CN1096440A - 椎间假体及其植入法 - Google Patents
椎间假体及其植入法 Download PDFInfo
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- CN1096440A CN1096440A CN94104361A CN94104361A CN1096440A CN 1096440 A CN1096440 A CN 1096440A CN 94104361 A CN94104361 A CN 94104361A CN 94104361 A CN94104361 A CN 94104361A CN 1096440 A CN1096440 A CN 1096440A
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Abstract
用一种植入体取代椎间盘(3)核区中再也承受不
起载荷的部分,植入体由若干弹性塑料制成的支撑件
(7)组成。借助于穿过椎间盘(3)外环形区(4)的导管
(6)将支撑件(7)一个接一个地塞入在核区中开好的
中心空腔(5)中,直到中心空腔填满为止。当空腔(5)
中塞满充填构件(7)时,这些构件聚集在环形区(4)的
界面壁处彼此相互拥挤,且在应力的作用下弹性变
形。这样就能得出一种能适应任何形状的空腔(5)且
形成较紧凑弹性支撑构件的万用植入体。
Description
本发明涉及一种椎间假体及其植入法,该椎间假体有一个植入体,可以插入椎间盘核心区的中心空腔以取代该核心区的一部分,且适宜于传递压缩力。
上述那种已知的椎间假体,其椎间盘植入体可借助于一个导管通过椎间盘的外圈(纤维环)引入其核心区(髓核)中,以便在主载荷方向上起支撑作用。例如,欧洲专利EP-A-0453393介绍了一种可引入椎间盘核心区的空心构件,这种空心构件可以卷成螺旋形,可以在卷曲状态下充以非压缩性流体。插入这种植入体之前,必须用辅导工具通过空心管清理再也承受不起载荷的椎间盘的核心区,以便用该植入体代替再也承受不起载荷的部分。鉴于外科医生必须在植入体的大小已确定的情况下工作,他不得不在椎间盘的核心区中开设与植入体相适应的空腔。为使植入体能始终最理想地发挥作用,必须确保植入体始终处于密封状态,使流体不致外溢,因此上述植入体在空心构件的设计上需要较大的开支。
本发明旨在弥补这些缺点。
本发明的目的是创造出一种使用起来简单的万用植入体,这种植入体可作为一支撑件而用于随机形成的、形状各种各样的空腔。
按照本发明,上述目的是这样达到的,植入体中加入至少三个可弹性变形的支撑件,这些支撑件可以塞入中心腔中就位。
本发明的一个好处在于,外科医生开设空腔时只须清除再也承受不起载荷的核心部分,且塞入支撑件时才须要确定待塞入的支撑件的数量。植入体由许多可间隔就位或彼此接触就位的支撑件组成,这些支撑件可以由不为人体所排斥的任何弹性材料制成,因此这种植入体适用于每一个椎间盘。支撑件塞满中心腔时紧靠着界面的腔壁,从而使压缩力在中心腔中普遍传递和均匀分布。在承受载荷期间,支撑件都变形,于是在支撑件轴线方向上作用的压缩力在纤维环中转变为边缘应力。
本发明植入这种椎间假体的方法包括下列步骤:
第一步,在椎间盘的外环形区中开一个通过所述环形区通向核区的孔;
第二步,通过该孔朝核心区插入一个圆凿,在核心区中切除椎间盘再也承受不起载荷的组织部分,由此凿出一个中心空腔,并将切除部分通过孔清除出去;
第三步,支撑件通过孔引入空腔中,从而使空腔基本上充满支撑件,且支撑件形成能承受压力的支撑构件;
第四步,引入最后一个支撑件之后,将孔封闭上。
有关该方法的改进方案见各附属权利要求。
按照本发明的一个最佳实施例,支撑件可以由弹性塑料制成。因此不难制取这样的一种植入体,该植入体由不为人体所排斥的适当塑性材料制成,制造费用低,而且尺寸始终稳定。
支撑件最好设计成旋转实心体的形式,这样就可以最理想地均匀传递压缩力。在这方面,设计成球体特别有利。
