CN1167391C - 体内脊骨融接植入物 - Google Patents

体内脊骨融接植入物 Download PDF

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Publication number
CN1167391C
CN1167391C CNB961955856A CN96195585A CN1167391C CN 1167391 C CN1167391 C CN 1167391C CN B961955856 A CNB961955856 A CN B961955856A CN 96195585 A CN96195585 A CN 96195585A CN 1167391 C CN1167391 C CN 1167391C
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CN
China
Prior art keywords
implant
present
bone
disc space
adjacent
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Expired - Fee Related
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CNB961955856A
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CN1190880A (zh
Inventor
���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

体内脊骨融接植入物，包括：一个用于先插入椎间盘空间的插入端，和一与插入端相对的尾端，一中间纵向轴，和一沿中间纵向轴的长度；在插入端和尾端之间的上和下表面，适于将相邻脊骨体隔开，植入物有一在上和下表面之间的高度；在上和下表面之间和在插入端和尾端之间的相对侧部，在相对侧部之间的宽度，和植入物的最大宽度大于所述植入物的最大高度，上和下表面沿植入物的长度的至少一部分相互呈一角度关系，上和下表面有至少一个穿过其中的开口，开口是相互连通的，允许骨从相邻脊骨体通过植入物生长进入相邻脊骨体，上和下表面各有一相对的内表面，内表面隔开形成一与开口相通近内部空腔。

Description

体内脊骨融接植入物
本申请是1994年6月22日提交的共同未决美国专利申请系列No.08/263 952的部分继续申请，此No.08/263 952则是1993年4月22提交的申请系列No.08/052 211的继续申请，而No.08/052211又是1990年7月2日提交的申请系列No.07/546849的继续申请，No.07/546849则又是1988年6月28日提交的申请系列No.07/212 480的继续申请。
技术领域
本发明一般涉及到体内脊骨融接植入物，具体涉及到这样的脊骨融接植入物，其构型能恢复和保持两相邻脊骨取正确的结构角度关系。
背景技术
人体脊柱的颈椎与腰椎区在健康状态下为脊柱前凸的，即使得它们向前凸弯。在脊柱病变状态下，通常会丧失脊柱前凸性。这样将显著地缩短脊骨小管而减小其容量。此外，脊柱前凸性的缺乏会使脊髓前移到使其椎有可能压向脊骨体和椎间盘的后部。最后，脊柱前凸性的丧失会干扰脊骨的力学性质，而这会在整个相邻的脊骨段上造成级联式的变质。
对椎间盘的各种塌缩状态和丧失脊柱前凸的脊骨衰变状况进行手术治疗通常涉及到脊骨融接。这是通过共用的骨压将相邻脊骨结合到一起。当共用的骨处在事先已为椎间盘占据的区域内时，便称作为体内融接。这方面的更进一步的史料见于申请系列No.08/263 952题名为“人造脊骨融接植入物”(母申请)中，现综合于此作为参考。
上述母申请公开了使用能放置在相邻脊骨间的人造脊骨融接植入物，而且这种植入物能在融接现场含有和提供包括骨料的融接促进物质。这样的植入物还能恢复椎间盘空间的高度和支承脊柱，并且是自稳定的还同样能使所植入的脊柱区稳定。
