CN1761433A - 用于前斜向插入的关节盘修补物 - Google Patents
用于前斜向插入的关节盘修补物 Download PDFInfo
- Publication number
- CN1761433A CN1761433A CNA2004800074141A CN200480007414A CN1761433A CN 1761433 A CN1761433 A CN 1761433A CN A2004800074141 A CNA2004800074141 A CN A2004800074141A CN 200480007414 A CN200480007414 A CN 200480007414A CN 1761433 A CN1761433 A CN 1761433A
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- Prior art keywords
- flange
- vertebrae
- joint
- repair apparatus
- described repair
- 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.)
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Links
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
Abstract
提供一种用于前斜向插入椎间位置的修复装置(600)。该修补装置包括具有与一第一脊椎骨在前斜方接合的第一法兰(640)的第一元件(602),第一法兰相对于第一元件的横轴和纵轴成斜角,和具有与一第二脊椎骨在前斜方接合的第二法兰(670)的第二元件(604),第二法兰相对于第二元件的横轴(R)和纵轴(T)成斜角,其中第一和第二元件合在一起,可以使第一和第二元件之间形成关节运动。
Description
相关申请的交叉引用
本申请要求基于申请日为2003年2月12日的美国临时申请No.60/446,963的优先权。基于正当理由,在本申请中将结合美国临时申请No.60/446,963。
发明背景
本申请主要涉及整形外科和脊椎外科手术,在一些实施例中,本申请涉及用于全部或部分替换天然椎间盘的椎间修补节及其使用方法和工具。
在治疗影响脊椎骨活动段,特别是椎间盘组织的疾病伤害或畸形的时候,长久以来采取将部分或全部退化、破裂或损坏的椎间盘取出。当有椎间盘组织被从脊椎活动部分取出或由其它方式消除时,采取矫正措施以保证原先由被取出的椎间盘分开的脊椎骨之间有适当的空间。
在某些情况下,两个相邻的脊椎骨通过移植的骨组织(一种人工凑合部件)或其它合成物或装置而凑合在一起。然而,对于脊椎骨连接方法,医疗界日益关注到椎间凑合的仿生机构刚性会使相邻脊椎骨的活动段迅速损坏。更具体地,与天然的椎间盘不同,脊椎骨凑合使被连接的脊椎骨无法进行相对的枢转和转动。这样的缺乏机动性会增加相邻脊椎骨的活动段承受的压力。
另外,在相邻的脊椎骨的活动段内会有一些情况发生,包括椎间盘退化、椎间盘破裂、不稳定、脊椎骨收缩、脊椎前移和关节炎。结果,由于脊椎骨凑合,许多病人会需要额外的椎间盘取出和/或另一种外科手术。因此,迫切需要脊椎骨凑合的替代方法。
特别地,本发明涉及一种可以从前斜方插入的关节盘修补物。
发明内容
提供了一种从前斜方插入椎间位置的修补装置。该修补装置包括具有与一第一脊椎骨在前斜方接合的第一法兰的第一元件,第一法兰相对于第一元件的横向和纵向轴成斜角,和具有与一第二脊椎骨在前斜方接合的第二法兰的第二元件,第二法兰相对于第二元件的横向和纵向轴成斜角,其中第一和第二元件配合在一起,可以使第一和第二元件之间形成关节运动。在另一个实施例中,提供了一种构成修补装置一部分的修补元件。该修补元件包括与脊椎骨在前斜方接合的第一法兰的第一表面,第一法兰相对于修补元件的横轴和纵轴成斜角,以及与第一表面成对置关系的第二表面,第二表面是用来连接另一个修补元件的。
在另一个实施例中,提供了一种从前面斜插入脊椎骨间位置的修补装置。该修补装置包括有第一关节表面和与之对置的第一支承表面的第一元件,从第一支承表面伸出一第一法兰,第一法兰相对于第一元件的横向和纵向轴成斜角,并且第一关节表面上有一个突起。该修补装置还包括有第二关节表面和与之对置的第二支承表面的第二元件,从第二支承表面伸出第一法兰,第二法兰相对于第二元件的横向和纵向轴成斜角,并且第二关节表面上有一凹处,凹处与突起相配合,使第一和第二元件之间形成关节运动。
在另一个实施例中,提供了一种将修补装置从前斜方插入脊椎骨间位置的方法。该方法包括提供一种修补装置,包括:第一元件和从第一元件的表面伸出的第一法兰,第一法兰相对于第一元件的横向和纵向轴成斜角,以及第二元件和从第二元件的表面伸出的第二法兰,第二法兰相对于第二元件的横向和纵向轴成斜角。该方法进一步包括从前斜方将第一元件插入第一脊椎骨和将第二元件插入第二脊椎骨,这样第一元件和第二元件就互相配合,使它们之间形成关节运动。
附图说明
图1是一脊椎骨错位的脊柱的一部分的侧视图;
图2是图1中的一对相邻的脊椎骨端板的侧视图;
图3a是用棒和螺丝固定的图2中的相邻的脊椎骨端板的侧视图;
图3b是图3a所示的相邻脊椎骨主体的纵视及部分剖视图;
图4a是本发明的一个实施例中用于横向插入的关节修补节的立体图;
图4b是本发明的另一个实施例中用于横向插入的关节修补节的立体图;
图4c是图4b横向插入的关节修补节的正视图;
图5是图4a所示修补节的纵视图;
图6是图4a所示修补节的侧视图;
图7是安装在一对脊椎骨错位的脊椎骨端板上的图4a所示修补节的侧视和部分剖视图;
图8是安装在一对脊椎骨端板上的另一种关节修补节的侧视和部分剖视图;
图9是本发明的另一个实施例中的又一个关节修补节的立体图;
图10是安装在一对脊椎骨错位的脊椎骨端板上的图9所示修补节的侧视和部分剖视图;
图11是安装在一对脊椎骨端板之间的又一个关节修补节的侧视和部分剖视图;
图12是本发明另一实施例中的盘修补物的立体图;
图13是本发明另一实施例中的又一个盘修补物的立体图;
图14是本发明的另一个实施例中用于前插入的关节修补节的立体图;
图15是图14所示的修补节的纵视图;
图16是图14所示的修补节的侧视图;
图17是安装在一对脊椎骨错位的脊椎骨端板上的图14所示修补节的侧视图;
图18是本发明的另一个实施例中用于前插入的又一个关节修补节的纵视图;
图19是本发明的再一个实施例中用于前插入的又一个关节修补节的纵视图;
图20是本发明的再一个实施例中用于前插入的又一个关节修补节的纵视图;
图21是一对有可以用来安装图18所示修补节的插口的脊椎骨端板的纵视图;
图22是一对有可以用来安装图19所示修补节的插口的脊椎骨端板的纵视图;
图23是一对有可以用来安装图20所示修补节的插口的脊椎骨端板的纵视图;
图24是安装在一对脊椎骨错位的脊椎骨端板上的图14所示修补节和一整形植入物的侧视和部分剖视图;
图25是安装在一对脊椎骨错位的脊椎骨端板上的图14所示修补节和一方头螺钉的侧视和部分剖视图;
图26是图25所示的排列的顶视示意图;
图27是标识出横绕脊孔插入的路径的脊椎骨主体顶视示意图;
图28是本发明的另一个实施例中用于横绕脊孔插入的关节修补节的立体图;
图29是图28所示修补节的侧视图;
图30是图28所示修补节的纵视图;
图31a是安装在一对脊椎骨端板上的图28所示修补节的侧视和部分剖视图;
图31b是安装在一对脊椎骨端板上的图28所示修补节的纵视和部分剖视图;
图32是形成在脊椎骨端板上有横绕脊孔的插口的的顶视示意图;
图33是显示一研磨设备插入脊椎骨端板的顶视示意图;
图34a是图33所示的设置在一对相邻脊椎骨端板之间的研磨设备的侧视图;
图34b是图34a所示研磨设备的研磨工具的详解图;
图34c是又一个研磨工具的详解图;
图35是图33所示研磨设备的示意图;
图36是本发明的另一个实施例中用于横绕脊孔插入的又一个关节修补节的立体图;
图37是图36所示修补节的侧视图;
图38是图36所示修补节的纵视图;
图39a是本发明的另一个实施例中用于前斜位插入的又一个关节修补节的立体图;
图39b是略微变化了的图39a所示修补节的顶视图;
图39c是图39b所示修补节的正视图;
图40是图39a所示修补节的纵视图;
图41是图39a所示修补节的侧视图;
图42是安装在一对脊椎骨端板上的图39a所示修补节的侧视和部分剖视图;
图43是安装在一对脊椎骨端板上的图39a所示修补节的纵视和部分剖视图;
图44a是脊椎骨端板上用来安装图39a所示修补节的插口的顶视示意图;
图44b是插入图39a所示修补节时的对准过程的示意图;
图45是本发明的另一个实施例中的又一个关节修补节的分解图;
图46是图45所示的修补节的立体图;
图47是图46所示修补节的纵视图;
图48是一对相邻脊椎骨端板的纵视图;
图49a是图45所示修补节的关节元件的俯视图;
图49b是图49a中所示关节元件沿线49b-49b的截面图;
图50a是图45所示的修补节的模块式突出部分的俯视图;
图50b是图50a所示的突出部分沿线50b-50b的截面图;
图51是图50a所示突出部分插入图49a所示关节元件的俯视图;
图52是图50a所示突出部分插入图49a所示关节元件的俯视图,其突出部分的位置不同于图51。
具体实施方式
为了便于对本发明原理的理解,现在将引用图中的实施例或例子,并加以说明。不过,应该了解此处并不是对本发明范围的限制。任何对所举的实施例的替换或者进一步修改,以及对本发明原理的进一步应用,对于本发明所涉及领域的技术人员来说都是正常的。可以对不同实施方式之间的单个特征进行组合,形成其它实施方式。此外,这里讨论了诸如脊椎前移之类的畸形;但是,此处所说的不同的修补装置不仅可以用于脊椎骨错位的脊椎骨,而且也可以用于基本上对准的脊椎骨。
1、侧位矫正
在许多畸形的情况下,例如脊椎前移,一块或多块脊椎骨会相对于其它脊椎骨或骶骨偏移。在这种畸形情况下,希望能通过将发生偏移的部分从原来的位置上重新定位,而减轻偏移的程度。减轻脊椎前移是一个需要一定技艺的过程,要求十分小心以防止神经或周围软组织的损伤。
现在看图1,其中显示了部分脊柱10的侧视图,图解是一组由天然椎间盘D1、D2、D3分离的上下相邻的脊椎骨V1、V2、V3、V4。显示四块脊椎骨仅仅是为了举例。另外的例子可以是一块骶骨和一块脊椎骨。
如图所示,脊椎骨V2相对于脊椎骨V1在箭头22所示的方向上脱位。同样的,脊椎骨V3在箭头23所示的方向上脱位,脊椎骨V4在箭头24所示的方向上脱位。希望能够通过将V2、V3、V4分别沿箭头22、23、24所示的相反方向移动,将它们的位置矫正。
见图2,为了进一步举例,将讨论两块偏移的脊椎骨,下面一块脊椎骨的标记为VL,上面一块脊椎骨的标记为VU。在一个例子中,位于两块脊椎骨VL和VU之间的椎间盘将通过切除或类似的外科手术方式部分或全部的去除,本领域的技术人员了解其具体过程。去除病变的或退化的椎间盘会在上部和下部脊椎骨VU、VL之间形成一间隔S。
