CN109890325B - 双模式调节-去调节型人工晶状体 - Google Patents
双模式调节-去调节型人工晶状体 Download PDFInfo
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Abstract
双模式调节‑去调节型人工晶状体包括:襻系统(100),该襻系统包括具有形状记忆的多个闭合回形襻;形变式柔性光学部(105),该形变式柔性光学部包括前光学部囊和后光学部囊,前光学部囊和后光学部囊融合在一起,在它们之间限定填充有流体的光学部囊泡,其中襻附连到光学部,允许襻的动作改变光学部的形状,双模式AD‑IOL在静置时处于完全调节构造;可连接到襻的限制环(255)以及将限制环连接到襻的突片(240)使得襻固定在AD‑IOL的去调节构造中。
Description
相关申请的交叉引用
本申请要求于2016年8月24日提交的美国临时专利申请序列号62/378,737的优先权及权益,其公开的全部内容由此通过引用的方式被并入。
技术领域
本发明的实施例总体上涉及人工晶状体。更具体地,本发明的实施例涉及调节与去调节型人工晶状体系统(AD-IOL),以及适于与悬韧带捕获襻(haptic)系统联接的形变式柔性光学部。该柔性光学部与悬韧带捕获襻系统的组合特征带来了新颖的双模式AD-IOL,在该新颖的双模式AD-IOL中,光学部在眼睛内在形状和位置两者上发生变化,模拟天然晶状体的行为,该小的光学部适于在由常规白内障手术导致的封闭且纤维化的囊袋中工作。
背景技术
正常情况下,健康的人眼通过睫状肌的收缩和松弛使眼睛内悬韧带上的张力收缩和释放而聚焦在近处和远处的物体上。眼睛的弹性力引起去调节,而晶状体的弹性回弹引起调节。这两个反向的弹性力之间的平衡通过睫状体的神经控制收缩而调整。睫状肌的收缩释放悬韧带张力(调节状态),并允许晶状体返回到更接近球形或球状的静置形状。睫状肌的松弛增加悬韧带上的张力,并且,眼组织中的弹性力克服固有的晶状体弹性,且结果是拉伸晶状体中纬线(equator)并使晶状体曲率变平(去调节状态)。
在某些实例中,例如,当与年龄相关的晶状体浑浊(白内障)干扰视力时,眼睛的天然晶状体需要被移除。一般而言,天然晶状体被替换为人造晶状体,例如人工晶状体(IOL)。
不幸的是,常规的IOL以及目前FDA批准的调节型IOL可能无法提供晶状体沿着视轴的充分的空间移动,从而为视近提供足够量的调节。为了使调节型IOL有效,优选对调节和去调节两者做同等准备。
在常规的囊外白内障手术中,晶状体基质通过环形撕囊由白内障超声乳化吸出术除去,留下完整的前后囊的薄壁以及到睫状体与睫状肌的悬韧带连接部。然后,人工晶状体被放在绕着IOL塌缩的囊袋中。常规的单焦点IOL僵硬地固定在不进行移动且纤维化的囊袋中。IOL在囊袋中的位置既不是处于调节状态,也不是处于去调节状态,而是如由袋收缩的量及IOL的设计决定的,在中间某处。该位置被称为“有效晶状体位置”,并且它在计算期望的光学部的屈光能力中被用到。光学部的屈光能力决定了完全聚焦视力的单点,该单点通常选择在实际臂长范围处。
常规的轴向移位调节型人工晶状体(AIOL)依赖睫状肌与悬韧带、囊及玻璃体流体腔的相互作用以诱导AIOL的光学部沿着其视轴运动。通常,AIOL固定在囊袋内,囊袋尝试转化由悬韧带施加的旋转及径向拉伸力,以试图实现光学部的期望的轴向移位。
然而,在植入后的纤维化愈合过程期间,前囊与后囊融合形成硬的囊盘、用于AIOL的约束套(strait jacket)。囊盘弹性的丧失作为结果产生,并限制了可由经悬韧带传递到IOL的眼睛去调节力或由人工晶状体在袋内的弹性回弹产生的离心及旋转运动的量,且因此导致晶状体可实现的轴向移位的量减小。晶状体既没有调节,也没有去调节。
已设计了多种晶状体系统来解决该调节损失。一种类型的被动移位单光学部晶状体、美国市场上目前销售的唯一的调节型晶状体设计成:当睫状肌很可能收缩并强制玻璃体向前时,在玻璃体体液压力下向前移动。由于囊的纤维化随后而至,并且运动有时候是向后的,因此由该晶状体在手术后立即产生的有限量的调节幅度甚至可能在手术后的前几周或第一个月内失去。美国市场上没有销售通过襻的直接机械作用将睫状肌收缩转化成光学部的向前移位的被动移位AIOL。
带有单个或多个光学晶状体组件的调节型晶状体设计公开在例如美国专利公开号2009/0125106、2005/0209692、2007/0156236、2009/0005866、2007/0005136和2009/0248154中。双光学晶状体仍然存在囊纤维化及幅度/运动损失的问题,尽管它们从理论上期望提供大量的调节。一种这样的IOL在欧洲获得了监管批准,但由于差劲且不可预测的临床效果被放弃并从市场上撤回。该晶状体没有获得FDA批准,且目前该解决方案看起来已被放弃。
最近,一种采用主动移位机构的晶状体系统被公开(见美国专利公开号2009/0204210和2007/0118216),其利用排斥的微型磁体,作为使调节在部分程度上独立于悬韧带及囊袋机械性能的手段。实现调节的其它方法包括引入具有期望折射率的可聚合流体到囊袋中(晶状体再填充)。仍需对这些方法的可行性作广泛的调查。
美国专利公开号2009/0234449公开了一种人工晶状体,其具有调节元件,调节元件与睫状体的悬韧带接触区的相当一部分接触;调节元件相对于光学元件定位,并构造成与眼睛中的睫状肌、悬韧带和/或玻璃体压力协作以实现光学元件的形状改变。根据‘449的公开,现有技术的多晶状体系统会是笨重的,且可能还要求利用塌缩囊袋不可能实现的、使调节型机构失效的轴向移位。
最近,一种采用新颖的悬韧带捕获襻(ZCH)(见美国专利公开号2011/0307058,其全部内容通过引用的方式被并入本文中)的晶状体系统被描述。晶状体系统经由两阶段程序提供改进的调节。在植入步骤(阶段1)中,将特别设计的可切分的襻(即ZCH)插入在前晶状体囊与后晶状体囊之间,并使其维持处于限制构造中。留出足够的时间用于两个囊瓣彼此的融合及纤维化,由此使襻组成部分永久地陷在囊之间。阶段2期间,激活手术可随后进行,以在各单独的襻组成部分之间对融合的囊袋进行切分,并释放限制机构,从而打破通常使其它“袋中”植入IOL的运动受限的机械限制。
发明内容
本发明的实施例的基础是带有柔性形变式光学部与悬韧带捕获襻的调节-去调节型IOL(AD-IOL),其具有双重模式的动作:光学部的轴向移位和光学部的形状变化两者,这两者由悬韧带捕获襻对柔性光学部的作用与光学部和或襻系统的形状记忆之间的动态平衡驱动。本发明的实施例将多个单独的元件组装在一起,成为新颖的、综合的且有凝聚力的设计,一些元件先前作为不同形式IOL的组成部分分别描述过。该独特的设计专门构造成用在如常规白内障手术之后遭遇的封闭且纤维化的囊袋中,且促成了与常规IOL具有相似尺寸的AD-IOL。光学部的形状变化允许比由轴向移位组成部分独自提供大上许多的调节范围。两个部件协同作用以增加所获得的调节量。没有避开白内障手术之后愈合和结痂的不可避免的生物反应,而是使之用于该双模式AD-IOL的由悬韧带的径向牵引促动的恰当功能。相比之下,现有技术描述了如下尝试:防止袋封闭,使用未融合的囊、开口的袋;压缩将力传递到各种光学设计件的机械结构;或者运用睫状肌的直接压缩。
