CN105407839A - 椎间融合器 - Google Patents

椎间融合器 Download PDF

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Publication number
CN105407839A
CN105407839A CN201480041616.1A CN201480041616A CN105407839A CN 105407839 A CN105407839 A CN 105407839A CN 201480041616 A CN201480041616 A CN 201480041616A CN 105407839 A CN105407839 A CN 105407839A
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CN
China
Prior art keywords
fusion device
aforementioned
framework
grid
grille body
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.)
Granted
Application number
CN201480041616.1A
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English (en)
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CN105407839B (zh
Inventor
W.里斯
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Joimax GmbH
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Joimax GmbH
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Publication of CN105407839B publication Critical patent/CN105407839B/zh
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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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Abstract

本发明涉及一种椎间的融合器(5),为了更好地连接到/生长到椎骨区域(3、4)中,所述融合器具有网状或格栅状区域。所述融合器尤其具有由实心的支承件构成的外部框架和内部的格栅体。确定外部轮廓的框架和处于所述框架内部的网状或格栅状区域一体地设计。所述融合器通过烧结、如借助电子束熔炼或激光烧结制造。

Description

椎间融合器
本发明涉及一种椎间融合器。
椎间融合器在英语中称为InterbodyCages。在一系列脊柱损伤,尤其是椎间盘损伤,如椎间盘突出之后的不稳定和椎滑脱以及椎狭窄和退化中,在两个涉及损伤的椎骨体之间对脊椎进行加强。为此,在从椎间腔或椎间盘间隙中移除损伤的和/或损伤(神经)的椎间盘之后,将融合器置入脊椎的两个直接相叠的椎骨之间,以便使椎骨保持预设的距离。至少这在两个椎骨的区域内对脊椎进行加强。这例如称为(腰)椎融合(LumbarInterbodyFusion-LIF)。必要时,椎骨还在微创脊椎手术中配设杆-螺钉单元、筋膜关节螺钉或穿层螺钉并且相对于置于其间的融合器预紧。由此期望骨头与融合器长在一起。因此,这种融合器通常配设有粗糙的表面。
本发明所要解决的技术问题在于,提供一种具有改善的性能的椎间融合器。
在此在优选设计方案中规定,确定外部轮廓的框架和处于所述框架内部的网状或格栅状区域一体地设计,其中,所述融合器通过烧结、如借助电子束熔炼或激光烧结制造。
所述技术问题按照本发明通过一种融合器解决,其至少具有带网状或格栅状结构的区域。因此所述融合器设计具有网状或格栅状区域。
这种融合器的制造优选通过烧结进行,尤其是借助(选择性的)电子束熔炼((Selective)ElectronBeamMelting,(S)EBM)或者借助激光烧结(LST)进行。因此,所述融合器通过烧结,如借助电子束熔炼或激光烧结制造。
网状或格栅状区域优选从上面或侧面到达平行对置的下面或侧面。由此实现了,骨组织不只在融合器的外表面上生长,而且也骨组织也长入网状或格栅状结构的空腔内,并且由此可以完全进入融合器或者说促进骨生长。由此实现了融合器与相邻的椎骨体之间的固定连接。
