CN1893896A - 椎间假体 - Google Patents

椎间假体 Download PDF

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Publication number
CN1893896A
CN1893896A CNA2004800323159A CN200480032315A CN1893896A CN 1893896 A CN1893896 A CN 1893896A CN A2004800323159 A CNA2004800323159 A CN A2004800323159A CN 200480032315 A CN200480032315 A CN 200480032315A CN 1893896 A CN1893896 A CN 1893896A
Authority
CN
China
Prior art keywords
intervertebral
plate
prosthese
prostheses
intervertebral prostheses
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2004800323159A
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English (en)
Inventor
史蒂文·斯特里特菲尔德·吉尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw plastic surgery Co Ltd
Original Assignee
史蒂文·斯特里特菲尔德·吉尔
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 史蒂文·斯特里特菲尔德·吉尔 filed Critical 史蒂文·斯特里特菲尔德·吉尔
Publication of CN1893896A publication Critical patent/CN1893896A/zh
Pending legal-status Critical Current

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Abstract

本发明涉及一种椎间假体。特别地，本发明涉及一种人造椎间盘假体。使用中，在外科手术切除掉退化或破碎的盘之后，将椎间假体固定到椎骨的端板上。椎间假体具有大致平坦的、带有大纹理表面的骨接合面。

Description

椎间假体
技术领域
本发明涉及一种椎间假体(Intervertebral prosthesis)。特别地，本发明涉及一种关节相连的椎间盘假体。使用中，在外科手术切除掉退化或破碎的盘后，将椎间假体固定到椎骨的端板上。本发明还涉及一种用于插入并取出本发明的椎间假体的方法和工具。
背景技术
脊柱疾病的外科治疗通常涉及到取下椎间盘。特别是当存在盘退化或破碎而促使挤压脊髓或神经根而导致神经症状时更是如此。取下盘后，通常的外科手术是植入骨植入物或将人造融合件插入盘间隙中以确保椎骨具有合适的间距并对齐。
然而，接下来的相邻椎骨的融合可能会使得邻近的脊骨运动段迅速退化。因而，许多患者可能因为脊柱融合术而需要额外的盘取下和/或融合疗法。为了避免后者并保持脊柱可移动性，已经提出了数种不同类型的椎间盘关节设备。这些设备包括通过将椎间盘更换成弹性体材料、容纳在袋或充满的囊中的吸湿剂而尝试模拟椎间盘的垫状特性。可替代的设计试图通过机械设备使椎骨保持分离并运动。典型地，这些包括两个关节联接的金属板或件，使得当该设备设置在椎间的间隙时，一个板与上部椎骨的端板接合，而另一个板与下部椎骨的端板接合。提出的关节接合装置包括：一个允许在一个平面上转动的铰链装置；一个带有凸起的下表面的上板，该下表面与下板的上表面的凹面相配合，使得上板可在多个平面内转动；一个带有凸起的下表面的上板，该下表面与下板的上表面的槽形相接合，使得该上板可转动并平移；和一个容纳在两板间相对空腔内的卵形聚氨酯核心，也使得其可转动并平移。