在本实施例中,要求在间隔S中插入一个修补节,类似于此处引用的申请日为2003年2月12日的美国临时申请60/446,963中所公开的修补节。但是,需要对上述引用的修补节进行一些改变。对于下面的说明,除了下面说明或提示的以外,所讨论和说明的修补节可以同上面引用的申请中的修补节一样。
到目前为止,侧位手术方法还没能矫正脊椎前移。但是在某些情况下,由于血管和/或神经束的存在,脊椎前移的矫正需要通过侧位方法。在某些例子中,虽然脊椎的其它部分也适用,但当矫正腰部脊椎骨的脊椎前移时,侧位方法特别合适。
见图3a和3b,脊椎前移的矫正可以通过侧位方法解决,例如,将一对接骨螺丝30、32分别插入脊椎骨VU、VL。在一个例子中,接骨螺丝30、32是双皮质层的。然而,可以理解的,接骨螺丝也可以是单皮质层的。另外,接骨螺丝30、32可以用例如可再吸收材料、钛、以及PEEK等不同材料制成。由于使用PEEK材料而产生的射线半透过性能,有利于PEEK材料的使用。进一步可以理解的是,接骨螺丝30、32还可以采用其它材料结构,例如钉子或铆钉。另外,接骨螺丝30、32与脊椎骨VU、VL的连接形式也不限于螺丝连接。
接骨螺丝30、32可以通过一根杆34互相连接,杆34被设置成可以绕两个螺丝钉转动。除了杆34以外,还可以使用其它不同形式的连接件连接接骨螺丝30、32。不同形式的连接件会导致各种用于帮助连接件绕接骨螺丝转动的插口和/或槽。杆34可以在接骨螺丝30、34插入脊椎骨VU、VL之前就连接好,或者可以在螺丝安放好以后再连接。通过给杆34一个箭头36方向上的转动力,上脊椎骨VU就被放回相对于下脊椎骨VL而应该在的位置。转动力可以用一个例如外科医生用的扳手(没有图示)施加。可以理解的,上脊椎骨VU没有被完全放回相对于下脊椎骨VL而应该在的矫正位置,但至少减轻了错位的程度。
虽然没有说明,但在另一个例子中可以预期,脊椎骨错位的脊椎骨VU、VL可以在两个侧面方向上都得到解决。这样,与接骨螺丝30、32基本相同的一对接骨螺丝在另一面从与接骨螺丝30、32相反的方向插入脊椎骨VU、VL。在这样的排列中,杆34可以与一个将两对接骨螺丝啮合在一起的带有棘齿的系统放在一起,同样的,脊椎骨VU、VL可以通过互相转动而促使它们回复到要求的位置。
还有,杆34可以包括任何数量和种类的可以与任何数量和种类的外科医生用转动工具相匹配的啮合方式。例如,楔形接合可以在杆34与相应的工具接合时提供更好的稳定性。再例如,用箝位工具,同时在杆34上形成一个用来与箝位工具相配合的箝位槽。这样的结构可以帮助获得转动所需要的力。
另外,可以使用额外的杆34和接骨螺丝30、32来转动脊椎骨错位的脊椎骨VU、VL使其回到相对于另一块所要求的位置。。额外的杆34和接骨螺丝30、32可以提供额外的稳定性。
另外,虽然说基本上是侧位插入,但接骨螺丝30、32的插入方向可以与侧位方向稍稍成一角度。插入接骨螺丝30、32时形成的这种角度可以为外科医生在开始相对于另一块脊椎骨转动脊椎骨VU、VL时提供更好的夹紧角度。
见图4a、5和6,其中是一个用来插入椎间位置S(图2),以帮助矫正脊椎前移的偏移椎间关节修补节40的一个实例。关节修补节40通常在纵向轴L的方向上延伸,并且包括第一关节元件42和第二关节元件44。关节元件42、44合在一起,形成尺寸和结构适于放置在相邻脊椎骨VU、VL(图2)间的椎间位置S(图2)的修补节40。
修补节40提供了相邻脊椎骨间的相对枢轴和转动运动,以保持与天然的椎间盘所提供的普通生物机械运动基本相似的运动。更具体地,关节元件42、44可以绕许多轴进行相对转动,包括绕纵向轴L的侧向和向两边的枢轴转动,以及绕横向轴T的前后转动。应该理解的是,在本发明的一个实施例中,关节元件42、44可以绕任何位于穿过纵轴L和横轴T的表面上的轴进行相对枢轴移动。
另外,较佳的,关节元件42、44还可以绕转动轴R互相转动。虽然对修补节40的说明和描述提供了一种特别的关节运动组合,但是应当理解为其它形式的关节运动组合也是可能的,例如相对的平移或直线运动。这种运动也被认为包括在本发明的范围之中。
虽然修补节40的关节元件42、44可以用多种不同的材料制成,在本发明的一个实施例中,关节元件42、44由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,关节元件42、44可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。
关节元件42、44分别包括一个支承表面46、48,该表面与脊椎骨直接接触并覆盖有一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,对关节元件42、44的支承表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以预见的表面粗糙处理手段进行。
关节元件42包括一具有关节表面52和与之相对的支承表面46的支撑板50。支撑板50的尺寸和形状基本上与相邻的脊椎骨VL的脊椎骨端板(图2)的尺寸和形状对应。支撑板50包括一个或多个槽54或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,帮助操纵修补节40并将其插入相邻脊椎骨VU、VL(图2)间的椎间位置S(图2)。手术器械(没有图示)的最好设置使其操纵和插入修补节40时,能在预定的同关节元件的相对位置和方位上固定住关节元件42、44,并在关节元件42、44安放到相邻脊椎骨间的合适位置以后放开。
在本发明的一个实施例中,关节元件42包括一个具有曲面的突起56,它被设置成圆形球(显示了一半)。应该理解的是,突起56还可以采取其它结构,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。还应该理解的是,关节元件42的其它部分可以采用平面或非平面结构,例如,在突起56周围延伸的尖角或圆锥形结构。
在支承表面46延伸出一个法兰部件或突瓣58,用来布置在相邻脊椎骨端板的开口中。同支承表面46一起,法兰58上覆盖有一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。
另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,对法兰58进行表面粗糙处理。在一个实施例中,法兰58沿横轴T延伸,且基本位于支承表面46的中间。但是,应该理解的是,法兰58还可以位于其它位置和方位。
在一个实施例中,法兰58沿关节元件42的主要部分的横向延伸。这样的实施例适用于侧位插入修补节40,而不是例如前向插入。在另一个实施例中,法兰58可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰58可以是翼形法兰,包括一个横穿法兰58主体的横向部分(没有图示)。
在一个实施例中,沿法兰58有三个开口60,用来帮助骨骼的生长以加强与相邻脊椎骨VU、VL(图2)之间的固定。然而,应该理解的是,沿法兰58,可以限定任意数量的开口60,包括一个开口或两个或更多开口。还应该理解的是,开口60不必沿法兰58排满,可以只沿法兰58的一部分排列。进一步的,应该理解,法兰58不必限定任何排满或排列在其一部分上的开口60。另外,虽然开口60被说明为具有圆形结构,但也可以采用其它形状的开口60。
在一个实施例中,关节元件44包括一具有关节表面72和与之相对的支承表面48的支撑板70。支撑板70的尺寸和形状基本上与相邻的脊椎骨VU的脊椎骨端板的尺寸和形状对应。支撑板70包括一个或多个槽74或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,如同上述关于关节元件42的讨论。在一个实施例中,关节表面72有一个凹处76。在一个实施例中,凹处76是一个凹面,被设置成一个圆球形孔。然而,应该理解的是,凹处76也可以是其它形状,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。关节表面72的其它部分可以成斜角或采用其它形状以方便修补物的插入和/或使用。
虽然凹处76被描述成基本上为光滑连续的关节面,应该理解的是,沿凹处76的一部分,可形成有一凹陷或洞,便于清除杂物,比如留在关节元件42、44相邻的表面之间的碎片。在这种情况下,突起56的突起关节面会形成一个基本上为光滑连续的关节面。在另一个实施例中,突起56和凹处76上各形成一个凹陷,以便于清除留在相邻的关节元件42、44之间的碎片。
从支承表面48处伸出一个布置类似于关节元件42上的法兰58的法兰部件或突瓣68。在一个实施例中,法兰68沿横轴T延伸并偏离支承表面48的中心。这一实施例适用于侧向插入修补节40。然而,应该理解的是,法兰68还可以有其它的形状、位置和方位。例如,在图4b和4c中,法兰58和68可以相对于横轴T成斜角,以帮助绕开静脉、动脉、骨骼部分、或其它在插入修补节40的过程中遇到的障碍。同时,法兰68可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,可以是翼形法兰,包括一个横穿法兰58主体的横向部分。
在一个实施例中,见图5,法兰68也有三个开口70,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰68,可以限定任意数量的开口70,包括一个开口或两个或更多开口。还应该理解的是,开口70不必沿法兰68排满,可以只沿法兰68的一部分排列。进一步的,应该理解,法兰68不必限定任何排满或排列在其一部分上的开口70。另外,虽然开口70被说明为具有圆形结构,但也可以采用其它形状的开口70。如上所述,直接与脊椎骨接触的支承表面46,48上最好覆盖有一层骨骼生长促进物质。具体地,支承表面48和法兰68的表面覆盖有羟磷灰石层,以促进脊椎骨VU的安置。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面48和法兰68进行表面粗糙处理。
在一些实施例中,法兰58、68中的一个或两个有一条锐利的向前的边,用图4中的边68a表示。有了这条边,将法兰插入脊椎骨就方便了。而且,边68a可以足够锋利,相邻的脊椎骨就不需要有插口来容纳法兰68了。在下面将详细描述。
见图7,为了配合将偏移修补节40插入脊椎骨错位的椎间位置,可以对上、下脊椎骨VU、VL进行部分调整,以准备容纳修补节40(见图7a)。特别的,可以沿上、下脊椎骨VU、VL的脊椎骨端板分别设置一条预定宽度和深度的拉长的开口或插口80、82。插口80、82互相间可以有侧向偏移,以配合移位的脊椎骨VU和/或VL。在一个实施例中,拉长的开口80、82是矩形的,并且分别沿脊椎骨VU、VL的侧面延伸。在一个特例中,插口80和82是凿出来或挖出来的。然而,其它本领域技术人员可以预见的完成插口80、82的方法也是可以的,例如,钻或铰。另外,在修补节40的一些实施例中,法兰58和/或68可以自己完成相应的插口80、82。
