CN102215783A - 具有硬质和软质末端的人工晶状体注射系统和方法 - Google Patents
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Abstract
一种将IOL注射到眼睛内的IOL注射器系统和方法引入了硬质和软质柱塞末端晶状体接合表面的益处,同时降低或消除了与其有关的缺点。
Description
技术领域
本发明涉及人工晶状体注射器系统,并且更特别地涉及具有硬质晶状体接合表面和软质晶状体接合表面的人工晶状体(“IOL”)注射器系统,硬质晶状体接合表面用于在柱塞前进的第一阶段期间在注射器本体内推进IOL,而软质晶状体接合表面用于在柱塞前进的第二阶段期间推进IOL,柱塞前进通过将IOL从注射器中挤出并且进入眼睛内而结束。
背景技术
IOL已经众所周知,并且在已知为白内障手术的普通外科手术过程中IOL被用于植入眼睛内以替换眼睛的被取出的自然晶状体。有很多不同类型的IOL可用,并且外科医生根据例如包括患者眼睛的生理学和屈光需要的一个或多个因素选择IOL。IOL被配置有光学部和从光学部延伸的一个或多个襻,所述一个或多个襻用作锚定元件以将IOL正确定位在眼睛内。IOL被植入眼睛内,光学部沿眼睛的视轴线对正。IOL可以植入眼睛内的多个位置,但典型地被定位于自然晶状体被取出的囊袋内。
借助于植入工具例如IOL注射器,IOL被植入眼睛内,IOL注射器包括具有腔和在腔内压缩的柱塞的主体部。IOL被置于腔内并且注射器末端被插入在眼睛上切割的切口内。柱塞被推进,同时柱塞末端的晶状体接合表面接合IOL并将其推出注射器末端推进眼睛内。注射器末端朝向末端开口向内减缩,导致IOL随着其被注射器末端推动进一步床注射器末端而压缩。因为IOL非常脆弱,所以当IOL被推动、压缩并且最后被柱塞从注射器末端推出时可能损坏IOL。阻挡IOL的最大(峰值)推出力(delivery force)发生在注射器末端开口处,例如,注射器末端开口直径典型地小于约3mm。
柱塞末端被设计有晶状体接合表面,用于接合并推动IOL穿过腔并且推出注射器末端开口。现有技术中已经建议了硬质和软质的晶状体接合表面,每个具有它们自身的优点和缺点。例如,具有由硬质材料制成的晶状体接合表面的柱塞末端的益处是提供可靠的且被控制的与IOL接合的接合轮廓,特别是,当IOL在注射器腔内被推进时。但是,由于硬质材料的不能弯曲特性,硬质晶状体接合表面还具有可能损坏IOL的缺点,特别是,在如上所述的末端开口处的峰值推出力点。另一方面,具有由软质材料制成的晶状体接合表面的柱塞末端的益处是在峰值推出力期间晶状体易弯曲,降低了损坏晶状体的危险,但缺点是不能像硬质柱塞末端晶状体接合表面那样提供可靠的且被控制的与IOL的结合轮廓。
因此,需要提供一种用于将IOL注射到眼睛内的改进的注射器系统和方法,同时具有硬质和软质柱塞末端晶状体接合面的益处,降低或消除与其有关的缺点。
发明内容
在一个或多个实施例中,本发明通过提供一种IOL注射器系统而满足了上述需要,该系统包括柱塞组件,其被可滑动地置于延伸至具有开口的注射器末端的注射器本体的腔内。柱塞组件包括第一部件,其包括在其远端具有晶状体接合表面的刚性本体并且包括干涉特征。可压缩套管被可滑动地置于所述第一部件上。柱塞组件还包括第二部件,其具有近端和远端以及在它们之间纵向延伸的中央孔。第一部件被可滑动地置于所述第二部件的中央孔内。第一部件、第二部件和套管被配置成在第一状态下在腔内滑动,在所述第一状态下,所述接合表面被置于所述可压缩套管远侧并且IOL被硬质晶状体接合表面在腔内运送,因此具有如上所述的可靠的且被控制的晶状体接合轮廓的益处。
柱塞组件的第二部件被配置成在第一部件的干涉特征与所述注射器本体的一部分干涉后所述第二部件相对于所述第一部件移动,从而致使所述套管的至少一部分在第一部件上滑动而被定位在晶状体接合表面远侧。当IOL靠近注射器末端时,可压缩套管的至少一部分前进经过第一部件的晶状体接合表面并且推动IOL穿过末端并且推出末端开口。如上所述,当IOL被推动穿过末端开口时传递到IOL上的力达到最大值。利用软质的、可压缩套管将IOL推出末端开口,实现了降低在峰值传递力期间损坏IOL 20的风险。
