CN1561185A - 椎间盘假体或髓核替代假体 - Google Patents

椎间盘假体或髓核替代假体 Download PDF

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CN1561185A
CN1561185A CNA018238610A CN01823861A CN1561185A CN 1561185 A CN1561185 A CN 1561185A CN A018238610 A CNA018238610 A CN A018238610A CN 01823861 A CN01823861 A CN 01823861A CN 1561185 A CN1561185 A CN 1561185A
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intervertebral disk
material group
disk prosthesis
external capsule
prosthesis
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CN100512777C (zh
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A·司徒德尔
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AO Technology AG
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MARS MEDICAL TECHNOLOGY AG
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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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    • A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
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    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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Abstract

本发明涉及一种椎间盘假体或髓核替代假体，该假体包括生物相容的外囊(1)，其中存在有可硬化且能流动的物质团(2)，这种物质团含有单体、共聚单体、均聚体、寡聚体或者其混合物。然后，置于外囊(1)之中的可硬化且能流动的物质团原位硬化。

Description

椎间盘假体或髓核替代假体
本发明涉及根据权利要求1的上位概念所述的椎间盘假体或髓核替代假体。
从现有技术中可获知较大量的这种椎间盘假体，但都是预制的，并且必须以预制的、体积相对庞大的状态植入椎间隙内。
进行上述的现有技术的讨论只是为了解释本发明的背景，并不是表示所引用的现有技术在本申请或本申请的优先权之前就已实际上发表或者公开了的。
本发明是以这样的问题为基础的，即制备一种椎间盘假体或髓核替代假体，这种假体可以尺寸上适度减小的状态植入椎间隙内，然后可以在用可硬化且能流动的物质团成功填充之后通过硬化过程而凝固。
本发明用具有权利要求1所述的特征的椎间盘假体解决了所提出的任务。
仍是空的椎间盘假体的外囊使得能够容易地将其以萎陷的状态导入椎间隙内，然后通过使用注射器经过合适的插管用能流动的单体混合物将其填充。外囊(或者囊形器)可以在确定用于与相邻椎体的盖板接触的面上具有特异性表面和/或厚度和/或特异性材料，例如聚碳酸酯尿烷(Polycarbonaturethah，PCU)或聚碳酸酯。
该实施方案的优点在于，与两个相邻椎体的终板(软骨层)接触的表面提供了在所出现的运动(旋转、延展、弯曲)方面最佳的关于滑动性、生物相容性、硬度等等的条件。
通过相应的加压可以用可聚合化的单体混合物将外囊这样宽松地膨胀起来，以致可将椎间盘高度恢复到解剖学上正确的原始高度。为此，可以用小于3个大气压的超压(优选为最大1.1个大气压)将物质团导入外囊中。
但是，假如通过使用合适的器械牵引相关的椎骨，也可以将物质团在基本无超压的情况下导入外囊中。
通过将光导体(例如玻璃纤维束)引入外囊之中或者引入外囊的开孔区域，可以例如用蓝光(例如具有340nm的波长)使得可聚合化的物质团进行光聚合化。在水性单体溶液的情况下，通过聚合交联化可以形成水凝胶。
因此，可获得这样的优点，即水凝胶一方面可以在超载时释放出水(体液)，另一方面可以在静止阶段吸收水。由此可导致缓冲效应以及附加的可能性来修复椎间盘至其原始高度。
优选的进一步改造在于将外囊制成双层，并将可硬化且能流动的物质团导入两层囊壁之间，这种物质团含有单体、共聚单体、均聚体、寡聚体或者其混合物，以致于椎间盘假体的中央是空心的。通过可自由选择的空腔的大小可以附加地调节植入体的柔韧性。
