CN101111197A - 在关节成形术中有利于提高准确性、速度和简单性的外科工具 - Google Patents
在关节成形术中有利于提高准确性、速度和简单性的外科工具 Download PDFInfo
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Abstract
公开于此的是修复关节面修复材料和修复关节面的工具(1020)。外科工具的设计为可定制或由患者高度可选择的,以提高进行全关节或部分关节成形术的速度、准确性和简单性。
Description
技术领域
本发明涉及关节表面重建的方法、系统和装置。本发明包括外科模型,设计该模型以在制备用于安装关节植入物中获取关节内的最佳切面。
背景技术
已有许多器械可帮助外科医生进行关节手术。例如,在膝关节中、1985年2月26日公布的授予McDaniel的美国专利4,501,266描述了一种用于膝关节成形术的膝关节牵引装置。该装置具有可调节的力校准机制,使该装置能够实现将受控选择的韧带-张力分别施加到膝关节的相对的两侧。1991年3月26日公布的授予Poggie等的美国专利5,002,547描述了一种用于制备骨表面以植入模块化全膝关节假体的模型设备。该设备具有切削导向件、模板、沿牵引器的对准装置以及提高调制性且便于骨切除和假体植入的钳夹装置。1993年10月5日公布的授予Poggie等的美国专利5,250,050也涉及一种模块化设备,用于制备骨表面以植入模块化全膝关节假体。1995年2月7日授予Thornhill等的美国专利5,387,216公开了一种用于膝关节修复手术的装置。该装置提供插入受损管道的轴承座套以获取额外的容积。一杆穿过座套并接触骨天然管道定位。然后,由轴承座套将该杆保持在固定位置。接着,可将切削导向件安装于杆上以切割骨并提供植入物的安装表面。2000年5月2日公布的Eng等的美国专利6,056,756描述了一种为植入假体植入物而制备远侧股骨末端的器械。该器械设置用于假体置换的切除,它包括枢轴支持相对骨组织的支柱,支柱以弯曲形式将相对骨组织抬起至目标假体的间隙。2000年8月22日授予Techiera的美国专利6,106,529公开了一种在切除术中使用的以上髁轴线定位的钻孔导向件,该切除术用于制备假体关节置换的骨末端。2001年10月2日授予Williamson的美国专利6,296,646公开了一种系统,该系统使得从业人员得以在植入过程结束时将腿置于取向对准位置,并可在腿部被固定成对准位置时切割股骨和胫骨。2003年9月16日授予Lombardi等的美国专利6,620,168公开了一种用于与胫骨组件一道进行髓间修复术的器械。
1996年11月26日授予Sanders等的美国专利5,578,037公开了一种用于股骨切除术的外科导向件。该导向件使外科医生能够在髋关节成形术中切除股骨颈,因而可植入股骨假体以保留或紧密接近髋关节旋转的解剖学中心。
目前可用的器械在制备用于植入的目标关节时,并不总能够让外科医生在骨表面上做出最准确的切口。
因此,仍然需要改进关节表面重建过程准确性的器械。
发明内容
本发明的一方面描述了用于制备关节以接受植入物的外科工具,例如包括至少部分地符合关节的关节面形状(例如,膝关节的股骨髁和/或胫骨平台)的一个或多个表面或元件的工具。在某些实施方式中,该工具括人造荧光树脂硅橡胶和/或其它聚合物或合适的材料。该工具可重复使用或为一次性使用。该工具可由单个组件或多个组件构成。在某些实施方式中,该工具包括一系列可调节的、间隔紧密的销。
该工具包括:模型,它具有接合关节面的表面;与模型连通的区段;和在所述区段中的至少一个导向孔。还描述了另一至少部分地原位形成的工具,它包括:模型,采用至少一个可膨胀中空装置或保持装置在原位形成的模型,以在至少一个表面上符合关节面,而该表面上有一个面与关节面接合;与模型连通的区段;和在所述区段中的至少一个导向孔。
根据本发明的多个实施方式,描述了接合髌骨表面的钻孔导向件。钻孔导向件包括模型,它具有第一表面,第一表面被构造成与髌骨表面基本匹配。模型可包括一个或多个孔。模型可包括基本上位于钻孔导向件中心的孔。或者,孔可偏离中心。整个第一表面部分可被构造成匹配髌骨。模型可选自模型库和/或可以是患者特异的。
根据本发明的另一个实施方式,描述了一种重建髌骨表面的方法。该方法包括:将在至少一部分第一表面上构建以匹配至少一部分髌骨表面的钻孔导向件置于髌骨上。通过位于钻孔导向件表面上的孔在髌骨表面中钻孔。利用髌骨表面上的钻孔相对于髌骨表面定位扩孔器。使用扩孔器重建髌骨表面。
在与本发明相关的实施方式中,所述钻孔导向件可包括模型,而模型包括第一表面。该方法可包括:使髌骨表面所指的部分成像,和基于图像加工第一表面和/或形成模型。该方法可包括从模型库选择模型。第一表面所指部分可整个被构造成与髌骨匹配。
在本文所述的任何实施方式和方面,关节可以是膝关节、肩关节、髋关节、椎关节、肘关节、踝关节、腕关节等。
附图说明
本专利文件包括至少一幅彩色附图。根据请求和支付所需费用后,专利商标局可提供有彩色附图的本专利的副本。
图1A沿机械和解剖学轴线显示了股骨、胫骨和腓骨。图1B-E显示了胫骨,采用解剖学和机械轴线产生切削股骨和胫骨后的切削平面。图1F显示了包括股骨头的股骨近端。
图2显示了一个外科器械的实施例,它包括一个匹配关节的关节面几何形状的表面。图中还显示了器械中的孔,能够控制钻孔深度和宽度并允许具有压嵌设计的植入物插入式植入。
图3是一流程图,描述了为关节成形术制备患者关节而制作模型的本发明的各种方法。
图4A描绘了一个例子的具孔外科器械的横截面视图,外科钻孔器或锯刀可通过孔与该器械匹配。孔引导钻孔器或锯刀在下方骨上制备适当的洞或切口。虚线代表在骨上制备的对应于孔的切口的位置。图4B以横截面视图描绘了一个具孔外科器械的例子,外科钻孔器或锯刀可通过孔与该器械匹配,该孔并可引导钻孔器或锯刀在骨上制备切口和洞。虚线代表在骨上制备的对应于孔的切口的位置。
图5A-Q显示了切削胫骨的区段和模型,用于形成垂直于解剖学轴线的表面以接受膝关节植入物的胫骨部分。
图6A-O显示了切削股骨的区段和模型,用于形成接受膝关节植入物股骨部分的表面。
图7A-G显示了切削髌骨的区段和模型,用于制备接受膝关节植入物的髌骨。
图8A-H显示了切削股骨头部的区段和模型,用于形成接受膝关节植入物股骨部分的表面。
图9A-D显示了切削髋臼的区段和模型,用于形成髋关节植入物的表面。
图10A显示了从CT数据模拟的髌骨。图10B-D显示了模型导向件,然后将是置于髌骨关节面上的模型导向件。图10E显示了通过模型钻孔导向件置于髌骨内的钻孔器。图10F显示了用于制备髌骨的扩孔器。
图11A显示了用于各髌骨尺寸的扩孔器。图11B显示了髌骨植入备用的经铰扩的髌骨。
图12A-F显示了植入髌骨上的凹进髌骨。
具体实施方式
提供下面的描述以使本领域普通技术人员能够制备和使用本发明。熟悉本领域者可以容易理解对所述实施方式的各种改进,并且本文所限定的一般原理可应用于其它实施方式和应用而不背离所附权利要求书限定的本发明的精神和范畴。因此,本发明并不限于所示实施方式,而是符合与本文所述原理和特征相一致的最广泛范围。以为实现所述发明的完全理解的程度为限,本申请所提到的所有公布的专利、专利出版物和专利申请的说明书和附图引用于此做为参考。
