CN104203163A - 模块式锚固骨融合护架 - Google Patents
模块式锚固骨融合护架 Download PDFInfo
- Publication number
- CN104203163A CN104203163A CN201280067336.9A CN201280067336A CN104203163A CN 104203163 A CN104203163 A CN 104203163A CN 201280067336 A CN201280067336 A CN 201280067336A CN 104203163 A CN104203163 A CN 104203163A
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- China
- Prior art keywords
- sept
- hole
- screw thread
- plate
- implant
- 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.)
- Granted
Links
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Abstract
提供一种模块式锚固骨融合护架。该护架包括间隔物,设置为适合配合在被融合在一起的两根骨的面之间的间隙中。具有至少一个主体部分的融合板通过连接器被耦接到间隔物。紧固件延伸穿过融合板以啮合骨。至少一些紧固件还延伸穿过间隔物以啮合骨相对的面。在骨融合之前,盖板被耦接到融合板以抑制紧固件退出。
Description
背景技术
人脊柱包括一系列被椎间盘分隔并以肌肉、韧带及其它***连接在一起的骨节段。许多种疾病可使这些部件中的一个或多个受折磨。随着年龄,当椎间盘开始损坏或者退化,导致盘中流体损失,继而导致盘变得较不易弯曲,一种示例性疾病通常发生。同样,椎间盘变薄使椎骨得以更靠近在一起。退化还可导致椎间盘的外层或环中的撕裂或裂缝。环的退化可使椎间盘开始向外凸出。在更严重的情况中,椎间盘的内材料或核实际上可以从椎间盘挤出。除了椎间盘中的退行性变化之外,由于来自汽车事故、跌落、举重及其它活动的创伤,脊柱也可发生改变。此外,在已知为椎管狭窄的过程中,由于过度的骨生长、椎管中的组织(例如韧带)增厚,或者二者兼具,椎管变狭窄。在所有的这些状况中,脊髓和脊神经根所穿过的间隙可能变得狭窄,导致对神经组织的压力,可引起身体各种部位中的疼痛、麻木、乏力,乃至瘫痪。最终,相邻椎骨之间的椎间关节可能退化并引起局部的和/或放射性的疼痛。所有以上状况以及其它未明确提及的在本文中统称为脊椎病。
按照惯例,外科医生通过尝试恢复相邻椎骨之间的正常间隔治疗脊椎病。这可以充分地减轻来自受影响的神经组织的压力。然而,通常还必需经外科手术除去冲击神经组织的椎间盘材料、骨或其它组织,和/或对椎间关节清创。通常,椎骨间隔的恢复是通过将由骨、金属或塑料制成的刚性间隔物***相邻椎骨之间的椎间盘间隙中并使椎骨得以生长在一起或者融合成单块骨实现。在此融合过程中,利用被紧固至相邻椎骨的骨板和/或椎弓根螺钉,典型地使椎骨稳定。
虽然近年来用于安置椎间的间隔物、板和椎弓根螺钉固定***的技术已变得侵入性较低,但是它们仍然需要将硬件深入安置在邻近脊柱的外科手术部位内。该硬件常常涉及椎骨间间隔物本身以及使与融合相关的椎骨节段固定的附加硬件。该附加硬件还抑制间隔物离开间隙。从这样的外科手术恢复可能需要数天的住院以及长而缓慢的康复至正常活动水平。
因此,适合的是,提供可植入的椎骨间间隔物,其呈尽可能低的轮廓同时仍然提供足够的硬件以便使被融合的椎骨节段固定。
发明内容
提供此概述,为了以简化和不完全的形式介绍选定的概念,突出在具体实施方式中进一步描述的一些方面。此概述以及上述背景技术并不旨在确认要求保护主题的基本方面的关键方面。此外,此概述并不旨在用作确定要求保护的主题的范围的辅助手段。
在本申请公开的技术的一些方面,提供一种植入物。植入物概括地涉及利用尽可能低的轮廓将两个骨节段融合在一起。在本技术的一个方面,植入物具有间隔物以及可被耦接到该间隔物的融合板。间隔物设置用以安装在两个骨节段之间并促进其间的融合。融合板耦接到间隔物的后部(有时前部)部分。融合板包括在尺寸和形状方面大体上符合间隔物的后部部分的主体部分,以及从融合板的主体部分延伸以覆盖在要被融合在一起的骨的部分上的第一延伸侧。通过延伸穿过融合板的紧固件耦接植入物。紧固件中的一些可以与间隔物的后部部分交叉并延伸穿过间隔物的顶部或底部部分。紧固件可延伸穿过融合板直接进入骨,但是紧固件的部分可以与间隔物的后部部分交叉。
在本申请提供的技术的其它方面,还可提供盖板。盖板可以被耦接到融合板以抑制紧固件反向旋拧从而促进骨节段的固定。
在某些实施方式中,间隔物可配置腔,其中融合板的主体部分配合在腔内以使融合板的部分得以位于骨节段之间的间隙中。在这些实施方式,第一延伸侧可从融合板的主体部分成角度或外倾以使第一延伸侧得以沿着相邻骨之一安置。第一延伸侧可以是直的、弯曲的、正弦形的,或其组合。
在本申请的技术提供的某些实施方式中,间隔物可具有被耦接到连接器的第一末端的间隔物孔。在某些方面,间隔物孔可具有与连接器例如定位螺钉的外螺纹协同地啮合的螺纹。融合板可相应地具有被耦接到连接器的第二末端的对齐的板孔。在某些方面,板孔可具有肩状物(shoulder),并且连接器的第二末端可具有带外翻唇(outturned lips)的多个凸出物。第二末端可以是弹性可变形的以形成连接器的第二末端的外翻唇与板孔的肩状物之间的搭扣配合(snap fit)。在某些方面,盖板还可具有带螺纹的盖板孔。盖板孔与板孔对齐。连接销将盖板耦接至融合板。在本技术的某些方面,连接销具有头和轴。该轴具有在该头近端的第一螺纹以及在该头远端的第二螺纹。该轴的中间部分可以是非螺纹的以分隔第一螺纹与第二螺纹。第二螺纹可以与连接器的内螺纹协同地啮合,并且第一螺纹可以与盖板孔的螺纹协同地啮合从而将盖板耦接到融合板。
