CN101902991A - 半假体 - Google Patents

半假体 Download PDF

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Publication number
CN101902991A
CN101902991A CN2008801213811A CN200880121381A CN101902991A CN 101902991 A CN101902991 A CN 101902991A CN 2008801213811 A CN2008801213811 A CN 2008801213811A CN 200880121381 A CN200880121381 A CN 200880121381A CN 101902991 A CN101902991 A CN 101902991A
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CN
China
Prior art keywords
prosthese
anchor member
buffer component
outer membrane
prosthesis
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Granted
Application number
CN2008801213811A
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English (en)
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CN101902991B (zh
Inventor
G·梅斯特雷蒂
M·阿茨多夫
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Synthes GmbH
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Synthes GmbH
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Publication of CN101902991A publication Critical patent/CN101902991A/zh
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Abstract

一种用于椎间盘空间的全部替换、局部替换或髓核替换的椎间盘假体(10),包括锚定构件(20)和缓冲构件(30)。锚定构件的尺寸和结构形成为接合下椎骨。缓冲构件的尺寸和结构形成为直接接触上椎骨的终板并联结锚定构件,该锚定构件固定在下椎骨上。因此假体包括用于接触下椎骨的单个终板和用于直接接触上椎骨的缓冲构件。在使用中,假体通过(a)通过椎骨体和假体之间的滑动或关节连接形成的直接关节连接,(b)通过假体的变形(例如压缩)形成的间接关节连接,或(c)它们的组合来便于椎骨体之间的运动。

Description

半假体
相关申请的交叉引用
本申请要求2007年10月19日提交的、名称为“作为髓核或全椎间盘置换物的半假体(HEMI-PROSTHESIS AS A NUCLEUS OR TOTAL DISCREPLACEMENT)”的美国临时申请60/981341的权益,其内容通过引用全文并入本文。
背景技术
数以百万计的人遭受着背痛,尤其是椎间盘的磨损。这种疼痛通常是由椎间盘的病理状态引起的,该病理状态例如由受伤或随年龄的退化引起的。目前对背痛的治疗方案涉及从保守的卧床休息到包括脊柱融合术和切除术的高侵入手术操作。脊柱融合术,即在患病的椎间盘的每一侧上融合或固定椎骨,是一种提供疼痛缓解并使融合部分更加稳定的操作。切除术,即用手术的方式去除椎间盘的一部分,是另一种手术方案。
用假体进行髓核和/或全椎间盘的置换是缓解背痛的另一种已知的方案,并且已经提出了多种这样的假体。用于髓核或全椎间盘置换的椎间盘假体优选地恢复椎间盘正常的灵活性,恢复椎间盘的高度和重新建立健康的椎间盘压力。
