CN114423385A - 用于至少部分置换与关节邻接的长骨的模块化假体 - Google Patents

用于至少部分置换与关节邻接的长骨的模块化假体 Download PDF

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Publication number
CN114423385A
CN114423385A CN202080065441.3A CN202080065441A CN114423385A CN 114423385 A CN114423385 A CN 114423385A CN 202080065441 A CN202080065441 A CN 202080065441A CN 114423385 A CN114423385 A CN 114423385A
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China
Prior art keywords
porous
modular
support body
endoprosthesis
modular endoprosthesis
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Pending
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CN202080065441.3A
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English (en)
Inventor
H·D·林克
S·斯帕思
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Publication of CN114423385A publication Critical patent/CN114423385A/zh
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Abstract

本发明涉及一种用于至少部分置换长骨(9)的模块化内置假体，其包括作为模块部件的杆(1)和端件(3)，杆(1)用于插入到长骨(9)的骨腔中，端件(3)包括支撑体(31)，支撑体(31)具有布置在其内侧的颈部(32)，其中，模块部件沿着杆的纵向轴线相互可耦合和可松开。端件(3)在其支撑体上具有至少两种不同实施的表面构型，即，在内侧(36)上的封闭表面(6')和在背离的外侧(38)上的表面的多孔构型(6)。后者实现并定位肌肉组织的生长，更确切地说无需缝合。因此，由于本发明具有肌肉的位置特定的直接生长，因而可以避免由缝合引起的肌肉损伤和在各个缝合位置处出现的负载峰值。因此，可以在降低并发症风险的情况下实现更快和更可靠的患者活动。

Description

用于至少部分置换与关节邻接的长骨的模块化假体
技术领域
本发明涉及一种用于至少部分置换长骨的模块化内置假体，其包括作为模块部件的杆和端件，该杆用于插入到长骨的骨腔中，该端件包括支撑体和布置在内侧的颈部，该颈部具有用于关节装置的收纳部。
背景技术
已知有各种类型的内置假体用于置换患病或有缺陷的骨骼和关节。尤其第，在本文中涉及纯关节内置假体或也部分或完全置换邻接长骨的内置假体。这些内置假体具有在要置换的长骨的长度上延伸的杆。杆置换或增强骨骼的患病或缺失区域。通常，杆与置换邻接关节(例如膝关节或髋关节)的关节单元连接。因此，必须根据患者的相应解剖结构和病理选择假体杆的尺寸。
已知有模块化内置假体系统用于适应个人需求。这些系统包括杆、必要时多个中间件以及端件，该端件通常也形成关节部件。这种系统例如从DE 20 2004 019 264 U1中已知。从先前使用中还已知的是来自DePuy,Inc.(USA)的称为矫形外科救助系统(Orthopaedic Salvage System)的模块化系统，其中端件设置有绕转式多孔涂层。
已经表明，以这种方式可以实现在仍然存在的骨残留物上的令人满意的生长行为。但是，在与软组织例如尤其是肌肉的附着方面存在改进需求。使用含钽涂层的实验已表明，这只能刺激结缔组织的生长，但不能刺激实际期望的肌肉附着。
发明内容
本发明基于的目的是提供一种开头提到的类型的模块化内置假体，该模块化内置假体在肌肉生长方面具有更好的行为。
根据本发明的解决方案在于独立权利要求的特征。有利的改进方案是从属权利要求的主题。
