CN101816596A - 用于替换受损椎间盘的装置 - Google Patents

用于替换受损椎间盘的装置 Download PDF

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Publication number
CN101816596A
CN101816596A CN201010128107A CN201010128107A CN101816596A CN 101816596 A CN101816596 A CN 101816596A CN 201010128107 A CN201010128107 A CN 201010128107A CN 201010128107 A CN201010128107 A CN 201010128107A CN 101816596 A CN101816596 A CN 101816596A
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CN
China
Prior art keywords
keeper
installed part
vertebra
artificial disc
engage
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Granted
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CN201010128107A
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CN101816596B (zh
Inventor
E·C·本茨
I·H·利伯曼
L·斯特尔纳德
J·M·库拉希
R·S·罗斯
C·F·小伯查尔
K·杜克
K·齐默斯
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Axiomed Spine Corp
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Axiomed Spine Corp
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    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097Visible markings, e.g. indicia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

一种用于替换脊柱中受损椎间盘的装置,所述装置包括:人工圆盘,所述人工圆盘包括具有第一表面和第二表面的弹性芯体,连接到所述弹性芯体的所述第一表面的第一保持件,和连接到所述弹性芯体的所述第二表面的第二保持件,所述第一保持件具有可与脊柱的第一椎骨接合的外表面和面对所述弹性芯体的所述第一表面的内表面,所述第二保持件具有可与脊柱的第二椎骨接合的外表面和面对所述弹性芯体的所述第二表面的内表面;和可与第一椎骨和所述人工圆盘连接以将所述人工圆盘定位在第一和第二椎骨之间的第一安装件,所述第一安装件在连接到第一椎骨之后可与所述人工圆盘接合以引导所述人工圆盘移动到第一和第二椎骨之间的位置中。

Description

用于替换受损椎间盘的装置
本申请是申请日为2004年12月8日,申请号为200480039605.6,发明名称为“用于替换受损椎间盘的方法和装置”的中国专利申请的分案申请。
技术领域
本发明涉及用于替换脊柱中受损椎间盘的装置,更具体而言,涉及用于替换脊柱中受损椎间盘的具有弹性芯体的装置。
背景技术
在美国专利No.5,370,697中公开了一种已知的人工圆盘件。美国专利No.5,370,697公开的人工圆盘具有连接到相邻椎骨的上和下支承体和弹性分隔体。所述分隔体具有连接到弹性芯体的相对侧上的覆盖板。所述分隔体是在支承体连接到椎骨之后可插入上和下支承体之间的独立插入部分。所述分隔体并不接合椎骨。
在美国专利No.6,419,706中公开了一种圆盘假体。美国专利No.6,419,706公开的假体具有弹性芯体和附着到芯体的多个壳体。所述壳体接合椎骨并且部分覆盖芯体。每个壳体具有朝着相对壳体延伸的瓣片和裙边。当假体处于未压缩状态时所述瓣片和裙边与芯体间隔。当假体被最大压缩时芯体接合瓣片和裙边。
发明内容
一种用于替换脊柱中受损椎间盘的装置,所述装置包括:
