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CN1622793A - 人造椎间盘 - Google Patents

人造椎间盘 Download PDF

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Publication number
CN1622793A
CN1622793A CNA028285107A CN02828510A CN1622793A CN 1622793 A CN1622793 A CN 1622793A CN A028285107 A CNA028285107 A CN A028285107A CN 02828510 A CN02828510 A CN 02828510A CN 1622793 A CN1622793 A CN 1622793A
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CN
China
Prior art keywords
baffle plate
guide rail
cover plate
artificial
intervertebral disc
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Granted
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CNA028285107A
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English (en)
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CN100444813C (zh
Inventor
A·凯勒
P·C·麦卡菲
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Priority claimed from EP02005630A external-priority patent/EP1344506A1/de
Priority claimed from EP02005631A external-priority patent/EP1344507A1/de
Priority claimed from EP02005632A external-priority patent/EP1344508B1/de
Application filed by Waldemar Link GmbH and Co KG filed Critical Waldemar Link GmbH and Co KG
Publication of CN1622793A publication Critical patent/CN1622793A/zh
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Public Health (AREA)
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  • Prostheses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

人造椎间盘，特别适用于颈椎，是由一个和第一椎体连接的第一盖板(1)，一个和第二椎体连接的第二盖板(2)以及一个人造髓核(10)组成，其与第二盖板(2)组成关节。人造髓核(10)保持在第一盖板(1)的底座(9，5)中，底座形成导轨装置(7，11，12)。人造髓核(10)相对于第一盖板(1)从腹侧向内推入其中。在第一盖板的腹侧端有一挡板(14)。该挡板能在滑动导轨(18)中从一个阻挡位置到一个非阻挡位置之间运动。

Description

人造椎间盘
技术领域
人造椎间盘用于替代椎间盘。人造椎间盘由二个盖板和一个关节装置组成，两个盖板的外面用于连接相邻的椎体，关节装置位于两盖板之间。已知的人造椎间盘(WO 01/01893，FR-A-2718635)的上盖板的内边为凹球形关节面，其与聚乙烯做成的人造髓核上边的凸球面共同组成关节。人造髓核的平坦底面和棱边位于合适的底座中，该底座是下盖板的一部分。底座由一个平坦的底面和在其三边(两边和背面)围着高出的棱边组成。其在AP方向的两棱边基本上为内凹边框，其与人造髓核凸出的框及槽互补地相配合。下盖板腹侧端是敞开的，人造髓核就能像抽屉样在AP方向移动推入盖板的棱边中。在推入状态盖板和人造髓核的凸出框及槽共同作用下，人造髓核不会向上脱出。特别是当弯向背侧，盖板伸展时，人造髓核不会远离规定位置而压向背侧脊髓。
