CN116940308A - 具有支撑元件和功能元件的多件式植入物 - Google Patents

具有支撑元件和功能元件的多件式植入物 Download PDF

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Publication number
CN116940308A
CN116940308A CN202280016316.2A CN202280016316A CN116940308A CN 116940308 A CN116940308 A CN 116940308A CN 202280016316 A CN202280016316 A CN 202280016316A CN 116940308 A CN116940308 A CN 116940308A
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CN
China
Prior art keywords
functional element
implant
support element
tissue
functional
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202280016316.2A
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English (en)
Inventor
A·阿克苏
S·格罗姆
F·赖瑙尔
T·沃尔弗拉姆
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Karl Leibinger Medizintechnik GmbH and Co KG
Original Assignee
Karl Leibinger Medizintechnik GmbH and Co KG
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Application filed by Karl Leibinger Medizintechnik GmbH and Co KG filed Critical Karl Leibinger Medizintechnik GmbH and Co KG
Publication of CN116940308A publication Critical patent/CN116940308A/zh
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Abstract

本发明提供一种多件式植入物(10),其包括:支撑元件(20),用于将植入物(10)固定在骨材料上;其中,支撑元件(20)构成容纳空间;和能引入容纳空间中的功能元件(30);其中,功能元件(30)能够由支撑元件(20)至少相对于一个自由度固定在容纳空间(26)中。

Description

具有支撑元件和功能元件的多件式植入物
技术领域
本发明涉及用于骨骼的植入物、尤其用于这样的骨骼的植入物,对于这种骨骼在结构上需要植入物具有一定的硬度和刚性,而另一方面希望植入物对身体自身的组织具有良好的可吸收性和/或可穿透性。
背景技术
现今可以用多种方法治疗骨缺损。这样的骨缺损例如出现在切除术中、创伤后或者由于骨炎等原因出现。对于治疗特别优选的通常是身体自身的自体骨移植。然而,用于这种骨移植的骨量的可用性有限,并且在提取部位可能出现并发症。
备用方案为使用具有骨传导作用的生物材料作为骨替代材料,即,该生物材料为此能够作为用于自然骨生长的引导支架起作用。为此特别优选的是具有生物相容性并且在愈合期后被再生的新骨(即新的骨材料)取代的生物材料。
然而,植入物在传统上通过固定元件如螺钉或钉子被定位。这以植入物或植入物材料的基本的原始强度为前提。对于在生物力学上较弱的植入系统、例如由可吸收的陶瓷材料或聚合物材料制成的植入系统,原始强度可能是一个问题。该问题常规上通过增加的材料使用和较大的设计结构来解决。然而,该解决方案与尽可能少地将外来材料引入体内的目标相矛盾,并且其可应用性受到几何和定型的边界条件的限制。
