CN1149059C - 截头圆锥形体内脊骨融接植入物 - Google Patents

截头圆锥形体内脊骨融接植入物 Download PDF

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Publication number
CN1149059C
CN1149059C CNB961955848A CN96195584A CN1149059C CN 1149059 C CN1149059 C CN 1149059C CN B961955848 A CNB961955848 A CN B961955848A CN 96195584 A CN96195584 A CN 96195584A CN 1149059 C CN1149059 C CN 1149059C
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implant
bone
present
spinal fusion
synosteosis
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CNB961955848A
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CN1190881A (zh
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���K�����ж�ɭ
加里·K·米切尔森
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Warsaw Orthopedic Inc
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Individual
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Abstract

本发明针对具有至少是部分截头圆锥状构型的脊骨融接植入物(220，320与420)，它们可以是较为实心或空心的，并可具有表面糙度来促进脊骨向内生长与稳定。上述植入物可以具有从表面延伸到内部的插孔(260)，用以保持融接促进物质和给脊骨向内生长提供定位区域。可以利用各种表面不规则性来提高植入物的稳定性和加大植入物的表面积，同时/或者借此将此脊骨融接植入物推入到融接位置。

Description

截头圆锥形体内脊骨融接植入物
本申请是共同未决美国专利申请系列NO.396414(1995，2，27提交)的部分继续申请，它是美国专利申请系列NO.08/074781(1993，6，10提交)的部分继续申请，后者是美国专利申请系列NO.07/698674(1991，5，10提交)的部分继续申请，而此后者则是美国专利申请系列NO.07/205935(1988，6，13提交)即现在的美国专利NO.5015247分案申请，它们的内容已全综合于此作为参考。
本申请还是1995，2，17提出的，题为人体内脊骨融接植入物的美国专利申请系列NO.08/390131的部分继续申请。
技术领域
本发明一般涉及体内脊骨融接植入物，具体涉及到其构形能在结构上脊柱前凸中恢复和保持两相邻脊骨的脊骨融接植入物。
背景技术
体内脊骨融接是指通过椎间盘空间，即相邻脊骨间通常为椎间盘占据的空间，来实现骨的桥连方法。能简化这种融接的众多植入物已为Cloward、Brantigan与其他人描述过，并且是本项技术中周知的。一般，粒形植入物的优点是，能适应易制备的覆盖椎间盘空间的接受孔并插入到各个相邻脊骨之间。这种孔可用钻头形成。作为解剖学上的事实是，颈椎与腰椎两者通常都是脊柱前凸立即向前凸出的。这种取向对于脊骨的正常功能是重要的。一般，要求由脊骨融接进行治疗的条件都连带要损失脊柱前凸。
于是，需要有能恢复结构上的脊柱前凸的脊骨融接植入物。
本发明针对这样一类体内脊骨融接植入物，它们具有至少是部分截头的圆锥构型以实现所需的脊骨结构上的脊柱前凸。在最佳实施例中，本发明的脊骨融接植入物具有这样的外轨迹，其中至少是此植入物的某些点在基本上是沿着此植入物的与脊柱的相邻脊骨接触的那些部分上包括着部分或全部截头的圆锥形，同时具有一插入端和尾端。
