CN103619272A - 最小侵入椎间的系统和方法 - Google Patents

最小侵入椎间的系统和方法 Download PDF

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Publication number
CN103619272A
CN103619272A CN201180056816.0A CN201180056816A CN103619272A CN 103619272 A CN103619272 A CN 103619272A CN 201180056816 A CN201180056816 A CN 201180056816A CN 103619272 A CN103619272 A CN 103619272A
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China
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implant
far
volutin
intervertebral
axle
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Granted
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CN201180056816.0A
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CN103619272B (zh
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托马斯·珀塞尔
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EIT Emerging Implant Technologies GmbH
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Individual
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Abstract

一种最小侵入椎间的植入物，该植入物包括：迂回体，其限定穿过其纵向延伸的腔轴。所述迂回体包括沿着所述迂回体的横轴相对地设置的近端和远端。所述近端和远端中的每一个包括穿过其设置的孔，使得所述迂回体包括：第一结构，其中所述近端和远端以最大间隔设置；和第二结构，其中所述近端和远端设置为比在第一结构中的距离更近。

Description

最小侵入椎间的系统和方法
相关申请的交叉参考
本申请要求2010年10月5日在美国提交的第61/389,986号临时专利申请的优先权，其全文通过引证的方式并入本文中。
技术领域
本发明一般涉及用于治疗椎间损伤的装置，更具体地，涉及最小侵入椎间的植入物，该植入物可塑性变形从而提高骨移植体积并且与椎体终板相接触。
背景技术
目前，使用三个主要原则设计椎间装置：外科手术方法的解剖限制，促进骨融合的骨移植体积的最优化，以及与椎体终板相接触从而抵制下沉的装置最优化。目前的装置基本是静止的，因为它们不能改变形状或体积。因此，当前装置被解剖学和技术所限制，因此不能提供最佳的骨移植体积或表面接触。
需要可以改变形状和/或体积的椎间装置或植入物。这样的装置得益于在具有减小的横向尺寸的第一结构中能够推进到植入位置并且随后转变为在植入位置具有期望的横向尺寸的第二结构的能力。这样的装置得益于通过材料的塑性变形可以保持在第二结构中的刚性结构和/或将装置锁定在第二结构中的机构。这样的装置还得益于通过将植入物放置和定位在植入位置并且还传送骨移植材料从而填充植入物的内部体积的简单工具可快速植入。
发明内容
