CN1183885C - 膝假肢系统 - Google Patents

膝假肢系统 Download PDF

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CN1183885C
CN1183885C CNB008044090A CN00804409A CN1183885C CN 1183885 C CN1183885 C CN 1183885C CN B008044090 A CNB008044090 A CN B008044090A CN 00804409 A CN00804409 A CN 00804409A CN 1183885 C CN1183885 C CN 1183885C
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condyle
knee prosthesis
prosthesis system
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CN1342060A (zh
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A·凯勒
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Waldemar Link GmbH and Co KG
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
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    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
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    • A61F2/00—Filters 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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    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
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Abstract

膝假肢系统，包括一个具有两个滑腔(7)的整体胫骨坪(2)和一个具有两个髁骨滑动面(6)的整体股骨元件(3)，它们的距离和形状与胫骨的滑腔(7)一致。作为整体股骨元件(3)的替代方案，该系统包括一对其滑动面形状与胫骨滑腔一致的、未连接的股骨的髁壳(10)。为了使该髁壳的相对位置包括其距离也与该滑腔一致，该系统包括一个定位器械来保证髁壳(10)的这个一致的相对位置。

Description

膝假肢系统
技术领域
人的膝关节有两对胫-股关节面，即一对内侧和一对外侧关节面，它们分别由一个股髁和一个与之共同作用的壳状胫骨或膝关节半月板的关节面构成。
背景技术
在膝假肢中，这些解剖情况用两个股骨的髁状关节面和两个胫骨的壳状关节面来模拟。其中，股骨关节面的外侧距离必须精确地符合胫骨的关节面的距离。为了保证这一点，一方面股骨的关节面和另一方面胫骨的关节面通常形成一整体(US-A-4 081 866；WO/79/007339，图36)。虽然还已知(WO/79/007339，图34)用股骨侧未连接的单假肢来置换股骨的关节面，该关节面与整体连接的、壳状的胫骨的关节面共同作用，但这种办法现今已被摒弃不用，因为不能保证股骨的滑动面的距离和对齐与胫骨的假肢部分匹配。
用同一个固定器械植入未连接的股骨和胫骨的假肢部分来保证两侧相同的滑动面距离，这种假肢技术同样也被认为是过时的(US-A-3 949 428)。此外，在只有一侧(股骨或胫骨一侧)进行关节面置换或共同作用的关节面不能达到精确对齐的情况中，提出了用一个定位器械植入未连接的假肢部分来保证其平行性(EP-A 824 904；W.Link：展望“Schalen-Kniegelenkprothesen-System SKI”)。
