CN1515234A - 新型的香蕉形支架 - Google Patents
新型的香蕉形支架 Download PDFInfo
- Publication number
- CN1515234A CN1515234A CNA2003101245277A CN200310124527A CN1515234A CN 1515234 A CN1515234 A CN 1515234A CN A2003101245277 A CNA2003101245277 A CN A2003101245277A CN 200310124527 A CN200310124527 A CN 200310124527A CN 1515234 A CN1515234 A CN 1515234A
- Authority
- CN
- China
- Prior art keywords
- antetheca
- rear wall
- maximum height
- support
- intervertebral disc
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Abstract
本发明涉及一种改进的香蕉形椎间融合支架,其可定位在椎间盘间隙的前半部分中。
Description
技术领域
本发明涉及一种新颖的香蕉形支架。
背景技术
下背部疼痛的主要原因是腰部椎间盘的破裂或退化。下肢中的疼痛是由脊神经根被突出的椎间盘压迫而引起的,而下背部疼痛是由椎间盘破裂和关节重量通过受损的不稳定的椎关节所产生的不利影响而引起的。治疗这些问题的一种所提出的方法是切除有问题的椎间盘,并用一种多孔式装置来代替它,这种装置可恢复椎间盘的高度,并允许骨头从中生长出来以与相邻的椎骨融合。这些装置通称为“融合装置”。
美国专利No.4743256(“Brantigan”)公开了一种用于消除因椎间盘破裂或退化所引起的脊背疼痛的改进的外科手术方法,它是通过将刚性的融合装置或“支架(cage)”跨置于相邻椎骨之间的椎间盘间隙上来实现的,该支架具有可促进骨向内生长的表面,其底部安放在椎骨的预处理部位上,以便使植入物与椎骨形成一体并提供可保持椎间盘间隙的永久重量的支撑柱。Brantigan提出,这些支架应当从脊柱的后侧直线式地插入到椎间盘间隙中。
由于Brantigan支架从脊柱的后侧直线式地插入到椎间盘间隙中,因此其上、下表面就只靠在相对的椎骨终板两侧中的一侧上。出于此原因,在每次外科手术操作中必须使用两个Brantigan支架。
美国专利No.6143032(“Schafer”)公开了一种具有香蕉形状的椎间融合装置,其包括通过凸起壁和下凹壁相连的引导壁和尾部壁。这一植入物还可具有楔形的形状,其中下凹壁的高度小于凸起壁的高度。见第3页第8-9行。
美国专利No.6245108(“Biscup”)公开了一种包括有一对D形支架的装置,该支架可相互间相邻地安装在椎间盘间隙内。各支架具有脊柱前凸的前-后楔形形状,其弯曲的壁比相对的壁更短,因此这种装置在整体上提供了一种圆顶形状。
美国专利No.6387130(“Stone”)公开了提供多个植入物,当这些植入物顺序地排列时可形成一种香蕉形的装置,它靠在椎间盘间隙的前半部分上。各植入物可具有如图5所示的脊柱前凸的形状,并且所述多个植入物可形成为锥形以便分散开并前凸,如图6所示。
PCT专利申请WO 01/28469A2(“Frey”)公开了一种具有香蕉形状的椎间融合装置,其包括通过凸起壁和下凹壁相连的引导壁和尾部壁。Frey支架从脊柱的后侧非直线式地插入到椎间盘间隙内,使其引导壁靠在脊柱的一侧上而尾部壁靠在脊柱的另一侧上。由于Frey支架靠在各相对终板的各侧上,因此在每次外科手术操作中只需使用一个Frey支架。
然而,Frey公开了以基本上侧面定位的方式将Frey支架定位在终板的前端和后端之间的大致中点处。由于终板的边缘提供了最稳定的支承面,因此Frey植入物必须具有延伸跨过终板宽度的宽度。通常来说,这种支架的宽度约为32毫米。