一种用于至少部分置换长骨的模块化内置假体，其包括作为模块部件的杆、端件以及至少一个中间件，该杆用于插入到长骨的骨腔中，该端件包括支撑体，该支撑体具有前侧、后侧、外侧和内侧并具有布置在内侧的颈部，该颈部具有用于关节装置的收纳部，其中，模块部件通过例如插塞连接件或其他类型的连接件沿着杆的纵向轴线相互可耦合和可松开，根据本发明规定的是，端件在其支撑体上具有至少两种不同实施的表面构型，即，在面向颈部的内侧上的封闭表面和在背离颈部的外侧上的表面的多孔构型。
术语外侧、内侧、前侧和后侧是在解剖学中用于方向数据的常见专门术语。在本文中，“外侧”是指侧向向外指向，“内侧”是指侧向朝(身体)中心指向，“前侧”是指向前指向，“后侧”是指向后指向。
本发明基于的思想是，有针对性地在特定位置，更确切地说专门仅在那里而不是以绕转的方式进行对肌肉组织的生长有利的表面的多孔构型。该特定位置是外侧，即在植入状态下侧向向外指向的一侧。因此，一方面，通过多孔构型为软组织，也包括肌肉组织在内的可靠生长奠定了基础，另一方面，通过多孔构型的精确定位并且将其集中在特定位置(并且仅在那里，即不是在周围)，以有针对性和特定的方式实现了肌肉的有利生长行为，在向假体(以及相应的肢体)进行有利的力传递的意义上，肌肉应准确地附着在该特定位置处。在用于近端股骨的内置假体的情况下，根据本发明有针对性地被提供位置特定的生长位置的肌肉是所谓的“臀中肌”。
本发明已经认识到，通过这样的构型，可以以产生肌肉的直接附着的方式实现肌肉的位置特定的生长。因此不再需要常规上为将肌肉附着到内置假体的端件所需的缝合。直接附着能够传递更大的力并且更坚固，尤其是与迄今在现有技术中常用的肌肉缝合技术相比。因为这种缝合基本上会损害肌肉并导致接缝区域中的负载集中，这会导致不利的负载峰值并因此导致负面预测的紧固(安全性)。针对直接附着的设计避免了这些缺点。由于本发明具有肌肉的位置特定的直接生长，因而可以避免由缝合引起的肌肉损伤和在各个缝合位置处出现的负载峰值。因此，可以在降低并发症风险的情况下实现更快和更可靠的患者活动。
符合目的地，规定的是，表面的多孔构型实施为开放晶胞式多孔晶格结构，该开放晶胞式多孔晶格结构由大量典型规则布置的基本晶胞形成；然而，不应排除基本晶胞的不规则布置。这样的开放晶胞式结构促进了肌肉组织的快速向内生长，甚至进入更深的孔中，由此作为进一步的优点产生了肌肉/内置假体连接的更高承载能力，因此也改善了肌肉和内置假体之间的力传递。在本文中，有利地，基本晶胞实施为拼装式结构并且各自由内腔和围绕内腔的多个相互连接的晶棱构成。例如，这样的拼装式结构可以有效地通过加成工艺(也包括3D打印)来制造。这样可以以受控的方式快速有效地制造具有带有底切部的复杂空腔结构的部件。基本晶胞的结构可以在本文中精确限定。这使得晶胞和形成它们的元件，尤其是它们的晶棱的限定布置成为可能。尤其地，这些方法适用于采用生物相容性材料来制造植入物，尤其是金属材料，选自包括纯钛、钛合金、钴铬合金、钽、不锈钢和锆的组。
有利地，多孔晶格结构设置有生长促进涂层。这样的涂层加速了软组织、尤其是肌肉材料及其肌腱的生长和向内生长。除了磷酸钙涂层之外，特别优选的是尤其具有钽材料的涂层。
符合目的地，多孔构型具有宽度在介于0.4mm和2mm之间、优选0.7mm至1.5mm的范围的孔。这些相对较大的孔提供了更有利的向内生长行为并且最重要的是为肌肉组织提供了锚定潜力。
符合目的的是，将支撑体和多孔构型或开放晶胞式多孔晶格结构实施为一体。因此，可以避免单独部件的否则所需的组装，由此产生在坚固性、更简单和直接的制造方面以及在耐用性方面的优势。尤其地，不用担心关节连接的失败或关节连接对周围组织的负面影响。这尤其适用于这样的事实，即在一体设计的情况下，整个支撑体，连同多孔构型一起，由完全相同的材料构成。
特别优选的是，多孔构型从外侧呈半壳状延伸到前侧和后侧。因此，多孔构型在支撑颈件的支撑体处的圆周的相当大的区域上延伸，但不是完全绕转的。这为邻接的软组织，尤其是肌肉创造了一个更广泛但仍然精确限定的生长区域。在本文中应定性地理解为半壳状；不一定必须是180°的圆周角，在许多情况下也可以更小(或多一点)。优选地，涂层的圆周角的范围为大约120°至210°。对于鉴定为半壳状来说重要的是，多孔构型从外侧开始不仅朝前侧而且朝后侧(向后侧)延伸，但也没有通过中间区域延伸(那将是绕转的，这应被排除)。
