CN1316230A - 塑料植入物 - Google Patents

塑料植入物 Download PDF

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CN1316230A
CN1316230A CN01112482A CN01112482A CN1316230A CN 1316230 A CN1316230 A CN 1316230A CN 01112482 A CN01112482 A CN 01112482A CN 01112482 A CN01112482 A CN 01112482A CN 1316230 A CN1316230 A CN 1316230A
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raceway groove
tinsel
implant
plastic implant
access hole
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A·凯勒
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Abstract

一种塑料植入物具有一条周向沟道(3)，用于容纳一根透视造影用金属丝(9)。沟道(3)完全或部分与外界封闭。金属丝优异之处在于形成了一种开环(图1)。

Description

塑料植入物
本发明涉及带有环形沟道的塑料植入物，该沟道可容纳一根透视造影用的金属丝。
塑料植入物在X光中不能清晰成象是由于塑料与机体软组织的对比度很小。为了检查插入的塑料植入物的位置，已知可给植入物安装一根在X光中可视的金属丝。为了这一目的，在植入物的表面可以制作一道环形沟道，造影用金属丝可以插入该沟道内，为了将金属丝固定在植入物上，金属丝的两端通常绞接在一起。在使用塑料植入物时，金属丝可能受应力而断开。如果金属丝断开后从其预定的位置迁移。就需要施行手术将其取出。
为克服金属丝断开的危险，已知代替金属丝的两端绞接在一起的办法有，将金属丝两端弯曲，将它们插入事先制成的、与植入物表面垂直的两个孔内。还有一种尝试是将金属丝的一端作成一个环，而让另一端钩住这个环，并留有一定间隙。但是，这些尝试的效果都不能令人满意。
因此，本发明的一个目的就是制备一种上述类型的塑料植入物，其中，透视造影金属丝断裂的危险和/或透视造影金属丝从预定位置迁移出的危险都得到了避免。
为此目的，本发明提供了一条容纳透视造影金属丝的沟道，可完全或部分与外界封闭。
这样，金属丝被固定在沟道内而避免了向外迁移。每一种防止保持在沟道内的金属丝迁移到外面的空间结构均包括在本发明内。金属丝两端不必彼此连接到一起。因此金属丝形成了开环，可随着植入物的变形而弯曲，从而不会受到明显的应力。例如，当植入物扩张时，金属丝适于通过沿沟道的滑动使植入物的周长增加。这适用于采用开环的金属丝，也适用于闭环金属丝断开的情况。
术语“向外”是与沟道的横剖面形状有关。沟道的路径不限于固定形状。但通常是沿着植入物边缘的路径。沟道不一定是封闭的。
沟道可以沿着其整个长度或大部分长度基本上连续封闭。不过，只要充分保证金属丝固定在沟道内，沟道在个别区段不封闭通常不会成为问题。甚至在沟道路径中只设几个封闭区限制金属丝外突也就足够了。
在横剖面上沟道不一定与外界完全封闭；相反，本发明还包括了一种部分封闭的沟道供选用。为了在制造时能够采用机加工切割，优选仅使部分沟道与外界封闭。
沟道与外界的部分封闭最好是利用其自身曲面的狭缝实现的，所述狭缝的宽度比金属丝厚度小。为保证金属丝精确就位，其直径只比沟道直径略小。将金属丝嵌入沟道是通过，例如，从外部挤压金属丝令其通过狭缝进入沟道。为此目的，在一个可能的实施例中，植入物制作成使狭缝部位具有弹性，而且狭缝的宽度在尺寸上允许弹性扩张以利嵌入金属丝。
但是，在另一个更好的实施例中，沟道沿周长方向有一个足够插入金属丝的插入开口。一方面，此插入开口必须具有足够的长度(沿沟道的长度方向)，以使金属丝容易插入沟道内。另一方面，此插入开口不能太长，以防止金属丝在沟道内沿长度方向运动时由此突出。在这一方面，沟道的两端开在插入开口中较好，特别是，沟道两端彼此对齐，以便金属丝的一端移出沟道的出入孔时可从插入口对面一侧的另一沟道出入口穿入返回沟道内。这样，金属丝保持嵌入在沟道内。如果沟道成曲线形，更具优势的是，金属丝在未受应力和未装配情况下具有与沟道近似相等的曲率。如果金属丝一端从沟道一端的出入孔移出，它会遵循这一曲线路径的连续性，另一沟道出入孔也在这一曲线路径上，结果它会非常容易地穿过沟道另一出入孔而返回沟道内。本文中的术语“对齐”可理解为弯曲沟道的两弯曲的轴线重合。
