CN1901855A - 可扩张的脊骨植入物 - Google Patents

可扩张的脊骨植入物 Download PDF

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Publication number
CN1901855A
CN1901855A CNA2004800397152A CN200480039715A CN1901855A CN 1901855 A CN1901855 A CN 1901855A CN A2004800397152 A CNA2004800397152 A CN A2004800397152A CN 200480039715 A CN200480039715 A CN 200480039715A CN 1901855 A CN1901855 A CN 1901855A
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CN
China
Prior art keywords
implant
moveable
along
expansion part
direction dimension
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.)
Pending
Application number
CNA2004800397152A
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English (en)
Inventor
C·L·布兰奇
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SDGI Holdings Inc
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SDGI Holdings Inc
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Publication of CN1901855A publication Critical patent/CN1901855A/zh
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    • A61F2/447Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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Abstract

一种可扩张的脊骨植入物(20)包括一主体,该主体具有多个可移动的部分(32),这些部分互相配合以形成一外横截面,该外横截面具有第一和第二横向方向尺寸以及通常彼此相对放置并适于接合毗邻的椎骨体(VU、VL)的第一和第二基本平坦的表面(34、36)。一扩张件(24)与可移动部分(32)共同作用,从而沿第一和第二横向方向尺寸扩张主体。

Description

可扩张的脊骨植入物
技术领域
本发明总的涉及脊骨植入物领域,尤其涉及一种可扩张的脊骨植入物。
背景技术
人们已经作出了很多尝试来开发一种脊骨间植入物以替换损坏的或退化的天然脊骨盘并在毗邻的脊骨之间保持椎间盘空间的足够稳定,至少到完成关节固定为止。这些类型的椎间植入物已采取多种形式。
例如,更加普遍的设计之一包括具有圆柱形状的脊骨植入物。对于圆柱形的植入物,植入物的外部通常制有螺纹以便于插入椎间盘空间中。另外,椎骨间植入物可为实心的,有时将这称为隔板或插头,或者该植入物可形成中空的内部,设计用来使骨骼得以生长,有时将这称为融合装置或融合笼。融合装置的内部可填充有骨骼生长促进物质以便于或促进骨骼长入并通过该装置。普遍接受的是便于或促进自然骨骼生长的椎骨间插入物通常可取得更加快速和稳定的关节固定。
上述椎骨间植入物设计通常没有涉及的一个领域是保持和复原融合的脊骨段的自然解剖结构。特别地,一旦将天然椎间盘材料取下,则脊柱的正常前凸和后凸弯曲就会被削弱或消失。对于具有几乎固定的外横截面的已有技术的植入物来说,恢复这种弯曲的需求被极大地忽略了。另外,在某些情况下,毗邻的脊骨体被铰孔以形成具有与植入物的具体形状相对应的形状的通道。在另一些情况下,在铰孔之前形成正常的弯曲,在铰孔之后将植入物插入。然而,这些技术通常使毗邻脊骨体的后部铰孔过度,从而造成将承受负荷的脊骨骨骼去除过多,其可导致所处理的脊柱部分不稳定。同样,铰孔穿过脊柱前凸程度最大的下腰部节段的后部通常是困难的。