融合器优选可以具有22mm至40mm的长度和数量级在10mm至15mm之间的宽度并且分别根据患者的体质和置入位置或椎骨体及其椎间盘间隙具有6mm至16mm之间的不同高度,融合器装入椎间盘间隙内。通过所述宽度和高度,融合器可以通过工作套筒装入椎骨体之间的椎间盘间隙内。
在此,在优选的扩展设计中规定,融合器具有由实心的支承件构成的外部的框架和内部的格栅体。通过将融合器设计为具有两个结构元件,也就是由实心材料和紧凑结构构成的外部框架和具有所述网状或格栅状结构的内部格栅体,在保持前述关于骨材料完全生长穿过融合器或其格栅状结构的优点的同时,使得融合器具有足够的强度和刚性。
本发明的另一个特别优选的设计方案规定,所述格栅体只在平行地沿一个方向(横向)延伸的面上与框架相连,但是所述格栅体在相对于这些面以有限的角度延伸的面和棱边中不与框架相连。由此以某种方式实现了外部框架与融合器的内部格栅体的脱耦,方法是两者沿融合器的纵向或主延伸方向脱耦(融合器在引入方向上比在横向和其高度方向上更长)。如果框架例如在构成其的肋的区域内在施加于其上的压力作用下受让变形,则压力不会传递到格栅体上。因此,格栅体保持未受影响并且长入格栅体中的骨结构也不会受到影响或受损。
在此,在优选的扩展设计中规定,所述格栅体的上部面和下部面具有与由框架部件围成的自由空间相同的尺寸,所述自由空间包围格栅体的所述面。
在按照本发明的融合器的另一种设计中,所述框架围成空腔,所述格栅体布置在所述空腔内。一种扩展设计规定,所述框架具有沿其纵向延伸的纵向肋。一种特别优选的设计方案规定,相邻的纵向肋在中间通过横向肋相连。由此在更长的融合器中也能提高框架的稳定性,并且由此提高融合器本身的稳定性。融合器的格栅体的网状或格栅状结构能够以不同的方式设计。在特别优选的设计方案中规定,所述格栅状区域或者格栅体具有金刚石结构。
在融合器的另一种设计方案中可以规定,所述融合器具有贯通的通道。在此,通道沿纵向延伸穿过框架并且尤其也穿过格栅体本身。由此实现了,融合器可以借助置入器械经由到达椎间腔或椎间盘间隙内的导引线通过管状的闸或内窥镜管引入。
按照本发明的融合器的其它优选设计方案的特征在于,所述格栅状区域或格栅体的每个开口的格栅开口直径为0.5mm至3.5mm,优选在融合器外侧上的每个开口的开口直径的数量级为0.5mm至0.7mm,和/或所述格栅状区域或者格栅体在融合器的内部具有直径为0.5mm至3.5mm的开口或穿孔,尤其设有用于将融合器与置入器械相连的近身(proximal;亦称“接近中央的”或“近侧的”)的连接区域。
如上所述,融合器尤其可以通过(选择性的)电子束熔炼((Selective)ElectronBeamMelting,(S)EBM)或者激光烧结技术(LST)由钛合金,尤其是Ti6Al4V按照ISO5832-3制造。所述构件即融合器通过借助电子束或激光束在高真空中熔化金属粉末制造。由此可以在不失去形状和芯的情况下产生侧凹或咬边。在此,通过电子束或激光束作为能量源,有针对性地熔化金属粉末,由此能够直接由设计数据制造具有几乎任何几何形状的紧凑构件。交替地在前述构件上借助滚轴施加粉末层并且借助电子束曝光。以此方式层状地产生期望的构件。
本发明的其它优点和特征由权利要求并且由以下参照附图对本发明实施例的详细说明得出。在附图中:
在优选的设计方案中规定,近身的端侧具有齿部。也可以设计两个或多个齿部。齿部的另一设计方案可以与置入器械协调适配。由此实现了融合器与置入器械之间的不同角定向和最佳的融合器可定位性。
图1示出两个椎骨的侧视图,在所述两个椎骨之间置入了椎间融合器;
图2示出设置了融合器的椎骨的立体俯视图;
图3以立体图示出按照本发明的融合器的第一实施形式;
图4以纵剖面示出图3的融合器;
图5以立体图示出图3、图4的融合器的框架件;
图6以立体图示出图3、图4的融合器的格栅体;
图7示出剖切按照本发明的融合器的另一实施形式得到的纵剖面;
图8示出图7的按照本发明的融合器的外部框架的立体图;
图9示出图7、图8的按照本发明的融合器的俯视图;
图10示出图7至图9的融合器的格栅体的立体图;
图11示出按照本发明的融合器以及置入器械;并且
图12示出图11的置入器械的远身区域上的融合器的放大视图。
当患者脊椎上的椎间盘损伤时,需要从脊椎1的两个叠置的椎骨3、4之间的椎间腔2中移除椎间盘,取而代之地置入融合器(Cage),以便使椎骨保持适当的距离,这在图1和图2中示出。为此,通常在这个区域内连接脊椎加强件,以使两个椎骨3、4不再相对移动,融合器5置入两个椎骨之间。可以附加地通过杆-螺钉系统、筋膜关节螺钉或穿层螺钉实现绷紧。此外追求的是,融合器5与椎骨长在一起并且因此相应地设计。
