CN1882286A - 脊柱柔性固定的方法和器具 - Google Patents

脊柱柔性固定的方法和器具 Download PDF

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CN1882286A
CN1882286A CNA2004800335885A CN200480033588A CN1882286A CN 1882286 A CN1882286 A CN 1882286A CN A2004800335885 A CNA2004800335885 A CN A2004800335885A CN 200480033588 A CN200480033588 A CN 200480033588A CN 1882286 A CN1882286 A CN 1882286A
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flexible
end portion
connecting member
flexible connecting
spinal fixation
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CN1882286B (zh
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张泰安
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N Spine Inc
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Abstract

一种柔性脊柱固定装置，该装置具有用于非刚性稳定脊柱的柔性金属连接元件。在一个实施方式中，固定装置包括至少两个构型可分别插入相邻脊柱蒂中的锁定元件，每个锁定元件各自包括联结组合件。固定装置还包括柔性金属连接件，构型可接纳和固定在各锁定元件的联结组合件内，以柔性稳定脊柱受侵袭区域。

Description

脊柱柔性固定的方法和器具
相关申请的交叉引用
本申请要求2003年9月24日提交的题为“动态脊柱固定装置”的根据35U.S.C.§119(a)的韩国申请序列号2003-0066108的优先权，该申请内容被纳入本文作为参考。
发明背景
发明领域
本发明涉及固定和稳定脊柱的方法和系统，更具体地说，涉及脊柱固定方法和系统，包括：将一个或多个螺钉型固定构件植入和固定入患者脊柱的一部分，以及将柔性、半刚性杆或板连接并固定于所述固定构件的上端，以提供脊柱的动态稳定。
相关技术的描述
变性性脊柱疾病，例如椎间盘变性性疾病(DDD)、椎管狭窄、脊椎前移等，在保守治疗不能取得较佳效果时需要外科手术。一般，脊柱减压是最先进行的外科手术方法。减压的主要目的是减小脊椎管及其中的神经根上的压力，通过切除某些脊柱组织以降低或消除压力和压力导致的疼痛。当切除脊柱组织时，可降低疼痛但也减弱了脊柱。因此，减压手术后常常需要融合手术(例如，ALIF、PLIF或后外侧融合)以稳定脊柱。然而，外科手术后，融合要达到最大的稳定需要一段时间，而通常采用脊柱固定装置来支承脊柱直到达到所需的融合水平。根据患者具体状态和条件，有时可在减压后立即进行脊柱固定手术，而不需要融合手术。在许多情况下因为可提供即刻术后稳定而进行固定手术，当也进行融合手术时，固定手术可提供脊柱支承直到达到足够的融合和稳定性。
脊柱固定的传统方法采用刚性脊柱固定装置来支承受损脊柱部分和防止受损部分的移动。这些传统固定装置包括：可以预定的深度和角度插入脊柱骨的脊柱蒂或骶骨中的固定螺钉，可邻近受损脊柱部分放置的杆或板，以及将杆或板与固定螺钉连接或联结成通过杆或板将受损脊柱部分支承和保持在相对固定的位置的联结元件。
美国专利6,193,720公开了一种传统固定装置，其中，将杆或板型连接元件安装在至少一个或多个插入脊柱骨脊柱蒂或骶骨的螺钉上端。使用诸如杆或板之类的连接元件来稳定由于减压导致减弱的脊柱受损部分。连接元件还可通过充分限制脊柱的移动来防止患者疼痛和受伤。然而，因为连接元件防止脊柱的正常运动，长时间使用后，该脊柱固定装置可导致不良作用，例如“结合综合征”(过渡性综合征)或“融合疾病”，导致其它脊柱相关的并发症和异常。具体地说，由于传统固定装置中使用的杆或板的高度刚性，外科受伤后患者的固定关节不能运动，而手术区上方和下方脊柱关节的运动就增加。结果，这种脊柱固定装置导致患者活动性降低，压力增加，邻接手术区的脊柱关节不稳定。
已有报道，由于刚性固定引起的负荷屏蔽，过度刚性的脊柱固定对融合手术是不利的。因此，进行了使用负荷分担的半刚性脊柱固定装置的尝试来消除该问题和帮助骨融合手术。例如，美国专利5,672,175、美国专利5,540,688和美国专利公开2001/0037111指出了具有允许轴向负荷平移(即沿脊柱的垂直轴线)的柔性设计的动态脊柱稳定装置，用于促进骨融合。然而，因为这些装置是预定为在骨融合手术后使用的，它们不太适合无需融合的脊柱固定。因此，最终结果是这些装置不能防止融合所导致的刚性固定的问题。
为解决上述与刚性固定相关的问题，开发了非融合技术。Graf带是非融合固定装置的一个例子，它无需骨融合而在减压后就可采用。Graf带由聚乙烯带和蒂螺钉构成，蒂螺钉将聚乙烯带与需稳定的脊柱椎骨连接。Graf带的主要目的是防止受损脊柱部分的矢状旋转(柔性不稳定型)。因此，它在选定的病例中有效而在需要较大稳定性和固定的情况下不合适。参见Kanayama等，Journalof Neurosurgery 95(1 Suppl)：5-10，2001，Markwalder & Wenger，ActaNeurochrgica 145(3)：209-14.)。近来引入了另一种非融合固定装置，称为″Dynesys″。参见Stoll等，European Spine Journal 11 Suppl 2：S170-8，2002、Schmoelz等，J of spinal disorder&techniques 16(4)：418-23，2003。Dynesys装置除了在螺钉之间使用聚碳化乙烷(polycarburethane)间隔物来维持两个相对的蒂螺钉的头部间的距离、从而维持螺钉固定的相邻椎骨间的距离以外，与Graf带相类似。Dynesys装置的发明者早先报道指出，该装置已在许多病例中取得成功。然而，在控制研究中尚未确定Dynesys装置能否保持长时间的柔性稳定性和耐久性。因为它具有聚乙烯部件和界面，存在机械故障的风险。而且，由于该装置的机械构型，将该装置安装于脊柱的外科技术复杂且繁琐。
