CN1486166A - 用于再造关节的植入体 - Google Patents

用于再造关节的植入体 Download PDF

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Publication number
CN1486166A
CN1486166A CNA028037065A CN02803706A CN1486166A CN 1486166 A CN1486166 A CN 1486166A CN A028037065 A CNA028037065 A CN A028037065A CN 02803706 A CN02803706 A CN 02803706A CN 1486166 A CN1486166 A CN 1486166A
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CN
China
Prior art keywords
implant
joint
distance member
implants
connector
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Granted
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CNA028037065A
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CN1248662C (zh
Inventor
安德斯·尼尔松
±���
本特·埃德贝里
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Artimplant AB
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Artimplant AB
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Abstract

本发明公开了一种用于再造关节的植入体。本发明的区别特征在于：设置了一个间隔部件(1)，其被设置在所要连接的两骨头的端部之间，间隔部件的一端被设计为可形成一关节表面，该关节表面顶接着其中一个所述骨端(6、7)。设置了一个关节稳定化连接件(2、3)，用于将所述的骨头连接起来。间隔部件(1)至少是用可与机体组织相容的材料制成的。

Description

用于再造关节的植入体
技术领域
本发明涉及一种用于再造关节的植入体，其中的关节优选为手关节和足关节。
背景技术
手关节和足关节的原发磨损、关节病是很常见的病症，尤其是对于中年妇女，其中的手、足关节例如是拇指的腕掌骨关节。研究表明：在50岁的年龄段中，约12％的妇女和8％的男子自诉在拇指的根部出现疼痛感。而大脚趾出现磨损、僵坶的发病率很可能会更高。这些病症会在关节不用力时造成疼痛，还会造成与使力有关的疼痛，且会降低关节的活动能力。对于手关节的情况，这会导致在执行各种抓握操作时出现痛感，因而会降低抓握强度。
对于足关节的情况，当患者行走时，关节磨损会造成疼痛感，并降低活动能力、减少运动的自由度。
目前，在拇指根部出现关节病的最初阶段，是用消炎药、在局部注射可的松、以及各种类型的支架来进行治疗的。而如果拇指根部的关节病已处于发展后的阶段，则就需要采用外科手术的方法。对于年轻男性以及尚在工作的中年男性，最好是用加强关节的手术方法来治疗关节磨损。
目前，对于中年妇女和老年妇女，所采用的外科方法涉及到某些形式的、利用腱筋的桥接移植手术。但是，腱移植手术需要很长的术后康复时间。疼痛的减轻、以及活动能力的增强也仅能维持6到9个月。另外，手术所涉及的患者必须要面临拇指抓握强度永久丧失的问题。
