CN1482890A - 骨植入物,特别是椎间植入物 - Google Patents

骨植入物,特别是椎间植入物 Download PDF

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CN1482890A
CN1482890A CNA018214193A CN01821419A CN1482890A CN 1482890 A CN1482890 A CN 1482890A CN A018214193 A CNA018214193 A CN A018214193A CN 01821419 A CN01821419 A CN 01821419A CN 1482890 A CN1482890 A CN 1482890A
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bone implant
implant
hollow body
bone
packing material
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CN1287752C (zh
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С�޲��ء���̩˹
小罗伯特·马泰斯
ϣ
贝亚特·莱希曼
I
贝亚特·加瑟
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AO Technology AG
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Synthes AG Chur
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Abstract

椎间植入物，由射线可透过的材料组成，并制成环形空心体(1)，它具有一空心柱形段式的外壳(6)，所述外壳包括一前部(9)、一后部(10)和两个侧部(11)，以及确定一柱形体中心线(7)。空心体(1)通过两个隔板(3)隔开，隔板基本上平行于柱形体中心线(7)分布并连接外壳的前部(9)和后部(10)。骨植入物的表面(2)具有至少2μm的表面粗糙度。这种表面粗糙度允许新生骨更好地固着在植入物上，亦即更好地骨融合。

Description

骨植入物，特别是椎间植入物
本发明涉及一种按权利要求1前序部分的骨植入物，特别是椎间植入物，以及一种按权利要求16前序部分的制造骨植入物的方法。
由FR-A-2 703 580 ROBERT已知一种这一类型的骨植入物，这种已知椎间植入物的缺点在于：
A)设有粗大的肋的植入物顶面和底面的光滑表面一所述表面与相邻脊椎体的端板相接触-不利于骨组织最佳地生根成长，
B)在植入物室腔内采用填充材料时，由于内壁很光滑，填充材料容易掉出来。
现有技术的上述讨论仅仅用来说明本发明的背景，并不意味着，所引用的现有技术在本专利申请的时刻或其优先权实际上已经发表或公开。
这里本发明提出一种改进措施。本发明的目的是，创造一种骨植入物，特别是椎间植入物，它具有对于骨组织生根成长最佳的表面结构。
本发明用具有权利要求1特征的骨植入物和具有权利要求16特征的方法实现所提的目的。
按本发明的至少2μm的表面粗糙度允许新长出的骨骼更好地固着在植入物上，亦即更好地骨融合(Knochenintegration)。
一种优选的改进结构是，空心体通过至少两个隔板分开，其中隔板最好借助于一个横杆相互支撑。这些隔板提高在脊椎体的相邻端板上的支承面积，从而减小面压力，并防止植入物沉入相邻脊椎体内。此外位于它们之间的空腔允许植入物与骨组织长合。
另一种优选的改进结构是，表面粗糙度小于10μm。太大的表面粗糙度使余留的尖端削弱，这又可能导致骨质溶解(Osteolyse)，从而不利于骨节固定(Arthrodese)。
另一种优选的改进结构在于，隔板设有穿孔，它们最好具有3.5mm2的最小面积。侧壁穿孔用于新长出的骨组织的空间固着以及必要时初始放入的填充物质的固定。
另一种优选的改进结构是，空心体外壳的侧面部分具有穿孔，它们最好具有3.5mm2的最小面积。外壳侧面部分的穿孔用于新生长的骨组织还有在起初装入植入物时的植入物支架的空间固定。
另一种优选的改进结构在于，射线可透过的材料从以下一组材料中选择，即聚芳醚酮(PAEK)、聚醚酰亚胺(PEI)、聚甲醛(POM)、液晶聚合物(LCP)、聚甲基戊烯(PMP)、聚砜(PSU)、聚醚砜(PESU或PES)、聚对苯二甲酸乙二酯(PETP)、聚甲基丙烯酸甲酯(PMMA)和超高分子聚乙烯(UHMW-PE)。
所有这些优选的材料都是弹性的，但具有不同的机械性能，如弹性模量(刚度)和强度。它们中的一些与其他聚合物相比具有好的蠕变特性，或者表现出小的吸水性。因此根据应用需要的不同可以进行最佳的选择。
另一种优选的改进结构是，射线可透过的材料是纤维强化的，尤其是用碳纤维或PEEK-纤维强化。射线可透过的材料的纤维强化一般性地或按特定要求加强机械性能。
另一种优选的改进结构在于，骨植入物的总体积V与空心体的体积v之比V∶v在1.9至2.3的范围内。实际表明，这个比例得到了植入物机械稳固的优点与新生长的骨组织体积最大化的统一。
另一种优选的改进结构是，植入物的表面至少局部设有X射线可穿透的涂层，或不影响X射线穿透性的薄涂层，X射线可穿透涂层的优点是保证在骨节固定长上期间的观察可能性。而纯PEEK的特征是具有突出的生物相容性(Biokompatibilitt)，由合适的材料组成的附加涂层可以提高机械性能和新生骨与植入物之间的结合面。对X射线穿透性没有大的妨碍的金属(非常小的厚度)尤其适合于作为涂层材料。特别合适的定钛、金或铂或其他合适的植入物金属。
另一种优选的改进结构是，涂层由陶瓷材料，尤其是羟基磷灰石或三代磷酸钙组成。适用于涂层的两种陶瓷-羟基磷灰石和三代磷酸钙-的特征在于这样的优点，即，它可完全融合在骨内或者甚至可由新的天然骨组织所取代。
另一种优选的改进结构是，空心体至少部分填充由磷酸钙尤其是羟基磷灰石或三代磷酸钙组成的填充材料。由此达到骨节固定的更好的、无害的控制。空心体也可以填充由硫酸钙、去矿质的骨骼、自溶性的骨骼或珊瑚物质组成的填充材料。
另一种优选的改进结构在于，空心体至少部分地用一种由可吸收尤其是多孔聚合物组成的不透X射线(rntgenopak)的填充材料填充。为了构成不透X射线的填充材料，在聚合物内加入反衬物质。例如可以在PLA中加入光点(Marker)如二氧化锆、在PEEK中混入硫化钡。
另一种优选的改进结构是，在有些情况下存在的植入物上的穿孔至少部分填充不透X射线的填充材料。由此防止填充材料掉出。
用来制造按本发明的骨植入物的方法是，通过压铸、热成形或热压技术制造环形空心体。通过热成形使聚合物压到所有形状单元内，其特征特别是具有更好的耐疲劳强度。
下面借助于一个实施例的局部示意图对本发明和本发明的改进结构作较详细的说明。
附图表示：
图1按本发明的椎间植入物的透视图；
图2按图1的植入物的俯视图；
图3按图1的植入物的正视图；
图4按图1的植入物的侧视图。
在图1至4中所示的椎间植入物由一种射线可透过的材料(PEEK，它可以选择用碳纤维或玻璃纤维强化)组成，它用压铸法制成环形空心体1。它包括一空心柱形段式的外壳6，外壳具有一前部9、一后部10和两个侧部11，以及确定一柱形体中心线7。
空心体1通过两个基本上平行于柱形体中心线7分布、并连接外壳的前部9和后部10的隔板3分成几个空腔。两个隔板3借助于一横杆4相互支撑。隔板3设有穿孔5，它们具有约10mm2的面积，外壳6的侧部11也具有穿孔8，它们具有约10mm2的面积。
骨植入物的表面2具有6μm的粗糙度，并设有薄的X射线可穿透的金组成的涂层。
骨植入物的总体积V和空心体1的体积v之比V∶v约为2.1。
空心体可以用由羟基磷灰石组成的不透X射线的填充材料填充，这里应该注意，存在的穿孔5；8最好也用不透X射线的填充材料填充。