此概述仅提供本文公开的技术的一些方面的一般概括。在考虑本文中的具体实施方式和图之后,本申请的技术的以上及其它方面可以是清晰的。然而,应理解,本申请的范围应取决于授权的权利要求而非取决于给定的主题是否解决背景技术中提到的任何或所有问题,或者包括发明内容中突出的任何特征或方面。
附图说明
参考附图讨论本发明的各种实施例。这些图仅描绘本发明的说明性实施例并不应被视为限制它的范围。
图1是具有根据本申请的技术的植入物的三个相邻椎骨的侧视图;
图2是根据本申请的技术间隔物的透视图;
图3是图2的间隔物的顶视平面图(顶部plan view);
图4是沿着图3的线A-A的截面视图;
图5是图2的间隔物的后面部分立视图;
图6是根据本申请的技术融合板的透视图;
图7是图6的融合板的另一个透视图;
图8是根据本申请的技术图7中所示的螺纹连接器的透视图;
图9是根据本申请的技术紧固件的透视图;
图10是可与本申请的技术一起使用的锁件的透视图;
图11是根据本申请的技术盖板的透视图;
图12是根据本申请的技术连接器销的透视图;
图13是根据本申请的技术的植入物的透视图;
图14是根据本申请的技术融合板的透视图;
图15是图14的融合板的侧立视图;
图16是根据本申请的技术盖板的透视图;
图17是图16的盖板的侧立视图;
图18是根据本申请的技术植入物的透视图;
图19是根据本申请的技术融合板的透视图;
图20是图19的融合板的侧立视图;
图21是根据本申请的技术盖板的透视图;
图22是图21的盖板的侧立视图;和
图23是根据本申请的技术植入物的透视图。
具体实施方式
参考各种图等,解释本专利申请的技术。虽然关于促进脊柱融合的植入物例如前路腰椎椎间融合(anterior lumbar interbody fusion)(ALIF)植入物描述本申请的技术,但是本领域技术人员在阅读本公开时可认识到,该技术可适用于其它植入物。例如,本文中所述的技术可用于植入物以促进其它脊柱融合的融合,例如经椎间孔腰椎椎间融合(transforaminal lumbar interbody fusion)(TLIF)、前路颈椎间盘切除术(anterior cervicaldiscectomy)(ACD)、后路腰椎椎间融合(posterior lumbar interbody fusion)(PLIF)、侧向胸腰融合(lateral thoracolumbar fusion),以及其它骨骼融合,例如长骨等。此外,参考本文中的某些示例性实施方式,描述本专利申请的技术。词语“示例性”在本文中用来指“用作示例、例子或例证”。本文中作为“示例性”描述的任何实施方式,在没有明确指出这样的实施方式或实施例相对于其它实施方式是优选的或有利的情况下,不一定解释为相对于其它实施方式或实施例是优选的或有利的。此外,在某些情形中,提供仅仅一个“示例性”实施方式。单个实施例不一定解释为唯一的实施方式。具体实施方式包括出于提供对本专利申请的技术的彻底理解的目的的具体细节。然而,在阅读本公开时,对本领域技术人员而言,显然在有或无这些具体细节的情况下可以实施本专利申请的技术。在本文中的一些描述中,可以在图中显示通常理解的结构和装置以帮助理解本专利申请的技术而不模糊本文中的技术。
首先参考图1,提供三个椎骨40、42和44。椎骨40、42和44各具有前侧46、后侧48和侧向侧50(仅示出一个)。三个椎骨40、42和44各具有棘突60。
在正常的脊柱中,椎间盘应位于椎骨40与42,以及椎骨42与44的每个末端板55之间。末端板55形成用于脊柱应用的相对骨表面,但是本文中所述的技术的用途可适用于跨越相对面向的骨表面要被融合的任何骨节段。为了便于图示说明,盘没有包括在图中。然而,损伤、老化、疾病或其它创伤可导致盘处于一种或另一种原因而退化。为了使盘恢复至适当的高度,外科医师可以例如除去全部或部分的盘并用间隔物替代它。例如,如图1中所示,可以将间隔物52经外科手术植入介于椎骨40和42之间的间隙中。如所示,将间隔物52从患者的前侧植入。如以下进一步解释,在图1中所示的技术的示例性实施方式中,融合板54被耦接到间隔物52并仅仅延伸穿过椎骨40和42之一。虽然示于脊柱的应用中,但是本申请的技术可用来促进其它骨的融合。
参考图2和3,显示示例性间隔物52。间隔物52大体上被定形以配合在椎间间隙内并具有向前的部分102,可被称为后部部分102,向后的部分104,可被称为前部部分104,顶部部分106,可被称为上部部分106,底部部分108,可被称为下部部分108,以及侧部分110。间隔物52可具有孔112以接纳无线电不透明的塞子114,用于在使用计算机辅助的外科手术时示踪,以及作为标记用于荧光透视法或其它成像技术,其中间隔物52可能难以显像。正面(后部)、背面(前部)、左、右、顶部(上部)和底部(下部)等的定向是为了参考而提供的,不应被解释为限制本申请的技术。提供间隔物52以合适整个配合在椎间间隙中;但是在某些实施方式中,向后的部分104可延伸超过椎骨的前部末端。
如图3中所示,向前的部分102定形为具有形成凹处118的凹面、凸面,以及凹面部分。凹处118设置用以避开脊柱应用中的硬膜,但是对于本技术的其它应用可能不是必需的。向后的部分104通常定形以具有与它被植入其间的椎骨40,42的前部形貌相符的凹形。向后的部分104包括具有深度D1的腔120以接纳以下进一步解释的融合板。侧面部分110提供在向前的部分102与向后的部分104之间过渡的内凹部分。如所示,间隔物52具有被中心支柱126分隔的第一和第二空隙122,124,赋予间隔物52近似的“B”形状。间隔物52的其它形状和类型是可行的,例如,其它融合护架、暗榫等。第一空隙122和第二空隙124可以用材料包装以促进椎骨40,42的骨生长和融合。第一和第二空隙122,124都大体上大于间隔物52表面积的20%。替代大的第一和第二空隙122,124,大量较小的骨生长通道是可行的。