本发明的脊骨融接植入物还可以修改成使其上与下表面是部分的截头圆柱体，同时至少有一侧都可截成与植入物中央纵轴线平行的平面而形成直的壁部。这种植入物在其插入端可有更斜削的外观以利插入。本发明的脊骨融接植入物可以是较为实心的和/或多孔质的和/或空心的，并且具有糙化的表面以促进脊骨向内生长和稳定化。
本发明的脊骨融接植入物具有从表面伸展到植入物材料之间的插孔，用以存放融接促进物质并提供脊骨向内生长的定位区域。这些插孔可以通入或通过植入物同时可以或可以不相交。本发明的脊骨融接植入物可以具有至少一个腔，此腔可经由至少一个孔口与植入物的表面通连。此腔可以具有至少一个入口用来将融接促进物质装载于腔内。此入口可以用盖或类似器件封闭。还可以利用各种各样的表明不规则性来增大植入物的稳定性和植入物的表面面积，以及/或者为了让此脊骨融接植入物易于插入但又能制止其反向运动。本发明的脊骨融接植入物的外部可以全部或部分地具有粗加工的，滚花的，带向前棘爪的或其它足以实现上述目的的表面不规则性。
本发明的脊骨融接植入物提供了显著超过现有技术植入物的优点：
1.由于本发明的脊骨融接植入物至少是部分截头圆锥形的，这些从前边缘到尾边缘斜削的植入物易于引入且易于完全插入待融接的脊骨段内。
2.本发明的植入物的形状同至少要由此植入物作部分更换的，前面通常高于背面而允许作正常脊柱前凸的椎间盘形状一致。本发明的植入物类似地是前面高于后面。
3.本发明的脊骨融接植入物取这样的几何构形，它能够在接受这种植入物的融接现场立即制造出。
本发明的脊骨融接植入物可以由适用于人体植入并具有足以用于脊椎融接目的的机械强度的任何材料制成，包括各种金属如钴、铬、不锈钢或钛及其合金；各种塑料，包括生物可吸收的塑料；以及各种陶瓷；或是能充分达到上述目的前述各类材料的组合。此外，本发明的脊骨融接植入物制造时可以采用实心材料、网状材料、多孔材料和/或可以部分或全部地包括这样的材料，它们可以直接参与脊骨融接过程，或能添加、包括、或是由其处理或涂层的化学物质如骨质物、骨的形态发育蛋白质、取任何形式的羟磷灰石、以及成骨蛋白质，以用来激活脊骨融接过程使它们成为生物活性的。本发明的植入物可以是全部地或部分地可为生物吸收的。
本发明的第一个目的在于提供具有锥形前端易于插入脊骨的脊骨融接植入物。
本发明的第二个目的在于提供高度上从一端到另一端呈与正常椎间盘锥度一致锥度的脊骨融接植入物。
本发明的第三个目的在于提供一种脊骨融接植入物，它能在脊骨融接过程中保持两相邻脊骨的取向和脊柱前凸。
本发明的第四个目的在于提供本身在脊骨内稳定的脊骨融接植入物。
本发明的第五个目的在于提供插入时能使相邻脊骨间具有稳定性的脊骨融接植入物。
本发明的第六个目的在于提供能在参与融接过程时含有融接促进物质或由其组成或为其处理的脊骨融接植入物。
本发明的第七个目的在于提供能在脊骨融接过程中分开和支承相邻脊骨的脊骨融接植入物。
本发明的第八个目的在于提供使用中能始终保持软骨下脊骨有一致厚度的脊骨融接植入物。
本发明的第九个目的在于提供一种脊骨融接植入物，它所具的外形能依随在融接现场易于形成的相辅孔。
本发明的第十个目的在于提供一种截头圆锥形脊骨融接植入物，它可以与横切同一椎间盘空间的第二个一致的植入物并排邻接，使得这两个植入物的组合宽度小于各植入物的高度之和。
本发明提供了一种体内脊骨融接植入物，用于插入人体脊柱两相邻脊骨间穿过椎间盘空间的高度，所述植入物包括：
一体部，其基本上呈截头圆锥状构型，一插入端，一大于所述插入端的尾端，和一外表面适于与各相邻脊骨体接触，所述尾端包括一结合件，用于与所述植入物插入的装置接合，所述外表面有一批孔口，适于使内能够通过所述植入物从相邻脊骨长入相邻脊骨；
所述骨结合件的构形使所述植入物可被推入与脊柱的相邻脊骨接合，所述植入物由适于人体植入的材料制造。
本发明的上述的和其它目的可以通过浏览附图和对附图的详细说明中获得理解。
附图说明
图1是本发明的脊骨融接植入物实施例的侧视图，此植入物具有截头的圆锥形体部以及包括有用来与骨啮合的棘齿的表面结构，同时设有用于使骨向内生长的插孔与通道。
图1A是沿图1的1A线的局部放大图，示明图1中植入物的表面结构。
图2是沿1中植入物的线2-2的横剖图，示明本发明植入物的通道与插孔。
图3是沿图1中植入物的线3-3的横剖图，示明本发明植入物的通道与插孔。
图3A是本发明的脊椎融接植入物另一实施例的侧视图，此植入物具有截头的圆锥形体部以及形成一种柱状外部构型的棘爪联轴节。
