CN101137340A - 弹性体在刚性结构上的固定 - Google Patents

弹性体在刚性结构上的固定 Download PDF

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Publication number
CN101137340A
CN101137340A CNA2006800062853A CN200680006285A CN101137340A CN 101137340 A CN101137340 A CN 101137340A CN A2006800062853 A CNA2006800062853 A CN A2006800062853A CN 200680006285 A CN200680006285 A CN 200680006285A CN 101137340 A CN101137340 A CN 101137340A
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China
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porous
implant
syndeton
matrix
elastomer
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CNA2006800062853A
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CN101137340B (zh
Inventor
凯西·K·李
乔治·马克里斯
阿拉斯泰尔·J·T·克莱莫
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Nexgen Spine Inc
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Nexgen Spine Inc
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Abstract

一种外科植入物，特别是人工椎间盘，包括刚性基体(513)和弹性体主体(510)，所述刚性基体具有覆盖基体一部分的多孔连接结构(512)，所述弹性体主体通过充满所述多孔连接结构而固定在基体上。所述多孔连接结构的净孔隙率高于21.5％。所述多孔连接结构可为例如与基体表面间隔开的穿孔板或筛、或骨金属层或开孔材料层。

Description

弹性体在刚性结构上的固定
相关申请的交叉引用
本申请要求2005年6月24日提交的美国临时申请第60/693,430号的优先权，其全部公开内容通过引用并入本文，以及2005年1月19日提交的美国临时申请第60/644,527号的优先权，其全部公开通过引用并入本文。
发明背景
发明领域
本发明涉及具有固定至刚性材料基体如金属上的弹性体的制品，更具体涉及具有接合至刚性构件上的弹性体构件的矫形装置，如置换哺乳动物椎间盘的假体、用作人造关节的植入物、人工韧带和腱等，其中弹性体构件牢固接合至刚性终板或其它用于与骨连接的结构上。
背景技术
下背痛是非常常见的病理状况，一度影响着约80％的总人口。虽然大多数患者仅偶尔感受疼痛症状并完全痊愈，但这些病人中有约10％的人，尽管进行了各种治疗，仍然发展为慢性和失能性下背痛。
慢性和失能性下背痛的最常见原因是位于脊椎骨之间并允许脊柱的各种自然运动的一个或多个椎间盘的退变。这样的椎间盘退变性疾病(DDD)可能变得难以进行非手术治疗，并且必须通过外科手术介入治疗。脊柱融合术已成为非手术治疗不起作用的慢性和失能性下背痛的传统且通常有效的治疗方法。最近，已经开发了涉及置换整个椎间盘或其核的替代性治疗方法用于治疗椎间盘源性疼痛。