多个凸出物116可被提供在顶部部分106、底部部分108或其组合上。如作为图3中穿过线A-A的截面视图的图4中最佳地显示的,凸出物116形成从向前的部分102朝着向后的部分104成角度的大体上尖牙形状。凸出物116通常阻止间隔物52移出介于椎骨40,42之间的椎间间隙。如截面图中所示,顶部部分106和底部部分108可以是凸形,赋予间隔物52从向前的部分102向着向后的部分104的双凸形,形成接近于脊柱前凸弯曲的穹形,或者椎骨的定位。向前的部分102(或后部部分102)具有锥形128以促进间隔物52的***。向前的部分102对称地在两侧上膨胀成较厚的截面。在此示例性实施方式中,间隔物52通常在向后的部分104中,但是通常在腔120的前方最厚。不是双凸的穹形,间隔物52可形成更常规的楔形,或者具有平面顶部部分106、平面底部部分108,或其组合。
仍参考图4,凸出物116由与间隔物52的表面形成钝角的第一表面130形成。第一表面130延伸至凸出物116的啮合表面132。啮合表面132适应于啮合椎骨40,42的末端板。啮合表面132可以形成至线接触、点接触,或者形成的与体表面大体上平行的扁平或凸出的表面。具体地,啮合表面132可以形成和定形以符合相关联的末端板的解剖学形状。也可将通过连接在顶部和底部部分106,108上的啮合表面132形成的表面,定形为符合相关联的末端板的解剖学形状。第二表面134从啮合表面132向后延伸至间隔物52的表面。第二表面134也形成钝角,但是可形成直角或者被稍微底切。凸出物116通常具有与主体统一的结构。凸出物116被介于每个凸出物之间的扁平或匙状间隙136分隔,并且通常延伸越过植入物的整个上部和下部表面。然而,向前的部分102具有没有凸出物的部分,通常与锥形128相关联。在一个具体的实施方式中,凸出物116具有美国专利7,041,137或7,427,294中概括公开的形状,二者都被转让给本申请的受让人,并且完整的公开内容通过援引并入本文中用于所有的目的。
参考图5,提供间隔物52的向后的部分104的立视图。腔120具有长度L1和高度H1,并且被调整尺寸以协同地啮合融合板,以下进一步进行解释。螺纹间隔物孔138在腔120中。如以下进一步解释,螺纹间隔物孔138用来耦接间隔物52和融合板。螺纹间隔物孔138可具有底切。螺纹间隔物孔138延伸入中心支柱126中。螺纹间隔物孔138具有第一螺纹T1。腔120具有在通向顶部部分106的过渡处的上边缘140,以及在通向底部部分108的过渡处的下边缘142。间隔物通道144是可从腔120进入,并存在于上边缘140和下边缘142的每个中。如所示,有两个邻近上边缘140的间隔物通道144,以及两个邻近下边缘142的间隔物通道144。间隔物通道144显示为具有大体上呈诸如,半管道、U形,或者V形等半圆柱形的形状,为紧固件提供引导,以下进一步进行解释。间隔物通道144还可以是孔。间隔物通道144显示在间隔物52的上边缘和下边缘140,142上。在本技术的某些方面,间隔物通道144可仅仅被定位在上边缘140或下边缘142上。
根据以上描述可知,间隔物52被配置具有长度L2和高度H1以提供具有合理低的轮廓的植入物,从而适合配合在具有外科医师期望的间隔的椎间间隙内。为了将间隔物52锚固至上椎骨和下椎骨,在本申请的技术的某些方面中提供融合板54(图1)。在许多实施方式中,提供的板具有尽可能低的轮廓。
参考图6和7,提供与本申请的技术一致的低轮廓融合板200。低轮廓融合板200具有向前的面202,以及与向前的面202相对的向后的面204。侧壁206延伸在向前的面202与向后的面204之间。可以将侧壁206的边缘变成斜面或切成斜面以减轻创伤。低轮廓融合板200具有长度L3,高度H2和深度D2以使低轮廓融合板200得以协同地啮合腔120。低轮廓融合板200具有多个紧固件孔208,通常对应于与间隔物52相关联的间隔物通道144。紧固件孔208具有内侧壁210,形成用于与以下描述的紧固件协同地啮合的凹表面。在一些实施方式中,由内侧壁210形成的凹表面大体是球形或弯曲。向前的面202可具有多个凸出物212,从其延伸以协同地啮合间隔物通道144。如所示,凸出物212被大体定形为部分圆柱形表面。
低轮廓融合板200还包括板孔214。板孔214适应于与螺纹间隔物孔138对齐。板孔214具有内壁216和外壁218(示于图7中),从向前的面202延伸入螺纹间隔物孔138中。板孔214在其远端末端可具有外翻唇220。通过使外翻唇220啮合螺纹间隔物孔138中的底切,板孔214可被装配至间隔物52。此外,内壁216可以被配置具有肩状物222,可以是延伸入孔中的壁架,或者延伸入壁中的凹槽。
在本技术的一个方面,利用如图7和8中所示的螺纹连接器224,将低轮廓融合板200耦接到间隔物52。螺纹连接器224具有槽头末端226。狭槽狭槽多个具有外翻唇230的可压缩的凸出物228。螺纹连接器224还具有螺纹轴232。螺纹轴232具有适应于协同地啮合螺纹间隔物孔138的螺纹T1的外螺纹T2。螺纹连接器224还可包括具有内螺纹T3的内螺纹孔234,以下进一步解释。
通过将螺纹连接器224的槽头末端226***板孔214中,将螺纹连接器224耦接到低轮廓融合板200。压缩头末端直至外翻唇230延伸超过肩状物222,在此点槽头膨胀而形成在螺纹连接器224和低轮廓融合板200之间的弹性锁扣。在替代实施方案中,用C-环、开口环等,将螺纹连接器224耦接到融合板200。接着,将螺纹连接器224旋拧入螺纹间隔物孔138中从而将低轮廓板耦接到间隔物52。
