CN1116016C - 用于手或脚的掌指骨或中间指骨关节的假体 - Google Patents

用于手或脚的掌指骨或中间指骨关节的假体 Download PDF

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Publication number
CN1116016C
CN1116016C CN96192606A CN96192606A CN1116016C CN 1116016 C CN1116016 C CN 1116016C CN 96192606 A CN96192606 A CN 96192606A CN 96192606 A CN96192606 A CN 96192606A CN 1116016 C CN1116016 C CN 1116016C
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China
Prior art keywords
prosthese
pin
joint
half housing
housing
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Expired - Fee Related
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CN96192606A
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CN1178456A (zh
Inventor
吉奥瓦尼·法奇奥利
伦佐·索菲亚蒂
毛里齐奥·彼得罗拉蒂
乔治·德莱里亚
贾利科·阿比亚蒂
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Tecres SpA
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Tecres SpA
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    • A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
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Abstract

本发明涉及一种掌指骨和/或中间指骨假体(1)，特别是用于手或脚中的关节，它包括一对可被移植入与一要修复的关节相邻的骨骼内的销子(2、3)，和与其相连接的包覆在由与销子相同的生物相容材料制成的一个保护外壳内的一个可弯曲的接头(4)。该生物相容材料可以是具有高相容性的塑性树脂混合物。所述外壳包括一对与相应的销子做成一体的半壳体(5、6)，它们在一个垂直地与接头的转动轴(a)相交的纵向对称平面(S)的相对面上沿轴向延伸。在第一个实施例中，轴(a)由插入到半壳体内的轴向空腔内的一个圆柱形销子(13)限定，该圆柱形销子(13)相对于至少一个位于与转动轴(a)相垂直平面内的轴，在一定限度的弯曲范围内，是可以自由转动的。在第二个实施例中，销子(13)由一个销子的一个圆柱形伸出部分(13′)或一个球形伸出部分(13″)来代替。轴(a)可以由一个螺旋弹簧(14)或由通过横向端板(25、26)与销子相连接的弹性金属线(23、24)来限定。