用于置换退变的椎间盘的第一代假体通常引入较硬的材料的相互滑动表面以提供弯曲、伸展、侧向弯曲和扭转中所需的椎间运动。虽然这样的假体已经发现是有帮助的，但已在寻找在减震作用和复制无损的椎间盘的自然运动方面的改进。
因此，后来开发的假体引入弹性体构件以提供所需的运动和减震作用。这样的假体通常包括用于接触相邻椎骨的终板并固定假体于其上的较硬的终板以及位于硬终板之间并连接于其上的弹性体盘核。
到目前为止，这类假体的弹性体核与其硬终板的连接通常通过粘合剂、通过机械嵌合凹部(undercuts)等、或通过在硬终板上提供与弹性体核啮合的多孔表面或这类方法的组合实现。例如，已有人提出通过如烧结等向与弹性体核接触的终板表面上覆盖结合到该表面上的通常为球形小珠粒的涂层。然后，弹性体核可模制在覆有珠粒的表面上或以其他方式施加于其上，由此弹性体渗入多孔珠粒涂层并提供硬终板与弹性体核间充分的机械嵌合。这样的结合表面公开于例如美国专利5,071,437中。
然而，仍存在对用于固定矫形装置的硬元件(如椎间盘假体的终板)与弹性体元件(如椎间盘假体的弹性体核)的其他方法的需求。
发明简述
根据其基本原理之一，本发明提供了其中弹性体构件牢固固定于基体上的装置和方法，所述固定通过充满连接结构而实现，所述连接结构限定为固体桥包围的孔组件、与基体为一体并延伸通过至少基体的大部分的表面，所述桥的至少一部分与基体的下方部分充分间隔开以在桥下提供弹性体层，所述弹性体层的强度足以抵抗方向通常为表面法向的张力引起的破坏。
在特定的实施方案中，连接结构可由穿孔板、筛、骨金属(trabecular metal)、多孔金属、伸出表面并具有侧孔的柱或翅片等提供，并优选由一般刚性材料制成。虽然原则上不受严格限制，但本发明最优选应用于外科植入物。
因此，根据其主要方面之一，本发明提供了一种外科植入物，所述植入物包括刚性的外科植入物基体、提供在基体上并覆盖基体一部分的多孔连接结构、和弹性体本体，所述弹性体本体具有与所述基体的所述部分相邻并充满所述多孔连接结构的部分，所述弹性体本体的所述部分填充与所述基体的所述部分相邻并包含所述多孔连接结构的体积的大部分，由此所述弹性体本体被固定于所述基体上。
根据其另一主要方面，本发明提供了一种外科植入物，所述植入物包括刚性的外科植入物基体、提供在基体上并覆盖基体一部分的多孔连接结构、和弹性体本体，所述弹性体本体具有与所述基体的所述部分相邻并充满所述多孔连接结构的部分，其中沿大体上与所述基体的所述部分平行的平面，在所述多孔连接结构的的整个厚度上，所述多孔结构的净孔隙率高于21.5％。
在其另一方面中，本发明提供了一种制造外科植入物的方法，所述方法包括提供所述外科植入物的刚性基体构件、提供多孔连接结构、连接所述多孔连接结构至所述刚性基体构件上、和用弹性体充满所述多孔连接结构以将所述弹性体固定于所述刚性基体构件上。
本发明的前述和其他方面将通过下面的详细描述得到更充分的理解。
附图简述
图1为植入相邻椎体间的本发明的椎间盘假体的示意性侧视图。
图2为安装在相邻椎体间的优选实施方案的剖视图。
图3a为局部剖视图，示出骨金属(trabecular metal)机械固定装置的使用。
图3b为局部剖视图，示出开孔泡沫金属机械固定装置的使用。
图4a为局部剖视图，示出穿孔板机械固定装置的使用。
图4b为局部剖视图，示出穿孔外围凸缘机械固定装置的使用。
图4c为局部剖视图，示出垂直延伸进弹性体核中的穿孔肋条机械固定装置的使用。
图4d为局部剖视图，示出丝网机械固定装置的使用。
图4e为局部剖视图，示出环形丝网机械固定装置的使用。
图5a为组装的中间穿孔板机械固定装置的局部剖视图。
图5b为在一个可选实施方案中所示的图5a的实施方案的局部剖视图，具有固定于中间穿孔板机械固定装置上的较硬的弹性体。
图5c为局部剖视图，示出图5b的实施方案的一种变体，其中中间穿孔板与刚性终板具有可滑动的榫接合。
图6a为本发明的可选实施方案的局部横截面，其具有施加于柔性核的边缘延长部分上的附加的压缩固定。