另外,Frey植入物的上支承面具有一个内端支撑1019,其将植入物的前壁和后壁相连。由于只设有一个支撑,因此支架容易围绕这一支撑摇动。
另外,虽然Frey公开了在植入物的任一端设有一对插入孔,然而插入孔的几何形状围绕支架的中线对称。因此,该对称的孔设置并未给医生提供任何内部操作的灵活性,以便调节病人解剖结构上的或进路上的差异。
另外,虽然Frey公开了前壁可具有比后壁更大的高度,然而Frey并未公开后壁可具有比前壁更大的高度。
最后,虽然Frey公开了上、下支承面可具有设于其中的沟槽,然而Frey并未公开上、下支承面可具有设于其上的齿。
已公布的PCT专利申请WO 01/70144(“Scolio”)公开了一种香蕉形状的植入物,其具有三个垂直设置的通孔,在这三个通孔之间形成了两个内部平面壁。该植入物还具有下凹壁,该壁具有多个从中穿过的开口。最后,该植入物具有脊柱前凸的前-后楔形形状,以及前部3到后部4的角度。Scolio申请中的图7公开了一种具有两个垂直设置的孔的类似植入物。该支架的几何形状(脊柱前凸且具有中间-侧面的斜度)要求它只能用于支撑椎间盘间隙的一半,这与Brantigan支架相同。
已公布的PCT专利申请WO 02/17823(“Kim”)公开了一种香蕉形状的植入物,其具有两个垂直设置的通孔,在这两个通孔之间形成了一个内部平面壁。该植入物还具有下凹壁和凸起壁,各壁均具有多个从中穿过的开口。植入物的上、下支承面具有设于其上的金字塔形齿。最后,该植入物具有脊柱前凸的前-后楔形形状,以及前部3到后部4的角度。该申请的图10A-E公开了将该植入物放置在椎间盘间隙的前半部分上,并且使其凸起壁朝向前方。
Kim支架只具有一个插入孔,因此不能如上所述地那样为医生提供灵活性。另外,它只具有一个中间柱,因而增加了在中间-侧面方向上倾斜的可能性。最后,它应具有恒定的多边形截面的要求阻止了其隆起的可能性。
已公布的美国专利申请2002/0055781(“Sazy”)公开了一种具有网状结构的香蕉形植入物。Sazy申请中的图7公开了该植入物大致定位在椎间盘间隙的中间。
已公布的美国专利申请2002/0077700(“Vargas”)公开了一种香蕉形的无孔式植入物。Vargas申请中的第55段讲授了将植入物尽可能地设置在椎间盘间隙中的前方。
发明内容
本发明人认识到,虽然Frey支架在支撑椎间盘间隙的中间部分方面可能是有效的,然而更需要一种可支撑椎间盘间隙的前部的融合支架。当装置这样定位时,采用后侧进路或后外侧进路的外科医生就获得了位于装置后方的额外空间,在这里可放置移植材料如自体移植材料。另外,当装置这样定位在椎间盘间隙的前三分之一的部分内时,所得到的作用在椎体上的悬臂式作用促使在椎体之间形成更自然的脊柱前凸关系,并且还减轻了分布在植入物上的应力。
类似的,该装置优于Vargas的装置,其原因在于,虽然Vargas的装置定位在椎间盘间隙的前部中,然而它缺乏开口,因而无法填充移植材料。
因此,与这些现有技术的装置相比,本发明的装置能够获得用移植材料填充椎间盘间隙的增强的效果。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出的水平截面的前壁,
b)后壁,
c)处于前、后壁之间(最好与它们相连)的第一和第二端壁,
d)位于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),以及从上支承面中穿过以促进骨融合的至少一个上开口,和
e)下支承面,其具有位于前壁下方的前部、位于后壁下方的后部,以及从下支承面中穿过以促进骨融合的至少一个下开口,
其中,上、下开口相通以促进穿过该装置的骨融合,
前壁具有中间部分和侧端部分,它们均具有最大高度,中间部分的最大高度大于侧端部分的最大高度,以及
各支承面的后部可以靠在椎间盘间隙的前半部分上。
附图说明
图1A-1G公开了本发明的脊柱前凸的香蕉形支架的各幅视图。
图2A-2G公开了本发明的平行的香蕉形支架的各幅视图。
图3A-3C公开了本发明的香蕉形支架的各幅视图,其中前壁具有几乎延伸到后壁上的凹腔。