因此,对于许多椎间插入物的设计,在恢复前凸弯曲方面努力有限或根本未作努力。结果,由于脊骨体被安排在椎间植入物周围,植入物有可能造成后凸变形。此外,对于试图恢复前凸弯曲的椎间植入物来说,植入物的扩张通常被限制在沿椎间盘空间高度的单一方向上,而没有考虑沿侧向扩张植入物以提供较大的总体空间以吸收/分散脊骨负荷并提高稳定性以及/或者增加防止沉入毗邻的脊骨体中的能力。
这样,在本领域中就有提供改进的可扩张脊骨植入物的需求。本发明满足了这一需求并以一种新颖的和非显而易见的方式提供了其它的好处和优点。
发明内容
本发明总的涉及一种可扩张的脊骨植入物。虽然这里所覆盖的本发明的实际特征只能参考附属权利要求确定,表现此处披露的优选实施例特征的本发明的某些形式简要描述如下。
在本发明的一个形式中提供有一种可扩张的脊骨植入物,它包括一主体,该主体具有多个可移动的部分,这些部分互相配合以形成一外横截面,该外横截面具有一第一横向方向尺寸(dimension)和一第二横向方向尺寸,并形成大致互相相对布置并适于接合毗邻的脊骨体的第一和第二基本平坦的表面。脊骨植入物还包括一扩张件,该扩张件与可移动部分共同作用,从而沿第一和第二横向方向尺寸扩张外横截面。
在本发明的另一个形式中提供有一种可扩张脊骨植入物,它包括一主体,该主体具有一纵轴线和多个可移动部分,这些可移动部分互相配合以形成一大致为矩形的外横截面,该外横截面具有一第一横向方向尺寸和一第二横向方向尺寸。脊骨植入物还包括一扩张件,该扩张件与可移动部分共同作用,从而沿第一和第二横向方向尺寸扩张外横截面。
在本发明的另一个形式中提供有一种可扩张脊骨植入物,它包括一主体,该主体具有一纵轴线和多个可移动部分,这些部分互相配合以形成一外横截面,该外横截面具有一第一横向方向尺寸和一第二横向方向尺寸,可移动部分具有互相配合以形成一内腔的大致平坦的诸内表面,该内腔具有基本为矩形的内横截面,而这些内表面沿纵轴线形成一向内的锥形。脊骨植入物还包括一扩张件,该扩张件具有一基本为矩形的外横截面并与可移动部分的诸内表面接合以在扩张件大致沿纵轴线位移时沿第一和第二横向方向尺寸扩张可移动部分。
在本发明的另一个形式中提供有一种可移动脊骨植入物,它包括一主体,该主体具有一纵轴线和多个可移动部分,这些部分互相配合以形成一外横截面,该外横截面具有一第一横向方向尺寸和一第二横向方向尺寸并形成大致互相相对布置并适于接合毗邻的脊骨体的第一和第二基本平坦的表面。脊骨植入物还包括用来沿第一和第二横向方向尺寸扩张外横截面的装置。
在本发明的另一个形式中提供有一种手术方法,该方法包括提供一可扩张脊骨植入物,该植入物具有多个可移动部分,这些可移动部分沿一纵轴线延伸并互相配合以形成具有一第一横向方向尺寸和一第二横向方向尺寸的一外横截面,可移动部分形成大致互相相对布置的第一和第二基本平坦的表面。该方法还包括:将脊骨植入物插入一椎间盘空间中,第一和第二基本平坦的表面毗邻第一和第二脊骨放置;以及分别沿第一和第二横向方向尺寸扩张外横截面。
本发明的一个目的是提供一种改进了的可扩张脊骨植入物。通过这里所包含的附图和说明可使本发明的其它目的、特征、优点、有利之处和方面变得明显。
附图说明
图1是根据本发明一个形式的可扩张脊骨植入物的立体端视图,该植入物被显示为未扩张结构。
图2是图1所示脊骨植入物的立体端视图,该植入物被显示为扩张结构。
图3是图1所示脊骨植入物的侧视图。
图4是图1所示脊骨植入物的近端视图。
图5是图1所示脊骨植入物的远端视图。
图6是图1所示脊骨植入物的俯视平面图。
图7是图6所示脊骨植入物沿图6中的线7-7看去的横截面侧视图。
图8是图7所示脊骨植入物沿图7中的线8-8看去的横截面图。
图9是图1所示脊骨植入物的局部横截面侧视图,该植入物以未扩张结构被放置在毗邻脊骨体之间并与一手术器械相接合。
图10是图1所示脊骨植入物的局部横截面侧视图,该植入物以完全扩张的结构被放置在毗邻脊骨体之间。
图11是以两边的形式并排放置在椎间盘空间中的一对完全扩张脊骨植入物的俯视平面图。
具体实施方式
为了能更好地理解本发明的原理,现在将参照附图所示的实施例并用具体的语言对它进行描述。然而应理解此处并非要对本发明的范围进行限制,考虑到本发明相关领域技术人员通常可以对所说明的装置进行改变和进一步的修改和/或进一步应用此处所说明的本发明的原理。
参见图1-8,在那里显示根据本发明一个形式的脊骨植入物20。脊骨植入物20沿纵轴线L延伸以及通常包含可扩张的融合笼22和扩张件24。如以下所讨论的,扩张件24是用来将融合笼22由图1所示的原始结构转变为图2所示的扩张结构。
在所述的本发明实施例中,融合笼22的扩张沿两个横向的方向尺寸进行(即沿横向于纵轴线L的方向尺寸),具体是沿第一横轴线T1和第二横轴线T2。然而,应该理解的是,在本发明的其它实施例中,融合笼22的扩张可沿任意数量的轴线进行,包括单根横轴线或者三根或更多的横轴线。如将在以下更详细描述的,在所述的本发明的实施例中,融合笼22被构造成沿第一横轴线T1扩张以将椎间盘空间分开和/或恢复/保持毗邻的椎骨体之间的前凸。另外,融合笼22被构造成沿第二横轴线T2扩张以将融合笼22的负荷分散到毗邻的脊骨终板的更大和更分散的面积上,从而使稳定性提高和/或增加抗下沉的能力。