总的来说，现有的现代膝假肢系统只具有整体连接的股骨滑动面，这些系统作为整体假肢设置一个股骨和胫骨的关节面置换，且在这种情况中呈壳状的胫骨滑动面设计成与股骨滑动面精确配合。这种实施方式之所以是可行的，是因为它存在这样的可能性：形成一个髌骨的滑动面或髌骨置换来作为髌骨板连接股骨的滑动面(US-A-4081 866)。由于这种假肢业经考验证明是有效的，所以也常用于股骨的髌骨滑道尚保持良好和实际上无须进行置换的场合。
发明内容
本发明提出一种膝假肢系统，这种系统包括一个具有两个滑腔的整体胫骨坪和一个具有两个髁滑动面的整体股骨元件，它们的距离和形状与胫骨的滑腔一致。此外，本发明对股骨滑动面仍保持很好而无须进行置换的情况提出了一个植入替代方案，即它作为整体股骨元件的替代方案为该系统补充一对连接的股骨髁壳。同整体的股骨元件的髁滑动面一样，这对髁壳的滑动面形状与股骨的滑腔是一致的。为了它们也具有整体元件的髁骨所具有的相互精确的相对位置，该系统还包括髁壳的一个定位器械，该定位器械对它们给定了一个与胫骨的滑腔一致的相对位置。
本发明可将同一个膝假肢系统用于不同的损伤场合。如果需要置换整个滑动面，则用整体的髁元件。反之，如果髌骨滑动面仍处于良好状态，则只置换髁滑动面。此外，如果随着时间推移证明髌骨滑动面也需要置换，则可通过一个相当小的手术用一个整体的股骨元件来置换髁壳。最后，手术期中以一个开始时考虑不甚周全的方案变成一个较周全的方案也是可能的。
与此同时，不必放弃象在整体假肢时发展的复杂滑动面形状。亦即迄今为止通常这样设计分离的假肢壳体和/或相应的胫骨滑动面，使之容许植入的不精确性，因为其形状不需要相互精确一致。但在本发明假肢系统的范围内，可通过补充一个定位器械来把分离的假肢壳体构成同整体股骨元件的髁滑动面那样，同样与胫骨元件一致，因为保证了足够精确的植入。所以髁壳的滑动面的形状和距离可与整体股骨元件的髁滑动面的形状和距离一致。
此外，如果在固定髁壳时需要髁的切除面，则该切除面最好与整体股骨元件的相应的切除面一致。这样不但具有可用相同锯的量规(Sgelehre)的优点，而且由此也容易从一个股骨的假肢方案过渡到别的方案。
由于整体的股骨元件在股骨髁的整个宽度延伸，所以不仅在髁的范围内而且还在中间范围内进行相应的锯切。在用髁壳时，不需要在中间范围内进行锯切。如果因此而影响了髌骨的股骨的滑动面区域，则甚至是有害的，这要视切除的位置而定。所以本发明建议，用于股骨假肢的两个方案的锯的量规在中间髁区具有护栏嵌件，该嵌件可使手术者保护该中间区，甚至可精确地根据髁壳边缘规定的位置界定相互面对的侧边上的髁切口。
髁壳的界定可选用任意的形式，但最好是这些界定面对相互平行的直线侧面。这样，在定位器械具有匹配的平行连接面时与定位器械的精确对齐就比较容易。
本发明的假肢系统一般包括多个具有不同髁壳距离的多种尺寸等级。相应地，本发明建议定位器械的平行连接面的相互距离可按不同的分级尺寸进行调节。这种调节最好基于分别只对应一个尺寸等级的可更换件的使用，因为这样可以减小髁壳距离的错误调节的危险。根据本发明的一种优选实施方式，定位器械的连接面由分别对应于各个髁壳的单块夹板构成，所述夹板各包括一块固定夹紧块。根据另一个特征，该夹板可用对应于各个尺寸等级的不同支撑板。
本发明其他的有利特征可从结合附图的一个实施例的下列说明中得知。
附图说明
图1具有整体股骨元件的假肢的整体视图；
图2具有两个股骨元件的假肢的整体视图；
图3锯的量规；
图4定位器械；
图5装上了髁壳的定位器械的俯视图；
图6定位器械的部分透视图；
图7在髁壳装到骨头上时带髁壳的定位器械；
图8在取下定位器械后，固定在骨头上的试验性髁壳；
图9处于装好状态的假肢壳。
具体实施方式
按图1，假肢由一块要固定在胫骨上端的胫骨板1、一个支承在该板上可旋转的用聚乙烯制成的胫骨坪2和一个整体的股骨元件3组成，该股骨元件具有一块用来构成一个髌骨滑动面的髌骨板4以及用来构成髁滑动面6的髁部5。胫骨坪2包括用来支承髁滑动面6用的相应型腔7。由于股骨元件3的胫骨坪2是整体构成的，所以保证了两个元件的形状一致的滑动面精确配合，共同作用。
图2表示整体的股骨元件3通过一对髁壳10来代替的实施方案，这对髁壳与整体股骨元件3的髁部5的形状完全相同；几乎可以说它们是以整体元件切开的。其滑动面6与整体元件的滑动面6完全一致并以相同的方式与滑腔7共同作用，前提是，其相对定位必须精确符合整体元件的髁部5的相对定位。假肢部分可按多种尺寸等级提供。