图4A-4C公开了本发明的香蕉形支架的各幅视图,该支架具有设置在端壁附近的内平面壁。
图5A-5C公开了本发明的另一脊柱前凸的香蕉形支架的各幅视图。
图6A-6C公开了本发明的另外一种脊柱前凸的香蕉形支架的各幅视图。
图7A-7C公开了本发明的平行的香蕉形支架的各幅视图,其中只有一部分后壁具有与前壁的对应高度相等的高度。
图8A-8C公开了本发明的香蕉形支架的各幅视图,其中前壁包括上、下脊部。
图9A-9C公开了本发明的香蕉形支架的各幅视图,其中端壁包括翼部。
图10A-10C公开了本发明的香蕉形支架的各幅视图,该支架具有设于前壁之前的带。
图11A-11D公开了将本发明的香蕉形支架插入到椎间盘间隙中的情况。
具体实施方式
现在参考图1A-1G,图中显示了椎间融合装置1,其包括:
a)前壁11,其具有凸出形状的水平截面,
b)后壁21,其具有下凹形状的水平截面,
c)与前壁和后壁相连的第一端壁31和第二端壁41,
d)上支承面71,其具有位于前壁上方的前部73和位于后壁上方的后部75,以及
e)下支承面91,其具有位于前壁下方的前部93和位于后壁下方的后部95,
其中,各支承面的前部适于靠在皮层前缘(anterior cortical rim)上,以及
各支承面的后部适于靠在椎间盘间隙的前侧。
最好,该支架可使第一端壁先插入到椎间盘间隙中,然后旋转该装置。
前壁优选凸起式地弯曲。更优选的是,它应成形为与椎骨终板的皮层前缘的形状相符。当前壁这样地成形时,支架就可以靠在椎骨终板的皮层前缘上并提供支撑。通常来说,前壁的凸曲线为圆弧的形式,其半径在15毫米到25毫米之间。这种曲线允许以非直线的方式插入支架。
在一些实施例中,前壁包括可促进骨融合的开口13。
在一些实施例中,这些开口具有一定的高度和宽度,其中开口的高度大于其宽度。在这种情况下,周边的材料可以更好地承受轴向压应力。
在一些实施例中,该开口占前壁的约14面积百分比(面积%)到约50面积%,最好占20面积%到30面积%。与前开口大约占前壁的70面积%的Frey结构相比,这些实施例具有更大的质量,因而为结构提供了比Frey结构更大的强度。这种增加的强度是很重要的,这是因为本发明装置的整体尺寸通常小于Frey装置的整体尺寸。
在一些实施例中,前壁的水平截面包括下凹部分15,从而形成了右侧的前壁端部17和左侧的前壁端部19。这一凹腔可用作椎间盘间隙内的对准导向。它还可允许在插入前使植入物预弯曲(材料性质允许)。最后,前壁提供了用于夹住植入物的端口,以便能够将其取出。
在一些实施例中,如图3A所示,前壁的下凹部分延伸超过了支架宽度的一半,并且在中央后切口中填充了材料以形成光滑的后壁。该实施例是有利的,这是因为它形成了有效的“双腔”植入物,并且在后壁中央具有比图1所示支架更多的材料,因而允许植入物能够响应于在插入期间受到的较高冲击力而更有效地抵抗弯曲。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出形状的水平截面和下凹部分的前壁,
b)后壁,
c)处于前、后壁之间(并最好与它们相连)的第一和第二端壁,
d)处于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),以及从上支承面中穿过以促进骨融合的至少一个上开口,和
e)下支承面,其具有位于前壁下方的前部、位于后壁下方的后部,以及从下支承面中穿过以促进骨融合的至少一个下开口。
在对腰椎特别有利的实施例中,前壁的最大高度的范围处于约5毫米到18毫米之间,前壁的最大厚度的范围处于约1毫米到3毫米之间。
后壁优选下凹式地弯曲。这种曲线允许以非直线的方式插入支架。通常来说,后壁的凹曲线为圆弧的形式,其半径在5毫米到20毫米之间。
在一些实施例中,后壁包括可促进骨融合的开口23。
在一些实施例中,如图1D所示,这些开口具有高度HO和宽度WO,其中开口的高度大于其宽度。在这种情况下,周边的材料可以更好地承受轴向压应力。
