CN101969888A - 关节置换装置 - Google Patents
关节置换装置 Download PDFInfo
- Publication number
- CN101969888A CN101969888A CN200980102498XA CN200980102498A CN101969888A CN 101969888 A CN101969888 A CN 101969888A CN 200980102498X A CN200980102498X A CN 200980102498XA CN 200980102498 A CN200980102498 A CN 200980102498A CN 101969888 A CN101969888 A CN 101969888A
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- Prior art keywords
- separator
- joint
- lower member
- modulus
- artificial spinal
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
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Abstract
一种用于插入上椎骨与下椎骨之间的人工脊椎关节包括一对双面的关节子部件。每个关节子部件包括:一个上部件,该上部件包括一个上椎骨接合表面;以及一个下部件,该下部件包括一个下椎骨接合表面。每个关节子部件进一步包括一个隔离件,该隔离件在上部件和下部件之间扩展。该隔离件包括一个第一弹性模量和一个第二弹性模量。该第一模量以一种梯度变化转变为该第二模量。
Description
背景
脊柱是一种总体上柔性的柱,它能承受拉伸和挤压负荷,允许作弯曲运动并为肋骨、肌肉、以及韧带的连接提供位置。通常,脊柱被分成三个部分:颈椎、胸椎和腰椎。图1示意性地展示出健康的人的脊柱的腰椎1和骶骨区域3。脊柱的这些部分是由被称为椎骨的单一的多块骨头构成,并且这些椎骨由位于它们之间的椎间盘分开。
图2展示了具有位于两个相邻的椎骨7、9之间的一个被损坏的椎间盘5的腰椎区域的右侧部分。腰椎区域包括一个前面的部分11和一个后面的部分13。在任何给定的关节处,上面的椎骨被称为上椎骨而下面的椎骨被称为下椎骨。每块椎骨包括一个总体上圆柱形的本体7a、9a,对应地,它们是椎骨7、9的主要的承重区域。椎骨7进一步包括一个棘突7b和多个横突7c、7d(例如在图2至图3中7b和7c是可见的,并且例如在图3中7d是可见的)。类似的,椎骨9包括一个棘突9b和多个横突9c、9d(未显示)。这些骨突连同其他功能一起,为肌肉和韧带连接提供了多个区域。对应地,一个关节面7e位于上椎骨和下椎骨7、9的关节突起7f、9f之间。
椎间盘起到减震器和关节的作用。它们被设计为吸收脊柱可能受到的挤压和拉伸负荷而同时允许相邻的椎体彼此相对地移动一个有限的量,特别是在脊柱弯曲(屈曲)时。因此,椎间盘处于恒定的肌肉和/或重力压迫下并且通常是腰椎表现出“磨损”的迹象的第一批部件。由于关节面几乎一直随着脊柱而移动,因此关节面的退化也是常见的。事实上,关节面退化和盘退化经常一起发生。通常,尽管一个可能是造成脊柱力学变化的主要问题而另一个是次要问题,在考虑手术选择时,典型地关节面退化和椎间盘退化均已经发生了。例如,关节面和/或椎间盘力学变化会造成脊柱狭窄、退行性脊椎前移以及退行性脊柱侧凸。
用于治疗这些病症的一种手术操作是脊柱关节固定术(即脊柱融合术),这可以从前部和/或从后部进行。后部方法包括原位融合、后侧部器械融合、经椎间孔腰椎体间融合术(“TLIF”)以及后路腰椎体间融合术(“PLIF”)。
将脊柱节段紧固地融合以消除在该水平面上的任何移位能够缓解即刻的症状,但可能随着时间导致相邻水平面的进一步退化。保持该关节的运动,例如通过使用一种人工椎间盘,可能是一些患者的解决方案。然而,没有一种已知的装置或方法提供本披露的这些实施方案的优点。因此,上述内容表明对改进的脊柱关节成形装置存在一种需要,此类装置避免了已知植入物的缺陷和缺点。
概述
在一个实施方案中,用于插入上椎骨和下椎骨之间的一种人工脊椎关节包括一对双面的关节子部件。每个关节子部件包括一种上部件,该上部件包括一种上椎骨接合表面;以及一种下部件,该下部件包括一种下椎骨接合表面。每个关节子部件进一步包括一种隔离件,该隔离件在上部件和下部件之间扩展。该隔离件包括一种第一弹性模量和一种第二弹性模量。该第一模量以一种梯度变化向该第二模量转变。
在一个第二实施方案中,用于插入一个上椎骨和一个下椎骨之间的一种人工脊椎关节包括一对双面的关节子部件。每个关节子部件包括一种上部件,该上部件包括一个上椎骨接合表面和一个上隔离件接合表面。每个关节子部件进一步包括一种下部件,该下部件包括一个下椎骨接合表面和一个下隔离件接合表面。每个关节子部件进一步包括一种隔离件,该隔离件在上部件和下部件之间扩展。该隔离件包括一种网式容器以及包含在该网式容器内的一种内芯。