随着光学部几何形状从调节构造变化到去调节构造,形变式柔性光学部的体积与表面积之间的比率发生变化。本文中描述的双模式AD-IOL的实施例适于以若干种方式改变该比率,以便光学部可获得其所需的球面度。
AD-IOL使调节和去调节能够在由悬韧带于术后纤维化囊袋中产生的力负载下进行,特别是由于它已经被实验性地测定并验证。调节与去调节之间的平衡由睫状肌控制,并经由悬韧带作为径向牵引传递到襻系统的悬韧带捕获部件,且然后传递到AD-IOL系统。AD-IOL响应由悬韧带在其上行使的去调节力,该去调节力抵消AD-IOL的固有的调节弹性力,AD-IOL构造成在静置时返回到完全调节构造。然后,睫状体收缩可以在神经控制下以测量的方式调节由悬韧带在AD-IOL上行使的去调节力,从而允许AD-IOL基于调节力和去调节力的平衡呈现期望的构造。悬韧带捕获襻先前在美国专利公开号2011/0307058中描述过。本发明的实施例包括人工晶状体系统,该人工晶状体系统包括形变式柔性光学部,即可变屈光能力的光学部,其中屈光能力可被眼睛中产生的调节力或去调节力改变,并且当这些力消退之后,光学部可返回到原始的屈光能力。人工晶状体系统还可包括悬韧带捕获襻系统。形变式柔性光学部可包括小的、流体填充的、具有弹性薄壁的光学部囊泡,具有适于被附连到其的襻的动作改变的特性。使用中,在调节或去调节期间,可通过襻系统的动作作用在光学部囊泡上。该动作改变光学部囊泡的形状,由此改变其屈光能力。
光学部和襻系统两者可具有形状记忆,该形状记忆旨在产生使AD-IOL在悬韧带张力减小时返回到调节状态的弹性回弹。襻和/或光学部系统的形状记忆特征协作促成AD-IOL在白内障手术及囊袋封闭且纤维化之后响应眼睛内产生的实际的、小的力的能力。
在一个方面,本发明的实施例涉及双模式调节-去调节型人工晶状体(双模式AD-IOL),其包括襻系统,襻系统具有多个具有形状记忆的闭合回形襻。形变式柔性光学部包括前光学部囊和后光学部囊,两个囊中的每个具有融合区且两个囊的融合区融合在一起,由此在两个囊之间限定光学部囊泡,光学部囊泡填充有流体。襻附连到光学部,允许襻的动作改变光学部的形状。形变式柔性光学部具有≤8mm的直径。由于襻系统的形状记忆和柔性光学部的形变能力的至少其中之一,双模式AD-IOL在静置时处于完全调节构造中。限制部件尺寸设计且构造成使襻以与调节构造相比时更平的角度和更大的直径的至少其中之一固定在AD-IOL的去调节构造中。
可包括以下特征中的一项或多项。闭合回形襻可以是梯形和T形的至少其中之一。双模式AD-IOL可包括光学环,光学环使襻彼此连接及连接到光学部。通过每个襻的一部分在融合区处嵌装在光学部中,襻可附连到光学部。每个闭合回形襻可构造成适于在AD-IOL的去调节期间将由悬韧带张力产生的径向牵引传递到光学部。每个闭合回形襻可构造成适于在AD-IOL的调节期间返回到设置的形状。
限制部件可以是布置在襻或光学环上的限制突片、由襻部分限定的限制孔、由光学部在其融合区限定的限制孔、襻臂上的横条、限制环和/或缝线。
环形板可嵌装在光学部的前光学部囊与后光学部囊之间。环形板可限定同心的至少一圈孔。环形板可包括具有形状记忆的材料。环形板(i)可比光学部更坚硬/刚性,以及(ii)可给光学部提供结构稳定性。环形板可包括非反射表面。
闭合回形襻中的每个可包括正弦曲线形的中纬线部分。闭合回形襻中的每个可包括第一连接特征,并且光学部可包括适于与第一连接特征接合的第二连接特征。
第一连接特征可以是由闭合回形襻中的每个限定的环,第二连接特征可包括由光学部限定的多个栓,且每个环可尺寸设计且构造成接收栓。
第一连接特征可包括由闭合回形襻中的每个限定的T形部,并且第二连接特征可包括由光学部限定且尺寸设计并构造成接收每个T形部的T形凹槽。闭合回形襻中的每个可形状设置成有助于光学部的轴向移位和形状变化。
多个闭合回形襻可由连续的环限定,所述环构造成响应双模式AD-IOL所植入于的囊袋的直径的变化而变化直径,从而减少光学部上的来自悬韧带的不规则的张力。
闭合回形襻中的每个可包括邻近光学部的间隔开的端部,从而使闭合回形襻能够膨胀。
襻系统可包括至少两个光学环,每个光学环包括两个闭合回形襻,光学环布置在光学部之上,且构造成旋转成使第一光学环的襻叠覆在相邻的光学环的襻之上,以缩减光学环的轮廓,从而方便双模式AD-IOL加载在注射机中。
至少一个闭合回形襻可包括径向部段和布置在径向部段上的桨叶部,桨叶部构造成压缩光学部的一部分。
光学部和襻系统的调节型记忆的总和在静置时可以是调节型的。
光学部和襻系统的至少调节型记忆或去调节型记忆的总和可以是小于1克力。光学部和襻系统的至少调节型记忆或去调节型记忆的总和可比悬韧带张力小。
前后光学部囊可利用结合材料融合,并且融合区可限定构造成接收过剩结合材料的通道。
柔性光学部的形状上的变化可改变光学部囊泡表面积与光学部囊泡变化体积的比率,并且襻系统可改变尺寸和形状以适应该比率的变化。
光学部囊中的一个可具有厚的、坚硬光学区,该坚硬光学区具有包括散光矫正的固定折光能力。坚硬光学区的轴线可在外部标记。坚硬光学区可用作襻系统的定中及固定区。
光学部囊中的一个可包括较薄、较容易变形的弯曲区,该弯曲区邻近中心光学区布置。光学部囊中的一个可具有较厚、较不容易变形的活塞区,活塞区布置在弯曲区光学区内或邻近,且适于朝着光学部囊泡的中心推压流体。较厚的活塞区可包括适于捕获并附接襻系统的径向臂的多个结构。
每个融合区可适于嵌装襻系统的各单独的襻。
光学部囊泡可以不超过最小拉伸的构造填充有恒定体积的流体,以对形状变化形成最小的阻力。
光学部囊泡可具有形状记忆。
流体可具有比水的折射率大的折射率,例如与光学部囊泡的折射率大体相同。
襻系统可适于配合在IOL注射系统内,例如适于卷成筒。
AD-IOL可适于在植入时以及在囊袋融合及纤维化期间限制在扁平、伸展开的去调节构造中。
AD-IOL可适于通过外部的激光施加被释放。外部的激光施加可通过襻之间的径向切口在同一时间将限制装置和眼睛的融合囊袋两者同时切分,径向切口从眼睛的前囊的边缘朝着眼睛的囊袋的中纬线延伸一段距离,该距离限制成在眼睛的纤维化的囊袋的硬度上产生期望量的释放。
在另一方面,本发明的实施例涉及用于植入双模式AD-IOL的方法。所述方法包括提供AD-IOL,该AD-IOL包括襻系统,襻系统具有多个具有形状记忆的闭合回形襻。形变式柔性光学部包括前光学部囊和后光学部囊,两个囊中的每个具有融合区且两个囊的融合区融合在一起,从而在两个囊之间限定光学部囊泡,光学部囊泡填充有流体。襻附连到光学部,允许襻的动作改变光学部的形状。形变式柔性光学部具有≤8mm的直径。由于襻系统的形状记忆和柔性光学部的形变能力的至少其中之一,双模式AD-IOL在静置时处于完全调节构造中。限制部件尺寸设计且构造成使襻以与调节构造相比时更平的角度和更大的直径的至少其中之一固定在AD-IOL的去调节构造中。将AD-IOL植入患者眼睛内。允许眼睛的囊袋穿过襻融合。通过在襻之间形成径向切口释放襻,径向切口从眼睛的前囊的边缘朝着眼睛的后囊的中纬线延伸一段距离,该距离限定成在眼睛的纤维化的囊袋的硬度上产生期望量的释放。
在一个实施例中,在调节期间,襻臂弯曲成更加靠近AD-IOL的轴线并挤压光学部囊泡,并促使光学部囊泡变得更加圆,即具有更多凸率的表面和更大的屈光能力。在去调节期间,相同的襻臂可对光学部囊泡施加牵引作用,促使光学部囊泡侧向拉伸且因此具有较少凸率的表面,即较低的屈光能力。