在一些实施例中,后壁中的这些开口总共占后壁的约14面积%到约50面积%,最好占20面积%到30面积%。在这一范围内,开口足够大以允许养分可穿过壁而传送。与后开口占后壁的约70面积%的Frey结构相比,这些实施例具有更大的质量,因而为结构提供了比Frey结构更大的强度。这种增加的强度是很重要的,这是因为本发明装置的整体尺寸通常小于Frey装置的整体尺寸。
在对腰椎特别有利的实施例中,后壁的最大高度处于约5毫米到18毫米之间,后壁的最大厚度处于约1毫米到3毫米之间。在例如图1所示的一些实施例中,后壁的高度使其上表面可以靠在上椎骨终板上。然而在其它一些实施例中,如图5所示,后壁的高度更小一些,其上、下表面均不靠在上、下椎骨终板上。
端壁的水平截面最好凸起式地弯曲。这种曲线允许在前壁和后壁之间形成平滑的过渡,并便于插入到椎间盘间隙中。通常来说,后壁的凹曲线为圆弧的形式,其半径处于1.5毫米到6.5毫米之间。
在一些实施例中,至少一个端壁为引导端壁,其包括可与插入器械相接合的特征部分121。这允许将支架基本上沿长度方向插入到椎间盘间隙的后侧中的小开口内,然后进行旋转,从而使前壁朝向椎间盘间隙的前部。
在一些实施例中,这些特征部分121包括适于容纳推动器械的开口。在优选实施例中,这些开口是可容纳螺纹式推动器械的螺纹开口。
在一些实施例中,这些可容纳推动器械的开口是端壁中的单个开口。这种设置保留了端壁的质量,从而为结构提供了更大的强度。
在一些实施例中,各端壁包括可与插入器械相接合的特征部分121,123,从而允许各端壁成为引导壁或尾部壁。这就为外科医生提供了额外的灵活性。在各端壁包括形式为可与插入器械相接合的孔的特征部分121,123的一些实施例中,这些特征部分围绕着装置的中心线不对称地设置(即这些特征部分以不同的角度延伸到支架中)。在图1A所示的支架中,右侧孔121以比左侧孔123更垂直于平面壁111的角度设置。这些特征部分的不对称设置为外科医生提供了灵活性,其可应付外科手术技术中的差异,或者是它们所暴露出来的大小和位置以及解剖结构的差异。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有引导端和尾部端的前壁,
b)具有引导端和尾部端的后壁,
c)与前、后壁的引导端相连并具有引导插入孔的引导端壁,
d)与前、后壁相连并具有尾部插入孔的尾部端壁,
其中,前壁和后壁在它们之间形成了中心线(如图2A中的标号CEN所示),以及
引导插入孔和尾部插入孔围绕中心线不对称地设置。
在一些实施例中,如图9所示,端壁形成了翼部151,153,它们从前壁的常态曲线上切向地延伸出来。这些翼部的功能是扩展前壁并沿皮层边缘增加额外的支撑。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出形状的前壁,
b)后壁,
c)处于前、后壁之间(并最好与它们相连)的第一和第二端壁,
d)处于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),以及从上支承面中穿过以促进骨融合的至少一个上开口,和
e)下支承面,其具有位于前壁下方的前部、位于后壁下方的后部,以及从下支承面中穿过以促进骨融合的至少一个下开口,
其中,端壁形成了从前壁的常态曲线上切向地延伸出来的翼部。
引导端壁的垂直截面最好形成锥形以便于将装置插入到椎间盘空隙中。各端壁优选为锥形,因此外科医生可使用任一端壁作为引导端壁。更优选的是,该锥形提供了子弹似的形状。这种子弹形端部在插入时可将椎体分开,并使任何附近的软组织产生偏移。
支架的上、下表面可以靠在形成了椎间盘间隙的相对椎体的相对表面上。在一些实施例中,上、下表面可以靠在椎体的终板部分上。或者,可在终板中切出通道,这些表面可以靠在通过这些通道而暴露出来的相对的骨面上。
各上、下表面优选在侧-侧截面上凸起式地弯曲。更优选的是,各表面成形为与椎骨终板的相对表面的形状相符。当上、下表面这样成形时,支架与椎间盘间隙更精确地相符。通常来说,上、下表面的凸曲线为圆弧的形式,其半径处于90毫米到240毫米之间。
在一些实施例中,上、下表面包括可促进骨融合的开口175,195。