面对骨头的股骨元件3和10的固定面相互协调地由平面11、12、13多边形组成，这些平面与骨头上的切除面吻合。还设置了位于吻合点的固定销14。当然，在髁壳10处不需要对应于髌骨板4的切除面和固定面。
为了切除股髁，采用了图3所示的锯的量规20，这种锯的量规是熟知的(WO 98/53747)，所以不再赘述。这种锯的量规在侧壁21之间设置有几对导向杆22来固定平面，以引导骨锯进行切除。如果用整体元件3，则刀口在骨质的髁对的整个宽度延伸。如果只装配髁壳10，则锯的量规20配有护栏嵌件23，用以保护中间髁区。它的侧面平行并与规定位置内的髁壳的内侧边缘一致。护栏嵌件23保护中间髁区，以免发生不希望的切除。应配置多个护栏嵌件，以便分别配合假肢的尺寸等级。
为了把髁壳10位置正确地装配到股骨上，采用了图4所示的定位器械30。它由一个把手31、一块支撑板32和两块用来夹紧髁壳10的夹板33。为了便于装配零部件，配置了一个底座34，该底座有一个与把手31的直径配合的垂直孔并在髁壳和夹板安装到所示位置的过程中固定住该定位器械。
从图5可以看出，夹板33具有内侧夹紧块35，这些夹紧块构成髁壳的内缘37的平行连接面36。连接面36与内缘37的共同作用保证了壳10的精确的平行对齐。当然，这些面如不呈直线，也可达到这个目的；只不过直线的外形容易制作并容易进行正确的壳配合的目检。此外，直线外形符合解剖学的情况。
夹板33在外侧由一个活动夹紧块40构成，该夹紧块平行于固定的内夹紧块35进行导向。在所示例子中，导向是通过导向杆41来实现的，这些导向杆与夹紧座42的相应孔共同作用，而该夹紧座则与固定的内夹紧块35刚性连接。用一个丝杆43和一个外部连接的旋钮44来进行调节。夹紧块35，40配有相向的凸起46。髁壳的边缘设有支承槽47，这些槽与这些凸起配合。这些凸起和槽做成纵长形，从而强迫髁壳按预定的方向位于定位器械内。
从夹紧座42的下侧伸出一个销子45，它与支撑板32的各一个孔48配合。在所示例子中，由于销子45和孔48的横截面呈方形，所以它们相互不能转动。这两个销子可用螺钉49锁定在孔中。这两个孔48在支撑板32中相互平行延伸。
对属于假肢系统的每个尺寸等级都配置了一块专门的支撑板32。不同尺寸等级的支撑板是通过其纵肌(LM)方向的宽度和其支承孔48的距离来区分的。所属的夹板33可以一致。也可用不同的夹板和同一个支撑板来代替上述的区分方式，这时销子45布置在夹板内，以保证夹板理想的距离。最后，也可设想只用一块具有多个支承孔48的支撑板，这些支承孔可以安装不同距离的夹板。
每块夹板33在夹紧块35、40之间都有一个伸入夹紧底座42中的调节螺钉的宽的头部50。该头部50的表面涂敷了一种柔性材料例如聚乙烯。在髁壳10夹紧在夹紧块35、40之间以后，调节螺钉50朝其面向它的滑动面拧紧并支撑它，所以在各项权利要求中也把它叫做滑动面支撑。它的作用是，在髁壳安放到骨头上时，可在安放的方向内把力从定位器械传递到髁壳上，而无须由凸起46来传递力。此外，当活动夹紧块40相对于另一块夹紧块35具有间隙时，或者当凸起46相对于支承它的支承槽47具有间隙时，滑动面支撑50有助于髁壳在定位器械中的正确定位。
当一对髁壳10安放到已切除的骨头上时，这对髁壳首先按上述方式被定位器械夹持住。然后把髁壳安放到骨头上，如图7所示。在髁壳固定后，首先用固定器械的把手31取下支撑板32，即松开螺钉49，并把支撑板32从夹板33及其销子45拉出。这样作之所以可能，是因为两块夹板33与支撑板32在其销子45的相同的松开方向内连接的缘故。然后，在必要时事先松动滑动面支撑50以后，往回拧动活动的夹紧块40，即可松开髁壳的夹板33。
如果髁壳是指最终的假肢部分，则在髁壳用粘固剂或不用粘固剂在骨头上足够固定后，把定位工具取下。如果是指试验性植入，在用固定销60事先把它固定在骨头上，为此在髁壳内设置有用于这些固定销的孔61。这些孔位于被夹板遮盖的区域以外，所以，只要假肢壳仍由固定器械固定，这些销子60就可以插入。在植入具有固定销14的部位，试验性植入体有一个相应尺寸的孔62。如果没有事先在骨内制作一个用来支承该销子的孔，则可在正确的部位制作试验性植入体的孔62。然后将一根固定螺栓63嵌入该孔62和位于下面的骨孔中，于是这个固定螺栓代替已取下的固定销60来固定试验性植入体，且其头部可埋入孔62中。植入定位和关节功能可用试验性植入体来检验。在取下试验性植入体以后，按相同的方式装配最终要用的假肢壳。

