CN106137369A - 骨钉及经皮微创椎弓根固定*** - Google Patents
骨钉及经皮微创椎弓根固定*** Download PDFInfo
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Abstract
本发明涉及一种经皮微创椎弓根固定***,其包含骨钉及钩杆,其中骨钉包含定位套及钉本体。该定位套包含固定座、校准套及钉本体通道,该固定座包含位于底部的通孔及在壁上彼此相对地设置的两开口,校准套具有壁部分及体积减小部分,其中壁部分经构形具有长形开口,且体积减小部分为壁上被移除以自该固定座的外表面内缩的一部分,一导引开口形成在该体积减小部分中,定位套包含位于校准套及固定座之间的第一易断裂部分,以使该校准套自定位套被移除。
Description
技术领域
本发明涉及骨钉及经皮微创椎弓根固定***,特别是关于适于用在经皮微创脊椎骨治疗的骨钉固定***。
背景技术
固定***的微创侵入性手术被用于治疗脊椎骨(vertebrae)中,由于伤口小,这种手术可大幅减少对于治疗部分及其附近组织的伤害、提升手术的安全性及减少治愈与恢复时间。为了固定***的准确定位及校准,固定***的骨钉典型地经提供有定位套,因此,固定***的骨钉可在进行手术时自人体外被定位且校准。
现有的骨钉固定***需要一分离的校准组件,以在将骨钉***骨头中时校准骨钉,该分离的校准组件较复杂及/或具有多个组件,因而导致不便利甚至在手术中需要具有较大宽度或长度的伤口。因此,需要发展一种相对简单且便利的骨钉固定***。再者,由于有时需要将多于一个的骨钉***患者的脊椎骨中,因而期待提供一种减小手术步骤的数量及/或手术时间的骨钉固定***。
发明内容
本发明可改善在侵入型脊椎骨手术中安装固定组件的效率及准确性。在经皮侵入型脊椎固手术中,最好能减小手术造成的伤口面积或尺寸,本发明的固定***包含长管状结构,其在***骨钉时有助于校准骨钉,该长管状结构可为具有用以使骨钉通过的通道的圆柱形校准套,且与将藉由骨钉被***且固定至骨头的基座一体地形成,在该植入程序完成之后该结构可接着被移除。当多于一个的骨钉需要彼此相邻地被植入时,最好该固定***的该被封闭的长管状结构的直径是较小的,或者具有经开发的较适当形状,以使这些校准套可被紧密地堆栈在一起且因此在***多个骨钉时仅需要小的患者伤口面积。
优选的骨钉固定***具有定位套,该定位套包含一固定座、一校准套及穿过该定位套形成的一骨钉本体通道,该固定座及该校准套是一体地构形,一通孔在固定座的底部且沿着骨钉本体通道被形成,该通孔具有小于骨钉本体的球形头部直径的一直径;该固定座的壁具有彼此相对且朝向固定座顶部开放的两个开口,使得穿过固定座的一第一通道被形成在所述两个开口之间且侧向穿过固定座;该校准套具有一壁部分及一体积减小部分;一长形开口被形成在该壁部分上且与所述两个开口中的一者连通;该体积减小部分是具有壁的一部分被移除且因此自固定座的外表面内缩的部分,且与所述两个开口中的另一者连通的一导引开口被形成在体积减小部分中;及一易断裂部分被形成在校准套及固定座之间,以促进校准套自定位套的移除。该易断裂部分是选自下列中一者:(a)一环形槽;(b)相对于固定座的宽度或直径具有明显地减小校准套宽度或直径的一部分;或(c)沿着校准套及固定座间的边界形成的一系列的小孔。定位套可进一步包含多个校准开口在校准套的壁部分位于远离固定座的远侧末端,及一第二凹槽在所述多个校准开口的稍微下方处且环绕校准套的中间部分,使得具有所述多个校准开口的部分可被断裂。
优选的是,该体积减小部分的整个壁被移除,使得体积减小部分自固定座的外表面内缩。由于该壁的移除形成导引开口,且该校准套的截面的内缩面积,自邻近固定座的一端朝向远离固定座的远侧端逐渐增加。更进一步的是,在校准套的长形孔的远侧末端,该截面的内缩面积优选等于或大于固定座顶部的截面的面积的一半。此外,固定座具有位在固定座底部部分的一球形坑,在球形坑上方的内表面经构形具有一螺纹用于骨钉的固定,且定位套具有85毫米至165毫米的一纵向长度。
