CN117979922A - 可置换光学器件和治疗物 - Google Patents
可置换光学器件和治疗物 Download PDFInfo
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- CN117979922A CN117979922A CN202280061242.4A CN202280061242A CN117979922A CN 117979922 A CN117979922 A CN 117979922A CN 202280061242 A CN202280061242 A CN 202280061242A CN 117979922 A CN117979922 A CN 117979922A
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Abstract
可置换光学器件系统(130)包括可以固定在眼睛内的眼内基座(100)。眼内基座包括一个或多个耦接器(110)和支撑结构(120)。一个或多个耦接器可释放地耦接到可置换光学器件或治疗物,并且可以包括磁性材料。支撑结构可以包括触件(150)和主结构(160),该主结构物理地支撑经由一个或多个耦接器耦接的可置换光学器件或治疗物。在一些情况下,眼内基座可以包括位于主结构内或主结构上的固定晶体。可置换光学器件可以包括对应的一个或多个耦接器,这些耦接器可以由磁性材料形成。治疗物可以是呈磁性粒子的形式。
Description
背景技术
人工晶体(IOL)是一种植入眼睛中的晶体。IOL包括有晶体眼(phakic)和假晶体眼(pseudophakic)两种,晶体眼被设计成在不进行白内障手术的情况下植入,假晶体眼被设计成结合白内障手术而植入。有晶体眼IOL具有驻留在囊袋与虹膜之间的沟空间中的能力,或替代地可以驻留在虹膜与角膜之间的前房中。最常用的假晶体眼IOL是后房型IOL,其包括触件(haptic),触件能够将晶体保持在眼睛内部的囊袋中。IOL的植入通常由眼科医生在手术中心进行,但也可以在眼科医生的诊室处在诊室内手术套间中执行。诊室内手术程序特别常见于有晶体眼IOL,就像激光屈光手术典型地在诊室内进行一样。假晶体眼IOL领域正在越来越多地解决老花眼的问题,老花眼是指某人在远处和近处都无法看到东西的情况。目前,老花眼并不是白内障手术保险范围的适应症。
随着该领域的成熟,除了即使戴有眼镜或某种形式的可配戴屈光矫正器仍存在的眩光和视力模糊问题(这是目前的适应症),IOL可能会越来越多地用于解决老花眼问题,。为了实现激光屈光手术的视觉质量,并随着技术的进步逐步改变晶体,亟需一种可完全定制和升级的IOL设计方法。屈光性白内障手术用先进的多焦点或扩展焦深(EDOF)IOL替换了天然的眼睛晶体。屈光性白内障手术尚未实现可以个体化达到高精度的角膜屈光手术(比如LASIK(激光辅助原位角膜磨镶术))的精度。此外,目前在白内障摘除术和IOL植入术中也缺乏波前引导精度。
波前引导方法是指考虑术前高阶像差的消融曲线,其最终目标是避免引起像差并消除存在的一些像差。这种方法通常用于激光屈光手术,比如LASIK和PRK,因为眼睛中的所有变量都是已知的。术前根据像差测量结果计算出激光消融曲线,并将其传输到激光系统中,以供例如在手术期间使用。对眼睛所做的唯一修改是角膜的形状。目前,这在白内障手术中是一项难以实现的任务,原因有二。首先,有效晶体位置(即IOL在眼睛中的最终位置)很难确定。前后位置的微小变化会使晶体的总焦度发生巨大变化。另外,手术所引起的小带无力和白内障主切口所造成的角膜散光的变化可能会分别改变晶体位置和角膜曲率。此外,IOL上的任何定制的散光和高阶像差矫正都会因IOL在囊袋内在X、Y、Z平面上的潜在移位而被先验地排除。
除了无法提供波前引导IOL优化外,目前的IOL系统还无法在放置非最佳IOL的情况下容易地进行矫正,也不允许容易地进行升级。IOL置换是一项具有挑战性的手术程序,即使在技术最娴熟的外科医生手中,也会对眼部结构造成严重创伤。以至于,IOL置换被视为最后的手段。然而,反复移除和替换传统IOL可能并非一种容易的手术程序,而且可能导致并发症。例如,使用传统IOL的IOL置换要求剥离囊袋,并通过角膜或巩膜取出展开的晶体。无论哪种取出方式(通过角膜或通过巩膜)都会对眼睛及其脆弱的结构造成高度创伤。大多数外科医生将对角膜执行LASIK或其他激光屈光手术程序,而不是置换IOL。由于每次手术程序都要消融角膜组织,因此这也不是无限重复的。重复激光矫正可能导致一系列并发症,包括角膜扩张和上皮内生。即使是年轻患者,也可能引起眼表疾病,因此在许多接受白内障手术的老年人中并不理想。
需要一种能够实现相对无限制的可置换光学器件以及波前引导晶体优化的系统。
发明内容
所描述的可置换光学器件和治疗物(therapeutic)可以实现在眼睛中逐步应用和置换晶体和/或治疗物。
可置换光学器件系统包括可以固定在眼睛内的眼内基座。眼内基座包括一个或多个耦接器和支撑结构。一个或多个耦接器可以包括磁性材料或其他可释放的固定材料或结构。例如,可释放的耦接器可以是呈钩环状的耦接器、比如用于将标签附连到衣物上的标签枪所用的记忆材料固定元件、纽扣紧固件、螺钉型紧固件、类似于袖扣的基于铰链的紧固件、基于吸盘的机构、粘合剂或任何其他可逆固定方式的形式。
