CN1288713A - 具有带齿连接板的椎间内用假体 - Google Patents

具有带齿连接板的椎间内用假体 Download PDF

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CN1288713A
CN1288713A CN00120149A CN00120149A CN1288713A CN 1288713 A CN1288713 A CN 1288713A CN 00120149 A CN00120149 A CN 00120149A CN 00120149 A CN00120149 A CN 00120149A CN 1288713 A CN1288713 A CN 1288713A
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tooth
intervertebral
type surface
connecting plate
internal prosthesis
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A·克勒
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Waldemar Link GmbH and Co KG
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • A61F2002/30845—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes with cutting edges
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891—Plurality of protrusions
    • A61F2002/30892—Plurality of protrusions parallel
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    • 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
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

一种插入物,特别是一种椎间内用假体,其具有一个连接板(3),它被固定在椎骨表面且沿横切其主延伸部分的作用方向接触骨表面。为了避免产生平行于其主延伸部分的剪切力,连接板(3)的齿(6)沿作用方向伸出。齿(6)由表面(11,12,13)限定组成,其中包括一主表面(11),沿作用方向且垂直于剪切方向设置,两个齿或多组齿在剪切方向相对并朝相反方向。

Description

具有带齿连接板的椎间内用假体
已知的椎间内用假体(EP-B-176,728)包括两个连接板，在它们之间包围有一个芯体。这些连接板将对一侧脊椎体的上皮片(plate)施加压力。为了保证假体不会因剪切力的作用失去其在脊椎体之间的预定位置，其中所述剪切力主要产生在与连接板主延展方向平行的前后方向上，该连接板必须以适宜的方式连接至脊椎体。为此，已知假体的边缘设有齿，其横向从每一连接板伸出，以便通过所述椎体之间作用的实际压力穿入脊椎体的上皮片。在这种情况下，它们将阻止连接板在相对于脊椎体上皮片以任何给定连接板和脊椎体表面方向进行位移。为了确保这种阻力足够大，在所述内用假体的特殊设计中，齿横切连接板和上皮片表面的延伸部分设置。实际上，它们通常由一对大致三角形的主表面构成，这些主表面沿其大致平行的底侧被装配至连接板且相对底侧设置的自由顶点朝向远离连接板方向。由于齿需具有足够的稳定性，因此其具有一定的厚度，该厚度对应于相互平行的三角形表面之间的距离。在底侧和顶点之间延伸的三角形表面的边缘由矩形平面连接，所述平面朝齿顶点成收敛状并形成一个脊状。
当使用假体时，将会发现在许多情况下，齿不能足够深地穿入脊椎体的上皮片。这样就存在它们不能正确完成其功能，即假体固定在预定位置上的危险性。实践已证明这必需依靠使用假体栓钉，这些栓钉被插入预先在脊椎体上钻好的孔中(DE-C-3,023,353,FR-A-2,659,226)。然而，在脊椎上作这项工作是十分困难的。它将延长手术时间并削弱脊椎体的强度。使用尖锥形齿的情况将被排除，这是由于齿朝底面变厚以便使齿更稳固，且它们是由斜面限定的，如果有剪切力存在，将使齿从骨头上脱离。
本发明的目的在于改进所述椎间内用假体，其方式是齿应充分牢固地插入脊椎体的上皮片，并且克服剪切力牢固地固定在那里。本发明的技术解决方案由权利要求1的特征且最好由从属权利要求的特征给出。
因而，所提供的椎间内用假体具有一个被固定的连接板，从而压在脊椎表面上。这一连接板沿横切其主延伸部分的作用方向接触脊椎表面。为了避免平行于其主延伸部分的剪切力，连接板的齿大致朝所述作用方向伸出。这些齿特别由主表面构成，该主表面是沿作用方向及横切剪切方向设置的。与传统的锥形齿轮结构相比，其中确定齿的面以与作用方向成相同的角度倾斜，本发明的角锥形齿相对于作用方向被设计成倾斜的，其是通过使主表面平行于作用方向且仅通过使其它表面倾斜而使齿从顶部朝其底部加宽来实现的。
非常规的髋关节内用假体由法国专利FR2,641,461 A1披露，其固定在髋骨上的半球状部分在外缘上具有一个楔形环，该环朝插入方向收敛。楔形体的外表面为圆柱形表面，其圆柱轴线为作用方向。然而，并不能清楚地确定外楔形表面的圆柱外形是否能实现其技术效果。