脊骨植入物20的部件优选由生物相容性材料形成。在一个实施例中,融合笼22和/或扩张件24由弹性模数几乎类似于骨骼弹性模数的材料制成。在另一个实施例中,融合笼22可/或扩张件24由可再吸收的材料制成,这种材料在人体内一段时期后被再吸收或退化以部分或完全地由骨骼替代。在本发明的一个具体实施例中,融合笼22和/或扩张件24由一种聚合材料制成,包括诸如聚醚醚酮(PEEK)之类的非可再吸收聚合物或聚乳酸酯(PLA)之类的可再吸收聚合物。然而,应该理解的是,也可设想将其它适合的聚合/非聚合材料和/或其它适合的可再吸收/非可再吸收材料用于本发明。其它适合的材料的例子包括合成聚合物、未加强的聚合物、碳加强的聚合合成物、碳纤维、PMMA、氢化钙、陶瓷、聚交酯、聚乙醇酸交酯、酪氨酸衍生的聚碳酸酯、聚酐、聚原酯、聚磷腈、磷酸钙、氢化钙、羟磷灰石、生物活性玻璃或它们的任意组合。也可考虑使用金属材料,包含,例如,不锈钢和不锈钢合金、钛和钛合金、形状记忆合金、钴铬合金或它们的任意组合。另外,还可使用骨骼或骨骼替代材料。
在本发明的一个方面,融合笼22包含固定的基部30和多个从固定基部30通常沿纵轴线L延伸的可移动分支部分32。在图解的本发明的实施例中,固定基部30包括在其中延伸并通常沿纵轴线L靠近融合笼的近端22a定位的孔31,其目的将在下面讨论。此外,在图解的实施例中,融合笼22包括四个可移动分支部分32,包括一对上分支部分32a、32b和一对下分支部分32c、32d。然而,应该理解的是,融合笼22可形成任意数量的可移动分支部分32,包括两个、三个、或者五个或更多可移动分支部分32。
可移动分支部分32以这样一种方式联结于基部30,即可使可移动分支部分32互相之间移动以使融合笼22扩张。在图解的本发明的实施例中,分支部分32与基部30形成整体以形成单件的、整体的融合笼22。这样,基部30将分支部分32柔性地互相连接,其连接方式为可通过分支部分32和/或基部30柔性材料的变形而使融合笼22扩张开。基部30和分支部分32之间的互相连接在融合笼22扩张的过程中以类似铰链的方式作用,从而提供了分支部分32基本上独立的运动。
虽然所示的融合笼22的实施例采用一体连接的分支部分32,也可以构想分支部分32可单独形成并连接到一起以形成多件式融合笼22组件。在另一个替代实施例中,分支部分32可枢轴连接于基部30或通过铰链或枢轴销直接互相连接,从而可使融合笼22扩张而没有柔性材料的变形。还可以构想其它将分支部分32联结到一起以使融合笼22扩张的适当的方法,包括将分支部分32直接互相形成或联结而不使用固定基部30。
在本发明的另一个方面,可移动分支部分32互相配合以形成大致为矩形的外部横截面。在一个实施例中,融合笼22包括通常沿第二横轴线T2(分别由分支部分32a、32b和32c、32d形成)延伸、基本上平坦的第一对上和下表面34、36;以及沿第一横轴线T1(分别由分支部分32a、32c和32b、32d形成)延伸、基本上平坦的第二对侧表面38、40。在再一个实施例中,融合笼22具有基本上为平行六面体的结构,它包括六侧,每一侧大致形成一平行四边形。然而,应该理解的是,分支部分32和融合笼22的其它形状、构造和外部横截面也认为包含在本发明的范围之内。
在本发明的另一个实施例中,融合笼22毗邻远端22b的上、下角为锥形或倾斜的,以便于将融合笼22插入椎间盘空间中和/或将毗邻的脊骨体VU、VL分开。具体来说,上分支对32a、32b的远端部分形成向内呈锥形的表面42,该表面从上表面34向融合笼22的远端22b延伸。类似地,下分支对32c、32d的远端部分形成向内呈锥形的表面42,该表面从下表面36向融合笼22的远端22b延伸。呈锥形的表面42对于易化通过压紧或推进技术而将融合笼22插入毗邻的椎骨体VU、VL之间可能特别有用。虽然没有在图中具体示出,应该理解的是分别由分支32a、32c和32b、32d形成的融合笼22的侧面或侧部角还可是倾斜的以形成向内呈锥形的表面,该表面从侧表面38、40向融合笼22的远端22b延伸。
在本发明的再一个实施例中,分别由分支32a、32b和32c、32d形成的上、下表面34、36形成许多骨骼固定件44,它们适于与毗邻的脊骨体VU、VL(图9和10)接合,从而一旦将融合笼22植入椎间盘空间时可防止或抑制融合笼22的运动。在一个具体的实施例中,骨骼固定件44包括多排三角形的脊状体或齿状体,它们大致沿横轴线T2延伸穿过融合笼22的宽度。然而,应该理解的是,其它形状、方向和/或构造的脊状体或齿状体也被认为包含在本发明的范围中。还应该理解的是,还可以构想将其它结构的骨骼固定件44与融合笼22一起使用,比如从融合笼的上、下表面34、36延伸的其它类型的突起,包括长钉、表面粗糙结构或螺纹。还应该理解的是,在本发明的其它实施例中,融合笼22的上、下表面34、36不需要包括骨骼固定件44,但是代替地可形成没有任何表面突起或不规则结构的基本上光滑的结构。在本发明的其它实施例中,在侧表面38、40某种程度上与毗邻的脊骨体VU、VL完全或部分接合的情况下,融合笼22的侧表面38、40也可形成骨骼固定件。
