CN1681445A - 用于连接到骨头上的支撑元件 - Google Patents

用于连接到骨头上的支撑元件 Download PDF

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CN1681445A
CN1681445A CNA038212838A CN03821283A CN1681445A CN 1681445 A CN1681445 A CN 1681445A CN A038212838 A CNA038212838 A CN A038212838A CN 03821283 A CN03821283 A CN 03821283A CN 1681445 A CN1681445 A CN 1681445A
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bone
support component
strip
granule
spongy
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CN100464718C (zh
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艾伦·戈登·麦克劳德
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Fondel Finance BV
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Abstract

本发明涉及一种用于连接到骨头上的支撑元件，其包括用于安置连接装置例如螺钉或料带的装置，以及用于抵靠着所述骨头安置的表面，其中所述表面至少在使用中设有海绵状生物相容性材料，所述海绵状生物相容性材料被包围在所述骨头和所述表面之间。

Description

用于连接到骨头上的支撑元件
技术领域
本发明涉及一种用于连接到骨头上的支撑元件。
背景技术
已知有通过螺纹连接在骨头上或骨头内的元件，如用于桥接骨折部的板。这些板通常由生物相容性材料例如钛制成，并且用固定螺钉固定到所述骨头上。所述板不可能既被坚固地拧紧到所述骨头上而又不损害下面骨头的生长。将板坚固地拧紧到所述骨头上将切断或至少限制所述板下面的骨头内的血管。溶骨可能发生。这意味着，由于所述板的固定部相对疏松，因此板/骨组合结构的机械性能不是最佳。此外，这些元件的使用将受到限制。例如，不得不限制或者甚至避免可导致和促进骨生长的受控振动，并且机械负载例如用于微运动控制的负载不得不被减至最小。
发明内容
本发明是针对一种支撑元件，其能够提供对骨头的更好连接和更好的机械性能。以前的发明曾试图使用在下侧上的凹纹样式来避免前述问题。
本发明的目的是提供一种用于连接到骨头上的支撑元件，该元件可以被相对坚固地连接，而不切断或限制血管、神经等。
本发明的另一个目的是提供一种支撑元件，其可以连接到骨头上，在使用中可引起和/或促进骨生长。
本发明进一步的目的是提供一种支撑元件，在所述元件连接到骨头上之后几乎可以直接机械加载。
本发明进一步的目的是提供一种用于将支撑元件固定到骨头上的方法。
本发明的这些和进一步的目的可以通过具有权利要求1中的特征的支撑元件实现。
通过在所述元件的一个表面上设置一种生物相容性海绵状材料，元件可以被相对坚固地连接，该元件放置在其所连接的骨头上，而所述海绵状材料提供了骨头可能生长的空间。此外，海绵状材料可防止切断或限制所述元件下面的血管。由此，至少可基本上防止溶骨。
由于依据本发明的元件可被相对坚固地连接到骨头上，所以其可被机械加载，甚至是在固定后直接进行。例如，该元件可被振动便于导致和促进骨生长，或者一种已知的机械装置可连接到所述元件上便于引起或控制所述元件的微运动。
优选地，所述海绵状材料至少部分地设置为具有内部孔隙的颗粒。这些颗粒优选利用四氯化钛反应产生的材料制成，该材料被压碎以维持内部微孔隙。所述颗粒可易于设置到所述元件的表面上，并提供理想的压力分布，而它们同时提供骨头可长入和/或长出的空间。如需要，颗粒可与例如骨粉或其它骨头生产诱发和/或促进物质例如化学剂、血液等混合。