目前已出现了多种类型的假体，例如用于治疗拇指根部的关节病。这些假体是用钛、钢、塑料、碳或硅制成的。但是，考虑到关节会出现脱臼，这些假体很快就会失效。已经发现：如果使用了碳制假体，则经过一段时间后碳纤维结构就会发生机械破坏，且碳纤维碎片趋于迁移到身体中。美国专利文献US 4411027提出了这样的方案：用一可被生物吸收的聚合物制成的壳罩包围着碳纤维结构，目的在于：至少在早期康复阶段，可保护碳纤维结构，使其免受外部的机械作用，并可对碎片进行定位保持。
瑞典专利文献SE-B-457962描述了一种可被植入的假体，其用于部分或完全地取代筋腱、韧带或十字韧带。美国专利文件US 6007580中也描述了一种用生物可降解材料制成的假体，该假体用于连接两决骨。
但是，迄今为止尚未出现可用于再造关节的合适植入体。对能实行良好功能的这种植入体的前提要求是：首先，其所具有的特性(例如所必需的强度和活动性)足以使其能取代已损坏关节的功能；其次，其应当是具有生物适应(相容)性的，也就是说，机体不会被该植入体毒害—或换言之被植入体损伤。由于为了实现自然的关节运动，关节要涉及到关节囊、韧带、软骨以及滑液多种结构，所以关节的结构是尤其复杂的。
如上文已提到的那样：在拇指根部出现关节损伤是很常见的症状，其会带来严重的问题，并造成患有该病症的患者遭受痛苦，并损害机体的功能。
另一个常见的病症是僵坶，僵坶是在大拇趾的根部处发生的一种关节病，患者主要为男性，其会造成大脚趾的跖骨指关节的运动受限。这就意味着当以正常方式行走时，脚无法伸展，患有此病的人员在行走时会感到疼痛，且步态的改变会造成行走速度的下降。
上述采用桥接筋腱移植术的方法意味着：在对拇指根部的关节病进行治疗的情况下，某一骨—即小多角骨会整体被取出，这就意味着拇指的长度会有一个1厘米数量级的缩短，缩短的拇指肌肉的功能范围就会发生改变。另外，掌骨的近端会失去其稳定性。为了减小不稳定性，并避免与舟状骨发生冲突，要用一筋腱来形成一桥接移植件。但是，这种技术并非就意味着掌骨获得了完全的稳定。与将拇指缩短的效果相结合，这种设计将会导致拇指永久性地丧失其在执行钥匙抓持和三点抓持时的强度。
如上文已提到的那样，迄今为止已制出的假体并不能令人完全满意。其中一个原因是：现有的假体并不能使掌骨的近端获得稳定，这就预示着假体会出现脱位。
因而，长期以来，一直希望能有一种技术方案来解决上述的问题，该方案应能对人和动物的已损坏关节进行令人满意的再造。
发明内容
本发明提供了一种按照说明书引言部分所述的植入体，其彻底解决了上述的问题。
根据本发明植入体的特征在于：设置了至少一个间隔部件，其将被设置在所要连接的两骨头的端部之间，间隔部件的一端被设计成可形成一关节表面，该关节表面顶在所述骨头的端部上；设置了一个关节稳定化连接件，用于将所述的骨头连接起来，该间隔部件至少是用与机体组织相容的材料制成的，在使用了植入体之后，关节稳定化连接件将在纵向方向上延伸跨过关节，并贴在关节所连接的两骨头至少一侧的上方。
由于植入体包括一间隔部件，所以避免了相邻骨头之间的直接接触，因而可消除由骨一骨摩擦而造成的疼痛感。
通过设置所述的间隔部件和关节稳定化连接件，可以确保植入体在新组织的生长时期内具有正确的形态，并具有合适的强度和活动性。
根据本发明的一个实施例，所用材质是多孔的—其或者完全为多孔的、或者是局部多孔体。结合这样一个设计：使孔眼的尺寸能允许新的生物组织向内生长，这样的设计意味着：根据本发明的植入体基本上能再造出一个具有机能的关节。
根据一优选实施例，间隔部件和关节稳定化连接件是由可降解的材料制成的。
根据另一实施例，关节稳定化连接件被与间隔部件制成一体。
根据一种实施方式，所述的可降解材料是由聚氨酯脲组成的。
根据又一实施例，所述可降解材料是由聚L-丙交酯组成的。
根据另一实施例，所述可降解材料是由聚二轴突细胞(polydiaxone)(PDS)组成的。
根据另一实施例，所述可降解材料是由聚β-羟基丁酸酯(PHB)组成的。