Claims (14)

1.膝假肢系统，包括一个具有两个滑腔(7)的整体胫骨坪(2)和一个具有两个髁滑动面(6)的整体股骨元件(3)，它们的距离和形状与胫骨的滑腔(7)一致，其特征为，该系统作为整体股骨元件(3)的替代方案包括一对其滑动面形状与胫骨滑腔(7)一致的、未连接的股骨的髁壳(10)和一个定位器械(30)，髁壳(10)给定一个与胫骨的滑腔(7)一致的相对位置，该整体的股骨元件(3)的髁切除面(11、12、13)的位置与髁壳(10)的位置一致。
2.按权利要求1的膝假肢系统，其特征为，髁壳(10)的滑动面(6)的形状和距离与整体股骨元件(3)的形状和距离一致。
3.按权利要求1的膝假肢系统，其特征为，该系统包括一个锯的量规(20)，该锯的量规具有既适用于整体股骨元件(3)又适用于髁壳(10)的一致的锯削平面。
4.按权利要求3的膝假肢系统，其特征为，锯的量规(20)在中间髁区(24)具有一个可取下的护栏嵌件(23)。
5.按权利要求1的膝假肢系统，其特征为：髁壳(10)面向相互平行的侧面(37)；定位器械(30)具有配合的平行连接面(36)。
6.按权利要求5的膝假肢系统，其特征为，平行连接面(36)的相互距离可根据属于不同尺寸等级的髁壳(10)不同距离分级进行调节。
7.按权利要求6的膝假肢系统，其特征为，这种可调节性基于更换件(32)的使用。
8.按权利要求1至7任一项的膝假肢系统，其特征为，连接面(36)由分别对应于髁壳(10)的分离的夹板(33)构成，所述夹板各包括一块固定的夹紧块(35)。
9.按权利要求8的膝假肢系统，其特征为，设置了不同宽度的支撑板(32)来支承夹板(33)。
10.按权利要求9的膝假肢系统，其特征为，这两块夹板(33)可在相同的松开方向从支撑板(32)取下。
11.按权利要求8的膝假肢系统，其特征为，髁壳(10)和夹板(33)配有共同作用的、使之相互定位的凸起(46)和槽(47)。
12.按权利要求8的膝假肢系统，其特征为，夹板(33)的夹紧块(35、40)在纵肌方向作用到髁壳(10)上并配有一个可调节的滑动面支撑(50)。
13.按权利要求1的膝假肢系统，其特征为，设置了试验性髁壳，这种髁壳在其被定位器械(30)夹持住的范围的外面配有定位销(60)用的孔(61)。
14.按权利要求13的膝假肢系统，其特征为，髁壳(10)具有至少一个固定销(14)，且试验性髁壳在这个销子的位置具有固定螺栓(63)用的一个孔(62)，该螺栓带有一个可埋入该孔(62)中的螺栓头。
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