磁性固定特别具有吸引力,因为与次级光学器件耦接的基座元件可以处于囊袋中,并且磁性次级光学器件可以通过磁力通过前囊袋耦接,而不物理地直接接触袋中的IOL。磁性吸引也是一种理想的机制,因为它允许以最小的力将次级光学器件从初级光学器件上脱离。相应地,对于磁性和其他类型的可释放的耦接器,可能重要的是要考虑对保持囊袋的脆弱小带的损伤。支撑结构可以包括触件和主结构,该主结构物理地支撑经由一个或多个耦接器耦接的可置换光学器件或治疗物。在一些情况下,眼内基座可以包括位于主结构内或主结构上的固定晶体。
提供本发明内容以便以简化形式介绍一系列精选的概念,这些概念将在下面的具体实施方式中进一步描述。本发明内容不旨在标识所要求保护的主题的关键特征或基本特征,也不旨在用于限制所要求保护的主题的范围。
附图说明
图1A和图1B图示了适用于可植入人工晶体和治疗物应用的可置换光学器件系统。
图2A至图2E图示了眼睛中可以设置可置换光学器件系统的各个位置。
图3A和图3B分别图示了具有用于耦接到眼内基座的夹持件的可置换光学器件的立体图和俯视图。
图4图示了具有用于耦接到眼内基座的螺钉安装件的可置换光学器件的立体图。
图5图示了具有柱和夹持件耦接的可置换光学器件系统的部分的侧视图。
图6A至图6D图示了一种具有多个堆叠晶体的可置换光学器件系统。
图7A和图7B图示了另一种具有多个堆叠晶体的可置换光学器件系统;图7A示出了眼内基座的另一个示例;以及图7B示出了使用输送系统将第二光学器件应用到眼内基座和第一光学器件上。
图8图示了由可以在输送套筒内同轴拉动的钩子构成的光学器件输送系统。
图9A和图9B示出了可以使光学器件或触件的三维旋转能够精确定向的基准点设计。
图10图示了具有磁性可置换人工晶体的示例可置换光学器件系统。
图11A至图11D图示了具有磁性可置换人工晶体的可置换光学器件系统的另一个示例。
图12A至图12D图示了用于可置换光学器件系统的示例触件设计。
图13A和图13B分别图示了具有可旋转晶体的可置换光学器件的侧视图和俯视图。
图14A至图14C图示了具有治疗物输送的可置换光学器件系统的示例。
图15A至图15C图示了可以用于在可置换光学器件系统上输送治疗物的示例磁性脂质体或纳米粒子。
具体实施方式
所描述的可置换光学器件和治疗物可以实现在眼睛中逐步应用和置换晶体和/或治疗物。
图1A和图1B图示了适用于可植入人工晶体和治疗物应用的可置换光学器件系统。如图1A和图1B所示,可置换光学器件系统包括可以固定在眼睛内的眼内基座100。眼内基座100包括一个或多个耦接器(例如,耦接器110)和支撑结构120。一个或多个耦接器可以包括磁性材料或其他可释放的固定材料或结构。在此示例中,示出了单个环形耦接器110。
参考图1A,可置换光学器件系统130可以包括眼内基座100,该眼内基座支撑可置换光学器件(例如,140-A、140-B)并可以固定在眼睛内。如上所述,眼内基座100可以包括一个或多个耦接器(例如,耦接器110)和支撑结构120。一个或多个耦接器(在本例中为环形耦接器110)用于将眼内基座100可释放地耦接到可置换光学器件140-A、140-B。支撑结构120可以包括主结构160(可以为圆形子结构)和用于将眼内基座100缝合或以其他方式固定在眼睛中的触件150,该主结构可以用于直接地或经由一个或多个耦接器间接地来物理地支撑可置换光学器件140-A、140-B。
触件150可以是使眼内基座100能够固定在眼睛内的任何合适的结构。图6A、图7A、图10、图11A和图12A至图12D示出了各种示例。
在图示的方案中,主结构160在中心开放,使得可置换光学器件140-A、140-B在眼内基座100的周缘处抵靠在近端表面上。在其他实现方式中,主结构160具有透明表面,可置换光学器件140-A、140-B抵靠在该透明表面上方。支撑结构120还可以可选地包括在主结构160内或主结构上的晶体或IOL(未示出)。在一些情况下,支撑结构120可以包括一个或多个突出部,该一个或多个突出部可以用于向上延伸穿过眼睛囊袋中的孔(例如,参见图2B的延伸部222和图11A的张力环延伸部1125)。在一些这种情况下,耦接器可以设置在突出部的端部处。此耦接器可以是用于基座的耦接器,也可以是用于基座的附加耦接器。
可置换光学器件140-A、140-B可以包括晶体170和一个或多个对应的耦接器180。为了应用可置换光学器件系统130,可以将眼内基座100布置在眼睛中。然后可以使用耦接器110、180(图示为磁体/磁性材料)将其中一个可置换光学器件140-A、140-B布置、定向/对齐并耦接到眼内基座100。对齐可以涉及相对于眼内基座、眼睛或眼睛内的一些结构的径向对齐。一个或多个可置换光学器件(例如,光学器件140-A、140-B)可以包括基准点,以帮助径向对齐,如图9A和9B所示。对齐还可以包括相对于眼内基座、眼睛或眼睛内的一些结构的深度对齐。
在一些情况下,“对应的耦接器”180的数量比眼内基座100的耦接器110的数量多或少。例如,基座的耦接器可以是点耦接器,而光学器件的耦接器可以是单个环形状。在图示的方案中,一个可置换光学器件140-A被示出为具有单个对应的耦接器180,其呈环形;并且,另一个可置换光学器件140-B被示出为具有两个对应的耦接器180,其被定位成均耦接到眼内基座100的环形耦接器110。眼内基座100与可置换光学器件140-A、140-B之间的耦接可以以各种方式实现,例如磁性地、使用摩擦或化学地。在图示的方案中,示出了磁性耦接。