根据另一实施例，所述可降解材料是由聚乙酰氨基葡糖、聚氨基葡糖或多聚糖组成的。
根据又一实施例，所述可降解材料是由胶原质或蛋白质组成的。
根据又一实施例，所述材料是由聚亚安酯(polyuretan)组成的。
根据又一实施例，所述材料是由硅酮组成的。
根据又一实施例，所述材料是由聚对苯二甲酸乙二醇酯(PET)组成的。
根据另一实施例，本发明的特征在于：植入体的总体横截面形状大致上为T字型，其中T字型的主干即为所述间隔部件。
根据一种实施方式，本发明的特征在于：间隔部件包括一薄膜状的元件，其被用作所述的关节表面。
根据另一实施例，本发明的特征在于：间隔部件是由一种可降解的、且与机体组织相容的材料组成的，该材料为泡沫、纤维或丝线的形式，对该材料执行浇注、编织、纺织、或其它的加工形式，从而能制出具有理想三维形状的结构件。
根据一种实施方式，所述连接件是由柔性的线状元件构成的。
根据一种实施方式，本发明的特征在于：关节稳定化连接件是由柔性的线状元件构成的，且在两骨头的中线两侧，所述线状元件具有至少一个部分，各个所述部分的两相对端锚固到对应的骨头上，且所述部分跨过关节，并被设计成可防止两骨头在横向上产生相对转动。
根据另一实施例，本发明的特征在于：所述线状元件包括两个部分，每一部分都连接着两骨头，所述两部分被设计成跨过关节而相互交叉，这样的结果是：可实现在多于一个平面上的移动。如果在拇指的根部，设置了根据该实施例的一植入体来再造关节时，则在康复过程中，拇指能以更为自然的方式移动，这反过来意味着：可刺激新组织的生长，使得拇指关节的功能改善。
所附权利要求书中还提出了其它的优选实施方式。
附图说明
下文将参照附图中表示的例示性实施例对本发明作更为详细的描述，在附图中：
图1是一个示意性的轴测图，表示了根据本发明的植入体的第一种例示性实施方式；
图2是图1所示植入体的横截面图，其中的植入体被设置在两骨头之间的关节中；
图3是沿图2中的III-III线所作的剖面图；
图4是图1所示植入体的横截面图，图中，该植入体以不同于图2所示的方式设置在两骨头之间的关节中；
图5是手部和腕部各块骨头的轴测图；
图6是图5所示手部一个部分，且图1所示的植入体被设置在拇指根部的关节中；
图7表示了根据本发明植入体的第二种例示性实施方式，图中，植入体设置在两骨头之间的关节中；
图8是图7所示植入体和骨头的侧视图；
图9是一个与图7类似的视图，表示了根据第三种例示性实施方式的植入体，相比于图7所示的实施例，其略有改动；
图10是图9所示植入体和骨头的侧视图；
图11表示了根据本发明植入体的第四种例示性实施方式，图中，植入体设置在两骨头之间的关节中；
图12是图11中例示性实施方式的侧视图；
图13和14表示了间隔体的两种尺寸设计，两间隔体用在根据图7至12所示的例示性实施方式而设计的植入体中，它们用于形成关节中的关节头。
图15和图16表示了两种尺寸的间隔体，两间隔体用在根据图9、10所示的例示性实施方式而设计的植入体中，它们用于形成关节中的关节窝；
图17和图18表示了一种间隔部件的结构，该间隔部件用在根据第五实施例的植入体中；
图19和图20以纵向剖面图的形式表示了一种间隔部件的结构，该间隔部件用在根据第六实施例的植入体中；以及
图21和图22表示了一种间隔部件的结构，该间隔部件用在根据第七实施例的植入体中。
具体实施方式