正如本领域技术人员所容易理解的那样,除非另有说明,本发明的实施可采用本领域技术范围内的X-射线成像与处理、X-射线层析照相组合、超声(包括A型扫描、B型扫描和C型扫描)、计算机断层(CT扫描)、磁共振成像(MRI)、光学相干性层析成像、单光子发射层析成像(SPECT)和正电子发射层析成像(PET)等常规方法。这些技术在文献中已详细阐明,本文不再描述。可参见,例如X-RayStructure Determination:A Practical Guide,第2版,Stout和Jensen主编、1989,JohnWiley & Sons出版;Body CT:A Practical Approach,Slone主编、1999,McGraw-Hill出版;X-ray Diagnosis:A Physician’s Approach,Lam主编、1998,Springer-Verlag出版;和Dental Radiology:Understanding the X-Ray Image,Laetitia Brocklebank主编1997,Oxford University Press出版。还参见The Essential Physics of MedicalImaging(第2版),Jerrold T.Bushberg等。
如本文所述,可获得修复系统,系统包括各种不同尺寸、曲率和厚度的外科器械、导向件和模型。这些包括外科器械、导向件和模型的修复系统可归类和保存,形成系统储库,每个患者可从中选择合适的系统。换言之,在特定对象中评价缺损或关节面,然后从储库中选择具有合适的形状和尺寸的现有修复系统进行进一步处理(例如成形)和植入。
施行全膝关节成形术是一项复杂操作。在用人工膝替代膝关节时,获得准确对准的下肢的解剖学和机械轴线,以确保植入膝的最佳功能是很重要的。
如图1A所示,髋关节102的中心(位于股骨132的头部130处),膝关节104的中心(位于胫骨136的髁间结节134与股骨相交的凹口处)和踝关节106大致位于一条直线110上,该线为下肢的机械轴线。解剖学轴线120向外翻,或向外偏离θ5-7°与机械轴线对准。
胫骨136的长轴线与下肢110的机械轴线共直线。由三维透视,在整个屈-伸圆弧上,身体下肢理想地在称为正中前-后平面(MAP-平面)的单平面内运动。为达到这种状况,屈-伸运动期间,股骨头130、股骨机械轴线、髌骨沟和髁间切迹、髌骨关节嵴、胫骨和踝保持在MAP-平面内。运动期间,胫骨随膝盖在与MAP-平面垂直的上髁轴线上的屈伸而旋转。
在每个关节处均可获取许多图像切片,例如膝关节150-150n,和髋关节152-150n。这些图像切片可如上文部分I中所述,与整个腿的图像一道,用来确定轴线。
当膝盖发生疾病或功能障碍时,解剖学轴线的对齐关系发生改变。进行全膝关节成形术是纠正患膝的一种方法。而全膝关节的植入,如Johnson &Johnson的PFC Sigma RP膝系统,则要求在构成膝关节的表面上进行一系列切除方能进行人工膝关节的安装。这一系列的切除应能够使安装的人工关节进行在MAP-平面内的屈-伸运动,并令患者下肢的解剖学和机械轴线达到最优。
首先,切除胫骨130以造成用于接受植入物的胫骨组件的平整表面。大多数情况下是在冠状面上垂直于中的胫骨长轴切除胫骨表面,但通常在矢状面上向后倾斜4-7°以配合胫骨的正常倾斜。熟悉本领域者可以容易理解,在所植入的装置不要求斜向的胫骨切口处,矢状倾斜度可为0°。切除线158垂直于机械轴线110,但切除线与平台160表面平面间的角度可根据膝盖损伤的程度而变化。
图1B-D分别显示了解剖上正常的胫骨构件、内翻膝盖中胫骨构件、和外翻膝关节的胫骨构件的切除的前视图。在每个图中,机械轴线110垂直延伸通过骨和切除线158在冠状面上垂直于机械轴线110,不同于根据关节损伤程度而由关节形成的表面线。图1B显示了正常膝关节,其中,对应于关节160表面的线平行于切除线158。图1C显示了内翻膝关节,其中,对应于关节160表面的线不平行于切除线158。图1D显示了外翻膝关节,其中,对应于关节160表面的线不平行于切除线158。
一旦胫骨表面制备完毕,外科医生即可转而制备股骨髁。
切除股骨平台170以提供与股骨假体内部连通的平整表面。对股骨的切口建立在胫骨和股骨间形成的间隙总高度的基础上。通常,需要20毫米的间隙,从而为植入的假体提供足够的空间以实现全范围运动。从股骨的机械轴线向外5-7°切除骨。切除表面172形成平整表面,与相邻表面174、176呈倾斜关系。表面172-174和172-176间的角度θ’、θ”根据植入物的设计而改变。
如图1F所示,股骨近端的外部几何形状包括:头部180、颈部182、小转子184、大转子186和股骨近端骨干。转子184、186、股骨头部中心102和股骨轴188的相对位置与颈-干交角的倾斜度相关。图中也显示了机械轴线110和解剖学轴线120。对这些关系进行估量可改变铰扩方向以实现假体与股骨管的中位对准。
采用前后位和侧位放射线照片,对近端和远端的几何形状进行测量以决定植入物的尺寸和最佳设计。
通常,通往髋关节的外科通路打开之后,股骨颈182是例如沿线190切除的。颈切除后,铰扩髓管。可用例如圆锥或直线扩孔器、或弹性扩孔器来进行铰扩。铰扩的深度由植入物的特别设计决定。通道铰扩完成之后,通过连续锉磨制备近端扩孔器,锉磨的方向为向下进入通道内。
此外,使用应用于关节软骨或骨(包括软骨下骨组织)外表面上的装置,以配合关节修复系统与受体部位或关节的对准,可有助于外科手术的进行。所述装置可为圆形、环形、椭圆形、椭球形、弯曲或不规则形状。可选择或调节形状以匹配或包括患病软骨区域或略大于患病软骨区域或显著大于患病软骨的区域。该区域可涵盖整个关节面或承重面。当考虑替换大部分或整个关节面时通常优选此类装置。
可使用机械装置以辅助外科手术的进行(例如外科器械),例如使用凝胶、模型、塑料或金属。可获取一种或多种电子图像或术中测量结果,提供对象的限定关节面和/或骨表面和形状的坐标。利用这些对象坐标或者可以塑造器械形状,例如使用CAD/CAM技术,使其适合患者关节解剖学结构,或者可用于选择与患者关节解剖学结构具有良好匹配的典型预先制备好的装置。该装置可具有匹配所有或部分关节或骨表面和形状的表面和形状,例如类似于“镜像”。该装置可包括:孔、槽和/或洞以容纳外科器械如钻孔器、扩孔器、刮刀、k-线、螺钉和锯刀。
通常会选择会带来解剖学上所需切面、钻孔或一般器械取向的位置,以便放置后续关节修复系统或有利于关节修复系统的放置。而且,可通过对装置的设计来控制钻孔器、扩孔器或其它外科器械的深度,例如钻孔器进入组织不能比装置所限定的更深,区段中洞的大小亦可设计为基本与植入物的尺寸相匹配。在选择这些槽或洞的位置时,可将关于其它关节或轴线的信息以及关节或肢体的对准信息包括在内。或者,可将装置中的开口制成大于容纳这些器械所需的大小。也可将装置构造成符合关节形状。所提供的孔或开口可以足够宽,以便允许改变外科器械如钻孔器、锯刀、钻孔器、刮刀和其它外科器械的位置或角度。然后将通常由相对坚硬的材料制成的器械导向件装在装置上。该装置可以帮助器械导向件相对于关节三维解剖学结构的取向。
