CN102905649B - 联锁相反髋部和翻修假体 - Google Patents

联锁相反髋部和翻修假体 Download PDF

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CN102905649B
CN102905649B CN201180012883.2A CN201180012883A CN102905649B CN 102905649 B CN102905649 B CN 102905649B CN 201180012883 A CN201180012883 A CN 201180012883A CN 102905649 B CN102905649 B CN 102905649B
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cup
acetabular
femoral
handle
ball
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CN102905649A (zh
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Z.特马尼尼
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Hip Innovation Technology LLC
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Hip Innovation Technology LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/902—Method of implanting
    • Y10S623/908—Bone

Abstract

相反髋部假体包括用于植入于髋臼窝中的髋臼杯。使用紧固件将髋臼杯固定到盆骨的髋臼窝。髋臼杯具有从其凹入部的中心延伸的柄，且髋臼球优选地借助于莫氏锥度而附连到柄上。股骨植入物具备附连到其近端的股骨杯。股骨杯具有柄，柄可以用模块化方式构建，具有若干柄长度以便适应不同患者的各种大小要求。在植入了髋臼杯和球和股骨杯之后，这些部件组装在一起从而使得股骨杯能在该髋臼球上铰接。本发明的假体具有较宽运动范围，且基本上改进了摩擦。由于股骨杯是铰接的，股骨杯的边缘移动到位于髋臼杯与髋臼球之间的空间内，且由此变得受限制，因而减小了在极端运动范围期间错位的可能性。

Description

联锁相反髋部和翻修假体
技术领域
本发明大体而言涉及髋部假体且更具体而言涉及联锁相反髋部假体，其允许增加的运动范围和在过度运动范围期间增加的稳定性。
背景技术
可意识到已在过去数年中使用了若干种髋部植入物。通常，常规的髋部植入物包括股骨构件，股骨构件具有附连到柄的关节股骨球。在制备且由手术医师使用适当扩孔钻来扩孔之后，将股骨柄插入于股骨的骨髓管内。可利用骨接合剂或者压配合来牢固固定该柄。在制备且适当扩孔之后，将杯状的髋臼构件插入于髋臼窝内，并且利用网状骨质接骨螺钉穿过在杯中的孔而固定。其也可利用骨接合剂或压配合或其组合来加以固定。
髋臼杯为金属的，且其在内部用高密度聚乙烯或陶瓷加衬。所述衬里通过压配机构而被固定到髋臼杯内。
常规髋部植入物的主要问题在于在过大运动范围时假体的不稳定性，由此造成关节股骨球离位和错位/脱臼。现有技术教导了一种或多种受约束和预先组装的球和杯装置，其中，球和杯构件被单独地植入，于是，球元件被推迫进入到杯中的弹性开口内，且之后由弹性材料保持就位。其它受约束的髋臼杯可包括锁定环，诸如由Albertorio等人在美国专利6,527,808中所描述的那种。在杯元件具有定位环的情况下，在植入了两个元件之后，球构件被迫插入于杯内。这构成了弱连结，其中由行走运动（ambulatorymotion）施加在假体上的力可超过用于组装植入物的力，由此造成球与杯分离开。
