CN104780953B - 由适于结合作为混合或复合材料的至少两种不同的可吸收和可生物可降解材料制成的骨植入物 - Google Patents
由适于结合作为混合或复合材料的至少两种不同的可吸收和可生物可降解材料制成的骨植入物 Download PDFInfo
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Abstract
本发明涉及一种骨植入物,包括由金属合金制成的支撑结构(1)并且包括可生物降解和可吸收的保护性结构(7),保护性结构(7)设置于支撑结构(1)处和/或在支撑结构(1)上,以便保护所述支撑结构(1)在锚定于个体如哺乳动物的骨中的位置免于接触任何侵蚀性体液,其中,支撑结构(1)由保护性结构(7)包围并且散置有保护性结构(7)。
Description
技术领域
本发明涉及一种骨植入物,其包括由可生物降解的金属或可生物降解的金属合金制成的支撑结构(支持结构,support structure)并且包括可生物降解和可吸收的保护性结构,该保护性结构设置于支撑结构处和/或在支撑结构上,以便保护支撑结构在锚定于个体的骨中的位置免于接触侵蚀性体液。
背景技术
可吸收生物降解材料如,PDLLA、PGA或PCL是由现有技术已知的。然而,这些材料确实具有比标准金属材料,如钛或植入物钢更低的机械强度性能。
可生物降解的陶瓷植入物材料令人遗憾地在许多领域表现出断裂强度不足和反向弯曲强度不足并且经常难于制作模型或根本不适于“椅旁”制作模型。
尽管在植入物领域中镁和镁合金的使用基本上是已知的,尤其是因为它们允许较高的强度,然而,当用于哺乳动物的骨和尤其是人类的骨时,在动力学、生理学方面、气体发展、降解机制和降解产物方面,仅在次优条件下发生吸收。吸收经常进行得非常快。
本发明的目的是要消除现有技术中已知的缺点,以提供最佳吸收的骨植入物,该植入物在骨再生的任何时刻具有足够高的强度。此外,这种类型的骨植入物目的是成本高效的并且允许尽可能长的储存时间而没有所需性能的劣化。
应该确保材料与人骨及人骨周围组织的相容性。
发明内容
根据本发明,这通过以下方式实现,在一般的骨植入物中,支撑结构由保护性结构包围和/或散置(interspersed)有保护性结构。
以这种方式,可能结合非降解的内含物或活性物质的至少两种或甚至更多种具有不同性质的可生物降解的材料,以非常明确的方式用于调节整个系统的不同的化学、物理、机械和生物性质。
当使用,例如镁或镁合金时,植入物表现出高强度。对于重要的在骨上的临床应用,用先前已知的镁或镁合金则很快发生降解。根据本发明,如果骨植入物由结合保护性结构(虽然其有可能表现出较低的强度,但保证了最优的降解动力学)的镁或镁合金制成,改进的设计成为可能。根据本发明利用两个或更多个包围的或散置的材料的组合,可以防止支撑结构过快的降解。因此,可以调节降解动力学/动理学。在植入物的环境中可以特定地进行生理/代谢活性的调节。也可以调节化学条件,如pH值、降解产物的浓度等以响应需求。在降解阶段,调节最初植入物的机械属性成为可能。在植入物的状态,可以保证的是由于较高的结构强度给出了较高的机械强度,优选金属部件。尽管更高强度的部件吸收,例如,低强度部件的密封结构则保留很长时间,并且保护高强度部件免于可能的过快吸收。当适当调节吸收动力学时,借助低强度部件的高强度材料的保护性护套导致,例如,用于周围组织的机械保护功能。可以实现组织保护的合理方式。
在从属权利要求中请求保护的有利的实施方式并将在下文进行阐述。
有利的是当金属合金是可生物降解和可吸收的材料时,因为在这种情况下,支撑结构也是由个体完全降解的。
还有利的是当保护性结构是由非金属材料制成或者包括(包含)非金属材料。
当材料包含由镁、铁、锌、锶、氟、锰和钙组中的至少一种元素或多种元素及其可能的离子时,可以使用特别适合的材料和材料的合金。
有用的是当保护性结构包括不同于支撑结构的材料或由这种不同的材料制成时。然后,不同的性质可以彼此结合并与要求一致。
有利的实施方式的特征还在于,保护性结构是由塑料材料制成并且优选地包含聚丙交酯化合物。该聚丙交酯化合物确保了在时间方面最佳的吸收动力学。
也已经证明有利的是,当保护性结构包含聚乳酸如PLA、和/或聚乙醇酸(PGA)和/或聚己内酯(PCL)如聚-ε-己内酯-共-丙交酯、PDLLA-TCP、PDLLA-碳酸钙和/或PDA时。