在一个第三实施方案中,一种用于在上和下椎骨之间植入人工脊椎关节的方法包括用一种后部的经椎间孔方法在这些上和下椎骨之间生成进入一个椎间盘空间的进入路径。该方法进一步包括将人工脊椎关节的一部件插入椎间盘空间。这个上部件包括一个上后部元件。该方法还包括将人工脊椎关节的一个下部件插入椎间盘空间。这个下部件包括一个下后部元件。该方法进一步包括将人工脊椎关节的一个隔离件插入椎间盘空间。该隔离件包括一种弹性体材料。该方法还包括安排这些上和下后部元件以便从该椎间盘空间向后扩展,并且将该上后部元件安置成与该下后部元件关节接合。
另外的和可替代的多种特征、优点、用途、以及实施方案在以下说明书、附图和权利要求中列出或将从后面的说明书、附图和权利要求中变得清楚。
附图简要说明
图1是一个人脊柱的腰椎和骶骨区的侧视示意图。
图2是一个详细的透视图,显示了如图1所示的具有位于两个椎骨之间的一种被损坏的椎间盘的这些腰椎的右侧部分。
图3是根据本披露原则构建的一种人工椎间关节的第一实施方案中展示的腰椎一部分的透视图。
图4是在图3中展示的人工椎间关节一个侧视图。
图5是在图3至图4中展示的人工椎间关节的一个截面视图。
图6是一种隔离件的正视图,该隔离件被用于根据本披露的第一实施方案构建的人工椎间关节中。
图7是根据本披露的第二实施方案构建的人工椎间关节的一部分的透视图。
图8是显示在图7中展示的人工椎间关节的腰椎的一部分的侧视图。
图9是显示在图7至图8中展示的人工椎间关节的腰椎的前视图。
图10是在图7至图9中展示的人工椎间关节的前视图。
图11是第三实施方案的人工椎间关节的透视图。
图12是在图11中展示的人工椎间关节侧视图。
图13是第四实施方案的人工椎间关节的透视图。
图14是在图13中展示的人工椎间关节的截面视图。
图15是第五实施方案的人工椎间关节的透视图。
图16是在图15中展示的人工椎间关节的截面视图。
图17A至图17D展示了在图15至图16中展示的人工椎间关节的可替代的后端的侧视图。
在以上涉及的这些视图中,应当理解相对于这些椎骨的人工椎间关节体系的大小和位置可以被修改。
说明
附图展示用于替换椎间盘或一种椎间盘与至少一个相应关节面的组合的一种人工椎间关节的不同实施方案。根据本披露这些原理的人工椎间关节的不同实施方案可用于治疗导致将它们用于关节更换的任何问题,具体地包括(例如)腰椎的退行性变化,创伤后的、椎间盘性的、关节面的疼痛或脊椎前移和/或保持腰椎在多个水平上的运动。
图3至图6展示出一种人工椎间关节的第一示例性的实施方案。如在图3至图4中所示,每个关节由一对关节成形术子部件30组成,其中它们各自具有一种隔离件31和一个夹持部分33。夹持部分33包括上部件33a和下部件33b。在图3中展示的实例中,上部件33a在下部件33b的上方(以上)并且隔离件31位于其间。虽然根据本示例性的实施方案的人工椎间关节包括一对关节成形术子部件,应当理解可以实施多种替代性实施方案,这样使得一个人工椎间关节包括一个单一关节成形术子部件或多于两个关节成形术子部件。还应当理解的是还可以用多种不相等尺寸的关节成形部件来实施多种替代的实施方案。在图3至图4中展示的示例性的实施方案中,隔离件31是一种单一的部件,该单一的部件被插入上部件33a与下部件33b之间。然而,应当理解的是在一些替代性实施方案中,隔离件可以与上部件和下部件的一个或者二者被整体地形成或者结合进入上部件和下部件的一个或二者之中。
上部件33a包括构造用于接合上椎体7a的一个上椎骨接合表面33e。同样地,下部件33b包括构造用于接合下椎体9a的一个下椎骨接合表面33f。另外,上部件33a包括一个可任选的上龙骨状突起35a,该突起从上椎骨接合表面33e扩展,并且下部件33b包括一个可任选的下龙骨状突起35b,它从下椎骨接合表面33f扩展,以使关节成形术子部件30稳定。上龙骨状突起和下龙骨状突起可能包括多个孔以便促进骨向内生长。另外,上龙骨状突起可能包括一个抓持件使得进一步帮助该上部件固定至该上椎骨7上。
在多个可替代实施方案中,这些龙骨状突起之一或两者的宽度和高度都可以变化。在其他实施方案中,这些龙骨状突起之一或两者的较低的部分可以是比这些龙骨状突起之一或两者的较高的部分更窄。在其他实施方案中,这些龙骨状突起之一或两者都可以逐渐变小或者具有一种波动的波形。在其他实施方案中,这些龙骨状突起之一或两者都可以具有不同高度的多个部分。
在本披露的这些不同实施方案中,上部件和/或下部件可以是刚性的,并且可以由任何适当的生物相容的材料(包括金属,如钴铬合金、钛合金、镍钛合金、和/或不锈钢合金)制成。陶瓷材料,如铝氧化物或氧化铝、锆氧化物或氧化锆,微粒的金刚石压实体和/或热解碳也是适用的。还可以使用多种聚合材料,包括聚芳醚酮(PAEK)族的任何成员,例如聚醚醚酮(PEEK)、碳增强的PEEK或聚醚酮酮(PEKK)、TECAMAX、聚砜、聚醚酰亚胺;聚酰亚胺、超高分子量聚乙烯(UHMWPE)和/或交联的UHMWPE。包括上部件和下部件的这些不同的部件可由不同材料制成。在本实施方案中,隔离件31是由一种弹性体材料制成,比如聚氨酯、硅树脂、硅树脂聚氨酯共聚物、聚烯烃(如聚异丁烯橡胶和聚异戊二烯橡胶、氯丁橡胶、丁腈橡胶、硫化橡胶)、以及它们的组合物。植入物的某些部分,比如多个较低的模量区域、层、或者区域可以由更易变形的或者柔顺性的材料(包括多种软的弹性体和聚合物的凝胶)制成。另外,如在图5至图6中展示的,隔离件31包括内部区31c和表面31d。该内部区31c位于隔离件31的内部并且该表面31d位于该隔离件31的外部。该内部区31c具有一个内部模量,并且该表面31d具有与内部模量不同的一个表面模量。如图6所示,从该表面模量至该内部模量存在一种逐渐的梯度变化。该表面模量可以是比该内部模量更高的,从而导致表面比内部更硬。可替代地,该表面模量可以是低于内部模量,从而导致表面比内部更软。该隔离件31还可包括一种表面涂层或者一种硬化处理。
