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CN1091585C - 支撑假体或用于重新连接的连接机构的紧固件 - Google Patents

支撑假体或用于重新连接的连接机构的紧固件 Download PDF

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Publication number
CN1091585C
CN1091585C CN 93120231 CN93120231A CN1091585C CN 1091585 C CN1091585 C CN 1091585C CN 93120231 CN93120231 CN 93120231 CN 93120231 A CN93120231 A CN 93120231A CN 1091585 C CN1091585 C CN 1091585C
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joint
anchoring
mechanism
supporting
areconstructed
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CN 93120231
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English (en)
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CN1088423A (zh )
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P·-I·布兰尼马克
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梅德弗洛普有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30749Fixation appliances for connecting prostheses to the body
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
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    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

一种支撑假体或者部分假体的紧固件(1)。该紧固件(1)是旋转对称的并带有外螺纹(20)和一个中心孔(2)。至少一道切口(3、4、5、6)设置成螺旋状围绕着元件(1)的纵向轴线(13)并至少在元件外壁的主要部分(11、12)上延伸。所述主要部分带有外螺纹(20),所述切口(3、4、5、6)的旋向与螺纹(20)相同。

Description

支撑假体或用于重新连接的连接机构的紧固件

本发明涉及一种用于支撑假体的紧固件,该紧固件具有大致呈螺钉状并设置成通过其外端部分与假体连接,并且,通过其相对的内端部分插入并紧固在骨骼组织中。

本发明也用于支撑连接机构,但最好用于切断术后的重新连接。

通过大致呈螺钉状的紧固件在骨骼组织中锚定已是公开技术。这种移植元件的与骨骼结合,及其固定物对紧固在颚骨上的假牙的防护功能,已在由BRANEMARK教授及其同事研究出的方法中获得优异的结果。除了固定物的设计外,固定物的材料及表面无损伤的外科手术的技术和特征对此非常重要。

为了重新连接,美国专利US-5171284提出一种旋转对称,至少是部分中空的紧固件作为重新连接物,特别是用于重新连接手指。这一公知紧固件具有大致旋转对称的结构,并且在其外的主要部分上具有外螺纹,以及其外端部用来连接在所述假体或连接部位上,而且,为了通过其相对的内端部插入并固定在骨骼组织上,至少有一带切割刃的切口从紧固件的内端部向其外端部方向延伸。已知紧固件的外表面可具有切割刃状的连续形成的孔。这些特征可使固定物紧固,而不需在骨骼组织上钻出带螺纹的孔,即固定物是自行钻孔的。这更进一步减少移植时导致的损伤,从而通过愈合过程促进其结合。在钻孔过程中,被切削下来的骨骼材料,由所述切口或腔室容纳,在以后的重新连接或再吸收。

但,这一公知紧固件的设计,是用来进行小连接件的连接的,特别是手指的连接。从这种意义上说,通过螺纹紧固该固定物的孔,是设置在一个骨骼纵向上的孔中。在此情况下,由钻孔切削下来的骨骼材料量相对来说是比较少的。

然而,这种固定物的自行钻孔的特性可进一步改进,特别是在固定物要用作大件连接时,为了在厚的骨骼组织中或在大深度的固定物上进行自行钻孔时,这种情况下,由钻孔切去的骨骼材料会有很大体积,为此,必须在固定物的空腔或切口中形成足够的空间。

本发明的一个目的是提供一种上述形式的紧固件,它没有这些缺陷并且可以设计成用来进行导管、骨髓等的连接及贯穿生长以限制骨髓萎缩,即骨髓干枯。

根据本发明,它提供了一个带有一中心通孔的紧固件,并具有环绕紧固件的纵向轴线并在外部开有外螺纹的主要部分上延伸的螺旋状切口,该切口的旋向与外螺纹的相同。

根据本发明的一可选择的方案,紧固件的壁厚在靠近内端部分上并向着该内端逐渐的减少。

根据本发明的一可选择的方案,一连接桥设置在切口壁之间并沿着切口部分从切口的封闭端延伸,所述连接桥穿透有至少一个孔,所述桥的内壁由中心孔划分且桥的径向厚度远远小于靠近带有桥的切口的部分的径向厚度。