人工圆盘,所述人工圆盘包括具有第一表面和第二表面的弹性芯体,连接到所述弹性芯体的所述第一表面的第一保持件,和连接到所述弹性芯体的所述第二表面的第二保持件,所述第一保持件具有可与脊柱的第一椎骨接合的外表面和面对所述弹性芯体的所述第一表面的内表面,所述第二保持件具有可与脊柱的第二椎骨接合的外表面和面对所述弹性芯体的所述第二表面的内表面;和
可与第一椎骨和所述人工圆盘连接以将所述人工圆盘定位在第一和第二椎骨之间的第一安装件,所述第一安装件在连接到第一椎骨之后可与所述人工圆盘接合以引导所述人工圆盘移动到第一和第二椎骨之间的位置中。
附图说明
当参考附图考虑本发明的以下描述时,本发明所属领域的普通技术人员将显而易见本发明的前述和其它特征,其中:
图1是根据本发明构造的替换受损椎间盘的装置的示图;
图2是图1的装置的截面图;
图3是图1的装置的人工圆盘的示图;
图4是图3的人工圆盘的示意性顶视图;
图5是图1的装置的安装件的示图;
图6是图1的装置在人体脊柱的相邻椎骨之间的示意性截面图;
图7是图1的装置在脊柱的相邻椎骨之间的示意性截面图,其显示了受压缩的脊柱;
图8是用于将图5中所示的安装件连接到相邻椎骨的致动器的示意性侧视图;
图9是用于与图8的致动器一起使用以将安装件连接到脊柱的相邻椎骨的插入件的示图;
图10是图9的插入件中的一个的示图;
图11是图10的插入件的示意性侧视图;
图12是图10的插入件的示意性顶视图;
图13是沿图12中的线13-13获得的插入件的一部分的截面图;
图14是可连接到图9的插入件中的一个的滑动件的示图;
图15是用于将安装件连接到图9的插入件中的一个的弹簧件的示图;
图16是用于将图2的人工圆盘插入到相邻椎骨之间的外科工具的示图;和
图17是图16的外科工具的一部分的放大图。
具体实施方式
本发明涉及替换人体脊柱中受损或退化椎间盘的装置或假体。图1-7示出了替换脊柱中受损或退化椎间盘的装置或假体10。装置10(图6)用于替换人体脊柱16的相邻上和下椎骨12和14之间的受损椎间盘。装置10(图17)包括人工圆盘18和帮助圆盘18连接到相邻椎骨12和14的安装件100。安装件100也帮助相对于椎骨12和14定位圆盘18。
装置10(图1)包括上或第一保持装置20,下或第二保持装置60和介于所述保持装置之间并且附着到它们上的弹性芯体90。上和下保持装置20和60彼此相同并且包括安装件100。装置10相对于水平延伸平面A对称(图3)。在此使用的术语“上”和“下”参考装置10在人体中的取向,如图6中所示,以为了引用目的辨别两个相同的保持装置。
上保持装置20包括上或第一保持环或保持件21和安装件100。人工圆盘18包括上保持件21。上保持件21是刚性的并且由诸如生物相容金属或聚合物这样的生物相容材料制造。可以预见上保持件21可以由钛合金制造。上保持件21具有可与椎骨12接合的外表面22。上保持件21的内凹表面24固定或粘结到弹性芯体90。可以预见内表面24可以具有烧结在内表面上的细粒(未示出)或蚀刻在内表面上的纹理结构(未示出)以帮助上保持件21连接到芯体90。
多个导轨或肋条26(图3-4)和中心肋条28从外表面22延伸。尽管上保持件21被显示成具有四个肋条26,可以预见上保持件可以具有任何数量的肋条26。肋条26接合椎骨12,如图6-7中所示,以将装置10保持在椎骨12和14之间的适当位置中。外表面22也可以具有烧结在外表面上的细粒(未示出)或蚀刻在外表面上的纹理结构(未示出)以进一步将装置10保持在椎骨12和14之间。
肋条26(图1-4)大体彼此平行地从圆盘18的近侧面30延伸到圆盘的前侧面32。中心肋条28从圆盘18的前侧面32延伸到上保持件21中的轴向延伸圆形开口36。可以预见肋条26和28可以沿任何期望的方向延伸。肋条26和28延伸的方向由圆盘18的插入方向确定。
轴向延伸开口36(图2-4)延伸通过上保持件21的外表面22和内表面24。上保持件21具有至少部分限定开口36的截头圆锥形表面37。开口36的上部具有第一直径,开口的下部具有小于第一直径的第二直径。开口36居中地位于两个肋条26之间。因此,没有肋条从圆盘18的近侧面30延伸到开口36。尽管开口36被显示成圆形,可以预见开口可以具有任何期望的形状。
凸缘部分38在圆盘18的前侧面32上从上保持件21延伸。凸缘部分38具有邻近中心肋条28的凹槽40。凹槽40由底表面42和从底表面42向上延伸的侧表面44和46限定。卵形狭槽48延伸通过凸缘部分38的底表面42。狭槽48沿肋条28延伸方向的横向方向延伸。