采用不同尺寸的支撑件可以提高充填密度。通过在支撑件上开沟槽形成腔,这样可以获得比实心构件更大的既定弹性变形。为控制植入体的硬度,可以混合塞入实心构件和空心构件。至于支撑件本身则要取多种形状,从不定向的球形、英状和扁豆状构件,以至椭圆形、圆柱形、香肠形构件均可。
可以把好几个支撑件连接成链条的形式,形成一连串柔韧的支撑,从而使两支撑件之间的间距至少相当于其中一个支撑件的直径,以便在塞入支撑件时能偏转180度。也可以采用同一种材料制成的单件链条,其中柔韧的中间链件设计成细长条。此外还可以用柔韧导管将各支撑件间隔起来。支撑件呈链条形的好处首先是链条中的支撑件不容易通过孔眼偏离中心腔,其次是在充填过程中要花一大把时间将链条抽出才能倒转操作程序。采用各个具有可弹性变形膨胀元件的支撑件,也可以达到同样的隔离作用,这种支撑件在通过导管插入的过程中在纵向上变形,在进入中心腔的过程中弹回来从而使横截面变大。
按确定的排列方向安置支撑件的另一种方法是在导管中引导支撑件,并用撞杆抛出,从而使导管的横截面适宜操纵支撑件的各面并有意识地将支撑件安置在中央空腔的预定部位,大致就象昆虫下蛋一样。荚形构件可以安置得例如使其扁平面对准着毗邻的各脊椎。
若支撑件含有位置指示剂,则可以控制支撑件的安置过程和以后的位置变化。指示剂一般取内容物的形式,由X光检查时可以看出来的物质制成,例如钽。
适宜用作这类支撑件的塑料有,例如聚氨酯。支撑件也可以用其它材料制成,例如水凝胶。相应的支撑件还可以用适当的泡沫材料制成。此外,还可以想象出另一种这样的设计,其中各支撑件由塑料丝或金属丝组成的茧式线圈制成。
为提高塞入和保存支撑件过程中的安全,在塞入支撑件之前可以把合成编织品或塑料薄膜制成的袋通过导管引入中心空腔中,从而使袋孔仍然处在导管外面。这时就可以通过该袋孔塞入支撑件,该袋孔是支撑在导管上的。中心腔和袋充满支撑件之后,可以用夹子或金属丝结扎袋口,以防止支撑件跑出来。
结合权利要求书,从下面就本发明在附图中所示的一些实施例进行的说明可以理解到本发明的其它特点和细节。
图1示出了脊椎骨的平面图连同椎间盘的横剖面,椎间盘中装有支撑件的一个植入体,各支撑件可以通过导管供应;
图2示出了椎间盘沿图1中的Ⅱ-Ⅱ线截取的纵剖面;
图3示出了椎间盘的横剖面,该椎间盘有一个修改实施例的植入体;
图3a示出了袋连同支撑件的横剖面;
图4a-4e示出了按本发明构制的支撑件的各种实施例;
图5示出了图4e所示的支撑件在通过以部分纵剖面示出的导管时的情况;
图6、7和8示出了不同实施例中的植入体,植入体由若干支撑件彼此连接起来组成。
从图1和图2的示意图可看到,位于两个椎骨体1和2之间的椎间盘3有一个完整的由天然组织组成的外环形区4,该天然组织围绕着中心核区。核区中形成有空腔5,这是由预先除去再也承受不起载荷的损伤椎间盘的盘核或其一部分(必要时除去外环形区的损伤部分)而形成的。形成空腔5和除去再也承受不起载荷的组织部分是借助于导管部分按周知的方式进行的,图中的导管部分以导管6的形式表示,导管6如例如本说明书开端所述的欧洲专利EP-A-0453393中所述的那样,通过从椎骨体1和2之间背侧较轻微的接合穿过外环形区4的孔30插入椎间盘3的核区中。将一个圆凿通过插管6插入核区中,用该圆凿开凿空腔5并清除经切除的组织部分。
这里,椎间假体呈植入体的形式,由若干支撑件7组成,这些支撑件由不为人体所排斥的弹性塑料(例如聚氨酯)制成,可以一个接一个地塞入空腔5中,是为取代已清除的核区的起码一部分而设的。支撑件7制成旋转实心体,在此实施例中取圆球的形式,圆球的尺寸选取得使这些圆球可以通过导管6塞入空腔5中。支撑件7装填入空腔5中,必要时可以借助于推杆8填入,直到支撑件7基本上充满空腔5为止,这时,各支撑件7彼此紧靠着,形成椎间盘3的能传递压缩力的新核心区。支撑件7的数量和尺寸可随机根据待充填的空腔5的给定尺寸和形状以及导管6的横截面加以改变。因此举例说可以设计出所需用的支撑件比上面所示的设计少的植入体,例如设计成适当大小的三个支撑件7。支撑件7可设计成不同的尺寸,或如所示的那样,设计成相同的直径。支撑件7也可以设计成按单层排列的形式,在此情况下可以例如彼此间隔一定间距或不同的间距配置。
