CN101039634A - 可调节人工晶状体和包含该晶状体的可调节人工晶状体组件 - Google Patents

可调节人工晶状体和包含该晶状体的可调节人工晶状体组件 Download PDF

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CN101039634A
CN101039634A CNA2005800345167A CN200580034516A CN101039634A CN 101039634 A CN101039634 A CN 101039634A CN A2005800345167 A CNA2005800345167 A CN A2005800345167A CN 200580034516 A CN200580034516 A CN 200580034516A CN 101039634 A CN101039634 A CN 101039634A
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intraocular lens
accommodating intraocular
aiol
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basal disc
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约书亚·本纳
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Nulens Ltd
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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
    • A61F2/1635—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 for changing shape
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

Abstract

一种可调节人工晶状体(AIOL)，包括用于使类碟形的弹性变形形状记忆光学元件(66)弹性变形的偏压机构(79)，以提供给AIOL用于近视的天然正屈光强度。该AIOL要被植入人眼(10)，这样其睫状体(19)的张驰使其眼囊隔膜施加用于克服偏压机构的调节力，以降低AIOL的用于远视的天然正屈光强度。

Description

可调节人工晶状体和包含该晶状体的可调节人工晶状体组件
技术领域
本发明涉及可调节人工晶状体和包含该晶状体的可调节人工晶状体组件。
背景技术
共同拥有的PCT国际申请号PCT/IL02/00693，PCT国际公布号为WO031015669的标题为“可调节晶状体组件”的PCT国际申请说明并描述了可调节人工晶状体(accommodating intraocular lens)组件(下文称为AIOL)，其内容通过引用合并于本申请中。该AIOL组件包括适合牢固地固定在人眼环形睫状(annular ciliary)沟的固定眼内镜片系统(haptics system)，其固定于至少两个空间上分开的固定的定位点，从而可作为可连续改变的屈光强度的AIOL的参考平面，其受作为在后面的方向的抵抗并在类括约肌睫状体的控制下的眼囊隔膜(capsular diaphragm)影响。WO031015669的图1和图2中展示了一种意为仿制人眼天然晶状体的调节性人工晶状体组件2。该调节性人工晶状体组件2具有硬质材料制成的透镜6和天然球形硅树脂球体10。人眼囊膈膜从后部方向直接地靠在硅树脂球体10上以使其在人眼睫状体的张驰下弹性可伸缩地变形成压缩的扁平形状，并以与人眼天然晶状体相同的方式降低其天然的正屈光强度以适合远视觉。然而，人眼，尤其是老化的人眼，也许会太虚弱以至不能施加足够的力以克服保持其天然形状的硅树脂球体的固有倾向，从而阻止调节。
可效仿的AIOL在授予特纳(Tennant)号码为No.4,254,509的美国专利，授予利维(Levy)号码为No.4,409,691的美国专利，授予合恩(Horn)等人号码为No.4,888,012的美国专利，授予特里(Turley)号码为No.4,892，543的美国专利，授予克里斯特(Christie)等人号码为4,932,966的美国专利，授予卡明(Cumming)号码为No.5,476,514的美国专利，授予斯克顿(Skottun)号码为No.5,489,302的美国专利，授予卡明(Cumming)号码为No.5,496,366的美国专利，授予克拉斯(Klaas)号码为No.5,522,891的美国专利，授予卡明(Cumming)号码为No.5,674,282的美国专利，授予斯克顿(Skottun)号码为No.6,117