另一方面,本发明提供这样一种骨钉,其包含如前述说明的一定位套及一骨钉本体。骨钉本体包含包含一螺杆及连接至螺杆顶部的一球形头部,骨钉本体被可旋转地连接至该定位套的一底部部分,使得骨钉本体的定位部分被设置在固定座的球形坑中。该球形头部的外径大于螺杆的外径,且球形头部经构形具有一接合槽及一止滑纹,该接合槽符合一驱动工具的形状且该止滑纹增加该球形头部外表面的摩擦力。螺杆具有包含一外螺纹的杆部分及包含一锐角角度的尖端。当骨钉被植入至一脊椎骨中时,该校准套的校准开口保留在该皮肤上方。
在又另一方面,本发明提供一种经皮微创椎弓根固定***,其包含如上所述的一骨钉、一钩杆及一固定螺钉。钩杆包含具有多边形结构的一杆,该多边形结构位于杆的后侧端,使得钩杆的安装角度及位置可藉由多边形结构被调整。固定螺钉可与该球形坑上方的内表面的螺纹锁固,以将钩杆与固定座固定。当骨钉的螺杆被植入至一脊椎骨中时,钩杆可通过皮肤的伤口被***,沿着校准套被导引至定位套的底部,且可延伸穿过校准套的长形开口及导引开口。
藉此,由于定位套被提供有长形孔及导引开口,使得连接构件可穿过定位套并沿着校准套被导引至定位套的底部。本发明的经皮微创椎弓根固定***使得连接构件的安装更为容易。此外,因为定位套,手术中的伤口的面积可以藉由堆栈多个骨钉的定位套而被减小。连接构件可为连接杆、钩杆或其类似物,用以连接上部及下部脊椎骨或连接椎弓根与脊椎骨而形成脊椎固定***,以解决脊椎退化或相关疾病造成的不稳定性。一种具有大约5.5毫米直径的钛合金连接杆可被用于作为一种连接杆。
上述说明并不意欲用以说明所揭露的每一实施方式或本发明的所有实施态样,以下图式及详细说明特别提供例示性实施方式作为例子。
附图说明
图1是根据本发明一种实施方式的骨钉的立体图;
图2是根据本发明一种实施方式的骨钉在分解状态下的立体图;
图3是根据本发明一种实施方式的骨钉在组合状态下的侧视图;
图4是根据本发明一种实施方式的钩杆的立体图;
图5A至5E描绘根据本发明一种实施方式的椎弓根固定***的安装过程,其中图5A展示骨钉被植入且锁入脊椎骨,图5B展示钩杆沿着校准套被导引至定位套的底部,图5C展示钩杆向外延伸穿过校准套的长形开口及导引开口且被钩于椎弓峡部,图5D展示钩杆被钩于椎弓峡部且固定至骨钉的固定座,及图5E展示钩杆被固定至骨钉的固定座的另一视图;
图6A至6E描绘根据本发明另一实施方式的骨钉的安装,其中图6A展示多个骨钉被植入脊椎骨中,图6B展示图6A的多个骨钉藉由校准治具校准,图6C展示图6B的多个骨钉藉由校准治具暂时固定且一连接杆定位在固定座中,图6D展示连接杆已被固定至多个骨钉的固定座且所述定位套的校准套已被移除,及图6E展示连接杆被固定至多个骨钉的固定座。
图7A及7B描绘根据本发明另一实施方式的骨钉的安装,其中图7A展示多个骨钉通过皮肤上的同一个小伤口被植入脊椎骨,及图7B展示两个骨钉的定位套的上部保留在皮肤上方且被堆栈在一起。
【符号说明】
100 骨钉本体
110 球形头部
112 接合槽
113 止滑纹
120 螺杆
121 外螺纹
122 尖端
200 定位套
210 固定座
211 球形坑
213 螺纹
214 开口
220 校准套
221 校准开口
222 校准开口
223 长形孔
224 第二凹槽
225 导引开口
228 壁部分
229 体积减小部分
230 环形槽
250 骨钉本体通道
260 第一通道
501 皮肤
501A 伤口
502 脊椎骨
503 椎弓峡部
600 校准治具
701 连接杆
800 钩杆
801 杆
802 弯钩部
803 多角形结构
900 固定螺钉
具体实施方式
下面结合附图对本发明进行说明。应了解,本领域技术人员在不脱离本发明的范围或精神的前提下,还可构思及完成其他实施方式。以下的优选实施例仅用于描述本发明,而非限制本发明。
如图1至3所示,骨钉包含定位套200及骨钉本体100,骨钉本体100包含螺杆120及球形头部110;骨钉本体100可以通过校准套220且可选转地连接至定位套200的一底部部分。球形头部110具有大于螺杆120外径的一外径,定位套200包含固定座210及校准套220及穿过定位套形成的骨钉本体通道250,固定座210及校准套220两者一体地形成。固定座210的底部形成有沿着骨钉本体通道250的一通孔,其具有小于骨钉本体100的球形头部110的一直径。固定座210的壁具有彼此相对且朝向固定座210顶部开放的两开口214,使得穿过固定座210的第一通道260形成在开口214之间且侧向地穿过固定座210。固定座210进一步包含位于固定座210的底部部分的球形坑211及位于球形坑211上方经构形具有螺纹213的内表面。