如图2所示,在融合笼22向扩张结构转变后,上分支部分32a、32b将相对于下分支部分32c、32d分离或张开,从而使融合笼22沿第一横轴线T1张开。类似地,上分支部分32a、32b将互相分离或张开,且下分支部分32c、32d也将互相分离或张开,从而使融合笼22沿第二横轴线T2扩张。结果,融合笼22就可以沿两个横向方向尺寸扩张。在本发明的一个实施例中,这两个横向方向尺寸与椎间盘空间的轴向/垂直方向尺寸(例如椎间盘空间的高度)以及椎间盘空间的侧向/水平方向尺寸(例如椎间盘空间的宽度或深度)相对应。
在图解的本发明的实施例中,由于可移动分支部分32与基部30;连成一体,融合笼22沿纵轴线L的扩张并不均匀。相反,毗邻基部30的分支部分32的固定近端保持相对静止,从而不会沿横轴线T1、T2扩张过大。然而,分支部分32的可移动远端分离或张开以使融合笼22的远端部分从最初的高度h1和宽度w1(图1)扩张到扩大的高度h2和宽度w2(图2)。在一个实施例中,融合笼22沿横轴线T1(h1和h2之间的高度变化)和沿横轴线T2(w1和w2之间的宽度变化)的扩张在大约2-4mm的范围内。然而,应该理解的是,还可以构想本发明的其它实施例,其中融合笼22被构造成沿横轴线T1和T2扩张小于2mm或大于4mm。在本发明的一个具体实施例中,融合笼22最初的高度h1和宽度w1各自为大约10mm,而融合笼22扩张后的高度h2和宽度w2各自为14mm。然而,应该理解的是,这些具体的尺寸只是示例性的,也可以构想出融合笼22的其它尺寸。
在图解的本发明的实施例中,融合笼22最初的高度h1和宽度w1基本上是相等的,从而为融合笼22提供具有正方形横截面的最初结构。同样,融合笼22扩张后的高度h2和宽度w2也被显示为基本相同,从而为融合笼22在毗邻远端22b之处提供具有正方形横截面的扩张结构。然而,应该理解的是,在本发明的其它实施例中,融合笼22最初的高度h1和宽度w1和/或融合笼22扩张后的高度h2和宽度w2可以是不同的。还应该理解的是,沿横轴线T1和T2的扩张速度不需要必须相等。代替地,可将融合笼22和/或扩张件24构造成提供沿横轴线T1和T2不等的或变化的扩张速度。另外,虽然图解的脊骨植入物20的实施例被构造成沿纵轴线L以不均匀的方式扩张融合笼22,但还可以设想分支部分32可以允许融合笼22沿纵轴线L相对均匀地扩张的方式互相连接,或者也可以是其它类型的不均匀扩张融合笼22,比如可使沿分支部分32的中心区域的扩张程度更大的结构。
在所述的本发明的实施例中,分支部分32具有壳状结构并互相配合而形成中空的内腔50(图7),该内腔通常沿纵轴线L延伸。在一个实施例中,腔室50的尺寸和结构被设置成用来容纳扩张件24于其中,从而扩张件24在腔室50中的运动使扩张件24与分支部分32接合以沿第一和第二横轴线T1和T2扩张融合笼22。在一个实施例中,扩张件24通常沿纵轴线L的轴向位移使分支部分32分离或张开,从而使融合笼22向扩张的结构转变。然而,应该理解的是,在本发明的其它实施例中,扩张件24的相对旋转或枢转位移会使分支部分32分离或张开以扩张融合笼22。另外,还可设想用于本发明的扩张件24的其它类型的相对位移,从而使融合笼22扩张,包括扩张件24沿横向于纵轴线L的方向上的位移。
如图7和8所示,分支部分32形成互相配合以形成内腔50的诸内表面52。在图解的本发明的实施例中,内表面52基本上平坦,从而为腔室提供对应于扩张件24的外部横截面的通常为矩形的内横截面(图8)。如图8所示,在一个实施例中,分支部分32互相配合以形成第一对基本平坦的上、下表面54、56(分别由分支部分32a、32b和32c、32d形成)和第二对基本平坦的侧表面58、60(分别由分支部分32a、32c和32b、32d形成)。如图7中所示,上、下表面54、56和侧表面58、60(未示出)为倾斜的或沿纵轴线L向内呈锥形以便于融合笼22沿横轴线T1和T2的扩张,下面将对其进行详细描述。然而,应该理解的是,分支部分32和融合笼22的其它形状、结构和横截面也被认为包含在本发明的范围中。
在本发明的再一个实施例中,一个或多个分支部分32毗邻融合笼22的远端22b形成一向内延伸的法兰或横向突起62(图5和7)。在图解的实施例中,分支部分32a-32d各自形成一向内延伸的法兰或横向突起62,它们互相配合形成绕腔室50的内部周边延伸的横向凸肩64。另外,如图5所示每个横向法兰的向内延伸的角各自形成切口或槽66,其目的将在下面详细描述。在图解的实施例中,槽66具有矩形结构,然而,其它的合适的形状和结构也被认为包含在本发明的范围中。