发明内容
本发明所要解决的技术问题是提供一种改进的植入物。该技术问题通过具有权利要求1的特征的植入物解决。
相应地提供一种多件式植入物(尤其两件式植入物),该植入物包括支撑元件,该支撑元件用于将植入物固定在有机硬组织上、尤其固定在诸如板状骨或管状骨(或者说长骨)之类的骨材料上。支撑元件的容纳结构构成(或者:形成)容纳空间,尤其如此构成,使得容纳空间向外保持可接触到或者说可接近(即不完全封闭)。植入物还包括能引入(或者已被引入)容纳空间中的功能元件。该功能元件由支撑元件(更准确地说:由支撑元件的容纳结构)至少相对于一个自由度能固定(或者已被固定)在容纳空间中。
优选地,容纳结构设计为使得功能元件在其中相对于多个自由度、特别优选相对于所有自由度能固定或者已被固定。在一些实施方式中可以规定,在将支撑元件固定在患者的骨材料上之后才相对于功能元件的所有自由度进行完全固定。
尤其地,将植入物设计为(至少)由两部分构成、即设计为具有支撑元件和由支撑元件保持和固定的功能元件的基本构思能够实现,提供植入物的一定的刚性和稳健性,该刚性和稳健性被需要用于例如将植入物配合精确且防移动地固定在人体中/人体上,而不会由此需要在显著程度上限制用于植入物的功能部分的材料和结构选择。植入物的功能元件(或:功能部分)可以理解为应该通过生物、化学和/或物理的相互作用部分或完全地取代身体自身组织和/或被身体自身组织吸收的那个部分。
因此,本发明的构思在于,通过功能元件提供植入物的功能部分,而支撑元件提供对植入物的固定和/或稳定化,并且在此尤其提供对功能元件的固定和/或稳定化。
因此,支撑元件补偿植入物的往往更软和/或更脆的功能元件的在生物力学方面的缺点,该功能元件也可以称为交互且一体化的“生物笼(原文:)”。此外,在选择用于功能元件的材料时可以在很大程度上忽略其机械特性,以便可以将焦点放在生物学和医学上最好且最有前景的材料上。因为在根据本发明的植入物中,植入物整体的机械稳定性不由或几乎不由功能元件提供,而是由支撑元件引起。因此,支撑元件提供用于机械固定和几何布置的附加可能性以及用于在其它情况下不能最佳地植入的生物笼(功能性植入部分)的立体定向解决方案。支撑元件也可以称为支架元件。
因此,植入物尤其可以设计为,使得植入物的固定在患者的硬组织部件(例如板状骨、管状骨)中进行,而功能元件的生物激活可以在其它、优选属于软组织类的组织结构中进行。属于软组织类的组织结构(或:软组织结构)例如包括软骨、肌肉组织或神经组织。
支撑元件和功能元件均可以由能够被吸收和/或不能被吸收的材料形成,这取决于希望的应用。支撑元件和功能元件均可以分别由能够被吸收和不能被吸收的材料构成的混合物形成。优选的是,支撑元件由不能被吸收的材料形成,并且功能元件至少部分或者完全地由能够被吸收材料形成。
功能元件特别优选地设计为多孔的,以便使功能元件的血液流通变得容易。与此相反,支撑元件优选设计为实心的(即不是多孔的),以便防止软组织可能生长到支撑元件中。以此方式可以将骨再生限制到希望的几何形状。
因此,如果理想的、即医学上优选的功能元件太脆或太软或者由于其它原因不能直接植入或者不能单独植入,例如因为功能元件不能通过通常的固定件(螺钉、钉子、粘合剂等)固定在患者上/中,或者功能元件本身不能保持结构上的完整,则可以特别有利地应用本发明。因此,在支撑元件和功能元件的优选材料组合中,在大多数实施方式中将支撑元件的材料设计(或选择)为比功能元件的材料更硬和/或与功能元件的材料相比不那么脆。
此外,所述支撑元件优选由不吸收外皮(保护外皮)处的骨细胞的材料构成并且因此在骨再生完成之后可以被容易地移除。因此,在一些应用中,在骨再生完成(或者与组织相互作用的功能元件具有足够的稳定性)之后,支撑元件又可以从人或动物患者的体内取出。与此相反,在其它应用中可以规定,即使在功能元件的(最佳可能或者说尽可能或者完全的)吸收完成的情况下,支撑元件仍然保持植入在体内。尤其当支撑元件的外轮廓取代骨骼在缺失部位处的外轮廓时,保留支撑元件可能是有用的。
支撑元件在骨材料上的固定可以用任意固定件实现,例如通过(一个或多个)螺钉、销钉、钉子、线材、通过缝合材料和/或通过胶粘剂实现。
