CN108431676A - 具有延伸的焦深的复曲面小孔口人工晶状体 - Google Patents
具有延伸的焦深的复曲面小孔口人工晶状体 Download PDFInfo
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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
- A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
- A61F2/1645—Toric lenses
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- 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
- 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
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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
- A61F2002/1696—Having structure for blocking or reducing amount of light transmitted, e.g. glare reduction
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- 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
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/16965—Lens includes ultraviolet absorber
- A61F2002/1699—Additional features not otherwise provided for
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- 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
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0071—Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
Abstract
提供了包括屈光元件和掩模的人工晶状体。屈光元件具有第一子午线中的第一焦度以及第二子午线中的大于第一焦度的第二焦度。第一焦度和第二焦度的大小以及第一子午线和第二子午线的位置被配置成矫正人眼中的散光。掩模被配置成阻挡大部分光穿过其环形区域并且允许大部分光穿过其中心孔口,以增大散光矫正旋转错位范围和焦深。
Description
相关申请
本申请要求于2015年11月24日提交的美国临时申请第62/259,524号的权益,其全部内容由此通过引用并入本文中。
技术领域
本申请涉及可以用于改善患有散光的患者的视力的眼科装置。
背景技术
人眼的功能是通过经由角膜并且经由眼睛中的晶状体透射和聚焦光以在视网膜上形成聚焦图像来提供视力。聚焦图像的质量取决于很多因素,包括眼睛的尺寸和形状、角膜和晶状体的透明度以及晶状体调节的能力。
眼睛的光焦度(optical power)是角膜和晶状体的光焦度的函数。在正常健康的眼睛中,远处物体的清晰图像形成在视网膜上。该视力状态称为正视。在近视眼中,远处物体的图像或者形成在视网膜前方的位置处。这可能是因为眼睛异常长或角膜异常陡。在远视眼中,图像形成在视网膜后方的位置处。这可能是因为眼睛异常短或角膜异常平。眼睛的聚焦效果可能是旋转非对称的,导致被称为散光的未补偿的柱面屈光不正。