图4是本发明的脊椎融接植入物又一实施例的侧视图，此植入物具有切成与其纵轴线平行的平表面的侧面以及一批半径与高度都不固定的棘爪联轴节。
图5是图4所示脊骨融接植入物的顶视平面图。
图6是本发明的脊椎融接植入物再一实施例的侧视图，此植入物具有由纤维质网状材料构成的部分截头圆锥形的体部，它的一侧切开以示明由虚线表示的所邻接的一致的第二个植入物。
图7是图6中植入物的7-7线的剖面图。
图8是沿图6中曲线8放大的局部图，示明图6中植入物的表面结构。
图9是沿图6中曲线8放大的局部图，示明由多孔状材料制的本发明植入物的表面结构的另一实施例。
图10是沿图9中线10-10的横剖图，示明由网状材料制的本发明植入物的表面结构的另一实施例。
图11是本发明的脊骨融接植入物又一实施例经部分切除的侧视图，此植入物具有截头圆锥状的体部以及包括一批相分开的柱件的表面结构。
图12是沿图11中线12-12的放大局部剖面图，示明图11中植入物的表面结构。
具体实施方式
参看图1，其中示明了本发明的脊骨融接植入物，统以以标号220标明。植入物220有截头圆锥状体部222和一条外轨线，此轨线呈基本上沿着植入物220与脊柱的相邻脊骨相接触部分的大致截头圆锥形。植入物220具有向前棘爪联轴节240组成的表面结构，适合与相邻的脊骨接合。这批棘爪联轴节240的每一个都有骨结合边缘242和坡部244。棘爪联轴节240有一个从植入物220中央纵轴线L4起测量的半径R4，后者从插入端224到尾端226渐次增大。棘爪联轴节240相对于体部222所测量的高度则在植入物220的整个长度上不变。棘爪联轴节240的取向使得植入物220的插入较取出容易，这是因为坡部244在相反方向行进时起到倾斜平面的作用，而骨黏合边缘242则抵抗相反方向的运动。这些向前的棘爪联轴节240则驱使植入物朝前，直到不更换的脊骨截止其进一步运动，而形成极其稳定的脊骨与植入物结构。
植入物220的尾端226有凹槽234，用以纳置和配合上用于插入植入物220的装置。凹槽234具有螺纹口236，得以让植入物螺合到用于插入植入物220的装置上。
在此最佳实施例中，联轴节240的骨结合边缘242从植入物220的体部222(根径)起测量的在最高点的高度是在0.25～2.0mm内，而用于颈椎的这一最佳高度是0.4mm，用于腰椎的这一最佳高度是1.25mm。
参看以横剖图示明植入物220的图2与3。植入物220具有经过其内部的通道250和形成于其表面上的插孔260。插孔260可与或不与通道250通连。在植入物220的最佳实施例中，通道250的直径为0.1～6mm，最佳的范围为2～3mm。插孔260的直径为0.1～6mm，最佳范围为1～3mm。虽然图示的通道250与插孔260图示为大致圆形构型，但在本发明的范围内，通道250与插孔260可以具有适用于所需目的的任意尺寸、形状、构型与分布的。
参看图1A，植入物220有一个多孔的外表面238给脊骨提供不规则的内表面以促进骨的向内生长。外表面238还能保持融接促进物质，并提供增大的表面面积来在融接过程与骨结合并提供进一步的稳定性。应知外表面238和/或整个植入物220可以包括在融接过程中足以保持融接促进物质和/或允许脊骨向内生长和/或能与脊骨结合的任何其它多孔材料或糙化表面。植入物220还可涂以生物活化的融接促进物质，包括但不限于羟磷灰石化合物、骨的形态发育蛋白质以及成骨蛋白质。图中所示植入物220为实心的，但应知它也可制成为基本上是空心的或部分空心的。
虽然植入物220图示为实心的，但应知它可以是至少部分空心的，以形成用来保持骨或任何其它融接促进物质的内腔。这种植入物能够设有孔口而允许植入物外的骨能长入此内腔中。这样的结构已详细地公开于共同未决申请系列NO.08/390113与共同未决申请系列NO.08/074781，它们的内容已都综合于此作为参考。
参看图3A，其中示明了统一以标号220′标明的植入物220的另一实施例。植入物220′的构型与植入物220类似，只是其体部222′为截头圆锥形结构，而且棘爪联轴节240′的从中央纵轴线L4量起的半径R3从插入端224′到尾端226′的尺寸不变。各个联轴节240′从体部222′量起的高度在植入物220′的全长上不是常数，而是从插入端224′至尾端220′递降。这样，这些联轴节240′形成了植入物220′的基本上呈圆柱形的外部构型，而体部220′则是截头圆锥形的。植入物220′的插入端可以具有直径较小的锥部223′以利植入物220′的插入。