切口的侧壁相互平行且穿透连接桥的孔是圆形的,所述孔的直径与切口宽度基本相同。

根据本发明的另一个可选择的方案,中心孔沿元件内端方向被加宽。最好孔加宽成锥形。紧固件最好在沿元件的内端方向加宽的部分上没有跨越螺旋切口的桥。

根据本发明的第三个可选择的方案,元件的内端部具有横切的环状边缘结构,其半径大致与外螺纹的内径相当。

根据本发明的一个可选择的实施例,螺旋切口的数目是两个或者三个或者二的倍数,如果数目是二或者是二的倍数,每对切口均关于中心孔轴线相对设置;在所有垂直于所述轴线的截面上,相邻切口距离互相相等。在这种连接中,由带有切口的紧固件所述部分中的切口占据大约15%到50%之间的区域。外螺纹的螺距与每道螺纹切口之间的比率在20∶1到500∶1之间,最好为100∶1。

与内端相邻的外壁部分最好不带螺纹但在车床上被粗车,而紧固件的内部部分则带有一定的径向弹性。假体或者部分假体的固定装置最好带有设置于紧固件的外端部的内螺纹和或六角形部分。

该元件最好在其外端部分带有一孔,该孔相对于中心轴线倾斜,其倾角B在25°到65°之间,从而为神经或供给装置提供一条通道或者腱或者外部连接。

至少在移植过程与组织接触的部分中紧固件最好是钛或者其它细胞组织不排斥的材料,并且至少对于其具有在移植过程与组织接触的表面的部分设置一带有微细凹坑的表面,该凹坑的直径在10到1000nm,最好为10-300nm。

本发明的紧固件是用来将假体或者其中一部分牢固地固定在骨髓组织上,或者用于外部连通或传送生物学和物理学参数。

本发明也公开了一种将假体或者假体的一部分固定在骨髓组织中的紧固件的固定方法,所述紧固件具有一中空的中心孔并带有外螺纹及自攻装置,所述方法包括:在骨髓组织上开一个孔,所述孔的直径与紧固件的外螺纹的内径大体一致,所述孔具有一与元件的插入深度相适应的长度,元件向孔中的插入通过自攻拧入完成,而切削切下骨髓材料并进而在孔中形成螺纹,所述螺纹与紧固件的外螺纹相对应,而切下的骨髓材料则由开在紧固件外壁上的一条或多条槽收容,并在槽中向着紧固件的外端部分传送,通过与将螺纹切入骨髓组织中的外螺纹共同配合实现元件的紧固,将假体或者假体的一部分固定在紧固件的外端,所述固定直接随着元件的移植或者在其后的很短时间内便会实现。所述方法最好进一步包括移植后的药理学灵敏剂的供入,诸如通过愈合过程促进结合的助剂和杀菌剂,所述供应是通过紧固件的对称中心孔供到带有元件移植孔的骨髓组织区域中。

下面将参照附图根据一个最佳的但非限制性的实施例对本发明进行更详细地说明。

图1是本发明的紧固件的立体图;图2是图1中朝着元件内端看的端面图;图3是图1中朝着元件外端看的端面图;图4是一系列垂直于紧固件旋转轴的截面A-H的草图,显示出了图1中元件的不同截面。

附图未按比例绘制并且仅表明了其近似的空间关系。

本发明图1中所示的紧固件1由已在车床上车削过的纯钛制成,并呈带有一对称中心通孔的近似圆形套筒形状。在其外侧,圆形套筒的外壁上开有螺纹20,从邻近一端,内端7开始向另一端,即外端8延伸,除了具有大约一个螺纹距宽度的窄区9和与外端8相邻的较宽的区域10以外,所述螺纹覆盖了外壁的绝大部分,该开有外螺纹的圆形套筒包括两个部分;一个接近宽外端区域10的非切割部分12(如图4所示),和一个沿元件的纵向分割有四个扇形体的部分11(如图4D到4H所示),该扇形体在非切割部分12与同切割部分11一样有扇形体的窄的内端区域9之间延伸。

