CN101083944B - 具有可移动的切割引导装置的远端股骨试验装置 - Google Patents

具有可移动的切割引导装置的远端股骨试验装置 Download PDF

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CN101083944B
CN101083944B CN2005800439338A CN200580043933A CN101083944B CN 101083944 B CN101083944 B CN 101083944B CN 2005800439338 A CN2005800439338 A CN 2005800439338A CN 200580043933 A CN200580043933 A CN 200580043933A CN 101083944 B CN101083944 B CN 101083944B
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Abstract

本发明的各种实施例提供了一种远端股骨试验装置，其允许外科医生使用植入物形状的试验装置来切割出远端股骨的中央盒体几何形状。该试验装置包括一切割引导装置，其可从试验装置上拆除并可相对于试验装置进行调节。该引导装置意在控制切割工具的深度和方向，上述切割工具用来制备适于后稳固植入的股骨。

Description

具有可移动的切割引导装置的远端股骨试验装置
本申请要求于2004年12月21日提交的名称为“远端股骨修复试验装置和切除引导装置(Distal-Femoral Prosthetic Trial and Resection Guide)”的系列号为60/638,185的美国专利申请的优先权，其全部内容结合在此作为参考。
技术领域
本发明总体上涉及手术矫形试验装置和方法，具体涉及用于制备患者远端股骨以接受股骨假体的试验装置和方法。
背景技术
遭受不稳固的、疼痛的膝关节(这种不稳定是由于缺乏后交叉韧带造成的)的患者是使用后稳固膝假体进行全膝关节成形术的适应人群。这种植入物或假体包括胫骨部件、股骨部件以及典型的活动轴承***物(膝盖骨部件)。
胫骨部件固定到患者胫骨的切除部分上。该部件具有接纳轴承或膝盖骨部件的一柱。股骨部件通常具有与手术制备的远端胫骨表面相接触的内部交叉平坦表面以及面对连接到患者胫骨的相应胫骨部件的带有曲率的外表面。股骨部件具有两个髁区域，这两个髁区域具有接受该胫骨柱的髁间稳固化外壳。这些后稳固的和受限的股骨植入物部件具有在股骨髁(或髁区域)之间的凸轮外壳。
自远端股骨的骨必须从该区域去除以适应该凸轮外壳的这种形状。这可称为切割出中央盒体几何形状。该外壳的尺寸可不同以适于后稳固和受限类型的股骨部件。上述尺寸在患者到患者之间以及植入物到植入物之间也不同。因此，依赖于患者和要使用的股骨植入物的类型需要去除不同量的骨深度。
为了获得最佳的结果、运动范围以及患者舒适性，在这些部件的植入过程中胫骨和股骨部件相对于胫骨和股骨精确对准是很重要的。有很多用于制备股骨的配套工具，例如切割块、钻孔器、锯、凿子和试验部件。
通常，上述从远端股骨去除的以适应凸轮外壳的后骨用切割块和夹头构造来去除。美国专利US 5,819,829中描述和示出了一个例子，其全部内容结合在此作为参考。将切割块放置在带有骨钉的患者股骨上，并用于进行前/后斜面切割。然后将旋转钻孔器***通过切割块中的夹头以制备适于凸轮外壳的股骨(以切割出中央盒体几何形状)。然后可用起钉錾来完成上述制备。所有上述制备都是将切割块作为参考引导装置来完成的。
使用这种***遇到的一些问题是一旦外科医生已经准备好在股骨中的所需切割，她/他将需要拆除切割块并将股骨试验装置固定到准备好的远端股骨以便检查适配性和尺寸。该试验步骤是很重要的，以便确保植入的最终部件与准备好的区域适配。如果需要完成对凸轮外壳区域的另外准备，那么就要拆除该试验装置，将切割块重新定位(其通常需要***另外的骨钉)，并且进一步完成上述切割。可能该过程会需要重复不止一次，在每一重新定位步骤中导致不希望和额外的骨去除或磨损。
此外，当通过切割块去除骨以接受后稳固和受限的股骨植入部件时，由于切割块的形状与植入物的形状不类似，外科医生对如何将切割与真正植入物关联没有“感觉”。其基本为方块。
其它***尝试通过股骨试验装置切割出中央盒体几何形状，但是他们没有使用受限的盒体表面形状，控制钻孔工具和防止损害不需去除的组织是很重要的。如果正在使用切割引导装置的试验装置没有后挡或止动部分，其通常不清楚后切割应该在哪停止。此外，这种***还不能提供在许多情况下所需的理想可调节性。如果切割引导装置只在相对于胫骨的单一位置处附连的话，外科医生在切割引导装置所处的那个位置制备盒体几何形状时就受到限制。参见例如美国专利US4,721,104，其全部内容结合在此作为参考。