美国专利5,282,863和4,748,260公开了一种使用塑料、非金属杆的柔性脊柱稳定系统和方法。美国专利公开2003/0083657指示了另一种使用柔性伸长元件的柔性脊柱稳定装置。这些装置具有柔性但它们对长期轴向负荷和压力不太适合。此外，所需的柔性对刚性的程度随各患者而有所不同。现有柔性固定装置的设计方案不太适合形成不同程度的柔性来给每个人提供最佳的结果。例如，美国专利5,672,175公开了一种采用金属合金和/或复合材料构成的固定杆的柔性脊柱固定装置。此外，围绕杆盘绕有压缩弹簧和拉伸弹簧，以提供沿所需方向的椎骨上的反旋力。然而，该专利主要涉及提供允许脊柱“沿垂直轴相对纵向平滑移动”的脊柱固定装置，既没有阐述也没有提及可提供各种柔性特征的任何连接元件的具体设计(例如，杆或板)。现有柔性杆，例如U.S.5,672,175提及的柔性杆，通常具有实体结构，直径较小以提供所需的柔性水平。因为它们通常为提供合适的柔性而非常薄，这种现有领域的杆易于机械断裂，已知在植入患者后会断裂。
因此，传统脊柱固定装置不能对与治愈脊柱疾病有关的问题提供综合和平衡的解决办法。许多现有装置的特征是过度刚性导致上述问题，而另一些装置虽然具有一些柔性，但不太适合提供变化的柔性程度。此外，现有柔性装置采用尚未证明可提供长期稳定性和耐久性的非金属部件。因此，需要改善的动态脊柱固定装置，这种装置可给脊柱受损部分提供所需的柔性水平，同时又可提供脊柱长期耐久性和恒定的稳定性。
此外，在将脊柱固定装置固定于脊柱的传统外科方法中，医生在背部中线处切开约10-15厘米的口子，然后向两侧剖切并回刀。在该方法中，医生进行肌肉剖切以暴露面关节的外部。接着，切除后，医生用放射成像装置(例如C-臂荧光仪)找出脊柱蒂的进入点，将脊柱固定装置的固定构件(称为“脊柱蒂螺钉”)插入脊柱蒂中。然后，将连接元件(例如杆或板)与蒂螺钉的上部结合以给脊柱受损部分提供支承和稳定性。因此，在传统脊柱固定手术中，切开患者的背部约10-15cm，结果，由于切开或损伤了对维持脊柱重要的背部肌肉，导致患者明显的术后疼痛和长的复原期。
近来，为减少患者创伤，开发了最小侵入性外科手术，该方法能通过在外科手术位置患者背部形成的较小的洞或“窗”来进行脊柱固定手术。通过使用内窥镜或显微镜，最小侵入性手术可使患者的受损区域成为小得多的切口。通过该较小的切口，利用导航系统将两个或多个脊柱固定装置的固定构件(例如蒂螺钉)拧入各自的脊柱蒂区域中。然后，使用特殊工具，将固定装置的稳定构件(例如杆或板)连接于固定构件。或者，外科手术包括将扩张器插入切口并渐渐增加扩张器直径的步骤。然后，将管形伸缩器插入扩张区域中以收缩患者肌肉并提供用于外科手术的肉眼可见视野。建立该视野后，进行减压和融合手术(需要时)，再进行固定手术，包括以下步骤：使用内窥镜或显微镜找出脊柱蒂的位置，将蒂螺钉插入脊柱蒂，以及将稳定构件(例如杆或板)固定于蒂螺钉以稳定和支承变弱的脊柱。
进行最小侵入性脊柱固定上述的一个最有挑战性的方面是在内窥镜或显微镜视野下定位蒂螺钉的进入点。通常利用解剖学标志和/或放射成像装置来找出进入点，但由于受限制的工作空间，常常难以识别清晰的解剖学关系。此外，最小侵入性手术要求切除显著量的软组织以暴露用于插入蒂螺钉的解剖学区域。切除软组织会导致受损区域出血，从而增加了找出插入固定构件的正确位置的难度，并引起外科手术区域周围肌肉和软组织损伤。而且，因为难以精确定位插入固定构件的点，传统手术会造成不必要的创伤。
为更精确和快速地找出插入固定构件的脊柱蒂位置，已提出和执行了放射成像技术。然而，使用放射成像技术时，由于外科手术期间使用的金属工具和设备会导致放射图像干扰，常常难以获得能用来找出相应的脊柱蒂位置所要求的清晰图像。而且，解释和说明放射图像是一项要求相当多的训练和专业技能的复杂任务。放射成像还具有另一个问题，即患者要经受显著量的辐射。
虽然已开发了可引导蒂螺钉插入脊柱蒂上所需的进入点的一些导向系统，但已证明这些现有系统难以用于手术操作，甚至还会阻碍手术。例如，现有用于插入蒂螺钉的导向系统采用长的丝，该丝可穿过已插入通过患者背部肌肉和组织的引导管。用放射成像方法(例如，C-臂荧光仪)来确定插入引导管的位置，并驱动引导管直到引导管的第一端到达蒂骨表面上的所需位置。然后，将引导丝的第一端(通常由生物相容金属材料构成)插入引导管并推入蒂骨中，而引导丝的另一端保留在患者背部之外。在将引导丝固定入蒂骨后，除去引导管，扩张并回缩引导丝周围的洞。最后，通过引导丝将构型可接纳引导丝穿过其中的轴向孔或通道的蒂螺钉引导至蒂骨上的所需位置，在该处螺钉驱动蒂螺钉而进入蒂中。
虽然该丝导向系统是一个很好的概念，但在实践中，很难使用引导丝。因为它较长且较细，在尝试将引导丝的一端驱动入蒂骨的过程中，常常不能保证引导丝的结构完整性，导致不必要的时间消耗和工作量。而且，因为插入期间引导丝弯曲和卷曲，它不能提供光滑且固定的锚，用于将后续工具和蒂螺钉引导到蒂上的进入点。而且，现有的经皮丝导向系统是用内窥镜或显微镜与C-臂荧光仪(或其它放射成像装置)联合应用的，而不是直接目测的。因此，现有的丝导向系统具有错位和蒂断裂的潜在危险。最后，因为丝的一端保留在蒂螺钉头和患者的背之外，该丝阻碍了外科医生在进行各种后续的脊柱固定外科有关手术时的活动自由。因此，需要提供一种改进的、适合在内窥镜或显微镜观察下用于最小侵入性蒂螺钉固定手术的导向系统，该导向系统更容易植入脊柱蒂且不会阻碍外科医生进行的后续手术。
如上所述，用于治疗脊柱疾病的现有方法和装置需要更大的改进。最常用的脊柱固定装置太硬且不易弯曲。这种过度刚性可导致进一步脊柱异常和疾病，以及患者明显的不适。虽然一些现有脊柱固定装置的确提供了一定程度的柔性，但这些系统不是设计成或制造成可容易地获得各种程度的柔性以给每位特定患者提供所需的柔性水平的。此外，具有柔性连接件(例如杆或板)的现有领域装置更有可能发生机械故障，并且不能提供脊柱长期的耐久性和稳定性。而且，进行脊柱固定手术的现有方法由于难以找出要将脊柱固定装置固定处的脊柱骨的脊柱蒂或骶骨的精确位置，而对患者造成不必要的创伤。
发明概述