,171的美国专利，授予卡明(Cumming)号码为No.6,197,059的美国专利，授予伍兹(Woods)号码为No.6,299,641的美国专利，授予卡明(Cumming)号码为No.6,342,073的美国专利，授予卡明(Cumming)号码为No.6,387,126的美国专利，授予拉格特(Laguette)等人号码为No.6,406,494的美国专利，授予沙法拉兹(Sarfarazi)号码为No.6,423,094的美国专利，授予伍兹(Woods)号码为No.6,443,985的美国专利，授予斯克顿(Skottun)号码为No.6,464,725的美国专利，授予卡明(Cumming)号码为No.6,494,911的美国专利，授予朗(Lang)等人号码为No.6,503,276的美国专利，授予卡明(Cumming)号码为No.6,638,306的美国专利，授予布鲁斯勒(Preussner)号码为No.6,645,245的美国专利，和依斯克(Esch)公开号为No.US2004/0169816的美国专利申请中被说明并描述。
发明内容
本发明涉及一种新型的AIOL，包括用于使可弹性变形的形状记忆光学元件弹性变形的偏压(biasing)机构，以提供给AIOL天然的正屈光强度以适合近视觉。所述偏压机构被设计为施加限定于其下侧的变形力FBM以在边上大于使光学元件变形的最小变形力FOE，及施加限定于其上侧在人眼睫状体的张驰的状态下由人眼囊膈膜在前部的方向作用产生的变形力FOE和调节力FCD的合力，以使光学元件回复到其天然的形状以降低AIOL的天然正屈光强度以适合远视视觉。作用在本发明AIOL的光学元件上的力在数学上可以表示为FOE+FCD＞FBM＞FOE。通过这样布置的功效，本发明的AIOL促进了人眼的调节性，甚至在老化的眼睛能够施加可能被认为小于健康的眼睛的调节力的调节力FCD情况下。
AIOL形成部分的AIOL组件，且AIOL组件设计为在至少两个空间分离的固定定位点自定位植入人眼睫状沟。该AIOL可以被安装在分离的固定眼内镜片系统(haptics system)中以使AIOL能够在原位延着人眼视轴位移，从而一般而言能进行精确的视力修正，尤其能补偿眼囊的收缩。可选地，该AIOL可与包含可塑性变形的固定眼内镜片机构的固定眼内镜片系统整体成型，同样能在原位使AIOL位移。共同拥有的标题为可调节人工晶状体组件和调节测量植入体的PCT国际申请PCT/IL2005/000456说明并描述了这样的分离的固定眼内镜片系统，以及包括带有都能在原位使AIOL位移的可塑性变形的固定眼内镜片机构和与AIOL整体成型固定眼内镜片系统的整体构造，其内容通过引用被结合到本文中。
附图说明
为了理解本发明并看出怎样在实践中实现本发明，现在通过非限制性的例子并参考所附的图叙述优选的实施例，图中相似的部分使用相同标号，其中：
图1是自然近视情况下人眼前部沿人体轴平面的剖视图；
图2是自然远视情况下人眼前部沿人体轴平面的剖视图；
图3是根据本发明的包含AIOL的第一优选实施例的被分离为两个部件的AIOL组件的透视图；
图4是根据本发明与AIOL的第一优选实施例整体成型的单一AIOL组件的透视图；
图5是图3所示的AIOL的爆炸视图；
图6是图3所示的AIOL在其近视状态下的纵向剖视图；
图7是图3所示的AIOL在其远视状态下的纵向剖视图；
图8是植入图3所示的AIOL的人眼的前部在近视状态下沿人体轴平面的剖视图；
图9是植入图所示3的AIOL的人眼的前部在远视状态下沿人体轴平面的剖视图；
图10是根据本发明的AIOL的第二优选实施例的透视图；和
图11是根据本发明的AIOL的第三优选实施例的透视图。
具体实施方式
图1和图2分别是在人体轴平面中在天然的近视和远视情况下具有视轴VA的人眼10前部的剖视图。人眼10具有角膜11，其周围在环状的巩膜-角膜接合点连接到由称为巩膜12的韧性结缔组织构成的球形外体上。虹膜14从其处于巩膜-角膜结合点13的根部16向内延伸入人眼10，将人眼前部划分为前房17和后房18。类括约肌的外周结构(称为睫状体)19包括由副交感神经激活的容纳睫状肌的睫状突(ciliary processes housing ciliary muscles)21。睫状肌21连接到小带纤维22上，小带纤维22依次地被外周连接到称为囊袋23的膜的中纬线边缘，前囊24和后囊26包裹着天然晶状体27。虹膜根部16和睫状体19在巩膜-角膜结合点13(称为睫状沟28)处界定了巩膜12内表面的一部分。在天然晶状体27摘除后保留的前囊24的剩余部分和完整的后囊26在后文中称为囊膈膜29。睫状体19的收缩使晶状体27沿视轴VA方向加厚到其自然厚度T1，以产生用于近视的更大的正屈光力(参见图1)。睫状体19的张驰拉紧小带纤维22，小带纤维22如图中箭头A所示径向地向外牵引囊袋23用于挤压晶状体27以沿着视轴VA减小其厚度到T2(T2＜T1)，以得到用于远视的较低的正屈光力(参见图2)。