外科医生可任选地在对准装置与器械导向件之间进行精确调节。以这种方式可找到最佳折衷方案,例如在生物机械对准与关节松弛或生物机械对准与关节功能之间,如在膝关节屈曲间隙与伸展间隙中,进行折衷。通过过度增大对准导向件上的开口,外科医生可利用这些器械并将它们插入器械导向件中而不会损伤对准导向件。因此,尤其是在对准导向件是塑料制品时,不会有碎屑被引入关节。通过使用例如插入的间隔物、楔形物、螺钉和其它本领域已知的机械或电子方法,亦可对对准导向件与器械导向件之间的位置和取向进行优化。
外科医生会希望能够同时影响到关节的松弛度及关节对准。这可根据不同的屈曲和伸展、外展、或内收、内部或外部旋转角来优化。为此目的,例如,可引入与一个或多个模型附连或接触的间隔物。术中外科医生可采用多个不同厚度的间隔物或一个或多个相同厚度的间隔物来评价关节的松弛或紧致度。例如,可在一个或多个模型存在的条件下将间隔物置于膝关节内,在膝关节处于屈曲位时估计屈曲间隙。然后,可将膝关节伸展并估计伸展间隙。最后,外科医生将选择对于给定关节和模型而言最佳的间隔物组合。可将外科切削导向件应用于模型,间隔物可任选地位于模型与切削导向件之间。以这种方式,可对外科切割件的精确定位施加影响,并通过调整该定位以实现最佳结果。熟悉本领域者会识别优化外科切割定位的其它方法。例如,可采用膨胀型或棘轮样装置,插入关节或者与模型附连或接触。也可采用铰链样装置。与此类似,支柱样装置也很有用。原则上,可使用能够精确调节切削导向件相对于模型的位置的任何机械或电子装置。
外科医生会希望能够同时影响到关节的松弛度及关节对准。这可根据不同的屈曲和伸展、外展、或内收、内部或外部旋转角来优化。为此目的,例如,可引入与一个或多个模型附连或接触的间隔物。术中外科医生可采用多个不同厚度的间隔物或一个或多个相同厚度的间隔物来评价关节的松弛或紧致度。例如,可在一个或多个模型存在的条件下将间隔物置于膝关节内,在膝关节处于屈曲位时估计屈曲间隙。然后,可将膝关节伸展并估计伸展间隙。最后,外科医生将选择对于给定关节和模型而言最佳的间隔物组合。可将外科切削导向件应用于模型,间隔物可任选地位于模型与切削导向件之间。以这种方式,可对外科切割件的精确定位施加影响,并通过调整该定位以实现最佳结果。熟悉本领域者会识别优化外科切割定位的其它方法。例如,可采用膨胀型或棘轮样装置,插入关节或者与模型附连或接触。也可采用铰链样装置。与此类似,支柱样装置也很有用。原则上,可使用能够精确调节切削导向件相对于模型的位置的任何机械或电子装置。
模型和任何相关结构,如间隔物或棘轮,可与张力计结合以更好地在术中对关节进行评价。可采用张力计以进一步优化关节解剖学对准和紧张度,并改善术后功能和结果。可任选地在术中,例如使用诸如Tekscan,South Boston,Mass生产的传感器,进行局部接触压的评价。
模型或对准导向件可由塑料或聚合物制成。在其它实施方式中,模型或模型的某些部分可由金属制成。可将金属插件应用于塑料组件。例如,塑料模型上可以有开口,以接受扩孔装置或锯刀。可使用金属插件以形成硬壁以接受扩孔器或锯刀。使用这种或类似的设计可以在锯刀或其它外科器械与模型接触时,避免塑料的或其它的碎屑在关节中的蓄积。
使用模型不仅有助于外科技术而且可以引导外科器械的放置与定向,此外,采用模型还可引导植入物或植入物组件的设置。例如,在髋关节内,髋臼构件倾斜是全髋关节成形术中常见的问题。可将一模型放在髋臼壁上,髋臼壁中心有一开口,大到足以容纳外科医生希望放置的髋臼构件。模型具有接纳器或凹口,匹配可为植入物的一部分或可施加于植入物上的小延伸部分的形状。例如,植入物可具有置于12点和6点位置的小元件或延伸部分。参见,例如图9A-D,讨论如下。通过使这些元件对准模型中的凹口或接纳器,外科医生可确保植入物没有倾斜或旋转地插入。在粘固设计中,这些凹口或接纳器还有助于在骨粘固剂变硬的过程中使植入物维持在适当位置。
外科手术期间可使用一个或多个模型。例如,在髋关节内,切除股骨头之前,可先将非常近似三维解剖学结构的模型置于股骨近端。模型可包括开口以容纳锯刀(参见图8-9)。开口位置的设置利于为后续铰扩和假体放置取得最佳定位的外科切割。外科切割完成之后,可接着将第二个模型置于近端股骨。放置假体之前,可使用第二模型引导扩孔器的方向。从该实施例以及其它实施例可见,任何外科干预之前均可制备模型。然而,也可以在外科医生已经进行选定的外科操作如切割、铰扩、钻孔等之后,再制备被设计成匹配骨或一部分关节的模型。该模型可为这些操作所导致的骨或关节的形状的根源。
在某些实施方式中,外科辅助装置包括一排可调节的、间隔紧密的销(例如,多个可单独移动的机械元件)。可通过获取一种或多种电子图像或术中的测量结果来提供限定关节面和/或骨表面和形状的对象坐标。可通过例如手动或用电子仪器将这些对象的坐标输入或转移入装置,利用该信息以通过移动一个或多个元件,例如与“图像”相似,制作匹配所有或部分关节和/或骨表面的表面和形状。该装置可包括槽或洞以容纳外科器械如钻孔器、刮刀、k-线、螺钉和锯刀。这些槽和洞的位置可通过一个或多个机械元件来调节。通常会选择会带来符合解剖学所需的切面、铰扩定向、或钻孔或器械取向的位置,以便放置后续关节修复系统或有利于关节修复系统的放置。在选择这些槽或洞的定位时,可包括关于其它关节或轴线的信息以及关节或肢体的对准信息。
图2显示了一个实施例的外科工具200,它具有一个表面210,与关节的关节面几何形状匹配。图中还显示了工具200中的孔215,能够控制钻孔深度和宽度并允许具有压嵌设计的植入物220的植入或插入。
在另一个实施方式中,可将-框架置于处患病骨或软骨之外区域中的骨或软骨上。框架可包括外科器械的夹持件和导向件。框架可附连于一个、或优选多个前面限定的解剖学参考点。或者,利用成像试验或术中的测量结果,例如一种或多种术中获得的荧光图像,可相对于一个、或多个解剖学标记交叉设定框架的位置。可通过获取一种或多种包括使用机械装置的电子图像或术中的测量结果,来提供限定关节面和/或骨表面和形状的对象坐标。可通过例如手动或用电子仪器将这些对象坐标输入或转进装置,且该信息可用于移动一个或多个外科器械的夹持件或导向件。通常会选择会带来符合解剖学所需的切面或钻孔取向的位置,以便放置后续关节修复系统。在选择这些槽或洞的定位时,可包括关于其它关节或轴线的信息以及关节或肢体的对准信息。
而且,也可制作和采用可重复使用的工具(例如,模型)。可重复使用的材料的非限制性例子包括油灰和其它可变形材料(例如,一排可调节的、间隔紧密的销,它被塑形成匹配关节表面的形态)。在其它实施方式中,可用气囊制备模型。气囊可任选地填充有硬化材料。可制出表面或将表面包括在气囊中,以实现外科切削导向件、铰扩导向件、钻孔导向件的放置或其它外科工具的放置。气囊或其它可变形材料的形状可在术中制成,以符合至少一个关节面。可制成其它表面的形状,以平行于或垂直于解剖学或生物机械轴线。在髋关节、膝关节或其它关节成形术中,采用术中成像试验或为此目常用的外科工具,可找到解剖学或生物机械轴线。