对金属丝两端留在回收口内的充分保证要求从沟道出入孔移出的金属丝一端能够穿入沟道另一出入孔而返回沟道，尽管这并非绝对必要；另一种替代办法是，金属丝一端从沟道中移出顶在相对的回收口的外壁上，从而防止了金属丝进一步从沟道内移出。
金属丝从插入口向外滑移还可通过下述方法加以避免，在安装位置从沟道出入孔伸出的金属丝两端可弯曲偏离沟道的轴线。金属丝的弯曲的两端与沟道相关端或由插入口形成的壁接触并顶在该处就可限制金属丝的位移。为了给金属丝弯曲的两端提供空间，插入口可以相对于沟道的横剖面展宽。
金属丝优选不在沟道两端处弯曲，而是在距所述两端一定距离处弯曲，以便留出一定间隙，用于对上述长度变化进行补偿。
为了限制插入时金属丝与沟道的外壁的摩擦力，环形沟道最好具有单一曲率。沟道最好能避免有急剧弯曲的部分。插入沟道时为避免金属丝卡在狭缝内，狭缝宽度最多可达金属丝直径的80％，优选70％，更优选60％。欲推入沟道的金属丝最好被倒圆，至少在前端处，以使插入时更容易些。
本发明应用于椎间盘内假体特别有利，采用一种如聚乙烯一类非刚性塑料制成的滑芯，在此情况下可能是由于压应力。滑芯可以向外扩张，其周长增大。
本发明在一个优选示范实施例的基础上加以说明，并请参阅附图，其中：
图1表示出一个穿过整个椎间盘内假体的滑芯的纵剖面图；
图2表示出图1中放大的细部，即透视造影金属丝在沟道内的部分；
图3表示出图1中滑芯的俯视图，在金属丝的插入口的部位有一个水平切口；以及
图4表示图1与图2中滑芯的侧视图，在滑芯的插入口的部位。
滑芯1封闭在上、下两个结合盘(未示出)之间；形成的椎间盘内的假体配装在两块椎骨之间。滑芯1基本上为盘状，带有一个环状外扩的边缘2。在圆周边缘2中有一个周边环形沟道3、4，用于容纳一根透视造影金属丝9。如图3中所见，沟道3、4的路径基本上是沿着滑芯的圆周边缘。滑芯是由非刚性塑料，特别是由聚乙烯制成。配装在沟道3、4内的金属丝9在X光中可观察到，从而能检查滑芯1的位置并评估与相对的椎骨(未示出)的铰接。
沟道3、4包括一个内沟道3与一个曲面狭缝4，该狭缝确定沟道与外部的界限。沟道3通过狭缝4实现与外界的部分封闭。狭缝4是通过在沟道外壁5上开出与沟道3平行的槽形成的。槽宽比如为0.4mm，而沟道宽度b为0.75mm。因此槽宽w与沟道宽度b的比例近似为50％。该值通常落在20％至80％的范围内，优选30％到70％，更优选40％到60％。在本示范实施例中，狭槽用于机械切割开出沟道3。金属丝直径为0.7mm，因此略小于沟道直径并大于狭缝宽度。
在一个优选为20-40°，本例中为30°的方位角区域，沟道3具有一个10mm周长L的插入口6，其通过在假体的边缘2上的切口而形成。在插入口的部位，形成狭缝4的槽被展宽到沟道的宽度，或比沟道略宽些。如图3中所见，插入口处切割得比沟道基线7更深，以使插入口6的基线8径向上进一步向内。
滑芯1所用的透视造影金属丝9的长度比沟道3的周长略短。金属丝在插入沟道3之前应大致弯曲成环状以对应沟道3的路径。金属丝两端部10自由安放在插入口内。在此理想的是，金属丝两端的间距大约有数毫米。安装时，金属丝通过插入口6推入沟道3直到到达图3和图4所示预定位置。预先将金属丝前端倒圆或斜切才有可能将其插入沟道。插入完毕后，金属丝9的两端部10位于插入口6处并向内弯曲，如在图3中所见。此弯曲十分轻微，弯曲处距沟道出入孔11有一定距离，该距离适合于为后面将要描述的长度补偿留出间隙。金属丝9自插入口6向外滑移是通过下述方法得到制止的：金属丝弯曲的两端部10顶在分别对应的沟道出入孔或顶在插入口6的两相对壁上。由于金属丝两端部10翘曲偏离沟道出入孔11的方向，故两端被卡住。如需要，金属丝可以很容易被取出或更换。
为了将金属丝固定在植入物上并防止其端部10从插入口6中移出，将金属丝的两端10弯曲并非绝对必要。如果该两端部仍维持原来的伸直形状或适合于沟道的弯曲形状，插入口的形状仍能防止金属丝脱离植入物。如果两个出入孔彼此对齐且都在沟道的轴线上，如果金属丝一端10移出相关的沟道出入孔11，它要么穿过相对的沟道出入孔10返回沟道内，要么顶在相对的沟道出入孔11周围的插入口的外壁上。
由于材料的非刚性特性，沿假体轴线A的方向加到滑芯1的压力荷载转变成沿中央平面E的向外扩展，这一扩展垂直于轴线A。这就引起滑芯1的周长的增加。在所示实施例中，开环金属丝相应的长度补偿是通过金属丝9的一端或两端10退入沟道3内相等的长度来实现的。随着滑芯1上压力荷载的减小，金属丝两端部10相应地从沟道内略为推回。