图6b为局部横截面，示出图6a的实施方案的一种变体，其中压缩固定通过压缩带施加。
图6c为局部横截面，示出另一种变体，其中压缩固定通过压在柔性核的边缘伸展部分上的环施加。
图7a示出包含弹性体关节假体的实施方案，其中弹性体构件连接到两个硬的结构性髓内构件上。
图7b为图13a的剖视图，示出弹性体构件与两个硬的结构性髓内构件的连接。
图8a示出包含前十字韧带置换假体的实施方案，其中可变形的弹性体构件连接到两个硬的骨固定栓上。
图8b为穿过图8a的骨固定件的剖视图，示出可变形的弹性体构件与硬的骨固定栓的连接。
图9a示出包含髓内固定杆的实施方案，所述杆具有中心低刚度区，其中可变形的弹性体连接于杆的两端。
图9b为穿过图9a的杆的中心部分的剖视图，示出可变形的弹性体与硬杆端的连接。
发明详述及优选实施方案
本发明提供了一种在医学植入物中将柔性弹性体材料构件连结至刚性结构上以使弹性体构件的连接强度足以承受其预期应用的载荷的方法。在若干优选的实施方案中，本发明通过提供含有可为刚性的多孔结构的制品达到此目的，所述多孔结构包含以固体材料为边界的开孔并与刚性基体构件的表面间隔开，以提供多孔结构与所述表面之间足够的空间，以便形成弹性体材料连续体或在至少一些填充有弹性体的孔之间形成弹性体材料的桥，由此在不破坏弹性体材料本体的情况下，所述弹性体材料不能与植入物机械分离。优选多孔结构的孔隙率大于21.5％，即孔在多孔结构下方的基体表面上的投影面积大于所述多孔结构下方表面面积的21.5％。
在一个优选的实施方案中，多孔结构与所述表面间隔开，以提供多孔结构与表面间连续不间断的弹性体层或薄层。也优选多孔结构的互连孔隙率大于21.5％(按面积计)，孔隙率更典型地在30％～80％的范围内。
在一特定的形式中，弹性体通过刚性金属支撑物或板中的穿孔固定到所述支撑物或板上，所述穿孔使弹性体在模制到支撑物上时可以渗透通过而到达支撑物的背面并在至少一些填充弹性体的穿孔间形成连续体。可改变这些穿孔的数量和尺寸并因此改变其横截面积来匹配弹性体与金属各自的强度。例如，如果金属的强度为弹性体的10倍且穿孔占据可得横截面积的90％，则穿孔内的聚合物将与剩余金属具有相同的承载能力。
利用本发明制得的优选装置实现了弹性体件与刚性基体的牢固固定，所述固定通过引入如下结构实现：
1)二维或三维网格结构，所述网格结构优选具有大于21.5％的互连孔隙率，以使网格内弹性体的量大于用常规的珠粒涂层等可获得的量；和
2)优选地，网格表面上的弹性体连续桥或层距离弹性体构件的主体最远，由此所述桥或层提供网格内弹性体部分间的强结合。这样的弹性体桥或层支撑网格内的弹性体部分并助其抵抗载荷下的变形，这种变形允许将其从网格中拉出，继而导致弹性体和基体间的连接失效并伴随医疗装置的失效。这样的桥或层可通过在网格中提供弹性体可绕其成环并因此形成连接相邻孔的连续弹性体带的结构而形成。或者，弹性体的支撑层可通过在向着基体表面的多孔结构表面上提供不间断的弹性体层形成，以便弹性体材料完全渗透孔隙。这样的聚合物连续层(与多孔结构的孔中的聚合物连续)提供了有助于防止弹性体被拉出网格的结合。
刚性固定可利用二维网格结构(如穿孔板、穿孔翅片、丝网或环形丝网)或三维网格结构(如开孔泡沫、骨金属多孔表面或其它至少有大部分嵌入在弹性体中的高度多孔结构)。
这样的网格结构优选构建为净系留孔隙率大于21.5％(用横贯由优选刚性的固定结构所形成的孔或开口的弹性体的总投影面积除以刚性结构和弹性体的总投影面积来计算)。从一个角度来看，充满刚性网格结构的孔或开口的弹性体材料连接回连续环等形式的弹性体主体。从另一个角度来看，充满孔的弹性体将弹性体主体与覆盖刚性网格结构另一侧的连续弹性体层连接起来。这样的网格和弹性体构造产生弹性体和刚性网格结构的牢固且稳定的组件。