在此示例性方面,通过多个紧固件236,将间隔物52和低轮廓融合板200耦接到上椎骨和下椎骨。紧固件236可以是任何常规的紧固件,例如,图9中所示的骨螺钉236。骨螺钉236可包括头238以及具有螺纹T的轴240。头238可配有凸的较低表面242从而协同地啮合低轮廓融合板200中的紧固件孔208的内侧壁210。通过从紧固件孔延伸入间隔物52的向后的部分104中并延伸出顶部部分106或底部部分108中的至少其一,使紧固件236适应而被旋拧入椎骨40,42的末端板中。
如常规已知的,紧固件236可具有反向旋拧或者从椎骨40,42、间隔物52和融合板54退出的倾向。可提供锁件以抑制紧固件236反向旋拧。在本技术的某些方面,锁件与图10中所示的衬套244相似。衬套244包括顶部边缘246、底部边缘248,以及延伸在顶部和底部边缘246,248的衬套壁250。衬套侧壁250可具有外表面252以协同地啮合融合板54的内侧壁210,以及内表面254以协同地啮合紧固件236的头238的凹下表面242。衬套的直径256可从顶部边缘246至底部边缘248变化。
如所示,在此示例性实施方式中,衬套通常是圆柱形,但是其它形状也是可行的。衬套244可具有与板孔214的直径一致的直径,并且配合在紧固件236的头238与板孔214的内侧壁210之间。如常规所知,衬套244可具有间隙258以使衬套244得以被压缩并配合入板孔214中。此外,衬套244可具有衬套244的底部部分中所示的多个狭槽259,这些狭槽259也可以在衬套244的顶部部分中,或者两者的组合。狭槽260使衬套244的部分得以挠曲从而促进植入紧固件236。衬套244,作为紧固锁件,帮助将紧固件236固定至板54。
替代衬套,锁件可以是盖板。参考图11,提供盖板260,可与低轮廓融合板200一起使用。盖板260具有第一面262,以及与第一面262相对的第二面264。盖板260可以被定形以配合在低轮廓融合板200的凹处266中,如图6中所示。如所示,盖板260通常具有带有盖板孔270的主体部分268,被显示为埋头区272。盖板孔270包括肩状物274,将具有盖板孔276的螺纹T4的螺纹部分276与非螺纹部分分隔。
以下进一步解释,连接销将盖板260耦接到低轮廓融合板200。盖板孔270与上述板孔214对齐。多个臂278或喇叭状延伸件280从主体部分268延伸。臂278从主体部分延伸足够的距离,从而臂的至少远端末端282延伸穿过紧固件孔208。因此,臂的远端末端282阻止紧固件236从植入物反向旋拧的能力。喇叭状延伸件280从主体部分延伸足够的距离,于是喇叭状延伸件280的至少远端末端282延伸超过紧固件孔208。因此,臂的远端末端282阻止紧固件236从植入物反向旋拧的能力。
可理解,形状、尺寸,以及臂或喇叭状延伸件是否与盖板260相关联,部分地取决于融合板54的形状和尺寸(示于图1中)。图11中具体所示的盖板260的形状和尺寸设计为与图6和7中所示的低轮廓融合板200一起使用。通常,盖板260上的臂与单个紧固件孔208相关联,而喇叭状延伸件280与多个紧固件孔208相关联。
如上所述,盖板孔270与板孔214大体上对齐。利用图12中所示的连接销286,将盖板260耦接到低轮廓融合板200。连接销286具有头288和轴290。头288具有唇292,其毗邻第二面262,或者,若盖板孔270是埋头,毗邻肩状物274。轴290具有邻近头288的近端部分294,被中间部分298分隔的远离头288的远端部分296。近端部分294具有第一螺纹T5,设计用以协同地啮合盖板260的螺纹T4。中间部分298显示为无螺纹的,并提供从近端部分至远端部分的过渡。远端部分296具有第二螺纹T6,设计用以协同地啮合螺纹连接器224的内螺纹孔234的螺纹T3。连接销286具有长度L4,并将盖板260耦接至低轮廓融合板200。
参考图13,提供与以上一致的低轮廓植入物300。低轮廓植入物300包括具有向后的部分104(或示例性脊柱应用的前部部分)的间隔物52,该部分带有被中心支柱126分隔的空隙122和124。凸出物116被显示在顶部(或上部)部分上。向后的部分104中的腔120具有在其中的低轮廓融合板200。低轮廓融合板200的紧固件孔208大体上与间隔物通道144对齐。紧固件236延伸穿过紧固件孔208、间隔物通道,并延伸出间隔物52的顶部部分和底部部分。盖板260配有覆盖两个紧固件孔208的臂278,以及覆盖另两个紧固件孔208的喇叭状延伸件280。然后将连接销286移入盖板孔270中。在一个具体的实施方式中,板200的总高度(沿着由下至上的方向测量)与间隔物52的总高度相似或相同。在此实施方式中,植入物300是“零轮廓(zero profile)”植入物,因为板200延伸不高于或低于其中安置有间隔物52的椎间盘间隙的高度。
在本技术的某些方面中,不可使用低轮廓融合板200。例如,椎骨的末端板或尺寸不可以以这样的方式支撑紧固件,促使紧固件236从向后的部分104延伸穿过顶部部分106或底部部分108所需的角度可能是不可行的,仅列举两种情形,其中如图13中所示的低轮廓结构可能是不可行或者不适合的。在这些情况中,可能需要提供具有比低轮廓融合板200轮廓稍高的融合板,有时称为如图14和15中所示的“单凸缘板”的中等轮廓融合板400。
