CN1094940A - 用于植入组织内部固定假体、人造关节部件或类似物的固定元件 - Google Patents
用于植入组织内部固定假体、人造关节部件或类似物的固定元件 Download PDFInfo
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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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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
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- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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- A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
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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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- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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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
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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
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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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- A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
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Abstract
一种由钛或其它与组织相容的材料制成、形状为
带有外螺纹的螺杆状、用于植入骨骼或其它组织中的
固定元件,可用于支持假体或人造关节组件一类物
体。为增加其旋转稳定性并防止该元件旋松,在螺杆
的螺纹上开了一些缺口,例如可通过在该元件的外周
表面上开一些横贯那些螺纹牙圈的螺旋形或直的凹
槽来形成这些缺口。以便这种固定元件植入例如骨
骼组织中以后,组织生长到这些缺口中,形成能防止
该固定元件转动或旋松的楔销。
Description
本发明涉及一种由组织相容性材料制成,植入到组织内部以固定假体(如假肢)、人造关节部件或类似物的固定元件。本发明特别涉及一种大体上为轴对称形状的固定元件,其外表面上至少部分地设置有向其***端延伸的外螺纹。在本文中,这种固定物被称作“特定种类的”固定物。
例如,在牙科领域内,如上所述的植入性固定元件已经使用了多年并且在固定单个假牙和固定牙桥方面获得了较大成功。例如,美国专利5064425描述了这种固定元件或固定物,它们被安装到一个在植入前预先开在骨组织中的孔内。在将这种固定物拧入到该孔中以后,经过一段较长的时间(大约四个月)它将借助于组织生长而逐渐附着在组织上。随后剥露出该固定物上部以便(在大多数情况下)借助于合适的调整垫安装一个假牙或牙桥。
一般说来,这种固定元件或固定物具有一个由钛制成的带有外螺纹的螺杆状主体,该主体与组织接触的外表面及这些螺纹具有特定的表面结构,以便与周围组织最佳地协同起来。这一特定的表面结构包括大量排列在其表面上的微凹,以便为毗邻的组织细胞及其细胞生长建立支持点和附着点(参见美国专利4330891及欧洲专利0338576)。与为实现这一目的而专门发展起来的良好的外科技术相结合,就能使这种带微凹的植入表面与组织细胞及其细胞生长形成所需的共同配合,完成理想的生物固定。
