CN100566670C - 柔性空间支撑器 - Google Patents

柔性空间支撑器 Download PDF

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CN100566670C
CN100566670C CN200510068004.4A CN200510068004A CN100566670C CN 100566670 C CN100566670 C CN 100566670C CN 200510068004 A CN200510068004 A CN 200510068004A CN 100566670 C CN100566670 C CN 100566670C
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tubular body
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CN1695567A (zh
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卢茨·比德曼
于尔根·哈姆斯
维尔弗里德·马蒂斯
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Biedermann Motech GmbH and Co KG
Biedermann Technologies GmbH and Co KG
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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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    • A61F2/4465—Joints 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 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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    • 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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    • A61F2/00—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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    • A—HUMAN NECESSITIES
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    • 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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Abstract

本发明涉及一种用于临时性或永久性地植入人体或动物体内的柔性空间支撑器，该支撑器由至少一种生物适合的刚性材料制成并具有一个管状的主体部分(1)，通过设置材料凹槽在主体部分中形成一个或多个柔性区域。

Description

柔性空间支撑器
技术领域
本发明涉及一种柔性(flexible)空间支撑器。
背景技术
在现代医学中，人体或动物体内的很多疾病可以通过使用植入器来治疗或使其影响最小。例如，已知用于椎骨或椎骨间片的空间支撑器可用于代替一个椎骨主体或一个椎骨间片。
对于空间支撑器来说，使用与人体或动物机体组织相容的材料制造该支撑器是很重要的，相容也就是说不会引起排异反应或导致由蜕变现象(disintegration phenomena)引发的机体负担。因此，植入器材料的选择有很多限制。
另外，最好能以尽可能简单的、特别是用少量部件的方式构造空间支撑器，因为部件的组合需要会增加操作员插入植入器的成本，在另一方面，在多个部件互相连接的位置更有可能产生错误和故障。因此，特别优选整体地形成植入器。
与此相反，而空间支撑器必须实现多种功能，这使得使用不同的材料和/或用多个部件形成空间支撑器显得更合适。例如，空间支撑器最好不仅能实现填补空间和支撑椎骨使其彼此间隔一定距离的功能，还能辅助椎骨向彼此靠近的移动，也就是在某个很窄的范围内实现关节功能。为此，可以例如提供如DE 10056977 C2中的空间支撑器，其中在邻近椎骨主体的支撑件之间放置一个风箱形状的管道，该管道可以在植入器的纵向方向延伸，同时该管道是由紧密地编织或密接纺织品材料制成的。然而，这具有上述缺点，即一些不得不使用的不同材料必须互相连接，这样会增加产生错误的机率。
发明内容