尤其是在半壳状延伸的情况下，而且在其他情况下，符合目的地在外侧与前侧和/或后侧之间的过渡部处设置有具有侧向平坦部的倒圆角部。使用在外侧上的这种平坦部，可以为周围的软组织、尤其是肌肉产生更宽且相对平坦的安置和生长表面。这有利于在更大表面上的生长，这实现了从肌肉到假体的更好且更强大的力传递。特别优选的是，侧向平坦部是平坦的或者具有从支撑体的前侧到后侧的距离的两倍的最小曲率半径。随后的倒圆角部确保了到前侧或后侧的和谐且无级以及无边缘的过渡，由此避免了在该关键区域中的已生长的软组织、尤其是肌肉的脱离的风险。在本文中，特别符合目的的是，倒圆角部具有曲率半径，该曲率半径至多为从支撑体的前侧到后侧的距离的四分之一。
在更全面地整合到周围软组织中的意义上进一步有利的是，多孔构型附加地延伸到支撑体的上侧，但仍然仅在侧向区域中。随着向上侧的延伸，为肌肉、尤其是臀中肌创造了生理和解剖学上有利的生长可能性。因此，实现了周围软组织、尤其是肌肉的生长表面在恰好该较高区域上的集中。如已经提到的，这在生理学和解剖学上是有利的，并且该优点因此可以用于将根据本发明的假体更有效地整合到周围软组织、尤其是肌肉中。符合目的地，还替代或附加的是，端件、尤其是其支撑体的下部区域保持没有多孔构型。因此，可以防止或减少该区域中的软组织的生长，这尤其抑制了不期望的结缔组织的生长。
然而，不应排除的是，在侧部区域中附加地设置有多个平行并排布置的通孔，这些通孔从支撑体的前侧延伸到后侧。因此，可以使用常规的紧固技术来进一步增强紧固安全性。在本文中，符合目的的是，通孔通向具有多孔构型的区域，并且它们各自的口部设置有封闭边界，该封闭边界又优选地由多孔构型完全围绕。因此，一方面，产生用于负载引入的统一位置，即在多孔构型的区域中，更确切地说也与通孔有关。因此，一切都保持集中在一个具有可比较的力比例的位置。
有利地，支撑体在其下端渐缩并且多孔构型延伸到渐缩区域。换句话说，这意味着多孔构型结束于到渐缩部的过渡区域中。因此，生长位置仅限于支撑体的上部区域，这在生物力学及其杠杆传动比方面提供了优势。
在一个特别符合目的的实施方式中，根据本发明的内置假体如此实施，使得其属于假体系统，该假体系统包括模块化部件，尤其是还有更换中间件和/或更换端件。在本文中，模块化部件可以借助匹配的连接件，尤其是插塞连接件和防旋转件连接。这能够将根据本发明的内置假体集成到已经存在的假体系统中，由此将已知假体系统的优点与本发明的有利效果相结合。
附图说明
下面参照附图例示性地基于实施例更详细地说明本发明。在附图中：
图1示出了根据一个实施例的用于具有端件的近端髋关节内置假体的股骨部件的模块化股骨假体的视图；
图2示出了全股骨假体的视图；
图3a、图3b示出了根据实施例的端件的正视图和立体图；
图4示出了多孔构型的相邻的基本晶胞的示意图；以及
图5示出了更换中间件的立体图。
具体实施方式
根据图中所示实施例的模块化内置假体实施为髋关节内置假体的模块化股骨部件，用于植入在股骨9上。该模块化内置假体包括作为主要部件的杆部1、中间件2以及端件3。各个部件1、2、3例如通过插塞连接件5以抗旋转的方式相互连接。
杆部1包括在下部部段中呈锥体状伸展的锚固区域11，该锚固区域1具有在杆部1的纵向方向上伸展的多个锚固肋13。锚固区域11构成为植入在股骨9的骨腔(髓内管)91中。
杆部1在其上部区域中还包括具有较大横截面的耦合部12。该耦合部12具有圆柱形外壳并通过锥体插塞连接件(在图1中不可见)借助凸形部件和布置在相邻中间件2上的凹形部件与中间件2连接。中间件2又相应地通过另一锥体插塞连接件5与端件3连接。
端件3分为两个区域：一方面，端件3包括作为主要组件的支撑体31，该支撑体31具有作为插塞连接件5到中间件2的一部分的凹锥体和颈部32，该颈部32包括成形为截锥体的保持销33，用于收纳作为人工髋关节的关节装置的一部分的关节球34，其中，关节球34在植入状态下可枢转移动地支承在人工髋关节的髋臼部件(未示出)的承窝中。颈部32的保持销33布置在端件3的内侧36；与内侧36相对的是端件3的外侧38，内侧36和外侧38各自通过前侧35或后侧37连接。前侧35和后侧37之间的距离决定了支撑体31的厚度d。另一方面，端件3具有作为另一主要组件的其表面的多孔构型6，该多孔构型6设置在支撑体31的上部区域中的外侧并且仅设置在该处。多孔构型6将在后面更详细地说明。
模块化内置假体的其他部件在图2中示出。可以看到端件3*，该端件3*对应于端件3，但与之不同，不具有外侧多孔构型6，而是以圆形绕转的方式具有不同设计的即封闭且光滑的表面6'。中间件2又插入到该端件3*中。然而，与图1所示的实施方式不同，杆部1*并非设置用于锚固在股骨9的髓内管91中，而是完全置换天然股骨9，即以长杆部置换天然股骨9，该长杆部由多个不同长度的中间件2'和2"组成。在杆部1*的相对下端布置有作为下端件的髁件10。髁件10复制了天然膝关节的髁的形状和功能并因此形成了人工膝关节的股骨部分。不言而喻，如图1和图2双方所示的模块化部件可以根据需要相互组合或更换。这样，能够使模块化内置假体适应患者的相应解剖条件和骨骼或关节缺陷。