在本发明的一个方面中，最小侵入椎间的植入物包括迂回体，其限定穿过其纵向延伸的腔轴。所述迂回体包括近端和远端，所述近端和远端沿着所述迂回体的横轴相对地设置。所述近端和远端中的每一个包括穿过其设置的孔，使得所述迂回体包括：第一结构，其中所述近端和远端以最大间隔设置；和第二结构，其中所述近端和远端设置为比在第一结构中的距离更近。
在本发明的另一个方面中，一种最小侵入椎间的植入物系统包括：最小侵入椎间的植入物和植入工具，该植入工具包括：套管，其包括一对从其远端向远端延伸的叉状物；轴，其适于经由套管纵向可滑动地设置并且包括螺纹远端；手柄，其连接到所述轴的近端。该系统可以还包括：漏斗，其具有适于可移除地连接到所述套管的近端的远端；和柱塞，其适于与所述漏斗的腔形成滑动密封从而使骨移植材料经过所述套管推入。
在本发明的另一个方面中，提供了一种使用植入工具植入最小侵入椎间的植入物的方法。该方法包括以下步骤：将在第一结构中的最小侵入椎间的植入物连接到所述轴的螺纹远端，使得一对叉状物啮合到向近端延伸的一对槽上；并且向着植入位置推进所述轴的远端使得所述迂回体的腔轴在植入位置与骨表面基本平行。该方法还包括以下步骤：旋转套管约90度使得所述腔轴基本垂直于所述骨表面；向近端相对于所述套管平移所述轴从而将最小侵入椎间的植入物从第一结构转变为第二结构；以及从最小侵入椎间的植入物上分离所述植入工具。所述方法可以还包括以下步骤：通过相对于所述套管旋转所述手柄从最小侵入椎间的植入物上分离所述轴，从所述套管中撤出所述轴，将所述漏斗连接到所述套管的近端，并且用柱塞将骨移植材料经由漏斗和套管推入直到最小侵入椎间的内部体积被填满。
附图说明
图1是在第一结构中的最小侵入椎间的植入物的实施方式的等距视图。
图2A是图1的最小侵入椎间的植入物在第一结构中的横向正面图。
图2B是图1的最小侵入椎间的植入物在第一结构中的腔的正面图。
图2C是沿着图2B的2C-2C线的最小侵入椎间植入物的截面图。
图3是图1的最小侵入椎间的植入物在第二结构中的等距视图。
图4是图1的最小侵入椎间的植入物在第二结构中的腔的正面图。
图5A例示了具有处于打开位置的锁定机构的活动铰链。
图5B例示了图5A的活动铰链处于锁定位置。
图6例示了连接到植入工具的一个实施方式的最小侵入椎间的植入物。
图7是图6的植入工具的近端正面图。
图8是植入工具基本沿图7的8-8线的截面图。
图9是植入工具的远端沿图6的9-9线的放大截面图。
图10A是在第一结构中的最小侵入椎间的植入物和在连接前的植入工具的远端沿图6的9-9线的截面图。
图10B是例示了图10A的与最小侵入椎间的植入物的槽啮合的植入工具的叉状物的视图。
图10C是例示了图10B的与最小侵入椎间的植入物的远端孔相啮合的植入工具的轴的螺纹端的视图。
图10D是例示了图10C的最小侵入椎间的植入物转变到第二结构的视图。
图11例示了最小侵入椎间的植入物在植入位置的一个实施方式使得植入物的腔轴在植入位置与骨表面基本平行。
图12例示了在旋转前在图11的植入位置的最小侵入椎间的植入物。
图13例示了在旋转后在图11的植入位置的最小侵入椎间的植入物使得植入物的腔轴基本垂直于骨表面。
图14例示了在旋转后并且在从第一结构转变为第二结构之前在图11的植入位置的最小侵入椎间的植入物。
图15例示了在填充骨移植材料前在图11的植入位置的在第二结构中的最小侵入椎间的植入物。
图16例示了在图11的植入位置在第二结构中的通过植入工具填充骨移植材料并且由漏斗和柱塞替换轴和手柄的最小侵入椎间的植入物。
结合附图，本发明的上述其它特征以及优点从下面详细描述的例示性实施方式中将显而易见，其中可以用相同的标号指定相同的结构或功能元件。
具体实施方式
术语近端和远端被用来表示本文描述的当前发明的部件的特定端。近端指的是当植入部件时靠近医职人员的部件的端。远端指的是当植入部件时远离医职人员的部件的端。
参照图1-4，最小侵入椎间的植入物100的一个实施方式包括迂回体105，其限定穿过其纵向延伸的腔轴110，如图1所示。迂回体105包括沿着所述迂回体105的横轴125相对地设置的近端115和远端120。在图2C中最明显，近端孔130穿过迂回体105的近端115设置，远端孔135穿过迂回体105的远端120设置。如图1所示，为了方便描述，定义了垂直于腔轴110和横轴125的水平轴140。在一个实施方式中，在远端孔135的腔表面145上设置螺纹（未示出）。