在其它实施形式中，外囊在化学上由与在外囊中存在的、可硬化的、能流动的物质团同样的材料构成，从而后者可以与外囊材料相结合。
在其它实施形式中，外囊由具有记忆效应的材料构成，从而其在体温条件下具有事先存储的几何形状。
在其它实施形式中，可硬化且能流动的物质团含有聚合催化剂，和优选地附加含有聚合促进剂。
在其它优选实施形式中，可硬化且能流动的物质团含有光引发剂(优选为自由基光引发剂)，光引发剂在此优选地在大约340-420nm的范围内吸收光。光引发剂可以为氧化膦，优选为酰基氧化膦。氧化膦可以与二甲替丙烯酰胺进行共聚化。相对于自聚合化，用蓝光进行聚合化的优点在于不会造成增加的热量产生，这种热量产生的增加可以破坏蛋白质分子。此外，光导体的操作是无危险的，通过其可将蓝光照射进囊形器中。蓝光照射的频率和持续时间可以通过对于光源的简单控制来调整。
可硬化且能流动的物质团所含有的单体、共聚单体、均聚体、寡聚体或者混合物可以合适地选自
a)聚乙二醇，优选为聚乙二醇(二)丙烯酸酯；
b)N-乙烯基吡咯烷酮；和
c)乙烯基化合物，优选为乙烯醇；和
d)苯乙烯。
因此，所获得的聚合化产物相关于其弹性可以在宽的范围内变化。
可硬化且能流动的物质团有利地含有30-160重量％的水，优选为40-90重量％的水。特别合适是45-55重量％的水。通过确定经聚合化的物质团(特别是水凝胶)之后应吸收多少水(溶胀因子)，可以调节对于脊柱段的附加的牵引。
用于生产根据本发明的椎间盘假体或髓核替代假体的方法包括下列的方法步骤：
A)将生物相容的外囊植入两个相邻的椎体的椎间隙内；
B)将可硬化且能流动的物质团导入经植入的生物相容的外囊内部之中，这种物质团含有单体、共聚单体、寡聚体或者其混合物，在此，经填充的外囊保持在椎间隙的中央；和
C)使置于外囊之中的可硬化且能流动的物质团原位硬化。
在根据本发明的方法的变化形式中，在步骤A和B之间可以用空气膨胀外囊。通过预牵引，可以对于脊柱段的牵引能力进行检查。
在根据本发明的方法的另外变化形式中，在步骤A和B之间可以用X射线造影剂填充外囊。通过使用图像转换器，X射线造影剂使外囊在脊柱段中的位置可见。这就给出外囊是否位于正确的位置上这一信息。
物质团的硬化可以通过自聚合化或者通过优选地用可见光或紫外光的光聚合来进行。
本发明和本发明的进一步改造在下面借助于几个实施例的部分示意性的描绘而更进一步地解释。
其展示：
图1，在用可硬化且能流动的物质团填充外囊的阶段中，穿过在两个相邻椎体之间植入的椎间盘假体的纵截面；
图2，在能流动的物质团进行硬化的阶段中，穿过根据图1的椎间盘假体的纵截面；
图3，穿过双层的椎间盘假体的纵截面；
图4，穿过用于填充椎间盘假体的阀门的纵截面；和
图5，穿过椎间盘假体的纵截面，该椎间盘假体具有以不同厚度形成的外表面。
在图1中，展示以髓核替代假体的形式的椎间盘假体，并且展示这样的状况，即在这种状况下，生物相容的外囊1已经植入了两个相邻椎体11、12的椎间隙10之中，且通过阀门15和插管16、用可硬化且能流动的物质团2、以在植入的生物相容的外囊1内部的水凝胶的形式、按照箭头17的方向将外囊填充。经填充的外囊1在此保持在椎间隙10的中央，并在此与相邻椎体11、12的两个终板13、14相接触。
在图2中展示了，如何通过将光导体18经过插管16导入植入的生物相容的外囊1之内而导致那里存在的物质团2通过光聚合化进行硬化。该物质团2为此含有自由基光引发剂。用于光聚合化的光为紫外光，其通过用箭头19显示。
在图3中展示了椎间盘假体的变体，在其中将外囊1制成双层并将物质团2导入两层囊壁3、4之间，以致椎间盘假体的中央5是空心的。
为了使物质团2既能填充单层的也能填充双层的椎间盘假体的变体，设置了特异的在图4中展示的阀门15。阀门15基本上由下列部分构成，即作为单向阀的具有由弹簧22支持的球体23的中央钻孔21，和作为单向阀的具有由弹簧26支持的球体25的外周钻孔24。中央钻孔21用于填充单层的变体(根据图1和2)，外周钻孔24用于填充双层的变体(根据图3)。在后者的情况下，然后可以将中央钻孔21用于充入空气或者X射线造影剂。
在图4中展示了椎间盘假体的另外变体，其中，在确定用于与相邻椎体11、12的盖板13、14进行接触的的囊壁6和7之上以比其他囊壁区域更厚的厚度来制成外囊1。至少外囊1的囊壁6和7由聚碳酸酯尿烷(PCU)或聚碳酸酯构成。
下面借助于几个实施例来说明本发明。
实施例1
将45g分子量为700的聚乙二醇二丙烯酸酯(PEGDA)以及5g 2，6-二甲基-3-乙烯基苯甲酰基氧化膦(DMVBPO)与二甲替丙烯酰胺的共聚物溶解在50g蒸馏水中。该水凝胶的硬化用具有2W/cm2的强度的波长为420nm的蓝光来进行。
实施例2
将45g分子量为720的聚乙二醇二丙烯酸酯(PEGDA)以及5g 4-(VBPO)与二甲替丙烯酰胺的共聚物溶解在50g蒸馏水中。该水凝胶的硬化用具有2W/cm2的强度的波长为420nm的蓝光来进行。
实施例3
将45g分子量为750的聚乙二醇二丙烯酸酯(PEGDA)以及5g 2，4，6-三甲基苯甲酰基-苯基-4-乙烯基苯基氧化膦(TMBVPO)与二甲替丙烯酰胺的共聚物溶解在50g蒸馏水中。该水凝胶的硬化用具有2W/cm2的强度的波长为420nm的蓝光来进行。