因此在该技术中需要提供一种远端股骨试验装置，其允许外科医生使用植入物形状的试验装置来切割远端股骨的中央盒体几何形状，同时还提供控制切割工具深度和方向的活动性和可调节性。还需求提供受限盒体表面形状的这种***。还需求使用这种试验装置的手术方法和工具包。
发明内容
本发明的各种实施例提供了一种远端股骨试验装置，其允许外科医生使用植入物形状的试验装置来切割出远端股骨的中央盒体几何形状。该试验装置包括一切割引导装置，其可从试验装置上拆除并可相对于试验装置进行调节。该引导装置意在控制切割工具的深度和方向，上述切割工具用来制备适于后稳固植入的股骨。
附图说明
图1示出根据本发明一个实施例的组件的分解透视图；
图2示出处于组装位置的图1的实施例；
图3A和图3B示出接收由使用本发明各种实施例制备的骨的植入物的例子；
图4示出结合在此所述组件的各种实施例可用于制备患者骨的钻孔器的例子；
图5A示出根据本发明各种实施例所使用的试验装置替换实施例的侧面透视图；
图5B示出试验装置替换实施例的顶视平面图；
图6示出根据本发明各种实施例所使用的切割块替换实施例的侧面透视图；
图7示出图5的试验装置与图6的切割块结合。
具体实施方式
图1示出股骨试验装置部件12，切割引导装置50以及保持螺栓80，统称为组件10。图7示出可替换的股骨试验装置部件112和切割引导装置150，统称为组件100。在两个实施例中，试验装置12、112制成为具有与将要使用的假体相同或相似的近端和前/后盒体几何形状，使其与已经切除的股骨的表面的几何形状相适配。而且除了具有接纳切割引导装置的开口外，其具有与所述假体相同的关节连接表面，以便制备中央稳固/约束用盒体几何形状。如图7中所示，该试验装置还可包括各种切割槽114，以允许试验装置还可用于在股骨上制备各种切除。该特征是任选的，并且虽然只在图8中所示实施例中有所体现，但是根据本发明的各种方面可用在任意试验装置上。
在一个具体实施例中，试验装置12具有两个髁区域14和带关节连接表面36的前膝盖骨区域34。髁区域14限定一开口16。该开口16是远端股骨准备接受植入物的地方，该植入物具有与胫骨柱相配合的凸轮。图3A和图3B示出实际植入物200的凸轮部分202的例子。股骨的骨头必须制备成为具有用于接纳该凸轮202的空间，并且在制备过程中试验装置12中的开口16允许该空间供工具通过。
开口16限定了植入物12的中央部分18，其具有最前部分22和开放侧边缘24。在示出的具体实施例中，在图1和图2中，开放侧边缘24限定了取向槽20。取向槽20适于接纳切割引导装置50的基部52。在示出的具体实施例中，切割引导装置基部52由外侧法兰58限定。法兰52的边缘可滑入到取向槽20中，以便将试验装置12和切割引导装置50固定到一起。
试验装置12还具有一个或多个固定孔26，在图2中示出它的一个例子。固定孔26适于接纳将试验装置22在患者骨上固定在位的销、螺钉、栓或者另外的固定机构。
在一个特定的实施例中，试验装置12具有接纳部分28，其适于接纳螺栓80。螺栓80用于将切割引导装置50保持在位，将在下面进行更详细地描述。接纳部分28可具有或不具有螺纹30。
试验装置12的另一实施例在试验装置的后端处可具有一个或多个小凹痕以提供止动点，当切割块移动到位时，允许该切割块的柱坐落于该凹痕中。例如，凹痕可接受该切割引导装置的可移动固定销，其将切割引导装置相对于试验装置12固定在位，而无需使用螺栓80，下面将更详细描述其的用途。也可以使用进一步的连接机构；总体构思是提供可固定在确定位置中的试验装置和切割块，但是该确定位置在固定之前是可调节的。
图5A和图5B中示出试验装置112的另一个实施例。由于该试验装置112具有髁区域和其它类似特征，因此其可类似于试验装置12。但是在示出的特定实施例中，试验装置112具有开口16，前部邻接部分116处于该开口的最前部分。该前部邻接部分116意在接纳切割块150的相应前部邻接销152，如图6中所示。在使用中，元件154(在箭头“A”的方向上)被提起，其导致销152在相同方向上被提起。上述可通过使用弹簧和弹簧销组件或任意其它特征来实现。如果使用弹簧和弹簧销，元件154的向上移动压缩搁置在元件154顶部上并保持在引导装置150中的弹簧156。当释放元件154时，弹簧156迫使销152伸出引导装置150到达图6中所示的延伸位置。
在使用中，当元件154被致动且销152缩回时，切割块150沿着取向槽20在试验装置112的开口中滑动就位。当达到正确位置时，使用者释放元件154，导致销152从块150伸出。在一些实施例中，如图7中所示，销152与试验装置112的邻接部分116相接合。如在图5B中所示的另一进一步和优选的实施例中，销152可由销接纳部分118接纳，以便将销152(亦即切割引导装置150)保持在位。为了从试验装置112移除引导装置150，提升回元件154，并且引导装置可自取向槽20滑动出。在一个特别优选的实施例中，试验装置112可具有销接纳部分118，如图5B中所示。在一个特定的实施例中，销接纳部分118捕获销的前部，保持该引导组件不从前面错位，同时允许相对于后止动部(或壁捕获器(wall capture))有向后的自由度。