校准套220具有壁部分228及体积减小部分229,壁部分228经形成具有一壁、与所述开口214中的一者连通的一长形孔223及位于远离固定座210的远侧末端的多个校准开口221,222。校准套220进一步具有第二凹槽224,第二凹槽224在校准开口221,222的稍微下方处且环绕校准套220,使得具有校准开口221,222的部分可被轻易断裂。体积减小部分229是具有壁的一部分被移除且因此自固定座210的外表面内缩的部分,导引开口225形成在该体积减小部分229中且与所述开口214中的另一者连通。另一优选实施方式是体积减小部分229的整个壁被移除,且因此体积减小部分229形成导引开口225。在一优选实施方式中,该校准套的截面的内缩面积,自邻近固定座210的一端朝向远离固定座210的末端逐渐增加,且在长形孔223的远侧末端大于固定座210顶部的截面的面积的一半,定位套200优选具有自85毫米至165毫米的轴向长度。
此外,定位套200具有易断裂部分,以促进校准套220的移除。举例而言,环形槽230形成在校准套220及固定座210之间,以使校准套220可以藉由使环形槽230断裂自定位套200被轻易地移除。另一种例子是,易断裂部分为相对于固定座210的宽度或直径具有明显地减小校准套宽度或直径的部分。易断裂部分也可以是沿着校准套220及固定座210间的边界形成的一系列的小孔。
在图2中,骨钉是在分解状态中。骨钉本体100包含螺杆120及连接至螺杆120顶部部分的球形头部110,球形头部110具有接合槽112及止滑纹113,接合槽112符合驱动工具的形状,止滑纹113用以增加球形头部110外表面的摩擦力。螺杆120具有包含外螺纹121的杆体部分及尖端122,尖端122经形成有位在杆体部分末端的锐角。
在骨钉的组合状态下,如图1及3所示,骨钉本体100是可旋转地连接至定位套200的底部部分,使得骨钉本体100的球形头部110被设置在固定座210的球形坑211中(如图2所示)。
图5A至5E展示经皮微创椎弓根固定***。经皮微创椎弓根固定***包含如上所述的骨钉、钩杆800及固定螺钉900。在此所述的弓根可能具有缺口或椎弓解离症(spondylolysis)的情况。如图4所展示的钩杆800具有弯钩部802、杆801及位在杆801的后侧端的多角形结构803,多角形结构803藉由工具促进钩杆800的安装角度及位置的调整。如图5D所示的固定螺钉900,可被沿着在球形坑211上方的定位套200的内表面的螺纹213锁固,以将钩杆800与固定座210固定。
以下参阅图5A至5E说明经皮微创椎弓根固定***手术的一种例子。首先,驱动工具(图中未展示)的前端抵靠骨钉本体100的球形头部110的接合槽112,并进入定位套200以旋转骨钉本体100及植入螺杆120至脊椎骨502中,如图5A所示。在螺杆120被锁固至骨头中后,固定螺钉900沿着螺纹213被锁固至固定座210的球形坑211中(如图2所展示),以避免螺杆本体100退出,且校准套200的一部分仍然位在皮肤的伤口上方。接着,如图5B至5C所示,钩杆800被***至定位套200且沿着定位套200被导引至定位套的底部,钩杆800沿着校准套220的长形开口223及导引开口225移动,且藉由多边形结构803及工具,钩杆800的安装角度及位置可被调整,因此,钩杆800的弯钩部802可以在一预定位置准确地与椎弓峡部(parsinterarticularis)503固定。再者,如图5D至5E所示,固定螺钉900沿着球形坑211上方的内表面的螺纹213被锁固,以固定钩杆800至固定座210。最后,施加一外力至定位套200的环形槽230,以断裂该环形槽230,藉此,校准套220可以自固定座210被分离及移除,而自人体内取出。