本发明另一优选的制品是引入固定于刚性终板上的弹性体盘核的椎间盘假体，其中，柔性弹性体模制在刚性(金属、聚合物、复合材料或陶瓷)穿孔板构件上，且弹性体从板件的一侧延伸通过穿孔并重新连接到其自身上。可控制这些穿孔的尺寸、形状和位置以获得所需的固定强度。对于某些几何形状，可计算净系留孔隙率。例如，其中含有直径为0.95L的单个中心圆孔、单位边长为L的方板区域将表现出约71％的系留孔隙率。同样，如果该区域具有边长等于0.95L的方孔，则将表现出约90％的净系留孔隙率。在两个这样的实例中，包围孔的金属的最小横截面将是相同的，即0.025L。相反，对于直径为L的密堆积的珠粒层，净系留孔隙率将低于21.5％。
在给定的实施方案中，穿孔板中穿孔的数量、位置和尺寸可根据弹性体和负载情况加以改变。优选使所述孔具有平滑的边缘，以避免在反复施加拉伸和压缩载荷的过程中对聚合物连接处的切割作用。与弹性体构件的主体相对侧的穿孔刚性板的弹性体连续层的厚度可根据弹性体材料的拉伸强度加以改变。
在根据本发明的使用弹性体盘核的椎间盘假体中，典型负载条件导致在弯曲和伸展过程中在弹性体核的最外侧区域(前区和后区)中产生最高的拉伸应力。此外，刚性和柔性材料间的刚度差异引入了附加的应力集中因数。在该假体中，具有高应力的周缘区域中，倾向于将刚性终板拉离弹性体核的应力可通过使弹性体核周缘延伸到刚性终板的边缘之外并将延伸部分卷曲至刚性终板的边缘区域上而降低。弹性体自由延伸的这种压缩预载荷抵消拉伸载荷并帮助保护弹性体核的最外侧部分免受拉伸离解应力。这种卷曲对所述盘的抗挠刚度贡献很小或没有贡献，但将在这些高度应力区域提供明显更牢固的固定。
本发明可由预期用来置换人脊柱中受损或退变的脊椎盘的人工椎间盘假体的结构进一步说明。图1示意性示出植入人的脊柱运动节段中相邻的上和下椎骨11和12之间的椎间盘假体10。
图2为盘假体10更详细的横剖面视图，示出了第一或上刚性板310、第二或下刚性板320以及插入在两个刚性板之间并通过刚性固定装置311和321固定组装到所述两个刚性板上的柔性弹性体核330。对于盘假体10，上和下刚性板310和320通常彼此相似，且盘假体10关于中线垂直平面对称放置。刚性板310和320预期用来通过各种通常常规的固定装置340和341(例如多孔表面涂层)固定到脊椎骨301和302上。刚性板310和320由生物相容性材料制成，并优选金属如Ti6A14V(Ti-6％Al-4％V)。可用常规金属制造方法来制造刚性板310和320。
图3a为适合用于图2的实施方案中的刚性固定装置的局部详视图，图中示出固定装置的优选构造，其中使用骨金属(trabecular metal)多孔结构402来产生大于21.5％(按投影面积计)的孔隙率。多孔结构402通过常规方法连接到终板320上并允许弹性体330从柔性核区域330延伸穿过高净系留孔隙404以充满多孔结构402并在其中与其自身互连，从而形成与核区域330再相连的整体连接，多孔结构402因此嵌入在弹性体中。由于弹性体典型的材料强度约为刚性多孔结构402的五分之一，因此，弹性体与金属的比率可适宜地为约80％(按投影面积计)以提供核区域330和刚性基体板320之间满意的结合。
图3b示出图3a的假体的一个可选实施方案，其中，弹性体核400由软的弹性体材料405和形成过渡板407的较硬的弹性体材料406组成。过渡板407通过充满多孔结构408(例如图中所示的开孔多孔结构)固定于刚性基体板320上以提供机械固定。这样的多孔结构可通过传统工艺形成，如用于通过化学或电化学蚀刻并任选使用图案化光刻胶层来形成图案化的基体表面的工艺等。弹性体材料406占据多孔结构408内的空间并由于孔410而形成机械连接。该实施方案还另外提供有侧向延伸到弹性体核405的垂直壁412之外的凸缘411。同样，多孔结构408可侧向延伸一段距离413以提供附加的机械固定。由于在脊柱弯曲过程中，椎间盘假体在垂直壁412的外缘处承受最大的应力，所以可提供凸缘411以进一步分散这些载荷于较宽的区域内并使因弹性体406与刚性多孔结构408之间不同的刚度而发生的应力集中最小化。这样的凸缘和多孔结构伸展部分可与本文中公开的本发明的所有实施方案一起使用，而不针对其他实施方案单独讨论。