在一个或多个实施例中,本发明通过提供一种将人工晶状体注射到眼睛内的方法而满足了上述需要,该方法包括下述步骤:提供柱塞组件和包括延伸至注射器末端的腔的注射器本体,所述柱塞组件被置于所述腔内,然后在第一状态下在所述腔内滑动所述柱塞组件,在所述第一状态下,包括硬质晶状体接合表面的第一部件与所述人工晶状体接触,使所述第一部件与所述注射器本体干涉,然后相对于所述第一部件滑动第二部件以相对于所述第一部件移动所述套管从而实现第二状态,在所述第二状态下,所述可压缩套管与所述人工晶状体接触并且IOL晶状体离开所述注射器末端。
附图说明
图1是根据本发明的实施例的IOL注射器系统的透视图;
图2是示出了在柱塞组件前进的第一阶段开始时的柱塞组件的图1的系统的剖视图;
图3是示出了在柱塞组件前进的第一阶段结束时的柱塞组件的图2的视图;
图4是示出了在柱塞组件前进的第二、结束阶段的柱塞组件的图2的视图;
图5A是在图4中在箭头5A的方向上看过去的第二部件28的实施例的平面图;
图5B是在图4中在箭头5A的方向上看过去的第一部件22的实施例的平面图;
图6是第一和第二部件之间的连接(interface)的另一实施例的片段的纵向剖视图;
图7是注射器本体和第一和第二部件之间的连接的另一实施例的放大的、片段的剖视图;以及
图7A是在图7中沿线7A-7A处的片段的剖视图。
具体实施方式
借助于注射器工具例如IOL注射系统10,IOL被外科医生植入眼睛内。注射系统10包括注射器本体12和可滑动地置于注射器本体12的腔16内的柱塞组件14。注射器本体12的腔16延伸至注射器末端18终止于开口18′内,IOL 20可以穿过开口18′并且因此被从注射系统10挤出而进入眼睛内(未示出)。
柱塞组件14包括第一部件22,在其远端22a包括具有晶状体接合表面24的杆。包括晶状体接合表面24的第一部件22被由任何适合的硬质材料制成,例如金属或塑料。在其近端22b被提供有干涉特征26,其目的将在下面解释。
柱塞组件14还包括第二部件28,其具有在远端和近端28a、28b之间纵向延伸的中央孔30以及位于近端28b的指压部32。第一部件22被可滑动地置于第二部件28的中央孔30内,并且第一部件22与其一起大体沿在图1中看到的纵向轴线X-X被可滑动地置于腔16内。用户通过将注射器本体12保持在手指之间并且抵靠在凸缘12a的朝向远端的表面上,将拇指压在指压部32上,柱塞组件14以注射器的方式在注射器本体12内前进。
如图2中所示,在晶状体接合表面24位于套管34远侧的第一状态下,可压缩套管34被可滑动地放置在第一部件22上(例如,通过压入配合)。可压缩套管34可以由将会压缩的任何适当的软质材料制成,例如硅酮弹性体。第二部件远端28a靠近并且邻接可压缩套管34布置。在此第一状态下,第二部件28的指压部32被与第一部件22的干涉特征26分开。
图2至3示出了柱塞组件前进的第一阶段,在图2中,干涉特征26被与注射器本体12分开。如上所述,用户按压指压部32,柱塞组件14在腔16内朝向末端18滑动。可以在第一部件22上提供止挡部23,以防止在柱塞组件14在腔16内前进的过程中套管34在第一部件22上朝向其近端22b滑动。图3示出了柱塞组件前进的第一阶段的结束,其中,第一部件22的干涉特征26邻接注射器本体12,防止了第一部件22在注射器本体12内的进一步滑动。这结束了柱塞组件前进的第一阶段,其中,晶状体接合表面24在腔16内朝向末端18运送IOL 20并且仍位于套管34远侧。