背景技术
在已知的人造椎间盘(EP-B-471821，US-A-5425773)中，下盖板腹侧边是封闭的。其缺点是，当装好盖板后不能在其中插入人造髓核，下盖板也不能阻止人造髓核向上脱出。本发明与该人造椎间盘相比，下盖板的底座由一个腹侧开放的移动导轨构成，允许人造髓核在植入盖板后，能插入其中。
为了使人造髓核不从底座腹侧脱出，在已知的人造椎间盘(FR-A-2718635，WO 01/01893)中，有一个制动挡块，是由人造髓核的下边和底座的底面的凸台和凹槽共同组成。为了在人造髓核推入底座达到相互啮合，底座必须是由弹性的塑料做成，在锁紧前该元件能有弹性变形。这有其缺点，原则上该锁紧并不可靠，因为人造髓核的相应弹性变形，可重新松开。为了提高制动可靠性，人们可以要求将人造髓核有一个尽可能大的抗变形性能。这样就使得动手术者难于将人造髓核推入底座。动手术者看不到的偶然原因，制动元件可能发生没有或不完全到达锁紧位置，例如因锁紧槽中有共物或者人造髓核因为偶然的阻碍不能完全推入底座中。
发明内容
本发明的任务是创造一个人造椎间盘，其髓核可靠地保持在人造椎间盘中，同时在动手术时不会造成困难。
本发明的解决方案见权利要求1的特征组合。
为了使人造髓核能在AP移动方向推入底座，底座在AP方向做成导轨装置。其由侧边相互平行的导轨组成，使得人造髓核保持在其中，并且仅能在AP方向移动。在此，导轨最好内凹的，可与人造髓核内凹的条框共同啮合。这样就能阻止人造髓核从保持它的盖板中向上取出。其优点是，限止人造髓核移动的装置不需要很高，所以也不会产生妨碍盖板之间的相对运动的危险。为了使人造髓核不在背侧或腹侧从导轨范围内滑脱，备有相应的止挡。背侧的运动止挡最好与盖板的底座(即导轨)刚性连接。腹侧的运动止挡可从阻挡位置移开，是为了在植入盖板后，能容易地将人造髓核插入。最后，止挡固定在阻止人造髓核脱出的位置处。
在盖板底座的腹侧边为一滑动导轨，止挡可在其中移动至阻挡位置或不阻挡位置。这样就创造了条件，让动手术者知道止挡是否已在阻挡位置。因此保证止挡到达阻挡位置。
一个最佳实施例，滑动导轨是由垂直于导轨装置的导轨缝隙组成，其容纳做成挡板的止挡。
例如，导轨缝隙有一个横穿过盖板伸出面的导轨方向，也就是挡板在阻挡位置，其一部分插入缝隙，保持在其中，另一部分伸出底座的底面，为了将人造髓核牢固地保持在底座中。在不阻挡位置，挡板在缝隙中下滑至底座的底面以下或者整个从上或从下取出。
此外，导轨缝隙还可有一个平行于第一盖板的伸出面，且垂直于AP方向的导轨方向。在这种情况下，挡板从侧面推入导轨缝隙，到达阻挡位置。
在每一个实施例中应用安全装置，将挡板固定在阻挡位置。一个特别可靠的安全装置是用固定螺钉横穿过挡板来固定，只有事先旋掉螺钉后，才能将挡板移开安全位置。为了这个目的，导轨缝隙至少有一个横穿过的螺孔，以及挡板有一个在阻挡位置时与其同轴的螺孔。本实施例，当导轨缝隙位于具有底座的盖板的腹侧固定凸缘中时特别有利。
另一个阻止挡板从导轨缝隙中脱出的安全装置，其人造髓核的一部分遮盖已插入导轨缝隙的挡板。人造髓核的遮盖部分为一缝隙，当人造髓核到达底座中规定位置时，该缝隙与导轨缝隙对准。盖板的导轨缝隙和对准的人造髓核缝隙组成容纳挡板的空间，挡板可容易地从侧面插入其中。
另一个可能采用的安全装置实施例，挡板在阻挡位置时，在导轨缝隙方向有一个伸出导轨缝隙容易折弯的安全凸耳。动手术者将挡板插入后，再将凸耳折弯，凸耳就不在挡的平面上，这样，挡板不可能从导轨缝隙中往回运动。
本发明挡板的另一个实施例，挡板从未阻挡位置转变为阻挡位置不是靠移动而是靠转动来实现的。在这里，挡板的滑动导轨是由盖板腹侧垂直于AP方向的滑动导轨面和在其上凸出的转动销组成，挡板可转动地支承在其中。挡板有一挡舌，在挡板转动到阻挡位置时，挡舌高出底座的底面，因而阻止人造髓核从底座脱出。在非阻挡位置，挡舌降至底座的底面以下。在支承挡板的滑动导轨面最好形成固定凸缘端面。其在转动销附近至少有一个螺孔。本发明的挡板用螺钉固定在该螺孔中，螺钉经旋入螺孔中的螺钉头将挡板叶片固定。