迂回体105包括第一结构200，其中近端115和远端120处于最大间隔，如在图1和2B中最佳示出地。参照图3和图4，迂回体105包括第二结构300，其中近端115和远端120以比最大间隔小的距离被分隔并因此比在第一结构中靠得更近。迂回体105可以通过材料的塑性变形保持在第二结构中。
在一个实施方式中，迂回体105包括刚性生物学惰性材料，通过例示而非限制的方式，包括钛、钛合金、和聚醚酮酮（PEEK）。通过弹性变形或塑性变形，迂回体105可以从第一结构200转变为第二结构300。优选地是，如果从第一结构200转变到第二结构300迂回体105是塑性变形，迂回体105在转变之后保持第二结构300。在远端120向着近端115施加足够的力，如图4中的箭头116所示，引起迂回体115从第一结构200转变为第二结构300。
参照图1、2B、3和4，在一个实施方式中，迂回体105包括具有分段150的单片单元，该分段150由设置在迂回体105的内表面157中的活动铰链155连接，并且在从第一结构200转变为第二结构300的过程中塑性变形。如图1、2B和5A所示，当迂回体105在第一结构200中时，活动铰链155处于打开位置。如图3、4和5B所示，一旦转变为第二结构300，分段150相对于彼此旋转，如图5A中的箭头165所示，使得活动铰链155处于闭合位置。
在一些实施方式中，活动铰链155从图1、2B和5A所示的打开位置塑性变形到如图3、4和5B所示的闭合位置，可以提供足够的塑性变形使得迂回体105在其转变后保持第二结构300。在其它实施方式中，可以设置锁定机构170，例如公压缩卡扣和母压缩卡扣170a,170b，如图5A和5B所示。在这个实施方式中，当进入母压缩卡扣170b时，公压缩卡扣170a的卡钩端向着彼此压入。最后，由于分段150旋转使得活动铰链155到达图3、4和5B所示的闭合位置，公压缩卡扣的卡钩端在母压缩卡扣内到达超过一组内部台肩的深度，在该点卡钩端弹开并且被内部台肩永久捕获。
可以使用其它锁定机构170来保持迂回体105在其转变后保持在第二结构300中，通过例示而非限制性的方式，包括接触粘合剂、与母卡扣啮合的单一的卡钩公卡扣等。本发明也构思了锁定机构170可以还包括棘轮机构（未示出），由此母压缩卡扣170b在更深的位置包括多套内部台肩使得活动铰链155可以锁定在位于如图1、2B和5A所示的完全打开位置和如图3、4和5B所示的完全闭合位置之间的任何多个位置。
参照图1、2B、3和4，在一些实施方式中，迂回体105的至少一个面向纵向的表面175包括适于提高与骨表面固定接触的纹理180。此外，参照图1、2A和3，迂回体105的近端115包括在近端115的外表面190相对地设置的一对向近端延伸的槽185。下文将充分描述，槽185适于容纳植入工具（参见附图6-9、12、13和16）的叉状物（参见附图6和9-11）。
参照附图6-9，用于最小侵入椎间的植入物100的植入工具400的一个实施方式包括套管405，其具有一对从套管405的远端415向远端延伸的叉状物410从而与在迂回体105中的槽185啮合。参照图8-10D，植入工具400包括轴420，其适于经由套管405纵向可滑动地设置。在一个实施方式中，轴420包括螺纹远端425，其适于与设置在迂回体105的远端孔135的腔表面145上的螺纹（未示出）啮合。在其它实施方式中，远端425包括其它用于连接到远端孔135的腔表面145的可移除固定机构，通过例示而非限制的方式，包括键控孔、卡扣槽等。手柄430连接到轴420的近端435。参照图16，植入工具400还包括柱塞和漏斗，该柱塞和漏斗在下文中将结合用于植入侵入椎间的植入物100的方法充分地描述。