见图8,在一个实施例中,上、下脊椎骨VU、VL可以完全矫正,这样,另一种关节修补节90可以用于矫正脊椎前移。修补节90可以同修补节40基本相同,除了修补节90上不同部件的方位。例如,为了适应插入完全矫正的上、下脊椎骨VU、VL,修补节90有一条基本上在修补节的上关节元件94中间的侧向延伸的法兰92和一条基本上在修补节的下关节元件98中间的侧向延伸的法兰96。此外,上关节元件94还有一个基本上位于中心的凹处100与基本上位于下关节元件98中心的突起102对应。在一个实施例中,当被放进完全矫正的上、下脊椎骨VU、VL之间时,上、下关节元件94、98基本上贴合。
为了配合偏移修补节90的插入,可以调整完全矫正的上、下脊椎骨VU、VL以接受插入其间的修补节90。特别的,可以沿上、下脊椎骨VU、VL的脊椎骨端板分别设置一条预定宽度和深度的拉长的开口或插口104、106。插口104和106可以基本上互相对准,以配合完全矫正的上、下脊椎骨VU、VL。在一个实施例中,拉长的插口104、106是矩形的,并且分别沿脊椎骨VU、VL的侧面延伸。在一个特例中,插口104和106是凿出来或挖出来的。然而,其它本领域技术人员可以预见的完成插口104、106的方法也是可以的,例如,钻或铰。另外,在修补节的一些实施例中,法兰92和/或96可以自己完成相应的插口104、106。
见图9,在另一个实施例中,可以用滑动修补节110来帮助进行侧向插入治疗脊椎前移。滑动节110在纵向轴L的方向上延伸,包括第一滑动元件112和第二滑动元件114。滑动元件112和114合在一起,形成尺寸和结构适于放置在相邻脊椎骨的椎间位置的滑动节110。
滑动节110提供了相邻脊椎骨间的运动,以保持部分与天然的椎间盘所提供的普通生物机械运动基本相似的运动。更具体地,滑动元件112和114可以在轴平面上相对移动。
虽然修补节110的滑动元件112、114可以用多种不同的材料制成,在本发明的一个实施例中,滑动元件112、114由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,滑动元件112、114可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。滑动元件112和114与脊椎骨直接接触的表面最好覆盖一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,最好对滑动元件112和114与脊椎骨直接接触的表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以预见的表面粗糙处理手段进行。
滑动元件112包括一个具有滑动表面118和与之相对的支承表面120的支撑板116。支撑板116包括一个或多个槽122或其它类型的标记,用来与手术器械(没有图示)上的对应部分配合,帮助操纵修补节110并将其插入相邻脊椎骨间的椎间位置。手术器械(没有图示)的最好设置使其操纵和插入修补节110时,能在预定的同关节元件的相对位置和方位上固定住滑动元件112、114,并在滑动元件112、114安放到相邻脊椎骨间的合适位置以后放开。
在支承表面120延伸出一个法兰部件或突瓣124,用来布置在相邻脊椎骨端板的开口中。在一个实施例中,法兰124从支承表面120垂直伸出,并基本上位于支承表面120的中间。但是,应该理解的是,法兰124可以有其它的位置和方位。
在一个实施例中,法兰124沿支撑板114的主体横向延伸。这样的实施例适用于侧位插入修补节110。在另一个实施例中,法兰124可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰124可以是翼形法兰,包括一个横穿法兰124主体的横向部分。
法兰124还包括沿其分布的开口126,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰124,可以限定任意数量的开口126,包括一个开口或两个或更多开口。还应该理解的是,开口126不必沿法兰124排满,可以只沿法兰124的一部分排列。进一步的,应该理解,法兰124不必限定任何排满或排列在其一部分上的开口126。另外,虽然开口126被说明为具有圆形结构,但也可以采用其它形状的开口126。如上所述,直接与脊椎骨接触的滑动元件112的表面上最好覆盖有一层骨骼生长促进物质。特别的,支承表面120和法兰124的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面120和法兰124的表面进行表面粗糙处理。
在一个实施例中,滑动元件114包括一个具有滑动表面130和与之相对的支承表面132的支撑板128。支撑板128的尺寸和形状最好基本上与相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。支撑板128包括一个或多个槽134或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,如同上述关于滑动元件112的讨论。
从支承表面132处伸出一个布置类似于滑动元件112上的法兰124的法兰部件或突瓣136。在一个实施例中,法兰136从支承表面132处垂直伸出并沿支承表面132偏移以配合脊椎骨错位的脊椎骨偏移。同时,法兰136的偏移位置可以帮助绕开静脉、动脉、骨骼部分、或其它在插入修补节110的过程中遇到的障碍。进一步应该理解的是,法兰136可以有其它的位置、形状、方位和数量。还应该理解的是,基于的同样或其它原因,法兰136可以有不同的位置、形状和方位,或使用多个法兰136。
在一个实施例中,法兰136沿支撑板128的主体横向延伸。这样的实施例适用于侧位插入修补节110,而不是其它方法,例如前向插入。在另一个实施例中,法兰136可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰136可以是翼形法兰,包括一个横穿法兰136主体的横向部分。
法兰136还包括沿其分布的三个开口138,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰136,可以限定任意数量的开口138,包括一个开口或两个或更多开口。还应该理解的是,开口138不必沿法兰136排满,可以只沿法兰136的一部分排列。进一步的,应该理解,法兰136不必限定任何排满或排列在其一部分上的开口138。另外,虽然开口138被说明为具有圆形结构,但也可以采用其它形状的开口138。如上所述,直接与脊椎骨接触的滑动元件114的表面上最好覆盖有一层骨骼生长促进物质。特别的,支承表面132和法兰136的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面132和法兰136的表面进行表面粗糙处理。
在一些实施例中,法兰124、136中的一个或两个有一条锐利的向前的边,用边124a、136a表示。有了这条边,将法兰124、136插入相应的脊椎骨就方便了。而且,边124a、136a可以足够锋利,相邻的脊椎骨就不需要有插口来分别容纳法兰124,136了。在下面将详细描述。
见图10,为了配合将偏移修补节110插入脊椎骨错位的椎间位置,可以对上、下脊椎骨VU、VL进行部分调整,以准备容纳修补节110。特别的,可以沿上、下脊椎骨VU、VL的脊椎骨端板分别设置一条预定宽度和深度的拉长的开口或插口142、144。插口142、144互相间可以有侧向偏移,以配合移位的脊椎骨VU和/或VL。在一个实施例中,拉长的开口142、144是矩形的,并且分别沿脊椎骨VU、VL的侧面延伸。在一个特例中,插口142和144是凿出来或挖出来的。然而,其它本领域技术人员可以预见的完成插口142、144的方法也是可以的,例如,钻或铰。另外,在修补节的一些实施例中,法兰124和/或136可以自己完成相应的插口。
见图11,在一个实施例中,上、下脊椎骨VU、VL可以完全矫正,这样,另一种关节修补节150可以用于矫正脊椎前移。修补节150可以同修补节110基本相同,除了法兰的方位。例如,为了适应插入完全矫正的上、下脊椎骨VU、VL,修补节150有一条基本上在修补节的上关节元件154中间延伸的法兰152和一条基本上在修补节的下关节元件158中间延伸的法兰156。在一个实施例中,当被放进完全矫正的上、下脊椎骨VU、VL之间时,上、下关节元件154、158基本上贴合。
为了配合偏移修补节150的插入,可以调整完全矫正的上、下脊椎骨VU、VL以接受插入其间的修补节150。特别的,可以沿上、下脊椎骨VU、VL的脊椎骨端板分别设置一条预定宽度和深度的拉长的开口或插口160、162。插口160和162可以基本上互相对准,以配合完全矫正的上、下脊椎骨VU、VL。在一个实施例中,拉长的插口160、162是矩形的,并且分别沿脊椎骨VU、VL的侧面延伸。在一个特例中,插口160和162是凿出来或挖出来的。然而,其它本领域技术人员可以预见的完成插口160、162的方法也是可以的,例如,钻或铰。另外,在修补节的一些实施例中,法兰152和/或156可以自己完成相应的插口160、162。
见图12和图13,凑合板和凑合笼也可以配备一个或多个法兰,并用同上述例子中一样的方法侧向插入,且优于常规的凑合法。特别见图12,一个侧向修补物170包括笼子172、上法兰174和下法兰176。笼子172通过支撑板178、180分别与上、下法兰174、176连接。笼子172具有许多Memphis,TN的Medtronic SofamorDanek提供的LT-CAGETM腰部锥形凑合装置的特性,并可以用于容纳生物材料和/或其它骨骼生长促进材料。同时,侧向法兰174、176可以在凑合时帮助固定矫正了的脊椎骨。
见图13,修补物190包括板192、上法兰194和下法兰196,上支撑板198和下支撑板200。板192可以用来保持支撑板198、200之间的距离并促进凑合。由于板192可以相对较薄,椎间位置的其它部分可以用来放生物材料、骨骼材料和/或其它骨骼生长促进材料。
2、前位矫正
在某些情况下,脊椎前移的矫正需要通过前位方法,参见图14-16,其中显示的是本发明的又一个实施例中的一个椎间关节修补节210。修补节210沿纵轴L延伸,包括一第一关节元件212和一第二关节元件214。关节元件212、214合在一起形成尺寸和结构适于放置在一对相邻脊椎骨间的椎间位置的修补节210,例如相邻脊椎骨VU、VL间的椎间位置S。
修补节210提供了相邻脊椎骨VU、VL间的相对枢轴和转动运动,以保持与天然的椎间盘所提供的普通生物机械运动基本相似的运动。更具体地,关节元件212、214可以绕许多轴进行相对转动,包括绕纵向轴L的侧向和向两边的枢轴转动,以及绕横向轴T的前后转动。应该理解的是,在本发明的一个实施例中,关节元件212、214可以绕任何位于穿过纵轴L和横轴T的表面上的轴进行相对枢轴移动。另外,关节元件212、214还可以绕转动轴R互相转动。虽然对修补节210的说明和描述提供了一种特定的关节运动组合,但是应当理解为其它形式的关节运动组合也是可能的,例如相对的平移或直线运动。这种运动也被认为包括在本发明的范围之中。
