CN101959468B - 小面干涉螺钉 - Google Patents

小面干涉螺钉 Download PDF

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Publication number
CN101959468B
CN101959468B CN200980106809XA CN200980106809A CN101959468B CN 101959468 B CN101959468 B CN 101959468B CN 200980106809X A CN200980106809X A CN 200980106809XA CN 200980106809 A CN200980106809 A CN 200980106809A CN 101959468 B CN101959468 B CN 101959468B
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China
Prior art keywords
facet
screw
parts
preferred
interfere
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Expired - Fee Related
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CN200980106809XA
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English (en)
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CN101959468A (zh
Inventor
B·莱希曼
P·W·帕夫洛夫
S·楚施密德
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AO Technology AG
Synthes USA LLC
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Synthes AG Chur
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00856—Coating or prosthesis-covering structure made of compounds based on metal nitrides
    • A61F2310/0088—Coating made of titanium nitride
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00856—Coating or prosthesis-covering structure made of compounds based on metal nitrides
    • A61F2310/00886—Coating made of chromium nitride

Abstract

用于插入在相邻上侧和下侧椎骨的小面关节之间的小面干涉螺钉(10)包括：外螺纹杆部和头部。小面干涉螺钉优选地分成第一部件(20)和第二部件(30)，各部件包括外部半圆形外螺纹表面(22、32)，这样，当连接在一起时，半圆形外螺纹表面形成外螺纹杆部分。第一和第二部件的内表面(24、34)可以包括弯曲接触表面，这样，当插入时，第一部件可相对于第二部件运动。也可选择，螺钉可以包括在第一部件和第二部件的内表面之间的阻尼部件(60a′)，以便于使得第一部件和第二部件相互阻尼。阻尼部件优选地还便于第一和第二部件的关节运动。

Description

小面干涉螺钉
相关申请的交叉引用
本申请要求美国临时专利申请No.61/034295的优先权，该美国临时专利申请No.61/034295的申请日为2008年3月6日，标题为“FACETINTERFERENCE SCREW”，该文献的内容整个被本文参引。
背景技术