通常使用的钻孔器是侧面切割，这样进行前/后切除直到切割器达到A/P止动部。如果止动部定位成使得没有A/P自由度，那么不需要在A/P方向上进行侧面切割或切除。这依赖于试验装置的尺寸和设计。
如图6中“L”所示，由块150的长度L控制方向性的界限。块150的长度越短，则在取向槽20中允许更前/更后的移动。
不需要块50、150与带有取向槽20的试验装置相配合。应该理解，块50可卡合在位或通过其它装置以其它方式连接到试验装置上。
切割引导装置50、150优选是盒状部件，其在股骨制备过程中意在引导工具。该盒子优选由四个完全竖向的侧面形成，但对于该盒子来说可能具有更少的侧面和具有不同高度和长度的侧面。(术语“盒子”只是为了便利的目的，并且意在指代切割引导构造)。在一个特定的优选实施例中，引导装置具有用来限制后切割的后壁或捕获器62。
在手术中制备内部盒体几何形状过程中，切割引导装置50、150意在连接到(和从其移除)试验装置12、112。引导装置50，150具有接纳钻孔器的内部盒体54，如图4中的例子所示。内部盒体的高度H可变化。另外，宽度和其它尺寸也可以变化，以便允许引导装置50与特定尺寸的股骨相适配，从而适应各种盒体几何形状深度和前/后长度。
在一个优选实施例中，提供多于一个的引导装置50、150，以适应各种植入物和患者尺寸。盒体几何形状深度由引导装置的高度确定。如图4中所示，可用于引导装置50的钻孔器210的例子具有颈圈212，其确定钻孔器延伸进入骨中的深度。颈圈112由引导装置50的顶表面60挡住。这样，提供具有不同高度的各种尺寸的引导装置50就允许外科医生使用同一钻孔器110来制备不同深度的空腔。
在图7所示的实施例中，由引导装置150的长度控制A/P方向。在图1和2所示的替换实施例中，由方向性限制槽56控制A/P方向。如果使用螺栓80的话，这些槽56适于接纳螺栓80。槽56在内侧/外侧上定位成使得槽56与假体耳形打孔器的孔位置104适配(图3B中所示)。槽56还允许将引导装置50定位在试验装置12的任何所希望的前/后位置上，使其与所希望的假体尺寸需要的稳固/约束用的盒体几何形状的位置和长度相关。如图2所示，槽56适于接纳螺栓，以便将引导装置50固定在位。
该特征使得外科医生按需要将试验装置12定位在内侧/外侧位置上，并且按需要在前/后方向上定位该引导位置，使得外科医生对相对于最终使用的植入物的形状和位置所进行的切割有清楚的了解。一旦引导装置50正确放置，螺栓80限制该前/后移动。
如图1和2中所示的那样，保持螺栓80具有柱86，其一端具有头部88而在另一端具有任选的螺纹。在一个优选的实施例中，螺栓80是中空的84，从而允许使用额外的固定销来进一步将引导装置50和螺栓80固定到患者的远端股骨。如果设有螺纹82，它们可与接纳部分28的螺纹30相配合。在一个特别优选的实施例中，螺栓头88具有扩孔，以允许使用六角形驱动器。
允许该块相对于试验装置移动的A/P距离可以以另一种方式来控制，即，通过不使用螺栓80的方向性限制槽或通过试验装置的任意其它区域，将骨钉或螺钉直接***远端骨中，这可固定该组件，并且无需使用作为A/P平移止动件的螺栓。另一可替换的实施例将是通过中空螺栓80***骨钉或螺钉。
在手术中，在已经进行预备切除来适应没有稳固/约束用的中央盒体的远端股骨假体之后，将试验装置12、112放置到远端股骨上。这种用于制备远端股骨的切割和方法在现有技术中是已知的。然后将试验装置12、112定位(通过用胫骨和/或膝盖骨的骨覆盖和/或试用)在所希望的内侧/外侧位置，并通过一个或多个固定孔26固定在位。在一个优选实施例中，至少一个固定孔26定位在膝盖骨区域34(或前法兰)上。
然后将切割引导装置50、150放置在位于试验装置12的开放侧边缘24上的取向槽20中，如果有必要的话，接着将保持螺栓80旋入试验装置12中的接纳部分28中。通过旋钮型头部或用六角形驱动器将螺栓80拧紧到所需的阻力。如果需要的话，可沿取向槽20和沿着方向性限制槽56用保持螺栓80将切割引导装置50拧紧在任意给定的位置中。如果需要额外的固定，骨钉或其它固定机构可放置穿过螺栓80的中空区域84并进入远端股骨。一旦使用已知方法通过切割引导装置50、150进行骨切除，那么将切割引导装置50，150从试验装置12拆除，同时试验装置12保持在患者股上的位置。在拆除试验装置12之前可进行任意的必要试验。如果需要制备额外的盒体几何形状，可以把切割引导装置50、150重新放入原位，而不需要将其再固定到骨上，其有助于防止由手术导致的骨磨损或损耗，并且无需再切割或再定位。
在不脱离本发明和下述权利要求的范围或精神下可以对上述和附图中所示的结构和方法进行变化和更改、增加和删除。