因此,需要用来替换退化的椎间盘的椎间盘假体,该假体能提供足够的脊柱运动,同时尽可能地缓解疼痛。
发明内容
简言之,本发明的优选实施例的目的是一种用于椎间盘空间的全部替换、局部替换或髓核替换的椎间盘假体。所述假体包括用于接合相邻的椎骨(优选是下椎骨)的锚定构件,和与另一椎骨(优选是上椎骨的终板)直接接触的缓冲构件。缓冲构件还优选地固定地联结到锚定构件。因此假体优选包括用于接触下椎骨的单个终板和用于直接接触上椎骨的缓冲构件。在使用中,假体通过(a)通过椎骨体和假体之间的滑动或关节连接形成的直接关节连接,(b)通过假体的变形(例如压缩)形成的间接的关节连接,或(c)它们的组合来便于椎骨体之间的运动。
在一个特别优选的实施例中,椎间盘假体的尺寸和结构形成为用于植入在相邻的上椎骨体和下椎骨体之间。假体包括锚定构件和缓冲构件。锚定构件包括上表面和下表面。锚定构件在假体处于植入位置时被固定到下椎骨体。缓冲构件在假体处于植入位置时被联结到锚定构件并与上椎骨体直接接触。缓冲构件优选地相对于上椎骨体用关节连接并且优选是可压缩的。缓冲构件优选包括用于联结锚定构件并用于接触上椎骨体的外部膜。外部膜优选围绕内部材料。
附图说明
当结合附图阅读时,前面的总结、以及随后的对本发明优选实施例的详细描述,将得到更好的理解。出于说明本发明的椎间盘假体的目的,在附图中示出了优选的实施例。但是,应当理解的是,本发明并不限于所示出的确切结构和手段。在图中:
图1示出了根据本发明第一优选实施例的植入在相邻的上椎骨体和下椎骨体之间的椎间盘假体的侧面正视、局部截面图;
图2示出了根据本发明第二优选实施例的植入在相邻的上椎骨体和下椎骨体之间的椎间盘假体的侧面正视、局部截面图;
图3示出了根据本发明第三优选实施例的植入在相邻的上椎骨体和下椎骨体之间的椎间盘假体的侧面正视、局部截面图;
图4A示出了根据本发明第四优选实施例的椎间盘假体的俯视透视图;
图4B示出了在图4A中示出的且植入在相邻的上椎骨体和下椎骨体之间的椎间盘假体的侧面正视、局部截面图;
图5示出了根据本发明第五优选实施例的植入在相邻的上椎骨体和下椎骨体之间的椎间盘假体的侧面正视、局部截面图。
具体实施方式
在下面的描述中使用的某些术语仅是为了方便,而不具有限定性。词语“右”、“左”、“顶”和“底”指示的是在所参照的附图中的方向。词语“向内”和“向外”分别指的是朝向和远离装置或其指定部分的几何中心的方向。词语“前”、“后”、“上”、“下”和相关词语和/或短语指示所参照的人体内的优选位置和方向并且不意味着具有限定作用。术语包括上述列出词语、它们的衍生词语和相似含义的词语。
下面将参照附图描述本发明的某些示例性实施例。总的来说,这些实施例与椎间盘假体有关。更具体地,本发明的目标是用于全椎间盘替换、局部椎间盘替换或髓核替换的椎间盘假体。这里将结合椎间盘替换来描述本发明的假体,但是本领域技术人员应当理解该***及其部件可用于人体的其它部分的组织替换,包括例如膝盖、臀部、肩部、手指或其它关节替换。
如下面所要更具体地描述的,优选实施例的椎间盘假体10、10’、10”、10’”、10””优选地包括至少一个缓冲构件50、50””,该缓冲构件50、50””的大小和结构形成为(a)接触第一椎骨V的终板和(b)联结到固定在第二椎骨上的锚定构件20、20’、20”、20’”。即,椎间盘假体10、10’、10”、10’”、10””包括用于接触一个相邻的椎骨(优选是下椎骨VI)的单个终板,和用于直接接触另一椎骨(优选是上椎骨VS)的缓冲构件50、50””。
椎间盘假体10、10’、10”、10’”、10””例如可以填充整个椎间盘空间以替换整个椎间盘空间。或者,虽然示出并描述了单个的椎间盘假体10、10’、10”、10’”、10””,但也可以使用多个椎间盘假体10、10’、10”、10’”、10””填充椎间盘空间。例如,可以使用两个或更多较小的假体10、10’、10”、10’”、10””来填充椎间盘空间。或者,可将椎间盘假体10、10’、10”、10’”、10””的大小和结构形成为仅部分地替换椎间盘空间,例如替换髓核。