已经描述了多种将人造盘假体固定在椎间间隙内的方法。这些包括多孔的平坦的骨接合面，其允许骨向内生长，如美国专利No.3,867,728(Stubstad等)及美国专利No.4,911,718(Lee等)所述。然而，其未表明这些设备在预设的骨向内生长之前将为椎骨提供足够的连接，以避免假体排出而接着对脊髓或神经造成损害。
可选地，假体盘的骨接合面可设置有突出物，包括穿透骨端板的栓钉、牙齿、长钉、脊部或螺钉等，如美国专利No.5,701,437(Stefee)；4,759,766(Buettner-Janz等)；4,309,777、5,123,926(Pisharodi)；4,874,389(Downey)所述。为了植入所述设备相邻的椎骨必须大致扩张使得彼此之间的距离比正常距离大，使得假体可在椎骨之间操作并固定在位。这个手术使得椎骨和软组织有额外受伤的危险，这可能导致韧带异位钙化并最终导致运动段的融合。
Bryan在美国专利5,674,299、5,865,846、6,001,130和6,156,067中描述的颈部盘假体具有多孔的凸起的金属骨接合面以促进骨的向内生长。为了插入该设备，将要连接的椎骨的相对关节面精确地加工有凹面以容纳并保持该椎骨。这需要复杂的检测仪器，这需要延长手术时间并增加组织外伤。该设备的插入还需要相邻椎骨间过度分离，并具有如上所述的后果。
美国专利No.6,113,637(Gill等)描述了一种使用插入到各个连接关节的前侧凸缘的螺钉而将盘假体固定到相邻椎骨间的方法。为了将关节插入到盘间隙，若要实现关节的稳固的固定，椎骨相对于关节面的前侧面的几何上的精确准备是重要的。若由于过度的骨赘形成而导致椎骨的前侧面变形，例如楔形或凹入的前侧面，这将会是有问题的。矫正所述变形可能需要过度去除骨皮质，接着会使螺钉固定变弱。未能在关节插入前充分地准备椎骨的关节面和前侧面的几何位置，可能导致关节的摇摆，并且导致过度的应力设置在螺钉上，其可能变松或破碎。
为了假体盘的长期稳定性，期望骨接合面为多孔或者有纹理的并允许骨向内生长，并期望这个表面与骨端板的接合面积最大。已经开发了多种纹理化方法来处理金属植入物的表面来改善其生物固定强度。这些包括将小球形颗粒应用到由与植入物相同的材料制成的表面。这些颗粒可通过气相沉积、等离子流喷射或任意其它合适的已知方式而施加到植入物的骨接合面。植入物的表面也可机械或化学蚀刻或纹理化。化学纹理化方法可商业地得到，例如：Chem Tex5-5-5(CYCAM inc；Houston，PA)及Tecotex1-103(Tecomet，Woburn，MA)。后一种纹理方法产生粗糙孔面，其带有半径一般大于0.4mm的孔；另外已知为大纹理表面。大纹理表面与较少粗糙或珠状涂层表面相比在生物固定方面具有内在的优点，因为其将更容易使其自身嵌入到骨中，并且在插入中可刮擦骨表面而刮去小颗粒，并迫使其进入到纹理的凹陷部中，从而有助于骨生长到该表面中。当骨生长到大纹理表面中时，剪切强度高并且将会更足以将假体保持在位。
有时因为初始定位差或假体陷入到椎骨的端板内引起关节不正和疼痛，或者因为先前的疾病和相对不移动的分段上重新建立运动而引起的骨关节疼痛，而期望取出盘假体。若盘假体感染或骨赘在同一节再次生长而引起脊髓病或神经根病，可能还需要取出该盘假体。若植入的盘假体具有骨向内生长表面，然后可通过绕假体而钻骨并松开假体而取出该假体，但是这将导致显著的骨疏松，使得后续的脊柱融合术或替换另一个假体盘非常困难。假体从椎骨端板的分离优选地使用骨刀或凿子而进行。
