CN100594845C - 经皮进入装置和骨锚组件 - Google Patents

经皮进入装置和骨锚组件 Download PDF

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CN100594845C
CN100594845C CN200480041478A CN200480041478A CN100594845C CN 100594845 C CN100594845 C CN 100594845C CN 200480041478 A CN200480041478 A CN 200480041478A CN 200480041478 A CN200480041478 A CN 200480041478A CN 100594845 C CN100594845 C CN 100594845C
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outer tube
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bone anchor
groove
access device
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CN1921804A (zh
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C·西克沃尔
E·洛佩斯
R·A·鲁伯特
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DePuy Spine SARL
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Abstract

一种经皮进入装置，包括一个内管(12)和一个安置在内管(12)的至少一部分的周围的外管(14)。外管(14)的尺寸做成可以从病人体上的一个皮肤切口跨越到一个靠近病人脊柱的部位。外管(12)的远端可适合于可以脱开地啮合一骨锚(102)。内管(12)可相对于外管(14)在一第一位置和一第二位置之间调整，在该第二位置中内管(12)的远端接触该骨锚(102)。一个骨锚组件(100)包括一个有一远端骨头啮合部分(106)的骨锚(102)和一个有一用于装入一个脊柱固定元件的凹部(114)的装入部件(108)。装入部件(108)的近端可以有一形成于其外表面上的弧形槽(130)，以便于将一器械连接在该装入部件上。

Description

经皮进入装置和骨锚组件
技术领域
本发明涉及经皮进入装置的骨锚组件。
背景技术
由于许多已知原因，在矫形外科中使用脊柱固定装置来对准和/或固定相邻的椎骨体之间的所要关系。此种装置通常包括一个脊柱固定元件如相当坚硬的固定棒或板，它们通过将该元件附接在各种锚定装置如钩子、螺栓、线或螺钉上而联接到邻近的椎骨上。该固定元件可以有一个按照目标植入部位的性质而设定的预定轮廓，而一旦安装好，该固定元件将该椎骨保持在一个所要的空间关系中，或者是直到所要的愈合或脊柱融合已发生，或者是要更长的时间。
脊柱固定元件可以锚定在该椎骨的特定部分上。因为每个椎骨的形状和尺寸都变化，所以已发展各种锚定装置来便于啮合骨头的特定部分。例如，蒂螺钉组件具有这样的形状和尺寸，它们做成能啮合蒂骨。此种螺钉通常包括一个适合于拧入一椎骨的螺杆和一个有一棒装入元件的头部部分，该元件通常为该头部中形成的U形凹部形式。使用一个定位螺钉、插塞或类似的闭合机构来将该固定元件如一个脊柱棒锁紧在该蒂螺钉的棒装入头部中。在使用中，每个螺钉的杆部分被拧入一根椎骨中，一旦合适地安置，一根棒通过每个螺钉的棒装入部件而安置，通过将一帽或其它闭合机构把每个螺钉和该固定棒固定地相互连接而将该棒锁紧在位置中。
最近，脊柱外科学中的趋势已移向提供侵害最小的装置和用于植入骨锚和脊柱固定装置的方法。
发明概要
此处公开的经皮进入装置便于将骨锚传送和植入骨头中，特别是脊柱的一个或多个脊柱体中。特别是，所公开的经皮进入装置允许以一种侵害最小的方式传送和植入一个或多个骨锚，由此限制了对周围组织的损伤。而且，此处公开的经皮进入装置能在一个皮肤切口和该骨锚之间提供一个经皮的通道，该通道用于传送骨锚的部件如紧固机构、固定元件和/或通到骨锚的器械。同时，此处公开的骨锚便于将器械如经皮进入装置连接到骨锚上。
按照一个示范的实施例，一个经皮进入装置包括一个内管和一个设置在至少一部分内管周围的外管。在该示范的实施例中，该外管的尺寸做成从病人体上的至少一个皮肤切口到靠近病人脊柱的一个预定部位。该外管的远端可适合于可以脱开地啮合一个骨锚。在该示范的实施例中，该内管可以相对于外管沿外管的纵轴线在一第一位置和一第二位置之间调整，在该第二位置中该内管的远端接触该骨锚。
按照另一示范的实施例，一种骨锚组件包括一个有一近端头部和一远端骨头啮合部分的骨锚与一个联接在该骨锚上的装入部件。在该示范的实施例中，该装入部件可以有一近端、一远端和一用于装入一个脊柱固定元件如一棒或一板的凹部。在该示范的实施例中，该装入部件的近端可以有至少一个形成于其外表面上的弧形槽，以便于将一器械如一经皮进入装置连接到该装入部件上。
附图简述
参照下列结合附图的详细描述将更充分地理解此处公开的经皮进入装置和骨锚组件的上述和其它特点和优点，各不同的附图中相同的标号指相同的元件。这些附图所示此处公开的经皮进入装置和骨锚组件，虽然并不按比例，但显示相对的尺寸。
