CN1221218C - 用于固定外科植入物的器械 - Google Patents

用于固定外科植入物的器械 Download PDF

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CN1221218C
CN1221218C CN00819880.2A CN00819880A CN1221218C CN 1221218 C CN1221218 C CN 1221218C CN 00819880 A CN00819880 A CN 00819880A CN 1221218 C CN1221218 C CN 1221218C
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CN1479591A (zh
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彼得·施泰格尔
罗伯特·弗里格
卢卡斯·埃施巴赫
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AO Technology AG
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Synthes AG Chur
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
    • F16B19/00—Bolts without screw-thread; Pins, including deformable elements; Rivets
    • F16B19/04—Rivets; Spigots or the like fastened by riveting
    • F16B19/08—Hollow rivets; Multi-part rivets
    • F16B19/10—Hollow rivets; Multi-part rivets fastened by expanding mechanically
    • F16B19/1027—Multi-part rivets
    • F16B19/1036—Blind rivets
    • F16B19/1045—Blind rivets fastened by a pull - mandrel or the like
    • F16B19/1054—Blind rivets fastened by a pull - mandrel or the like the pull-mandrel or the like being frangible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks

Abstract

按照本发明的器械用于骨骼骨折治疗和/或用于在骨骼里或骨骼上固定外科植入物、外科缝线或织物，该器械主要包括一个固定部件(1)和一个铆钉(2)，该铆钉与中心轴线(6)同心地包括一个铆钉杆体(3)、一个与中心轴线(6)相交的后端部(18)、一个在轴向上位于后端部(18)对面的杆体前端部(7)和一个同心地贯穿铆钉(2)的通孔(5)，使所述固定部件(1)的杆体(10)可以同心地在通孔(5)中移动而所述端头(11)轴向顶靠在杆体前端部(7)上。此外，所述铆钉杆体(3)在外部包括至少两个槽(9)，这些槽从杆体前端部(7)开始平行于中心轴线(6)地向后端部(18)方向延伸。

