CN101516280A - 杂化骨固定设备 - Google Patents
杂化骨固定设备 Download PDFInfo
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Abstract
公开了一种整形外科骨固定装置,在一个实施例中该装置包括具有腔的锚构件以及插入构件。所述锚构件将所述插入构件至少部分地或全部地保持在所述腔内。所述插入构件具有插入孔口以容纳部分螺丝起子或其他装置。
Description
背景技术
本公开内容涉及用于骨接合及其他整形外科手术过程的装置和植入物。具体地,本公开内容包括具有锚构件和插入构件的骨固定装置。
许多技术和系统已经被用于校正并稳定骨头特别是脊骨的损伤或畸形。为了整形外科校正和/或稳定已经提出了螺钉、钩、夹具和其他类型的锚或其他装置。许多材料已经被用于制造这样的装置。与金属螺钉相比,例如由聚醚醚酮(PEEK)制成的螺钉可以通常具有低的剪切强度以及低的扭转强度。其他类型的螺钉可以由钛或不锈钢制成。然而,不锈钢或钛螺钉不可透过射线,并且他们易于呈现x射线或MRI假象,特别是在螺钉尖端附近或在外科医生试图提取植入装置和/或组织周围信息的区域内,例如在脊柱和椎骨动脉的区域内。
附图说明
图1是具有骨固定装置的一个实施例的部分横截面图的侧面视图。
图2是具有骨固定装置的另一个实施例的部分横截面图的侧面视图。
图3是具有骨固定装置的另一个实施例的部分横截面图的侧面视图。
图4是将细长构件的一个实施例固定到脊骨的一部分上的骨固定装置的一个实施例的部分横截面图。
图5是使用在此公开的骨固定装置的一个实施例的多轴向骨锚的一个实施例的部分横截面图。
具体实施方式
为了有助于理解公开内容的原理,将针对在附图中所示的实施例进行说明,并且特定语言被用于描述相同特征。不过应当理解不意于限制权利要求的范围,本公开内容所涉及领域内的技术人员通常能够想到对于所述装置的这种改变及进一步改进以及对于这里描述的公开内容的原理的进一步应用。
一般参考附图,描述了骨固定装置20的实施例。在所述实施例中,装置20包括锚构件22和插入构件24。装置20可以被连接到例如椎骨的骨头或其他组织上,并且可以被用于与整形外科板、连接件、棒或其他类型的器械或植入物连接在一起。
在图1中所示的所述实施例中,锚构件22包括轴部分26和头部分28。轴部分26具有第一端部30和第二端部32且具有跨越两个端部之间的长度A。轴部分26包括沿长度的纵轴线L。如所示,第一端部30可以是锥形端部,或者在其他实施例中第一端部30可以是平的或其他形式的构造。在一个实施例中,螺纹34形成绕轴部分26基本从第一端部30朝向第二端部32的螺旋式样,并且可以基本沿轴部分26的全部长度A延伸。可以看到,装置20的其他实施例可以具有沿轴部分26的部分长度A的螺纹34。此外,在所述实施例中的螺纹34具有单一导程,不过可以理解可以在轴26上使用多导程螺纹(例如具有两个导程)。螺纹34可以是标准多孔形态或者是能够与人体组织或骨头接合的任意形状或构造。
在所述实施例中,头部分28的形状基本是球形。在其他实施例中,头部分28可以是其他形状,例如立方体或梯形。头部分28限定了具有一个或多个腔壁38和下表面或腔底座40的腔36。腔36的所述实施例是基本圆柱形的,并且因而限定了单一连续的圆柱形壁38。如果腔36是矩形、三角形或其他多边形,则多个壁38可以围绕腔36。类似地,如果包括穿过头部分28和腔36的U形通道,则这种通道可以产生两个或多个段或壁38。在图1所示实施例中,腔底座40基本垂直于轴线L,并且一个(多个)腔壁38基本平行于轴线L。一个(多个)腔壁38和底座40也可以相对于轴线L腔壁38和/或相对彼此倾斜或者成锥形,例如形成斜角。
腔36的形状和尺寸被制成与插入构件24兼容。在所述实施例中,插入构件24被完全插入到腔36内,不过可以仅使得插入构件24部分地插入到腔36内。例如,在一个实施例中,腔壁38和插入构件24均具有螺纹,这样插入构件24可以被扭入或旋转进入腔36并且与腔壁38螺纹配合。在一些实施例中,腔36可以是斜面的,以便一个(多个)壁38经由基本圆锥表面42(图3)展开,这样表面42相对于一个(多个)壁38倾斜。如下面将更详细描述的,插入构件24可以包括相应的凸缘部分来接触表面42。