一些人患有晶状体丧失了透明度的白内障。在这样的情况下,可以移除晶状体并且用人工晶状体(intraocular lens,IOL)替换。然而,商业认可的人工晶状体不能恢复全部的视力功能,并且即使在眼睛中出现小的错位也可能导致次优的视力矫正。因此,许多患者经历了不便的手术后应对策略。
发明内容
本申请涉及为经历眼内屈光视力矫正的患者提供更好的结果。本申请公开了可以简化对复杂病例(例如缺乏调节、具有白内障和/或散光的患者)的治疗的装置。
在一个实施方式中,提供了包括屈光元件和掩模的人工晶状体。屈光元件具有第一子午线中的第一焦度以及第二子午线中的大于第一焦度的第二焦度。第一焦度和第二焦度的大小以及第一子午线和第二子午线的位置被配置成矫正人眼中的散光。掩模被配置成阻挡大部分光穿过其环形区域并且允许大部分光穿过其中心孔口以增大散光矫正旋转错位范围。
在另一实施方式中,提供了包括适合于对抗人眼中的散光的屈光元件和掩模的人工晶状体。掩模被配置成防止光穿过其环形区域。掩模被配置成允许光穿过其中心孔口以增加焦深并且将对眼睛内的旋转错位的容忍度增加多达15度。
在另一实施方式中,提供了矫正散光的方法。在该方法中,将人工晶状体放入到患者的眼睛中。该人工晶状体具有与其子午线对准的柱面焦度部件和包括由不透明构件包围的小孔口的掩模。然后,确认人工晶状体的子午线在超过眼睛的局部最小焦度的5度的范围内被对准以减少眼睛中的散光,使得眼睛达到功能性敏度。
本文中公开的任何特征、结构或步骤可以使用本文中公开的任何其他特征、结构或步骤替换或与本文中公开的任何其他特征、结构或步骤组合或省略。此外,为了概述本公开内容的目的,本文中已经描述了本发明的某些方面、优点和特征。应当理解,并非任何或全部这样的优点都根据本文中公开的本发明的任何特定实施方式来实现。本公开内容的任何方面都不是必需的或不可缺少的。
附图说明
为了说明的目的,在附图中描绘了各种实施方式,并且绝不应该将其解释为限制实施方式的范围。此外,不同公开的实施方式的各种特征可以被组合以形成作为本公开内容的一部分的另外的实施方式。
图1示意性地示出沿着具有散光的眼睛的水平子午线的未矫正和矫正的聚焦效果,其中眼睛的最低焦度(power)子午线与水平子午线对准。
图2示意性地示出沿着具有散光的眼睛的垂直子午线的未矫正和矫正的聚焦效果,其中眼睛的最高焦度子午线与垂直子午线对准。
图3示出了被配置成矫正图1和图2中所示的旋转非对称屈光不正的人工晶状体(IOL)的屈光元件的焦度分布。
图4A至图4D示出了具有屈光元件和与屈光元件耦接的掩模的IOL的实施方式。
图5A示出了掩模的实施方式。
图5B示出了掩模的另一实施方式。
图6示意性地示出了图5A和图5B的掩模的焦深延伸效果。
图7示出了与另外包含小孔口光学器件的相同IOL相比具有角膜像差矫正的单焦点IOL的模拟散焦性能。
图8示出了与另外包含小孔口光学器件的相同IOL相比具有角膜像差矫正的单焦点IOL的模拟柱面性能。
图9示出了与另外包含小孔口光学器件的相同IOL相比具有柱面角膜的眼睛系统中的单焦点复曲面IOL的模拟散焦性能。
图10示出了与另外包含小孔口光学器件的相同IOL相比在角膜处具有柱面并且在IOL平面处具有另外的柱面的眼睛系统中的单焦点复曲面IOL的模拟柱面性能。
图11示出了与另外包含小孔口光学器件的相同IOL相比在角膜处具有柱面的眼睛系统中的单焦点复曲面IOL的模拟旋转未对准性能。
图12是如本文中某些实施方式提供的示出对错位的容忍度增加的眼睛的示意图。
具体实施方式
患有散光的患者在眼睛的不同旋转位置处具有不同的光焦度。眼睛的焦度在眼睛的一些子午线中比在其他子午线中大。经历IOL植入手术的患者可能患有散光。这可能是因为:即使IOL具有完全对称的光学器件,放置有IOL的眼睛的角膜也可能以提供不均匀的旋转非对称的焦度的方式形成。
图1和图2示出了散光眼10如何使穿过晶状体的光聚集的简单示例。图1示出了眼睛10的水平子午线H。入射在水平子午线上的光穿过晶状体18并且在视网膜14后方聚集。实线示出沿着水平子午线H通过的光聚焦在视网膜14后方第一量的位置处。图2示出了眼睛10的垂直子午线V。在图2中,实线示出沿垂直子午线V通过的光聚焦在视网膜14后方第二量(大于第一量)的位置处,这是散光的光学效果。
