CN109475659A - 采用附加的选择性激光烧结制造植入物的方法及植入物 - Google Patents
采用附加的选择性激光烧结制造植入物的方法及植入物 Download PDFInfo
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Abstract
本发明涉及一种用于制造植入物的方法,其中超高分子量聚乙烯(UHMWPE)和/或高密度聚乙烯(HDPE)和/或聚丙烯(PP)的组的颗粒通过选择性激光烧结方法被逐层熔合在一起。本发明还涉及根据该方法制造的植入物。
Description
技术领域
本发明涉及一种用于制造植入物的方法。
背景技术
其中已知的是要对特定的颗粒进行加工,特别是UHMWPE颗粒(超高分子量聚乙烯颗粒)。在本文中,UHMWPE被认为是一种以合成方式纯化的纯的形式的颗粒。
例如,US 6,641,617 B1中公开了一种由UHMWPE制成的经辐射处理的医用假体。基于此可知,UHMWPE被熔化时,其基本上不存在可检测的自由基。
EP 1 563 857 A2中还公开了一种制造耐磨抗氧化聚乙烯(PE)的方法。基于此可知,在低于聚乙烯熔化温度的温度下提供聚乙烯,然后对其进行辐照,以获得交联结构并产生足够的热量同时至少部分地熔化聚乙烯。之后,聚乙烯被冷却。
US 8142886 B2中公开了激光烧结多孔聚合物制品,其具有包含特定量无机材料的芯。这个芯具有至少两个另外的层,具有的无机材料包括金属/金属合金、磷酸钙、不锈钢和玻璃的组中的至少两个组分的混合物。
从EP 1 276 436 A1中也已知一种用于改善植入物耐磨性和抗氧化性的方法制成的植入物,其中UHMWPE被采用并且植入物的照射剂量在4Mrad以上进行。进一步的,在此文中,氧化剂与聚乙烯粉末的混合被公开。
从US2014/0052264A1也已知一种包括多个烧结聚合物颗粒的多孔植入物,其表面上存在抗氧化剂。因此,该专利申请重点在于一种包括多个聚合物颗粒的多孔植入物,多个聚合物颗粒在多个接触点处被烧结在一起以形成具有若干孔的多孔网络,其中多个聚合物颗粒也可包含有聚乙烯。抗氧化剂被布置在至少一些聚合物颗粒的表面上和/或多孔网络的孔中。
发明内容
本发明的目的是提供一种可获得的更快、更低成本且更容易实施的方法,该方法适于更快速且更成功地整合到哺乳动物组织中的植入物。
根据本发明,通过以下事实来实现这一目的,例如,仅由超高分子量聚乙烯(UHMWPE)和/或高密度聚乙烯(HDPE)和/或聚丙烯(PP)的组的颗粒,特别是由它们制成的但不同类型的混合物,通过选择性激光烧结法(SLS法)将其逐层熔合在一起。此外,例如作为填料的其它颗粒也可以被混合。因此,UHMWPE、HDPE和PP中的每一种可以仅以纯的形式单独使用或以两种组分的混合比例使用或以所有三种类型颗粒的混合物使用。分别作为添加剂和混合物,材料(例如HAP、CaCO3、Mg、α/βTCP)或其它聚酯材料(例如PDLLA、PLGA、PLA、PGA、壳聚糖纤维、壳聚糖颗粒)是合适的。
特别地,UHMWPE、HDPE和PP组分已被证明可用于植入物的制造。所述植入物至少部分地显示出期望的软组织和骨组织的向内生长。即使是保密进行的第一次临床试验,其也是成功的,特别是具有相适应结构的新植入物。这里,特别好的向内生长是显而易见的。
具体实施方式
优选的实施例在从属权利要求被要求保护,并将在下面详细解释。
当用于形成块状主体或包括夹带空气/孔隙的(多孔)主体的颗粒被熔合在一起时是有利的。除了快速向内生长之外,还实现了持久耐用性能和适当的负载承受性能。
当主体具有完整的几何形状(例如包括底切和/或凹陷)时,甚至制造特定于患者的个体植入物是可能的。甚至可以制造最复杂的几何形状,其能够在人体上进行广泛用途的使用,例如,特别是在颅、手、胸骨、和脚部区域。
当颗粒呈马铃薯状或球状形状时,已经被证实有利于人体组织生长到植入物中。