图1所示例示性实施方式的植入体的横截面形状为T字型，其带有一间隔部件1和两连接分支2、3，在使用该植入体的过程中，两连接分支被用于构成一关节稳定化连接件。在图示的例示性实施方式中，植入体被浇注成一单体件。该植入体所用的合适材料是：带有水解性酯基、并包含氨基甲酸脂基团的聚合物；或带有酯链的、并包括尿素基团和氨基甲酸酯基团的水解性聚合物。用于制造植入体的合适原料是带有水解性酯基、并包含尿素基团和氨基甲酸酯基团的线型嵌段共聚物。在瑞典专利505703中描述了这种类型的材料。该专利公开文件所描述的材料可被浇注成图1所示的结构类型，或者也可被纺成纤维，然后再对纤维进行编织或纺织，以形成所需的最终制品。另一种合适的材料是网状聚合物，其主要是缺少了尿素基团。在第510868号瑞典专利中描述了这种类型的材料。用所述材料制成的植入体还可以通过浇注与编织或纺织相结合的方法来制成。例如，可通过将所讨论的聚合物浇注到一个由同种材料制成的增强物上形成一间隔部件，其中的增强物被设计成软管或类似的形式，并被接合到骨头的端部上。通过选择分子结构以及所涉及的分子链，并通过加入各种物质，就可在机械性能以及降解时间方面，对所述瑞典专利505073、510868中描述的所述各种材料进行控制。
根据本发明的植入体被确定为用在人和动物受损关节的再造过程中。根据所针对的用途而选择植入体的几何形状设计和机械性能。植入体将临时替代受损的关节，且植入体的降解时间必须要超过在间隔部件中形成软骨状组织所需的时间、以及用于形成关节稳定化连接件的关节稳定化连接组织的形成时间。该植入体被设计成：在康复期间，其具有足够的强度和活动性来完成所针对关节的功能。如上文已提到的那样，与间隔部件是多孔的、且其孔眼尺寸能允许新生物组织向内生长的事实相结合，这样的设计将意味着：根据本发明的植入体能在其发生降解的同时再造出一个具有机能的关节。按照文件SE 505703和SE 510868所述的材料可被水解作用破坏掉，因而，其在随后就会被从机体中清除掉。
在图2中，图1所示的植入体被设置在一受损的关节中，该关节例如是位于两骨4、5之间的一个手指关节。间隔部件1被设置在两骨头的骨端6、7之间，利用该间隔部件来防止两相邻骨端直接接触到一起，从而避免由于骨一骨摩擦而带来的疼痛感。在将植入体置入之前，先要在骨头4、5上制出凹陷部分8，凹陷8用于容纳由分支2、3构成的关节稳定化连接件。在图2所示状态下，骨端7起到一关节窝的作用，且骨头5可在箭头A的方向上绕由间隔部件1形成的临时关节表面转动。该植入体是柔性的，但在正常的使用中基本上是不可延展的，其中的正常使用也就是指：植入体受到手指关节以自然方式进行弯折时所产生的力的情形。因而，骨头5可从图2所示状态弯折约90°，并再弯折回来，但却不能从图2所示状态沿顺时针方向弯折。间隔部件的另一相反表面与作为骨头4上关节头的骨端6相接触，且骨头4可相对于骨头5、在箭头B的方向上作相应的转动。与植入体的其余部分一样，间隔部件也是多孔材质的，其孔眼尺寸能允许新生的软骨组织向内生长，从而连续地再次形成一个永久性的关节。孔眼的尺寸还使得植入体两分支2、3中的关节稳定化连接组织能向内生长，以便于不断地取代临时性的关节稳定化连接件。由新软骨组织来形成间隔体的过程将需要1.5到2年的时间，因而，临时间隔体的总降解时间必须要长于该时间段。能取代临时连接件的连接组织的成形时间短于软骨组织的成形时间，连接组织完全再造成形所耗的时间在六个月到一年半之间。
在图2和图3所示的例示性实施方式中，植入体是利用缝合线9固定到骨头4、5中的，如图3所示，缝合线9将植入体的分支2、3连接到对应的骨头上。
在图4所示的例示性实施例中，对于与图2、3所示例示性实施例中结构类似的细节特征将用相同的数字标号指代。与图2和图3相比，图4表示了用于对图1所示植入体进行固定的一种备选装置。从图4可看出，并非采用凹陷8的形式，而是在骨头4、5中为分支2、3制出了切槽10。构成了关节稳定化连接件的两分支2、3分别通过连续式螺杆9′被固定在骨头4、5中。在图4所示的方法中，会在骨头4和5上形成一个连续的硬骨外表面。
如在引言部分中叙述的那样，例如在拇指的腕掌骨关节处出现原发磨损是非常普遍的症状，该病症会造成关节软骨的退化和磨损。图5是从上方对手部的骨头进行观察时的视图，也就是说，附图表示的是手的背面。在该附图中，用标号12来指代第一掌骨，标号13指代小多角骨。所述关节病症—即拇指根部的关节病发生在第一掌骨12与小多角骨13之间的关节中。