然而，这需要将允许骨向内生长的纹理化表面施加到平坦表面，并且带有如现有技术中所述的从大致平坦的骨接合面生出的突出物的设备将会阻碍凿子或骨刀的通道，而使得脱离极其困难。类似地，若骨接合面为拱顶形，如美国专利No.5,865,846所述，手术将面临类似的困难。当假体采用相当大的前侧凸缘用于螺钉固定时，如美国专利No.6,113,637所述，将不推荐使用骨向内生长表面，因为它们将会妨碍接触该表面而便于其从骨上脱离。
发明内容
因而，对于椎间假体存在一种需求，需要容易植入到椎间间隙中例如盘间隙中，而不会过度分散椎骨。假体接触骨的表面将带有一个表面，该表面将提供稳定的初始固定并允许骨向内生长而确保长期的稳定性。盘假体将如此设计，使得其后续的取出能安全而不会有明显的骨破坏或损耗地实现。假体优选地设置有移动工具，该工具将允许植入或取出。
本发明涉及一种简单的椎间假体，该椎间假体能够在取出病变、破碎或退化盘之后固定到椎骨端板上。
本发明提供了一种椎间假体，该椎间假体包括第一板和第二板，其中各个板包括一个大致平坦的骨接合面，该骨接合面带有能够磨锉椎间骨(interstitial bone)表面的大纹理表面；和一个或多个凸耳，其在假体的椎间插入部分抵靠住椎骨的非椎间表面以限制假体的插入。
大致平坦的骨接合面提供粗糙锉状表面，该表面当放置在椎骨间后通过移动该假体，能够机械地嵌入到骨中，从而骨接合面磨锉椎间骨表面，即骨端板。优选地，往复转动施加到假体上。大纹理表面与椎骨端板之间的机械接合为假体提供了初步的固定。为了将椎间假体保持在位，该初步固定是足够的。初步定位后，骨向内生长到骨接合面的凹陷部中提供了长期的稳定性。
大纹理骨接合面形成了与椎骨端板之间的足够强度的结合，使得除了出现大量的椎间移动的情形，椎间假体不需要以任何方式固定在位，例如螺钉等。椎间假体保持在位，因为施加在假体上的主要力是椎骨间的压力。当板关节联接到一起而允许板间生理范围内的运动时，施加在板上任意其它力将由该关节分散。这致使压力大致成为假体上唯一的力。
优选地，大纹理表面为盘形。盘形的大纹理表面有助于使得假体在插入在椎骨间时可以转动。假体转动着嵌入到椎骨端板间。
优选地，本发明的椎间假体不包括任何诸如螺钉之类的、使其固定到椎骨的非锥间表面的固定装置或任何容置该固定装置的孔。
优选地，椎间假体的各板包括一个位于大纹理表面和一个或多个凸耳之间的未纹理化的区域。未纹理化区域的目的是使得当椎间假体插入并且大纹理表面磨锉并穿入椎骨端板时，接触未纹理化区域的骨表面得以保持，即骨不会与未纹理化区域形成粘合。未纹理化区域的出现有助于在椎间间隙中保持假体并有助于椎间假体的任意后续的取出。特别优选地，未纹理化区域为凹陷部区域并且优选地比大纹理表面约低0.4～1mm。优选地，未纹理化区域在大纹理表面和一个或多个凸耳之间形成一个边界并且该边界可有介于2～10mm的可变宽度。
术语“未纹理化区域”是指未经大纹理化的表面区域且在其上骨不能向内生长的区域。未纹理化区域可为平坦光滑的或者可成形为使得骨能接触该表面并可接合该表面，但是不能与该表面结合。
未纹理化区域的出现确保了骨与未纹理化区域接合的表面作为支持物并有助于将假体保持在椎间间隙中。
椎间假体的一个或多个凸耳用作止挡件而防止了假体运动，该凸耳抵靠住椎骨的非椎间表面。优选地，每个板包括两个凸耳。更优选地，凸耳位于椎间假体的一侧。使用中，本发明的椎间假体一般以前后方向插入到椎骨间。椎间假体的导缘——即插入到椎间间隙中的边缘被称作后缘。相对的边缘被称作前缘。需要理解的是，一个或多个凸耳优选地设置在前缘上以通过抵靠住椎骨的非椎间表面而防止假体进一步向后移动。