在不同实施例中,腔36可以具有各种长度。例如,图1示出了被包含在头部分28内的具有一个(多个)壁38和底座40的腔36。可替换地,如图2所示,腔36及其一个(多个)壁38和底座40可以沿轴线L延伸穿过头部分28进入轴部分26,这样底座40可以位于轴部分26内。
锚构件22可以是由任意生物相容性材料制成。生物相容性金属包括钛、不锈钢、钛合金、镍-钛合金、镍钛诺以及铬合金(仅举几个例子)。生物相容性塑料包括聚亚安酯、聚酯、聚醚、聚烯烃、聚乙烯、聚酰胺、聚氟乙烯、聚醚醚酮(PEEK)或聚四氟乙烯(PTFE)。在所述实施例中,轴部分26和头部分28由相同材料制成,并且在具体实施例中轴部分26由PEEK或其他射线可透过的身体相容性材料制成。已经发现,由射线可透过材料制成的轴部分26最小化了x射线和MRI假象,例如当锚构件22被插入到椎骨内时在外科医生能够提取关于脊柱和椎骨动脉的有价值信息的区域附近的第一端部30处。可以看出,轴部分26和头部分28可以由不同材料制成。例如,轴部分26可以由生物相容性金属制成并且头部分28可以由生物相容性塑料制成。
在一些实施例中,不透射线标签70可以被置于锚构件22的一部分上或内。例如,点、圆柱或球形金属或其他材料形式的不透射线标签70可以被置于锚构件22的第一端部30内或附近。在其他实施例中,不透射线标签70可以被置于轴部分26或头部分28上的其他位置。例如由例如PEEK的射线可透过材料制成的位于轴部分26上或内的标签70提供可清楚地记录在x射线图片、MRI或CT扫描或其他形式的成像中的在轴26上的点或位置。虽然如此,PEEK轴部分26的射线透过质量减少了或消除了x射线、MRI或其他成像过程中的假象。外科医生或其他医疗工作人员可以经由不透射线标签70来识别锚构件22的位置,同时减轻或避免由于这个假象而造成的观察错误。
锚构件22也可以被涂覆有生物活性材料,例如用于骨向内生长和骨附连的生长因子或者用于软组织内生长的生长因子。生长因子的示例可以包括类胰岛素生长因子、碱性成纤维细胞生长因子、转化生长因子、血小板源性生长因子、骨源性生长因子、精氨酸、骨成型蛋白质、LIM矿化蛋白质及其组合。
在所述实施例中,如图1和图2所示,插入构件24是基本圆柱形的并且包括插入壁50和插入底座52。插入壁50具有第一端部54和相对第二端部56。如上述,插入构件24被大体构造成适配在腔36内,并且可以具有类似于或基本等同于腔36的形状或尺寸的形状和尺寸。因此,当腔36是多边形时,插入构件24可以是基本相同的多边形形状。此外,当头部分28和腔36是基本U形时,插入构件24可以也是U形(具有多个壁部分50),这样通道延伸穿过头部分28和插入构件24。在其他实施例中,插入构件24可以具有不同于腔36的形状。如一个示例中,如果腔36是基本圆柱形的,则插入构件24可以是正方形的且具有至少稍大于腔36直径的对角长度,这样这种插入构件的拐角将可以牢固地接合腔36的一个(多个)壁38。当插入构件24和腔36均为基本圆柱形时,插入构件24的直径或该插入构件24的其他部分的直径可以稍大于腔36的直径。
在所述实施例中,插入构件24进一步包括插入孔口58。一个(多个)壁50可以具有在插入构件24的孔口58和外表面之间测量的基本恒定的厚度,并且插入底座52可以具有与一个(多个)壁50类似的厚度,其中该壁50的厚度为在插入构件24的孔口58的底部和外表面之间测量的厚度。在其他实施例中,底座52可以是与一个(多个)壁50不同的厚度。例如,如图2所示,底座52基本比壁50厚。
孔口58的尺寸和形状被制成接收用于抓持、保持骨固定装置20或向骨固定装置20上施加旋转力的螺丝起子或其他工具或器械,如下面将详细描述的。在所述实施例中,孔口58是基本六边形的。在其他实施例中,孔口58可以是六叶瓣形、矩形、星形、一个或多个切口或适于承担转动工具或夹持工具的其他形状。
