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CN101272743B - 使用多轴式板的系统 - Google Patents

使用多轴式板的系统 Download PDF

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CN101272743B
CN101272743B CN200680034340XA CN200680034340A CN101272743B CN 101272743 B CN101272743 B CN 101272743B CN 200680034340X A CN200680034340X A CN 200680034340XA CN 200680034340 A CN200680034340 A CN 200680034340A CN 101272743 B CN101272743 B CN 101272743B
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G·E·奥斯丁
J·A·哈蒙
S·W·詹纳
J·K·赖因斯
J·B·施奈德
T·J·佩蒂斯
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
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Abstract

本发明的实施例提供一种骨骼固定组件(10)，其可提供多轴式固定。该多轴式固定可通过从骨板(12)中的开口(18)突出的鳍状部(24)或从紧固件头部(104)突出的鳍状部(110)提供。

Description

使用多轴式板的系统 
本申请要求享有在2005年7月25日提出申请的名称为“锁定螺钉(Locking Screw)”的美国临时申请第60/702,231号的权益，其全部内容通过引用结合到本文中。 
技术领域
本发明大体而言涉及用于骨折固定的矫形外科固定装置和接骨板系统，且特别地涉及使用骨板的系统与方法，该骨板提供了紧固件的多轴式固定。 
背景技术
常常通过越过骨折紧固骨板来修复骨折。取决于将要被治疗的骨骼，骨板可能是直的或弯曲的，以匹配它被设计用于的骨骼轮廓。骨板还可能以许多形状和大小来提供。在骨骼严重粉碎的情况下或者在骨段缺失的情况下，骨板与螺钉系统的使用通过在骨骼与板之间提供刚性固定或支承结构促进了骨折愈合。 
可以多种方式将骨板紧固到骨骼上。现有解决方案是一种板与螺钉系统，其中螺钉被锁定于板中。使骨钉穿过板中的开口并且到骨骼内。然后，经由螺钉头部中的螺纹将螺钉紧固到骨板上，在螺钉头部中的螺纹与骨板中的螺纹开口合作。这相对于骨骼紧固该板并且提供刚性固定，这是因为板与螺钉之间的关系是固定的。因为锁定螺钉的头部与该板中的螺纹相互交错接合，所以该板与螺钉形成一个稳定的系统，而且骨折的稳定性可取决于该构造的硬度。将螺钉锁定到板内可实现角度与轴向稳定性，并排除了螺钉套挂(toggle)、滑动或拉出(dislodge)的可能性，从而减小了术后复位丢失(loss of reduction)的风险。 
然而，尽管可能减小松动的发生率，但它们只提供板与螺钉之间的一个固定的角度关系。它们具有受限制的插入角，这是因为头部的螺纹与孔中的螺纹只是单向配合。该螺钉的纵向轴线与该孔的中心轴线共线并且不允许有角度变化。简而言之，锁定螺钉是单向的，这限制了它们在某些情形下的使用。 
举例说来，当治疗严重骨折时，碎片可能是散碎的并且处于不规则的局面。尽管外科医生可能希望获得锁定螺钉与骨板一起使用的益处，但锁定螺钉在特定开口从该板延伸的角度可能不是允许外科医生“抓住”(或卡住，或以其它方式紧固)所希望的无规骨碎片的角度。在这种情况下，外科医生可能需要将该板紧固到骨骼的其它部位上或者使用非锁定螺钉。尽管非锁定螺钉并不锁定到该板内，但它们可能以各种角度插入。 
具体说来，非锁定螺钉以与锁定螺钉相同的方式紧固到骨骼内，但它们并不被紧固到板上。它们的头部通常是圆的，它们在头部与骨板接触。因此，非锁定螺钉的一个优势在于它们能够以各种角度插入，因为它们并不受到锁定螺钉与骨板的螺纹至螺纹接触的限制。然而，如果外科医生希望锁定螺钉与板的刚性稳定构造，那么使用非锁定螺钉来获得所希望的角定向未必是最佳的。 