为了获得特别有利的实施方式,有利的是当支撑结构和保护性结构以材料复合组分或混合(hybrid)组分的方式,比如以单粒级凝结物(concrete)的方式彼此渗透(穿透,扩散,penetrated)或混合时。在整个3D体积上,材料复合物表现出恒定的降解特性,使得其例如在造型、弯曲、分离和/或机械加工期间,降低骨植入物对于机械表面损伤的敏感性。例如在没有材料复合物的植入物的所谓“涂覆”期间发生的缺点,因此可以避免。通常在植入物的机械加工过程中,例如在造型或分离期间,损伤了涂层,即局部发生的“腐蚀性”侵袭,然后导致在这类位点的植入物的不期望的降解动力学,这可以通过根据本发明的多孔结构避免。也在弯曲期间,使得保护层防止受到损伤,即防止位于其下方的镁植入物暴露于和显现于腐蚀下,即使是在高负载的横截面下也是可行的。
进一步有利的是,当支撑结构包括相邻的支撑颗粒的形状时,如细粒(grain)和/或球,和/或网格元件(lattice element)如棒(bar)和/或六角形元件和/或三角形和/或鱼尾纹形(crow’s foot)的元件和/或蜂窝和/或纤维。在这种情况下,尤其可以产生可负载的和通用的骨植入物。
当支撑结构具有金属泡沫的几何形状时,制造可以是容易的。还有利的是当支撑颗粒彼此相邻时使得在其间提供腔体时。这有助于引入保护性结构。
如果至少一个腔体或优选多个腔体,例如所有腔体,至少部分地、优选完全用保护性结构的材料填充,可以获得特别高强度的紧密的骨植入物,使得骨植入物保持防止受到按照根据本发明调节的降解动力学的腐蚀。
特别有利的是,当一些腔体完全用保护性结构的材料填充而一些腔体仅是部分地用保护性结构的材料填充时,并且优选地,完全填充的腔体与部分地填充的腔体的比例是20:1至10:1,进一步优选地,比率是约15:1。
在测试时,已经证明特别有利的是当支撑结构和保护性结构彼此缠绕和/或结合为夹层构造时。
为了合理地结合单独的属性,有利的是当支撑结构表现出比保护性结构更高的强度时。
此外,有利的是当骨植入物是以板、颅骨植入物、钉、网格、织物或螺钉的形式时。也可以选择铆钉的形式。
此外有利的是,当支撑结构是烧结结构的形式时。可能的是,单独的复合部件,如镁颗粒,在它们的接触点彼此“焊接”以产生烧结结构。例如,用PDLLA填充复合材料内部的自由空间并且防止体液在镁支撑结构上过快的腐蚀性侵袭。颗粒也可以用标准的几何形状,例如蜂窝层的三维三角形以盔甲屏障(armor barrier)几何结构或网格结构的方式替换。此外,在烧结结构中,其中支撑结构以前述提及的标准的几何形状的结构制成是有利的。
层可以以夹层构造结合金属和PDLLA。金属泡沫也可以用PDLLA填充。除非这些系统旨在机械加工,基本上具有周围PDLLA材料的金属制成的固体植入物也是可以的。
当在支撑结构上在更高的机械和/或化学负载的区域提供比周围区域无比地更厚的保护性结构时,也在高负载的骨植入物的情况下,可以确保最佳地控制时间。
有用的是当骨植入物并不像腔内人造血管那样设计为中空的或柔性的时。
在下文中,本发明将借助于附图进行详细说明。这些不同的实施方式形象地见于附图并将在下文中进行更详细地说明。
附图说明
图1示出了复合起始材料的示意性视图,由该起始材料制成骨植入物并且在其中以球形提供支撑结构。
图2示出了复合起始材料的示意性视图,由该起始材料制成骨植入物并且在其中以纤维形或板形的形式提供支撑结构。
图3示出了复合起始材料的示意性视图,由该起始材料制成骨植入物并且在其中以棒形的形式提供支撑结构。
图4示出了复合起始材料的示意性视图,由该起始材料制成骨植入物并且在其中以第一类型的支架提供支撑结构。
图5示出了复合起始材料的示意性视图,由该起始材料制成骨植入物的并且在其中以第二类型的支架提供支撑结构。
图6示出了复合起始材料的示意性视图,由该起始材料制成骨植入物的并且在其中以蜂窝形式提供支撑结构。
图7示出了复合起始材料的示意性视图,由该起始材料制成骨植入物的并且在其中以盔甲屏障形式提供支撑结构。
图8示出示出了复合起始材料的示意性视图,由该起始材料制成骨植入物并且在其中以网格形式提供支撑结构。
这些图只是示意性的并且仅用于理解本发明。
具体实施方式
在图1中示出了用于骨植入物的起始材料,其中没有再现骨植入物的特定形状。这类骨植入物可以具有板、颅骨植入物、钉、网格、织物、铆钉或螺钉的最终形状。可以采用切割和非切割成形的方法以获得植入物的最终形状。
在图1所示的实施方式中,制成根据本发明的骨植入物的起始材料包括具有球形形状的支撑元件2的支撑结构1。因此,支撑元件2具有球3的形状。
多个球3彼此接触并且布置成一层或多层,例如第一层4。存在位于其他层的另外的球3。在本文所示的实施方式中,提供了球3的另外的第二层和球3的另外的第三层。同时提供了具有参考标号4的第一层,提供了具有参考标号5的第二层,提供了具有参考标号6的第三层。
第二层的球3接触相同层的4个球3,除非它位于层的边缘。第一层4的至少一个球3和第三层6的一个球3相同地接触二层5的所述球3。