虽然修补节210的关节元件212、214可以用多种不同的材料制成,在本发明的一个实施例中,关节元件212、214由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,关节元件212、214可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。关节元件212和214与脊椎骨直接接触的表面最好覆盖一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,最好对关节元件212和214与脊椎骨直接接触的表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以设想的表面粗糙处理手段进行。
关节元件212包括一具有关节表面218和与之相对的支承表面220的支撑板216。支撑板216的尺寸和形状基本上与一块相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。支撑板216包括一个或多个槽222或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,帮助操纵修补节210并将其插入相邻脊椎骨间的椎间位置。手术器械(没有图示)的最好设置使其操纵和插入修补节210时,能在预定的同关节元件的相对位置和方位上固定住关节元件212、214,并在关节元件212、214安放到相邻脊椎骨间的合适位置以后放开。
在一个实施例中,关节表面218包括一个具有曲面的突起224,它被设置成圆形球(显示了一半)。应该理解的是,突起224还可以采取其它结构,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。还应该理解的是,关节表面218的其它部分可以采用平面或非平面结构,例如,在突起224周围延伸的尖角或圆锥形结构。
在一个实施例中,突起224的曲面关节表面被一沿突起224的下压或下陷的表面226所阻断。在一个实施例中,下陷表面226为一条槽。然而,应该理解的是也可以采用其它形式的下陷表面,也包括非下陷表面。槽226的一个用途是便于清除留在相邻的关节元件212、214之间的物质。
在支承表面220延伸出一个法兰部件或突瓣230,用来布置在相邻脊椎骨端板的开口中。在一个实施例中,法兰230从支承表面220垂直伸出,并基本上位于支承表面220的中间。但是,应该理解的是,法兰230可以有其它的位置和方位。
在一个实施例中,法兰230基本上沿支撑板216延伸全长。这样的实施例适用于前位方法插入修补节210。在另一个实施例中,法兰230可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰230可以是翼形法兰,包括一个横穿法兰230主体的横向部分(没有图示)。
沿法兰230还包括一对开口232,以便于骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰230,可以限定任意数量的开口232,包括一个开口或三个或更多开口。还应该理解的是,开口232不必沿法兰230排满,可以只沿法兰230的一部分排列。进一步,应该理解,法兰230不必限定任何排满或排列在其一部分上的开口232。另外,虽然开口232被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口232。如上所述,关节元件212直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。具体地,支承表面220和法兰230的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面220和法兰230的表面进行表面粗糙处理。
在一个实施例中,关节元件214包括一具有关节表面242和与之相对的支承表面244的支撑板240。支撑板240的尺寸和形状基本上与相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。支撑板240包括一个或多个槽246或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,如同上述关于关节元件212的讨论。在一个实施例中,关节表面242包括一个凹处250,具有一个凹面,例如一个圆球形凹座。然而,应该理解的是,凹处250也可以是其它形状,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。关节表面242的其它部分可以成斜角或采用其它形状以方便修补物210的插入和/或使用。
虽然凹处250被描述成基本上为光滑连续的关节面,应该理解的是,沿凹处250的一部分,可形成有一凹陷或凹穴,便于清除杂物,比如留在关节元件212、214相邻的表面之间的碎片。在这种情况下,突起224的突起关节面会形成一个基本上为光滑连续的关节面。在另一个实施例中,突起224和凹处250上各形成一个凹陷,以便于清除留在相邻的关节表面之间的碎片。
从支承表面244处伸出一个布置类似于关节元件212上的法兰230的法兰部件或突瓣260。在一个实施例中,法兰260从支承表面244垂直伸出,并基本上位于支承表面244的中间。但是,应该理解的是,法兰260可以有其它的位置和方位。还应该理解的是,关节元件214可以有两个或多个从支承表面244处伸出的法兰260。
在一个实施例中,法兰260沿支撑板240的主体基本上延伸其全长。这样的实施例适用于前位方法插入修补节210。在另一个实施例中,法兰260可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰260可以是翼形法兰,包括一个横穿法兰260主体的横向部分(没有图示)。
沿法兰260还包括一对开口262,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰260,可以限定任意数量的开口262,包括一个开口或三个或更多开口。还应该理解的是,开口262不必沿法兰260排满,可以只沿法兰260的一部分排列。进一步的,应该理解,法兰260不必限定任何排满或排列在其一部分上的开口262。另外,虽然开口262被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口262。如上所述,关节元件214直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。具体说,支承表面244和法兰260的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面244和法兰260的表面进行表面粗糙处理。
在一些实施例中,法兰230、260中的一个或两个有一条锐利的向前的边,图14中用边260a表示。有了这条边,将法兰插入相应的脊椎骨就方便了。而且,边260a可以足够锋利,脊椎骨就不需要有插口来容纳法兰260了。下面将详细描述。
对于脱位的脊椎骨,例如图1中脊椎前移的脊椎骨V1-V5,人们认识到想要完全矫正并对准脊椎骨错位的部分,用外科手术方法会无法达到这一目的,也是不令人满意的。因此,在共同待审批并结合于此的美国申请10/042589中所公开的基本的关节现在有与脊椎骨位移相对应的关联偏移。即,对于两相邻的脊椎骨错位的脊椎骨之间的偏移量,修补节210的关节也有相对应的偏移。在一些实施例中,这种偏移可以通过在关节元件212的关节表面218上的偏移位置设置一个或多个突起224,以及在关节元件214的关节表面242上的偏移位置设置一个或多个凹处250而受到影响。这就允许没有矫正或部分矫正的偏移能活动。
尤其是,见图14和17,突起224相对于关节表面218偏移。例如,当下脊椎骨(图17中的VL)向后偏移(图17中用箭头P表示),关节元件212会设置成突起224相对于关节表面218向前偏移。继续本例,上脊椎骨VU就相对于下脊椎骨VL向前偏移(图17中用箭头A表示),这样,关节元件214就设置成凹处250相对于关节表面242向后偏移。在这个方式下,关节元件212、214可以设置成通过突起224和凹处250接合,但又互相偏移以配合图17中上、下脊椎骨VU、VL脊椎骨错位的关系。
现在见图16,在另一个实施例中,关节节210可以修改为:支撑板216包括一延伸部分270以适应比图17更加明显的偏移(箭头272表示)和/或提供额外的稳定性以防止半脱位。突起224可以设置在延伸部分270,为关节元件212、214提供更加明显的位移。
见图2和17,为了配合将修补节210插入脊椎骨的椎间位置S,可以对上、下脊椎骨VU、VL进行调整,以准备容纳修补节210。具体说,可以沿上、下脊椎骨VU、VL的脊椎骨端板分别设置一条预定宽度和深度的细长的开口或插口280、282。在在一个实施例中,细长的开口280、282是矩形的,并且从脊椎骨VU、VL的前边284开始向后边延伸。在一个特例中,插口280、282是凿出来或挖出来的。然而,其它本领域技术人员可以预见的完成插口280、282的方法也是可以的,例如,钻或铰。另外,在修补节210的一些实施例中,法兰230和/或260可以自己完成相应的插口280、282。插口280、282的制备和实例尺寸在共同待审批并结合于此的美国申请10/042589中有详细描述。
现在见图18-20,在其它实施例中,关节元件212、214之一或两者会包括不同数量的法兰和/或修改过的法兰。尤其是见图18,用290和292表示的两个法兰从支承表面244上伸出,并设置成可放入相邻脊椎骨端板上已经形成的开口中。在一个实施例中,法兰290、292都从支承表面244上垂直伸出,并互相平行,沿支承表面244的中间部分间距相等。
特别看图19,两个标识为294和296的法兰从支承表面224伸出,并设置成可放入相邻脊椎骨端板上已经形成的开口中。在一个实施例中,法兰294、296都从支承表面224上垂直伸出,并互相平行,沿支承表面224的中间部分间距相等。应该理解的是,法兰290、292、294和296可以有其它的位置和方位。
特别看图20,从支承表面244上伸出一与图14中法兰260类似的法兰298,除了法兰298包括与支承表面244相对的横向伸出或“翼状”部分300。翼状部分300可以提供一些功能,包括将支承表面244紧紧的固定在脊椎骨VU上,以及基本上防止关节元件214的纵向位移。同样的,一法兰302从支承表面224上伸出,并且包括与支承表面224相对的翼状部分304。翼状部分304可以提供一些功能,包括将支承表面224紧紧的固定在脊椎骨VL上,以及基本上防止关节元件212的纵向位移。