小面关节是脊骨运动段的连接关节，它可能由于老化、损伤、经常使用和其它因素而退化。在脊骨的各个区域中的小面关节定向在不同平面中，例如，腰部小面关节大致位于矢状平面Sp中，胸部小面关节大致定位在冠状平面Cp中，而颈部小面关节大致定位在轴向或横向平面Ap中(图1和2)。这些定向有利于在脊骨的各区域中的不同类型运动。
退化的小面关节通常由于例如在两个关节炎的关节连接表面(该关节连接表面环绕滑液关节囊)之间的磨损而疼痛。小面关节的表面由关节软骨来覆盖。当小面的软骨表面退化或裂开时可能产生炎症反应，从而导致直接的骨-骨接触和产生疼痛。周围关节囊的过度分散也可能引起病人疼痛。病人通常进行融合外科手术以便减轻该疼痛。
希望开发一种植入件，用于插入在相邻的上侧和底侧椎骨之间的小面关节中，以便减轻由于退化的小面关节导致的疼痛，该植入件不会导致小面关节的直接融合。
发明内容
本发明涉及一种脊骨植入件。更具体地说，本发明的优选实施例涉及一种小面干涉螺钉(facet interference screw)，用于插入相邻上侧和下侧椎骨的小面关节之间。小面干涉螺钉优选地包括头部部分和外螺纹杆部分，这样，小面干涉螺钉可以通过插入仪器例如螺丝刀或螺丝刀状仪器而旋转插入或拧入小面关节中。优选地，小面干涉螺钉包括第一和第二部件，各第一和第二部件包括外部半圆形外螺纹表面和内表面，这样，当连接在一起时，半圆形外螺纹表面形成外螺纹杆部分。
在优选实施例中，第一和第二部件的内表面可以包括弯曲接触表面。该弯曲接触表面优选地允许在第一和第二部件之间沿纵向轴线进行弓形运动，并横向于该纵向轴线的限制运动。
在小面干涉螺钉的另一优选实施例中，阻尼部件可以插入第一和第二部件的内表面之间，以便于第一和第二部件彼此相对阻尼。阻尼部件可以成两件式阻尼部件的形式，包括上部阻尼部件，该上部阻尼部件有用于与第一部件的内表面接触的外表面以及内表面。阻尼部件还可以包括下部阻尼部件，该下部阻尼部件有用于与第二部件的内表面接触的外表面以及内表面。上部和下部阻尼部件的内表面各自包括弯曲接触表面，这样，上部阻尼部件可相对于下部阻尼部件关节式连接。上部阻尼部件优选地固定在第一部件上，下部阻尼部件优选地固定在第二部件上，这样，小面干涉螺钉的大部分关节式连接是在上部和下部阻尼部件之间在上部和下部阻尼部件的弯曲接触表面处。
本发明还涉及用于将优选的小面干涉螺钉插入相邻的上侧和下侧椎骨的小面关节之间的方法。
附图说明
当结合附图阅读时，将更好地理解本申请的前述内容以及下面对优选实施例的详细说明。为了表示本申请的优选小面干涉螺钉和用于插入该小面干涉螺钉的外科手术方法，在图中表示了优选实施例。不过应当知道，本申请并不局限于所示的确切结构和手段。附图中：
图1A表示根据本发明的一个后面所述优选实施例的两个小面干涉螺钉的后视透视图，这两个小面干涉螺钉安装在病人脊骨的腰部部分的安装位置处的小面关节中；
图1B表示了在图1A所示的安装位置中的小面干涉螺钉的侧视透视图；
图2A表示了根据本发明第一优选实施例的小面干涉螺钉的侧向透视图；
图2B表示了图2A中所示的小面干涉螺钉的分解侧向透视图；
图2C表示了图2A中所示的小面干涉螺钉的侧向透视图，具有临时间隔件；
图3A表示了根据本发明第二优选实施例的小面干涉螺钉的顶部透视图；
图3B表示了阻尼部件的顶部透视图，该阻尼部件可以用于图3A所示的小面干涉螺钉，该阻尼部件包括贯穿的插管开口；
图3C表示了可选阻尼部件的顶部透视图，该阻尼部件可以用于图3A所示的小面干涉螺钉，该阻尼部件为大致实心和连续；
图3D表示了还一可选阻尼部件的顶部透视图，该阻尼部件可以用于图3A所示的小面干涉螺钉，该阻尼部件包括T形槽道，用于与形成于图3A的小面干涉螺钉的第一部件和第二部件中的一个或两个中的槽接合；
图4A表示了根据本发明第三优选实施例的小面干涉螺钉的侧向透视图；
图4B表示了示例性两件式连接部件的侧向透视图，该连接部件可以用于图4A所示的小面干涉螺钉；
图5A表示了图4A所示的小面干涉螺钉沿图4A中的线5-5的剖视图，该小面干涉螺钉表示为处于中间位置；
图5B表示了图4A所示的小面干涉螺钉沿图4A中的线5-5的剖视图，该小面干涉螺钉表示为进行弯曲；
图5C表示了图4A所示的小面干涉螺钉沿图4A中的线5-5的剖视图，该小面干涉螺钉表示为进行伸长；
图6A表示了图4A中所示的小面干涉螺钉的后视图，该小面干涉螺钉表示为处于中间位置；