已经开发了接骨板系统，它们向外科医生提供了选择非锁定螺钉或锁定螺钉的选择自由。在某些实施例中，这些系统提供带有某些螺纹孔(其可接纳锁定螺钉或非锁定螺钉)和某些非螺纹孔(用于非锁定螺钉)的板。还存在某些系统，其提供部分带螺纹的槽，以允许非锁定螺钉或锁定螺钉一起使用。这种组合槽向外科医生提供了关于使用板与锁定螺钉、非锁定螺钉还是二者的组合的术中选择。这些组合槽通常具有部分地带螺纹的开口，其可接纳压紧螺钉或锁定螺钉。然而，因为这些组合槽仅部分带螺纹，因此在生理负荷下锁定螺钉可能不能够维持螺钉与板之间的固定角度关系。具体说来，在该板内的锁定螺钉仅部分地被俘获并且因此仅部分地被螺纹包围。在高应力与负荷状 态下，该槽可能会扭曲并允许锁定螺钉与板之间的固定角度关系改变。这可导致固定丢失或所形成的术中板定向丢失。而且，锁定螺钉仍然只能以单一角度(由制造商所限定的预定角度)插入。 
另外，当前骨板与螺钉系统仍然限制外科医生(a)相对于骨板锁定紧固件，但仍然(b)允许紧固件以各种角度从骨板延伸的能力。锁定螺钉锁定到板内，但仅处于单一角度配置，而且非锁定螺钉允许各种角度配置，但它们并不提供与板的稳定构造。因此，这些选择自由均不允许外科医生俘获不与以刚性方式提供到该板上的开口的轴线共线的骨碎片。这种问题的示例在图21中示出。因此，目前可提供的选择自由仍然可能会导致不对准和不良的临床效果。 
然而，已做出一些尝试来提供多轴锁定系统。举例说来，一个努力成果包括提供接受固定角锁定栓和多方向锁定栓的孔，其具有插入到多方向栓上的螺帽来将它夹持到适当位置。这种系统在使用上可能较为麻烦，这是因为：尽管多方向栓能够以任何角度插入，但是然后外科医生需要将较小的帽拧到到栓头部的顶部上并到该板内，这需要额外的步骤、额外的时间和额外的仪器使用。这种系统也未能允许结合锁定与多方向栓使用非锁定构件。 
曾尝试提供多轴式固定的其它系统包括在孔外围向骨板提供由可变形材料制成的嵌入物，该板的其余部分由钛制成。制造该板且然后将嵌入物推入到孔外围内并且通过变形与压力而接合在适当位置。当插入螺钉时，嵌入物在该板的孔的边缘之间变形并压缩，这将螺钉与嵌入物夹持在适当位置。这种系统所存在的挑战在于它们不可用于非锁定螺钉，嵌入物并不具有接纳并夹持常规锁定螺钉的强度(即，它们并不向外科医生提供选择自由)，且带有可变形嵌入物的板在制造上比常规骨板更昂贵。其它尝试也未能提供适当的锁定机制。 
关于多轴式固定的另一尝试包括带有孔的板，这些孔具有内夹套，内夹套具有远离孔的轴线延伸或延伸到内夹套表面内的凹部。这个尝试在名称为“骨板(Bone Plate)”的国际申请WO 2005/018472中 介绍。在该申请中所介绍的板的内夹套表面是带螺纹的或者具有肋状件或突起。通过内夹套表面将骨钉拉入到该板的孔内。如果该骨钉头部带螺纹，那么当该螺钉倾斜时，该螺纹头部会“跳过”在该板的孔中被凹部中断的螺距，而不是“穿越”它们。该发明的目的在于提供一种骨板，它可使骨钉以与该孔的指定轴线不同的角度引入并且被紧固到适当位置。 
然而，这个尝试的解决方案所遭遇的一些问题在于：(1)在骨板中的螺纹开口通常需要该板具有特定厚度，并且因此使得它们并不适用于薄板；(2)与骨板中的非螺纹开口相比，螺纹开口在制造上可能比较困难并且更昂贵，以及(3)螺纹开口在使用中可能需要更多的功夫，因为外科医生需要适当的对准才能使用。而且，该申请的螺纹是较短的，因为它们被凹部中断，因此紧固件将很可能实际上并不“抓住”螺纹以得到良好的接合。 
因此，仍存在对于改进的接骨板系统的需要，该改进的接骨板系统克服现有技术的缺陷。需要一种使用紧固件来提供骨骼与骨板之间的稳定连接的系统，其在该紧固件锁定到骨板内时允许在该骨板与该紧固件之间获得不同角度。这将允许外科医生俘获处于不规则局面的无规骨碎片，例如，在产生非常零碎的骨碎片的严重骨折的情况下。在这些和其它情况下，最好提供一种紧固件与板系统，其允许外科医生选择特定角度将螺钉穿过该板的开口的插入，并且刚性地附加到该板的开口中。 