图6表示了图1所示植入体是如何设置到所述骨头12与13之间的。在图示的实施例中，小多角骨13上的一个已磨损部分被切除掉，间隔部件1被设置在该经过切截的骨头与第一掌骨12之间。间隔部件1被紧压在已切截骨头13的表面上。分支2、3通过缝合线9连接到对应的骨头12和13上，从而在拇指的根部形成一关节稳定化连接件。
图7和图8表示了根据本发明植入体的第二种例示性实施例，其设置在两骨头4、5之间的关节中，骨头4、5例如是手指或脚趾中的骨头。在两骨之间的关节中设置了一个间隔部件14。该间隔部件14优选地是用与根据第一实施例植入体相同的材料制成的。在图13和图14中，对用在图7、8所示植入体中的这种间隔部件单独进行了表示，这种类型的间隔部件可被制成不同的尺寸和厚度。图13表示了一种非常薄的间隔部件14，图14表示了一种非常厚的间隔部件14。对于手、足中的关节，间隔部件所必需厚度的变动范围为0.5到7mm。对于动物体内的关节，图13和图14所示这种类型间隔体的厚度优选地是在更宽的限度范围内变动。间隔体14上设置有一个固定部分15，很方便的设计是：用与间隔体其余部分相同的材料来制成该固定部分15。图13所示的固定部分15例如被制成纺织或编织韧带的形式。作为备选方案，固定部分可以是用缝合线、或其它的可降解材料制成的，其中的可降解材料最好是能被生物侵蚀的材料。固定部分15用于将间隔部件14锚固到其中一块骨头上。图7示意性地表示了固定部分15是如何利用缝合线9连接到骨头4上。图7和图8所示的植入体包括一柔性的线状元件16，其被用作临时性的关节稳定化连接件。从图7和图8可看出，在两块骨头中线的两侧，线状元件具有17、18两个部分，这两个部分沿骨头的纵向延伸，并跨过关节。在该例示性的实施例中，线状元件被制成一单体件，并具有两个部分19、20，它们分别延伸穿过骨头4、5上的孔洞。
如图2和图3所示的实施例那样，骨头5和4可从图8所示的状态分别沿箭头A和箭头B的方向进行弯折。线状元件是用可降解—优选为可生物侵蚀的材料制成的，该材料优选为上述的线型嵌段共聚物，另外，线状元件还被设计成：在其自然的功能范围内，其具有与自体韧带类似的机械性能。这就意味着：至少在正常韧带的功能范围内，该线状元件具有类似的机械特性，但如果活动超出了该功能范围，则其相比于正常的韧带就成为了超限的。线状元件16是柔性的，但基本上是不可延展的，这就意味着：图8所示状态中的骨头4、5不能绕着关节、分别以与箭头A、B相反的方向弯折。
图9、10所示的第三种例示性实施例在很大程度上与图7、8所示实施例相对应。所述两实施例中对应的细节结构将用相同的数字标号指代。图9、10所示植入体与结合图7、8所描述的实施例的区别在于：另外还设置了一个间隔部件21，其贴接着骨头5的骨端7。图15和图16单独表示出了这种类型的间隔部件，其被设计成为一关节窝。按照与结合图13、14所作描述相同的方式，间隔部件的厚度可在同样的限度内变化。另外，如图7、8所示那样，被设计成关节窝的间隔部件上设置有固定部分15，其利用缝合线9而将间隔体21锚固到骨头5上。
图11和图12表示了根据本发明植入体的第四种例示性实施例。该第四实施例与图7、8中例示性实施例的区别仅在于线状元件方面。从图11、图12可看出，该实施例中设置了两丝线部分22、23，它们跨越两骨头4、5之间的关节而相互交叉。线状部件被制成一单体件16，并具有两个部分24、25，它们分别延伸穿过骨头4、5上的孔洞。在图7到图10所针对的实施例中，两丝线部分17、18是在两骨头纵向中线的两侧延伸的，从而能防止两骨头在横向上产生相对转动，而本实施例中的丝线部分22、23由于能相比于上述实施例中的丝线部分22、23在骨头的一侧上更为自由地延伸，所以，骨头4、5除了具有绕图12中的箭头A和B方向进行转动的可能性之外，还可在另一平面一例如图11中用箭头C指示的平面上转动。