本发明旨在通过提供一种用于稳定受伤或变弱脊柱的改进的方法和系统来解决了上述和其它需要。
为克服传统脊柱固定装置的缺陷，在一个实施方式中，本发明的发明者开发了一种具有改进的结构和设计的新型柔性脊柱固定装置，该装置使用金属或金属合成混合组件以提供所需的柔性、稳定性和耐久性。
作为一个用以减少最小侵入性脊柱外科手术所需的手术时间、最大程度地减少外科手术区域周围组织的损伤的长期研究的结果，在另一个实施方式中，本发明提供用于精确和快速找出插入脊柱固定装置的锁定元件的脊柱位置的方法和装置。使用一种新型引导/标示装置以指出插入锁定元件的脊柱位置。
附图简要说明
图1显示根据本发明一个实施方式的脊柱固定装置的立体图。
图2显示根据本发明另一个实施方式的脊柱固定装置的立体图。
图3显示根据本发明一个实施方式，图1和2的蒂螺钉2的联结组合件14的分解图。
图4显示根据本发明一个实施方式的柔性杆连接件的立体图。
图5显示根据本发明另一个实施方式的柔性杆连接件的立体图。
图6显示根据本发明又一个实施方式的柔性杆连接件的立体图。
图7显示根据本发明一个实施方式的预弯曲的柔性杆连接件的立体图。
图8显示根据本发明一个实施方式的连接元件柔性部分的立体剖视图。
图9显示根据本发明另一个实施方式的连接元件柔性部分的立体剖视图。
图10显示根据本发明又一个实施方式的连接元件柔性部分的立体剖视图。
图11显示根据本发明一个实施方式的柔性杆连接件的立体图。
图12A显示根据本发明一个实施方式，在两端部分之间具有一个或多个间隔物的柔性连接件的立体图。
图12B显示图12A的柔性连接件的分解图。
图12C显示根据本发明一个实施方式，图12A和12B的柔性连接件的阴阳互锁元件的视图。
图13显示根据本发明又一个实施方式，柔性连接件的立体图。
图14显示根据本发明另一个实施方式，脊柱固定装置的立体图。
图15显示图14的脊柱固定装置的分解图。
图16A显示根据本发明一个实施方式的柔性板连接件的立体图。
图16B显示根据本发明又一个实施方式的柔性板连接件的立体图。
图16C显示图16A的柔性板连接件的侧视图。
图16D显示图16A的柔性板连接件的俯视图。
图16E显示根据本发明又一个实施方式的具有预弯曲构型的图16A的柔性板连接件的侧视图。
图17显示根据本发明另一个实施方式的柔性板连接件的立体图。
图18显示根据本发明另一个实施方式的柔性板连接件的立体图。
图19显示根据本发明又一个实施方式的具有柔性中间部分的混合杆-板连接件的立体图。
图20显示利用图19的混合杆-板连接件的脊柱固定装置的立体图。
图21显示植入患者脊柱后的图1脊柱固定装置的立体图。
图22A和22B分别显示采用图16A和16B的板连接件的脊柱固定装置的立体图。
图23A显示根据本发明一个实施方式，以倾斜角插入两相邻椎骨的蒂中的两个蒂螺钉的立体图。
图23B显示根据本发明一个实施方式的蒂螺钉的联结组合件的结构图。
图23C显示根据本发明一个实施方式的斜面稳定间隔物的立体图。
图23D显示图23C的斜面稳定间隔物的侧视图。
图23E是图23的蒂螺钉的圆柱形头部的俯视图。
图24显示根据本发明一个实施方式的标示和导向装置的立体图。
图25是图24的标示和导向装置的分解图。
图26A提供了外科手术期间将图24的标示和导向装置插入后，患者脊柱的透视剖面图。
图26B提供当除去图24的标示和导向装置的内套针时，患者脊柱的透视剖面图。
图27A和27B分别显示两个实施方式的基准销的立体图。
图28是根据本发明又一个实施方式的推针的立体图。
图29A显示根据本发明的一个实施方式，当使用图28的推针将基准销驱动进入脊柱蒂指定位置时，患者脊柱的透视剖面图。
图29B显示根据本发明的一个实施方式，两个基准销植入两相邻脊柱蒂后，患者脊柱的透视剖面图。
图30是根据本发明一个实施方式的套管锥的立体图。
图31是根据本发明的一个实施方式，当使用图30的套管锥来扩张蒂螺钉的进入点时，患者脊柱的透视剖面图。
图32提供根据本发明的一个实施方式的基准销取回装置的立体图。
图33是根据本发明又一个实施方式，具有用于接纳至少一部分基准销于其中的轴向圆柱形空腔的蒂螺钉的立体图。
图34是根据本发明一个实施方式，蒂螺钉植入脊柱蒂的指定位置后，患者脊柱的透视剖面图。
图35是根据本发明的一个实施方式，两个蒂螺钉植入两相邻脊柱蒂的指定位置后，患者脊柱的透视剖面图。
优选实施方式的具体描述
下面将参考附图详细描述本发明，图中，相似的元件用相似的的数字表示。
图1描述了根据本发明一个实施方式的脊柱固定装置。该脊柱固定装置包括两个锁定元件2(表示为2′和2″)和一个柔性固定杆4，该固定杆的构型可被接纳和锁定在联结组合件14内，如下参见图3所详细描述的那样。每个锁定元件2包括螺纹螺旋型轴10，它被构造成可插入和拧入患者脊柱蒂。如图1所示，螺旋型轴10包括形成在轴10的整个长度上的外螺旋式螺纹12和轴10端部的锥形头，该锥形头被构造成可在指定位置插入患者脊柱。如果该锁定元件2可插入和固定于脊柱并稳固地联结于杆4，则锁定元件2的其它已知形式可与本发明联用。
如上所述，通过将锁定元件2安装在脊柱的所需位置处而将脊柱固定装置用于脊柱疾病的外科治疗。在一个实施方式中，杆4延伸跨过两个或多个脊柱椎骨，并由锁定元件2锁定以稳定两个或多个椎骨的移动。
图2显示根据本发明又一个实施方式的脊柱固定装置的立体图。除了杆4包括并置在杆4的两刚性末端部分9之间的柔性中间部分8以外，图2的脊柱固定装置与图1的脊柱固定装置相类似。
图3提供了根据本发明一个实施方式的图1和2的锁定元件2的分解图，显示了联结组合件14的各种组件。如图3所示，联结组合件14包括：位于螺旋型轴10顶部的圆柱形头部16，沿圆柱形头部16的内壁表面形成的螺旋螺纹或槽18，以及构成为可接纳杆4于其中的U-形座槽20。联结组合件14还包括外-螺纹螺母22，其具有在螺母22的外侧表面上形成的螺旋螺纹24，其中，螺旋螺纹24被构造成可与圆柱形头部16的内螺旋螺纹18相匹配。在另一个实施方式中，联结组合件14包括固定帽26，它被构造成可安装在圆柱形头部16的一部分上方以覆盖和保护外螺纹螺母22并更稳固地使杆4保留在座槽20内。在一个实施方式中，固定帽26的内径被构造成可稳固地与圆柱形头部16的外径相匹配。将固定帽26锁定于圆柱形头部的其它方法，例如相应位置的凹口和槽(未示出)，对本领域技术人员是显而易见的。在优选的实施方式中，锁定元件2的组件和部件可由高度刚性和耐用的生物相容材料如不锈钢、钢铁、钛或钛合金构成。如本领域所知，在这里使用的“生物相容”材料指植入患者体内后不会引起任何不良化学或免疫反应的材料。
