CN101790356A - 脊柱椎间置换器械 - Google Patents

脊柱椎间置换器械 Download PDF

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Publication number
CN101790356A
CN101790356A CN200880105078A CN200880105078A CN101790356A CN 101790356 A CN101790356 A CN 101790356A CN 200880105078 A CN200880105078 A CN 200880105078A CN 200880105078 A CN200880105078 A CN 200880105078A CN 101790356 A CN101790356 A CN 101790356A
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China
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element according
support surface
main body
front side
extends
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K·T·福雷
K·S·希普
R·E·陈
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

本发明实施方式包括支撑椎骨的脊柱椎间置换器械。该器械可限定上支承表面和相对的下支承表面,其中上支承表面限定在前侧和后侧之间的凸弯轮廓,而下支承表面限定在前侧和后侧之间的平面轮廓。

Description

脊柱椎间置换器械
背景技术
骨结构的修复和重构有时是通过相对彼此固定相邻骨结构实现的,如通过板材。在其他情形中,骨生长诱导材料可引入到相邻骨结构中,这会随时间形成坚固的骨连接。在某些情形中,相邻骨结构不足以坚固到保持其开放性,这是由于骨愈合或骨在邻近结构之间生长穿过骨生长诱导材料。在这些情形中,网状结构或笼状结构被提供来接合相邻骨结构,以提供额外稳定性。笼状结构通常是中空的并可配置来接触相邻骨结构的较硬皮层骨。笼状结构的中空部分可填充以骨生长诱导材料。
在相邻椎骨之间的椎间盘空间内放置器械,以在相邻椎骨彼此融合时提供支撑。还提供器械以置换移去的椎骨体,并在一个或多个移去的椎骨体任一侧在余下椎骨之间提供支撑结构。然而,仍然需要改进的器械,用于置换一个或多个椎骨体,和/或在相邻椎骨之间椎间盘空间内用一个或多个器械提供相邻椎骨的支撑。本发明旨在满足这些需求和其他方面。
发明内容
本发明提供了置换一个或多个椎骨体以支撑余下椎骨的器械。也提供了一个或多个器械,其在相邻椎骨间椎间盘空间内支撑相邻椎骨。
根据一个方面,脊柱椎间融合元件包括主体,该主体包含前侧、后侧和在前侧与后侧之间延伸的一对相对侧。主体也限定了上支承表面和相对的下支承表面。上支承表面包括在前侧和后侧之间的凸弯轮廓,而下支承表面包括在前侧和后侧之间的平面轮廓。
按照另一个方面,脊柱椎间融合元件包括主体,该主体包含前壁、后壁和在前壁和后壁之间延伸的一对相对侧壁。这些壁限定了上支承表面和相对的下支承表面和穿过上及下支承表面的腔体开孔。上支承表面包括在前壁和后壁之间的凸弯轮廓,而下支承表面包括在前壁和后壁之间的平面轮廓。上支承表面和下支承表面在后壁的后侧朝引导端鼻逐渐变小。