本发明的止挡不仅仅适用于人造髓核不动地位于底座中，而且特别适用于在AP方向作自由移动。底座的导轨装置不仅用于人造髓核的推入，而且适合在其中运动。这就特别适用于人造颈椎间盘，其人造髓核的关节面基本上延伸至整个盖板。在这种情况下，关节面的曲率半径要小，为了降低椎间盘的高度。这样，人造髓核能在AP方向运动，可使人造椎间盘的前弯性能更接近自然状态。本发明的特点是，在人造椎间盘系统中，一个有AP方向运动的椎间盘与相近的另一个人造髓核与保持它的盖板之间无AP方向运动的人造椎间盘两者有一致的外形。医生有可能在外科手术期间决定在AP方向是否需要运动或不需要。在AP方向可运动的和不可移动的人造椎间盘的盖板形状相同，差别仅在人造髓核上，这是很实用的。但是也可能，人造髓核和与其组成关节的盖板所有类型相同，而产生AP方向运动是由保持人造髓核的盖板来实现。最后也可能所有三部分都相一致，仅仅人造髓核在腹侧AP方向受限位置的不同。
当提及下和上盖板时，不应该理解为用作人造髓核底座的盖板一定必须在下面，也可将该结构反过来选用。因此在权利要求中只一般化地称第一和第二盖板。
附图说明
以下结合附图说明优先采用的实施例。见图示：
图1第一实施例的正剖面；
图2第一实施例的纵向剖面；
图3第一实施例拆开时的立体图；
图4第一实施例的另一方案；
图5第二实施例的纵向剖面；
图6第二实施例拆开时的立体图；
图7第二实施例在挡板转向时的立体图；
图8和9是图10中B和C剖面线的纵向剖面；
图10和11第三实施例的两个透视图；
图12第三实施例的挡板；
图13第四实施例拆开时的立体图；
图14第四实施例的下盖板的另一方案。
具体实施方式
第一实施例的下盖板1和上盖板2有外表面3或4，规定其与所属椎体固定。外表面首选为平面。但还可考虑其它基本上为平坦表面形状，只要有利于将其很好固定在椎骨上。盖板首选由金属做成。
下盖板1面向上盖板2的一面为一平的底面5，其三边呈领子6状镶边，在领子内切口上部构成向内凸出的框7。下盖板1的顶视图呈蛋形或近似长方形。
下盖板1的底面5和领子6构成用作人造髓核10的底座，人造髓核由有利于滑动的材料做成，例如聚乙烯。人造髓核有一个与底面5相匹配的下平面，其边上和背侧围成边条框11，位于其上为一槽12。边条框11与领子6框7下面的内凹部分啮合。框7与槽12啮合。因而保证人造髓核10不会从下盖板1向上脱出。在领子6和下盖板1和人造髓核10的棱之间存在滑动空隙。领子6或框7和边条框11和槽12在下盖板的边8，9范围内的部分相互直线平行。
人造髓核10的顶视图的轮廓形状基本上全部与下盖板1和上盖板2相同。特别是人造髓核遮盖在领子6上面，所以人造髓核顶面的滑动面22的尺寸不小于领子6的尺寸。领子6的高度比人造髓核10的高度小。因为向内凸出的框7和边条框11共同作用，阻挡人造髓核从下盖板1中向上取出，则人造髓核不会从下盖板1和上盖板2组成的空间脱出。
盖板1，2在其腹侧端分别有一个近似直角凸出的凸缘15，16，其上含有可将盖板固定在椎体上的螺孔17。在下盖板1的凸缘15上有一缝隙18，其构成挡板14的滑动导轨，挡板被限止在缝隙中移动。挡板在图2中位于阻挡位置，构成人造髓核10向前运动的止挡。挡板还能向下移动或全部取出，因而人造髓核很容易从下盖板底座腹面放入盖板之间。挡板有两个孔19，在阻挡位置时挡板的孔与螺孔17对准。当螺钉通过螺孔17将下盖板1固定在椎体上时，固定螺钉也通过孔19，就将挡板14固定在阻挡位置。
领子6侧边和框7与人造髓核10的边条框11和槽12组成人造髓核10的导轨装置，人造髓核可从腹侧开口端(图2中右边)在AP方向(图3中所示)推入导轨装置中。衣领6的背侧部分21作为安全止挡，阻止人造髓核在盖板1和2之间的空间中从背侧方向脱出。衣领6和人造髓核棱的内切口部分，仅在下盖板1和人造髓核10的两侧范围8和9构成导轨功能，但是衣领6的背侧部分21不形成导轨功能。
人造髓核10的上边优先采用凸球状的关节面22，具与上盖板2的凹球状的滑动面23组成一个关节。
图2是实施例在装配状态中，人造髓核10在衣领的背侧部分21和腹侧挡板14之间不能活动是固定的。图4所示另一个实施例中，人造髓核10在腹侧处(图4中右边)的下盖板短一些，因此，当人造髓核紧靠背侧时，其腹侧端13与挡板14间形成间隙，在组转状态时，人造髓核10在AP方向可有一个间隙大小的活动空间。当身体向前弯时，在图4中，上盖板2相对于下盖板1在顺时针方向稍些摆动，在伸展时刚相反。当上盖板2正确按滑动面22，23规定方向摆动时，该摆动同时也和一个移动连在一起的，在向前弯时，向前移动(图4中向右)，在伸展时，向后移动(图4中向左)。该向前向后移动的部分可与生理学的情况相矛盾，而产生不希望有的压力。该压力会产生一个反作用力，在本发明人造椎间盘该实施中，该反作用力导致上盖板相对于下盖板作相反方向运动，将不希望有的运动分量平衡了。