虽然这些装置可适合用于它们所解决的特定目的，它们并不提供如在本发明的相反髋部植入物设计中的联锁机构。申请者的设计的本质允许增加的运动范围、和在极端运动范围的有所增加的稳定性，由此降低了错位/脱臼的风险。
在这些方面，根据本发明的联锁相反髋部假体基本上偏离了现有技术的常规概念和设计，因为现有技术的关节股骨球被关节股骨杯替换且髋臼杯具备髋臼球。因而，提供了一种设备，其主要发展用于减小在极端运动范围的情况下髋部植入物错位的风险的目的。
而且，由于本发明的股骨杯的关节表面100%的时间完全接触着髋臼球的表面，显然，这将会改进摩擦，因为在关节表面上改进了承重分布，因而减小了接触的表面的磨损且降低了在关节中释放磨损颗粒的风险。磨损颗粒对于关节的正常功能的危害性很大。
发明内容
本发明提供一种新的联锁相反髋部假体构造，其中髋臼球稳固地且同心地经由莫氏锥度（Morsetaper）而附连到髋臼杯的中心突起或柄上。在优选实施例中使用金属髋臼杯。股骨杯(在本文中也被称作半球股骨杯或关节股骨杯)优选地凭借莫氏锥度而稳固地附连到股骨植入物。也可使用本领域技术人员已知的其它附连手段。且每当在本文中提到莫氏锥度时，预期是描述一种优选实施例。莫氏锥度能由其它合适的附连机构替换，如将会对于本领域技术人员显然的。
髋臼杯植入于由外科医师在盆骨中所构建的髋臼窝中，利用一个或多个紧固件通过在髋臼杯中的一个或多个开口而将其牢固地固定到盆骨上。紧固件可为可变数量的网状骨质接骨螺钉或生物相容性可再吸收的螺柱。股骨植入物然后插入且压紧到股骨骨髓管内，骨髓管已由外科医生使用适当扩孔钻制备且挖空。在行走期间，关节股骨杯边缘或唇缘将会舒服地且同心地滑移到位于髋臼球与髋臼杯之间的空间内。如对于本领域技术人员将会显然的，申请人的发明的几何构造使得当运动的范围增加时股骨杯很难错位，因为其变得受约束在介于髋臼杯与髋臼球之间的空间内。
如上文所指出的那样，股骨杯的关节表面总是完全接触髋臼球的关节表面，这改进了重量分布，减小了接触的表面的磨损、且降低了磨损颗粒在关节中释放的风险。
在本发明的任选实施例中，申请者已解决了软组织可能变得卡在/嵌入在植入物中、在介于髋臼杯与髋臼球之间空间中的较少发生的可能性。保护套可用于避免这种可能性。如在下文中更详细地讨论，该套置于介于髋臼杯与髋臼球之间的空间中且允许在其中自由地滑移。
因而已概述了本发明的更重要特点以便可更好地理解详细描述，且从而使得可更好地意识到本发明对于该技术的贡献。本发明的新颖特点在于髋关节的关节表面的位置(即，球和窝)是相反的。这得到新的相反的髋部植入物，其并非在单独或以任何组合考虑时由任何先前髋部假体而能预料到，变得显然，建议或甚至暗示出的。
在此方面，在详细地解释本发明的至少一个实施例之前，应了解本发明在其应用方面并不致力于在下文的描述所陈述或在附图所示的构件的构造和布置的细节。本发明能具有其它实施例且以对于本领域技术人员从本文描述所显而易见的各种方式来实践和执行。而且，应了解，本文所用的术语是出于描述目的而且不应认为具有限制意义。
为了实现上述和相关目的，本发明可以用附图中所示的形式来实施。但是，附图只是引导性的，且在不偏离本发明的原理的情况下可对图示的任何具体构造做出变化。
附图说明
本发明的各种其它目的、特点和优点将会变得完全理解，因为当结合附图来考虑时，它们将会变得更好理解，在所有几个附图中，相同的附图标记表示相同或相似的元件，且在附图中：
图1为本发明的联锁相反髋部假体的透视图。
图2为联锁相反髋部假体的截面图。
图3为处于延伸和外旋转时的联锁相反髋部假体的截面图。
图4为处于延伸和内旋转时的联锁相反髋部假体的截面图。
图5为本发明的假体的透视图，示出了任选的软组织保护套。
图5A为保护套本身的透视图。
图6为图5的实施例的截面。
图7为示出股骨杯的截面图，其具有凹部而不是柄部用于连接到股骨植入物。
图8为已铰接到极端位置的图7的实施例的截面图。
具体实施方式