按照另一个方面,椎体置换器械包括连接元件,其包括沿纵轴在上端和相对的下端之间延伸的主体。连接元件包括从上端延伸的上延伸件,和从下端延伸的下延伸件。该上端进一步包括至少一个绕上延伸件延伸的平面表面部件,而下端包括绕下延伸件延伸的凹弯表面。置换器械进一步包括绕上延伸件和下延伸件的每一个可拆除地连接到连接体的上椎间盘置换元件和下椎间盘置换元件。上椎间盘置换元件包括用于接触相邻椎骨的端板的上支承表面和包括至少一个平面轮廓的相对下支承表面,该平面轮廓以毗邻接合连接体的上端的至少一个平面表面部件设置。下椎间盘置换元件包括用于接触相邻椎骨端板的下支承表面和包括凸弯轮廓的相对的上支承表面,该凸弯轮廓以毗邻接合连接体的下端的凹弯表面设置。
根据进一步的方面,椎骨体置换器械包括连接元件,其包含沿纵轴在上端和相对下端之间延伸的主体。连接元件包括从上端延伸的上延伸件和从下端延伸的下延伸件。椎骨置换器械进一步包括绕上延伸件和下延伸件的各个可拆除地连接到连接体的上椎间盘置换元件和下椎间盘置换元件。上椎间盘置换元件包括用于接触上椎骨端板的上支承表面,该上支承表面包含在上椎间盘置换元件的前侧和后侧之间的凸弯轮廓。下椎间盘置换元件包括用于接触下椎骨端板的下支承表面,该下支承表面包括至少一个平面轮廓,其从下椎间盘置换元件的前侧向下椎间盘置换元件的后侧在下支承表面的相当大部分上延伸。
根据另一方面,支撑脊柱的椎骨的方法包括:从前面途径进入椎骨间的空间;和以椎间器械在椎骨之间支撑椎骨,其中椎间器械包括接触一个椎骨的端板的上支承表面,其具有在椎间器械前侧和后侧之间的凸弯轮廓,该椎间器械进一步包括接触其他椎骨的端板的下表面,其具有至少一个从椎间器械的前侧向后侧沿下表面的大部分延伸的平面轮廓。
这些和其他方面将在下面进一步讨论。
附图说明
图1A是脊柱段和设置在椎骨之间置换一个或多个被除去椎骨的椎骨置换器械的示意图。
图1B是脊柱段和相邻椎骨间椎间盘空间内椎间盘置换元件的示意图。
图2是图1B中椎骨置换器械的椎间盘置换元件的透视图。
图3是图2中椎间盘置换元件的平面图。
图4是图3中椎间盘置换元件的左端正视图。
图5是图2中椎间盘置换元件的侧视图。
图6是图5的区域VI中示出的部分椎间盘置换元件的放大图。
图7是图5的区域VII中示出的部分椎间盘置换元件的放大图。
图8是从与图3相对侧观看的图2中椎间盘置换元件的平面图。
图9是沿图8中线IX-IX的截面图。
图10是沿图8中线X-X的截面图。
图11是图1A中椎骨置换器械的连接元件的正视图。
图12是从与图11中所示侧相对的连接元件侧观看的图11中连接元件的正视图。
图13是沿图12中线XIII-XIII的截面图。
图14是图13中区域XIV中示出的部分连接元件的放大图。
图15是图13中区域XV中示出的部分连接元件的放大图。
图16是向着图11中连接元件端部观看的透视图。
图17是沿图16中线XVII-XVII的截面图。
具体实施方式
为了促进理解本发明原理,将参考所示实施例且特定语言将用来描述所示实施例。然而,应该理解这不是为了限制本发明的范畴。本发明的任何变化和进一步修改,以及所描述的本发明原理的任何进一步应用都将被考虑,如对本领域技术人员通常想到的。
所公开的实施例涉及置换脊柱中一个或多个椎骨体和/或相邻椎骨间一个或多个椎间盘空间的器械。本发明考虑在融合过程中置换器械将支撑椎骨。本发明进一步考虑椎骨置换器械的一个或多个零件可设置在相邻椎骨的椎间盘空间内,以便在融合过程中支撑相邻椎骨。也考虑在非融合过程中应用。
该器械被配置来在器械相对端接合椎骨端板。在一个实施例中,器械具有管状形式,其中空腔延伸通过其中并在每端有开口。椎骨由器械支撑,而腔室含有骨生长诱导或生骨材料。器械端部包括与相邻椎骨端板接合的接合腔室。在进一步的实施例中,器械一端包括凸弯构型,而器械其他端包括平面构型。