多种结构可以提供干涉特征26和第二部件28之间的连接。在图5A和B中,第二部件28被分成两部分28c和28d,它们分别延伸穿过形成在干涉特征26中的第一和第二开口25a和25b。虽然在图5A和B中指压部32和干涉特征26被示出为矩形,但其他形状当然也是可能的(例如,方形、圆形、椭圆形等)。在图6中,第二部件28包括干涉特征26′延伸通过的纵向延伸槽31。在图7和7A中,如在图5A的实施例中所示的第二部件28被分成两部分28c和28d,并且干涉特征26被形成为第一和第二凸缘26a和26b,它们分别被构造成适于延伸穿过在部分28c和28d之间限定出的纵向延伸开口28e和28f。凸缘26a、26b的长度“L”可以变化,以相对于本体凸缘12a′设置第二部件28的适当停止点。在图7、7A的实施例中,为清楚起见,图中没有示出晶状体接合表面24、套管34和末端18。另外,本体12′在截面图中被示出为圆形,并且干涉特征26a、b在平行于注射器轴线X-X的平面内延伸,但在图1-6的实施例中,本体12是矩形的并且干涉特征26在垂直于注射器轴线X-X的平面内延伸。本领域内的那些技术人员应了解,允许干涉特征26,26′,26a、b与注射器本体12干涉的包括注射器本体以及第一和第二部件22和28之间的滑动连接的注射器零件的其他结构当然也是可能的。
当干涉特征26、26′滑动到与注射器本体12邻接接触时,用户继续按压指压部32,导致第二部件28相对于第一部件22在远端方向上滑动,而由于干涉特征26、26′邻接注射器本体12第一部件22自身被阻止了进一步前进。在图3和4之间发生的柱塞组件前进的第二阶段期间,干涉特征26和指压部32之间的空间封闭,并且第二部件远端28a推动套管34,导致套管34相对于第一部件22在远端方向(朝向注射器末端18)上滑动。当套管34的最远端部分滑动经过晶状体接合表面24时,其与IOL 20接触并且从晶状体接合表面24上脱开IOL 20,并且开始使IOL 20朝着注射器末端开口18′前进。当套管34被推动经过注射器末端18时,由于末端18的向内减缩套管压缩。第二部件28完全前进时,套管34从开口18′挤出IOL20,如在图4中可以看到的。
应了解,在图2和3之间发生的柱塞组件前进的第一阶段期间,IOL20被晶状体接合表面24运送通过腔16,晶状体接合表面24是刚性的并且因此具有可靠的且被控制的晶状体接合轮廓的益处,如上所述地。当干涉特征26、26′邻接注射器本体12,并且第二部件28进一步相对于现在静止的第一部件22前进时,可压缩套管34的至少一部分被致使前进经过晶状体接合表面24,并且因此推动晶状体20穿过末端18并且从开口18′出来。如上所述,当IOL 20被推动通过开口18′时,传递到IOL 20上的力到达最大值。利用软质套管34将IOL 20推出开口18′,还实现了降低在传递到IOL 20上的峰值力期间损坏IOL 20的风险。
因此,提供了一种IOL注射器系统和方法,在柱塞组件前进的第一阶段期间获得了刚性晶状体接合表面的益处,并且在峰值IOL传递力期间在柱塞组件前进的第二或最后阶段期间获得了软质晶状体接合表面的益处。
Claims (9)
1.一种人工晶状体注射器系统,包括:
A)柱塞组件,包括:
a)第一部件,其包括在其远端具有晶状体接合表面的刚性本体并
且包括干涉特征;
b)可压缩套管,其被置于所述第一部件上;
c)第二部件,其具有近端和远端以及在它们之间纵向延伸的中央
孔,所述第一部件被可滑动地置于所述中央孔内;以及
B)注射器本体,其包括延伸至注射器末端的腔,所述柱塞组件被可滑动地置于所述腔内,
所述第一部件和所述套管被配置成在所述接合表面被置于所述可压缩套管远侧的第一状态下在腔内滑动,并且所述第二部件被配置成使得在所述干涉特征与所述注射器本体的一部分干涉后所述第二部件适于相对于所述第一部件移动,从而致使所述套管被置于所述接合表面远侧。
2.根据权利要求1所述的人工晶状体注射器系统,还包括在所述第一部件上设置止挡部,所述套管被设置于所述止挡部远侧并且所述止挡部防止所述套管在所述第一部件上向近侧滑动经过所述止挡部。