一个相关的对比文件是美国专利NO.3,867,728(授予stubstadet al.)，其中公开了一种柔性脊骨椎间盘修复物，其结构能绕骨向内生长，并能保持脊骨的活动性，但其中没有公开脊骨融接植入物，其优点是用柔性椎间盘修复物而不用融接，以减少相邻椎间盘的机械压力。
发明内容
本发明是针对这样的体内脊骨融接植入物，它所具备的结构能保持和确立两相邻脊骨的正常的解剖学上的角度关系，从而保持和形成脊柱前凸。本发明的脊骨融接植入物的尺寸能配合到通过除去两相邻脊骨间的椎间盘物质而形成的椎间盘空隙之内，并能全部或部分地仿随所形成的椎间盘空隙内。本发明的脊骨融接植入物具有上表面和下表面，形成支持相邻脊骨端板的支承结构。在最佳实施例中，此上与下表面配置成相互会聚的角度关系，使得本发明的植入物在侧视图上整体呈“楔形”的。这种上、下表面的角度关系使得与这些表面相邻的脊骨相互定位和保持一种角度关系，形成和保持着所需的脊柱前凸。
本发明的植入物可以具有表面的不规则性来加大其表面面积和/或进一步结合相邻的脊骨而提高稳定性。本发明的脊柱前凸的植入物所具有的表面不规则性，在高度上沿着上、下脊骨结合表面的纵轴线是一致的，或可以在高度上从植入物的一端到另一端增加。这就是说，此植入物和所形成的表面以及突起都可以类似为楔形的。表面突起的外部轮廓可以至少是矩形的而底下的植入物可以是楔形的；或者相反，底下的植入物主体至少是矩形的，而表面突起的轮廓则同植入物的一端到另一端呈楔形。
本发明的植入物可以有种种面部构型，它们可以弯曲仿随与除去的椎间盘区域相邻的脊骨表面的形状。具体地说，此上和/或下表面可以是凸形的，和/或此前和/或后表面可以是凸形的。本发明的植入物的表面可以具有能或不能全部通过它们的孔口以及一与这些表面通孔通连的中央室。这些孔口可以具有任意的尺寸和/或形状和/或分布。这类植入物本身可以由不同材料组成和/或经过表面处理，以促进极细微的骨的向内长入到植入物内。
在进行后向的腰椎体内融接时，要是已进行了总的细胞核解剖，那就不能用单一的大型植入物作为包含脊髓的精细的硬脑膜囊来取代椎间盘的除去的部分，同时神经根则始终覆盖住前向椎间盘空隙的至少某些部分。如前述母申请中所述，在这种情形下使用“模件式植入物”是恰当的。这种模件式植入物的长度近似于所除去椎间盘物质的深度但是较其要窄的多，使得它们能从后向引入椎间盘空隙内到硬脑膜囊的任一侧，然后并列于此椎间盘空隙内，使得它们中所具有的长度与从有关区域中除去的椎间盘深度一致的这批内的各个，组合成使其所具宽度等于除去的椎间盘物质的宽度。
本发明的模件式植入物可大致呈楔形，并可具有仿随脊骨端板轮廓的上表面与下表面，这种轮廓包括但不限于较为平直的形状或凹形。由于腰椎的椎间盘空间大体上是脊柱前凸形的，所述的植入物在最佳实施例中于向前方向亦即在植入物的插入端较高，而在朝后方向即植入物的尾端较低。为了将插入端高于椎间盘空间后方可资利用的空间的植入物引入，即使是此椎间盘空间作最恰当地岔开，也是成为问题的。
本发明的模件式植入物对上述问题提供了两种解决方法。在第一实施例中，这种模件式植入物的插入端可以具有缩减的尺寸，包括但不限于子弹头形、凸形以及倒棱成较小的前表面。于是就提供了这样的植入物，它具有足够小的面积，当椎间盘空隙适当地岔开时能引入此空隙的后方。同时此种植入物的特定前部的轮廓能使得，当此植入物向前推入椎间盘空隙内时，相邻的脊骨能相对于此植入物形成斜坡。
本发明的植入物对上述同一问题提供了第二种解决方法。在这种模件式植入物的最佳实施例中，植入物在其侧视图中仍旧是楔形的。它的插入端高于尾端。但是，这种植入物的尾端处装有用来与插入器械结合的装置如在前述母申请所公开的箱形与螺纹孔的结构。由于在最佳实施例中，这类植入物在竖立时于侧视图中呈楔形，而从顶视平面图观察时呈大致的矩形，于是这类植入物便设计成能在其侧面处引入椎间盘空隙内时，使得植入物的侧壁能同相邻脊骨的端板邻接。这种植入物所具有的边对边尺寸当竖起时小于通过此植入物插入端的尺寸。这样就能容易地通过植入物的边部将它们插入，然后再用与植入物结合的插入器械使植入物在完全插入后转过90°而至其完全竖立的位置。插入之后，植入物的上与下表面便同相邻脊骨的端板邻接，由于此植入物的上与下表面相互相对成一定角度关系，而使相邻的脊骨保持和形成所需的角度关系。