这种改进将允许外科医生朝向骨碎片引导紧固件，这些骨碎片不一定位于板中开口的直接下方。还将提供相对于骨折放置该板的灵活性。允许外科医生选择将紧固件插入到该板内的角度将得到该系统对于将要被治疗的骨折的特定性质的更好的适应。还将允许外科医生在接近手术部位之后但将紧固件插入到骨骼材料内之前根据需要来调整他们的策略。另外，在需要在同轴或多轴方向将紧固件插入到板内的情形下，本文所介绍的实施例将提供这样的紧固装配。 
发明内容
本发明的实施例涉及一种骨骼固定组件，其可提供多轴式固定。该多轴式固定可通过在骨板的开口中突出的鳍状部或从紧固件头部突出的鳍状部提供。例如，根据本发明的一个方面，可提供一种多轴式骨骼固定组件，包括： 
(a)骨板，其包括下表面、上表面和从该下表面延伸到该上表面的至少一个开口； 
(b)紧固件，其可穿过该开口插入；以及 
(c)在该开口与该紧固件之间合作的至少一个构件，包括位于该开口内或该紧固件上的多个突出鳍状部。 
在具体方面或实施例中，该开口具有非螺纹内表面且其中鳍状部位于该内表面上。 
另外的实施例具有鳍状部，这些鳍状部是一系列凹入地缩进的(concavely indented)、向内突出的鳍状部，其适合以变化的角度来将紧固件的螺纹头部紧固到适当位置。 
根据另一实施例，该开口还被在上表面的圆形周边和在下表面的突出鳍状部所形成的锯齿状周边限定。 
根据另一实施例，突出鳍状部形成内表面的凹入部分。 
根据又一实施例，突出鳍状部具有基部，基部基本上在同一平面中与内表面会合。 
根据另一实施例，该紧固件具有螺纹头部，该螺纹头部适合与突起鳍状部接合。 
另一实施例提供鳍状部，其形状为渐缩形、直形、矩形或三角形。 
另一实施例提供一种骨板，该骨板具有位于头部的开口。 
在另一具体方面或实施例中，该紧固件具有带鳍状部的头部，其中鳍状部适合与骨板中的螺纹合作。 
根据另一实施例，鳍状部以多于一个层提供。 
另一实施例提供在骨板中带一个或多个矩形螺纹的开口。 
在另一实施例中，鳍状部为梯形、圆形、椭圆形、矩形、弯曲的、偏菱形、菱形或三角形。鳍状部还可具有向内、向外逐渐变细或彼此大约平行的鳍状部边缘。 
根据另一实施例，骨板适合与股骨、胫骨远端、胫骨近端、肱骨近端、肱骨远端、锁骨、腓骨、尺骨、桡骨、足骨或手骨接触。 
另外的实施例具有带有下列特征中的一个或多个特征的骨板： 
(a)仿形的(contoured)、直的或平的； 
(b)轮廓与特定骨骼表面相匹配的头部部分； 
(c)展开形成L形、T形或Y形的头部；以及 
(d)它们的任何组合。 
其它实施例提供带有下列开口中的一个或多个开口的骨板： 
(a)螺纹开口； 
(b)非螺纹开口； 
(c)适合接纳锁定紧固件或非锁定紧固件的开口； 
(d)组合槽；或 
(e)它们的任何组合。 
本发明的其它方面还提供使用多轴式固定将骨板紧固到骨骼上的方法。举例说来，一个方面提供了使用多轴式固定将骨板紧固到骨骼上的方法，包括： 
(a)提供骨板，该骨板包括下表面、上表面和从该下表面延伸到该上表面的至少一个开口，该开口具有非螺纹内表面，其中一个或多个突出鳍状部位于该内表面上； 
(b)提供紧固件，其具有轴杆与头部，该头部具有至少一组螺纹，这些螺纹适合与突出鳍状部合作； 
(c)将该紧固件插入到该骨板的该开口内并且允许该至少一组螺纹与该板的鳍状部接合；以及 
(d)将该骨板紧固到骨骼上。 
另一方面提供使用多轴式固定将骨板紧固到骨骼上的方法，包 括： 
(a)提供骨板，其包括下表面、上表面和从该下表面延伸到该上表面的至少一个开口；该开口具有一个或多个螺纹； 
(b)提供紧固件，其具有轴杆与头部，该头部具有至少一组鳍状部，这些鳍状部适合与该板的螺纹合作； 
(c)将该紧固件插入到该骨板的该开口内并且允许该或该等螺纹与该紧固件头部的鳍状部接合；以及 
(d)将该骨板紧固到骨骼上。 
上述方面的实施例包括使用多轴式固定来将骨碎片拉成对准状态。 
另一实施例包括将锁定螺钉或非锁定螺钉插入到骨板内。 
本文所用的“实施例”可被认为指本发明的方面或目的，反之亦然。 
附图说明
图1示出根据本发明的一个实施例的具有鳍状部的骨板的透视图，其带有插入其内的紧固件。 
