CN101431966A - 植入物和制造这种植入物的方法 - Google Patents

植入物和制造这种植入物的方法 Download PDF

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Publication number
CN101431966A
CN101431966A CNA2006800490752A CN200680049075A CN101431966A CN 101431966 A CN101431966 A CN 101431966A CN A2006800490752 A CNA2006800490752 A CN A2006800490752A CN 200680049075 A CN200680049075 A CN 200680049075A CN 101431966 A CN101431966 A CN 101431966A
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CN
China
Prior art keywords
implant
cover member
mould
foam
bone
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CNA2006800490752A
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English (en)
Inventor
H·H·魏南斯
J·A·N·费哈尔
P·莱尔坎普
B·莫泽拉尔
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FT Innovations FTI BV
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FT Innovations FTI BV
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Application filed by FT Innovations FTI BV filed Critical FT Innovations FTI BV
Publication of CN101431966A publication Critical patent/CN101431966A/zh
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22C—FOUNDRY MOULDING
    • B22C9/00—Moulds or cores; Moulding processes
    • B22C9/02—Sand moulds or like moulds for shaped castings
    • B22C9/04—Use of lost patterns
    • B22C9/046—Use of patterns which are eliminated by the liquid metal in the mould
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Abstract

在人的髋磨损或损伤的情况下，可以通过外科手术布置植入物。这些植入物的平均使用寿命目前总计为约15至20年。这意味着许多人通常必须经历第二次相对严重的置换植入物的手术，在该手术中植入物被置换。第二植入物的使用寿命通常比第一植入物的短。此外，在分离过程中会发生骨丢失。置换磨损的第二植入物的第三次手术通常相对困难，并且有时甚至不可能进行。本发明涉及一种改进的植入物。本发明还涉及一种用于制造这种植入物的方法。

Description

植入物和制造这种植入物的方法
技术领域