融合器5可以沿相对于棘突2.1、3.1不同的方向置入,在所示实施例中作为斜融合器(O-Cage)以相对于棘突约6°的角定向置入。后部融合器(P-Cages)比O-Cages更短并且根据患者具有24mm至30mm的长度。它们从背部在棘突旁边略微倾斜于棘突地引入椎间盘间隙内。
融合器5的高度必须与椎间腔或椎间盘间隙2的原始高度适配,所述原始高度对于每个人可能是不同的。因此,根据患者的体质设置具有不同高度的融合器5。在图6中显示了高度为8mm的融合器,在图7至图8中显示了高度为14mm的融合器。通常以mm的步进值设置融合器。
在附图所示的优选实施形式中,按照本发明的融合器原则上由两个主要组成部分构成,也就是实心的外部框架和内部格栅体7。
格栅体7具有格栅结构,优选是具有薄肋片7.1和处于其间的自由间隙的金刚石格栅结构,其中,肋片7.1的尺寸,尤其是其厚度(沿垂直于肋片延伸方向的方向在结点之间厚度,在所述结点上它们分别与格栅的其它肋片相连)相对于框架6的结构部件的总体尺寸、如框架6的肋片宽度是较小的。尺寸比至少为1比10。相应地适用于格栅体7的杆7.1在两个结点之间的长度和框架6的结构件、如所述肋片的纵向尺寸,所以在此比例也至少为1比10。
即使融合器5由两个主要组成部分即框架6和格栅体7构成,但融合器仍是一体式的。
框架6具有四个纵向肋片6.1,它们将融合器5的远身(distal;亦称“远中的”或“远侧的”)的端部区域6.2与近身的连接区域6.3相连并且通过所述连接区域围成空腔6.4,在制造完成的融合器中,格栅体处于所述空腔内。肋片6.1居中地,也就是大约在其长度的一半处通过横向肋片6.5相互连接,也就是分别相邻的肋片6.1。因此在横向肋片6.5之间保留了通道6.6。在远身的端部区域6.2和近身的连接区域6.3中也具有相应的通道6.2.1和6.3.1。此外,格栅体7也配设有纵向通道7.2,所述纵向通道与前述的通道对齐。
在特别优选的设计方案中,格栅体7和框架6只在垂直于纵向L并且因此横向延伸的(面)区域内相互一体地连接,也就是只通过面7.3、7.4、7.5、7.7相连(参见图6和图10)。
因此,格栅体7的纵向面如7.8和纵向棱边如7.9不与框架6固定相连。此外,上部面的尺寸和平行地在格栅体7的下侧与上部面对置的下部面的尺寸相应于凹处或通过纵向肋片6.1、横向肋片6.5和端侧区域6.2以及近身的连接区域6.3留出的区域。这导致,在通过椎骨体2、3将压力负载作用在纵向肋片6.1上时,所述压力负载不会传递至格栅体7上的纵向侧并且因此所述格栅体7保持不变形,并且在这种情况下也能够发挥其功能,也就是确保骨材料长入格栅体6的蜂窝腔或中间腔内。融合器5的连续的纵向通道使得融合器可以通过横卧的导引线引入椎间间隙内。
在按照本发明的融合器5的图7至图10的设计方案中,所述融合器的近身连接区域6.3(在框架6上)在其近身指向的外端侧6.3.3上具有齿部6.3.4。所述齿部用于在将融合器5固定在置入器械8(参见图12)的远身端部上时通过轴向绷紧在置入器械的锤状锁定元件与置入器械的支座8.3之间来确保在置入器械8与融合器5之间的预设角度定向。所述齿部6.3.4由向下在圆弧上依次相续的齿构成。在融合器的近身通道6.2.1的每一侧上均具有齿部6.3.4。
齿部6.3.4的设计方案(例如数量、距离、形状)可以与置入器械8和/或啮合部分协调适配。由此,一方面实现了与置入器械8的最佳兼容性、在置入器械8的支座8.3与融合器5的近身连接区域6.3之间的提高的连接稳定性,另一方面实现了多个连接角度。
置入按照本发明的融合器5的过程借助置入器械8实现,这在图11和图12中显示。通过外部管8.1形成的锁定元件具有能够围绕其纵轴线旋转的锤状锁定部件(两者均未示出),所述锤状锁定部件例如在融合器6的图3至图5的视图中沿垂直定向引入融合器5的近身连接区域6.3的通道6.3.1内。为此,融合器5在其近身端侧具有咬边或侧凹开口,其开口横截面相应于置入器械8的锁定元件;该咬边或侧凹开口在融合器5上构成锁定元件,由此实现置入器械8和融合器5的锁定。
置入器械的锤状锁定部件在接下来相对于外部管8.1翻转90°,因此其被抓握或啮合在近身连接区域6.3的壁内侧的侧凹6.3.2内。借助置入器械8的近身端部上的夹紧装置,所述锤状锁定部件和在设置于外部管8.1远身侧的支座8.3上的凹形弯折的端棱8.2在中间设有被锁定部件抓握或啮合的、融合器5的近身连接区域6.3的情况下彼此绷紧或张紧。由此将融合器5固定地保持在置入器械上。由此,融合器5能够沿其延伸方向并且以一个部件朝向置入器械8的延伸方向运动。因为融合器5的近身连接区域6.3在其(外部)端侧6.3.3上具有齿部6.3.4,所以由此也确保了置入器械8与融合器5之间所形成的角位置。如尤其是具有圆形形状的按照图4的凹处6.3.2的设计的视图所示,在置入器械8与融合器5之间可以沿垂直于两者纵向延伸L的方向围绕高达30°和更大的显著角度进行翻转。