凸耳优选地安装在第一和第二板前缘的每一端。特别优选地，凸耳能接合到插入工具使得通过使用插入工具而操纵所述板。在特别优选的实施方式中，凸耳为棱柱形。棱柱形的凸耳能承受大的力量并特别适于连接到保持工具，这将在下文进一步描述。优选地，各个棱柱形凸耳的方位为使得其前后朝向顶边的平坦底面将与椎骨的前面的非椎间表面接合。
需要注意的是，凸耳抵靠住椎骨的非椎间表面但不使用固定装置固定到椎骨上。通过避免必须将椎间假体固定到椎骨上，插入过程得以简化并更快速。此外，由于不必要插入螺钉或其它固定装置，椎骨也会更少地受损。
第一和第二板关节联接到一起，从而在板间提供生理范围内的运动。本领域技术人员知道很多允许板间合适运动的结构。
本发明的椎间假体的骨接合面大致是平坦的。这意味着骨接合面不包括一系列大的峰或槽，反之，大纹理表面充分一致而提供一个仍然大致平坦的粗糙表面，从而，骨接合面能通过使用骨刀或凿子从椎骨端板分离。通过在骨接合面上避免大的峰或槽，骨接合面可从椎骨端板上通过简单地沿骨接合面的大致平坦的表面切开而取出。此种方法的优点在于取下椎间假体时仅有少量骨的损耗。
可由任意已知的方法制造大纹理表面，其中包括机械或化学方法。化学纹理方法包括Chem Tex5-5-5(CYCAM Inc；Houston，PA)及Tecotex1-103(Tecomet，Woburn，MA)。Surfi-SculptTM技术(TWI Limited，Cambridge，UK)可用于制造大纹理表面。Surfi-SculptTM技术包括采用电子束来使材料精确地再成形。基本上，大纹理表面足够粗糙而可磨锉椎间骨表面。特别是，大纹理表面必须在插入或插入后移动(例如转动)时磨锉骨表面，而刮下被迫进入大纹理表面的凹陷部的小颗粒，从而有助于使骨生长到表面内。优选地，大纹理表面包括许多半径一般大于0.4mm的孔或凹陷部。本领域技术人员已经熟知合适的大纹理表面。
优选地，端板间的关节应该是可承重的，并保持关节连接的椎骨间的正常分离，而便于椎骨间生理范围内的运动。特别优选地，第一和第二端板通过美国专利No.6,113,637(Gill等)中描述的机构而关节联接到一起。
椎间假体可由任意的生物相容的材料制成。合适的材料包括不锈钢、钛、碳化钛、锆及其等同物。
优选地，在椎间假体的各个板的后缘处有一个斜切。该斜切有助于椎间假体插入。
本发明还提供一种研磨试验设备，该设备大致与本发明的椎间假体具有相同的尺寸，并包括一个或多个尺寸、形状和位置与本发明的椎间假体的凸耳相应的凸耳，其中试验设备的板的表面具有使椎骨端板光滑的研磨表面。在研磨试验设备插入椎间时，一个或多个凸耳抵靠住椎骨的非椎间表面以限制研磨试验设备的插入。
研磨试验设备用于依照椎间间隙的尺寸而制造并准备，使得其能容纳本发明的椎间假体。研磨试验设备具有和椎间假体大致相同的尺寸。换言之，研磨试验设备具有与椎间假体大致相同的形状和尺寸，但是其比假体低第一和第二板的大纹理的组合高度。可以想象的是，外科医生将可得到本发明的不同尺寸的椎间假体用于植入，并且将提供类似的多种研磨试验设备以配合椎间假体的轮廓。
研磨试验设备上的一个或多个凸耳以与椎间假体上的凸耳相同的方式而操作。特别是，凸耳用于防止研磨试验设备的过度插入。
研磨试验设备的板表面与椎骨端板接触并设置有研磨表面，该表面使得椎骨端板变得光滑从而准备椎间间隙以容纳椎间假体。研磨表面可通过设置一系列切削刃或镶嵌金刚石的表面而获得，以形成一个锉或精加工的锉刀状表面。
特别地，研磨试验设备用于依照椎间间隙的尺寸而制造并准备，使得其能容纳本发明的椎间假体。