在一个实施例中,器械是包括连接元件和连接到连接元件上端的上元件以及连接到连接元件下端的下元件的椎骨置换器械。上元件和下元件每个都具有相对端表面。各上元件或下元件的端表面彼此具有不同构型。在一个实施例中,一个端表面具有凸弯构型,而相对端表面具有平面构型。连接元件的端部也包括不同构型,以接收连接到其上的相邻上元件和下元件的各个弯曲端表面和平面端表面构型。
上元件和下元件以及连接元件中的每个都在横向于组装器械中心轴的平面上具有相同的横截面形状。在一个实施例中,形状是由凸弯前壁、线型后壁、和朝后壁彼此汇聚的相对侧壁限定的。也考虑其他横截面形状,包括圆形、跑道形、矩形、正方形、椭圆形、D形、三角形、回飞棒形、肾形、或其他多边形。上元件和下元件每个都包括其壁包围的内腔。连接元件也可包括在接合时与上元件和下元件的内腔大致对准的内腔。其他实施例考虑上元件、下元件或连接元件的一个或多个侧对腔体开孔。
在一个实施例中,上元件和下元件可伸缩地且不可旋转地与连接元件各端接合。连接元件包括从其延伸的上延伸件和下延伸件。上延伸件和下延伸件形式为绕连接元件各端延伸的基本连续的环。上元件和下元件是绕各相邻延伸件设置并以在延伸件和绕其设置的上或下元件之间延伸的接合元件轴向固定的。在另一个实施例中,延伸件提供在上元件和下元件上,且这些延伸件接收在内腔或连接元件各端的开口内。每个上延伸件和下延伸件,以及上元件和下元件的每个腔体具有非圆形横截面和接口,从而防止绕延伸件设置的连接元件和上或下元件之间的相对旋转。在一个实施例中,连接元件的上延伸件和下延伸件每个都包括接合元件,其装配到各上元件和下元件的内壁表面内的接收座中,从而轴向固定各上元件和下元件到连接元件。
椎骨置换器械的任一或所有零件可由任何生物相容材料制成,包括合成的或天然的自体移植组织、同种异体移植组织或异种移植组织,并且本质上是可吸收或不可吸收的。组织材料的例子包括硬组织、连接组织、去矿化骨基质和它们的组合。可吸收材料的进一步例子是聚交酯、聚乙交酯、酪氨酸衍生的聚碳酸酯、聚酐、聚原酸酯、聚磷腈、磷酸钙、羟磷灰石、生物活性玻璃、和它们的组合。的非吸收性材料的进一步例子是非增强聚合物、碳增强聚合物复合材料、PEEK和PEEK复合材料、形状记忆合金、钛、钛合金、钴铬合金、不锈钢、陶瓷和它们的组合以及其他材料。
考虑任何合适的生骨材料或成分,用于设置在由零件或椎骨置换器械限定的腔室内。这样的生骨材料包括,例如自体移植物、同种异体移植物、异种移植物、去矿化骨、合成和天然骨移植替代物,如生物陶瓷和聚合物、以及骨诱导因子(osteoinductive factor)。骨材料设置在椎骨置换器械的零件的腔室内时,材料可在器械移植前预装到中空腔室内,或可在器械设置在脊柱上适当位置后,通过多个壁开口推入。也可使用保持材料在器械腔室内的独立载体。这些载体可包括胶原蛋白基载体、生物陶瓷材料如
Figure GPA00001038595000051
羟磷灰石和磷酸钙成分。载体材料可以海绵、块、折叠片、油灰、浆料、植骨材料或其他合适形式提供。而且,椎骨置换器械中含有的生骨成分可包括有效量的骨形态生成蛋白(bone morphogenetic protein)、转化生长因子β1、胰岛素样生长因子1、血小板源生长因子、成纤维细胞生长因子、LIM矿化蛋白(LMP)、和它们的组合或其他治疗或抗感染剂,保持在合适的载体材料中。
在图1A中,示出了椎骨V1和V3之间的椎骨置换器械10的正视图。一个或多个椎骨,如椎骨V2(图1B)已经在椎骨部分切除术中除去。椎骨置换器械10设置在两个余下椎骨V1、V3之间的空间内,从而提供脊柱的支撑和稳定化。椎骨提供器械10包括连接元件12、上元件30a、和下元件30b。设置上元件30a以便其上表面接触椎骨V1的下端板,设置下元件30b以便其下表面接触椎骨V3的上端板。在图1B中,所示上元件30a设置在相邻椎骨V1和V2之间的椎间盘空间内。上元件30a包括接触椎骨V1的下端板的上表面32,和接触椎骨V2的上端板的下表面34。在所示实施例中,上表面32包括凸弯轮廓,同时下表面34包括平面轮廓。下元件30b也可单独采用在椎间盘空间内,替代或补充上元件30a。如这里所用,上元件30a和下元件30b在这里整体和单独地用来指椎间盘置换元件30或元件30。