在本发明的另一个实施例中,一个或多个分支部分32形成保持件72,该保持件从毗邻融合笼22的远端22b的内表面52延伸(图7)。保持件72适于与扩张件24接合并在融合笼22扩张时使扩张件24相对于分支部分32固定在选定的位置和方向上(图10)。在一个实施例中每个分支部分32a-32d包括一个保持件72,从而形成大致绕内腔50延伸的外围保持件。在图解的本发明的实施例中,保持件72被构造成从分支部分32的内表面52沿横向于纵轴线L的方向延伸的横向突起或脊状体。在一个具体实施例中,保持件72具有三角形结构,包括沿纵轴线L向内呈锥形的斜向或倾斜部分74以及横向凸肩部分76,该部分的朝向通常与分支部分32a-32d的远端部分所形成的凸肩部分64相对。然而,保持件72的其它适当的形状和结构也应被认为是在本发明的范围中。关于保持件72和扩张件24之间的相互作用的详细情况将在下面进行讨论。
在本发明的一个实施例中,分支部分32形成许多骨骼生长孔80,这些孔延伸穿过上、下外表面34、36并与内腔50连通以使骨骼从毗邻的脊骨体生长进并可能穿过融合笼22。在一个实施例中,骨骼生长孔80基本沿内腔50的整个长度分布并定位于诸排三角形脊状体或齿状体44之间。虽然显示骨骼生长孔80具有确定相对小直径的圆形横截面,应该理解的是,也可以设想骨骼生长孔的其它形状、尺寸和/或结构。例如,在本发明的其它实施例中,骨骼生长孔80可具有较大的直径或加长的槽形结构。另外,虽然显示骨骼生长孔80延伸通过各个分支部分32,但在本发明的其它实施例中,在毗邻的分支部分32a、32b和32c、32d之间可形成一个或多个孔80。另外,虽然显示骨骼生长孔80延伸通过上、下外表面34、36,但应该理解的是骨骼生长孔还可延伸通过融合笼22的侧表面38、40。应该进一步理解的是,虽然骨骼生长孔80被显示和描述为与内腔50连通,但在其它的实施例中,孔80不需要延伸通过整个分支部分32。
参见图7和8,其中示出位于融合笼22的内腔50中的扩张件24。扩张件24包括主体部分90和从其轴向延伸而出的柄状部分92。虽然在这里显示和描述了扩张件24的一个具体实施例,但应该理解的是扩张件24的其它适合的结构也落入本发明的范围中。
在所示的扩张件24的实施例中,主体部分90具有通常为矩形的外横截面,该横截面几乎与内融合腔50的内部矩形横截面相对应。主体部分90包括适于在扩张件24沿内腔50轴向位移以使融合笼22转变成扩张结构的过程中沿分支部分32的倾斜内表面52滑动的外表面。在本发明的一个实施例中,主体部分90的外表面基本上平坦并大致平行于纵轴线L布置。然而,还可设想在本发明中使用主体部分90的其它形状、结构和外部横截面。主体部分90还形成孔96,该孔的尺寸和构造被设置成用来将手术器械的远端部分容纳于其中以便于扩张件24沿融合笼22的内腔50轴向位移。在所示的实施例中,工具容纳孔96具有大致为圆形的内横截面,以将对应形状的手术器械的远端部分容纳于其中。然而,还可设想孔96的其它形状和结构以用于本发明中,比如矩形或六边形结构。
在图解的扩张件24的实施例中,柄状部分92的尺寸和形状被设置成在将扩张件24毗邻融合笼22的远端22b放置的时候,可将该柄状部分放置于可移动分支32a-32d的远端横向法兰62所形成的切口或槽部分66中(图10)。在一个实施例中,柄状部分92具有通常矩形的外横截面,然而,也可以设想柄状部分92的其它形状和结构以用于本发明,例如六边形或圆形结构。
现在参见图9,其中示出与植入物20接合的手术器械100,该器械用于将融合笼22转变为扩张结构。在本发明的一个实施例中,手术器械100通常包括外部套管102和内部驱动轴104。手术器械100还可包括手柄(未示出)以帮助操作和处理脊骨植入物20。然而,应该理解的是,可设想手术器械的其它适当的类型和结构以用于本发明,且其元件和操作可与此处所说明和描述的手术器械100的实施例不同。例如,可用于本发明的该器械的另一个实施例在授予Liu等人的美国专利6,436,140中有所描述和说明,该文件的整体内容结合于此作为参照。
手术器械100的套管102具有适于与融合笼22接合的远端部分。再一个实施例中,套管102的远端部分和融合笼22之间的接合是对接接合。然而,应该理解的是还可以设想其它类型的接合,比如螺纹接合、键接合、企口接合、摩擦接合或其它任何适合的接合方法。内部驱动轴104放置在外部套管102中并延伸穿过融合笼22的基部30中的孔31,且与扩张件24接合。在本发明的一个实施例中,驱动轴104的远端部分和扩张件24之间的接合为对接接合。然而,也可以设想其它类型的接合,比如螺纹接合、键接合、企口接合、摩擦接合或其它任何适合的接合方法。在本发明的再一个实施例中,驱动轴104的远端部分被构造成可容纳在扩张件24中的孔96中。在图解的实施例中,驱动轴104的末梢部分108具有基本为圆形的外横截面,该横截面与孔96的内横截面相对应,从而在驱动轴104和扩张件24之间提供固定接合。然而,还可以设想末梢部分108的其它形状和结构以用于本发明中,包括矩形或六边形。