在具体实施例中,如图3所示,插入构件24包括邻近第二端部56的凸缘57,其接触头部分28的表面42。凸缘57可以被构造成基本类似于表面42,并且因而在一个实施例中具有与表面42的所述实施例匹配的基本圆锥底面。
插入构件24可以进一步包括从壁50延伸出的一个或多个凸起60。如附图所示,一个(多个)凸起60可以是沿壁50的长度基本从第一端部54向第二端部56延伸的单导程或多导程螺纹。一个(多个)螺纹凸起60可以以与锚构件22的螺纹34相同的方式被螺旋定向,例如在具体实施例中是右手螺纹。在该构造中,插入构件24可以被旋入并且被螺纹拧入锚构件22中直到插入构件24位于腔36内,并且之后施加到插入构件24上的进一步回转力起作用从而将锚构件22螺纹地拧入组织内,如下面进一步所述。在其他实施例中,螺纹或其他形式的一个(多个)凸起60可以仅沿部分壁50延伸。除右手或左手螺纹外,一个(多个)凸起60可以是一个或多个棱锥形、突出、矩形、倒钩或产生摩擦力或与头部分28的壁38产生干涉配合或戳入头部分28的壁38的其他形状。因此,当插入构件24被插入到锚构件22内时,例如当插入构件24的底座52接触头28的腔底座40时,一个(多个)凸起60接合并/或刺入腔壁38。
插入构件24可以由任意结实的生物相容性材料特别是金属制成。例如,仅举几个例子,插入构件24可以由例如钛、不锈钢、钛合金、镍-钛合金、镍钛诺、铬合金的生物相容性金属制成(仅举几个例子)。
插入构件24可以通过各种方法被插入到或以其他方式附连到锚构件22。在一个实施例中,锚构件22可以绕插入构件24被过模铸造或者成型,特别是当锚构件22是由PEEK制成或者由易于在模具中流动且成形制造的其他生物相容性塑料材料制成时。在一种形式下,当塑料材料在模具内并且是软的,则插入构件24可以被插入到锚构件22的软的头部分28内。这个插入形成了绕插入构件24的腔36,并且如果插入构件24包括一个(多个)凸起60,则塑料材料可以绕所述一个(多个)凸起60流动或者以其他方式容纳所述一个(多个)凸起60。之后塑料材料被容许绕插入构件24硬化或以其他方式固化。大体而言,这样的硬化或固化过程会导致塑料材料至少稍有收缩。存在这样的收缩并且存在任意一个(多个)凸起60向塑料材料中的牙间交错或扩张,则插入构件24被保持在锚构件22中。在另一种形式下,插入构件24可以被放置在模具中,并且之后易流动的生物相容性塑料材料被注入模具内或以其他方式被置为绕插入构件24。如上所述,塑料材料将绕插入构件24形成,从而生成腔36和在插入构件24上的任意一个(多个)凸起60周围的紧密配合。在固化或硬化之后,插入壁50和插入底座52分别保持被附连到并接触腔壁38和腔底座40。
在另一个实施例中,插入构件24可以超生地被插入到锚构件22的腔36中。在这种方法中,锚构件22可以由PEEK或其他合适的生物相容性塑料被预成形从而包括腔36,且该腔36的尺寸与插入构件24的尺寸大致相同或稍小于插入构件24的尺寸。超声能量或用于加热锚构件22的一部分的其他适当能量被施加到头部分28,具体地是腔36的区域上,从而软化邻近腔36的材料。插入构件24可以被插入到腔36中,这样插入壁50接触腔壁38,插入底座52接触腔底座40并且多个凸起60接合腔壁38。如上所述,硬化或其他方式固化的头部分28的一个(多个)被软化部件提供在锚构件22和插入构件24及其一个(多个)凸起(如果存在的话)之间的紧密配合。
当一个(多个)凸起60具有螺纹时,插入构件24可以被旋入锚构件22的腔36中从而被螺纹地插入。锚构件22可以被成形为具有或不具有在一个(多个)壁50内的绕腔36的母螺纹。如果通过模制过程或者通过使用攻丝器械攻螺纹来提供这种母螺纹,则之后它们可以具有与一个(多个)螺纹凸起60基本相同的构造。如果不提供这种母螺纹,并且腔36的直径至少稍小于一个(多个)螺纹凸起60的顶部直径,则之后一个(多个)螺纹凸起60可以在一个(多个)壁38内绕腔36切割出母螺纹路径。当邻近腔36的PEEK或其他材料稍软或可塑时,可以更容易地切割这种路径,不过可以使用金属螺纹从而在许多结实的生物相容性塑料上进行这种切割而基本没有开裂的危险。
