CN100404003C - 眼内透镜 - Google Patents
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- 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
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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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
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Abstract
一种眼内透镜,包括一个光学部(1)以及一个或多个触觉部(3a,3b),其中所述的一个触觉部或所述多个触觉部中的每一个(3a,3b)能够在所述透镜平面内被压缩,另外还包括围绕所述光学部(1)的一个环形边(7b),所述环形边(7b)在使用时与后囊膜相接触;并且,所述的一个触觉部或所述多个触觉部中的每一个被如此地弯曲并成型,使得在压缩的第一阶段,所述触觉部的近部被充分地压缩,并在第二阶段,所述触觉部的远部被压缩。
Description
技术领域
本发明涉及一种眼内透镜,它在使用时抑制后囊膜(或晶状体囊后部)混浊。
背景技术
后囊膜混浊(PCO)是长期以来白内障手术的常见并发症。在白内障手术过程中,晶体的中央前囊膜(或晶状体囊前部)被摘除,用一个人造眼内透镜代替天然晶状体。晶状体后囊膜保持不动。手术之后,天然晶状体的活的上皮细胞继续位于晶状体囊的赤道线内。这些细胞能够迁移通过后囊膜的内表面,造成后囊膜混浊。这种影响,即PCO,类似于白内障,为此有时它被称作“继发白内障”。PCO是和年龄有关的,常常在儿童中而不是成人中出现。
对PCO的标准治疗是钕:钇-铝-石榴石(Nd-YAG)激光后晶状体切开术。应用激光以便在后囊膜的中央形成一个开口,从而产生一个用于光线到达视网膜的无障碍区域。虽然该过程是非侵害性的,但是会产生诸如视网膜脱落以及晶状体损伤等并发症。
欧洲专利EP-A-0962196描述了一种眼内透镜,其中触觉部被如此地成形,使得在压缩的第一阶段,触觉部的近部被充分地压缩;并在第二阶段,触觉部的远部被压缩,以提供一个透镜,它最终能阻止触觉失效。
已经提出了许多用于防止PCO的透镜,但是总体来说对PCO的减少微乎其微。仍然需要一种能够有效减少PCO的眼内透镜。
发明内容
本发明的眼内透镜包括一个光学部和一个或多个触觉部,其中所述的一个触觉部或所述多个触觉部中的每一个在所述透镜平面内被压缩,所述眼内透镜还包括围绕所述光学部的一个环形边,所述环形边在使用时与所述后囊膜相接触。环形边优选地位于透镜的前面和后面上;由于医生不需要区分两个表面,所以便于塞入透镜。
环形边的厚度(即深度)优选地在接近所述的一个触觉部或所述多个触觉部中的每一个的一个区域是最大的。这就使得更容易折叠透镜并通过一个较小的切口而塞入透镜。环形边厚度的变化优选是逐渐的。
优选地,所述的一个触觉部或所述多个触觉部中的每一个是如此地弯曲和成形,使得在压缩的第一阶段,所述触觉部的近部被充分地压缩,并在第二阶段,所述触觉部的远部被压缩。这种两阶段压缩已经被显示在维持环形边和囊膜之间的接触方面是特别有效的。
本发明的透镜在抑制PCO方面是有效的。触觉部压缩使得能维持光学部的边与后房之间的接触,因此防止上皮细胞迁移进入晶状体的后区。
附图说明
图1为本发明的眼内透镜的平面图;
图2A-2C为眼内透镜的侧视图,其中图2A-2B应用了本发明;
图3A、3B分别是本发明的透镜的顶视图和剖视侧视图,其中所述环形边的厚度在光学部与触觉部相结合的区域是最大的;
图4A-4D是本发明的四种透镜的剖视侧视图,每种透镜在前面和后面上均具有一个环形边;每种透镜具有一个相对于其他透镜的几何形状不同的边;
图5A-5D类似于图4A-4D,除了这些透镜仅仅包括一个位于后面上的环形边以外;
图6A、6B是本发明的两种透镜的“展开”视图,即它们示出了完整的光学部边缘。还示出了本发明的透镜的顶视图,以清楚地显示“展开”视图与光学部圆周相对应的位置。
具体实施方式
所述环形边的尺寸优选地最小化,以允许所述光学部能够尽可能地大。眼内透镜通常使用一个喷射器而塞入眼睛内。在这种情况下,本发明的透镜必须能够经受得住喷射力。
本发明的透镜包括一个负和/或正放大率的光学部。通常的负放大率为-10到-1屈光度,但并不限制于此。通常的正放大率为+1到+34屈光度,但并不限制于此。
