CN1964680B - 关节假体、其用途以及应用关节假体的方法 - Google Patents

关节假体、其用途以及应用关节假体的方法 Download PDF

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CN1964680B
CN1964680B CN200580017773XA CN200580017773A CN1964680B CN 1964680 B CN1964680 B CN 1964680B CN 200580017773X A CN200580017773X A CN 200580017773XA CN 200580017773 A CN200580017773 A CN 200580017773A CN 1964680 B CN1964680 B CN 1964680B
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bending
articular prosthesis
anchoring
plane
joint body
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佩-英瓦尔·布兰尼马克
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PIOS Biotech AB
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • A61F2002/4243Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for interphalangeal joints, i.e. IP joints
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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Abstract

本发明涉及一种关节假体,其包括:第一锚固元件(1a)、第二锚固元件(1b)和弹性材料的关节主体(9)。关节主体(9)与两个锚固元件(1a、1b)连接。所述锚固元件被设置固定到具有各自锚固轴线(A、B)的各自骨头中。根据本发明,所述锚固轴线(1a、1b)被设置成在关节假体处于无负荷状态时彼此不重合。本发明还涉及本发明的关节假体的用途以及应用关节假体的方法。

Description

关节假体、其用途以及应用关节假体的方法
技术领域
本发明在第一方面涉及关节假体,其包括第一锚固元件、第二锚固元件和弹性材料的关节主体,其中设置了关节主体从而关节假体至少可以在第一弯曲平面内偏斜,而且其中关节主体与所述第一及第二锚固元件连接,每一个关节假体中锚固元件被设置固定到具有各自锚固轴线的各自骨头中,所述锚固轴线在各自骨头的纵向轴线上延伸,其中在关节假体处于无负荷状态时,锚固轴线与另一个锚固轴线不重合。
在第二方面,本发明涉及所发明的关节假体的用途。
在第三方面,本发明涉及应用一种关节假体的方法,该关节假体包括与第一及第二锚固元件连接的弹性关节主体,锚固元件被固定到具有各自锚固轴线的各自骨头中,所述锚固轴线在各自骨头的纵向轴线上延伸
背景技术
现在可以通过例如US5011497而了解上述类型的关节假体。
现有的关节假体包括具有弹性材料网的关节主体,该关节主***于一对销钉之间,所述销钉***一对用于固定在骨头中的管状螺丝中的各自的一个中,在骨头之间将安装上关节假体,销钉通过嵌入到弹性材料中的凸缘固定于所述网中。销钉和螺丝由生物适合性材料构成。
现有的关节假体在很多方面是有利的,并且以简单的结构提供了良好的功能可靠性。但是,其具有偶尔会带来缺陷的一定局限。
因此,设计了根据US5011497的关节假体,从而在假体处于无负荷时固定到各自的骨头中的销钉彼此排成直线定位。这需要关节主体的弹力用于保持关节成直线。
但是,对于某些病人,需要关节在无负荷状态下成微小的角度。例如,有下述情况,对于患风湿性关节炎的病人,具有关节、例如手指关节成角度的内在倾向。在传统的关节假体中,例如通过US5011497而已知的类型,关节在每个时刻都受到抵抗成角的力。
通过EP1300122和US6319284,可以进一步了解锚固轴相互成角度的关节假体。
现有的关节假体被设置为允许仅在一个弯曲平面内弯曲。在很多情况下,还需要获得可控的横向成角,即与关节的主移动方向垂直。
本发明的目的即为了满足所述的需要。
发明内容
在本发明的第一方面,所提出目的可以通过以下方式实现,即在权利要求1的序言中定义的一种关节假体具有特定的特征,该特征为:关节主体还可以被设置为使关节假体在与所述第一弯曲平面垂直的第二弯曲平面内偏斜,关节主体在第一弯曲平面弯曲的抵抗力矩比其在第二弯曲平面弯曲的抵抗力矩小。