图6B表示了图4A中所示的小面干涉螺钉的后视图，该小面干涉螺钉表示为进行横向弯曲；
图7A表示了第一、第二和第三优选实施例的上述小面干涉螺钉中的一个的后方透视图，其包括优选的防旋转机构；
图7B表示了第一、第二和第三优选实施例的上述小面干涉螺钉中的一个的后方透视图，其包括可选的优选防旋转机构；
图8表示了根据本发明的优选方法，根据第一、第二和第三优选实施例中的至少一个的两个小面干涉螺钉的后方透视图，所述两个小面干涉螺钉同时插入病人脊骨的小面关节中；
图9A表示了图4A的小面干涉螺钉安装在优选的螺丝刀上的顶部透视图，其中，螺丝刀的优选套筒(以虚线表示)处于延伸位置；
图9B表示了在图9A的圆9B中的图4A的小面干涉螺钉顶部透视图；
图9C表示了安装在螺丝刀上的、图4A的小面干涉螺钉的侧向透视图，该螺丝刀的套筒处于缩回位置；以及
图9D表示了安装在螺丝刀上的、图4A的小面干涉螺钉的放大顶部透视图，该螺丝刀的套筒处于进一步缩回位置。
具体实施方式
下面的说明书中使用的某些术语只是为了方便，而不是限定。词语“右”、“左”、“顶部”和“底部”表示所参考的图中的方向。词语“内侧”和“外侧”是指分别朝向和远离小面干涉螺钉和其所表示部件的几何中心的方向。词语“前面”、“后面”、“上面”、“下面”、“侧面”、“径向”、“轴向”、“冠状”和相关词语和/或短语是指所参考的人体的优选位置和方位，而不是进行限制。术语包括上述词语、衍生词和类似意思的词。
下面将参考附图介绍本发明的某些示例实施例。本发明的优选实施例涉及：(i)小面干涉螺钉10、10′、10″的第一、第二和第三优选实施例，用于插入在相邻上侧和下侧椎骨V的小面关节FJ之间；以及(ii)用于在病人的脊骨的相邻上侧和下侧椎骨V的小面关节FJ之间插入优选的小面干涉螺钉10、10′、10″的示例外科手术方法。应当知道，尽管本申请的优选小面干涉螺钉10、10′、10″介绍为和大致可以用于脊骨(例如腰部、胸部或颈部区域)，但是本领域技术人员应当知道，优选的小面干涉螺钉10、10′、10″以及它的部件可以用于身体其它部分，例如膝盖、臀部、肩部、手指、关节、手、脸、脚中的长骨或骨，例如包括手的掌骨、小多角骨(trapecoidal)和腕舟骨关节以及脚的跖骨-趾骨关节等。
参考图1A和1B，图中表示了在病人脊骨的腰部区域中的两个示例椎骨V。各椎骨V包括在棘突SP各侧的一对上侧关节小面Fs和一对下侧关节小面Fi。在上侧椎骨V上的下侧小面Fi和在下侧椎骨V上的上侧小面Fs通过关节囊或小面关节空间FJ1、FJ2而可运动地相互连接，该关节囊或小面关节空间FJ1、FJ2引导和限制运动段的运动。图1A和1B中所示的椎骨V包括位于棘突SP左侧的第一小面关节FJ1和位于棘突SP右侧的第二小面关节FJ2。第一和第二小面关节FJ1、FJ2分别包括第一和第二小面关节平面FJp1、FJp2，它们大致定向在大部分腰部脊骨中的矢状平面Sp内。
小面关节FJ1、FJ2引导和便于在上侧和下侧椎骨V之间的运动。由于脊骨S的自然或损伤退化，小面关节FJ1、FJ2可能受到影响。例如，当小面关节FJ1、FJ2的软骨表面退化时，可能产生炎症反应，这可能导致在形成于上侧椎骨V上的下侧小面Fi和形成于下侧椎骨V上的上侧小面Fs之间直接接触，从而引起小面关节FJ1、FJ2疼痛。
增大小面关节FJ1、FJ2以便减轻在疼痛区域上的压力可以通过在形成于上侧椎骨V上的下侧小面Fi和形成于下侧椎骨V上的上侧小面Fs之间插入植入件(优选地小面干涉螺钉10、10′、10″)来实现。优选的小面干涉螺钉10、10′、10″能够处理小面关节FJ1、FJ2，从而能够保留活动性和/或稳定性，同时能够在任何时候需要额外的内部固定时使得椎弓根(pedicle)保持完整。增大小面关节FJ1、FJ2可以通过插入两个优选的小面干涉螺钉10、10′、10″来实现，一个小面干涉螺钉10、10′、10″用于一个小面关节FJ1、FJ2。此外，优选的小面干涉螺钉10、10′、10″可以在有或没有间隔件的情况下插入在相邻椎骨V之间的椎间盘空间Ds中。