图3示出了可以对眼睛中的引起散光的屈光力(refractive power)的旋转非对称进行矫正的屈光元件100。屈光元件100包括具有屈光力的表面104。亦即,表面104被配置成使得在散光眼中被折射并且穿过元件100的光线在共同的焦点处聚集。表面104可以具有引起这样的聚集的折射率,可以被弯曲以引起这样的聚集,或者可以将折射率和曲率组合在一起或与其他光学效应组合以引起这样的聚集。在一个实施方式中,表面104具有第一曲率108和第二曲率112。第一曲率108小于第二曲率112。因此,第一曲率108具有比第二曲率112更小的光焦度。与第一曲率108相比,第二曲率112引起沿着第二曲率112的线入射在表面104上的光线的更多的聚集。
如果屈光元件100被适当地放置在图1和图2所示的散光眼10中,则屈光元件100可以矫正散光。屈光元件100可以被放置在眼睛10中使得第一曲率108与图1中所示的水平子午线H对准。当如此放置时,第一曲率108将眼睛10的水平子午线H上的相对较小的远视误差矫正了第一量。屈光元件100可以被放置在眼睛10中使得第二曲率112与图2中所示的垂直子午线V对准。当放置成使得第二曲率112与垂直子午线对准时,相对较大的远视误差被矫正了比在水平子午线H中矫正的量更大的量。因此,两条子午线上的光线都聚焦在相同位置处。在需要的情况下可以提供另外的焦度以将焦平面移动至视网膜,如图1和图2中的实聚集线所示。
图3示出了由虚线包围的屈光元件100。如下面进一步讨论的,包含屈光元件100的IOL的其他部件可以在植入之前或者在包含屈光元件100的IOL的使用寿命的过程期间与屈光元件100耦接。
人工晶状体
如图4A至图4D所示,人工晶状体1000包括光学器件1004和掩模1012。光学器件1004可以由透光材料形成,而掩模1012可以由不透明材料形成。光学器件1004可以包括屈光元件100以矫正屈光不正例如旋转非对称焦度,例如散光。除了屈光元件100之外,光学器件1004还可以包括其他结构以改善IOL 1000的整体视力性能。
光学器件1004可以是单焦点或多焦点的,并且其可以具有正光焦度或负光焦度。光学器件1004可以是非球面的或如上下文可以指示的任何其他配置。在各种实施方式中,光学器件1004具有柱面焦度或其他旋转非对称焦度,使得光学器件1004可以如以上所讨论的矫正眼睛的散光。在一些实现方式中,光学器件1004的最大厚度是光学器件1004的中心处。在其他实现方式中,光学器件1004在其中心处可以具有减小的厚度,这在2010年8月13日提交的美国公开第2011/0040376号中进一步描述,其全部内容由此通过引用并入本文中。光学器件1004可以是基本圆形的,其中外径在大约5.0mm与大约8.0mm之间,例如大约6.0mm。光学器件1004的中心厚度可以小于或等于大约1.0mm,例如在大约0.75mm与大约1.0mm之间。
人工晶状体1000可以包括一个或更多个触觉件(haptic)1008(例如,一个、两个、三个、四个或更多)以防止人工晶状体1000在眼睛内移动或旋转。如本文中所使用的,术语“触觉件”旨在是包括支柱(strut)和其他机械结构的广义术语,所述支柱和其他机械结构可以抵靠眼睛的内表面对置(appose)并且被安装至光学器件以将人工晶状体牢固地定位在眼睛的光路中。取决于人工晶状体1000被植入眼睛中的位置,触觉件1008可以是各种形状和尺寸。触觉件1008可以是C形、J形、板式设计或任何其他设计。触觉件1008可以被制造为相对于光学器件呈基本上平坦或拱形。在2010年8月13日提交的美国公开第2011/0040376号中可以找到关于光学器件和触觉件的形状的变型,其全部内容由此通过引用并入本文中。
掩模1012可以形成在光学器件1004的前表面1016上(参见图4A至图4D),形成在光学器件1004的后表面1020上或者被嵌入在光学器件1004内。当掩模1012被嵌入在光学器件1004内时,掩模1012可以基本形成在光学器件1004的后部1020与前表面1016之间的中线处。但是掩模1012也可以形成在光学器件1004内的其他位置处。关于制造这样的人工晶状体的另外的信息可以在2016年10月3日提交的PCT/US2016/055207中找到,其全部内容由此通过引用并入本文中。