图1是一种经皮进入装置的一个示范实施例的透视图；
图2是图1的经皮进入装置的部件的透视图；
图3是图1的经皮进入装置的远端的透视图；
图4是联接在一骨锚组件的示范实施例上的图1的经皮进入装置的远端的透视图；
图5是图4的骨锚组件的侧视图；
图6是图4的骨锚组件的装入部件的侧视图；
图7是联接在图4的骨锚组件的装入部件上的图1的经皮进入装置的远端的侧视截面图；
图8是图1的经皮进入装置的外管远端和图4的骨锚组件的装入部件的侧视截面图；
图9和10是图1的经皮进入装置的内管远端和图4的骨锚组件的装入部件的侧视截面图；
图11A～11D是图1的经皮进入装置的远端和图4的骨锚组件的装入部件的透视图，例示将经皮进入装置可脱开地联接在骨锚组件的装入部件上的示范的步骤；
图12是骨锚组件的另一示范实施例的侧视图；
图13是图12的骨锚组件的装入部件的侧视图；
图14是图12的骨锚组件的装入部件的侧视截面图；
图15是图12的骨锚组件的装入部件的弧形槽的侧视截面图；
图16是联接在图12的骨锚组件的装入部件上的经皮进入装置的另一示范实施例的远端的侧视截面图；
图17A和17B是经皮进入装置和骨锚组件的一替代实施例的透视图，例示经皮进入装置和骨锚组件之间的螺纹连接；
图18A和18B是经皮进入装置和骨锚组件的一个替代实施例的透视图，例示用于与一器械如经皮进入装置的可脱开的啮合的多个可移动的外螺纹薄片；
图19A～19D是经皮进入装置和骨锚组件的一个替代实施例的透视图，例示用一根或多根内线连接的经皮进入装置和骨锚组件；
图20A～20D是经皮进入装置和骨锚组件的一个替代实施例的透视图，例示用一根或多根外线连接的经皮进入装置和骨锚组件；
图21是一种骨锚组件的一个替代实施例的透视图，该骨锚组件有用于与一器械如经皮进入装置可脱开地啮合的多个可移动的薄片；
图22A～22B是经皮进入装置的一个示范实施例的透视图，例示设置在经皮进入装置的外管中的轴向切口；以及
图23A～23B是经皮进入装置和骨锚组件的一个替代实施例的透视图，例示设置在经皮进入装置的远端上的用于与骨锚组件可脱开地啮合的可弯曲的薄片。
发明的详细描述
现在描述一些示范实施例来提供对此处公开的经皮进入装置和骨锚组件的结构、功能、制备和使用的原理的全面理解。在附图中例示这些实施例的一个或多个例子。该技术的普通专业人员将会理解，特别在此处描述和在附图中例示的经皮进入装置和骨锚组件是不起限制作用的示范实施例，而本发明的范围唯一地由权利要求书限定。联系一个示范实施例而例示或描述的特点可以与其它实施例的特点组合。此类修改和变化预期包括在本发明的范围内。
此处使用的冠词“一个”指该冠词的语法意义的一个或多于一个(即至少一个)。作为例子，“一个元件”指一个元件或多于一个元件。
此处对任何部件或结构使用的术语“远的”通常指相对地接近待对其应用一骨锚的骨头表面的位置或方位。相反，此处相对于任何部件或结构使用的术语“近的”通常指一个离待对其应用一骨锚的骨头表面相对地远的位置或方法。
术语“包括”、“包含”和“具有”及其衍生用语在此处可以互换地用作容易领会的无尽头的术语。例如，“包括”、“包含”或“具有”的使用指无论包括、包含或具有什么元件都不是含有该动词的句子的主语所覆盖的唯一元件。
图1～5例示一个经皮进入装置10的示范实施例。该示范的经皮进入装置10能够有利于将骨锚如下面例示和描述的示范的骨锚组件100传送和植入骨头中，特别是脊柱的一个或多个椎骨体中。特别是，示范的经皮进入装置10能够有利于以侵害最小的方式传送和植入一个骨锚，并能够在病人的皮肤切口和骨锚之间提供一条经皮通道，该经皮通道可用于将骨锚的部件如闭合机构、一个或多个固定元件和/或器械传送给骨锚。经皮进入装置10最好适合于通过一个侵害最小的经皮切口而引入，该切口相当小，通常切口的长度小于被插入通过其间的装置的直径或宽度。虽然下面描述的示范的经皮进入装置10被设计成主要用于椎骨用途，但该技术的专业人员将理解，示范的经皮进入装置10以及下面描述的其它示范实施例可以用于便于将任何类型的骨锚植入任何类型的骨头中。
该示范的经皮进入装置10包括一个内管12和一个外管14，外管14安置在内管12的至少一部分的周围。在例示的示范实施例中，外管14同轴地设置在内管12的周围，使得内管12和外管14共用一根共同的纵轴线16。但是，该技术的专业人员将会理解，外管14和内管12不需要同轴地对准。在示范的实施例中，内管12和外管14通常为圆筒形，具有近似圆形的截面。但是，该技术的专业人员将会理解，内管12和外管14可以有其它截面形式，例如包括椭圆形或矩形。在示范的实施例中，内管12和外管14具有相似的截面，但该技术的专业人员将会理解，内管12和外管14可以有不同的截面形式。内管12和外管14的轴向长度可以变化，这取决于(例如)病人的解剖生理、所用的手术和/或其中使用装置10的脊柱面积。内管12和外管14可以是线性的，如示范实施例中那样，或者可以沿其一个或多个截面或整个长度而弯曲或有角度。内管12和外管14可以用任何合适的生物兼容材料包括金属如不锈钢或聚合物用任何传统的制造药物装置的方法来制造。
虽然例示的示范实施例包括一根内管和一个外管，但该技术的专业人员将理解，可以利用任何数目的管子如一根或多根管子，这取决于(例如)所用的骨锚的类型和将装置可以脱开地啮合到骨锚上的方式。例如，下面描述有单独一根外管的经皮进入装置的示范实施例。