本发明涉及一种植入物。本发明还涉及一种制造这种植入物的方法。
背景技术
在人的关节磨损或损伤的情况下，可以通过外科手术引入植入物，例如人造髋。这些植入物的平均使用寿命是有限的并且取决于病人的活动和年龄以及植入物的类型。对于相对年轻的病人(60岁以下)，植入物的使用寿命通常短于20年。这意味着越来越多的病人必须经历相比第一次手术更严重的第二次手术，在第二次手术中第一植入物由第二植入物置换。由于发生在假体周围的骨丢失，第二植入物的使用寿命通常比第一植入物的使用寿命短。由于进一步的骨丢失，置换已磨损的第二植入物的第三次手术通常很困难，会损伤病人，并且有时甚至是不可能的。
骨水泥植入物和非骨水泥植入物之间存在区别。骨水泥植入物通过聚甲基丙烯酸甲酯(PMMA)骨水泥固定在骨中。这是最老的原理，并且迄今为止已经以此获得了最多的经验。骨水泥会经历老化过程并且必须在第二次手术中移除，由此会发生另外的骨丢失。在使用非骨水泥假体的最近15年中已经获得了越来越多的经验。根据一些研究，15年后非骨水泥假体的效果至少等于骨水泥柄，甚至更好。已经报导15年后有90％以上的骨水泥柄残存。在非骨水泥植入物的情况下，没有使用骨水泥用于连接，植入物尽可能紧贴地放置在骨中。这种植入物的表面粗糙且多孔，由此骨趋于和有机会固定在植入物上，由此可以在植入物和骨之间实现连接。这个过程可以通过生物活性涂层来加强。但是非骨水泥假体最大的缺陷是假体周围骨丢失的发生。这是由于假体的刚度比骨的刚度大而引起的。实际上骨将由此开始绕着假体运动，由此通常相对快速地发生分离和骨丢失。此外，坚固的金属假体不会均匀地将力传递给骨。更特别的是，在人造髋的情况下，在膝侧发生的力传递比在髋侧多。因此髋侧骨受到的压力和作用减轻并且伴随骨质疏松。这个过程通常称为“应力遮挡”。一方面因为这些植入物越来越经常地应用于年轻病人，同时另一方面因为年老病人的平均寿命继续在增加，并且年老病人群体也仍然越来越活跃，所以(髋)植入物有限的使用寿命形成了越来越突出的社会和经济问题。因此在医学界很需要使用寿命延长且优选为终身的植入物，由此可以优选最终地避免置换植入物。对改进的植入物必不可少的是植入物和骨之间相对好的力传递，这使得“应力遮挡”产生的骨丢失减到最小程度。
发明内容
为了这个目的本发明提供了一种非骨水泥植入物，该植入物具有改进的向内生长能力和机械刚度，并且因此相对耐用。
为了这个目的，本发明提供了一种根据权利要求1的植入物。基本构件和套构件实际上在这里形成一个整体，其中基本构件和套构件优选用一个生产步骤制成。由于植入物的整体构造，可以省去相对脆弱的分离粘合层(中间层)，由此可以获得相对坚固的并且因此耐用的植入物。根据本发明的植入物的另一显著优点是基本构件和套构件的固有特性可以相互独立地优化。因此推荐相对于传统非骨水泥植入物至少局部地显著地降低植入物的刚度，其中尤其套构件优选具有比基本构件的刚度相对小的刚度。因此植入物的总刚度不再仅仅由植入物的设计决定，还由套构件的位置和厚度分布决定，由此可以优化植入物和骨之间的应力分布，并且其中可以将接合应力降到最小，因此连接更加耐用。而且根据本发明的植入物的安装在其特殊应用中可以通过相对简单的方式被优化。于是这种优化就在植入物总刚度减小的同时，改进了骨与植入物之间的连接，这就得到了相对牢固、可靠且耐用的植入物。应当注意的是，本发明决不限于髋植入物。相反，本发明涉及通常意义上的植入物，这些植入物可以应用于置换或完善人和动物缺少或缺损的身体部分。可应用的植入物例子尤其包括全髋假体、股骨和髋臼部件、全膝假体、股骨和胫骨部件、肩假体、指假体、笼(椎骨间融合器)、牙齿植入物、软组织锚钉和用于肿瘤学的植入物。
多孔套构件基本由具有开孔的构件形成，这些构件例如更尤其是可以具有开孔的泡沫。应用泡沫的优点是泡沫相对轻且相对坚固，并且最重要的是具有与天然的海绵状(松质)骨中存在的微结构基本相应的多孔结构，并且因此起到用于容纳蜂窝状骨组织的基质的作用。而且泡沫提供了渗透性和相对高的比表面面积用于促进新骨的向内生长，并因此能够进行改进且耐用的植入物锚固。套构件优选至少部分可塑性变形(在相对高的作用力下)，由此基本可以增大在冲击负荷因为减震而消失期间的应力峰值和植入物的减震能力，这可以显著地提高植入物的使用寿命。