掩模
图5A示出了具有环形区域2036a的掩模2034a,该环形区域2036a包围基本位于掩模2034a中心上的孔口2038a。环形区域2036a的前表面可以具有从环形区域2036a的外周至内周的曲率,并且环形区域2036a的后表面可以具有类似的曲率。图5B示出了在一些实施方式中掩模2034b可以是平坦的。掩模2034b可以包括环形区域2034b,该环形区域2034b包围基本上以掩模2034b的光轴2039b为中心的孔口2038b。虽然下面描述的特征是相对于掩模2034a描述的,但是所述特征中的一个或更多个可以被应用于掩模2034b。
在一些实施方式中,掩模2034a的外周通常为具有至少大约3mm并且小于大约6mm的外径的圆形。在一些实施方式中,掩模2034a的外周的直径为至少大约3mm并且小于或等于大约4mm。
掩模2034a的厚度可以是恒定的,或者可以在内周(靠近孔口)和外周之间变化。例如,厚度可以从掩模2034a的外周和/或内周起并且朝向环形区域2036a的径向中线增加。通常,掩模2034a的任何位置处的厚度可以小于或等于大约200微米,或者小于或等于大约100微米,但是优选地在大约1微米和大约20微米之间。例如,掩模2034a的厚度可以在如下范围内:从大约1微米至大约40微米、从大约5微米至大约20微米、从大约5微米至大约15微米。在一些实现方式中,掩模2034a的厚度可以在如下的大约2微米内:大约15微米、大约10微米、大约8微米或大约5微米。
孔口2038a可以透射基本上全部的沿着光轴2039a的入射可见光。例如,孔口2038a可以是环形区域2036a中的通孔或其基本上透光(例如对可见光透明的)部分。孔口2038a可以是基本上圆形的和/或基本上以掩模2034a的光轴2039a为中心。孔口2038a的尺寸可以是有效增加患有远视眼的患者的眼睛的焦深的任何尺寸。具体地,孔口2038a的尺寸可以取决于眼睛内的掩模2034a的位置(例如,距离视网膜的距离)。在一些实现方式中,孔口2038a可以具有如下大小的直径:至少大约0.85mm并且小于或等于大约2.8mm、至少大约1.1mm并且小于或等于大约1.6mm,或者至少大约1.3mm并且小于或等于大约1.4mm。
环形区域2036a可以防止如下光谱的透射:入射可见光的光谱(例如,对人眼可见的电磁光谱中的辐射能量)的基本上全部或至少一部分和/或非可见光的光谱(例如,对人类可见的范围之外的辐射能量)。防止可见光透射通过环形区域2036a可以阻挡不会聚集在视网膜和中央凹(fovea)处的光以形成清晰的图像。图6示出了这样的效果。具体地,IOL1000被放置在眼睛10的囊袋中。掩模1012以眼睛10的光轴为中心。由虚线示出不会聚集在视网膜14上的光线。这些光线被掩模1012的环形区域2036a或环形区域2036b阻挡,并且因此防止通过引起视网膜上的模糊而视力下降。聚集在视网膜14上的光线穿过掩模1012的孔口。如下面进一步讨论的,通过这种聚焦光提供在一定距离范围内的清晰图像。
在一些实现方式中,环形区域2036a可以防止透射至少大约:90%的入射可见光、92%的入射可见光、95%的入射可见光、98%的全部入射可见光或99%的全部入射可见光。环形区域2036a可以透射不超过大约:10%的入射可见光、8%的入射可见光、5%的入射可见光、3%的入射可见光、2%的入射可见光或1%的入射可见光。
在一些实施方式中,实现了环形区域2036a的不透明性,因为用于制造掩模2034a的材料是天然不透明的。在其他实施方式中,用于制造掩模2034a的材料可以是天然基本透明的,但是用染料或其他染色剂(例如炭黑)处理。在一些实施方式中,掩模由与晶状体本体相同的材料制成,其中添加了染料或其他染色剂。在其他实施方式中,掩模由与晶状体本体不同的材料制成。