图2示出根据本发明的一个实施例的在骨板中的开口的顶部透视图。 
图3示出具有多个开口的骨板的顶视图，其带有插入其内的紧固件。 
图4示出图3的骨板的下面的视图。 
图5示出带有插入到其内的紧固件的骨板的侧部透视图，其示出该板接纳紧固件可成的多个角度中的几个角度。 
图6示出用于本文所介绍的各种骨板的紧固件的示例。 
图7示出在骨板中的开口的备选实施例的顶部平面图。 
图8示出图7的骨板的透视图。 
图9示出在骨板中开口的另一实施例的顶部平面图。 
图10示出图9的骨板的透视图。 
图11至图15示出可用于本发明的各种实施例的骨板的备选形状与类型。 
图16示出备选实施例的截面图，其具有处于骨板中适当位置的带鳍状部的紧固件。 
图17示出根据本发明的一个实施例的具有带鳍状部的头部的紧固件的侧部透视图。 
图18示出图17的紧固件的顶部透视图。 
图19示出可用于接纳图17与图18的紧固件的骨板的顶部透视图。 
图20示出图19的板的螺纹的截面图。 
图21示出可利用本发明的各种实施例进行治疗的骨折的示例。 
具体实施方式
本发明的实施例提供一种骨骼固定组件，该骨骼固定组件能够以多个角度接受并固定紧固件。骨骼固定组件10的具体实施例在图1中被示为骨板12与紧固件80。如在图2至图4中更详细示出的那样，骨板12具有下表面14与上表面16以及从该下表面14延伸到该上表面16的一个或多个开口18。 
本文所介绍的实施例可结合任何类型的骨板使用，骨板的非限制性示例在图11至图15中示出。板12可适合与股骨、胫骨远端、胫骨近端、肱骨近端、肱骨远端、锁骨、腓骨、尺骨、桡骨、足骨或手骨中的一种或多种接触。骨板可以是弯曲的、仿形的、直的或平的。它可能是包围关节的板或直板。在图11中示出直板的示例。板可具有轮廓与特定骨骼表面(诸如干骺端或骨干)相匹配的头部部分，该头部部分从轴杆部分展开与轴杆部分形成L形、T形、Y形，或者形成任何其它适当的形状来装配将要被治疗的骨骼。T形板的示例在图12至图15中示出，在这些附图中的板上的开口在下文中更详细地介绍。 
骨板12可包括钛、不锈钢、钴铬合金、塑料(诸如，聚醚醚酮(PEEK)、聚乙烯、超高分子量聚乙烯(UHMWPE))，或碳复合材料(可再吸收的聚乳酸(PLA)、聚乙醇酸(PGA))、这些材料的组合或合金，或具有足够的强度来紧固到骨骼上或夹持骨骼同时还具有充分生物相容性以植入到体内的任何其它适当材料。虽然上述材料列表包括制造骨板的许多典型材料，但应了解的是，由任何适当材料组成的骨板均在本发明的范围内。 
板12的开口18被显示具有中心轴线20而且它适合接纳紧固件。该紧固件可以是任何典型、标准锁定紧固件或非锁定紧固件，但本文所介绍的实施例将特别地使用锁定紧固件，这些锁定紧固件在它们的头部上具有一系列螺纹。图5至图6示出根据本发明的实施例可能使用的紧固件80的示例。如图6具体示出，紧固件80具有轴杆82和头部84。轴杆82可通过螺纹或者被另外构造成与骨骼接合。它可能是完全螺纹，部分螺纹，包括螺旋叶片和/或可能包括一个或多个平头钉(tack)、开展开的爪状件、扩展元件等等。允许轴杆82与骨骼接合的任何结构都被认为在本发明的范围内并且为了方便起见可被统称作“螺纹轴杆”。然而，轴杆82也可能没有螺纹，使得紧固件80采取栓或销的形式。这个备选实施例在特定过程中可能是优选的，例如，在其中主要目的在于防止骨段倾斜的过程中，或者，在其中不用考虑紧固件80从骨骼中拉出并且因此不需要轴杆82通过螺纹或另外被构造成与骨骼接合的过程中。为了参考起见，轴杆82还被显示具有纵向轴线86。轴杆82的端部可能是自攻顶端或自钻顶端，如图5中更详细地显示的那样。 
紧固件80的头部84优选地具有至少一组螺纹88。螺纹88通常为任何标准型螺纹。举例说来，螺纹88可能是连续脊或非连续脊。它可包括螺旋的一部分、一个完整的螺旋、多个螺旋、单个导程或多个导程或在本领域已知的任何其它螺纹。另外或选择性地，紧固件80的头部84可包括任何其它表面，该表面将与板的特定结构接合并支 承于板的特定结构内(在下文中进一步介绍)。举例说来，头部84可具有一系列的凹痕、脊、凸点、织构化区域或可如本文所介绍可使紧固件80紧固的任何其它表面。如将在下文中更详细地介绍的那样，头部的螺纹88适合与开口18的鳍状部24接合、与鳍状部24相关联或另外鳍状部24合作。简而言之，任何类型的螺纹紧固件头部均用于本发明的各种实施例。 
