CN114848239A - 模块化人工膝盖系统 - Google Patents
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Abstract
一种模块化膝关节假体构造成在伸展位置和屈曲位置之间移动。模块化膝关节假体包括构造成安装到股骨的股骨部件。股骨部件在其中心区域中具有第一切口或开口,用于接纳股骨插入件。模块化膝关节假体还包括胫骨部件,其构造成(i)直接地或间接地安装到胫骨,并且(ii)接合股骨部件。胫骨部件在其中心区域中具有第二切口或开口,用于接纳胫骨插入件。一种套件包括模块化膝关节假体、具有不同几何结构的至少两个股骨插入件和具有不同几何结构的至少两个胫骨插入件。
Description
技术领域
本发明大体上涉及用于全膝关节置换(TKR)的人工膝盖假体,并且更特别地涉及具有人工前交叉韧带(ACL)和/或后交叉韧带(PCL)的膝关节假体。
背景技术
如在Garino的美国专利申请公开No. 2017/0252173(其以其整体通过引用而并入本文中并且用于所有目的)中所描述的,假体膝盖大体上包括三个主要部件:股骨部件(图1A和图1B),其附接到股骨的远端;胫骨底板(图2A和图2B),其植入到胫骨的近端上;和关节胫骨插入件(图3A和图3B),其安装到胫骨底板上并为股骨部件提供摩擦表面。这些部件被设计成在膝盖的整个运动范围内模拟人类膝盖的关节和相关联的力学。部件通常以具有不同尺寸(在图1A至图3B中标识为尺寸A-H和J-T)的各种形状被提供,使得医生能够根据患者的具体解剖结构选择部件的最佳组合。膝盖的大小和形状取决于各种因素,包括患者的年龄、性别和体型。因此,通常可以获得相当大的部件库存,从而可以为患者定制假体膝盖。
在利用TKR进行的常规膝盖构建过程期间,在绝大多数情况下ACL被移除,并且根据所选择的TKR设计,患者的PCL被保留或用某种机构取代,以替代丧失的PCL的功能。即使当PCL被保留时,通常在手术期间也必须切除或部分切除PCL的一部分,以有助于膝关节置换的平衡。当PCL被完全移除时,PCL被柱和凸轮机构取代。
TKR大体上包括:股骨部件10;胫骨底板16,其具有植入形成在胫骨中的内孔内的柱18;和关节插入件22,其位于胫骨底板16的顶部安装部分20上,用于与股骨部件10对接。关节插入件22可如所示的那样与胫骨底板16分离,或者与胫骨底板16集成为单个部件。关节插入件22和胫骨底板16在本文中可一起或单独地被称为“胫骨部件”。
参考图1A、图1B、图3A和图3B,提供了柱和凸轮机构的典型设计的图示。关节插入件22包括突出到股骨部件10的开口12中的延伸部24。具有向上伸出的壁的框11形成在股骨部件10的内侧上,并且包括与开口12相交的内部区域。延伸部24包括后表面25,当关节屈曲时,后表面25意在用于与开口12的后表面14摩擦接触。当延伸部24承靠股骨部件10中的开口12的后表面14时产生的阻力意在用于模拟原本应由健康的后交叉韧带(PCL)产生的阻力。
通过在延伸部24的前表面和开口12的前表面之间形成凸轮表面,凸轮和柱机构被制造成部分地替代ACL的功能;然而,这种解决方案仅提供了ACL的部分取代,因为延伸部24的前侧最多只能在0至20度屈曲之间接触开口的前侧。
缺乏解剖学上正确的替代物可能导致TKR与原始膝盖相比功能性降低。这可能会在手术后的物理治疗期间造成困难,并限制患者在治疗后参与体育活动的能力或愿望。几乎所有现代的全膝关节置换术都牺牲了ACL,或者用粗糙的凸轮和柱机构不充分地取代它,从而使重建的膝盖具有的运动学(kinematics)类似于有ACL缺陷的膝盖的运动学。因此,正常的膝盖运动学仍然难以实现(elusive)。此外,在ACL和PCL(它们一起驱动正常的膝盖运动学)之间缺乏适当的相互作用使得TKR重建无法为患者产生相对正常的膝盖。