所示椎骨置换器械10是沿纵轴11延伸并限定沿轴11延伸贯穿的腔室的管状形式。骨生长可通过该腔室发生以便在器械10每端支撑的椎骨体之间融合。连接元件12包括在上端16和相对下端18之间延伸的主体14。上元件30a以其下表面与上端16毗邻接合而定位,而下元件30b以其上表面与下端18毗邻接合而定位。上端16包括平面结构,从而提供与上元件30的平面下表面轮廓的紧密配合。下端18包括凹弯结构,从而提供与下元件30b的凸弯上表面轮廓的紧密配合。
主体14的壁和上元件及下元件30的壁被显示为实心。其他实施例考虑元件12、30的任何一个或组合的壁可包括一个或多个与其内部腔室连通的开口。开口也可考虑不同形状,包括非圆形,如正方形、菱形、三角形、椭圆形和/或矩形,圆形,和/或多边形。元件12、30的任何一个或组合的壁也可包括至少部分延伸穿过的许多孔。这些孔可带螺纹或被定尺寸和/或配置以便与一个或多个插入工具(未示出)接合。
再参考图2-10,讨论椎间盘置换元件30的一个实施例。椎间盘元件30包括绕中央腔室42延伸的环形体40。体40包括前壁44和相对的后壁46。一对相对侧壁48、50在前壁44和后壁46之间延伸并将前壁44连接到后壁46。在所示实施例中,壁44、46、48、50在其外表面和其内表面84之间具有恒定厚度,该厚度限定腔室42的周界。其他实施例考虑一个或多个壁具有与其他壁不同的厚度。在其他实施例中,沿一个或多个壁的厚度可改变。在所示实施例中,前壁44凸弯,而侧壁48、50从前壁44汇聚到后壁46。后壁46在侧壁48、50之间线性延伸。
壁44、46、48和50限定元件30的上表面32和元件30的下表面34。上表面32和下表面34在用作椎间盘置换元件或邻近端板时提供接触相邻椎骨端板的支撑表面,并在用于椎骨置换器械10时提供连接元件12的端部。表面32、34包括许多横向延伸从而形成细长的接合元件36、38的凹口,该细长的接合元件36、38在侧壁48、50之间延伸,通过穿过上表面32和下表面34的中央腔室42位于侧壁48、50之间。前壁44包括孔52以接收插入工具。孔52可带螺纹或采用其他任何合适构型以接合插入工具。
在所示实施例中,元件30包括射线照相标记,该射线照相标记通过合适外科成像系统可见,从而确定植入位置和主体40的取向,而不侧面暴露脊柱。如图3所示,主体40包括上和下延伸的标记54、56。标记54设置在前壁46上并在主体40植入和成像后提供主体40的后位置指示。标记56设置在前壁44的相对端,邻近各侧壁48、50。在植入元件30的侧图像中,当主体40适当设置在椎骨之间的空间内时,标记56在前后方向上彼此对准。在主体40的植入位置和取向通过成像确定后,可根据需要和以植入主体40额外图像确认的定位做出调整。考虑主体40的其他实施例被提供,其中无标记,和/或通过不用标记的外科手术成像系统可见的材料形成。
参考图3,椎间盘置换元件30包括前壁44的最前侧和后壁46的最后侧之间的总体长度L5。前壁44包括沿侧壁48、50之间半径R2延伸的前表面。前壁44也限定侧壁48、50之间总体宽度W1,而后壁46限定侧壁48、50之间总体宽度W2。在一个实施例中,中间侧向上最大宽度W1大于前后方向上长度L5。主体40具有尺寸适于占据椎骨端板一半面积以上的覆盖区,支承表面贴着该椎骨端板设置。在一个具体实施例中,L5约11毫米,半径R2约11毫米。宽度W1约14毫米,而宽度W2约11毫米。其他实施例考虑其他尺寸的长度L5、半径R2和宽度W1、W2,只要主体40在前后方向和中间-侧边方向上尺寸适于设置在椎间盘空间内。