当然,虽然环形耦接器110是一个示例,但眼内基座处的一个或多个耦接器可以是由磁性材料形成的两个耦接器,使得使用两点耦接实现耦接,其中眼内基座的一个或多个耦接器中的第一个耦接器设置在眼内基座一侧上的近端表面(即,面向眼睛外侧的表面)处,而一个或多个耦接器中的第二个耦接器设置在眼内基座另一侧上的近端表面处。然后,对应的一个或多个耦接器将以使可置换光学器件定向并与基座耦接的方式设置在可置换光学器件处。例如,对应的一个或多个耦接器将对齐设置,用于耦接到眼内基座的一个或多个耦接器上。
如上所述,一个或多个耦接器110和对应的一个或多个耦接器180可以由磁性材料形成。磁性材料可以是任何合适的铁磁或亚铁磁材料。磁性材料的大小和形状被确定成最小化或避免对比如MRI等强外部磁场的易感性(例如,避免/最小化移动或成像干扰)。
应该理解的是,尽管本文中所包含的示例提到耦接器是磁体或磁性的,但在某些实现方式中也可以使用其他类型的可释放的耦接器(例如,基于化学、机械或摩擦)。使用磁性耦接器还能够应用某些治疗物。
事实上,参考图1B,相同的眼内基座100可以用于应用治疗物190。在图示的方案中,治疗物190可以耦接到眼内基座100上。在一些情况下,一旦眼内基座100布置在眼睛中,就应用治疗物190。在一些情况下,治疗物190可以在最初布置之前应用,然后可选地在布置之后再应用。
图2A至图2E图示了眼睛中可以设置可置换光学器件系统的各个位置。图2A至图2C示出了可置换光学器件系统的眼内基座定位在眼睛的囊袋内的示例。参考图2A,可置换光学器件系统210的眼内基座200可以定位在眼睛的囊袋212内。通过使用磁性耦接,可置换光学器件215(或治疗物)可以布置到眼睛的沟空间216(并且甚至稍后从其移除)。参考图2B,具有延伸部222的眼内基座220可以定位在眼睛的囊袋212内。延伸部222(或其他突出结构)可以穿过囊袋212中的一个或多个孔延伸到沟空间216中。例如,可以存在来自白内障手术的开口,延伸部222可以穿过该开口突出。在一些情况下,可以制作小的开口,以允许延伸部222突出穿过。可以在延伸部222的端部处提供磁性、机械或化学耦接器,以供布置到沟空间216(并且甚至稍后从其移除)的可置换光学器件225耦接。参见图2C,可置换光学器件系统230可以完全定位在囊袋212内。
参考图2D,在一些情况下,可置换光学器件系统240可以完全定位在虹膜242后方、囊袋212前方的沟216中。参考图2E,在一些情况下,可置换光学器件系统250可以定位在角膜252后方、虹膜242前方的前房中。图2D和图2E所示的示例可以用于有晶体眼(具有原生晶体)患者。有利地,如果眼内基座固定在前房中(如图2E所示)或沟空间中(如图2D所示),则可以不需要白内障手术。
对于这些位置中的任一位置,如果该系统的重量大于小带强度,则可以将漂浮在水液中的气囊或装置的一部分并入眼内基座中。本发明的这种浮力部件可以是永久性并入的,例如可压缩泡沫浮标,该可压缩泡沫浮标具有用于航海设备、泳池玩具和冲浪板的密封泡沫。替代地,该装置可以具有充当气囊的储器,该气囊填充有气体或任何比水轻的材料。这将能够基于填充程度调节浮力。
如上所述,一个或多个耦接器110(以及对应的一个或多个耦接器180)可以包括磁性材料或其他可释放的固定材料或结构。例如,可释放的耦接器可以是呈钩环状的耦接器、比如用于将标签附连到衣物上的标签枪所用的记忆材料固定元件、纽扣紧固件、螺钉型紧固件、类似于袖扣的基于铰链的紧固件、基于吸盘的机构、粘合剂或任何其他可逆固定方式的形式。
图3A和图3B分别图示了具有用于耦接到眼内基座的夹持件的可置换光学器件的立体图和俯视图;图4图示了具有用于耦接到眼内基座的螺钉安装件的可置换光学器件的立体图;以及,图5图示了具有柱和夹持件耦接的可置换光学器件系统的部分的侧视图。
参考图3A和图3B,可置换光学器件300可以具有夹持件310,该夹持件可以附接到眼内基座的耦接器(未示出)上。在一些情况下,可置换光学器件300可以包括肋部320,以有助于例如在眼内基座的主结构内的牢固配合。
参考图4,可置换光学器件400可以具有用于固定到眼内基座处的对应耦接器(未示出)的螺钉安装件410。在一些情况下,可置换光学器件400可以包括叉头420,以有助于例如在眼内基座的耦接器和主结构内的牢固配合。
参考图5,可置换光学器件510可以使用柱530和镍钛夹持件540耦接到眼内基座520。
对于基座与可置换光学器件(或两个可置换光学器件)之间的任何直接连接,期望的是使耦接机构位于在前破裂的范围内。这将能够实现在囊袋212外部的可置换光学器件(例如,图2B的可置换光学器件225)与囊袋中的眼内基座(例如,图2B的眼内基座220)之间的直接连接。替代地,飞秒激光或其他精密手术平台不仅可以制作初级破裂,还可以在前囊中制作两个或更多的次级小开口,耦接机构(例如,延伸部222)可以通过这些次级小开口突出。使用飞秒激光或其他精密手术平台形成次级开口(耦接机构可以通过这些次级开口突出)可以起到将晶体对齐特定轴线的次级功能,这例如对复曲面IOL是有用的。事实上,飞秒激光或其他精密手术平台可以用于在IOL必须通过的轴线处在破裂附近制作两个附加的孔。
有许多耦接机构可以用来代替磁性材料或作为磁性材料的补充。在一些情况下,可置换光学器件可以具有固定元件,该固定元件具有形状记忆材料成分,该形状记忆材料成分可以通过在前囊中所制作的孔穿过眼内基座处的孔放置。与用于将价格标签附接到衣物上的标签枪类似,T臂可以在被推动穿过光学触件接合点处的孔中时屈曲,并且一旦穿过孔,就会恢复到打开的位置。