在一些实施例中,这些开口具有一定的长度和宽度,其中开口的长度大于开口的宽度。由于优选的支架具有较长的长度,在这种情况下,只需要从上到下地对一些开口进行填充,以便如所需地用移植材料来填充支架。
在一些实施例中,这些开口占上、下支承面的约30面积%到约60面积%。与上、下开口大约占上、下表面的约70到80面积%的Frey结构相比,本发明的这些实施例具有更大的质量,因而为结构提供了比Frey结构更大的强度以及提高的抗下陷能力。这种增加的强度是很重要的,这是因为本发明装置的整体尺寸通常小于Frey装置的整体尺寸。
在一些实施例中,如图1所示,各上、下表面的水平截面包括下凹部分76,96,从而形成了上、下表面部分的右部77,97和左部79,99。下凹部分的功能是形成一个工字梁结构,以便在插入期间帮助防止弯曲。它还可用于对准,用于在外科手术之后观察终板-支架界面处的融合情况,并且可以帮助防止下陷。
在对腰椎特别有利的实施例中,各上、下表面的最大长度处于约20毫米到30毫米之间。
在一些实施例中,如图2所示,前壁的最大高度等于后壁的相应最大高度,使得上、下支承面相互平行。在图7所示的特定设计中,少于一半的后壁平行于前壁,后壁的其余部分具有更小一些的相应高度。
在一些实施例中,如图1所示,前壁的最大高度401大于后壁的最大高度403,这样上、下支承面就提供了脊柱前凸。这些高度最好使得所形成的脊柱前凸处于约1度到约10度之间。这一范围符合脊柱的腰部段和颈部段中的脊柱前凸的自然生理范围。在一些实施例中,上、下表面直线式地形成斜度,使得脊柱前凸角度从前壁到后壁上保持一致。在另一些实施例中,这些斜度可基本上完全地处于前壁上,或者如图6所示,这些斜度可基本上完全地处于前壁和端壁上。
在一些实施例中,前壁的最大高度小于后壁的最大高度,使得上、下支承面提供了脊柱后凸。这些高度最好使得所形成的脊柱后凸处于约1度到约10度之间。这一范围符合脊柱胸部段中的脊柱后凸的自然生理范围。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出形状和最大高度的前壁,
b)具有下凹形状和最大高度的后壁,
c)与前壁和后壁相连的第一和第二端壁,
其中,前壁的最大高度小于后壁的最大高度。
在一些实施例中,前壁包括具有最大高度401的中间部分301和具有最大高度405的侧端部分305,中间部分的最大高度大于侧端部分的最大高度。这提供了与自然椎间盘间隙的高度相符的有利的隆起效果。
在一些实施例中,上、下支承面形成有齿120,其可用于夹住椎骨终板并抵抗支架的位移。这些齿包括两个形成一定角度的支承面部分121,123,它们形成了一个可夹住终板的角度。在一些实施例中,形成一定角度的支承面部分121,123相汇合而形成了一个尖锐连接125。在另一些实施例中,在形成一定角度的支承面部分121,123之间设置了承接面127。齿的成角度的特性提供了夹持面,这比Frey支架中提供的由大致平行的表面所形成的沟槽具有更好的效果。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出的水平截面的前壁,
b)后壁,
c)处于前、后壁之间(并最好与它们相连)的第一和第二端壁,
d)位于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),和
e)位于前壁和后壁之间的下支承面(最好具有位于前壁下方的前部和位于后壁下方的后部),以及
f)第一和第二横向支柱,它们从上支承面的前部延伸到上支承面的后部,
其中,上、下支承面形成了齿,其从各横向支柱中延伸出来并可夹住椎骨终板。
在一些实施例中,如图8所示,各上、下表面的垂直截面包括下凹的脊部131,141,从而形成了上、下表面部分的右部77,97和左部79,99。这些脊部的功能是形成植入物的左侧和右侧,从而提高了植入物的稳定性(类似于图1中的通道),并且提供了切口以便能接触到融合生长的部位。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出形状和最大高度的前壁,