在这些实施方式中,模型可在外科手术期间由关节直接产生,或者从关节图像得到,例如,采用一种或多种计算机程序来确定限定关节表面轮廓的对象坐标并将这些坐标转移(例如,呼叫)至工具。接下来,使工具精确对准在关节上方,因而外科器械导向件或植入物将更精确地放置在关节面内上或其上方。
在单次使用和可重复使用的实施方式中,可通过对装置的设计来控制钻孔器的深度和/或方向,即钻孔器进入组织不能比装置所允许的更深,器械中洞或孔的尺寸亦可设计为大致匹配植入物的尺寸。工具可用于一般的假体植入,包括但不限于本文所述的关节修复植入物和在全关节成形术中用于铰扩骨髓。
也可使用这些外科工具(装置)切除患病软骨和下方骨区域或稍微大于患病软骨和下方骨的区域。此外,可在“供体”如尸体标本上使用该装置,以获得可植入的修复材料。通常将装置置于与受体内被切除的组织的部位相同的一般解剖学区域中。然后,利用装置的形状来识别能够提供供体组织样品与受体部位之间的天衣无缝或几乎天衣无缝匹配的供体部位。这可通过识别装置的位置来实现,当采用该位置时,该装置置于软骨上时,供体(例如尸体标本)中的关节面与内表面的接触天衣无缝或几乎天衣无缝。
可基于患病软骨区域的大小和基于软骨或下方软骨下骨组织的曲率或两者的结合来模制、机加工或形成装置。模制关节表面构型时可考虑到外科切除,例如,半月板。然后,将装置应用于供体(例如尸体标本),使用刀片或锯刀或其它组织切除装置获得供体组织。然后,将装置应用于受体患病软骨区域,用刀片或锯刀或其它组织切割装置切除患病软骨和下方骨,从而使包括患病软骨在内的被切除的组织的大小和形状紧密类似供体组织的大小和形状。然后,将供体组织附连于受体部位。例如,所述附连可使用螺钉或销(例如,金属、非金属或可生物重吸收的)或其它固定装置来实现,包括但不限于组织粘合剂。附连可通过软骨表面或者可通过髓隙实现。
可使用自动装置制备植入物部位。自动装置可利用来自电子图像的信息来制备受体部位。
植入物部位的选定和制备以及植入物的插入可由外科导航系统支持。在该系统中,可在一个或多个二维或三维图像中实时追踪外科器械相对于患者解剖学结果的位置或取向。这些二维或三维图像可从手术前获得的图像(例如,MR或CT图像)计算而得。也可采用基于非图像的找轴线或解剖学结构的外科导航系统,例如利用关节运动的。外科器械以及模型,包括对准导向件、外科器械导向件、铰扩导向件、钻孔导向件、锯刀导向件等的位置和取向可由附连于这些装置的标记物确定。这些标记物可通过检测器,例如使用光学、声学或电磁信号来定位。
植入物部位的识别和制备及植入物的插入也可使用C-臂系统来支持。C-臂系统可提供在一个或优选多个平面中的关节图像。多平面成像能力有助于限定关节面的形状。该信息可用于选择与关节面具有良好匹配的植入物。目前可获得的C-臂系统也提供了截面成像能力,例如用于识别和制备植入物部位和插入植入物。C-臂成像可结合射线照相对照进行。
在又另外的实施方式中,本文所述外科装置可包括一种或多种硬化形成关节面模型的材料。前面描述了许多可原位硬化的材料,包括可触发相转变的聚合物,例如液体或半液体的聚合物,接触空气、应用紫外光、可见光、接触血液、水或其它离子变化后硬化成固体或凝胶。(例如,参见2002年9月3日颁予Felt等的美国专利6,443,988和引用在此的文件)。合适的固化和硬化材料的非限制性例子包括聚氨酯材料(例如,授予Felt等的美国专利6,443,988,1994年2月22日公布的授予Khalil的美国专利5,288,797,1978年3月4日公布的授予Graham等的美国专利4,098,626和1986年6月10日公布的授予Chapin等的美国专利4,594,380;和Lu等(2000年)于发表于BioMaterials 21(15):1595-1605的文中,描述了多孔聚(L-丙交酯酸泡沫);所公布的亲水聚合物,例如于美国专利5,162,430中所述;水凝胶材料,例如象Wake等在(1995)CellTransplantation 4(3):275-279一文,Wiese等(2001)在J Biomedical MaterialsResearch 54(2):179-188一文和Marler等(2000)在Plastic Reconstruct.Surgery105(6):2049-2058一文中所述的材料;透明质酸材料(例如,Duranti等(1998)Dermatologic Surgery 24(12):1317-1325)一文;膨胀珠,例如甲壳质珠(例如,Yusof等(2001)J Biomedical Materials Research 54(1):59-68一文);无结晶金属如Liquidmetals,和/或牙科应用中使用的材料(参见,例如Brauer和Antonucci,″Dental Applications″第257-258页,《聚合物科学与工程的简明百科全书》(“Concise Encyclopedia of Polymer Science and Engineering”)和1983年1月11日公布的授予Weissman的美国专利4,368,040)。可使用充分可流动以允许递送至关节并在生理学可接受的条件下在关节中发生完全原位固化的任何生物相容性的材料。材料也可以是可生物降解的。
可固化材料可与本文所述外科工具联用。例如,外科工具上可包括一个或多个适于接受注射的孔,可固化材料经孔注入。在原位固化之前,材料会符合朝向外科工具的关节面,因而会在固化后形成该表面的镜像印象,从而再次产生正常或接近正常的关节面。此外,可固化材料或外科工具也可与本文所述的任何成镜测试和分析联用,例如基于关节图像模制这些材料或外科工具。
图3是一流程图,显示了设计用于制备关节面的模型的步骤。通常,第一步是测量患病软骨或软骨损失区域的尺寸(300)。软骨损失的大小测量好之后,使用者可测量相邻软骨的厚度(320),然后测量关节面和/或软骨下骨组织的曲率(330)。或者,使用者可跳过测量相邻软骨厚度的步骤(302)。在确立了对软骨缺损性质的了解和测量之后,或者从模型库选择(332)模型,或者制作患者特异性模型(334)。无论哪种情况,接下来都是制备植入部位(340)和进行植入(342)。任何上述步骤可跳过任选的重复步骤301、321、331、333、335、341来重复。
可采用许多技术来形成模型形状。例如,在考虑膝关节手术时,一些经选择的髋关节的CT片,以及整个膝关节的全螺旋CT,和一些选出来的整个踝关节的切片有助于限定轴线。限定轴线之后,即可得到软骨下骨组织的形状,然后将标准化软骨损失应用上去。可使用其它更加复杂的扫描技术来产生信息而不背离本发明的范围。
现在转到用于特定关节应用的工具,这些应用旨在公开设计的概念,此概念会接下来应用于体内其它关节:
当考虑全膝关节成形术时,患者可如前面所更详细地描述,接受显示膝关节的关节解剖学结构,例如股骨髁的宽度、胫骨平台等,的成像试验。此外,成像试验中可包括其它关节,由此可产生关于股骨和胫骨轴线、变形如内翻和外翻及其它关节对准的信息。成像试验可以是X-射线图像,优选直立的负重位置、CT扫描或MRI扫描或其结合。成像试验产生的关节面和形状以及对准信息可用于外科辅助装置的塑形、用于从具有预定形状和尺寸的不同装置库中选择外科辅助装置,或者可输入外科辅助装置,并可用于确定锯开导向件或钻孔或铰扩装置或其它外科器械导向件的优选位置和取向。术中,对外科辅助装置可通过使其表面与关节面匹配或使其附连于骨或软骨上的解剖学参照点,将其应用于胫骨平台然后是股骨髁。然后,外科医生可将扩孔器或锯刀通过导向件引入,制备用于植入的关节。通过沿解剖学限定平面切割软骨和骨,实现植入物更加可复制的放置。通过根据患者解剖学结构优化施加在植入物和周围骨组织上的生物机械应力和通过尽可能减小植入物的轴线对不准的程度,可最终带来术后效果改善。此外,外科辅助装置可显著降低全或单室膝关节成形术所需外科器械的数目。这样,使用一种或多种外科辅助装置有助于更精确地进行关节成形术,改善术后效果,提高植入物长期存活率,通过减少所用外科器械的数目降低成本。而且,使用一种或多种外科辅助装置将有助于降低手术技术难度,有助于缩短手术室(“OR”)时间。
因此,例如当制备接受植入物的部位时,也可设计和使用本文所述外科器械来控制钻孔对准、深度和宽度。例如,本文所述的典型地符合关节表面的工具可提供改善的钻孔对准和任何植入物更精确的设置。解剖学上正确的工具可由许多方法来构建,可由任何材料构成,优选半透明材料如塑料、人造荧光树脂、硅橡胶、SLA或此类等,模制之前典型地是区段样形状。
图4A描绘了模型400的一个例子的截面视图,用于具有上表面420的胫骨表面上。模型400包括孔425,外科钻孔器或锯刀可穿过此孔适配。孔引导钻孔器或锯刀在下方骨410中制备适当的洞或切口,如图1B-D所示。虚线432显示了在骨上所做的对应于孔的切口。
图4B描绘了适用于股骨的模型408。由图可见,提供了额外的孔以能在骨表面做额外切口。由于孔405故可在股骨表面上进行切口406。所得股骨形状对应于股骨植入物内表面的形状,典型地如图1E所示。需要时,通过改变孔的尺寸、取向和位置可实现其它形状。例如当植入物股骨组件的内表面要求不同形状的制备好的股骨表面时,是需要这些改变的。
现在转到图5,提供了许多图示,显示胫骨的切削区段和模型系统。图5A显示了胫骨切削区段500与尚未切除的胫骨502。在该图中,切削区段500由至少两个元件构成。第一个元件是患者特异性内部元件510或模型,它被设计成在其下表面512匹配或大致匹配患者胫骨502的现有几何形状。第一个元件510的上表面514和侧表面516被构造成匹配在外部元件520的内部。可重复使用的外部元件520匹配在内部元件510上。由于该系统的构造,模型被保持在骨上。
可重复使用的外部元件具有上表面522和与第一元件510相匹配的下表面524。可重复使用的外部元件520包括切削导向件528,以便外科医生进行上述胫骨表面切削。如本文所示,提供多个切削导向件,以提供许多位置供外科医生在进行胫骨切削期间选择。需要时,可提供额外的间隔物,匹配在患者构建或模制第一元件510和可重复使用外部第二元件之间,或切削区段720之间。
无论关节患病程度如何,内部元件的可变性有利于获得最精确切削,因为设置外部元件520从而实现垂直于机械轴线的切割。内部元件510或外部元件520可由部分II中描述的任何材料形成,或由任何其它合适的材料形成。此外,熟悉本领域者会容易理解,本发明并不限于这里所述的两元件构型。基于响应已知或常用胫骨表面尺寸和缺损开发的实质缺损均一形状库,可重复使用的外部元件520和患者特异性内部元件510可以是单个元件,是患者特异性(材料制造成本支持这种产品)的或可重复使用。
通常将内部元件510模制到胫骨,包括软骨下骨组织和/或软骨。外科医生通常切除任何残留的半月板组织,然后应用模型。模型内表面512任选地包括部分或所有半月板的形状信息。
现在转到图5B-D,图中显示了许多可拆除的外部元件520。外部元件的顶面520可相对平坦。毗邻内部元件的下表面524符合内部元件上表面的形状。在该示例中,内部元件的上表面是平的,因而可重复使用的外部元件的下表面524也是平的,以提供最佳匹配表面。
提供了沿至少一部分外部元件520的一侧延伸的导向板526。导向板526具有一个或多个槽或导向件528,锯刀通过槽或导向件528插入以实现胫骨表面所需的切削。此外,槽或导向件可被构造成使锯刀以垂直于机械轴线的线切削,或者以垂直于机械轴线的线切削但在矢状面中倾斜4-7°以匹配胫骨正常斜率。
可任选地提供中央通孔530,使钻孔器能够铰扩孔进入骨组织,用于设置膝关节植入物胫骨组件的杆。
图5E-H从多个角度显示了内部的患者特异性的元件510。图55E显示了该元件的侧视图,显示形状统一的上表面514和形状统一的侧表面516以及不规则下表面516。下表面匹配胫骨502的不规则表面。图5F显示了内部患者特异性模型元件510的上方视图。任选地具有孔530。图5G显示了内部的患者特异性的模型元件510的下方视图,还显示了包括凸出和凹陷部分的不规则表面,以在需要时实现与胫骨表面的最佳匹配。图5H显示了内部的患者特异性的模型元件510的截面视图。如图所示,内部元件的表面沿其长度而改变。
由图5B和D清楚可见,导向板526的长度可以沿全部或部分胫骨平台延伸,例如当导向板526为图5B所示不对称设置或如图3D所示对称设置时。若考虑全膝关节成形术,导向板526的长度通常沿整个胫骨平台延伸。若考虑单室关节成形术,导向板的长度通常沿外科医生进行手术的区室长度延伸。类似地,若考虑全膝关节成形术,模制内部元件510的长度通常沿整个胫骨平台延伸;它包括一侧或两侧胫骨棘。若考虑单室关节成形术,模制内部元件的长度通常沿外科医生进行手术的区室长度延伸;它可任选地包括胫骨棘。
现在转到图5I,显示了孔530的一个可选实施方式。在该实施方式中,孔的特征为侧向突起,以容纳使用扩孔器或冲头在骨中形成接受具缘杆的开口。
图5J和M描绘了本发明可选实施方式,它被设计成控制切削区段520相对于模型510的运动和旋转。如图5J所示,提供了从模型上表面延伸的栓钉540形式的一系列突起。熟悉本领域者会容易理解,可使用一个或多个栓钉而不背离本发明的范围。为了示例的目的,图5J中显示了两个栓钉。根据所需的控制,栓钉540的构型可匹配在允许旋转调节的弯曲槽542内,如图5K所示,或匹配在符合栓钉540形状的凹穴544内,如图5L所示。熟悉本领域者会容易理解,凹穴544的尺寸可紧密围绕栓钉,或者其尺寸大于栓钉尺寸以允许限制的侧向运动和旋转运动。
如图5M所示,模型510的表面可被构造成凸穹形550,匹配在切削区段520内表面上提供的凹陷井552内。该构型能够实现围绕机械轴线的较大旋转运动,同时限制侧向运动或平移。也可使用其它实施方式和构型来实现这些结果而不背离本发明的范围。
熟悉本领域者会容易理解,适当时,可使用两个以上的元件来构成系统。例如, 患者特异性内部元件510可以是两个元件,被构造成当置于胫骨上时可形成单个元件。此外,外部元件520也可以是两个组件。第一组件可具有切削导向孔528。利于切削导向孔528进行切除之后,除去外部元件520,使用不具有导向板526和切削导向孔528但具有孔530的的第二外部元件520’,便于在胫骨表面穿孔以接受膝关节植入物胫骨组件的杆。需要时,任何这些设计的特征也可以是图5J-M所示的表面构型。
图5N显示了切削区段520的一种可选设计,具有额外的结构560以在制备结构平台期间保护交叉韧带免于切削。这些额外的结构可以是如图5N所示的齿状导向件560或其它合适的结构。