如图1和2所示，在优选的实施方式中，通过以垂直于锁定元件2的螺纹轴10的长度的方向，将杆4平行插入联结件14的座槽20内，使杆4连接于锁定件2。然后接纳外螺纹螺母22并拧入杆4上方的圆柱形头部16中以将杆4锁定在座槽20中。然后，将固定帽26放置在圆柱形头部16上方以覆盖、保护和更稳固地将组件锁定在圆柱形头部16的内腔中。图4-7显示了根据本发明，各种实施方式的可用于固定装置的杆4的立体图。图4显示图1的杆4，其中，整个杆被制造和设计成柔性的。在该实施方式中，杆4包括具有预定厚度的圆柱形壁5的金属管或导管。在一个实施方式中，为给杆4提供柔性，沿杆4的长度以螺旋形方式切割圆柱形壁5，形成螺旋式切口或槽6。如本领域技术人员所明白的，可调节螺旋形槽6的宽度和密度，以提供所需的柔性水平。在一个实施方式中，槽6由穿透杆4圆柱形壁的整个厚度的、非常薄的螺旋切口或割口形成。如本领域技术人员所知，管状壁5的厚度和材料也影响柔性水平。
在一个实施方式中，杆4被设计成具有基本上等于正常背部的柔性。正常背部的柔性范围是本领域技术人员已知的，普通技术人员可容易地确定管状壁5的厚度和材料、以及槽6的宽度和密度，以达到正常背部范围内的所需柔性或柔性范围。当指槽6时，术语“密度”指螺旋形槽形槽6的致密性，或者，换句话说，也就是相邻槽线6之间的距离，例如如图4所示。然而，应理解，本发明并不限于具体、预定的柔性范围。在一个实施方式中，除具有所需的侧向柔性特征外，杆4的刚性还应能够耐受相对于患者固有脊柱的其余部分的、以均一方式沿脊柱垂直轴线施加于患者脊柱的垂直轴向负荷。
图5显示了图2的杆4，其中，只有中间部分8被制造和设计成柔性，两端部分9被制造成刚性。在一个实施方式中，其中不具有槽的金属末端环或帽9′被置于图4的杆4的两端以使末端部分9呈刚性。使用已知方法如将金属压制和/或焊接在一起，环或帽9′可永久性固定于杆4的末端。在另一个实施方式中，只沿中间部分8的长度切割螺旋形槽6，末端部分9为不具有槽6的管状壁5。由刚性金属或金属混合材料构成的管状壁5，不具有槽6，显示出高度刚性。
图6显示另一个实施方式的杆4，它具有多个区段，两个柔性区段8插入三个刚性区段9之间。例如，可使用该实施方式以使三个相邻椎骨彼此稳定，其中，将三个蒂螺钉固定于各自的椎骨，而三个刚性区段9连接于各个蒂螺钉2的联结组合件14，参见图3，如上所述。各个柔性区段8和刚性区段9可参见图5如上所述那样制造。
图7显示另一个实施方式的杆4，它具有预弯曲的结构和构型以符合和维持患者脊柱曲率，称为“脊柱前凸”，同时稳定脊柱。一般，患者腰椎为“C”形，根据本发明的一个实施方式，当用于图2的脊柱固定装置时形成杆4结构以与正常腰椎形状相一致。在一个实施方式中，预弯曲杆4包括被制造和设计成柔性的中间部分8，该中间部分插入两刚性末端部分9之间。中间部分8和末端部分9可参见图5如上所述那样制造。制造各种尺寸、长度和预弯曲构型的金属或金属混合管状杆的方法是本领域公知的。此外，或者可选地，当两相邻蒂螺钉不是相互平行插入时，杆4的预弯曲结构和设计可抵消倾斜角，参见图23A如下进一步详细所述。
可采用其它设计和材料来形成柔性管状杆4或柔性中间部分8，参见图8-10，如下所示。图8显示根据本发明一个实施方式的柔性管状杆4或杆部分8的立体剖视图。在该实施方式中，柔性杆4，8由具有其中切割的螺旋形槽6的第一金属管5构成，参见图4-7，如上所述。将具有其中切割的螺旋形槽31、且直径小于第一管5的第二管30插入第一管5的圆柱形空腔中。在一个实施方式中，第二管30具有螺旋形槽31，该螺旋形槽31是以与第一管5中切割的螺旋形槽6相反螺旋方向切割的，以使第二管30的旋转扭转特征抵消第一管5的至少一些旋转扭转特征。将第二柔性管30插入第一管的芯中，以进一步给柔性杆4，8提供耐久性和强度。第二管30可由与第一管5相同或不同的材料构成。在优选的实施方式中，用于制造第一管5和第二管30的材料各自可为以下示例性金属中的任何一种或组合：不锈钢、钢铁、钛和钛合金。
图9显示根据本发明又一个实施方式的柔性杆4，8的立体剖视图。在该实施方式中，柔性杆4，8包括由金属丝32构成的内芯，金属丝32包括许多重叠的金属细纱，如钢纱、钛纱或钛合金纱。金属丝32被金属、或金属混合的柔性管5包围，柔性管5具有其中切割出的螺旋形槽6，如上所述。金属丝中金属纱的数目和厚度也影响杆4，8的刚性和柔性。通过改变纱的数目、厚度或材料，可增加或降低柔性。因此，可调节金属丝32中金属纱的数目、厚度和/或材料，以根据患者具体需要来提供所需的刚性和柔性。本领域技术人员可容易地确定纱的数目、厚度和材料，结合给定的管5的柔性，以达到杆4，8所需的刚性与柔性特征。
图10显示另一个实施方式的柔性杆4，其中柔性管5包围着非金属、柔性芯34。芯34可由已知生物相容形状记忆合金(例如NITINOL)或生物相容合成金属如：碳纤维、聚醚醚酮(PEEK)、聚醚酮酮醚酮(PEKKEK)或超高分子量聚乙烯(UHMWPE)构成。
图11显示另一个实施方式的柔性杆35的立体图，其中，参见图9，如上所述，许多金属丝32交织或编织在一起形成编织的金属丝杆35。因此，编织的金属丝杆35可由与金属丝32相同的材料构成。除如上所述可改变金属丝32的刚性和柔性外，还可通过改变编织结构35中使用的金属丝32的数目和厚度来进一步改变编织杆35的刚性和柔性，以达到所需的特征。例如，为达到已知正常健康脊柱弯曲范围内的各种弯曲程度或范围，本领域普通技术人员可通过改变和测定由采用金属丝的不同量规、数目和材料来形成编织的金属丝杆35所提供的弯曲程度，容易地制造各种设计方案的编织金属丝杆35。在另一个实施方式中，编织的金属丝杆35的两端被刚性金属帽或环9′包围，参见图5-7，如上所述，形成具有柔性中间部分8和刚性末端部分9的杆4。在又一个实施方式中(未示出)，可采用编织的金属丝杆35作为柔性内芯，该柔性内芯以与图8-10所示实施方式相类似的方式，被具有其中切割螺旋形槽6的金属管5包围，以形成柔性金属杆4或杆部分8。这里所用的术语“编织”或“编织结构”包括两根或多根以重叠方式交织的丝、条、索、带和/或其它形状的材料。各种交织丝、条、索、带和/或其它形状的材料的方法是本领域已知的。这种交织技术包括在本发明范围内。在另一个示例性实施方式(未示出)中，柔性金属杆35包括编织的金属结构，具有两个或多个以对角重叠方式交织的金属条、索或带、