然而在所示实施方式中,各个层的球3的以紧密的球形堆积的方式排列。从而提供了六角球形的层。除了这种六角形紧密球形堆积外,立方体形紧密球形堆积也是可能的。而且“dhcp”类型的结构是可能的。作为替代,当然,各个球3也可以以在空间中的网格立方中心的方式(bcc)排列。
可生物降解和/或可生物吸收的保护性结构7包围所有的球3,即支撑元件2的所有不同层的所有球3。保护性结构7在各个球形支撑元件2之间具有同样穿透的腔体8,使得球3不同地保留在保护性结构7中。
与其它球3互相连接的球3,即彼此接触的支撑元件2,粘附性地连接,例如彼此焊接在一起。在本情况下使用烧结方法以相互连接支撑元件2。已经证明特别有效的是当激光作用在以粉末形式提供的支撑元件2的材料上时。
通过适当地将支撑元件2彼此附接在一起延长了用于腐蚀性材料的通路。通过裂缝进入到保护性结构7的内部的这些腐蚀性材料,例如,必须覆盖从易受腐蚀性侵袭的一个支撑元件2到下一个的特别长的距离,以便能够攻击全部的其他所述支撑元件2。这对于腐蚀的持续时间有影响。需要特别长的时间直到下一个支撑元件2受到侵袭并降解。
因此,需要特别长的时间直到经过若干时间支撑结构1弱化并且所有的支撑元件2降解。这样,通过将各个支撑元件2布置于保护性结构7内可以特定地调整降解动力学。降解动力学取决于支撑结构1和保护性结构7中各自使用的材料。可以以有针对性的方式选择在这方面使用的材料,和调整为一种其他的材料用于期望的目的。
在图2至图8中示出的实施方式同样遵循该规律。同样地各个支撑元件通常相互连接,优选粘附性连接,进一步优选焊接或通过烧结连接。成品骨植入物优选在所有面上(onall sides,在各个方向上),由保护性结构7包围。然而,基本上也可能的是至少部分的支撑结构1突出于成品骨植入物的表面。
在图2至图8的实施方式中使用的支撑结构1的支撑元件2表现为不同的形式。
根据图2的实施方式的支撑元件2分别是纤维9或板的形式。纤维9是还可以部分地相交的平面板状结构。虽然它们也可以是细丝状。它们在其边缘具有圆形部分,但是它们也可以是矩形或者甚至可以是锥形。还可能的是纤维本身是板的形式,并且在这种情况下不是平面的而是具有波形的形式,如凸起或凹面形式。它们可以具有恒定的厚度,但它们也可以是椭圆形的。特别地透镜形状是可能的。
在根据图3的实施方式中,支撑元件2是以棒的形式。提供具有参考标号为10的棒并且是柱形的。它们具有圆形横截面,但是它们也可以具有多边形横截面。棒10具有恒定的横截面。但该横截面也可以变化。
至少一个棒10接触另一个棒10并且在接触区域中粘附性连接,如关于图1和图2的实施方式已经说明的。已经证明有利的是,当2、3、4、5、6、7、8、9、10、11和多个棒在一定时间相互连接时。在这种情况下,同样,如前述两个实施方式,保护性结构7中散置有支撑结构1并且分别包围后者。
尽管在根据图3的实施方式中各个棒10几乎随机地设置于保护性结构7中,在图4和图5的实施方式中,棒10以几何上重复排列的支架11的方式布置。支架11也可以设计为点对称的。
图4和图5的实施方式不同在于支架11的层数。在根据图5的实施方式中,提供了三层支架11,而在根据图4的实施方式中仅提供了一层支架11。
在根据图6的实施方式中,各个支撑元件2设计为板12的方式,各个板12形成蜂窝型结构的层,其中,蜂窝型结构的各个层彼此相对偏离。各个板12由此形成复杂的蜂窝型结构13。
在图7中,支撑结构1是由各个支撑元件2以盔甲屏障元件14的方式形成的。每个盔甲屏障元件包括四个圆柱段15。这四个圆柱段15的每一个具有来自相同的装甲屏蔽元件14的最近圆柱段15的相同的立体角。圆柱段15末端是圆形。但它们也可以具有非圆形的边缘。各个圆柱段15可以由固体物质制造,但它们也可以是中空的。
腔体8依次由保护性结构7填充。
这些各个圆柱段15可具有固定直径或变化的直径。各个圆柱段15可以具有与相邻的圆柱段相同的直径或相同的直径行进方向(diametrical course)或可以具有与其不同的直径或直径行进方向。
在图8中,根据本发明的支撑结构1的另一实施方式示出于根据本发明的待生产的骨植入物中。支撑结构1的各个支撑结构元件2以网格16的形式彼此结合,优选在不同的层中。网格16的各个棒10垂直相交。为了得到尽可能高的机械强度,特别是在植入之后,有利的是设置于保护性结构7中的各个支撑元件彼此尽可能紧密地相邻。
基本上,类似于单粒级混凝土的构造也是可以的。
参考标号表
1 支撑结构
2 支撑元件
3 球
4 第一层
5 第二层
6 第三层
7 保护性结构
8 腔体
9 纤维
10 棒
11 支架