由于环形边的形状/尺寸与光学部的放大率成比例,所以可以用数学方法表示这种关系。这就使得环形边的尺寸能够通过确定病人的光放大率而被简单地计算。
现在参照附图中的例子来描述本发明的实施例。
图1示出了一种具有光学部1的眼内透镜,它包括凸面(示出了后面2b)以及触觉部3a、3b。每个触觉部包括一个分别是4a、4b的孔。示出了每个孔的相对部位:5a和6a、5b和6b。
这些特征是这样的:使得触觉部的最初压缩导致所述孔的相对壁相接合,使得相对部位5a和6a、以及5b和6b相接触,从而确定出一个被完全压缩的近部以及一个经受进一步压缩的远部。这种进一步压缩使得每个触觉部的远端大致与光学部的外围相接触,从而形成一个大致为椭圆的平面形状。
在光学部的每个前、后面上,所述透镜分别包括一个环形边;后环形边7b被示出。光学部的后面8b的外围也被示出。
触觉部将囊膜紧密地保持在后环形边上,从而防止上皮细胞移至光学部区域,这就抑制了PCO的发作。
图2A和2B示出了本发明的透镜,每个透镜包括一个具有前面2a和后面2b的双凸光学部1。所述透镜包括可压缩的触觉部3a、3b以及环形边4a、4b。在每种情况下,后囊膜5压缩触觉部,使得后环形边4b与后囊膜紧密接触。图2A中的透镜比图2B中的透镜具有更高的放大率,并需要更厚的环形边,这是由于双凸光学部更宽。
图2C示出了一种传统的平面触觉型PCO阻滞透镜,代替包括环形边,与触觉部相接触的光学部的边缘表面6a和6b实际成锥形。由于在后囊膜与透镜边之间仍然存在间隙,所以锥形边缘不能阻止细胞的迁移。细胞会迁移通过该间隙,从而造成PCO。
图3A、3B示出了与图1类似的一种透镜,除了在与触觉部相结合的光学部区域环形边的厚度是最大的以外。
图4A-4D示出了适用于本发明的一系列边缘几何形状。相对于后囊膜示出了这些透镜。每个透镜有一个不同的边缘几何形状。尤其参考图4D中的透镜,其中边缘和触觉部被有效地用作一个整体单元,几乎抵靠着后囊膜。
图5A-5D示出了与图4A-4D类似的边缘几何形状,除了每个透镜仅仅包括位于后面上的一个边缘以外。
图6A和6B是本发明的两种透镜的光学部边缘的”展开”视图。一般而言,在90°和270°的位置减小光学部的宽度是适宜的(如图6A和6B所示),这是由于厚的光学部边缘的一个公知负效应是增加了由内反射而引起的眩光。
图6A示出了本发明的一种透镜,其中光学部的边缘突然地由厚变薄。这种突然变化是不理想的,这是由于来自玻璃体的轻微压力不足以使后囊膜进入诸如由角度B表示的“角”区。
图6B示出了本发明的一个优选实施例,其中边缘厚度逐渐地改变,使得在屏障与囊膜之间有完整的(即360°)密封,从而大大地减少了任何边缘眩光效应。角度A优选地小于15°。
下面的例子说明了本发明。
例子
进行实验以比较使用公知的眼内透镜“A”(570H CenterflexTM透镜,Rayner眼内透镜有限公司)与使用本发明的透镜“B”(570C)所产生的PCO程度。基本上,透镜B与透镜A相同,除了透镜B包括一个环形边以外。
进行本研究的所有透镜均具有一个光学体,其直径为5.75毫米,折射率为+21D。每种类型使用5个眼内透镜(IOL)。由同一个医生将这些透镜以任意的方式植入。
使用重量为2.4-3.0千克的荷兰产花色兔。每个动物准备外科手术,在15分钟内,每隔5分钟用1%的盐酸环戊通和2.5%的苯肾上腺素滴剂局部地滴眼睛,进行瞳孔放大。将盐酸克他命(50mg/kg)和甲苯噻嗪(7mg/kg)以7∶1混合来进行肌肉注射,从而获得麻醉。在手术开始之前,在每只眼睛内还滴入一滴外用盐酸丙美卡因麻醉剂。围绕眼睛的区域盖上消毒帷帘,并放置一个眼睑镜以收缩眼睑。
应用消毒技术以及一个蔡斯外科显微镜,形成一个穹基结膜瓣。然后应用一个海狸刀片得到一个局部厚3.2-毫米的缘切口,并到达前房。1毫升的肝磷脂(10,000单位/毫升)被注射进入所述前房,然后注射一种粘弹性材料(Amvisc PlusTM,Bausch & Lomb)。使用撕囊术镊子以形成连续的曲线形晶状体切口,其直径大约为4.5至5.0毫米。晶状体手柄件(Alcon Coopervison Series 10,000)被插入后房中以去除晶状体核和皮层材料。每500毫升的冲洗溶液中加入0.5毫升的肾上腺素1∶1000和0.5毫升的肝磷脂(10,000美国药典单位/毫升),以加快瞳孔放大并控制发炎。应用囊内技术,使晶状体乳化完全在囊袋内发生。然后利用同样的手柄件去除任何残余的皮层。在晶状体摘除之后,应用粘弹性材料使囊袋膨胀。然后应用制造商推荐的注射装置(Rayner titanium注射器)将IOL插入囊袋内。在抽出粘弹性材料之后,用10.0单丝尼龙缝合线获得伤口的闭合。