研磨试验设备能以与椎间假体相同的方式连接到中间插入工具，即借助一个或多个凸耳。可选地，研磨试验设备可形成为具有加长柄的单个单元而使得其可插入到椎间间隙中。
如上所述，根据本发明的椎间假体，一个或多个凸耳优选地为位于椎间假体前缘的两个棱柱形凸耳。优选地，研磨试验设备在相同位置包括同样的凸耳。
优选地，各个棱柱形凸耳的指向为使得其前后朝向顶边的平坦底面将与椎骨的前面的非椎间表面接合。该装置的优点在于若研磨试验设备分节地容纳在椎间间隙中，凸耳将凹入(indent)前面的椎骨的非椎间表面从而标注出其接触点。若所有四个凸耳未能与椎骨正确接触，那么外科医生可取下任意的不规则骨以确保椎间假体将会正确地就位。当然，将凸耳压入前面的椎骨体的过程将产生互补的凹陷部，也有助于以此种方式实施。
不具有研磨面的试验设备，这里是指具有确定尺寸的试验设备，可用于检查椎间间隙的尺寸。确定尺寸的试验设备与要插入的假体具有相同的形状和尺寸，除了其比假体低第一和第二板的大纹理的组合高度。
本发明还提供一种确定尺寸的试验设备，其具有与本发明的椎间假体大致相同的尺寸，并包括一个或多个棱柱形凸耳，该凸耳的尺寸、形状和位置都与本发明的椎间假体相对应。
本发明还提供了一种插入工具，其能可松开地连接到本发明的椎间假体。特别地，本发明提供了一种插入工具，包括：
一个轴杆，其具有一个近端和一个远端，其中近端包括一个柄，远端包括两个偏置分开的假体接合臂；和
一个圆筒，其具有一个近端和一个远端，其与主轴杆转动地接合，
其中圆筒的远端接触假体接合臂并且当圆筒向远端转动时，该圆筒的远端推动假体接合臂合拢以握住根据本发明的椎间假体。
使用中，外科医生将握住轴杆的近端并转动圆筒，使得其向远方移动。随着圆筒向远方移动，其将接合假体接合臂并由于圆筒的运动而推动该假体接合臂合拢。随着假体接合臂的合拢，该臂能握住根据本发明的椎间假体。松开椎间假体可通过简单地转动圆筒而使得其向近端移动而实现。
优选地，圆筒的近端为内螺纹并与轴杆的相应螺纹段接合。
假体接合臂形状为，圆筒向远端移动时，该臂被合拢，优选地，假体接合臂包括凹陷部以接合形成于本发明的椎间假体的各个板上的一个或多个凸耳。该凹陷部形成为使得当两臂被一起推动时，椎间假体可被稳固地握住。优选地，本发明的椎间假体在每个板上包括一个或多个——最优选地为两个——棱柱形的凸耳。从而优选地，插入工具的两个假体接合臂在接合臂中包括互补的凹陷部，使得椎间假体可以由插入工具稳固地握住。在保持工具的臂中采用棱柱形凸耳及相应的凹陷部是特别有利的，因为这使得握住更为稳固。稳固握住是因为假体的每个棱柱形凸耳由该保持工具的臂中的各个凹陷部保持在四个面中。另外，由于棱柱形凸耳和凹陷部的相互的形状，凸耳会自动与保持工具连接。凸耳在凹陷部中的位置受限，并且第一和第二板相对于彼此锁定在其位。此外，保持工具的臂只需要移动一段短距离以在握持位置和非握持位置之间切换。
本发明的试验设备和插入工具可由任意合适的生物相容的材料制成，例如不锈钢、钛、碳化钛、锆及其等同物。
本发明还提供一种套件，包括一个或多个根据本发明的椎间假体、一个或多个根据本发明的研磨试验设备和一个或多个根据本发明的确定尺寸的试验设备。
优选地，该套件还包括一个根据本发明的插入工具。
优选地，该套件包括一系列不同尺寸的椎间假体和对应的一系列不同尺寸的研磨试验设备及确定尺寸的试验设备。
本发明还包括一种将本发明的椎间假体插入的方法，该方法包括：
准备椎骨端板，所述端板间将插入椎间假体，通过在椎间间隙内插入并移动本发明的研磨试验设备，而使端板光滑并确保试验设备的一个或多个凸耳与椎骨的非椎间表面接合；和
将椎间假体插入到准备好的椎间间隙中；和
在椎间间隙内移动假体以确保大纹理表面与椎骨端板接合。
