CN108025109A - 用于模制待植入人体的装置或关节占位器的材料 - Google Patents
用于模制待植入人体的装置或关节占位器的材料 Download PDFInfo
- Publication number
- CN108025109A CN108025109A CN201680010216.3A CN201680010216A CN108025109A CN 108025109 A CN108025109 A CN 108025109A CN 201680010216 A CN201680010216 A CN 201680010216A CN 108025109 A CN108025109 A CN 108025109A
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- Prior art keywords
- compatible
- human body
- bio
- additive
- implanted
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Classifications
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Abstract
用于获得用于治疗骨或关节座的占位器装置或可以植入人体的装置的生物相容的且可植入人体的材料,所述材料包含丙烯酸类树脂或塑料材料或聚乙烯(PE)或低密度聚乙烯或高密度聚乙烯或超高分子量聚乙烯(UHMWPE)或聚丙烯或聚酰胺或聚醚醚酮(PEEK)或其混合物,其中所述材料可以被模制并且包含添加剂,例如药用或医用物质和/或不透射线剂和/或另外的添加剂;用上述材料获得的用于治疗骨或关节部位的占位器装置或可以植入人体的装置以及用于获得根据本发明的材料的方法。
Description
技术领域
本发明涉及待用于模制能够植入人体的装置(例如导管、占位器(spacer)装置、假体等)的生物相容的且可植入的材料。
背景技术
增材生产(additive production,增材式生产)或物体三维打印技术正变得日益流行。
特别地,代表2D打印的自然发展的三维或3D打印允许通过叠加连续的材料层从三维模型重现物体,直至获得期望的形状。这样的三维模型通过合适的软件获得。
相对于其他增材生产技术,3D打印机通常更快、更可靠和更易于使用,并且还提供了在单个构建过程中模制和组装由具有不同物理和机械特性的不同材料制成的部件的可能性。
三维打印机的操作是基于使用由合适的软件开发的3D文件。
目的物体的3D模型通过上述软件以其截面中的一系列部分或层来制备。
然后一个在另一个之上地打印每个部分或层,以便重建整个三维物体。
存在不同的3D打印技术;它们的主要区别在于打印各个层的方式。
为了制造各个层,一些方法使用熔化或软化的材料。这样的技术的一些实例是“选择性激光烧结”(SLS)或“直接金属激光烧结”(DMLS)或“熔融沉积成型”(FDM)。
另一些方法提供了液体材料的沉积叠层,其用不同技术进行设置。这样的技术的一个实例被称为“数字光处理”(DLP)。
此外,在层合系统的情况下,存在根据期望的形状被切割,然后通过已知技术接合在一起的薄层。
基本的3D打印方法由通过挤出材料的打印系统组成。打印机每次创建模型的一个层,在其上铺上一层粉末(石膏或树脂)并分配粘合剂,例如像用喷墨进行打印。
逐层重复该过程,直至获得期望形状的物体。
以这种方式,可以对成品进行预测。
用于常规快速成型的FDM技术提供了对适合在支撑结构上逐层沉积熔融聚合物的喷嘴的支持。