当空腔5完全充满时,可以用例如另一个导管6′加以监视,(导管6′可从图1右侧从背侧通过孔30′插入空腔5中),这时可按周知的方式将导管6或导管6和6′从环形区4中抽出来,接着将管6和6′各自的通孔30和30′在所塞入的最后一个插入件7前面封闭上。进行这一道工序时可以按即将加以说明的方式配备一种间隔装置,这种间隔装置的作用使支撑件不容易通过通道跑出来。
为了监视空腔5的清理情况和/或植入操作过程,可以通过导管6′插入观察仪9,或者插入辅助用具(图中未示出)协助清理和植入操作。显然,除图中所示的导管6和6′外,也可以采用任何形状和设计的其它适当的保护和/或导向元件。
图3中,相应的各部分用同样的编号表示。按照这个实施例,支撑件7可以放入封包它们的封包件中,图中是放入袋10中。袋10可以在空袋状态下通过导管6塞入空腔5中,然后再通过仍然留在导管6外的孔充以支撑件7。袋10可以由编织品、针织品或不为人体所排斥的弹性塑料(例如聚乙烯)的薄膜制成。袋10充满了支撑件7并与这些支撑件连接,形成适宜在椎骨1与2之间传递压缩力的紧凑弹性植入体时,可以用密封件11结扎起来,使支撑件7保持在一起,密封件11可以取例如夹子的形式,或者如图中所示的那样,取预先塞进来的金属丝环的形式。这之后,切断袋10的端部,将其与导管6一起抽出。
特别是从图3a中可以看到,袋10能适应待充填的空腔5根据主要的解剖条件所要求的任何形状。
支撑件7有多种实施方案。例如,可以不设计成旋转实心体而设计成多面体的支撑件。如图4a中所示,所示设计中的球形支撑件7或至少其中一个或某些支撑件7可设计成具封闭腔12,腔中装有插入物13,该插入物取球形内含物的形式,由X光检查时可以看得到的材料(例如钽)制成,作为显示支撑件7各自的位置的位置指示剂。也可以设计成不带插入物13。在此情况下,借助于封闭腔12可以相应提高支撑件的弹性变形程度。
从图4b中可以看到,该或至少某些支撑件7的直径D或D1不同,支撑件设计成有沟槽14通过其中,沟槽14两端敞开着,或者如图中所示的那样,可配备有棒形插入物15作为位置指示剂,使我们可以看到插入物15相应的取向。
如图4c中所示,支撑件7可以设计成基本上圆柱体的形式,圆柱体的两端成球面,这里也可配备沟槽14和/或棒形内含物15,或例如配备两个相应的内含物,彼此在支撑件7轴线方向上的作用相抵消。这些支撑件7的直径D或D1和/或长度L或L1也可以不同。
如图4d中所示,该或起码一些支撑件7可以呈英形,在此实例中则呈椭球体的形状,因而可设计成带既定的支撑面16,从而使支撑件7可以有意识地安置得使其支撑面16对准毗邻的椎骨体1、2。从图4d中也可以看到,导管6的横截面可设计成相应的形状,如图中所示的那样成椭圆形,从而形成支撑面16的导沟17。
如图4e中所示,至少其中一个支撑件,例如待塞入腔5中的最后一个支撑件7,可配备至少一个(在图中为4个)弹性变形膨胀元件18,元件18在膨胀状态下从支撑件7横向凸出,且如图5中所示的是在通过导管6纵向塞入受应力的位置时变形,当离开导管6而进入空腔5时,在膨胀状态下弹回,从而防止支撑件通过通孔脱离腔5跑进导管6中。
从图6中可以看到,若干支撑件可以按珍珠项链上珍珠的形式配置在柔韧的带状或线绳状的载体20上,并与该载体连接,形成紧密结合在一起的植入体。载体20最好设有止动件21配置在支撑件7之间,如图中所示的那样呈构成在载体20上的结节扣的形式,配置得使支撑件7之间形成预定的最小间距A,该间距相当于至少其中一个支撑件7的直径,或者,在支撑件7的尺寸变化的设计中,相当于毗邻的支撑件7的半径的总和。
如图7中所示,支撑件7和载体20用同一种材料制成,且连接起来形成单件的植入体,其中载体20起隔离作用。按照图8中所示的情况,一系列支撑件7可配置在呈紧紧包绕着支撑件7的导管22的形式的包覆件中,且可与该包覆件连接形成紧密结合的植入体。导管22和袋10一样可以由相应的编织品、针织品或薄膜制成。
总之,本发明因此可以如下那样叙述:
用一种由若干弹性塑料支撑件7组成的植入体取代椎间盘3核心区的再也承受不起载荷的部分。支撑件7借助于穿过椎间盘3的外环形区4的导管6一个接一个地塞入核区中形成的中心空腔5中,直到充满所述中心空腔为止。所充填的支撑件7充满中心空腔5时聚集在环形区4的界面壁处,彼此相互拥挤,在应力的作用下弹性变形。因此可以得出这样一种万用植入体,该植入体能适应任何形状的空腔5,形成较紧凑的弹性支撑构件。
Claims (18)
1、一种有一个植入体的椎间假体,该植入体可塞入椎间盘(3)核心区的中心空腔(5)中,且适宜传递压缩应力,取代该核心区的一部分,其特征在于,植入体中装有至少三个弹性变形支撑件(7),这些支撑件可被塞入中心空腔(5)中并在空腔中就位。
2、根据权利要求1所述的假体,其特征在于,支撑件(7)由弹性塑料制成。
3、根据权利要求1或2所述的假体,其特征在于,支撑件(7)设计成旋转实心体的形式。
4、根据以上任一权利要求所述的假体,其特征在于,所塞入的支撑件(7)设计成不同的尺寸(D,D1,L,L1)。
5、根据以上任一权利要求所述的假体,其特征在于,至少其中一个支撑件(7)设计成有一个沟槽(14)通过其中。
6、根据以上任一权利要求所述的假体,其特征在于,至少其中一个支撑件(7)设计成有一个封闭的腔(12)。
7、根据以上任一权利要求所述的假体,其特征在于,至少其中一个支撑件(7)设计成有至少一个由在X光检查时能看得到的材料(例如钽)制成的插入物(13,15)。
8、根据以上任一权利要求所述的假体,其特征在于,支撑件(7)按珍味项链的形式配置在一个柔韧的例如线绳状的载体(20)上,载体(20)有一些隔离装置,在支撑件(7)之间按预定的最小间距(A)配置。
9、根据权利要求8所述的假体,其特征在于,支撑件(7)之间的最小间距(A)至少大致相当于其中一个支撑件(7)的直径(D)。
10、根据权利要求8或9所述的假体,其特征在于,隔离装置包括至少一个止动件(21)装设在各支撑件(7)之间,呈构成在柔韧载体(20)上的结节扣的形式。
11、根据权利要求8或9所述的假体,其特征在于,各支撑件(7)和柔韧载体(20)由同一种材料制成,且彼此连接起来形成单件植入体。
12、根据以上任一权利要求所述的假体,其特征在于,支撑件(7)配置在将其包覆着的包覆件(10,22)中。
13、根据以上任一权利要求所述的假体,其特征在于,起码其中一个支撑件(7)配备有起码一个可弹性变形的膨胀元件(18)从支撑件的主部横向伸出。
14、根据以上任一权利要求所述的假体,其特征在于,起码其中一个支撑件(7)有一个限定支撑面(16),供与构制在导向件(导管6)中的导沟(17)相互作用,借助该支撑面支撑件(7)可以在中心空腔(5)中既定的位置就位。
15、椎间假体的一种植入法,该假体的植入体起码有三个可弹性变形的支撑件(7),植入体可塞入椎间盘(3)的核心区中;
其特征在于:
第一步,在椎间盘(3)的外环形区(4)中开一个通过所述环形区通向核区的孔;
第二步,通过孔(30)朝核区插入一个圆凿,在核心区中切除推间盘再也承受不起载荷的组织部分,由此凿出一个中心空腔(5),并将切除部分通过孔(30)清除出去;
第三步,支撑件(7)通过孔(30)引入空腔(5)中,从而使空腔基本上充满支撑件(7),且支撑件(7)形成能承受压力的支撑构件;
第四步,引入最后一个支撑件(7)之后,将孔(30)封闭上。
16、根据权利要求15所述的方法,其特征在于,往穿过外环形区(4)的孔(30)中插入一个管状保护件和/或导向件(导管6),圆凿和支撑件(7)即通过导管6塞入核区中。
17、根据权利要求15或16所述的方法,其特征在于,在外环形区(4)中开另一个孔(30′),通过该孔(30′)朝核心区塞入第二个导向件(导管6′),借助于导管6′可分别监视或影响空腔(5)的清理情况和/或支撑件(7)的引入情况。
18、根据15至17任一权利要求所述的方法,其特征在于,中心腔(5)清理好之后,接着往空腔(5)中引入即将塞入空腔(5)中的支撑件(7)的包覆件(10),从而使充填孔仍然留在外环形区(4)外面。