考虑到膝关节的力学的复杂性以及患者在手术后难以适应人工膝盖,需要一种解剖学上正确的膝关节置换系统,其更准确地模拟以前由移除的韧带提供的回弹性和支撑。为了提供解剖学上更正确的TKR,复制由ACL和PCL两者提供的功能的假体实施例是合乎人意的。
现在参考图4,健康的人的膝盖被示出为具有画在原始解剖ACL和PCL的位置上的环30,其代表示例性的人工ACL/PCL韧带。构成人工PCL的环30的区段由点26A和26B界定。构成人工ACL的环30的区段由点28A和28B界定。
现在参考图5、图6A和图6B,其示出了Garino的美国专利申请公开No. 2017/0252173中公开的实施例,人工材料的连接点26a、26b、28a和28b被提供为韧带44,并且被提供为人工韧带44的轮廓的横跨在连接点之间的段(lengths)构造成模拟如图4所示的人类膝盖中ACL和PCL的尺寸和附接点。可提供至少一段人工韧带来连接TKR的关节插入件22和股骨部件10。
虽然Garino的美国专利申请公开No. 2017/0252173为这些复杂问题提供了解决方案,但是为了改善膝关节的力学性能,不断寻求该领域的发展。
发明内容
在本发明的一个实施例中,一种模块化膝关节假体构造成在伸展位置和屈曲位置之间移动。模块化膝关节假体包括构造成安装到股骨的股骨部件。股骨部件在其中心区域中具有第一切口或开口,用于接纳股骨插入件。模块化膝关节假体还包括胫骨部件,其构造成(i)直接地或间接地安装到胫骨,并且(ii)接合股骨部件。胫骨部件在其中心区域中具有第二切口或开口,用于接纳胫骨插入件。
在本发明的另一个实施例中,一种套件包括上述模块化膝关节假体、具有不同几何结构的至少两个股骨插入件和具有不同几何结构的至少两个胫骨插入件。可基于包括患者的年龄、性别和体型的各种因素选择不同的插入件。
附图说明
图1A是由本领域普通技术人员已知的膝关节假体的股骨部件的侧视图。
图1B是图1A的股骨部件的仰视图。
图2A是由本领域普通技术人员已知的膝关节假体的胫骨部件的俯视图。
图2B是图2A的胫骨部件的侧视图。
图3A是由本领域普通技术人员已知的膝关节假体的关节插入件的俯视图。
图3B是安装在胫骨部件的底板上的图3B的关节插入件的前视图。
图4是膝关节的侧视图,示出了ACL和PCL的解剖位置以及意在用于替代ACL和PCL的人工材料的构造。
图5是根据现有技术的用于TKR的股骨部件、关节插入件和人工韧带的侧视图。
图6A是沿着图5的线I-I的横截面的俯视图。
图6B是沿着图5的线I-I的横截面的仰视图。
图7A是从顶部、左侧和后侧观察时的并根据第一示例性实施例的模块化膝关节假体的组装图。
图7B是图7A的模块化膝关节假体的分解图。
图7C至图7F分别描绘了图7A的模块化膝关节假体的侧立面视图、俯视平面图、后/后侧立面视图和前/前侧立面视图。
图7G描绘了沿着线7G-7G截取的图7F的模块化膝关节假体的剖视图,其中模块化膝关节假体被示出为处于伸展位置。
图7H描绘了类似于图7G的模块化膝关节假体的另一个剖视图,但是其中模块化膝关节假体被示出为处于屈曲位置。
图8A是根据第二示例性实施例的模块化膝关节假体的组装图。
图8B是图8A的模块化膝关节假体的分解图。
图8C至图8F分别描绘了图8A的模块化膝关节假体的侧立面视图、俯视平面图、后立面视图和前立面视图。