其上开有四个纵剖面上环形分布的扇形体33、44、55、66的内端区域9和部分11的切割是通过割开圆筒壁并与中心孔2相连的四道狭长切口3、4、5、6形成的。切口3、4、5、6呈螺旋形并相对于圆形套筒的孔的中心线13对称分布且具有平行的侧壁41、42以及与元件的内端7相一致的开口端。切口3、4、5、6在由切割部分11与非切割部分12之间边界限定的另一端是封闭的。切口3、4、5、6的节距与外螺纹20的螺距的比例大约是100∶1,每一个切口3、4、5、6均相应于整个螺纹的四分之一(90度的螺纹扇形体,图4中的转角α)。切口3、4、5、6以及扇形体33、44、55、66的旋转从图4D-4H的剖示图中已清楚表明出来。

元件1的切割只是在从内端7开始向外端8延伸并接近带有切割的保留部分的部分切割16才完成(如图4D、4E、4F)所示。部分切割是由于有连接桥23连接着扇形体33、44、55、66,就其中心轴线13而言是从孔2径向向外延伸,且在该方向上具有靠近桥23的紧固件1带螺纹圆筒壁径向厚度的四分之一的厚度。每个桥23都由具有直径与切口3、4、5、6的宽度相应圆孔(如图4D、4F的剖示图所示)。而该孔中也可以有另外的形状,例如椭圆形。带有桥23的切口部分呈螺旋凹口或螺旋槽状。四个孔24为一组,每个相应于一个切口3、4、5、6设置在与中心轴线13垂直的面内。为了便于理解,在图1中只有连接桥23(通过图4E所示的这种桥式连接的截面)连接着扇形体33和66。

紧固套筒1的孔2朝着内端7呈锥形变宽(如图4G、4H的剖示图所示),形成三角锥形外罩式扇形体27、28、29、30,其基部与切割了的圆形内端边缘31相一致,该边缘由锥形与圆筒表面的外壁相切而形成。在靠近内端7的一部分中,外表面是斜切的,如同将外螺纹20的轴向宽度朝着内端7逐渐减小;所述部分包括靠近内端7的上述窄区9和一些外螺纹20。

通过外螺纹20的切口3、4、5、6的分割形成锋利的边缘或者凸缘25从而在拧入期间形成骨屑脱落。脱落下来的原材料由内端7外变宽锥形以及切口3、4、5、6所构成的空间容纳。通过将切口3、4、5、6安排成与外螺纹20螺旋方向相同,切口3、4、5、6上的骨屑在紧固件1拧期间向紧固件1的外端8方向传递。这避免了原材料组织的压缩及局部积存。由于邻近内端7的壁厚度较小,在径向还可获得一种弹性效应;这有助于拧入同时减少了内端的压力,特别是在工作负载下。桥23在紧固件1的扇形体33、44、55、66的切线方向收缩变形并因而维护了其自攻能力,同时桥之间的孔24为孔2与面对自由骨骼壁面的切口3、4、5、6提供了一连接。

在元件移植时,如果促进组织向内生长的因素或抗生素自外端通过孔2导入,这种通道非常重要。通过愈合过程的结合后,紧固也被加强,除了骨骼狭窄部分的连接通路外并且获得了骨骼的紧固。

在靠近紧固件1外端8又无螺纹的紧固件宽区10具有一个环形凸缘37(如图4B的剖示图所示),与开有螺纹的但没有切割的表面部分12相邻,还有一个小直径的端部38(如图4A的剖示图所示),与环形凸缘37相邻,该区域没有螺纹且位于紧固件1的外端位置。在从外端8朝内端7方向延伸的部分中,孔2带有内螺纹39用于假体或部分假体的固定。假如假体或者部分假体装到了元件1上,外端壁40中的凹槽30用于紧固件1的拧入并作为一限制器,例如通过将假体或者假体元件的螺纹装置拧到内螺纹39中。至于其它,紧固件的外端是以传统方式设计的,以便获得最理想的假体或者假体元件的固定。

带有圆环形状并深深切入材料中的切口适当安置在固定物的内部,再伸出的便被去掉(如果需要很大程度的伸直),因为环可以向假体移动。

例如,根据本发明的紧固件的移植物可以通过下面的方式实现:在紧固件移植物的外科手术中,在选作紧固座的骨骼上用具有与外螺纹的内径20基本相同直径的钻头钻孔,所述孔的深度比从元件1的内端7到环形凸缘37的距离大一些,但大得不很多。而后将紧固件拧入孔中,进而通过螺纹在骨骼材料上的切削和成形移去骨骼削屑。紧固件1在2-6个月的时间里经愈合过程进行结合以实现永久的紧固,即与骨结合成一体。而后,紧固件1的外端露在外面;且假体或者部分假体安装于其上。这样,装好的假体就能够正好开始承担负载。