Claims (9)

1．一种塑料植入物，其具有一条周向沟道(3)，用于容纳一根透视造影用金属丝(9)，其特征在于：沟道(3)完全或部分与外界封闭。
2．如权利要求1所述的塑料植入物，其特征在于：利用其外形的狭缝(4)使沟道(3)与外界部分封闭。
3．如权利要求2所述的塑料植入物，其特征在于：狭缝的宽度小于金属丝的直径。
4．如权利要求1或3所述的塑料植入物，其特征在于：沟道(3)设有一插入口(6)，金属丝(9)可由此推入沟道。
5．如权利要求1至4中任一项所述的塑料植入物，其特征在于：沟道(3)具有单一曲率。
6．如权利要求1至5中任一项所述的塑料植入物，其特征在于：金属丝(9)的至少一端的边缘被倒圆或斜切。
7．如权利要求4至6任中一项所述的塑料植入物，其特征在于：沟道出入孔(11)在插入口(6)处彼此对齐。
8．如权利要求4至6中任一项所述的塑料植入物，其特征在于：如下特点：在插入口(6)的与沟道出入孔(11)相对朝向的一侧具有一个接触壁，用于与从该沟道出入孔(11)出来的金属丝端部(10)接触。
9．如权利要求4至8中任一项所述塑料植入物，其特征在于：插入口(6)与沟道相比略微展宽，金属丝(9)的至少一端部(10)由此处内弯。
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Cited By (2)

* Cited by examiner, † Cited by third party
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CN1329009C (zh) * 2002-04-04 2007-08-01 斯恩蒂斯有限公司 椎间盘假体
CN106691636A (zh) * 2015-07-15 2017-05-24 优适医疗科技（苏州）有限公司 椎间融合器

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IL141722A0 (en) 2002-03-10
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US6764512B2 (en) 2004-07-20
AR028308A1 (es) 2003-05-07
TR200100932A2 (tr) 2001-11-21
US20010027343A1 (en) 2001-10-04
RU2001108846A (ru) 2003-02-10
KR20010095257A (ko) 2001-11-03
ATE390099T1 (de) 2008-04-15
BR0101300A (pt) 2001-11-06
EP1142544A1 (de) 2001-10-10
AU782057B2 (en) 2005-06-30
DE50015060D1 (de) 2008-05-08
ZA200101733B (en) 2001-05-09
CA2342028A1 (en) 2001-10-04
EP1142544B1 (de) 2008-03-26
MXPA01002854A (es) 2002-08-06

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