光学部囊泡可由两个单独的部件制成,即由光学部前囊和光学部后囊制成。两者在它们的外边缘处融合,允许中间的空间填充有流体。流体可具有比水高的折射率,从而给予双凸的光学部囊泡正度数的屈光能力。理想情况下,流体的折射率与光学部囊泡的折射率相匹配,从而消除来自光学部囊泡内表面的光学干涉。
在一个实施例中,光学部囊泡设计成相对较小的且尺寸上或体积上与标准双焦点IOL光学部相当,在人眼尺寸设计的AD-IOL中具有8mm或更小的总体去调节直径和6mm或更小的光学区。尺寸设计用于由猕猴眼睛组成的实验模型的相同的光学部囊泡实施例具有6mm的总直径和4mm的光学区。
在一个实施例中,光学部囊中的一个,例如前囊,具有较厚或更坚硬的光学区,使得它不会在眼睛中产生的调节力或去调节力下改变自身的形状。这是IOL的规定部件,其适于矫正个体患者的屈光不正。它可成形为给予IOL的折光能力的固定量以及如果期望的话还可能地散光矫正能力。该散光矫正的轴线可标记在该较厚光学区的边缘上或固定光学部的结构的边缘上。
在一个实施例中,相对的囊,例如后光学部囊,最大限度地保持薄和柔性,以允许在来自襻系统的臂的压力或张力下的最大的弓形化或变平,并因此给予调节期间额外数目的屈光度。这是光学部的调节部件。
在一个实施例中,流体填充的光学部囊泡的体积在所有AD-IOL中是恒定的,并且薄的柔性的光学区的曲率是可预测的。不同眼睛所需的屈光能力的不同由坚硬光学区、规定组成部分的固定屈光能力控制。
在一个实施例中,光学部前囊和或后囊具有更坚硬的区域,其是较厚的,且成形为配合在襻光学环内或融合区内或用于牢固定中的其它襻装置内。在其它实施例中,脊、隆起或其它结构确保在光学环或其它襻装置中的定中。
在一个实施例中,光学部前囊或后囊具有较薄的、最大程度柔性的区域,该区域对应于襻弯曲区并允许光学部囊泡的形状以最小的阻力发生变化。该弯曲区处于光学区周缘。在另一实施例中,弯曲区具有用于襻近端部的直接附连的外部栓。
在一个实施例中,光学部前囊或后囊具有较厚的区域、带凹槽的块,以并入并固定襻的径向臂。另外的较厚的且更坚硬的区域可存在于襻之间中。该区域的总硬度允许其还作为活塞区工作,向中心驱赶流体,以促使较薄的囊光学区弓形化。该区域处于弯曲区周缘。
在一个实施例中,襻臂具有适于压在光学部弯曲区上的宽板状结构。
在一个实施例中,在光学部前囊下侧,光学部前囊的最靠外的区域具有融合区,该融合区设计成融合到光学部囊泡的后囊上的对应区域。通道或凹槽允许过剩的结合材料淤积在融合区处并且不向外散布。可向较厚的块区或其它适合的位置中构建一个或多个流体填充通道。
在一个实施例中,柱或脊或肋在内部构建于前囊与后囊之间,以减少调节期间更坚硬的规定区的运动。这样的结构具有如下增添的益处:给柔性光学部的形状增添结构稳定性,并限制变形。
在一个实施例中,光学部囊泡利用流体填充至完全未拉伸体积或最小拉伸体积,其中光学部囊泡的囊形状设置成去调节构造。AD-IOL的调节弹性力主要由襻系统提供。
在一个实施例中,光学部囊泡与襻系统分开独立构造,并且两者通过将光学部囊泡压入襻结构中组装在一起。光学部囊泡通过精确的几何形状和机械紧贴配合(snug fit)卡入襻系统中并固定到襻系统,或者光学部囊泡的多个部分可并入融合区中,或者光学部囊泡可在组装之后利用添加到容纳襻臂或其它襻附连部件的凹槽的额外的聚合物或粘合剂另外固定。
在一个实施例中,襻系统在IOL植入后利用聚丙烯或其它相似的生物相容材料的回形件或环维持去调节,所述生物相容材料可通过利用例如YAG或飞秒激光之类的激光或者利用手术器械而被办理并变成无效。这样的回形件可固定到AD-IOL的多个位置,使得如果限制回形件被切开,则回形件的部段在光学区外保持附连到AD-IOL,且不需要被从眼睛移除。
在一个实施例中,光学部可结合有人造虹膜元件,其阻挡光通过光学部的周缘区,以免被传递到眼睛内。周缘区经历使中心光学区重新成形的目的性的机械变化,但可在其自身中导致不期望的图像失真和伪影。
在一个实施例中,光学部可结合有机械增强元件,机械增强元件使光学部囊泡的形状稳定并可具有形状记忆或超弹性。
在一个实施例中,光学部囊泡可具有与襻系统分开的一体的襻限制部件。
在另一实施例中,所结合的人造虹膜、增强元件以及襻限制元件可共存在单个元件中,且该元件可具有非反射表面。
在一个实施例中,襻系统可适于卷成窄的筒,以方便其在手术时注射到囊袋中。这样的调适可包括但不限于改变襻臂的数目、改变襻臂之间的连接部、改变使眼睛的前后囊能穿过其融合并因此固定襻的回形件的形状或尺寸,以及本领域技术人员已知的任何其它特征。
在另一实施例中,各自带有两个襻的两个或更多个光学环叠加并可绕光学部旋转。出于限制注射机尺寸的缘故,在将AD-IOL加载在注射机中之前,一个或多个顶部环被旋转,使得它们的襻叠覆底部环,实际上形成两襻式AD-IOL。一旦植入眼睛内,外科医生旋转一个或多个顶部环,使得所有四个或更多个襻均匀地分布在囊袋中。
在特定实施例中,光学部囊泡、限制环和襻可各自包括生物相容的塑料,比如聚丙烯、聚(甲基丙烯酸甲酯)、聚酰胺、尼龙、聚酯、聚偏氟乙烯和/或硅酮。襻和光学部固定部件以及限制部件可各自包括生物相容的金属或合金,比如不锈钢和/或镍钛合金。
在一个实施例中,光学部囊泡利用生物相容的流体填充,该生物相容的流体具有大于水的折射率,比如但不限于硅油。
在本发明的另一实施例中,光学部囊泡被填充到无拉伸或最小拉伸的体积,且形状设置成调节构造。在该实施例中,悬韧带捕获襻的动作主要是将光学部囊泡拉伸到其去调节的、较平的形状。弹性调节力主要被包含在流体填充的囊泡中,而不在襻结构中。
在该实施例中,通过限制装置的作用,AD-IOL以拉伸后的去调节构造被植入。
在另一实施例中,弹性调节力被包含在流体填充囊泡和襻结构两者的形状记忆中,且它们的弹性回弹可以是相加的或相减的,以取得可通过悬韧带张力以每个独立的襻约1克力或更小的力进行去调节的总水平。
在另一实施例中,当通过拉伸或非拉伸光学部柔性区、或通过在襻的作用下泵入或抽出流体使光学部囊泡从调节状态变化到去调节状态而符合期望的几何形状时,光学部囊泡可改变它的表面积与体积的比率。
附图说明
图1A和1B是根据本发明的实施例的处于去调节位置(图1A)和调节位置(图1B)的双模式AD-IOL的透视图,图示了调节情况下光学部的轴向移位和形变;
图2是根据本发明的实施例的光学部囊泡的俯视图叠加在现有技术的襻系统的图片上的示意图,光学部囊泡通过手术镊维持在完全去调节位置,襻系统由镍钛诺构成,且尺寸适于猕猴眼睛;
图3A、3B、3C和3D是根据本发明的实施例的光学部前囊和光学部后囊的示意图,具体地,前部俯视图(图3A)、截面图(图3B)、从上看的后部(图3C)以及呈截面图形式的示意图(图3D);
图4是根据本发明的实施例的光学部前囊和光学部后囊的已经融合且光学部囊泡填充有流体之后的呈截面图形式的示意图;
图5A和5B是根据本发明的实施例的全部组装后的双模式AD-IOL的呈透视图形式(图5A)和呈部分截面图形式(图5B)的CAD生成图像,显示了光学部囊泡与襻系统的相互作用;
图6A是根据本发明的实施例的襻结构的示意图,其包括一些改动,以允许AD-IOL卷成紧实的筒,从而方便穿过小的切口经注射植入眼睛内;图6B和6C示出本发明的实施例,其中两个带有两个襻的光学环叠覆并且可绕着光学部旋转,因此在注射机中加载之前,使顶环旋转成顶环的襻叠覆底环的襻。一旦植入眼睛内,外科医生就将顶光学环旋转90度,恢复四襻式构造。