根据上述说明,本发明的经皮微创椎弓根固定***可被用以锁固椎弓峡部(parsinterarticularis)503、增加脊椎骨稳定性及避免椎弓峡部(pars interarticularis)503恶化或转变成椎弓解离症(spondylolysis)或脊椎滑脱症(spondylolisthesis)。
以下参阅图6A至6E说明一种微创手术中用于多个脊椎骨的固定***的安装的例子。首先,如图6A所示,骨钉200被置入皮肤501的伤口中,驱动工具(图中未展示)抵靠骨钉本体100的球形头部110的接合槽112并进入定位套200,以用于将螺杆120旋转及植入至脊椎骨502中。在骨钉被植入至脊椎骨502后,由于定位套200具有大约100毫米的一长度且脊椎骨通常位于皮肤下方大约35毫米至50毫米的深度,因此定位套200的校准套220的一大部分保留在皮肤上方。特别是,壁部分228的校准开口221,222保留在皮肤上方,使得骨钉可以藉由校准治具600自皮肤上方被校准。如图6A及6B所示,四个骨钉分别被植入至四个脊椎骨中,两个校准治具600穿过校准套220的校准开口221,222,当骨钉的角度及位置经调整后,校准开口221,222被适当地定位以符合校准治具600的曲线。校准治具具有一曲线,其大约等同于固定***所欲安装的脊椎的曲线,换言之,在校准后,骨钉的位置大约符合脊椎的曲线。
如图6C所示,校准治具600中较低的一者被移除以促进连接杆701的***。连接杆701被设置在固定座210的开口214中,并藉由固定螺钉900被固定至固定座210,其中固定螺钉900沿着球形坑211上方的内表面的螺纹213被锁固。由于连接杆701具有类似校准治具600的曲线的一曲线,因此连接杆701可被准确地定位在定位套200的固定座210上。亦可适用的是,由于第二凹槽224促进移除的步骤,藉由施加一外力移除校准治具600两者及校准套位在第二凹槽224上方的部分。
最后一步是移除校准治具600并藉由分离工具(图中未展示)或手施加一外力以移除定位套210,由于定位套的环形槽230,校准套220可被轻易地断裂且移除。因此,如图6D及6E所示,定位套200的校准套220已自固定座210被分离且已自人体中被移除,微创手术中多个脊椎骨的固定***的安装被完成。
在本发明的另一实施方式中,如图7A及7B所示,两个或两个以上的骨钉彼此相邻地被植入,而在***多个骨钉时仅需要小的患者伤口面积。由于定位套200的体积减小部分229,在安装多个骨钉时,一定位套200的壁部分可被部分地接收于另一定位套200的体积减小部分中,亦即具有体积减小部分229的一定位套200与另一定位套堆栈在一起,藉此,可相当地减小伤口501A的面积及所需治愈及恢复的时间。
虽然以上关于本发明的特定实施方式进行说明,但本领域技术人员可清楚理解,还有其他多种变化及修饰及其他使用。因此,本发明的保护范围由权利要求书界定。
Claims (11)
1.一种骨钉的定位套(200),用以装配一骨钉本体(100),该定位套(200)包含一固定座(210)、一校准套(220)及穿过所述定位套形成的一骨钉本体通道,所述固定座(210)及所述校准套(220)是一体地构形,其中:
一通孔,在所述固定座(210)的底部且沿着所述骨钉本体通道被形成,所述通孔具有小于骨钉本体(100)的球形头部(110)直径的一直径;所述固定座(210)的壁具有彼此相对且朝向固定座(210)顶部开放的两个开口(214),使得穿过所述固定座(210)的一第一通道被形成在所述两个开口(214)之间且侧向穿过所述固定座(210);
所述校准套(220)具有一壁部分(228)及一体积减小部分(229);一长形开口(223)被形成在所述壁部分(228)上且与所述两个开口(214)中一者连通;所述体积减小部分(229)是具有所述壁的一部分被移除且因此自所述固定座(210)的外表面内缩的部分,且与所述两个开口(214)中另一者连通的一导引开口(225)被形成在所述体积减小部分(229)中;及
一第一易断裂部分被形成在所述校准套(220)及所述固定座(210)之间,以促进所述校准套(220)自所述定位套(200)的移除。
2.如权利要求1所述的骨钉的定位套(200),其中多个校准开口(221,222)被形成在所述校准套(220)的所述壁部分(228)位于远离所述固定座(210)的远侧末端。