中等轮廓融合板400具有与低轮廓融合板200结构相似的主体部分401,包括向前的面402,以及与向前的面402相对的向后的面404。侧壁406延伸在向前的面402与向后的面404之间。可以将侧壁406的边缘变成斜面或切成斜面以减轻创伤。通常向前的面402被调整尺寸以配合间隔物52的腔120。因此,向前的面402可具有长度L3、高度H2和深度D2以使中等轮廓融合板得以协同地地配合在腔120中。中等轮廓融合板400还具有第一延伸侧408,仅在向上或向下的方向之一从主体部分401延伸超过高度H2,在此示例性实施方式中,显示为在向下方向延伸。第一延伸侧408的远端边缘可具有凹形。第一延伸侧408具有成角度向前的面402以及成角度向后的面404。第一延伸侧408相对于向后的面404成角度410(示于图15中)以使第一延伸侧408得以与被融合的骨之一重叠。角度410允许第一延伸侧408的远离向后的面404的部分从间隔物52向后的部分104偏置。虽然为了方便而被描述为角,第一延伸侧408可具有稍微弯曲或正弦的形状而不是平角的表面。在一个具体的实施方式中,第一延伸侧408以一定方式弯曲从而延伸侧408的远端顶端部分与主体部分401大体上平行。
可理解,中等轮廓融合板400具有在向前和向后的面402,404中的多个紧固件孔412,它们与植入物中的间隔物通道配合以使一组紧固件得以从中等轮廓融合板400经由间隔物52延伸入关联椎骨40,42的末端板中。虽然可以形成与以上间隔物52一致的间隔物,但是作为设计选择,在此示例性实施方式中的间隔物可以配有上边缘140上的间隔物通道144,并且在下边缘142上没有间隔物通道144。
第二多个紧固件孔414配置在第一延伸侧408中。将紧固件孔414排布以使紧固件236得以延伸穿过成角度的向前的面402和成角度的向后的面404,直接延伸入例如下椎骨42的椎弓根中。紧固件孔412,414具有内侧壁416,形成与紧固件236的头238的凹下表面242协同地啮合的凹表面。中等轮廓融合板400包括与板孔214相似的板孔418以接纳将中等轮廓融合板400耦接至间隔物52的螺纹连接器224。
参考图16和17,显示中等轮廓盖板420的透视图和侧立视图。盖板420具有第一面422,以及与第一面422相对的第二面424,与上述盖板260相似。盖板420可以被定形以配合在中等轮廓融合板400的凹处426中,如图14中所示。盖板420,如所示,通常具有带有盖板孔430的主体部分428,可与上述盖板孔270相似地进行构建以接纳连接销286从而将盖板420耦接到中等轮廓融合板400。中等轮廓融合板400包括以角度410从主体部分428延伸的多个臂432,以及从主体部分428延伸的喇叭状延伸件434。使臂428成角度以与第一延伸侧408的角度410一致,从而臂432延伸越过紧固件孔414的一部分。作为设计选择,臂432可以具有介于它们之间的材料网(未示出)从而形成喇叭状延伸件替代臂。此外,臂432设计用以与凹处426协同地啮合,并因此可具有弯曲或正弦的形状。
臂从主体部分延伸足够的距离,从而臂的至少远端末端436延伸超过紧固件孔414。因此,臂的远端末端436阻止紧固件236从植入物反向旋拧的能力。喇叭状延伸件434从主体部分延伸足够的距离,从而喇叭状延伸件434的至少远端末端438延伸超过紧固件孔412。因此,远端末端438阻止紧固件236从植入物反向旋拧的能力。
可知,形状、尺寸,以及臂或者喇叭状延伸件是否与盖板420关联部分地取决于融合板54的形状和尺寸(示于图1中)。盖板420的尺寸和形状,具体示于图16和17中,设计为与图14和15中所示的中等轮廓融合板400一起使用。通常,在盖板432上的臂与单个紧固件孔414相关联,并且喇叭状延伸件434与多个紧固件孔412相关联。
参考图18,提供与上述一致的中等轮廓植入物450。中等轮廓植入物450包括具有带被中央支柱126分隔的空隙122和124的向后的部分104(或者示例性脊柱应用的前部部分)的间隔物52。凸出物116显示于顶部(或上部)部分上。向后的部分104中的腔120具有在其中的中等轮廓融合板400。中等轮廓融合板400的紧固件孔412与间隔物通道144大体上对齐。紧固件236延伸穿过紧固件孔412和间隔物通道并延伸出间隔物52的顶部部分和底部部分。在此实施例中,中等轮廓融合板400的第一延伸侧408中的紧固件孔414与下椎骨42对齐,但是,取决于用途,紧固件孔414可以与上椎骨40或其它骨表面对齐。紧固件236延伸穿过紧固件孔414并延伸入下椎骨42的椎弓根或前部侧46中。取决于尺寸,延伸穿过紧固件孔414的紧固件236不可以穿过间隔物通道144,并且在那些情况中,可以移去间隔物通道。在一个具体的实施方式中,延伸穿过紧固件孔414的紧固件236与间隔物52表面大体上平行。以此方式,紧固件236可以大体上垂直于它们被耦接到的骨表面。在替代的实施方式中,延伸穿过紧固件孔414的紧固件236相对于间隔物52上表面或下表面处于分散或会聚的角。盖板260配有覆盖两个紧固件孔414的臂432,以及覆盖另两个紧固件孔412的喇叭状延伸件434。通常,臂432与第一延伸侧上的孔相关联,并且喇叭状延伸件与融合板剩余部分上的孔相关联。连接销286将盖板420耦接到中等轮廓融合板400。
在一些应用中,由于多种原因,中等轮廓融合板400不可以使用或者不适合。在这些情况中,可能必需提供具有与中等轮廓融合板400相比略高轮廓的融合板,有时被称为高轮廓融合板500或“双凸缘板”,如图19和20中所示。高轮廓融合板500具有与低轮廓融合板200结构相似的主体部分501,包括向前的面502,以及与向前的面502相对的向后的面504。侧壁506延伸在向前的面502与向后的面504之间。可以将侧壁506的边缘变成斜面或切成斜面以减轻创伤。通常向前的面502被调整尺寸以配合间隔物52的腔120。因此,向前的面502可具有长度L3、高度H2和深度D2以使高轮廓融合板得以协同地啮合腔120。