掩模的进一步变型可以在以下项中找到:2015年10月5日提交的美国申请第62/237429号(律师案卷ACUFO.169PR)、2004年5月26日提交的美国专利第7,628,810号、2012年2月19日提交的美国公开第2012/0143325号、2010年8月13日提交的美国公开第2011/0040376号;2012年11月30日提交的美国公开第2013/0268071号;美国公开第2014/0264981号;2014年8月7日提交的美国公开第2015/0073549号;1996年6月14日提交的美国专利第5,662,706号;1996年6月14日提交的美国专利第5,905,561号;以及1996年12月6日提交的美国专利第5,965,330号,以上所有的全部内容由此通过引用并入本文中。
模拟测试的讨论
图7的上行是对21屈光度(diopter)单焦点IOL的光学性能的Zemax光学模拟。在模拟中,矫正了角膜像差并且模拟假设具有3mm瞳孔的真实多色模型眼睛。最左侧的框示出了针对0屈光度散焦的视敏度(visual acuity)。所示出的敏度在20/20或更高处是可接受的。从左侧起的第二个框示出了使用与最左侧框中使用的晶状体和模型相同的晶状体和模型针对﹣0.5屈光度散焦的视敏度。可以看到,性能已经下降,但是阈值敏度水平仍然在大约20/20处。从左侧起第三个框示出了使用与在生成最左侧框中使用的晶状体和模拟模型相同的晶状体和模拟模型针对﹣1.0屈光度散焦的视敏度。可以看到,该框没有记录任何水平的视敏度,并且因此IOL在该散焦量和更大的散焦量处完全无效。
图7的下行是对其中设置有用于延伸焦深的小孔口掩模的IOL的光学性能的Zemax光学模拟。小孔口光学器件可以具有1.36mm的有效孔径。IOL具有最佳的焦点。模拟使用了具有3mm瞳孔的真实多色模型眼睛。最左侧的框示出针对0屈光度散焦的视敏度,该视敏度在20/20或更高处是可接受的。与上行相比,下行中的来自﹣0.5屈光度、﹣1.0屈光度、﹣1.5屈光度和﹣2.0屈光度散焦的从最左侧框起朝向右侧的散焦位置中的每一个示出了20/20视敏度或更好的视敏度。该模拟证实了图6中所示的小孔口光学器件的有效性。
图8的上行是对使用具有3mm瞳孔的真实多色模型眼睛来矫正角膜像差的21屈光度单焦点IOL的光学性能的Zemax光学模拟。最左侧的框示出了针对0屈光度添加的柱面焦度的视敏度。所示出的敏度在20/20或更高处是可接受的。从左侧起的第三个框示出了使用与最左侧框中使用的晶状体和模型相同的晶状体和模型针对﹣0.5屈光度添加的柱面焦度的视敏度。可以看到,性能已经下降,但是阈值敏度水平仍然在大约20/20处。从左侧起的第五个框示出了使用与在最左侧框中使用的晶状体和模型相同的晶状体和模型针对﹣1.0屈光度添加的柱面焦度的视敏度。可以看到,该框没有记录任何有用的视敏度水平并且因此IOL在该量和更大量的柱面处完全无效。
图8的下行是对具有提供延伸的焦深的小孔口掩模的IOL的Zemax光学模拟。掩模设置有1.36有效孔径并且IOL具有最佳焦点。再次使用具有3nm瞳孔的真实多色模型眼睛构建该模型。最左侧的框示出针对0添加的柱面焦度的视敏度,并且在该框中所示的敏度在20/20或更高处是可接受的。从左侧起第三个框和第五个框示出了使用与在下行的最左侧框中使用的晶状体和模型相同的晶状体和模型针对﹣0.5和﹣1.0屈光度添加的柱面焦度的视敏度。可以看到,性能已经下降,但是阈值敏度水平仍然在大约20/20处。事实上,小孔口IOL的性能仍然是可接受的,即使是示出了具有﹣1.5屈光度的柱面的性能的最右侧的框。因此,图8示出小孔口IOL可以为即使达到﹣1.5屈光度的添加柱面的小量散光提供视力矫正。
图9示出了复曲面IOL的性能。具体地,图9的上行是对使用具有3mm瞳孔和复曲面角膜的真实多色模型眼睛的3屈光度复曲面单焦点IOL的光学性能的Zemax光学模拟。复曲面IOL的性能与图7所示的单焦点IOL的性能类似。亦即,它可以容忍大约﹣0.5屈光度的散焦。但是更大量的散焦使视敏度过度劣化,而使复曲面IOL不能提供功能性视敏度。相比之下,图9的下行示出了可以通过具有小孔口光学器件的3屈光度复曲面IOL(例如具有1.36mm有效孔径,其中IOL具有最佳焦点)来更加鲁棒地矫正眼睛中的散光。下行示出具有小孔口光学器件的复曲面IOL在高达﹣2.0屈光度的散焦处仍然可以表现良好。