图3显示了用于自定位植入人眼睫状沟28的AIOL组件31，以使裸眼的视觉(spctacle free vision)超过人类视觉的标称范围。AIOL组件31包括分离的固定眼内镜片系统32以可选择地在其中保持分离的AIOL33。所述固定眼内镜片系统32由适合的生物相容性材料制成，例如聚甲基丙烯酸甲酯(PMMA)等等。固定眼内镜片系统32包含具有纵轴36且轴向长度为L1的管状主体34(参见图6)，和一对在固定眼内镜片系统32的前视图中从其以相反的方向切向延伸的直径相反的固定眼内镜片机构37。所述固定眼内镜片机构37具有一对平行且相对的附加板38，其上设有足够强度的尖锐穿刺元件39，用于强行穿入人眼巩膜12的坚韧结缔组织。该穿刺元件39最好是尺寸确定的，以便穿入巩膜略微超过一半的厚度，大约为1毫米。关于该固定眼内镜片系统32的进一步详情大体上在上述的PCT国际申请No.PCT/IL2005/000456中说明并描述了，尤其是附图3-5中。
图4显示了用于自定位植入人眼睫状沟28的AIOL组件41，以使裸眼的视觉(spctacle free vision)超过人类视觉的标称范围。AIOL组件41包括与AIOL43整体成型的固定眼内镜片系统42，其中AIOL43在结构和运转方式上与分离的AIOL33相似。该固定眼内镜片系统42在结构上与固定眼内镜片系统32相似，但在一定范围内与其不同，其包括带有区域46的可塑性变形的固定眼内镜片机构44，区域46被充满对辐射敏感的生物相容性化学品，例如对红外(IR)敏感的吲哚菁绿(ICG)等等，这样的固定眼内镜片机构44能通过加热到所谓的玻璃转化温度来塑性地形变。关于该固定眼内镜片系统42的进一步详情大体上在上述的PCT国际申请No.PCT/IL2005/000456中说明和描述了，尤其是附图12-16中。
图5-7显示了AIOL33，其包括杯形外壳51、引导面53、和阶梯状外表面54，其中外壳51由如PMMA等的适当的硬质生物相容性化学品制成、并具有沿着纵轴52的轴长度L2，外表面54具有用于牢固地夹在主体34的大直径引导部56和小直径曳尾部57，垂直的圆柱形内表面58，和确定通孔62的与环形凸缘61一起成型的曳尾面59。外壳的轴长度L2大于主体的轴长度L1，这样主体34能沿长度大于主体轴长度L1的调整行程与外壳51接触。引导部56形成有三个周向布置的纵向槽63，该纵向槽63形成有在引导面53上的切口64。外壳51上具有天然的类似碟形的光学元件66，其由适当的具有大于水的折射率的可弹性形变的生物相容性材料制成，例如聚合胶(polymeric gel)、冷凝胶(hydrogel)等类似物质。适当的聚合胶包括商业上可从美国纽西技术有限公司(NuSiL Technology LLC，USA，www.nusil.com)购买的硅树脂胶。光学元件66通过施加最小形变力FOE开始沿其纵向经受弹性形变。
硬质托架67从外部可滑动地安装在外壳51上，并包括形成有孔69的环形基盘68，三个具有自由端72且其上设有孔73的纵向定向柱71，具有引导部76和曳尾部77的孔隙透镜74，曳尾部77形成有三个径向均匀间隔用来与通孔73搭扣配合的定向凸起78。基盘68最好由适当的硬质生物相容性材料制成，如PMMA等。孔隙透镜74最好由适当的硬质生物相容性材料制成，如PMMA等。孔隙透镜74最好具有足够的正屈光强度，即大约在+10至+30的范围内，用于基本视力矫正。定向柱71被滑动地接收在定向槽63中，这样孔隙透镜74处于引导面53侧向，基盘68处于曳尾面59侧向。托架67在第一极限位置和第二极限位置之间的行程S往复运动，在第一极限位置基板68邻近曳尾面59，在第二极限位置基板68相对于第一极限位置远离曳尾面59。由压缩弹簧构成的偏压机构79布置在曳尾部57和定向柱71之间，以推动托架67到达其第二极限位置。偏压机构79施加用于使感光元件66变形到鼓出通孔62的变形力FBM(其中FBM＝FOE+A)，以为AIOL33提供适合近视的高正屈光强度(参见图6)。偏压机构79设计为在睫状体19张驰的状态下在前部方向抵抗基板68施加的调节力FCD满足FOE+FCD＞FBM的条件，这样托架67呈现其第一极限位置以使感光元件66回复到其天然的类似碟形以降低用于远视的AIOL的天然正屈光强度(参见图7)。
图8和9分别显示了在外围布置的固定定位点AP自定位植入人眼睫状沟的在其近视和远视状态下的AIOL组件31。所述AIOL组件31植入人眼10，这样囊膈膜29在人眼睫状体19收缩状态下轻轻地靠在基盘68上，这样在睫状体19张驰时，囊膈膜29推动AIOL33从其近视状态到达远视状态。
尽管本发明通过有限数量的实施例描述，但是可以理解的是具有多种变化和改进，本发明的其他申请将落入附加的权利要求范围中。例如，偏压机构79可以由纵向的可压缩弯曲元件81(参见图10)、叶片弹簧(参见图11)等类似结构实现。同样地，基本视力矫正可以由圆形基盘代替孔隙透镜来作用。此外，托架可以由非机械方式装配，例如粘贴、焊接等。