此外,用于增材合成的一些3D打印机使用热塑性聚合物线状物作为构建材料。
在矫形学领域中,三维打印技术已导致骨或其部分被制造。例如,已经可以向患者植入3D打印的颅骨。
通过使用3D打印机用特定树脂制造了颅盖。通过基于钛的材料的三维打印获得了其他最近开发的假体。
通常用于3D打印的材料是:塑料材料,例如热塑性聚合物(例如用于SLS和FDM);金属;砂;玻璃(例如用于SLS);光聚合物(例如用于立体平版印刷术);层合片(通常为纸类型)和相关的胶;钛合金(例如用于“电子束熔化”或EBM);树脂;粘土;陶瓷等。
特别地,对于喷射或线型3D打印,所使用的材料必须是熔化的并且可通过适合于此目的的喷嘴挤出。
因此,为了能够三维打印一些物体,特别是用于医疗或矫形用途的物体,待解决的问题之一正是制造具有必须制成物体的最终目的的适当特性且同时具有适合于所选择的三维打印方法的特性的材料。
基本上,外科手术实践在体内在短时间内(例如对于导管)或永久地(例如对于聚甲基丙烯酸甲酯或PMMA(骨粘固剂(bone cement)的组分);对于作为髋部、膝部、肩部假体等中的摩擦表面的超高分子量聚乙烯或UHMWPE或简言之PE;或对于作为颅骨假体、脊柱笼等的聚醚醚酮或PEEK)提供对植入树脂或塑料材料的支持。
除了骨粘固剂的PMMA之外,所有其他塑料材料都经历机械加工以获得待植入人体的假体或装置。
这发生均归因于模制那些特定塑料材料的客观困难,并且特别是待植入人体的极不相同的形状和尺寸的假体或装置的极端异质要求(仅机械加工才可以快速满足的要求)。
然而,这些塑料材料(例如PE和PEEK)不含有且不能含有药用或医用物质,例如一种或更多种抗生素;也不含有且不能含有不透射线剂(radio-opacifying agent),例如钡;也不含有且不能含有用于治疗患者或外科手术治疗的可能的另外的医用添加剂。
然而,这样的物质在这样的塑料中将是非常有用的和可以理解的以实现愈合功能(例如局部抗生素),并且容易通过放射成像被检测,如另一方面通过具有不透射线剂的负载抗生素的骨粘固剂所完成的。
因此,需要添加有药用或医用物质和/或不透射线剂和/或其他有用的添加剂的生物相容的且可植入的材料来用于模制(也是三维地)待植入人体的装置或占位器装置。
发明内容
本发明的任务是改进现有技术。
在这样的技术任务中,本发明的目的是提供一种生物相容的且可植入的材料,其适用于模制技术(也可能是三维打印),并且其可以添加有药用或医用物质和/或另外的添加剂。本发明的目的是提供可挤出的生物相容的且可植入的材料。
根据本发明的一个方面,提供了根据权利要求1的生物相容的且可植入的材料。
根据本发明的另一方面,提供了根据权利要求9的用生物相容的且可植入的材料制成的用于治疗骨或关节部位的占位器装置或待植入人体的装置。
这样的用于治疗骨或关节座(joint seat)的占位器装置或待植入人体的装置的一个优点在于能够添加有药用或医用物质或添加剂并且能够通过模制(可能是三维模制)制造。
用于治疗骨或关节部位的占位器装置或待植入人体的装置的另一个优点在于能够是个性化的或者以快速且简单的方式连续制造,而基本上不需要进一步的表面精整加工。
根据本发明的另一方面,提供了根据权利要求14的用于获得生物相容的且可植入的材料的方法,所述材料适用于打印技术(也可能是三维打印),并且其可以添加有药用或医用物质和/或不透射线剂和/或另外的添加剂。
这种方法的优点在于其快速且简单,而基本上不需要进一步的表面精整加工步骤。
从属权利要求涉及本发明的优选和有利的实施方案。
具体实施方式
本发明涉及用于获得用于治疗骨或关节座的占位器装置或可以植入人体的装置的生物相容的且可植入人体的材料。