继续参照图1～5，内管或套管12包括一个近端20和一个远端22及在近端20和远端22之间的腔24。外管或套管14包括一个近端30、一个远端32和延伸在近端30和远端32之间的腔34。腔34可以延伸外管14的长度，并限定外管14的纵轴线36。内管12可安置在外管14的腔36内。在示范的经皮进入装置10中，内管12可相对于外管14沿纵向调整。例如，内管12可以从一第一近端位置和一第二远端位置调整，在该第一近端位置中，内管12的远端22安置在如图3中所示的外管14的远端32的附近，而在该第二远端位置中，内管12的远端22安置在外管14的远端32的附近。在示范的实施例中，如图4和7中所示和如下面更详细地讨论的，当内管12处在第二位置时，内管12的远端22最好至少接触骨锚组件的一部分。
示范的经皮进入装置10可以包括一个调整机构40，后者允许操作人员调整内管12和外管14的相对纵向位置。在例示的实施例中，例如，调整机构40是一个空心的管状帽41，具有内螺纹42，能啮合外管14的近端30上的外螺纹44。螺纹42、44允许帽41相对于外管14沿纵向调整。在该示范的实施例中，内管12连接在帽41上，因此，当帽41相对于外管14进退时，内管12能与帽41一起移动。例如，该示范实施例的内管12的近端30可以包括一个或多个弹性片46，其一个或多个可以有一位于帽41的内表面上的环槽中的凸出部48，由此将内管12的近端30连接在帽41上。在所示的实施例中，两个弹性片46设置在外管14的相对两侧上。在该示范的实施例中，凸出部48的尺寸做成在帽41的槽中一起转动，从而允许帽41相对于内管12转动。弹性片46沿径向可以弯曲，从而有利于连接到帽41上和从帽41移走。该技术的专业人员将会理解，也可以有将内管12连接在帽41上的其它构型，它们包括在本发明的范围内。
可以禁止内管12相对于外管14转动，将内管12和外管14的相对运动限制于沿该经皮进入装置的纵轴线16移动。例如，可以在内管12的近端20和远端22之间约半中间处的内管12上设置一个或多个弹性片56，虽然其它位置也可以。在例示的实施例中，两个弹性片56设置在外管14的相对两侧上。弹性片56中的一个或多个可以包括一凸出部58，其尺寸和形状做成位于外管14中的一个纵向槽54中。弹性片56沿径向可以弯曲，以便于插入槽54中和从槽中取出。凸出部58可以在槽54内滑动，从而能够将内管12和外管14之间的相对运动限制于沿经皮进入装置10的纵轴线16移动。该技术的专业人员将会理解，也可以有将内管12连接在外管14上的其它构型，它们包括在本发明的范围内。
内管12可以有一个或多个在其中形成的侧壁开孔或槽60。在例示的示范实施例中，内管12包括两个对置的槽60，它们沿纵向从内管12的远端22延伸。像内管12一样，外管14可以有一个或多个在其中形成的侧壁开孔或槽62。在例示的示范实施例中，外管14包括两个对置的槽62，它们沿纵向从外管14的远端32延伸。槽60和62可以用于便于相对于一个或多个骨锚安置一个脊柱固定装置，如棒或板。用于脊柱固定元件的安置的方法和装置公开于2003年12月16日申请的题为“用于脊柱固定元件的安置的方法和装置”的共同拥有的共同待审的美国专利申请书No.10/737,537和2003年12月16日申请的题为“用于侵害最小的脊柱固定元件的安置的方法和装置”的共同拥有的共同待审的美国专利申请书No.10/738,130中，这两篇专利均参考合并于此。为了便于安置脊柱固定元件，槽60和槽62最好沿经皮进入装置10的纵轴线的至少一部分彼此对准。槽60和槽62的宽度和长度可以变化，取决于使用的特定方法、器械和固定元件。在一个示范的实施例中，例如，槽60和槽62的长度选择为至少跨越从皮肤切口分别到内管12和外管14的远端。在这些实施例中，槽60和62可从病人外部接触到。在另一示范实施例中，槽60和62的长度选择为分别跨越从内管12和外管14的远端到远离皮肤切口的一个点。在这些实施例中，槽60和62可以仅从内外管的腔可接触到。
在采用多重槽的实施例中，槽60、62不需要尺寸(宽度和/或长度)相似。例如，一个或多个槽60的尺寸可以做成不同于一个或多个槽62，内管上的一个或多个槽60的尺寸可以做成不同于其它槽60，外管上的一个或多个槽62的尺寸可以做成不同于其它槽6。虽然示范的实施例在内管12和外管14上分别包括两个对置的槽，但该技术的专业人员将会理解，可以设置任何数目的槽，例如，无槽，一个、两个、三个等槽，取决于所用的方法、器械和/或固定元件。
该技术的专业人员将会理解，槽60和62是任选的，在某些实施例中可以没有槽。
参照图1～5和7，经皮进入装置10最好可以脱开地啮合在一个骨锚上。在该示范的实施例中，外管14可以可脱开地啮合在一骨锚如骨锚组件100上。例如，外管14可以以这样一种方式啮合在一根骨头上，就是允许将经皮进入装置在使用期间例如在将一个脊柱固定元件植入和/或传送和/或固定在该骨锚上期间连接于骨锚100上，并允许在手术结束时从骨锚100上脱开该经皮进入装置。最好是，可以从远处脱开经皮进入装置10。例如，在示范的实施例中，如下面更详细地讨论的，可以通过操纵经皮进入装置10的远端而从骨锚上脱开经皮进入装置10。
外管14的远端32包括一对可以脱开地啮合一个骨锚的对置地沿纵向延伸的薄片70A和70B。在该示范的实施例中，薄片70A和70B由外管14的侧壁限定并由槽62A和62B隔开。在某些示范的实施例中，薄片70A和70B可以弯曲并沿径向有弹性，以便于与一骨锚连接。例如，薄片70A和70B可以沿径向弯曲而离开一个第一松弛位置，以便于薄片在一部分骨锚上沿纵向前进。一旦围绕一部分骨锚而安置，当薄片70A和70B试图返回到第一松弛位置时，薄片70A和70B可以在骨锚上提供一个径向压紧力。在其它示范实施例中，包括示范的经皮进入装置10，薄片70A和70B不需要可以弯曲和有弹性。