参考图2A和2B，小面干涉螺钉10的第一优选实施例大致成骨螺钉10的形式。第一优选实施例的小面干涉螺钉10包括头部部分14和外螺纹杆部分16。头部部分14优选地包括用于与螺丝刀225接合的机构。例如，头部部分14优选地包括多个凹口44，用于与形成于螺丝刀225的尖端228上的多个凸起229接合(如后面更详细所述)，尽管可以考虑其它结构，包括但不局限于：内部凹口、外部六边形、星形驱动模式、十字槽螺丝帽模式、用于螺丝刀的狭槽、用于相应螺杆的螺纹等。杆16的特殊特征(包括例如螺纹节距、自钻孔结构、自攻结构、杆直径、杆形状等)可以互换，且本领域技术人员显然知道，小面干涉螺钉10并不局限于任何特殊类型的杆16或螺纹结构。
第一优选实施例的小面干涉螺钉或骨螺钉10沿小面干涉螺钉10的纵向轴线13纵向分开，这样，小面干涉螺钉10包括第一部件20和第二部件30。各第一和第二部件20、30包括外部的优选地半圆形外螺纹表面22、32以及内表面24、34，这样，当连接在一起时，半圆形外螺纹表面22、32形成外螺纹杆部分16。因此，在使用中，小面干涉螺钉10优选地通过例如由螺丝刀225旋转(如下面将更详细地描述)而插入形成于上侧椎骨V上的下侧小面Fi和形成于下侧椎骨V上的上侧小面Fs之间。第一优选实施例的内表面24、34优选地大致连续地从头部部分14延伸至杆部分16的尖端16a，并限定关节式连接平面Rp，第一和第二部件20、30可以在安装位置大致沿该关节式连接平面Rp彼此相对运动，如后面更详细所述。内表面24、34优选地在装配结构和在安装结构中沿它的较大部分进行接触，以便引导第一部件20相对于第二部件30的运动。
第一优选实施例的小面干涉螺钉10的第一和第二部件20、30的内表面24、34可以包括弯曲接触表面，该弯曲接触表面有例如凸形和/或凹形表面，用于分别与另外部件20、30的弯曲接触表面相互作用，这样，当插入时，第一部件20可相对于第二部件30沿弯曲或弓形路径运动。也就是，例如第一部件20的内表面24可以包括凸形表面，用于与形成于第二部件30的内表面34上的凹形表面接触。不过，如本领域普通技术人员已知，第二部件30的内表面34可以有凸形表面，而第一部件20的内表面24可以有凹形表面。也可选择，两个内表面24、34可以有凹形表面或凸形表面。内表面24、34的凸形或凹形形状(导致在第一和第二部件之间的弓形运动路径)优选地在安装位置安装在一个小面关节FJ1、FJ2中，以便大致模拟小面关节FJ1、FJ2的配合表面的自然弓形形状，如本领域普通技术人员已知的那样。
第一和第二部件20、30的内表面24、34还可以包括插管开口42，用于接收引导线200(图8)，如后面更详细所述。
参考图2C，第一优选实施例的小面干涉螺钉10还可以包括临时间隔件40，该临时间隔件40至少在插入结构中位于第一和第二部件20、30的内表面24、34之间。优选地，临时间隔件40包括用于接收引导线200(图8)的插管开口42，如后面更详细所述。在使用时，临时间隔件40在插入结构中插入在第一和第二部件20、30的内表面24、34之间。具有安装于其中的临时间隔件40的小面干涉螺钉10通过小面干涉螺钉10的旋转而插入形成于上侧椎骨V上的下侧小面Fi和形成于下侧椎骨V上的上侧小面Fs之间。一旦位于安装位置，优选地除去间隔件40，内表面24、34相对接合或接触，以便于它们之间的运动。引导线200可以包括在远端处的较大直径部分202，该较大直径部分202与临时间隔件40接合并在从小面关节FJ1、FJ2上除去引导线200时除去该临时间隔件40。这样，间隔件40有利于第一优选实施例的小面干涉螺钉10借助于引导线200而插入在下侧小面Fi和上侧小面Fs之间。在使用时，间隔件40防止在第一和第二部件20、30的内表面24、34之间进行表面接触。在安装位置，优选地，间隔件40的取出使得弯曲内表面24、34能够沿弯曲或弓形路径而连接。此外，第一优选实施例的小面干涉螺钉10位于安装位置中，这样，小面干涉螺钉10的关节式连接平面Rp分别大致平行于第一或第二小面关节平面FJp1、FJp2，以便于各小面关节FJ1、FJ2恢复接近正常的关节式连接或运动。