图17表示了一种用可降解材料制成的编织结构—或换言之被制成网状的结构26，其中的可降解材料优选为文件SE 505703中公开的所述线型嵌段聚合物。所述结构具有罩帽的形状，其被用作植入体中的增强物。植入体是用可降解的材料制成的，该可降解材料优选为带有可水解酯基的聚氨脂，其从外部浇注到所述罩帽的顶部。文件SE 510868描述了这种材料。
图18表示了在浇注之后、最后完成的间隔部件，其将被用作关节中的关节头，其中的关节例如为手指关节。在图18中，外浇的材料用标号27指代。网状结构26形成了一段软管，其从内侧对间隔体进行增强，且网状部分28从浇注体27向外突出而形成软管部分，该部分用于接合到某一骨头上，该骨头通过该关节而与相邻骨头连接起来。除了作为增强组织之外，网状结构的另一个功能是与骨头形成高度的摩擦作用，从而有利于新骨在其内的生长。网状结构26在被固定到骨头上之后，还能促进缝合时的稳定性。
图19按照与图17类似的方式，表示了一种编织结构—或换言之被制成网状的结构29，该结构被用作一间隔部件的外增强物，其中的间隔部件将被作为一关节窝，也就是说，该间隔部件与参照图17、18所述的那种间隔部件是互补的。
网状结构29上设置有一个或多个固定部分30，该固定部分将通过缝合线等措施固定到骨头的外侧上。固定部分30可被制成一完整的环圈，或者是用一个或多个紧固部分组成的。
在附图所示的例示性实施例中，设置了两个固定部分30。
从图20可看出，一种可降解材料一优选为带有可水解酯基的聚氨脂被浇注到网状结构的内部，从而形成一关节窝。在图20中，被浇注上去的材料用标号31指代。图20所示网状结构的功用与上文参照图18所描述的相同，也就是说：用作间隔部件中的增强物；与骨头形成摩擦、以及促进骨头的生长。
图17到21所示的这些薄间隔部件是与图13和图15所示的间隔部件相对应的。
图21a和21b表示了一种编织结构、或换言之被制成网状的结构32，这种网状结构属于上文参照图17所描述的那种类型。网状结构32与图17所示结构的区别在于：结构的顶部33是被填实的，且如图22所示，头部33中增强物的深度基本上与可降解材料34的厚度相对应，可降解材料34从外侧进行浇注，并透过顶部33处网状结构的层厚。方便的设计是：所浇注材料34与网状结构的材料相同，均是由带有可水解酯基的聚氨脂制成的。
图22所示实施例中实际间隔部件的厚度显著地超过了图18所示间隔部件的厚度。大体上来讲，此差异的形成方式与上文结合图13和14所描述的尺寸差异方式是相同的。网状结构32能完成与上文参照图17到图20所描述的实施例相同的功用。
但是，在顶部34处，网状结构32的层厚很大，且在这一区域，其还作为所浇注材料的内部增强物。很重要的一个要求是：间隔部件在关节中受到压力时不会发生塌陷，而且该临时性的间隔部件必须能将两相邻骨端撑开一定的距离，其中的压力是在关节正常使用过程中产生的。当然，还很重要的是：临时间隔部件应具有抗磨性。
图17到图22所示间隔部件的各种不同实施例与一关节稳定化连接件组合使用，其中的关节稳定化连接件例如是结合图7到图12所述的、柔性线状元件的形式。
本发明并不仅限于上述这些例示性的实施例，在所附权利要求书的保护范围内，可按照多种形式对其进行改动。
如上文所描述的那样，间隔部件是浇注形成的，或者是先通过制成纺线，然后再制成编织或纺织结构，或者可被制成其它的结构，间隔部件带有加强丝线，该加强丝线是用与结构其余部分相同的材料、或者是其它可降解并与机体组织相容的材料制成的。
可对所述加强丝线进行设置而形成一增强骨架，其用于使结构具有稳定性，且不会对结构造成锁止。该加强丝线例如被设置在限定的方向上，从而能提高该方向上的强度。
增强骨架可由一壳罩构成，其包围着结构的其余部分。除了所说的壳罩之外，增强结构还可包括设置在一个或多个限定的方向上的加强丝线。
在上述实施例中，提到了可用来制造可降解植入体的材料的几种合适例。在所附的权利要求书中，还限定了可用于制造根据本发明的植入体的可降解材料的其它实例。