图5O显示了一种系统的截面视图,该系统包括在内部元件510表面上的锚定栓钉562,将内部元件510锚定在软骨或半月板区域中。
图5P和Q显示了装置500,它被构造成覆盖一半胫骨平台,因而是单室的。
现在转到图6,描绘了股骨模型系统,便于制备股骨表面,从而使最终植入的股骨植入物实现最佳机械和解剖学轴线对准。
图6A显示了模型第一部分610位于其上的股骨600。在该图中,模型612的顶面具有许多孔。在该实施例中,孔由一对矩形孔614、一对方形孔616、一中央通孔618和一长方形孔620构成。第一部分610的侧面622也具有矩形孔624。当模型第一部分的材料由柔软材料如塑料制成时,各孔大于股骨上制备的最终切口,因而不会在关节表面制备过程期间发生不经意切削。此外,可调节形状,例如矩形式梯形,以产生沿一个区域切削长度的更大灵活性,而不增加另一区域的灵活性。熟悉本领域者会容易理解,可使孔或空穴变为其它形状而不背离本发明的范围。
图6B从侧表面622的角度显示了第一部分610,显示了孔624。如图所示,外表面611具有平面或相对平面构型的均一表面,而内表面613具有符合或大致符合股骨表面的不规则表面。
图6C显示了第一患者特异性模制部分610的侧视图,更具体地显示了内部不规则表面613。图6D从顶部视角显示了第一部分610。任选地提供中央通孔618以便设置第一元件和防止中央旋转。
图6D显示了第一部分610的底视图。图示底部对应于膝关节的前侧位置。从底部视角,显示了上述各孔。熟悉本领域者会容易理解,孔的形状可不同而不背离本发明的范围。
现在转到图6E,显示了股骨600,切削区段第一部分610位于股骨上,第二外侧部分640位于第一部分610上。第二外侧部分640的特征是一系列凹槽(642-650),以便插入锯刀来进行实现图1E所示股骨形状所需的切削。这些凹槽使刀片能以90°角或以45°角到达外侧部分表面。其它角度也是可能的而不背离本发明的范围。
如虚线所示,第二部分640的凹槽(642-650)覆盖在第一层的孔的上方。
图6F显示了第二外侧切削区段部分640的侧视图。从侧视图可见,提供单个孔650以到达股骨切口。图6G是第二外侧部分640的另一侧视图,显示矩形凹槽的位置和相对角度。由图可见,凹槽642、648和650的取向垂直于第二外侧部分640的至少一个表面。凹槽644、646的取向倾斜但不垂直于第二外侧部分640的至少一个表面。这些凹槽(644、646)有利于在股骨中制备倾斜倒角切口。
图6H是第二外侧部分640的顶视图。熟悉本领域者会容易理解,凹槽的位置和取向将根据股骨植入物的设计和连通植入物的股骨所需形状而改变。
图6I显示了在第一部分610和第二部分640间使用的间隔物601。间隔物601相对于第一部分提升第二部分,从而相对于股骨表面提升制备切削通槽624的区域。熟悉本领域者会容易理解,可采用一个以上的间隔物而不背离本发明的范围。间隔物也可用于制备胫骨切口。可提供任选的凹槽或通道603以容纳图6J所示销660。
类似于上文参考图5所述的设计,使用可选的设计来控制切削区段640相对于模型610的运动和旋转。如图6J所示,提供了从模型上表面延伸的一系列突起,显示为栓钉660。需要时,这些栓钉或突起可以伸缩以便于模型的使用。熟悉本领域者会容易理解,可使用一个或多个栓钉而不背离本发明的范围。为了示例的目的,图6J中显示了两个栓钉。参照胫骨切削系统所述,根据所需的控制,栓钉660的构型可匹配在允许旋转调节的弯曲槽内(类似于图5K所示的槽),或匹配在形状符合栓钉的凹穴内(类似于图5L所示)。熟悉本领域者会容易理解,凹穴662的尺寸可紧密围绕栓钉,或者其尺寸大于栓钉尺寸以允许限制的侧向运动和旋转运动。
如图6K所示,可构建模型610的表面使得上表面形成凸穹形664,匹配在切削区域640内表面上提供的凹陷井666中。该构型能够实现围绕机械轴线的较大旋转运动,图示限制侧向运动或平移。
在安装植入物的过程中,使用胫骨区段切削胫骨表面,例如,如图6所示。将患者特异性模型置于股骨上。然后在需要时,将膝盖置于延伸部分和间隔物670中,例如图6I所示,或使用垫片,直到在伸展和屈曲运动中实现最佳关节功能。通常,间隔物、垫片尺寸递增,例如5毫米厚以在腿发生伸展和屈曲运动时提供增加的距离。张力计有助于上述确定或可包含在模型或间隔物中以提供最佳结果。张力计的设计是本领域已知的,包括在此不是为了避免模糊本发明。合适的设计包括例如,1997年5月20日公布的Todd的美国专利5,630,820。
如图6N(矢状视图)和6M(冠状视图)所示,模型610的内表面613可包括小齿665或延伸部分,以助于抵靠软骨666或软骨下骨组织667稳定模型。
现在转到图7,提供了多个示例,显示了髌骨切削区段的模型系统。图7A-C显示了髌骨切削区段700与尚未切割的髌骨702。在该视图中,切削区段700仅由一个元件或由多个元件构成,按照需要。内表面703是患者特异性的,别设计成匹配或大致匹配患者髌骨702的现有几何形状。存在小开口707以接受锯刀。模型或区段可仅具有一个开口或具有多个开口。开口可大于锯刀以允许一些旋转或其它精细调节。图7A是矢状面A的视图。显示了四头肌腱704和髌骨腱705。
图7B是轴向平面A的视图。显示了软骨706。模型可被模制成软骨或软骨下骨组织或其组合。图7C是模型前视图,显示了锯刀开口707。虚线表示髌骨702的相对位置。
图7D(矢状视图)和E(轴向视图)显示了髌骨切削区段708与尚未切割的髌骨702。在该视图中,切削区段708由至少两个元件构成。第一元件是患者特异性内部元件710或模型,其被设计成下表面712匹配或大致匹配患者髌骨702的现有几何形状。第一元件的后表面714和侧表面716被构造成匹配在外部元件720的内部。可重复使用的外部元件720匹配在内部元件710上并使其保持在髌骨上。可重复使用的外部元件具有匹配第一元件710的内表面724。可重复使用的外部元件720包括切削导向件707,便于外科医生进行髌骨表面切削。可提供多个切削导向件,以使外科医生在进行髌骨切削期间具有许多位置可供选择。需要时,可提供额外的间隔物,匹配在第一患者构建或模制元件710和第二可重复使用外部元件或切削区段720之间。
第二可重复使用的外部元件或切削区段720可具有凹槽722或延伸部分725,它被设计成匹配外科器械如髌骨钳726。髌骨钳726可具有环状抓紧器728和锁定机构如棘轮样机构730。抓紧器中的开口732匹配在第二可重复使用的外部元件720的延伸部分725上。抓紧器第一手柄部分可相对于第二手柄部分呈斜角734,或弯曲(未示出),以便插入。通常,面向关节内侧的抓紧器部分具有倾斜或弯曲形状,以允许稍微更小的切口。
无论关节患病程度如何,内部元件的可变性有利于获得最精确切削,因为它将外部元件720设置在所需平面中。内部元件710或外部元件720可由上文部分II中描述的任何材料形成,或由任何其它合适的材料形成。此外,本领域技术人员将理解,本发明并不限于这里所述的两元件构型。基于响应已知或常用胫骨表面尺寸和缺损开发的实质缺损均一形状库,可重复使用的外部元件720和患者特异性内部元件710可以是单个元件,是患者特异性的(材料制造成本支持这种产品)或可重复使用。