参考图3A-3D，小面干涉螺钉10′的第二优选实施例与小面干涉螺钉10的第一优选实施例类似，除了小面干涉螺钉10′的第二优选实施例包括位于第一和第二部件20′、30′的内表面(在第二优选实施例中未示出)之间的阻尼部件60a′、60b′、60c′，以便于阻尼和/或第一和第二部件20′、30′的彼此相对运动。第二优选实施例的小面干涉螺钉10′用类似参考标号表示类似元件，并加上符号(′)，以便于区别第二优选实施例的小面干涉螺钉10′的元件。优选的阻尼部件60a′、60b′、60c′优选地便于第一和第二部件20′、30′相对于彼此压缩。此外，优选的阻尼部件60a′、60b′、60c′能够在第一和第二部件20′、30′之间进行横向和纵向运动。阻尼部件60a′、60b′、60c′优选地由相对弹性的材料来构成，其使得在第一和第二部件20′、30′之间能够沿六个自由度运动。例如，阻尼部件60a′、60b′、60c′可以由聚合物材料构成，该聚合物材料足够强，以便承受小面干涉螺钉10′在安装于小面关节FJ中时遇到的典型负载，并能够承受在永久性植入小面关节FJ内时遇到的环境。
第二优选实施例的阻尼部件60a′、60b′、60c′可以通过本领域目前或以后已知的任意机构而与第一和/或第二部件20′、30′预先装配和/或连接，该机构包括但不局限于：粘接剂、机械连接件等。也可选择，阻尼部件60a′、60b′、60c′可以在第一和第二部件20′、30′在安装位置插入小面关节FJ内之后插入内表面24′、34′之间，其中有或没有临时间隔件(图3A-3D中未示出)。也就是，例如第二优选实施例的小面干涉螺钉10′可以插入小面关节FJ中，然后，第一和第二部件20′、30′可以分开，以便在它们之间接收阻尼部件60a′、60b′、60c′。
在第二优选实施例中，阻尼部件60a′、60b′、60c′可以有多种结构，包括：第一优选阻尼部件60a′，它包括在其中的插管开口42′；第二优选阻尼部件60b′，它是大致实心和连续的；以及第三优选阻尼部件60c′，它包括引导和锁定机构70′。第一优选阻尼部件60a′包括插管开口42′，以便在小面干涉螺钉10′的植入过程中使得引导线200容纳于其中。优选地，第一优选阻尼部件60a′在植入小面关节FJ内之前永久性地粘接在第一和第二部件20′、30′上。第二优选阻尼部件60b′包括大致实心的整体结构，而没有插管开口42′。第二优选阻尼部件60b′可以永久性地粘接或连接在第一和第二部件20′、30′上，或者可以在最初植入和除去间隔件40′(图3A-3D中未示出)之后插入在第一和第二部件20′、30′之间。第三优选阻尼部件60c′优选地包括引导和锁定机构70′，以便于阻尼部件60c′插入在第一和第二部件20′、30′之间。引导和锁定机构70′可以包括目前或以后已知的任意机构，包括但不局限于：舌片和槽系统。例如，第一和第二部件20′、30′中的至少一个的内表面24′、34′可以包括槽(未示出)，用于与从阻尼部件60′伸出的T形锁定机构70′匹配。此外，与第一和第二部件20′、30′匹配的第一和第二优选阻尼部件60a′、60b′的表面并不局限于大致扁平和连续，如图所示，而是可以包括接合特征，或者可以大致粗糙，以便于与第一和第二部件20′、30′的内表面进行接合和匹配。例如，第一、第二和/或第三阻尼部件60a′、60b′、60c′可以注塑模制在第一和第二部件20′、30′上，该第一和第二部件20′、30′具有粗糙、开槽、有尖顶或其它不平坦内表面，从而有助于将阻尼部件60a′、60b′、60c′保持在第一和第二部件20′、30′上。
参考图4A-6B，小面干涉螺钉10″的第三优选实施例包括两件式阻尼部件60″，尽管也考虑了三个或更多件。第三优选实施例的小面干涉螺钉10″用类似参考标号表示类似元件，并加上符号(″)，以便于区别第三优选实施例的小面干涉螺钉10″的元件。两件式阻尼部件60″优选地包括：上部阻尼部件62″，该上部阻尼部件62″安装在第一部件20″的内表面24″上；以及下部阻尼部件64″，该下部阻尼部件64″安装在第二部件30″的内表面34″上。上部和下部阻尼部件62″、64″优选地各自包括弯曲接触表面62a″、64a″，这样，上部阻尼部件62″可相对于下部阻尼部件64″运动，且第一部件20″可相对于第二部件30″运动。更优选地，形成于上部和下部阻尼部件62″、64″上的弯曲接触表面62a″、64a″优选地具有沿纵向方向(例如平行于纵向轴线13″)和沿横向方向(例如垂直于纵向轴线13″)的相应球形表面。这样，球形弯曲接触表面62a″、64a″方便弯曲/伸长的关节式连接和横向关节式连接，如图5A-6B中所示。内表面24″、34″也可以便于用于接收引导线200的插管开口42″来引导第三优选实施例的小面干涉螺钉10″的植入。不过，第三优选实施例的小面干涉螺钉10″并不局限于包括插管开口42″，可以构成为没有插管开口42″，这样，上部和下部阻尼部件62a″、64a″在装配构造中基本沿它们整个球形弯曲接触表面62a″、64a″进行接触。
