CN103237514B - 利用压缩性植入物固定或融合骨的系统 - Google Patents
利用压缩性植入物固定或融合骨的系统 Download PDFInfo
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- CN103237514B CN103237514B CN201180058533.XA CN201180058533A CN103237514B CN 103237514 B CN103237514 B CN 103237514B CN 201180058533 A CN201180058533 A CN 201180058533A CN 103237514 B CN103237514 B CN 103237514B
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Abstract
由骨折线或关节分隔的第一和第二骨段通过产生穿过第一骨段,穿过骨折或关节并进入第二骨段的插入通道并且插入锚固在第二骨段中的远端处的锚固主体来固定或融合。使长形的植入物结构经过锚固主体以跨越骨段之间的骨折或关节。锚固主体的近端被锚固到第一骨段的外部并使锚固主体和骨段处于受压地放置。
Description
相关申请
本申请是于2005年5月24日提交的共同待审的美国专利申请序列号11/136,141的部分继续申请,该部分继续申请是于2004年8月9日提交的美国专利申请序列号10/914,629(现已放弃)的部分继续申请。
发明领域
本申请大体涉及骨的固定或融合。
发明背景
许多类型的硬件均可用于骨折的骨的固定以及待融合(关节固定)的骨的固定。
例如,人骨盆带(参见图9和图10)由三块大骨组成,这三块大骨由三个相对固定的关节连接。其中一块骨被称作骶骨并且其位于腰脊柱的底部,骶骨在此处与L5椎骨连接。其它两块骨通常被称作“髋骨”并且在学术上被称为右髂骨和左髂骨。骶骨在骶髂关节(简写为SI-关节)处与髋骨连接。
SI-关节在力从脊柱到下肢的传递中起作用,且反之亦然。SI-关节被描述为高至22%的下背痛的疼痛产生部位。
为了缓解由SI关节产生的疼痛,骶髂关节融合通常被表示为例如用于退行性骶髂关节炎、炎性骶髂关节炎、骶髂关节的医源性不稳定性、髂骨致密性骨炎或骨盆的外伤性骨折脱位的外科治疗。目前,螺丝和带有板的螺丝被用于骶髂融合。同时,软骨必须从SI关节的“滑膜关节”部位除去。这需要大的切口来接近损伤的、半脱位的、脱位的、骨折的或退化的关节。
发明概述
本发明提供了骨固定/融合系统、装置,以及以微创的方式来稳定邻近的骨段(bonesegment)的相关方法。邻近的骨段可包括同一骨的骨折部位,或由间隙(space)或关节分隔的两根或更多根单骨。如本文所用的,“骨段”或“邻近的骨区域”是指以下两种情况中的任一种,即,(装置用来固定的)单根骨中的骨折线,或者(装置用来关节固定或融合的)不同骨段之间的间隙或关节。因此,装置可用来在两根或更多根单骨之间执行固定功能,或者在同一根骨的两个或更多个部位之间执行融合功能,或者这两种功能。
本发明的一个方面提供了用于固定或融合包括由骨折线或关节分隔的第一骨段和第二骨段的骨结构的组件及相关方法。组件和相关的方法包括锚固主体(anchorbody),其被依尺寸设计并配置成引入到第一骨段和第二骨段中。锚固主体具有定位在第二骨段的内部区域的远端;定位在第一骨段的外部区域之外的近端;以及跨越第一骨段和第二骨段之间的骨折线或关节的中间区域。组件和相关的方法还包括远端锚固件,其被固定到第二骨段的内部区域并附加到锚固主体的远端以在第二骨段中锚固远端。组件和相关方法进一步包括近端锚固件,其被固定到第一骨段的外部区域并附加到锚固主体的近端,该近端锚固件与远端锚固件协力使锚固主体处于受压以相对于骨折线或关节压缩并固定骨段。组件和相关的方法还包括长形的植入物结构,其由锚固主体的中间区域承载并跨越骨段之间的骨折线或关节。长形的植入物结构包括外表面区域,其被处理以沿着植入物结构提供骨内生长(bonyin-growth)或穿骨生长(bonythrough-growth),以促进保持受压的并且由锚固主体固定的第一骨段和第二骨段的固定或融合。
骨固定/融合系统、装置和相关方法非常适合用于稳定SI-关节中的邻近的骨段。
因此,本发明的另一方面提供了用于融合髂骨和骶骨之间的骶髂关节的方法。方法包括产生穿过髂骨、穿过骶髂关节并进入骶骨的插入通道。方法包括提供锚固主体,锚固主体被依尺寸设计并配置成通过插入通道侧向引入到髂骨和骶骨中。锚固主体具有远端,其被依尺寸设计并配置成定位在骶骨的内部区域中;近端,其被依尺寸设计并配置成定位在髂骨的外部区域之外;以及中间区域,其被依尺寸设计并配置成跨越骶髂关节。方法包括提供长形的植入物结构,长形的植入物结构被依尺寸设计并配置成经过锚固主体以跨越髂骨和骶骨之间的骶髂关节。长形的植入物结构包括外表面区域,其被处理以沿着植入物结构提供骨内生长或穿骨生长。方法包括使锚固主体引入穿过自从髂骨开始、通过骶髂关节并进入骶骨的插入通道。方法包括将锚固主体的远端锚固在骶骨的内部区域中。方法包括使长形的植入物结构经过锚固主体以在髂骨和骶骨之间跨越骶髂关节,并将锚固主体的近端锚固到髂骨的外部区域,锚固主体的近端与锚固的远端协力使锚固主体处于受压以压缩并固定骶髂关节。植入物结构的骨内生长或穿骨生长区域促进了保持受压的并由锚固主体固定的骶髂关节的固定或融合。
本发明的另一方面提供了用于融合在髂骨和骶骨之间的骶髂关节的方法,该方法包括产生侧向穿过髂骨、穿过骶髂关节并进入骶骨的侧向插入通道(lateralinsertionpath)。方法包括提供骨固定植入物并且使骨固定植入物侧向插入穿过自髂骨开始、穿过骶髂关节并进入骶骨的插入通道。方法包括在骶骨的内部区域中锚固骨固定植入物以固定骶髂关节。
本发明的另一方面提供了用于融合在髂骨和骶骨之间的骶髂关节的方法,该方法包括产生从髂骨的髂后棘进入,成角度地穿过骶髂关节并终止于骶翼的后侧向插入通道(postero-lateralinsertionpath)。方法包括提供骨固定植入物并通过后侧向插入通道插入骨固定植入物。方法包括在骶翼的内部区域中锚固骨固定植入物以固定骶髂关节。
在一个实施方案中,骨固定植入物包括螺丝样的结构(screw-likestructure)。
在一个实施方案中,骨固定植入物包括融合笼形的结构。
