CN1329009C - 椎间盘假体 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A—HUMAN NECESSITIES
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Abstract
椎间盘假体或髓核置换假体,包括一纵向挠弹性的且可螺旋形卷绕的主体(2),其具有第一外端(3)、第二内端(4)和一纵向的中心轴线(5)。主体(2)的正交于中心轴线(5)的横截面(10)向第二内端(4)的方向缩小。
Description
技术领域
本发明涉及一种椎间盘假体或髓核置换假体(Nukleus-Ersatz-Prothese)。
背景技术
这样的假体在摘除损坏的自然椎间盘或损坏的椎间盘髓核以后植入两邻接的椎骨体的椎骨间隙中,其目的在于,重新尽可能恢复到类似自然的状态,亦即特别是重新恢复原来的椎间盘高度并从而恢复两邻接的椎骨体之间的原来的间距。
由现有技术已知椎间盘假体,例如由BRESLAVE的FR-A-2 712486,其中一可挠曲的、但非挠弹性的维可牢带(VELKRO-Band)成螺旋形卷绕成一圆盘。为了能够进行带的螺旋形卷绕,该已知假体需要一圆柱形中心件,将带固定在其上,然后通过中心件的转动将带卷绕在其上。
在该已知的椎间盘假体中不利的是,在较大的中心件与较窄的带之间存在的过渡以及带缺乏挠弹性。中心件的大小也同时确定进入口的大小,其中后者应该保持尽可能的小,但这在该已知的假体中是不可能的。
由EP-A-0 773 008已知一种椎间假体。在该已知的假体中不利的是,圆柱形中心件仍然较大,其上通过一构成为铰链、宽度较小的过渡元件固定长形的螺旋形体。圆柱形中心件与随带的铰链式过渡元件,由于其弹性铰链式的构造,而使得其操作困难和费事。并且圆柱形中心件是有阻碍的。
以上关于现有技术的讨论仅仅用于说明本发明的背景,并不意味着所引述的现有技术在本申请的申请日或其优先权日之前也确实被公开或公知。
发明内容
在这里本发明将消除上述弊端。本发明的目的在于,提供一种椎间盘假体或髓核置换假体,其由于其几何形状而可以恢复椎间盘高度,吸收在整个表面上-优选构成为凸形的表面上-出现的负荷力,卸载小平面铰链(Facettengelenken)中的压力,将作用力导入椎间盘纤维环(Anulus)中而且并不是妨碍而是支持自然的运动。
通过缩小椎间盘假体或髓核置换假体的第二内端可以简化成套工具的操作。从而,在将植入物引入到插置工具中时阻力得以减小。
由于终板中心是很薄的,可以较容易地将其压入;由于在植入物的中心横截面较小,而使其构成为较柔性的区域,从而更好地吸收产生的压力。
本发明利用这样一种椎间盘假体达到所提出的目的,即提出一种椎间盘假体或髓核置换假体,包括一纵向挠弹性的且可螺旋形卷绕的主体,其具有一第一外端、一第二内端和一纵向的中心轴线,其中,主体的正交于中心轴线的横截面向所述第二内端的方向缩小。
优选连续地并优选向主体的第一外端方向实现正交于中心轴线的横截面的缩小。垂直于中心轴线测量的主体宽度,从其中间起观察,同样应该向该第一外端方向优选连续地减小。此外,该宽度也可向第二内端方向优选连续地减小,因此提高了柔性,以便用成套工具操作植入物。
主体的宽度在其中间通常比在其第二内端和第一外端宽50%至500%,优选100%至300%。借此可以控制各自的柔性并且得到对椎骨体的盖板的较大的支承面。
在一特别的实施形式中,主体在相对中心轴线螺旋形卷绕的状态中具有一上螺旋面和下螺旋面,它们是凸面拱形的并且适于支承在两邻接的椎骨体的盖板上。以此达到植入物在椎骨体的凹面终板中的自动定心,并加大支承面和减小单位面积压力。总体上实现在椎间盘纤维环和盖板中较好的力传导。
适宜地,主体在螺旋形卷绕且未受载的状态中在螺旋线之间具有一间隙,其一方面便于主体的生产,而另一方面确保最好的柔性。该间隙的宽度应该为至少0.4mm,优选至少0.5mm。另一方面该间隙应该宽至多1.0mm,优选至多0.8mm。在该范围内得到螺旋形卷绕的主体的最佳存储效应(Memory-Effekt)。
在一特别的实施形式中,主体在螺旋形卷绕的状态中,在螺旋平面观察,具有一椭圆形的或肾形的外形,优选具有在螺旋平面测量为250至750mm2的面积,这可最好地适应于解剖学的边界条件。
在一优选的实施形式中,主体包括一水凝胶或甚至于仅仅由一水凝胶构成。水凝胶是这样一种胶体,其中分散的相(胶体)与连续的相(水)结合成一粘性的凝胶状的产品,例如胶凝的硅酸。与其他材料相比,其优点是,受压时排水而卸压时吸水,亦即类似于自然的髓核。
主体宜用注塑成型技术制造,其中其注射点优选定位在第二内端的区域内。这意味着在生产中注入技术上的优点。优选注射点沉降地设置。从而,由于拔出针形喷嘴时出现的偏斜不出现在表面上,而是进入沉孔内。
在一特别的实施形式中,第一外端朝螺旋内部不对称地设置。因此螺旋形卷绕的主体的外形是倒圆的。
主体可以构成为不透X射线的,优选通过添加硫酸钡实现。由此能够检查植入物的位置和控制其全方面的移动。为了同一目的,主体还可以包含不透X射线的元件,其优选为长丝、金属丝或小球的形式。
在一特别的实施形式中,螺旋形卷绕的主体的至少360°圆周的最后的外螺旋圈相对于其余的螺旋圈具有较薄的横截面。因此植入物的外边缘就植入物的功能而言是较柔性的。