该方法可包括另外一个步骤，即在插入假体之前使用本发明的确定尺寸的试验设备来检查椎间间隙的尺寸。本领域技术人员可理解的是，试验设备和椎间假体的插入和移动可通过使用本发明的插入工具而实现。
当椎间假体的大纹理表面已机械地接合到椎骨的端板时，优选地，通过该端板在椎间间隙中侧向转动，假体将稳定到足以正常地和立即地操作。插入操作将在大纹理表面的凹陷部中撒下微细的骨颗粒，这将刺激骨向内生长从而提供永久的稳定性。
本发明还提供了一种方法，该方法用于在骨生长到大纹理表面后取出本发明的椎间假体。因而，本发明提供一种方法，该方法用于从椎间间隙中取出本发明的椎间假体，该方法包括在各个端板的大纹理表面和椎骨端板之间穿入精工凿和骨刀。
精工凿或骨刀可设置有一个止挡件，以限制其可插入的量。本领域技术人员将会清楚的是，本发明的保持工具可用于通过与假体的凸耳接合而取出假体。
附图说明
现在将通过例子参照下述各图描述本发明。
图1示出了椎间假体的上板和下板的立体图(位于板之间的关节未示出)。
图2示出了椎间假体的上板的俯视图。
图3示出了椎间假体的上板和下板的截面侧视图。
图4示出了沿脊骨(图4a)的截面图，其中椎间假体已插入到其中(图4b)，仅仅作为示例，第一和第二端板之间示出的关节为一个球槽式的，如美国专利No.6,113,637所述。
图5示出了根据本发明的研磨试验设备的立体图。
图6示出了根据本发明的保持工具的立体图。
图7示出了本发明保持工具的截面图。
图8示出了椎间假体插入到颈部盘间隙中，示出了将椎间假体的大纹理表面嵌入到椎骨端板中的往复旋转运动。
具体实施方式
实施例1-假体
椎间假体1如图1所示，其带有第一板3和第二板5。椎间假体由碳化钛制成。板3和5由任意合适的机构关节联接到一起。在如图4b所示的假体中，示出了美国专利No.6,113,637描述的球槽式关节。各板3和5具有带有大纹理表面的骨接合面7和9。大纹理表面由例如Chem Tex或Tecotex的化学纹理化方法而形成并包括带孔的表面，其中孔的半径一般大于0.4mm。大纹理表面大致平坦。形成于大纹理表面上的孔的深度大致相同，使得大纹理表面大致均匀。
各板3和5具有斜切的后缘13，如图2和3所示。后缘13是假体1的导缘，即插入到椎间间隙中的边缘。相对的边缘是前缘。斜切的后缘13不具有大纹理表面并有助于假体1的插入。
在板3和5的前缘和大纹理表面7和9之间，有一个未纹理化的凹陷部边界15和17。在大纹理表面7和9嵌入到椎骨端板间后，未纹理化的凹陷部边界15和17将在椎骨的前缘处接合到骨的支持物，该处已被预留，即未被大纹理表面磨锉，从而有助于在椎间间隙中保持该假体1。
在板3和5的前缘的各端，假体1包括棱柱形凸耳11。棱柱形凸耳11的平底与板3和5的前缘对齐，棱柱形凸耳的顶边设置成使得当假体插入时该凸耳抵靠住椎骨的非椎间表面。
在图4b中示出了位于椎间间隙内的本发明的假体1。板3和5的大纹理表面7和9已由假体1的旋转运动而嵌入到椎间端板中。棱柱形凸耳11抵靠住椎骨的前表面，防止假体1任何向后的运动。可以看到，骨在椎骨前缘处的支持物与边界15和17接合，从而有助于将假体1保持在位。
实施例2-假体的使用
麻醉了的病人仰卧在手术台上，颈部保持在中间位置，并且使用例如Holter牵引系统施加颈部牵引。前面的颈部脊骨由横向颈部切口在合适的节露出。
颈部的切除及减压依传统方式进行，然后使用磨石使椎骨端板平行。现在释放颈部牵引。
接着，使用选择的研磨试验设备来确定盘间隙的深度和高度。图5中示出了一个合适的研磨试验设备19。研磨试验设备具有与将要配合的假体1大致相同的尺寸，除了其低于假体的第一板7和第二板9的大纹理的组合高度，并且其在相应于假体1上的凸耳11的位置设置有棱柱形凸耳21。研磨试验设备具有端板接合面23，其是一个研磨面，可使得椎骨端板变得光滑，其中所述椎骨端板间将插入假体1。研磨表面由一系列精细的切削刃形成。研磨试验设备连接到一个手柄，使得其可插入到椎间间隙中。