本发明并不仅限于用可降解材料制成的植入体。硅酮和聚对苯二甲酸乙二醇酯是非降解材料的两种实例。
根据本发明的植入体还可采用与上述的植入体不同的形式。对于附图中示意性地表示出的T型植入体，其所有拐角最好都经过了滚圆处理。
可将植入体的形状设计成一块板件，其上一体地制有紧固部件或关节稳定化连接件。植入体的形状可被设计成：集成有稳定化连接件的海绵体形式。
如果一植入体被设计成在受到负载作用时、其形状与机体组织的解剖结构相适应，则该植入体就属于本发明的保护范围。
可以采用不同于上文所述的其它形式来设计关节稳定化连接件。
间隔部件的材质可以是聚四氟乙烯(PTFE)。同样，关节稳定化连接件也可以用同种材料制造。这种材料通常是以其商品名“特氟纶”进行称呼的。

Claims (33)

1.用于再造关节的植入体，其中的关节优选为手关节和足关节，其特征在于：
设置了至少一个间隔部件(1)，其被设置在所要连接的两骨头的端部之间，所述间隔部件的一端被设计成可形成一关节表面，该关节表面顶接着所述骨头的端部(6、7)；
设置了一个关节稳定化连接件(2、3)，用于将所述的骨头连接起来；
所述间隔部件至少是用一种可与机体组织相容的材料制成的；以及
在使用了所述植入体之后，所述关节稳定化连接件(2、3)将在纵向方向上延伸跨过所述关节，并贴在所述关节所连接的两骨头(4、5)至少一侧的上方。
2.根据权利要求1所述的植入体，其特征在于：所述间隔部件(1)所用材料完全地、或部分地是多孔材料。
3.根据权利要求1或2所述的植入体，其特征在于：所述间隔部件(1)和所述关节稳定化连接件是由可降解的材料制成的。
4.根据上述权利要求之一所述的植入体，其特征在于：所述关节稳定化连接件与所述间隔部件(1)制成一体。
5.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由聚氨酯脲组成的。
6.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由聚L-丙交酯组成的。
7.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由聚二轴突细胞(PDS)组成的。
8.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由聚β-羟基丁酸酯(PHB)组成的。
9.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由聚乙酰氨基葡糖、聚氨基葡糖或多聚糖组成的。
10.根据权利要求3或4所述的植入体，其特征在于：所述可降解材料是由胶原质或蛋白质组成的。
11.根据权利要求1、2或4所述的植入体，其特征在于：所述材料是由聚亚安酯组成的。
12.根据权利要求1、2或4所述的植入体，其特征在于：所述材料是由硅酮组成的。
13.根据权利要求1、2或4所述的植入体，其特征在于：所述材料是由聚对苯二甲酸乙二醇酯(PET)组成的。
14.根据权利要求1、2或4所述的植入体，其特征在于：所述材料是由聚四氟乙烯(PTFE)组成的。
15.根据上述权利要求之一所述的植入体，其特征在于：所述植入体的总体横截面形状大致上为T字型，该T字型上的主干即为所述间隔部件(1)。
16.根据权利要求15所述的植入体，其特征在于：所述植入体上集成地带有缝合线或其它的紧固部件。
17.根据权利要求15或16所述的植入体，其特征在于：三维T字型的所有拐角都经过了滚圆处理。
18.根据权利要求1至14之一所述的植入体，其特征在于：所述植入体被制成一板件的形式，其上一体地制有紧固部件或关节稳定化连接件。
19.根据权利要求1至14之一所述的植入体，其特征在于：所述植入体大体上呈海绵状结构，并一体地带有关节稳定化连接件。