图12A显示另一个实施方式的柔性连接件36，它具有两刚性末端部分9′和示例性数目的刚性间隔物37。在一个实施方式中，刚性末端部分9′和间隔物可由上述生物相容材料或金属混合材料构成。参见图9，如上所述，连接元件36还包括柔性丝32，该柔性丝32在每个刚性末端部分9′和间隔物37中贯穿轴向空腔或洞(未示出)。图12B显示连接元件36的分解图，还显示金属丝32插入通过刚性末端部分9′和间隔物37的中央轴线洞的方式。图12B还显示，末端部分9′和间隔物37各自包括阳互锁元件38，它被构造成与紧邻的末端部分9′或间隔物37中的阴互锁空腔(未示出)相匹配。图12C显示分解的侧视图，用虚线指出用以接纳相应的阳互锁元件38的阴互锁空腔39的位置和形状。
图13显示根据本发明另一个实施方式的柔性连接件40的立体图。连接元件40类似于上述连接元件36，然而，间隔物42被构造成具有与刚性末端部分9’相同的形状和设计。此外，末端部分9′具有位于侧表面上的出口孔或槽44，用金属夹(未示出)或其它已知技术可将金属丝32从出口孔或槽44中拉出、拉紧、夹紧或固定。这样，就可在手术时改变柔性连接件36或40的长度，以与每位患者独特的解剖学特征相匹配。在一个实施方式中，可用金属夹或制动件(未示出)来固定金属丝32。例如，夹或制动件可包括一小型管状圆锥体，其内径稍大于金属丝32的直径，以使金属丝32穿过其中。将金属丝经过管状制动件拉至所需张力后，压缩制动件以捏紧包含其中的金属丝32。或者，可在其中具有预定数目间隔物37，42的杆样连接元件36，40的制造期间采用已知技术预先固定金属丝32。
图14显示根据本发明另一个实施方式的脊柱固定装置。该脊柱固定装置包括：至少两个锁定元件2和联结组合件14，其中，锁定元件2包括具有外螺旋螺纹12的伸长螺钉型轴10。该装置还包括板连接件50或简称为“板50”，其被构造成可稳固地连接于两锁定元件2的联结组合件14。板50包括两个刚性连接元件51，每个刚性连接元件具有一平的表面、且通过柔性中间部分8连接在一起。参见图4-11，可根据上述任何实施方式来制造柔性中间部分8。每个连接元件51包括联结孔52，其被构造成可在其中接纳联结组合件14的第二螺纹轴54(图15)。
如图15所示，锁定元件2的联结组合件14包括螺栓头56，螺栓头56毗邻第一螺纹轴10的顶部、且圆周或直径大于第一螺纹轴10的圆周。第二螺纹轴54从螺栓头56向上延伸。联结组合件14还包括螺母58和一个或多个垫圈60，螺母58具有与第二螺纹轴54匹配的内螺纹，一个或多个垫圈60用于夹紧连接元件51与螺栓头56的上表面，从而使板50与蒂螺钉2稳固地结合。
图16A和16B显示两个实施方式的板连接件40，它具有至少两个连接元件51和至少一个位于其间并与两相邻连接元件51结合的柔性部分8。如图16A和16B所示，柔性中间部分8包括柔性金属丝编织结构3，参见图11如上所述。然而，参见图4-11，可根据上述任何实施方式或其组合制造和设计柔性部分8。图16C和16D分别显示了图16A的板50的侧视图和俯视图。如上所述，使用已知的冶金学制造方法可容易地实现不同实施方式的具有不同类型柔性中间部分8的柔性连接件50和58的制造。
图16E显示根据本发明又一个实施方式，预弯曲的板连接件50′的侧视图。该板连接件50′，除了在板连接件50’的制造期间以与水平面53呈θ角形成和弯曲连接元件51′以外，与板50相类似。如同对上述图7的预弯曲的杆样连接元件4所述，该预弯曲构型被设计成可模拟和支承固有脊柱曲率(例如，脊柱前凸)。此外，或者可选地，当两相邻蒂螺钉不是相互平行插入时，这种预弯曲结构可抵消倾斜角，参见图23A如下进一步详细所述。
图17显示板连接件60的立体图，图中，板连接件60具有两平面的连接元件62，每个连接元件62中具有耦合孔64用于接纳蒂螺钉2的第二螺纹轴44。柔性中间部分8位于两连接元件62之间并与两连接元件62结合。在一个实施方式中，如同对图9所述的那样，以与上述金属丝32相似的方式制造柔性中间部分8，除了它具有矩形构型而不是图9所示的圆柱形或圆形构型以外。然而，应理解，可根据上述任何实施方式的设计和材料来制造该柔性中间部分8。
图18显示另一个实施方式的图17的板60的立体图，图中，耦合孔64包括一个或多个切割入连接元件62顶部的螺母引导槽66，以使螺母58(图15)容纳和固定入耦合孔64中。螺母引导槽66被构造成其中可接纳和保留至少一部分螺母58，并在将连接元件62与蒂螺钉2的螺栓头56夹紧后，可防止螺母58在耦合孔64的侧向滑动。
图19显示混合板和杆连接件70的立体图，参见上述图4-7，在连接件70的一端具有刚性杆样连接元件4，9或9′，参见上述图14-18，在连接件70的另一端具有板样连接元件51或62。在一个实施方式中，位于杆样连接元件9(9′)和板样连接元件52(64)之间的是柔性元件8。参见图8-13，可根据任何上述实施方式来设计和制造柔性元件8。
图20显示采用图19的混合板和杆连接件70的脊柱固定装置的立体图。如图20所示，该固定装置采用两种类型的锁定元件2(例如，蒂螺钉)，第一锁定元件2′被构造成可稳固地保持板连接元件42(64)，参见图15如上所述，第二锁定元件2″被构造成可稳固地保持杆连接元件4，9或9′，参见图3如上所述。
图21显示与两相邻椎骨80和82结合以柔性稳定椎骨后的、两个根据图1所示实施方式的脊柱固定装置的俯视立体图。图22A和22B分别显示了与两个或多个相邻脊柱椎骨结合后，采用图16A和16B的柔性稳定元件50和58的脊柱固定装置的俯视图。
图23A显示植入两相邻椎骨后，脊柱固定装置的侧视图。如图所示，将蒂螺钉2安装入蒂骨中，以使螺钉2的中轴线80偏移水平面82θ角，两螺钉2的中轴线80相互偏离约2θ角。蒂螺钉2的这种非平行插入常常是由于进行最小侵入性外科手术时可获得的有限空间量所造成的结果。此外，由于患者的固有脊柱曲率(例如，脊柱前凸)，蒂螺钉2具有偏离水平面而倾斜的趋势。因此，由于蒂螺钉2最终固定于脊柱蒂的非平行方式，当杆或板连接件与各个蒂螺钉2结合时，需要抵消这种倾斜。