由于这些轴线彼此不重合,即或者平行位移、或者成角度,所以当关节假体被安装到病人身体上时,关节主体的弹性将使得关节假体用于向关节提供成角度的位置,这将适合于使病人感到方便的角度。预先弯曲的关节的一个很大的优点在于,由于预先弯曲的关节不需要弯曲到直线关节的程度,所以可以降低弯曲引起的张力。这在简单的日常操作中特别明显,其中MCP关节的角度通常比ROM的小很多。由于关节主体还可以设置为使关节假体在与第一弯曲平面垂直的另一弯曲平面内偏斜,所以该关节是以不被传统的关节假体允许的方式在空间中可控的。这样,可以满足以下需要,还获得一定程度的侧向地、即相对于关节的实际运动方向为横向地可控的成角度力。由于关节主体在第一弯曲平面弯曲的抵抗力矩比其在第二弯曲平面弯曲的抵抗力矩小,所以关节假体具有最适于在常规的关节弯曲方向上允许较大弯曲的特性,其中通常可以获得较大的弯曲角度,而在侧向上的弯曲能力则受到更多限制并且适合于在附近侧向上受限制的弯曲需要。
根据本发明的优选实施例,锚固轴线在所述第一弯曲平面的投影彼此形成一角度。在大多情况下,这构成了最有利的选择办法,使得关节在安装时呈现成角的位置。
根据本发明附加的优选实施例,所述角度在5-30°的区间内,优选在10-20°的区间内。这些为对关节的倾斜通常最合适的角度区间,并且因此具有在该区间内的轴线相对彼此的成角是有利的。
根据本发明附加的优选实施例,所述锚固轴线还在第二弯曲平面内彼此形成一角度,并且所述第一角度比所述第二角度大。通过这种方式,也可以在第二平面获得成角能力,并且通过上述角度的彼此配合使得在第二弯曲平面的倾斜角度受到更多限制而且适合于在其方向上的弯曲需要。
根据本发明附加的优选实施例,两个锚固轴线彼此平行。这是一个可选择的方式来确保关节假体在被安装时被赋予用于使关节成一角度的预应力。
根据本发明附加的优选实施例,关节主体包括第一边界面和第二边界面,所述第一和第二边界面位于锚固轴线在所述第一弯曲平面中的每一个投影的一侧,其中边界面在所述第一弯曲平面的截面具有不同的轮廓,并且每一个轮廓具有至少一个靠向所述弯曲轴线所述投影凹入的部分。
通过关节主体的边界面的不均匀的轮廓,获得了在偏斜度和弯曲力之间的预定功能,并且其从松弛位置在一个或另一个方向上的弯曲变得不同。因此,根据该实施例的关节假体将满足通常出现的需要,从而应该可以在一个方向上比在另一个方向上更容易地弯曲关节。
根据本发明附加的优选实施例,两个边界面和它们各自的凹入部分具有不同的曲率半径。这是一个简单且有利方式来为在一个方向上或在其他方向上的弯曲提供所期望的不同弯曲特性。
根据本发明附加的优选实施例,从第一锚固元件的锚固轴线到两个边界面的相应的凹入部分的距离不同。这是一个可选择的简单方式来实现期望的不对称。其也可以有利地构成对具有不同曲率半径的凹入部分的上述结构的补充。
根据本发明附加的优选实施例,第一锚固元件比第二锚固元件更靠近凹入部分的位置。由此,也在关节的纵向方向上引入不对称,从而关节假体的不对称弯曲特性进一步影响到期望的程度。
根据本发明附加的优选实施例,至少一个锚固元件包括固定于关节主体的末端凸缘,其中凸缘具有包括朝向关节主体的中央部分的凸面在内的弯曲形状。相适应地,两个锚固元件具有该设计。根据以介绍的方式提及的US5011497,在锚固元件上且嵌于关节主体中的末端凸缘也呈现在关节主体上,尽管其中末端凸缘为平面形。凸面弯曲带来了在末端凸缘和将其嵌入的关节主体之间的更优良的固定效果,特别在关节假体适用于呈现静止的特定成角时。
根据本发明附加的优选实施例,所述关节假体为手指关节假体。对于手指关节,形成本发明基础的需要最为显著,并且其中本发明所包括的优点最有价值。
本发明的关节假体的上述优选实施例被从属于权利要求1的权项限定。
在本发明的第二方面,所述的目的可以通过使用本发明的关节假体代替身体上有缺陷的关节来实现。
在本发明的第三方面,所述的目的可以通过以下的方式来实现,即在权利要求13的序言中定义的一种方法包括对设置关节主体的特定调节,从而关节假体还可以在与所述第一平面垂直的第二弯曲平面内偏斜,关节主体在第一弯曲平面弯曲的抵抗力矩比其在第二弯曲平面弯曲的抵抗力矩小。
本发明的方法的优选实施例在从属于权利要求13的权项中被限定。
利用本发明的方法及其优选的实施例,可以获得根据对本发明的关节假体及其优选的实施例所进行的描述的优点。
本发明将通过随后的本发明的关节假体的优选的具体实施例的详细描述以及结合附图被更进一步地阐述。
附图说明
图1为现有的关节假体的纵向剖面图;
图2为根据本发明的关节假体的一个实例的纵向剖面图;
图3为根据本发明的关节假体的附加实例的纵向剖面图;
图4为根据本发明的关节假体的又一个实例的纵向剖面图,其截面与图1-图3中的截面垂直;
图5-图9为根据本发明的关节假体的附加实例的纵向剖面图;