如应该知道的,驱动轴104沿箭头A的轴向位移将相应地移动扩张件24通过内腔50,由此使融合笼22向图10所示的完全扩张结构转变。在一个实施例中,驱动轴104可通过在驱动轴104和孔31之间延伸通过融合笼22的固定基部30的螺纹接合而移动。这样,驱动轴104的旋转运动及其与孔31的螺纹连接会造成驱动轴104大致沿箭头A所指的纵轴线L的方向轴向运动。在另一个实施例中,可利用内部驱动轴104和外部套管102之间的螺纹接合来使驱动轴104大致沿箭头A所指的纵轴线L方向移动。其它用于轴向移动驱动轴104的适当的技术也被认为包含在本发明的范围中。
如以上所讨论的,当扩张件24沿融合笼22的内腔50轴向位移时,扩张件24的外表面可滑动地与分支部分32的倾斜内表面52接合。如应该知道的,扩张件24沿倾斜表面54、56、58和60的滑动接合(图8)使分支部分32a-32d沿各个横轴线T1和T2分离或张开,从而使融合笼22从图1和9所示的原始结构转变为图2和10所示的完全扩张的结构。随着扩张件24沿上、下倾斜表面54、56滑动位移,融合笼22的上、下外表面34、36沿横轴线T1互相移开以使椎间盘空间分开和/或恢复/保持上、下脊骨VU、VL之间的前凸。同样,随着扩张件24沿倾斜表面58、60滑动位移,融合笼22的外侧表面38、40沿横轴线T2互相移开。这样,从上、下脊骨VU、VL传向融合笼22的负荷就被分散到毗邻的脊骨终板的更大且更分散的面积上,从而使稳定性提高和/或增加抵抗下沉的能力。
随着扩张件24向毗邻融合笼22的远端部分22b前行,扩张件24将与保持件74接合。具体来说,扩张件24将沿保持件72的倾斜部分74滑动并将最终定位于分别由分支部分32a-32d和保持件72所形成的横向凸肩64和76之间的保持件72之上(图7)。如图10中所示,扩张件24的主体部分90被限制在横向凸肩64、76之间以将扩张件24固定在内腔50中的适当方向和位置上并使融合笼22保持扩张的结构。还是如图10所示,扩张件24的柄状部分92位于由分支部分32a-32d的横向法兰62a-62d所形成的切口部分66中。柄状部分92与横向法兰62a-62d的接合提供了扩张件24和融合笼22之间的稳定性且还提供了对分支部分32的远端的附加支承。
在融合笼22的扩张之后,可将手术器械100从脊骨植入物20脱开并从患者身上去除。在本发明的再一个实施例中,可将一种骨骼生长促进材料120(图10)载入融合笼22的内腔50中以便于或促进骨骼从上、下脊骨VU、VL穿过孔80长入且有可能穿过融合笼22。在一个实施例中,骨骼生长促进材料120包含一种骨骼移植材料、一种骨骼成形蛋白(BMP)或任何其它合适的骨骼生产促进材料或物质,这些材料包括但不限于骨片或骨髓、一种去矿物质骨骼基质(DBM)、间质干细胞、和/或LIM矿化蛋白(LMP)。应该理解的是,骨骼生长促进材料120可以采用或不采用适当的载体。
在一个实施例中,通过延伸经过固定基部30的孔31将骨骼生长促进材料120注入内腔50。在另一个实施例中,骨骼生长促进材料120在融合笼22扩张之后位于内腔50中。然而,应该理解的是,融合笼22和扩张件24还可被构造成允许以另一种方式和/或在融合笼22扩张之前或之中将骨骼生长促进材料120载入内腔50中。
在说明和描述了脊骨植入物20的元件和操作之后,现在将参照根据本发明一个实施例的将脊骨植入物20植入椎间空间中的技术。然而,应该理解的是,也可设想其它的植入技术和程序,以下的技术并非对本发明的范围的限制。
参见图9和10,确定所要处理的脊骨水平,随后通过完全或部分椎间盘切除术将至少一部分天然椎间盘去除。随后使用已知的手术器械和技术(例如旋转割刀、挖匙、凿子等)准备上、下脊骨VU、VL的终板。注意,由于脊骨植入物20并非外螺纹的,因此不需要形成在毗邻脊骨VU、VL之间并穿过它们的圆柱形通道,也不需要对通道攻螺纹。因此使从上、下脊骨VU、VL去除椎骨组织最少以及对其破坏最小。
在准备好椎间盘空间和上、下脊骨VU、VL之后,通过合适的插入技术将脊骨植入物20放入椎间盘空间中,比如通过压紧或推进插入技术。注意,由于脊骨植入物20没有螺纹,因此不必通过脊骨植入物20拧入或旋转到位就可完成将其插入椎间盘空间。此外,在一个优选实施例中,以非扩张的结构将脊骨植入物20插入椎间盘空间以使对神经系统的破坏最小。然而,应该理解的是,在某些情况下会需要在插入椎间盘空间之前或之中使脊骨植入物20转变为扩张结构。在本发明的再一个实施例中,通过使用内窥镜装置、直径较小的管子或套管、或者通过其它适当的使侵入性最小的手术技术,就可以侵入性最小的方式(即通过一个较小的进口)将脊骨植入物20插入椎间盘空间。然而,应该理解的是,也可以使用其它传统的手术方法和技术。