通常将内部元件710模制到髌骨,包括软骨下骨组织和/或软骨。
由此,确定平衡膝盖所需的空间量,然后使用适当数量的间隔物联合切削区段和模型以实现切削表面和防止除去过多的骨。在制备切削膝盖的过程中,当切削区段的厚度为10毫米,各间隔物的厚度为5毫米时,在屈曲和伸展运动期间,在应用切削区段以实现所鉴定的最佳切削平面时,除去两个间隔物。可利用位于模型和切削导向件之间的棘轮或支柱样设计得到类似的结果。
现在转到图8,多个图显示了髋关节中使用的样品模型和切削区段系统。图8A显示了股骨810,设置模型和切削区段系统820以提供横跨股骨颈部812的切削平面830,以便切除股骨头部814和产生表面816,用于植入髋关节球形假体。
图8B显示了切削区段系统820的顶视图。切削区段系统820包括内部患者特异性模制部分824和外部切削区段表面822。内部患者特异性模制部分824可包括通道826以便将内侧部分824设置到股骨颈部。熟悉本领域者会容易理解,通道宽度取决于用来制备内部模制部分的材料的刚性。外部切削区段表面822被构造成紧密匹配围绕内侧部分。可提供其它结构,类似于上文参考膝关节切削取向系统所述,控制外部取向区段824相对于内部模制部分822的运动,熟悉本领域者会容易理解。当内部824包围所有或部分股骨颈部时,构建切削区段系统以助于在(例如)使用手柄801制备切口后切除股骨头部。
图8C显示了第二种切削区段系统850,可将其设置在切削股骨上以在采用图8A所示切削区段切除股骨头部之后提供铰扩导向。图8D是图8C所示切削区段的顶视图。熟悉本领域者会容易理解,图8C-D所示切削区段可以是一个或多个元件。如图8E所示,可构建孔852从而能够相对于股骨表面呈90°角铰扩植入物后部。或者,如图8F所示,需要时可构建孔852以提供除90°之外的铰扩角。
图9A(矢状视图)和9B(前视图,向下到模型上)显示了髋臼957的模型系统955。模型可具有凹槽959,使其抵靠髋臼缘960稳定。外科器械如扩孔器可穿过模型956中的开口。开口962的侧壁可引导扩孔器或其它外科器械的定向。金属插套964可插入侧壁962,从而保护模型侧壁以免损伤。金属插套964可具有唇件966或伸出边缘以抵靠模型固定插套且有助于避免插套相对于关节面的运动。
图9C是图9A和图9B所示相同模型系统的前视图。在6和12点位置加入凹槽970。利用凹槽可精确定位或放置外科器械。利用凹槽还可精确设置髋臼组件而没有旋转误差。熟悉本领域者会容易理解,使用一个以上的凹槽或内部导向件,不仅能够减少旋转误差而且能够减少与植入物倾斜有关的误差。如图9D所示,植入物975可具有匹配凹槽的小延伸部分977,从而引导植入物的放置。延伸部分977可以是植入物设计的永久部件,或者它们是可拆卸的。注意髋臼组件的金属缘979和内部聚乙烯杯件980。
图9D显示了系统截面视图,其中,模制的部分924的内表面960具有齿962或凹槽以用于抓紧股骨颈。
如本文所述,使用专有U-形软骨缺损定位装置鉴定软骨缺损和标记皮肤表面之后,设置3-厘米切口并插入组织牵引器。可见软骨缺损。
将匹配股骨髁三维表面的第一人造荧光树脂区段设置到软骨缺损上方。人造荧光树脂区段的中央部分包括例如内径为1.5厘米的钻孔,对应于植入物的基板直径。将具有深度控制钻孔导向件的标准外科钻孔器插入人造荧光树脂区段,制备植入物基本组件的受体部位。然后,除去钻孔器和人造荧光树脂区段。
然后,将相同外径的第二人造荧光树脂区段置于植入物受体部位上方。第二人造荧光树脂区段具有匹配第一钻孔尺寸(且匹配片植入物基底组件形状)的圆形、圆柱形延伸部分,直径比第一钻孔小0.1毫米,比植入物基底件小0.2毫米。圆柱形的延伸部分位于第一钻孔内。
第二人造荧光树脂区段包含从区段外表面向圆柱形延伸部分伸出的钻孔。第二钻孔的内径匹配植入物鳍形稳定支杆远端部分的直径,例如3毫米。将具有钻孔导向件的钻孔器,例如直径3毫米的,插入第二孔,制备具有四鳍件和阶梯设计的稳定支杆的受体部位。然后除去钻孔器和人造荧光树脂区段。
然后,将基底组件直径比最终植入物直径小0.2毫米的匹配最终植入物三维形状的塑料模型/试验植入物和直径比最终植入物远端部分小0.1毫米的圆柱体而非锥形支杆稳定件置于软骨缺损内侧。使用塑料模型/试验植入物来确认植入物表面与周围软骨对齐。然后外科医生进行最终调节。
接着,将植入物置于受体部位内侧。用红色标记植入物的前部鳍件,标识为“A”。后部鳍件标为绿色,标识为“P”,中部鳍件标为黄色,标识为“M”。然后,将人造荧光树脂区段置于植入物上方。采用塑料锤将植入物缓慢推入受体部位。在支杆的锥形和四鳍设计的帮助下,并且基本组件相对于钻孔直径稍大(0.1毫米),以实现压配合。除去人造荧光树脂区段。然后除去组织牵引器。使用标准外科技术关闭3厘米切口。内侧股骨髁的上述相同过程也可应用于外侧股骨髁、内侧胫骨平台、外侧胫骨平台和髌骨。需要时,通过与骨粘固剂结合即可实现装置的立即稳定。
图10A显示了髌骨1000,它有髌骨脊1002、髌骨小面1004、1004。还显示了上表面1010、下表面1012、外侧面1014和内侧面1016。
图10B从髌骨匹配表面1022的角度显示了模型钻孔导向件1020。构建模型钻孔导向件1020,使其大致为圆形圆柱体。但是,也可采用其它形状而不背离本发明的范围。这些形状可以是严格的几何形状如椭圆形亦可为非几何形状。
髌骨匹配表面1022具有匹配、或紧密符合髌骨表面的关节面。提出该设计旨在将导向件模制为精确匹配每个患者髌骨关节面的解剖学结构,从而提供所需髌骨刨削成面的精确位置。对本领域熟悉者可很容易理解,虽然需要准确或精确匹配,但仍可存在偏离精确匹配而不背离本发明的范围的情况。因此,预计设计中存在一定量的误差是可容忍的。
图10C从相反方向显示了导向件1020。平面导向表面1024显示为平的或基本上平的。但是,熟悉本领域者会容易理解,也可采用其它表面构型而不背离本发明的范围。图10A和B均描绘了孔1030、1032。提供了可以接纳例如1/8英寸钻头的中央孔1030。可定位中央孔1030,使其位于导向件中心、偏离中心、或稍微偏离中心,而不背离本发明的范围。偏离中心或稍微偏离中心型可用于圆形圆柱体构型,但也可用于其它构型。可提供一个或多个额外的孔1032,以钻孔栓钉洞。孔1032可被构造成直径比第一孔1030大、比其小、或相同。
如图10D所示,将模型钻孔导向件匹配在髌骨关节面上。因为朝向表面的关节面(图10A所示)被构造成匹配或基本匹配髌骨关节表面,钻孔导向件与髌骨表面匹配,使钻孔以植入物所需的位置排列。图10E显示了匹配在髌骨关节表面上的模型钻孔导向件,1/8英寸钻头1050位于中央孔1030内。
在髌骨中形成中央孔1018之后,使用髌骨扩孔器1060重建髌骨1000表面。扩孔器1060具有导向件1062,匹配在孔1018内,扩孔器1064具有刨削表面或刀片表面1066。
转到图11A,显示了扩孔器1060。刨削表面1066被构造成提供双刨削表面,以切削髌骨和切除周围骨组织。提供双刨削表面有助于确保仅多金属关节连接。图11B显示了相对于髌骨的扩孔器。制备区域1062以插入30毫米髌骨,并铰扩周围区域1061。