参看图4与5，其中示明了统一以标号220″标明的植入物220的另一实施例。此植入物220″在构型上与植入物220类似，而所具有的棘爪联轴节240″从中心纵轴线L
Figure C9619558400101
5量起的半径R5则同插入端224″至尾端226″递增。各个联轴节240′从体部222″量起的高度在植入物220″的全长上并非固定的。在此最佳实施例中，联轴节的半径R5与高度的尺寸从插入端224″至尾端226″递增。
如图5所示，植入物220″有平截的边270与272形成两个平表面，径向相对且平行于纵轴线L4。此时可将两个植入物220″并列放置而以各个植入物的边270或272之一接触成，使得相邻脊骨与棘爪联轴节240″间的接触面积最大。另外，植入物220″可以有一平截的边部。
参看图6-8，其中示明了统一以320a表示的本发明的脊骨融接植入物的另一实施例。此植入物320a与以虚线所示第二个一致的植入物320b邻接设置。植入物320a有一个由包括可以是金属绞合索在内的网状材料制成的体部322，上述材料压紧并模制成基本上沿着与相邻脊骨接触植入物320a的那部分的部分截头圆锥形构型。植入物320a有一插入端324和一尾端326，可以全由或部分由实心和/或多孔质和/或网状材料制成，或可以有一个糙化的表面。应知植入物320a可以是实心的或部分空心的且包括着至少一个内腔。如图8所示，上述网状材料包括可以是金属制的铰合索，它们经压紧成形到一起，使得至少是在植入物320a的外表面338中的铰合索之间，存在有一批能保持融接促进物质和允许骨向内生长的间隙。
参看图9与10，植入物320a可以另由多孔质材料350制成类似于人体的松质骨，其中具有孔隙352能使外表面338具有如图9和10所示的构型。由于植入物320a可以完全或部分地由多孔材料350制成，孔隙352可以存在于外表面338和/或整个植入物320a内，以促进骨向内生长和保持骨的融接促进物质。
再来参看图7，植入物320a是部分截头圆锥形的，与植入物20的外形类似，但至少有一边340截成与植入物320的中央纵轴线平行的平表面。此平截边340允许两个植入物320a与320b在并列放置于两相邻脊骨间时紧靠到一起，如美国专利申请系列NO.08/390131所示，其内容已综合于此作为参考。植入物320a可以部分地带有螺纹或者可以类似于这里所述的其它实施例，或者是功能上等效的其它形式。
参看图11，其中以部分切除的侧视图示明了统一以标号420标明的本发明的植入物的又一实施例。植入物420有体部422为截头圆锥形的，基本上沿着植入物420的与相邻脊骨接触的部分，还有插入端424和尾端426。植入物420具有外表面438，能放置和保持脊骨或是其它可参与融接过程和/或可促进骨向内生长的物质。在此最佳实施形式中，表面438包括一批柱件440，它们相分开提供一批间隙442，后者是部分插孔式的，这些不完全的插孔能装盛和保持研碎的骨料或任何合成的促进骨向内生长的物质。植入物420可以用适当加融接促进物质进行灌浆或涂层其表面438。
参看图12，其中示明了植入物420的表面438的放大图。在此最佳实施例中，柱件440具有直径较其余部分大的头部444，而各个间隙442则具有与柱件444相反的构型，其底部446宽于其入口部448。柱件440和间隙442的这种构型有助于将骨料保持于植入物420的表面438上，还有助于将植入物420锁定到由于骨向内生长而形成的骨融接物质中。由于间隙442的底部466处骨向内生长的宽度大于在入口448处的，向内长成的骨就不会从入口448处出去而被锁定于间隙442内。植入物420的表面438提高了表面面积的有效利用量，而通过糙化处理、絮化或以其它方式来形成不光滑的表面则能进一步提高上述效果。
在上述实施例中，柱体440的最大直径范围约为0.1～2mm而高约为0.1～2mm，相互分开约0.1～2mm而使得间隙宽度约为0.1～2mm。在同一植入物内，柱体的尺寸、形状与分布是可以变化的。
尽管业已相对最佳实施例详述了本发明，但应知在不背离本发明的创造性概念的前提下是可以设计出本发明的其它变型的。特别应知，可以将这里在各具体实施例中述及的种种原理以不同的方式综合，使得其中各个特点不限于上述各具体实施例谈到的。
上述各实施例中公开的种种特点及它们的等效内容都可以合并成足以实现本发明前述目的任何组合形式。