在所示的示范实施例中，每个薄片70A和70B可以包括一个或多个沿径向向内面向的凸出部72，其尺寸和形状做成可安置在骨锚的一部分中设置的孔内。凸出部的尺寸、形状和数目可以根据(例如)设置在骨锚上的开孔和所希望的连接类型而变化。在所示的示范实施例中，例如，每个凸出部72A、72B的形状大体上为弧形，其截面与下述示范的骨锚组件100的脊柱固定元件装入部件108中设置的弧形槽130互补。特别是，如图8中所示，凸出部72A有一远表面74、一近表面76和一跨越在远表面74和近表面76之间的大体上沿径向面对的连接表面78。在例示的实施例中，远表面74的取向大体上垂直于外管14的纵轴线，而连接表面的取向大体上平行于外管14的纵轴线并垂直于远表面74。近表面76和远表面74之一或两者除了垂直于外管14的纵轴线以外，还可取向为对纵轴线成一角度。例如，近表面76的取向可以对正交线80成一角度A，该正交线80的取向垂直于外管14的纵轴线。在该示范的实施例中，角度A可以是约5度～约30度，最好为约20度。远表面74和近表面76可以像示范实施例中那样以同一角度取向，或者可以以不同角度取向。
参照图2、3、4、7、9和10，内管12的远端22可以包括一个接触表面81，当内管12处在第二位置时，该接触表面81接触一骨锚的至少一部分。例如，在图示的实施例中，内管12的远端22可以有两个大体上对置的弧形接触表面81。在该示范的实施例中，接触表面81的取向近似地垂直于内管12的纵轴线。在例示的示范实施例中，接触表面81的构型做成接触该示范的骨锚组件100的装入部件的近端上的大体上弧形的接触表面。最好是，接触表面81的尺寸、形状和取向与骨锚上的接触表面互补。该技术的专业人员将会理解，接触表面81的构型如其数目、尺寸、形状和取向可以变化(例如)来适应所用的骨锚。
内管12的远端22和/或外管14的远端32的构型可以做成禁止骨锚组件相对于经皮进入装置10转动。例如，内管的远端22可以包括一个或多个指状延伸部82，后者从内管12的远端22近似地沿轴向伸出并啮合一骨锚而禁止该骨锚相对于经皮进入装置转动。例如，一个或多个延伸部82可以安置在该骨锚中设置的沟、凹部、槽或类似结构中。或者是，一个或多个延伸部82可以包括一个接触表面84，用于接触该骨锚的一个沿轴向延伸的表面，如该示范的实施例的情况中和如下面详细讨论的。
图5～6例示一个特别适合于与已描述的示范的经皮进入装置10一起使用的骨锚组件100。但是，该技术的专业人员将会理解，此处公开的经皮进入装置不限于与示范的骨锚组件100一起使用，而相反地可以做成与任何类型的骨锚一起使用，如骨螺钉或骨钩，单轴向的或多轴向的。示范的骨锚组件100包括一个有一近头部104和一远骨头啮合部分106的骨螺钉102如蒂螺钉，在例示的示范实施例中，该啮合部位106是一个内螺纹螺杆。该示范的骨螺钉组件100也包括一个装入部件108，其构型做成将一个脊柱固定元件如脊柱棒或脊柱板装入到骨锚组件100上。
装入部件108可以用任何熟知的传统方式联接到骨锚102上。例如，该骨锚组件可以是多轴线的，像在当前的示范实施例中那样，其中骨锚102可以相对于装入部件108调整到多个角度，或者该骨锚组件可以是单轴线的，例如，骨锚102相对于装入部件108是固定的。美国专利No.5,672,176中描述了一种示范的多轴线骨螺钉，该专利参考合并于此。在单轴线的实施例中，骨锚102和该装入部件可以是共轴线的，或者其取向可以彼此成一角度。在多轴线实施例中，可以将该骨锚偏压到一个特定的角度或角度范围，从而给骨锚提供一个有利的角度。美国专利申请书出版物No.2003/0055426和美国专利申请书出版物no.2002/0058942中描述了示范的角度有利的骨螺钉，这两篇专利均参考合并于此。
该例示的示范实施例的装入部件108包括一个近端110、一个远端112和一个用于装入一脊柱固定元件如脊柱棒的凹部或槽114。装入部件108的近端110有一个限定一第一开孔轴线118的第一开孔116。凹部114与第一开孔116连通，使得可以通过第一开孔116将一个脊柱固定元件安置在凹部114中。远端122有一个与第一开孔116对置的第二开孔120，后者限定一第二开孔轴线122。第二开孔轴线122设计成能装入骨锚102的头部104，以便将骨锚102联接在装入部件108上。在该例示的实施例中，头部104安置在第二开孔116中。因为骨锚组件的该例示的示范实施例是多轴线的，所以骨锚102相对于装入部件108可以自由转动，使得骨锚102的纵向轴线124可以安置成相对于第二开孔轴线120成一角度。第二开孔116可以成锥形，以便于相对于装入部件108调整骨锚102。在角度有利的实施例中，第二开孔轴线122可以安置成对第一开孔轴线118在一角度(不是零度)。在该例示的实施例中，装入部件108有一个被由凹部114隔开的两个支脚124A和124B界定的大体上U形的截面。每个支脚124A、124B在装入部件108的近端110处是不受约束的。
装入部件108的构型做成可装入一个将一脊柱固定元件锁定在凹部114中的闭合机构。该闭合机构可以是一个帽，该帽可以通过装入部件108的第一开孔116而前进，并对着该脊柱固定元件安置。例如，该帽可以有外螺纹，该外螺纹啮合设置在如示范实施例中支脚124A、124B上的装入部件108内设置的内螺纹148。可以使用任何类型的传统的闭合机构，包括(例如)没有螺纹的帽、多部件闭合机构和/或外帽。