图7A和7B是根据本发明的实施例的成形且填充到调节填充体积的光学部囊泡的CAD生成图像,悬韧带捕获襻彼此独立且在去调节期间主要通过拉伸光学部囊泡起作用。图7A绘出组装后的AD-IOL,其上方具有限制环,且图7B是各部件的分解视图;
图8A和8B以截面图的形式示出图7A和7B的AD-IOL,AD-IOL处在变化后的去调节位置(图8A)和处在静置的调节构造中(图8B)。AD-IOL在去调节位置具有较大的直径和较薄且弯曲较小的光学部囊泡;
图9图示根据本发明的实施例的与图7的AD-IOL相似、但带有通过连续环连接的襻的AD-IOL,该AD-IOL适于响应调节期间眼睛囊袋的直径减小。在该实施例中,襻结构和光学部囊泡两者都对调节AD-IOL所需的弹性力有所贡献;
图10图示图9中所绘AD-IOL的光学性质的有限元分析,示出处于光学部囊泡中心处的无像差光学区;
图11A和11B是根据本发明的实施例的镍钛诺限制环的图片(图11A),以及就位使AD-IOL去调节的镍钛诺限制环(图11B);
图12A、12B和12C是根据本发明的实施例的双模式AD-IOL的一部分的呈透视图(图12A)、截面图(图12B)和整个AD-IOL的透视图(图12C)形式的CAD生成图像。在该实施例中,襻直接对光学部的薄的前囊施加径向牵引,光学部的薄的前囊代表光学部的调节组成部分。后囊是坚硬的,并且传递规定光学屈光能力;
图13是适于与图12C的双模式AD-IOL一起工作的连续镍钛诺线襻的构造的示意图;以及
图14是根据本发明的实施例的双模式AD-IOL的截面的CAD生成图像,其中襻的臂上的桨叶状结构压在光学部囊泡的薄的区域上,以将流体引导到前光学表面,这在调节期间提供增加的屈光能力。后光学表面是更坚硬的,并且传递规定折光能力。
具体实施方式
本文中引用的所有专利申请、专利及其它参考文献的全部内容由此通过引用的方式并入本公开中。
在眼科学中,术语“襻”指的是从人工晶状体的光学元件伸出的、通常用于使晶状体在眼的囊袋内保持就位的结构。本文中,“襻”有时候称为“悬韧带捕获襻”,或者共同地称为“悬韧带捕获襻系统”,或者简单地称为“襻系统”,以及指的是如下的结构或材料:其不仅协助使晶状体安置在囊袋内并定中以将悬韧带运动传递到晶状体,而且其能够在天然晶状体移除和人造晶状体安置之后牢固固定在前囊与后囊中间或者固定到前囊或后囊。襻系统还可包括用于保持光学部的光学部保持件。“光学部保持件”是襻系统中保持光学部的部分,例如环、销或其它附连机构。
图1A和图1B绘出了带有悬韧带捕获襻100的双模式调节-去调节型IOL的一个实施例,悬韧带捕获襻100联接到既轴向移位又形状变化的柔性光学部105。悬韧带捕获襻100先前已在美国专利No.9,364,318中描述,该专利的全部内容通过引用的方式并入本文中。悬韧带捕获襻100包括弯曲区110、径向臂115和囊袋捕获区120,囊袋捕获区120具有正弦曲线的凹进部125,其允许周向部与囊袋的中纬线同时变化。各单独的襻100具有T形闭合回形件构造,其允许眼睛的前囊和后囊穿过闭合回形件并绕着闭合回形件接触和融合。多个襻100限定与融合的囊袋共存的盘。襻100的中纬线区随囊袋中纬线是大致圆周的,且将融合的袋的主锚区提供给襻系统;由此它们代表悬韧带捕获区。在襻100之间或替代地在各个襻臂115的两侧上,限制突片130从光学环135水平且径向突出。它们在长度上延伸超过弯曲区110的长度,且它们构造成与襻臂115的弯曲区相比是相对较坚硬的。襻100形状设置成在静置时处于调节构造中,且可通过利用生物相容的缝线或其它相似的装置将它们固定到限制突片130而限制成扁平的去调节构造。襻100优选由0.001”-0.002”薄的镍钛诺构成,并可通过悬韧带张力去调节,该悬韧带张力由融合的囊袋以约1克力或更小的力施加在每个襻100上。
悬韧带捕获襻100通过光学环135彼此连接及连接到光学部105,光学环135可以是单个连续结构,或可由设计成保持光学部105的多个部段或元件制成。光学环135或光学环部段可通过如下方式附连到光学部105,即:紧贴配合到光学部105的多个部分;融合到光学部105的外侧;或者,部分或全部地容纳在光学部105的融合区内或光学部105的适于该目的的其它部分内。
在图1A中,IOL示出为处于扁平的去调节位置,并且去调节的光学部的厚度由双箭头140标示。在图1B中的调节位置,晶状体厚度增加了由双箭头45绘出的额外量,并且光学部通过在眼睛中向前拱起而轴向移位由双箭头150绘出的量。
使用中,限制突片130用于在植入时和植入后的数周时间将襻结构锁定在去调节构造中,直至囊袋融合及纤维化已完成的这样一个时间为止。襻臂115借助生物相容材料的回形件维持在水平位置,所述生物相容材料的回形件比如是交织在襻臂115下方和限制突片130上方的缝线,或者比如是图11A和图11B中的环155。襻100给融合囊袋中从外科前囊膜切边缘朝着袋中纬线的径向部段留出空间。这些径向切口的长度可调整到囊袋纤维化限制释放所需的量,并可利用YAG或飞秒激光无创执行。在调节期间,襻100向后弯曲并将光学部囊泡挤压成更接近球形的形状。在去调节期间,襻将光学部囊泡拉伸成不像球形的形状。
参考图2,形变式光学部105包括流体填充的囊泡。光学部囊泡被绘出为叠加在根据现有技术的襻系统的图片上,以图示两个结构之间的关系。两者的尺寸都设计用于猕猴的眼睛。由镍钛诺构成的襻系统通过手术镊维持在完全去调节位置。襻100具有较薄的弯曲区160,该较薄的弯曲区160大致位于襻弯曲区110之下,中心光学区165周缘。弯曲区110的周缘部170可以是较厚的,并用作活塞区;周缘部170可具有更坚硬的组成部分,其被成形为块175,用以保持和固定襻臂115的远侧部分。
图3A、图3B、图3C和图3D是图2中所示的形变式光学部105的组成部分的简图,具体地,前部俯视图(图3A)、截面图(图3B)、从上方看的后部(图3C)和呈截面图形式的简图(图3D)。光学部具有光学部前囊180和光学部后囊185。
在一个实施例中,光学部前囊180具有中心光学区165,中心光学区165是较厚的、更坚硬的,且紧贴配合在襻结构的光学环内。这样的光学表面可给IOL提供预定的、可定制的屈光能力,该屈光能力对于每位患者是特定,例如15D对比16.5屈光度,且这样的光学表面还可具有散光矫正组成部分,如果这样期望的话。这是IOL的规定组成部分。该表面的轴线标记在光学区的边缘上或将光学部105保持在位的襻结构的边缘上。在一轮迭代中,例如200-500微米的较大厚度的固定式光学表面被选出,以使其足够坚硬,不会因襻100的作用或移位流体的作用而在形状上改变。紧邻光学区165周缘、大致位于襻弯曲区110之下的较薄的弯曲区160帮助调节期间光学部105在径向襻臂115的挤压或牵引下变化形状。弯曲区160可以是25-50微米薄。弯曲区160的周缘方面170可以更坚硬,并用作活塞区,且具有更坚硬的组成部分,其被成形为块175,用以保持并固定襻臂115的远侧部分。襻臂115可紧贴配合(例如卡入)在这些块内或之间的凹槽或凹口中,并且当组装晶状体时,襻臂115可利用生物相容的聚合物或粘合剂另外固定。在结构下侧,光学部前囊的最外缘被设计作为到光学部后囊195的对应融合区的融合区190。