手术之后,将抗生素/类固醇混合药膏(新霉素和多粘菌素B硫酸盐,和地塞米松)涂抹在眼睛中。手术后第一周每天四次地将同样的药膏涂在兔子的眼睛内。一周后停止这样做。在手术后的第二周,每个动物每天点四次外用醋酸氢化波尼松眼药水,在手术后第二周之后停止。
在手术后的第一周、第二周和第三周,通过狭缝灯检查对所有的眼睛进行评估并对眼睛的发炎反应进行记分。在每次检查中应用不同特定类别中的一种标准记分方法,包括角膜水肿的评估,以及前房内的细胞和眩光的存在。借助瞳孔完全放大,通过后视对PCO进行评估。
在三周的最终临床检查后,将1.6毫升的7∶1的盐酸克他命和甲苯噻嗪混合物进行肌肉内注射,使动物麻醉,然后静脉内注射1毫升的戊巴比妥钠/苯妥英钠(Delmarva实验室),对动物进行人道性的安乐死。它们的眼球被去核并且放置在10%的中性缓冲福尔马林中达24小时。然后在赤道线的正前方对眼球进行冠状对切。从后面(Miyake-Apple视图)进行总检查和照相,以评价PCO的发展。中央和外围的PCO强度从0-4级记分;见Hansen等人在J.CataractRefract.Surg.14:605-613(1988)中对这种记分方法进行的详细描述。
表1总结了从后视方向(Miyake-Apple)所进行的PCO记分结果。在表1中,OD(眼睛右侧)指的是右眼,OS(眼睛左侧)指的是左眼。在每个眼睛中,中央和外围的PCO记分对于透镜B是低的,对于透镜A是高的。透镜A和B的平均中央PCO记分分别是0.90和0.39。透镜A和B的平均外围PCO记分分别是1.85和0.83。这显示了本发明的透镜更合乎需要。
表1
Claims (7)
1.一种眼内透镜,包括一个光学部和一个或多个触觉部,其特征在于:所述的一个触觉部或所述多个触觉部中的每一个在透镜平面内被压缩,所述透镜还包括围绕所述光学部的一个环形边,所述环形边在使用时与后囊膜相接触;
并且,所述的一个触觉部或所述多个触觉部中的每一个被如此地弯曲并成型,使得在压缩的第一阶段,所述触觉部的近部被充分地压缩,并在第二阶段,所述触觉部的远部被压缩。
2.如权利要求1所述的透镜,其特征在于:在使用时,所述光学部接触所述后囊膜。
3.如权利要求1或2所述的透镜,其特征在于:所述透镜还包括位于所述透镜的前面上的一个环形边。
4.如权利要求1所述的透镜,其特征在于:所述的一个触觉部或所述多个触觉部中的每一个包括一个孔,在压缩的第一阶段,使所述孔的相对壁相接触。
5.如权利要求1或4所述的透镜,其特征在于:每个压缩阶段是连续的,从触觉部的近部向着远部逐渐地达到完全压缩。
6.如权利要求1或2或4所述的透镜,其特征在于:所述环形边的厚度在接近所述的一个触觉部或所述多个触觉部中的每一个的那个区域更大。
7.如权利要求6所述的透镜,其特征在于:所述环形边的厚度逐渐地改变。
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GBGB0217606.3A GB0217606D0 (en) | 2002-07-30 | 2002-07-30 | Intraocular lens |
GB0217606.3 | 2002-07-30 |
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CN1671335A CN1671335A (zh) | 2005-09-21 |
CN100404003C true CN100404003C (zh) | 2008-07-23 |
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US (2) | US20040024454A1 (zh) |
EP (1) | EP1531755B1 (zh) |
JP (1) | JP2005534364A (zh) |
CN (1) | CN100404003C (zh) |
AU (1) | AU2003281756B2 (zh) |
BR (1) | BR0313049B1 (zh) |
CA (1) | CA2493583C (zh) |
CY (1) | CY1113303T1 (zh) |
DK (1) | DK1531755T3 (zh) |
ES (1) | ES2393148T3 (zh) |
GB (1) | GB0217606D0 (zh) |
HK (1) | HK1077492A1 (zh) |
IS (1) | IS2896B (zh) |
PL (1) | PL215164B1 (zh) |