视解剖学特性和使用目的而定,在同一外部支撑元件中也能够装入或者已装入多个功能元件。每个功能元件优选设计为一件式,特别优选通过增材制造制成。备选地,一个功能元件也可以多件式地由多个部件组成,例如以便在植入物的植入期间在两个部件之间容纳组织部件。在这种情况下,外部支撑元件20不只可以用于固定功能元件整体,而且还可以用于将功能元件的两个(或者多个)单独部件相互固定(并且因此必要时也固定包围在两个或者多个单独部件之间的组织部件)。
根据一些优选实施方式、实施方式的变型方案或者扩展设计,支撑元件设计为外部支撑元件,并且容纳空间是由外部支撑元件部分地包围的内部空间。“部分地包围”应当尤其是指,内部空间仍部分地向外敞开,以便能够容纳功能元件。优选地,在引入(或:插入)功能元件之后,容纳空间或内部空间完全填满。在一些实施方式中,功能元件完全容纳在内部空间中;在其它实施方式中,功能元件突伸超出内部空间。
将支撑元件设计为外部支撑元件的优点在于,支撑元件例如由此可以起到保护处于内部的功能元件(在该情况下功能元件也可以称为“内部元件”)的作用,以及支撑元件可以从外部固定功能元件并且还可以在结构上缚紧功能元件。有利地,以此方式还防止从外部作用在功能元件上的较高作用力,从而骨再生可以不受干扰地并且在没有功能元件移动的情况下继续进行。
根据一些优选实施方式、实施方式的变型方案或扩展设计,支撑元件具有窗结构或肋结构,穿过该窗结构或肋结构能接近功能元件,尤其作为对开口的补充,通过该开口能够将功能元件引入支撑元件的容纳空间中。以此方式,组织可以更快且更容易地与功能元件相互作用,并且植入物的X射线透明度也可以得到改善。优选地,当功能元件已按规定被插入支撑元件中时,功能元件封闭窗结构或肋结构。窗结构可以具有环绕地闭合的框架,或者也可以只具有环绕地延伸的框架的一部分。尤其可以让窗结构的边缘或边缘区段是自由的,例如以便提供进入组织容纳结构的入口。
在其它实施方式中,可植入的支撑元件可设计为位于植入物的内部并且从内部固定和/或在结构上稳定功能元件。
功能元件可以优选由生物相容的、能够被吸收的生物材料形成。功能元件例如可以由磷酸三钙(β-TCP)、羟基磷灰石(HA)或者由可生物降解的复合材料(由例如金属、聚合物、陶瓷或生物玻璃制成)形成,这些材料具有类骨成分和良好的骨传导性。在一些实施方式中,功能元件由掺有碳酸钙或镁的可生物降解且生物相容的聚合物构成。同样地,特定的实施方式还可以掺有磷灰石。
用于功能元件的一般可能的材料是所有可能的能够被吸收的系统,诸如可生物降解的镁、可生物降解的镁合金、可生物降解的铁合金、可生物降解的锌合金、可生物降解的陶瓷系统、可生物吸收的聚合物或共聚物或者上述材料的混合变体或混合物或组合。
合适的可生物降解且生物相容的聚合物例如包括:聚乳酸,例如左旋聚乳酸(英文:Poly(L-Lactic Acid),缩写:PLLA)或外消旋聚乳酸(英文:Poly(D,L-Lactic Acid),缩写:PDLLA)或聚谷氨酸(英文:Polyglutamic acid,缩写:PGA)或丙交酯-乙交酯共聚物(单体乳酸和乙交酯的共聚物,或者说聚(丙交酯-共-乙交酯),英文:Poly(lactid-co-glycolid),缩写:PLGA)或聚己内酯(英文:Polycaprolactone,缩写:PCL)。
根据一些优选实施方式、实施方式的变型方案或扩展设计,支撑元件由不能被吸收的材料、尤其由钛或钛合金、由PEEK(聚醚醚酮)、由植入钢和/或UHMWPE(超高分子量聚乙烯,英文全称:Ultra-High-Molecular-Weight Polyethylene,例如商标名称Dyneema、IZANAS或Spectra)形成。
根据一些优选实施方式、实施方式的变型方案或扩展设计,功能元件能够卡入和/或夹入(或者已被卡入或夹入)容纳空间中。为此,容纳空间尤其可以由支撑元件的翻起的边缘构成,其中,功能元件能够卡入该翻起的边缘(或:翻起部)中。以此方式可以在不使用附加固定件的情况下将功能元件相对于支撑元件固定,并且随后将功能元件与支撑元件共同地例如固定在患者的骨骼上。