在一个实施方案中,骨固定植入物包括具有直线横截面的长形的植入物结构,长形的植入物结构包括处理过的外表面区域以沿着植入物结构提供骨内生长或穿骨生长。
在一个实施方案中,插入通道以无损方式产生而不用事先除去软骨。
在一个实施方案中,插入通道包括钻孔,该钻孔近似地以骨固定植入物的外部最大尺寸或近似地以大约骨固定植入物的外部最大尺寸定尺寸。
附图简述
图1是在邻近的骨区域中组装的压缩杆组件(compressionstemassembly)的侧视截面图,为了图示的目的,其以图解方式显示于图1中,而没有解剖学细节,该解剖学细节之后显示于例如图16中。
图2是图1中所示的压缩杆组件的部件在组装之前的分解透视图。
图3至图7是植入物结构的可选的实施方案,该植入物结构形成图1和图2所示的压缩杆组件的一部分,图示了植入物结构20的不同横截面几何形状和构型。
图8A至图8L是图1和图2所示的压缩杆组件的引入和组装的侧视截面图,为了图示的目的,其以图解的方式显示于图8A至图8L中,而没有如之后显示于例如图16中的解剖学细节。
图9和图10分别是包括骶骨和髋骨(右髂骨和左髂骨)的人骨盆带的前部和后部解剖学视图,骶骨在骶髂关节(简写为SI-关节)处与两个髋骨连接。
图11至图13A和图13B是分别以分解透视图、组装的透视图、组装的前视图和组装的轴向截面图显示的解剖学视图,在没有压缩杆组件的关联的情况下,利用侧向方法侧向穿过髂骨、SI-关节并进入骶骨S1来植入三种植入物结构用于固定SI-关节。
图14至图16A和图16B是分别以分解透视图、组装的透视图、组装的前视图和组装的轴向截面图显示的解剖学视图,在与压缩杆组件关联的情况下,利用侧向方法侧向穿过髂骨、SI-关节并进入骶骨S1来植入三种植入物结构用于固定SI-关节。
图17至图19A和图19B是分别以分解透视图、组装的透视图、组装的侧视图和组装的轴向截面图显示的解剖学视图,在没有压缩杆组件的关联的情况下,利用后侧向方法从髂骨的髂后棘进入,成角度地穿过SI-关节并终止于骶翼来植入三种植入物结构用于固定SI-关节。
图20至图22A和图22B是分别以分解透视图、组装的透视图、组装的侧视图和组装的轴向截面图显示的解剖学视图,在与压缩杆组件关联的情况下,利用后侧向方法从髂骨的髂后棘进入,成角度地穿过SI-关节并终止于骶翼来植入三种植入物结构用于固定SI-关节。
图23和图24A及图24B是分别以分解透视图、组装的前视图和组装的轴向截面图显示的解剖学视图,利用侧向方法侧向穿过髂骨、SI-关节并进入骶骨S1来植入螺丝样结构用于固定SI-关节。
图25和图26A及图26B是分别以分解透视图、组装的侧视图和组装的轴向截面图显示的解剖学视图,利用后侧向方法从髂骨的髂后棘进入,成角度通过SI-关节并终止于骶翼来植入螺丝样结构用于固定SI-关节。
图27和图28A及图28B是分别以分解透视图、组装的前视图和组装的轴向截面图显示的解剖学视图,利用侧向方法侧向穿过髂骨、SI-关节并进入骶骨S1来植入融合笼形结构用于固定SI-关节。
图29和图30A及图30B是分别以分解透视图、组装的侧视图和组装的轴向截面图显示的解剖学视图,利用后侧向方法从髂骨的髂后棘进入,成角度通过SI-关节并终止于骶翼来植入融合笼形结构用于固定SI-关节。
图31是压缩杆组件的可选实施方案的部件在组装之前的分解透视图。
图32和图33是图31中所示的压缩杆组件的可选实施方案在组装之后的透视图,显示了与组件关联的锚固板从对齐位置(图32)旋转到扣紧骨的位置(图33所示),以将组件锚固在骨中。
图34是在邻近的骨区域中组装的图31中所示的压缩杆组件的侧视截面图,为了图示的目的,其以图解方式显示于图34中,而没有解剖学细节。
图35A和图35B是压缩杆组件的可选实施方案在邻近骨区域中组装之前(图35A)和组装之后(图35B)的侧视截面图,为了图示的目的,其以图解方式显示于图35A和图35B中,而没有解剖学细节。
图36A和图36B是径向可压缩的植入物在邻近骨区域中组装之前(图36A)和组装之后(图36B)的侧视截面图,为了图示的目的,其以图解方式显示于图36A和图36B中,而没有解剖学细节。
优选实施方案的描述
虽然在此的公开内容是详细的并且准确的以使本领域技术人员能够实现本发明,但是本文公开的物理实施方案仅仅示例本发明可以体现在其它特定的结构中。虽然描述了优选的实施方案,但是在不偏离本发明的情况下可以改变细节,本发明由权利要求限定。
I.压缩杆组件
图1和图2分别以组装视图和分解视图显示了压缩杆组件10的代表性构型,其被依尺寸设计并配置用于固定骨折(即,固定同一根骨的部位),或用于固定待融合(关节固定)的骨(即固定邻近和/或连接的两根或更多根单骨)。为了简略表达,有时组件10将被称作骨固定/融合压缩组件,以表明其可在两根或更多根单骨之间执行固定功能,或在同一根骨的两个或更多个部位之间执行融合功能,或者执行这两种功能。如本文所用的,“骨段”或“邻近的骨区域”是指以下两种情况中的任一种,即,在单根骨中的骨折线,或者在不同骨段之间的间隙或关节。在图1中,为了图示的目的,示意性地显示了骨段或邻近的骨区域而没有解剖学细节。之后,例如在图13至图16以及图20至图22中,以具体的解剖学布置显示了骨段或邻近的骨区域,包括在盆骨的骶骨和髂骨之间的关节,解剖学上还称作骶髂关节(SI-关节)。
如图1和图2中所示,压缩杆组件10包括锚固主体12,其(如图1所示)被依尺寸设计并配置成受压地放置在骨段或邻近的骨区域中。在代表性的实施方案中,锚固主体12采取圆柱形锚固销或杆的形式。然而,锚固主体12可具有其它几何结构。
锚固主体12的远端锚固到远端锚固螺丝14,该远端锚固螺丝14耦合到间隙或关节的一侧内的内部骨区域。锚固主体12的近端通过锚固螺母16和锚固垫圈18固定到间隙或关节的相对侧的外部骨区域。远端锚固螺丝14和锚固螺母16使锚固主体12保持受压,并且在这种情况下,锚固主体12压缩并固定骨段或邻近的骨区域。
在骨区域或骨段中的锚固主体12具有长形的、杆样的管状植入物结构20。植入物结构20包括内部钻孔22,该内部钻孔22通过在锚固主体12上滑动来接纳其布置。如图2所示,植入物结构20包括区域24,该区域24沿着植入物结构20的长度的至少一部分形成以促进骨内生长到结构表面上或结构表面中和/或完全穿过全部结构或结构的一部分的骨生长。沿着植入物结构20的表面的骨内生长或穿骨生长区域24促进了在植入物结构20上、在植入物结构20中或穿过植入物结构20的骨内生长或穿骨生长。在植入物结构20上、在植入物结构20中或穿过植入物结构20的骨内生长或穿骨生长帮助加速保持受压的并且由锚固主体12固定的骨段或邻近的骨区域的融合过程或骨折愈合时间。