图8G描绘了沿着线8G-8G截取的图8F的模块化膝关节假体的剖视图,其中模块化膝关节假体被示出为处于伸展位置。
图8H描绘了类似于图8G的模块化膝关节假体的另一个剖视图,但是其中模块化膝关节假体被示出为处于屈曲位置。
图9A是根据第三示例性实施例的模块化膝关节假体的组装图。
图9B是图9A的模块化膝关节假体的分解图。
图9C至图9F分别描绘了图9A的模块化膝关节假体的侧立面视图、俯视平面图、后立面视图和前立面视图。
图9G描绘了沿着线9G-9G截取的图9F的模块化膝关节假体的剖视图,其中模块化膝关节假体被示出为处于伸展位置。
图9H描绘了类似于图9G的模块化膝关节假体的另一个剖视图,但是其中模块化膝关节假体被示出为处于屈曲位置。
图10A是根据第四示例性实施例的模块化膝关节假体的组装图。
图10B是图10A的模块化膝关节假体的分解图。
图10C至图10F分别描绘了图10A的模块化膝关节假体的侧立面视图、俯视平面图、后立面视图和前立面视图。
图10G描绘了沿着线10G-10G截取的图10F的模块化膝关节假体的剖视图,其中模块化膝关节假体被示出为处于伸展位置。
图10H描绘了类似于图10G的模块化膝关节假体的另一个剖视图,但是其中模块化膝关节假体示出为处于屈曲位置。
具体实施方式
本发明提供了膝关节假体的各种实施例。在图中,“A”代表前侧或前方向,“P”代表后侧或后方向,“M”代表内侧或内方向,并且“L”代表外侧或外方向。
图7A至图7H描绘了根据第一示例性实施例的模块化膝关节假体700。尽管在下文中示出并描述了用于左膝的假体700,但是应当理解,右膝假体基本上类似,并且下面的解释也适用于右膝假体。
假体700大体上包括模块化股骨部件702、构造成安装到股骨部件702的股骨插入件705、模块化关节部件704和构造成安装到关节部件704的胫骨插入件706。
模块化股骨部件702包括具有相对的髁710的U形主体。销711从部件702的内表面向上延伸,用于将股骨部件702植入股骨中,如本领域已知的。矩形切口712在髁710之间的中心位置处限定在股骨部件702中。切口712在前-后方向上和矢状面中延伸。切口712包括在部件702的后侧处的开口。切口712延伸穿过部件702的整个壁厚。切口712包括三个互连且面向内部的侧面,即在矢状面中延伸的外侧、在矢状面中延伸的内侧以及连接外侧和内侧的前侧。切口712的后侧是敞开的,用于接纳插入件705。
在切口712的相对的内侧和外侧中的每个上形成浮凸。浮凸一起形成狭槽或轨道713,狭槽或轨道713构造成接纳形成在股骨插入件705的相对侧上的轨条715(即,肩部),使得插入件705可安装在部件702上。应当理解,轨道713可设置在插入件705上,并且轨条715可设置在部件702上,以实现相同或相似的结果。
应当理解,可提供除了轨道713和轨条715之外的用于将插入件705安装到部件702的装置。备选地,用于安装的装置可包括狭槽、导轨、轨条、卡扣特征、摩擦配合、过盈配合、紧固件(螺钉、螺栓、螺母)、焊接、粘合剂、燕尾榫(或其它配合表面)。
模块化关节部件704构造成位于胫骨部件(未示出)的顶部安装部分上,用于与股骨部件702对接。关节部件704构造成安装到固定地安装到胫骨的胫骨底板16(参见图2B和图5)。备选地,并且尽管未示出,关节部件704可与胫骨底板16集成,以形成固定地安装到胫骨的单个一体式胫骨部件。因此,“胫骨部件”可包括关节部件704(单独)或关节部件704和胫骨底板16两者。