这样的材料可以包含以下材料中的一种或更多种:丙烯酸类树脂或塑料材料或聚乙烯(PE)或低密度聚乙烯或高密度聚乙烯或超高分子量聚乙烯(UHMWPE)或聚丙烯或聚酰胺或聚醚醚酮(PEEK)或其混合物。
在本发明的一个实施方案中,这样的塑料材料是不溶的。
在本发明的另一个实施方案中,塑料材料是可溶的且包含例如聚乳酸或聚乙醇酸聚合物或其他合适的聚合物。
可能的丙烯酸类树脂包含由MMA、苯乙烯和丙烯酸乙酯组成的丙烯酸共聚物或聚甲基丙烯酸甲酯或者含有丙烯酸类聚合物和/或共聚物的混合物。
这样的材料的主要特征之一是其是可模制的,例如通过注射成型或通过三维打印或通过成型压机或通过热塑性模制技术。
以这种方式,特别当涉及三维打印时,可以根据简单且快速的程序模制这样的材料,能够提供连续制造的医疗装置或占位器装置和个性化装置两者。
在后者情况下,实际上,可以获得待通过选择最适合于患者的外科手术或解剖需要的尺寸和形状或结构而获得的装置的三维模型,并且生产适合于特定患者的相关装置。
然而,在上述情况下,由于根据本发明的材料的可模制性,可以获得成品装置而基本上不需要进行进一步的表面精整或其加工步骤。
根据本发明的材料还包含至少一种添加剂,例如药用或医用物质和/或不透射线剂和/或另外的添加剂。包含在根据本发明的材料中的药用或医用物质可以由以下组成:至少一种抗生素,例如硫酸庆大霉素或另一种合适的抗生素;或有机或无机性质的防腐剂;抑菌剂,例如以其诸如金属粉末或盐如柠檬酸盐、蛋白盐、胶体、电解质的多种形式或可以用于人体的其他形式存在的银等。
例如,如果防腐剂或抑菌剂是金属银,则它对根据本发明将接收它的塑料材料的熔化温度不敏感。
此外,多种盐化的银如胶体银粉末对根据本发明的材料的仅几种塑料材料的熔化温度不敏感。
可能的抑菌剂还包含以其多种形式(例如其盐或组分)存在的铜和/或金以及上述银。这样的材料实际上是热稳定的。具有加药作用的其他热稳定无机物质可以有利地包含在熔融塑料材料中。另一个实例是具有防腐作用且在300℃以上热稳定的硼酸。
当待用所述材料获得的装置是用于治疗存在于骨或关节部位中的感染的占位器装置时,这样的选择是特别有意义的。
实际上,占位器装置的功能是保持被感染的假体(其为此原因而被去除)留下的关节间隙,并且同时治疗骨部位感染,在内部包含例如待在要治疗的区域中洗脱的药用或医用物质(例如至少一种抗生素)。
作为替代或补充,根据本发明的材料还可包含不透射线剂,例如金属粉末,如钨、钽、银,或者盐,如硫酸钡、氧化锆、氧化铋等。
如已知的,这样的试剂对X射线可见,并因此使得其可以监测待植入人体的装置或占位器装置,以及根据本发明的包含它们的材料的位置。
此外,根据本发明的材料可以包含另外的医用添加剂,例如粉末或颗粒形式的可溶和/或可再吸收的陶瓷材料,例如磷酸三钙或硫酸钙或羟基磷灰石等;或者生物相容类型且适合于引入人体的着色物质等。
如果这样的添加剂是不溶的或不可再吸收的,则它们可能永久地停留在人体内,或者如果包含它们的生物相容的且可植入的材料被除去,则它们可以被除去。
根据本发明的材料的待解决的问题之一是当所述材料被加热时或当其被模制(例如通过注射成型或三维打印或另一种模制技术)时,其中包含的物质可以由于根据本发明的材料遭遇的温度和/或压力而被降解或经历改性。
特别地,根据本发明的材料可以是例如直径可以在1毫米至10毫米之间或在1毫米至5毫米之间变化的线状物的形式,所述线状物例如适用于供给到线或喷墨型三维打印机或用于另一种模制技术中。
用于使根据本发明的材料减小到适用于被挤出和/或注射和/或三维打印的线状物的方法之一如下。
提供例如丸粒(例如压制丸粒)或颗粒形式的基础材料;将该材料添加到合适的机械(例如挤出机)中,并添加诸如药用或医用物质和/或不透射线剂和/或另外的添加剂中的至少一种的添加剂。
