CN101938956B - 一种用于晶状体输送系统的盒 - Google Patents
一种用于晶状体输送系统的盒 Download PDFInfo
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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
- A61F2/1662—Instruments for inserting intraocular lenses into the eye
- A61F2/1664—Instruments for inserting intraocular lenses into the eye for manual insertion during surgery, e.g. forceps-like instruments
Abstract
一种用于IOL输送系统的盒(10),其注射尖端(12)的几何形状被设计成减小IOL插入眼睛时在切口伤口边缘处产生的应力。
Description
根据USC第35条第119款,本申请要求于2008年2月7日提交的申请序列号为61/026,805美国临时申请的优先权。
技术领域
本发明涉及人工晶状体(IOLs),更具体地涉及与将IOLs注入眼睛的设备一起使用的盒。
背景技术
人眼最简单的功能是通过由称为角膜的透明外部传送和折射光线、并进一步借助晶状体将图像聚焦到位于眼睛背部的视网膜上来提供视觉。聚焦的图像质量与很多因素有关,这些因素包括眼睛的大小、形状和长度,以及角膜和晶状体的形状和透明度。
当因外伤、年龄或疾病的缘故导致晶状体的透明度变差时,由于能够传送到视网膜上的光线变少,视觉变差。眼睛晶状体上的这种缺陷在医学上被称作白内障。这种状况的治疗方法是通过外科手术摘除晶状体并植入人工晶状体或IOL。
而早期的IOLs是由硬质塑料(诸如聚甲基丙烯酸甲酯,PMMA)制成的,由硅酮、柔性丙烯酸树脂和水凝胶制成的柔性、可折叠的IOLs由于能够折叠或卷起这些柔性晶状体并经由较小切口将其插入而越来越受欢迎。采用了数种卷起或折叠方法。一种流行的方法是注射盒,其折叠晶状体并提供直径相对小的内腔,通常可以借助软头柱塞通过所述内腔将晶状体推入眼睛。最常用的注射盒设计在第4,681,102号美国专利(Bartell)中示出,其包括分离的、纵向铰接的盒。在第5,494,484号和第5,499,987号美国专利(Bartell)及第5,620,450号美国专利(Eagles等人)中示出了类似设计。为尝试避开第4,681,102号美国专利的权利要求,已调查研究了数种实体盒,参见例如第5,275,604号美国专利(Rheinish等人)和第5,653,715号美国专利(Reich等人)。
现有技术的这些设备旨在经由相对大(约3.0mm或更大)的切口将IOL注入无晶状体的眼睛的眼后房。已经开发出允许经由小很多的切口(2.4mm或更小)实现整个外科手术过程的外科技术和IOLs。这种小切口要求IOL受到非常紧地压缩,并且用在注射盒上的喷嘴具有非常薄的壁。在使用过程中,让受到紧压缩的晶状体穿过壁非常薄的喷嘴常常导致喷嘴裂开。另外,虽然外科医生能够形成尺寸非常特定的切口,但是盒和晶状体的插入和操作频繁压迫切口的壁,从而使切口的尺寸变大并且对周边组织造成外伤。
因此,仍然需要一种能够在减少组织外伤的情况下经由相对小的切口注入IOL的人工晶状体注射盒。
发明内容
本发明通过提供一种用于IOL输送系统的盒来改善现有技术,其中盒的注射尖端几何形状被设计成减小将盒尖端穿过伤口时作用于切口上的应力,从而减小盒尖端插入过程中撕裂或过度拉伸伤口的可能性,以及在将晶状体输送到眼睛中时滞留在伤口中的时间。
因此,本发明的目标是提供一种用于晶状体输送系统的盒,所述盒的注射尖端几何形状被设计成减小伤口上的应力。
本发明的另一目标是提供一种减小插入后对伤口的外伤的用于晶状体输送系统的盒。
通过参考附图和下面对附图及权利要求的描述,本发明的其它目标、特征和优点将变得显而易见。
附图说明
图1是比较圆、椭圆和直线的弧长的图;
图2是说明各种尖端尺寸下的理论切口尺寸的图;
图3是本发明的晶状体输送系统盒的放大透视图。
图4示出了选择拐点处的过渡半径的一个实例。
具体实施方式
本发明涉及具有尖端12的盒10,尖端12的几何形状被设计成减小IOL插入眼睛时产生的应力。虽然可以使用任意尺寸的切口,但以下讨论中的尺寸是在眼睛切口或伤口为2.0mm的情况下给出的。
将盒尖端12穿过切口伤口的动作在伤口边缘处产生应力,其会引起切口的外伤和撕裂。发明人已发现在伤口的应力程度与盒尖端的几何形状之间存在关联。基于这种发现,发明人确定能够将切口或伤口建模成大体具有长轴约2.0mm、短轴约0.25mm的椭圆外部尺寸的可变形体。另外,发明人确定当假定尖端12的喷嘴在IOL插入眼睛的过程中不发生任何变形并且在伤口上出现任何变形时,盒尖端12喷嘴可建模成刚性体。由于没有真实的组织材料特性可供使用,因此可以利用Arruda-Boyce材料模型为伤口组织的材料特性建模。假定尖端12的喷嘴的面积大于伤口的面积,发明人向伤口内部施加理论负载以将伤口“拉伸”至足够大以允许喷嘴尖端12进入。通过降低理论负载直至内部伤口边缘接触尖端12的整个外周面,能够确定剩残余应力、应力、应力分布和接触压力。