因此，本发明的目的是提供用最简单的部件、特别是易于连接的一个或几个部件制成的空间支撑器，其中除了其它的功能以外，可以确保植入器或其周围具有一定的柔性和可移动性。另外，这些植入器是可以很容易地被制造和植入的，同时在操作中是安全的，且具有较长的使用寿命和多样的应用可能性。
此目的由本发明的用于椎骨和/或椎骨间片且具有空间支撑器和重量转移功能的空间支撑器所实现，该支撑器用于临时性或永久性地植入人体或动物体内并由至少一种生物适合的刚性材料制成，该支撑器具有一个管状主体并在管状主体的端部具有用于与邻近躯体组织连接的装置，在管状主体中设置有用于在其所设位置减小刚性的材料凹槽(material recesses)。其他有益实施例是由从属权利要求体现的。
对于空间支撑器，现有技术是这样的，可移动性或弹性是通过附加的部件和/或不同种类的材料获得的。本发明采用另一种方法，其中柔性或可移动性不是由另一种材料或由提供附加的分离部件形成的，而是在整个植入器或植入器部件的情况下，需要获得柔性或可移动性的区域是通过在多个材料凹槽的设计中进行改进而实现的。
根据本发明，该空间支撑器具有带有一个中央管式主体部分及设置在各个端部的连接件的管状主体，材料凹槽用于在中央管式主体部分中提供柔性。
空间支撑器的连接件优选地具有连接空间支撑器和邻近躯体部分例如椎骨的相应装置，该装置以位于端部的钩状突出和/或套筒表面上的凹槽、狭缝(grooves)和孔(openings)的形式被设置，以便空间支撑器可以伸入并结合组织。然而为此，连接件的空腔或凹槽一定不能与用于在管状主体部分获得空间支撑器的柔性和可移动性的材料凹槽混淆。由于连接件与邻近的躯体部分例如椎骨是完全连接的，因此该连接件对椎骨的柔性或可移动性不起作用。
这样，通过避免附加的弹性材料和相应的连接部件或附加的分离部件，可以在空间支撑器或其部件中简便地获得柔性和可移动性。为此，除了空间支撑器的必须功能以外，还可以提供弹性或可移动性功能，或者将弹性或可移动性功能作为必须功能的一种。特别地，这样就能以简单且可靠的方式实现、特别是在一个整体的空间支撑器中实现压缩、转动和/或扩展地带。
相应地，可以为优选整体形成的空间支撑器使用稳定的、坚硬的材料，特别是为所期望的使用条件，提供一种刚性的，最好是柔性刚性(flexible rigid)的材料，例如钛、钛合金、塑性材料和类似材料。通常，所有生物适合的材料都是不会引起排异反应或显示出作为身体负担的任何蜕变现象的候选者中的一员。
可以优选地以狭缝状凹槽或开孔的形式在管状主体部分的壁部设置该材料凹槽。可以根据负载需要的变化来调整该材料凹槽的形状、数量和设置。
作为可以满足多种需要的通用形状，可以特别地以围绕管状主体的螺旋形状设置该材料凹槽，以便特别地出现一种螺旋弹簧的形状，在本例中，通过材料凹槽在螺旋弹簧件的相邻条带之间呈现自由空间是一个显著的优点。除了更简单的制造和相应更广泛的材料选择以外，这具有可获得更大柔性的优点。
特别有利地，可以提供两种材料凹槽，该凹槽被形成为双轨(twin-track)或双飞(twin-flight)螺旋。这样，设置在彼此内部的两个螺旋弹簧可以被特殊地形成。如果螺旋状凹槽的区域具有相同的高度，则可以用双螺距(double pitch)的两个螺旋状凹槽代替一个低螺距(lowpitch)的螺旋状凹槽。
用于连接管状主体与邻近的躯体部分的装置既可以被整体地设置在管状主体特别是该主体的延伸的端部上，还可以被可分离地设置在端部上，例如在可以被旋入管状主体端部的端板上。
当用材料凹槽围绕管状主体时，优选地提供这样的可分离端板或与管状主体整体连接的端板，为了获得弹性或可移动性，设置至少一个弹性材料的套筒或在管状主体中提供至少一个弹性芯。一种优选的弹性体制造的弹性芯或弹性套筒具有以下优点，该弹性芯或弹性套筒允许管状主体或空间支撑器的弹性或刚性被精确地调节。考虑到阻尼(damp i ng)作用，通过带有相应凹槽及芯和/或套筒的模块状设置，使用不同刚性的不同组件可以以简单的方式实现精确定义的植入器的刚性。这样，带有用于获得柔性的材料凹槽的一个空间支撑器部件与一个包含用于调整所定义的刚性的柔性材料的空间支撑器的组合是本发明的一个非常核心的目的。
为了获得一种改变的刚性，只有组件的组成必须被改变，也就是例如不同刚性的一种不同的芯或一种不同的套筒需要与柔性管状主体一起使用。尽管，可以想象一个套筒及一个芯可以同时与柔性的管状主体一起使用，出于简化的目的，通常只出现管状主体与芯或管状主体与套筒的组合。为此，套筒还具有用优选的螺旋状凹槽保护管状主体不受外部影响的优点，然而，与此相反，当使用一个芯时，该芯被管状主体保护。
芯与套筒都是优选地由设置在管状主体端部上的端板所支撑的，在设置有套筒的情况下，端板优选地探出管状主体，并从而具有比管状主体略大的直径。该端板可以至少部分地，即在一端与管状主体整体连接，以便在此处获得一个烧杯状形状。另外，该端板可以被可分离地从一端或两端连接到管状主体上，例如，通过一个螺钉(screw)或螺纹连接。因此，可以在端板和管状主体上提供外螺纹。