现转至附图，在所有若干视图中，附图标记表示相同或相似元件，图1至图4示出了联锁相反髋部假体，其包括髋臼杯(11)，髋臼杯(11)具有平滑凹表面和凸非关节表面。当髋臼杯植入于患者中时凸非关节表面邻接着盆骨中的窝，且提供多孔表面，多孔表面具有多个微凸体（asperity）和微孔隙以允许骨骼向内生长。而且，髋臼杯{11}在不同位置提供一个或多个孔(12)用于使用一个或多个紧固件(14)的目的。紧固件(14)可为不同直径和长度的螺钉或可再吸收的非金属和生物相容性螺柱。螺柱，其可被称作骨骼(orthobiologic)可再吸收的螺柱，将在骨骼向内生长的初始阶段固定住髋臼杯(11)且将在一年内再吸收，被新生长的骨骼替换且变成宿主盆骨的部分。在该期间，髋臼杯(11)通过骨骼向内生长而变得稳固地附连到盆骨(4)中的髋臼窝上。髋臼杯(11)具有凹入半球形表面，其中安置较大髋臼杯柄(9)。髋臼杯柄(9)具有凸型莫氏锥度，用于以借助于具有凹型莫氏锥度的髋臼球凹口(10)而组装到髋臼球(8)上。参看图2至图4和图6，股骨杯(6)具有带凸型莫氏锥度的股骨杯柄(7)，而股骨植入物(1)具有带位于颈部(3)中的凹型莫氏锥度的协同工作的股骨植入物凹口(5)。图7和图8示出了股骨杯(20)，股骨杯(20)具备颈部(22)、以及具有凹型莫氏锥度的股骨杯凹口(21)。此与具有凸型莫氏锥度(未图示)的股骨植入物柄协同工作。在一种优选实施例中，模块化系统用于根据本发明的套件中，其中股骨杯柄(7)或颈部(22)可具有不同长度来适应患者的大小需要。因此，在本发明的套件中，提供具有不同柄长度的两个或多个股骨杯。在一种不太优选的实施例中，股骨植入物(1)的颈部(3)或股骨植入物柄(未图示)的长度也可具有各种长度以适应患者大小需要，且在包括此实施例的套件中，将包括具有不同长度的两个或更多的颈部或柄构件。为了满足不同大小需要的设计的其它变型将会对于本领域技术人员显然。
本发明的重要优点在于交错接合越大，植入物就越稳定，与常规球和窝髋部植入物不同，在常规球和窝髋部植入物中增加的运动范围通常与增加的错位风险相关联。
参看图2，近端股骨(2)以常用方式扩孔以接纳股骨植入物(1)，股骨植入物(1)能胶结或压配到股骨的骨髓管内。在盆骨(4)中的髋臼窝被扩孔到适当大小以接纳髋臼杯(11)，髋臼杯(11)被压紧来用于以正确倾斜和前倾角度实现压入配合。呈固定螺钉或生物相容性可再吸收的螺柱形式的紧固件(14)然后插入就位以牢固固定髋臼杯(11)。髋臼球(8)然后附接到髋臼杯柄(9)上，图2还示出了中心线(C-C)。在图示位置，中心线(C-C)通过髋臼杯(11)的中心，髋臼杯柄(9)的纵向中心线、髋臼球(8)的中心、股骨杯柄(7)的纵向中心线和股骨植入物凹口(5)的纵向中心线。显然，当股骨杯在球上被铰接时，与股骨构件相关联的中心线将并不与髋臼构件的中心线共线。该线以此方式简单地示出是为了方便起见。
参看图3、图4和图8，当股骨杯(6)或(20)在髋臼球(8)上铰接时，股骨杯(6)或(20)的边缘移动进出半球空间(16)且股骨杯(6)或(20)的关节表面在整个运动范围上维持了与髋臼球(8)接触的相同面积。换言之，在整个运动范围维持了股骨杯(6)或(20)的100%关节接触面积。图3示出了处于延伸和外旋转的本发明的假体，图4示出了处于屈曲和内旋转的该假体，以及图8示出了股骨杯(20)在髋臼球(8)上的极端铰接位置。
在一实施例中，股骨杯(6)或(20)的关节表面包含不同厚度但不多达4mm的高分子量聚乙烯衬里。在不同实施例中，衬里可为瓷、陶瓷或金属合金。
本发明的重要特点在于能将髋臼球(8)置于最小化或消除髋臼杯和髋臼柄上的扭矩力的位置。这在图3中示出，其中，髋臼球(8)附接于髋臼杯柄(9)上在髋臼杯的赤道平面(P-P)穿过髋臼球中心(15)的位置。
图5至图8中所示的本发明的任选实施例向上文所述的实施例添加了软组织保护套(17)。保护套，本身也在图5A中以透视图示出，解决了下面这样的很少发生的情况：软组织可能由于本发明的假体关节的铰接而卡在空间(16)中。