Claims (13)

1.一种股骨试验装置和切割引导装置组件，包括：
(a)股骨试验装置，该股骨试验装置包括由一开口分开的髁区域，所述开口限定了具有最前部分和开放侧边缘的中央部分；以及
(b)可拆卸的切割引导装置，其适于由所述开口接纳，并与所述最前部分成可调节的关系地固定在所述开口内。
2.权利要求1所述的组件，其中，所述切割引导装置具有用来限制后切割的后捕获器。
3.权利要求1所述的组件，其中，所述开放侧边缘包括接纳所述切割引导装置的基部的取向槽。
4.权利要求1所述的组件，其中，所述切割引导装置具有方向性限制槽，所述方向性限制槽允许相对于所述股骨试验装置来调节所述切割引导装置。
5.权利要求4所述的组件，还包括保持螺栓，该保持螺栓由该方向性限制槽接纳，以将所述切割引导装置固定到所述股骨试验装置。
6.权利要求5所述的组件，其中，所述螺栓是中空的。
7.权利要求1所述的组件，其中，所述股骨试验装置包括一个或多个接纳部分，该接纳部分适于接纳保持螺栓的端部。
8.权利要求1所述的组件，其中，所述切割引导装置具有可移动的固定销，该固定销滑动进入所述股骨试验装置中的凹痕内，以便将所述切割引导装置保持在股骨试验装置的方向性限制物中。
9.权利要求1所述的组件，其中，所述股骨试验装置具有一个或多个固定孔，该固定孔允许将该股骨试验装置固定到准备好的的远端股骨。
10.权利要求1所述的组件，其中，所述切割引导装置具有适于接纳和挡住切割工具的内部捕获器。
11.权利要求1所述的组件，其中，所述组件具有多个具有不同尺寸的切割引导装置，以提供不同的深度和前/后长度选择。
12.权利要求1所述的组件，其中，所述试验装置具有前部邻接部分，并且所述切割引导装置具有销，该销适于由所述前部邻接部分接纳，以便将所述切割引导装置相对于所述试验装置固定在位。
13.权利要求12所述的组件，其中，所述切割引导装置具有可缩回的元件，该可缩回元件致动一弹簧，以允许所述销相对于所述切割引导装置上升和下降以及相对于所述试验装置固定在位。
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US8764759B2 (en) 2014-07-01
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US20110213378A1 (en) 2011-09-01
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