3.根据权利要求1所述的人工晶状体注射器系统,其中,所述第二部件包括纵向延伸的槽,所述干涉特征可滑动地延伸经过所述槽。
4.根据权利要求1所述的人工晶状体注射器系统,其中,所述第二部件包括第一和第二部分,它们分别被构造成适于可滑动地延伸穿过形成在所述干涉特征中的第一和第二开口。
5.根据权利要求1所述的人工晶状体注射器系统,其中,所述第二部件包括在它们之间限定出第一和第二纵向延伸开口的第一和第二部分,并且所述干涉特征包括分别被构造成适于可滑动地延伸穿过所述第一和第二纵向延伸开口的第一和第二凸缘。
6.根据权利要求1所述的人工晶状体注射器系统,其中,所述套管被由硅酮弹性体形成。
7.根据权利要求1所述的人工晶状体注射器系统,其中,所述注射器本体包括被配置成与所述干涉特征干涉的凸缘。
8.根据权利要求1所述的人工晶状体注射系统,还包括被置于所述第二部件的近端的指压部。
9.一种将人工晶状体注射到眼睛内的方法,包括下述步骤:
a)提供柱塞组件;
b)提供包括延伸至注射器末端的腔的注射器本体,所述柱塞组件被置于所述腔内;
c)在第一状态下在所述腔内滑动所述柱塞组件,在所述第一状态下,包括硬质晶状体接合表面的第一部件与所述人工晶状体接触;
d)所述第一部件与所述注射器本体干涉;以及
e)相对于所述第一部件滑动第二部件,从而相对于所述第一部件移动所述套管,并且实现第二状态,在所述第二状态下,所述可压缩套管与所述人工晶状体接触并且所述人工晶状体离开所述注射器末端。
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US12/273,715 | 2008-11-19 | ||
US12/273,715 US20100125278A1 (en) | 2008-11-19 | 2008-11-19 | Hard and Soft Tip Intraocular Lens Injector System and Method |
PCT/US2009/065115 WO2010059805A1 (en) | 2008-11-19 | 2009-11-19 | Hard and soft tip intraocular lens injector system and method |
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CN102215783A true CN102215783A (zh) | 2011-10-12 |
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EP (1) | EP2346441B1 (zh) |
JP (1) | JP2012509154A (zh) |
KR (1) | KR20110102341A (zh) |
CN (1) | CN102215783A (zh) |
CA (1) | CA2742860A1 (zh) |
ES (1) | ES2402759T3 (zh) |
WO (1) | WO2010059805A1 (zh) |
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KR20110102341A (ko) | 2011-09-16 |
WO2010059805A1 (en) | 2010-05-27 |
JP2012509154A (ja) | 2012-04-19 |
EP2346441B1 (en) | 2013-03-27 |
ES2402759T3 (es) | 2013-05-08 |
CA2742860A1 (en) | 2010-05-27 |
EP2346441A1 (en) | 2011-07-27 |
US20100125278A1 (en) | 2010-05-20 |
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