A.锚固主体、螺母和垫圈
锚固主体12、螺母16和垫圈18可例如通过机械加工、模塑或挤出由可用于假体技术中的材料形成,其能够放入并保持压缩力,并且不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。锚固主体12、螺母16和垫圈18旨在在足以使骨折或融合部位稳定的时间内保留在合适的位置。这样的材料的实例包括但不限于,钛、钛合金、钽、铬钴、外科手术用钢,或任何其它整个关节置换金属和/或陶瓷、烧结玻璃、人造骨、任何未胶结的金属或陶瓷表面,或其组合。
在长度上(参见图1),锚固主体12被依尺寸设计以跨越通过一个邻近的骨段或区域,通过介于中间的间隙或关节,并且至少部分地进入其它邻近的骨段或区域的距离。根据局部解剖学依尺寸设计锚固主体12的长度和直径。通常,医学专业人员可利用人体骨骼解剖学的教科书以及他们对部位及其疾病或损伤的知识来理解局部结构的形态。医师还能够在目标骨区域的形态的事先分析的基础上利用例如平面膜x-射线、荧光镜x-射线,或者MRI或CT扫描来确定锚固主体12的大小。锚固主体12的代表性的直径可以在3.2mm至3.5mm之间的范围。
如图2中最佳示出的,锚固主体12的至少近端区域和远端区域包括外螺旋螺脊或螺纹26和28,其围绕锚固主体12的圆柱形体形成。可选地,如果希望,锚固主体12可以大体上沿着其整个长度是带螺纹的。期望地,在锚固主体12的近端区域和远端区域,螺纹26和28的方向相同的,例如,其期望地包括右手螺纹。
带有螺纹26的锚固主体12的近端区域被依尺寸设计以在使用时在一个邻近骨段或区域之外延伸一定距离。以这种方式,在使用时近端区域被暴露以便可附接近端的锚固螺母16和垫圈18。锚固螺母16包括互补的内螺纹,其被依尺寸设计并配置成与锚固主体12的近端区域的外螺纹26配合。3.2mm的锚固主体12的锚固螺母16和锚固垫圈18的代表性直径分别是3.2mm和8mm。
带螺纹28的锚固主体12的远端区域被依尺寸设计以至少部分地延伸入其他邻近的骨段或区域中,其中其被耦合到锚固螺丝14,如以下将要描述的。
B.锚固螺丝
如同锚固主体12、螺母和垫圈18,锚固螺丝14同样可例如通过机械加工或模塑由可用于假体技术中的耐用材料形成,锚固螺丝14能够螺旋进入骨中,并且不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。如同压缩组件10的其它部件,锚固螺丝14旨在在足以使骨折或融合部位稳定的时间内保留在合适的位置。这样的材料的实例包括但不限于,钛、钛合金、钽、铬钴、外科手术用钢,或任何其它整个关节置换金属和/或陶瓷,或其组合。
锚固螺丝14被依尺寸设计以在锚固主体12的带螺纹的远端区域28的末端在其它邻近的骨段或区域内跨越一定距离。如图2中最佳示出的,锚固主体14包括外螺旋螺脊或螺纹30,其围绕锚固螺丝14的圆柱形体形成。外螺纹30被依尺寸设计并配置成旋转时在骨中增加旋紧,以便锚固螺丝14可通过旋转前进到并容纳到骨段或区域内的骨中。容纳在骨中的锚固螺丝14抵抗轴向移动和分隔。再次根据局部解剖学的需求,锚固螺丝14的长度的代表性范围可以在5mm至20mm之间。锚固螺丝14的代表性直径是约7mm。
锚固螺丝14还包括内螺旋螺脊或螺纹32,其形成在锚固螺丝14的钻孔中。内螺纹32被依尺寸设计并配置成与锚固主体12的远端区域上互补的外螺纹28匹配。当螺纹连接到锚固螺丝14的内螺纹32并且与锚固螺丝14的内螺纹32匹配时,锚固螺丝14将锚固主体12的远端区域锚固到骨以抵抗锚固主体12的轴向移动。如之前描述的,锚固螺丝14(在远端)和锚固螺母16和锚固垫圈18(在近端)使锚固主体12受压,从而压缩并固定骨段或邻近的骨区域。
可选地,锚固螺丝14可由无外螺纹的内部带螺纹的部件代替,其被依尺寸设计并配置成例如通过进行干涉配合和/或通过使用粘合剂来固定的其它方式来牢固地附加到最远端的骨段的开口的钻孔中,该开口的钻孔终止于最远端的骨段。如同锚固螺丝14,干涉配合和/或粘合剂锚固整个植入物结构。粘合剂也可与锚固螺丝14组合使用。
C.植入物结构
植入物结构20可例如通过机械加工、模塑或挤出由可用于假体技术中的耐用材料形成,该植入物结构20不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。如同压缩组件10的其它部件,植入物结构20旨在在足以使骨折或融合部位稳定的时间内保留在合适的位置。这样的材料包括但不限于,钛、钛合金、钽、tivanium(铝、钒和钛)铬钴、外科手术用钢,或任何其它整个关节置换金属和/或陶瓷、烧结玻璃、人造骨、任何未胶结的金属或陶瓷表面,或其组合。可选地,植入物结构20可由合适的耐用的生物材料或者金属与生物材料的组合诸如生物相容的骨填充材料来形成。植入物结构20可由可流动的生物材料例如丙烯酸骨接合剂来模塑,该可流动的生物材料例如通过UV光固化成不可流动材料或固体材料。
植入物结构20根据局部解剖学来依尺寸设计。通常,医学专业人员可利用人体骨骼解剖学的教科书以及他们对部位及其疾病或损伤的知识来理解局部结构的形态。医师还能够在目标骨区域的形态的事先分析的基础上利用例如平面膜x-射线、荧光镜x-射线,或者MRI或CT扫描来确定植入物结构20的大小。
如图3至图7所示的,植入物结构20可呈现不同的形状并具有不同的横截面几何形状。植入物结构20可具有例如大体曲线(即,圆形或椭圆形)的横截面--如图3为图示目的所示的-或者大体直线的横截面(即,正方形或矩形或三角形)-如图4为图示目的所示的--或其组合。在图2中,植入物结构20被显示为三角形的横截面,其有效地抵抗了植入时的旋转和微移动。
如图5和图6所示的,植入物结构20(无论是曲线的(图5)还是直线的(图6))可至少沿着其轴向长度的一部分包括锥形区域34,意味着植入物结构20的宽度或直径沿着其轴向长度递增地增加。令人期望地,锥形区域34在使用时与植入物结构20的近端区域(即,植入物结构20的进入骨的最后部分)相对应。宽度或直径的递增增加的量可以变化。作为一个实例,对于具有7mm的标准直径的植入物结构20,其最大递增增加的量级可在约.25mm至1.25mm之间的范围内。锥形区域34进一步增强了骨段或骨区域之间的压缩的产生和保持。