在本发明的另一实施例中，可将一种机械式的植入物插入塌缩位置，然后可调节加大此植入物的高度而使两相邻脊骨间隙的高度得到最恰当的恢复。这种机械式的植入物可以是楔形的和具有上与下表面，此植入物的轮廓一般依随相邻脊骨端板的接触区，而这种轮廓可以包括但不限于较平直的或凸的形状。此外，这种机械式的植入物可以是楔形的或大致矩形的，但通过调节可加大楔形的高度与宽窄程度。通过将本例中所用的两个楔形结构之一较另一更大或更陡，就易于实现上述目的。另外，也可采用单一的楔形件，而在有以上需要时可增大植入物一端的高度而限制其另一端高度，此时，植入物的端部可装设一铰接装置，通过从远端向此铰接端牵引一楔形件、棒、球或其它器件，得以驱使所述上、下表面依楔形相分开。
在本发明的又一实施例中公开了一种具有可用机械方法展开的骨结合装置的植入物。这种植入物在侧视图上通常为楔形的，所具有的上与下表面一般仿随脊骨端板为植入物接触的轮廓。而此上与下表面可以是但不限于平直的和或凸形的。应用这种可展开的骨结合装置特别有利于可将最大限度的植入物插入到椎间盘空间和骨结合装置中，后者要是固定于表面上则会阻碍植入物的插入，插入之后即可以展开而使此上与下骨结合装置梢端间的距离超过插入时可资利用的空间高度。这一特点当植入物为楔形时特别有利，因为在胸椎两端上显著的压缩载荷有可能将楔形植入物推出椎间盘空间。
本发明的第一个目的在于提供具有锥状前端，易于插入脊骨内的脊骨融接植入物；
本发明的第二个目的在于提供一种脊骨融接植入物，它在从一端到另一端时于高度上所具有的锥度和正常椎间盘的锥度一致；
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在解剖学上的一致性和脊柱前凸；
本发明的第四个目的在于提供本身在脊骨内能稳定化的脊骨融接植入物；
本发明的第五个目的在于提供插入时能使两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一种脊骨融接植入物，它在融接过程中能使相邻脊骨的间隙分开并支承成一定角度关系。
本发明的第七个目的在于提供能配合到相邻脊骨之间并保持脊骨端极的脊骨融接植入物。
本发明的第八个目的在于提供所具外形能仿随相邻脊骨端板的脊骨融接植入物。
本发明提供了一种体内脊骨融接植入物，用于插入一植入空间，该植入空间穿过人脊柱的相邻脊骨体之间椎间盘空间的外科手术校正的高度，所述植入物包括：
一个用于先插入椎间盘空间的插入端，和一与所述插入端相对的尾端，一中间纵向轴，和一沿所述中间纵向轴的长度；
在所述插入端和尾端之间的上表面和下表面，适于将相邻脊骨体隔开，所述植入物有一在所述上表面和下表面之间的高度；
在所述上表面和下表面之间和在所述插入端和尾端之间的相对侧部，在所述相对侧部之间的宽度，和所述植入物的最大宽度大于所述植入物的最大高度，其特征在于：所述上表面和下表面沿所述植入物的长度的至少一部分相互呈一角度关系，所述上和下表面有至少一个穿过其中的开口，所述开口是相互连通的，允许骨从相邻脊骨体通过所述植入物生长进入相邻脊骨体，所述上和下表面各有一相对的内表面，所述内表面隔开形成一与所述开口相通的内部空腔。
本发明上述的和其它目的可通过参阅附图及其详细说明而得以了解。
附图说明
图1是本发明的脊柱前凸的体内脊骨融接植入物的透视图，其中按部分打开的位置示明一给此植入物内腔提供通道的滑动门。
图2是本发明的脊柱前凸的体内脊骨融接植入物的顶视平面图。
图3是本发明的脊柱前凸的体内脊骨融接植入物的左侧视图。
图4是本发明的脊柱前凸的体内脊骨融接植入物的右侧视图。
图5是本发明的脊柱前凸的体内脊骨融接植入物的前端视图，表明上述滑动门处于部分打开位置。
图6是本发明的脊柱前凸体内脊骨融接植入物的后端视图，表明了用来结合插入器械的装置。
图7是沿图2中曲线7的局部放大图，表明本发明的脊柱前凸的体内脊骨融接植入物的骨结合面的构型。
图7A是一段脊柱的侧视图，其上有本发明的植入物按两相邻脊骨间不同的椎间盘高度插入到椎间盘空隙内，以维持和纠正相邻脊骨在解剖学上的一致性。
图8是本发明的脊柱前凸的体内脊骨融接植入物另一实施例的顶视平面图。
图9是图8中的植入物的左侧视图。
图10是图8中的植入物的前端视图。
图11是图8中的植入物的后端视图，表明用来结合插入器械的装置。
图12是沿图8中曲线12的局部放大图，表明本发明的脊柱前凸体内脊骨融接植入物的表面构型。