上述实施方案示出固定于基体上的高度多孔结构的应用。由于制造难度和与质量控制和加工相关联的高成本，这样的结构可能存在挑战。因此，图4a示出一个可选实施方案，其中通过使用弹性体510获得牢固而稳定的固定，其中弹性体510延伸穿过连接到刚性基体(如椎间盘假体的金属终板)513上的刚性结构(如板)512中的穿孔511。弹性体材料从主弹性体核510延伸穿过穿孔511并在刚性结构512的相对侧上形成基本连续的弹性体层或片514。刚性结构512和穿孔511可呈如图4a中所示的穿孔板的形式或具有其他开口几何形状和取向的其他类似构造的结构。图4b示出一个附加可选实施方案的局部剖面，其具有水平外围凸缘515，凸缘515构成刚性固定装置并具有一系列穿孔516。弹性体510延伸穿过穿孔516并连接回凸缘的相对一侧上的主聚合物核，一般表示为514。
图4c示出另一个实施方案，其具有一个或多个凸缘或肋条520，凸缘或肋条520从基体表面通常垂直伸展突入柔性弹性体核510中并具有通常横向贯穿凸缘520的穿孔521。以与图4b中所示实施方案相似的方式，弹性体材料贯穿穿孔521，由此弹性体材料沿凸缘520的侧边形成弹性体材料的基本连续体522。
图4d示出一个可选实施方案，其中丝网530固定于刚性基体532上，并通过连接到通常垂直的周缘531上而与其表面间隔开。弹性体510从丝网530的第一侧533贯穿丝网的系留孔隙而在丝网530相对侧上形成弹性体连续层或片534。或者，丝网结构可如图4e中所示通过将含直立丝网环540的结构与基体542的表面的连接结构件541形成。在该实施方案中，弹性体510从区域545和丝网环540的第一侧543贯穿系留孔隙(如544所示)并回到其自身，从而形成穿过丝网环540的弹性体连续体。图4e的实施方案也可通过使用具有较硬的过渡板和/或具有横向延伸的凸缘(如图3b的实施方案中所示)的弹性体核而具有附加的固定强度。
弹性体构件(如椎间盘假体的弹性体核)可通过配合或匹配的结构固定到刚性基体(如该假体的金属终板)上，从而形成模块化的结构组件。组装这类模块化结构的常规方法包括压配合、凹槽和形成于弹性体中的过盈锁紧或榫固定机构。但这类配合或匹配的结构可能因在组件受到倾向于分开部件的力时弹性体部件可能变形和分离而存在问题。
与这类传统组件不同，本发明的方法和装置允许构建易于组装还能抵抗弹性体部件分离的模块化的组件。这类装置可使用如图5a和5b的实施方案中所示的中间(优选刚性的)锚固结构605。在所示的形式中，锚固结构605由穿孔板609的从属外围凸缘构成。刚性板600提供有边缘机械固定装置602(由接合中间锚固结构605的突起604的凹槽603所示)，从而在两个刚性结构即刚性(如金属)锚固结构605和刚性(如金属)基体600之间形成牢固的连接。中间锚固结构605可如图所示与多孔连接结构(如板609)连为一体，或多孔连接结构和锚固结构可作为彼此连接的分立的部件形成。弹性体核510通过多孔结构(如前面所描述和在此处由金属板609所示例的那些)牢固固定于中间锚固结构605上。在这些实施方案中，弹性体核510固定于中间锚固结构605上，中间锚固结构605再固定于刚性终板600上。应了解，该实施方案对于产品系列可能需要大量不同的聚合物和刚性板构造的场合减少生产库存是有用的。这样，具有相同聚合物和中间锚固装置的组件可独立组装到若干不同尺寸和设计的刚性终板上。
图5b示出其中弹性体核510结合于较硬的弹性体608上的实施方案，其中，较硬的弹性体608固定(通过板609)于中间锚固结构605上，中间锚固结构605再组装到刚性终板600上。刚性终板600具有由与锚固结构605的突起604配合的凹口或凹槽603所示的机械固定装置602，从而形成与板600的牢固连接。
图5c示出与图5b中所示相似的另外的实施方案。在该实施方案中，硬弹性体608固定于通常为金属的多孔板710上，多孔板710引入与形成于刚性终板600上的鸠尾槽731牢固接合的榫舌711。