现参看图2，可见所示实施例具有开口18，该开口18具有内表面22，该内表面22被一系列凹入地缩进的、向内突出的鳍状部24限定。鳍状部24朝向中心轴线20延伸到开口18内。鳍状部24的基部26在或靠近上表面16的圆形周边30形成凹入部分28。(用语“圆形”周边用于指任何圆形状，诸如正圆形、椭圆形、卵形周边或形状适合接纳紧固件80的头部的任何其它开口)。鳍状部24的基部26可能全部基本上在同一平面中会合且然后以类似的角度或斜率向下并向内成角度。 
值得注意的是，凹入部分28是平滑的而且是非螺纹的。实际上，在凹入部分28上或在开口18的内表面22上的任何地方都没有任何螺纹。不带有螺纹有助于简化板12的制造并且允许根据需要将板制造得较薄。 
举例说来，板12的厚度与鳍状部24的尺寸通常取决于紧固件80的螺距和螺纹。举例说来，与较小板(例如，用于较小骨骼上)相比，与较大紧固件一起使用的较大板12(例如，用于股骨上)将很可能具有更大且更厚的鳍状部。在具体实施例中，鳍状部24特别薄，使得它们可向上或向下移动并且在压力下变形。在某些实施例中，可能朝向板开口的边缘按压鳍状部。鳍状部的厚度的非限制性示范性范围可能是从大约0.5mm到大约5mm，但也可能具有更大或更小的大小。理论上，鳍状部24将装配于紧固件80的螺纹结构的卷曲牙(crimp)之间，如图1所示。 
提供非螺纹内表面22还允许紧固件80以任何所希望的角度插入 到开口18内，因为并不存在任何螺纹妨碍所希望的角度，如图5所示。鳍状部24会略微弯曲或变形，以便将紧固件80紧固定到开口18中的适当位置。鳍状部24实际上接合紧固件10的螺纹88或其它表面。 
现再次参看图2，在所示实施例中，随着鳍状部24朝向中心轴线20延伸，它们逐渐变细以形成渐缩形侧部32。鳍状部止于圆形顶端34，但顶端34也可能是尖的、正方形、矩形或任何其它适当配置。例如，如图7与图8所示，鳍状部24可具有直边缘或侧部42和直的端部44。这个实施例显示了部分为矩形的鳍状部24。在鳍状部24之间的开口46是狭缝形。 
在图9和图10中示出备选实施例，其示出具有更接近三角形状的鳍状部24。在这个实施例中，鳍状部24被显示具有向内逐渐变细的侧部52和平且小的边缘54，这形成尖区56，侧部52在尖区56结束。在鳍状部24之间的开口58比开口46更加细长。在这些备选实施例中的两组开口46、58被显示具有圆背部60，在此它们与开口18的内表面22会合。然而，应了解的是，这些只是鳍状部24形状与开口46、58的示例，且任何适当形状是可能的并且被认为在本发明的范围内。非限制性示例包括梯形、正方形、圆形、正圆形、三角形(具有尖端作为尖区56的替代)和任何其它可能的选择。 
如图4所示，由于鳍状部24形成下表面14的一部分，在板12的下表面或下面的表面14处的第二周边36可能比在上表面16处的圆形周边30更加呈锯齿状。该周边可呈现为差不多“花朵状”，每个鳍状部24呈现为形成该周边的花瓣。或者，对于图7至图10的实施例，第二周边将呈现为与鳍状部24所形成的形状类似。 
尽管附图示出开口18具有大约五个到八个鳍状部24，但应了解任何数目的鳍状部24均被视作在本发明的范围内。举例说来，取决于开口18预期要用于的板，可能存在两个或三个鳍状部，或者十个或二十个鳍状部24。 
鳍状部24的主要目的在于夹住螺纹头部紧固件的一个或多个螺纹88，以便将紧固件以任何角度紧固在骨板12中的适当位置。举例说来，与螺纹开口(其与紧固件的头部螺纹只是单向接合，这限制了外科医生根据需要使紧固件成角度的能力)相反，这个实施例的鳍状部24仍将紧固件的头部螺纹紧固到适当位置，但是能够成任何角度。随着紧固件被插入，它的螺纹开始与鳍状部24接合，如图1所示。如上文所讨论的那样，鳍状部24可能非常薄，使得在头部螺纹88开始抓住鳍状部24时，鳍状部24可能酌情向上或向下移动来接合螺纹88并紧固该紧固件88。简而言之，螺纹88接合鳍状部24(或装配于鳍状部24之间)。在大多数情况下，鳍状部24的这种移动是永久变形，使得鳍状部不会弹回(flex back)并允许紧固件脱出(work its way out)。 