图13是网状材料制的本发明的脊柱前凸体内脊骨融接植入物又一实施例的顶视平面图。
图14是图13中植入物的左侧视图。
图15是图13中植入物的前端视图。
图16是图13中植入物的后端视图，表明用来与插入器械结合的装置。
图17是沿图13中曲线8的局部放大图，表明本发明的植入物的表面构型。
图18是本发明的脊柱前凸体内脊骨融接植入物另一实施例的透视图。
图19是图18中植入物的顶视平面图。
图20是图18中植入物的左侧视图。
图21是图18中植入物的后端视图。
图22是图18中植入物的前端视图。
图23是沿图18中曲线23的局部放大图，表明本发明的植入物的表面构型。
图24是本发明的脊柱前凸体内脊骨融接植入物又一实施例的透视图。
图25是图24中植入物的左侧视图。
图26是图24中植入物的后端视图。
图27是图24中植入物的前端视图。
图28是沿图24中植入物的曲线28的局部放大图，表明本发明的植入物的表面构型。
图29是沿图28中线29-29的剖面图。
图30是人体脊柱一段的侧视图，其中以剖面图表明的本发明的脊柱前凸脊骨融接植入物的实施例是可调与可展开的，插入于椎间盘空间的不同高度内以保持和校正相邻脊骨在解剖学上的一致性。
图31是本发明的脊柱前凸植入物的又一实施例的侧视剖面图，此植入物上有突剌708形状的可动突起，能在植入物700内从第一位置运动到伸至植入物外的第二位置。
具体实施方式
参看图1至7，其中示明了统一以100标明的用于椎间盘空间的本发明的脊柱前凸体内脊骨融接植入物。植入物100呈大致矩形结构，有上表面112和下表面114。在最佳实施例中，此植入物100的上与下表面112和114设置成相互会聚的角度关系，使植入物100在图3与4的侧视图中呈楔形。上与下表面112和114具有内表面，对于植入物100插入的两相邻脊骨的端板形成为支承结构。上与下表面112和114的角度关系使得邻接适当表面的脊骨定位和保持成一种角度关系，确立和保持着脊柱所需的前凸性。
植入物100的上与下表面112和114可以是平坦的或弯曲的，仿随植入物100插在的相邻脊骨的端板的形状。植入物100仿随从脊骨中除去的髓核和部分纤维环的形状。上与下表面112和114包括表面糙化结构，提供了当植入物100经手术植入后适合与相邻脊骨结合且使植入物稳定的表面。此上与下表面112和114的表面糙化结构包括表面滚花121。
参看图7，其中示明了钻石形骨结合构型的植入物100的表面滚花121的局部放大图。植入物100可以在上与下表面112和114的全部或局部具有表面滚花121或是其任何组合形式，这些都不脱离本发明的范围。还应知表面滚花121除所示构型外还可有其它构型。
在此实施例中，植入物100是空心的，包括一批通过上与下表面112和114而进入中央空心腔116的孔口115。孔口115使得骨能从脊骨经孔口115生长到内腔116中。孔口115在图中所示虽为圆形的，但应知其可取适用于植入物的任何形状、尺寸、构型或分布而不脱离本发明的范围。例如，此种孔口可以具有泪滴形如图1与2中所示的孔口115a。植入物100的上与下表面112和114为同样包括一批孔口122的侧壁118所支承和分开。
植入物100的插入端120和尾端130两者都可以是弧形或平直形。植入物的尾端130可以是凸的而形成脊骨的曲率，并且有用来扩张植入物插入器械的装置，后者包括一带有用来接纳驱动器械结合端的螺纹口126的下凹部124。植入物100的插入端120包括入口132和用来关闭入口132的滑动门134。滑动门134关闭着通入腔116的入口132并可让自生的骨料进入腔116内。
使用时，将滑动门134置于敞开位置而将有关物料装到腔116内。滑动门134有一凹座便于此门的关/闭。内腔116可装填和保持任何天然或人造的骨传导、骨感生、骨成长的物质或其它融接促进物质。这类物质的某些例子是从病人身体取下的骨，或是骨生长的诱发物质但不限于羟磷灰石或羟磷灰石三磷酸钙或是骨的形态发育蛋白质。植入物100本身是由适于人体插入的材料制成例如钛；同时/或者可以由促使骨向内生长的物质例如但不限于羟磷灰石或羟磷灰石三磷酸钙或任何其它骨传导的、骨感生的、骨生长的或其它融接促进物质制成和/或充填和/或涂层。