关节部件704包括两个凹表面721,用于在假体700在屈曲位置和伸展位置之间移动时与股骨部件702的凸形髁710物理接合。矩形切口723在凹表面721之间的中心位置处限定在关节部件704中。切口723在前-后方向上和矢状面中延伸。切口723包括在关节部件704的后侧处的开口。切口723延伸穿过关节部件704的壁厚。切口723包括三个互连且面向内部的侧面,即在矢状面中延伸的外侧、在矢状面中延伸的内侧以及连接外侧和内侧的前侧。在切口723的相对的内侧和外侧中的每个上形成浮凸。浮凸一起形成狭槽或轨道724,狭槽或轨道724构造成接纳形成在胫骨插入件706的相对侧上的轨条725(肩部),使得插入件706可通过沿着轨道724滑动轨条725而安装在关节部件704上。应当理解,轨道724可设置在插入件706上,而轨条725可设置在关节部件704上,以实现相同或相似的结果。
应当理解,可提供除了轨道724和轨条725之外的用于将插入件706安装到关节部件704的装置。备选地,用于安装的装置可包括狭槽、导轨、轨条、卡扣特征、摩擦配合、过盈配合、紧固件(螺钉、螺栓、螺母)、焊接、粘合剂、燕尾榫(或其它配合表面)。
股骨部件702和关节部件704是第一至第四实施例中通用的模块化部件。股骨部件702和关节部件704可一起形成模块化子组件。
现在转到能够选择性地安装在那些模块化部件702和704上的部件,股骨插入件705构造成安装到股骨部件702,并且胫骨插入件706构造成安装到关节部件704(或者称为胫骨部件704)。股骨插入件705和胫骨插入件706一起工作来引导假体700在图7G和图7H所示的屈曲位置和伸展位置之间的运动。
股骨插入件705包括L形主体。主体限定细长的水平部分731,轨条715在该水平部分上从其相对的侧表面突出。水平部分731尺寸设计成紧密地配合在股骨部件702的切口712内。主体的竖直部分733从水平部分731正交地延伸。在组装形式中,竖直部分733与股骨部件702的髁710齐平并桥接髁710。竖直部分733还用作指状突出部,以便于将插入件705手动插入到股骨部件702上或从股骨部件702手动移除。股骨插入件705可以可释放地或不可释放地连接到股骨部件702。
呈凸表面形式的齿轮734从插入件705的L形主体的前和后面向外部的表面向外突出。齿轮734包括具有倒圆外表面的多个单独的齿轮齿。齿轮齿沿着齿轮734的外周边均匀地间隔开。如在图7D和图7E中可观察到的,齿轮734遵循螺旋路径。具体地,齿轮734围绕(i)在内-外方向上延伸的其自身的轴线740(图7G和图7H)和(ii)在前-后方向上延伸的轴线(参见图7E)曲线运动。换句话说,齿轮734沿着彼此正交定向的两个不同的轴线曲线运动。齿轮734位于L形主体的前表面和后表面上,而轨条715设置在主体的左侧和右侧上,并且面向顶部和面向后方的表面是平面的。股骨插入件705可为一体式整体部件。
胫骨插入件706包括细长的矩形主体。轨条725在前-后方向上延伸,并从主体的相对侧表面突出。如上面所描述的,轨条725尺寸设计成配合在形成于关节部件704上的轨道724内,使得轨条725在其对应的轨道724中滑动。指状突出部744限定在插入件706的下后边缘上,以便于手动操纵插入件706。胫骨插入件706可以可释放地或不可释放地连接到胫骨部件704。
弯曲通道750在前-后方向上延伸穿过插入件706的主体。通道750具有彼此面对的相对的弯曲侧壁。例如,如图7B所示,通道750围绕竖直轴线(在上-下方向上或沿着矢状面)弯曲。通道750的基部表面具有从其上向上延伸的一系列齿轮齿752,用于与齿轮734的齿啮合。基部表面可为平坦的(除了齿752之外),或者基部表面可围绕轴线740弯曲(图7H)。插入件706可为一体式整体部件。