为了进一步增强骨段或骨区域之间的压缩的产生和保持(参见图7),植入物结构20(不论是曲线的还是直线的或锥形的)可包括“齿”或翼或类似形式的突出的扣紧骨的表面36。齿或翼36可从植入物结构20的表面伸出例如2至4mm,并且在植入物结构20的近端和远端处的压缩力方向上的面随着其通过压缩组件一起压缩而旋紧到骨段中。
骨内生长或穿骨生长区域24可沿着植入物结构20的整个外表面延伸,如图1或图2所示的,或者骨内生长或穿骨生长区域24可仅仅覆盖骨段或骨折线的任一侧上指定的距离。骨内生长区域24或穿骨生长可包括,例如,贯通孔,和/或不同的表面图案,和/或不同的表面纹理,和/或孔,或其组合。当然,骨内生长或穿骨生长区域24的构型可以变化。通过实施例的方式,骨内生长或穿骨生长区域24可包括开放的网眼构型;或珠状构型;或小梁构型;或包括孔或开窗。有益于骨内生长和/或穿骨生长的任何构型将满足需要。
骨内生长或穿骨生长区域24可被涂覆或包裹或表面处理以提供骨内生长或穿骨生长区域,或者其可由这样的材料形成,该材料自身内在地具有有益于骨内生长或穿骨生长的结构,诸如多孔网、羟基磷灰石,或其它多孔表面。骨内生长或穿骨生长区域可包括允许骨在整个区域中生长的孔。
在优选的实施方案中,骨内生长区域或穿骨生长区域24包括在植入物结构20上的多孔的等离子体喷雾涂层。这产生了生物力学上严密的固定/融合系统,其被设计成支持可靠的固定/融合以及敏锐的承重能力。
骨内生长或穿骨生长区域24可进一步覆盖有多种其它涂层诸如抗微生物剂、抗血栓形成剂和骨诱导剂,或其组合。如果希望,整个植入物结构20可包含这样的剂。
D.压缩杆组件的植入
为了图示的目的,图8A至图8L图解地显示了用于植入压缩杆组件10的代表性程序。更具体地,之后将描述SI-关节中的压缩杆组件10的具体植入技术的解剖学集中描述。
医师识别将要被固定或融合(关节固定)的骨段或邻近的骨区域(参见图8A)。通过常规的可视化技术的帮助,例如,利用X射线图像增强器诸如C-形臂或荧光镜来产生显示于TV屏上的活动图像供给(liveimagefeed),将引导销38通过常规的装置(参见图8B)引入通过一个邻近的骨段或区域,通过介于中间的间隙或关节,并且部分地进入其它邻近的骨段或区域。
管状钻头40经过(passover)引导销38(参见图8C)以形成通过一个邻近的骨段或区域、通过介于中间的间隙或关节,并且部分地进入其它邻近的骨段或区域的先导插入通道或钻孔42。可利用单个钻头或多个钻头40来钻通骨碎片或骨表面以产生希望大小和构型的先导钻孔。先导钻孔42的远端的骨区域未被钻孔并且自然用于容纳锚固螺丝14。当先导钻孔42完成时,移除管状钻头40。
具有与植入物结构20的外部几何形状和大小匹配的外部几何形状和大小的凿子44(在图示的实施方案中,该凿子44是三角形的)(参见图8D)经引导销38轻击(tap)通过先导钻孔42。成形的凿子44沿着先导钻孔42的边缘切削以形成希望的轮廓(在图示的实施方案中,该凿子44是三角形的),以接纳植入物结构20通过一个邻近的骨段或区域、通过介于中间的间隙或关节,并且部分地进入其它邻近的骨段或区域。
将凿子44取出(参见图8E),并且锚固螺丝14(其内螺纹与管状带螺纹的螺丝刀46的远端配合)经过引导销38到远端骨段的开口的钻孔48的末端。锚固螺丝14通过螺丝刀46的操作越过开口的钻孔48的末端螺纹连接到未钻的且自然的骨中。例如,锚固螺丝14可以是前进的并且越过开口的钻孔48的末端埋入骨中至少5mm。
通过从锚固螺丝14反向旋转将带螺纹的螺丝刀46钻出,并移除引导销38(参见图8G)。插入锚固主体12,并且将其带螺纹的远端28螺纹连接到并与锚固螺丝14的内螺纹32配合(参见图8H)。
如图8H中所示的,由于其有目的的大小和构型,当其带螺纹的远端28适当地螺纹连接到锚固螺丝14时,锚固主体12的带螺纹的近端26在开口的钻孔48的近端的外部伸出暴露的距离。
植入物结构20通过使其在锚固主体12上滑动而经过锚固主体12,直到植入物结构20的远端位于对接贴着锚固螺丝14的近端(参见图8I)。
锚固垫圈18通过在锚固主体12的暴露的带螺纹的近端26之上滑动而变成对接贴着外部骨表面(参见图8J)。锚固螺母16螺纹连接到锚固主体12的带螺纹的近端26上并与锚固主体12的带螺纹的近端26配合(参见图8K)。利用手动(或动力)卡盘50将锚固螺母16贴着锚固垫圈18紧固(参见图8L),直到通过组件10将希望量的压缩应用于骨区域。压缩将减小骨段之间的距离,同时还使植入物结构20在开口的钻孔48中压缩,确保开口的钻孔48中的骨内生长区域24和骨之间的紧密接触。
由骨内生长或穿骨生长区域24之间的压缩产生的沿着植入物结构20的表面的紧密接触加快了在植入物结构20上、在植入物结构20中或者通过植入物结构20的骨内生长或穿骨生长,以加快融合过程或骨折愈合时间。
如之后将要更详细地描述的,可将多于1个压缩杆组件10植入给定的骨段中。例如,如之后将要描述的(参见,例如,图20),可植入三个这样的压缩杆组件以使SI-关节融合。
E.可选择的实施方案
(1)远端锚固板
图31至图33中显示了压缩杆组件10的可选择的实施方案。如已经描述的,为了骨固定或关节融合的目的,在使用中,压缩杆组件10被依尺寸设计并配置成植入由间隙或关节分隔的邻接的骨段中。
在这个实施方案中(参见图31),锚固主体12、螺母16和垫圈18如先前所描述的一样被依尺寸设计并且配置。同样地,植入物结构20被依尺寸设计并配置成大体直线的横截面,还如早前所描述并且如图4中所示的。
在这个实施方案中,代替带螺纹的锚固螺丝14,通过大体直线的锚固板58将组件10的远端锚固到骨中。锚固板58例如通过机械加工或模塑由可用于假体技术中的坚硬的耐用材料形成,锚固板58能够插进骨中并且在骨中增加旋紧,并且不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。
如图31和图32中最佳示出的,直线的锚固板58被依尺寸设计并配置成与植入物结构自身的直线的横截面匹配。在图示的布置中,植入物结构20的横截面是大体三角形的,因此,锚固板58的横截面也是大体三角形的。这样,锚固板58包括尖端64。尖端之间的锚固板58的边被削尖以包括骨切削边缘72。