如图10A-10D所示，植入工具400将迂回体105从第一结构200转变为第二结构300。此外，如图11-16所示，植入工具400在植入位置协助放置、定位和填充最小侵入椎间的植入物。参照图10A，在第一步骤中，最小侵入椎间的植入物100处于第一结构200中。套管400的远端415被放在靠近迂回体105的近端115使得一对叉状物410与一对槽185对齐。接下来，套管405相对于最小侵入椎间的植入物110向远端推进，如图10B中的箭头440所示，使得一对叉状物410与一对向近端延伸的槽185啮合。
在图10B中所示的方法的点，套管405连接到迂回体105的近端115使得套管405的旋转引起迂回体115的旋转。该旋转独立于可以自由旋转并且在套管405内沿着横轴135自由平移的轴420。
参照图10C，轴420相对于套管405向远端推进使得轴420的远端425经由近端孔130穿过。参照图2C、10A、10B和10D，在一个实施方式中，内部凹槽195设置为在迂回体105的内表面157中沿着横轴125横向延伸。内部凹槽195为轴420提供了从近端孔130到远端孔135穿过迂回体的空隙。该空隙允许迂回体105在第一结构200中被横向压缩。与如果没有内部凹槽195的情况相比，该横向压入可以允许迂回体105进入到更小的空间，例如，椎间隙。
轴420相对于套管405向远端进一步推进，如图10C中的箭头445所示，直到远端425穿入远端孔135。在这个实施方式中，使用连接到轴420的近端435的手柄430，远端425和远端孔135的腔表面145可以通过轴420相对于套管405的旋转螺纹啮合。参照图10D，在将轴420的远端425连接到远端孔135之后，在相对于套管405沿近端方向，向轴420施加一个力。在这个实施方式中，在轴420内，所述力作为张力被有效地传递，将侧向压力施加到位于远端孔135和近端115之间的迂回体105。在迂回体105从第一结构200转变为第二结构300之后，轴420的远端425从远端孔135断开并且从套管405移除。
上文结合附图10A-10D描述了植入工具400如何将迂回体105从第一结构200转变为第二结构300，现在将描述植入工具400在植入位置放置、定位和填充最小侵入椎间的植入物100。参照图11，在第一步骤中，植入工具400的远端415，包括处于第一结构200中与其连接的具有与远端孔135啮合的轴420的远端425的最小侵入椎间的植入物100，在例如位于脊椎510的椎骨505间的空间位置被推进到植入位置500。最小侵入椎间的植入物100被定位在植入位置500使得迂回体105的腔轴110在植入位置500与骨表面515基本平行。
迂回体105一开始如图11所示定向的一个原因是由于这样的定向可以相对容易地进入椎间隙。现有技术已知，在将最小侵入椎间的植入物100放进在椎间隙之前，在椎间隙任意侧的椎骨被转移。在一些方法中，转移通过具有桨叶的工具完成，该桨叶可以从椎间进入，并且然后可以散开从而分开椎骨。对分开椎骨有用的工具可以例如在Reindel等人发明的美国专利公开第2009/0306672号中找到，该专利公开的内容通过引证的方式全文并入本文中。
在分开椎骨之后的常规步骤包括准备用来引入植入物的椎间隙。准备椎间隙在现有技术中已知可以包括移除椎间盘环的一部分或撤出椎间盘核。其它步骤可以包括在椎骨上移除软骨终板。为了引入植入物在准备椎间隙时有用的工具可以在例如Jansen等人发明的美国专利第7,632,278号中找到，该美国专利的全文通过引证的方式并入本文中。
如上所述，结合图2C、10A、10B和10D和内部凹槽195，迂回体105的横向压入相比如果没有内部凹槽195的情况可以允许迂回体105进入更小的空间。将迂回体放入更小空间的这个能力有利于减小周围椎骨分开。因此，迂回体105被引入到椎间隙中使得外表面190最初面向骨表面515，并且面向纵向的表面175不面向骨表面515。
参照图12和13，在最小侵入椎间的植入物100的初始放置之后，迂回体105旋转约90度，如图12中的箭头520所示。图13和图14例示了迂回体150随后旋转并定位，使得纵向面向的表面175面向骨表面515并且外表面190不面向骨表面515。