图23B显示根据本发明一个实施方式的蒂螺钉头的侧视图。螺钉2包括类似于上述图3的圆柱形头部16的圆柱形头部84，除了圆柱形头部84包括斜座86以外，斜座86被构造成可接纳并保持柔性杆4倾斜取向，以抵消上述蒂螺钉2的斜角或倾斜角θ。改进的蒂螺钉2还包括斜面稳定间隔物88，它被构造成可稳固地适配入圆柱形头部84的腔内、并以与斜座86相同的倾斜度挡住杆4。蒂螺钉2还包括外螺纹螺母22，它被构造成可与沿圆柱形头部84内表面(未示出)的螺旋形螺纹相匹配，以将斜面间隔物88和杆4夹住并锁定于斜座86，进而夹住和锁定于蒂螺钉2的圆柱形头部84。
图23C显示根据本发明的实施方式，斜面间隔物88的立体图。间隔物88包括圆形中间部分90和两个从圆形中间部分90的相对侧向外延伸的矩形末端部分92。图23D显示间隔物88的侧视图，还显示从一端到另一端的斜角补偿或抵消蒂螺钉2的倾斜角θ。图23E显示圆柱形头部84的俯视图，它被构造成可在其中接纳杆4和斜面间隔物88。通过圆柱形头部84圆柱壁中的两个开口或狭槽94接纳杆4，以使杆4进入圆柱形头部84的圆形或圆柱形空腔96，并保留在形成于圆形或圆柱形空腔94中的斜座86的顶部。将杆4放置于斜座86上之后，空腔96接纳斜面稳定间隔物88，以使两个矩形末端部分92被接纳在两狭槽94内，从而防止间隔物88在圆柱形空腔96内的侧向旋转。最后，将外螺纹螺母22和固定帽26插入斜面间隔物88上方，以使间隔物88和杆4稳固地保留在圆柱形头部84内。
图24显示标示和导向装置100的立体图，该装置100用于标示脊柱蒂上所需插入蒂螺钉2的位置、并采用最小侵入性外科手术技术将蒂螺钉2引导至标示的位置。如图24所示，标示装置100包括管状中空导向件52，其空腔中接纳内套针104，套针104的一端具有穿过患者肌肉和组织以达到脊柱蒂的尖头105。内套针104的另一端还包括便于套针104的插入和取出的套针握把106。在一个实施方式中，标示和导向装置100包括导向件把手108，以便于掌握好装置100。
如图25所示，套针104为长管或圆柱体形式，直径小于导向件102空腔的内径，以便插入管状导向件102的空腔。套针104还包括尖锐或削尖的头105，以通过蒂穿透椎体。套针104还包括套针握把106，其直径大于导向件102管腔的直径，以防止套针104弯曲滑出空腔。套针握把106还便于套针104的掌握。
图26A和26B提供了插入患者背部并推过肌肉和软组织而达到所需的脊柱蒂上位置后，标示和导向装置100的立体图。采用已知技术，例如进行较短时间的X-射线或放射成像，确定所需的位置。插入标示和导向装置100后，无需使患者长时间暴露于X-射线辐射。如图26B所示，在将导向管102置于蒂上所需位置后，除去内套针104以使基准销(未示出)插入导向管102空腔，然后固定入蒂中。
图27A和27B分别显示两个实施方式的基准销110和112的立体图。如上所述，穿过中空导向件102之后，插入本发明基准销110和112并固定入脊柱蒂。销110和112为圆柱形，且其直径小于导向管102空腔的内径，以能穿过导向件102的空腔。各基准销的末端为尖端111，它被构造成可容易地插入并固定入脊柱的脊柱蒂中。在一个实施方式中，如图27B所示，基准销的另一端包括螺纹轴114，它被构造成与用于取出销112的取出件(未示出)的内螺纹管相匹配。下面将参见图32更详细地描述取出件。
优选用耐久和刚性的生物相容金属(例如，不锈钢、钢铁、钛、钛合金)来制成基准销110，112，以便于插入蒂骨。与现有领域的引导丝不同，因为它的长度相对较短，结构较刚性，基准销110，112易于插入脊柱蒂中而没有弯曲或结构故障的危险。如上所述，现有领域中引导丝的驱动过程常常非常困难且耗时。外科医生将基准销110，112插入脊柱蒂上的进入点要容易得多且很方便，而且不会由于引导丝延伸出患者背部而阻碍后续手术。
图28显示圆柱形推针116，其圆柱形头部118的直径大于推针116椎体的直径。根据本发明，基准销110或112插入导向件102的空腔后，将推针116插入导向件102的空腔，以使基准销110或112进入和固定入脊柱蒂。在销插入过程中，医生用凿或锤敲击套针头部118，以驱动基准销110和112进入脊柱蒂。在优选的实施方式中，推针116为圆柱管形，其直径小于导向管112空腔内径。推针116还包括圆柱形头部118，其直径大于推针116的直径，以使医生更容易地用凿或锤敲击。当然，在另一些实施方式中，无需凿或锤。例如，根据每个病例的情况，外科医生可选择用他或她的手掌或其它物体推压或敲击推针116的头部118。
图29A显示如何使用锤或槌120和推针116以驱使销110，112穿过导向管102空腔并进入脊柱蒂的指定位置。图29B显示为将两个基准销110，112驱动和固定入两相邻椎骨后，脊柱的透视剖面图。
如上所述将基准销110或112插入脊柱蒂之后，在一个实施方式中，以各个销110，112为中心、在其周围产生较大的洞或区域，以便于将蒂螺钉2插入和安装入蒂骨中。用如图30所示的套管锥122形成较大的洞。在固定于脊柱蒂所需位置的基准销110，112上方插入套管锥122。锥122呈圆柱形中空管形式，其管腔内径大于基准销110和112的外径，以使销110，112可插入锥122的管腔。锥122在其第一端还包括一个或多个尖齿124，用于切割和研磨组织和骨、以形成围绕基准销110，112的较大的孔，使蒂螺钉2更容易植入基准蒂中。图31显示当将套管锥122插入患者背部、基准销110，112上方的最小侵入性切口中以形成蒂螺钉2(未示出)较大的插入洞时，患者脊柱的透视剖面图。如图31所示，将收缩件130插入外科手术区域上方最小侵入性切口中，收缩件130的下管体膨胀，将周围组织向外推而远离外科手术区域，并提供更大空间和视野以便外科医生操作。为插入收缩件130，在一个实施方式中，在用于插入两个基准销110，112的导向管102的两个进入点之间的患者背部中制备最小侵入性切口，并连接这两个进入点。在插入收缩件130之前，一般需要用一系列分步扩张器(未示出)先膨胀最小侵入性切口，后一个扩张器的直径大于前一个扩张器的直径。在最后一个分步扩张器位于适当位置之后，插入收缩件130，此时，其下管体为收缩、非膨胀状态。当将收缩件130向脊柱蒂推入至所需深度后，如图31所示膨胀下管状部分。分步扩张器和收缩件的使用是本领域公知的。