在使用中,椎间盘假体10、10’、10”、10’”、10””例如通过(a)由椎骨体VI、VS和椎间盘假体10、10’、10”、10’”、10””之间的滑动或关节连接形成的直接关节连接、(b)由椎间盘假体10、10’、10”、10’”、10””的变形(例如,压缩)形成的间接关节连接、或(c)它们的组合以便于椎骨体VI、VS间的运动。
参照图1-5,优选实施例的椎间盘假体10、10’、10”、10’”、10””包括锚定构件20、20’、20”、20’”和缓冲构件50、50””。锚定构件20、20’、20”、20’”的大小和结构优选地形成为接合相邻的椎骨V中的一个,优选接合下椎骨VI。锚定构件20、20’、20”、20’”可被牢固地固定到椎骨V(优选是下椎骨VI)以吸收预期载荷并保持假体10、10’、10”、10’”、10””就位。锚定构件20、20’、20”、20’”可被以任何方式固定到到椎骨V,优选是下椎骨VI,这些方式包括但不限于:机械方式,该机械方式包括但不限于螺钉固定、装龙骨、咬合、长钉固定、铆钉固定、钉定、装置叶片、夹紧或它们的组合;化学方式,该方式包括但不限于粘合;诸如焊接之类的热结合。出于方便的目的将本发明的椎间盘假体10、10’、10”、10’”、10””的优选实施例的锚定构件20、20’、20”、20’”在这里描述为被固定到下椎骨VI,当并不限定于此,并可以固定到上椎骨VS,而不明显地影响优选的椎间盘假体10、10’、10”、10’”、10””的设计和/或操作。通过对锚定构件20、20’、20”、20’”的表面进行改性以允许骨头向内生长来实现对锚定构件20、20’、20”、20’”的二次固定。这可以通过任何方法来实现,这些方法包括但不限于羟基磷灰石、Ti-VPS涂层、骨传导材料等。
例如,如图1和5最佳地示出的,椎间盘假体10、10””的第一和第五优选实施例的锚定构件20可以是包括用于结合椎骨V(优选是下椎骨VI)的龙骨或纵向支撑体22的板21的形式。或者,在如图2最佳地示出的第二优选实施例,椎间盘假体10’的锚定构件20’可以是包括用于结合椎骨V(优选是下椎骨VI)的骨头锚定部分24的板21’的形式。骨头锚定部分24的大小和结构优选形成为能从下椎骨VI前侧被推入下椎骨VI中。或者,在如图3最佳地示出的第三优选实施例中,椎间盘假体10”的锚定构件20”可以是包括用于接收骨螺钉28以接合下椎骨VI的螺钉孔26的板21”的形式。作为选择,螺钉28可被附连到杆或外部固定装置,这对本领域技术人员来说是显而易见的。锚定构件20”还可包括一个或更多开口30,以便于骨头向内生长并促进锚定构件20”到下椎骨VI的二次固定。虽然参照图3示出并描述了开口30,但开口30可以与优选实施例的任意锚定构件20、20’、20”、20’”结合使用以提供锚定构件20、20’、20”、20’”到椎骨V(尤其是下椎骨VI)的额外固定。而且,在如图4A和4B最佳示出的第四优选实施例中,椎间盘假体10’”的锚定构件20’”可以是联结到板36的网34的形式。网34优选地为骨头的向内生长和/或螺钉、卡钉、钉、销等提供空间,从而将锚定构件20’”固定到椎骨V上,优选固定到下椎骨VI上。
锚定构件20、20’、20”、20’”可以是刚性的或具有一些柔性并可由任意的生物材料制造,这些材料包括但不限于,诸如CoCr、Ti、Ti合金之类的金属,或诸如PEEK、PEKK之类的聚合物。
缓冲构件50、50””的大小和结构优选地设计成(a)接合锚定构件20、20’、20”、20’”,(b)与相邻的椎骨V的终板接触和/或关节连接,和(c)压缩、弯曲和/或关节连接以使假体10、10’、10”、10’”、10””能运动(例如压缩、关节连接、平移等)从而使退化的椎间盘尽可能地恢复到它的原始或自然状态。即,缓冲构件50、50””优选地被构造成以与在植入锚定构件20、20’、20”、20’”之前优选地从上椎骨VS和下椎骨VI之间去除的椎间盘相类似的方式对来自病人的脊柱的载荷和上椎骨VS与下椎骨VI之间的规定移动做出反应。