人造髓核和盖板之间的导轨装置共同起作用，左侧边方向留有间隙，也允许在该方向有稍些相对运动。
人造颈椎间盘在AP方向的运动间隙尺寸首选一至四毫米，最好是二至三毫米。如果在侧边方向允许有相对运动，其尺寸不能超过二毫米。
上述说明对于第二个实施例来说，除了腹侧的止挡外，其它都适用。盖板1，2在其腹侧端分别有一个直角凸出凸缘15，16，其上含有可将盖板固定在椎体上的螺孔17。在下盖板1凸缘15的两螺孔17中间有一个挡板28，用一个带头销钉29可转动地固定。挡板可在凸缘15的滑动面上转动，因此该面称为滑动导轨面。挡板有两个向两边伸出的叶片30及在其横向伸出的舌31。挡板由弹性金属做成，其叶片30相对于滑动导轨面受预紧压力。挡板含有合适的开口或槽32，为了能插入旋转工具例如螺钉起子。如图6的装配图所示，该挡板位于未超出下盖板的底面5。人造髓核10就能无障碍地被推入由领子6组成的移动导轨中。挡板如图5和7所示旋转180°，舌31伸出底面5，形成一个止挡，其限止人造髓核10在导轨中向腹侧脱出。
在图6所示装配图中，挡板28是在露出装固定螺钉用的螺孔17的位置。如图7所示，叶片30位于安全位置，其全部或部分遮盖3螺孔17，且弹性地压住螺钉头，阻止其从螺孔17中脱落。叶片有孔，在预紧力条件下，该孔卡住在图6中所示螺钉头33的顶部，因此阻止挡板离开安全位置。在用作人造髓核10止挡的挡板28的舌31和与其相对的人造髓核10的面13之间，存在几个毫米的空间(如图7所示)。因此，人造髓核10可在衣领6两侧8，9组成的导轨中沿AP方向运动某一距离(见图4说明)。假如不希望有这个运动间隙，将面13和挡板14之间的自由空间降至零，如图6所示。
上述图1至图3的说明，对于图8至图12的第三个实施例来说，除了腹侧的阻挡外，其它都适用。
顺着下盖板1的腹侧端开一缝40，该缝在图10凸缘15的左半部分从上到下是全通的，以图10中虚线41为界，缝在凸缘15的右半部分是受到限止的。在人造髓核10的底面与缝40相对处开一个与缝40对准的缝42。两个缝40，42用于容纳挡板43，由缝40，42组成的轮廓形状约与要容纳挡板的形状相同。如图10所示，推入人造髓核10后，挡板从一边插入缝40，42中。
挡板43的末端可附有凸耳44，挡板43整个插入缝46，42中后，凸耳可在右边看到(见图M)，将其弯曲能销住挡板。凸缘15上有螺孔17，用它将下盖板1固定在所属的椎体上。在凸缘的左边部分，那里的螺孔17横穿过缝40(见图10)，该处的缝扩展到凸缘15的整个高度，为了容纳挡板左边宽的翼45。宽的挡板翼45也含有螺孔46，当挡板43插入时(图9和11)与那里的螺孔17对准。当在螺孔中旋入固定螺钉后，挡板43不会从安全位置脱出。
螺孔46和凸耳44相互独立地起到安全装置的作用。所以在设计时不要求两者都有。如果有螺孔46，可省掉凸耳44。如果有凸耳，可省掉线47以下的挡板宽翼45以及固定凸缘15缝的相应部分。挡板只需要设计成点划线47(图12)以上部分就足够了。为了使挡板不从缝40，42右边脱出，在这种情况下可在挡板43的左端设计成与凸耳44相似的安全凸耳(图中未示出)。挡板43不会从上面脱出，因为被人造髓核10缝42的那部分遮盖住了。
本发明的第四实施例如图13和14所示，是支承人造髓核10的下盖板1的底座的另一可选实施例。在该实施例中，人造椎间盘有一下盖板51和一上盖板52。下盖板的上底面53是一平面，在其上安放人造髓核54。在前面所述实施例中，人造髓核的导轨是在其外边，在第四实施例中，在人造髓核中有一个带内凹部分58的槽55，其与带相应内凹边58的下盖板的纵向延伸的凸台57共同作用。因此人造髓核54在下盖板51的AP方向(如第一实施例所述)作相对运动。此外，因为内凹部分的相互作用，防止人造髓核从下盖板中向上取出。阻止人造髓核在两盖板之间从腹背侧的止挡未在图中示出。
下盖板51可用如图14中所示的下盖板51a替代，其与下盖板51的区别在于，凸台57a不是在长度方向延伸，而在俯视图上为一圆。可使被其支承的人造髓核54和上盖板52一起绕舌台57a垂直轴旋转，且不妨碍在AP方向运动。
在人造髓核54和上盖板52之间为非球面是受欢迎的。

Claims (15)

1.人造椎间盘，特别适用于颈椎，是由一个和第一椎体连接的第一盖板(1，51)，一个和第二椎体连接的第二盖板(2，52)以及一个人造髓核(10，54)组成，人造髓核与第二盖板(2，52)组成关节，并被保持在第一盖板(1，51)的底座中，底座形成导轨装置(7，11，12，56，57，57a)，人造髓核(10，54)相对于第一盖板(1，51)从腹侧向内推入其中，其特征在于，第一盖板(1，51)的腹侧端有滑动导轨(18，29，40)，一个挡板(14，31，43)能在滑动导轨中从一个阻挡位置到一个非阻挡位置之间运动。