翻起的边缘可以具有曲率,由此翻起的边缘可以在多个侧面上或者在多个维度或自由度中固定或限定功能元件。也可以存在多个翻起的边缘,功能元件最初被卡在这些翻起的边缘之间。
在这些实施方式中,特别有利的是,功能元件设计为平坦的或扁平的结构,该结构具有300至3000微米、优选在500至2500微米之间、特别优选在900至1800微米之间的厚度。备选地,功能元件也可以总体较宽地设计或者设计为具有其它形状,但在至少一个边缘处设计得较平坦,以便功能元件能够通过该边缘卡入或夹入支撑元件上的外翻部(即容纳空间)中。
根据一些优选实施方式、实施方式的变型方案或扩展设计,功能元件的内部具有至少一个特殊结构(或者说例外结构),该特殊结构设计用于增大功能元件的表面,例如以便能够实现功能元件与患者的天然组织的尽可能大面积的相互作用。
所述至少一个特殊结构可以包括功能元件中的至少一个(优选分别多个)空腔和/或至少一个隧道和/或至少一个盲孔。所述至少一个特殊结构的尺寸可以设计为使得产生或者防止毛细效应。
此外,无论是否存在一个或多个特殊结构都优选的是,功能元件是多孔的,以便能够实现更好的血液流通(或者被其它液体如淋巴液等穿过)。
根据一些优选实施方式、实施方式的变型方案或扩展设计,功能元件具有组织容纳结构,组织部件能插入该组织容纳结构中,和/或组织部件能导引穿过该组织容纳结构。可以设置有具有多个向外的开口的单独的组织容纳结构,或者也可以设置有多个组织容纳结构。有利地,当功能元件已被装入支撑元件中时,支撑元件具有与组织容纳结构的一个或多个开口相对应的开口。这样的组织部件(或组织结构)例如可以是血管(脉管、静脉、毛细血管......)或膜。组织容纳结构可以设计为向外敞开的沟或通道,例如以便使组织部件的插入或嵌入变得容易。但例如当要实现定向的组织生长时,组织容纳结构例如也可以单边地封闭。一般性地可以设有在不同侧敞开和闭合的组织容纳结构,这取决于什么样的组织部件要被装入或向内生长、这要从哪一侧并且要向何处进行等更多的考虑因素。
根据另一方面,本发明还包括一种用于植入根据本发明的植入物的方法,该方法包括以下步骤:将功能元件插入(尤其卡入或夹入)支撑元件的容纳空间中;将支撑元件与插入容纳空间中的功能元件一同引入人或动物患者的体内;将支撑元件固定在用于固定植入物的骨骼上。可选的步骤可以包括将患者的组织部件或组织结构引入植入物的组织容纳结构中,其中,组织部件的所述引入可以在将外部支撑元件引入患者体内之前、期间和/或之后执行。另外的可选步骤可以包括在不从患者体内移除功能元件的情况下从患者体内移除支撑元件。
附图说明
以下根据附图中的实施例详细阐述本发明。在此,在局部简化的视图中:
图1示出根据第一和第二实施方式的植入物的应用的示意性概览;
图2示出从侧面观察图1中根据第一实施方式的植入物的组合视图;
图3示出剖切图2中的植入物得到的横剖面图;
图4示出图1中根据第二实施方式的植入物的视图;
图5示出根据本发明的第三实施方式的植入物的从上方观察的示意性俯视图;
图6a示出图5中的植入物的示意性侧视图;
图6b示出图5中的植入物的示意性横剖面图。
在全部附图中,相同或功能相同的元件和装置只要没有另作说明则配设有相同的附图标记。
具体实施方式
图1示出根据本发明的第一实施方式的植入物10以及根据本发明的第二实施方式的植入物110的应用的示意图。
在图1中还示出人的头骨1。针对植入物10的描述假定该头骨的下颌骨2上例如由于事故或切除术缺失一块3。这意味着,在当前情况中,植入物10被用于板状骨。针对植入物110假定头骨1的右颧骨上的缺失部位。
植入物10用于至少在短期内通过人工材料替代下颌骨2中的缺失部位3。为此,植入物10包括外部的支撑元件和能够被吸收的功能元件,以下还参照图2和图3详细阐述该支撑元件和功能元件。功能元件在此要促进和引导自然骨再生并且在中期被再生的骨组织吸收。
图2示出图1中的植入物10在植入状态下的从外侧观察的视图,其中,在该情况中,外侧是指当植入物10按规定已被植入之后背离头骨1(或者一般而言:待治疗、待替换或待补充的骨骼)的那一侧。在图2中可以看到,功能元件30如何装入外部支撑元件20中并且已经与该支撑元件共同地植入、即尤其固定在骨骼(在此为下颌骨2)上。