然后,将整个物体加热直至达到一定温度,例如其熔化温度,或加热至适合于使所讨论的材料(与所添加的添加剂的可能的混合物一起)熔化或软化的温度,加热至能够以线状物被挤出或可模制的这样的点。
这样的熔化温度随着根据本发明包含的聚合物变化而变化。大多数这样的聚合物的熔化值为60℃至300℃。这样的熔化温度可以例如为约250℃。
在本发明的一个实施方案中,然后存在通过合适的机械(例如同一挤出机)以一根或更多根具有上述直径的线状物的形式挤出加热或熔融的材料的步骤。
这样的至少一种线状物可以缠绕成卷,使得被挤出,其冷却并变得固结,并因此适合于然后被处理和储存。
这样的至少一种线状物可以用于供给到注射模具或3D打印机的喷嘴。
这样的线状物可以通过三维打印机或通过注射成型或通过成型压机或通过热塑性模制技术进行模制,以获得用于治疗骨或关节部位的占位器装置或可以植入人体的装置。
另外地或作为上述那些的替代方案,这样的方法可以提供对可能在其冷却之后对基础材料进行粉碎或造粒的步骤的支持。
在本发明的一个实施方案中,这样的步骤通过合适的造粒机进行。
此后,将基础材料或者经粉碎或经造粒的材料用于热塑性压机(通过其获得了模制产品)中。
在这种情况下,在一个实施方案中,在模制之前未获得线状物,而在第二实施方案中,其是如前所述获得的可能在其冷却之后被粉碎或造粒的线状物。
然后例如通过注射模压机模制经粉碎或经造粒的材料。
如所陈述的,材料熔化的温度必须低于药用或医用物质或不透射线剂或另外的添加剂的降解或破坏温度,因此它们在材料熔化后在线状物或所得的材料中还保持其原始特性。
因此,在本发明的一个实施方案中,根据具体需要,挤出或模制(而不是3D打印)在比上述物质降解的温度低的温度下通过适当地选择具有特别低的熔化或软化温度(例如低于药用或医用物质的熔化或降解温度)的塑料材料来进行,以获得包含药用或医用物质或不透射线剂或另外的添加剂中至少一种的最终产品。
例如,熔化温度为180℃的抗生素为了在模制期间不被降解而不得超过这样的温度。
通过上述材料可以获得可以植入人体的装置,例如导管,对于所述装置,具有加药形式、非加药形式、X射线可见形式、有色形式等可以是有用的。
或者,通过上述材料可以获得可以植入人体的装置,例如医疗“线”,对于所述装置,具有加药形式(例如包含抗生素和/或不透射线物质)可以是有用的。
在本发明的一个实施方案中,所述材料适用于制造最初不含药用或医用物质但在其被模制之后在随后的时间能够吸收这样的物质的可以植入人体的装置或占位器装置。
以这种方式,如果所讨论的材料需要以线状物的形式获得它的熔化温度或者高于药用或医用物质的降解温度的模制温度,则同样可以在无破坏它们的风险的情况下获得所讨论的装置并在随后的时间插入目的物质。在这种情况下,所讨论的装置为多孔的。装置的多孔性使其能够在其形成之后通过例如毛细管作用吸收这样的物质。
在另一个实施方案中,这样的装置由已经添加有至少一种药用或医用物质但是为多孔的材料制成,一旦形成,它们就能够吸收相对于它们中已经含有的物质相同或不同的另一种物质。
以这种方式,已看到,根据本发明的材料如何能够被模制以及可能能够以线状物的形式被制造,这允许根据患者的外科手术或解剖学需要在形状和尺寸两者以及其中包含的药用或医用物质或另外的添加剂或药剂方面以快速、简单和可能的可个性化的方式获得能够植入人体的装置或占位器装置。
本发明还涉及用于治疗骨或关节部位的占位器装置或可以植入人体的装置,其包含根据本发明的生物相容的且可植入人体的材料。
事实上,这样的装置包含如先前对于根据本发明的材料所描述的添加剂,例如药用或医用物质和/或不透射线剂和/或另外的添加剂。