优选地，上部和下部阻尼部件62″、64″由聚合物材料构成，该聚合物材料提供一些弹性，但是有足够刚性，以便防止在安装位置处的使用过程中在弯曲接触表面62a″、64a″处明显磨损。例如，上部和下部阻尼部件62″、64″可以由聚醚醚酮(PEEK)材料而构成，但是并不局限于此，且可以由提供阻尼和磨损能力以及能够承受正常工作情况和安装位置的环境的几乎任意材料而构成。此外，第一和第二部件20″、30″优选地由金属材料构成，例如钛或钢，但是并不局限于此，且可以由能够采取第一和第二部件20″、30″的总体形状和承受小面干涉螺钉10″的正常工作情况的几乎任意可生物相容材料而构成。
参考图7A和7B，第一、第二和第三优选实施例的小面干涉螺钉10、10′、10″还可以包括防旋转机构或特征100a、100b，以便阻止小面干涉螺钉10、10′、10″旋出安装位置。例如，第一防旋转机构100a可以为间隔件100a的形式，该间隔件100a插入在第一和第二部件20、30之间，这样，小面干涉螺钉10、10′、10″的轮廓在安装位置中不再为圆形，因此在安装位置不可能旋出或以其他方式旋转。间隔件100a优选地由阻尼类型材料构成，以便允许在第一和第二部件20、30之间进行限制的运动。更优选地，如图7B中所示，第二优选防旋转间隔件100b可以在它的长度的至少一部分处具有比小面干涉螺钉10、10′、10″的直径宽的宽度，从而进一步限制旋出。防旋转机构100a、100b可以与优选的阻尼部件60a′、60b′、60c′、60″分开和不同，或者可以与它们形成一体。也可选择，小面干涉螺钉10、10′、10″可以包括具有U形的防旋转机构，如美国公开专利申请No.2006/0064099中所述，该美国公开专利申请No.2006/0064099的标题为Articular FacetInterference Screw，申请日为2002年11月13日，该文献被本文参引。
参考图2A、3A、4A、5A、6A和7A，优选实施例的小面干涉螺钉10、10′、10″优选地具有螺钉直径D和螺钉长度L。螺钉长度L优选地在5和25毫米之间，螺钉直径D优选地在4和11毫米之间。小面干涉螺钉10、10′、10″并不局限于这些尺寸，但优选地落在这些范围内，以便允许将小面干涉螺钉10、10′、10″微创插入小面关节FJ中、限制尖端16a穿过小面关节FJ延伸、使得小面干涉螺钉10、10′、10″能够在微创手术过程中穿过插管(未示出)运行、以及用于其它相关考虑。此外，优选实施例的小面干涉螺钉10、10′、10″优选地包括头部部分14、14′、14″，以便于与插入和/或除去工具接合，并限制小面干涉螺钉10、10′、10″插入小面关节FJ内的距离。
参考图6A-7B，优选实施例的小面干涉螺钉10、10′、10″可以包括在头部14、14″上的关节式连接指示器50、50″，它们与小面干涉螺钉10、10′、10″的关节式连接平面Rp对齐。关节式连接指示器50、50″向外科医生提供了视觉指示器，以便证明小面干涉螺钉10、10′、10″的关节式连接平面Rp与安装位置中的小面关节平面FJp1、FJp2对齐。关节式连接平面Rp的未对准或错误取向通常限制小面干涉螺钉10、10′、10″以它的预定方式操作，并可能导致小面关节FJ熔合。也可选择，外科医生可以选择插入小面干涉螺钉10、10′、10″，使得关节式连接平面Rp与小面关节平面FJp1、FJp2未对准，从而无意中促使在小面关节FJ中熔合。而且，关节式连接指示器50、50″可以弯曲，或者以其它方式提供内表面24、34弯曲的指示，以便产生弯曲的关节式连接路径，这样，外科医生能够通过小面关节FJ的自然弯曲关节连接来布置关节式连接平面Rp。