Claims (20)

1.椎间盘假体或髓核替代假体，所述假体具有生物相容的外囊(1)，其中存在有可硬化且能流动的物质团(2)，所述物质团含有单体、共聚单体、均聚体、寡聚体或者其混合物。
2.根据权利要求1所述的椎间盘假体，其特征在于，物质团(2)含有光引发剂，优选为自由基光引发剂。
3.根据权利要求2所述的椎间盘假体，其特征在于，光引发剂优选地在大约340-420nm的范围内吸收光。
4.根据权利要求2或3所述的椎间盘假体，其特征在于，光引发剂为氧化膦，优选为酰基氧化膦。
5.根据权利要求4所述的椎间盘假体，其特征在于，将氧化膦与二甲替丙烯酰胺共聚。
6.根据权利要求1-5中任何一项所述的椎间盘假体，其特征在于，单体、共聚单体、均聚体、寡聚体或者其混合物选自
a)聚乙二醇，优选为聚乙二醇(二)丙烯酸酯；
b)N-乙烯基吡咯烷酮；和
c)乙烯基化合物，优选为乙烯醇；和
d)苯乙烯。
7.根据权利要求1-6中任何一项所述的椎间盘假体，其特征在于，物质团(2)含有30-160重量％的水，优选为40-90重量％的水。
8.根据权利要求1-7中任何一项所述的椎间盘假体，其特征在于，物质团(2)含有水凝胶。
9.根据权利要求1-8中任何一项所述的椎间盘假体，其特征在于，将外囊(1)制成双层，并将物质团(2)导入两层囊壁(3、4)之间，以致椎间盘假体的中央(5)是空心的。
10.根据权利要求1-9中任何一项所述的椎间盘假体，其特征在于，外囊(1)由具有记忆效应的材料构成，从而其在体温条件下具有事先存储的几何形状。
11.根据权利要求1或者6-10中任何一项所述的椎间盘假体，其特征在于，物质团(2)含有聚合催化剂，和优选地附加含有聚合促进剂。
12.根据权利要求1-11中任何一项所述的椎间盘假体，其特征在于，外囊(1)在化学上由与在外囊(1)中存在的物质团(2)同样的材料构成。
13.根据权利要求1-11中任何一项所述的椎间盘假体，其特征在于，在确定用于与相邻椎体(11、12)的盖板(13、14)进行接触的囊壁(6、7)之上以更厚的厚度来制成外囊(1)，其优选地由聚碳酸酯尿烷(PCU)或聚碳酸酯构成。
14.生产椎间盘假体或髓核替代假体的方法，其特征在于下面的方法步骤：
A)将生物相容的外囊(1)植入两个相邻的椎体(11、12)的椎间隙(10)内；
B)将可硬化且能流动的物质团(2)导入经植入的生物相容的外囊(1)内部之中，这种物质团含有单体、共聚单体、寡聚体或者其混合物，在此，经填充的外囊(1)保持在椎间隙(10)的中央；
C)使置于外囊(1)之中的可硬化且能流动的物质团(2)原位硬化。
15.根据权利要求14所述的方法，其特征在于，物质团(2)的硬化通过光聚合来进行，优选地用可见光或紫外光。
16.根据权利要求14或15所述的方法，其特征在于，在步骤A和B之间用空气进行膨胀外囊(1)。
17.根据权利要求14或15所述的方法，其特征在于，在步骤A和B之间用X射线造影剂填充外囊(1)。
18.根据权利要求14-17中任何一项所述的方法，其特征在于，物质团(2)的硬化通过自聚合来进行。
19.根据权利要求14-18中任何一项所述的方法，其特征在于，将物质团(2)在基本无超压的情况下导入外囊(1)中。
20.根据权利要求14-18中任何一项所述的方法，其特征在于，将物质团(2)用小于3个大气压的超压导入外囊(1)中，优选为小于1.1个大气压的超压。
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