参照图6、8、12、13和16，在一些实施方式中，植入工具可以包括固定地连接到套管405的旋转位置指示器525。因为套管通过啮合在槽185中的叉状物410可旋转地固定到迂回体105，迂回体105的相对旋转位置由旋转位置指示器525的相对旋转位置反映。
还参照图6、8、12、13和16，在另一个实施方式中，植入工具400可以还包括覆盖构件530，其附加在套管405的近端535之上使得手柄430的远端540被覆盖构件530的近端545容纳。覆盖构件530提供了更大的表面使得医职人员可以更容易地握持和操作。此外，覆盖构件可旋转地固定到套管405并且可以包括孔547，经由该孔可以看见旋转位置指示器。
第一位置标记550和第二位置标记555靠近手柄430的远端540设置。当能够看见第一标记550且第二标记555被覆盖构件530遮挡时，轴420的远端425从套管405的远端415延伸第一距离，该第一距离例如对应于操作地连接到在第一结构200中的迂回体105的远端孔135的轴420。当第一标记550和第二标记555都能够被看见时，轴420的远端425从套管405的远端415延伸第二距离，该第二距离例如对应于操作地连接到在第二结构300中的迂回体105的远端孔135的轴420。因此，除了通过现有技术中的其它已知方法能看见植入位置500以外，第一标记550和第二标记555可以给医疗工作者提供视觉帮助来确定迂回体105的状态。
再参照图14，迂回体105被适当地定向从而从第一结构200转变为第二结构300。如图15所示，在上文中结合10A-10D的详细描述，迂回体105通过在其近端和远端之间施加侧向压力从第一结构200转变为第二结构300。
参照图16，在迂回体105传递和定向并且转变到第二结构300之后，轴420和手柄430从套管405上移除，如上文结合10A-10D详细描述地那样。在一个实施方式中，植入工具400包括具有远端565的漏斗560，该远端565适于可移除地连接到套管405的近端535。漏斗560可以通过现有技术中的任何已知方法连接到套管405，通过例示而非限制的方式，包括按压卡扣、滑入卡扣、卡销插座、螺纹等。
为了使骨移植材料经由套管405到达位于迂回体105内的植入位置500，柱塞570适于与漏斗560的腔形成滑动密封。因此，在植入最小侵入椎间的植入物的最后一个步骤中，利用柱塞570骨移植材料经由漏斗560和套管405被推入直到最小侵入椎间的植入物的内部空间被填满。
本发明介绍了最小侵入椎间的植入物、其植入工具以及用来植入的植入方法。植入物受益于具有可扩展的几何形状从而允许植入物放置在比典型地固定几何形状植入物更小的椎间隙内。
本领域技术人员将理解地是，在不偏离本文描述的广义概念的情况下可以对上文的实施方式进行改变。因此，应理解，本文不限于所描述的具体实施方式，而旨在覆盖各种修改，这些修改可以包括在一个或多个实施方式中的特征与在任何其它实施方式中的特征的组合。当回顾本说明书时，本发明可以应用的各种修改、等同方法以及各种结构对本领域技术人员将是显而易见的。因此，本说明书仅是示意性的并且为了使本领域技术人员能够制造并使用本文描述的最小侵入椎间的植入物、其植入工具、及其植入方法而示出并且教示了实施它们的最佳实施方式。

Claims (20)

1.一种最小侵入椎间的植入物，该植入物包括：
迂回体，其限定穿过其纵向延伸的腔轴；
近端和远端，所述近端和远端沿着所述迂回体的横轴相对地设置；
并且其中所述迂回体包括：
第一结构，其中所述近端和远端以最大间隔设置；和
第二结构，其中所述近端和远端设置为比在第一结构中的距离更近。
2.根据权利要求1所述的最小侵入椎间的植入物，其中所述迂回体包括由活动铰链连接的分段，该分段在从所述第一结构转变为所述第二结构的过程中可塑性变形。
3.根据权利要求2所述的最小侵入椎间的植入物，其中所述活动铰链在所述第二结构中锁定所述迂回体。
4.根据权利要求1所述的最小侵入椎间的植入物，其中所述近端和远端中的至少一个包括用于接收植入工具的孔。
5.根据权利要求1所述的最小侵入椎间的植入物，其中所述迂回体的至少一个纵向面向的表面包括适于提高与骨的固定接触的纹理。