示范的骨锚组件100的装入部件108的构型做成可以脱开地连接在一个如上述示范的经皮进入装置10的器械上。例如，装入部件108可以包括至少一个槽130，其构型做成能装入一个器械的一部分，以便将该器械可以脱开地连接在该骨锚组件上。槽的尺寸、形关、位置和数目可以变化，取决于(例如)所用器械和所希望的连接类型。在某些实施例中(例如)，在装入部件108的近端110的外表面上可以设置至少一个弧形槽130。在其它示范实施例中，在装入部件108的近端110的一个内表面上可以设置至少一个弧形槽。在例示的示范实施例中，每个支脚124A和124B可以分别在支脚124A、124B的自由近端上设有一个弧形的槽130A、130B。槽130A、130B可以围绕每个支脚124A、124B的近端的一部分或全部周边而延伸。每个槽130A、130B的尺寸和形状可以与该器械上设置的凸出部的尺寸和形状互补。例如，在例示的示范实施例中，每个槽130A、130B可以是弧形的，并可以有一个与外管14的薄片70A、70B上设置的凸出部72A、72B的截面互补的截面。特别是，如图8中例示的，槽130可以有一远表面132、一近表面134和一个在远表面132与近表面134之间跨越的中间连接表面136、远表面132和/或近表面134的取向可以例于将一凸出部插入槽130中和/或禁止该凸出部与槽130在不希望地隔开。在例示的示范实施例中，例如，远表面132的取向可以大体上与取向垂直于装入部件108的纵轴线的正交线140成角度B，以便于将该凸出部插入槽中。在例示的实施例中，角度B可以是约零度～约45度，最好为约30度～40度。在例示的示范实施例中，近表面134的取向可以不是垂直于装入部件108的纵轴线，以禁止该凸出部与槽130隔开，特别是沿径向。例如，近表面134的取向可以与垂直于装入部件108的纵轴线的正交线142成一角度C。在例示的实施例中，该角度C可以是约5度～约30度，最好是约20度。远表面132和近表面76的取向可以是同一角度，或者如示范的实施例中那样，可以是不同角度。槽130A和130B以及任何额外的槽可以如例示的示范实施例的情况中那样有相似的截面几何形状，或者可以有截然不同的几何形状。
参照图7和8，每个凸出部72的近表面76的取向可以形成一个近似地等于对应的槽的近表面134的角度C。在一个优选实施例中，例如，角度A和角度C每个近似地为20度。该技术的专业人员将会理解，角度A和角度C不需要近似地相等，而相反，可以是截然不同的角度。
装入部件108的近端110可以包括一个或多个接触表面，后者可以被一器械如经皮进入装置10接触。在例示的示范实施例中，例如，每个支脚124A、124B的近端可以包括一个或多个大体上弧形的近似面对的接触表面145。
该经皮进入装置的外径可以选择为近似地等于该骨锚的外径，以便于通过一条经皮通道而将该骨锚插入人体中。例如，在例示的示范实施例中，图7中用线D1表示的外管14的外径至少在外管14的远端32处近似地等于或小于在图6和7中用线d1表示的装入部件108的外径。例如，外管14的直径可以从近端直径D2渐窄到外管14的远端32处的远端直径D1。或者是，外管14的外径可以近似地等于或小于沿外管14的整个长度的装入部件108的外径。为了装入外管14，装入部件108的近端110的直径d2可以小于装入部件108的远区段的直径D1，如图6中所示。例如，接近槽130A、130B的直径d2可以小于装入部件108的直径d1，以便在装入部件的近端130处提供一个直径减小的部分。在图6和8中用线E表示的该直径减小的部分150的外表面和装入部件108的外表面之间的距离最好大于或近似地等于如图8中用线F表示的薄片70A、70B的径向厚度。
为了便于将一些装置通过经皮进入装置10送到骨锚组件，至少在内管12的远端处，图7中用线F表示的内管12的腔24的内径可以大于或近似地等于图7中用线f表示的至少一部分装入部件的内径。
下面参照图11A～11D来描述带有示范的骨锚组件的经皮进入装置10的示范操作。为了可以脱开地连接经皮进入装置10，外管14的远端32这样取向，使得70A和70B与凹部114对准，如图11A中所示。从远处推进经皮进入装置10，直到每个薄片70A、70B置于支脚124A和124B之间，如图11B中所示。经皮进入装置10可以围绕其纵轴线16转动而使凸出部72A、72B分别转入槽103B、130A中，如图11C中所示。可以从远处沿经皮进入装置10的纵轴线16将内管12从图11A～C中例示的第一近位置推进到图11D中例示的第二远位置，其中内管12的接触表面81接触设置在示范的骨锚组件100的装入部件的近端上的接触表面145A、145B，从而将经皮进入装置10可以脱开地连接到骨锚组件100上。一个或多个延长部82的接触表面84可以啮合沿轴向延伸的接触表面152(图5和6)，以禁止经皮进入装置和骨锚组件之间的转动。
在植入骨锚组件之前或在将骨锚组件植入病人体内之后，经皮进入装置10可以连接到示范的骨锚组件100上或另一骨锚组件上。