PT (1) | PT1531755E (zh) |
SI (1) | SI1531755T1 (zh) |
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- 2003-07-18 PL PL374100A patent/PL215164B1/pl unknown
- 2003-07-18 BR BRPI0313049-5A patent/BR0313049B1/pt not_active IP Right Cessation
- 2003-07-18 CA CA2493583A patent/CA2493583C/en not_active Expired - Fee Related
- 2003-07-18 CN CNB038181088A patent/CN100404003C/zh not_active Expired - Fee Related
- 2003-07-18 AU AU2003281756A patent/AU2003281756B2/en not_active Ceased
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- 2003-07-18 WO PCT/GB2003/003122 patent/WO2004010895A2/en active IP Right Grant
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- 2003-07-18 JP JP2004523918A patent/JP2005534364A/ja active Pending
- 2003-07-18 DK DK03740824.2T patent/DK1531755T3/da active
- 2003-07-29 US US10/629,272 patent/US20040024454A1/en not_active Abandoned
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- 2005-11-22 HK HK05110569.5A patent/HK1077492A1/xx not_active IP Right Cessation
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WO2004010895A2 (en) | 2004-02-05 |
BR0313049B1 (pt) | 2013-04-24 |
AU2003281756B2 (en) | 2007-08-02 |
EP1531755A2 (en) | 2005-05-25 |
US20060276892A1 (en) | 2006-12-07 |
IS2896B (is) | 2014-09-15 |
PL215164B1 (pl) | 2013-10-31 |
US8419791B2 (en) | 2013-04-16 |
SI1531755T1 (sl) | 2013-03-29 |
CA2493583C (en) | 2014-10-28 |
EP1531755B1 (en) | 2012-09-12 |
WO2004010895A3 (en) | 2004-07-15 |
JP2005534364A (ja) | 2005-11-17 |
PT1531755E (pt) | 2012-10-18 |
BR0313049A (pt) | 2007-07-17 |
PL374100A1 (en) | 2005-09-19 |
AU2003281756A1 (en) | 2004-02-16 |
ES2393148T3 (es) | 2012-12-18 |
CA2493583A1 (en) | 2004-02-05 |
HK1077492A1 (en) | 2006-02-17 |
IS7706A (is) | 2005-02-22 |
GB0217606D0 (en) | 2002-09-11 |
DK1531755T3 (da) | 2012-10-01 |
CY1113303T1 (el) | 2016-04-13 |
ZA200500781B (en) | 2006-07-26 |
CN1671335A (zh) | 2005-09-21 |
US20040024454A1 (en) | 2004-02-05 |
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