锚固板58在其几何中心还包括钻孔60(参见图31)。内螺旋螺脊或螺纹62形成于钻孔68中。内螺纹62被依尺寸设计并配置成与锚固主体12的远端区域上的互补的外螺纹28配合。从而锚固主体12的远端可螺纹连接到锚固板58(如图32所示的)。当螺纹连接到锚固主体12时,锚固板58与锚固主体12共同地旋转(如图33所示的)。
在将植入物结构20引入以先前描述(并且如图8A至图8D中所示)的方式形成的开口的钻孔48中之前,锚固主体12穿过植入物结构20的钻孔22,并且锚固板58被螺纹连接到锚固主体12的远端带螺纹的区域26,其被依尺寸设计以伸出超过植入物结构20的远端。而且,如图32所示的,锚固板58另外旋转地定向于与植入物结构20的远端对齐的位置。在对齐的位置中(图32),锚固板58的尖端64与植入物结构20的远端的尖端66重叠并对准。植入物结构20、锚固主体12和锚固板58作为单元引入以图32所示的方位穿过开口的钻孔48。在对齐的位置中,锚固板58对植入物结构20穿过开口的钻孔48的通道不提供阻力。
当接触开口的钻孔的末端时,锚固主体58的近端旋转60度(如图33中所示的)。旋转时锚固板58移动到延伸的扣紧骨的位置中,该位置不再与植入物结构20的远端对齐(如图33中所示的)。在延伸的扣紧骨的位置中,三角形的锚固板58的尖端64从植入物结构20的三角形边68径向向外伸出锚固板58存在于植入物结构20的远端,存在大于植入物结构自身的横截面面积的扩大的侧面面积。
在锚固板58向扣紧骨的位置旋转的过程中,锚固板58的切削边缘72前进到骨中并切削骨,将锚固板58容纳在骨段或区域的骨中(参见图34)。在扣紧骨的位置中,锚固板58将锚固主体12的远端锚固到骨中。锚固板58以与锚固螺丝14十分相同的方式抵抗轴向移动和分隔。
在结构20的远端处的植入物结构20的边68优选地包括切口70(参见图31和图32)。切口70被依尺寸设计并配置使得当锚固板58旋转到其扣紧骨的位置时,邻接尖端的锚固板58的主体锁定(detent)并停留在切口70中,如图33所示的。嵌套在切口70中,进一步使锚固主体12的近端的锚固螺母16和垫圈18紧固,如先前所描述的,将锚固板58锁定在扣紧骨的锚固位置中。通过紧固锚固螺母,植入物结构在远端锚固板58和近端螺母/垫圈之间压缩(如图34所示的),从而构成压缩杆组件10。
(2)两件式可压缩的植入物结构
图35A和图35B中显示了可压缩的植入物结构的可选择的实施方案。如已经描述的,为了骨固定或关节融合的目的,在使用中,植入物结构被依尺寸设计并配置成植入由间隙或关节分隔的邻接的骨段中。
在这个实施方案中(参见图35A),植入物结构可具有如先前所描述的圆形的或曲线的横截面。不像先前的植入物结构,图35A中所示的植入物结构20包括两个配合的植入物部件74和78。
如之前所描述的,每个植入物结构74和78可例如通过机械加工、模塑或挤出由可用于假体技术中的耐用材料形成,这些植入物部件不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。每个植入物结构74和78包括如先前所描述的外部骨内生长或穿骨生长区域。
在将植入物结构引入之前,以先前所描述的以及图8A至图8D所示的方式形成穿过骨段的开口的钻孔。植入物部件74被依尺寸设计并配置成例如通过进行干涉配合和/或通过使用粘合剂来固定的其它方式来牢固地附加到最远端的骨段的开口的钻孔中,该开口的钻孔终止于最远端的骨段。植入物部件74旨在锚固整个植入物结构。
植入物部件74还包括支柱76,其延伸通过开口的钻孔进入最近端的骨段中,开口的钻孔源于该最近端的骨段。支柱76包括内螺纹80。
第二植入物部件78被依尺寸设计并配置成引入到最近端的骨段的开口的钻孔中。第二植入物部件74包括内部钻孔,以便植入物部件78通过将其滑动经过第一植入物部件74的支柱76来安装,如图35B所示的。
锚固螺丝16(期望地,带有垫圈18)包括外螺纹,其被依尺寸设计并配置成与支柱76内的互补的内螺纹80配合。紧固锚固螺丝16使第一和第二植入物部件74和78接合,使所得的植入物结构压缩,如图35B所示的。
(3)径向压缩
(分隔的植入物结构)
图36A和图36B中显示了植入物结构82的可选择的实施方案。如已经描述的,为了骨固定或关节融合的目的,在使用中,植入物结构82被依尺寸设计并配置成植入由间隙或关节分隔的邻接的骨段中。植入物结构82被依尺寸设计并配置成处于径向压缩。
植入物结构82包括如先前所描述的可具有圆形或曲线的横截面的主体。如之前所描述的,植入物结构82可例如通过机械加工、模塑或挤出由可用于假体技术中的耐用材料形成,该植入物结构82不随着时间而遭受周围骨或组织的明显的生物吸收或再吸收。植入物结构82包括如先前所描述的一个或多个外部骨内生长或穿骨生长区域。
不同于先前描述的植入物结构,植入物结构82的近端包括包含裂缝(split)84的弱化区的轴向区域。还包括自攻螺丝(self-tappingscrew)16。螺丝16包括锥形的带螺纹的主体。锥形的主体在朝向螺丝16的头部的方向上形成递增直径的楔子。螺丝16是自攻的,被依尺寸设计并配置成当旋转到裂缝84中时逐渐地前进,同时产生其自身的螺纹,如图36B所示的。
在将植入物结构84引入之前,以先前所描述的以及图8A至图8D所示的方式形成通过骨段的开口的钻孔。如图36A所示的,将植入物结构84引入开口的钻孔中。植入物结构84被期望地依尺寸设计并配置成例如通过进行干涉配合和/或通过使用粘合剂来固定的其它方式来固定地附加到最远端的骨段的开口的钻孔中,该开口的钻孔终止于最远端的骨段。干涉配合和/或粘合剂锚固整个植入物结构84。
将植入物结构84引入开口的钻孔之后,自攻螺丝16(期望地,具有垫圈18)通过旋转到裂缝84中渐进地前进。螺丝16的楔子形状的带螺纹的主体逐渐推动植入物结构84的主体沿着裂缝84径向向外扩展,如图36B所示的。植入物结构82的主体的直径关于裂缝84的扩展压迫植入物结构82的近端与邻近的骨紧密接触。植入物结构82的主体关于裂缝84的径向扩展使植入物结构82的近端贴着骨产生压缩。径向压缩确保骨内生长区域和开口的钻孔中的骨之间的紧密接触,并且抵抗了植入物结构82在骨段中的旋转移动和轴向移动。
F.未经压缩的植入物结构