可以通过包括注入模制方法的多种模制方法来实现在梯度上的渐变。在由一种原本均质材料形成的隔离件内,弹性模量可以通过改变化学交联的量值和类型而被改变。这些梯度改变还可以产生于在贯穿一种原本均质材料中的以改变量值组合或者分配额外的材料得到,从而实现一种希望的组合的或混合的模量。模量渐变还可能通过使用增强的材料而实现。此外,在渐变中的变化可以通过物理特性而获得,比如改变植入物的厚度、多种表面模式、材料多孔性、或者材料间隙。如在图3中展示的,该上部件33a与该下部件33b位于两个相邻的椎骨7、9之间。更具体地讲,上部件33a可以沿着上椎体7a的一个下表面放置,并且下部件33b可以位于下椎体9a的一个上表面上。然而,本领域的普通技术人员应当理解上部件和下部件不局限于这种安排,并且可以在不同位置上取向和/或形成与在此所说明不同的形状。
在本披露的这些不同的实施方案中,接触这些椎骨的保留末端板的关节成形的上部件和下部件的这些表面可以用一种粒状材料包被或用等离子体喷涂以促进骨向内生长和它们之间的稳固地连接。具体地讲,促进骨向内生长的表面可以是具有一种钛/钙/磷酸盐双层涂层的钴铬钼合金、一个网格表面、或其他有效的表面最终处理。可替代的或者在组合中,一种胶粘剂或者粘结剂比如聚甲基丙烯酸甲酯(PMMA)可以被用来将这些植入物全部或部分地固定于这些终板之一或二者上。
在本实施方案中,上部件33a和下部件33b被构造为从而将隔离件31保留在它们之间。例如,在具有在图4至图6中最好展示了的两个凸起表面31a、31b的隔离件31的情况下,每一个上部件33a和下部件33b对应地具有一个凹表面33c、33d,它们限定一个空间,其中隔离件31可以被保留在该空间之内。在如图4至图5所示的示例性的实施方案中,隔离件31的上凸表面31a装配在由该上部件33a的非球状的凹表面33c所定义的凹腔之内,并且该隔离件31的下凸表面31b装配在由该下部件33b的非球状的凹表面33d所定义的凹腔之内。在本披露的不同实施方案中,这些凸表面和凹表面可以是圆柱形的、长方形的、椭圆的、囊状的、肾形的、它们的组合、和/或多种其他非球的形状。一种非球的形状被理解为包括不具有一个统一的曲率半径的任何形状。在本披露的多个替代性实施方案中,上部件和下部件可能具有一种球状的凹表面和/或隔离件可能具有一种球状的凸表面。
隔离件31可以被可移动地与上和下部件相接合从而上部件33a的表面33c例如可以滑动和/或相对于隔离件31的表面31a转动。在本披露的其他实施方案中,该隔离件可以被模制于(例如、连接)上和下部件之间。
隔离件31、上部件33a、以及下部件33b一起工作从而允许或者限制上部件33a相对于下部件33b的移位。基于隔离件31的弹性和隔离件31的凸表面31a,31b的形状而允许或限制这种移位,这些表面对应地与上部件33a以及下部件33b的凹表面33c,33d形成关节。通过隔离件31的弹性形变连同隔离件31与上部件33a以及下部件33b的关节连接允许或者限制弯曲伸展。侧向弯曲和转动主要是通过隔离件31的弹性形变而被允许或者受限制。
本实施方案的人工椎间关节是充分的紧凑的这样使它可以通过一种双面的后路手术被插入而没有牺牲这些关节面。本实施方案的人工椎间关节还可以经由一种前路手术而被插入。另外,本实施方案的人工椎间关节是机械上足够坚固的以便在腰椎或颈椎处提供支持。此外,本实施方案的人工椎间关节是足够柔韧的以允许具有可变转动中心的一种所希望的范围的运动,而在L5-S1级别的在恒定剪切以及动载荷之下又是充分耐用的。虽然本披露的这些实施方案可以总体上是指脊柱的腰段和骶段区域,应当理解的是这些人工椎间关节的多种可替代实施方案可以被用于脊柱的颈段和胸段区域。
图7至图10展示出一种人工椎间关节的第二示例性的实施方案。如在图7中展示的,每个关节由两个关节成形术子部件50组成,其中每一个具有隔离件51、上部件53、以及下部件55。在图7中展示的实例中,上部件53在下部件55的上方(以上)并且隔离件51位于其间。
下部件55包括一个前部的部分56和从该部的部分56向后延伸的一个桥接件57。如安装的状态,桥接件57可以进一步从在上椎体7a和下椎体9a之间的椎间盘空间向后延伸,并且沿着椎弓根的至少一部分到达的远端57a。在一个替代实施方案中,一个椎弓根的全部或者一部分可以被去除,为桥接件留下很少或没有来自自然结构的支持。另外,在本实施方案中,桥接件57将下部件55连接到一种连接机构59上。
可以使上部件53和下部件55位于两个相邻的椎骨之间。更具体地讲,上部件53可以沿着上椎体7a的一个下表面放置,并且下部件55的前部区域56可以位于下椎体9a的一个上表面上,其中桥接件57以及连接机构59从椎间盘间隔件向后延伸。然而,本领域的普通技术人员应当理解,上部件、下部件、桥接件、以及连接机构不局限于这样一种安排,并且可以在不同的位置上取向和/或形成与在此所说明不同的形状。