上保持件21的内凹表面24(图2)固定或粘结到弹性芯体90。上保持件21包括朝着下保持装置60延伸的周边凸缘部分50。凸缘50围绕芯体90。凸缘50具有面对芯体90的径向内表面52。表面52从凹表面24向外并且朝着下保持装置60径向地延伸。凸缘50上的表面52与芯体90间隔,如图6中所示,直到预定负荷施加于装置10。
当负荷施加于装置10以使上和下保持装置20和60相对于彼此移动时芯体90朝着凸缘90上的表面52偏转。当预定负荷施加于装置10时,如图7中所示,芯体90偏转到与凸缘50上的表面52接合。当芯体90接合凸缘50时,由于芯体的进一步偏转受到凸缘50限制而使芯体变硬。
凸缘50的表面52可以具有任何期望的构造。表面52可以具有第一部分,该第一部分比第二部分更接近芯体90延伸,从而芯体在接合表面52的第二部分之前接合表面52的第一部分。因此,当不同负荷施加于装置10时芯体90可以接合表面52的不同部分以在不同负荷下改变芯体的硬度。
可以预见保持件21可以具有内表面(未示出),所述内表面从凹内表面24延伸到开口36并且与芯体90间隔直到预定负荷施加于装置10。当预定负荷施加于装置10时,芯体90偏转到与从凹表面24延伸到开口36的内表面(未示出)接合。当芯体90接合从凹表面24延伸到开口36的内表面时,由于芯体的进一步偏转受到保持件21限制而使芯体变硬。
下保持装置60(图1-2)在构造上与上保持装置20相同。下保持装置60包括下或第二保持件或保持环61和安装件100。圆盘18包括下保持件61。下保持件61与上保持件21相同。因此,将不再具体描述下保持件61。下保持件61是刚性的并且由与上保持件21相同的材料制造,例如钛合金。下保持件61具有可与椎骨14接合的外表面62。下保持件61的内凹表面64固定或粘结到弹性芯体90。可以预见内表面64可以具有烧结在内表面上的细粒(未示出)或蚀刻在内表面上的纹理结构(未示出)以帮助下保持件61连接到芯体90。
多个导轨或肋条66(图2和3)和中心肋条68从外表面62延伸。下保持件61可以具有任何数量的肋条66。肋条66接合椎骨14,如图6和7中所示,以将装置10保持在椎骨12和14之间的适当位置中。外表面62也可以具有烧结在外表面上的细粒(未示出)或蚀刻在外表面上的纹理结构(未示出)以进一步将装置10保持在椎骨12和14之间。
肋条66大体彼此平行地从圆盘18的近侧面30延伸到圆盘的前侧面32。中心肋条68(图2)从前侧面32延伸到下保持件61中的轴向延伸圆形开口70。可以预见肋条66和68可以沿任何期望的方向延伸。肋条66和68延伸的方向由圆盘18的插入方向确定。
轴向延伸开口70(图2)延伸通过下保持件61的外表面62和内表面64。下保持件61具有至少部分限定开口70的截头圆锥形表面71。开口70的下部具有第一直径,开口的上部具有小于第一直径的第二直径。开口70居中地位于两个肋条66之间。因此,没有肋条从圆盘18的近侧面30延伸到开口70。尽管开口70被描述成圆形,可以预见开口可以具有任何期望的形状。
凸缘部分72在圆盘18的前侧面32上从下保持件61延伸。凸缘部分72具有邻近中心肋条68的凹槽74。凹槽74由上表面76和从上表面76向下延伸的侧表面78和80限定。卵形狭槽82延伸通过凸缘部分72的上表面76。狭槽82沿中心肋条68延伸方向的横向方向延伸。
下保持件61的内凹表面64(图2)固定或粘结到弹性芯体90。下保持件61包括朝着上保持装置20延伸的周边凸缘部分84。凸缘84围绕芯体90。凸缘84具有面对芯体90的径向内表面86。表面86从凹表面64向外并且朝着上保持装置20径向地延伸。凸缘84上的表面86与芯体90间隔,如图6中所示,直到预定负荷施加于装置10。
当负荷施加于装置10以使上和下保持装置20和60相对于彼此移动时芯体90朝着凸缘84上的表面86偏转。当预定负荷施加于装置10时,如图7中所示,芯体90偏转到与凸缘84上的表面86接合。当芯体90接合凸缘84时,由于芯体的进一步偏转受到凸缘84限制而使芯体变硬。
凸缘84的表面86可以具有任何期望的构造。表面86可以具有第一部分,该第一部分比第二部分更接近芯体90延伸,从而芯体在接合表面86的第二部分之前接合表面86的第一部分。因此,当不同负荷施加于装置10时芯体90可以接合表面86的不同部分以在不同负荷下改变芯体的硬度。也可以预见当预定负荷施加于装置10时下保持件61上的凸缘84可以接合上保持件21上的凸缘50。
可以预见保持件61可以具有内表面(未示出),所述内表面从凹内表面64延伸到开口70并且与芯体90间隔直到预定负荷施加于装置10。当预定负荷施加于装置10时,芯体90偏转到与从凹表面64延伸到开口70的内表面(未示出)接合。当芯体90接合从凹表面64延伸到开口70的内表面时,由于芯体的进一步偏转受到保持件61限制而使芯体变硬。