对这类植入物的综合性临床跟踪研究表明,这种固定器对轴向负载具有极好的固定性能。
但是,由于新近将这种固定元件推广用于固定假体部件,特别是用于固定诸如指关节、髋关节、手关节一类的各种关节,因为出现了非轴向负载,显然也应注意这种固定器的扭转稳定性。因为每当出现这种扭转负荷都可能引起这种的固定器旋转移位,所以需要有这种旋转稳定性来防止这种固定器由于反复受到扭转负荷而松动。在发生了这种旋转移位后,即使这种固定器又借助于其新位置处的组织生长重新牢固地固定住,该固定器固定到周围组织中的固定能力仍将受到破坏。
本发明的一个目的是尽量减少上述问题和困难并提供一种特定种类的固定元件,这种固定元件在使用过程中具有比已知的固定元件强得多的旋转稳定性,同时也保持了克服轴向负载的能力,因而这种固定元件不易松动。
按照本发明的一个方面提供了一种可植入到组织中的固定元件,这种固定元件是由与组织相容的材料制成,并包括一个具有中心轴的、总体上为轴对称形状的主体,该元件具有一个带螺纹的外周表面,并至少在该螺纹的一圈上带有横断的缺口,以便当固定元件被值入组织中时,组织可以生长到所述的缺口中,形成一个阻止该固定元件在组织中转动的楔销。
这些缺口的深度最好与所述外螺纹的深度相同。
在本发明的一个优选实施例中,至少有一条总体上以螺旋形延伸的凹槽与螺纹相交形成这些缺口,所述凹槽的螺距明显大于该螺纹的螺距。另外,也可以沿该固定元件轴的平行方向开多条凹槽,这些凹槽与螺纹的多条螺圈相交,形成许多缺口。
如果凹槽是螺旋形的,其螺距最好比螺纹的螺距大三倍以上。
位于相邻螺圈上的缺口可以沿一条假想的螺旋线彼此隔开一定距离。
可以在该元件的外周表面开两条或两条以上螺旋形凹槽。例如可以开许多具有相同手旋方向和螺距的螺旋形凹槽,这些凹槽围绕着该元件彼此隔开。其中的每一条凹槽都可以贯通该元件的整个外螺纹表面。
也可以通过开一些大体上与元件的轴平行的凹槽来形成缺口。这些凹槽最好贯通该外螺纹的至少五个相邻螺圈。也可将这些轴向凹槽沿着该元件的纵向彼此移位。
这些凹槽的横截面最好是V形的。螺纹牙顶最好是圆的,位于相邻螺纹齿侧面之间的纹间表面(该纹间表面限定了该固定螺杆的根径)的轴向宽度远大于一般工程用螺杆的相应部位的常规宽度。
下面将参照附图举例描述本发明的优选实施例。
图1是一个常规固定元件的侧视图;
图2是图1所示元件的顶视图;
图3是通过图1所述元件的螺纹的局部剖视图,图中示出了螺纹的轮廓;
图4是构成本发明第一实施例的一种固定元件的透视图;
图5是一幅透视图,显示了构成本发明的第二实施例的固定元件的一部分;
图6是图5中一个部分的放大视图,详细地展示了该固定元件的外表面;
在这些附图中,把植入组织中(例如骨骼中)的固定元件指定为1。
图1至3显示了一种常规的固定元件。这种固定元件1由一种能与组织相容的材料(例如钛)制成,并且包括一个用于安装假体部件、人造关节部件等部件的上连接部2以及一个下固定部3,沿着下固定部3的外表面开有外螺纹4,外螺纹4一直朝着固定元件1的下端(即***端6)延伸,***端6是该元件的端部,在使用时,首先将这个端部***到在骨骼或其它组织中为植入该元件而开好的孔中。在本例中示出的螺纹4是右旋的。图3示出了这种外螺纹的一种较合适形式。如图中所示,在螺纹剖面上,螺纹牙顶4a在轮廓上是圆形的,而位于螺纹齿侧面之间的纹间表面则是平的。标号4b表示位于相邻螺纹齿侧面之间区域的一个虚构部分,如果这两个倾斜的螺纹齿侧面向内延伸直至相交,就会形成这一部分。
为了在组织中达到生物学意义上的最佳固定,至少固定元件1上的那些在使用过程中与组织接触的区域具有一种特殊的表面结构,这种结构包括一些彼此邻近的微凹。专业人员根据对本技术领域的常用术语的理解,认为“微凹”指的是尺寸为10至10,000纳米(通常为10至300米)的表面凹陷,“大凹”指的是尺寸为几微米至200微米及200微米以上的表面凹陷。微凹和大凹各有多种已知的制备方法,例如美国专利4330891和欧洲专利0338576分别对它们做了描述。
这些微凹将构成一些分别起支持组织细胞作用和供这些细胞增长部分附着的点,并能与良好的外科技术结合起来,为植入表面与周围组织之间形成理想的生物协同创造必要的条件。综合临床研究表明,这样的表面结构为植入表面和周围细胞组织之间的良好固定创造了条件。这种固定技术又称作骨整合。