应了解，在前述各个实施方案中，多孔连接结构提供在基体构件上以覆盖其一部分，而弹性体材料填充与基体覆盖部分相邻并含有多孔连接结构的体积的大部分(>50％)。弹性体材料由此牢固固定于基体上。在具有与基体相面对的表面部分间隔开的多孔连接结构如板、筛等的实施方案中，多孔连接结构与基体相面对的表面部分之间的整个体积可有利地填充以弹性体(例如在图4a、4b和4d中)。
图6a-6c详细示出本发明的其他实施方案的局部横截面，其具有如上文所讨论的刚性固定结构905并另外引入贴着弹性体的刚性固定结构或贴着刚性基体压缩侧向延伸的弹性体凸缘的结构。在图6a中，弹性体核902的侧向伸展部分优选采取从核902向外延伸的凸缘900的方式。在该实施方案中，具有由阴影部分903所示的原始形态的凸缘被具有阴影部分904所示的原始形态的压缩元件901压缩。变形的压缩元件901优选与刚性固定装置906构成整体，如图所示，但或可在组装弹性体核和刚性终板后组装至假体上以提供所需的压缩。柔性核902和凸缘元件903是预先形成的，随后压缩元件904永久变形为901处所示的形状，从而与凸缘元件903接合并使之变形为压缩形态900。在该实施方案中，压缩元件906可呈周缘带的形式，通过在柔性核凸缘901上的过盈配合获得压缩。可选实施方案可使用与外围凸缘相连的螺丝、丝网、夹子或其他传统固定装置来提供压缩柔性核凸缘所需的压缩力。
图6b详细示出图6a的一个可选实施方案的局部横截面，其中压缩带920组装在具有原始形态922的凸缘921上并将凸缘921压缩进凹槽923中形成变形的形状924。
图6c详细示出图6a的一个可选实施方案的局部横截面，其中通过凸缘元件932与外部周缘保留槽933之间沿周缘延伸的压缩元件931的强力组件获得压缩固定，由此凸缘932被压在刚性基体910上的内部保留槽934上。
图7和7b示出根据本发明的弹性体关节假体550，其适于用作例如指关节的置换假体。所述假体包括柔性弹性体本体552，其固定至由金属、刚性塑料等制成的刚性髓内构件554上并通过常规方法插入指骨556中。髓内构件554在其适当的末端处具有凹进区558。由金属等制成的刚性穿孔板560(图7a中阴影部分所示)延伸通过髓内构件554的末端，在穿孔板560与髓内构件554的主体之间留下空隙。柔性弹性体本体552通过模制或其他方式连接到髓内构件554上，以使弹性体材料贯穿各个穿孔板556并在板560后面形成聚合物材料的连续层(在图7b的局部剖视图中清楚可见)。
图8a和8b示出根据本发明的另一假体570，其适于用作膝关节前十字韧带或其他韧带、腱等的置换假体。图8a在部分阴影中示出植入在膝关节的股骨572与胫骨574之间的韧带假体570。假体570包含伸长体576，其末端处提供有硬的刚性骨固定栓578，其可由常规材料构建并通过常规方法植入。如图所示并在图8b的局部剖视图中清楚可见，各个骨固定栓578优选呈管状，位于各个平面中的穿孔板等580基本与栓轴平行并横向贯穿管状栓578的内腔。弹性体本体576通过模制或其他方式连接到骨固定栓578上，以使弹性体材料贯穿各个穿孔板580并在板580后面形成聚合物材料的连续层。
图9a和9b示出包括用于长骨如股骨的髓内固定杆650的实施方案，其中所述杆具有中心低刚度区652，其中可变形的弹性体插入在杆的两个髓内部分654之间。图9b为穿过图9a的固定杆650的中心区域652的剖视图，示出连接于固定杆650的髓内部分654的内端658上的可变形弹性体段656。弹性体段656的弹性体通过模制或其他方式连接到从髓内部分654的内端658延伸的刚性穿孔突起660(阴影中所示)上并贯穿刚性突起660的穿孔以形成将髓内部分654固定在一起的整体。
实施例
本实施例示出与已知的弹性体与带珠粒层的刚性基体的固定相比用本发明的实施方案可获得的附加强度和均匀性。