Description

用于手或脚的掌指骨或中间指骨关节的假体
技术领域
本发明涉及一种掌指骨的或中间指骨的假体，特别是用于手和脚中的关节。
背景技术
当一个手指或脚趾失掉，或者其功能行为因损伤、撞击、风湿性关节炎、骨关节炎、后天的外伤或后天的传染性骨关节炎而造成损害时，现代外科技术可以用一个人工的关节替代原来的关节，人工关节位于掌骨和指骨之间或两个相邻的指骨之间。
有些类型的指骨假体通常包括一个连接两个销子的接头部分，两个销子中的每一个都可以插入掌骨和/或指骨内，这样的假体已被使用多年。
所用销子可以由刚性材料，如钢、钛、石墨制造而成，也可由软性材料如树脂或硅橡胶制成。
后面这种情形最初是由Swanson在70年代引入，所用销子是由一整体的连接元件连接在一起，该连接元件有一个横向的凹槽，此凹槽有助于接头部分的弹性弯曲及销子的转动。虽然这种类型的接头从美学角度来讲很令人满意，也有相当大的活动范围，但它有一些短期的缺点，如接头的完全倒转和在一横向平面内的过大移动，并且从长远的角度来讲，它还有骨骼的逐渐碎裂和接头的逐渐硬化的缺点。
在金属假体中，销子可以是裸露的，也可以包一层生物相容材料，如羟磷灰石。这些假体的一个不利因素是它们有不断释放金属的趋势，而释放出的金属会进入血液循环，引起金属中毒。另一个不利因素来自于原材料价格昂贵且极其稀少，比如钛。
在刚性假体中，接头是铰链或球接头，并包括有弹性元件，这样的假体的缺点是随着时间的推移，它们将会出现硬化，并引起感染，因为它们与骨和结缔组织相接触。
US-A-4204284公开了一种手指关节假体，包括两个销子和一个可弯曲的接头，其中销子由生物相容材料制成(参见第4列第45行至第6列第15行；图1和图2)。
EP-A-280424公开了一种手指关节内置假体，文中记载了使用相容材料的优势，并在详细的例子中，说明了一种和用于所有元件如保护套等的相同的材料(参见第3列第52行至第4列第4行)。
发明内容
本发明的目的是排除或至少是减少上述缺点，提供一种刚性的销子内置假体，使其插入容易而没有不相容和感染的危险，以保证在一定时期之后，接头仍具有灵活性。
本发明通过提供一种掌指骨或中间指骨假体，实现了这些目的，该假体适用于手或脚中的关节，它包括：两个销子，其可被插入与一个要修复的关节相邻的骨骼中；和一个可弯曲的接头，其将所述的销子相互连接起来。所述销子由与其周围组织生物相容的材料制成，所述接头被包覆在一个保护壳体内，其特征在于，所述壳体由与销子相同的原材料制成，并包括与相应的销子作成一体的一对相对的半壳体。
由于销子和销子的壳体是用与销子和接头的包覆层相同的原材料制成，因此本发明的内置假体保证了其在骨骼中的连接的绝对的稳定性和耐久性，而其感染和排斥的危险则为最小。
该生物相容材料最好是一种具有高相容性的硬化的塑性树脂。
构成所述销子和所述壳体的材料最好是一种骨水泥混合物，比如包括与一种液体的单甲基丙烯酸甲酯单聚物相结合的一种固体的聚甲基丙烯酸甲酯聚合物，来形成一种可硬化的塑性树脂。
所述的一对相对的半壳体，与相应的销子作成一体，相对于一个与接头的转动轴大体垂直的对称的纵向平面，沿相对的两端延伸。
在第一个最佳实施例中，该半壳体基本上是一个具有一个轴向空腔和一个横向端面的圆柱形，接头的转动轴由插入半壳体的轴向空腔内的一个销子来确定，使得相对于它们中至少一个，以一个预定的间隙，自由转动。
在第二个实施例中，转动轴由一个置于所说的中空连接部件内部的一个螺旋弹簧来限定。
借助于构成销子和接头的保护壳体的材料，此内置假体在其植入位置处的生物相容性和稳定性得到绝对的保证。而且，相对密封的保护壳体的存在避免了结缔组织和接头材料的直接接触，降低了感染和假体的错误动作的危险。
附图说明
本发明的更多的特性和优点通过对本发明的指骨内置假体的一些优选的但不是全部的实施例的描述将变得更为清楚明了，下面将参照附图，借助一个非限制性的例子，对本发明进行说明。附图包括：
图1是一个本发明的内置假体的透视图，该内置假体移植在手的一个掌指骨关节上，
图2是一个图1所示假体的前视图，
图3是一个图1所示假体的侧视图，
图4是沿第一个实施例或对图1至图3中假体的改进形式的轴向平面所作的断面视图。
图5是沿图1至图3中所示假体的第二个实施例的轴向平面所作的断面视图，
图6是沿图1至图3中所示假体的第三个实施例的轴向平面所作的断面视图，
图7是沿图1至图3中所示假体的第四个实施例的轴向平面所作的断面视图，
图8是沿图1至图3中所示假体的第五个实施例的轴向平面所作的断面视图，
图9是沿图1至图3中所示假体的第六个实施例的轴向平面所作的断面视图。
具体实施方式
参照上述附图，一个以参考数字1表示的掌指骨或中间指骨假体作为一个整体一般包括从一个连接接头4的相对侧延伸的两个销子2、3。
销子2、3的形状是朝向其末端逐渐变细，并在接近接头处有轻微的向上弯曲度。由于这种形状，销子可以被插入在相邻的掌骨M和指骨F中由外科手术制成的合适的轴向座中，如图1中虚线所示。
显然，假体可被移植在两个相邻的指骨之间，来代替移植在一个掌骨和一个指骨之间，而不改变本发明的基本特性。也很显然的是，可以提供不同尺寸的假体来适应病人的尺寸和移植的位置。