图4至6展示了体现本发明的两种不同形式的固定元件。两种形式的固定元件都具有一个总体上围绕中心轴轴对称的主体。更具体地说,这两个实施例中的固定元件是一个带有外螺纹4的圆柱体,外螺纹4最好也具有如图3所示的螺纹形状。每一实施例中的固定元件都最好是由钛制成或者具有钛质的外表层或镀层,以便与将要植入的骨头或其它组织接触。图4所示实施例具有一条围绕该元件的轴线螺旋状延伸的凹槽5,该凹槽5从元件1的上端2朝其下端(即***端6)延伸,并与螺纹4的每一圈相交。螺旋形凹槽5的深度大致上与螺纹4的深度相等。凹槽5横截其长度方向的截面最好是V形的,使得凹槽位于螺纹牙顶位置的部分宽于其位于螺纹根部的部分。从图4可明显看出,螺旋形凹槽5的螺距比螺纹4的螺距大得多,从而在螺纹4的每一圈8上都形成一个缺口7,于是每一缺口7的横截面形状都与凹槽5的相同。为了不影响将元件拧入预先开好的孔中,该螺旋形凹槽应该与螺纹4具有相同的走向,即相同的手旋方向。
当然,在本发明的构思范围内,图4所示的实施例还可以有多种变化形式。可以将凹槽5只限制在元件1的带螺纹的处表面的一段区域内。在这种情况下,凹槽5最好延伸过螺纹4的至少5圈螺纹牙。另外,还可以开若干条最好具有相同手旋方向和螺距的螺旋形凹槽5,并使它们围绕着元件1的外周彼此间隔开。还有一种形式是,可以在固定元件的带螺纹表面上开许多短的纵向凹槽,每一凹槽只通过一圈螺纹产生一个缺口或只通过几圈螺纹产生几个缺口。在这种情况下,可以使每一个短凹槽或由它们形成的每一个缺口都位于穿过固定元件外周表面的同一根假想的螺旋线上。
图4所示的固定元件是自攻丝的,例如它可以具有如美国专利5064425描述的总体形状。也就是说它可以具有一个封闭的底部9以及许多排列在所述封闭底部9正上方的轴向伸展的狭缝10,所述的狭缝与存在于元件1中的空腔11共同配合,收集在将固定元件1拧入预先开在组织中的孔内时从组织上切削下来的东西。从这一点来讲,这些狭缝10提供了合适的切削刃。
图5和6示出了根据本发明设计的另外一种用于增加旋转稳定性的、穿过螺纹的切口7的排列形式。在这一实施例中,在固定元件的外周开了一些与固定元件的轴平行的凹槽13以取代图4所示的螺旋状延伸的凹槽5,这些凹槽13在各自的缺口处与螺纹圈相交。这些凹槽13可以和凹槽7一样具有V形横截面。这些凹槽的深度也最好和螺纹4的相同,并且这些凹槽彼此之间可以靠得很近或者隔开较大距离。还可将这些凹槽13相互纵向移位,并且这些凹槽最好具有一定的长度以便在螺纹4的很多(最好是三个以上)相邻的螺圈8上形成彼此相邻的缺口12。
如图5所示。这些轴向凹槽13最好是分布在固定元件1的螺纹表面4在轴向上彼此隔开的几个区域或区段的每一个之一。在这种情况下,它们应该首先至少排列在固定元件1的将要接触周围骨组织并承受负荷的那些区段上。从图6可明显看出这些轴向凹槽13是如何在螺纹3的一些圈上产生缺口12的。
实验表明,根据本发明设计的带有旋转稳定缺口的固定元件与过去已知的固定元件相比,旋转稳定性显著提高。一旦植入这种固定元件,周围组织便会生长到这些缺口中,并在这些缺口中形成有效的“楔销”,从而防止固定元件在使用过程中因受到扭转载荷而移动乃至拧松。但是,还可明显看到,本发明的这些旋转稳定缺口不会对在值入过程中外螺纹4使固定元件旋入开在骨头或其它组织中的孔内的功能产生不利影响,也不会对由该外螺纹产生的轴向载荷稳定性产生不利影响。
不难理解,这种沿外螺纹延伸的螺旋形凹槽不只限于用在如图4和图5所示的以及具有美国专利US5064425所公开特征的特定固定元件上,如图4所示的凹槽及如图5所示的轴向凹槽当然还可用于没有封闭底部及自攻丝特性的固定元件。
当然,本发明不只限于参照附图描述的上述实施例,在所附权利要求范围内,本发明可以有多种变化形式。外螺纹4的尺寸一般来说可以和图3所示的已有技术的尺寸相同。另外,还可将这种固定元件用于穿透皮肤固定或用于其它目的,例如用于固定电线。本发明的固定元件还可用于其它目的,例如用于固定电线。本发明的固定元件还可用于支撑髋关节,当然,这种固定元件的长度要能保证其安全固定在骨头中。尤其是在髋部假体方面,由于已知的固定装置还存在一些实质性问题,所以非常需要具有旋转稳定性的固定器。已知的固定装置在使用了比较短的时间后常常会松动。
Claims (16)
1、一种由与组织相容的材料制成、用于植入组织中的固定元件,包括一个具有中心轴的、总体上为轴对称形的主体,其特征于,该元件具有一个带螺纹的外周表面,在该螺纹的至少一圈螺纹牙上形成有横断的缺口,当该固定元件被植入组织中后,组织可以生长到所述的缺口中,形成一个阻止该固定元件在组织中转动的楔销。
2、根据权利要求1所述的固定元件,其特征在于,在该固定元件的至少一个区段上带有几圈所述螺纹,每一圈螺纹都有一个所述的横断缺口。
3、根据权利要求1所述的固定元件,其特征在于,所述缺口的深度与所述螺纹的深度相同。
