45 |
图8示出了按实例13制备的镜片的照片。该镜片成形良好且其矢状深度与设计矢状深度的偏离不超过100微米。
如前述,粘度有助于维持接触镜片中央部分内的光致变色。然而,为了调整接触镜片的内(光致变色瞳区)单体和外(透明区)单体的粘度,重要的是将两种单体调整成使得一种或多种最终聚合物的水合溶胀不会引起在光致变色和非光致变色区域之间发生的过渡区域中的应力。过渡区中的溶胀匹配可以通过调整单体组分例如亲水性单体的含量和种类来达成,所述亲水性单体包括甲基丙烯酸羟乙酯(HEMA)、N,N-二甲基丙烯酰胺(DMA)、N-乙烯基吡咯烷酮(NVP)、N-甲基乙酰胺、甲基丙烯酸、聚硅氧烷、交联剂、聚乙烯基吡咯烷酮(PVP)、聚丙烯酸(PAA)、聚甲基乙酰胺、聚二甲基丙烯酰胺、聚乙烯醇以及稀释剂。
本发明的水凝胶具有约20%-约75%的含水量。在又一个实施例中,本发明的水凝胶接触镜片具有至少约25%的含水量。本发明的镜片中也可具有其它所需的性能,包括小于约200psi的拉伸模量,在一些实施例中小于约150psi,在其它实施例中小于约100psi。这些镜片还可以具有大于约50巴勒(barrer)的透氧性,并在一些实施例中大于约100巴勒。应当理解,上述特性的组合是理想的,以上引用的范围可以被结合进任何组合。在一些实施例中,可能需要具备基本上相配的光致变色聚合物和非光致变色聚合物的性质(约10%内)。
接触镜片单体通常包含一种可通过暴露于光化辐射而聚合的反应混合物。单体A通常可包括具有表1中列出的反应组分和稀释剂(D30)的单体,它们可以在约23℃下搅拌或碾压至少约3个小时而混合在一起,直到所有组分被溶解。所提供的活性组分数值为所有活性组分的重量百分比,稀释剂为最终反应混合物的重量百分比。为了形成镜片,反应混合物可被置入热塑性接触镜片模具并经受光化辐射,诸如(举例来说)在45℃下在N2气氛中经受约20分钟的荧光灯泡照射。模具可被打开,然后镜片被取出并放入50∶50(重量)的IPA和H2O的溶液,并浸泡在IPA中在环境温度下保持约15小时,以除去残留的稀释剂和单体,并放置在去离子H2O中约30分钟,然后在硼酸盐缓冲液中平衡至少约24小时,并在122℃下高压灭菌30分钟。
虽然文中描述了本发明的原理,但本领域技术人员自然了解,该描述仅以举例方式作出并且不构成对本发明范围的限制。除了这里示出和描述的示例性实施例,本发明的范围内还构思有其他实施例。由本领域普通技术人员之一作出的修改和替换均被视为在本发明的范围内,该范围除了由后续的权利要求书限定之外不应受到限制。
Claims (13)
1.一种用于制备光致变色的水凝胶接触镜片的方法,其包括:
将第一水凝胶镜片组合物分配到前接触镜片模具部件;其中所述第一水凝胶镜片组合物包含至少一种接触镜片单体和一种光致变色材料;
将第二水凝胶镜片组合物在所述第一组合物的顶部分配到所述接触镜片模具部件,其中所述第一组合物的粘度大于所述第二接触镜片组合物的粘度;
将第二模具部件设置成贴近第一模具部件,从而形成镜片腔,所述第一镜片组合物和所述第二组合物位于所述镜片腔内,并固化所述第一和第二组合物以形成所述水凝胶接触镜片,所述水凝胶接触镜片的实际矢状深度与设计矢状深度的偏离不超过约100微米。
2.根据权利要求1所述的方法,其中所述第二接触镜片组合物被分配成围绕所述第一组合物的环。
3.根据权利要求2所述的方法,其中大致在所述第一和第二镜片组合物融合在一起时将底曲面模具置于所述前曲面模具上。
4.根据权利要求1所述的方法,其中所述第一组合物包含第一接触镜片单体、光致变色材料和第一平衡单体;并且所述第二镜片组合物包含接触镜片单体和第二平衡单体,使得包含所述第一平衡单体和所述第二平衡单体导致所述第一镜片组合物和第二镜片组合物具有基本相同的膨胀系数。
5.根据权利要求1所述的方法,其中所述第一组合物的粘度大于所述第二镜片组合物的粘度至少约1000厘泊。
6.根据权利要求1所述的方法,其中所述光致变色材料包含至少一个可聚合基团。
7.权利要求6所述的光致变色染料,其中可聚合基团之一是甲基丙烯酸酯基团。
9.根据权利要求1所述的方法,其中所述镜片通过光辐射固化。
10.一种水凝胶接触镜片,其包含:
具有前曲面和底曲面的本体,其中所述前曲面具有瞳区和外区,所述瞳区是光致变色的并与所述外区同心,其中所述水凝胶接触镜片的中心矢状深度与设计矢状深度的偏离不超过100微米。
11.根据权利要求10所述的接触镜片,其中所述瞳区包含瞳区单体组合物而所述外区包含基本透明的单体组合物,其中所述瞳区单体组合物包含光致变色染料并具有比所述透明单体组合物高至少约1000厘泊的较高粘度。
12.根据权利要求10所述的接触镜片,其中所述瞳区具有约9mm或更小的直径。
13.根据权利要求10所述的接触镜片,其中所述瞳区具有约4mm和约7mm之间的直径。
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