6.根据权利要求1所述的最小侵入椎间的植入物，其中所述近端包括在其外表面相对地设置的一对向近端延伸的槽，其中所述槽适于容纳植入工具的叉状物。
7.根据权利要求1所述的最小侵入椎间的植入物，其中所述迂回体包括从由钛、钛合金和聚醚酮酮组成的组中选择的刚性生物学惰性材料。
8.一种最小侵入椎间的植入物系统，该系统包括：
植入物，该植入物包括：
迂回体，其限定穿过其纵向延伸的腔轴；
近端和远端，所述近端和远端沿着所述迂回体的横轴相对地设置；
其中所述迂回体包括：
第一结构，其中所述近端和远端以最大间隔设置；和
第二结构，其中所述近端和远端设置为比在第一结构中的距离更近；
植入工具，该植入工具包括：
套管，其包括一对从其远端向远端延伸的叉状物，所述一对
叉状物被设置为在所述植入物的近端与槽啮合；
轴，其适于经由具有设置为与所述植入物的远端啮合的螺纹
远端的套管纵向可滑动地设置，其中所述轴的远端从所述套
管的远端延伸；和
手柄，其连接到所述轴的近端；
其中，旋转所述手柄使所述迂回体从所述第一结构转变为所述第二结构。
9.根据权利要求8所述的植入物系统，其中旋转所述手柄使得所述轴的远端在从所述套管的远端的第一距离位置和第二距离位置之间移动，向所述迂回体施加压力从而使所述迂回体从所述第一结构转变为所述第二结构。
10.根据权利要求8所述的植入物系统，其中所述轴的所述螺纹远端适于可螺纹连接到所述迂回体的远端中的孔。
11.根据权利要求8所述的植入物系统，其中所述迂回体包括由活动铰链连接的分段，该分段在从所述第一结构转变为所述第二结构的过程中可塑性变形。
12.根据权利要求11所述的植入物系统，其中所述活动铰链在所述第二结构中锁定所述迂回体。
13.根据权利要求8所述的植入物系统，该系统还包括：
漏斗，其具有适于可移除地连接到所述套管的近端的远端；和
柱塞，其适于与所述漏斗的腔形成滑动密封从而使骨移植材料在所述第二结构中经由所述套管进入到所述植入物的内部空间。
14.根据权利要求8所述的植入物系统，该系统还包括固定地连接到所述套管的旋转位置指示器。
15.根据权利要求8所述的植入物系统，其中外部盖附加在所述套管的近端之上，其中第一和第二位置标记设置在靠近所述手柄的远端，使得当能看见第一标记且第二标记被所述外部盖挡住时，所述轴的远端从所述套管延伸第一距离，并且当第一标记和第二标记都能被看见时，所述轴的远端从所述套管延伸第二距离。
16.一种使用植入工具植入最小侵入椎间的植入物的方法，该方法包括以下步骤：
将在第一结构中的最小侵入椎间的植入物连接到所述植入工具的轴的螺纹远端，并且将在植入工具的套管上的一对叉状物啮合到在所述植入物上向近端延伸的一对槽上；
向着植入位置推进所述轴的远端使得所述植入物的迂回体的腔轴在植入位置与骨表面基本平行；
旋转套管约90度使得所述腔轴基本垂直于所述骨表面；
向近端相对于所述套管平移所述轴从而将最小侵入椎间的植入物从第一结构转变为第二结构；以及
从最小侵入椎间的植入物上分离所述植入工具。
17.根据权利要求16所述的植入方法，其中所述植入物包括：
迂回体，其限定穿过其纵向延伸的腔轴；
近端和远端，所述近端和远端沿着所述迂回体的横轴相对地设置；并且
其中在第一结构中，所述近端和远端以最大间隔设置；并且在第二结构中，所述近端和远端设置为比在第一结构中的距离更近。
18.根据权利要求17所述的植入方法，其中所述迂回体包括由活动铰链连接的分段，该分段在从所述第一结构转变为所述第二结构的过程中可塑性变形。
19.根据权利要求16所述的植入方法，该方法还包括：
将漏斗连接到所述套管的近端；以及
在第二结构中将骨移植材料经由所述漏斗推入所述最小侵入椎间的植入物的内部空间中。
20.根据权利要求16所述的植入方法，其中所述植入位置是椎间隙，并且在连接步骤前包括以下步骤：
进入所述椎间隙；
在椎间隙的任一侧分开相邻的椎骨；以及
准备所述椎间隙。
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