支撑元件20可以例如由不能被吸收的材料、尤其由钛或钛合金、由PEEK(聚醚醚酮)、由植入钢和/或UHMWPE(超高分子量聚乙烯,英文全称:Ultra-High-Molecular-WeightPolyethylene,例如商标名称Dyneema、IZANAS或Spectra)形成。
外部支撑元件20设计为具有长形延伸的载体结构23,在该载体结构的两个纵向端部处分别布置有固定区段,在这些固定区段中或固定区段上形成固定件或者用于固定件的辅助件、在此为各三个螺纹孔27。当然,除了螺纹孔27之外,其它固定件或者用于固定件的辅助结构(如用于螺钉的螺纹孔)也可以设计在外部支撑元件20上。用于容纳销钉系统的孔结构也是可行的,这些销钉系统可以用于临时固定。
在载体结构23的固定区段之间形成窗结构25作为外部支撑元件20的另外的部分,在未植入状态下,通过该窗结构可以看到并且接近功能元件30(更准确地说:功能元件30的外侧31)。因此,在植入之后,在外部支撑元件20的外侧覆盖植入物10的有机组织可以直接与功能元件30的外侧31接触。此外,这种窗结构25可以实现植入物10的最大可能的X射线透明度。
外部支撑元件20围绕窗结构25的区段可以称为框架结构24。在此,框架结构24不是完全围绕窗结构25闭合,尤其地,该框架结构将在侧视图中呈四边形的功能元件30只在一个边缘处完全地(通过载体结构23的一部分)包围以及在两个另外的边缘处只部分地包围、优选至少包围一半。这两个另外的边缘各自的其它部分例如可以由骨材料包围或接触,如同根据图3更清楚的那样。在第四边缘36处,功能元件30在所示实施方式中由下颌骨3本身限定,如以下参照图3还要更详细地描述的那样。
此外,框架结构24将功能元件30也在其外侧31处至少部分地包围,以便将功能元件沿该方向固定,如根据图3还要更详细地描述的那样。
能够被吸收的功能元件30例如可以由可生物降解的镁、可生物降解的镁合金、可生物降解的铁合金、可生物降解的锌合金、可生物降解的陶瓷系统、可生物吸收的聚合物或共聚物或者上述材料的混合变体或混合物或组合形成。
功能元件30可以具有在功能元件30的内部中和/或表面上形成的特殊结构。所述特殊结构尤其可以是功能元件30中的至少一个(优选分别多个)空腔和/或至少一个隧道和/或至少一个盲孔。所述至少一个特殊结构的尺寸可以设计为使得产生或者防止毛细效应。
功能元件30的通过增材制造的有利制造能够实现计划准确并且极精确地形成这些特殊结构。
图2还示出,功能元件30可选地具有第一组织容纳结构34和两个另外的组织容纳结构35。
组织容纳结构可以如在当前情况中那样例如设计为尤其处于功能元件30的外侧31中的连续的沟,或者设计为连续的隧道。在本示例中,第一组织容纳结构34设计为连续的U形沟,该U形沟的纵向两端均布置在功能元件30的同一第四边缘36上。另外的组织容纳结构35形成为线形的直沟,这些直沟从功能元件30的第四边缘36延伸到功能元件30的贴靠在外部支撑元件20上(更准确地说:框架结构24和载体结构23上)的相对置的边缘。例如当要实现定向的组织向内生长时,每个组织容纳结构34、35例如也可以单边地封闭。
在植入所述植入物之后或者在植入期间可以将患者的组织部件或者组织结构尤其从功能元件30的外侧31和/或边缘36引入组织容纳结构34、35中。因此,以此方式可以有利地预设该组织部件相对于植入物10的希望的走向。组织部件例如可以是血管或者膜或者类似物。
当然,对于其它使用位置或者其它解剖学条件,组织容纳结构34、35也可以形成为具有只一个单独开口的盲孔,该开口(或多个开口)不必布置在边缘上,入口开口和出口开口可以位于不同的边缘上,等等。这些考虑适用于如本例中的扁平的、平坦的功能元件30。当然,对于功能元件30的其它几何形状,组织容纳结构34、35的开口的设计和布置还有许多其它可能性。
图3示出沿A-A'线剖切图2中的植入物10得到的示意性横剖面图。在图3中可以清楚地看到,植入物10在当前情况中设计为“高嵌体”,即,功能元件30支承在骨骼(在此为下颌骨2)的一部分上。在图3中的横剖面中可以看到,功能元件30在此充满缺失部位3。在其它实施方式或应用中,功能元件30也可以设计为完整增加物(Komplettaugmentation)。