见图21-23,为了配合将上述修改过的修补节210插入脊椎骨的椎间位置S,可以对上、下脊椎骨VU、VL进行调整,以准备容纳修补节210。特别见图21,对应于图18中的修补节210的设置,沿上脊椎骨VU的脊椎骨端板上设置有多重插口310和312,沿下脊椎骨VL的脊椎骨端板上设置有一条插口314。特别见图22,对应于图19中的修补节210的设置,沿上脊椎骨VU和下脊椎骨VL的脊椎骨端板上分别设置有多重插口316、318和320、322。特别见图23,对应于图20中的修补节210的设置,沿上脊椎骨VU和下脊椎骨VL的脊椎骨端板上分别设置有翼形插口324、326。插口310、312、314、316、318、320、322、324、326的制备方法可以同关于图17的讨论中的方法一样。关于翼形插口324、326,可以用一个标准的凿子,或用一个特制的带翼状的凿子完成。
见图24,除了修补节210,还可以用一个整形外科用的编织植入物330来充当两个脊椎骨VU、VL之间的人工韧带。编织植入的一个实例公开于美国申请10/082579,结合于此作为引用。发挥天然韧带作用的植入物330将用于,并帮助稳定并进一步地将两个脊椎骨VU、VL固定在一起,并防止进一步的脱位(或防止脱位回复到手术前的状态)。
见图25和26,可以预期,在用前位法进行脊椎前移的矫正时,也会对部分骨折,例如将后部部分(如关节突起334)与脊椎骨相连的骨部分332处的骨折进行治疗。出于提高清晰度的目的,图25中骨折的骨部分332有所夸大。可以通过将一个具有螺丝部分336a和非螺丝部分336b的方头螺丝钉336钉入脊椎骨VL中的开口338,通过骨部分332,进入关节突起334的方法修复部分骨折。在一些实施例中,开口338的部分或全部可以用钻子或凿子(没有图示)预先钻好。方头螺丝钉336从前面插入,对于修复多处突起可以使用多个螺丝钉。固定住骨折的后部部分,旋紧方头螺丝钉,脊椎骨VL就修复了。
3、横绕脊孔修补节
在某些情况下,由于对神经根、脊膜、黄韧带和椎间韧带会有潜在的损伤,要够到并清理损坏的椎间盘位置是困难的。例如,韧带组织的完好对于该部分以及相邻的对应部分保持生物机械稳定性十分重要。在这种情况下,在一边开一个神经孔,用横绕脊孔方法可以清理整个的椎间盘位置。在适当的清理之后,通过背面关节贯通分离的方法,可以得到进一步扩大的、清理过的椎间间隔。而这种方法已经用于凑合技术,如腰部横绕脊孔交互凑合(Transforaminal Lumbar InterbodyFusion)或TLIF,到目前为止它还没有被用于保持活动性的植入物中。
见图27,在横绕脊孔方法中,通过箭头400的方向靠近椎间盘V。该方向在背面方向及侧面方向之间,而且在一些情况下,只需要暴露椎间盘的一边以完成这一过程。
见图28-30,其中显示了本发明中的另一形式的椎间关节修补节410。关节节410通常在纵轴L的方向上延伸,并且包括第一关节元件412和第二关节元件414。关节元件412、414合在一起,形成尺寸和结构适于放置在相邻脊椎骨间的椎间位置的关节节410。
修补节410提供了相邻脊椎骨间的相对枢轴和转动运动,以保持与天然的椎间盘所提供的普通生物机械运动基本相似的运动。更特别的,关节元件412、414可以绕许多轴进行相对转动,包括绕纵向轴L的侧向和向两边的枢轴转动,以及绕横向轴T的前后转动。应该理解的是,在本发明的一个实施例中,关节元件412、414可以绕任何位于穿过纵轴L和横轴T的表面上的轴进行相对枢轴移动。另外,较佳的,关节元件412、414还可以绕转动轴R互相转动。虽然对关节节410的说明和描述提供了一种特定的关节运动组合,但是应当理解为其它形式的关节运动组合也是可能的,并被认为包括在本发明的范围之中。还应该理解的是,还可以有其它类型的关节运动,例如相对的平移或直线运动。
虽然修补节410的关节元件412、414可以用多种不同的材料制成,在本发明的一个实施例中,关节元件412、414由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,关节元件412、414可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。关节元件412、414与脊椎骨直接接触的表面最好覆盖有一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,最好对关节元件412、414与脊椎骨直接接触的表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以预见的表面粗糙处理手段进行。
关节元件412包括一具有关节表面418和与之相对的支承表面420的支撑板416。支撑板416的尺寸和形状基本上与一块相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。在一个实施例中,支撑板416的形状被设置成适合横绕脊孔插入方法。这样,支撑板416包括弯曲的边422a、422b,它们通常由在关节表面418和支承表面420之间延伸的支撑板416的延长部分形成。虽然没有图示,支撑板416可以包括一个或多个槽或其它类型的标记,用来容纳手术器械(也没有图示)上的对应部分并与之接合,帮助操纵修补节410并将其插入相邻脊椎骨间的椎间位置。手术器械(没有图示)最好设置成使其操纵和插入修补节410时,能在预定的同关节元件的相对位置和方位上固定住关节元件412、414,并在关节元件412、414安放到相邻脊椎骨间的合适位置以后放开。
在一个实施例中,关节表面418包括一个具有曲面的突起424,它被设置成圆形球(显示了一半)。应该理解的是,突起424还可以采取其它结构,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。还应该理解的是,关节表面418的其它部分可以采用平面或非平面结构,例如,在突起424周围延伸的斜角或圆锥形结构。
在支承表面410延伸出一个法兰部件或突瓣426,用来布置在相邻脊椎骨端板的开口中。在一个实施例中,法兰426从支承表面420垂直伸出,并基本上位于支承表面420的中间。但是,应该理解的是,法兰426可以有其它的位置和方位。
在一个实施例中,法兰426横贯支撑板416的主要部分。法兰426是弯曲的,弯曲方向一般同图27中箭头400的方向相似。法兰426的曲度可以基本上与边422a、422b相似和一致。这样的例子适用于用不同于上述的前位和侧位插入的横绕脊孔插入方法插入修补节410。在另一个实施例中,法兰426可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰426可以是翼形法兰,包括一个横穿法兰426主体的横向部分(没有图示)。
沿法兰426还包括三个开口428,用来方便骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰426,可以限定任意数量的开口428,包括一个开口或三个或更多开口。还应该理解的是,开口428不必沿法兰426排满,可以只沿法兰426的一部分排列。进一步的,应该理解,法兰426不必限定任何排满或排列在其一部分上的开口428。另外,虽然开口428被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口428。如上所述,关节元件412直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。特别的,支承表面420和法兰426的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面420和法兰426的表面进行表面粗糙处理。
在一个实施例中,关节元件414包括一具有关节表面432和与之相对的支承表面434的支撑板430。支撑板430的尺寸和形状基本上与相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。在一个实施例中,支撑板430的形状被设置成适用于横绕脊孔插入法。这样,支撑板416包括弯曲的边436a、436b,它们通常由在关节表面432和支承表面434之间延伸的支撑板430的延长部分形成。虽然没有图示,支撑板430可以包括一个或多个槽或其它类型的标记,用来容纳手术器械(也没有图示)上的对应部分并与之接合,如同上述关于关节元件412的讨论一样。
在一个实施例中,关节表面432包括一个凹处440,具有一个凹面,可设置为一个圆球形凹座。然而,应该理解的是,凹处440也可以是其它形状,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。关节表面432的其它部分可以成斜角或采用其它形状以方便修补物的插入和/或使用。
虽然凹处440被描述成基本上为光滑连续的关节面,应该理解的是,沿凹处440的一部分,可形成有一表面凹陷或凹穴,以便于清除杂物,比如留在关节元件412、414相邻的表面之间的碎片。在这种情况下,突起424的突起关节面会形成一个基本上为光滑连续的关节面。在另一个实施例中,突起424和凹处440上各形成一个凹陷,以便于清除留在相邻的关节表面之间的碎片。
在支承表面434延伸出一个形状与关节元件412上的法兰426相类似的法兰部件或突瓣450。在一个实施例中,法兰450可以居中定位,并直接放置或与法兰450平行地排列。法兰450是弯曲的,弯曲方向一般同法兰426和图27中箭头400的方向相似。法兰450的曲度可以基本上与边436a、436b相似和一致。这样的例子适用于用不同于上述的前位和侧位插入的横绕脊孔插入方法插入修补节410。在一些实施例中,法兰450的位置可以偏移以帮助绕开静脉、动脉、骨骼部分、或其它在插入修补节410的过程中遇到的障碍。
还应该理解的是,基于类似的或其它原因,法兰450可以有不同的位置、形状或方位,或者可以用更多的法兰450。而且,法兰450可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰450可以是翼形法兰,包括一个横穿法兰450主体的横向部分(没有图示)。
在一个实施例中,沿法兰450还包括三个开口452,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰450,可以限定任意数量的开口452,包括一个开口或三个或更多开口。还应该理解的是,开口452不必沿法兰450排满,可以只沿法兰450的一部分排列。进一步的,应该理解,法兰450不必限定任何排满或排列在其一部分上的开口452。另外,虽然开口452被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口452。如上所述,关节元件414直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。特别的,支承表面434和法兰450的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面434和法兰450的表面进行表面粗糙处理。
在一些实施例中,法兰426、450中的一个或两个有一条锐利的向前的边,图28c中分别用边460、462表示。有了这条边,将法兰插入相应的脊椎骨就方便了。而且,边460、462可以足够锋利,脊椎骨就不需要有插口来容纳法兰426、450了。下面将详细描述。