在套管锥122形成用于蒂螺钉2的较大的插入洞之后，在一个实施方式中，除去基准销110，112。如上所述，如果使用了基准销112，可在植入蒂螺钉2之前，用取回装置140取出基准销112。如图32所示，取出件140包括长管状或圆柱形部分，其具有内螺纹端142，内螺纹端142被构造成与基准销112的外螺纹顶部114相匹配。在将取出件末端142拧入螺纹端114上之后，医生可将基准销112拔出脊柱蒂。在另一个实施方式中，如果使用不具有螺纹顶部的基准销110，则可采用适当的工具(例如，特殊设计的针头钳)来拔出基准销110。
在另一些实施方式中，基准销110，112不从脊柱蒂中取出。相反，将特殊设计的蒂螺钉144插入销110，112上方的脊柱蒂中，而不需要先取出销110，112。如图33所示，特殊设计的蒂螺钉144包括外螺纹轴10和联结组合件14(图3)，联结组合件14包括圆柱形头部16(图3)以接纳柔性杆形连接元件4(图4-13)。或者，联结组合件14被构造成可接纳图14-20所示的板样连接元件。蒂螺钉144还包括螺纹轴10内的纵轴通道(未示出)，轴10在其尖端处具有开口146，且轴10被构造成可在其中接纳基准销110，112。
图34显示用插入装置150将蒂螺钉2插入第一脊柱蒂之后，患者脊柱的透视剖面图。可使用本领域已知的各种类型的插入装置150来插入蒂螺钉2。如图34所示，植入第一蒂螺钉2之后，调节和稍稍移动收缩件130以提供可用以在第二基准销110，112的位置插入第二蒂螺钉的空间和视野。
图35提供了根据本发明，将两个蒂螺钉2分别植入两相邻脊柱蒂之后，患者脊柱的透视剖面图。在蒂螺钉2适当就位之后，将上述图4-20所示的柔性杆、板或混合连接元件与蒂螺钉联结，以给脊柱提供柔性稳定。然后，除去收缩件130，闭合和/或缝合最小侵入性切口。
上文已描述了本发明的各种实施方式。然而，本领域普通技术人员将理解，优选实施方式的上述描述仅仅是示例性的，可用上述装置和技术的改进或变化来实施本发明。本领域普通技术人员将明白，或能够用常规实验确定所述本发明具体实施方式的许多等价形式。这些改进、变化和等价形式包括在本发明的精神和范围内，如所附权利要求所述。

Claims (43)

1.一种脊柱固定装置，所述装置包括：
第一和第二锁定元件，锁定元件各自具有构型可分别插入两相邻椎骨指定进入点的螺纹轴元件，各个锁定元件具有用以接纳和固定各连接件末端部分于其中的联结组合件；以及
柔性连接件，其具有构型可接纳和固定在第一锁定元件的联结组合件内的第一末端部分和构型可接纳和固定在第二锁定元件的联结组合件内的第二末端部分，其中，柔性连接件包括具有沿其管状主体的至少一部分形成的螺旋形槽的金属管，以给连接件提供柔性。
2.如权利要求1所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成杆样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
3.如权利要求1所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成板样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
4.如权利要求1所述的脊柱固定装置，其特征在于，所述第一末端部分被构造成杆样连接元件，所述第二末端部分被构造成板样连接元件，所述第一锁定元件的联结组合件被构造成可接纳和固定所述第一末端部分，所述第二锁定元件的联结组合件被构造成可接纳和固定所述第二末端部分。
5.如权利要求1所述的脊柱固定装置，其特征在于，所述柔性连接件包括位于两刚性部分之间的柔性中间部分，其中，柔性中间部分包括其中具有所述螺旋形槽的金属管的管状主体的所述部分。
6.如权利要求1所述的脊柱固定装置，其特征在于，所述柔性连接件形成预弯曲构型。
7.如权利要求1所述的脊柱固定装置，其特征在于，所述第一和第二锁定元件为蒂螺钉，所述各联结组合件各自包括斜座和斜面间隔物，斜座用于以θ角接纳所述柔性连接件的一末端部分，斜面间隔物被构造成可稳固地将柔性连接件的末端部分固定于斜座。
8.一种脊柱固定装置，所述装置包括：
第一和第二锁定元件，锁定元件各自具有构型可分别插入两相邻椎骨指定进入点的螺纹轴元件，各个锁定元件还具有用以接纳和固定各连接件末端部分于其中的联结组合件；以及
柔性连接件，其具有构型可接纳和固定在第一锁定元件的联结组合件内的第一末端部分和构型可接纳和固定在第二锁定元件的联结组合件内的第二末端部分，其中，柔性连接件包括至少一根包含许多金属纱的金属丝，以给连接件提供柔性。
9.如权利要求8所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成杆样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
10.如权利要求8所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成板样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
11.如权利要求8所述的脊柱固定装置，其特征在于，所述第一末端部分被构造成杆样连接元件，所述第二末端部分被构造成板样连接元件，所述第一锁定元件的联结组合件被构造成可接纳和固定所述第一末端部分，所述第二锁定元件的联结组合件被构造成可接纳和固定所述第二末端部分。
12.如权利要求8所述的脊柱固定装置，其特征在于，所述柔性连接件包括位于刚性部分之间的柔性中间部分，其中，柔性中间部分包括所述金属丝。
13.如权利要求8所述的脊柱固定装置，其特征在于，所述柔性连接件形成预弯曲构型。
14.如权利要求8所述的脊柱固定装置，其特征在于，所述第一和第二锁定元件为蒂螺钉，所述各联结组合件各自包括斜座和斜面间隔物，斜座用于以θ角接纳所述柔性连接件的一末端部分，斜面间隔物被构造成可稳固地将柔性连接件的末端部分固定于斜座。
15.如权利要求8所述的脊柱固定装置，其特征在于，所述柔性连接件包括多根以编织结构交织的金属丝，以给所述柔性连接件提供所需的柔性水平。
16.如权利要求15所述的脊柱固定装置，其特征在于，所述柔性连接件包括位于刚性部分之间的柔性中间部分，其中，柔性中间部分包括以编织结构交织的所述多根金属丝。
17.一种脊柱固定装置，所述装置包括：
第一和第二锁定元件，锁定元件各自具有构型可分别插入两相邻椎骨指定进入点的螺纹轴元件，各个锁定元件还具有用以接纳和固定各连接件末端部分于其中的联结组合件；以及