参看图6至图8，套(17)延伸超过髋臼杯(11)的圆形外边缘且具有定位环(18)。通过在安装髋臼球(8)之前将套(17)放置于髋臼杯(11)中来安装套(17)。套(17)可具有如图所示的实心表面或者其可被穿孔而具有孔、槽或类似物，其可根据需要具有相同或不同形状和尺寸。
如从图6至图8可看出，允许套(17)在空间(16)内自由移动，仅受到髋臼球(8)和髋臼杯柄(9)的限制。套(17)还通过使得定位环(18)与股骨杯(6)或(20)的外边缘接触而移动。定位环(18)将会例如接触着股骨杯(6)或(20)的外边缘，特别是在如图8所示的假体关节的极端铰接位置。
在如图6至图8中也所示的本发明的另一实施例中，髋臼杯(11)被设计成用于髋部的翻修外科手术。翻修为移除现有植入物的手术程序。这最通常需要移除髋臼杯且其与高水平的发病率相关联。移除先前植入的髋臼杯在外科手术上可相当困难，特别是在该杯具有用于使骨骼向内生长的金属珠粒时。在这些情况下，移除也与医源性骨骼损失相关联，导致难以插入另一常规髋臼杯。
存在下面这样的情况：其中髋臼杯并未正确地植入，或者其中现有植入物的衬里变得磨损且需要替换。髋部植入物的复发错位通常是在常规髋臼杯的手术错放（misplacement）之后而继发的。例如，如果在初始程序期间，该杯放置为过于竖直或后倾(即，朝向后而不是朝向前)。
为了治疗上述并发症，有时候，外科医师使用常规骨接合剂简单地将常规翻修杯胶结到先前植入的髋臼杯内。但是，如果先前植入的髋臼杯的初始位置过于竖直或后倾，防止常规翻修杯胶合于先前植入的髋臼杯中，则会出现问题。因此，移除先前植入的髋臼杯变得有必要，因为对患者引起较大风险和可能的发病率，如上文所述的那样。
本发明的另一重要优点在于，倾斜和后倾角并非至关重要的，因为申请者的植入物的联锁机构将会补偿先前植入的髋臼杯的不对准。
申请者的联锁相反髋部假体的髋臼杯(11)能任选地具备位于所述杯的赤道平面附近的薄周向凹槽(19)，如在图6至图8中所示的那样。
在使用本申请者的发明的髋部假体的翻修外科手术中，移除了先前植入的髋臼杯的塑料聚乙烯插件。联锁相反髋部假体的周向凹槽(19)将会承载被翻修的先前植入的髋臼杯的定位“O形环”，由此提供了申请者的翻修联锁相反髋部假体到到先前植入的髋臼杯的稳固固定。
本发明的相反髋部假体的构件由通常用于本领域中的生物相容性材料制成，且基于本文的公开，合适的材料对于本领域技术人员将会显而易见。诸如钛或钴铬这样的金属或金属合金为合适的。对于某些构件，诸如髋臼球，可使用金属或陶瓷。高密度聚乙烯也适合于某些构件，例如，保护套或者用于股骨杯的凹入部的任选衬里。其它生物相容性材料或其组合可用于各种构件，如对于本领域技术人员将会显然的。
本发明的相反髋部假体的各种构件的尺寸可易于由本领域技术人员通过本文的公开来确定，对于半球形的髋臼杯，约35毫米(mm)至约65mm的外径将适合于大部分应用。球形髋臼球应具有从约28mm至约45mm的直径。髋臼球的直径应小于髋臼杯的内径从约7mm至约12mm，因而形成宽度为从约7mm至约12mm的半球形空间或间隙，以允许股骨杯在其中铰接。当然，股骨杯的凹入半球形关节表面的大小将与髋臼球相兼容以允许顺利铰接。高度抛光的钴铬为用于股骨杯的关节表面的优良材料，但也可使用诸如生物相容性金属合金这样的其它材料。股骨杯也可包含由高密度聚乙烯、陶瓷或生物相容性金属合金制成的衬里。
因此，本发明的目的在于提供一种新的且改进的联锁以及受限制的相反髋部假体系统，其中，髋关节的两个常规关节表面相反且联锁。在本发明中描述了该系统,其具有现有技术设计的所有优点而无现有技术的任何缺点，且具有优于现有技术的许多改进，特别是在显著增加运动范围且减少磨损颗粒释放到关节内的降低的风险方面。