充填到植入物100的腔116内的融接促进物质是用来促进骨向内生长到植入物100与相邻脊骨之间的。一旦骨开始向内生长后，植入物100便会永久地固定，防止植入物脱开和在相邻脊骨间有任何运动。
然后滑动门134在植入之前关闭。在关闭位置，此滑动门仿随植入物100的插入端120的曲率。可以采用种种方法将自生的骨料来充填植入物100以获得完全充填好的植入物100。
植入物100的插入方法已详述于申请系列No.08/263 952中，其内容已综合于此作为参考。驱动器械的螺纹端装附到植入物100的尾端130的螺纹口126中，而使驱动器械配合到下凹部124内以防植入物100相对驱动器械运动。然后将植入物100置于两相邻脊骨V之间的椎间盘空间的进口处。再以足够结实的轻击驱动器械将植入物100驱入椎间盘空隙内。
植入物100的尺寸与它将取代的椎间盘物质的尺寸基本一致，但取决于为形成所用椎间盘空隙而除去的椎间盘物质量，可以较大或较小。在有关胸椎的最佳实施例中，植入物100宽约28-46mm而最好是36mm。植入物100的高度要求能使椎间盘空隙的解剖高度复原，其平均高度为8-16mm而最佳平均高度为10-12mm。深度的最大范围为20-34mm而最佳的最大深度为26-32。在颈椎情形，此植入物宽约14-28mm而最佳为18-22mm，高约5-10mm而最佳为6-8mm，深约11-21mm而最佳为11-13mm。
参看图7A，其中示明了脊柱S一段横向的侧视图，植入物100插在两相邻脊骨V2与V3的椎间盘空隙D2中。植入物100沿箭头A的示向插入椎间盘空隙D2中，将两脊骨V2与V3相互保持成可恢复脊柱S的这段的自然前凸的角度关系。植入物100的前椎为脊骨V2与V3端板中的天然骨突B所阻止。植入物100的退出则为上与下表面112和114的骨结合面滚花121所制止。
参看图8～12，其中示明了统一的200标明的本发明的脊柱前凸体内脊骨融接植入物的另一实施例。植入物200的总体结构与上述植入物100的相似。在此最佳实施例中，植入物200是实心的，包括许多从上表面212通过植入物200到下表面214的通道215。通道215给骨的向内生长提供了条件，便于将脊柱融接物质加入植入物200中。这些通道也可在植入之前装载例如前述的融接促进物质。应知通道215并不需要完全通过植入物200而是可以具有类似插孔的结构，可以保持溶融促进物质并允许骨向内生长到上与下表面212和214内。
植入物200除通道215外还可以有在侧壁218之上的通过或不通过整个植入物200的小孔222。小孔222可与通道215通道，使得可从孔口222到通道215发生骨向内生长而使植入物200锁定于融接物质中。要是小孔222不通过整个植入物200，它们就可起到小插孔的作用来保持前述融接促进物质。
在植入物200的最佳实施例中，通道215的直径为0.1-6mm而最佳为2-3mm。小孔222的直径为0.1-6mm而最佳为1-3mm。应知通道215与小孔222虽然图示为大致的圆形，但它们在本发明的范围内是可以根据所用目的而取任意尺寸、外形、构型与分布的。植入物200的上与下表面212和214上可有一批用来与相邻脊骨结合的联轴节250。联轴节250包括有骨结合边缘252与角段254。
具体参看图9，在植入物200的楔形的侧视图中，尾端230比插入端220高。这批联轴节250按插入端220的方向取向，由于骨结合边缘222结合脊骨并在植入物植入后防止其退出，而为植入物200提供了单向插入方式。另外，尾端的联轴节的高度可以较低，以使成组的联轴节的总体外形呈凸形。
参看图11，植入物200的尾端230具有用来与插入器械结合的装置，此装置包括有如以前所述用于植入物100的螺纹孔226。
参看图12，沿图8中曲线12的局部放大图表明了植入物200的表面构型。植入物200的上与下表面212和214，除联轴节250外尚包括多孔结构260以给骨提供不规则的表面促进其向内生长。多孔结构260也能用来保持融接促进物质，并在融接过程提供与骨结合的加大了的表面区同时进一步增强稳定性。多孔结构260也可以存在于侧壁218上。应知外壁面和/或整个植入物200可以包括任何其它多孔材料或糙化的表面，只要它们足以保持融接促进物质和/或在融接过程允许骨向内生长和/或与骨结合。植入物200还可涂以生物活性的融接促进物质，其中包括但不限于羟磷灰石化合物、骨生长蛋白质和骨形态发育蛋白质。