在这种实施方案中,连接机构59包括一个骨螺钉接受器59a和一个骨螺钉59b,然而在可替代实施方案中,连接机构,如直钉、回形钉、或者其他的机械的或者化学的紧固件可能是适当的。连接机构59的取向许可使骨螺钉59b变成从椎弓根外插入,这样骨螺钉59b以一个倾角或者偏离通过一个椎弓根定义的一个中心轴线而进入。骨螺钉59b可以被旋拧穿过该椎弓根的一部分并且进入下椎体9a中。椎弓根外固定可以是进入椎弓根的任何的固定,它不沿通常由穿过椎弓根从后到前定义的中轴线的路径。在本实施方案中,骨螺钉59b穿过一个椎弓根的上壁并能获得很强的皮层固定。在一些实施方案中,这些连接机构可以至少部分地是凹陷的以便不干扰关节、软组织和神经结构。
按照安装的状态,桥接件57和连接机构59可以限制人工椎间关节的过度移动、特别是在弯曲/延伸运动期间。另外,桥接件57可以将载荷分配在下椎骨9上,减少对于下部件55下沉进入下椎骨9的的可能性。
上部件53包括构造用于接合上椎体7a的一个上椎骨接合表面53a。同样,下部件55包括构造用于接合下椎体9a的一个下椎骨接合表面55a。另外,上部件53包括一个可任选的上龙骨状突起53b,它从上椎骨接合表面53a扩展,并且下部件55包括一个可任选的下龙骨状突起55b,它从下椎骨接合表面55a扩展,以使该关节成形术稳定。另外,上龙骨状突起53b包括一个上抓持件53c从而进一步帮助上部件53固定至上椎体7a上。在本实施方案中,抓持件53c包括一种锐化的并且凹切的前沿。另外,上龙骨状突起和下龙骨状突起可能包括多个孔从而促进骨向内生长。
此外,上部件53包括从上椎骨接合表面53a的后缘向上延伸的一个上接片53d。在本实施方案中,上接片53d通常可以是相对于上椎骨接合表面53a垂直的或者轻微地呈锐角的。上接片53d可以是与上龙骨状突起53b的后末端整体形成的或者以其他方式与的上龙骨状突起53b的后末端邻接。上接片53d可以作为一种停止件以防止本披露的人工椎间关节被向前插入太远而进入椎间盘空间。一旦定位在脊柱中,上接片53d可以接合上椎体7a。
隔离件51具有一种双模量的弹性,但是在替代性实施方案中可以具有一种单一模量的弹性或多于两种模量。隔离件51可以由一种单一材料或者多种材料制成。隔离件51可以在两个的模量之间具有一种渐变转变、或者梯度改变。可替代地,在这些模量之间一种清楚的变化可以是适当的。在一个实例中,隔离件51(与上部件53和下部件55相邻安置)的末端可以具有一种比隔离件51(安置在隔离件51的末端之间)的中部更高的模量(即更硬的)。在另一个实例中,隔离件51的核心可以具有一种比隔离件51的外周边更高的模量。
梯度的渐变可以通过包括注入模制方法的多种模制方法而实现。在由一种原本均质材料形成的一种隔离件内,该弹性模量可以通过改变化学交联的量值和类型而被改变。这些梯度改变还可产生于在贯穿一种原本均质材料中以变化的量值组合或者分散额外的材料,从而实现一种希望的组合的或混合的模量。模量渐变还可产生于使用多种增强材料。此外,在渐变中的变化可以通过物理特征来实现,比如植入物厚度的变化、多种表面模式、材料的多孔性、或者材料的空隙。
隔离件51可以由弹性体材料制成,比如聚氨酯、硅树脂、硅树脂聚氨酯共聚物、聚烯烃(比如聚异丁烯橡胶和聚异戊二烯橡胶、氯丁橡胶、丁腈橡胶、硫化橡胶)、以及它们的组合物。该植入物的某些部分,比如多种较低模量的区域、层、或者面积可以由更易变形的或者柔性的材料(包括多种软的弹性体和聚合物的凝胶)制成。
隔离件51、上部件53、以及下部件55一起工作从而允许或者限制上部件53相对于下部件55的移位。本实施方案的人工椎间关节可以通过一种双面的后路途径而被插入。隔离件51的双模量允许隔离件51在轴向压缩中是硬的,而仍然提供一种阻尼效应。同样,隔离件51的双模量允许隔离件51足够软以允许弯曲/扩展、轴向转动、以及侧向弯曲的移动。另外,隔离件51的双模量将通过提供随活动范围增加而增加阻力来模拟关节囊和正常盘的功能。与传统的杵臼关节相比,本实施方案的人工椎间关节可以产生更少的磨损碎片、可以允许一种在侧向弯曲和转动过程中更自然的运动、并且可能更不太可能锁住或者脱离对位。
图11至图12展示出第三个示例性的实施方案的一种人工椎间关节。在此仅对与第二个实施方案的不同特征详细进行讨论。在第三实施方案中,上部件53’包括一个第一上面的肩台71a和一个第二上面的肩台71b从而接合隔离件51’并且防止隔离件51’的脱位。第一个上肩台71a和第二个上肩台71b从与上椎骨接合表面53a’相对的一种表面上延伸。这些肩台71a、71b可以至少部分围绕隔离件51’的一个上部从而限制剪切力和相对于上部件53’的隔离件51’的侧向的和/或前-后向的移位。类似的,下部件55’包括一个第一下肩台73a和一个第二下肩台73b从而接合隔离件51’并且以防止隔离件51’的脱位。第一个下肩台73a和第二个下肩台73b从与下椎骨接合表面55a’相对向的一个表面上延伸。这些肩台73a、73b可以至少部分围绕隔离件51’的一个下部从而限制相对于下部件55’隔离件51’的侧向的和/或前-后向的移位。图13至图14展示出一个第四示例性实施方案的人工椎间关节。如图13中展示的,每个关节由两个关节成形术子部件80组成,其中每一个是在图14中最清楚地展示的一种单体的聚合体的装置。每一个关节成形术子部件80具有上部件81、连接部件83、以及下部件85。在图13和14中展示的实例中,上部件81是在下部件85的上方(以上)并且连接部件83连接在其间。虽然根据本示例性的实施方案的人工椎间关节包括一对关节成形术子部件,应当理解的是可以使用可替代的多种实施方案从而使一种人工椎间关节包括一种单一关节成形术子部件或多于两个关节成形术子部件。还应当理解,替代性实施方案还可以用不等尺寸的关节形成的多种子部件来实施。