如上文所讨论的那样，带鳍状部的开口18可设于所有类型的骨板上，这些骨板的示例在图11至图15中示出。图11示出带鳍状部24的开口18(被称作带鳍状部的开口18)，平滑开口60、螺纹开口62和临时销开口64的具体示例。其它选择为可与螺纹紧固件或非螺纹紧固件以及组合槽一起使用的孔。应了解这些各种类型的开口可以任何组合或以任何大小在任何类型的骨板上使用，它们的示例在图12至图15中示出。图12示出在骨板12的头部70中的多个带鳍状部的开口18。这可能帮助实现断裂骨骼的更好的固定，因为紧固件可以多种角度插入以俘获在骨折期间从骨骼分裂开的“脱离的”或无规的骨碎片，但仍将骨碎片紧固到板上。举例说来，如果腕骨破裂，将会存在可能在各个方向散碎的多个碎片。在本文中所介绍的带鳍状部的开口18的板12可用于以各种角度来放置紧固件8，以便俘获只使用锁定紧固件或非锁定紧固件原本不能紧固到骨板上的脱离的碎片。另外还应了解的是，其它类型的开口(除了带鳍状部的开口18或作为带鳍状部的开口18的替代)可存在于头部70中，以及板12的其它地方。 
如先前所提到的，紧固件80可以是由任何适当材料制成的任何典型紧固件。它将通常具有用于接纳起子的孔口，以便将紧固件紧固 到骨骼内并且到板12内。接纳孔口可以具有任何大小与形状，例如，它可具有六边形的配置来接纳相应的六边形起子、十字槽头螺钉头、平头、星形配置、圆头鱼尾(Torx)或可与起子合作来放置紧固件的任何其它适当配置。 
现在来介绍植入方法，外科医生接近相关手术部位，该部位可能是骨折所位于的内部部位，其需要被稳定以确保适当愈合。可利用常规钳状骨针与导子(guide)(这对于本领域技术人员是已知的)减轻骨折并且将具有适当大小与形状的骨板放置到骨折部位上。在某些情形中，可能使用临时固定销来将骨板暂时紧固到骨骼上。在图11与图12所示的骨板中，可穿过该板中的临时销开口或任何其它开口(螺纹或非螺纹或带鳍状部)来使用临时固定销。在穿过骨板放置固定螺钉之前，临时固定提供将骨板到骨骼上的暂时紧固，以便在放置骨钉以将骨板永久固定到骨骼上之前能够确信骨板被适当地定位。而且，利用临时固定，可在视场中没有过多仪器的情况下对骨板/构造进行X射线检查。 
一旦将骨板12紧固到相对于骨折的所希望位点(通常使用一个或多个临时固定销，但也可使用任何其它适当方法)，然后，外科医生确定插入角或方向，该紧固件80沿着该方向穿过选定开口80插入并且被打入到骨骼材料内。如果骨板12包括多于一个开口(如图所示)，那么外科医生还要选择将要使用的特定开口。在选择所希望的插入角与开口之后，外科医生穿过开口18插入轴杆紧固件80直到顶端接触骨骼材料。在某些情况下，可需要沿着插入角在骨骼内钻出或攻出孔，以便于紧固件80的初始攻螺纹或插入。然后，外科医生使用适当的推进工具(driving tool)在头部84的接纳孔口中操控紧固件80到适当位置。 
因为紧固件10的插入角度可能不与开口18的中心轴线20对准，如图5所示，所以紧固件80可用于抓住或紧固不符合锁定螺钉通常被插入的传统角度的骨碎片。外科医生可能需要套挂或操纵该紧固件 80以便紧固移位的骨碎片或者向里拉移位的骨碎片。 
一旦紧固了骨碎片，紧固件80便准备好被紧固到板12上。随着紧固件80被进一步打入到骨骼内，它还被进一步拉入到板12内。紧固件头部84的螺纹88开始接触鳍状部24，允许鳍状部在螺纹内接合来以所希望的角度将紧固件80夹持在适当位置，即使成不符合中心轴线20的角度。在鳍状部24与螺纹88之间的接合作用以所希望的插入角将紧固件80刚性地附加到骨板12上。在某些实施例中，然后，外科医生可能在板上的其它开口中使用传统锁定螺钉和/或非锁定螺钉。若需要，这可进一步帮助将骨板紧固到骨折上。开口18的一个优势在于它适合接纳可用于板12的可能紧固件中的任一种紧固件。 
在某些情形中，一旦放置好所有紧固件和/或螺钉，外科医生可能在未使用的开口上放置覆盖件(特别是在存在越过骨折的任何未用的开口的情况下)，以巩固该板12。另外或选择性地，外科医生可能使用骨骼移植材料、骨接合剂、骨骼空隙填充剂和任何其它材料来帮助骨骼愈合。 