本领域技术人员清楚地知道,此布置可以以多种方式进行修改。例如,在一些情况下,T臂固定元件可以并入眼内基座中,并穿过囊袋突出到沟空间中。可置换光学器件可以在其中具有孔,T固定元件通过该孔突出。在囊袋皮过长使囊袋相对于初级光学器件中的孔发生位置移位的情况下,这可能是优选的选项。通过使T固定元件突出超出囊袋,这有助于确保即使发生囊袋皮过长,也能保持耦接机构通过。此外,T形固定元件可以由各种记忆材料制成,这些记忆材料包括形状记忆聚合物和形状记忆金属。适用于所描述的固定元件的记忆聚合物包括但不限于聚降冰片烯、聚己内酯、聚烯烃、尼龙、聚环辛烯(PCO)、PCO和丁苯橡胶的混合物、聚醋酸乙烯酯/聚偏二氟乙烯(PVAc/PVDF)、PVAc/PVDF/聚甲基丙烯酸甲酯(PMMA)的混合物、聚氨酯、苯乙烯-丁二烯共聚物、聚乙烯、反式异戊二烯、聚己内酯和丙烯酸正丁酯的混合物、以及它们的组合。适用于所描述的固定元件的记忆金属包括但不限于不锈钢、钴、镍、铬、钼钛、镍钛合金、钽、铂铱合金、金、镁、或它们的组合。进一步,应该理解的是,T形固定元件还可以使用其他端部形状。例如,端部形状可以是圆形、三角形或者比其要固定通过的孔大的任何形状。
在一些情况下,眼内基座或可置换光学器件可以具有通过前囊切开术切口或通过在前囊中所创建的次级孔突出的柱。在具有柱突出部的一个这种实现方式中,可置换光学器件于是可以通过柱配合,并且可以在可置换光学器件上方将弹性带放置到柱上,从而将可置换光学器件保持就位。对保持可置换光学器件的弹性带的操作方式类似于橡胶带将金属丝保持就位到牙套上的支架的方式。在柱突出部的另一种实现方式中,柱可以在其中具有螺纹,螺钉可以安装在该螺纹上。在另一种实现方式中,柱可以包括孔,开口销或记忆材料可以通过该孔放置。在另一种实现方式中,柱可以包括杠杆臂。与袖扣类似,柱既可以是直上直下的,也可以当在铰链处转动时将形成T。此布置不涉及形状记忆,而是仅涉及机械铰链。当固定元件处于直线位置时,可以将具有类似于衬衫袖口特征的可置换光学器件螺纹连接在固定元件上,然后一旦就位,就可以转动铰链,使柱形成T,而不是直的,从而将可置换光学器件和眼内基座保持在一起。
在一些情况下,例如,如果设计具有足够低的摩擦力,则眼内基座和可置换光学器件可以使用按扣式布置。
在一些情况下,眼内基座和可置换光学器件可以与柱一起使用扭转机构,其中柱包括T或L形端部,并且一旦柱穿过另一部分中的开口,可置换光学器件就可以旋转,使得每个柱的端部抓住表面,以将两者保持就位。例如,如果一个柱元件是呈L形,但其穿过的槽仅比L的水平分量稍大,则如果眼内基座和可置换光学器件相对于彼此旋转,则L的前缘会移动超出其穿过的槽的边缘,从而将眼内基座和可置换光学器件保持在一起。在一些情况下,可以并入形状记忆材料。例如,L形可以在每一端部处都具有突出部(比如呈非常明显的衬线L的形式)。L的端部处的突出部可以配合到与凹口相邻的孔(例如,类似于一些圆珠笔中所采用的孔)中。因此,当L形通过凹口而螺纹连接时,L的端部处的突出部部分会与凹口边缘抵接,并稍稍弯曲避开,因此可以继续旋转。一旦旋转了足够远的距离,L上的突出部就会到达凹口旁边的孔,并落到合适的位置,从而使L再次与眼内基座和可置换光学器件共面。在一些情况下,可置换光学器件和L形柱都可以由具有记忆形状特性的材料形成。
图6A至图6D图示了一种具有多个堆叠晶体的可置换光学器件系统。图6A图示了可置换光学器件系统600的分解视图,该可置换光学器件系统包括眼内基座610和多个光学器件(包括第一光学器件621和第二光学器件622)。眼内基座610可以具有支撑结构630,该支撑结构带有触件环640,该触件环可以缝合以固定连接到眼睛上。一个或多个耦接器可以处于支撑结构上。例如,一个或多个耦接器可以是点源,也可以是环(比如用白色虚线650表示),该环设置在支撑结构的圆周上或环绕支撑结构的圆周(例如,另参见图11A和图11B)。参考图6B,眼内基座610可以设置在眼睛内(例如,在沟空间中)。如图6C所示,第一光学器件621可以可释放地附接到眼内基座610上。替代地,在一些情况下,第一光学器件621(或第三光学器件)固定地附接到眼内基座610上,或内置到眼内基座上(例如,参见图10的晶体1060)。然后,如图6D所示,第二光学器件622可以在第一光学器件621上方可释放地附接到眼内基座610上。在一些情况下,来自眼内基座610的磁力足以耦接两个光学器件。在一些情况下,对两个光学器件的定位使一个或多个耦接器的至少一部分能够专用于两个(或更多个)光学器件中的相应一个。在一些情况下,第一光学器件621包括一个或多个耦接器,以供第二光学器件622耦接。在一些情况下,第一光学器件621固定地附接到眼内基座610,而支撑结构上的耦接器被配置用于附接第二光学器件622。
图7A和图7B图示了另一种具有多个堆叠晶体的可置换光学器件系统;图7A示出了眼内基座的另一个示例;以及,图7B示出了使用输送系统将第二光学器件应用到眼内基座和第一光学器件上。
参考图7A,眼内基座710可以具有支撑结构720,该支撑结构带有触件730,该触件可以缝合以固定连接到眼睛上。一个或多个耦接器可以处于支撑结构720上。例如,一个或多个耦接器可以是点源,也可以是环(比如用白色虚线740表示),该环设置在支撑结构的圆周上或环绕支撑结构的圆周(例如,另参见图11A和图11B)。