Claims (16)

1.骨植入物，特别是椎间植入物，它由射线可透过的材料组成，并制成环形空心体(1)，具有一空心柱形段式的外壳(6)，所述外壳包括一前部(9)、一后部(10)和两个侧部(11)，以及确定一柱形体中心线(7)，其中所述空心体(1)通过至少一个隔板(3)分开，此隔板基本上平行于柱形体中心线(7)分布，并使外壳的前部(9)与后部(10)连接，其特征为：所述骨植入物的表面(2)具有至少2μm的表面粗糙度。
2.按权利要求1的骨植入物，其特征为：所述空心体(1)通过至少两个隔板(3)分开，其中隔板(3)最好借助于一横杆(4)相互支撑。
3.按权利要求1或2的骨植入物，其特征为：所述表面粗糙度小于10μm。
4.按权利要求1至3之任一项的骨植入物，其特征为：所述隔板(3)设有穿孔(5)，穿孔最好具有3.5mm2的最小面积。
5.按权利要求1至4之任一项的骨植入物，其特征为：所述外壳(6)的侧部(11)具有穿孔(8)，穿孔最好具有3.5mm2的最小面积。
6.按权利要求1至5之任一项的骨植入物，其特征为：所述射线可透过的材料从以下一组材料中选取：聚芳醚酮(PAEK)、聚醚酰亚胺(PEI)、聚甲醛(POM)、液晶聚合物(LCP)、聚甲基戊烯(PMP)、聚砜(PSU)、聚醚砜(PESU或PES)、聚对苯二甲酸乙二酯(PETP)、聚甲基丙烯酸甲酯(PMMA)、和超高分子聚乙烯(UHMW-PE)。
7.按权利要求1至6之任一项的骨植入物，其特征为：所述射线可透过的材料是纤维强化的，尤其是碳纤维、玻璃纤维或PEEK-纤维强化的。
8.按权利要求1至7之任一项的骨植入物，其特征为：骨植入物的总体积V与空心体(1)的体积v之比在1.9至2.3的范围内。
9.按权利要求1至8之任一项的骨植入物，其特征为：其表面至少局部设有X射线可穿透的涂层，或对X射线的可穿透性影响很小的薄涂层。
10.按权利要求9的骨植入物，其特征为：所述涂层由金属尤其是钛、金或铂组成。
11.按权利要求9的骨植入物，其特征为：所述涂层由陶瓷材料尤其是羟基磷灰石或三代磷酸钙组成。
12.按权利要求1至11之任一项的骨植入物，其特征为：所述空心体(1)至少部分填充有由磷酸钙尤其是羟基磷灰石或三代磷酸钙组成的填充材料。
13.按权利要求1至11之任一项的骨植入物，其特征为：所述空心体(1)至少部分填充有由硫酸钙、去矿质的骨骼、自溶性的骨骼或珊瑚物质组成的填充材料。
14.按权利要求1至11之任一项的骨植入物，其特征为：所述空心体(1)至少部分填充有由可吸收的尤其是多孔的聚合物组成的填充材料。
15.按权利要求4至14之任一项的骨植入物，其特征为：在有些情况下存在的穿孔(5；8)至少部分填充有不透X射线的填充材料。
16.用来制造按权利要求1至15之任一项的骨植入物的方法，其特征为：所述环形空心体(1)由压铸、热成形或热压技术制成。
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