2.如权利要求1的人造椎间盘，其特征在于，具有一个将挡板固定在阻挡位置的装置(19，33，46，44)。
3.如权利要求1或2的人造椎间盘，其特征在于，滑动导轨是由垂直于导轨装置(7，11，12，56，57，57a)的导轨缝隙(18)组成，其容纳做成挡板(14)的止挡。
4.如权利要求3的人造椎间盘，其特征在于，导轨缝隙(18)有一个横穿过第一盖板(1)伸出面的导轨方向(D)，在导轨方向(D)运动的挡板(14)，位于阻挡位置时，其一部分保持在缝隙(18)中，其另一部分伸出第一盖板底面(5)。
5.如权利要求4的人造椎间盘，其特征在于，导轨缝隙(18)至少有一个横穿过的螺孔(17)，以及挡板(14)有一个在阻挡位置时与螺孔(17)对准的螺孔(19)。
6.如权利要求4的人造椎间盘，其特征在于，导轨缝隙(18)位于第一盖板腹侧端的固定凸缘(15)处。
7.如权利要求3的人造椎间盘，其特征在于，导轨缝隙(40)有一个平行于第一盖板(1)的伸出面，且垂直于AP方向的导轨方向(E)，挡板(43)在该方向运动至阻挡位置。
8.如权利要求7的人造椎间盘，其特征在于，人造髓核(10)有一部分遮盖已插入导轨缝隙(40)的挡板(43)，人造髓核阻止挡板(43)在垂直于导轨方向(E)离开导轨缝隙(40)。
9.如权利要求4或8的人造椎间盘，其特征在于，人造髓核有一个缝(42)与导轨缝隙(40)对准，且能容纳挡板(43)的一部分。
10.如权利要求7的人造椎间盘，其特征在于，导轨缝隙(40)至少有一个横穿过的螺孔(17)，以及挡板(43)有一个在阻挡位置时与其对准的螺孔(46)。
11.如权利要求3至10的人造椎间盘，其特征在于，挡板(14，43)在导轨缝隙(18，40)的导轨方向(D，E)有一个容易折弯的安全凸耳(44)。
12.如权利要求1或1的人造椎间盘，其特征在于，挡板(28)的滑动导轨是由盖板(1)腹侧垂直于AP方向(A)的滑动导轨面和在其上凸出的转动销(29)组成，挡板(28)转动地支承在其上，挡板(28)有一挡舌(31)，在挡板(28)转动到阻挡位置时，挡舌高出第一盖板的底面(5)，以及在非阻挡位置时，挡舌降至第一盖板的底面(5)以下。
13.如权利要求12的人造椎间盘，其特征在于，在转动销(30)附近至少有一个螺孔(17)，以及挡板(30)的叶片(30)，在阻挡位置时，用旋入螺孔(17)的螺钉头固定。
14.如权利要求1至13的人造椎间盘，其特征在于，人造髓核(10)的关节面(22)基本上遮盖了整个第一盖板(1)。
15.如权利要求14的人造椎间盘，当止挡在阻挡位置时，人造髓核(10)相对于第一盖板(1)还能在AP方向运动。
CNB028285107A 2002-03-12 2002-10-15 人造椎间盘 Expired - Fee Related CN100444813C (zh)

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EP02005630A EP1344506A1 (de) 2002-03-12 2002-03-12 Zwischenwirbelprothese für die Halswirbelsäule
EP02005631A EP1344507A1 (de) 2002-03-12 2002-03-12 Zwischenwirbelprothese für die Halswirbelsäule
EP02005632A EP1344508B1 (de) 2002-03-12 2002-03-12 Zwischenwirbelprothese, insbesondere für die Halswirbelsäule
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CN105934221A (zh) * 2013-12-18 2016-09-07 索尔科生物医疗株式会社 具有弹力的人工椎间盘
CN105105890A (zh) * 2015-08-31 2015-12-02 北京市春立正达医疗器械股份有限公司 一种颈椎椎间盘假体
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