销子可利用骨水泥或骨粘固粉固定地或不固定地嵌入座内。
接头4是一个铰链或枢轴a，与销子相垂直，它可以有相当大的活动性，避免接头的过大的弯曲。
根据本发明，销子2、3由一种与关节的骨组织相容的材料制成。特别是销子的原材料可包括与用于将销子固定在其骨座内的材料相同的骨水泥，这种材料已在矫形术上使用了40多年。
生物相容材料最好是两组分粘合剂混合物，其中国相包括一种粉末状的聚甲基丙烯酸甲酯(PMMA)，并带有不同的颗粒尺寸的球状颗粒，液相包括一种单聚物和一种催化剂。
在混合物中应该包括有利的活性和医药活性的组分，促进骨组织的再生。在意大利专利1,234,978中，以申请人的名义描述和申请的粘合剂混合物已被证实特别适用于此目的。
销子可以利用铸模制成，粘合剂混合物以粘稠状态倒入铸模中，然后使其硬化，直到得到所必需的密度和硬度。
以这种方式形成的销子将能很好地与骨组织和固定骨水泥的薄层相容，并且它们的原材料将被周围组织完全吸收。因此现有技术中的典型的感染和排斥出现的可能性将会降低。在移植手术操作过程中，最好经外科医生的轻磨或其它相似操作，使销子能够与其座相配合。
在一个最佳实施例中，销子2、3之间的连接接头4由与销子的材料相同的材料构成的几乎密封的保护外壳所包覆。
上述外壳可以由两个相对的半壳体5、6构成，半壳体5、6分别与相应的销子2、3共同构成一个整体。这两个半壳体5、6相对于大体与接头的轴a相垂直的一个对称平面S，分别位于相对的两侧。
半壳体5、6可以是一个圆柱形，具有横向端面7、8和相对的圆形边9、10，限定了位于所说的纵向对称平面S内的密封表面。
在销子的连接区域内，半壳体5、6具有凸起11、12，它们形成了在指骨的伸展方向上在一定角度内限定了销子的相对转动的对头接合表面，如图3中以虚线所示。在相反方向上的转动是没有角度限定的，因此可允许手指有完全的弯曲。
接头的转动轴a与嵌入在两个半壳体内的能够保持它们连接在一起的一个物理元件相吻合。
图4给出了接头的一个第一实施例，该实施例中，限定了其轴的物理元件包括一个金属销13，例如可以是AISI316型不锈钢，其外径略小于两个半壳体5、6的内径。两个半壳体中的一个可以具有略小于销子13的直径的内径，以便与其一同形成一个过盈配合连接，而另一个的内径要略大一些，以便与所述销子形成一个准确的间隙配合。在每一种情形中，两个销子与它们相应的半壳体都将保持在同一轴线内，在与转动平面相垂直的一个平面内的可能的摆动角度α的幅度要小于大约15°，如图4中虚线所示。两个销子也将由周围的组织轴向固定住，而不需任何的接触表面。
图5所示的第二个实施例与第一个不同的是限定转动轴的物理元件包括一个与销子6相结合的圆柱形伸出部分13′，该伸出部分13′插入销子5内的相应的圆柱形空腔内。
图6所示的第三个实施例与第二个不同的是伸出部分13″基本上是球形的，并与在销子5内形成的互补形状的空腔弹性配合。
在图7所示的第四个实施例中，限定接头的转动轴的物理元件包括一个弹簧14，弹簧14最好但不必是螺旋型的，其终端部分15、16嵌入相应的半壳体5、6的横向端面7、8内。在静止状态下，弹簧14的轴向长度近似等于所述半壳体内的空腔的深度的二倍。弹簧14在两个半壳体内施加轴向应力，增加沿边缘9、10的密封，以便为周围组织提供一个机械屏障。
另外，弹簧14的弹力抵制半壳体的相对转动，并因而限制了销子的动作，有助于保持手指的伸展。这里再一次允许在与转动平面相垂直的一个平面内的接头的轻微的弯曲。
在图8所示的第五个实施例中，弹簧14再次出现，但这一次它不是以一件出现，而是包括两个部分18和19，沿轴向相间布置。这两个部分由一个矫正环20连接起来，该矫正环20沿径向指向外面，并向后折叠成U形，最终嵌入销子3中。两部分21、22的外端被延伸，并向后折叠形成沿轴向指向内的第一段，与沿径向指向外的第二段相连接，后者被植入另一个销子2的原材料中。
图9给出了接头4的另一个实施例，其中限定转动轴的物理元件包括一对被加工成圆形并抛光的金属线23、24，两者由嵌入半壳体的底面7、8内的两个横向端板25、26连接起来。在静止状态下，金属线23、24基本上是平行的，但在关节转动期间，它们将发生扭转，如图9中虚线所示，产生一个轴向的吸引力，以增加半壳体的圆形边9、10的密封。该两个金属线也可以被轻微地预旋转，以便在相反方向转动时，减轻轴向缩短效果。板25、26中的一个可以被嵌入相应的空腔内，保持在轴向有一个数量很小的间隙，以允许其接近而不引起轴的缩短，所以也不会使关节变得僵硬。
金属线23、24和端板25、26一起限定了一个弹性元件，该弹性元件相当于一个扭转棒，但它具有相当的柔韧性，并且很轻。
在使用中，假体被植入，使其销子插入掌骨和/或指骨的空腔内，不会出现任何不相容和感染的问题。因为仅有的金属部分由相对的半壳体形成的保护壳体所包覆，与周围组织接触的可能性和金属释放的可能性都降到最小。
通过本发明假体的简单结构和所用材料的结构特性，可以看出本发明假体是相当可靠和耐用的，并且相对价格低廉，实现了上述的所有的发明目的。