在图16至图18中示出固定组件的备选实施例。这些图示出具有带鳍状部头部104的紧固件102。具体说来，带鳍状部的头部104在它的上部108包括接纳孔口和绕头部104的主体部分112延伸的至少一组鳍状部110。鳍状部110被显示为具有逐渐变细边缘的正方形或梯形，但它们也可能是任何其它形状，诸如圆形、椭圆形、矩形、弯曲的、偏菱形、菱形、三角形或任何其它适当形状。鳍状部110的边缘111可能向内、向外逐渐变细或彼此大约平行。鳍状部110可绕头部104以单行提供或在多个行中分层(如图所示)。如果在多个行中分层，那么每个单独鳍状部110可能在另一鳍状部的直接上方(因此，紧固件100的顶部看起来与图18所示的情形相似)。或者，在下层中的每个单独的鳍状部110可能相对于更高中层的鳍状部偏移。在一组中鳍状部24的数目还可从大约两个或三个到高达可装配于头部104的主体部分112上的任何所希望的数目变化。如同上文所介绍的开口18 的鳍状部24的情况，鳍状部110优选地相当薄，厚度视紧固件与板的用途而不同。举例说来，与较小紧固件(例如，用于较小骨骼)相比，用于较大板的较大紧固件102(例如，用于股骨)可能具有更大且更厚的鳍状部110。在具体实施例中，鳍状部110特别薄使得它们可向上或向下移动或在压力下压缩。鳍状部的厚度的非限制性示范性范围可能是从大约0.5mm到大约5mm，但也可能具有更大和更小的大小。理论上，鳍状部110将装配于板的螺纹结构之间。紧固件还可具有带螺纹或不带螺纹的轴杆114，如上文关于紧固件80所介绍。 
紧固件102可用于具有螺纹开口的任何骨板。在上文中所介绍的且在附图所示的其中任一示例可与紧固件102一起使用。可与紧固件110一起使用的特定骨板的一个选择在图19中示出。这个骨板120具有爱克姆螺纹(Acme thread)124，爱克姆螺纹124具有更接近矩形的形状而不是通常用于骨板的尖锐角螺纹。如图20所示，开口122具有止于它们的边缘126的矩形螺纹124。提供具有更平的边缘126的矩形允许更大的通道用于鳍状部110接合。在更具体实施例中，螺纹124可能与开口122的中心轴线130偏移成大约15°到20°的角度，且更具体地说来，与中心轴线130偏移大约18°。 
使用方法的示例与上文所述的方法类似。在紧固件102被插入到骨板120内(但应了解可使用任何传统骨板；爱克姆螺纹并不是必要条件)时，鳍状部110将与板的螺纹接合，而且与上文所介绍的骨板的鳍状部非常类似，鳍状部110非常薄，使得在板的螺纹开始抓住鳍状部110时，鳍状部110可酌情向上或向下移动来接合板的螺纹并且将紧固件102紧固于适当位置，如图16所示。在大多数情况下，鳍状部110的这种移动是永久变形使得鳍状部不可弹回并且允许紧固件脱出。 
本发明的示范性实施例的前文描述只是出于说明与介绍的目的而提供而且不是详尽的或限制本发明为所公开的精确形式。在不背离上述公开内容与所附权利要求的范围或精神的情况下，可能对上文所 引用和附图所示的结构和方法做出许多的修改与变化。选择并介绍这些实施例以解释本发明的原理和它们的实践应用使得本领域技术人员能够做出或利用本发明和各种实施例并且做出适合预期的特定用途的各种修改。对于本发明所涉及领域的技术人员而言，在不背离本发明的精神与范围的情况下，备选实施例将显而易见。 

Claims (22)

1.一种多轴式骨骼固定组件，包括：
(a)骨板，包括下表面、上表面和从所述下表面延伸到所述上表面的至少一个开口；
(b)紧固件，其能够通过所述开口插入；以及
(c)在所述开口与所述紧固件之间合作的至少一个构件，包括位于所述开口内或所述紧固件上的多个突出鳍状部，所述鳍状部可向上或向下移动，所述鳍状部的这种向上或向下移动是永久变形，使得所述鳍状部不会弹回并允许紧固件脱出。
2.根据权利要求1所述的多轴式骨骼固定组件，其特征在于，所述开口具有非螺纹内表面，且所述鳍状部位于所述内表面上。
3.根据权利要求2所述的多轴式骨骼固定组件，其特征在于，所述鳍状部被提供为一系列的凹入地缩进的、向内突出的鳍状部，所述鳍状部适合以变化的角度将紧固件的螺纹头部紧固于适当位置。