Description

用于固定外科植入物的器械
技术领域
本发明涉及一种的器械，该器械用于骨骼骨折治疗和/或用于在骨骼里或骨骼上固定外科植入物、外科缝线或织物。
背景技术
铆钉、尤其是盲铆钉也可以用于外科骨折治疗或用于在骨骼里或骨骼上固定外科植入物、外科缝线或织物。特别适用的铆钉是其铆钉镦头由分离的、可相对宽向扩张的锚固舌构成。由非医用领域、例如由GB 2054 082装填固定器(TUCKER FASTENERS)已知这种盲铆钉。锚固舌在盲铆钉前端上借助于锥角形锐棱铆钉镦头通过铆钉杆体壁的轴向断裂成形，该铆钉镦头在空心圆柱形铆钉杆体里从前端开始被拉拔。这种已知盲铆钉的缺陷是只能应用于软材料并且为了在盲铆钉上形成铆钉镦头需要很大的固定力(Schliesskraft)。
发明内容
本发明将设法补救。本发明的目的是，实现可在医学上应用的固定装置、尤其是可应用于外科的盲铆钉，这种铆钉允许采用具有较高强度的材料、例如钛材料并可以通过在外科中正当的固定力固定。
本发明通过用于骨折治疗和/或用于在骨骼里或骨骼上固定外科植入物、外科缝线或织物的器械实现所提出的目的。
按照本发明的器械主要包括：
A)一个固定部件(Schliesselement)，该部件具有杆体和位于端部与杆体牢固连接的或例如通过螺纹连接与杆体相连的端头；以及
B)一个铆钉，该铆钉包括一个与中心轴线同轴的铆钉杆体和一个同轴贯穿铆钉的通孔。
固定部件的杆体可在通孔中同心地移动，使端头轴向顶靠在杆体前端部上。固定部件的端头和杆体可以设计成两体式或一体。此外铆钉杆体在外部包括至少两个槽，该槽从杆体前端部开始平行于中心轴线地在长度L上向铆钉后端部方向延伸。该槽用作为理论断开位置，使得固定部件在铆钉杆体的铆钉头方向上继续移动时，通过固定部件的端头使铆钉杆体在其整个长度的一部分上被分成多个锚固舌。长度L相对于铆钉杆体整个长度的比例为20％至90％之间，使锚固舌在径向上可以扩展成一个平面F，该平面可以3倍至20倍于铆钉杆体的横截面面积。
在按照本发明器械的优选实施例中，铆钉杆体包括一个缝隙，该缝隙一方面在杆体前端部上通到通孔，而另一方面平行于中心轴线通到槽。通过这个缝隙有利于铆钉杆体的断裂。
在按照本发明器械的另一实施例中，铆钉在后端包括一个铆钉头，该铆钉头可以牢固地与铆钉连接或者例如通过螺纹连接与杆体相连接。
在按照本发明器械的另一实施例中，铆钉材料的材料特性位于边界数据以内，该边界数据在拉伸强度(Rm，以N/mm2为单位)与断裂延伸率(A5以％为单位)的比例范围内，即10∶1至50∶1、最好为10∶1至30∶1之间。
在按照本发明器械的另一实施例中，这样选择铆钉的几何尺寸，使铆钉杆体的外径da与通孔直径d的比例在1.1∶1至2.5∶1的范围内，最好在1.5∶1至2∶1的范围内。
槽的径向深度t与铆钉杆体壁厚的比例适合在1∶1.2至1∶2.5、最好在1∶1.7至1∶2.3的范围内。壁厚可以由外径da与直径d之间的差值获得。
那么具有这种几何关系的铆钉具有这样的几何尺寸，它们位于下列边界数据范围内：
铆钉杆体的外径da：2至12mm，最好为3至8mm；
通孔的直径d：1至8mm，最好为1.5至5mm；
铆钉杆体的壁厚：0.2至4mm，最好为0.5至2mm；以及
槽的径向深度t：0.1至3mm，最好为0.2至1mm。
在按照本发明器械的另一实施例中，槽具有垂直于中心轴线的三角形横截面，其中槽底处三角形的锐角度范围在30°至80°、最好在40°至70°之间。均分铆钉杆体圆周的槽数量合理地在3至8、最好在3至5之间。在固定的铆钉中由槽的数量也得到锚固舌的数量。
铆钉材料最好为金属并且分别包括下列材料合金：
a)铁基材料、最好是钢；
b)钛基材料、最好是化学纯钛和钛合金；
c)钴基材料、最好是钴基合金；
d)钽基材料、最好是钽基合金；以及
e)锆基材料、最好是锆基合金。
本发明的其它优点在从属权利要求中给出。
通过本发明实现的优点主要在于，借助于本发明的器械：
-比在骨骼中采用螺栓时实现更加均匀的力传导；以及
-比在骨骼中采用螺栓时并对于较差的骨骼质量也可以产生更稳定的锚固。
附图说明
下面通过部分示意的多个实施例附图详细描述本发明和本发明的进一步构成。附图中：
图1为按照本发明器械的视图；
图2为图1中所示按照本发明器械的实施例的纵向剖面图；
图3为在图1和2中沿线I-I截取所示按照本发明器械实施例的截面图；
图4为图1至3中所示按照本发明器械实施例的透视图；以及
图5为按照本发明器械的另一实施例的纵向剖面图。
具体实施方式
在图1中示出按照本发明器械实施例的铆钉2和固定部件1。铆钉2具有中心轴线6并由一个平行于中心轴线6延伸的圆柱形铆钉杆体3、一个牢固地与铆钉杆体3连接的铆钉头4和一个沿着中心轴线6同心穿透铆钉2的圆柱形通孔5所组成，其中铆钉杆体3不必一定为圆柱形。铆钉杆体3具有外径da并包括槽9，该槽平行于中心轴线6延伸，从杆体前端部7延伸长度L并从外表面14出发具有深度t。深度t这样设计，使得由直径da和d以及深度t所确定的壁厚在铆钉2与固定部件1连接时能够将铆钉2在要被固定的部分上分开成分离的多个锚固舌13(图4)，其中锚固舌13的数量等于设置在铆钉2外表面14上的槽9的数量。对于在这里所示的铆钉2实施例，铆钉杆体3的壁厚等于外径da的14％。缝隙12(Schlitze)从铆钉杆体3的前端面15平行于中心轴线6贯穿铆钉杆体3，该缝隙一方面在杆体前端部7上通到通孔5，而另一方面平行于中心轴线6地通到槽9。固定部件1包括一个平行于中心轴线6的杆体10和一个位于端部的端头11，该端头截锥形地通到杆体10。铆钉2的固定在插入铆钉2后、例如插入骨骼板(Knochenplatte)和骨骼(未示出)中后通过固定部件1实现。固定部件1的端头11具有一个大于通孔5直径d的直径D，使固定部件1的端头11通过施加到杆体10上的拉力压进通孔5的内锥面8(图2)。当继续将固定部件1的截锥形端头11压进通孔5的内锥面8时(图2)，铆钉杆体3的壁20被扩张(图2)，并在继续压进固定部件1端头11时在由槽9所形成的理论断裂位置上分开成多个锚固舌13(图4)。
在图2中示出的铆钉2属于上述的按照本发明器械的实施例。铆钉2具有一个中心轴线6、一个具有与中心轴线6相交的杆体前端部7的环柱形铆钉杆体3和一个在与中心轴线6相交的后端部18上位于端部的同样环柱形的铆钉头4。在杆体前端部7上具有垂直于中心轴线6的前端面15。铆钉头4向着杆体前端部7方向成凸面或截锥形地收缩到铆钉杆体3，并同样成凸面或截锥形地收缩到后端位于后端部18上的铆钉2端面19。与中心轴线6同心且从杆体前端部7到后端18透穿铆钉2地设置一个通孔5。该通孔5在杆体前端部7上通过内锥面8扩展地通到前端面15。槽9平行于中心轴线6设置，该槽从杆体前端部7沿长度L(图1)贯穿铆钉杆体3，并具有垂直于中心轴线6的V形横截面(图3)。此外缝隙12从前端面15开始同样平行于中心轴线6地贯穿铆钉杆体3。这些缝隙12具有垂直于中心轴线6的矩形横截面(图1)并且平行于中心轴线6地构成圆弓形。缝隙12平行于中心轴线6延伸并通到前端面15、外表面14和槽9。
图4示出的铆钉2具有中心轴线6、铆钉头4、扩张的铆钉杆体3和处于铆钉2的连接状态的固定部件1。铆钉杆体3在长度L上(图1)扩张并包括3个锚固舌13。
在图5中示出铆钉2的一个实施例，该铆钉与图1和2所示实施例的不同之处仅在于，铆钉2在后端18处不包括铆钉头4(图1和2)。此外固定部件1只在其整个长度的一部分上贯穿铆钉2并由同心地贯穿固定部件1的孔21构成，该孔在位于端头11的轴向对面的端部22设有同轴内螺纹23。基尔施纳金属丝(Kirschnerdraht)24可以旋进这个内螺纹并可以在连接铆钉2之后继续从内螺纹23中旋出来。