在将脊骨植入物20插入椎间盘空间之后,融合笼22通过手术器械100的内部轴104沿箭头A(向融合笼的远端22b)的方向的轴向位移转变为扩张结构,这相应地使扩张件24移动通过内腔50。如上所讨论的,扩张件24的轴向位移造成扩张件24和分支部分32之间的滑动接合,由此造成分支部分32沿每根横轴线T1和T2分离或张开,从而使融合笼22转变为如图10所示的完全扩张结构。如以上所讨论的,融合笼22沿横轴线T1的扩张将上、下脊骨VU、VL分开并/或恢复/保持脊骨之间的前凸,上脊骨支承表面34相对于下脊骨支承表面36呈一角度。
当融合笼22完全扩张到图10所示的结构时,扩张件24被固定限制在保持件72和分支部分32的横向法兰之间以将扩张件24锁定在适当的方向和位置上,并使融合笼22固定保持于扩张结构。虽然融合笼22仅仅通过扩张件24和分支部分32之间的接合而保持于扩张结构,但应该理解的是,还可以设想一个或多个辅助的内部固定元件用于融合笼22,尤其是在存在过大的脊骨负荷和/或不稳定时。还应该理解的是,如果在将一个或多个脊骨植入物20插入并在椎间盘空间中扩张之后发生过大的残余不稳定,还可使用辅助的外部脊骨固定元件和/或稳定技术。
一旦融合笼22完全扩张,则将诸如BMP和适当的载体之类的骨骼生长促进材料120注入或载入融合笼22的内腔50中以便于或促进骨骼从上、下脊骨VU、VL通过骨骼生长孔80长入并有可能穿过融合笼22。此外,可将分碎的(morselized)自体移植骨骼或类似的材料毗邻扩张的融合笼22以进一步促进融合。
在本发明的一个实施例中,脊骨植入物20进入脊柱和插入椎间盘是通过后部手术插入法来完成的。然而,应该理解的是还可通过其它的手术方法来完成脊骨植入物20进入脊柱和插入椎间盘,比如前向插入或侧向插入法。在本发明的另一个实施例中,使用脊骨植入物20来治疗脊柱的腰部区域,其中上、下脊骨VU、VL包括腰椎。然而,仍然应该理解的是,本发明还可以应用于脊骨的其它部分,包括脊柱的颈椎、胸椎、或骶骨区域。此外,如图11所示,在本发明的再一个实施例中,可将一对脊骨植入物20a、20b以双边的布置并排放置在椎间盘空间中。然而,应该理解的是将单个脊骨植入物20单边或中心放置在椎间盘空间中也被认为包含在本发明的范围中。
虽然已经在附图中和在前的描述中对本发明进行了详细的描述,但应该将其认为是说明性的而非对其特征的限定,应该理解的是,现在只示出和描述了优选实施例,所有落入本发明的精神中的变化和修改都应受到保护。

Claims (39)

1.一种可扩张脊骨植入物包括:
一主体,该主体具有一纵轴线并包括多个可移动的部分,这些可移动部分沿所述纵轴线延伸并互相配合以形成一外横截面,该外横截面具有一第一横向方向尺寸和一第二横向方向尺寸,所述可移动部分形成通常互相相对布置并适于接合毗邻脊骨体的第一和第二基本平坦的表面;以及
一扩张件,该扩张件与所述可移动部分共同作用,从而沿所述第一和第二横向方向尺寸扩张所述外横截面。
2.如权利要求1所述的植入物,其特征在于,所述可移动部分互相配合以形成第三和第四基本平坦的表面,这两个表面通常彼此相对布置并在所述第一和第二基本平坦的表面之间延伸。
3.如权利要求2所述的植入物,其特征在于,所述可移动部分互相配合以形成一基本为矩形的外横截面。
4.如权利要求1所述的植入物,其特征在于,所述主体具有一大致平行六面体的结构。
5.如权利要求1所述的植入物,其特征在于,所述第一和第二基本平坦的表面互相平行地布置。
6.如权利要求1所述的植入物,其特征在于,所述第一和第二基本平坦的表面沿所述第一和第二横向方向尺寸之一延伸。
7.如权利要求1所述的植入物,其特征在于,所述第一横向方向尺寸大致垂直于所述第二横向方向尺寸。
8.如权利要求1所述的植入物,其特征在于,所述诸可移动部分互相配合以形成一内腔,该内腔的尺寸被设置成用来将所述扩张件容纳于其中;以及
所述扩张件在所述内腔中的位移使所述扩张件与所述可移动部分接合以沿所述第一和第二横向方向尺寸扩张所述可移动部分。
9.如权利要求8所述的植入物,其特征在于,所述位移包括所述扩张件在所述内腔中通常沿所述纵轴线的运动。
10.如权利要求9所述的植入物,其特征在于,所述可移动部分具有形成所述内腔的诸内表面,所述内表面沿所述纵轴线形成向内的锥形,所述扩张件接合所述可移动部分的所述内表面以在所述扩张件通常沿所述纵轴线移动时沿所述第一和第二横向方向尺寸扩张所述主体。
11.如权利要求10所述的植入物,其特征在于,所述可移动部分的所述内表面基本平坦。
12.如权利要求10所述的植入物,其特征在于,所述可移动部分的所述内表面形成具有基本为矩形的内横截面的所述内腔。