在该情况下,呈粉末形式的颗粒具有大约20μm至大约300μm的直径或者大约50μm至大约300μm的直径,则是被期望的。
呈粉末粒存在的颗粒应具有大约40μm至大约200μm的直径,优选140μm的直径。
为了能够有效地从原始植入物以及从后来成品植入物中去除任何粒、颗粒和残余粉末成分,当以等离子体处理、雪喷射、用冷冻CO2薄片加压轰击(例如通过由加压空气驱动的超音速应用方式)、或者超声波浴形式进行表面处理是有利的。
一个优选示例性实施例的特征还在于对原始植入物进行热处理以增加强度。
当热处理跟随在表面处理后是有利的。特别是当在选择性激光烧结之后进行热处理以使待制造的植入物的孔保持未密封或打开时,稳定性得到改善并且将在适当的水平上促进向内生长。
为了获得特别卫生的制成品,当进行γ-灭菌处理时,优选在约25kGy下进行是有利的,例如在表面处理之前和/或在热处理之后。作为一种可选的方案,采用环氧乙烷(ETO)灭菌,电子束灭菌和等离子体灭菌的方法也是合适的。
本发明还涉及根据本发明方法制造的植入物的术中修改方法,即通过有针对性地引入热量。
此外,本发明还涉及以根据本发明的方式制造的植入物。
进一步的,还可以进一步开发该植入物,因为它是以CMF植入物(颅-颌-面植入物)的形式,以用于重建人体的软骨和/或骨组件,尤其是颅植入物。
发明人说明如下,孔径高达至600μm时,血管和结缔组织的迅速向内生长。
由于在植入物框架内的活细胞营养物质供应仅在从大约150μm至大约200μm的距离上是可能的,因此血管的新生成就该植入物的成功整合而言是决定性的过程。现在提出的方法有助于促进软组织和骨骼的向内生长。这种全面的血管向内生长有助于将控制感染的重要细胞运输到该植入物中。同时,软组织的向内生长增加了植入物的强度。因此,营养物质的供应和强度会得到改善。
本发明中,通过对UHMWPE、HDPE和/或PP进行选择性激光烧结(SLS)的方式来制造三维植入物,在此,通过限定的能量输入,UHMWPE和/或HDPE和/或PP粉末粒被局部地限定熔合在一起。然后,所有三种组分、仅两种或仅一种组分本身(以纯的形式或以混合物形式)彼此熔合/自身熔合。通过根据本发明的逐层熔合方式和随后固化,通过叠加或互连多个单独的层来形成三维植入物。
因此,可以保证植入物的短期制造以及植入物对相应/预期/期望的解剖学区域的适应性。
依靠SLS技术,生产块状和/或多孔的、几何形状复杂的(例如特定于患者的)个体植入物,以及标准植入物变成了可能。
特别地,能够实现对个体患者的快速适应,特别是就地适应,即在手术地点。
通过随后的热处理实现强度的提高。表面处理有利于向内生长行为,特别是当采用等离子体处理或基于CO2的技术时。提供了随后的通过热处理对手术中进行修正的选择。
应该提及机械连接功能的可能实现。例如,可以实施与其他材料,例如合成材料(例如可吸收合成材料)的结合。可以合理地实现一种互连/连接,例如以桥的形式接至另一材料的或以不同材料的桥的形式。
结合植入物几何形状的集成固定选项的可能性被促进。
基于相对于总体积的空容积,总孔隙率在大约5%到大约90%之间的激光烧结多孔植入物是使用者首选的,并且可以通过所提出的方法生产。即使大于60%的总孔隙率也可以容易地实现。
当孔径在大约100μm和大约3500μm之间时,尤其在大约80μm到大约120μmm之间,优选地大约为100m时,是理想的。
植入物的所有层可由UHMWPE和/或HDPE和/或PP制成也是可能的。
所有的层可以是多孔层的形式。当多孔激光烧结植入物用于限定的解剖区域,其已经被证实是有利的。还可以获得互连的孔结构。将表面有针对性地粗糙化到大约5μm,至最高到大约900μm是可以想象的。然而,多孔激光烧结植入物在使用前不包含更多的残余粉末颗粒。进行热处理,这样就不会发生孔的密封,获得互连孔链之间的强度增加。采用热空气、红外发射器和/或热去毛刺和/或爆炸去毛刺进行表面处理。这导致熔合/密封而没有任何孔隙密封;同时,氧气和燃料以及任选的添加剂可以在3000℃左右点燃。