见图31a和31b,为了配合将上述修改过的修补节410插入脊椎骨的椎间位置,可以对上、下脊椎骨VU、VL进行调整,以准备容纳修补节410。特别见图31a,对应于图28-30中的修补节410的设置,沿上脊椎骨VU和下脊椎骨VL的脊椎骨端板设置有多重插口470和472。插口470、472可以由法兰426、450靠自身形成,或者可以预先设置好。
再看图32,最好在将修复节410插入上、下脊椎骨VU、VL间之前准备一个或更多插口470、472。插口470、472可以是根据弯曲的法兰426、450而弯曲的,就如同插口472所表示的那样,从而方便修复节410在插入过程中的移动。
看图33-35,作为替代只能用来切割直插口的凿子的手段,可以将一研磨导杆500与一研磨工具502连接使用,在上、下脊椎骨VU、VL中切割出弯曲的插口470、472(在图32中用472表示)。研磨导杆500和研磨工具502可以由任何一种材料,包括如钛等适于生物应用的材料。研磨导杆500包括一细长的弯曲部件503,其中形成一与插口470、472的弯曲形状相应的弯曲开口504。当然,研磨导杆500以及弯曲开口504的曲率会根据插口470、472所要求的曲线而不同。在一个实施例中,研磨导杆500是由一种在还原后能保持刚性形状的易曲折的材料制成,这样弯曲开口504就可以改变其曲率而不需要更换研磨导杆。研磨导杆500以及弯曲开口504还足够长,从而当插口470、472需要继续通过任何脊椎骨的背面部分时,此类插口的延长可以同时完成。
具体见图34a和34b,在一个实施例中,研磨工具502包括一个位于弯曲开口504中、可以平移和旋转的钻头510。在一个实施例中,钻头510是一个双槽刳钻,它可以同时伸进上、下脊椎骨VU、VL。
钻头510还可以受到平移力的作用,从而可以在弯曲开口504中往复运动。见图34b,在一个实施例中,钻头把柄530以常规的方法连接于外壳522(图示了一部分)中。把柄530从外壳522伸出,穿过在靠近医生(没有图示)一侧端头534上的插口532。这样,医生就可以移动把柄530,从而沿弯曲开口504移动钻头510。用这样的方法,把柄530就将平移运动传送给钻头510。为了配合钻头510在弯曲开口504中的移动,可以将一对支承部件512、514与外壳522邻接安装,用来在弯曲开口中引导钻头510。
外壳522包覆了一个旋转部件,在一个实施例中,它是齿轮部件524。齿轮部件524包括一个与转动轴528连接并围绕其环状伸出的传动齿轮524。轴528通过电源516(图35)所表示的外部电源转动。在一个实施例中,轴528被包覆在把柄530中。
齿轮部件524进一步包括一钻头齿轮530,它与钻头510连接并围绕其环状伸出。钻头齿轮530位于钻头510之上,从而钻头齿轮与传动齿轮526垂直并接触。这样,通过齿轮部件,轴528将其转动传送给钻头510。一对环状侧翼534、536也与钻头510连接,从而钻头可以很容易的在弯曲开口504内来回移动,而不会在上下方向滑动,如图34b所示。可以理解的是,齿轮部件524仅仅是一个可用于钻头510的旋转传动部件的范例。其它形式的旋转传动部件也被认为落入本发明的范围中,如气动型系统。
见图34c,在一个这样的实施例中,可以用气动系统538来向钻头510传送旋转运动。在一个实施例中,用Medtronic Midas RexLegend TM马达来向气动系统提供动力(用P表示)。用一个常规的阀门539来控制用来使钻头510旋转的空气流量和压力。在其它的实施例中,认为手动或混合动力是较佳的电源516(图34b)和P(图34c)。
再看图34a和34b,还提供了一根导杆540,从而研磨导杆500可以相对于钻头510独立运动。这样,在一个实施例中,可以用一只手通过导杆540握住研磨导杆500,同时可以用另一只手通过把柄530使钻头510在弯曲开口504内移动。在一些实施例中,把柄530如图34b所示那样通过导杆540。结果(见图35),钻头510可以沿箭头R1所示的方向转动,并可以沿箭头R2所示的方向在弯曲开口504内移动。
在操作中,可以用研磨导杆500和研磨工具502切出一个插口(比如插口472)以使脊椎骨VL准备好容纳修补节410的下半部分。外科医生首先选择插口472所需要的曲率并选择或设置相应的研磨导杆500。然后,外科医生用横绕脊孔方法对脊椎骨VL进行处理,以将研磨导杆500放进上、下脊椎骨VU、VL间的椎间盘位置、并将钻头510抵靠在上、下脊椎骨VU、VL上。放置妥当后,外科医生将通过电源516启动研磨工具502,开始用钻头510切入上、下脊椎骨VU、VL。
研磨导杆500可以用外科医生的手或通过一外部装置握住,从而在钻头510沿研磨导杆移动时保持研磨导杆的稳定。研磨导杆500的曲率引导钻头510横绕脊孔通过上、下脊椎骨VU、VL切出横绕脊孔的插口(如图32所示的在下脊椎骨上的插口472)以使上、下脊椎骨准备好容纳横绕脊孔修复节410。
在另一个实施例中,修复节410的法兰可以采用其它的形状和设置以帮助弯曲地、横绕脊孔地插入修复节。见图36-38,法兰(用550和560表示)分别从支承表面434和420上伸出。与图28-30中的法兰450、426相比,法兰550、560相对较短并分别沿支承表面434、420较短的一部分延伸。法兰550、560的相对较短有助于这样的法兰分别进入开口470、472。另外,法兰550、560的相对较短以及由此带来的易于分别进入开口470、472,使该法兰可以设置成直的或弯曲的法兰,这增加了修复节410的设计选择。法兰550、560还可以设置成楔形,以帮助法兰进入上、下脊椎骨VU、VL。
4、前斜位修补节
另一种可以用来避免对神经根、脊膜、黄韧带和椎间韧带潜在损伤的方法是前斜位方法。例如,由于会碰到脊柱前部的主要血管,直接从前位进入脊椎骨L4和L5之间的椎间盘位置以及上一级的椎间盘,会在插入全部替代植入物的过程中存在高度的手术危险。
见图39a和40-41,其中显示了一种根据本发明的另一种形式的椎间关节修补节600。修补节600通常在纵轴L的方向上延伸,并且包括第一关节元件602和第二关节元件604。关节元件602、604合在一起,形成尺寸和结构适于放置在相邻脊椎骨间的椎间位置的关节节600。
修补节600提供了相邻脊椎骨间的相对枢轴和转动运动,以保持与天然的椎间盘所提供的普通生物机械运动基本相似的运动。尤其是,关节元件602、604可以绕许多轴进行相对转动,包括绕纵向轴L的侧向和向两边的枢轴转动,以及绕横向轴T的前后转动。应该理解的是,在本发明的一个较佳的实施例中,关节元件602、604可以绕任何位于穿过纵轴L和横轴T的表面上的轴进行相对枢轴移动。另外,关节元件602、604还可以绕转动轴R互相转动。虽然对关节节600的说明和描述提供了一种特定的关节运动组合,但是应当理解为其它形式的关节运动组合也是可能的,并被认为包括在本发明的范围之中。还应该理解的是,还可以有其它类型的关节运动,例如相对的平移或直线运动。
虽然修补节600的关节元件602、604可以用多种不同的材料制成,在本发明的一个实施例中,关节元件602、604由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,关节元件602、604可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。关节元件602、604与脊椎骨直接接触的表面最好覆盖有一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,最好对关节元件602、604与脊椎骨直接接触的表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以预见的表面粗糙处理手段进行。
关节元件602包括一具有关节表面612和与之相对的支承表面614的支撑板610。支撑板610的尺寸和形状基本上与一块相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。在一个实施例中,610的形状被设置成类三角形,以便于从脊柱的左侧或右侧斜向插入,同样的包括侧向部分P1、P2和P3。侧向部分P1、P2和P3可以采用不同的形式,包括弯曲(P2表示)或直的(P1和P3表示)结构。
支撑板610可以包括一个或多个槽616或其它类型的标记,用来容纳手术器械(也没有图示)上的对应部分并与之接合,帮助操纵修补节600并将其插入相邻脊椎骨间的椎间位置。手术器械(没有图示)的最好设置使其操纵和插入修补节600时,能在预定的同关节元件的相对位置和方位上固定住关节元件602、604,并在关节元件602、604安放到相邻脊椎骨间的合适位置以后放开。
在一个实施例中,关节表面612包括一个具有曲面的突起620,它被设置成圆形球(显示了一半)。应该理解的是,突起620还可以采取其它结构,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。还应该理解的是,关节表面612的其它部分可以采用平面或非平面结构,例如,在突起620周围延伸的尖角或圆锥形结构。
在支承表面614延伸出一个法兰部件或突瓣640,用来布置在相邻脊椎骨端板的开口中。在一个实施例中,法兰640从支承表面614垂直伸出,并大概位于支承表面614的中间。但是,应该理解的是,法兰640可以有其它的位置和方位。另外,出于类似的或其它原因,可以使用更多的法兰640。
在一个实施例中,法兰640横贯支撑板610的主要部分。法兰640是直的,但沿着朝向诸槽616的方向延伸,并与支撑板610的诸侧向部分之一P1平行。在本实施例中,法兰640位于横轴T和侧轴L之间。这样的例子适用于用不同于上述的前位、侧位和横绕脊孔插入方法的斜向方法插入修补节600。在另一个实施例中,法兰640可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰640可以是翼形法兰,包括一个横穿法兰640主体的横向部分(没有图示)。
沿法兰640还包括一对开口646,用来帮助骨骼的生长以加强与相邻脊椎骨之间的固定。另外,在法兰640上还形成一个缺口648以进一步方便骨骼的生长。缺口648还有一个参考点,这样在插入修补节600时,可以用X射线来估计支撑板602的放置和对准。然而,应该理解的是,沿法兰640,可以限定任意数量的开口646或缺口648,包括一个开口或缺口或多个开口或缺口。还应该理解的是,开口646和缺口648不必沿法兰640排满,可以只沿法兰640的一部分排列。进一步的,应该理解,法兰640不必限定任何排满或排列在其一部分上的开口646或缺口648。另外,虽然开口646被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口646。如上所述,关节元件602直接与脊椎骨接触的表面上可以覆盖有一层骨骼生长促进物质。尤其是,支承表面614和法兰640的表面可以覆盖有羟磷灰石层,以促进与相邻脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,可以对支承表面614和法兰640的表面进行表面粗糙处理。