图3还示出框架结构24可以如何在横剖面中设计为弯曲的,以便将功能元件30在其完全被框架结构24覆盖的边缘37(可称为“外边缘”)处包围、附加地还部分在功能元件30的外侧31处包围。功能元件30的与外侧31相对置的内侧32完全被下颌骨2覆盖,并且反之亦然。因此,框架结构24在横剖面中的该弯曲构成容纳结构28,该容纳结构定义用于功能元件30的容纳空间26,其中,容纳空间26被功能元件30完全填满,但功能元件30(甚至大部分地)从容纳空间26突伸出来。
框架结构24也可以在功能元件30的只部分被框架结构24包围的两个不同的另外的边缘处在横剖面中设计为弯曲的,以便分别也部分包围功能元件30的外侧31。
在功能元件30的边缘37处,一个锁定件22或者多个这样的锁定件可以布置在功能元件的内侧32上。通过这种锁定件22、例如通过外部支撑元件20中的开口打入骨骼2中的销钉也可以改善外部支撑元件20在载体结构23的纵向端部处的固定区段之间的区域中与骨骼2(或者说在骨骼上)的连接(或固定)。
容纳空间26用于容纳功能元件30。容纳空间26的轮廓刚好适应功能元件30的贴靠的边缘。优选地,容纳空间26在容纳功能元件30之后完全填满。
容纳袋28可以具有一个(或多个)中断部,该中断部允许从植入物10外部接近至少一个组织容纳结构34、35的开口。这些中断部也可以分别布置在这样的位置,在该处所述功能元件30根据希望的使用位置或者在该处的解剖学结构具有开口。
在所示实施方式中,容纳结构28通过将外部支撑元件20的框架结构24(更准确地说:将框架结构24的边缘)朝内侧的方向(即,朝骨骼2的方向)翻起构成,其中,在翻起部的端部,在框架结构24的横剖面中基本上存在90度的弯曲。这在当前情况中是有利的,因为在高嵌体应用中,健康的下颌骨2在功能元件30的内侧32上封闭(或:构成)容纳空间26。在应该由功能元件30完全替代(或:填充)骨板的缺失部位的应用中,翻起部也可以如此设计,使得该翻起部在功能元件30的外侧31处开始并且部分接合在功能元件后方,即,以平坦地贴靠在功能元件30的内侧32上的区段结束。
图4示出图1中根据第二实施方式的植入物110的视图。如图1所示,植入物110是植入物10的变型方案并且同样针对板状骨设计。在植入物110的情况下,外部支撑元件120同样包括框架结构124,该框架结构定义容纳空间126,能够被吸收的功能元件130可插入或者已被插入该容纳空间中。
如同参照图3描述的那样,框架结构124可以分别朝骨骼的方向翻起,以便横向固定功能元件130,或者甚至可以如此程度地翻起,使得在功能元件的内侧上接合在功能元件130后方。以此方式,框架结构124的翻起部构成容纳结构128,该容纳结构又定义用于功能元件130的容纳空间126。在该情况中,容纳空间126又完全被功能元件130填满,其中,功能元件130只以很小的部分(即在露出的边缘区段136处)从所述容纳空间126突伸出来,或者可选地也完全不突伸出。根据翻起部的类型、位置和程度,容纳结构128沿不同的方向或者相对于不同的自由度固定功能元件130。
外部支撑元件120在功能元件的外侧(即背离骨骼的一侧)只部分地包围功能元件130,因此功能元件130保持在外侧能够通过外部支撑元件120接近。换而言之,框架结构124又构成窗结构,通过该窗结构,贴靠在植入物110上的组织仍可接近功能元件130。
框架结构124几乎完全包围功能元件130,其中,基本上平坦地形成的功能元件130的边缘区段136同样保持自由。在该自由的边缘区段136上可以设计有组织容纳结构34、35的开口,如同例如参照图2和图3已经描述的那样。以适应植入物110设计所针对的骨骼几何形状的方式,在外部支撑元件120的区段上布置有用于固定支撑元件120的螺纹孔127。
外部支撑元件120、功能元件130以及固定件可以分别如上所述地选择。尤其地,支撑元件120可以例如由不能被吸收的材料、尤其由钛或钛合金、由PEEK(聚醚醚酮)、由植入钢和/或UHMWPE(超高分子量聚乙烯,英文全称:Ultra-High-Molecular-WeightPolyethylene,例如商标名称Dyneema、IZANAS或Spectra)形成。能够被吸收的功能元件130例如可以由可生物降解的镁、可生物降解的镁合金、可生物降解的铁合金、可生物降解的锌合金、可生物降解的陶瓷系统、可生物吸收的聚合物或共聚物或者上述材料的混合变体或混合物或组合形成。