可以使上部件81和下部件85位于两个相邻的椎骨7、9之间。更具体地讲,上部件81可以沿着上椎体7a的一个下表面放置,并且下部件85可以位于下椎体9a的一个上表面上。然而,本领域的普通技术人员应当理解上部件和下部件不局限于这样一种安排,并且可以在不同的位置取向和/或形成不同与在此所说明不同的形状。
上部件81包括构造用于接合上椎体7a的一个上椎骨接合表面81a。同样地,下部件85包括构造用于接合下椎体9a的一个下椎骨接合表面85a。另外,上部件81包括一种可任选的上龙骨状突起81b,它从上椎骨接合表面81a扩展,并且下部件85包括一种可任选的下龙骨状突起85b,它从该下椎骨接合表面85a扩展,以使关节成形术稳定。另外,上龙骨状突起81b可能包括一种上抓持件从而进一步帮助将上部件81固定至上椎体7a上。上龙骨状突起81b和下龙骨状突起85b可能包括多个从而促进骨向内生长。
虽然每一个关节成形术子部件80是一种单体结构,它的多种成分可以具有不同材料性能。确切地说,上部件81、下部件85、以及连接部件83可以具有不同弹性模量。例如,上部件81可能具有至少一个上部件模量,下部件85可能具有至少一个下部件模数,并且连接部件83可具有至少一个连接部件模量。上部件81、下部件85、以及连接部件83可以由一种材料或者多种材料制成。例如,连接部件83可包括在模量方面的一种逐渐的梯度改变,其中被安置为与上部件和下部件85相邻的连接部件83的末端是一种比连接部件83的中心(被安置为在连接部件83的末端之间)更高的模量(即更硬的)。上部件模量81和下部件85模量可以是高于连接部件83的模量。这样,上部件81和下部件85可以是比连接部件83更硬的。
用于上、下、以及连接部件的适当材料可以是弹性材料,比如例如聚氨酯、硅树脂、或者一种硅树脂型弹性体、硅树脂聚氨酯共聚物、一种层状合成聚合物材料、聚烯烃、比如聚异丁烯橡胶和聚异戊二烯橡胶、氯丁橡胶、丁腈橡胶、硫化橡胶以及它们的组合。该植入物的某些部分,比如多种较低的模量区域、层、或者面积可以由更易变形的或者柔性的材料(包括多种软的弹性体和聚合物的凝胶)制成。在梯度渐变可以通过多种模制方法(包括注入模制方法)而实现。在由一种原本均质材料形成的隔离件内,弹性模量可以通过改变化学交联的量值和类型而被改变。这些梯度改变还可产生于在贯穿一种原本均质材料中以改变量值的组合或者分散的额外的材料,以此实现一种希望的组合的或混合的模量。模量渐变还可产生于使用增强材料。此外,在渐变中的变化可以通过物理特性来实现,比如改变植入物的厚度、多种表面模式、材料多孔性、或者材料的空隙。
该连接部件83、上部件81、以及下部件85一起工作以允许或者限制上部件81相对于下部件85的移动。在这些部件之间的不同模量使连接部件83在轴向压缩中变硬,同时仍然提供一种阻尼效应。同样,连接部件的模量允许连接部件83变得足够软以允许在弯曲/延伸、轴向转动、以及侧向弯曲中的移动。这些不同模量可能起作用以通过提供随活动范围增加而增加的阻力来模拟关节囊(facet capsule)和正常盘的功能。与一种传统的杵臼关节(如装入与一种类似尺寸的半球形凹座的关节接合中的一种半球状的凸起)相比,本实施方案的人工椎间关节可能导致更少的磨损碎片,可以允许在侧向弯曲和转动期间一种更自然的移动,并且可能更不太可能锁住或者脱离对位。本实施方案的人工椎间关节可以通过一种双面的后路途径而被插入。
图15至图17D展示出第五示例性的实施方案的人工椎间关节。如在图15至图16中展示的,每个关节由两个关节成形术子部件130组成,它们各自具有上部件131、下部件133、以及网式部件135。在图15至图16中展示的实例中,上部件131在下部件133的上方(以上)并且网式部件135位于其间。虽然根据本示例性的实施方案的人工椎间关节包括一对关节成形术子部件,应当理解的是可以使用可替代的多种实施方案,这样使一种人工椎间关节包括一个单一关节成形术子部件或多于两个关节成形术子部件。还应当理解,多个替代性实施方案也可以用不等尺寸的关节成形的多种子部件来实施。在本实施方案中,网式部件135是一种分离的部件,它被插入上部件131与下部件133之间。然而,应当理解,该网式部件135可以是与上部件131和下部件133之一或二者整体形成的或者整合到上部件131和下部件133之一或者二者中。
可以使上部件131和下部件133位于两个相邻的椎骨7、9之间。更具体地讲,上部件131可以沿着上椎体7a的一个下表面放置,并且下部件133可以位于下椎体9a的一个上表面上。然而,本领域的普通技术人员应当理解上部件和下部件不局限于这样一种安排,并且可以在不同的位置取向和/或形成不同与在此所说明不同的形状。另外,上部件131包括构造用于接合上椎体7a的一个上椎骨接合表面131a。同样地,下部件133包括构造用于接合下椎体9a的一个下椎骨接合表面133a。此外,上部件131和下部件133各自可以是由一种刚性材料制造的,该刚性材料对应地促进与上椎体7a以及下椎体9a的一种连接。另外,上部件131包括可任选的上龙骨状突起137,并且下部件133包括可任选的下龙骨状突起139,以使关节成形术稳定。上龙骨状突起137和下龙骨状突起139可包括多个孔以促进骨向内生长。