应理解,具有骨内生长和/或穿骨生长区域的细长的杆样植入物结构20(如图2中所示的那种)可被依尺寸设计并配置成在不与如所描述的压缩杆组件10相关联或者没有用于实现如所描述的植入物结构的压缩的其它装置的情况下固定骨折(即,固定相同骨的部分)或固定将要融合(关节固定)到整个身体中的骨。在不与压缩杆组件10相关联的情况下,用于固定骨折(即,固定相同骨的部分)或用于固定将要融合的骨的具有骨内生长和/或穿骨生长区域24的代表性的细长的杆样植入物结构20的构型和用途例如描述在于2005年5月24日提交的序列号为11/136,141的美国转流申请中,其在此通过引用方式并入。
II.利用植入物结构的骶髂关节的关节固定
如图2中所示的细长的杆样植入物结构20(以及可选择的实施方案)使得在与压缩杆组件10关联或不关联的情况下以微创方式固定(分别在图9和图10的前视图和后视图中所示的)SI-关节成为可能。这些植入物结构20可通过利用两种可选的外科手术方法被有效地植入;即,(1)侧向方法,或(ii)后侧向方法。通过常规的侧向和/或前面-后面(A-P)可视化技术来帮助任何一种程序,例如,利用X射线图像增强器诸如C-形臂或荧光镜来产生显示于TV屏上的活动图像供给。
A.侧向方法
(1)与压缩杆组件不相关联
在侧向方法的一个实施方案中(参见图11、图12和图13A/B),一个或多个植入物结构20被侧向地引入(在未使用压缩杆组件10的情况下)通过髂骨、SI-关节并进入骶骨S1。图12和图13A/B中最佳地显示了这种通道以及得到的植入物结构20的布局。在图示的实施方案中,以这种方式放置了三个植入物结构20。另外,在图示的实施方案中,植入物结构20的横截面是三角形的,但是应理解,可以利用如先前所描述的其它横截面的植入物结构20。
在进行侧向植入程序之前,医师利用例如SI关节的Faber试验或CT-导向的注入或X射线/MRI来识别将要固定或融合(关节固定)的SI-关节段。
在侧向和前面-后面(A-P)c-形臂的帮助下,并且患者俯卧位(俯卧)躺着,医师(利用侧向可视化)对齐坐骨大切迹(greatersciaticnotche)以提供真实的侧卧位。与骶管的后皮质对齐开始3cm的切口,然后对髂骨进行血液-组织分隔。由侧向图,引导销38(具有套筒)(例如,斯坦曼销)开始在骶骨S1末端板的下方并且恰好骶管的前面的位置停留在髂骨上。在A-P图和侧向图中,引导销38应当以小的角度向前地(例如,如图13A所示的离水平15°至20°)平行于S1末端板。在侧向图中,引导销38应当在骶骨前壁的后面。在A-P图中,引导销38应该在S1下部孔的上面以及中线的侧面。这大体相应于图8A和图8B中图解示出的顺序。在移除引导销38套筒之前,软组织保护器(未显示)期望地滑过引导销38并稳固地贴着髂骨。
经引导销38(并且通过软组织保护器)以先前描述的方式钻孔先导钻孔42,如图8C中图解显示的。先导钻孔42延伸通过髂骨、通过SI-关节并进入S1。移除钻头40。
将成形的凿子44经引导销38(并通过软组织保护器)轻击到先导钻孔42中以产生具有用于植入物结构20的期望轮廓的开口的钻孔48,在图示的实施方案中该植入物结构20是三角形的。这大体相应于图8D图解显示的顺序。开口的钻孔48的三角形轮廓还显示与图11中。
如图11和图12中所示,可通过软组织保护器经引导销38立刻轻击三角形植入物结构20(在这个实施方案中,没有与压缩套筒组件相关联)通过髂骨、跨过SI-关节并进入S1,直到植入物结构20的近端贴着髂骨的侧壁齐平(还参见图13A和图13B)。取出引导销38和软组织保护器,使植入物结构20处于开口的通道中,与髂骨的侧壁平齐(参见图13A和图13B)。在图示的实施方案中,以这种方式植入两个额外的植入物结构20,如图12最佳示出的。
根据局部解剖学来确定植入物结构20的大小。对于SI-关节,根据局部解剖学,代表性的植入物结构20的大小可在长度从约35mm至约55mm以及直径约7mm的范围内变化。通常,医学专业人员可利用人体骨骼解剖学的教科书以及他们对部位及其疾病或损伤的知识来理解局部结构的形态。医师还能够在目标骨区域的形态的事先分析的基础上利用例如平面膜x-射线、荧光镜x-射线,或者MRI或CT扫描来确定植入物结构20的大小。
(2)与压缩杆组件相关联
如图14至图16A/B中所示的,侧向方法还适用于引入与如先前所描述的压缩杆组件10相关联的一个或多个植入物结构20,侧向通过髂骨、SI-关节并进入骶骨S1。图16A和图16B中最佳地显示了这种通道以及得到的植入物结构20的布局。如图11至图13A/B中所示的实施方案,以这种方式放置了三个植入物结构20。另外,如图11至图13A/B中所示的实施方案,植入物结构的横截面是三角形的,但是仍然应理解,可以利用如先前所描述的具有其它横截面的植入物结构。在侧向方法的这个实施方案中,在形成开口的钻孔48之后没有立即插入植入物结构20。相反,首先将压缩杆组件10的部件安装到开口的钻孔48中以接纳植入物结构20。
更具体地,在形成开口的钻孔48之后,如先前所描述的,移除引导销38,同时将软组织保护器保持在合适的位置。压缩杆组件10的锚固螺丝14大体以图8E至图8G中所示的方式处于越过开口的钻孔48的末端的骶骨S1的骨中。在这种布置中,为了容纳压缩杆组件10的锚固螺丝14的布局,越过先导钻孔42和开口的钻孔48的末端自然地并且未钻孔地保留骶骨S1中的一定程度的骨。锚固螺丝14前进并埋入骶骨S1中的这一程度的自然的且未钻孔的骨中,如图16A和图16B所示的,以耦合到锚固主体12的带螺纹的远端28。
将锚固主体12的带螺纹的近端28螺纹连接到并且与骶骨S1中的锚固螺丝14配合,如先前所描述的并且如图8H中所示的,并且锚固主体12的剩余部分近端地延伸通过SI-关节和髂骨,以在髂骨的侧壁的外部伸出暴露的距离,如图16A和图16B所示的。然后,植入物结构20通过将其在锚固主体12之上滑动来放置,直到贴着髂骨的侧壁齐平,如先前所描述的以及如图8I中所示的。然后安装锚固垫圈18和螺母并将其紧固到锚固主体12的近端上,如先前所描述的以及如图8J至图8L中所示的,使得组件压缩。得到的组件显示于图15和图16A/B中。
如图14和图15中所示的,可通过侧向方法跨过SI-关节安装三个压缩杆组件10。由于单个压缩杆组件通过紧固锚固螺母16而压缩地放置,邻近的压缩杆组件的植入物结构可前进以越过髂骨的侧壁略微伸出。如果这种情况发生,则伸出的植入物结构20可经其各自的锚固销12进一步轻轻地轻击到髂骨中。
B.后侧向方法
(1)与压缩杆组件不相关联