3.如权利要求2所述的骨钉的定位套(200),其中一第二凹槽(224)被形成在所述多个校准开口(221,222)的稍微下方处且环绕所述校准套(220)的中间部分,使得具有所述多个校准开口(221,222)的部分可被断裂。
4.如权利要求1所述的骨钉的定位套(200),其中所述易断裂部分是选自下列中一者:(a)一环形槽(230);(b)相对于所述固定座(210)的宽度或直径具有明显地减小所述校准套(220)宽度或直径的一部分;或(c)沿着所述校准套(220)及所述固定座(210)间的边界形成的一系列的小孔。
5.如权利要求1所述的骨钉的定位套(200),其中,在所述体积减小部分(229)中,所述壁被移除以形成所述导引开口(225),其中所述校准套(220)的截面的内缩面积,自邻近所述固定座(210)的一端朝向远离所述固定座(210)的远侧端逐渐增加。
6.如权利要求所述5的骨钉的定位套(200),其中在所述校准套(220)的所述长形孔(223)的远侧末端,所述截面的所述内缩面积等于或大于所述固定座(210)顶部的截面的面积的一半。
7.如权利要求所述1的骨钉的定位套(200),其中所述固定座(210)进一步包含位在所述固定座(210)底部部分的一球形坑(211),且在所述球形坑(211)上方的内表面经构形具有一螺纹(213)。
8.如权利要求所述1的骨钉的定位套(200),其中所述定位套(200)具有85毫米至165毫米的一纵向长度。
9.一种骨钉,其包含:
如权利要求1至8中任一项所述的一定位套(200);及
一螺杆本体(100),其包含一螺杆(120)及连接至所述螺杆(120)顶部的一球形头部(110),其中:
所述螺杆本体(100)被可旋转地连接至所述定位套(200)的一底部部分,使得所述螺杆本体(100)的定位部分被设置在所述固定座(210)的所述球形坑(211)中;
所述球形头部(110)的外径大于所述螺杆(120)的外径;
所述球形头部(110)经构形具有一接合槽(112)及一止滑纹(113),所述接合槽(112)符合一驱动工具的形状,且所述止滑纹(113)用以增加所述球形头部(110)外表面的摩擦力;及
所述螺杆(120)具有包含一外螺纹(121)的一杆部分及包含一锐角角度的一尖端(122)。
10.如权利要求9的骨钉,其中当所述骨钉被植入至一脊椎骨中时,所述校准套(220)的所述多个校准开口(221,222)保留在所述皮肤上方。
11.一种经皮微创椎弓根固定***,包含:
如权利要求9或10的一骨钉;
一钩杆(800),其包含具有多边形结构(803)的一杆(801),所述多边形结构(803)位于所述杆的后侧端,使得所述钩杆(800)的安装角度及位置可藉由所述多边形结构(803)被调整;及
一固定螺钉(900),其可与所述球形坑(211)上方的所述内表面的所述螺纹(213)锁固,以将所述钩杆(800)与所述固定座(210)固定,其中:
当所述骨钉的所述螺杆(120)被植入至一脊椎骨中时,所述钩杆(800)可通过皮肤(521)的伤口(501A)被***,沿着所述校准套(220)被导引至所述定位套(200)的所述底部,且可延伸穿过所述校准套(220)的所述长形开口(223)及所述导引开口(225)。
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Also Published As
Publication number | Publication date |
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US9615855B2 (en) | 2017-04-11 |
TW201707654A (zh) | 2017-03-01 |
CN106137369B (zh) | 2021-05-18 |
TWI695702B (zh) | 2020-06-11 |
US20160331410A1 (en) | 2016-11-17 |
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