端板的最后准备可使用带有端板接合面23的研磨试验设备19而实现，该接合面上设置有精细的切削刃。当所述设备19在盘间隙内往复并进进出出地移动时，其将方便地使得端板变得光滑而容纳合适尺寸的假体1。研磨试验设备19还用于确保假体1在盘间隙中正确地就位，从而出现在研磨试验设备19的两个端板接合面23的前端的凸耳将与准备好的盘间隙的各侧的椎骨体的前面相接合。这可能需要去除额外的骨。
选择一个不具有研磨面的确定尺寸的试验设备，以紧密地配合在准备好的盘间隙内，但不分散该盘间隙。这个确定尺寸的试验设备与盘假体1相匹配，该盘假体1比该试验设备要高一定量，该量值为相当于假体1的板7和9的纹理的组合厚度。典型地，其将介于0.8～2mm的范围。
选定的假体1固定在插入工具26中。图6和7示出了一个合适的保持工具26。该工具包括一个带有近端和远端的轴杆25。柄27设置在近端，一对假体接合臂29设置在远端。轴杆25的远端沿其纵轴分叉而形成臂29。所述臂形成为使得其偏置分开。所述工具26还包括绕轴杆25旋转接合的圆筒31，其中圆筒31的远端接合出现在轴杆25远端的分叉臂29。圆筒31包括一个与轴杆25的螺纹部分35接合的内螺纹部分33。圆筒31沿顺时针方向的转动使得圆筒相对于轴杆25向远方移动并促使臂29靠近。沿逆时针方向的转动使得臂分开。
臂29包括凸耳容纳凹陷部37，其设置成与出现在假体1上的凸耳11接合。当工具26的臂29靠近时，其稳固地握住假体1的第一板3和第二板5，并将其固定为适合植入的方向。由于棱柱形凸耳11，这是方便的，所述凸耳的四面被迫地保持在保持工具26的臂29的互补凹陷部内。
施加颈部牵引以扩大盘间隙并且将假体1插入到其中。松开颈部牵引并且假体1往复转动数次以确保假体1的锉刀状大纹理表面7和9与椎骨端板接合。所述运动在图8中示出。
插入工具26从假体1脱离，伤口闭合。
当假体的大纹理表面7和9已经机械地接合到椎骨的端板中后，假体1应该足够稳定以便于其正常并立即地发挥功能。插入过程将在大纹理表面7和9的凹陷部中种入精细的骨颗粒，这将刺激骨向内生长，从而提供永久的稳定性。
在骨已经向内生长到大纹理表面7和9后取下假体的操作可如下实现：
通过外科手术露出合适的运动段，并且将假体1的第一板3和/或第二板5上的凸耳11保持在保持工具26中。然后，精工凿或骨刀穿过凸耳11之间并跨置在上和/或下表面上，以将其从端板脱离，其中该精工凿或骨刀设置有止挡件以防止其穿透而超过假体的已知深度。现在，可使用保持工具26将假体1从椎间间隙中取出。
上面所有引述的文档全文引入以供参考。

Claims (29)

1.一种椎间假体，其包括第一板和第二板，其中各个板包括：一个大致平坦的骨接合面，该骨接合面带有能够磨锉椎间骨表面的大纹理表面；和一个或多个凸耳，其在该假体进行椎间插入时，抵靠住椎骨的非椎间表面以限制假体的插入。
2.如权利要求1所述的椎间假体，其中所述大纹理表面为盘形。
3.如前述权利要求中任一项所述的椎间假体，其不包括任何用于将假体固定到椎骨的非椎间表面的固定装置或用于容纳此类固定装置的孔。
4.如前述权利要求中任一项所述的椎间假体，其中所述各板包括一个位于所述大纹理表面和所述一个或多个凸耳之间的未纹理化区域。
5.如前述权利要求中任一项所述的椎间假体，其中所述未纹理化区域比大纹理表面低约0.4～1mm。
6.如前述权利要求中任一项所述的椎间假体，其中所述未纹理化区域在所述大纹理表面和所述一个或多个凸耳之间形成一个边界，并且该边界有介于2～10mm的可变宽度。