4.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述开口还被在所述上表面的圆形周边和在所述下表面由所述鳍状部所形成的锯齿状周边限定。
5.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述鳍状部形成所述内表面的凹入部分。
6.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述鳍状部具有基部，所述基部基本上在同一平面中与所述内表面会合。
7.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述紧固件具有螺纹头部，所述螺纹头部适合与所述鳍状部接合。
8.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述鳍状部为渐缩形或直形。
9.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述鳍状部为矩形或三角形。
10.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述骨板适合与股骨、胫骨远端、胫骨近端、肱骨近端、肱骨远端、锁骨、腓骨、尺骨、桡骨、足骨或手骨接触。
11.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述骨板具有下列特征中的一个或多个特征：
(a)仿形的、直的或平的；以及
(b)展开形成L形、T形或Y形的头部。
12.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述骨板具有下列特征中的一个或多个特征：
(a)直的或平的；
(b)轮廓与特定骨骼表面相匹配的头部部分；以及
(c)展开形成L形、T形或Y形的头部。
13.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述骨板具有头部，且所述开口位于所述头部上。
14.根据权利要求2或3所述的多轴式骨骼固定组件，其特征在于，所述骨板还包括下列开口中的一个或多个开口：
(a)螺纹开口；
(b)非螺纹开口；
(c)适合接纳锁定紧固件或非锁定紧固件的开口；或
(d)组合槽。
15.根据权利要求1所述的多轴式骨骼固定组件，其特征在于，所述紧固件具有带有鳍状部的头部，且所述鳍状部适合与在骨板中的螺纹合作。
16.根据权利要求15所述的多轴式骨骼固定组件，其特征在于，所述鳍状部以多于一个层提供。
17.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，在所述骨板中的所述开口包括一个或多个矩形螺纹。
18.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，所述鳍状部是梯形、圆形、椭圆形、矩形、弯曲的、偏菱形、菱形或三角形。
19.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，所述鳍状部的边缘向内、向外逐渐变细或彼此大约平行。
20.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，所述骨板适合与股骨、胫骨远端、胫骨近端、肱骨近端、肱骨远端、锁骨、腓骨、尺骨、桡骨、足骨或手骨接触。
21.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，所述骨板具有下列特征中的一个或多个特征：
(a)仿形的或平的；
(b)直的或包围关节的；或
(c)展开形成L形、T形或Y形的头部。
22.根据权利要求15或16所述的多轴式骨骼固定组件，其特征在于，所述骨板还包括下列开口中的一个或多个开口：
(a)螺纹开口；
(b)非螺纹开口；
(c)适合接纳锁定紧固件或非锁定紧固件的开口；或
(d)组合槽。
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