弹性芯体90是一个整体并且可以由位于加利福尼亚州伯克利市的Polymer Technology Group生产的氨基甲酸乙酯硅酮混合物制造。弹性芯体90可以以本领域中任何已知方式粘附或粘结到上和下保持件21和61。可以预见弹性芯体90可以嵌入模制、传递模制或注射模制在上和下保持件21和61之间。可以通过将用于芯体的材料通过开口36或70中的一个注射到上和下保持件中而将芯体90模制在上和下保持件21和61之间。
弹性芯体90可以由一种聚合物制造,该聚合物是位于加利福尼亚州伯克利市的Polymer Technology Group生产的、名称为CarboSilTM的硅酮—聚碳酸酯—氨基甲酸乙酯共聚物。弹性芯体90通过多步体积合成制备,在此期间将聚二甲基硅氧烷包含到带有脂族、羟基封端的聚碳酸酯低聚物的聚合物柔性链段中。硬链段由带有低分子量乙二醇增链剂的芳族二异氰酸酯组成。所述共聚物链用硅酮封端。
弹性芯体90的材料结合了硅酮弹性体的生物相容性和生物稳定性与热塑氨基甲酸乙酯弹性体的可加工性和韧性。弹性芯体90的材料具有较高的硬链段含量,当与患者的身体达到平衡时所述硬链段明显软化。相关的平衡包括植入体内后在大致37℃与身体的热平衡和聚合物的水和溶质摄取平衡。与室温相比弹性芯体90在37℃具有减小的模量。因此,更高硬度的聚合物可以因其生物稳定性而被使用,因为人体内的条件将聚合物的模量降低到压缩硬度的期望范围。
弹性芯体90为楔形。上保持件21靠近圆盘18的近侧面30与下保持件61间隔第一距离。上保持件21靠近圆盘18的前侧面32与下保持件61间隔大于第一距离的第二距离。可以预见上保持件21可以与下保持件61间隔任何期望的距离。
芯体90具有上或第一凸表面92。上凸表面92固定到上保持件21的凹内表面24。下或第二凸表面94固定到下保持件61的凹内表面64。
芯体90包括径向外表面96。弧形过渡表面98在径向外表面96和上和下表面92和94之间延伸。径向外表面96与上和下保持件21和61上的凸缘50和84间隔直到预定负荷施加于装置10。
周围表面96和过渡表面98可以具有任何期望的构造。表面96和98可以具有第一部分,该第一部分比第二部分更接近凸缘50和84延伸,从而第一部分在第二部分之前接合凸缘50和84。因此,当不同负荷施加于装置10时表面96和98的不同部分可以接合凸缘50和84以在不同负荷下改变芯体90的硬度。
保持装置20和60(图1-7)均包括安装件100以帮助圆盘18连接到椎骨12和14。安装件100也帮助圆盘18定位在椎骨12和14之间。当装置10连接到椎骨12和14时安装件100(图6)延伸到保持件21和61中的开口36和70中。在安装件100连接到椎骨之后圆盘18被插入到椎骨12和14之间。圆盘18的开口36和70的相对侧上的肋条或导轨26和66接合安装件100以将圆盘引导到椎骨12和14之间的期望位置中。安装件100彼此相同。因此,将仅仅具体描述一个安装件100。
安装件100(图5)是刚性的并且由诸如生物相容金属或聚合物这样的生物相容材料制造。可以预见安装件100可以由钛合金制造。安装件100具有面对椎骨的外表面102。安装件100的内凹表面104面对弹性芯体90。上保持装置20的安装件100的内凹表面104面对芯体90的上表面92。下保持装置60的安装件100的内凹表面104面对芯体90的下表面94。
当负荷施加于装置10时弹性芯体90朝着凹表面104偏转以使上和下保持装置20和60相对于彼此移动。如图7中所示,当脊椎16受到预定负荷时芯体90偏转到上和下保持件21和61中的开口36和70中并且与凹表面104接合。当芯体90接合安装件100的表面104时,由于芯体朝着保持装置20和60的进一步偏转受到限制而使弹性芯体变硬。可以预见安装件100可以具有轴向延伸开口以允许气体从芯体90和安装件之间排出。
安装件100的表面104可以具有任何期望的构造。当不同负荷施加于装置10时芯体90可以接合表面104的不同部分以在不同负荷下改变芯体90的硬度。也可以预见保持装置20的安装件100的表面104可以具有不同于保持装置60的安装件100的表面104的构造。
突出106从安装件100的外表面102延伸。突出106接合椎骨12和14以帮助装置10保持在椎骨12和14之间的适当位置中。尽管安装件100被显示成具有四个突出106,可以预见安装件可以具有任何数量的突出。可以预见突出106可以具有任何期望的形状、尺寸和/或尖端构造。突出106可以包括用于骨生长的通道,具有倒刺,和/或具有弯钩。