优选地，带有用以获得柔性和可移动性的材料凹槽的空间支撑器或管状主体可以沿空间支撑器的纵向轴在纵向方向延伸或压缩0.5％到20％，特别是1％到15％，同时可以绕与空间支撑器的纵向轴垂直的径向轴弯曲，以便邻近的躯体部分可以相对纵向轴枢转大约0.5到10度，特别地1到6度。另外，在优选实施例中，可以实现绕纵向轴的0.5到2.5度的转动。
附图说明
根据下面结合附图对两个优选实施例的详细描述，本发明的优点、特点和特征将变得更加明显。附图以纯粹示意的形式显示。
图1是用于椎骨或椎骨间盘片的一种空间支撑器的立体图；
图2是图1的空间支撑器的侧视图；
图3是图1和2的空间支撑器的详细侧视图；
图4a)-c)是另一种空间支撑器的各个视图；及
图5a)-c)是第三空间支撑器的各个视图。
具体实施方式
图1是一种根据本发明第一实施例的植入器的立体图，该植入器表现为用于椎骨或椎骨间盘片的空间支撑器的形式。空间支撑器10具有一个管状主体1和两个设置在管状主体1的端部、用于将空间支撑器10连接到邻近的躯体部分例如人体内的骨骼或软骨的连接件2。
被设置在管状主体1的端部的连接件2在所示实施例中具有相同的形状，但是也可以具有不同的形状。连接件2在其端部的每个自由端上具有锯齿状突起3，该锯齿状突起可以在植入位置与邻近躯体组织结合。
锯齿状突起3由空间支撑器10的两端上的三角形凹槽5形成，以便形成可以结合并抱紧邻近的躯体组织的梯形锯齿状突起3。
另外，连接件2具有钻石状的空腔4(参见图2)，而且这些空腔是沿着连接件的整个圆柱形外套筒表面相互邻接的。因此，大量钻石状的互相连接的条带6又为其本身形成每个连接件，其中由条带6形成的钻石状的尖端被切掉从而形成梯形锯齿状突起3。
在所示实施例中，位于柱体的每个端部上的连接件2之间的管状主体1有一个螺旋状的材料凹槽7，以便壁部11(见图3)本身呈现出螺旋状。由于空间支撑器10是另外作为一个中空圆柱整体形成的，在连接件2与材料凹槽7之间的管状主体1呈现一个弹性区域或一个移动区域，甚至当空间支撑器10本身是由非常坚硬的材料例如钛或钛合金形成的。通过材料凹槽7，空间支撑器10在管状主体1的区域内获得与设计相关的弹性，该弹性使得可以在该区域填充单独的弹性材料以获得单独的弹性或可移动性。特别地，这样避免了不得不使用必须安装在一起的多个部件来制造空间支撑器。
通过螺旋形状，材料凹槽7以一种简便的方式获得了沿空间支撑器10的纵向轴9的可延伸性和可压缩性，以及绕与纵向轴9垂直的转向轴的可弯曲性，该转向轴例如是由轴线8所示(图2)。在此，材料凹槽7的螺旋形状特别有用，该形状促进了在更多方向的平衡的弹性和可移动性。然而，自然地，当适用于单独情况或载荷分布(load profile)的解决方案可行时，其它形状的材料凹槽及这些材料凹槽的不同数量及设置是可以实现且可以设想的。
在图4a)-c)中示出了带有管状主体101的第二实施例的空间支撑器100的三个不同的立体分解图，其中图4(b)是一个剖视图，该管状主体101在下端被与管状主体101整体连接的端板125闭合，以便产生烧杯状的形状。
管状主体101在其壁部111中具有螺旋状的凹槽107，该凹槽根据本发明为管状主体101提供一定的柔性。
为了精确地调整空间支撑器100的刚性，在管状主体101内部设置由弹性材料制成的可替换的芯元件130，该元件的下端由端板125支撑，其上端由管状主体101中的端板126支撑。
在空间支撑器上端的端板126具有一个外螺纹127，通过该螺纹端板126可以被旋入在管状主体101内部的管状主体101的内螺纹128中。端板126具有一个肩部，借助该肩部端板126可以紧密地靠在壁部111上。锯齿状突起103是全部沿着壁部111的端部设置的，并伸出越过端板125和端板126且可以与邻近的组织结合，以便将该空间支撑器稳固地支撑于该处适当位置中。
端板126具有连接孔129，通过该连接孔，端板126可以被旋入管状主体101中。端板125和端板126可以另外被粗糙化或由生物活性材料涂敷，以便有助于与邻近的躯体组织结合。
图5a)到c)中示出了空间支撑器的第三实施例，其中图a)到c)示出分解立体图，同时子图b)示出一个立体剖视图。在图5的实施例中，管状主体201还在主体壁部211中具有螺旋状的凹槽207。
在下端，管状主体201还被一个整体设置的端板225闭合，以便这里仍出现管状主体201的烧杯状形状。不可否认地，端板225形成为具有比管状主体201稍大的直径，螺旋状的材料凹槽207被设置在管状主体中。这样，形成了一个肩部，该肩部为由弹性材料制成的管状套筒230形成了接纳处。弹性套筒230被推过管状主体201以便该主体是完全被套筒包围的。在上端，一个端板226通过螺纹连接旋入管状主体201。在此，端板226的外螺纹227与管状主体201的内螺纹228连接，以便套筒230被牢固地支撑在端板225与端板226之间。套筒230还用于调节整体刚性，其中用与可替换芯130类似的方式(参见图4)简单更换套筒230就可以简便地控制整个植入器100和植入器200的刚性。
在端板226和端板225上设有金字塔形状的锯齿状突起203，该锯齿状突起用以与邻近组织连接以便稳固地支撑空间支撑器。
盖226也具有连接孔229，借助该孔端板226可以被旋到管状主体201上。