为了更详细地说明端件3及其多孔表面构型6，现在尤其参照图3a和图3b。在上部区域的外侧38上可以看出，支撑体31的表面在那里设置有多孔表面构型6。在本文中，多孔表面构型6也从外侧38向前或向后延伸。因此，多孔表面构成6也呈半壳状通过过渡部延伸到前侧35和后侧37。因此，相对于端件3的中心轴线30，多孔构型6通过大约160°的圆周角延伸；精确的值并不那么重要，而相反重要的是，多孔构型6不是圆形绕转，即角度明显小于360°，优选至多200°或甚至最大180°。在剩余的角度范围内，表面6'被不同地设计，即在所示实施例中是封闭且光滑的。
多孔构型6大约位于端件3的支撑体31的上半部中。多孔构型6形成软组织的限定起始位置，更确切地说，具体地用于臀中肌(未示出)的生长。由于多孔构型6，肌肉可以恰好在由多孔构型6标记的表面上生长，而不是在其他区域中生长。这样，实现了肌肉与模块化内置假体的精确限定附着。因此，有效地防止了在不期望位置处的生长。
多孔构型6的例示性结构在图4中示意性示出。多孔构型6在该实施例中构成为开放晶胞式多孔晶格结构。该开放晶胞式多孔晶格结构由借助加成工艺(3D打印)例如EBM制成的结构形成，该结构包括大量规则布置的基本晶胞4。这些基本晶胞4在所示实施例中这样形成，即，基本晶胞4各自具有内腔40和多个相互连接的晶棱41、42、43、44。因此，产生了一种开放晶胞式结构，该开放晶胞式结构一方面由于许多相互连接的内腔40而确保良好的穿透，另一方面由于存在许多底切部而确保了牢固和坚固的紧固，这尤其是在力传递肌肉组织的附着时是相当大的优势。此外，多孔晶格结构6可以设置有生长促进涂层45。符合目的地，该生长促进涂层45也布置在各个基本晶胞4中，即在不同的晶棱41、42、43、44上，更确切地说也布置在开放晶胞式多孔构型6的深部中。由此，进一步促进了向内生长行为，并因此实现了患者的快速且可靠的再活动。
如在图3a和图3b中还可以看出，多孔构型6还优选附加地部分延伸到支撑体31的上侧，但仍然仅在上侧的侧向区域中。支撑体31的下部区域，优选为下部三分之一，优选地在周围保持完全没有多孔构型6，在该下部三分之一中，支撑体31在其宽度方面渐缩。
为了进一步改善向内生长行为，优选地在外侧38设置有平坦部39(参见图3b中的由粗体虚线突出显示的区域)。因此，在那里产生了一种更平坦的结构，该结构为肌肉组织在大范围内生长提供了特别有利的条件。在本文中，“平坦”被理解为没有或仅有轻微的曲率，其曲率半径R至少是从支撑体31的前侧到后侧的距离d，优选为该距离d的两倍。与此相对，支撑体31在从侧向平坦部39到前侧或后侧的过渡部的区域中以更强倒圆角的方式实施，并且具有曲率半径r，该曲率半径r至多为距离d的一半或更小，尤其是小于距离d的四分之一。
此外，可以在支撑体31的横向于中心轴线30的侧向区域中布置一个或多个延伸的通孔8，这些通孔8通向多孔构型6的区域。这里，这些通孔8的各自的口部80由边界81围绕，该边界81呈庭院状围绕各自的口部80。在该区域中，表面实施为封闭，即不是多孔的。
用于模块化内置假体的另一符合目的的补充部分在图5中示出。该补充部分是指更换中间件2*。更换中间件2*基本上与图1和图2中所示的中间件2设计相同并且与该中间件2一样具有锥体插塞连接件5。然而，与中间件2不同，更换中间件2*在其表面上也设置有多孔构型6。该多孔构型6是对应于多孔构型6构造的，但以全绕转的方式覆盖更换中间件2*的侧表面。因此，可以为模块化内置假体提供更换件，该更换件可以根据需要在医疗指征要求有利于软组织生长的条件下使用。由此扩展了模块化内置假体的应用范围。

Claims (16)

1.一种用于至少部分置换长骨(9)的模块化内置假体，其包括作为模块部件的杆(1)、端件(3)以及优选至少一个中间件(2)，所述杆(1)用于插入到所述长骨(9)的骨腔中，所述端件(3)包括支撑体(31)，所述支撑体(31)具有前侧、后侧、内侧和外侧(35，37，36，38)并具有布置在所述内侧的颈部(32)，所述颈部(32)具有用于关节装置(34)的收纳部，其中，所述模块部件沿着所述杆的纵向轴线相互可耦合和可松开，其特征在于，所述端件(3)在其支撑体上具有至少两种不同实施的表面构型，即，在面向所述颈部的内侧(36)上的封闭表面(6')和在背离所述颈部的外侧(38)上的表面的多孔构型(6)。