安装件100包括突出106从其延伸的圆形主体110。尽管安装件100的主体110被显示成圆形,可以预见主体110可以具有任何期望的构造,所述构造允许安装件100滑动到圆盘18中的开口36和70中。
安装件100的主体110具有截头圆锥形径向外表面112。圆形过渡表面113从径向外表面112延伸到凹表面104。主体110具有靠近外表面102的第一直径和靠近过渡表面113的第二直径,第二直径小于第一直径。安装件100的径向外表面112和/或过渡表面113接合保持件21和61上的肋条或导轨26和66以沿相对于安装件和椎骨12和14的第一后向方向导引圆盘18的移动。当圆盘被插入到期望深度之后上和下保持件21和61上的中心肋条28和68用作止挡以防止圆盘18沿第一方向移动。中心肋条28和68接合安装件100上的径向外表面112和/或过渡表面113。当中心肋条28和68接合安装件100时,径向外表面112和/或过渡表面113沿在第一方向横向的第二方向引导安装件和保持件21和61之间的相对运动,从而安装件移动到圆盘18中的开口36和70中。
当安装件在圆盘18中的开口36和70中时,安装件100上的截头圆锥形径向外表面112接合上和下保持件21和61上的截头圆锥形表面37和71。表面112与表面37和71的接合产生了安装件100和圆盘18之间的过渡配合。因此,防止了圆盘18相对于安装件100移动。
径向外表面112具有四个凹槽114,其中的两个在图5中示出。凹槽114被定位成相对于彼此成90°。尽管安装件100被描述成具有四个凹槽,可以预见安装件100可以具有任何数量的凹槽。
可以使用外科工具将安装件100连接到椎骨12和14,所述外科工具包括致动器120和一对插入件140(图8和9)。安装件100连接到元件140并且致动器120使所述元件彼此远离以将安装件连接到椎骨。致动器120(图8)可以是由德国的Friedrich GmbH of Solingen生产的模块化脊椎撑开器(distractor),元件140与之连接。致动器120在本领域中是已知的,因此将不再具体描述。
致动器120包括一对致动手柄122和可连接到元件140的一对分离器124。手柄122由联动系统126连接到分离器124。当手柄122朝着彼此移动时,联动系统126导致分离器124彼此远离。致动器120也包括用于在彼此相距的期望距离锁定分离器124的锁定机构128。
插入件140(图9-13)可连接到分离器124。元件140彼此相同。因此,将仅仅具体描述一个元件140。
元件140包括可插入到致动器120的分离器124的一个中的开口(未示出)中的连接端144。末端144包括一对突出146。突出146(图12)大体彼此平行地延伸并且在它们之间限定通道148。末端144以一种已知的方式插入到致动器120的分离器124中的开口(未示出)中以将元件140连接到致动器。元件140可以以一种已知的方式从分离器124卸除。可以预见元件140的末端144可以具有任何期望的构造以将元件连接到期望的致动器。
突出146(图9-12)从元件140的中心体152的第一端150延伸。中心体152具有上表面154和从中心体的第一端150延伸到第二端158的平行下表面156。突出146与表面154和156成一个角度延伸。可以预见突出146可以以任何期望的角度延伸到表面154和156。上表面154具有扇形凹槽164。
侧表面160和162从上表面154延伸到下表面156。位于侧表面160和162中的一对纵向延伸沟槽166(图10)沿主体152延伸。沟槽166从第一端150延伸到第二端158。
滑动件168(图9和14)可以连接到元件140的中心体152。滑动件168接合椎骨12和14中的一个以防止安装件100在椎骨之间近侧方向的进一步插入。该滑动件168包括一个带有螺纹开口172的主体部分170。一对突缘174从主体部分170向下延伸。该突缘174(见图14)大体彼此平行延伸并且包括朝向彼此延伸的部分176。该部分176容纳在部件140的主体152的槽166中。滑动件168在面对且与部件140的连接端144离开的表面179包括一垂直延伸槽178。
滑动件168可以相对于主体152朝着和远离元件140的末端144移动。固定螺钉(未示出)拧入到开口172中并且延伸到扇形凹槽164中以防止滑动件相对于主体152移动。扇形凹槽164限定了滑动件168相对于元件140的多个位置。