在一个实施例中,关节元件604包括一具有关节表面652和与之相对的支承表面654的支撑板650。支撑板650的尺寸和形状基本上与一块相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。在一个实施例中,650的形状被设置成类三角形,以便于从脊柱的左侧或右侧斜向插入,同样的包括侧向部分P4、P5和P6。侧向部分P4、P5和P6可以采用不同的形式,包括弯曲(P5表示)或直的(P4和P6表示)结构。支撑板650可以包括一个或多个槽656或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,就像上述关于关节元件602的讨论中的那样。
在一个实施例中,关节表面652包括一个凹处660,具有一个凹面,可设置为一个圆球形凹座。然而,应该理解的是,凹处660也可以是其它形状,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。关节表面652的其它部分可以成斜角或采用其它形状以方便修补物的插入和/或使用。
虽然凹处660被描述成基本上为光滑连续的关节面,应该理解的是,沿凹处660的一部分,可形成有一凹陷或凹穴,便于清除杂物,比如留在关节元件602、604相邻的表面之间的碎片。在这种情况下,突起620的突起关节面会形成一个基本上为光滑连续的关节面。在本发明的另一个实施例中,突起620和凹处660上各形成一个凹陷,以便于清除留在相邻的关节表面之间的碎片。
在支承表面654延伸出一个形状与关节元件602上的法兰640相类似的法兰部件或突瓣670。在一个实施例中,法兰670可以居中定位,并直接放置或与法兰640平行地排列。法兰640是直的,但沿着朝向诸槽656的方向延伸,并与支撑板650的诸侧向部分之一P4平行。这样的例子适用于用不同于上述的前位、侧位和横绕脊孔插入方法的斜向方法插入修补节600。在一些实施例中,法兰670的位置可以偏移,以帮助绕开静脉、动脉、骨骼部分、或其它在插入修补节600的过程中遇到的障碍。
应该进一步理解的是,法兰670可以有其它的位置、形状、方位和数量。还应该理解的是,出于类似的或其它原因,可以用更多的法兰670。同样的,法兰670可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰640可以是翼形法兰,包括一个横穿法兰670主体的横向部分(没有图示)。
在一个实施例中,沿法兰670还包括一对开口676,用来便于骨骼的生长以加强与相邻脊椎骨之间的固定。另外,在法兰670上还形成一个缺口678以进一步便于骨骼的生长。缺口678也有一个参考点,这样在插入修补节600时,可以用X射线来估计支撑板604的放置和对准。应该理解的是,沿法兰670,可以限定任意数量的开口676或缺口678,包括一个开口或缺口或多个开口或缺口。还应该理解的是,开口676和缺口678不必沿法兰670排满,可以只沿法兰670的一部分排列。进一步的,应该理解,法兰670不必限定任何排满或排列在其一部分上的开口676或缺口678。另外,虽然开口676被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口676。如上所述,关节元件602直接与脊椎骨接触的表面上可以覆盖有一层骨骼生长促进物质。特别的,支承表面654和法兰670的表面可以覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,可以对支承表面654和法兰670的表面进行表面粗糙处理。
在一些实施例中,法兰640、670中的一个或两个有一条锐利的向前的边,分别用边680、682表示。有了这条边,将法兰640、670插入相应的脊椎骨就方便了。而且,边680、682可以足够锋利,脊椎骨就不需要有插口来容纳法兰640、670了。下面将详细描述。
见图42-44a,为了配合将上述修改过的修补节600插入脊椎骨的椎间位置,可以对上、下脊椎骨VU、VL进行调整,以准备容纳修补节600。特别见图43,对应于图38-40中的修补节410的设置,沿下脊椎骨VL和上脊椎骨VU的脊椎骨端板设置有多重插口690和692。插口690、692可以由法兰640、670靠自身形成,或者可以用上述的一种或更多的方法预先设置好。从图42-44可以看到,如果一根或多根血管阻挡了直接从前向插入的路径,可以在前位/侧位插入中使用用斜向的方法。植入物600的设计保证了与结构VU、VL的脊椎骨端板接触的有效接触表面。
见图44b,在一个实施例中,修补节600可以用如美国共同待审批申请10/430473中公开的导杆那样的装置插入椎间位置,该申请援引与此作为参考。在一个插入修补节600的过程的例子中,脊椎骨VU、VL的中线M用成像设备定位,并且钉子695沿中线钉入上脊椎骨VU。斜向导杆696通过法兰697与钉子695连接,同时将与斜向导杆696连接的把柄(没有图示)调整到适当位置。接着,斜向导杆696的斜向钉698钻进上脊椎骨VU以固定斜向导杆,从而指出了进口参考点和修补节600的植入方向。接着可以用导杆(没有图示)从前斜向将修补节600植入椎间位置,其详细情况在美国共同待审批申请10/430473中讨论。
见图39b和39c,修补节600可以改造为包括不同的槽和/或孔,以配合插入或其它类型的器械。例如,可以在修补节上形成一槽684用以容纳插入器械的一部分(没有图示)。在一些实施例中,槽684可以为钩形形状。另外,在修补节600上还可以形成一通孔686和销孔688,而且其尺寸和结构对应于一插入器械。应该理解的是,槽684、通孔686,以及销孔688可以有任意数量的配置以使修补节600可以和插入器械接合。另外,槽684、通孔686,以及销孔688的制备可以防止修补节600在插入过程中的旋转。
5、移动支承修补节
在另一个实施例中,上述修补节可以改造为可提供平移运动以及旋转运动。例如,见图45-47,一个用于前位插入的移动支承修补节总的用标号700标示。可以理解的是,对移动支承修补节700的说明是关于前位插入仅仅是出于为了清楚的缘故,因此移动支承修补节可以用于不同方向的插入。
修补节700沿纵轴L延伸,包括一第一关节元件702和一第二关节元件704。关节元件702、704合在一起形成尺寸和结构适于放置在一对相邻脊椎骨间的椎间位置的修补节700,例如相邻脊椎骨VS、VI间的椎间位置S1。
修补节700提供了相邻脊椎骨VS、VI间的相对枢轴和转动运动,以保持与天然的椎间盘所提供的普通生物机械运动基本相似的运动,还有附加的平移运动。尤其是,关节元件702、704可以绕许多轴进行相对转动,包括绕纵向轴L的侧向和向两边的枢轴转动,以及绕横向轴T的前后转动。应该理解的是,在一个实施例中,关节元件702、704可以绕任何位于穿过纵轴L和横轴T的表面上的轴进行相对枢轴移动。另外,关节元件702、704还可以绕转动轴R互相转动。此外,关节元件702、704还可以如下面将要进一步说明的那样互相进行平移运动。
虽然修补节700的关节元件702、704可以用多种不同的材料制成,在本发明的一个实施例中,关节元件702、704由钴-铬-钼合金(ASTM F-799或F-75)制成。但是,在本发明的另一个实施例中,关节元件702、704可以由其它材料制成,例如钛或不锈钢,或聚乙烯等聚合材料,或其它对本领域技术人员显而易见的适于生物应用的材料。关节元件702、704与脊椎骨直接接触的表面最好覆盖有一层骨骼生长促进物质,比如由磷酸钙组成的羟磷灰石层。另外,为了进一步加强生长中的骨骼,在覆盖上骨骼生长促进物质之前,最好对关节元件702、704与脊椎骨直接接触的表面进行表面粗糙处理。这种表面粗糙处理可以通过例如酸蚀、压花、涂布颗粒、或其它本领域技术人员可以预见的表面粗糙处理手段进行。
关节元件702包括一具有关节表面708和与之相对的支承表面710的支撑板706。支撑板706的尺寸和形状基本上与一块相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。支撑板706包括一个或多个槽712或其它类型的标记,用来容纳手术器械(没有图示)上的对应部分并与之接合,帮助操纵修补节700并将其插入相邻脊椎骨间的椎间位置。手术器械(没有图示)最好设置成使其操纵和插入修补节700时,能在预定的同关节元件的相对位置和方位上固定住关节元件702、704,并在关节元件702、704安放到相邻脊椎骨间的合适位置以后放开。
在一个实施例中(参见图49a和49b),在关节表面708上形成一个凹处714。在关节表面708上限定凹处714的圆周边716与下凹表面718是同心的,但由于凹处714的扩张圆边720(图48b)的缘故,其直径比下凹表面的要小。虽然作为参考将凹处714描述成圆形的,但可以理解的是,它还可以有不同的形状,例如方形、三角形或矩形。
参见图50a和50b,凹处714(图49b)被设计成可以容纳一个标准突起部件722的一部分。突起部件722包括一边缘部分724,其形状与凹处714的形状对应。这样,边缘部分724包括扩张圆周边726,其终止于一基本为平面的接触表面728。接触表面728是用来与基本为平面的下凹表面718(图49b)配合。但是可以理解的是,虽然被描述成基本为平面,但接触表面728与下凹表面718可以是任何相对应的形状。接触表面728的直径比下凹表面718的要小,从而允许突起部件722能相对于关节元件702平移。
突起部件722的其它部分由具有弯曲表面的突起730形成,它被设置成圆形球(显示了一半)。应该理解的是,突起730还可以采取其它结构,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。还应该理解的是,关节表面708的其它部分可以采用平面或非平面结构,例如,在突起224周围延伸的斜角或圆锥形结构。
在一个实施例中,突起730的曲面关节表面被一沿突起730的下压或下陷的表面732所阻断。在一个实施例中,下陷表面732为一条槽。然而,应该理解的是也可以采用其它形式的下陷表面,也包括非下陷表面。槽732的一个用途是便于清除留在关节元件702、704相邻部分之间的物质。尤其是,槽732可以帮助清除留在关节元件702、704相邻部分之间的物质,例如细微颗粒。
见图45和49b,在支承表面710延伸出一个法兰部件或突瓣740,用来布置在相邻脊椎骨端板(例如图47中的VI)的开口中。在一个实施例中,法兰740从支承表面710垂直伸出,并大概位于支承表面710的中间。但是,应该理解的是,法兰710可以有其它的位置和方位。
在一个实施例中,法兰740沿支撑板706基本上延伸其全长。这样的实施例适用于前位方法插入修补节700。然而,如同以上所述,其它方法,如侧位、横绕脊孔和前斜向方法也可以用于插入修补节700。在另一个实施例中,法兰740可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰740可以是翼形法兰,包括一个横穿法兰740主体的横向部分(没有图示)。