20.根据上述权利要求之一所述的植入体，其特征在于：所述植入体被设计成在受到压力作用时，呈解剖学形状，并集成有使关节稳定的功能。
21.根据上述权利要求之一所述的植入体，其特征在于：所述间隔部件(1)包括一薄膜状的元件，其被用作所述的关节表面。
22.根据上述权利要求之一所述的植入体，其特征在于：所述间隔部件(1)是由一种可降解的、且与机体组织相容的材料组成的，该材料为泡沫、纤维或丝线的形式，对该材料执行浇注、编织、纺织、或其它的加工形式，从而能制出具有理想三维形状的结构件。
23.根据上述权利要求之一所述的植入体，其特征在于：所述连接件是由柔性的线状元件(16)构成的。
24.根据权利要求23所述的植入体，其特征在于：所述线状元件(16)在其固有功能范围内，具有与自体韧带类似的机械性能。
25.根据权利要求23或24所述的植入体，其特征在于：所述线状元件(16)的材料是由线型嵌段共聚物组成，其包含带有水解性酯基的尿素基团和氨基甲酸酯基团。
26.根据上述权利要求之一所述的植入体，其特征在于：所述关节稳定化连接件(2、3、16)被设计成可防止关节出现脱臼。
27.根据权利要求26所述的植入体，其特征在于：所述关节稳定化连接件是由柔性的线状元件(16)构成的；
在两骨头的中线两侧，所述线状元件具有至少一个部分(17、18)；
所述部分(17、18)的两相对端锚固到对应的骨头(4、5)上；以及
所述部分(17、18)跨过所述关节，并被设计成可防止两骨头在横向上产生相对转动。
28.根据权利要求23到25之一所述的植入体，其特征在于：所述线状元件(16)包括两个部分(22、23)，每一部分都连接着两骨头(4、5)，所述两部分被设计成跨过关节而相互交叉，因而可实现在多于一个平面上的移动。
29.根据权利要求22所述的植入体，其特征在于：构成所述间隔部件的浇注结构、编织结构、纺织结构、以及用其它方式形成的结构带有加强丝线，该加强丝线是用与结构其余部分相同的材料、或者是其它可降解并与机体组织相容的材料制成的。
30.根据权利要求22所述的植入体，其特征在于：所述加强丝线被设计为可形成一增强骨架，其用于使结构具有足够的稳定性，且不会对结构造成锁止。
31.根据上述权利要求之一所述的植入体，其特征在于：所述加强丝线按一限定方向设置。
32.根据权利要求30或31所述的植入体，其特征在于：所述增强结构是由一壳罩构成的，其包围着结构的其余部分。
33.根据权利要求32所述的植入体，其特征在于：除了所说的壳罩之外，所述增强结构还包括设置在一个或多个限定方向上的加强丝线。
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ATE321508T1 (de) 2006-04-15
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SE525131C2 (sv) 2004-12-07
US20040093081A1 (en) 2004-05-13
ES2261668T3 (es) 2006-11-16
JP2004527274A (ja) 2004-09-09
EP1351630B1 (en) 2006-03-29
US20060149261A1 (en) 2006-07-06
JP4156924B2 (ja) 2008-09-24
DK1351630T3 (da) 2006-07-24
EP1351630A1 (en) 2003-10-15
DE60210271D1 (de) 2006-05-18
WO2002054992A1 (en) 2002-07-18
SE0100127D0 (sv) 2001-01-15
CN1248662C (zh) 2006-04-05
DE60210271T2 (de) 2006-12-28

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