如图5所示,椎间盘置换元件30的一个实施例为上和下表面32、34提供特定构型,该构型匹配或紧密相应于各相邻椎骨端板的轮廓同时最小化端板准备工作。上表面32包括在前壁和后壁44、46之间的凸弯轮廓58,而下表面34限定在前壁44和后壁46之间有平面部件60a、60b的平面轮廓。第一平面部件60a基本与前壁44正交地延伸,而第二平面部件60b向上表面32与第一部件60a成角度,从而以弯曲的上表面轮廓58在后壁46形成减小的高度。在一个实施例中,凸弯轮廓58沿半径R1延伸,而成角度部件60b以角度A1向上表面32逐渐减小。在一个具体实施例中,半径R1是17毫米,而角度A1是30度,因此平面部件60a、60b在前壁44和后壁46之间形成约150度的坡口角度(included angle)。其他实施例考虑其他半径的R1和尖角A1。
在所示实施例中,上表面32和下表面34在侧壁48、50之间的方向上是大致线性的,因此在平行于前壁46的任何段上观察时,主体40的相对侧具有相同高度。主体40的高度通常向后壁46渐小,从而在前后方向上提供楔形轮廓。下表面34的平面部件60a沿相当部分的长度L5延伸。在所示实施例中,平面部件60a沿长度L5延伸一半以上。上表面32的凸弯轮廓几乎沿整个长度L5延伸。
主体40限定接合元件36、38的最外端之间总最大高度H1。最大高度H1在约5毫米到约14毫米之间,但基于解剖学,也考虑小于5毫米和大于14毫米的最大高度。主体40也包括在前壁44的外表面处的前端壁高度H2。在所示实施例中,高度H2比高度H1小约1毫米,因为最前接合元件36a包括截头的最远端。前端壁高度H2范围也在约5毫米到约14毫米之间,但根据脊骨解剖学,也可以小于5毫米或大于约14毫米。主体40也包括上位置66和下位置68之间的后高度H3。后鼻62是通过位于位置66、68之间的渐小表面形成的,并逐渐减小到后壁46的最后侧,如下面进一步讨论的。高度H3相应于在位置66、68的上表面32和下表面34之间的高度。在一个具体实施例中,后高度H3比高度H1小约1.4毫米,且可以在约4毫米到约13毫米的范围内,但根据脊骨解剖学,也可小于4毫米或大于13毫米。
下表面34的锥形位置68与鼻62的最后侧距离L1设置。在一个实施例中,距离L1约3.5毫米。尖角A1从该锥形位置68延伸到后壁46的最后表面。邻近上表面32的位置66在上尖角A2与后壁46的最后表面的上延伸件相交的位置。尖角A2从最前接合元件36a与朝向后壁46的前壁44的最前表面相交处延伸。尖角A2是从中心轴64测量的,该中心轴与下表面34的平面部件60a平行并与前壁44的最前表面正交。在一个实施例中,尖角A2在约4到5度之间。其他实施例考虑其他尖角A2。
鼻62包括在后壁46的最后表面处测量的高度。鼻高度相应于后高度H3,其小于下表面34的部件60b的下锥形高度H4,并小于上位置66和后壁46最后表面之间的上锥形高度。在一个实施例中,下锥形高度H4约2毫米,而上锥形高度是上锥形表面从最后接合元件36b到鼻62的最后侧以角度A1延伸形成的。因此,鼻62是上表面和下表面形成的,该上表面和下表面以角度A1在后壁46的最后表面向后以角度A1汇聚。
现在参考图6,详细说明接合元件36。接合元件36是由上表面32中一系列凹口形成的。接合元件36的最外端70限定沿半径R1限定的弧设置的表面,而接合元件36的底座72也沿平行于半径R1限定的弧设置。尾端壁74与各邻近底座72大致正交地延伸,而前端壁76相对底座72沿角度A3倾斜。底座72沿主体40具有长度L2,尾端壁74以长度L3分隔。接合元件36具有从底座72到最远端70延伸的高度H5。在一个实施例中,长度L2约0.5毫米,长度L3约1.5毫米。高度H5约0.5毫米,而角度A3约16度。其他实施例考虑其他尺寸和/或构型的接合元件36。