转到图7B,晶体750可以经由工具(光学器件输送系统760)通过巩膜770中的小切口容易地应用到眼内基座710上。光学器件输送系统760可以包括钩子或其他精细器械,其可以同轴地拉动,从而允许最小的切口,该最小切口最小化了在光学器件引入或置换之后角膜散光的变化和对眼部结构的损伤。光学器件输送系统可以同轴地存储囊袋并通过最小的切口进入,该囊袋包含新光学器件,该新光学器件包含例如次级晶体750。如图7B所示,一旦进入眼睛内部接近眼内基座710的位置,光学器件输送系统760就可以释放囊袋,使其接近沟空间。钩子(参见图8)可以用于操纵囊袋或次级晶体,以相对于眼内基座710正确地定向。在某个时刻,新光学器件750可以耦接到眼内基座,此时钩子可以可选地用于使新光学器件相对于眼内基座正确地定向。基准点标记可以用于有助于定向和对齐(例如,参见图9A和图9B,可以在光学相干断层扫描-OCT下使用)。在一些情况下,可置换光学器件(例如,晶体750)可以包括孔口,该孔口可以被光学器件输送系统的器械钩住。
在此图示的方案中,晶体750是第二光学器件;然而,本方法可以针对第一光学器件(例如,光学器件621)、甚至替换性第二光学器件(例如,如图6D所示,在应用光学器件622之后替换第二光学器件622)来进行。
图8图示了光学器件输送系统的操作。参考图8,光学器件输送系统810可以包括钩子815,该钩子可以在光学器件输送系统810的输送套筒内同轴地被拉入眼睛中。在第一步骤中,钩子815可以处于伸出位置。如在第二步骤中所图示的,钩子815可以与光学器件820的周缘内的孔825接合,以能够取出。如在第三步骤中所图示的,钩子815可以同轴地拉回到光学器件输送系统810中,从而将光学器件820带向输送套筒。在某个时刻,钩子815可以完全被拉入光学器件输送系统810内,此时光学器件820可以被迫向内折叠,并与钩子一起被拉入光学器件输送系统810中,如步骤4所示。
图9A和图9B示出了可以使光学器件或触件的三维旋转能够精确定向的基准点设计。基准点可以放置、蚀刻或绘制在晶体或其他光学器件上,以帮助晶体或其他光学器件在布置后定向。基准点标记可以具有适用于通过IR、超声、荧光、x射线、MRI等检测的材料。在一种实现方式中,基准点可以被眼部反应分析仪(例如,光学相干断层扫描-OCT)检测到。基准点标记可以用于确定精确的有效晶体位置(ELP)。作为一些示例,可以将对应的标记应用于触件处的眼内基座处、应用于可选的晶体上、或应用于支撑结构上。在一些情况下,对应的基准点设计可以设置在眼内基座处(例如,图1A中的主结构区域160上)。
参考图9A,基准点可以是L形。L形的臂可以不同。如果L形基准点的大小和形状已知,则可以使用表观长度来通知晶体或光学器件在三维中的旋转。参考图9B,基准点可以是靶心形状(例如,圆圈内的单个斑点)。特别是,使用靶心形状可以允许将部分基准点打印在晶体或光学器件的相反侧上。基准点位于晶体或光学器件的两侧可以使斑点相对于圆圈产生更大的表观运动,从而允许更准确地了解其在三维空间中的取向。
在晶体或触件接收系统的一侧上所打印的几个L形基准点(例如,如图9A所示)或在晶体的一侧上的圆圈和在另一侧上在前后查看时放置在圆圈内的斑点(例如,如图9B所示,提供靶心)将能够对任何倾斜进行灵敏测量。通过可视化L臂的长度或斑点相对于圆圈的位置关系,可以确定晶体或触件接收器所处的位置。
在一些实现方式中,在可置换光学器件和眼内基座上都提供了可以使用OCT读取的基准点。基准点可以相对于眼睛的静止特征(例如,用角膜地形图/断层扫描预先登记的结膜血管图案、生物测量数据,等)读取。然后,OCT可以引导触件上光学器件的放置。在移除可置换光学器件时眼内基座发生移动的情况下,基准点支持对眼内基座的实时跟踪。当重新定位或置换可置换光学器件时,OCT装置可以通过基准点实时地计算出什么位置改变是必要的。
如上所述,可置换光学器件系统可以包括用于眼内基座的各种结构。此外,眼内基座的耦接器可以设置在各个位置,并配置成各种形状。以下示例是针对带有具有磁性耦接的眼内基座的可置换光学器件系统;然而,实施例并不限于此。
图10图示了具有磁性可置换人工晶体的示例可置换光学器件系统。参考图10,可置换光学器件系统1000可以包括:眼内基座1010,该眼内基座具有触件1020和圆形磁体耦接器1030;以及可置换光学器件1040。可置换光学器件1040可以是磁性光学器件,该磁性光学器件在其周缘具有对应的圆形磁体1050。
在图示的方案中,触件1020是呈双C环触件的形式。在一些情况下,眼内基座1010可以进一步包括晶体1060。例如,眼内基座1010可以类似于传统的IOL,但进一步包括一个或多个耦接器(例如,这里呈设置在周缘处的磁体的形式)。然后,磁性光学器件1040可以布置、旋转到任何精确的取向,例如使用如图9A和9B所示的基准点对齐,并耦接到眼内基座结构1010。在一些情况下,可置换光学器件1040可能在潜在的几年内被布置和/或可能在几年后被替换,以布置更精确的晶体。允许布置、旋转和耦接磁性光学器件(例如,可置换光学器件1040)的眼内基座结构1010可能例如在精确的复曲面散光矫正中是有利的。此外,由于可以添加附加的晶体和/或替换可置换光学器件1040,因此可以在破坏性较大的手术之后添加进一步的矫正性晶体,或在手术之后几年添加矫正性晶体,或布置更精确的晶体,例如特制晶体或三维打印的晶体。