最后,主体的第一外端设有一些结构,它们适于借助一插置工具夹持椎间盘假体,其优选为凹槽或突起的形式。
附图说明
以下借助一个实施例的示意图还要更详细地说明本发明及其进一步构成,其中:
图1 本发明的椎间盘假体的透视图;
图2 按图1的椎间盘假体的水平的横剖面图;
图3 沿图2中线III-III截取的横剖面图;
图4 按图1的椎间盘假体的侧视图;
图5 图3中在中心注射点的区域内的放大的剖面图;
图6 按图1的成螺旋形卷绕的主体的第一外端的放大的透视图;以及
图7 按图1的成螺旋形卷绕的主体的第一外端的一个方案。
具体实施方式
图1至4中所示的椎间盘假体1包括一纵向挠弹性的且可螺旋形卷绕的主体2,其具有第一外端3、第二内端4和一纵向的中心轴线5。主体2的正交于中心轴线5的横截面不仅向第二内端4的方向而且向第一外端3的方向连续地缩小,如图2和3中所示。
在图2中测量的主体2的宽度在第二内端4处为约2.5mm,在第一外端3处也为约2.5mm,并且在其之间向主体2的中间方向一直增大到约4.5mm。
图3中测量的椎间盘假体1的高度相当于解剖学的椎骨间隙。在凸面椎间盘假体1中间的高度与边缘固定的部分相比在两侧凸出0.5至3.0mm。
在主体2的螺旋形卷绕的、未受载的状态中,如其在图1和2中所示,在螺旋圈之间具有0.65mm的间隙。
主体2基本上包括一护套,该护套由聚碳酸聚氨酯和/或由硅酮-聚碳酸聚氨酯以及一聚乙烯醇水凝胶填料构成。其他的适用于护套及其填料的材料,可由仍在审查中的国际专利申请PCT/CH01/00700得知。
图5中示出,注射点9是如何定位在第二内端4的区域内,亦即接近于螺旋形主体2的中心,以及注射点9是如何相对于上螺旋面6进行沉降式(沉孔式)设置。
图6示出主体2的第一外端3具有一些结构的一种可能的方案,所述结构为两个横向于中心轴线5的凹槽11的形式,它们借助于一合适的插置工具例如一钳子可以方便地夹持椎间盘假体。
图7示出主体2的第一外端3具有一些结构的第二方案,所述结构的形式为两个横向于中心轴线5延伸的平缓凹槽12以及一平行于中心轴线5设置的切口13和一圆柱形根切14。
Claims (20)
1.椎间盘假体(1),包括一纵向挠弹性的且可螺旋形卷绕的主体(2),其具有一第一外端(3)、一第二内端(4)和一纵向的中心轴线(5),其特征在于,主体(2)的正交于中心轴线(5)的横截面(10)向所述第二内端(4)的方向缩小。
2.按照权利要求1所述的椎间盘假体(1),其特征在于,所述正交的横截面(10)连续地缩小。
3.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)的正交于中心轴线(5)的横截面(10)向所述第一外端(3)的方向缩小。
4.按照权利要求1或2所述的椎间盘假体(1),其特征在于,垂直于中心轴线(5)测量的主体(2)的宽度,从主体的中间起观察,向第一外端(3)的方向减小。
5.按照权利要求1或2所述的椎间盘假体(1),其特征在于,垂直于中心轴线(5)测量的主体(2)的宽度,从主体的中间起观察,向第二内端(4)的方向减小。
6.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)的宽度在其中间比在其第二内端(4)和第一外端(3)宽50%至500%。
7.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)在相对中心轴线(5)螺旋形卷绕的状态中具有一上螺旋面(6)和一下螺旋面(7),这两个面都是凸面拱形的并且适于支承到两邻接的椎骨体的盖板上。
8.按照权利要求1所述的椎间盘假体(1),其特征在于,主体(2)在螺旋形卷绕且未受载的状态中在螺旋线之间具有一间隙。
9.按照权利要求8所述的椎间盘假体(1),其特征在于,所述间隙的宽度为至少0.4mm。
10.按照权利要求8所述的椎间盘假体(1),其特征在于,所述间隙的宽度至多为1.0mm。
11.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)在螺旋形卷绕的状态中,在螺旋平面观察,具有一椭圆形的或肾形的外形。
12.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)包含一种水凝胶。
13.按照权利要求1所述的椎间盘假体(1),其特征在于,主体(2)用注塑成型技术制造并且其注射点(9)定位在第二内端(4)的区域内。
14.按照权利要求13所述的椎间盘假体(1),其特征在于,注射点(9)相对于上螺旋面(6)沉降地设置。
15.按照权利要求1或2所述的椎间盘假体(1),其特征在于,第一外端(3)朝螺旋内部非对称地设置。
16.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)是不透X射线的。
17.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)包含不透X射线的元件。
18.按照权利要求1或2所述的椎间盘假体(1),其特征在于,螺旋形卷绕的主体(2)的从第一外端(3)向第二内端(4)方向的至少360°圆周的外螺旋圈相对于其余的螺旋圈具有较薄的横截面。
19.按照权利要求1或2所述的椎间盘假体(1),其特征在于,主体(2)的第一外端(3)设有一些结构(11,12、13、14),它们适于借助一插置工具夹持椎间盘假体(1)。