可选择地,使用热空气的热处理也是可行的。在该情况下,于从300℃至650℃的温度下使用热空气流即可证明。然而,在处理期间植入物的温度较低。观察到的距离应该在大约10cm到30cm。热处理进行约5s至60s。这样操作时,可使用直径为14mm至9mm的缩小喷嘴,或尺寸为50mm×2mm至5mm的狭缝喷嘴,或者尺寸为75mm×2mm至5mm的狭缝喷嘴,或扁平模具。
当植入物是疏水的和/或亲水的时是有利的。例如,一侧可以是疏水的,而另一侧可以是亲水的。例如,基础材料可以是疏水的。在用低压等离子体处理时,可获得最优结构。涂层可以以这样的方式施加,例如,在特定区域中提供亲水行为,例如仅在一侧。这有助于从这一侧实现更快的向内生长。植入物可以用低压等离子体处理。
因此,当植入物基本显示出一种(例如疏水性)性质时,另一种性质(例如亲水性)可以通过涂层引起。反之亦然。
由UHMWPE、HDPE和/或PP组成的组的所述颗粒也可以专用和/或至少显著地/主要地使用。特别可能的是仅由其形成的混合物。
Claims (10)
1.一种用于制造植入物的方法,其中超高分子量聚乙烯(UHMWPE)和/或高密度聚乙烯(HDPE)和/或聚丙烯(PP)的组的颗粒通过选择性激光烧结方法被逐层熔合(verschmolzen)在一起。
2.根据权利要求1所述的方法,其特征在于,所述颗粒熔合在一起以形成块状主体或包括夹带空气的多孔主体。
3.根据权利要求2所述的方法,其特征在于,所述主体具有复杂的几何形状。
4.根据权利要求1-3中任一项所述的方法,其特征在于,所述颗粒具有马铃薯状或球状形状。
5.根据权利要求4所述的方法,其特征在于,呈粉末形式的所述颗粒具有大约20μm至大约300μm的直径。
6.根据权利要求5所述的方法,其特征在于,呈粉末粒存在的所述颗粒具有大约130μm至大约150μm的直径。
7.根据权利要求1-6中任一项所述的方法,其特征在于,表面处理以等离子体处理、雪喷射、用冷冻CO2薄片加压轰击、或者超声波浴的形式进行。
8.根据前述权利要求中任一项所述的方法,其特征在于,在选择性激光烧结之后进行热处理使得待制造的植入物的孔保持未密封或打开,和/或在选择性激光烧结之后进行热处理使得待制造的植入物的孔在整体或仅在部分区域中被表面密封。
9.根据前述权利要求中任一项制造的植入物。
10.根据权利要求9所述的植入物,其特征在于,所述植入物形成为CMF植入物,用于重建人体的软骨和/或骨组件。
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DE102018121552A1 (de) * | 2018-09-04 | 2020-03-05 | Karl Leibinger Medizintechnik Gmbh & Co. Kg | Lasergesinterter Filter, Verfahren zum Herstellen des Filters sowie Verfahren zum Flüssigkeitstransport |
DE102020210038A1 (de) * | 2020-08-07 | 2022-02-10 | Karl Leibinger Medizintechnik Gmbh & Co. Kg | Verfahren zur Herstellung eines biokompatiblen Implantats und Implantat |
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CA3026717A1 (en) | 2017-12-14 |
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