图5示出根据本发明的第三实施方式的植入物210的从上方观察的示意性俯视图。植入物210用于消除、即填满管状骨202中的缺失部位203。在此经常出现的情况是,良好地适合于此的材料例如由于其吸收特性等原因只能困难地被固定在剩余的管状骨202上,但该材料必须固定在该处,直到愈合完成和/或已完全吸收。
图6a示出与图5相同的情况,但示出侧视图;图6b示出沿图5中的剖面A-A'或图6a中的剖面B-B'的横剖面视图。
图5中的植入物210包括外部支撑元件220以及功能元件230。外部支撑元件220包括长形的笔直接板221(或:长形的载体结构),该接板在两端均具有连接件、在此为螺纹孔227。通过穿过螺纹孔227插入的螺钉能够将接板221的两端分别固定在管状骨202的一部分上。在缺失部位203的区域中,外部支撑元件220的十个肋结构228布置在接板221上,其中,接板221相对于肋结构128的位置类似于人的脊柱相对于人的肋骨的位置。这些肋结构228共同包围(或:定义)柱体形的内部空间226(或:容纳空间)。
功能元件230同样基本上、即就其外轮廓而言形成(或者说设计)为柱体形,更确切地说如此形成,使得功能元件刚好可引入柱体形的内部空间226中。功能元件230沿轴向方向的移动受到管状骨202的两个部分的限制或阻碍。功能元件230沿切向和径向方向的移动受到肋结构228的限制或阻碍。因此,肋结构228构成用于功能元件230的容纳结构。
当然,管状骨天然地不完全形成为柱体形;因此不言而喻的是,植入物210可以根据管状骨202的实际形状调整。
如同从图6a中可以特别清楚地看到的那样,具有装入内部空间226中的功能元件230的植入物210可以很容易地从上方(在图6a中)被植入,更确切地说如此被植入,使得具有功能元件230的内部空间226刚好填满缺失部位203。之后可以将骨螺钉插入螺纹孔227中并且因此可以将植入物210在一侧与管状骨202螺纹连接、即固定在管状骨上。
接板221的长度、螺纹孔227的数量、肋结构228的数量等分别可以根据使用位置来调整。
图5、图6a和图6b同样示出,功能元件230又可以设计为具有开口235,这些开口使功能元件230内部中的组织容纳结构(未示出)可接近。
尽管以上根据优选实施例描述了本发明,但本发明不局限于此,而是能够以各种方式方法进行修改。尤其地,本发明可以在不脱离本发明核心的情况下以各种方式改变或修改。
附图标记列表
1头骨
2下颌骨
3缺失部位
10植入物
20外部支撑元件
22锁定件
23载体结构
24框架结构
25窗结构
26内部空间
27螺纹孔
28容纳结构
30功能元件
31功能元件的外侧
34组织容纳结构
35组织容纳结构
36功能元件的边缘
37功能元件的边缘
202 管状骨
110 植入物
124 框架结构
126 容纳空间
127 螺纹孔
128 容纳结构
130 功能元件
136 边缘区段
203 缺失部位
210 植入物
220 外部支撑元件
221 接板
226 容纳空间
227 螺纹孔
228 肋结构
230 功能元件
235 开口

Claims (10)

1.一种多件式植入物(10;110;210),包括:
支撑元件(20;120;220),用于将植入物(10;110;210)固定在骨材料(2;202)上;
其中,支撑元件(20;120;220)的容纳结构(28;128;228)构成容纳空间(26;126;226);和
能引入所述容纳空间(26;126;226)中的功能元件(30;130;230);
其中,功能元件(30;130;230)能够由容纳结构(28;128;228)至少相对于一个自由度固定在容纳空间(26;126;226)中。
2.根据权利要求1所述的植入物(10;110;210),
其中,支撑元件(20;120;220)设计为外部支撑元件,并且容纳空间(26;126;226)是由容纳结构(28;128;228)部分包围的内部空间。