试样通过将直径11.2mm、长4mm的圆柱状弹性体核连接于两个钛合金终板上制备，以便可对整个组件进行拉伸破坏实验。所用弹性体为75D计示硬度的聚碳酸酯-聚氨酯(Chronoflex-C，Cardio Tech Inc.，Wilmington，MA)，其通过注射成型连接到由Ti-6％Al-4％V医用合金制成的金属终板上。实验中考察了包括多孔涂层和穿孔板构造的不同的连接装置。
测试了两个系列的样品，测试了各个系列中的若干样品：
A.用直径为-45+60的双层烧结珠粒提供孔隙率为约21％的多孔表面
B.用1.5mm通孔规则阵列的穿孔表面提供约44％的孔隙率。该设计提供贯穿所述孔的弹性体并在远侧上提供整层厚1mm的聚合物。
测试：在模拟生理条件保持温度37℃的水浴中，以2.5mm/分钟的速率对所有样品进行单轴拉伸破坏实验。结果在下表1中给出。
表1
样品 连接装置 最大力(N)
A -45+60双层珠粒 493±42
B 穿孔板 811±50
实验结论：使用穿孔板将弹性体固定在金属结构上提供了比使用多孔涂布或珠粒表面可获得的明显更高的固定强度。同其中孔由珠粒等的球形表面限定的多孔涂布或珠粒表面比较，通过使用其中孔部分或全部由非球形表面限定的结构可获得连接强度优势。
已就某些实施方案对本发明进行了描述，但对本领域技术人员而言显而易见的是可作许多变化和改动而不偏离本发明的精神和本质特征。本公开因此应理解为示意性的而非限制性的。此外，从前面的描述应理解，本发明提供了许多有利的效应。例如，本发明总体提供了弹性体与刚性基体的牢固连接。在外科植入物中，本发明提供了柔性弹性体构件与刚性的植入物基体构件间(例如固定于脊椎盘假体的终板上的弹性体核)增大的固定强度，而不单独依赖于多孔涂层或是粘合剂层进行连接。本发明还提供了使生产更简单以及最终产品的检查更容易的固定弹性体构件于刚性构件上的装置。本发明的其他优点对本领域技术人员而言将是显而易见的。

Claims (41)

1.一种外科植入物，所述外科植入物包括：
刚性的外科植入物基体，
多孔连接结构，其提供在所述基体上并覆盖所述基体的一部分，和
弹性体主体，其具有与所述基体的所述部分相邻并充满所述多孔连接结构的部分，所述弹性体主体的所述部分填充与所述基体的所述部分相邻并包含所述多孔连接结构的体积的大部分，由此所述弹性体主体被固定于所述基体上。
2.权利要求1的植入物，其中所述多孔连接结构具有面对所述基体的所述部分的表面并与之间隔开，并且所述弹性体主体包括覆盖所述多孔结构的所述表面的一部分的弹性体连续层。
3.权利要求2的植入物，其中所述多孔连接结构包括周缘固定于所述基体上的穿孔板。
4.权利要求2的植入物，其中所述多孔连接结构包括周缘固定于所述基体上的筛。
5.权利要求1的植入物，其中所述多孔连接结构包括骨金属层。
6.权利要求1的植入物，其中所述多孔连接结构包括开孔金属层。
7.权利要求1的植入物，其中所述多孔连接结构包括接合至所述基体的衬面上的筛。
8.权利要求1的植入物，其中所述多孔连接结构包括所述基体表面上的多个直立的刚性环。
9.权利要求1的植入物，其中所述多孔连接结构包括从所述基体的表面上直立的多个翅片，各个所述翅片均提供有多个孔。
10.权利要求1的植入物，其中所述基体具有直立的周缘支撑结构，并且所述多孔连接结构包括大体上从所述周缘支撑结构径向向内延伸并与所述基体的所述部分间隔开的凸缘。
11.权利要求1的植入物，其中所述植入物为椎间盘假体。
12.权利要求1的植入物，其中所述植入物为关节置换体且所述基体为髓内构件。
13.权利要求1的植入物，其中所述植入物为韧带置换体或腱置换体之一且所述基体为固定栓。
14.权利要求2的植入物，其中所述弹性体连续层与所述基体的所述部分基本共同延伸。
15.一种外科植入物，所述外科植入物包括：
刚性的外科植入物基体，
多孔连接结构，其提供在所述基体上并覆盖所述基体的一部分，和
弹性体主体，其具有与所述基体的所述部分相邻并充满所述多孔连接结构的部分，
其中，沿大体上与所述基体的所述部分平行的平面，在所述多孔连接结构的整个厚度上，所述多孔结构的净孔隙率高于21.5％。