本领域技术人员知道:由于高和宽相等,因此圆形或圆的盒尖端的纵横比为1。然而,如图1所示,当通过缩短高度来减小纵横比时,弧长发生变化,其通过减小伤口边缘处的应力而起到减小伤口拉伸程度的作用。本领域技术人员还知道:连接高和宽的直线形成这些点之间的最短距离,并且代表在不形成负弧的情况下相对于施加在伤口上的应力可能的最短“弧”长。不希望出现负弧,因为在使用负弧或非曲面几何形状时,晶状体会受到损伤或发生不希望的折叠。
代表注射尖端12几何形状的椭圆的横截面形式可以用椭圆形状系数来分析。这个形状系数’ε’可以在尖端尺寸从3.0mm以及更小开始变化时保持不变以维持相同形式。通过改变其他参数值,维持该形式,同时减小周边和最终的理论切口尺寸,如下表1和图2所示。
下面从椭圆方程开始进一步讨论形状系数ε(也称作偏心率)。平行于坐标轴的平面上的椭圆横截面形成椭圆。通常,该二维椭圆可以用下列方程表示:
其中,h、k代表椭圆中心,’a’为长轴,’b’为短轴。椭圆形状可以用其偏心率ε来表示,所述ε被定义为:
其中0<ε<1。ε值越大则表示a/b值越大,椭圆会越细长。另外,在给定偏心率值的情况下,如果知道参数’a’或’b’,则利用该方程能够轻易地计算出另一参数。整体而言,要注意:参数’a’和’b’受下列方程限制:
c2=a2-b2
其中’(±c,0)’代表椭圆的焦点。要注意:椭圆横截面被修正成椭圆中心不一定在原点上,而是可以移动。然而,当位于象限I中的椭圆部分围绕x轴旋转时,椭圆的偏心留下拐点(尖锐特征)。为使该点平滑,利用过渡半径来使x轴交点的切线处于90度。偏心椭圆及过渡半径这两个特征形成经修正的椭圆构造的横截面。
上述椭圆方程的可选形式可以表达成:
Ax2+Bxy+Cy2+Dx+Ey+F=0
其中B2<4AC,且所有系数均为实数。可以通过配方并获得表现椭圆中心及长、短轴长度的形式将该方程转变成第一方程。
利用上述指导,能够计算出这些参数。象限I中的椭圆曲线与普通椭圆相符,且发现(h,k)=(0.0,-0.13),(a,b)=(0.95,0.72)。偏心率ε然后被计算出为0.65。在该偏心率下,如果椭圆的两个轴向尺寸之一发生变化,则可以利用上述方程计算出另一尺寸。一般而言,拐点的过渡半径可被选择为与上、下曲线均相切且在x轴交点上有90度切线的可能的最小圆,诸如图4的圆100。
在下表1中能够看到上述确定的最小弧长、纵横比及过渡半径的应用示例,在表1中示出了各个变量的典型值。表1将典型的修正椭圆值定义成切口尺寸的函数。1.0、2.0和3.0mm的切口尺寸被用于举例说明弧长宽度和椭圆偏心率保持不变时的关系。在盒尖端设计中使用这些数值可以在最小弧长下获得最大内部体积,其共同使得切口伤口边缘上的应力明显变小,同时使晶状体的压缩度及最终的晶状体注射作用力最小。
表1:作为切口尺寸的函数的修正椭圆典型尺寸
上述步骤得到一种用于盒尖端12的设计,其在最小弧长下提供最大内部体积。这种组合导致切口伤口边缘上的应力明显变小,同时使晶状体的压缩度及最终的晶状体注射作用力最小。本文所描述的发明提供注射盒10或喷嘴尖端12的形状,其借助减小的纵横比和弧长使得将盒尖端12穿过伤口所需要的作用力变小。另外,这种曲线形式有利于通过消除尖锐的外部和内部特征或过渡点减少伤口外伤和晶状体受损的可能性。
虽然在上面已经描述了本发明的某些实施例,但这些描述只是用于说明和解释的目的。可以改进、改变、修改和偏离上述系统和方法,而不脱离本发明的范围或精神。
Claims (3)
1.一种用于人工晶状体输送系统的盒,其包括:
主体,以及
管状喷嘴,其连接至所述主体且远离所述主体地伸出,所述喷嘴具有一横截面,所述横截面由下列线条限定:
一椭圆的位于笛卡尔坐标系统的第一象限和第二象限中的一部分,该椭圆的中心偏离笛卡尔坐标系统的原点且位于所述原点的正下方,所述椭圆的所述一部分限定了第一曲线;
第二曲线,所述第二曲线是通过使所述第一曲线绕笛卡尔坐标系统的横坐标轴旋转而形成的所述第一曲线的镜像曲线而限定的,所述第一曲线和第二曲线在第一曲线和第二曲线与笛卡尔坐标系统的横坐标轴相交的位置处形成第一拐点和第二拐点;
在靠近所述第一拐点和第二拐点处形成的两个圆弧,所述两个圆弧中的每个圆弧是连接所述第一曲线和第二曲线的圆的一部分,所述圆与第一曲线和第二曲线相切,并且所述圆弧在与所述横坐标轴交叉的位置处的切线处于90度。
2.如权利要求1所述的盒,其中,所述横截面的椭圆偏心率是0.65。
3.如权利要求1所述的盒,其中,在所述两个圆弧与所述横坐标轴相交的位置之间沿着所述横坐标轴的距离限定了所述横截面的宽度;
所述横截面的第一段包括:所述两个圆弧中的一个圆弧的从所述横坐标轴到所述第一曲线的那一部分、所述两个圆弧中的另一个圆弧的从所述第一曲线到所述横坐标轴的那一部分、所述第一曲线的在所述两个圆弧之间的部分;所述横截面的所述第一段的长度限定了弧长;
所述弧长与所述宽度的比值是1.386。
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US2680508P | 2008-02-07 | 2008-02-07 | |
US61/026,805 | 2008-02-07 | ||
PCT/US2009/033401 WO2009100337A1 (en) | 2008-02-07 | 2009-02-06 | Lens delivery system cartridge |
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CN101938956B true CN101938956B (zh) | 2013-12-18 |