本发明的进一步的特征在于：在所有情况下，两个齿或多组齿沿剪切方向彼此相对设置且朝向相反方向，其是指两个配套齿对的主表面彼此面对或彼此朝向远离的方向。以下的推论是在基于这样一个事实上作出的，横切作用方向且斜面穿入脊椎骨时产生的力方向相反，因而彼此抵销。因此，齿可以以预期的作用方向，即主表面方向穿入脊椎骨。
本发明的齿外形具有两个优点。第一，当产生的剪切力平行于连接板的主延伸部分时，总是至少存在这样一个齿的主表面，该主表面与剪切力的方向垂直，因此为确保克服剪切力而插入的位置提供了最好的条件。从而消除了锥形齿脱离的危险性，即防止了由于沿倾斜齿表面剪切方向的移动而使插入脊椎的齿从支承位置上脱离。
第二个优点在于脊椎的表面不受伤害，借助于它在穿透时与齿的主表面相互配合，且它们克服剪切力被支撑。与作用方向倾斜的齿表面具有这样的作用，当它穿入脊椎皮层时，它将使脊椎皮层逐渐断开，以便容纳不断增大的穿入齿的横截面积，这种断裂将削弱相关脊椎部分的稳定性。相反，沿作用方向延展的主齿表面上没有这种逐渐断裂发生。因此，相应的脊椎部分为因此不受伤害，可以更稳定更好地支承齿，上皮片的脊椎皮层的完整性以及其承受力的能力在齿的穿透区域被更好地维护，为此通常能省略附加固定装置，如螺栓等。
特别理想的是，如果主表面的边缘是锐利的，那么当它们穿入椎骨时，它们将切割椎骨而不会使其断开。如果主表面是平面，则主表面边缘的锐度可通过以一锐角(沿平行于连接板的主延伸部分的横截面)设置的与主表面相邻的齿表面来获得。齿的底部通常是这样的，例如是一个三角形或不规则四边形。然而，主表面也不一定非是一个平面，它也可以有两个或多个以理想钝角相互连在一起的平面，或者它也可以被设计成具有或多或少的均匀曲率。
作用方向通常为设法插入脊椎骨的方向。如果连接板是平的，则它通常垂直于脊椎皮片的表面。如果连接板是弯曲的，作用方向一般为实际垂直于连接板延伸的平均方向(the average direction)。它也可以是从产品中所示的主表面相互平行延伸的方向。
剪切力通常是一组不规则定向力的分力，克服该剪切力，齿将椎间内用假体固定在脊椎上，在前后方向分力是非常大的并会对插入脊椎的固定造成特殊威胁。因此，相对于脊椎骨上皮片的前后方向固定连接板是特别重要的。因此，插入连接板上的齿主表面是沿A-P方向和邻接方向取向的。推荐设置两组齿，一组用于承受前后的定向力，另一组用来承受后面的定向力。这两组齿以相反的方向相对设置，这样横切作用方向且当它们插入骨骼时，由其斜面产生的力就基本上相互抵销了。
在这种连接中，相对于剪切力横向延伸的对称轴的对称排布或相对于镜象对称中心点的对称排布可以是特别稳定的。然而，对称不是必须的。
下面，将参照附图对实施例进行描述来进一步说明本发明的特征，其中：
图1为一横截面视图，它是从后侧或前侧方向进行观察的，在两个脊椎体椎间设置有一椎间内用假体；
图2为连接板带齿侧的平面图；
图3为沿图2中Ⅲ-Ⅲ线的横截面视图；
图4,5和6为齿的一个平面放大图和两个放大侧视图。
插在两个脊椎体2之间的椎间内用假体1包括两个连接板3和一个芯4，连接板3的外侧5具有多个尖齿6，这些齿6由沿箭头7方向作用的力以及可还包括作用在脊椎体2之间的实际压力被压入外皮端片8中，从而确保所述假体处于理想的位置。
齿6在连接板3的腹侧和背侧边缘9被分为两组，且对称于沿腹侧一背侧方向延伸的一径向轴线10。每组的中间齿均相对于直径方向10定位，同时，外围的齿以与直径方向成夹角α围绕，该α角约为30°且应大于20°。其原因在于由齿克服以将假体固定在脊椎体上的剪切力大致但不仅仅处于A-P方向。
每个齿由4个表面，即通常由一主表面11，两个侧表面13和一后表面12限定。主表面11相对连接板3成90°角，更准确地说是相对于大致由连接板3的齿支承外表面的平均方向规定的平面成90°角。在所示的实施例中，垂直于连接板3的主表面11指向外侧(远离直径方向10的中心)。反之，也可以应用。
相对的后表面12的截面平行于连接板，贯穿齿的截面平行于主表面11。在垂直截面(图6所示)，它相对于连接板3倾斜，即在本实施例中以115°角延伸。该角度最好在105°和145°之间。
主表面11和后表面12的边缘14和15由侧表面13相连，这些侧表面同样为三角形，其与主表面11和后表面12汇聚于同一点。相对于主表面11，它们在一平行于连接板3的截面上以一锐角β延伸，其锐角最好小于80°，这样，主表面11和侧表面13之间的边14就成为了一种切割刀。侧表面13相对于主表面11的锐角实际上是通过使主表面11的顶角稍大于后表面12而获得的。在图5中，这些角分别被标示为55°和40°。这两个角之间的差别越大，由边14形成的切割刀就越尖。主表面11的顶角应该小于70°，最好小于60°，同时，后表面的顶角应小了10°-25°，最好小了约15°。
这样具有以下作用：如齿可以穿入脊椎体的骨质的外皮层。主表面11与穿透方向平行，齿的顶点一穿入骨质的外皮层，主表面11便能沿最初形成的剪切或穿透边前进。当穿透过程进行时，相应于主表面11增大的宽度，该边的长度也会增加。由于这种扩大发生在切割边14的作用区域内，因而其具有剪切作用而不是切断作用，因此，最终形成与主表面11配合的骨质边缘基本上避免了断裂的危险，因而可以更好地承受由主表面11传送的力。
相反，后表面12和侧表面穿透是通过骨外皮层的配合边的逐渐位移来实现的。但是，这并没有任何损坏发生，由于克服剪切力的插入支承主要是由主表面11承受的。
为了确保在所有主表面方向上力的良好传递，径向彼此相对设置的齿的主表面11以相对的方向定位。
已发现，与现有技术中的齿相对，根据本发明构成的齿能更可靠地保证假体的定位，且在横切A-P方向上能呈现出大致相同的齿面尺寸(图2)。