为了能够优化套构件与整体构造的植入物的基本构件的相互粘合，基本构件和套构件的材料成分可以基本相同。通过这种方式可以提供均匀构造的植入物，该植入物相对坚固并且可以通过相对耐用的方式引入人(动物)体中。
尽管根据本发明的植入物可以由不同的材料制成，但是植入物的至少一部分优选由至少一种下述材料制成：生物相容金属、生物相容陶瓷、生物相容塑料和具有类似玻璃结构的生物相容材料。但是在应用生物相容金属的情况下，也可以设想应用金属合金。金属或金属合金优选从包括Ti、TiNb、TiV、Ta、TaNb、CoCr、CoCrMo、不锈钢、合金和它们的组合物的组中选择。为了能够实现根据本发明的具有整体构造的植入物，通常推荐钛和钛合金，例如Ti6Al4V，以及钴铬合金和不锈钢，这是因为这些材料的生物相容性已经被证实并且这些材料具有可加工性。具有类似玻璃结构的生物相容材料通常由非晶体金属合金(“松散金属玻璃合金”)制成。这些材料通常比钢坚固，不易磨损，比陶瓷硬，而且具有相对大的弹性。
在优选实施例中，套构件的孔隙度从厚度方向上看具有渐进性。套构件的孔隙度更优选在厚度方向上增大，其中套构件整体地连接在基本构件上的部分具有相对小的孔隙度，并且其中套构件远离基本构件的部分具有相对大的孔隙度。从厚度方向上看的这种孔隙度渐变的优点是：一方面，因为在植入物的芯内或正好周围存在相对小的空间，所以可以提供相对坚固的植入物；另一方面，指向骨的高密度多孔部具有相对开放的结构并且(因此)可以变形和相对容易地自己适应相邻的骨。而且外部相对开放的套构件提供相对大的接触表面，由此可以优化骨(向内)生长。尤其，为了能够进一步优化骨(向内)生长，套构件远离基本构件的部分优选具有与多孔骨相同的孔隙度，由此在骨和假体之间实现最佳连接。
套构件中的每英寸孔数(ppi)优选基本大于10ppi，更优选在60到100ppi之间。具有大于60ppi的每英寸孔数的套构件相对开放，这可以促进骨(向内)生长。套构件中的每英寸孔数优选基本不变。但是如前面所述，有利的是允许套构件的孔隙度从套构件的厚度方向上看是渐进的。孔隙度可以通过增大套构件的多孔网格的线(thread)粗度来减小，由此可以优化套构件的性能。基本构件和套构件优选通过在模具中浇铸液化生物相容材料的方法在一个生产步骤中制成。为了能够简化浇铸过程，套构件优选每英寸应用的孔数在30到45ppi之间。限定(在基本不变的每英寸孔数下的)孔隙度的孔径优选在100到1500μm，更优选在200到500μm。套构件的厚度可以变化，但是为了能够实现显著的骨(向内)生长，套构件的厚度优选等于套构件孔径的至少三倍。更优选的是，套构件的厚度基本在300μm到15mm之间。在这里套构件的厚度可以根据套构件所述部分的位置而变化。但是也可以设想套构件的厚度是基本均匀的。套构件的杨氏弹性模量优选大于0.5GPa，并且更优选在5到30GPa之间。为了能够提供足够可靠的植入物，抗压强度和抗张强度优选至少为10MPa。
在优选实施例中，套构件具有至少一种下述添加剂：骨生长刺激剂、血管生成刺激因子、抗菌剂和炎症抑制剂。为了提高套构件的生物相容性，套构件的孔可以具有含钙和/或磷酸盐的材料。该材料的例子是羟磷灰石(HA)、氟磷灰石、磷酸三钙(TCP)和磷酸四钙、磷酸八钙(OCP)、透钙磷石(作为HA的前体)和碳酸钙。因为植入物和骨的接合层优选是相对弹性的，所以可以选择性地应用一个或多个纳米涂层。在特别优选的实施例中，至少部分所述至少一种施用的添加剂通过基本遮挡的方式结合在套构件中，其中可以通过电磁辐射释放所述添加剂。在没有或至少不充分的骨(向内)生长发生的情况下，可以仅仅通过辐射植入物这种方式相对容易地释放一定剂量的骨生长刺激物质，由此可以免除外科手术介入。除了通过电磁辐射的方式辐射植入物之外，也可以设想使植入物振动以释放所述添加剂。