除了将光学部固定到襻径向臂以便光学部囊泡可通过襻臂的弯曲和伸展而压缩和拉伸之外,这样的坚硬部段还用作活塞区,强制调节期间因压缩移位的流体朝着光学部囊泡的中心。另外的活塞区可根据需要置于襻之间。
在一个实施例中,光学部后囊185是薄的,例如具有例如25微米到50微米的厚度,且在其最外缘195上融合到光学部前囊。光学部后囊的中心部分是光学区200,并且可具有或可不具有另外模制的折射形状,并且它代表可变屈光能力光学区、IOL的调节部件。
参考图4,图3A-3D中图示的部件可被组装,以形成形变式光学部105。前囊与后囊之间的空间205由折射率高于水的折射率的生物相容流体(比如,例如硅油)填充。理想情况下,流体具有与光学部囊泡中的材料相同的折射率,从而减少任何的内部光学干涉。当光学部囊泡填充有流体时,薄的后囊呈现凸形构造,形成正度数折射面。
调节期间,当襻臂115朝着IOL的轴线弯曲时,光学部105中的流体借助光学部前囊的活塞区而向中心移动,结果是光学部后囊另外的弓形化和其折光能力的增加。在该实施例中的光学部后囊足够薄,从而能够在对襻臂115的最小阻力下经历形状变化。在另一实施例中,较厚的固定式光学区可置于光学部后囊上,且可变光学区置于光学部前囊上。在这样的实施例中,可在光学部前囊上构建另外的栓或脊或其它固定结构(未示出),以允许光学部前囊在襻光学环135上居中。
在另一实施例中,整个光学部110在旋转模制机中制造,旋转模制机一次性形成单个囊泡并消除将分开模制的囊融合的需要。
参考图5A和图5B,襻系统与光学部囊泡的示例性组合被图示。CAD生成图像示出了坚硬的前囊165上带有规定部件且薄的后囊200上带有可变调节部件的双模式AD-IOL的透视图(5A)和截面图(5B);襻弯曲区110与光学部弯曲区160之间的关系也被图示。调节期间,襻110的弯曲将流体驱赶向中心,以强制调节部件变得更接近球形。去调节期间,襻100的伸展将流体驱赶向周缘,以促使调节部件变得不像球形。光学部105和襻系统的形状记忆构造成总的提供比由眼产生的去调节力小的调节弹性力,以便AD-IOL的运动可由睫状肌的作用控制。例如,襻系统可形状设置成调节构造,而光学部105形状设置成去调节构造,或反之亦然,或者襻系统和光学部105两者都可设置成调节构造。准确的组合由襻与光学部系统的尺寸和材料性质决定。
参考图6A,在一个实施例中,襻系统可适于卷成窄的筒,以方便其在手术时注射到囊袋内。这样的调适可包括但不限于改变光学环135、弯曲区110和/或襻臂115的数目,改变襻臂115之间的连接部,改变襻100的允许眼睛的前囊和后囊融合穿过并从而固定该襻100的回形件的形状或大小,以及本领域技术人员已知的任何其它适合的特征。在图示的实施例中,襻100的闭合回形件在各个襻臂115的端部处具有与注射管的内径在尺寸上成比例的减小的直径,使得它们可穿过管而不会皱褶成永久扭曲的形状。出于相同的原因,襻臂115是窄的,并取向成使得它们可例如沿着6-12点钟轴线卷附在光学部105上进入注射管内。将襻臂115卷附在卷曲的光学部105上防止材料中可导致襻100皱褶或永久外形损伤的尖锐弯曲。
图6B和图6C示出了如下实施例,其中,各自具有两个襻100的两个光学环135’和135”叠覆并可绕光学部105旋转。在加载在注射机中之前,顶部光学环135’被旋转成:它的襻臂115叠覆底部光学环135”的襻臂115,实际上呈现给注射机仅180度分隔的两个襻100。一旦植入眼睛中,外科医生可即刻将顶部光学环135’旋转90度,恢复四襻构造。替代地,对于具有多于四个襻100的襻构造,多个光学环135可被叠覆。襻100的数目越大,悬韧带向光学部105的力传递越均匀,通过纤维化阶段的囊袋几何形状的控制越好,但注射机和IOL设计的复杂性更大,植入更加困难。实现恰当平衡的襻100的最小数目仅可由任何产品迭代所使用的特定材料和尺寸决定,可能三到四个。底部光学环135”包含去调节限制装置(未示出)。在图6A中,襻100差不多完全重叠,在图6B中,它们处于期望的构造中。
在一个实施例中,IOL内流体的体积计算为恒定填充量,为无拉伸或最小程度拉伸的囊泡的体积。这允许囊泡以最小的阻力进行形状变化。光学部囊泡的填充使例如光学部后囊上的可变屈光能力区、调节部件向外弓形化成对于每个对应的襻构造预定的、固定的屈光能力。该屈光能力加上相对的囊上的坚硬光学区,规定部件的屈光能力构成了对于该特定襻构造的关于远视力或去调节视力的IOL屈光能力。调节期间,另外的屈光能力通过由襻100的弯曲、光学部囊泡的弹性回弹或者两者引起的压缩获得,上述压缩使光学部后囊进一步弓形化,并且通过这样做使IOL的屈光能力增加多达14屈光度。可在光学部囊泡的较厚的区域(比如,活塞块或襻保持块或任何其它适合的位置)内构造一个或多个填充通道。这些通道被使用,以利用流体填充光学部囊泡并移除组装期间任何不经意的气泡。
参考图7A、图7B、图8A和图8B,在另一实施例中,静置时,弹性光学部囊泡形状设置成调节构造。在图7A中,包括限制环155的装置被组装,图7B是关于各单独的部件的分解视图。同一装置以截面图的形式示出为处于变化后的去调节构造(图8A)和处于静置调节构造(图8B)。在这些实例中,襻100在去调节中通过拉伸光学部起作用。
如图7A、图7B、图8A和图8B中,悬韧带捕获襻100’可以是分开的。替代地,参考图9和图10,悬韧带捕获襻可采用连续环220的形式。襻被嵌装在前囊与后囊之间的融合区中。襻能够在开口或凹口215中接收限制装置。在图7A、图7B、图8A和图8B中,陷在融合区内的襻部段各自限定例如两个环。这些环内的开口代表限制孔215,且尺寸上与限制环155中对应的限制孔210大致匹配。这些孔的直径可以是例如100-500微米,且这些孔在两侧上可由融合区的硅酮层覆盖,或者开口可延伸通过整个融合区。限制孔的准确的数目和尺寸由限制缝线或限制栓的机械性能和热性能以及施加在限制孔上的机械负载决定。缝线或栓的数目和尺寸越小,利用外部激光释放它们就越安全和容易,条件是:在植入时及之后,限制是稳定的、可靠的,并且被锁定的AD-IOL的几何形状是适当的。
参考图7A、图7B、图11A和图11B,IOL可利用比如环之类的限制装置155植入,限制装置155具有对应的限制孔210或栓,限制孔210或栓适于与襻限制孔215联接,以保持光学部105拉伸或形变到完全去调节直径。光学部105中的对应的限制孔通过生物相容材料的缝线或栓附接到限制环155中的孔210,该生物相容材料的缝线或栓优选可通过外部的激光施加或者利用手术器械切开或熔化或减小尺寸,以断开结合。弹性光学部囊泡的拉伸抵抗去调节期间的变形,并在襻100停止对光学部囊泡的牵引时使光学部囊泡返回到拉伸较小的构造。前光学区和后光学区两者都是可变的,但它们的厚度轮廓可以是或者可以不是对称的或均匀的。它们在去调节状态下的折光能力的总和构成规定屈光能力,而它们在调节状态下的屈光能力的总和代表对于患者的近视矫正。多个襻附连点绕着光学部的均匀分布使力能够均匀地分布在光学部105上,并带来无变形光学区,如图10中有限元分析软件生成简图中所见的区。如果使用连续的襻220,则这可进一步减少可导致不规则光学部变形的囊袋不规则收缩的风险。连续的襻220是大致正弦曲线形的,以允许与融合囊袋的直径变化同步的直径变化。连续的襻220可形状设置成:通过其整个直径的变化、轴向移位的变化或两者,而有助于调节或去调节的努力。