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US (1) | US8894664B2 (zh) |
EP (1) | EP2254509B1 (zh) |
JP (1) | JP5204247B2 (zh) |
KR (1) | KR101264267B1 (zh) |
CN (1) | CN101938956B (zh) |
AU (1) | AU2009212211B2 (zh) |
BR (1) | BRPI0907725B8 (zh) |
CA (1) | CA2712972C (zh) |
ES (1) | ES2566542T3 (zh) |
IL (1) | IL207163A (zh) |
MX (1) | MX2010008552A (zh) |
NZ (1) | NZ586950A (zh) |
RU (1) | RU2470612C2 (zh) |
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- 2009-02-06 WO PCT/US2009/033401 patent/WO2009100337A1/en active Application Filing
- 2009-02-06 CN CN2009801044127A patent/CN101938956B/zh active Active
- 2009-02-06 KR KR1020107019706A patent/KR101264267B1/ko active IP Right Grant
-
2010
- 2010-07-22 IL IL207163A patent/IL207163A/en not_active IP Right Cessation
- 2010-07-28 ZA ZA2010/05386A patent/ZA201005386B/en unknown
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US6605093B1 (en) * | 1997-10-24 | 2003-08-12 | Tekia, Inc. | Device and method for use with an ophthalmologic insertor apparatus |
EP1075826A2 (de) * | 1999-08-10 | 2001-02-14 | Aixmed Gesellschaft für Medizintechnik mbH | Vorrichtung zur Faltung und Implantation einer Intraokularlinse oder Intracorneallinse |
FR2820633A1 (fr) * | 2001-02-13 | 2002-08-16 | Biotech | Dispositif et procede d'injection de lentille intraoculaire |
Also Published As
Publication number | Publication date |
---|---|
BRPI0907725B1 (pt) | 2019-12-24 |
RU2470612C2 (ru) | 2012-12-27 |
CA2712972A1 (en) | 2009-08-13 |
NZ586950A (en) | 2013-01-25 |
KR20100112639A (ko) | 2010-10-19 |
AU2009212211B2 (en) | 2013-03-14 |
CA2712972C (en) | 2013-05-28 |
BRPI0907725B8 (pt) | 2023-04-04 |
EP2254509A1 (en) | 2010-12-01 |
AU2009212211A1 (en) | 2009-08-13 |
IL207163A (en) | 2012-07-31 |
IL207163A0 (en) | 2010-12-30 |
ZA201005386B (en) | 2011-11-30 |
RU2010137103A (ru) | 2012-03-20 |
BRPI0907725A2 (pt) | 2017-06-13 |
US20090204123A1 (en) | 2009-08-13 |
MX2010008552A (es) | 2010-10-25 |
US8894664B2 (en) | 2014-11-25 |
JP2011511672A (ja) | 2011-04-14 |
CN101938956A (zh) | 2011-01-05 |
JP5204247B2 (ja) | 2013-06-05 |
ES2566542T3 (es) | 2016-04-13 |
WO2009100337A1 (en) | 2009-08-13 |
KR101264267B1 (ko) | 2013-05-22 |
EP2254509B1 (en) | 2016-01-06 |
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