Claims (10)

1.用于进行骨骼骨折治疗和/或用于在骨骼里或骨骼上固定外科植入物、外科缝线或织物的器械，该器械包括一铆钉(2)，该铆钉与中心轴线(6)同心地包括一个具有外表面(14)的铆钉杆体(3)、一个与中心轴线(6)相交的后端部(18)、一个在轴向上位于后端部(18)对面的杆体前端部(7)和一个同心地贯穿铆钉(2)的通孔(5)，其中所述铆钉杆体(3)包括至少两个槽(9)，该槽平行于中心轴线(6)延伸、从杆体前端部(7)开始沿长度L向着后端部(18)方向延伸，并具有从外表面(14)开始测量的径向深度t，其特征在于，所述铆钉(2)材料的材料特性位于边界数据以内，该边界数据在拉伸强度Rm与断裂延伸率A5的比例范围内，即10∶1至50∶1之间，其中，Rm以N/mm2为单位，A5以％为单位。
2.如权利要求1所述的器械，其特征在于，所述长度L与铆钉杆体整个长度的比例为20％至90％之间。
3.如权利要求1或2所述的器械，其特征在于，所述铆钉杆体(3)具有缝隙(12)，该缝隙一方面在杆体前端部(7)上通到通孔(5)而另一方面平行于中心轴线(6)地通到槽(9)。
4.如权利要求1或2所述的器械，其特征在于，所述拉伸强度Rm与断裂延伸率A5的比例范围为10∶1至30∶1之间，其中，Rm以N/mm2为单位，A5以％为单位。
5.如权利要求1所述的器械，其特征在于，所述铆钉杆体(3)的外径da与通孔(5)的直径d的比例在1.1∶1至2.5∶1的范围内。
6.如权利要求5所述的器械，其特征在于，所述铆钉杆体(3)的外径da与通孔(5)的直径d的比例在1.5∶1至2∶1的范围内。
7.如权利要求1所述的器械，其特征在于，所述槽(9)的径向深度t与铆钉杆体(3)壁厚的比例在1∶1.2至1∶2.5的范围内。
8.如权利要求7所述的器械，其特征在于，所述槽(9)的径向深度t与铆钉杆体(3)的壁厚的比例在1∶1.7至1∶2.3的范围内。
9.如权利要求1或2所述的器械，其特征在于，所述器械包括一个固定部件(1)，该固定部件具有一个杆体(10)和一个位于端部的端头(11)，使所述固定部件(1)的杆体(10)可以同心地在通孔(5)中移动而所述端头(11)轴向顶靠在杆体前端部(7)上。
10.如权利要求1或2所述的器械，其特征在于，所述铆钉(2)在后端部(18)上具有铆钉头(4)。
CN00819880.2A 2000-09-07 2000-09-07 用于固定外科植入物的器械 Expired - Fee Related CN1221218C (zh)

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CN1479591A (zh) 2004-03-03
CA2422464A1 (en) 2003-03-07
JP2004507332A (ja) 2004-03-11
US20030199877A1 (en) 2003-10-23
BR0017331A (pt) 2003-06-03
WO2002019931A1 (de) 2002-03-14
MXPA03002015A (es) 2003-07-24
US7485135B2 (en) 2009-02-03
EP1315462B1 (de) 2009-07-15
DE50015692D1 (de) 2009-08-27
ES2326784T3 (es) 2009-10-20
JP4215502B2 (ja) 2009-01-28
EP1315462A1 (de) 2003-06-04

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