图10示出了对21屈光度单焦点复曲面IOL与具有小孔口光学器件(例如具有1.36mm有效孔径的光学器件)的相同IOL的性能的进一步比较。图10示出了这两种IOL在与逐渐增多的另外的柱面焦度一起工作时维持视敏度的能力。上行示出复曲面IOL可以维持高达添加的﹣0.5屈光度的柱面的可接受的视敏度。下行示出即使当经受高达﹣1.5屈光度的柱面时具有小孔口光学器件的复曲面IOL也可以表现良好。这意味着,即使在患有逐渐恶化的散光的患者中,具有小孔口光学器件的复曲面IOL也可以在比标准复曲面IOL长得多时间内继续提供良好的视力,而无需另外的晶状体或过程。
图11示出了对21屈光度单焦点复曲面IOL与具有小孔口光学器件(例如具有1.36mm有效孔径的光学器件)的相同IOL的性能的进一步比较。图11示出了这两个IOL维持旋转错位的能力。上行示出了复曲面IOL可以维持5度旋转错位或未对准。超过该数量,由标准复曲面IOL提供的视敏度不足。下行示出了具有小孔口光学器件的复曲面IOL在高达15度的旋转错位或未对准下可以表现良好。这意味着,即使IOL植入过程未按照手术前计划进行,IOL也将表现良好。这是因为IOL具有宽得多的可接受旋转放置的窗口。图11的下行表明可以提供30度窗口,患者在该窗口内将具有可接受的视敏度。这比标准IOL可以容忍的更多限制的放置范围大三倍。这表示对复曲面IOL设计的显著改进,提高了IOL的鲁棒性,使得即使在放置为次优的情况下,结果不佳的可能性也被大大降低。
模拟性能可以总结如下:
图12示意性地示出了某些实施方式的方面。具体地,在矫正之前眼睛10中存在柱面焦度,从而引起散光。在该情况下,垂直子午线V中的焦度显著小于水平子午线H中的焦度。包括屈光元件100的IOL 1000被提供并且被放置在眼睛10中。如以上所讨论的,屈光元件100在不同部分具有不同的焦度。例如,屈光元件100的子午线可以具有第一曲率108,并且元件100的另一子午线可以具有大于第一曲率的第二曲率112。曲率108、112沿着垂直的子午线,但是可以根据眼睛的焦度分布彼此处于其他角度。如以上所讨论的,较陡的第二曲率112引起更多的聚集。因此,第二曲率112应该与眼睛10的垂直子午线V最佳地对准,使得眼睛10的局部较低的焦度通过第二曲率112来补偿,以使得垂直子午线V和水平子午线H能够在相同位置聚集。然而,如图所示,屈光元件100从最佳对准位置旋转偏移。有利的是,通过屈光元件100的复曲面配置和掩模1012的组合使得IOL 1000能够具有比从最佳位置的常规可接受的旋转偏移大得多的旋转偏移。图12在阴影饼状区域中示出了在较大IOL放置范围内存在可接受的敏度。在该实施方式中,该范围在最佳(垂直)位置的两侧例如对称地延伸。同样地,IOL 1000提供了对旋转错位的容忍度的增加。范围延伸超过IOL 1000的错位角度。在常规IOL中,范围将小得多,例如在第二曲率112的位置与垂直子午线V之间,阻止常规IOL在如图12所示放置时提供功能性视敏度。
术语
除非在所使用的上下文中另有特别说明或以其他方式解释,否则条件性语言诸如“能够”、“可”、“可能”或“可以”通常旨在表达某些实施方式包括而其他实施方式不包括某些特征、元件和/或步骤。因此,这样的条件语言通常并不旨在暗示特征、元件和/或步骤无论如何都是一个或更多个实施方式所需的,或者一个或更多个实施方式必然包括用于在有或者没有用户输入或提示的情况下决定在任何特定实施方式中是否包括或要执行这些特征、元件和/或步骤的逻辑。
术语“包括”、“包含”、“具有”等是同义词,并且以开放式的方式包含性地被使用,并且不排除另外的元件、特征、动作、操作等。此外,术语“或”以其包含性含义(而不是其排他性含义)被使用,使得例如当用于连接一系列元件时,术语“或”意指列表中的元件中的一个、一些或全部。
如本文所使用的术语“近似地”、“大约”和“基本上”表示接近所述量的量,其仍然执行期望的功能或实现期望的结果。例如,术语“近似地”、“大约”和“基本上”可以指在小于所述量的10%内的量,如上下文可以指示的。
本文中公开的范围还涵盖任何和全部交叠、子范围及其组合。诸如“高达”、“至少”、“大于”、“小于”、“之间”等语言包括所列举的数字。以诸如“大约”或“近似地”的术语在前的数字包括所列举的数字。例如,“大约3mm”包括“3mm”。