Claims (17)

1.一种掌指骨或中间指骨假体，其适用于手或脚中的关节，所述假体包括：两个销子(2、3)，其可被插入与一个要修复的关节相邻的骨骼中；和一个可弯曲的接头(4)，其将所述的销子相互连接起来；所述销子(2、3)由与其周围组织生物相容的材料制成，所述接头(4)被包覆在一个保护壳体内，其特征在于，所述壳体由与销子(2、3)相同的原材料制成，并包括与相应的销子(2、3)作成一体的一对相对的半壳体(5、6)。
2.根据权利要求1所述假体，其特征在于，所述的生物相容材料是生物相容的硬化树脂以及塑胶的混合物。
3.根据权利要求2所述假体，其特征在于，构成所述壳体和所述销子的材料是一种骨水泥混合物，其包括一种固体的聚甲基丙烯酸甲酯聚合物与一种液体的单甲基丙烯酸甲酯单聚物相结合，形成一种硬化的塑性树脂。
4.根据权利要求3所述假体，其特征在于，所述半壳体(5、6)相对于一个基本与接头的转动轴(a)相垂直的纵向对称平面(S)从相对面沿轴向延伸。
5.根据权利要求4所述假体，其特征在于，所述半壳体(5、6)基本上是一个圆柱形，其横向端面(7、8)和相对的圆形边(9、10)限定了位于所述的纵向对称平面(S)上的密封表面。
6.根据权利要求5所述假体，其特征在于，所述半壳体(5、6)具有适用于限制销子在与指骨的延伸相一致的方向上的相对转动的对头接合表面(11、12)。
7.根据权利要求6所述假体，其特征在于，所述的对头接合表面(11、12)包括在所述销子(2、3)和相应的半壳体(5、6)之间的连接区域内形成的凸起部分。
8.根据权利要求5所述假体，其特征在于，所述接头的转动轴(a)由一个圆柱形销子(13)限定，该销子(13)插入所述半壳体(5、6)的轴向空腔内，并且相对于至少其中之一，在一个与所述转动轴(a)相垂直的平面内，在一定限度的弯曲范围内，可以自由转动。
9.根据权利要求5所述假体，其特征在于，所述转动轴(a)由一个基本上为圆柱形的伸出部分(13′)从所述半壳体中的一个(6)插入在所述半壳体中的另一个(5)内形成的一个形状相同的空腔内来限定。
10.根据权利要求5所述假体，其特征在于，所述转动轴(a)由一个基本上为球形的伸出部分(13”)从所述半壳体中的一个(6)插入在所述半壳体中的另一个(5)内形成的一个具有互补形状的空腔内来限定。
11.根据权利要求5所述假体，其特征在于，所述转动轴(a)由一个置于所述半壳体(5、6)的轴向空腔内的一个弹簧(14)的轴线来限定。
12.根据权利要求11所述假体，其特征在于，所述弹簧(14)的轴向长度近似等于所述半壳体内空腔深度的两倍，并且其末端(15、16)固定在与它们相应的底板壁面(7、8)上。
13.根据权利要求5所述假体，其特征在于，所述弹簧(14)沿轴向被分为两个轴向的独立的部分(18、19)，两者由一个弯成“U”形的并且相对于接头的轴线沿径向指向外的中介部分(20)连接起来。
14.根据权利要求13所述假体，其特征在于，所述被折成“U”形的中介部分(20)至少部分地嵌入所述销子中的一个(3)的原材料中。
15.根据权利要求14所述假体，其特征在于，轴向分离弹簧的两个部分(18、19)在它们的末端具有沿轴向指向接头的对称平面的金属线的第一段，与相对于接头的轴线沿径向指向外的金属线的第二段相连接，使所述第二段(21、22)至少部分地嵌入所述销子的另一个中。
16.根据权利要求5所述假体，其特征在于，所述转动轴由至少一对大体平行或轻微预旋转的金属线(23、24)的中心之间的距离所限定，所述金属线的轴向末端与固定在所述半壳体(5、6)的相应的横向壁面(7、8)上的两个横向板(25、26)连接在一起。
17.根据权利要求16所述假体，其特征在于，至少所述板中的一个(25)以极小的轴向间隙放置于与其相连的所述半壳体的底板壁面(7)的一个空腔内。
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