接触这些椎骨的保留的终板的关节成形术的上部件131和下部件133的这些表面可以用一种粒状材料包被或用等离子体喷涂以促进骨向内生长和它们之间的一种稳固连接。具体地讲,促进骨向内生长的表面可以是具有一种钛/钙/磷酸盐双层涂层的钴铬钼合金、一种网格表面、或其他有效表面最终处理。可替代地或者相结合地,一种胶粘剂或者粘结剂比如聚甲基丙烯酸甲酯(PMMA)可以被用来将这些部件的全部或部分地固定于这些终板之一或二者上。在本实施方案中,网式部件135包括一种网式容器135a和一个内芯135b。如在图15至图16中可见,内芯135b被包容在网式容器135a之内。网式容器135a包括交织纤维并且可以由一种材料制成,比如例如金属、聚合物、尼龙、gortex、或者任何其他适当的材料。网式容器135a通过例如加热或者一种化学的熔化物可以连接到在上部件131和/或下部件133上,。该网式容器135a在其前部和后部末端处可以是较厚的以模拟一种自然环带的功能。
内芯135b可以由一种弹性的和/或可膨胀的材料制成,这些材料包括:例如硅树脂、乳胶液、一种聚烯烃共聚物、聚乙烯、聚碳酸酯、聚对苯二甲酸乙二酯、聚氯乙烯、苯乙烯系塑料树脂、聚丙烯、热塑性聚酯、弹性体材料、合成橡胶、聚异丁烯、聚异丙烯、氯丁橡胶、丁腈橡胶、硫化橡胶、硫化共聚物、热塑塑料聚氨酯、脂肪族聚氨酯、芳香族聚氨酯、分段的聚氨酯、亲水性的聚氨酯、聚醚氨酯、聚碳酸氨酯、硅树脂聚碳酸酯聚氨酯、硅树脂聚醚氨酯、热塑性弹性体、聚碳酸酯、丙烯腈-丁二烯-苯乙烯树脂、丙烯酸的、聚氨酯、尼龙、苯乙烯丙烯腈、纤维素、和/或任何其他适当的弹性的或者可膨胀的材料。在一些实施方案中,核心135b可以是一个可膨胀的气球。在多种实施方案中,其中核心135b由一种可膨胀的材料制成,一旦将该内芯135b安置在一位患者体内它即可以膨胀。该芯135b可以具有一种缩小的第一种形式,该第一种形式在膨胀前适合放进入网式容器135a的开口。内芯135b在缩小的第一种形式时可以是流体并且可以具有一种初始粘度以便在网式容器135a已经安置在脊柱之内以后被递送进入网式容器135a中。一旦内芯135b在该网式容器135a之中,它可以固化,并且一旦固化可以不再从网式容器135a中泄漏。内芯135b在被安置于网式容器135a之内时,内芯135b可以固化和/或膨胀或者可替代地,通过将一种生物材料注射进入内芯135b可以使内芯135b固化和/或膨胀。
本实施方案的内芯135b可以是充分紧凑的从而使用一种最小限度的侵入空间即可将它插入。一旦人工椎间关节被安置在脊柱之内,该内芯135b可以膨胀从而维持能够保持在上部件131和下部件133之间的一种间距的一种基本上刚性的形状。上部件131和下部件133对应地包括一个上后部元件141和一个下后部元件143。在本实施方案中,上后部元件141向下弯曲并且下后部元件143向上弯曲。上后部元件141的一个外表面能够可滑动地接合下后部元件143的一个内表面。换言之、上后部元件141可以与下后部元件143接合并与下后部元件143形成关节结合从而产生一种关节,该关节(至少部分地)模仿一种自然的关节面的行为。这些元件141、143的所描述的安排可以进一步防止上部件131在向后方向上的位移。在不同的实施方案中,上后部元件141和下后部元件143可以如在图17A至图17D中所展示的以多种构型相连接,图17A至图17C展示了在脊柱处于多种位置时上后部元件141和下后部元件143通过一种限制物(比如栓系151)连接。图17A展示了在人工椎间关节位于处于中立位置的脊柱内时的这些后元件141、143。图17B展示了在人工椎间关节位于弯曲的脊柱内时的这些后元件141、143。如在图17A至图17B中可见,该栓系151在脊柱处于弯曲时比在脊柱处于中立位置时更紧。图17C展示了在人工椎间关节位于在伸展中的脊柱内时的这些后元件141、143。如在图17B至图17C中可以看见的,栓系151在脊柱处于伸展时比在脊柱处于弯曲时更松。图17D展示了一种替代的实施方案,其中上后部元件141和下后部元件143通过另一个网式部件153连接。该另一个的网式部件153包括另一个网式容器153a和另一个内芯153b,该另一个网式容器153和另一个内芯153b对应地包括与网式容器135a和内芯135b相似的材料和功能性,如以上参照图15至图16的讨论。
在其他替代性实施方案中,上后部元件141和下后部元件143可以通过其他的限制物相连接,比如包裹上后部元件141和下后部元件143的一种网袋。当上后部元件141和下后部元件143被网袋包裹时,该网袋可以限制上后部元件141相对于下后部元件143的移动(以类似于图17A至图17C的栓系151以及图17D的另一个网式部件153的方式)。在其他实施方案中,上部件131和下部件133可以被一种袋子被完全包裹,该袋子可以是非多孔性的或者部分多孔性的(如一种网孔)。该袋子还可以包含一种润滑材料(例如、一种流体或者凝胶)。