植入之后,可通过利用外部的无创性的激光或利用手术器械将环155切成段或通过使环155与IOL断开连接,而使环155失效,并且基于多种可能的构造,可能需要或可能不需从眼睛移除环155。
如图11A和图11B中所见,限制环155可具有帮助切开环155的较薄的区225、优化襻100的限制位置的较厚的区230和帮助限制环155定中的突片235。限制环155可被动地置放在AD-IOL上,或可被固定在位。
限制环155可以与襻元件之间、眼睛的融合囊袋中的径向切口同时被切开。这些切口可从在眼睛的前囊中以外科手术方式执行的前囊膜切开术的边缘朝着眼睛的囊袋的中纬线延伸预定的距离,该预定的距离被测定为在眼睛的纤维化囊袋的僵硬度上引起充分的释放,从而获得本发明的实施例的AD-IOL的期望的移动量。
图12A和图12B示出了双模式AD-IOL的一部分的CAD生成透视图和截面图,并且图12C以透视图方式示出了整个双模式AD-IOL。在该图示的实施例中,调节部件由非常薄的前囊180制成,该前囊180可以是25-50微米薄,并由形状记忆硅酮弹性体制成。当处于去调节位置时,前囊180可具有从6mm至8mm的范围选择的总直径。前囊180的中心光学区165可具有从4mm至6mm的范围选择的直径。理想情况下,设计目标在于:由最小直径的整个光学部105提供最大的光学区。
光学部105的弯曲区160紧邻前囊180的中心光学区165周缘,弯曲区160包括用于附连到襻附连环245(以下描述)的突出的栓240。栓240的形状可以是圆形的或非圆形的,可在与视轴平行的方向或者不同的方向处突出,可具有较宽的基部以支撑襻附连环,并可具有较宽的蘑菇状的帽,以防止栓240在张力下被驱逐。在实施例中,栓240是柱形的,具有100-500微米的直径和200-500微米的高度,每个襻附连点带有一个栓240,优选6个栓或更多,优选8个。限制栓240的总数目和尺寸由光学部和襻部件的机械性质和尺寸与设计和使用限制相平衡后控制。栓240的数目越大,施加到光学部105的悬韧带张力越均匀,每个栓240上的机械负载越低,并且AD-IOL构造和使用的复杂性越大。替代地,襻100的近端与柔性光学部105之间的连接部的几何形状可具有替代的几何形状,比如在相配的凹槽中的T形或锚形襻端部,或者是本领域已知的其它构造。
弯曲区160的处于栓240之间的区域可以是较厚的,并且构造上可以是正弦曲线的,连续地或以分开的部段的方式,以使光学区上的牵引向量更加均匀地分布且分布在光学区的更广区域上,而不妨碍去调节期间弯曲部160和光学区膨胀到更宽直径的能力。在示例实施例中,弯曲区160可具有从25微米到50微米的范围选择的厚度,和从200微米到500微米的范围选择的宽度。
前光学部的融合区290处于弯曲区160的周缘,前光学部在此处融合到后光学部185的融合区195。前光学部的融合区290可具有从100微米到1000微米的范围选择的宽度。设置在前光学部融合区的外周上或替代地设置在后光学部融合区上的悬吊唇部250允许当组装元件时更好的定中和更加牢靠的密封。该前光学部部件提供老花眼矫正。
后光学部元件185是大体较厚的,以抵抗变形,并具有规定折光能力,矫正个体患者的无晶状体折射的屈光能力。后光学部元件195的厚度可从100微米到500微米的范围选择。后光学部元件195具有后光学部融合区,具有从100微米到1000微米的范围选择的宽度。一般而言,允许规定光学区抵抗调节期间弯曲的最小尺寸是优选的,因为它减小了AD-IOL的整个体积。
由比如镍钛诺的形状记忆金属制成的环形板255嵌装在前光学部融合区与后光学部融合区之间。板255从光学区的外缘朝着周缘延伸且一直到融合区中的悬吊唇部,被完全封装在融合的硅酮囊内。板255在弯曲区160下的区域是实心的,而在融合区290内的区域由同心的一圈或多圈孔穿透,每个孔具有例如100微米到500微米的直径。如以下描述的,孔优选间隔开50微米到200微米,以方便缝线的使用。板255的厚度可以是0.001”到0.002”。板255的表面可借助激光表面改性或者化学沉积或色素沉积处理成暗色或非反射的。暗色或非反射的表面减少眼内的光散射,当患者的瞳孔例如在弱光环境中扩大时,眼内的光散射可导致图像降质、患者不舒适和/或患者瞳孔中的从妆容上令人讨厌的镜状表面。出于相同的原因,可对光学环和襻应用相似的处理。
在实施例中,环形板255具有三个单独的功能。位于前囊的弯曲区160下的近中心区260用作人造虹膜,以通过光学部105的弯曲和融合区阻挡周围的杂散光和防止图像失真与降质。处于环形板255中心的孔的大小变成有效的瞳孔,仅允许传播通过光学部105的光学区的光到达患者的视网膜。孔的大小优选与光学区的直径大致匹配,且孔的直径可以是例如4mm至7mm,以允许最大量的非失真的光穿过到达视网膜。
限制区265紧邻近中心区260的周缘布置,限制区265限定一圈或多圈同心限制孔270,同心限制孔270尺寸设计且分布成在植入时和之后的数周时间帮助将襻限制在去调节位置,以下描述。相应地,限制孔270延伸通过前囊、环形板255中限定的孔和后囊,或可由硅酮弹性体的连续层完全覆盖。限制孔270优选具有100微米到500微米的直径,且间隔开50微米到200微米。优选地,至少2至4个孔布置在每个栓240附近。限制孔270的理想数目和大小已在以上论述。未就位成限制襻臂115的其余的孔270是大致较大的,以允许前光学部的融合区与后光学部的融合区之间更加粘性的接触,同时维持板255的结构一体性,且不允许太多的杂散光传播到眼睛的后部。
在该实施例中,襻100是由比如镍钛诺的形状记忆金属制成的悬韧带捕获襻,并且可以是0.002”薄。襻115的臂在与融合区相同的平面中移动,该平面对应于由悬韧带在封闭且融合的囊袋中的轴向牵引的平面。各单独的襻100给在襻100之间的径向囊切分留出空间。襻110的弯曲区是短的,且成相对较陡的角度,以允许襻栓环245接近光学部栓240用于固定。光学部栓环可以是圆形的或不同的形状,与栓240的形状大致匹配,且尺寸设计成在栓240上形成紧配合或紧挤压。如以下描述的,通过缝合穿过光学部融合区、通过限制孔,襻臂115上的横条275允许襻100限制成去调节构造。除了限制功能之外,孔允许前囊与后囊之间的直接接触,以及与结合材料的直接接触,以形成前光学部和后光学部的更加牢固的融合。襻100的短且陡的弯曲区110将径向悬韧带牵引中的大多数转化成光学部105上的形状变化效果和朝着光学部105的轴向移位的较小效果。各个襻100的远侧部分具有正弦曲线的形状125,以允许襻100的该端部周向地膨胀和收缩,且与囊袋在调节和去调节期间的直径变化一致,以便襻100不会阻碍融合囊袋的运动。出于相似的原因,每个襻100的附连到光学部105的栓的两个近端不彼此连接。而是,近侧襻端部形成开口回形件,使得当去调节期间前囊拉伸时栓和襻端部能够移动到较大的直径。襻100形状设置成调节构造。
使用中,缝线穿过融合硅酮周缘囊,通过限制孔,并绕过襻115的臂上的每个横条275,从而形成回形件,以使襻100固定在拉伸后的去调节位置。缝线可由现有技术中已知的任何生物相容的材料制成。这样的缝线可通过比如YAG或飞秒激光之类的无创的外部激光的施加被切开。切开后的缝线部段可陷在硅酮融合区中,并且可能不一定要将之从眼睛移除。一旦缝线被切开,襻100就自由地移动。