参看图13～17，其中示明了统一以300标明的本发明的脊柱前凸体内脊骨融接植入物的又一实施例。植入物300是由包括可由金属制的股绳的网状材料经压紧模制形成。上与下表面312和314可以是凸形的，防随脊骨端板的天然表面曲率。此外，整个植入物300可以模制成仿随从两相邻脊骨间取出椎间盘物质所形成的椎间盘空隙的形状。于是，植入物300具有弯曲的上与下表面312和314，弧形的侧壁318和倒棱的边缘319。
参看图7A，植入物300依箭头A示向插入相邻脊骨V1与V2间的椎间盘空隙D1中。植入物300仿随相邻脊骨V1与V2的端板的形状，因为上与下表面312和314是凸形的，而侧壁318则弯曲仿随脊骨V1与V2的天然曲率。此时，植入物300的尺寸与从相邻脊骨V1和V2间除去的椎间盘物质的相同。
植入物300可以全部或部分地由实心材料和/或多孔材料和/或网状材料制成。植入物300的表面可以由多孔材料、网状材料构成或可以是具有粗糙结构的表面。应知植入物300可以是实心的或部分空心的，并可以包括至少一个与所述上与下表面通连的内腔。
如图17所示，网状材料包括压制成形到一起的股绳，使得至少是在植入物300外表面上的股绳之间存在的孔隙能保持融接促进物质并允许骨向内生长。此外应知植入物300可由网格状材料制成类似于人体松质骨的构型，具备允许骨向内生长的孔隙。由于植入物300可以完全或部分由网格材料制成，上述孔隙可以存在于植入物300的外表面和/或整个植入物内，以促进骨向内生长和保持骨的融接促进物质。
参看图18～23，其中示明了统一以400标明的本发明的植入物的又另一实施例。植入物400基本上呈矩形，具有上与下表面412和414。此上与下表面412和414支承相邻脊骨，并以前述的相同方式设置成相互会聚的角度关系。
植入物400的宽度W显著地小于植入物100～300的宽度，使得可把一系列这种植入物用作体内脊骨融接植入物，它们相互紧邻放置成近似于除去的椎间盘的尺寸。植入物400的尺寸长约26mm，宽度足以使四个这种植入物能基本上填满脊骨间空隙，当然要取决于所融接的脊骨。
在进行后向胸椎体内融接时，要是已从事了总的细胞核解剖时，那就不能用单一的大型植入物作为包含脊髓的精细的硬脑膜囊来取代椎间盘的除去的部分，同时神经根则始终覆盖住前向椎间盘空隙的至少某些部分。在这种情形下使用模件式植入物400是恰当的。模件式植入物400的长度近似于所除去椎间盘物质的深度但是较其要窄的多，使得它们能从后向引入椎间盘空隙内到硬脑膜囊的任一侧，然后并列于此椎间盘空隙内，使得它们之中所具有的长度与从有关区域中除去的椎间盘深度一致的各个，组合成使其所见宽度等于除去的椎间盘物质的宽度。由于胸椎的椎间盘空隙通常是脊柱前凸式的，模件式植入物400的插入端420必需较高，而在后向于尾端430处则较低。为了将插入端高于椎间盘空间后方可资利用的空间的植入物引入，即是使此椎间盘空间作最恰当地岔开，也是成为问题的。模件式植入物400对此问题提供了两种解决方法。模件式植入物400的插入端420可以具有缩减的尺寸，包括但不限于子弹头形、凸形以及倒接成较小的前表面。于是所提供的植入物400便具有足够小的面积使当椎间盘空隙适当地岔开时能引入到此空隙的后方，同时此植入物400的特定前部的轮廓则能使得，当此植入物400向前推入椎间盘空隙内时，相邻的脊骨能相对于植入物400形成斜坡。
另一方面，或者是与以上所述相结合，由于在此最佳实施例中，这一植入物400在竖立时于侧视图中呈楔形，而从顶视平面图观察时呈大致的矩形，这样的植入物便能在其侧面处引入椎间盘空隙内时，使得植入物的侧壁能同相邻脊骨的端板邻接。植入物400所具有的边对边尺寸当竖起时会小于通过此植入物插入端的尺寸。这样就能容易地通过植入物的边部将它们插入，然后再用与植入物400结合的插入器械使植入物400在完全插入后转过90°而至其完全竖立的位置。插入之后，上与下表面412和414便同相邻脊骨的端板邻接，由于植入物499的上与下表面412和414相互相对成一定角度关系，而使相邻的脊骨保持和形成所需的角度关系。