一旦经皮进入装置10可以脱开地连接到如图1和11D中例示的骨锚组件100上，该经皮进入装置10就可以在皮肤切口和骨锚100之间提供一条经皮通道，该经皮通道便于将器械、脊柱固定元件和/或骨锚组件的部件如闭合机构传送到骨锚组件100上。在例示的示范实施例中，例如，腔24向骨锚组件100的装入部件100的第一开孔116提供一条通道，这可以允许将一个闭合机构如螺帽传送到骨锚组件的装入部件108上和/或允许将一个螺丝刀之类推进到与骨锚102的头部104啮合。而且，在例示的示范实施例中，内管的槽60和外管14的槽62可以与设置在装入部件108中的凹部114对准。槽60和62与凹部114的对准便于将一个脊柱固定装置传送到该骨锚组件上。用于将一脊柱固定元件传送到一骨锚组件的示范方法和装置描述于2003年12月16日申请的题为“用于侵害最小的脊柱固定元件的安置的方法和装置”的共同拥有的共同待审的美国专利申请书顺序号No.10/738,130和2003年12月16日申请的题为“用于脊柱固定元件的安置的方法和装置”的共同拥有的共同待审的美国专利申请书顺序号No.10/737,537中，这两篇专利均参考合并于此。
经皮进入装置10可以通过围绕其纵轴线转动经皮进入装置10和从远处退出该装置10而从该骨锚脱开。
图12～16例示一种骨锚组件200的替代的示范实施例和一种示范的经皮进入装置300，装置300的构型可以做成可脱开地啮合骨锚组件200。该示范的骨锚组件200在构造上类似于上述示范的骨锚组件10，不同之处是骨锚组件200的装入部件208在其近端110处有一大体上恒定的外径d1，如图14和16中所示，并因而缺少骨锚组件100的直径减小部分150。结果，由图16中的线D2表示的示范的经皮进入装置300的外管14的远端32的外径可以近似地等于或如例示的实施例中那样可以大于装入部件208的近端110的直径d1。外管14的外径可以如例示的示范实施例中那样地恒定，或者可以沿外管14的长度变化。
图17A和17B例示一种经皮进入装置350和一种骨锚组件400的另一实施例，其中该经皮进入装置和骨锚组件用螺纹连接。例如，经皮进入装置350可以有一根外管352，外管352有一个设有内螺纹的远端354，该内螺纹能可以脱开地啮合骨锚组件400的装入部件408的近端412上的外螺纹406。最好是，外螺纹406是计时的，以便于使设置在外管14上的槽62(如果有的话)与设置在装入部件408中的凹部414对准。在该例示的实施例中，经皮进入装置350包括一根单独的管(外管352)；可以设置一根内管，但并非必须。
图18A和18B例示一个替代的实施例，一个骨锚组件500，其中装入部件508包括一个或多个可以移动的外螺纹薄片502，后者在经皮进入装置350和骨锚组件500之间提供一种螺纹连接。在例示的示范实施例中，一对相邻地延伸的薄片502A和502B分别从支脚524A和524B伸出。在该例示的示范实施例中，每个薄片502大体上为弧形，并包括外螺纹，用于与设置在该经皮进入装置上的内螺纹啮合。薄片502可以包括内螺纹415，以便于将一个闭合机构推进到骨锚组件上。通过过分拉紧经皮进入装置350可以切断薄片502而使其离开骨锚组件500，或者在用合适的器械退出经皮进入装置350后可从骨锚组件500上移去薄片502。
图19A～19D例示经皮进入装置550和骨锚组件600的一个替代实施例，其中经皮进入装置500和骨锚组件600用一个或多个内线551可脱开地相互连接。在该例示的示范实施例中，例如，一对线551通过外管552的对置侧壁沿轴向延伸。每根线通过设置在外管552的侧壁中的平行的轴向孔而延伸。每根线551可形成一个能啮合骨锚组件的装入部件608的环553。这些线可以用任何合适的生物兼容材料制成，包括(例如)金属如不锈钢或聚合物。在该示范实施例中，装入部件608包括两对用于装入线551的沿轴向延伸的孔611。每对孔611可以终止于一个取向垂直于孔611的槽613中。外管和装入部件中设置的线和孔的数目可以随用途而变化。每根线551可以被拉紧而将经皮进入装置550联接在骨锚组件上。线551可以通过(例如)从远处抽回线551而被拉紧。通过(例如)割断线551或从近处推进线551而松开对线551的拉紧，可以使经皮进入装置550从骨锚组件600上松开。在例示的示范实施例中，经皮进入装置550包括一个单独的管，外管552；可以提供一根内管，但并非必须。
图20A～20D例示经皮进入装置650和骨锚组件700的替代实施例，其中经皮进入装置650和骨锚组件700用一根或多根外置的线551而可以脱开地相互连接。在例示的示范实施例中，线551沿轴向沿经皮进入装置650的外管652的外表面延伸和沿轴向沿骨锚组件700的装入部件708的外表面延伸。外管652可以包括一个或多个沿轴向取向的槽653，槽中可以安置线551。同样，装入部件708可以包括一个或多个槽707，槽中可以安置线651。线和/或槽的数目可以根据具体用途而变化。在该例示的实施例中，例如，一对平行的槽653设置在外管652的对置侧壁中，而一对平行的槽707设置在装入部件708的对置支脚724A、724B中。每根线551可以被拉紧而将经皮进入装置650联接在骨锚组件700上。线551可以通过(例如)从远处抽回线551而被拉紧。通过(例如)割断线551或从近处推进线551而松开对线551的拉紧。可以使经皮进入装置650从骨锚组件700上松开。在例示的示范实施例中，经皮进入装置650包括一个单独的管，外管652；可以提供一根内管，但并非必须。