现在参考图7,详细说明接合元件38。接合元件38是由一系列在下表面34中形成的凹口形成的,并类似于接合元件36,但最远端76和底座78是位于平面部件60a或平面部件60b中的平面。尾端壁80与各邻近底座78大致正交地延伸,而前端壁82相对底座78沿角度A4倾斜。底座78沿主体40具有长度L2,且尾端壁80被长度L3分隔。最远端76限定平面表面,该平面表面在尾端壁80和前端壁82倾斜部分的端部之间长度相应于长度L3和L4之差。接合元件38具有从底座78到最远端76延伸的高度H5。在一个实施例中,长度L3约1.5毫米,而长度L4约1.375毫米。高度H5约0.5毫米,而角度A4约30度。其他实施例考虑接合元件38的其他尺寸和/或构型。
图8-10示出椎间盘置换元件30的接收座(receptacle)和其他特征,该接收座将椎间盘置换元件30完全地接合到连接元件12。在图8a中,以沿包围腔室42的内壁表面84的部分截面,示出椎间盘置换元件30的平面图。如图9所示,侧壁50包括上接收座86a和上接收座86b。侧壁48类似地包括上接收座88a和下接收座88b,如图10所示。接收座86a、86b和接收座88a、88b彼此平行延伸并沿内表面84在前后方向上延伸。当上表面32与连接元件12毗邻接合设置时,上接收座86a、88a被设置来接合连接元件12。当下表面34与连接元件12毗邻接合设置时,下接收座86b、88b被设置来接合连接元件12。如图10所示,接收座86a、86b和接收座88a、88b由内壁表面84中浅V形凹口限定,其不延伸穿过各侧壁48、50。V形凹口有利于椎间盘置换元件30与连接元件12的连接和脱离,同时提供足够的轴限制以防止脱离,除非施加足够的力来克服连接结构。其他实施例考虑接收座的其他形状,包括圆形、椭圆、三角形、非圆形、和不规则形状。在其他实施例中,接收座也完全延伸穿过元件30的壁。
图11-17示出连接元件12的一个实施例。连接元件12包括在上部或上端100和下部或下端102之间延伸的主体14。主体14包括管状形式和如同椎间盘置换元件30的限定圆周的外表面轮廓。主体14包括具有凸弯的外表面的前壁104、具有线性外表面的后壁106和具有从前壁104向后壁106汇聚的线性外表面的侧壁108、110。前壁104包括孔118,用于插入工具接合。孔118可类似于上面讨论的孔52配置或包括任何合适的构型。
连接元件12进一步包括从上端100延伸的上延伸件114和从下端102延伸的下延伸件116。上延伸件和下延伸件114、116包括匹配内腔42形状的外周,因此内壁表面84与各上延伸件和下延伸件114、116靠近或紧密地设置。连接元件12进一步限定轴向延伸的中央腔室112,其延伸穿过上端和下端100、102并也穿过上延伸件和下延伸件114、116。在所示实施例中,腔室112包括椭圆形状,其在侧壁108、110之间的方向上伸长,如图16所示。其他实施例考虑其他形状的腔室112,包括圆形、非圆形、多边形和不规则形状。在其他实施例中,腔室112包括一个或多个将其划分为腔室部分的分隔件。在又一个实施例中,腔室112在轴向是不连续的,但包括一个或多个边、壁、或沿在其中延伸的主体14长度的分隔件。
如图14所示,下端102包括具有半径R1限定的凹陷形状的端部支承表面120。支承表面120与椎间盘置换元件30的上表面32的形状一致,因此接合元件36的最外端完全支撑在支承表面120上。下延伸件116包括至少一个向外延伸的接合元件122,该接合元件122可接合在连接元件12下端上设置的椎间盘置换元件30的一个或多个相邻上接收座86a、88a中。接合元件122可提供在下延伸件116两侧上,其尺寸和形状适于可拆卸地接收在接收座86a、88a中,因此元件30在下端102可拆卸地连接到连接元件12。