如图1和5中最佳地示出的,第一和第五优选实施例的锚定构件20的上表面23被联结到缓冲构件50、50””的下表面52,而缓冲构件50、50””的上表面54的大小和结构设计成与上椎骨VS的终板直接连接和/或关节连接。缓冲构件50、50””可构成为因作用在其上的力或被引入到其中的材料而压缩和/或变形(到各种程度)。作为选择,缓冲构件50、50””可被构造成固定地保持其原始形状。而且,缓冲构件50、50””可被定制成基于所植入的椎间盘假体10、10””在脊柱中的高度而具有可变化的弹性。例如,如果锚定构件20被设计为用于植入在腰椎中,那么缓冲构件50、50””可具有相对刚性的构造,而如果锚定构件20设计为植入到颈椎中,那么缓冲构件50、50””可具有相对弹性的构造。
缓冲构件50、50””可包括用于与锚定构件20、20’、20”、20’”联结并用于与相邻的、优选是上椎骨VS接触和/或关节连接的外部刚性的复合物或膜60,和优选地位于外部刚性的复合物或膜60内并用于允许压缩、柔性和/或活动性的内部较柔软的材料或复合物62。
例如,缓冲构件50、50””可被构造成使得外部膜60是枕状的复合物或聚合物膜,被填充有液体或胶体,即相对柔软的复合物62。外部膜60可以是弹性的或非弹性的。而且,如图5中最佳所示,椎间盘假体10””可包括允许在术中对缓冲构件60进行填充或排放的阀70,使得液体或胶体复合物62可在植入后被注入到外部膜60中。作为选择,液体或胶体复合物62可在植入前被注入到外部膜60中。作为选择或附加地,向缓冲构件50、50””内填充的材料液体或胶体复合物62的量可根据病人差别、外科医生的偏好、植入位置(例如腰部、胸部或颈部)等而变化。虽然阀70是参照图5示出和描述的,但阀70可以与优选实施例的任何缓冲构件50结合使用,从而是液体或胶体复合物62能被注入外部膜60中。
外部膜60可由充满液体或胶体复合物62的柔性球状物构成,该复合物62的形式是流体、胶体、柔软聚合物、固体聚合物等。作为选择,缓冲构件50、50””可由例如由金属、聚合物或这些选项的组合制造的具有相对低的刚度的机械结构构成。
作为选择,外部膜60可包括充满液体或胶体复合物62的缓冲膜,复合物62包括不可压流体。作为选择,外部膜60例如可以是充满液体或胶体复合物62的外部球状物,复合物62包括固体髓核和周围的流体或者反之亦然。构成液体或胶体复合物62和外部膜60的材料可以是上面讨论过的任何材料,或满足对接收假体10、10’、10”、10’”、10””的人减少疼痛并增加活动性功能的其它材料。
缓冲构件50、50””优选永久地、牢固地固定到锚定构件20、20’、20”、20’”。缓冲构件50、50””可通过现在或以后已知的任何方法固定到锚定构件20、20’、20”、20’”,这些方法包括但不限于,机械结合、化学结合、热结合、缝合、夹紧诸如槽道中的楔形榫头或嵌用舌片之类的机械交错接合、干涉配合等,或它们的任意组合。例如,缓冲构件50、50””可通过粘合、通过将锚定构件20、20’、20”、20’”的一部分卷在缓冲构件50、50””的一部分上、通过将螺钉或其它机械构件固定到锚定构件20、20’、20”、20’”上并然后将所述螺钉或其它机械构件嵌入到缓冲构件50、50””内、通过将缓冲构件50、50””的一部分模制在锚定构件20、20’、20”、20’”的一部分周围等牢固地固定在锚定构件20、20’、20”、20’”上。
在使用中,可以以各种方式改变椎间盘假体10、10’、10”、10’”、10””以满足各种需要。例如,如在图5中最佳所示,缓冲构件50””可被调整为具有多个部分65、66,其中部分65、66中的任一个,但优选是外部65,由不同的材料充满,这些材料包括但不限于流体或诸如球、圆柱形物体、三角等的固体。可改变缓冲构件50””使其在某些区域具有不同的弹性范围,例如,缓冲构件50””可包括一个或更多由不同的材料充满的部分,或者这些部分被以不同的压力填充。
作为选择或附加地,缓冲构件50、50””可包括术中填充或部分排放缓冲构件50、50””的可能性,借此使外科医生能够控制缓冲构件50、50””的尺寸和缓冲效果。可以设置可调节的缓冲构件50、50””使得尺寸和/或缓冲效果在植入之前或之后是可控的。缓冲构件50、50””可包括各种几何形状的固体材料,例如金属、人工合成材料等。缓冲构件50、50””还可具有渗透性质并具有渗透性填充物,例如内部盐浓缩物。