12 板
13 复合蜂窝结构
14 盔甲屏障元件
15 圆柱段
16 网格。
Claims (15)
1.一种骨植入物,包括由金属合金制成的支撑结构(1)并且包括可生物降解和可吸收的保护性结构(7),其中,所述保护性结构(7)包括不同于所述支撑结构(1)的材料,并且所述支撑结构(1)由所述保护性结构(7)包围和/或散置有所述保护性结构(7),其中,所述保护性结构(7)设置于所述支撑结构(1)处和/或在所述支撑结构(1)上,以便保护所述支撑结构(1)在锚定于个体的骨中的位置免于接触任何侵蚀性体液,其特征在于,所述支撑结构(1)包括多个彼此材料连接的各个支撑元件(2)。
2.根据权利要求1所述的骨植入物,其特征在于,所述金属合金是可生物降解和可吸收的材料。
3.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)的材料包含由镁、铁、锌、锶、氟、锰和钙组成的组中的至少一种元素或多种元素以及它们的可能的离子。
4.根据权利要求1或2所述的骨植入物,其特征在于,所述保护性结构(7)由不同于所述支撑结构(1)的材料制成。
5.根据权利要求1或2所述的骨植入物,其特征在于,所述保护性结构(7)是非金属的。
6.根据权利要求1或2所述的骨植入物,其特征在于,所述保护性结构(7)包含聚乳酸和/或聚乙醇酸和/或聚己内酯。
7.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)和所述保护性结构(7)以材料复合组分或混合组分的方式彼此渗透或混合。
8.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)表现出相邻的支撑颗粒的形式。
9.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)具有金属泡沫的结构。
10.根据权利要求8所述的骨植入物,其特征在于,所述支撑结构(1)的所述支撑颗粒彼此相邻,以便在其间设置腔体。
11.根据权利要求10所述的骨植入物,其特征在于,至少一个腔体,至少部分地用所述保护性结构(7)的材料填充。
12.根据权利要求11所述的骨植入物,其特征在于,一些腔体完全用所述保护性结构(7)的材料填充,而一些腔体仅部分地用所述保护性结构(7)的材料填充。
13.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)与所述保护性结构(7)以夹层构造缠绕和/或结合。
14.根据权利要求1或2所述的骨植入物,其特征在于,所述支撑结构(1)表现出比所述保护性结构(7)更高的机械强度。
15.根据权利要求1或2所述的骨植入物,其特征在于,所述骨植入物是以板、颅骨植入物、钉、网格、织物、铆钉或螺钉的形式。
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2012
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- 2012-11-09 ES ES12192006.0T patent/ES2582610T3/es active Active
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CN104780953A (zh) | 2015-07-15 |
MX2015005338A (es) | 2015-08-13 |
WO2014072507A1 (en) | 2014-05-15 |
ES2582610T3 (es) | 2016-09-14 |
JP2018020134A (ja) | 2018-02-08 |
US20150289979A1 (en) | 2015-10-15 |
MX365135B (es) | 2019-05-24 |
AR093397A1 (es) | 2015-06-03 |
AU2013343439A1 (en) | 2015-06-04 |
EP2730298B1 (de) | 2016-05-18 |
JP6360952B2 (ja) | 2018-07-18 |
BR112015010458A2 (pt) | 2017-07-11 |
EP2730298A1 (de) | 2014-05-14 |
JP2015536724A (ja) | 2015-12-24 |
MY168040A (en) | 2018-10-11 |
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