图11A至图11D图示了具有磁性可置换人工晶体的可置换光学器件系统的另一个示例。参考图11A和图11D,在可置换光学器件系统1100中,眼内基座1110可以包括具有可选的张力环延伸部1125的囊张力环1120和两个或多个耦接器1130。如上关于图2B所述,通过使用一个或多个突出部(比如张力环延伸部1125),囊张力环1120可以被设计成使得两个或多个磁性臂(例如,具有耦接器1130的张力环延伸部1125)通过前囊切开术切口类似于艾哈迈德(Ahmed)节段出现,从而使光学器件能够放置在沟空间中。替代地,囊张力环可以被设计成使得囊张力环不会从前囊切开术切口中升起,而是保持在袋中。在一些情况下,除了耦接器1130或作为耦接器1130的替代性方案,还可以包括次级磁体环1140,其可以为磁性光学器件1150提供360度对接平台,如图11C和图11D所示。也就是说,如图11C所示,可以布置具有对应耦接器的光学器件,而囊张力环1120(和/或可选的次级磁体环1140)的臂上的耦接器1130与光学器件1150上的对应耦接器之间的吸引力可以可释放地将光学器件1150保持就位。
图12A至图12D图示了用于可置换光学器件系统的示例触件设计。眼内基座的支撑结构可以用各种不同形状和图案的触件来实现。除了图6A和图7A所示的形状、图10所示的双环C形触件以及图11A所示的囊张力环构型外,还可以使用其他触件形状。例如,图12A示出了可置换光学器件系统1200,其具有眼内基座1210和磁性耦接光学器件1220,该眼内基座设计具有十字形触件图案1215。图12B示出了可置换光学器件系统1230,其具有眼内基座1240和磁性耦接光学器件1220,该眼内基座设计具有触件设计1245,该触件设计可以有助于类似于戈尔人工晶体(Gore Akreos lens)的次级巩膜缝合晶体。图12C示出了可置换光学器件系统1250,其具有眼内基座1260和磁性耦接光学器件1220,该眼内基座设计具有四叉头触件臂1265。图12D示出可置换光学器件系统1270,其具有眼内基座1280和磁性耦接光学器件1220,该眼内基座设计具有环状触件1285。
随着白内障手术的进行,角膜的形状以及晶体的光学器件和有效晶体位置都会发生改变。即使精确定位在适当的位置,术后晶体移位的情况也并不少见。本文所描述的可置换光学器件系统可以解决这些障碍。首先,通过经由袋将囊袋夹在磁性光学器件与磁性触件接收器之间,该系统不太可能相对于囊袋旋转或移位。其次,在某些实施例中,比如对波前引导定制人工晶体进行3D打印,允许具有晶体触件系统的眼内基座在囊袋内形成疤痕可能更有意义。随着囊袋收缩,眼内基座的最终有效晶体位置然后将被知晓。通过包括基准点,波前扫描可以计算出在白内障手术之后角膜的形状,根据基准点确定有效晶体位置,并且当实现所有变量时,可以使用此数据来3D打印出定制晶体。然后,可以将定制晶体随后附接到所确定的规格。这实现了不仅打印波前优化单焦点IOL、而且打印定制波前优化多焦点和扩展焦深人工晶体的能力。眼内基座还为任何未来迭代的晶体提供了向前兼容的系统,因为晶体可以用最新迭代的晶体替换/置换。
在一些这种情况下,提供主焦度的晶体可以与眼内基座一起布置(例如,参见关于图10所述的晶体1060),并且波前引导光学器件可以二次输送,以附接到具有晶体1060的眼内基座上。波前引导光学器件(“次级晶体”)可以通过小得多的切口来布置,并且与ICL手术和LASIK类似,可以适用于基于诊室的手术程序。也就是说,次级光学器件可以通过足够小的角膜切口来布置,或可以使用以前的手术切口,而且可以最小化再次进入角膜所造成的额外变化。这将使初级晶体和触件系统能够像目前的IOL一样布置在袋中,只需使用磁性系统。在囊袋已完全收缩的第二时间段,基准点提供了有效晶体位置。此外,通过对眼睛的长度使用地形图/断层扫描和波前测量,可以控制所有光学变量。如有必要,穿透角膜来输送次级光学器件所引起的散光程度可以通过调整定制光学器件设计来控制,以考虑所引起的散光。因此,可以先验地确定有效晶体位置(ELP),并确定哪种定制或非定制晶体对眼睛来说是理想的。
作为所述可置换光学器件系统的一部分,可以将专用光学器件应用于眼内基座。图13A和图13B分别图示了具有可旋转晶体的可置换光学器件的侧视图和俯视图。晶体外壳系统被设置用于可旋转设计,该可旋转设计使眼内基座或可置换光学器件的晶体能够旋转。参考图13A,可置换光学器件1300的设计可以具有:耦接框架1310,眼内基座1330的耦接器1320可以附接到该耦接框架上;静止体1340,该静止体可以配合在眼内基座1330的开口内;以及旋转体1350,该旋转体可以取决于静止体1340与旋转体1350之间的耦接在一个或两个维度上旋转。
如前所述,眼内基座不仅可以用于支持可置换光学器件的输送,还可以提供用于输送治疗物的表面。图14A至图14C图示了具有治疗物输送的可置换光学器件系统的示例。
磁性脂质体或纳米粒子可以与可置换光学器件系统的磁性部件一起使用。
除了将药物输送聚合物植入物或储器直接并入该装置的触件或光学器件系统外,眼内基座的磁性部件还提供了将磁性纳米粒子和脂质体耦接到该装置的方式。磁性脂质体或粒子可以预装载到该装置上,并且在手术时或手术后施用。
磁性脂质体或纳米粒子可以在布置在眼睛中之前耦接到磁性眼内基座上。替代地或另外,脂质体或纳米粒子可以在将磁性眼内基座布置到眼睛中之后通过玻璃体内、经小带、囊内或巩膜内方法引入,并耦接到眼睛中的磁性眼内基座。磁性粒子可以用于输送治疗物,包括但不限于抗生素、类固醇和非甾体抗炎药(NSAID)。这些治疗物可以如图15A至图15C所展示地进行配置,以有助于附着到眼内基座上。磁性眼内基座将能够使磁性粒子驻留在触件系统上,直到它们降解或释放铁磁流体到磁吸引力不再足以保持结合的程度,而不是通过正常的流出路径快速离开眼睛。