高轮廓融合板500还具有第一延伸侧508以及第二延伸侧509,第一延伸侧508在向上或向下的方向之一,延伸超过高度H2,在此示例性实施方式中,显示为在向下方向延伸。第一和第二延伸侧508,509可以被箍缩以至于第一和第二延伸侧508,509的远端边缘具有凹形。第一延伸侧508具有成角度的向前的面5021以及成角度的向后的面5041。第二延伸侧具有成角度的向前的面5022以及成角度的向后的面5042。第一延伸侧508和第二延伸侧509相对于向后的面504以角度510成角度,从而使第一和第二延伸侧508,509各自得以重叠被融合的骨的相对的骨。角度510允许第一和第二延伸侧508,509远离向后的面504的部分从间隔物52向后的部分104偏置。虽然为了方便被描述为角度,但是第一和第二延伸侧508,509可具有稍微弯曲或正弦的形状,而不是平角表面。延伸侧508,509之一或二者可具有取向或弯曲,和/或与以上关于第一延伸侧408所述的那些相似的紧固件孔。此外,虽然被描述为对称的,但是第一延伸侧508和第二延伸侧509可以是不对称的,并且在某些解剖学情况中可能必须如此。
可理解,高轮廓融合板500具有在第一和第二延伸侧508,509中的多个紧固件孔512,与一组紧固件配合,从而从高轮廓融合板500延伸入相关椎骨40,42的椎弓根或前侧中。虽然可以形成与以上间隔物52一致的间隔物,但是在此示例性实施方式中,作为一种设计选择,可以提供在上和下边缘140,142上没有间隔物通道144的间隔物。紧固件孔512具有内侧壁514,形成与紧固件236的头238的凹下表面242协同地啮合的凹表面。高轮廓融合板500包括与板孔214相似的板孔518以接纳将高轮廓板500耦接到间隔物52的螺纹连接器224。
参考图21和22,显示高轮廓盖板520的透视图和侧立视图。盖板520具有第一面522,以及与第一面522相对的第二面524,与上述盖板260,420相似。盖板520可以定形从而配合在融合板500的凹处526中,如图19中所示。如所示,盖板520通常具有带有盖板孔530的主体部分528,可以与上述盖板孔270,430相似进行构建,以接纳将盖板520耦接到高轮廓融合板500的连接销286。
盖板520包括以角度510从主体部分528延伸的多个臂532。使臂532成与第一和第二延伸侧508,509的角度510一致的角度,于是臂532延伸超过紧固件孔512的一部分。臂532可具有介于其间的材料534的网。作为设计选择,材料534的网可以从喇叭状延伸件而不是臂延伸。另外,臂532设计用以协同地啮合凹处526,并因此可具有弯曲的或正弦的形状。臂从主体部分延伸足够的距离从而臂的至少远端末端536延伸超过紧固件孔512。因此,臂的远端末端536阻止紧固件236从植入物反向旋拧的能力。如图21和22中所示,臂532的远端末端536可以具有垫538,从臂532延伸入紧固件孔512中从而接触紧固件头238。本文中所示的垫538可以被配置在上述臂或喇叭状延伸件中的任一个上。
可理解,形状、尺寸以及臂或喇叭状延伸件是否与盖板520相关联部分地取决于融合板54的形状和尺寸(示于图1中)。盖板520的形状和尺寸,具体示于图21和22中,设计用于与图19和20中所示的高轮廓融合板500一起使用。通常,在盖板520上的臂与单个紧固件孔512相关联,并且具有材料534的网的喇叭状延伸件可以与多个紧固件孔512相关联。
参考图23,提供与以上一致的高轮廓植入物550。高轮廓植入物550包括具有向后的部分104(或用于示例性脊柱应用的前部部分)的间隔物52,该部分带有被中心支柱126分隔的空隙122和124。凸出物116被显示在顶部(或上部)部分上。向后的部分104中的腔120具有在其中的高轮廓融合板500。在此实施例中,高轮廓融合板500的第一和第二延伸侧508,509中的紧固件孔512与下椎骨和上椎骨42,40的椎弓根或前侧对齐,但是,取决于用途,紧固件孔512可以与其它骨表面对齐。紧固件236延伸穿过紧固件孔512,并延伸入上椎骨和下椎骨40,42的椎弓根或前侧中。取决于尺寸,延伸穿过紧固件孔512的紧固件236可以不穿过间隔物通道144,并且在那些情况中,可以除去间隔物通道。紧固件236可以大体上垂直于椎骨40,42的前侧46,或者可以替代地在一个或多个平面以分散或会聚的角度进入椎骨。盖板520配有覆盖紧固件孔512的臂532。连接销286将盖板520耦接到高轮廓融合板500。
注意:参考低轮廓融合板、中等轮廓融合板和高轮廓融合板,描述上述植入物。在阅读本公开时,本领域普通技术人员可认识到,低轮廓、中等轮廓和高轮廓的使用是相对术语以区分上述实施方式,是为了参考而提供的,不应被解释为限制本申请的技术。
本申请的技术还包括用于植入上述装置的方法。虽然以某些个别步骤提供所述方法,但是,本领域普通技术人员可认识到,所述的步骤可以被分成多步步骤,或者多步步骤可以被合并成单步步骤。此外,在不脱离本申请的技术,可以改变或重排所提供的事件的顺序。鉴于此,外科医师可首先确定要使用的适当的间隔物。在脊柱应用中,可以调整间隔物尺寸以恢复与健康椎骨的高度相符的高度。在其它应用中,间隔物可以被调整尺寸以容易地促进融合等。
一旦确定适当的间隔物,螺纹连接器可以被旋拧入间隔物孔中,虽然螺纹连接器可能已经被旋拧至间隔物。接着,外科医师可将间隔物和螺纹连接器植入融合部位。注意,作为外科手术技术,当间隔物处于融合部位中时,螺纹连接器可以被旋拧。接着,外科医师可确定低轮廓、中等轮廓或高轮廓的融合板是否适合于患者的解剖学。融合板可被耦接到螺纹连接器。例如,槽头上的凸出物可以被压缩和配合入融合孔中直至在槽头和融合板之间形成搭扣配合(snap fit)。融合板可以被配合至螺纹连接器,以至于间隔物和融合板同时被安置在融合部位。