元件上的已经设有或将要设有所述生物相容性海绵状材料的至少一个表面可具有至少一个凹空部，例如通过设置一个直立周围的壁来形成凹空部。当元件被螺纹固定时，该直立壁至少基本上接合所述骨头，使至少一部分所述表面与所述骨头保持一段距离，所述海绵状材料设置在它们中间。这导致易于包围所述材料。所述表面至少在一个方向上可被弯曲，用于更好地装配到骨头上，例如所谓的长骨上。但是，显然，任何形状、尺寸或型式适于使用。
本发明还涉及一种料带，其至少在一侧设有海绵状生物相容性材料，例如钛基材料。当所述钛基材料是由四氯化钛反应而制成的时，料带具有相对柔性，这种料带特别适于采用。这种本身同样具有创造性的料带特别适用于与例如依据本发明的螺纹固定型元件组合使用。在所述元件被安置之前，一条料带可被设置在所述元件上和/或所述元件的表面上。接下来，可依靠例如患者和元件的类型选择料带的数量和可能需要选择的种类。接着，料带表面上的材料数量和类型以及例如分布可以改变。料带也可被单独使用，其与所述元件分开，例如用于缠绕骨头；或者能被卷绕起来以用作填充物。
本发明还涉及一种由支撑元件例如螺纹固定型元件与具有内部孔隙的海绵状生物相容性材料颗粒构成的组件，其中设有用于将颗粒材料包围在所述元件和骨头之间的装置(物质)。为此，颗粒材料可设有或混合有粘结性物质，例如血液、生物相容性粘结剂等，或者可以设置在所述料带或相似物质上。或者，可以使用机械装置，其优选相对于对骨生长剂、血液等而言具有(半)渗透性。
在一个优选的实施例中，依据本发明的组件的特征在于，依据本发明的料带设置在支撑元件的至少一个表面上或者至少连接到其上，用于至少提供所述元件向骨头的局部连接。
这种组件的优点在于，如果所述料带和/或所述颗粒在两侧设有粘结性物质，则可以利用所述料带将元件至少暂时连接到骨头上。这样，在需要时，可容易地安置所述支撑元件和螺纹固定所述元件。也可通过在元件和骨头周围缠绕所述料带而将该元件(板)连接到所述骨头上。显然，元件(板)自身也可设有粘结装置(物质)。
依据权利要求15，本发明还涉及生物相容性颗粒的应用，并且依据权利要求16，本发明还涉及用于连接到骨头上的元件的制备。
本发明还涉及一种用于将元件连接到骨头上的方法，其由权利要求17中的特征来限定。
在依据权利要求17的方法中，一个元件易于连接到骨头上，例如，特别是在其相对光滑、平坦或弯曲的外表面上，可防止切断或限制所述骨头内的血管、神经等。颗粒还具有可促进骨生长，或至少防止溶骨的优点。
在其它权利要求中描述了本发明其它有益实施例，它们被引用于此。
附图说明
为更好地理解以示例的方式给出的本发明，下面将参照附图来显示和描述依据本发明的支撑元件、组件、料带、应用、制备和方法的实施例。
图1是依据本发明的支撑元件在不带颗粒的情况下从前侧看的示意性透视图。
图2是依据图1的元件从后侧看的视图；
图3是图1和图2的元件局部充填了颗粒后从前侧看的视图；
图4和图4A是依据本发明的元件螺纹连接到骨头上的剖视图；
图5是在第一个替代性实施例中依据本发明的元件拧紧到断裂骨头上的视图；
图6是依据本发明的一卷料带的侧视图；
图7是图6的料带的局部截取的正视图；
图8是依据图6和7的料带被部分扭弯的透视图；和
图9示出了依据本发明的支撑元件通过系紧装置设置在骨头上。
具体实施方式
在本申请中，相同或者相应的部分具有相同或者相应的附图标记。这些实施例仅通过示例的方式示出，并且不应理解成以任何方式限制本发明。在本说明书中，名词“颗粒”被用于表示生物相容性材料例如金属的相对较小的粒料，优选为至少具有微孔隙的海绵状，这些颗粒可以由大粒料断裂或者研磨而成，并且它们优选的是由四氯化钛反应而成。这些颗粒优选以维持它们内部的微孔隙的方式压碎。不同尺寸和不同材料的颗粒可以被单独或者组合使用。
图1-3示出了第一个优选实施例中的支撑元件，该支撑元件可以被称为螺纹固定型的板1。板1由生物相容性材料(例如，但不限于，钛、钛合金)或者生物相容性或生物降解性塑料制成。板1具有弯曲的结构，以致其在纵向L上基本是直的，并且其在横向W上被弯曲，基本上形成一个环段。板1在其凸出的外侧2上基本光滑，并且设有延伸穿过该板的两个通孔3。在相反的底侧4上，一个直壁5围绕着所述板的外边缘延伸并包围一个内凹的下表面6，在使用中该底侧4面对着将板1拧紧到其上的骨头。通孔3在板1的底侧4上也被壁7围绕。由此，板1形成有至少一个凹空部或凹槽8，它们由下表面6、壁5的内边9及壁7构成。