如上所述,用于输送治疗物的磁性粒子可以应用于各种形式的眼内基座。参考图14A,呈囊张力环形式的眼内基座1410可以由吸引磁性粒子的磁性材料形成或涂覆有该磁性材料。在一些情况下,不同区域可以应用有不同的治疗物,例如,抗生素1412区域、类固醇1414区域和NSAID(非甾体抗炎药)1416区域。当然,治疗物的应用方式可以是将各种治疗物分散到眼内基座1410的整个表面。
参考图14B,眼内基座1420(具有或不具有晶体)可以包括用于附接磁性粒子1430的磁性耦接器/环1422。因此,磁性粒子1430可以围绕环1422布置和附着。
参考图14C,具有磁性触件1442的眼内基座1440可以用于附接磁性粒子1450。
参考图15A,磁性粒子可以由具有聚合物涂层的磁铁矿芯和聚乙二醇外壳构成。磁铁矿芯可以使磁性粒子被吸引到磁性眼内基座上,从而允许相对精细的布置。如果存在多个磁铁矿粒子,则磁性粒子与磁性眼内基座之间的吸引力会减弱。磁性眼内基座上的磁性强度以及磁铁矿的浓度、聚合物粒子的大小和降解速率可以调整驻留时间,以进一步微调局部剂量。在特定的实施例中,聚合物降解速率可以根据药物释放速率进行调整。这可以允许磁性粒子在输送了大部分(甚至全部)药物之后由于吸引力减小而解离。
参考图15B,磁性粒子可以在单个聚合物粒子内具有多个磁性粒子,而不是如图15A所示的单个磁铁矿芯。
参考图15C,磁性粒子可以形成为具有铁磁流体芯的脂质体粒子。治疗物可以包括脂质体外壳、脂质体外壳内的磁性铁磁流体以及脂质体外壳内的药物或治疗物芯。磁性铁磁流体和药物或治疗物芯可以结合在脂质体外壳内部。由于铁磁流体和治疗物被结合在脂质体外壳内,药物或治疗物的释放可以与铁磁流体的释放相一致。在某些实现方式中,铁磁流体释放的速率可以根据药物释放速率进行调整,因此当大部分药物释放时,脂质体与眼内基座之间的吸引程度会降低到脂质体解离的程度,然后可以通过小梁网自由流出眼外。
由于已知游离铁对视网膜有毒性,因此磁性纳米粒子包含在生物相容性外壳中,与目前的铁基MRI造影剂(比如来自Berlex Laboratories公司的)非常相似。纳米粒子具有足够的大小,以便在移除眼外磁铁时通过小梁网自由排出眼外。然后,纳米粒子会像目前临床上使用的其他铁基纳米粒子一样被肝脏清除。
用于磁性纳米粒子的生物相容性外壳的生物相容性材料可以选自由以下各项构成的组:聚乙烯醇、聚丙烯酸钠、丙烯酸酯聚合物、透明质酸酶聚合物、胶原蛋白膜、多孔HA/TCP陶瓷复合材料、羟基磷灰石骨水泥、PVP/PMMA、磷酸三钙、羟基磷灰石涂层胶原纤维、硫酸钙、羟基磷灰石(HAp)、磷酰胆碱(PC)、硅酮、超高分子量聚乙烯、聚乙烯、丙烯酸、尼龙、聚氨酯、聚丙烯、聚(甲基丙烯酸甲酯)、聚四氟乙烯、涤纶、缩醛、聚酯、硅酮-胶原复合材料、聚醛、聚氯乙烯、丙烯酸硅酯、聚四氟乙烯、甲基丙烯酸羟乙酯(HEMA)、聚(甲基丙烯酸甲酯)(PMMA)、聚(乙丙交酯)、聚羟基乙酸、四氟乙烯、六氟丙烯、聚羟基乙酸、聚(乳酸)、去氨基酪氨酸乙酯、聚二氧六环酮、纤维蛋白、明胶、透明质酸、磷酸三钙、聚乙醇酸(PGA)、聚己内酯、聚(丙交酯-共-乙交酯)、聚羟基丁酸酯、聚羟基戊酸酯、碳酸三亚甲酯、聚酸酐、聚原酸酯、聚(乙烯醇)、聚(N-乙烯基-2-吡咯烷酮)、聚(乙二醇)、聚(羟乙基甲基丙烯酸酯)、n-乙烯基-2-吡咯烷酮、甲基丙烯酸、甲基丙烯酸甲酯和马来酸酐、聚己内酯、聚(氨基酸)、聚(L-赖氨酸)、聚(l-鸟氨酸)、聚(谷氨酸)、聚氰基丙烯酸酯、聚磷腈、聚(乳酸)、聚(乙醇酸)、冠醚、环糊精、环芬、乙二醇、丙烯酸甲酯、对二甲苯、生物降解共聚物、共聚物表面涂层、淀粉聚合物、聚乳酸、玻璃纸、酪氨酸聚碳酸酯、乳酸和乙二醇聚合物、胶原蛋白、聚四氟乙烯(PTFE)、硅酮、角蛋白基材料、纤维复合材料—碳纤维和粒子、聚合物复合材料、人工/天然材料复合材料、玻璃-陶瓷/金属复合材料、玻璃-陶瓷/非金属复合材料、牙科复合材料、水凝胶、定时释放泡沫和聚合物载体。
根据某些实现方式,磁性纳米粒子可以包括金属氧化物和聚合物或脂质体制剂。示例脂质体包括来自由脂肪酸、脂肪酸衍生物、单甘油酯、双甘油酯和三甘油酯、磷脂、鞘脂、胆固醇和类固醇衍生物、油、维生素和萜类构成的组的元素,包括但不限于蛋黄L-磷脂酰胆碱(EPC)、1,2-二肉豆蔻酰基-sn-甘油-3-磷脂酰胆碱(DMPC)、1,2-二棕榈酰基-sn-甘油-3-磷脂酰胆碱(DPPC)、1,2-二油酰基-sn-甘油-3-磷脂酰胆碱(DOPC)、1,2-二硬脂酰基-sn-甘油-3-磷脂酰胆碱(DSPC)、1,2-二月桂酰基-sn-甘油-3-磷脂酰胆碱(DLPC)、1,2-二油酰基-sn-甘油-3-磷脂酰乙醇胺(DOPE)、1-棕榈酰基-油酰基-sn-甘油-3-磷脂酰乙醇胺(POPE)、1,2-二肉豆蔻酰基-sn-甘油-3-磷脂酰乙醇胺(DMPE)、1,2-二棕榈酰基-sn-甘油-3-磷脂酰乙醇胺(DPPE)和1,2-二硬脂酰基-sn-甘油-3-磷脂酰乙醇胺(DSPE)、磷脂酸、磷脂酰胆碱(含饱和和不饱和脂质)、磷脂酰乙醇胺、磷脂酰甘油、磷脂酰丝氨酸、磷脂酰肌醇、溶血磷脂衍生物、心磷脂、13-酰基-y-烷基磷脂、二-油酰基磷脂酰胆碱、二-肉豆蔻酰基磷脂酰胆碱、二-十五酰基磷脂酰胆碱、二-月桂酰基磷脂酰胆碱、二棕榈酰基磷脂酰胆碱、二硬脂酰基磷脂酰胆碱、二花生酰基磷脂酰胆碱、双二十二酰基磷脂酰胆碱、双二十三酰基磷脂酰胆碱、双二十四酰基磷脂酰胆碱;以及磷脂酰乙醇胺。