图10为根据具有尺寸标注的本发明的关节假体的实例的侧视图;
图11为图10中的关节假体的端视图;
图12为根据本发明的关节假体的实例的细节的侧视图;
图13为图12中的细节的端视图。
具体实施方式
图1为现有的关节假体的纵向剖面图,此时为手指关节假体。关节假体包括弹性体的关节主体110,该弹性体可以由硅橡胶或聚氨酯构成。该关节主体与一对锚固元件连结,所述锚固元件是以由生物适合性材料、优选为钛构成的销钉111的形式,该销钉111通过以下的方式被固定到关节主体中,即通过围绕销钉的末端凸缘112使关节主体注塑成型,从而这些末端凸缘完全嵌入到弹性材料中。
每一个销钉111都***管状螺丝117中,管状螺丝同样地应该由生物适合性材料构成,而且合适地具有与销钉相同的性质,即其应该由钛构成。该螺丝具有末端凸缘118并且旋拧进入固定于骨头中的通道中,这样不会使骨头由于不均匀的负荷而被分解,而且假体可以在更长的时间承受更大的负荷,从而充满活力的年轻病人还可以获得在长时间内比现有假体更起作用的假体。螺丝中的钻孔足够地长,使销钉在完全***钻孔中时接触不到钻孔的底部。在螺丝117已经固定于骨头中时,通过可以将销钉111***螺丝117中而容易进行关节假体的组装。在组装后,销钉被设置于它们之间的弹性关节主体110保持为压入到螺丝中。或者,在组装后可以将销钉锁定于螺丝中。由于使用假体时在销钉和螺丝之间不发生运动,所以假体的磨损变得最小,由此在实践中,使用寿命将增大并且完全消除了由从假体进入到身体组织的颗粒引起的感染和疼痛的风险。另一个优点是,如果关节假体由于某些原因而工作不良,那么可以在螺丝仍然固定在骨头中的情况下通过简单的手术容易地将关节与附属销钉一起更换。销钉可以为圆柱形,从而其可以在螺丝中旋转,由此假体更易于调整,但旋转也带来了假体在使用中有角度地移动出了其合适的位置的风险。即使可旋转的实施例比装置被设置成防止旋转的实施例成本低,也可以由此优选销钉以不能旋转的方式被导入钻孔中。可以通过以下方式获得销钉的不旋转,即通过使销钉或钻孔中的凸起分别可拆卸地容置于钻孔或销钉中的凹槽,或通过使销钉和钻孔具有相配的非圆形。例如,销钉和钻孔可以为六角形的截面形状,其优点在于,在紧固时螺丝可以通过销钉扳手被紧固结合于其钻孔中。在其它情况下,可以形成带有螺丝刀狭缝或带有六角凸缘的螺丝,以便在紧固时得到同样的结合。由于有弹性关节主体10,所以关节假体为非锁定的。
图2显示了根据本发明的实施例的手指关节假体。图2中所示的关节假体具有与根据图1的现有的关节假体基本相似的特点。因此,该关节假体具有可***到管状螺丝7a、7b中的锚固元件1a、1b。图2中所示的根据本发明的关节假体与图1所示的现有的关节假体之间的不同之处在于,当关节假体无负荷时,根据本发明的关节假体中的锚固元件1a、1b的锚固轴线A、B彼此形成一角度α。在所示的实施例中,角度α=15°。关节主体9的弹性用于将关节假体导向到该松弛位置。
图3显示了根据本发明的手指关节假体的一个可选实施例。在该实施例中,在无负荷状态下,两个锚固轴线A、B平行但彼此位移距离d。当根据该实施例的假体利用在各自的通道中的锚固元件即销钉1a、1b而安装于两个彼此相对的骨头中,轴线A、B之间的位移d将产生受迫的关节成角。
在图4中,以与图1-图3所示的截面垂直的纵向截面显示了手指关节假体的实例,其中锚固轴线A、B在无负荷状态下还在第二弯曲平面内相互形成角度β。在该平面内的倾斜产生了在横向方向上的受迫倾斜。在该实例中,角度β=7°。
在图5-图9中,以纵向截面显示了关节假体的一些具体实施例,其中关节主体具有各种不同形式的轮廓,其轮廓具有实现关节假体的成角度的松弛位置的可能性,并且有助于通过与施加的肌肉力和不同方向移动的成角之间的关系相关的松弛位置得到良好的特性。
在根据图5的实例中,在一侧,关节主体9具有在中央设置的凹形10,并且在相反一侧具有由凸起部12隔开的两个凹形11。
在根据图6的实例中,在一侧,关节主体9具有曲率半径相对较大的凹形13。在另一侧具有曲率半径相对较小并且在关节的纵向方向上侧向位移的凹形14。
图7显示了相似于图6的实例,其中锚固轴线在截面平面中成角度。
在图8和图9中,显示了附加的实例,其中凹形13、14具有相互不同的曲率半径,并且相对彼此以及相对于在纵向方向上的关节主体9的中央具有不同的位置。
在图10中,在侧视图中显示了手指关节假体的附加实例,其中关节主体的轮廓的适合尺寸以mm被标注。
图11为图10中关节假体的端视图。
在上述实例中,锚固销钉1的末端凸缘2为弯曲的。在图12中更详细地显示了侧面图,并且包含了其适用于手指关节假体时的尺寸标注。图13为图12中锚固元件1的端视图。
关节主体9的材料可以合适地为命名为ChronoflexTM 80 shore A或PellethaneTM 85 shore A型的弹性体。