植入物400具有矩形槽式的大的孔口415，用来保持融接促进物质以促进骨从脊骨通过上与下表面412和414而生长到植入物400内。由于植入物400是模件式的，一次可植入多个，大的孔口415也能存在于植入物400的侧壁418内而让骨能从一个植入物生长到另一植入物上，使得在相继融接之后，这些模件或植入物400能互连成一个单元。
参看图21，所示植入物400的尾端430具有插入器械结合装置，后者包括有矩形槽424和螺纹孔426。
参看图23，其中以沿图18的曲线23的局部放大图来说明植入物400的表面构型。植入物400的表面构型与前述多孔结构260相同。
参看图24，其中示明了统一以500标明的本发明的脊柱前凸的体内脊骨融接植入物。植入物500为模件式插入物，整体结构与植入物400类似。植入物500不具有槽415而具有上与下表面512和514，它们能接收和保持骨料或是其它能参与融接过程和/或能促进骨向内生长的物质。在最佳实施例中，此上与下表面512与514包括一批相分开的柱件，它们形成出一批孔隙542为带有不完全壁部的部分式插孔，能储放与保持研碎的骨料或任何其它人造的促进骨向骨生长的物质。植入物520在用于植入目的时，可用合适的融接促进物质浇注或涂层其表面538。
参看图28与29，其中示明了植入物500的上表面512的放大图及其部分横剖面。在最佳实施例中，柱件540具有直径较它的其余部分为大的头部544，而各个间隙542则取与柱件540相反的构型，具有的底部546较间隙542的入口要宽。柱件540与孔隙542的这种构型有助于将骨料保持于植入物520的表面538内，还有助于将植入物520锁定于由于骨向内生长而形成的骨融接物质中。由于在间隙542底部546处内生长的宽较入口548宽，向内生长的骨就不会从入口548出来而锁定于间隙542内。植入物520的表面538能加大可资利用的表面面积，而通过粗糙化加工、絮化或以其它方式形成不光滑的表面还能进一步加强上述效果。
在最佳实施例中，柱件540的最大直径约为0.1-2mm，高约0.1-2mm而间距约0.1-2mm，使得孔隙的宽度约为0.1-2mm。柱件的尺寸、外形与分布在同一植入物内也可不同。
应知植入物500具有与上述植入物400相同的结构与特点。
图30是以脊柱前凸形式示明的一段人体脊柱S的侧视图，而以600标明的可调节与可展开的脊柱前凸的脊骨融接植入物的另一实施例则插入于一空隙中，用来恢复和保持相邻脊骨在解剖学上的正确一致。植入物600包括下部件682和上部件684，它们配合到一起形成基本上是矩形的植入物。上部件684和下部件682具有相互面对的空心部分，纳置下配合于其中的锥形楔686与688。此上与下部件682和684各具有楔形的内表面689a与689b，后者弯向植入物600的内部。楔形的上与下部件682和684在其大端处高于这两个部件间组合的空心空间，  而在其另一端则较此空心空间浅。
楔形件686与688具有相互一致的中央螺孔690与692以接纳螺杆694。当螺杆694拧入螺孔690时，楔形件686与688便抵贴上与下部件682和684的内部斜面689a与689b。随着螺杆694的转动，楔形件686与688便引导到一起，而这些楔形件的斜坡部便迫使上部件682与下部件684分开。由于内部的斜面689a和689b在尾端630附近的斜率大于插入端620附近的，上与下部件682和684在插入端620处便较在尾端630处分开得较大。结果，此上与下部件682和684便相互配置成会聚的角度关系，并以此同一角度关系支承着相邻的脊骨V1与V2。
参看图31，其中统一以标号700示明了本发明的又一实施例。植入物700有突剌708形式的可动突起，后者可从植入物700内的第一位置移动到延至此植入物外的第二位置。植入物700取大致矩形构型，具有的顶面702和底面704带有槽706，而允许在其端部有突剌708的枢轴件707通过所述的槽707突出。突剌708在一端710处以销钉连接于植入物100内。
植入物700所具备的相对楔形件712和714具有中央螺孔716来接纳带头部720和槽722的螺杆718。楔形件712与714相互面对，使得在螺杆718转动时，这两个楔形件712和714将导引到一起而促致突剌708绕其端部710转动，通过准直的槽706而突向植入物700的外部。植入物700的上与下表面702和704中可有一批用来促进骨向内生长和融接的孔。