在使用时，优选实施例的小面干涉螺钉10、10′、10″能自攻和/或自钻孔。第一和第二部件20、30优选地单独或者连同优选的临时间隔件40和/或阻尼部件60a′、60b′、60c′、60″通过例如在螺钉头部14中的刚性连接件而预先装配，这样，在使用时，小面干涉螺钉10、10′、10″可以通过用螺丝刀225使得小面干涉螺钉10、10′、10″旋转进入小面关节FJ中而插入，如图8中所示。优选地，小面干涉螺钉10、10′、10″的关节式连接平面Rp与安装位置中的小面关节平面FJp1、FJp2对齐，以便允许小面关节FJ与安装于其中的小面干涉螺钉10、10′、10″关节式连接。也可选择，关节式连接平面Rp可以有意与小面关节平面FJp1、FJp2不对准，以便促进熔合或限制小面关节FJ中的运动。
参考图9A-9D，用于将小面干涉螺钉10、10′、10″插入、植入和/或驱动到小面关节FJ中的优选螺丝刀225包括用于将第一和第二部件20、30以及任意附加部件固定在一起以及在插入过程中保持足够力矩的机构。优选的螺丝刀225包括杆227和套筒230。杆227优选地包括用于同时与小面干涉螺钉10、10′、10″的第一和第二部件20、30接合的尖端228。该尖端228优选地包括多个凸起229，用于与形成于小面干涉螺钉10、10′、10″的头部部分14中的多个凹口44接合。套筒230优选地从伸出位置(如图9A和9B中的虚线所示)至退回位置(如图9C中所示)可运动地布置在杆227上面，在该伸出位置，套筒230包封与螺丝刀225的远端连接的小面干涉螺钉10、10′、10″，在该退回位置，与螺丝刀225的远端连接的小面干涉螺钉10、10′、10″露出。套筒230优选地通过例如弹簧235而偏压向伸出位置。
螺丝刀225优选地在螺丝刀225手柄的近端处包括指示器225a，以便提供小面干涉螺钉10、10′、10″的关节式连接平面Rp的指示。小面干涉螺钉10、10′、10″优选地可沿单个方位安装在螺丝刀225上，这样，指示器225a与小面干涉螺钉10、10′、10″的关节式连接平面Rp对齐。因此，外科医生能够在安装位置验证关节式连接平面Rp的方位，以便与小面关节平面FJp1、FJp2对齐而促进关节式连接，或者未对齐以便促进熔合，如本领域普通技术人员根据本发明的教导可知。
在使用时，用户优选地使得套筒230运动至退回位置，这样，小面干涉螺钉10、10′、10″可以与螺丝刀225的远端连接。套筒230通过弹簧偏压而运动至伸出位置，这样，小面干涉螺钉10、10′、10″由套筒230包围。在伸出位置，套筒230帮助将小面干涉螺钉10、10′、10″的第一和第二部件20、30保持在一起，这样，小面干涉螺钉10、10′、10″的多个部件可以作为单个单元而旋转到小面关节FJ中。在插入过程中，在套筒230的远端和病人的骨之间的接触使得套筒230从伸出位置运动至退回位置，以便露出小面干涉螺钉10、10′、10″。小面干涉螺钉10、10′、10″被驱动到小面关节FJ中，直到头部14与小面关节FJ的骨接触，且外科医生优选地使得指示器225a与小面关节平面FJp1、FJp2对齐。
小面干涉螺钉10、10′、10″在小面关节FJ中的主要固定通过小面干涉螺钉10、10′、10″的杆部分16上的外螺纹与上侧和下侧小面Fs、Fi接合来实现。辅助固定可以通过骨结合来实现。例如，小面干涉螺钉10、10′、10″和(特别是)形成于小面干涉螺钉10、10′、10″的杆部分16上的外螺纹可以为粗糙的和/或进行涂覆，用于骨传导。小面干涉螺钉10、10′、10″可以涂覆有目前或以后已知的任何生物活性涂层，该生物活性涂层包括但不局限于：Ti等离子体喷雾、阳极化表面增强物，例如APC、HA或任何Ca-P增强物等。
优选的小面干涉螺钉10、10′、10″和防旋转机构100、100′可以由本领域已知的任意生物相容材料来制造，该生物相容材料包括但不局限于：不锈钢、钛、钛合金、聚合物例如PPEK、PEKK、PEK、PEKK-EK，有或没有可选的碳纤维增强物等，超高分子量聚乙烯(UHMWPE)、钴-铬-钼(CCM)等。
阻尼部件60a′、60b′、60c′、60″可以由本领域已知的任意生物相容材料来制造，该生物相容材料包括但不局限于：弹性体-热塑性聚合物(PCU或聚合硅酮)、多个PUR或硅酮族、共聚物等。优选地，阻尼部件60a′、60b′、60c′、60″的轮廓(例如尺寸和形状)与第一和第二部件20、30的轮廓(例如尺寸和形状)匹配或基本匹配。阻尼部件60a′、60b′、60c′、60″可以局部或完全进行涂覆，以便降低磨损量。例如，阻尼部件60a′、60b′、60c′、60″可以涂覆有任何金属碳化物或氮化物、DLC族的元素、Al2O3、ZrO2、TiC、TiN、(A)DLC、CrN、CrC等。