这样的装置通过模制制造,例如通过三维打印机或通过注射成型或通过成型压机或通过热塑性模制技术。
可以用根据本发明的材料获得的另一个实施方案是颅骨假体。以这种方式,假体可以从根据解剖和植入要求所需的结构和尺寸形成的CAT数据直接制造,然后植入目的骨部位。
这样的颅骨假体可以含有药用或医用物质和/或不透射线剂和/或另外的添加剂。
由此构思的本发明可以经历多种修改和变型,这些修改和变型均被本发明的构思所涵盖。
在不脱离本发明的保护范围的情况下,可以将针对一个实施方案或实施方案呈现的特征与另一个实施方案或实施方案的特征组合。
此外,所有细节都可以用其他技术上的等同的要素替代。在实践中,所使用的材料以及可能的形状和尺寸可以根据需要为任意的,而不会因此原因而脱离所附权利要求书的保护范围。
Claims (19)
1.一种可以植入人体的生物相容的材料,用于获得用于治疗骨或关节部位的占位器装置或可以植入人体的装置,包含塑料材料例如丙烯酸类树脂或塑料材料或聚乙烯(PE)或低密度聚乙烯或高密度聚乙烯或超高分子量聚乙烯(UHMWPE)或聚丙烯或聚酰胺或聚醚醚酮或上述材料的混合物,其特征在于,其包含添加剂例如药用或医用物质和/或不透射线剂和/或另外的添加剂,以及所述生物相容的材料为可模制的。
2.根据权利要求1所述的材料,其中所述生物相容的材料被挤出成线状物或可挤出成线状物。
3.根据权利要求2所述的材料,其中所述线状物的直径为1mm至10mm或1mm至5mm。
4.根据前述权利要求中任一项所述的材料,其中所述生物相容的材料是可通过三维打印机或通过注射成型或通过模压机或使用热塑性模制技术模制的材料。
5.根据权利要求1所述的材料,其中所述药用或医用物质包含至少一种抗生素,一种有机抗生素,硫酸庆大霉素或另一种合适的抗生素,或者有机或无机性质的防腐剂,抑菌剂,例如多种形式的银,所述形式例如:金属粉末或盐如柠檬酸盐、蛋白盐、胶体、电解质或者可以用于人体的其他形式,或者多种形式的铜或金,所述形式例如:金属、合金或盐,硼酸等。
6.根据权利要求1所述的材料,其中所述不透射线剂包含钨、钽或银金属粉末或者他们的盐或硫酸钡、氧化锆、氧化铋等。
7.根据权利要求1所述的材料,其中所述另外的添加剂包含粉末或颗粒形式的可溶和/或可再吸收的陶瓷材料,例如磷酸三钙或硫酸钙或羟基磷灰石等;或者生物相容类型的且适合于引入人体的着色物质等。
8.根据权利要求1所述的材料,其中所述丙烯酸类树脂包含含有MMA、苯乙烯和丙烯酸乙酯的丙烯酸共聚物或聚甲基丙烯酸甲酯或含有丙烯酸类聚合物和/或共聚物的混合物。
9.一种用于治疗骨或关节部位的占位器装置或可植入人体的装置,包含可以植入人体的生物相容的材料,其中所述生物相容的材料包含塑料材料例如丙烯酸类树脂或聚乙烯(PE)或低密度聚乙烯或高密度聚乙烯或超高分子量聚乙烯(UHMWPE)或聚丙烯或聚酰胺或聚醚醚酮(PEEK)或上述材料的混合物,其特征在于,所述生物相容的材料包含添加剂例如药用或医用物质和/或不透射线剂和/或另外的添加剂。
10.根据权利要求9所述的装置,其中所述装置通过用三维打印机或通过注射成型或通过模压机或使用热塑性模制技术模制所述生物相容的材料获得。
11.根据权利要求9或10所述的装置,其中所述药用或医用物质包含至少一种抗生素,一种有机抗生素,硫酸庆大霉素或另一种合适的抗生素,或者有机或无机性质的防腐剂,抑菌剂,例如多种形式的银,所述形式例如:金属粉末或盐如柠檬酸盐、蛋白盐、胶体、电解质或者可以用于人体的其他形式,或者以其形式和合金形式存在或作为盐的铜或金,等。
12.根据权利要求9至11中任一项所述的装置,其中所述不透射线剂包含钨、钽或银金属粉末或盐例如硫酸钡、氧化锆、氧化铋等,和/或其中所述另外的添加剂包含粉末或颗粒形式的可溶和/或可再吸收的陶瓷材料,例如磷酸三钙或硫酸钙或羟基磷灰石等;或者生物相容类型的且适合于引入人体的着色物质等。