嵌装的板255的第三重目的是增强柔性硅酮光学部的结构稳定性和形状记忆,以确保它在压缩之后或在植入步骤期间例如因被强制通过小切口的注射机变形之后返回到期望的形状。类似地,薄得足以因弱的悬韧带力而形状变化的光学部105具有一些在襻运动期间稳定几何形状的优选区域,以将所有的运动能量引导到调节元件而非柔性光学部的其余部分。
在图12A-12C中图示的实施例中,在去调节期间,悬韧带的径向牵引大多数转化成襻的径向牵引,该径向牵引被传递给光学部的弯曲区上的栓。该径向牵引使光学区变平,从而通过增加光学区的直径减小光学区的光学屈光能力。在静置调节形状中,光学部填充有如硅油的具有高折射率流体的流体。流体的优选折射率是例如至少1.30到1.55。折射率越大,对于形状上越小的改变提供的调节屈光能力越大。然而,这可导致更大的粘性,这会使运动更加困难,或者在化学组成上,其可能在几十年内与光学部囊泡聚合物不相容。由于光学部囊泡中的流体的体积是恒定的,因此前囊将拉伸以增加其表面积,以达到由较平的光学部的几何形状所要求的体积/表面积比。前囊是非常薄的,以允许该拉伸低于可由眼睛产生的去调节负载水平发生。当睫状体收缩抵消悬韧带的径向牵引时,光学部和襻两者的形状记忆使光学部重新成形到更加凸出的形状和更加前部的位置,由此使它的屈光能力增加多达10-15屈光度。
AD-IOL由组装在一起的四个分开的部件制成。两个光学元件(前囊和后囊)由硅酮弹性体或相似的生物相容材料模制成单独的部件。单独的襻和环板由期望厚度的镍钛诺片材激光切割而成,所述期望厚度可以是0.002-0.001英寸薄。襻被热成形至它的调节构造。例如通过化学或电化学酸洗,或者氧化浴,或者本领域已知的其它工艺,镍钛诺部件的表面经化学处理,以增加生物相容性并去除任何由激光引起的不规则部。环板利用融合区中的结合材料(比如未固化的硅酮弹性体或硅酮粘合剂)在后光学部元件中定位在位。添加另外的结合剂,并通过悬吊唇部覆盖环板与后光学部囊之间的接缝而添加前囊。将三个部件夹紧并热处理,以使结合材料固化。针切向穿过融合区进入光学部,并且硅油被注射到中心腔内;任何的气泡被小心翼翼地去除。调整硅酮填料,以利用薄的前囊最小程度的拉伸或没有拉伸而实现期望的光学屈光能力。当针被移除时,利用结合材料进一步密封自密封针通道的外部口。通过抓住光学部栓并牵引它们通过襻中对应的孔,襻被安置在位。额外的结合材料像蘑菇头一样被涂覆到栓,或者可利用微型铆栓、缝线或本领域已知的其它装置固定光学环。替代地,光学部囊泡通过旋转模制或相似的技术制造成单件,并且环板在外部地融合到后融合区或前融合区。
替代的襻构造使用连续回形镍钛诺线,回形件以与血管支架相似的方式捕获附连光学部栓、限制孔和囊袋的中纬线。该连续回形襻与融合囊袋的中纬线中更多的点形成接触,并遍及襻系统分布不均匀的侧向负载,以降低非常薄的前囊的光学失真的风险。尤其,参考图13,连续回形镍钛诺线襻220可适于与图12C的双模式AD-IOL一起工作。襻具有用以捕获光学部栓240的回形件245、用于在光学部105的融合区邻近接收限制装置的开口或凹口215和适于与囊袋同步改变直径的正弦曲线形中纬线区125。襻的形状设置成与柔性光学部的弹性回弹协作工作,并允许在眼睛中所产生的力负载下进行调节和去调节。襻的连续回形件允许像可能发生在囊袋封闭和纤维化之后的侧向应力或不规则周向应力均匀地分布在襻上,并如此以使柔性光学部的不规则变形最小化。
图14是通过替代的双模式AD-IOL的截面的CAD生成图像。该实施例采用由前囊180和后囊185融合在一起制成的柔性光学部和基本上与图5中相似的襻系统构造。该襻构造已被证明在一段扩展的时间内在纤维化且融合的囊袋内捕获猕猴试验模型眼睛内的运动幅度和动态,并将该运动转化成最大的轴向移位。
襻系统包括光学环135、径向延伸的限制突片130和径向延伸的闭合回形襻。每个襻100具有变成捕获在融合囊袋中的中纬线区120,并具有大致正弦曲线的形状125,以允许襻100的该端部周向地膨胀和收缩,并在调节和去调节期间与囊袋直径上的变化一致,使得襻100不阻碍融合囊袋的运动。径向臂115以及使径向臂115附连到光学环的弯曲区110邻近中纬线区。襻100形状设置成在静置位置差不多以45度向后倾斜。与图5A和图5B中绘出的襻结构相反,该实施例具有较少的限制突片,从而给附连到径向臂115的宽桨叶状结构280留出空间,宽桨叶状结构280叠覆光学部105中的压缩区285,并可在调节期间对光学部囊泡的这些薄的区域施加压力,以使流体移位。桨叶状结构280可由镍钛诺制成,优选由与襻系统的其余部分的相同厚度和相同片材制成,并具有例如100微米×500微米的尺寸,以尽可能多地包围光学部弯曲区110。如果需要,桨叶部280可通过结合到其的另外的材料的添加或通过折叠相同材料中的一些而变硬,并可形状设置成光学部105的曲率,以驱动尽可能多的流体。
前囊180包括中心光学区165和处于周缘的较厚的融合区290,融合区290适于结合到后光学部的融合区。融合区具有倒圆的边缘,以形成通道或空间295,过剩的结合材料可堆压和积聚在此处而非朝着光学表面散布。中心前囊由形状记忆硅酮弹性体制成,且可以是25-50微米薄。光学区的厚度可以是在各处一致的,或从中心向周缘逐渐变化。前囊提供IOL的调节部件。
后囊185是大体较厚的,以在调节期间抵抗变形,并且它还具有中心光学区200和周缘融合区195。融合区具有相似的倒圆边缘,以允许过剩的结合材料堆压在周向空间295中而不朝着光学表面或襻臂115散布。光学区带有患者的规定屈光能力、矫正患者的无晶状体屈光不正(包括可能的像散差)所需的屈光力。散光矫正的轴线在外部标记。后囊的前中纬线区具有可压缩区285和不可压缩区300。可压缩区285紧靠襻100的桨叶部280元件下方,并且非常薄,从而它们可容易地由襻100挤压。不可压缩区300位于襻100的限制突片下。这里,前后囊的中纬线区与柱或肋305融合。当压力由襻100施加给可压缩区295时,这给予后光学表面结构硬度。
在该实施例中,悬韧带轴向牵引促使襻结构变平和后部轴向移位。当悬韧带张力减弱时,襻100朝着视轴向后弯曲,并使光学部向前轴向移位,且还使光学部几何形状发生形变。该实施例的柔性光学部是流体填充的,且当襻100压在使流体向中心及向前移位的薄的周缘压缩区上时,该柔性光学部适于变化到薄的前光学部囊的更加调节、凸出的构造。当另外体积的流体通过襻100压缩发生移位且光学区变得更接近球形时,薄的前光学部囊、调节元件的表面积会在调节期间变化或拉伸。这些变化维持由调节光学部105的几何形状所需的适当的体积/表面积比。压缩区的厚度可以是小如25-50微米,并且压缩区可比前光学区更薄且可拉伸性更强。
内腔205填充有折射率比水大的流体,比如例如硅油,且优选地所述流体具有与前后囊元件所用的弹性体相同的折射率。腔205被填充到它的去调节形状,其中,光学区大致没被拉伸,但压缩区可能被或可能没被拉伸,取决于它们的厚度和相反方向的力的期望的平衡。生物相容缝线或环用于使襻100悬置到限制突片,给予襻100大致水平的构造,使之在植入之前处于与光学环和封闭囊袋相同的平面中。缝线或环是可修补的,以由比如YAG或飞秒之类的外部无创激光切分。在植入后的数周之后,一旦囊袋已经封闭、融合且纤维化,使襻陷在其内,就切开缝线或环,并且还可在襻100之间执行囊袋中的径向切口。这允许襻系统响应悬韧带张力运动。在调节期间,悬韧带张力减弱,襻100可朝着它们的静置状态运动,向后拱起并压缩中间的压缩区。该压缩使内部流体向中心和向前移位,并使前光学表面弓形化成更加凸出的调节构造。当去调节期间悬韧带张力恢复时,襻100被拉开,并且前光学区的拉伸将流体向下和向外推压并填充压缩区。