外科手术技术
第一、第二和第三优选实施例的小面干涉螺钉10、10′、10″可以通过本领域已知的任何外科手术技术来插入。小面干涉螺钉10、10′、10″可以经皮插入，类似于在美国专利申请No.11/126976中所述的小面干涉螺钉的插入，该美国专利申请No.11/126976的标题为ArticularFacet Interference Screw，它的申请日为2005年5月10日，并转让给Synthes(U.S.A)，该文献整个被本文参引。
参考图8，在使用时，第一、第二和第三优选实施例的小面干涉螺钉10、10′、10″通过微创手术过程而插入小面关节FJ中。可以设想，小面干涉螺钉10、10′、10″也可以通过开放外科手术来插入。在插入小面干涉螺钉10、10′、10″的一个示例方法中，引导线200被经皮引入在相邻上侧和下侧椎骨V之间的各小面关节FJ中。引导线200的引入可以通过任意方式(包括但不局限于：C形臂造影、CT扫描、微型开口接近小面关节FJ等)而引导到小面关节FJ中。在验证引导线200的对称位置之后，可选的组织保护套筒、插管、牵引器和/或套管针(未示出)可以引导到小面关节FJ，以便打开通向小面关节FJ的通路。小面干涉螺钉10、10′、10″引入小面关节FJ中，优选地通过引导线200和通过保护套筒、插管、牵引器或套管针。然后，小面干涉螺钉10、10′、10″的方位优选地进行校验，并除去引导线200、仪器和临时间隔件40(当需要时)。需要时，阻尼部件60a′、60b′、60c′、60″和防旋转机构100a、100b(如果需要)可以插入第一和第二部件20、30的内表面24、34之间。关节式连接平面Rp的方位由一个或两个指示器50、225a来验证，特别是相对于小面关节平面FJp1、FJp2来验证。
本领域技术人员应当知道，在不脱离本发明的广义概念的情况下可以对上述实施例进行改变。因此，应当知道，本发明并不局限于所述特殊实施例，而是将覆盖在如附加权利要求确定的本发明精神和范围内的变化。

Claims (7)

1.一种小面干涉螺钉，所述小面干涉螺钉用于插入在上侧椎骨的下侧小面和下侧椎骨的上侧小面之间的小面关节中，所述小面干涉螺钉包括：
第一部件，所述第一部件包括第一外部半圆形螺纹表面和第一内表面；以及
第二部件，所述第二部件包括第二外部半圆形螺纹表面和第二内表面，所述第一部件和第二部件在装配结构中限定头部部分、尖端、在所述头部部分和尖端之间延伸的纵向轴线以及外螺纹杆部分，所述第一内表面和第二内表面在装配结构中从所述头部部分延伸至所述尖端；以及
上部内部件和下部内部件，所述上部内部件具有内表面和与所述第一部件的第一内表面接触的外表面，所述下部内部件具有内表面和与所述第二部件的第二内表面接触的外表面，所述上部内部件的内表面和下部内部件的内表面弯曲，并相互接触，使得所述上部内部件能够相对于所述下部内部件进行关节式连接。
2.根据权利要求1所述的小面干涉螺钉，其中：所述第一内表面和第二内表面大致平行。
3.根据权利要求1所述的小面干涉螺钉，其中：所述小面干涉螺钉的所述第一部件的第一内表面和第二部件的第二内表面弯曲。
4.根据权利要求1所述的小面干涉螺钉，其中：所述第一部件和第二部件中的至少一个的内表面包括引导机构。
5.根据权利要求1所述的小面干涉螺钉，其中：弯曲的接触表面是球形表面。
6.根据权利要求1所述的小面干涉螺钉，其中：所述上部内部件和所述下部内部件具有与所述第一部件和第二部件的轮廓匹配的轮廓。
7.根据权利要求1所述的小面干涉螺钉，还包括：在头部部分上的指示器，所述指示器与小面干涉螺钉的关节式连接平面对齐。
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US8696708B2 (en) 2014-04-15
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BRPI0908122A2 (pt) 2015-08-04
JP2011514208A (ja) 2011-05-06
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