Claims (19)

1.一种基本上旋转对称的紧固件,用于支撑假体或者部分假体,在它外部的主要部分上带有外螺纹并被用来将其外端部分连接在所述假体或部分假体上,而通过其相对的内端部分插入并固定在骨骼组织上,其中至少一道带有切割刃的切口自其内端部分向着外端部分延伸,其特征在于:该紧固件设置有一个中心通孔,并且所述切口呈螺旋状环绕紧固件的纵向轴线并至少在该紧固件外壁的主要部分上延伸,所述主要部分带有外螺纹,该切口的旋向与外螺纹的相同。
2.根据权利要求1所述的紧固件,其特征在于:紧固件的壁厚在靠近内端部分上并向着该内端逐渐减少。
3.根据权利要求1或2所述的紧固件,其特征在于:一个连接桥设置在切口二壁之间,并沿着切口部分从切口的封闭端延伸,所述连接桥至少被一个孔穿透,所述桥的内壁由中心孔定界且桥的径向厚度远远小于从连接桥处径向伸出的紧固件部分的壁厚。
4.根据权利要求3所述的紧固件,其特征在于:切口的侧壁相互平行且穿过连接桥的孔是圆形的,所述孔的直径与切口宽度基本相同。
5.根据权利要求3所述的紧固件,其特征在于:切口的侧壁相互平行且穿过连接桥的孔为椭圆形。
6.根据权利要求1至3中任一项所述的紧固件,其特征在于:紧固件的中心孔沿元件内端方向被加宽。
7.根据权利要求6所述的紧固件,其特征在于:孔被加宽成锥形。
8.根据权利要求6所述的紧固件,其特征在于:紧固件在沿元件的内端方向加宽的部分上,在螺旋切口之间并没有桥式连接材料。
9.根据权利要求1至3中任一项所述的紧固件,其特征在于:元件的内端具有横切的环状边缘结构,其半径大致与外螺纹的内径相当。
10.根据权利要求1至3中任一项所述的紧固件,其特征在于:设置有多个螺旋切口。
11.根据权利要求1至3中任一项所述的紧固件,其特征在于:螺旋切口的数目是两个或三个或二的倍数,每对切口均对于中心轴线相对设置,且在所有垂直于所述轴线的截面上,相邻切口距离互相相等。
12.根据权利要求11所述的紧固件,其特征在于:由带有切口的紧固件所述部分中的切口占据大约15%到50%之间的区域。
13.根据权利要求1至3中任一项所述的紧固件,其特征在于:与内端边缘的外壁部分是没有外螺纹的。
14.根据权利要求1至3中任一项所述的紧固件,其特征在于:紧固件的内端部分带有一定的径向弹性。
15.根据权利要求1至3中任一项所述的紧固件,其特征在于:用于假体或部分假体的固定装置,带有设置于紧固件的外端部中心孔的内螺纹。
16.根据权利要求1至3中任一项所述的紧固件,其特征在于:该元件在其外端部分带有一孔,该孔相对于中心轴线倾斜,其倾角B在25°到65°之间,从而为神经或供给装置提供一条通道。
17.根据权利要求1至3中任一项所述的紧固件,其特征在于:外螺纹的螺距与每道螺旋切口的螺距之间的比率在20∶1到500∶1之间。
18.根据权利要求1至3中任一项所述的紧固件,其特征在于:至少在移植过程与组织接触的部分中紧固件最好是钛或组织细胞不排斥的其它材料,并且至少对于其具有在移植过程与组织接触的表面的部分设置一带有微细凹坑的表面,该凹坑的直径在10到100nm。
19.根据权利要求1至3中任一项所述的紧固件,用来将假体或其一部分支撑在骨骼组织上。
CN 93120231 1992-10-29 1993-10-28 支撑假体或用于重新连接的连接机构的紧固件 CN1091585C (zh)

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