20.按照权利要求1所述的椎间盘假体(1),其特征在于,所述椎间盘假体构成为髓核置换假体。
Applications Claiming Priority (1)
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PCT/CH2002/000189 WO2003084444A1 (de) | 2002-04-04 | 2002-04-04 | Bandscheibenprothese oder nukleus-ersatz-prothese |
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CN1329009C true CN1329009C (zh) | 2007-08-01 |
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CNB028289439A Expired - Fee Related CN1329009C (zh) | 2002-04-04 | 2002-04-04 | 椎间盘假体 |
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US (1) | US20050119750A1 (zh) |
EP (1) | EP1490000B1 (zh) |
JP (1) | JP2005521516A (zh) |
KR (1) | KR20050002927A (zh) |
CN (1) | CN1329009C (zh) |
AT (1) | ATE362354T1 (zh) |
AU (1) | AU2002242570A1 (zh) |
BR (1) | BR0215679A (zh) |
CA (1) | CA2481375A1 (zh) |
DE (1) | DE50210179D1 (zh) |
ES (1) | ES2287251T3 (zh) |
HU (1) | HUP0500171A2 (zh) |
IL (1) | IL164330A0 (zh) |
WO (1) | WO2003084444A1 (zh) |
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- 2002-04-04 JP JP2003581689A patent/JP2005521516A/ja active Pending
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- 2002-04-04 DE DE50210179T patent/DE50210179D1/de not_active Expired - Fee Related
- 2002-04-04 ES ES02708118T patent/ES2287251T3/es not_active Expired - Lifetime
- 2002-04-04 HU HU0500171A patent/HUP0500171A2/hu unknown
- 2002-04-04 WO PCT/CH2002/000189 patent/WO2003084444A1/de active IP Right Grant
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- 2002-04-04 BR BR0215679-2A patent/BR0215679A/pt not_active IP Right Cessation
- 2002-04-04 CN CNB028289439A patent/CN1329009C/zh not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
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JP2005521516A (ja) | 2005-07-21 |
WO2003084444A1 (de) | 2003-10-16 |
BR0215679A (pt) | 2005-02-01 |
ATE362354T1 (de) | 2007-06-15 |
ES2287251T3 (es) | 2007-12-16 |
CN1625373A (zh) | 2005-06-08 |
IL164330A0 (en) | 2005-12-18 |
HUP0500171A2 (hu) | 2005-05-30 |
EP1490000A1 (de) | 2004-12-29 |
EP1490000B1 (de) | 2007-05-16 |
US20050119750A1 (en) | 2005-06-02 |
CA2481375A1 (en) | 2003-10-16 |
AU2002242570A1 (en) | 2003-10-20 |
DE50210179D1 (de) | 2007-06-28 |
KR20050002927A (ko) | 2005-01-10 |
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