接着,外科医师可使用紧固件将植入物耦接至骨节段,例如,对于脊柱应用而言,至上椎骨和下椎骨。最终,与融合板对应的盖板被选择和耦接到融合板。例如,连接销可以被旋拧穿过盖板孔和融合板孔,进入螺纹连接器的内螺纹以耦接盖板、融合板和间隔物。
植入物可以被补充骨生长促进物质以促进在棘突、椎板、横突、面和/或其它脊柱结构之间相邻椎骨的融合。可以将骨生长促进物质与植入物隔开,邻近植入物安置,夹在植入物和下面的骨之间,置于植入物内,涂布在植入物上,和/或相对于植入物安置。若它被涂布在植入物上,它可以覆盖整个植入物,或者仅仅植入物的选定的部分例如延伸件、紧固件、间隔物的接触棘突的部分和/或其它部分。
在本文中使用时,骨生长促进物质可包括骨糊、骨碎片、骨条、结构性骨移植物、血小板源性生长因子、骨髓抽吸物、干细胞、骨生长蛋白、骨生长肽、骨附着蛋白、骨附着肽、羟磷灰石、磷酸钙、其它适合的骨生长促进物质,和/或其组合。
植入物及任何相关的环扎器或其它部件可以由任何适合的生物相容性材料制成,包括金属、可重吸收的陶瓷、不可重吸收的陶瓷、可重吸收的聚合物,以及不可重吸收的聚合物等。一些具体的实例包括:不锈钢、钛及它的合金包括镍-钛合金、钽、羟磷灰石、磷酸钙、骨、氧化锆、氧化铝、碳、生物玻璃、聚酯、聚乳酸、聚乙醇酸、聚烯、聚酰胺、聚酰亚胺、聚丙烯酸脂、聚酮、氟聚合物和/或其它适合的生物相容性材料及其组合。
公开了用于治疗脊柱骨折的各种方法、***和装置。虽然以上已提供一个后多个实施方式的详细描述,各种替代、修改和等效方式是可行的。因此,以上描述不应被视为限制可行的实施方式的范围,该范围由随附的权利要求书限定。
Claims (23)
1.一种设置为***在待被融合在一起的两根骨的相对的面之间的植入物,所述植入物包括:
设置为配合在所述两根骨的相对的面之间以促进所述两根骨的融合的间隔物,所述间隔物具有向前的部分、向后的部分、顶部部分、底部部分以及两侧的部分;所述向后的部分包括至少一个腔,所述间隔物具有从所述向后的部分延伸至所述顶部部分或所述底部部分中的至少其一的至少一个间隔物通道;
与所述间隔物耦接的融合板,所述融合板包括主体部分和第一延伸侧部分,所述主体部分包括向前的面、与所述向前的面相对的向后的面,以及连接所述向前的面和所述向后的面的侧壁,所述向前的面和至少一部分的所述侧壁被接纳在所述至少一个腔中,所述第一延伸侧部分设置为延伸超过所述间隔物的顶部部分或底部部分中的至少其一,所述融合板包括至少第一孔,所述第一孔与所述至少一个间隔物通道对齐并从所述融合板的向后的面延伸至向前的面,以及从所述向后的面延伸至所述向前的面的第一延伸侧部分中的第二孔;
多个紧固件,包括至少第一紧固件,延伸穿过所述第一孔,延伸穿过所述至少一个间隔物通道,并延伸出所述顶部部分或底部部分并设置用以将所述植入物耦接到第一根骨的末端板,以及至少第二紧固件,延伸穿过所述第二孔从而将所述植入物耦接到第二根骨;和
锁件,该锁件与至少所述融合板耦接以抑制所述多个紧固件移出所述第一和第二根。
2.权利要求1所述的植入物,其中所述锁件包括覆盖每个所述紧固件的部分的盖板。
3.权利要求1所述的植入物,其中所述第一延伸侧部分包括以一角度排布的成角度的向前的面,以及成角度的向后的面,
所述角度设置为使所述成角度的向前的面得以位于所述第一或第二根骨之一上面。
4.权利要求1所述的植入物,包括具有第一末端以及与所述第一末端相对的第二末端的螺纹连接器,所述螺纹连接器的第一末端具有外螺纹,所述螺纹连接器的第二末端具有外翻唇,并且其中所述间隔物包括在所述至少一个腔中的螺纹间隔物孔,并且所述融合板包括具有肩状物的融合板孔,所述融合板孔与所述螺纹间隔物孔对齐,从而通过使所述外翻唇啮合所述肩状物将所述融合板耦接到所述螺纹连接器,并且通过将所述螺纹连接器旋拧入所述螺纹间隔物孔中将所述螺纹连接器耦接到所述间隔物孔,由此将所述间隔物与所述融合板连接。
5.权利要求1所述的植入物,包括从所述融合板的向前的面延伸以啮合所述至少一个间隔物通道的凸出物。
6.权利要求4所述的植入物,其中所述锁件包括覆盖每个所述多个紧固件的部分的盖板。
7.权利要求6所述的植入物,还包括连接销,其中所述盖板包括与所述融合板孔对齐的盖板孔,从而将所述连接销经由所述盖板孔***并耦接到所述螺纹连接器,由此所述盖板被耦接到所述融合板。
8.权利要求7所述的植入物,其中所述连接销具有螺纹轴和头,并且其中所述螺纹连接器具有带内螺纹的孔,从而所述连接销的螺纹轴旋拧在所述螺纹连接器的内螺纹上。
9.权利要求8所述的植入物,其中所述螺纹轴具有邻近所述连接销的头的带第一螺纹的第一末端,以及在所述连接销的远端的具有第二螺纹的第二末端,并且其中所述盖板孔具有螺纹,从而当所述连接销的第二末端与所述螺纹连接器的内螺纹旋拧时,所述连接销的第一螺纹与所述盖板孔的螺纹旋拧,由此所述盖板、融合板和间隔物被耦接。
10.权利要求7所述的植入物,其中所述盖板孔具有接纳所述连接销的头的埋头孔。
11.权利要求1所述的植入物,其中所述至少一个间隔物通道是孔。
12.权利要求11所述的植入物,其中所述孔从所述至少一个腔延伸至所述顶部部分。
13.权利要求1所述的植入物,其中所述至少一个间隔物通道以半圆柱的形状形成,并设置为使紧固件得以从所述至少一个腔延伸至椎骨的末端板。
14.权利要求2所述的植入物,其中所述融合板具有其中配合有所述盖板的凹处。
15.权利要求1所述的植入物,其中所述锁件包括在至少所述第一孔和在至少所述第二孔中的衬套。
16.一种设置为***在待被融合在一起的两根骨的相对的面之间的植入物,所述植入物包括:
设置为配合在所述两根骨的相对的面之间以促进所述两根骨的融合的间隔物,所述间隔物具有向前的部分、向后的部分、顶部部分、底部部分以及两侧的部分;所述向后的部分包括至少一个腔,所述间隔物具有从所述向后的部分延伸至所述顶部部分或所述底部部分中的至少其一的至少一个间隔物通道,以及在所述至少一个腔中具有第一螺纹的间隔物孔;