Claims (7)

1、一椎间内用假体，其具有一个连接板(3)，该连接板(3)被固定在脊椎表面上且其以作用方向施加在脊椎表面，该作用方向横切于它的主延伸方向，并且为了免受平行于主延伸方向的剪切力，连接板(3)的齿大致沿作用方向伸出，所述齿由表面(11,12,13)限定，其中包括一沿作用方向且横切剪切方向设置的主表面(11)，两个齿(6)或多组齿均在剪切方向上彼此相对设置并朝向相反方向。
2、根据权利要求1所述的椎间内用假体，其特征在于：彼此相对设置且指向相反方向的齿(6)的主表面(11)被定位成彼此相互离开。
3、根据权利要求1或2所述的椎间内用假体，其特征在于：所述主表面(11)的边(14)是尖的。
4、根据权利要求3所述的椎间内用假体，其特征在于：在一个平行于连接板(3)的横截面上，齿(6)的侧面(13)相对于主表面(11)包围一不大于80°的角度(β)。
5、根据权利要求4所述的椎间内用假体，其特征在于：齿(6)的主表面为不规则四边形，主表面(11)为最大的侧面。
6、根据权利要求1-5中任意一条所述的椎间内用假体，其特征在于：一组齿(6)在所有情况下均被设置在连接板(3)的两个相对边缘区域内。
7、根据权利要求5的椎间内用假体，其特征在于：每组齿(6)的主表面(11)分别与直径方向(10)成一角(α)设置，其角度(α)至少为±20°。
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MXPA00004876A (es) 2002-03-08
ES2195470T3 (es) 2003-12-01
JP2000350740A (ja) 2000-12-19
US6416551B1 (en) 2002-07-09
DE59904848D1 (de) 2003-05-08
BR0002436A (pt) 2001-01-02
AU3540500A (en) 2000-11-30
AU770122B2 (en) 2004-02-12
EP1057462B1 (de) 2003-04-02
KR20010014947A (ko) 2001-02-26
CN1200657C (zh) 2005-05-11
EP1057462A1 (de) 2000-12-06

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