元件140的插入端180(图9-13)从主体152的第二端158延伸。插入端180可以与主体152的上和下表面154和156成一个角度延伸并且大体平行于突出146。可以预见插入端180可以相对于表面154和156以任何期望的角度延伸。插入端180(图11)具有与主体152的下表面156成一个角度延伸的下表面182。
插入端180(图12)包括用于接纳安装件100的凹槽184。凹槽184大体为带有开口端186的U形,安装件100可以通过所述开口端插入到凹槽中和从凹槽卸除。凹槽184由通过后壁192互连的侧壁188和190限定。底壁194大体垂直于188和190以及后壁192延伸。
侧壁188具有径向向外延伸的缺口198。侧壁190包括径向向外延伸的缺口200。后壁192具有朝主体152延伸的缺口202。沟槽206(图10和13)形成于侧壁188中从开口端186附近延伸到缺口198。沟槽208从缺口198延伸到缺口202。类似于沟槽208在缺口202和缺口200之间延伸的沟槽(未示出)形成于侧壁190中。类似于沟槽206从缺口200延伸到开口端186附近的另一凹槽(未示出)形成于侧壁190中。
第一圆形开口216延伸通过底壁194并且居中地位于凹槽184中。需要时开口216允许从凹槽184卸除安装件100。第二更小的圆形开口218延伸通过底壁194并且位于缺口202中。
弹簧件230(图9和15)容置在凹槽184中以将安装件100保持在凹槽中。弹簧件230大体为U形并且包括从基部236延伸的一对臂232和234。突出238在与臂232和234相反的方向从基部236延伸。突出238具有用于接纳销(未示出)以将弹簧件230连接到元件140的圆形开口240。所述销(未示出)延伸通过弹簧件230中的开口240并且进入元件140中的开口218以将弹簧件连接到元件140。
臂232包括接合安装件100以将安装件保持在元件140中的向上延伸端246。末端246具有径向向内延伸的突出248。突出248延伸到安装件100的凹槽114中的一个中以将安装件保持在元件140中。
臂234具有向上延伸端252。末端252具有径向向内延伸的突出254。突出254延伸到安装件100的凹槽114中的一个中以将安装件保持在元件140中。
弹簧件230通过开口端186插入到凹槽184中。当弹簧230正被插入到凹槽184中时,臂232和234延伸到侧壁188的沟槽206和从缺口200延伸到开口端186附近的侧壁190的沟槽(未示出)中。臂232和234的末端246和252朝着彼此移动。当末端246和252靠近缺口198和200时,末端246和252彼此远离地移动。
当弹簧230(图9)插入到凹槽184中时,臂232延伸到沟槽208中并且臂234延伸到从缺口202延伸到元件140的插入端180中的缺口200的沟槽(未示出)中。弹簧件230的突出238中的开口240与插入端180中的开口218对准。销(未示出)延伸通过弹簧件230中的开口240并且进入开口218以将弹簧件保持在凹槽184中。末端246和252向上延伸到侧壁188和190中的缺口198和200中。
当安装件100插入到弹簧230的末端246和252之间时,所述末端径向向外彼此远离地移动到缺口198和200中直到凹槽114与突出248和254对准。当凹槽114与突出248和254对准时,末端246和252朝着彼此移动到凹槽中以将安装件100保持在插入端180中。可以通过克服由弹簧件230施加的保持力而从凹槽184卸除安装件100。
在安装件100连接到椎骨12和14之后用于在椎骨12和14之间插入圆盘18的插入工具300在图16和17中示出。工具300(图16)类似于一对普通剪刀并且具有可枢转地彼此连接的一对腿302和304。工具300包括由腿302和304上的一对夹钳308形成的夹持端306。夹钳308(图17)包括朝着彼此延伸的卵形突出310。突出310插入到圆盘18中的开口48和82中以夹持圆盘用于插入到椎骨12和14之间。
腿302(图15)具有与夹钳308相对的扩大端312。需要时扩大端312可以用锤子敲击以将圆盘18推入椎骨12和14之间。腿304具有与夹钳308相对的弯曲手柄314。手柄314容易由外科医生抓握以用于操作工具300。
当突出310被插入到圆盘18中的开口48和82中之后锁定机构320防止夹钳308彼此远离地枢转。锁定机构320包括杆322,该杆枢转地连接到从腿304延伸的安装部分324。杆322具有延伸通过腿302中的开口328的螺纹端326。螺母332螺接杆322的末端326并且接合腿302以防止夹钳308彼此远离地枢转。