16.权利要求15的植入物，其中所述多孔连接结构具有面对所述基体的所述部分的表面并与之间隔开，并且所述弹性体主体包括覆盖所述多孔结构的所述表面的一部分的弹性体连续层。
17.权利要求16的植入物，其中所述多孔连接结构包括周缘固定于所述基体上的穿孔板。
18.权利要求16的植入物，其中所述多孔连接结构包括周缘固定于所述基体上的筛。
19.权利要求15的植入物，其中所述多孔连接结构包括骨金属层。
20.权利要求15的植入物，其中所述多孔连接结构包括开孔金属层。
21.权利要求15的植入物，其中所述多孔连接结构包括接合至所述基体的衬面上的筛。
22.权利要求15的植入物，其中所述多孔连接结构包括从所述基体的表面上直立的多个翅片，各个所述翅片均提供有多个孔。
23.权利要求15的植入物，其中所述基体具有直立的周缘支撑结构，并且所述多孔连接结构包括大体上从所述周缘支撑结构径向向内延伸并与所述基体的所述部分间隔开的凸缘。
24.权利要求15的植入物，其中所述植入物为椎间盘假体。
25.权利要求15的植入物，其中所述植入物为关节置换体且所述基体为髓内构件。
26.权利要求15的植入物，其中所述植入物为韧带置换体或腱置换体之一且所述基体为固定栓。
27.权利要求16的植入物，其中所述弹性体连续层与所述基体的所述部分基本共同延伸。
28.一种生产外科植入物的方法，所述方法包括：
提供所述外科植入物的刚性基体构件，
提供多孔连接结构，
连接所述多孔连接结构至所述刚性基体构件上，和
用弹性体充满所述多孔连接结构，以将所述弹性体固定于所述刚性基体构件上。
29.权利要求28的方法，其中所述多孔连接结构连接至所述基体构件上，以便具有面对所述基体构件的一部分并与之间隔开的表面，所述弹性体包括覆盖所述多孔结构的所述表面的一部分的弹性体连续层。
30.权利要求29的方法，其中所述多孔连接结构包括穿孔板。
31.权利要求29的方法，其中所述多孔连接结构包括筛。
32.权利要求28的方法，其中所述多孔连接结构包括骨金属层。
33.权利要求28的方法，其中所述多孔连接结构包括开孔金属层。
34.权利要求28的方法，其中所述多孔连接结构包括筛。
35.权利要求28的方法，其中所述多孔连接结构包括丝网构件，所述丝网构件连接在所述基体构件的表面上以形成直立其上的多个刚性环。
36.权利要求28的方法，其中所述植入物为椎间盘假体。
37.权利要求28的方法，其中所述植入物为关节置换体且所述基体构件为髓内构件。
38.权利要求28的方法，其中所述植入物为韧带置换体或腱置换体之一且所述基体构件为固定栓。
39.权利要求29的方法，其中所述弹性体连续层与所述基体构件的所述部分基本共同延伸。
40.权利要求28的方法，其中所述多孔连接结构连接在所述基体构件上以便覆盖所述基体构件的一部分，并实施所述充满，以形成具有与所述基体构件的所述部分相邻的部分的弹性体主体，所述弹性体主体的所述部分填充与所述基体构件的所述部分相邻并包含所述多孔连接结构的体积的大部分。
41.权利要求28的方法，其中所述多孔连接结构连接在所述基体构件上以便覆盖所述基体构件的一部分，其中沿大体上与所述基体构件的所述部分平行的平面，在所述多孔连接结构的整个厚度上，所述多孔结构的净孔隙率高于21.5％。
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EP1838249B1 (en) 2012-03-14
US8864831B2 (en) 2014-10-21
CA2595258A1 (en) 2006-07-27
CN101137340B (zh) 2010-11-10
WO2006078662A1 (en) 2006-07-27
KR20070118593A (ko) 2007-12-17

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