那么关于上文的描述，应认识到本发明的零件的最佳尺寸关系，包括大小、材料、形状、形式、功能和操作方式、组装和使用方面的变型，认为对于本领域技术人员显然，且本发明预期涵盖附图所示和说明书所描述的那些的所有等效关系。因此，前文的描述被认为只是说明了本发明的原理。另外，由于本领域技术人员将会易于想到许多修改和变化，无需限制本发明为所图示和所描述的确切构造和操作，且因此，可采取属于本发明范围内的所有合适修改和等效物。

Claims (13)

1.一种相反髋部假体，包括：
髋臼杯（11），其具有凸表面和凹表面，所述凸表面用于附连到盆骨（4）中的髋臼窝，所述凹表面与所述凸表面相对着而定位，所述凹表面具有附接于其中且从那里向外突出的髋臼杯柄（9），
髋臼球（8），其附接于所述髋臼杯柄（9）上，所述髋臼球（8）具有表面，
所述髋臼杯（11）的所述凹表面与所述髋臼球（8）的所述表面彼此间隔开，由此在其间限定间隙（16），
股骨植入物（1），其用于植入于股骨近端的骨髓管中；以及
股骨杯（6;20），其附接于所述股骨植入物（1）的近端，所述股骨杯（6;20）的大小适于在间隙（16）中铰接，从而使得所述股骨杯（6;20）具有凹表面，所述股骨杯的凹表面的大小适于在所述髋臼球的表面上铰接，所述间隙（16）的大小适于且配置成用于当将所述股骨杯（6;20）约束于所述间隙（16）内时允许实现所述铰接。
2.根据权利要求1所述的假体，其中，所述髋臼杯（11）的凹表面为半球形，所述髋臼球（8）为球形且所述股骨杯（6;20）的凹表面为半球形。
3.根据权利要求1或2所述的假体，其中，所述髋臼杯（11）的凹表面具有中心，且所述髋臼杯柄（9）附接到所述中心且到所述中心内。
4.根据权利要求1或2所述的假体，其中，所述髋臼球（8）具有髋臼球凹口（10），髋臼球凹口的大小适于接纳所述髋臼杯柄（9）。
5.根据权利要求1或2所述的假体，其中，所述股骨杯（6;20）具有在与其凹表面相反方向上从那里向外突出的股骨杯柄（7），且所述股骨植入物（1）在其近端处具有大小适于接纳所述股骨杯柄（7）的凹口（5）。
6.根据权利要求1或2所述的假体，其中，所述股骨植入物（1）具有从所述股骨植入物（1）向近端延伸的股骨植入物柄，且所述股骨杯（6;20）具有凹口（21），凹口大小适于接纳所述股骨植入物柄。
7.根据权利要求1或2所述的假体，其中，所述髋臼球（8）具有中心，所述髋臼杯柄（9）具有纵向中心线、且所述髋臼球凹口（10）具有纵向中心线，两个纵向中心线共线且穿过所述髋臼球（8）的中心。
8.根据权利要求5所述的假体，其中，所述髋臼杯（6;20）具有凹半球形部分，所述凹半球形部分具有中心线，所述股骨杯柄（7）具有纵向中心线，且所述股骨植入物凹口（5）具有纵向中心线，其中所有中心线共线。
9.根据权利要求6所述的假体，其中，所述髋臼杯（6;20）具有凹半球形部分，所述凹半球形部分具有中心线，所述股骨植入物柄具有纵向中心线，且所述股骨杯凹口（21）具有纵向中心线，其中所有中心线共线。
10.根据权利要求1或2所述的假体，其中，所述髋臼杯（11）还包括位于凸表面中的周向凹槽（19），所述周向凹槽（19）位于所述髋臼杯（11）的周向边缘附近。
11.根据权利要求1或2所述的假体，其特征在于，还包括：半球形保护屏蔽件（17），其可移动地安置在所述间隙（16）中，所述保护屏蔽件（17）具有定位环（18），以用于与所述股骨杯（6;20）的周向外边缘接合，由此所述股骨杯（6;20）在所述髋臼球上的铰接造成所述保护屏蔽件的移动。
12.一种套件，包括权利要求5至11中任一项所述的假体，且还包括一个或多个额外股骨杯（6;20），其中所述股骨杯柄（7）具有不同长度。
13.一种套件，包括权利要求6或9所述的假体，其中，所述股骨杯凹口（21）安置于颈部（22）中，所述颈部从所述股骨杯（6;20）在与所述股骨杯的凹表面相反方向上向外突出，还包括一个或多个额外股骨杯（6;20），其中所述股骨杯颈部（22）具有不同长度。
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