聚合物制剂(例如,形成纳米粒子的基质)可以选自由以下各项构成的组:聚(丙烯酰胺)、聚(N-异丙基丙烯酰胺)、聚异丙基丙烯酰胺-共-1-乙烯基咪唑、聚(N,N-二甲基丙烯酰胺)、聚(N,N-二甲基丙烯酰胺)、聚(1-乙烯基咪唑)、聚(丙烯酸钠)、聚(甲基丙烯酸钠)、聚(2-羟乙基甲基丙烯酸酯)(HEMA)、聚(N-二甲基丙烯酸二甲氨基乙酯)(DMAEMA)、聚(N-三(羟甲基)甲基丙烯酰胺)、聚(1-(3-甲基丙烯酰氧基)丙磺酸)(钠盐)、聚(烯丙基胺)、聚(N-丙烯酰氧琥珀酰亚胺)、聚(N-乙烯基己内酰胺)、聚(1-乙烯基-2-吡咯烷酮)、聚(2-丙烯酰胺基-2-甲基-1-丙磺酸)(钠盐)、聚((3-丙烯酰胺丙基)三甲基氯化铵)和聚(二烯丙基二甲基氯化铵)、聚(羟基酸)、聚酸酐、聚原酸酯、聚酰胺、聚碳酸酯、聚亚烷基、聚亚烷基二醇、聚亚烷基氧化物、聚对苯二甲酸亚烷基二酯、聚乙烯醇、聚乙烯醚、聚乙烯酯、聚乙烯卤化物、聚乙烯吡咯烷酮、聚硅氧烷、聚(乙烯醇)、聚(醋酸乙烯酯)、聚苯乙烯、聚氨酯及其共聚物、合成纤维素、聚丙烯酸、聚(丁酸)、聚(戊酸)、聚乳酸-共-己内酯、乙烯-醋酸乙烯酯、共聚物及它们的混合物。
有利地,所描述的眼内基座能够定制和置换光学器件以及输送治疗物。
尽管已经以特定于结构特征和/或行为的语言描述了主题,但是应当理解,在所附权利要求中限定的主题不一定限于上述具体特征或动作。而是,上文所述的具体特征和行为是作为实现权利要求的示例而公开的,并且其他等同的特征和行为旨在处于权利要求的范围之内。
Claims (20)
1.一种可置换光学器件系统,包括:
眼内基座,所述眼内基座包括:
一个或多个耦接器,用于可释放地耦接到可置换光学器件或治疗物;以及
支撑结构,用于在经由所述一个或多个耦接器耦接到所述眼内基座的情况下物理地支撑所述可置换光学器件或治疗物。
2.根据权利要求1所述的可置换光学器件系统,还包括:
所述可置换光学器件,其中所述可置换光学器件包括一个或多个对应的耦接器。
3.根据权利要求2所述的可置换光学器件系统,其中,所述眼内基座还包括位于所述支撑结构上或所述支撑结构内的次级晶体。
4.根据权利要求3所述的可置换光学器件系统,其中,所述可置换光学器件包括波前引导光学器件,并且所述次级晶体提供主焦度。
5.根据权利要求2所述的可置换光学器件系统,还包括:
所述眼内基座上的第一组基准点;以及
所述可置换光学器件上的第二组基准点。
6.根据权利要求1所述的可置换光学器件系统,其中,所述一个或多个耦接器中的每一个耦接器包括磁性材料。
7.根据权利要求6所述的可置换光学器件系统,其中,所述一个或多个耦接器包括所述支撑结构上的磁性环。
8.根据权利要求1所述的可置换光学器件系统,其中,所述支撑结构包括:
触件,用于在眼睛内固定地耦接所述眼内基座;以及
主结构。
9.根据权利要求8所述的可置换光学器件系统,其中,所述一个或多个耦接器位于所述主结构的周缘上。
10.根据权利要求8所述的可置换光学器件系统,其中,所述支撑结构包括人工晶体,其中所述主结构包括所述人工晶体的晶体。
11.根据权利要求8所述的可置换光学器件系统,还包括:所述主结构上的基准点。
12.根据权利要求1所述的可置换光学器件系统,还包括:
所述治疗物。
13.根据权利要求12所述的可置换光学器件系统,其中,所述治疗物包括磁性粒子。
14.根据权利要求13所述的可置换光学器件系统,其中,所述磁性粒子包括:
具有聚合物涂层和聚乙二醇外壳的磁铁矿芯。
15.根据权利要求13所述的可置换光学器件系统,其中,所述磁性粒子包括:
脂质体外壳;
所述脂质体外壳内的磁性铁磁流体;以及
所述脂质体外壳内的药物或治疗物芯。
16.根据权利要求13所述的可置换光学器件系统,其中,所述一个或多个耦接器包括所述支撑结构的触件上的磁性材料或所述支撑结构上的磁性环。
17.一种可置换光学器件,包括:
晶体;以及
所述晶体上的一个或多个磁体。
18.根据权利要求17所述的可置换光学器件,还包括:在所述晶体的周缘内的孔。
19.根据权利要求17所述的可置换光学器件,还包括:所述晶体上的基准点。
20.根据权利要求17所述的可置换光学器件,其中,所述一个或多个磁体对齐设置,以用于耦接到眼内基座的对应的一个或多个耦接器上。
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US17/471,496 | 2021-09-10 | ||
US17/471,496 US11357620B1 (en) | 2021-09-10 | 2021-09-10 | Exchangeable optics and therapeutics |
PCT/US2022/043014 WO2023039138A2 (en) | 2021-09-10 | 2022-09-09 | Exchangeable optics and therapeutics |
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CN117979922A true CN117979922A (zh) | 2024-05-03 |
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KR (1) | KR20240055090A (zh) |
CN (1) | CN117979922A (zh) |
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