Claims (11)

1.一种可调节人工晶状体(AIOL)，其特征在于，包含：
(a)杯形外壳，该杯形外壳具有引导面，带有孔的曳尾面，和至少一个可弹性变形的形状记忆光学元件；
(b)托架，该托架具有基盘和孔隙透镜，并滑动地安装在所述外壳上，且所述基盘在所述曳尾面侧向以在第一极限位置和第二极限位置之间往复运动，其中在所述第一极限位置所述基盘邻近所述曳尾面，在第二极限位置所述基盘相对于所述第一极限位置远离所述曳尾面；和
(c)偏压机构，该偏压机构相对于所述外壳朝向所述第二极限位置推动所述托架，以使所述至少一个形状记忆光学元件变形到至少部分鼓出所述孔，以提供给可调节人工晶状体用于近视的天然正屈光强度，
通过在与上述推动方向相反的方向施加外力到所述基盘，所述托架被驱动到所述第一极限位置，以使至少一个形状记忆光学元件回复到其天然形状，以降低可调节人工晶状体的用于远视的天然正屈光强度。
2.如权利要求1所述的可调节人工晶状体，其特征在于，其中所述偏压机构布置在所述曳尾面和所述基盘之间。
3.如权利要求2所述的可调节人工晶状体，其特征在于，其中所述偏压机构是压缩弹簧。
4.如权利要求1至3任一项所述的可调节人工晶状体，其特征在于，其中所述孔隙透镜具有在大约+10至大约+30的范围内的屈光强度，以用于基本视力矫正。
5.如权利要求1至4任一项所述的可调节人工晶状体，其特征在于，其中所述基盘是环形。
6.如权利要求1至5任一项所述的可调节人工晶状体，其特征在于，其中所述孔隙透镜处于所述引导面的侧向。
7.如权利要求1至6任一项所述的可调节人工晶状体，其特征在于，其中所述托架安装在所述外壳的外部。
8.如权利要求1至7任一项所述的可调节人工晶状体，其特征在于，其中所述至少一个形状记忆光学元件具有天然的类似碟形。
9.一种用于植入人眼的可调节人工晶状体(AIOL)组件，该人眼包含睫状沟和通过从收缩状态变成张驰状态在前部方向推动囊膈膜的睫状体，其特征在于，所述可调节人工晶状体组件包含：
(a)用于在人眼睫状沟至少两个空间上分离的固定定位点自定位植入可调节人工晶状体组件的固定眼内镜片系统；和
(b)如权利要求1至8中任一项所述的可调节人工晶状体，其中所述人眼囊膈膜通过其睫状体的张驰从反向施加所述外力到所述基盘。
10..如权利要求9所述的可调节人工晶状体组件，其特征在于，其中所述固定眼内镜片系统具有沿其纵轴的轴长度为L1的主体，且所述可调节人工晶状体的外壳沿其纵轴的轴长度为L2(L2＞L1)，这样所述主体能沿大于所述主体轴长度的调节行程夹紧所述可调节人工晶状体的外壳。
11.如权利要求9所述的可调节人工晶状体，其特征在于，其中所述固定眼内镜片系统包括可塑性变形的固定眼内镜片机构。
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CN110868961A (zh) * 2017-07-17 2020-03-06 威里利生命科学有限责任公司 具有弯液面的适应人工晶状体

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US20070244561A1 (en) 2007-10-18
CA2580142A1 (en) 2006-04-20
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AU2005293142B2 (en) 2010-09-02
AU2005293142A1 (en) 2006-04-20

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