柔性连接件，其具有构型可接纳和固定在第一锁定元件的联结组合件内的第一末端部分和构型可接纳和固定在第二锁定元件的联结组合件内的第二末端部分，其中，柔性连接件包括至少一个位于第一和第二末端部分之间的金属间隔物和位于至少一个金属间隔物的纵轴通道中的柔性金属材料，以给柔性连接件提供柔性。
18.如权利要求17所述的脊柱固定装置，其特征在于，所述至少一个金属间隔物还包括阳互锁元件和阴互锁空腔，它们各自被构造成分别与各个具有相应的阴互锁空腔和阳互锁元件的相邻金属间隔物或末端部分结构互锁。
19.如权利要求17所述的脊柱固定装置，其特征在于，所述柔性金属材料是包含许多金属纱的金属丝。
20.如权利要求17所述的脊柱固定装置，其特征在于，所述柔性金属材料是包含多根交织金属丝的编织的金属丝结构。
21.如权利要求17所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成杆样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
22.如权利要求17所述的脊柱固定装置，其特征在于，所述第一和第二末端部分被构造成板样连接元件，所述各联结组合件被构造成可接纳和固定所述第一和第二末端部分。
23.如权利要求17所述的脊柱固定装置，其特征在于，所述第一末端部分被构造成杆样连接元件，所述第二末端部分被构造成板样连接元件，所述第一锁定元件的联结组合件被构造成可接纳和固定所述第一末端部分，所述第二锁定元件的联结组合件被构造成可接纳和固定所述第二末端部分。
24.一种用于脊柱固定装置的柔性金属连接件，所述连接件包括具有沿其管状主体的至少一部分形成的螺旋形槽的第一金属管，以给连接件提供柔性。
25.如权利要求24所述的柔性金属连接件，还包括直径小于所述第一金属管的第二金属管，以使第二金属管被构造成可适配入第一金属管的纵轴通道内，其中，所述第二金属管包括沿其管状主体的至少一部分形成的第二螺旋形槽。
26.如权利要求24所述的柔性金属连接件，还包括具有许多金属纱的金属丝，其中，所述金属丝被构造成可适配入所述第一金属管的纵轴通道内。
27.如权利要求24所述的柔性金属连接件，还包括具有许多交织金属丝的编织的金属丝结构，其中，所述编织的金属丝结构被构造成可适配入所述第一金属管的纵轴通道内。
28.如权利要求24所述的柔性金属连接件，还包括位于所述第一金属管的纵轴通道内的柔性芯材料。
29.如权利要求28所述的柔性连接件，其特征在于，所述柔性芯材料包括以下材料中的至少一种：碳石墨、PEEK、PEEKEK、NITINOL、UHMWPE。
30.如权利要求24所述的柔性连接件，还包括位于两刚性部分之间的柔性中间部分，其中，柔性中间部分包括其中具有螺旋形槽的金属管的管状主体的所述部分。
31.如权利要求24所述的柔性连接件，其特征在于，所述柔性连接件形成预弯曲构型。
32.一种用于脊柱固定装置的柔性连接件，所述连接件包括至少一根具有许多金属纱的金属丝，其中，金属纱的材料、厚度和数目决定柔性连接件的柔性水平。
33.如权利要求32所述的柔性连接件，还包括位于刚性部分之间的柔性中间部分，其中，柔性中间部分包括所述金属丝。
34.如权利要求32所述的柔性连接件，其特征在于，所述柔性连接件形成预弯曲构型。
35.一种具有编织的金属结构的用于脊柱固定装置的柔性连接件。
36.如权利要求35所述的柔性连接件，其特征在于，所述编织结构包括多根金属丝以编织的方式交织，以给所述柔性连接件提供所需的柔性水平。
37.如权利要求36所述的柔性连接件，还包括位于刚性部分之间的柔性中间部分，其特征在于，所述柔性中间部分包括编织结构的所述多根金属丝。
38.如权利要求35所述的柔性连接件，其特征在于，所述柔性连接件形成预弯曲构型。
39.一种用于脊柱固定装置的柔性连接件，所述连接件包括至少一个位于两末端部分之间的金属间隔物和位于至少一个金属间隔物的纵轴通道中的柔性金属材料，以给柔性连接件提供柔性。
40.如权利要求39所述的柔性连接件，其特征在于，所述至少一个金属间隔物还包括阳互锁元件和阴互锁空腔，它们各自被构造成分别与各个具有相应的阴互锁空腔和阳互锁元件的相邻金属间隔物或末端部分结构互锁。
41.如权利要求39所述的柔性连接件，其特征在于，所述柔性金属材料是包含许多金属纱的金属丝。
42.如权利要求39所述的柔性连接件，其特征在于，所述柔性金属材料是包含多根交织金属丝的编织的金属丝结构。
43.一种用于脊柱固定装置的蒂螺钉，所述蒂螺钉包括构型可插入和固定于脊柱蒂骨的螺纹轴部分和连接于螺纹轴部分的顶端的联结组合件，其中，联结组合件包括斜座和斜面间隔物，斜座用于以θ角接纳所述柔性连接件的一末端部分，斜面间隔物被构造成可稳固地将柔性连接件的末端部分固定于斜座。
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US20050177157A1 (en) 2005-08-11
US7993370B2 (en) 2011-08-09
IL174444A0 (en) 2006-08-01
EP1686906A4 (en) 2011-07-27
US20070055247A1 (en) 2007-03-08
EP1677689A4 (en) 2010-02-17
EP1677689A2 (en) 2006-07-12
WO2005030029A3 (en) 2005-09-22
US20050065515A1 (en) 2005-03-24
US20070123871A1 (en) 2007-05-31
KR100499559B1 (ko) 2005-07-05
KR20050030142A (ko) 2005-03-29
WO2005030031A2 (en) 2005-04-07
CN1882286B (zh) 2010-05-26
JP2007506514A (ja) 2007-03-22
AU2004275735B2 (en) 2009-12-10
US20050065516A1 (en) 2005-03-24
US8968366B2 (en) 2015-03-03
US20060195093A1 (en) 2006-08-31
CA2539923A1 (en) 2005-04-07

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