Claims (20)

1.一种椎间融合器,具有网状或格栅状区域(7)。
2.按权利要求1所述的融合器,其具有由实心的支承件(6.1、6.2、6.3、6.5)构成的外部的框架(6)和内部的格栅体(7)。
3.按权利要求1或2所述的融合器,其特征在于,确定外部轮廓的框架和处于所述框架内部的网状或格栅状区域一体地设计。
4.按前述权利要求中的任一项所述的融合器,其特征在于,所述融合器通过烧结、如借助电子束熔炼或激光烧结制造。
5.按权利要求2至4中的任一项所述的融合器,其特征在于,所述格栅体(7)只在平行地沿一个方向(横向)延伸的面(7.3、7.4、7.5、7.6)上与框架(6)相连,但是所述格栅体在相对于这些面(7.3、7.4、7.5、7.6)以有限的角度延伸的面(7.8)和棱边(7.9)中不与框架(6)相连。
6.按权利要求2至5中的任一项所述的融合器,其特征在于,所述格栅体(7)的上部面和下部面(7.10)具有与由框架部件(6.1、6.2、6.3、6.5)围成的自由空间相同的尺寸,所述自由空间包围格栅体(7)的所述面(7.10)。
7.按权利要求2至6中的任一项所述的融合器,其特征在于,所述框架(6)围成空腔,所述格栅体(7)布置在所述空腔内。
8.按权利要求2至7中的任一项所述的融合器,其特征在于,所述框架(4)具有沿其纵向延伸的纵向肋(6.1)。
9.按权利要求8所述的融合器,其特征在于,相邻的纵向肋(6.1)居中地通过横向肋(6.5)相连。
10.按前述权利要求中的任一项所述的融合器,其特征在于,所述格栅状区域或者格栅体(6)具有金刚石结构。
11.按前述权利要求中的任一项所述的融合器,其特征在于,所述融合器具有贯通的通道(7.2、6.6)。
12.按前述权利要求中的任一项所述的融合器,其特征在于,所述格栅状区域或格栅体(7)的每个开口的格栅开口直径为0.5mm至3.2mm,优选在融合器外侧上的每个开口的开口直径的数量级为0.5mm至0.7mm。
13.按前述权利要求中的任一项所述的融合器,其特征在于,所述格栅状区域或者格栅体(7)在融合器的内部具有直径为0.5mm至3.2mm的开口或穿孔。
14.按前述权利要求中的任一项所述的融合器,其特征在于,设有用于将融合器与置入器械(8)相连的近身的连接区域(6.3)。
15.按权利要求14所述的融合器,其特征在于,所述连接区域(6.3)在融合器(5)的侧壁的内侧上具有凹处(6.3.2),所述凹处实现了与置入器械(8)的角度可活动或角度可调的咬边连接。
16.按前述权利要求中的任一项所述的融合器,其特征在于,连接区域(6.3)在融合器(5)的上侧具有实现融合器(5)与置入器械(8)之间的角度可活动性或角度可调性的局部。
17.按前述权利要求中的任一项所述的融合器,其特征在于,近身的端侧(6.3.3)具有齿部(6.3.4)。
18.按权利要求17所述的融合器,其特征在于,所述齿部(6.3.4)通过沿垂直方向在圆弧段上依次排列的多个齿而空心地构成。
19.按权利要求17或18所述的融合器,其特征在于,所述齿部(6.3.4)布置在居中地设计于近身端侧上的近身通道(6.3.1)的两侧。
20.一种用于制造尤其按前述权利要求中的任一项所述的椎间的融合器的方法,所述方法借助(选择性的)电子束熔炼(SelectiveElectronBeamMelting,(S)EBM)或者借助激光烧结(LST)进行。
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