正如可从图3看到，所述凹槽或凹空部8可以用一种生物相容性颗粒材料完全或部分充填，这种生物相容性颗粒材料以下指的是前面描述过的颗粒10。颗粒10通过使用例如粘结性物质11例如血液、生物相容性粘结剂、明胶等安置在所述凹空部或凹槽8内，以使颗粒10至少暂时彼此粘接和/或粘附到板1上，特别是粘附到所述下表面6上。显然，颗粒10也可以不同方式设置，例如通过将颗粒装入袋、网等中，以便颗粒可被设置在所述板至少一个表面的至少一部分上，特别是在下表面6上。特别地讲，在这样的实施例中，下表面6也可以完全或基本平坦而不带有直立壁5。
在图4中的沿着图3中线IV-IV所作剖视图中，显示了依靠延伸穿过所述通孔3并且拧入到骨头12内的螺钉13而螺纹固定在骨头12上的元件1。颗粒12因此被包围在骨头12的外表面14和元件1的内表面6之间。由于元件1通过螺钉13被拧紧并且主要通过颗粒10支撑在表面14上，所以螺钉13可被相对坚固地拧紧，以挤压在所述两个表面6、14之间的颗粒10，而没有切断骨头12内的神经、血管等的风险。
在图4A中，以与图4相同的剖视图示出元件的一个替代性实施例，其中颗粒依靠一个粘附材料层15例如双面粘结性料带或生物相容性胶层15粘附在元件1上，特别所述内表面6上。显然，该层15可以由任何具有粘附性能的材料制成，包括胶质状材料。在本实施例中，元件1同样是利用螺钉13拧紧到骨头12上。
在图5中，依据本发明又一个替代性实施例的元件1利用螺钉13被螺纹固定在骨头12上，将颗粒10包围在内表面6和骨头12的外表面14之间。在本实施例中，元件1延伸跨越骨头12内的一个开裂面16，并且在外表面2上设置一个连接元件17，例如一个钮状元件。作为示例，钮状元件上可以连接一个连接装置，这样就可以与外部线束、振动装置等相连，以便向所述元件1进行机械加载，从而例如引起或控制所述元件1的微运动。这些装置在现有技术中是已知的。
图6-8示出了依据本发明的料带18，其如上所述在至少一个外表面19上设有颗粒材料10。这种颗粒材料10可被设置在所述外表面19上，完全充填所述外表面，如图8中所示，其中颗粒10具有基本相似的尺寸并且密实地设置在所述表面上。颗粒10也可以特定的样式设置在所述表面上，如图7中所示，其中两个颗粒相对密集的区域20沿着所述料带18的外边缘21设置，而一个颗粒不密集的区域22沿所述外表面19的中间设置。所述区域20、22可以被不带有任何颗粒的区域23分开。图7仅示出这种样式的一个例子。任何分布所述颗粒的样式都是明显可能的。可以在所述外表面19上设置一种粘结剂，将颗粒粘附在其上来制成这种料带。颗粒本身也可设有一种粘结性材料，例如血液、明胶、生物相容性胶等。在这样的实施例中，料带18可以依靠所述粘结性物质粘附在任何表面上，例如骨头或依据本发明的元件1的表面上。
依据图6-8的料带18可以作为一个层与图4A中示出的层15和颗粒10的组合使用，并被包围在依据本发明的元件1和骨头12之间。但是，所述料带18可以被折叠、揉捏、扭弯等，以适合用作骨头填充物等。在一个替代性实施例中，料带18可缠绕在元件1的外表面2和骨头12的周围，其中料带18可以粘附到所述元件1、所述骨头12和/或其自身上。
在图9中，示出依据本发明的组件的另一实施例，其中，带有颗粒10的元件1(例如图3所示)依靠系紧装置25例如生物相容性塑料系条、弹性带等连接到骨头12的外表面14上。料带18也可用作系紧装置25。
通过使用依据本发明的组件，例如由支撑元件1、料带18和/或连接装置如螺钉、所述料带和/或系条等构成的组件，依据本发明的支撑元件1可被设置在骨头(例如骨端等人体骨骼部分)的表面14上，从而可以相对坚固地固定在所述骨头上，防止血液循环、神经等的切断，并且预防溶骨。这种支撑元件在连接到所述骨头上之后几乎可立即加载外力。颗粒10将允许并且甚至可能促进骨生长到所述颗粒内，以便获得一个更好的连接。颗粒10可与例如骨头材料，特别是患者的骨头材料混合，其可以导致骨头长入和长出所述颗粒材料，从而进一步增强了元件1的连接。
本发明在任何意义上均不局限于所描述的和附图中示出的实施例。在由权利要求或说明书中限定的发明范围内，有关本发明的许多改进和实施方式都是可行的。
例如，依据本发明的料带18可以被例如设置成双面带有颗粒材料，它们可以是相似的材料或完全不同的材料。依据本发明的支撑元件1可以具有任何形状、尺寸或构造，可以适用于特定的骨头结构，如长骨、短骨、骨盆、肩骨等。依据本发明的料带18特别适合于和依据本发明的元件1一起使用，但是也可以单独的使用。颗粒可以至少部分地被替换为其它以相似方式分布连接力的生物相容性材料，例如具有糙化表面的垫子等。其它连接装置可用于替代螺钉13，如螺母和延伸穿过所述骨头的螺栓、钉子等。