沿法兰740还包括一对开口742,用来方便骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰740可以限定任意数量的开口742,包括一个开口或三个或更多开口。还应该理解的是,开口742不必沿法兰740排满,可以只沿法兰740的一部分排列。进一步应该理解,法兰740不必限定任何排满或排列在其一部分上的开口742。另外,虽然开口742被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口742。如上所述,关节元件702直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。特别的,支承表面710和法兰740的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面710和法兰740的表面进行表面粗糙处理。
参见图45-47,在一个实施例中,关节元件704包括一具有关节表面752和与之相对的支承表面754的支撑板750。支撑板750的尺寸和形状基本上与相邻的脊椎骨的脊椎骨端板的尺寸和形状对应。支撑板750包括一个或多个槽756或其它类型的标记,用来容纳手术器械上的对应部分并与之接合,如同上述关于关节元件702的讨论。
在一个实施例中,关节表面752包括一个凹处758(图47),具有一个凹面,例如一个圆球形凹座。然而,应该理解的是,凹处758也可以是其它形状,例如,圆柱形、椭圆形或其它类型的曲面或可能非曲面的结构。关节表面752的其它部分可以成斜角或采用其它形状以方便修补物700的插入和/或使用。
虽然凹处758被描述成基本上为光滑连续的关节面,应该理解的是,沿凹处758的一部分,可形成有一凹陷或凹穴,便于清除杂物,比如留在关节元件702、704相邻的表面之间的碎片。在这种情况下,突起730的突起关节面会形成一个基本上为光滑连续的关节面。在另一个实施例中,突起730和凹处758上各形成一个凹陷,以便于清除留在相邻的关节表面之间的碎片。
从支承表面754处伸出一个布置类似于关节元件702上的法兰740的法兰部件或突瓣760。在一个实施例中,法兰760从支承表面754垂直伸出,并大概位于支承表面754的中间。但是,应该理解的是,法兰760可以有其它的位置和方位。还应该理解的是,关节元件704可以有两个或多个从支承表面754处伸出的法兰760。
在一个实施例中,法兰760基本上沿支撑板750延伸全长。这样的实施例适用于前位方法插入修补节700。然而,如同以上所述,其它方法,如侧位、横绕脊孔和前斜向方法也可以用于插入修补节700。在另一个实施例中,法兰760可以成斜角、成锥形或其它形状以满足法兰的功能要求。在另一个实施例中,法兰760可以是翼形法兰,包括一个横穿法兰760主体的横向部分(没有图示)。
沿法兰760还包括一对开口762,用来方便骨骼的生长以加强与相邻脊椎骨之间的固定。然而,应该理解的是,沿法兰760,可以限定任意数量的开口762,包括一个开口或三个或更多开口。还应该理解的是,开口762不必沿法兰760排满,可以只沿法兰760的一部分排列。进一步的,应该理解,法兰760不必限定任何排满或排列在其一部分上的开口762。另外,虽然开口762被说明为具有圆形结构,但也可以采用其它尺寸和形状的开口762。如上所述,关节元件704直接与脊椎骨接触的表面上最好覆盖有一层骨骼生长促进物质。尤其是,支承表面754和法兰760的表面覆盖有羟磷灰石层,以帮助与脊椎骨的接合。还是如上所述,在覆盖上羟磷灰石层之前,对支承表面754和法兰760的表面进行表面粗糙处理。
在一些实施例中,法兰740、760中的一个或两个有一条锐利的向前的边,在图45和46中用边760a表示。有了这条边,将法兰740、760插入相应的脊椎骨就方便了。而且,边760a可以足够锋利,脊椎骨就不需要有插口来容纳法兰760了。下面将详细描述。
参见图45,移动支承修补节700通过将突起部件722插入形成于关节元件702的关节表面708之上的凹处704组装而成。通过组装,修补节700就做好了插入相邻脊椎骨VS、VI间的椎间位置S1的准备。
参见图48,为了配合将上述修改过的修补节700插入脊椎骨的椎间位置S1,可以对相邻的脊椎骨VS、VI进行调整,以准备容纳修补节700。对应于图45-47中的修补节700的设置,沿脊椎骨VL和脊椎骨VU的脊椎骨端板分别设置有插口770、772。插口770、772可以由法兰740、760靠自身形成,或者可以用上述的一种或更多的方法预先设置好。
插入椎间位置S1后,因为突起部件722与关节元件704的曲面凹处758接触,修补节700可以使关节元件704相对于关节元件702平移。例如,在图51中,显示突起部件722在靠后的位置(这会导致关节元件704在向后的方向P上移动),而在图52中,显示突起部件722在靠前的位置(这会导致关节元件704在向前的方向A上移动)。图51和52显然只是使用了突起部件722和相应的凹处714后所产生的平移运动的范例,这样,突起部件722(也就是关节元件704)相对于关节元件702的移动量可以变化,包括除P和A以外的其它方向。
另外,将突起部件722放到在关节元件702的凹处714中,使突起可以相对于关节元件702旋转。这样,在这一实施例中,突起部件722增加了能独立于传送给关节元件704的平移运动而给予关节元件704旋转运动这一好处(通过于凹处758的配合)。这种平移运动和旋转运动之间的独立性使修复节700相对于平移运动依靠旋转运动的修补节来说,增加了机动性,反之亦然。
本说明书结合了一些较佳实施例进行说明。在阅读了本说明书后,对本领域技术人员显而易见的改进和修改被认为属于本发明的精神实质和范围之中。例如,上述关节节的关节元件可以对换而并不违背本发明的某些方面。因此可以理解的是,可以对前述发明进行一些修改、变化和替代,在某些情况下,一些特征可以不与相应的其它特征一起用。还可以理解的是,所有空间概念,例如“纵向”和“横向”只是用来说明的,并且在本发明的范围内可以不同。因此,所附的权利要求范围较宽是合适的并且与说明书的范围一致。
Claims (33)
1、一种从前斜方插入椎间位置的修补装置,包括具有与第一脊椎骨在前斜方接合的第一法兰的第一元件,第一法兰相对于第一元件的横轴和纵轴成斜角,和具有与第二脊椎骨在前斜方接合的第二法兰的第二元件,第二法兰相对于第二元件的横轴和纵轴成斜角,其中第一和第二元件结合在一起,可以使第一和第二元件之间形成关节运动。
2、权利要求1所述的修补装置,其特征在于第一法兰和第二法兰适用于在修补装置插入椎间位置时基本上对准。
3、权利要求1所述的修补装置,其特征在于第一法兰和第二法兰适用于在修补装置插入椎间位置时互相偏移。
4、权利要求1所述的修补装置,其特征在于第一元件的形状是三角形,形成第一、第二和第三边缘部分。
5、权利要求4所述的修补装置,其特征在于第一法兰同第一、第二和第三边缘部分之一平行。
6、权利要求1所述的修补装置,其特征在于第二元件的形状是三角形,形成第一、第二和第三边缘部分。
7、权利要求6所述的修补装置,其特征在于第二法兰同第一、第二和第三边缘部分之一平行。
8、权利要求1所述的修补装置,其特征在于第一法兰沿第一元件的主体延伸。
9、权利要求1所述的修补装置,其特征在于第一法兰包括一形成于其中的缺口。
10、权利要求1所述的修补装置,其特征在于第一法兰包括一尖锐部分,用以接合并刺入第一脊椎骨。
11、权利要求1所述的修补装置,其特征在于第二法兰沿第二元件的主体延伸。
12、权利要求1所述的修补装置,其特征在于第二法兰包括一形成于其中的缺口。
13、权利要求1所述的修补装置,其特征在于第二法兰包括一尖锐部分,用以接合并刺入第二脊椎骨。
14、权利要求1所述的修补装置,其特征在于第一元件包括一具有一突起的第一关节表面,而第二元件包括一具有一凹处的第二关节表面;突起和凹处适合于互相配合使第一和第二元件之间形成关节运动。
15、权利要求14所述的修补装置,其特征在于突起是凸面和凹处是凹面。
16、权利要求1所述的修补装置,其特征在于第一法兰适合于放置在第一脊椎骨中预先形成的前斜向开口中。
17、权利要求1所述的修补装置,其特征在于第二法兰适用于放置在第二脊椎骨中预先形成的前斜向开口中。
18、权利要求1所述的修补装置,其特征在于第一法兰和第二法兰包括至少一个穿过其形成的孔。
19、权利要求1所述的修补装置,其特征在于第一法兰和第二法兰上涂覆有一层骨骼生长促进物质。
20、权利要求1所述的修补装置,其特征在于第一元件包括一对形成于其上的槽,形成于第一元件上的两个槽的方向基本上与第一法兰平行。
21、权利要求1所述的修补装置,其特征在于第二元件包括一对形成于其上的槽,形成于第二元件上的两个槽的方向基本上与第二法兰平行。
22、一种形成修补装置的一部分的修补元件,包括一具有与脊椎骨在前斜方接合的法兰的第一表面,法兰相对于修补元件的横轴和纵轴成斜角;和与第一表面成对置关系的第二表面,第二表面是用来连接另一个修补元件的。
23、一种从前斜方插入椎间位置的修补装置,包括:
一第一元件,包括:
第一关节表面和与之相对的第一支承表面,
从第一支承表面伸出的第一法兰,第一法兰相对于第一元件的纵轴和横轴成斜角,和
从第一关节表面伸出的一突起;和
一第二元件,包括:
第二关节表面和与之相对的第二支承表面,
从第二支承表面伸出的第二法兰,第二法兰相对于第二元件的纵轴和横轴成斜角,和
在第二关节表面上形成的一凹处,凹处适合与突起接合使第一和第二元件之间形成关节运动。
24、权利要求23所述的修补装置,其特征在于第一法兰是用来与一第一脊椎骨在前斜方接合。
25、权利要求23所述的修补装置,其特征在于第二法兰是用来与一第二脊椎骨在前斜方接合。
26、权利要求23所述的修补装置,其特征在于第一元件的形状是三角形,形成第一、第二和第三边缘部分。
27、权利要求26所述的修补装置,其特征在于第一法兰同第一、第二和第三边缘部分之一平行。
28、权利要求23所述的修补装置,其特征在于第二元件的形状是三角形,形成第一、第二和第三边缘部分。
29、权利要求28所述的修补装置,其特征在于第二法兰同第一、第二和第三边缘部分之一平行。
30、一种将修补装置从前斜向插入椎间位置的方法,包括:
提供一种修补装置,它具有一第一元件和从第一元件的一表面伸出的第一法兰,第一法兰相对于第一元件的纵轴和横轴成斜角,和一第二元件和从第二元件的一表面伸出的第二法兰,第二法兰相对于第二元件的纵轴和横轴成斜角;和
从前斜向将第一元件插入一第一脊椎骨和将第二元件插入一第二脊椎骨,从而第一元件和第二元件接合使两者之间形成关节运动。
31、权利要求30所述的方法,其特征在于在插入过程中,第一和第二法兰相配合并分别刺入第一和第二脊椎骨。
32、权利要求30所述的方法,其特征在于在插入过程中,第一和第二法兰分别插入第一和第二脊椎骨中预先形成的开口。
33、权利要求30所述的方法,其特征在于第一和第二法兰分别插入第一和第二脊椎骨中基本上在同一时间完成。
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2004
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