13.如权利要求1所述的植入物,其特征在于,所述可移动部分至少一个包括一保持件,该保持件适于与所述扩张件接合并且在所述主体沿所述第一和第二横向方向尺寸扩张时相对于所述可移动部分将所述扩张件保持在一选定的位置上。
14.如权利要求13所述的植入物,其特征在于,所述保持件包含延伸自所述可移动部分之一的一内表面的一脊状体。
15.如权利要求14所述的植入物,其特征在于,所述保持件包括一对相对的脊状体,它们两个延伸自所述可移动部分中的相对的两个内表面。
16.如权利要求14所述的植入物,其特征在于,所述保持件还包括一横向法兰,该横向法兰从所述可移动部分之一的所述内表面向内延伸,将所述扩张件定位于所述保持件和所述横向法兰之间以使所述扩张件保持在所述选定位置上。
17.如权利要求1所述的植入物,其特征在于,所述诸可移动部分互相配合以形成一内融合腔。
18.如权利要求17所述的植入物,其特征在于,所述第一和第二基本平坦的表面形成多个在其中延伸并连通所述内融合腔的孔。
19.如权利要求17所述的植入物,其特征在于,它还包括一种骨骼生长促进物质,该物质被置于所述内腔中以便于与毗邻脊骨体的融合。
20.如权利要求19所述的植入物,其特征在于,所述骨骼生长促进物质包括一种骨骼成形蛋白。
21.如权利要求1所述的植入物,其特征在于,所述第一和第二基本平坦的表面形成有多个固定件,这些固定件适于将植入物与毗邻的脊骨体接合。
22.如权利要求21所述的植入物,其特征在于,所述固定件包括诸脊状体,这些脊状体通常沿所述第一和第二横向方向尺寸中相应的一个延伸并沿纵轴线轴向间隔开。
23.如权利要求1所述的植入物,其特征在于,所述主体由一种弹性模数基本上类似于骨骼的材料形成。
24.如权利要求1所述的植入物,其特征在于,所述主体由一种聚合材料形成。
25.如权利要求24所述的植入物,其特征在于,所述聚合材料包括一种合成聚合体。
26.如权利要求1所述的植入物,其特征在于,所述主体由一种可再吸收材料形成。
27.如权利要求26所述的植入物,其特征在于,所述可再吸收材料包括一种聚合材料。
28.如权利要求1所述的植入物,其特征在于,所述主体包括一固定基部,该固定基部具有一恒定的外横截面,每个所述可移动部分从所述固定基部伸出。
29.如权利要求28所述的植入物,其特征在于,所述可移动部分与所述固定基部形成一体以形成一单件的、整体的主体。
30.一种可扩张的脊骨植入物包括:
一主体,该主体具有一纵轴线并包括多个可移动的部分,这些可移动部分沿所示纵轴线延伸并互相配合以形成通常为矩形的一外横截面,该外横截面具有一第一横向方向尺寸和一第二横向方向尺寸;以及
一扩张件,该扩张件与所述多个可移动部分共同作用,从而沿所述第一和第二横向方向尺寸扩张所述外横截面。
31.如权利要求30所述的植入物,其特征在于,所述主体具有一基本上为平行六面体的结构。
32.如权利要求30所述的植入物,其特征在于,所述第一横向方向尺寸与所述第二横向方向尺寸几乎垂直。
33.如权利要求30所述的植入物,其特征在于,所述诸可移动部分互相配合以形成一内腔,该内腔的尺寸被设置成用来将所述扩张件容纳于其中;以及
所述扩张件在所述内腔中的位移使所述扩张件与所述可移动部分接合以沿所述第一和第二横向方向尺寸扩张所述可移动部分。
34.如权利要求33所述的植入物,其特征在于,所述位移包括所述扩张件在所述内腔中通常沿所述纵轴线的运动。
35.如权利要求33所述的植入物,其特征在于,所述可移动部分具有形成所述内腔的诸基本平坦内表面,所述内表面沿所述纵轴线形成向内的锥形,所述扩张件接合所述可移动部分的所述平坦内表面以在所述扩张件通常沿所述纵轴线移动时沿所述第一和第二横向方向尺寸扩张所述主体。
36.如权利要求30所述的植入物,其特征在于,所述诸可移动部分互相配合以形成一内融合腔,该内融合腔容纳一种骨骼生长促进物质以便于与毗邻脊骨体融合。
37.如权利要求30所述的植入物,其特征在于,所述诸可移动部分形成通常相对地放置并适于接合毗邻的脊骨体的第一和第二基本平坦表面,所述平坦外表面形成多个固定件,这些固定件适于将植入物与毗邻脊骨体接合。
38.如权利要求30所述的植入物,其特征在于,所述主体包括一固定基部,该固定基部具有一恒定的外横截面,每个所述可移动部分从所述固定基部伸出。
39.如权利要求38所述的植入物,其特征在于,所述可移动部分与所述固定基部形成一体以形成一单件的、整体的主体。
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EP1699389A1 (en) 2006-09-13
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CA2546856A1 (en) 2005-06-09
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