网式部件135、上部件131、以及下部件133一起工作从而允许或者限制上部件131相对于下部件133的移动。根据该内芯135b的弹性和/或形状、和/或上后部元件141与下后部元件143的连接,可以允许或者限制这种移动,其结果可以是一种改进的转动中心和在椎骨相邻水平面的移动转变,并且可以减少将本披露的人工椎间关节安置在脊柱内而损坏高于或低于该位置的椎间盘的可能性。另外,网式容器135a可以是柔性的并且可以吸收/储存从内芯135b传输到网式容器135a上的力/能量(即环向应力)。
再一次,这些示例性的实施方案仅为说明性的而且并非旨在成为本发明所有可能的设计、实现方式、变更以及用途的穷尽的清单。此外,与本披露的一个实施方案结合的描述的特征可与其他实施方案结合使用,即使以上没有明确地说明也是如此。
尽管从以上讨论对本领域的普通技术人员而言应当很容易明白,不过下面还是提供了对可以用来植入人工关节的合适手术方法的一个简要说明。总体上,如上所述,人工椎间关节的一个实施方案可以使用与这些已知的TLIF或PLIF方法相似的后部经椎间孔方法植入到人体内来实施。根据这一方法,可在患者的背部形成一个切口(如一个中线切口)并且通过该孔将一些或全部受影响的椎间盘以及周围组织去除。取决于是否更换任何关节面,可修剪这些自然关节面以为这些人工关节面留出空间。然后,人工椎间关节的这些子部件可以通过这些左和右经椎间孔的开口对应地逐块插入。即(若分别提供的话包括上下保留部分,具有或不具有多个关节面部件)将人工椎间关节的这些部件穿过这些孔装入并定位在适当椎间空间中。该人工关节的这些部件可以是完全分离的或者将它们的两个或多个在穿过孔插入之前用纱布或本领域中已知的其他材料捆绑或包装在一起。在其中至少一部分自然盘的外环的可以保留的情况下,插入人工椎关节的每侧的这些下部保留部分从而使它们邻接这些环的一个对应部分。如果提供了中线前侧连接,将保留部分的左和右这些子部件装在一起并由外环保持在位。这样,该环的剩余部分可位于在该步骤前基本上相同的位置。此外,在必须完全去除自然盘的环或没有足够的环保留的情况下,例如可能使用本披露的第二示例性的实施方案,其中采用多种椎弓根螺钉从而确保人工椎间关节块保持在位。本领域的普通技术人员应当理解,通过前部方法或前部方法和背部结合方法可将人工关节植入,尽管后部方法的优点是有限的。例如,可以从前部方法和后部的其他方法插入某些人工椎间关节的部件。
在此所披露的人工椎间关节的不同的实施方案可以在椎骨7、9之间安置。总体上,人工椎间关节可以使用一种与这些已知的TLIF或PLIF方法相似的一种后部的经椎间孔方法植入到人体内。PLIF方法通常地更接近中间并依赖过往根和发出根更多的收缩以进入脊椎的间隙。这些结构之间的空间被称为安全三角(Kambin’s triangle)。TLIF方法通常更倾斜、需要更少的的发出根的收缩以及由于更少过往结构收缩导致的更少硬膜外出血。使用一种远侧方法(在该发出神经根的位置以上并且在安全三角之外)进入该间隙也是可能。在一些情况中,有可能经由远侧进入间隙而无需切除这些关节面。此外,通过腰肌的直侧方法是已知的。该方法完全避开后部神经元。预计本发明的实施方案可以使用任何这些普通方法。
根据这些方法中的至少一种,可在患者的背部形成诸如中线切口的切口并且经由该孔可以将一些或全部受影响的盘以及周围组织去除。可将该下椎骨9的上终板表面碾磨、锉磨或另外地切除以匹配下椎骨结合表面的外形,从而使该下椎骨9的上终板表面上的应力分布均一化和/或在骨生长前提供初始固定。下椎骨9的终板的准备可导致一种平坦表面或导致诸如口袋、沟或其他外形的表面外形,它们可以匹配下椎骨结合表面上相应的特征。可类似地制备上椎骨7的下终板从而接受该上椎骨接合表面。根据是否更换任何关节面,可修剪椎骨7、9的自然关节面以为这些人工椎间关节的空间腾出空间。然后,人工椎间关节的这些子部件可以通过左侧和右侧的经椎间孔开口对应地分段被插入。也就是说,包括上和下部件人工椎间关节的多个部件对应地适合穿过这些孔并被置于这些总体上的圆柱体7a、9a之间的适当椎间盘间空间内。人工关节的这些部件可以是完全分离的或者在插入穿过这些孔前,用纱布或本领域中已知的其他材料将两个或更多个人工关节块捆绑或包装在一起。在其中至少一部分可以保留的情况下,插入人工椎间关节的每侧的这些下部件从而它们邻接这些环的一个对应部分。
另外,应当理解,所有的空间性参照,比如“水平的”、“垂直的、”“顶部”、“上”、“下”、“底部”、“左”、以及“右”,都仅仅是出于说明性的目的并且可以在本披露的范围内变化。在权利要求中,装置加功能短语的意图是覆盖在此说明的这些结构实现叙述的功能、并且不仅是结构等效物而且是多种等效的结构。尽管上面仅详细说明了一些示例性的实施方案,本领域的普通技术人员将会容易地理解在这些示例性的实施方案中、在实质上不脱离本披露的新颖性的传授内容和优点的前提下可作出许多变更。因此,所有这些变更和替换旨在被包括在由以下权利要求所定义的本发明范围之内。本领域内的技术人员还应当意识到:这类变更和等效结构或方法没有脱离本披露的精神和范围,并且不脱离本披露的精神和范围可以作出不同改变、置换和代替。
Claims (15)
1.一种用于插入上椎骨与下椎骨之间的人工脊椎关节,所述人工脊椎关节包括:
一对双面的关节子部件,每个关节子部件包括,
一种上部件,该上部件包括一个上椎骨接合表面;