13.根据权利要求9至12中任一项所述的装置,其中所述丙烯酸类树脂包含由MMA、苯乙烯和丙烯酸乙酯构成的共聚物或聚甲基丙烯酸甲酯或含有丙烯酸类聚合物和/或共聚物的混合物。
14.一种用于获得根据权利要求1至8中任一项所述的可以植入人体的生物相容的材料的方法,包括以下步骤:
□提供塑料材料,所述塑料材料包含丙烯酸类树脂或塑料材料或聚乙烯(PE)或低密度聚乙烯或高密度聚乙烯或超高分子量聚乙烯(UHMWPE)或聚丙烯或聚酰胺或聚醚醚酮(PEEK)或上述材料的混合物,其中所述材料可以被模制,
□提供添加剂,例如药用或医用物质和/或不透射线剂和/或另外的添加剂,
□混合或添加所述塑料材料和所述添加剂获得经混合或经添加的基础材料。
15.根据权利要求14所述的方法,包括以下步骤:
□将所述经混合或经添加的基础材料加热至预定温度并以一根或更多根线状物的形状挤出熔化材料,或者
□将所述经混合或经添加的基础材料加热至预定温度,使其冷却,将所述材料粉碎或造粒以获得经粉碎或经造粒的材料,或者
□将所述经混合或经添加的基础材料加热至预定温度,以一根或更多根线状物的形状挤出熔化材料,并将呈一根或更多根线状物的形状的所述材料粉碎或造粒以获得经粉碎或经造粒的材料。
16.根据权利要求14或15所述的方法,包括以下步骤:通过三维打印机或通过注射成型或通过模压机或使用热塑性模制技术模制所述线状物或所述经粉碎或经造粒的材料,以获得用于治疗骨或关节部位的占位器装置或可以植入人体的装置。
17.根据权利要求14或15所述的方法,其中所述材料的所述混合或添加步骤和所述加热步骤在专用机械如挤出机中同时进行。
18.一种用于三维打印的线状物,包含根据权利要求1至8中任一项所述的材料。
19.一种用于获得根据权利要求9至13中任一项所述的用于治疗骨或关节部位的占位器装置或可植入人体的装置的方法,包括以下步骤:
□获得根据权利要求1至8中任一项所述的生物相容的材料,以及
□模制所述生物相容的材料。
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CN109847107A (zh) * | 2019-01-28 | 2019-06-07 | 湖南博隽生物医药有限公司 | 一种医用人工关节材料及其制备方法 |
CN109847107B (zh) * | 2019-01-28 | 2021-09-03 | 湖南博隽生物医药有限公司 | 一种医用人工关节材料及其制备方法 |
CN110935064A (zh) * | 2019-12-11 | 2020-03-31 | 深圳薪创生命科技有限公司 | 3d打印医用假体材料及其线材生产方法 |
CN113289060A (zh) * | 2020-05-03 | 2021-08-24 | 深圳海思医疗有限公司 | 组合物及应用、关节植入物型材、关节植入物及制备方法 |
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KR20170117417A (ko) | 2017-10-23 |
KR102573610B1 (ko) | 2023-08-31 |
WO2016132289A1 (en) | 2016-08-25 |
US20180028724A1 (en) | 2018-02-01 |
EP3258976A1 (en) | 2017-12-27 |
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