缓冲构件50、50””的高度HC还可以是例如,通过改变外部膜60内的流体或胶体复合物62的压力可调的。而且,缓冲构件50、50””的高度HC在缓冲构件50、50””的前侧和后侧之间是可变的或者也可以是在横向上是可变的从而为脊柱的弯曲以及上椎骨VS和下椎骨VI的相邻终板之间的自然角度差提供空间。然而,缓冲构件50、50””的总体弹性以及缓冲构件50、50””和椎骨V之间的优选直接接合可以在植入椎间盘假体10、10’、10”、10’”、10””的外科手术后就允许病人的上椎骨VS和下椎骨VI自然地相对于彼此处于它们优选的方向和位置,而不需要专门地使缓冲构件50、50””形成为具有可变的高度HC
优选实施例的椎间盘假体10、10’、10”、10’”、10””可以通过外科手术方法从任何角度植入,包括但不限于后面(单边或双边)、穿过椎孔(单边或双边)、在椎孔外(单边或双边)、极外侧(例如穿过腰大肌)、前面、前面斜向或前面-侧向。
可以以任何方法进行实施植入,但优选通过最小侵入技术进行,例如通过插管,该插管带有例如具有最大直径或宽度约为10mm到15mm的插管(未示出)或切口。
在植入之后,优选实施例的椎间盘假体10、10’、10”、10’”10””优选具有可变的、自定位旋转中心。
本领域技术人员应当清楚的是,在不脱离本发明的广泛的发明概念的情况下,可以对上述实施例进行改变。因此,应当理解的是,本发明不限于所公开的特定实施例,而是使本发明覆盖在本发明的精神和范围内的所有变形,本发明的精神和范围由所附的权利要求定义。

Claims (16)

1.一种用于植入在相邻的第一和第二椎骨体之间的椎间盘假体,所示假体包括:
基本上刚性的锚定构件,其具有上表面和下表面,所述锚定构件在所述假体处于植入位置时被固定到所述第一椎骨体上;和
联结到所述锚定构件的缓冲构件,所述缓冲构件在所述假体处于植入位置时与所述第二椎骨体直接接触。
2.如权利要求1所述的假体,其中所述缓冲构件是可压缩的,从而允许相对于所述第二椎骨体的关节连接。
3.如权利要求1所述的假体,其中所述锚定构件通过固定构件固定在所述第一椎骨体上,所述固定构件选自由骨螺钉、龙骨、长钉、钉和骨锚定部组成的组。
4.如权利要求1所述的假体,其中所述锚定构件包括一个或更多开口,这些开口从所述上表面延伸到所述下表面以允许骨的向内生长从而实现所述锚定构件的二次固定。
5.如权利要求1所述的假体,其中所述锚定构件包括联结到板的网结构。
6.如权利要求1所述的假体,其中所述缓冲构件包括用于联结到所述锚定构件并用于接触所述第二椎骨体的外部膜,所述外部膜包围内部材料。
7.如权利要求6所述的假体,其中所述内部材料是液体。
8.如权利要求7所述的假体,其中所述液体在所述假体植入前被注入到所述外部膜内。
9.如权利要求6所述的假体,其中所述缓冲构件通过机械结合、化学结合、热结合、缝合、夹紧、机械交错接合和它们的任意组合中的一种联结到所述锚定构件。
10.如权利要求6所述的假体,其中所述外部膜包括多个部分,所述多个部分中的至少一个填充有不同的内部材料或以不同的压力填充。
11.如权利要求6所述的假体,其中所述假体包括允许在术中填充或排放所述缓冲构件的阀。
12.一种用于植入在相邻的第一和第二椎骨体之间的椎间盘假体,所示假体包括:
基本上刚性的锚定构件,其具有上表面和下表面,所述锚定构件在所述假体处于植入位置时被固定到所述第一椎骨体上;和
联结到所述锚定构件的缓冲构件,所述缓冲构件在所述假体处于植入位置时与所述第二椎骨体直接接触,所述缓冲构件包括包围液体的外部膜。
13.如权利要求12所述的假体,其中所述外部膜是充满所述流体的球状物。
14.如权利要求13所述的假体,其中所述流体是可压缩的。
15.如权利要求13所述的假体,其中所述球状物通过机械结合、化学结合、热结合、缝合、夹紧、机械交错接合和它们的任意组合中的一种被联结到所述锚定构件。
16.如权利要求13所述的假体,其中所述液体在所述假体植入前通过阀被注入到所述外部膜内。
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