包括主体部分和第一延伸侧部分的融合板,所述主体部分包括向前的面、与所述向前的面相对的向后的面,以及连接所述向前的面和所述向后的面的侧壁,所述向前的面和至少一部分的所述侧壁被接纳在所述至少一个腔中,所述第一延伸侧部分从所述主体部分呈喇叭形展开并设置为延伸超过所述间隔物的顶部部分或底部部分中的至少其一,所述融合板包括多个紧固件孔,包括至少第一紧固件孔,所述第一紧固件孔与所述至少一个间隔物通道对齐并从所述融合板的向后的面延伸至向前的面,以及从所述向后的面延伸至所述向前的面的第一延伸侧部分中的第二紧固件孔,所述主体部分包括与所述间隔物孔对齐的板孔,并具有置于其中的肩状物;
具有第一末端以及与所述第一末端相对的第二末端的连接器,所述连接器的第一末端具有设置用以与所述第一螺纹有效啮合的第二螺纹,所述连接器的第二末端具有带外翻唇的槽头,所述连接器通过与带所述肩状物的外翻唇啮合而被连接到融合板,并且所述连接器通过将所述连接器的第二螺纹与所述间隔物孔的第一螺纹有效啮合而被耦接到所述间隔物孔;
多个紧固件,包括至少第一紧固件,延伸穿过所述第一紧固件孔、所述至少一个间隔物通道,并延伸出所述顶部部分或所述底部部分,并设置用以将所述植入物耦接到第一根骨的末端板,以及至少第二紧固件,延伸穿过所述第二紧固件孔从而将所述植入物耦接到第二根骨;
盖板,该盖板与所述融合板耦接以防止所述多个紧固件退出所述植入物。
17.权利要求16所述的植入物,其中所述连接器包括具有第三螺纹的内孔,并且所述盖板被连接销耦接到所述融合板,使所述连接销的轴上的第四螺纹有效地啮合所述第三螺纹。
18.权利要求17所述的植入物,其中所述盖板包括具有第五螺纹的盖板孔,并且所述连接销包括位于所述连接销的头与所述连接销的轴上的第四螺纹之间的第六螺纹,其中所述第六螺纹有效地啮合所述第五螺纹从而将所述连接销耦接到所述盖板。
19.权利要求18所述的植入物,其中所述多个紧固件孔包括内凹表面,并且所述多个紧固件包括头和轴,其中所述头具有凸表面以协同地啮合所述多个紧固件孔的内凹表面从而使每个所述多个紧固件的取向得以被调整。
20.一种用于植入融合护架的方法,所述方法包括:
选择设置用以配合在待被融合在一起的两根骨之间的间隙中的间隔物,所述间隔物具有用于***的前部部分,以及与所述前部部分相对的后部部分,所述后部部分具有凹处以及带第一螺纹的间隔物孔;
将连接器旋拧入所述间隔物孔中,所述连接器具有带外第二螺纹的第一末端以及带有具有外翻唇的槽头的第二末端,以至于所述第二螺纹协同地啮合所述第一螺纹;
将融合板配合在所述连接器上,所述融合板具有板孔,肩状物位于所述板孔中,使所述肩状物协同地啮合所述外翻唇,以至于将所述融合板耦接到所述连接器;
旋拧多个紧固件,经由所述融合板至所述两根骨之一,其中所述多个紧固件中的至少其一被旋拧穿过所述间隔物;和
将盖板耦接到所述融合板以抑制所述多个紧固件的反向旋拧。
21.一种设置为***在待被融合的两根骨的相对的面之间的植入物,所述植入物包括:
设置为配合在所述两根骨之间并具有顶部和底部部分的间隔物;
与所述间隔物耦接并至少部分地被置于所述两根骨的外部的融合板,所述融合板包括与所述间隔物连接的主体部分,以及设置为延伸超过所述间隔物的顶部部分或底部部分中的至少其一的第一延伸侧部分;
第一紧固件,所述第一紧固件延伸穿过所述融合板和间隔物,并延伸入所述两根骨的第一根中;
第二紧固件,所述第二紧固件延伸穿过所述融合板,并延伸入所述两根骨的第二根中;
锁件,所述锁件被至少耦接到所述融合板以抑制所述第一和第二紧固件移动出所述第一和第二根骨。
22.权利要求21所述的植入物,其中所述间隔物包括向前的部分、向后的部分、顶部部分、底部部分、两侧部分,以及从所述向后的部分延伸至所述顶部部分或底部部分中至少其一的至少一个间隔物通道,并且所述融合板包括第一孔,所述第一紧固件延伸穿过至少一个间隔物通道和所述第一孔。
23.权利要求22所述的植入物,其中所述融合板包括所述第一延伸侧部分中的第二孔,所述第二紧固件延伸穿过所述第二孔。
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2013
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Also Published As
Publication number | Publication date |
---|---|
EP2779954B1 (en) | 2018-10-17 |
EP2779954A4 (en) | 2015-11-18 |
US10085847B2 (en) | 2018-10-02 |
US9370435B2 (en) | 2016-06-21 |
US20130345814A1 (en) | 2013-12-26 |
EP2779954A1 (en) | 2014-09-24 |
US20140330386A1 (en) | 2014-11-06 |
US9913729B2 (en) | 2018-03-13 |
US9364342B2 (en) | 2016-06-14 |
CN104203163B (zh) | 2016-10-26 |
US20160324657A1 (en) | 2016-11-10 |
US20180147068A1 (en) | 2018-05-31 |
WO2013075124A1 (en) | 2013-05-23 |
US20160338852A1 (en) | 2016-11-24 |
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