图21例示骨锚组件800的一个替代实施例，组件800有一个或多个可以移出的薄片801，用于与一个器械如上述经皮进入装置的一个实施例可以脱开地啮合。在该例示的示范实施例中，一对对置的薄片801A、801B从骨锚组件800的装入部件808的近端附近伸出。在该例示的示范实施例中，每个薄片801A、801B为大体上弧形并安置成靠近装入部件808的相应支脚824A、824B并从其伸出。薄片801的尺寸、形状和数目可以变化而并不偏离本发明的范围。薄片801可以包括一个机构，用于便于用一器械可脱开地啮合。例如，薄片可以设有外螺纹，像上述图17A、17B中例示的实施例的情况中一样，或者可以包括一个或多个槽。在该例示的示范实施例中，每个薄片801A、801B包括一个或多个在构造上可与上述槽130A、130B类似的弧形槽830A、830B。薄片801可包括内螺纹815，以便于将一个闭合机构推进到该骨锚组件上。通过该经皮进入装置或器械可以切断薄片801而使其离开骨锚组件800，或者在用合适的器械退出该经皮进入装置或器械后可从骨锚组件800上移去薄片801。
图22A～22B例示经皮进入装置850的一个示范实施例，装置850有一个或多个设置在该经皮进入装置的外管852中的一个或多个沿轴向延伸的切口853。如图22B中所示，一个沿轴向延伸的切口853可以由于尽可能减小装置之间的干扰而便于使用多个经皮进入装置。例如，在某些脊柱用途中，安置在相邻的椎骨上的骨锚可能以导致器械之间干扰的方式密切地相隔安置和/或成角度安置，这些器械例如是与相邻的骨锚同时使用的此处公开的经皮进入装置。通过提供沿轴向的切口853，通过对准切口853A、853B，可以在相邻的骨锚或紧密安置的骨锚上利用两个或多个经皮进入装置850A、850B。切口852的长度和深度可以根据用途而变化。一个或多个切口可以设置在此处描述的经皮进入装置的任何示范实施例中，或带有与骨锚一起使用的其它器械，如钻、驱动器、插管等等。在包括一根内管或其它管子的器械中，其它管子也可以设有切口853。
图23A～23B例示经皮进入装置950和骨锚组件900的一个替代实施例，其中经皮进入装置950的内管954的远端956包括一个或多个可以弯曲的骨锚啮合片958，用于与骨锚组件900的装入部件908可以脱开地啮合。在该示范的实施例中，一对对置的薄片958A、58B从内管954的远端956向远处伸出。在该例示的示范实施例中，每个薄片958在近端处连接到内管954上并有一自由远端960。一个或两个薄片958能从一第一位置弯曲到一第二位置，在该第一位置中薄片958近似地沿轴向取向，例如平行于内管954的纵轴线，而在第二位置中薄片958的取向大体上与内管954的纵轴线成一角度。在该示范的实施例中，例如，每个薄片958A、958B可以从其中薄片958A、958B近似平行的第一位置沿径向向外(例如，互相离开地)弯曲到一个其中薄片958A、958B互相成一角度地取向的第二弯曲的位置，薄片958可以被偏压到第一位置。例如，薄片958A、958B可以被偏压到第一平行位置，使得薄片958A、958B对装入部件908提供一个沿径向压紧的力而可以脱开地啮合装入部件908。一个或多个薄片958可以设有一个凸出部之类，用以啮合可以设置在装入部件908的外表面中的一个孔、槽等。虽然该示范的实施例包括两个薄片958A、958B，但也可以设置任何数目(一个或多个)薄片958。
经皮进入装置950可以包括一个外管952，当薄片958可以脱开地啮合装入部件908时，外管952可以围绕薄片958而前进。例如，在该例示的示范实施例中，当这些薄片处在第二弯曲的位置中时，外管952可以围绕薄片958A、958B而从远处前进，以便阻止薄片958A、958B分开和/或在薄片上提供一个沿径向压紧的力。
此处描述的骨头固定板的应用的不起限制作用的例子包括长骨头骨折的固定/稳定、小骨头稳定、腰脊柱以及胸脊柱的稳定/融合、颈脊柱压紧/固定和头颅骨骨折/重建骨折镶片法。
虽然已参照其示范实施例特定地表示了本发明的经皮进入系统和骨锚组件，但该技术的普通专业人员将理解，可以在此处的形式和细节中进行各种变化而并不偏离本发明的范围和精神。该技术的普通专业人员将认识到或能够利用不超过常规的实验方法来对此处特定地描述的示范实施例确定许多等同方案。这些等同方案预期均包括在本发明和所附权利要求书的范围内。

Claims (18)

1.一种经皮进入装置，包括：
一根有一近端、一远端和一在该近端和远端之间延伸的腔的内管，该内管有一个在其中形成的第一槽，该第一槽在该内管的远端处开口并向该内管的近端延伸一第一槽长度；以及
一根设置在该内管的至少一部分的周围的外管，该外管有一近端、一远端和一在该近端和远端之间延伸的腔，该外管的尺寸做成从病人体上的至少一个皮肤切口跨越到一个靠近病人的脊柱的预定部位，该外管有一个在其中形成的第二槽，该第二槽在该外管的远端处开口并向该外管的近端延伸一第二槽长度，该外管的远端适合于可脱开地啮合一个骨锚，该内管可以相对于外管沿外管的纵轴线在一第一位置和一第二位置之间调整，在该第二位置中该内管的远端接触该骨锚。
2.权利要求1的经皮进入装置，其特征在于，该内管的腔有一个接近该内管远端的内径，它大于或等于一个在该骨锚的装入部分中形成的孔的内径。
3.权利要求1的经皮进入装置，其特征在于，该外管有一个接近其远端的外径，它小于或等于该骨锚装入部分的外径。
4.权利要求1的经皮进入装置，其特征在于，该内管和外管是共轴线的。
5.权利要求1的经皮进入装置，其特征在于，该第一槽与第二槽对准。
6.权利要求1的经皮进入装置，其特征在于，该第一槽长度被做成在皮肤切口的外部可以进入。
7.权利要求1的经皮进入装置，其特征在于，该第一槽和第二槽各自的宽度近似地等于在该骨锚的装入部件中形成的凹部的宽度。
8.权利要求1的经皮进入装置，其特征在于，该外管的远端包括一对对置的薄片，每个薄片有一沿径向向内的凸出部，其尺寸和形状能安置在骨锚的装入部件中形成的一条槽内。