一旦例如通过上述方法中的一种方法已经制造或组装装置20,则其可以被用于整形外科手术。如上述,装置20可以与各种例如椎板的整形外科植入物、连接件和其他设备一同使用。在所述实施例中,当锚定构件22是螺钉时,螺纹轴26可以被旋转并且被螺纹地插入到骨头或其他组织内。例如,大体参考图4,通过将装置20延伸通过板内的孔并且进入组织、朝向板构件紧固头部分28并且将板构件固定到骨头上,从而将具有贯穿其中的孔74的板构件72附连到椎骨76或其他组织上。
装置20也可以被用作较大的锚结构的一部分。例如,装置20可以被用作多轴向骨锚的锚部分。大体参考图5,在某些类型的多轴向骨螺钉中,提供具有U形通道82的接收构件80,例如装置20的所述实施例的锚构件可以延伸穿过该接收构件80。这样的多轴向锚结构也可以包括一个或多个的冠构件84、扣环86以及锁定构件88,并且可以被连接到例如棒R的细长构件上。在美国专利No.6,280,442中示出了多轴向螺钉的实施例的进一步公开内容,该专利的全部内容被并入本文以供参考。
骨固定装置20的其他实施例可以被看作为落入本公开内容的范围内。例如,锚构件22可以包括骨接合钩的弯曲刀片而不是螺钉的螺纹轴。螺栓、夹具和其他类型的植入物可以包括本公开内容的各方面。
金属插入构件24为PEEK或其他塑料锚构件22提供附加强度,特别是在头区域内,当使用螺丝起子旋转装置20以将其插入到骨头内时,该区域处于最大张力下。金属螺丝起子直接作用在金属插入构件上,而不是作用在可能地较软或更有延展性的塑料上,从而限制或防止了从螺丝起子到锚构件22的头部分28的损坏。因此,生物相容下PEEK(或者锚构件22的其他塑料)接触骨头和/或其他组织,从而减小了组织损伤和组织关于所述材料向内生长的隐患,同时插入工具作用在较强的金属插入构件24上。与使用由金属构成的全部头或全部锚相比,在PEEK或其他塑料的锚构件22中的金属插入构件24提供了在头部分28内的更小的不透射线标记。在轴部分26内具有不透射线标记的实施例中,装置20因而具有两个离散标记从而在成像的同时最小化成像假象或其他误差。插入构件24也可以与锚构件22具有不同颜色。
虽然在附图和上述说明中已经详细示出并描述了本公开内容,不过其应被认为是示意性的并且不限制其特征,应该理解的是,仅示出并描述了优选实施例并且所有的改变和改进均落入所需要保护的本公开内容的精神范围内。
Claims (17)
1.一种用于整形外科医疗应用的固定装置,其包括:
锚构件,其具有用于接合骨头的锚部分和头部分,所述头部分限定腔,该腔限定至少一个腔壁和腔底座;以及
插入构件,其具有插入壁和插入底座,所述插入壁具有至少一个外凸起,所述插入构件限定尺寸为接收医疗器械的孔口,
其中所述插入构件接合所述腔壁和所述腔底座。
2.根据权利要求1所述的装置,其中:
所述插入构件由钛制成;以及
所述锚部分和所述头部分由聚合物材料制成。
3.根据权利要求2所述的装置,其中所述聚合物材料是聚醚醚酮。
4.根据权利要求1所述的装置,其进一步包括在所述锚部分内或所述锚部分上的不透射线标记。
5.根据权利要求1所述的装置,其中:
所述至少一个凸起包括螺纹。
6.根据权利要求1所述的装置,其中:
所述插入壁具有第一端部和第二端部,所述第一端部包括插入凸缘;以及
所述插入构件基本齐平于所述锚构件的端部。
7.一种整形外科医疗设备,其包括:
由聚醚醚酮制成的具有轴部分和头部分的锚构件,所述轴部分具有纵轴线,所述头部分具有沿所述纵轴线的腔,所述腔限定至少一个壁;
由金属制成的限定内孔口的插入构件,所述插入构件的尺寸基本适配在所述腔内,以及
所述插入构件具有刺入所述壁中的至少一个凸起。
8.根据权利要求7所述的设备,其中所述腔延伸进入所述轴部分中。
9.根据权利要求7所述的设备,其进一步包括在所述轴部分内或所述轴部分上的不透射线标记。
10.根据权利要求7所述的设备,其中所述孔口具有六边形横截面形状。