如图17至图19A/B中所示的,可以以后侧向方法引入一个或多个植入物结构(而不使用压缩杆组件10),从髂骨的髂后棘进入,成角度通过SI-关节并终止于骶翼。图18和图19A/B中最佳地显示了这种通道以及得到的植入物结构20的布局。在图示的实施方案中,以这种方式放置了三个植入物结构20。另外,在图示的实施方案中,植入物结构20的横截面是三角形的,但是应理解,可以利用如先前所描述的其它横截面的植入物结构20。
后侧向方法比侧向方法涉及少的软组织破坏,因为存在较少的覆盖髂骨的髂后棘的进入点的软组织。因此,从这个区域引入植入物结构20使得更小的、更加灵活的切口成为可能。而且,植入物结构20沿着后侧向途径比完全侧向的途径穿过更多的骨,从而涉及SI-关节的更多的表面积并且导致SI-关节的更多的融合以及更好的固定。利用后侧向方法还可以绕开包括L5神经根的全部神经根。
用于后侧向方法的装置与用于侧向方法的装置大体相同。期望地,涉及利用例如SI关节的Faber试验或CT-导向的注入或X射线/MRI来识别将要固定或融合(关节固定)的SI-关节段。期望地,在患者俯卧位(俯卧)躺着并且在侧向和前面-后面(A-P)c-形臂的帮助下进行。现在,除了先导钻孔42的路径从髂骨的髂后棘起始,成角度通过SI-关节并且终止于骶翼以外,利用相同的外科手术工具经引导销38形成先导钻孔42。如之前所描述的(显示于图17中),利用凿子将先导钻孔42成形为期望的轮廓,并且将植入物结构20以图18和图19A/B所示的方式插入开口的钻孔48中。将三角形的植入物结构20经引导销38轻击(在这个实施方案中,未与压缩套筒组件10相关联)通过软组织保护器,从髂骨的髂后棘,成角度通过SI-关节,并终止于骶翼,直到植入物结构20的近端贴着髂骨的髂后棘齐平,如图18所示的。如图17至图19A/B中所示的,以这种方式引入三个植入物结构20。由于沿着后侧向途径的骨的解剖学形态,建议引入不同大小的植入物结构,其中最优者的长度最长,并且其它的长度较短。
(2)与压缩杆组件相关联
如图20至图22A/B中所示的,后侧向方法还适用于自身引入与如先前所描述的压缩杆组件10相关联的一个或多个植入物结构20,从髂骨的髂后棘进入,成角度通过SI-关节并前进到骶翼中。图22A/B中最佳地显示了这种通道以及得到的具有压缩杆组件10的植入物结构20的布置。如图17至图19A/B中所示的实施方案,以这种方式放置了三个植入物结构20。另外,如在图17至图19A/B中所示的实施方案中,植入物结构20的横截面是三角形的,但是还应理解,可以利用如先前所描述的其它横截面的植入物结构20。在后侧向方法的这个实施方案中,在形成开口的钻孔48之后没有立即插入植入物结构20。而是,如图20中所示的先前已描述的,首先将压缩杆组件10的部件安装到开口的钻孔48中以接纳植入物结构20。
如之前说明的,用于后侧向方法的装置与用于侧向方法的装置大体相同。期望地,在患者俯卧位(俯卧)躺着并且在侧向和前面-后面(A-P)c-形臂的帮助下进行。利用相同的外科手术工具经引导销38形成先导钻孔42,其从髂骨的髂后棘起始,成角度通过SI-关节并且终止于骶翼。如之前所描述并且如图20中所示的,利用凿子44将先导钻孔42成形为期望的轮廓。在这种布置中,为了容纳压缩杆组件10的锚固螺丝14的布局,越过形成的先导钻孔42和开口的钻孔48的末端自然地并且未钻孔地保留骶翼中的一定程度的骨。锚固螺丝14前进并埋入骶翼中的这一程度的自然的且未钻孔的骨中,如图22A/B所示的,以耦合到锚固主体12的带螺纹的远端28。由于骶翼的形态,锚固螺丝14可以比通过侧向方法埋入骶骨S1中的锚固螺丝14短。
将锚固主体12的带螺纹的近端28螺纹连接到并且与骶翼中的锚固螺丝14配合,如先前所描述的并且如图8H中所示的,并且锚固主体12的剩余部分近端地延伸通过SI-关节以在髂骨的髂上棘的外部伸出暴露的距离,如图21至图22A/B所示的。然后,植入物结构20通过将其在锚固主体12之上滑动来放置,直到贴着髂骨的髂上棘齐平,如先前所描述的以及如图8I中所示的。然后安装锚固垫圈18和螺母并将其紧固到锚固主体12的近端上,如先前所描述的以及如图8J至图8L中所示的,使得组件10压缩。得到的组件10显示于图21和图22A/B中。
如图20和图21中所示的,可通过后侧向方法跨过SI-关节安装三个压缩杆组件10。如之前说明的,由于单个压缩杆组件10通过紧固锚固螺母16而压缩地放置,邻近的压缩杆组件10的植入物结构20可前进以越过髂骨的髂上棘略微伸出。如果这种情况发生,则伸出的植入物结构20可经其各自的锚固主体12进一步轻轻地轻击到髂骨的髂上棘中。
C.结论
利用后部方法或后侧向方法,在与压缩杆组件10关联或不关联或其组合的情况下,可以以微创的方式将一个或多个植入物结构20单独地插入跨过SI-关节,如所描述的。常规的组织进入工具、比赛器、插管和/或钻头可用于这一目的。在形成插入通道或插入植入物结构20之前不需要关节准备、除去软骨或解体(scraping),因此需要形成大概以或大约植入物结构20的最大外部直径定尺寸的微创的插入通道。
与压缩杆组件10相关联或不关联的植入物结构20排除了自体骨移植材料、额外的带蒂螺丝和/或杆、空心的模块化锚固螺丝、管状压缩螺丝、关节内的螺纹笼或骨折固定螺丝的需求。
在代表性过程中,根据患者的大小和植入物结构20的大小可能需要一至六个,或许八个植入物结构20。安装之后,建议患者在融合过程中防止SI-关节的负载。根据患者的健康以及他或她对术后方案的坚持,这可以是六至十二星期的周期或更多。
植入物结构20使比传统的开放的外科手术侵入小并且没有大量的软组织剥离的外科手术技术成为可能。对SI-关节的侧向方法和后侧向方法提供了与微创的外科手术技术互补的简单的外科手术方法。植入物结构20的轮廓和设计使旋转和微动降到最小。由钛制成的坚硬的植入物结构20提供了即刻的术后SI关节的稳定性。包含具有不规则表面的多孔的等离子体喷雾涂层的骨内生长区域24提供稳定的骨固定/融合。植入物结构20和外科手术方法使较大的融合表面积的布局成为可能,该布局被设计成使术后重量承受能力最大化并提供生物力学精确的植入物,该植入物被具体地设计成使重量负载的SI-关节稳定。
III.利用其它结构的骶髂关节的关节固定
在常规的侧向和/或前部-后部(A-P)可视化技术的帮助下,对SI-关节的侧向方法和后侧向方法使利用其它形式的固定/融合结构以微创的方式固定SI-关节成为可能。任何一种方法使最小的切口大小并且最小的软组织剥离、最小的肌腱刺激、较少的疼痛、降低的感染和并发症的危险,以及最小的血液损失成为可能。