虽然本文中已经描述了某些实施方式和示例,但是本领域技术人员将会理解,本公开内容中示出和描述的方法和IOL的许多方面可以被不同地组合和/或修改以形成另外的实施方式或可接受的示例。所有这样的修改和变型在本文中旨在被包括在本公开内容的范围内。各种各样的设计和方法都是可能的。本文中公开的任何特征、结构或步骤并不是必须的或不可或缺的。
为了本公开内容的目的,在本文中描述了某些方面、优点和新颖特征。应当理解的是,根据任何特定实施方式不一定可以实现全部这样的优点。因此,例如,本领域技术人员将认识到,本公开内容可以以实现如本文中所教导的一个优点或一组优点的方式来实施或执行,而不必实现如本文中可能教导或建议的其他优点。
此外,虽然本文已描述了说明性的实施方式,但是本领域技术人员将基于本公开内容理解具有等同元件、修改、省略、(例如跨越各种实施方式的方面的)组合、适应和/或改变的任何和所有实施方式的范围。权利要求中的限制将基于权利要求中使用的语言来广义地解释,而不限于本说明书中或在本申请的实践期间描述的示例,这些示例将被解释为非排他性的。此外,可以以任何方式修改所公开的过程和方法的动作,包括通过对动作重新排序和/或插入附加动作和/或删除动作。因此,旨在将说明书和示例仅视为说明性的,其中,真正的范围和精神由权利要求及其等同物的全部范围指示。
Claims (16)
1.一种人工晶状体,包括:
屈光元件,其包括第一子午线中的第一焦度和第二子午线中的大于所述第一焦度的第二焦度,所述第一焦度和所述第二焦度的大小以及所述第一子午线和所述第二子午线的位置被配置成矫正人的眼睛中的散光;以及
掩模,其被配置成阻挡大部分光穿过所述掩模的环形区域并且允许大部分光穿过所述掩模的中心孔口,以增大散光矫正旋转错位范围。
2.根据权利要求1所述的人工晶状体,其中,所述散光矫正旋转错位范围包括﹢/﹣15度。
3.根据权利要求1所述的人工晶状体,其中,所述掩模与包含所述掩模的光学器件的前表面耦接。
4.根据权利要求3所述的人工晶状体,其中,所述掩模形成在背驮式IOL上,所述背驮式IOL被配置成与所述眼睛耦接以将所述掩模放置在所述光学器件的前表面上。
5.根据权利要求1所述的人工晶状体,其中,所述掩模被嵌入在包括所述屈光元件的光学器件中。
6.根据权利要求1所述的人工晶状体,其中,所述掩模包括小于大约1.4mm的孔口。
7.根据权利要求1所述的人工晶状体,其中,所述掩模被配置成在通过小孔IOL插入器放置在所述眼睛中时以可预测的方式破裂。
8.根据权利要求1所述的人工晶状体,其中,所述掩模包括多个小孔,所述多个小孔被布置成通过所述环形区域,以将所述掩模固定至包括所述屈光元件的光学器件。
9.一种人工晶状体,包括:
屈光元件,其适于对抗人的眼睛中的散光;以及
掩模,其被配置成防止光穿过所述掩模的环形区域并且允许光穿过所述掩模的中心孔口,以增加焦深并且将对所述眼睛内的旋转错位的容忍度增加多达15度。
10.根据权利要求9所述的人工晶状体,其中,所述屈光元件包括复曲面配置。
11.根据权利要求9所述的人工晶状体,其中,所述掩模被配置成将焦深增加相当于高达2屈光度的添加焦度的量。
12.一种矫正散光的方法,包括:
将人工晶状体放入到患者的眼睛中,所述人工晶状体包括:柱面焦度部件,其与所述人工晶状体的子午线对准;以及掩模,其包括由不透明构件包围的小孔口;以及
确认所述人工晶状体的子午线在超过所述眼睛的局部最小焦度的5度的范围内被对准以减少所述眼睛中的散光,使得所述眼睛达到功能性敏度。
13.根据权利要求12所述的方法,其中,所述范围从5度以内延伸至15度以内。
14.根据权利要求12所述的方法,其中,确认所述人工晶状体的子午线在所述范围内包括:执行对所述眼睛和所述人工晶状体的术中像差测量,以确认所述眼睛的术前柱面焦度被减小。
15.根据权利要求12所述的方法,其中,确认所述人工晶状体的子午线在所述范围内包括:观察所述晶状体的旋转对准功件与术前限定的旋转位置相比的位置。
16.根据权利要求15所述的方法,还包括:确认视敏度为至少20/20。
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