Claims (16)

1.一种用于椎骨和/或椎骨间片且具有空间支撑器和重量转移功能的空间支撑器，该支撑器用于临时性或永久性地植入人体或动物体内并由至少一种生物适合的刚性材料制成，该支撑器具有一个管状主体(1)并在管状主体的端部具有用于与邻近躯体组织连接的装置(2)，在管状主体中设置用于在其所设位置减小刚性的材料凹槽，其特征在于，
管状主体被由弹性的生物适合的材料制成的套筒围绕或/和设有由弹性的生物适合的材料制成的芯，所述生物适合的材料与带有材料凹槽的支撑器部件一起作用以获得一种柔性，以便可以设置整个支撑器的一种确定的刚性或可移动性，同时以便空间支撑器在轴向是可压缩且可伸展的，该支撑器参照设置在端部的连接装置(2)是绕与纵向轴垂直的径向轴可弯曲的同时是绕轴向旋转轴可转动的。
2.如权利要求1所述的空间支撑器，其特征在于，管状主体(1)与用于与邻近躯体组织连接的装置(2)是由一种材料整体形成的。
3.如前述权利要求之一所述的空间支撑器，其特征在于，用于管状主体(1)的生物适合的材料，在期望的使用条件下，是挠性刚性材料。
4.如权利要求1所述的空间支撑器，其特征在于，该生物适合的材料是钛、钛合金或塑性材料。
5.如权利要求1所述的空间支撑器，其特征在于，材料凹槽(7)被形成为壁部的一个狭缝状凹槽和/或开孔，且以螺旋的形状形成。
6.如权利要求1所述的支撑器，其特征在于，具有两种材料凹槽，所述凹槽形成为双轨螺旋或双飞螺旋，从而形成在彼此内部的两个螺旋弹簧。
7.如权利要求1所述的空间支撑器，其特征在于，用于将管状主体部分(1)连接到邻近躯体部分的装置(2)包含突起，特别包含在管状主体部分的轴向延伸的锯齿状突起(3)，该锯齿状突起具有一个三角形或梯形的形状，用于与邻近的躯体部分结合。
8.如权利要求7所述的空间支撑器，其特征在于，所述邻近的躯体部分为骨骼或软骨。
9.如权利要求1所述的空间支撑器，其特征在于，用于将管状主体部分(1)连接到邻近躯体部分的装置(2)形成为管状主体部分的延伸部分，该装置与管状主体部分(1)整体形成，其中设有用于伸入组织的位于套筒表面上的凹槽(4)、狭缝和孔。
10.如权利要求1所述的空间支撑器，其特征在于，用于将管状主体部分(1)连接到邻近躯体部分的装置(2)设置在一个端板上，该端板可分离地设置在管状主体部分(1)的端部。
11.如权利要求1所述的空间支撑器，其特征在于，所述弹性材料是弹性体。
12.如权利要求11所述的空间支撑器，其特征在于，该套筒和/或芯通过一个螺钉或螺纹连接由整体地或可分离地设置在管状主体上的端板支撑。
13.如权利要求1所述的空间支撑器，其特征在于，该空间支撑器在其纵向是弹性可延伸的，可压缩0.5％到20％。
14.如权利要求13所述的空间支撑器，其特征在于，该空间支撑器在其纵向可压缩1％到15％。
15.如权利要求1所述的空间支撑器，其特征在于，空间支撑器是绕与纵向轴垂直的径向轴弹性可弯曲的，以便设置在端部的用于连接到邻近躯体部分的装置(2)可以从管状主体的纵向轴(12)枢转0.5到10度，或者空间支撑器可以绕一个转轴转动，这样用于连接到邻近躯体部分的装置(2)可以转动0.5到5度。
16.如权利要求15所述的空间支撑器，其特征在于，空间支撑器是绕与轴向旋转轴垂直的径向轴弹性可弯曲的，以便设置在端部的用于连接到邻近躯体部分的装置(2)可以从管状主体的纵向轴(12)枢转1到6度，或者空间支撑器可以绕一个转轴转动，这样用于连接到邻近躯体部分的装置(2)可以转动1到3度。
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US8771357B2 (en) 2014-07-08

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