本发明还涉及一种用于制造根据本发明的植入物的方法，该方法包括下述步骤：A)在植入物成型模具中布置至少一个泡沫成型模具，B)在植入物成型模具和植入物成型模具中容纳的泡沫成型模具中布置，尤其是浇铸生物相容材料，和C)从在步骤B)过程中形成的植入物处移除泡沫成型模具。在植入物成型模具中布置泡沫成型模具必须小心翼翼地进行并且可以通过已知技术来实现。这里泡沫成型模具通常通过块来形成，管道系统在该块中形成以便能够形成套构件。这里也可以设想多个泡沫成型模具同时布置在植入物成型模具中。在优选实施例中，根据步骤B)的在植入物成型模具中布置，尤其是浇铸生物相容材料在升高的温度下进行。在该升高的温度下，在室温下为固体的生物相容材料将是液体，由此材料可以浇铸在这两个模具中。所述方法更优选包括步骤D)，步骤D)包括在根据步骤B)的在植入物成型模具中布置，尤其是浇铸生物相容材料之后，使植入物成型模具中浇铸的生物相容材料固化。使生物相容物质固化通常通过使形成的植入物主动或被动地冷却来进行。根据本发明的方法尤其适用于生产由金属或金属合金制成的植入物。
在优选实施例中，所述方法还包括步骤E)，步骤E)包括在植入物成型模具中布置至少一个泡沫成型模具之前，优化泡沫成型模具的设计，以便能够在确定的应用中使用于成形的植入物的骨生长能力最大化。泡沫成型模具的制造可以描述如下。首先，在外壳中放置网状泡沫(步骤1)。然后用耐热材料充分渗透泡沫(步骤2)。为了能够产生该耐热材料的固体结构，随后对耐热材料进行加固(步骤3)。进一步从外壳中取出其中具有加固的耐热结构的泡沫(步骤4)，此后从耐热结构处移除泡沫(步骤5)，同时形成可以在根据本发明的方法中应用的真正的泡沫成型模具。泡沫的移除也可以与液态金属的浇铸同时进行。在后一情况下，泡沫由于液态金属的高温而消失。可选的方法将是用耐热颗粒填充耐热外壳(步骤1)，此后可以通过振动和挤压的方式获得相对致密的颗粒包装(步骤2)。但是这种可选的泡沫成型模具通常较不优选，因为这种泡沫成型模具不如移除外壳后的稳定。
该方法还优选包括步骤F)，步骤F)包括在根据步骤C)的从形成的植入物处移除泡沫成型模具之后，对形成的植入物进行抛光。抛光尤其有利地能够优化植入物相对于骨的安装。抛光在这里通常将具有机械特性，其中植入物例如可以在制造之后通过研磨、打磨和/或磨光来抛光。
附图说明
将在以下附图中所示的非限制性典型实施例的基础上对本发明进行说明。其中：
图1示出了作为人体髋关节部件的根据本发明的植入物的示意性横截面。
具体实施方式
图1示出了根据本发明的植入物1的示意性横截面，该植入物1作为人体髋关节2的部件。植入物1通常也称为假体，是非骨水泥植入物1，其中植入物1可以通过骨(向内)生长的方式锚固在骨3上，从而形成髋关节2的一部分。为了这个目的根据本发明的植入物1包括基本实心的芯4，芯4实际上由头部4a和与头部4a连接的支撑部4b构成，其中支撑部4b局部被多孔套构件5包围。在这里套构件5具有由相互连接的孔组成的网状结构。这里特别的是芯4和套构件5相互整体地连接，因此不需要介入粘合层，并且最重要的是基本具有相同的材料成分，由此植入物1相对坚固并因此耐用。此外，由于这种特殊构造，使得可以相互独立地优化芯4和套构件5的测定特性，例如刚度和设计，由此同样可以优化用户友好性和骨(向内)生长，并因此优化在相邻骨3上的锚固。由此可以将植入物1和骨3之间的接合应力降到最小。与上面的骨3连接的植入物1的承窝(socket)6也由多孔套构件形成。在图示的典型实施例中，芯4和两个套构件5、6由生物相容材料，尤其是金属合金，更尤其是钴铬合金制成。在这里应用钴铬合金是有利的，因为这种合金可以相对容易地达到它可以浇铸的状态，由此植入物1可以通过浇铸的方式用一个生产步骤制成。套构件5、6的孔隙度不是均匀的，而是在各个套构件5、6的厚度方向上渐进。