2.根据权利要求1所述的模块化内置假体，其特征在于，所述表面的多孔构型(6)实施为开放晶胞式多孔晶格结构，所述开放晶胞式多孔晶格结构由大量优选规则布置的基本晶胞(4)形成。
3.根据权利要求2所述的模块化内置假体，其特征在于，所述基本晶胞(4)实施为拼装式结构并且各自由内腔(40)和围绕所述内腔(40)的多个相互连接的晶棱(41，42，43，44)构成。
4.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述表面的多孔构型(6)，尤其是所述开放晶胞式多孔晶格结构，与所述支撑体实施为一体。
5.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述多孔构型(6)设置有生长促进涂层(45)，尤其是具有钽材料的涂层。
6.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述多孔构型(6)从所述外侧(38)呈半壳状延伸到所述前侧和后侧(35，37)。
7.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，在所述外侧(38)与所述前侧(35)和/或所述后侧(37)之间的过渡部处设置有具有侧向平坦部(39)的倒圆角部。
8.根据权利要求7所述的模块化内置假体，其特征在于，所述倒圆角部具有曲率半径(r)，所述曲率半径(r)至多为从所述支撑体(31)的前侧到后侧的距离(d)的四分之一。
9.根据权利要求7或8所述的模块化内置假体，其特征在于，所述侧向平坦部(39)是平坦的或者具有从支撑体(31)的前侧到后侧的距离(d)的两倍的最小曲率半径(R)。
10.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述支撑体仅在其外侧(38)具有所述表面的多孔构型(6)。
11.根据权利要求10所述的模块化内置假体，其特征在于，所述多孔构型(6)附加地延伸到所述支撑体(31)的上侧，但仅在侧向区域中。
12.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述端件(3)的下部区域没有所述多孔构型(6)。
13.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，在所述侧向区域中附加地设置有多个平行并排布置的通孔(8)，所述通孔(8)从所述支撑体(31)的前侧延伸到后侧。
14.根据权利要求13所述的模块化内置假体，其特征在于，一个或多个通孔(8)通向具有所述多孔构型(6)的区域，并且它们各自的口部(80)设置有非多孔边界(81)，所述非多孔边界(81)又优选地由所述多孔构型(6)完全围绕。
15.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述多孔构型具有宽度在介于0.4mm和2mm之间、优选0.7mm至1.5mm的范围的孔。
16.根据前述权利要求中任一项所述的模块化内置假体，其特征在于，所述模块化内置假体属于一种假体系统，其模块化部件(1，2，3)可以借助匹配的连接件(5)例如插塞连接件和防旋转件连接，并且所述假体系统还包括不具有多孔构型的更换端件(3*)和/或具有多孔构型的更换中间件(6*)。
CN202080065441.3A 2019-09-18 2020-09-16 用于至少部分置换与关节邻接的长骨的模块化假体 Pending CN114423385A (zh)

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US20080281428A1 (en) * 2007-05-07 2008-11-13 Zimmer, Inc. Methods and apparatuses for attaching soft tissue to orthopaedic implants
US8177849B2 (en) * 2007-05-07 2012-05-15 Zimmer, Inc. Methods and apparatuses for attaching tissue to orthopaedic implants
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