两个光学部件由比如硅酮的形状记忆弹性体制成,且优选由与填充光学部囊泡的流体不同的硅酮族制成。它们分开模制,并利用襻环组装在一起,并被结合。融合区既确保两个光学部件的定中,还确保光学环陷在两个光学部件之间,这有助于稳定IOL的结构。
襻系统由镍钛诺制成,从可薄至0.0001”或0.0002”的片材激光切削,形状设置到它的静置调节构造,且经化学表面处理以增加其生物相容性并减少由激光引起的不规则部。一旦三个部件被组装和结合,就利用切向穿过晶状体的较厚区域的针使腔填充有比如硅油的流体。
尽管本文中描述并绘出了本发明的若干方面,然而本领域技术人员可实施替代的方面以实现相同的目标。因此,意图的是,所附权利要求涵盖落入本发明的真实精神和范围内的所有这些替代的方面。
要求保护的权利要求书如附。
Claims (19)
1.一种双模式调节-去调节型人工晶状体,包括:
襻系统,所述襻系统包括具有形状记忆的多个闭合回形襻;
形变式柔性光学部,所述形变式柔性光学部包括前光学部囊和后光学部囊,两个囊中的每个包括融合区且两个囊的融合区融合在一起,由此在两个囊之间限定光学部囊泡,所述光学部囊泡填充有流体,其中,(i)襻附连到光学部,允许襻的动作改变光学部的形状,(ii)形变式柔性光学部具有小于或等于8mm的直径,以及(iii)由于襻系统的形状记忆与柔性光学部的形变能力的至少其中之一,双模式调节-去调节型人工晶状体在静置时处于完全调节构造中;以及
限制部件,所述限制部件尺寸设计且构造成使襻以与所述完全调节构造相比时更平的角度和更大的直径的至少其中之一固定在调节-去调节型人工晶状体的去调节构造中。
2.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述闭合回形襻是梯形和T形的其中之一。
3.如权利要求1所述的双模式调节-去调节型人工晶状体,还包括:
光学环,
其中,所述光学环使襻彼此连接及连接到光学部。
4.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,通过每个襻的一部分在融合区处嵌装在光学部中,所述襻附连到所述光学部。
5.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,每个闭合回形襻构造成适于在调节-去调节型人工晶状体的去调节期间将由悬韧带张力产生的径向牵引传递到光学部。
6.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,每个闭合回形襻构造成适于返回到在调节-去调节型人工晶状体调节期间的设置形状。
7.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述限制部件从由如下构成的组选择:设置在襻或光学环上的限制突片、由襻部段限定的限制孔、由光学部在其融合区中限定的限制孔、襻臂上的横条、限制环和缝线;所述光学环使襻彼此连接及连接到光学部。
8.如权利要求1所述的双模式调节-去调节型人工晶状体,还包括环形板,所述环形板嵌装在光学部的前光学部囊与后光学部囊之间。
9.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述闭合回形襻中的每个包括第一连接特征,并且所述光学部包括适于与所述第一连接特征接合的第二连接特征。
10.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述闭合回形襻中的每个形状设置成有助于光学部的轴向移位和形状变化。
11.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述襻系统包括至少两个光学环,每个光学环包括两个闭合回形襻,所述光学环设置在光学部之上,且构造成旋转成使第一光学环的襻叠覆在相邻的光学环的襻之上,以缩小所述光学环的轮廓,从而方便双模式调节-去调节型人工晶状体加载在注射机中。
12.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,至少一个闭合回形襻包括径向部段和设置在径向部段上的桨叶部,所述桨叶部构造成压缩光学部的一部分。
13.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述光学部和所述襻系统的至少调节型记忆的总和或者所述光学部和所述襻系统的至少去调节型记忆的总和是小于1克力。
14.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述前光学部囊和后光学部囊利用结合材料融合,并且融合区限定了被构造成接收过剩结合材料的通道。
15.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,柔性光学部的形状上的变化改变光学部囊泡表面积与光学部囊泡体积的比率,并且襻系统改变尺寸和形状以适应所述比率的变化。
16.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,光学部囊中的一个包括较薄、较容易变形的弯曲区,所述弯曲区邻近中心光学区设置。
17.如权利要求16所述的双模式调节-去调节型人工晶状体,其中,光学部囊中的一个包括所述中心光学区,并且所述中心光学区具有包括散光矫正的固定折光能力,所述中心光学区的厚度选自200至500微米的范围,其中所述厚度大于邻近于所述中心光学区设置并位于所述襻的襻弯曲区之下的所述弯曲区的厚度。
18.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述光学部囊泡具有形状记忆。
19.如权利要求1所述的双模式调节-去调节型人工晶状体,其中,所述襻系统适于配合在人工晶状体注射系统内。
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2017
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- 2017-08-23 US US15/684,313 patent/US10512535B2/en active Active
- 2017-08-23 CN CN201780065600.8A patent/CN109890325B/zh active Active
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JP2019524364A (ja) | 2019-09-05 |
CN109890325A (zh) | 2019-06-14 |
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