Claims (16)

1.体内脊骨融接植入物，用于插入人体脊柱两相邻脊骨体之间穿过椎间盘空间的高度，所述植入物包括：
一体部具有一插入端，一尾端，和一外表面适于与各相邻脊骨体接触，所述尾端包括一结合装置，用于与将所述植入物插入的装置接合，所述外表面有一批孔口，适于使骨能够通过所述植入物从相邻脊骨体长入相邻脊骨体；所述植入物由适于人体植入的材料制造，其特征在于：
所述体部有基本上呈截头圆锥状的构型，所述尾端大于所述插入端，和
骨结合件，所述骨结合件的构形使所述植入物可被推入与脊柱的相邻脊骨体接合。
2.如权利要求1所述的植入物，其特征在于：所述骨结合件的外部轨迹基本形成一截头圆锥状构型。
3.如权利要求1所述的植入物，其特征在于：所述骨结合件的外部轨迹基本形成一圆柱体构型。
4.如权利要求1所述的植入物，其特征在于：所述骨结合件包括一批棘爪联轴节。
5.如权利要求4所述的植入物，其特征在于：所述棘爪联轴节是朝前的。
6.如权利要求1所述的植入物，其特征在于：所述骨结合件包括滚花。
7.如权利要求1所述的植入物，其特征在于：所述植入物有一内腔，和一用于通到所述内腔的入口。
8.如权利要求7所述的植入物，其特征在于：所述植入物有用于关闭所述入口的装置。
9.如权利要求1所述的植入物，其特征在于：所述体部有一中央纵轴线和至少一个平截边，该平截边形成一个与所述中央轴线平行的平表面。
10.如权利要求1所述的植入物，其特征在于：所述植入物具有的构型能并列且准直地与第二个脊骨融接植入物紧邻放置，当所述植入物和所述第二植入物放在一起时，具有的结合全宽度小于所述植入物和所述第二植入物各自最大直径的和。
11.如权利要求1所述的植入物，其特征在于：所述植入物由比骨更结实的材料制成。
12.如权利要求1所述的植入物，其特征在于：所述植入物由不同于骨的人造材料制成。
13.如权利要求12所述的植入物，其特征在于：所述材料为海绵状。
14.如权利要求1所述的植入物，其特征在于：所述植入物至少部分为生物可吸收的。
15.如权利要求1所述的植入物，其特征在于：所述植入物与融接促进物质相结合。
16.如权利要求15所述的植入物，其特征在于：所述融接促进物质至少为骨、骨的形态发育蛋白质和羟磷灰石之一。
CNB961955848A 1995-06-07 1996-06-06 截头圆锥形体内脊骨融接植入物 Expired - Fee Related CN1149059C (zh)

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US08/484,928 US6923810B1 (en) 1988-06-13 1995-06-07 Frusto-conical interbody spinal fusion implants

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US7942933B2 (en) 2011-05-17
DE69633287T2 (de) 2005-01-13
ATE274889T1 (de) 2004-09-15
JP4005613B2 (ja) 2007-11-07
DE69637271D1 (de) 2007-11-08
US7691148B2 (en) 2010-04-06
US20050165489A1 (en) 2005-07-28
US6923810B1 (en) 2005-08-02
JP2006061708A (ja) 2006-03-09
AU6036096A (en) 1996-12-30
US20100217394A1 (en) 2010-08-26
EP1442732A1 (en) 2004-08-04
ES2293113T3 (es) 2008-03-16
ATE373999T1 (de) 2007-10-15
CA2224249A1 (en) 1996-12-19
JPH11506656A (ja) 1999-06-15
CN1190881A (zh) 1998-08-19
CA2224249C (en) 2007-11-27
EP1442732B1 (en) 2007-09-26
US8409292B2 (en) 2013-04-02
US20050165399A1 (en) 2005-07-28
EP0836457A4 (en) 1999-09-15
US20110224795A1 (en) 2011-09-15
WO1996040019A1 (en) 1996-12-19
JP4011616B2 (ja) 2007-11-21
DE69637271T2 (de) 2008-01-24
EP0836457B1 (en) 2004-09-01
EP0836457A1 (en) 1998-04-22
DE29623360U1 (de) 1998-03-19
DE69633287D1 (de) 2004-10-07

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