4、根据权利要求1所述的固定元件,其特征在于,一条沿该固定元件的外周表面延伸并与所述螺纹的一些螺纹牙相交的凹槽的一些部分形成一些所述的缺口。
5、根据权利要求4所述的固定元件,其特征在于,所述的凹槽螺旋状延伸,该螺旋形凹槽的螺距明显大于所述螺纹的螺距。
6、根据权利要求5所述的固定元件,其特征在于,所述螺旋形凹槽的螺距比所述螺纹的螺距至少大三倍。
7、根据权利要求1所述的固定元件,其特征在于,在围绕该固定元件外周表面的一条假想螺旋线上的相应位置处连续的各圈螺纹牙上,形成一些所述的缺口。
8、根据权利要求4所述的固定元件,其特征在于,在所述的螺纹上形成几组所述的缺口,每组所述的缺口由沿该元件的外周表面延伸并与所述螺纹的很多螺纹牙圈相交的相应的一条凹槽的几部分形成,所述的这些凹槽围绕该固定元件彼此隔开。
9、根据权利要求8所述的固定元件,其特征在于,所述的这些凹槽是一些具有相同手旋方向和螺距的螺旋形凹槽。
10、根据权利要求4所述的固定元件,其特征在于,所述的凹槽在该固定元件的整个螺纹区延伸,因而与该螺纹的每一圈螺纹牙相交。
11、根据权利要求4所述的固定元件,其特征在于,所述的凹槽平行于固定元件的轴延伸。
12、根据权利要求4所述的固定元件,其特征在于,所述的凹槽至少垮过所述螺纹的五圈。
13、根据权利要求1所述的固定元件,其特征在于,每个所述缺口都有V形的横截面,在该固定元件的圆周方向上,所述的横截面在各螺圈的牙顶处比在螺纹根部宽。
14、根据权利要求1所述的固定元件,其特征在于,所述螺纹牙顶的侧形为圆形。
15、根据权利要求1所述的固定元件,其特征在于,该元件由钛制成。
16、根据权利要求1所述的固定元件,其特征在于,所述固定元件的外周表面具有钛质的表层或镀层。
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- 1994-04-22 TW TW083103584A patent/TW299225B/zh active
- 1994-04-26 DK DK94850068T patent/DK0622058T3/da active
- 1994-04-26 JP JP6088557A patent/JPH06319759A/ja active Pending
- 1994-04-26 CZ CZ941005A patent/CZ284044B6/cs not_active IP Right Cessation
- 1994-04-26 PL PL94303186A patent/PL174716B1/pl unknown
- 1994-04-26 AT AT94850068T patent/ATE180654T1/de not_active IP Right Cessation
- 1994-04-26 CN CN94104696A patent/CN1094940A/zh active Pending
- 1994-04-26 FI FI941934A patent/FI941934A/fi unknown
- 1994-04-26 ZA ZA942870A patent/ZA942870B/xx unknown
- 1994-04-26 DE DE59408327T patent/DE59408327D1/de not_active Expired - Fee Related
- 1994-04-26 NO NO941524A patent/NO302506B1/no not_active IP Right Cessation
- 1994-04-26 ES ES94850068T patent/ES2133524T3/es not_active Expired - Lifetime
- 1994-04-26 EP EP94850068A patent/EP0622058B1/de not_active Expired - Lifetime
- 1994-04-26 CA CA002122192A patent/CA2122192A1/en not_active Abandoned
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- 1994-04-27 AU AU60733/94A patent/AU689462B2/en not_active Ceased
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Cited By (12)
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CN101883537A (zh) * | 2007-04-23 | 2010-11-10 | 诺贝尔生物服务公司 | 牙植入物 |