一种下部件,该下部件包括一个下椎骨接合表面;以及
在该上部件与该下部件之间扩展的一种隔离件,该隔离件包括一种第一弹性模量与一种第二弹性模量,该第一模量以一种梯度变化转变为该第二模量。
2.如权利要求1所述的人工脊椎关节,其中该第一模量是该隔离件的一种内部模量,并且该第二模量是该隔离件的一种表面模量。
3.如权利要求1所述的人工脊椎关节,其中该第一模量是大于该第二模量的。
4.如权利要求3所述的人工脊椎关节,其中该第一模量是一种上表面模量。
5.如权利要求1所述的人工脊椎关节,其中该隔离件、该上部件、以及该下部件是一种整体形成的单元。
6.如权利要求1所述的人工脊椎关节,其中该隔离件与这些上和下部件是可滑动地相接合的。
7.如权利要求1所述的人工脊椎关节,其中该隔离件被固定地连接在这些上和下部件之间。
8.如权利要求1所述的人工脊椎关节,其中该上部件包括从该上椎骨接合表面延伸的一个龙骨状突起。
9.如权利要求1所述的人工脊椎关节,其中该下部件包括一种桥接件,该桥接件的尺寸被确定为从这些上和下椎骨的椎体之间向后延伸。
10.如权利要求1所述的人工脊椎关节,其中或者该上部件或者该下部件包括一个肩台部,该肩台部至少部分地围绕该隔离件的周边延伸。
11.一种用于插入上椎骨与下椎骨之间的人工脊椎关节,所述人工脊椎关节包括:
一对双面的关节子部件,每个关节子部件包括,
一种上部件,该上部件包括一个上椎骨接合表面和一个上隔离件接合表面;
一种下部件,该下部件包括一个下椎骨接合表面和一个下隔离件接合表面;以及
在该上部件与该下部件之间扩展的一种隔离件,该隔离件包括一种网式容器以及包含在该网式容器内的一种内芯。
12.如权利要求11所述的人工脊椎关节,其中该内芯包括一个气球。
13.如权利要求11所述的人工脊椎关节,其中该隔离件通过在该内芯中注入一种流体材料是可膨胀的。
14.如权利要求11所述的人工脊椎关节,其中该内芯包括一种弹性体材料。
15.如权利要求11所述的人工脊椎关节,其中该上部件包括,
一种上后部元件,该上后部元件的尺寸被确定为从这些上和下椎骨的椎体之间向后延伸;
一种下后部元件,该下后部元件的尺寸被确定为从这些上和下椎骨的椎体之间向后扩展,
其中该上后部元件被配置为与该下后部元件进行接合和铰接。
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US12/015,176 US8118873B2 (en) | 2008-01-16 | 2008-01-16 | Total joint replacement |
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PCT/US2009/030181 WO2009091627A1 (en) | 2008-01-16 | 2009-01-06 | Joint replacement device |
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US (1) | US8118873B2 (zh) |
EP (1) | EP2247266B1 (zh) |
JP (2) | JP5580213B2 (zh) |
KR (1) | KR101568439B1 (zh) |
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US11432941B2 (en) | 2015-06-10 | 2022-09-06 | Biedermann Technologies Gmbh & Co. Kg | Intervertebral implant and system of an intervertebral implant and an instrument for inserting the intervertebral implant |
CN105877878A (zh) * | 2016-05-20 | 2016-08-24 | 北京爱康宜诚医疗器材有限公司 | 低位移人工椎间盘 |
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WO2009091627A1 (en) | 2009-07-23 |
EP2247266A1 (en) | 2010-11-10 |
JP2014221399A (ja) | 2014-11-27 |
KR101568439B1 (ko) | 2015-11-11 |
JP2011509747A (ja) | 2011-03-31 |
US8118873B2 (en) | 2012-02-21 |
US20090182429A1 (en) | 2009-07-16 |
AU2009205599B2 (en) | 2011-12-15 |
EP2247266B1 (en) | 2013-03-20 |
KR20100129270A (ko) | 2010-12-08 |
AU2009205599A1 (en) | 2009-07-23 |
JP5580213B2 (ja) | 2014-08-27 |
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