一方面为了能够保证植入物1具有足够的强度和弹性(塑性变形性)，另一方面为了能够优化骨(向内)生长，每个套构件5、6靠近芯4的孔隙度优选在50％到70％之间，同时靠近骨3的孔隙度在约85％到96％之间。套构件5、6的每英寸孔数(ppi)优选为基本不变并且在30到45ppi之间。如在与植入物1头部4a相互作用的套构件6中所示，骨的向内生长将保持只受套构件6的表面层6a的限制，其中套构件6的较深层6b将不(直接)用于将植入物1锚固到骨3。但是由于套构件6的这个较深层6b中的永久空孔，会产生一定的永久弹性，并由此产生永久减震能力。套构件6可以选择性地具有添加剂，例如骨生长刺激剂。这些添加剂尤其布置在套构件6表面层6a的孔中，但是也可以布置在套构件6的较深层6b中。在后一实施例中，可以设想的是，结合在较深层6b中的添加剂受到物理和/或化学遮挡，并且(如果必要)只可以通过辐射植入物1的方式释放添加剂。
显然本发明不限于文中所示和描述的典型实施例，相反对本领域技术人员来说是不言而喻的许多变形可能落在所附权利要求的范围内。

Claims (16)

1.一种植入物，包括：
基本实心的基本构件，和
至少部分地围绕基本构件的多孔套构件，其用于连接蜂窝状组织，
其中基本构件和套构件相互整体地连接，并且多孔套构件基本由具有开孔的构件形成。
2.如权利要求1所述的植入物，其特征在于：基本构件和套构件的材料成分基本是相同的。
3.如权利要求1或2所述的植入物，其特征在于：套构件具有基本可塑性变形的结构。
4.如前述权利要求中任一项所述的植入物，其特征在于：植入物至少部分地由至少一种下述材料制成：生物相容金属、生物相容陶瓷、生物相容塑料和具有类似玻璃结构的生物相容材料。
5.如前述权利要求中任一项所述的植入物，其特征在于：套构件的孔隙度从厚度方向上看具有渐进性。
6.如前述权利要求中任一项所述的植入物，其特征在于：套构件的远离基本构件的部分具有与多孔骨相同的孔隙度。
7.如前述权利要求中任一项所述的植入物，其特征在于：套构件中的每英寸孔数(ppi)基本大于10ppi。
8.如前述权利要求中任一项所述的植入物，其特征在于：套构件的孔的孔径基本在100到1500μm之间。
9.如前述权利要求中任一项所述的植入物，其特征在于：套构件的厚度基本在300μm到15mm之间。
10.如前述权利要求中任一项所述的植入物，其特征在于：套构件具有至少一种下述添加剂：骨生长刺激剂、血管生成刺激因子、抗菌剂和炎症抑制剂。
11.如权利要求10所述的植入物，其特征在于：至少部分所述至少一种施用的添加剂以基本遮挡的方式结合在套构件中，其中可以通过电磁辐射和/或通过使植入物振动来释放所述添加剂。
12.一种用于制造如权利要求1-11中任一项所述的植入物的方法，包括以下步骤：
A)在植入物成型模具中布置至少一个泡沫成型模具，
B)在植入物成型模具和植入物成型模具中容纳的泡沫成型模具中布置，尤其是浇铸生物相容材料，以及
C)从步骤B)过程中形成的植入物处移除泡沫成型模具。
13.如权利要求12所述的方法，其特征在于：根据步骤B)的在植入物成型模具中布置，尤其是浇铸生物相容材料在升高的温度下进行。
14.如权利要求13所述的方法，其特征在于：该方法还包括步骤D)，步骤D)包括在根据步骤B)的在植入物成型模具中布置，尤其是浇铸生物相容材料之后，使植入物成型模具中的生物相容材料铸件固化。
15.如权利要求12-14中任一项所述的方法，其特征在于：该方法还包括步骤E)，步骤E)包括在植入物成型模具中布置至少一个泡沫成型模具之前优化泡沫成型模具的设计。
16.如权利要求12-15中任一项所述的方法，其特征在于：该方法还包括步骤F)，步骤F)包括在根据步骤C)的从形成的植入物处移除泡沫成型模具之后对形成的植入物进行抛光。
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Application publication date: 20090513