7.如前述权利要求中任一项所述的椎间假体，其中所述一个或多个凸耳位于各板的一侧。
8.如前述权利要求中任一项所述的椎间假体，其中各板包括两个凸耳。
9.如前述权利要求中任一项所述的椎间假体，其中各板插入到椎间间隙中的边缘被称作后缘且相对的边缘被称作前缘，并且所述凸耳位于各板的前缘上。
10.如权利要求9所述的椎间假体，其中在椎间假体的各个板的后缘处有一个斜切以有助于椎间假体插入。
11.如前述权利要求中任一项所述的椎间假体，其中所述凸耳能接合到插入工具。
12.如前述权利要求中任一项所述的椎间假体，其中所述凸耳为棱柱形。
13.如权利要求12所述的椎间假体，其中各个棱柱形凸耳的方向设置为在椎间插入时，其前后朝向顶边的平坦底面将与椎骨的前面的非椎间表面接合。
14.如前述权利要求中任一项所述的椎间假体，其中所述第一板和第二板关节联接到一起而在板间提供生理范围内的运动。
15.如前述权利要求中任一项所述的椎间假体，其中所述大纹理表面包括半径一般大于0.4mm的孔或凹陷部。
16.如前述权利要求中任一项所述的椎间假体，其中该假体由不锈钢、钛、碳化钛、锆及任意生物相容的等同物制成。
17.一种研磨试验设备，该设备大致与根据权利要求1～16中任一项的椎间假体具有相同的尺寸，并包括一个或多个尺寸、形状和位置与根据权利要求1～16中任一项的椎间假体的凸耳相应的凸耳，其中试验设备的板的表面具有使椎骨端板光滑的研磨表面。
18.如权利要求17所述的研磨试验设备，其中所述研磨表面包括一系列切削刃或镶有金刚石的表面，以形成一个锉或精加工的锉刀状表面。
19.如权利要求17或18所述的研磨试验设备，其能由一个或多个凸耳连接到一个插入工具。
20.如权利要求17或18所述的研磨试验设备，其形成为具有加长柄的单个单元而使得其可插入到椎间间隙中。
21.一种确定尺寸的试验设备，具与权利要求1～16中任一项的假体大致具有相同的形状和尺寸，并包括一个或多个棱柱形凸耳，该凸耳的尺寸、形状和位置都与权利要求12中的椎间假体的凸耳相对应。
22.一种插入工具，包括：
一个轴杆，其具有一个近端和一个远端，其中近端包括一个柄，远端包括两个偏置分开的假体接合臂；和
一个圆筒，其具有一个近端和一个远端，其与主轴杆转动地接合，
其中圆筒的远端接触假体接合臂并且当圆筒向远端转动时，该圆筒的远端推动假体接合臂合拢以握住根据权利要求1～16中任一项的椎间假体。
23.一种套件，包括一个或多个根据权利要求1～16中任一项的椎间假体、一个或多个根据权利要求17～20中任一项的研磨试验设备和一个或多个根据权利要求21的确定尺寸的试验设备。
24.如权利要求23所述的套件，其还包括根据权利要求22的插入工具。
25.如权利要求23或24所述的套件，其包括一系列不同尺寸的椎间假体和相应的一系列不同尺寸的研磨试验设备及确定尺寸的试验设备。
26.一种插入根据权利要求1～16中任一项的椎间假体的方法，包括：
准备椎骨端板，所述端板间将插入所述椎间假体，通过在椎间间隙内插入并移动根据权利要求17～20中任一项的研磨试验设备，而使端板光滑并确保所述试验设备的一个或多个凸耳与椎骨的无椎间表面接合；和
将椎间假体插入到准备好的椎间间隙中；和
在椎间间隙内移动假体以确保大纹理表面与椎骨端板接合。
27.一种从椎间间隙中取出根据权利要求1～16中任一项的椎间假体的方法，包括在各端板的大纹理表面和假体端板之间穿入一个精工凿或骨刀。
28.将根据权利要求1～16中任一项的椎间假体用于治疗中。
29.将根据权利要求17～20中任一项的研磨试验设备或根据权利要求21的确定尺寸的试验设备用于治疗中。
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