如图15所示,上端100包括具有第一平面部件124a和第二平面部件124b的端部支承表面124。第二平面部件124b相对第一平面部件124a以角度A1成角度。平面部件124a、124b匹配椎间盘置换元件30的下表面34的平面部件60a、60b的构型,以便接合元件38的最远端完全沿支承表面124被支撑。上延伸件114包括在其相对侧向外延伸并可接合在设置在连接元件12上端100中的椎间盘置换元件30的邻近上接收座86b、88b中的接合元件126a、126b(图17)。接合元件126a、126b尺寸和形状适于可拆卸地接收在各接收座86b、88b中,以便椎间盘置换元件30可拆卸地在上端100连接到连接元件12。
连接元件12在其每端用于椎间盘置换元件30,用于椎骨体置换方法。支承表面120、124完全绕各延伸件114、116延伸,从而提供椎间盘置换元件30的支承。在上端和下端之间,根据要置换的椎骨的数目和尺寸,连接元件12可提供有不同高度。考虑范围在5毫米到约62毫米或更多之间的高度H6。在一种形式中,一组不同高度的连接元件12与不同高度的一组椎间盘置换元件30一起提供在工具包中。提供所需总高度的连接元件和椎间盘置换元件被选择并组装,从而形成椎骨置换器械10。
而且,当器械10用于椎骨体置换过程中时,要支撑的椎骨端板可不彼此平行延伸,而是在前方向上以一定角度分开。连接元件12在上端100和下端102与上延伸件114和下延伸件116的外端128、130之间提供有不同角度取向。例如,上端100和下端102可以角度A6在平面部件124a和轴132之间形成,该轴132在下端102在支承表面120的前侧和后侧之间延伸。角度A7限定在轴132和中央轴134之间,其与中央纵轴11正交延伸。角度A8限定在轴134和外端128之间。外端130和轴134也限定它们之间的角度A8。
在一个应用中,连接元件12端部成角提供了连接结构,从而允许椎间盘置换器械30的上端和下端连接到连接元件12的各端,从而向后汇聚(向前分开)以便更好地与要支撑的余下椎骨的端板配合。椎骨间跨度越短,椎间盘置换元件30间成角越小。在一个实施例中,高度H6小,约为5毫米,角度A6在大约1到2度之间,角度A7约在1到2度之间,角度A8约3度。在另一个实施例中,高度H6大,约62毫米,角度A6约在19到20度之间,角度A7在约7到8度之间,而角度A8约在12度。其他长度考虑端部128、130和连接体12其他部分之间的其他角结构,从而提供与脊柱解剖学的期望配合。例如,在一个实施例中,端部128、130彼此平行延伸。在其他实施例中,端部128、130成角度以向前汇聚并向后分开。
椎骨置换器械10可用于置换利用已知技术从脊柱段上移去的椎骨。器械10是通过固定上元件30a到连接元件12的上端100,并固定下元件30b到连接元件12的下端102而组装的。这提供了椎骨置换器械10,其具有等于主体14高度H6和上元件30a、下元件30b的元件高度H2之和的总前高度。
虽然没有要求,但考虑高度H6代表被移去椎骨的高度,而高度H2代表被移去椎骨和余下椎骨V1、V3之间各椎间盘空间的高度。虽然附图没有示出,但也考虑可接合稳定结构,并在椎骨间空间外部沿其外表面在椎骨V1、V3或V1、V2之间延伸,从而在融合前、融合过程中以及如果该结构不是可吸收的并留在患者体内则在融合之后,提供额外支撑并稳定化脊柱段。稳定化结构可以是杆系统、板系统或人工韧带系统。进一步考虑稳定化构造可连接到椎骨任意部分,包括前部、前侧部、侧部、后侧部或后部。