现在转到图7G和图7H,关节部件704上的齿轮齿752与股骨部件702的齿轮齿734啮合,使得关节部件704在股骨部件702上旋转,反之亦然。当股骨部件702在后方向上旋转到图7H所示的屈曲位置时(如由箭头所示),啮合齿不会滑过彼此。由于齿轮齿734在内-外方向上的弯曲导致的当假体700在屈曲位置和伸展位置之间移动时关节部件704在内-外方向上的轻微旋转模仿了真实膝关节中经历的轻微旋转。
图8A至图8H描绘了根据第二示例性实施例的模块化膝关节假体800。应当理解,假体800类似于假体700,并且下文将仅描述它们之间的区别。
假体800包括股骨部件702和关节部件704,然而,它包括不同的股骨插入件和胫骨插入件。与股骨插入件705相比,股骨插入件805也具有齿轮834,然而,齿轮834具有较少数量的单独齿。类似地,胫骨插入件806也具有较少数量的单独的齿轮齿852。假体800的单独齿在尺寸方面大于它们在假体700中的对应齿。
图9A至图9H描绘了根据第三示例性实施例的模块化膝关节假体900。应当理解,假体900也类似于假体700,并且下文将仅描述它们之间的区别。假体900包括股骨部件702和关节部件704,然而,它包括不同的股骨插入件和胫骨插入件。与股骨插入件705相比,股骨插入件905不具有任何齿。相反,股骨插入件905包括刀片934。如所示的,刀片934的自由和下边缘可为平坦的和钝的,并且不一定是锋利的。
像齿轮734一样,刀片934遵循螺旋路径,即,与齿轮734相同的螺旋路径。胫骨插入件906具有像插入件706的通道750一样的通道950。然而,通道950的基部表面是平面的,并且不包括齿。在操作中,刀片934的自由端部沿着通道950的平坦基部表面在屈曲位置和伸展位置之间既旋转又平移。
图10A至图10H描绘了根据第四示例性实施例的模块化膝关节假体1000。应当理解,假体1000类似于假体700,并且下文将仅描述它们之间的区别。
假体1000包括股骨部件702和关节部件704,然而,它包括不同的股骨插入件和胫骨插入件。股骨插入件1005包括下凸表面1034和穿过插入件1005的厚度在竖直方向上(即,当处于伸展位置时在上-下方向上)设置的基本上矩形的切口1035。
胫骨插入件1006包括上凹表面1050,其形状和尺寸设计成接纳股骨插入件1005的下凸表面1034。柱1052从上凹表面1050向上延伸。柱1052具有如在剖面(图10G)中观察到的直角三角形形状,由此柱1052的斜边限定在前侧上,并且柱1052的竖直面1055限定在后侧上。在假体1000的组装形式中,柱1052配合在切口1035内。当假体1000在伸展位置和屈曲位置之间移动时,柱1052保持在切口1035内。股骨部件702可朝向屈曲位置移动,直到柱1052的竖直面1055与切口1035的后侧上的支承面1057接合。
应当理解,股骨插入件和胫骨插入件中的每个可分别与股骨部件702和关节部件704可互换地使用。各种股骨插入件具有不同的几何结构,并且类似地,各种胫骨插入件具有不同的几何结构。如果需要的话,所有的股骨插入件和胫骨插入件都可作为套件设置有一个股骨部件702和一个关节部件704。在使用中,不同的股骨插入件和胫骨插入件可由外科医生基于包括例如患者的年龄、性别、病症和体型的各种因素来选择。
膝关节假体的部件可由相同或相似的材料制成。然而,一般来说,所有材料都优选是惰性的,不容易引起感染,并且在其它方面是安全的,并且被批准用作外科植入物。示例性材料包括聚乙烯、外科上批准的金属合金、外科上批准的陶瓷材料或它们的组合。外科植入物领域中的任何众所周知的材料都可用于制造根据本发明的任意各种实施例或其部分。