b)具有大致均匀高度的中间部分以及侧端部分并具有凸出形状的后壁,
c)与前、后壁相连的第一和第二端壁,
d)位于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),并具有包括下凹脊部的中间部分、侧端部分和至少一个开在其上以促进骨融合的上开口,和
e)下支承面,其具有位于前壁下方的前部、位于后壁下方的后部,以及至少一个开在其上以促进骨融合的下开口。
在一些实施例中,支架外表面中的开口延伸到支架中以在其中形成腔151,153。这些腔可将骨移植材料保持在其中并促进骨融合。在一些实施例中,中央支柱限定了两个腔,与一个大腔相比,这种尺寸较小的两个腔能够更容易地保持住移植材料。
在一些优选实施例中,支架包括至少一个支柱101,其从上支承面的前部延伸到上支承面的后部。这种支柱有助于稳定支架并提高支架的机械强度。
在一些实施例中,支架包括第一横向支柱101和第二横向支柱103,它们从上支承面的前部延伸到上支承面的后部。采用两个支柱有助于防止支架绕其中线的中间-侧面摇动(在采用一个支柱的情况下会发生)。
因此,根据本发明,提供了一种适用于非直线式地插入的椎间融合装置,其包括:
a)具有凸出形状的前壁,
b)后壁,
c)与前、后壁相连的第一和第二端壁,
d)上支承面,其具有位于前壁上方的前部和位于后壁上方的后部,和
e)下支承面,其具有位于前壁下方的前部和位于后壁下方的后部,以及,
f)第一和第二横向支柱,其从上支承面的前部延伸到上支承面的后部。
在一些实施例中,第一横向支柱101和第二横向支柱103是从前壁横向地延伸到后壁的较大内平面壁111的一部分。该内平面壁可将支架有效地分成具有左、右移植腔的左、右部分。当内壁设置在支架中心线附近时这是有利的,这是因为这些较小的腔能够比一个大腔更有效地保持被压在其中的移植材料。
在一些实施例中,如图4所示,内平面壁设置在支架端壁的附近。
在一些实施例中,如图10所示,装置还包括从前壁中向前延伸出来的水平设置的带210。这种带的功能是与插入器械相配合以便于插入,或者与引导器械相配合以便于对准。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)具有凸出形状的前壁,
b)后壁,
c)与前、后壁相连的第一和第二端壁,
d)位于前壁和后壁之间的上支承面(最好具有位于前壁上方的前部和位于后壁上方的后部),以及从上支承面中穿过以促进骨融合的至少一个上开口,和
e)位于前壁和后壁之间的下支承面(最好具有位于前壁下方的前部和位于后壁下方的后部),并最好具有至少一个下开口从下支承面中穿过以促进骨融合,以及,
f)从前壁中向前延伸出来的水平设置的脊部(最好为带)。
本发明的装置可采用体内融合手术所常用的任何生物相容的材料制成。
在一些实施例中,支架可由一种复合材料制成,该复合材料含有:
a)40-99%的聚芳基乙基酮PAEK,和
b)1-60%的碳纤维,
其中,聚芳基乙基酮PAEK选自聚醚醚酮PEEK、聚醚酮酮PEKK、聚醚酮醚酮酮PEKEKK和聚醚酮PEK。
碳纤维优选为切短纤维。PAEK和碳纤维最好均匀地混合。复合材料优选大致上含有PAEK和碳纤维。复合材料优选含有60-80重量%的PAEK和20-40重量%的碳纤维,最好是65-75重量%的PAEK和25-35重量%的碳纤维。在一些实施例中,支架可由在美国马萨诸塞州Raynham的DePuy AcroMed所销售的碳纤维支架中所用的材料制成。在一些实施例中,该复合材料为可从美国北卡罗来纳州Greenville的Invibio中买到的PEEK-OPTIMATM。
在另一些实施例中,支架可由金属如钛合金制成,该钛合金例如为Ti-6Al-4。
在另一些实施例中,支架可由同种异体移植材料制成。
在一些实施例中,支架可由陶瓷、最好是至少能部分地再吸收的陶瓷如HA或TCP制成。在另一些实施例中,该陶瓷包括氧化物,例如氧化铝或氧化锆。
在一些实施例中,支架可由聚合物、最好是至少能部分地再吸收的聚合物如PLA或PLG制成。