3.根据权利要求2所述的植入物(10;110;210),
其中,支撑元件(20;120;220)具有窗结构(25;125)或肋结构(228),穿过该窗结构或肋结构能接近容纳空间(26;126;226)中的功能元件(30;130;230)。
4.根据权利要求1至3中任一项所述的植入物(10;110;210),
其中,功能元件(30;130;230)由以下材料中的至少一种材料形成或者组成:
-可生物降解的镁;
-可生物降解的镁合金;
-可生物降解的铁合金;
-可生物降解的锌合金;
-可生物降解的陶瓷系统;
-可生物吸收的聚合物或共聚物。
5.根据权利要求1至4中任一项所述的植入物(10;110;210),
其中,支撑元件(20;120;220)由不能被吸收的材料、尤其由钛或钛合金、由聚醚醚酮、由植入钢和/或由超高分子量聚乙烯形成。
6.根据权利要求1至5中任一项所述的植入物(10;110;210),
其中,功能元件(30;130;230)能够卡入和/或夹入容纳空间(26;126;226)中。
7.根据权利要求1至6中任一项所述的植入物(10;110),其中,容纳空间(26;126)至少由支撑元件(20;120)的翻起的边缘构成。
8.根据权利要求1至7中任一项所述的植入物(10;110;210),
其中,功能元件(30;130;230)的内部具有至少一个特殊结构,该特殊结构设计用于增大功能元件(30;130;230)的表面。
9.根据权利要求8所述的植入物(10;110;210),
其中,所述至少一个特殊结构包括功能元件(30;130;230)中的至少一个空腔和/或至少一个隧道和/或至少一个盲孔。
10.根据权利要求1至9中任一项所述的植入物(10;110;210),
其中,功能元件(30;130;230)具有组织容纳结构(34、35),组织部件能插入该组织容纳结构中,和/或组织部件能导引穿过该组织容纳结构。
CN202280016316.2A 2021-02-23 2022-02-07 具有支撑元件和功能元件的多件式植入物 Pending CN116940308A (zh)

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PCT/EP2022/052836 WO2022179835A1 (de) 2021-02-23 2022-02-07 Mehrteiliges implantat mit stützelement und funktionselement

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WO2002036049A2 (en) 2000-11-03 2002-05-10 Osteotech, Inc. Spinal intervertebral implant and method of making
US6846327B2 (en) 2001-05-01 2005-01-25 Amedica Corporation Radiolucent bone graft
WO2005009729A2 (en) * 2003-07-24 2005-02-03 Tecomet, Inc. Assembled non-random foams
JP2007512874A (ja) 2003-11-18 2007-05-24 スパイナル・エレメンツ・インコーポレーテッド 骨伝導性の一体化された脊椎ケージおよびそれを作る方法
US8266780B2 (en) * 2005-04-21 2012-09-18 Biomet Manufacturing Corp. Method and apparatus for use of porous implants
EP3733099B1 (en) 2011-02-28 2022-08-31 DePuy Synthes Products, Inc. Modular tissue scaffolds
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