CN101883537B (zh) * | 2007-04-23 | 2014-06-04 | 诺贝尔生物服务公司 | 牙植入物 |
CN102046109A (zh) * | 2008-05-30 | 2011-05-04 | 株式会社南都精密 | 植入体及其制造方法和牙科用植入物 |
CN102316819A (zh) * | 2009-02-24 | 2012-01-11 | 尼尔生物技术有限公司 | 牙科用种植体 |
CN102316819B (zh) * | 2009-02-24 | 2014-09-24 | 尼尔生物技术有限公司 | 牙科用种植体 |
CN102596094A (zh) * | 2009-10-01 | 2012-07-18 | 奥那吉路易吉&奥那吉朱塞佩和安吉洛公司 | 具有改善的骨结合特性的牙植入体 |
CN102596094B (zh) * | 2009-10-01 | 2015-09-02 | 奥那吉路易吉奥那吉朱塞佩和安吉洛公司 | 具有改善的骨结合特性的牙植入体 |
CN103857357A (zh) * | 2011-10-07 | 2014-06-11 | 贺利氏古萨有限公司 | 用于***具有配对定位部的塑料模型中的具有定位部的实验室模拟体 |
CN103857357B (zh) * | 2011-10-07 | 2017-10-10 | 贺利氏古萨有限公司 | 用于***具有配对定位部的塑料模型中的具有定位部的实验室模拟体 |
CN102920501A (zh) * | 2012-11-30 | 2013-02-13 | 毕思维 | 具有应力分散结构的金属接骨板 |
CN102920501B (zh) * | 2012-11-30 | 2015-04-15 | 毕思维 | 具有应力分散结构的金属接骨板 |
CN114259287A (zh) * | 2021-12-24 | 2022-04-01 | 北京理贝尔生物工程研究所有限公司 | 髓内锁钉组件 |
Also Published As
Publication number | Publication date |
---|---|
JPH06319759A (ja) | 1994-11-22 |
FI941934A0 (fi) | 1994-04-26 |
DK0622058T3 (da) | 1999-06-23 |
TW299225B (zh) | 1997-03-01 |
CZ100594A3 (en) | 1994-11-16 |
SE9301407D0 (sv) | 1993-04-27 |
EP0622058B1 (de) | 1999-06-02 |
NO941524L (no) | 1994-10-28 |
US5702445A (en) | 1997-12-30 |
DE59408327D1 (de) | 1999-07-08 |
EP0622058A2 (de) | 1994-11-02 |
KR100295127B1 (ko) | 2002-09-19 |
EP0622058A3 (de) | 1995-01-04 |
BR9401613A (pt) | 1994-11-22 |
HU217008B (hu) | 1999-11-29 |
ATE180654T1 (de) | 1999-06-15 |
NO302506B1 (no) | 1998-03-16 |
US5702443A (en) | 1997-12-30 |
PL174716B1 (pl) | 1998-09-30 |
FI941934A (fi) | 1994-10-28 |
AU689462B2 (en) | 1998-04-02 |
ZA942870B (en) | 1995-11-23 |
HUT67974A (en) | 1995-05-29 |
NO941524D0 (zh) | 1994-04-26 |
CZ284044B6 (cs) | 1998-07-15 |
AU6073394A (en) | 1994-11-03 |
CA2122192A1 (en) | 1994-10-28 |
ES2133524T3 (es) | 1999-09-16 |
GR3030398T3 (en) | 1999-09-30 |
HU9401068D0 (en) | 1994-07-28 |
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