在一些实施例中,支架以无菌的形式提供。
在一些实施例中,将从病人髂嵴中得到的自体骨移植材料插入到支架的腔中。
在另一些实施例中,可以采用从同种异体颗粒如网状骨质碎片和脱矿质骨基质中得到的骨移植材料。
在另一些实施例中,可以采用浓缩的骨诱发(osteoinductive)材料,例如自体富血小板的血浆或重组体生长因子。
在另一些实施例中,可以采用浓缩的骨生成(osteogenetic)材料,例如自体间充质干细胞(MSC)或重组体MSC。
最好将本发明的装置放入到椎间盘间隙内,使得整个装置被安放在椎间盘间隙的前三分之一的部分(即椎间盘间隙的前侧)中。更具体地说,本发明的装置应被放入到椎间盘间隙内,使得整个装置被安放在椎间盘间隙的前五分之一的部分中,最好是椎间盘间隙的前八分之一的部分中。
因此,根据本发明,提供了一种椎间融合装置,其包括:
a)前壁和后壁,在它们之间形成了一定的宽度,
b)将前壁和后壁相连并在它们之间形成了一定长度的第一和第二端壁,
其中,前壁具有中间部分和侧端部分,它们均具有最大高度,中间部分的最大高度大于侧端部分的最大高度,
该装置的宽度小于装置的长度,并且装置的长度小于椎间盘间隙的宽度的一半。
本发明的装置可用于通过各种技术和进路方式非直线式地插入到椎间间隙内,通常是采用一种单向进路而插入到椎间盘间隙内。
植入物的设计有助于将其安全且高效地插入到椎间间隙内,并允许对体内手术提供对称的单支架的解决方案。
现在来看图11A,一旦已完全地去除了椎间盘物质并用圆锉(未示出)对椎骨终板进行了预处理,就将导杆501插入到椎间盘间隙内,其用作所选试配件(trial)和植入物的导向件。所公开的导杆是弯曲的导向件或斜轨,其设计成可使支架转向而进入到正确的位置。导杆的曲率与植入物前壁的曲率大致相符。
接着,采用一试配件(未示出)来确定植入物的适宜尺寸和脊柱前凸的适宜程度。
然后按照手术进路和病人的解剖结构来将插入器503连接到植入物的两个插入孔之一中。这些螺纹插入孔相对于植入物的中心轴线不对称,从而提供了两个不同的插入角。试配物提供了相同的选择。
然后将植入物放入到支架衬块(未示出)中,并且用自体骨移植材料或替代物来对其进行填充。
然后采用导杆来将植入物引入到椎间盘间隙内,导杆作为引导和背面支撑以便适当地定位植入物。参考图11B-11C,使用木槌(如果需要的话)将植入物几乎插入到最终位置。
再参考图11D,出于解剖方面的考虑将插入器从植入物上拆下来。然后采用直线式和/或成角度的冲击器并用导杆作为引导来将支架夯实到最终位置。
支架的最终位置应当处于椎间盘间隙的前部,并相对于椎间盘间隙的中间-侧面中线对称地设置。这可保证形成最稳定的结构。
然后将骨移植材料或替代材料填入到椎间盘间隙的剩余的后半部分内,以便进一步促进体内融合。
如果在操作过程中的任何时刻需要取出植入物的话,可以使用移去器。
Claims (10)
1.一种椎间融合装置,其包括:
a)具有凸出的水平截面的前壁,
b)后壁,
c)处于所述前、后壁之间的第一和第二端壁,
d)位于所述前壁和后壁之间的上支承面,所述上支承面具有后部,并具有至少一个从中穿过以促进骨融合的上开口,和
e)位于所述前壁和后壁之间的下支承面,所述下支承面具有后部,并具有至少一个从中穿过以促进骨融合的下开口,
其中,所述上、下开口相通以促进穿过所述装置的骨融合,
所述前壁具有中间部分和侧端部分,所述中间部分和侧端部分均具有最大高度,所述中间部分的最大高度大于所述侧端部分的最大高度,以及
各所述支承面的后部适于靠在椎间盘间隙的前半部分上。
2.根据权利要求1所述的装置,其特征在于,各所述支承面的后部适于靠在椎间盘间隙的前三分之一的部分上。
3.根据权利要求1所述的装置,其特征在于,各所述支承面的后部适于靠在椎间盘间隙的前五分之一的部分上。
4.根据权利要求1所述的装置,其特征在于,所述装置是一个整体。
5.根据权利要求1所述的装置,其特征在于,所述后壁具有下凹的水平截面。
6.根据权利要求1所述的装置,其特征在于,所述装置适于从脊柱的后侧非直线式地插入。