例如(参见图23和图24A/B),可利用本文所描述的侧向方法引入一个或多个螺丝样结构52,例如,空心的模块化锚固螺丝或管状压缩螺丝,或骨折固定螺丝,其侧向地放置,穿过髂骨、SI-关节并进入骶骨S1。图23和图24A/B中显示了这种通道以及得到的螺丝样结构52的布局。期望地,螺丝样结构采用如所描述的骨内生长材料或穿骨生长构型,以及被依尺寸设计并配置成在植入后阻止旋转。
同样地,可利用本文所描述的后侧向方法引入螺丝样结构52中的一个或多个,从髂骨的髂后棘进入,成角度通过SI-关节,并终止于骶翼。图25和图26A/B中显示了这种通道以及得到的螺丝样结构的布局。期望地,螺丝样结构52采用如所描述的骨内生长材料或穿骨生长构型,以及如之前所描述的,被依尺寸设计并配置成在植入后阻止旋转。
作为另一个实例,可利用如本文所描述的侧向方法引入包含骨移植材料的一个或多个融合笼结构54,其被侧向地放置穿过髂骨、SI-关节并进入骶骨S1。图27和图28A/B中显示了这种通道以及得到的融合笼结构54的布局。这样的结构54可包括锚固螺丝部件56,其位于骶骨S1中,如图27和图28A/B中所示的。
同样地,可利用本文所描述的后侧向方法引入融合笼结构54中的一个或多个,从髂骨的髂后棘进入,成角度通过SI-关节,并终止于骶翼。图29和图30A/B中显示了这种通道以及得到的融合笼结构54的布局。这样的结构54可包括锚固螺丝部件56,其位于骶翼中,如图27和图28A/B中所示的。
IV.结论
前述方面仅仅被认为是本发明的原则的示例。此外,由于对于本领域的技术人员来说,许多改良和变化是易于出现的,因此不期望将本发明限制为所显示并描述的精确的构造和操作。虽然描述了优选的实施方案,但是在不偏离本发明的情况下可以改变细节,本发明由权利要求限定。
Claims (23)
1.一种用于固定或融合骨结构的组件,所述骨结构包括由骨折线或关节分隔的第一骨段和第二骨段,所述组件包括:
锚固主体,其被依尺寸设计并配置成引入到所述第一骨段和第二骨段中横向地跨过所述骨折线或关节,所述锚固主体具有定位在所述第二骨段的内部区域的远端;定位在所述第一骨段的外部区域之外的近端;以及中间区域,其跨越所述第一骨段和第二骨段之间的所述骨折线或关节;
远端锚固件,其被固定到所述第二骨段的所述内部区域并附加到所述锚固主体的所述远端以在所述第二骨段中锚固所述远端;
近端锚固件,其被固定到所述第一骨段的所述外部区域并附加到所述锚固主体的所述近端,所述近端锚固件与所述远端锚固件协力使所述锚固主体处于受压以相对于所述骨折线或关节压缩并固定所述骨段;以及
长形的植入物结构,其被配置为由所述锚固主体的所述中间区域承载并横向地跨越所述骨段之间的所述骨折线或关节,所述长形的植入物结构包括外表面区域,所述外表面区域被处理以沿着所述植入物结构提供骨内生长或穿骨生长以促进保持受压的并且由所述锚固主体固定的所述第一骨段和第二骨段的固定或融合。
2.根据权利要求1所述的组件,
其中所述远端锚固件包括带外螺纹的螺丝。
3.根据权利要求2所述的组件,
其中所述锚固主体的所述远端被螺纹连接为接合在所述螺丝的内钻孔中形成的螺纹。
4.根据权利要求1所述的组件,
其中所述远端锚固件包括在所述锚固主体的所述远端和所述第二骨段的所述内部区域中的骨之间的干涉配合。
5.根据权利要求1所述的组件,
其中所述远端锚固件包括被应用在所述锚固主体的所述远端和所述第二骨段的所述内部区域中的骨之间的粘合剂。
6.根据权利要求1所述的组件,
其中所述远端锚固件包括具有骨切削边缘的板,所述板是可旋转成与骨接合的。
7.根据权利要求1所述的组件,
其中所述远端锚固件包括具有骨切削边缘的带尖端的三角形板,所述三角形板是可旋转成与骨接合的。
8.根据权利要求1所述的组件,
其中所述远端锚固件包括板,所述板响应于所述锚固主体的所述远端区域的旋转而可旋转到扣紧骨的位置中。
9.根据权利要求8所述的组件,
其中所述植入物结构包括邻近所述板的远端区域,所述远端区域包括切口,并且
其中,当处于所述扣紧骨的位置时,所述板的区域嵌套在所述切口中。
10.根据权利要求1所述的组件,
其中所述近端锚固件包括螺母。
11.根据权利要求10所述的组件,
其中所述近端锚固件还包括垫圈,所述垫圈在所述螺母和所述第一骨段的外表面之间。
12.根据权利要求10所述的组件,
其中所述锚固主体的所述近端被螺纹连接为接合在所述螺母的内钻孔中形成的螺纹。
13.根据权利要求12所述的组件,
其中所述近端锚固件包括在所述螺母和所述第一骨段的所述外表面之间的垫圈。
14.根据权利要求1所述的组件,
其中所述植入物结构具有大体曲线的横截面。
15.根据权利要求1所述的组件,
其中所述植入物结构具有大体直线的横截面。
16.根据权利要求1所述的组件,
其中所述植入物结构具有大体三角形的横截面。
17.根据权利要求1所述的组件,
其中所述植入物结构包括锥形区域。
18.根据权利要求1所述的组件,
其中所述植入物结构包括锥形近端区域。
19.根据权利要求1所述的组件,
其中所述植入物结构的横截面与靠近所述远端锚固件相比更靠近所述近端锚固件处更大。
20.根据权利要求1所述的组件,
其中所述植入物结构包括外部扣紧骨的表面。
21.根据权利要求1所述的组件,
其中所述植入物结构的骨内生长或穿骨生长区域包括多孔的等离子体喷雾涂层。
22.根据权利要求1所述的组件,
其中所述近端锚固件与所述远端锚固件协力使所述植入物结构处于受压以使骨内生长或穿骨生长区域与所述第一骨段和第二骨段中的骨紧密接触。
23.根据权利要求1所述的组件,
其中所述锚固主体包括圆柱形的销或杆状的几何结构。
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- 2011-10-05 JP JP2013532916A patent/JP5771277B2/ja active Active
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US20140257298A1 (en) | 2014-09-11 |
JP2015211849A (ja) | 2015-11-26 |
US9486264B2 (en) | 2016-11-08 |
US20110087294A1 (en) | 2011-04-14 |
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