9.权利要求8的经皮进入装置，其特征在于，每个薄片的宽度小于或等于在该锚的装入部件中形成的一条槽的宽度。
10.权利要求1的经皮进入装置，其特征在于，该内管的远端限定多个接触表面，当该内管处在第二位置中时，每个接触表面接触该骨锚的装入部件的一个邻近表面。
11.权利要求10的经皮进入装置，其特征在于，一个延伸部自至少一个接触表面沿轴向伸出，当该内管处在该第二位置时，该延伸部啮合该骨锚而阻止该内管相对于该骨锚转动。
12.一种经皮进入装置，包括：
一根有一近端、一远端和一在该近端和远端之间延伸的腔的内管，该内管有一个在其中的第一槽，该第一槽在内管的远端处有一孔，并向该内管的近端延伸一第一槽长度；以及
一根在该内管的至少一部分内管周围成共轴地设置的外管，该外管有一近端、一远端和一在该近端和远端之间延伸的腔，该外管的尺寸做成从病人体上的至少一个皮肤切口跨越到一个靠近病人的脊柱的预定部位，该外管的远端适合于可脱开地啮合一个骨锚，该外管有一个接近其远端的外径，它小于或等于该骨锚装入部分的外径，该外管有一个在其中形成而与该第一槽对准的第二槽，该第二槽在该外管的远端处有一孔，并向该外管的近端延伸一第二槽长度，该内管可沿该外管的纵向轴线移动。
13.权利要求12的经皮进入装置，其特征在于，该内管可在一第一位置和一第二位置之间移动，在该第二位置中该内管的远端接触该骨锚。
14.权利要求12的经皮进入装置，其特征在于，该第一槽长度和第二槽长度大致相等。
15.权利要求12的经皮进入装置，其特征在于，该第一和第二槽的长度被选定为自病人身上的至少一个皮肤切口分别跨越到该内管和外管的近端。
16.一种医疗装置，包括：
一种经皮进入装置，包括：
一根有一近端、一远端和一在该近端和远端之间延伸的腔的内管，该内管有一个在其中形成的第一槽，该第一槽在该内管的远端有一孔并向该内管的近端延伸；以及
一根在该内管的至少一部分的周围共轴地设置的外管，该外管有一近端、一远端和一在该近端和远端之间延伸的腔，该外管的尺寸做成从病人体上的至少一个皮肤切口跨越到一个靠近病人的脊柱的预定部位，该外管有一个在其中形成与该第一槽对准的第二槽，该第二槽在该外管的远端处有一孔并向该外管的近端延伸；
一种骨锚组件，包括：
一个有一近端头部和一远端骨头啮合部分的骨锚；以及
一个装入部件，该装入部件有带有第一孔的一近端、一与近端对置且带有一个第二孔的远端，和一用于装入一个脊柱固定元件并与该第一孔连通的凹部，该第二孔的尺寸能装入该骨锚的头部，
其中该外管的远端适合于可以脱开地啮合该装入部件，且当该外管的远端可以脱开地啮合该装入部件时，该第一和第二槽与装入部件中的弧形槽对准。
17.权利要求16的医疗装置，其特征在于，该装入部件有一个由两个被该凹部隔开的支脚限定的基本上U形截面，每个支脚在该装入部件的近端处是自由的。
18.权利要求17的医疗装置，其特征在于，一个第一弧形槽形成于第一支脚的近端的外表面上，而一个第二弧形槽形成于第二支脚的近端的外表面上，该外管的远端构造成可以脱开地啮合所述第一和第二弧形槽。
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EP2292168A2 (en) 2011-03-09
KR20070092927A (ko) 2007-09-14
US20180085146A1 (en) 2018-03-29
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US20190216506A1 (en) 2019-07-18
US9439699B2 (en) 2016-09-13
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DE202004021977U1 (de) 2014-10-15
US20170156761A1 (en) 2017-06-08
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US20180235665A1 (en) 2018-08-23
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US10299839B2 (en) 2019-05-28
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US20050131408A1 (en) 2005-06-16
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US7179261B2 (en) 2007-02-20
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US20110060374A1 (en) 2011-03-10
EP2292168B1 (en) 2014-11-19
EP2826431A3 (en) 2015-05-06
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US20190117267A1 (en) 2019-04-25
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US8617210B2 (en) 2013-12-31
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