7.根据权利要求1所述的装置,其特征在于,所述前壁具有最大高度,所述后壁具有最大高度,所述前壁的最大高度大于所述后壁的最大高度。
8.根据权利要求1所述的装置,其特征在于,所述前壁具有最大高度,所述后壁具有最大高度,所述前壁的最大高度小于所述后壁的最大高度。
9.根据权利要求1所述的装置,其特征在于,所述第一端壁是适于插入到椎间盘间隙内的引导端壁,所述引导端壁为锥形的。
10.根据权利要求1所述的装置,其特征在于,所述至少一个上开口占据了所述上表面的30面积%到60面积%。
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- 2003-12-23 CA CA002454046A patent/CA2454046A1/en not_active Abandoned
- 2003-12-24 NZ NZ530383A patent/NZ530383A/en unknown
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- 2003-12-30 DE DE60323930T patent/DE60323930D1/de not_active Expired - Lifetime
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- 2003-12-30 BR BR0305984-7A patent/BR0305984A/pt not_active Application Discontinuation
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- 2003-12-31 CN CNB2003101245277A patent/CN100467004C/zh not_active Expired - Lifetime
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2004
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CN107625564A (zh) * | 2017-10-20 | 2018-01-26 | 常州华森医疗器械有限公司 | 腰椎椎间融合器 |
CN116919679A (zh) * | 2023-09-18 | 2023-10-24 | 吉林大学 | 一种个性化定制颈椎零切迹椎间融合器及制作方法 |
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AU2003271330A1 (en) | 2004-07-15 |
USRE44417E1 (en) | 2013-08-06 |
JP4381798B2 (ja) | 2009-12-09 |
MXPA04000054A (es) | 2005-06-17 |
US7500991B2 (en) | 2009-03-10 |
BR0305984A (pt) | 2004-10-05 |
CN100467004C (zh) | 2009-03-11 |
EP1437105A1 (en) | 2004-07-14 |
EP1437105B1 (en) | 2008-10-08 |
AU2003271330B2 (en) | 2009-07-16 |
JP2004209249A (ja) | 2004-07-29 |
DE60323930D1 (de) | 2008-11-20 |
NZ530383A (en) | 2005-05-27 |
ATE410121T1 (de) | 2008-10-15 |
CA2454046A1 (en) | 2004-06-30 |
US20040127990A1 (en) | 2004-07-01 |
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