Claims (11)

1.一种关节假体,其包括:第一锚固元件(1a)、第二锚固元件(1b)和关节主体(9),其中关节主体(9)为弹性材料并且设置为至少可以使关节假体在第一弯曲平面内偏斜,而且其中关节主体(9)与所述第一锚固元件(1a)及第二锚固元件(1b)连接,每一个关节假体中锚固元件被设置为固定到具有各自锚固轴线(A、B)的各自骨头中,所述锚固轴线(A、B)在各自骨头的纵向轴线上延伸,其中在关节假体处于无负荷状态时,锚固轴线(A、B)彼此不重合,所述锚固轴线(A、B)确定第一弯曲平面,其特征在于,关节主体设置为使关节假体在与所述第一弯曲平面垂直的第二弯曲平面内偏斜,关节主体(9)在第一弯曲平面弯曲的抵抗力矩比其在第二弯曲平面弯曲的抵抗力矩小。
2.根据权利要求1所述的关节假体,其特征在于,所述锚固轴线(A、B)在所述第一弯曲平面的投影彼此形成第一角度(α),所述第一角度(α)在5-30°的区间内。
3.根据权利要求2所述的关节假体,其特征在于,所述第一角度(α)在10-20°的区间内。
4.根据权利要求2所述的关节假体,其特征在于,所述锚固轴线(A、B)在所述第二弯曲平面的投影彼此形成第二角度(β),并且所述第一角度(α)比所述第二角度(β)大。
5.根据权利要求1所述的关节假体,其特征在于,所述第一和第二锚固轴线(A、B)彼此平行。
6.根据权利要求1所述的关节假体,其特征在于,关节主体(9)包括在关节主体(9)的一侧的第一边界面和在关节主体(9)的另一侧的第二边界面,所述第一和第二边界面位于锚固轴线在所述第一弯曲平面中的每一个投影的一侧,其中边界面在所述第一弯曲平面的截面具有不同的轮廓,并且每一个轮廓具有至少一个靠向所述弯曲轴线投影凹入的部分(10、11、13、14)。
7.根据权利要求6所述的关节假体,其特征在于,第一边界面的凹入部分(10、13)具有与第二边界面的凹入部分(12、14)不同的曲率半径。
8.根据权利要求6或7所述的关节假体,其特征在于,从第一锚固元件的锚固轴线到相应的边界面的凹入部分(10、11、13、14)的距离为不同大小。
9.根据权利要求6或7所述的关节假体,其特征在于,至少一个所述的凹入部分(14)的位置到第一锚固元件(1a)的距离比到第二锚固元件(1b)的距离远。
10.根据权利要求1所述的关节假体,其特征在于,至少一个锚固元件包括固定于关节主体(9)的末端凸缘(2),其中凸缘具有包括朝向关节主体的中央部分的凸面在内的弯曲形状。
11.根据权利要求1所述的关节假体,其特征在于,其为手指关节假体。
CN200580017773XA 2004-06-01 2005-05-30 关节假体、其用途以及应用关节假体的方法 Expired - Fee Related CN1964680B (zh)

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