11.根据权利要求7所述的设备,其中所述轴部分包括螺纹以接合骨头。
12.根据权利要求7所述的设备,其中:
所述插入构件包括具有第一端部和第二端部的插入壁,所述第一端部包括凸缘;
所述腔限定腔底座;
所述凸缘基本齐平于所述锚构件的一个端部;以及
所述插入构件的所述第二端部接触所述腔底座。
13.一种整形外科医疗设备,其包括:
由聚醚醚酮制成的具有轴部分和头部分的锚构件,所述轴部分具有纵轴线,所述轴部分具有螺纹,所述头部分具有沿所述纵轴线延伸并且限定腔壁和腔底座的腔;
由钛制成的、具有插入壁和插入底座并且限定了孔口的插入构件,所述孔口的尺寸被设计为接收工具,所述插入构件的尺寸基本适配在所述腔内,其中所述插入底座接触所述腔底座并且所述插入壁接触所述腔壁;以及
所述插入构件具有刺入所述锚构件中的至少一个凸起。
14.根据权利要求13所述的设备,其中所述多个凸起是倒钩。
15.根据权利要求13所述的设备,其中:
所述至少一个凸起是螺纹。
16.根据权利要求13所述的设备,其中:
所述插入构件包括第一端部和第二端部;以及
所述插入构件在所述第一端部包括插入凸缘。
17.根据权利要求16所述的设备,其中所述插入凸缘相对于所述插入壁倾斜。
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2006
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2007
- 2007-09-10 EP EP07842109A patent/EP2073731A1/en not_active Withdrawn
- 2007-09-10 JP JP2009528406A patent/JP2010503470A/ja active Pending
- 2007-09-10 KR KR1020097006648A patent/KR20090064407A/ko not_active Application Discontinuation
- 2007-09-10 AU AU2007296739A patent/AU2007296739A1/en not_active Abandoned
- 2007-09-10 CN CNA2007800343705A patent/CN101516280A/zh active Pending
- 2007-09-10 WO PCT/US2007/077963 patent/WO2008033742A1/en active Application Filing
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CN102256557A (zh) * | 2008-12-19 | 2011-11-23 | 塞皮泰克基金会 | 骨钉 |
CN102256557B (zh) * | 2008-12-19 | 2013-10-23 | 塞皮泰克基金会 | 骨钉 |
CN106473787A (zh) * | 2016-12-12 | 2017-03-08 | 运怡(北京)医疗器械有限公司 | 一种多孔peek锚钉 |
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JP2010503470A (ja) | 2010-02-04 |
US8267978B2 (en) | 2012-09-18 |
US20080086129A1 (en) | 2008-04-10 |
EP2073731A1 (en) | 2009-07-01 |
AU2007296739A1 (en) | 2008-03-20 |
KR20090064407A (ko) | 2009-06-18 |
WO2008033742A1 (en) | 2008-03-20 |
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