本发明还考虑连接元件12可被提供被配置来贴着椎骨端板支承的一端,且上元件30a和下元件30b中仅一个接合到连接元件12的其他端。组装的器械可设置在相邻椎骨之间,其中连接元件12的一端和上元件30a或下元件30b的一端与相邻椎骨端板接触。
虽然本发明已经在附图和前述说明中进行了详细图解并说明,但其本质上仅被看作示例性的而非限制性的。所有在本发明精神范围内的变化和修改都期望被保护。

Claims (15)

1.一种脊柱椎间融合元件,其包括:
主体,其包括前侧、后侧、和在所述前侧和后侧之间延伸的相对横侧,其中所述主体限定上支承表面和相对的下支承表面,其中所述上支承表面限定在所述前侧和后侧之间的凸弯轮廓,而所述下支承表面限定在所述前侧和后侧之间的平面轮廓。
2.根据权利要求1所述的元件,其中所述主体包括穿过所述上支承表面和所述下支承表面的腔室开口。
3.根据权利要求1所述的元件,其中所述主体包括至少横跨部分所述上支承表面和所述下支承表面的接合元件。
4.根据权利要求1所述的元件,其中所述下支承表面和上支承表面在后侧向引导端鼻逐渐变小。
5.根据权利要求1所述的元件,其中所述主体包括在上表面和下表面之间的高度,其尺寸适于置换脊柱的至少一个椎骨。
6.根据权利要求1所述的元件,其中所述主体包括在上表面和下表面之间的高度,其尺寸适于设置在相邻椎骨之间的椎间盘空间内。
7.根据权利要求1所述的元件,其中所述主体包括在所述前侧和所述后侧之间的长度和在相对的横侧之间的宽度,其中所述宽度大于所述长度。
8.根据权利要求1所述的元件,其中所述相对的横侧彼此相对朝后壁汇聚。
9.根据权利要求1所述的元件,其中所述前侧包括在所述横侧之间延伸的凸弯外表面。
10.根据权利要求2所述的元件,其中绕所述腔室延伸的内表面被限定在所述前侧、所述后侧和所述相对横侧的内部,所述内表面包括至少一个沿至少一个所述相对横侧延伸的细长接收座。
11.根据权利要求10所述的元件,其中所述至少一个接收座包括沿每个相对横侧在所述内表面内的接收座。
12.根据权利要求3所述的元件,其中一个或多个接合元件包括沿所述上支承表面和所述下支承表面的各个的最远端表面,一个或多个接合元件包括朝向所述前侧的尾端壁和朝向所述后侧的前端壁,其中所述尾端壁大致与端部支承表面正交取向,而所述前端壁向各端表面倾斜取向。
13.根据权利要求1所述的元件,其中所述下支承表面包括从所述前侧延伸的第一平面部件和在所述第一平面部件和引导端鼻之间延伸的第二平面部件。
14.根据权利要求13所述的元件,其中所述第一平面部件与所述前侧的前表面正交取向,而所述第一平面部件和所述第二平面部件在所述引导端鼻和所述前表面之间形成约150度角。
15.根据权利要求1所述的元件,其中所述上支承表面的平面轮廓在所述前侧和后侧之间的所述下表面的一半长度上延伸。
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US20090062917A1 (en) 2009-03-05
EP2194929A1 (en) 2010-06-16
AU2008299219B2 (en) 2013-08-22
BRPI0816147A2 (pt) 2015-02-18
JP5373797B2 (ja) 2013-12-18
CA2696938A1 (en) 2010-02-16
JP2010537729A (ja) 2010-12-09
KR20100081303A (ko) 2010-07-14
AU2008299219A1 (en) 2009-03-19
EP2194929B1 (en) 2012-10-03
WO2009035817A1 (en) 2009-03-19

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