当装置10将插入到椎骨12和14之间时,使用腹膜后或经腹膜的方法暴露靠近椎骨的前隙。建立中线基准。放置中线标记,例如K线,以将参考点保持在椎骨12和14中的一个的中心。撑开(distract)椎骨12和14之间的间隙并且切除椎骨之间的受损椎间盘。当切除受损椎间盘之后,从椎骨12和14去除软骨端板。然后可以根据需要雕刻椎骨12和14。
通过使用尝试筛选器(trial sizer)确定合适大小的装置10。尝试筛选器类似于圆盘18。尝试筛选器插入椎骨12和14之间以确定替换被切除椎间盘所需的期望的印迹,楔角,和圆盘高度。使用荧光检查法确定期望的印迹,楔角和圆盘高度。
安装件100然后插入到椎骨12和14之间。基于期望的锲角选择用于椎骨12和14之间的合适元件140。安装件100插入元件140中的凹槽184中。元件140的插入端180插入到椎骨12和14之间直到中线标记延伸到滑动件168上的沟槽178中并且滑动件168接合中线标记正下方的椎骨12和14中的一个的前脊。一旦元件140的插入端180被插入到期望深度,致动器120使插入端彼此远离地移动以将安装件100上的突出106插入到椎骨12和14中。当安装件100连接到椎骨12和14之后,从椎骨12和14之间取出元件140,留下安装件140。
当安装件100连接到椎骨12和14之后,尝试筛选器可以重新插入到椎骨之间。可以使用荧光检查法实现尝试筛选器位置的检验。如果确定安装件100未处于期望位置,安装件可以容易地被取出并且重新定位在椎骨中。
当安装件100在它们的期望位置连接到椎骨12和14之后,插入工具300与圆盘18连接。圆盘18然后插入到椎骨12和14之间。在圆盘18的插入期间,开口36和70的相对侧上的肋条26和66接合安装件100上的表面112和113以引导圆盘的插入。当圆盘18在椎骨12和14之间插入到期望深度时中心肋条28和68接合安装件100。圆盘18上的肋条26,28,66和68引导安装件100插入到圆盘18中的开口36和70中。
当圆盘18放置到椎骨12和14之间的期望位置时,从圆盘取出工具300。当安装件100插入到圆盘18中的开口36和70中时圆盘18上的肋条26,28,66和68接合椎骨12和14。安装件100和肋条26,28,66和68将装置10保持在椎骨12和14之间的适当位置中。
当装置10在脊柱16中使用时,上保持装置20固定到椎骨12。肋条26和28和安装件100上的突出106抵抗上保持装置20和椎骨12之间的相对运动。下保持装置60固定到椎骨14。肋条66和68和安装件100上的突出106抵抗下保持装置60和椎骨14之间的相对运动。
当上和下保持装置20和60相对于彼此移动时,例如当脊椎16被压缩时,如图7中所示,弹性芯体90朝着安装件100上的凹表面104偏转。当负荷施加于装置时弹性芯体90也朝着保持件21和61上的表面52和86偏转。因此,当上和下保持装置20和60作相对运动时芯体90消耗能量以减小芯体中的应力,从而为装置10提供比较长的疲劳寿命。
当施加预定负荷时弹性芯体90偏转到与安装件100的表面104接合。当施加预定负荷时芯体90也偏转到与保持件21和61上的表面52和86接合。因此,当芯体接合表面104,52和86时由于芯体的进一步偏转受到限制而使芯体90变硬。可以预见芯体90可以在不同施加压力下接合表面104,52和86。
尽管圆盘18上的肋条26和66被描述成接合安装件100以引导圆盘插入椎骨12和14之间,可以预见安装件100可以具有圆盘18上的肋条延伸到其中的沟槽以引导圆盘插入。也可以预见安装件100可以具有延伸到圆盘18中的沟槽中的肋条以引导圆盘插入。此外,可以预见圆盘18可以在不使用安装件100的情况下插入到椎骨12和14之间。如果在没有安装件100的情况下使用圆盘18,可以预见保持装置20和60的保持件21和61将包括类似于安装件的内凹表面104的内凹表面。芯体90可以与保持件21和61上的内凹表面间隔并且当预定负荷施加于装置10时偏转到与内凹表面接合。
将会理解本发明的以上描述容易进行各种改进、变化和调整,其意味着包含在所附权利要求的等价物的含义和范围内。无论从哪个方面来看当前公开的实施方式都被视为是示例性的,而不是限定性的。本发明的范围由所附权利要求而不是由前面的描述指出,并且在其含义和范围内的所有变化都意味着包含于此。

Claims (11)

1.一种用于替换脊柱中受损椎间盘的装置,所述装置包括:
人工圆盘,所述人工圆盘包括具有第一表面和第二表面的弹性芯体,连接到所述弹性芯体的所述第一表面的第一保持件,和连接到所述弹性芯体的所述第二表面的第二保持件,所述第一保持件具有可与脊柱的第一椎骨接合的外表面和面对所述弹性芯体的所述第一表面的内表面,所述第二保持件具有可与脊柱的第二椎骨接合的外表面和面对所述弹性芯体的所述第二表面的内表面;和
可与第一椎骨和所述人工圆盘连接以将所述人工圆盘定位在第一和第二椎骨之间的第一安装件,所述第一安装件在连接到第一椎骨之后可与所述人工圆盘接合以引导所述人工圆盘移动到第一和第二椎骨之间的位置中。
2.如权利要求1所述的装置,其中所述第一保持件包括可与所述第一安装件接合的导轨,所述导轨从所述第一安装件的所述外表面延伸并且可与第一椎骨接合。
3.如权利要求1所述的装置,其中所述第一保持件包括可与所述第一安装件接合的第一和第二导轨,所述第一和第二导轨大体彼此平行地延伸。
4.如权利要求1所述的装置,其中所述第一保持件包括可与所述第一安装件接合的所述止挡以防止在第一方向上所述第一保持件和所述第一安装件之间的相对运动,所述止挡在横过第一方向延伸的第二方向上引导所述第一保持件相对于所述第一安装件的运动。
5.如权利要求1所述的装置,其中所述第一保持件具有开口,所述第一保持件的所述内和外表面延伸通过所述开口,所述第一安装件延伸到所述开口中。
6.如权利要求5所述的装置,其中所述开口轴向地延伸通过所述第一保持件的所述内和外表面。
7.如权利要求1所述的装置,其中所述第一安装件包括面对所述芯体并且与所述芯体间隔的内表面,当在所述第一和第二保持件之间作相对运动时所述芯体偏转到与所述第一安装件的所述内表面接合。
8.如权利要求1所述的装置,其中所述第一安装件具有可与所述人工圆盘上的截头圆锥形表面接合的截头圆锥形表面以防止所述第一安装件相对于所述人工圆盘移动。
9.如权利要求1所述的装置,进一步包括可与第二椎骨和所述人工圆盘接合以将所述人工圆盘定位在第一和第二椎骨之间的第二安装件,所述第二安装件可与所述人工圆盘接合以引导所述第二保持件移动到第一和第二椎骨之间的位置中。
10.如权利要求1所述的装置,其中所述芯体包括在所述芯体的所述第一和第二表面之间延伸的径向外表面,所述径向外表面面对所述第一和第二保持件中的一个的一部分,所述径向外表面与所述第一和第二保持件中的所述一个的所述部分间隔,当在所述第一和第二保持件之间作相对运动时所述芯体偏转到与所述第一和第二保持件中的一个的所述部分接合。
11.如权利要求1所述的装置,其中所述第一保持件包括可与用于将所述人工圆盘插入到椎骨之间的外科工具接合的一部分,所述第一保持件的所述部分包括外科工具的一部分延伸到其中的开口。
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EP1703869A2 (en) 2006-09-27
CA2650756C (en) 2012-01-31
CN1901854A (zh) 2007-01-24
WO2005058194A3 (en) 2006-01-19
US7695517B2 (en) 2010-04-13
US20050131542A1 (en) 2005-06-16
EP1703869A4 (en) 2009-05-27
AU2004299008A1 (en) 2005-06-30
KR100753465B1 (ko) 2007-08-31
CA2650756A1 (en) 2005-06-30
CA2549101C (en) 2009-08-04
US20050131543A1 (en) 2005-06-16
EP1703869B1 (en) 2011-11-23
US20050131544A1 (en) 2005-06-16
US7128761B2 (en) 2006-10-31
US7588600B2 (en) 2009-09-15
JP2007513711A (ja) 2007-05-31
EP2387976A1 (en) 2011-11-23
CN101816596B (zh) 2013-07-24
ATE534350T1 (de) 2011-12-15
WO2005058194A2 (en) 2005-06-30
CA2549101A1 (en) 2005-06-30
JP4750042B2 (ja) 2011-08-17
AU2004299008B2 (en) 2010-02-25
KR20060101865A (ko) 2006-09-26
CN1901854B (zh) 2010-05-12

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