Claims (17)

1、一种用于连接到骨头上的支撑元件，其包括用于安置连接装置例如螺钉或料带的装置，以及用于抵靠着所述骨头安置的表面，其中所述表面至少在使用中设有海绵状生物相容性材料，所述海绵状生物相容性材料被包围在所述骨头和所述表面之间。
2、如权利要求1所述的支撑元件，其特征在于，所述海绵状材料以具有内部孔隙的颗粒的形式提供的，并且所述颗粒之间至少具有在使用时供骨头长入和/或长出的微空间。
3、如权利要求1或2所述的支撑元件，其特征在于，所述海绵状材料包括钛，特别是由四氯化钛反应而制成的钛。
4、如前面任一权利要求所述的支撑元件，其特征在于，所述表面设有至少一个凹空部，所述材料设置在所述凹空部中。
5、如前面任一权利要求所述的支撑元件，其特征在于，所述材料粘附到所述至少一个表面上。
6、如前面任一权利要求所述的支撑元件，其特征在于，所述支撑元件是或者具有至少一个局部平板形元件，所述局部平板形元件包括设有所述海绵状材料的所述至少一个表面。
7、如前面任一权利要求所述的支撑元件，其特征在于，所述表面在至少一个方向上弯曲。
8、如前面任一权利要求所述的支撑元件，其特征在于，骨生长促进物、特别是骨生长诱发或促进化学剂设置在所述海绵状材料之上和/或之内和/或所述表面上。
9、由支撑元件和具有内部孔隙的海绵状生物相容性材料颗粒构成的组件，所述支撑元件的一个表面可被连接、特别是螺纹固定在骨头上，所述组件设有用于将所述颗粒安置在所述骨头和所述表面之间的装置。
10、如权利要求9所述的组件，其特征在于，所述颗粒由钛制成，特别是通过四氯化钛反应形成。
11、一种料带，其在至少一侧包括海绵状生物相容性材料，例如钛基材料，特别是由四氯化钛反应形成的材料，所述料带具有相对柔性。
12、如权利要求11所述的料带，其特征在于，该料带至少局部是粘结性的，以使料带可被粘着到一个要被固定到骨头上的元件和/或骨头和/或自身上。
13、如权利要求11或12所述的料带，其特征在于，其柔性使之足以被折叠或弯曲成任何可被用作填充物的形状。
14、如权利要求1-10中任一所述的支撑元件，其特征在于，如权利要求11-13中任一所述的料带被设置在支撑元件的表面上。
15、具有内部孔隙结构的生物相容性颗粒在将一个元件螺纹连接或粘接到骨头上的操作中的应用。
16、一种用于连接、特别是螺纹固定在骨头上的元件的制备，其中，具有内部孔隙结构的生物相容性材料被安置在一个将要面对所述骨头设置的表面上，以使这些颗粒被包围在所述表面和所述骨头之间。
17、一种用于将一个元件连接、特别是螺纹连接在骨头上的方法，其中具有内部孔隙结构的生物相容性材料被安置在所述元件的一个表面和所述骨头之间，其中所述元件被坚固地连接在所述骨头上，并且促进所述骨头长入所述颗粒之中和之间。
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CN100464718C (zh) 2009-03-04
AU2003247235B2 (en) 2008-12-11
JP2006502761A (ja) 2006-01-26
HK1082396A1 (en) 2006-06-09
EP2258291A2 (en) 2010-12-08
NL1021137C2 (nl) 2004-01-27
WO2004021905A1 (en) 2004-03-18
JP4588450B2 (ja) 2010-12-01
US20050177162A1 (en) 2005-08-11
EP1553884A1 (en) 2005-07-20

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