图12A显示了髌骨植入物1200。植入物1200的下表面具有一个或多个栓钉1210。在该实施例中,同时显示了下表面1202与三个栓钉1210。植入物1200被置于髌骨上,如图12C所示,使得植入物上表面1204上的突起1220大约位于天然髌骨的顶点。图12D-F显示了位于髌骨内的植入物,更清楚地显示对应于天然髌骨顶点的该突起。
本文还描述了套盒,它包括一种或多种本文所述的方法、系统和/或组合物。具体地说,套盒包括一种或多种以下物品:获得电子图像的说明书(方法);评价电子图像的系统或说明书;能够分析或处理电子图像的一种或多种计算机方法;和/或植入关节修复系统的一种或多种外科工具。该套盒可包括其它材料,例如说明书、反应试剂、容器和/或成像辅助件(例如,胶片、夹具、数字转换器等)。
提供本发明实施方式的上述说明是出于阐明和叙述的目的。并非详尽的或将本发明完全限于所述形式。许多改进和变化是熟悉本领域者可以容易理解的。所选择和描述的实施方式是为了能够最佳地解释本发明的原理及其实际应用,从而使本其它熟悉本领域者能够理解本发明及其各种实施方式,以及所考虑到的适用于特定应用的各种改进。本发明的范围由所附权利要求书来限定。
Claims (13)
1.用于接合髌骨表面的钻孔导向件,所述钻孔导向件包括:
模型,它具有第一表面,第一表面被构造成与所述髌骨表面基本匹配。
2.如权利要求1所述的钻孔导向件,其特征在于,所述模型有孔。
3.如权利要求1所述的钻孔导向件,其特征在于,所述的孔基本上位于所述钻孔导向件的中心。
4.如权利要求1所述的钻孔导向件,其特征在于,所述的孔偏离所述钻孔导向件的中心。
5.如权利要求1所述的钻孔导向件,其特征在于,所述模型具有多个孔。
6.如权利要求1所述的钻孔导向件,其特征在于,所述第一表面的整个部分被构造成与髌骨相匹配。
7.如权利要求1所述的钻孔导向件,其特征在于,所述模型选自模型库。
8.如权利要求1所述的钻孔导向件,其特征在于,所述模型是患者特异的。
9.一种重建髌骨表面的方法,所述方法包括:
将于至少一部分第一表面上构建以匹配至少一部分髌骨表面的钻孔导向件置于髌骨上;
通过位于钻孔导向件表面上的孔在髌骨表面中钻孔;
利用髌骨表面中的钻孔相对于髌骨表面定位扩孔器;和
使用扩孔器重建髌骨表面。
10.如权利要求9所述的方法,其特征在于,所述钻孔导向件包括具有所述第一表面的模型。
11.如权利要求10所述的方法,所述方法还包括:
使髌骨表面部分成像;和
基于图像形成模型。
12.如权利要求10所述的方法,所述方法还包括:
从模型库选择模型。
13.如权利要求9所述的方法,所述方法还包括:
使髌骨表面部分成像;和
基于图像加工所述第一表面。
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2005
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- 2005-12-02 WO PCT/US2005/044008 patent/WO2006060795A1/en active Application Filing
- 2005-12-02 EP EP10181743A patent/EP2316357A1/en not_active Withdrawn
- 2005-12-02 JP JP2007544608A patent/JP5148284B2/ja active Active
- 2005-12-02 DE DE602005027391T patent/DE602005027391D1/de active Active
- 2005-12-02 CN CNA2005800460057A patent/CN101111197A/zh active Pending
- 2005-12-02 AT AT05853044T patent/ATE504245T1/de not_active IP Right Cessation
- 2005-12-02 CA CA002588907A patent/CA2588907A1/en not_active Abandoned
- 2005-12-02 AU AU2005311558A patent/AU2005311558A1/en not_active Abandoned
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2007
- 2007-12-03 HK HK07113188.8A patent/HK1104776A1/xx not_active IP Right Cessation
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2009
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2010
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2012
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Also Published As
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DE602005027391D1 (de) | 2011-05-19 |
US7534263B2 (en) | 2009-05-19 |
US20050234461A1 (en) | 2005-10-20 |
JP2008522665A (ja) | 2008-07-03 |
AU2005311558A1 (en) | 2006-06-08 |
CA2588907A1 (en) | 2006-06-08 |
EP1833387A1 (en) | 2007-09-19 |
US8122582B2 (en) | 2012-02-28 |
US9095353B2 (en) | 2015-08-04 |
ATE504245T1 (de) | 2011-04-15 |
EP1833387B1 (en) | 2011-04-06 |
US20130211409A1 (en) | 2013-08-15 |
US8366771B2 (en) | 2013-02-05 |
US9066728B2 (en) | 2015-06-30 |
US20100281678A1 (en) | 2010-11-11 |
WO2006060795A1 (en) | 2006-06-08 |
EP2316357A1 (en) | 2011-05-04 |
US20120158001A1 (en) | 2012-06-21 |
JP5148284B2 (ja) | 2013-02-20 |
US20090307893A1 (en) | 2009-12-17 |
HK1104776A1 (en) | 2008-01-25 |
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