虽然本文已经示出和描述了本发明的优选实施例,但是将理解,这样的实施例仅仅是通过示例的方式被提供。在不脱离本发明的精神的情况下,本领域技术人员可想到许多变型、改变和替换。因此,意图是,所附权利要求书覆盖落入本发明的精神和范围内的所有这样的变型。
Claims (14)
1.一种模块化膝关节假体,其构造成在伸展位置和屈曲位置之间移动,所述模块化膝关节假体包括:
股骨部件,其构造成安装到股骨,所述股骨部件在其中心区域中具有第一切口或开口,用于接纳股骨插入件;
胫骨部件,其构造成(i)直接地或间接地安装到胫骨,并且(ii)接合所述股骨部件,所述胫骨部件在其中心区域中具有第二切口或开口,用于接纳胫骨插入件。
2.根据权利要求1所述的模块化膝关节假体,其特征在于,还包括所述股骨插入件和所述胫骨插入件。
3.根据权利要求2所述的模块化膝关节假体,其特征在于,还包括设置在所述股骨插入件上的股骨齿轮和设置在所述胫骨插入件上的胫骨齿轮,其中,所述股骨齿轮和所述胫骨齿轮构造成啮合在一起。
4.根据权利要求3所述的模块化膝关节假体,其特征在于,所述股骨齿轮和所述胫骨齿轮构造成在所述伸展位置和所述屈曲位置二者都啮合在一起。
5.根据权利要求3所述的模块化膝关节假体,其特征在于,所述股骨齿轮和所述胫骨齿轮具有齿轮齿。
6.根据权利要求3所述的模块化膝关节假体,其特征在于,当所述膝关节假体移动到所述伸展位置时,所述齿轮中的至少一个遵循螺旋轨迹以引起所述胫骨部件在内或外方向上的移动。
7.根据权利要求2所述的模块化膝关节假体,其特征在于,还包括从所述股骨插入件突出的刀片和设置在所述胫骨插入件上的狭槽,其中,所述刀片构造成在所述伸展位置和所述屈曲位置二者都定位在所述狭槽内。
8.根据权利要求7所述的模块化膝关节假体,其特征在于,当所述膝关节假体移动到所述伸展位置时,所述刀片遵循螺旋轨迹以引起所述胫骨部件在内或外方向上的移动。
9.根据权利要求2所述的模块化膝关节假体,其特征在于,还包括从所述胫骨插入件突出的柱和设置在所述股骨插入件上的开口,其中,所述柱构造成在所述伸展位置和所述屈曲位置二者都定位在所述开口内。
10.根据权利要求9所述的模块化膝关节假体,其特征在于,所述柱从形成在所述胫骨插入件上的凹表面突出,并且所述开口设置在形成在所述股骨插入件上的凸表面上,其中,所述凹表面构造成在所述伸展位置和所述屈曲位置二者都抵靠所述凸表面定位。
11.根据权利要求1所述的模块化膝关节假体,其特征在于,所述胫骨部件包括关节插入件,并且所述第二切口或开口形成在所述关节插入件中,并且其中,所述关节插入件构造成夹在所述股骨部件和直接安装到所述胫骨的胫骨底板之间。
12.一种套件,包括根据权利要求1所述的模块化膝关节假体,并且还包括具有不同几何结构的至少两个所述股骨插入件和具有不同几何结构的至少两个所述胫骨插入件。
13.根据权利要求1所述的模块化膝关节假体,其特征在于,还包括所述股骨插入件和所述胫骨插入件,其中,所述股骨插入件可移除地安装在所述股骨部件的所述第一切口或开口内,并且所述胫骨插入件可移除地安装在所述胫骨部件的所述第二切口或开口内。
14.根据权利要求13所述的模块化膝关节假体,其特征在于,所述股骨插入件通过轨条和狭槽接合可移除地安装在所述股骨部件的所述第一切口或开口内,并且所述胫骨插入件通过滑动轨条和狭槽接合可移除地安装在所述胫骨部件的所述第二切口或开口内。
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