应用时，在除去椎间盘物质后，将带有处于后撤位置的突剌的植入物700插入椎间盘空隙内。然后转动螺杆718，直到突剌708受迫进到脊骨内而由此使植入物700牢牢保持就位时。
上面虽然相对于最佳实施例和许多其它的实施例描述了本发明，但应认识到，在不脱离本发明的范围内还可以设计出本发明另外的种种实施形式。

Claims (15)

1.体内脊骨融接植入物，用于插入一植入空间，该植入空间穿过人脊柱的相邻脊骨体之间椎间盘空间的外科手术校正的高度，所述植入物包括：
一个用于先插入椎间盘空间的插入端，和一与所述插入端相对的尾端，一中间纵向轴，和一沿所述中间纵向轴的长度；
在所述插入端和尾端之间的上表面和下表面，适于将相邻脊骨体隔开，所述植入物有一在所述上表面和下表面之间的高度；
在所述上表面和下表面之间和在所述插入端和尾端之间的相对侧部，在所述相对侧部之间的宽度，和所述植入物的最大宽度大于所述植入物的最大高度，其特征在于：所述上表面和下表面沿所述植入物的长度的至少一部分相互呈一角度关系，所述上和下表面有至少一个穿过其中的开口，所述开口是相互连通的，允许骨从相邻脊骨体通过所述植入物生长进入相邻脊骨体，所述上和下表面各有一相对的内表面，所述内表面隔开形成一与所述开口相通的内部空腔。
2.如权利要求1所述的植入物，其特征在于：所述植入物包括一在所述上和下表面之间的入口，所述入口的形状允许骨生长促进物质进入所述内腔。
3.如权利要求2所述的植入物，其特征在于：所述入口大于所述最大的开口。
4.如权利要求1所述的植入物，其特征在于：在所述上和下表面还包括一组表面突起，用于与相邻脊骨体接合，以将所述植入物保持在椎间盘空间内。
5.如权利要求4所述的植入物，其特征在于：所述表面突起的形状对于植入物在植入空间内的运动在插入方向比在相反方向有较小的阻力。
6.如权利要求1所述的植入物，其特征在于：所述侧部是相互平行的。
7.如权利要求1所述的植入物，其特征在于：所述植入物的形状从所述尾端到所述插入端是锥形的。
8.如权利要求1所述的植入物，其特征在于：所述植入物为楔形。
9.如权利要求1所述的植入物，其特征在于：所述植入物包括一组可动突起，其形状可与相邻脊骨体接合。
10.如权利要求1所述的植入物，其特征在于：所述植入物包括一网状材料，其有一批孔隙用于接纳融接促进物质。
11.如权利要求1所述的植入物，其特征在于：所述植入物包括：一批模件，每个模件形成：所述上和下表面，所述插入端和尾端，和所述相对的侧部，从而所述一批模件的形状当插入两相邻脊骨体之间时能相互接近地定位以形成所述植入物。
12.如上述权利要求中任一所述的植入物，其特征在于：所述植入物至少部分是生物可吸收的。
13.如权利要求1-11中任一所述的植入物，其特征在于：所述植入物与融接促进物质相结合。
14.如权利要求13所述的植入物，其特征在于：所述融接促进物质至少包括骨、骨的形态发育蛋白质、羟磷灰石、羟磷灰石三磷酸钙的一种。
15.如权利要求1-11中任一所述的植入物，其特征在于：所述植入物与一驱动器械相结合用于将植入物插入脊骨。
CNB961955856A 1995-06-07 1996-06-06 体内脊骨融接植入物 Expired - Fee Related CN1167391C (zh)

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WO1996040015A1 (en) 1996-12-19
US6447544B1 (en) 2002-09-10
CA2223964A1 (en) 1996-12-19
EP1829503A2 (en) 2007-09-05
US6302914B1 (en) 2001-10-16
EP1829503B1 (en) 2009-09-16
JP2007236972A (ja) 2007-09-20
US8444696B2 (en) 2013-05-21
DE69638030D1 (de) 2009-10-29
US20030040798A1 (en) 2003-02-27

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