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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 |
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- 1994-04-19 AU AU60520/94A patent/AU673052B2/en not_active Ceased
- 1994-04-20 CN CN94104361A patent/CN1096440A/zh active Pending
- 1994-04-20 FI FI941831A patent/FI941831A/fi unknown
- 1994-04-20 CZ CZ94946A patent/CZ94694A3/cs unknown
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- 1994-04-21 JP JP6083471A patent/JPH06319760A/ja active Pending
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1996
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CN100464723C (zh) * | 2002-01-11 | 2009-03-04 | 科丰公司 | 采用具有内部限制件的可膨胀本体来压缩松质骨的装置和方法 |
CN101548906B (zh) * | 2002-01-11 | 2012-03-14 | 科丰有限公司 | 采用具有内部限制件的可膨胀本体来压缩松质骨的装置和方法 |
CN1329009C (zh) * | 2002-04-04 | 2007-08-01 | 斯恩蒂斯有限公司 | 椎间盘假体 |
CN100349553C (zh) * | 2003-05-07 | 2007-11-21 | 阿利瓦医药有限公司 | 通过重建养分与废物的交换治疗背痛的器件 |
CN100508915C (zh) * | 2004-04-02 | 2009-07-08 | 斯恩蒂斯有限公司 | 椎间盘假体 |
CN104586545A (zh) * | 2007-06-15 | 2015-05-06 | Ldr医疗公司 | 髓核假体 |
CN106562843A (zh) * | 2016-10-20 | 2017-04-19 | 山东冠龙医疗用品有限公司 | 网袋扎口方法、扎口部件、骨融合器及骨融合器使用方法 |
Also Published As
Publication number | Publication date |
---|---|
AU6052094A (en) | 1994-10-27 |
US5702454A (en) | 1997-12-30 |
HUT67437A (en) | 1995-04-28 |
JPH06319760A (ja) | 1994-11-22 |
HU9400863D0 (en) | 1994-06-28 |
NO941428L (no) | 1994-10-24 |
EP0621020A1 (de) | 1994-10-26 |
NO941428D0 (no) | 1994-04-20 |
CA2121001A1 (en) | 1994-10-22 |
FI941831A0 (fi) | 1994-04-20 |
US5755797A (en) | 1998-05-26 |
TW302277B (zh) | 1997-04-11 |
CZ94694A3 (en) | 1994-11-16 |
AU673052B2 (en) | 1996-10-24 |
FI941831A (fi) | 1994-10-22 |
KR940023446A (ko) | 1994-11-17 |
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