CN101150996B - 矫正儿童扁平足用的中空钛植入物 - Google Patents
矫正儿童扁平足用的中空钛植入物 Download PDFInfo
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Abstract
用于矫正儿童扁平足的中空钛植入物(螺钉),其特征在于:a)杆的直径是D=4.8mm±25%,推荐4.8mm±10%,并尤其推荐4.8mm;b)植入物是中空的,中空直径是C=2mm±25%,推荐2mm±10%,并尤其推荐2mm;c)螺纹高度是1.15mm±25%,推荐1.15mm±10%,并尤其推荐1.15mm;d)在螺钉的终止于90°角度的尖端上,在顶点螺纹上是120°角度的三等分切口。顶点螺纹的边缘以55°的角度切割。在螺钉尖端的最顶部处,顶点螺纹的三等分切口伸进孔道内螺纹的1.5mm的长度;e)这种类型的尖端代替了钻和攻丝设备的使用。
Description
发明描述
1.发明领域
本发明被设计来用于手术矫正足跟外翻儿童的极度扁平足(III-IV级扁平足(Pes planovalgus gr III-IV)),对于这种扁平足,尽管在十二岁之前使用了全部现有的物理矫正方法并利用了修复术(orthrotics),还是不可以矫正足跟轴(the axis of the heel)并带来足跟弓(the arch of the heel)的永久的令人满意的结果。
2.技术问题
目前,人们试图通过不同的外科手术方法来解决问题已经有许多年了,但他们直到目前还需要(通过一30-50mm的切口)手术来打开跗骨,即通过打开手术区域以改变跗骨(足部骨骼)的关系,而这需要损害周围组织。
螺钉已经可以对准正确的位置并通过打开骨骼表面而进入正确的地方。因此,术后恢复需要较长的时间,并且在很多病例中需要长期(几周)的活动(mobilization)。
第二个问题在于:插入的螺钉在足部矫正完成前就断裂了。因此,去除残留的螺钉小片将导致损坏大量的健康骨骼。
第三个问题是螺钉的过早松动,而该螺钉应当工作达30个月(螺钉在那段时间植入)以便足弓和足跟轴的适当矫正将随着足部发育而发生。
第四个问题是现有的普通螺钉头部(head of the screw)。当经由皮(cutem)去除螺钉时,人们需要使用注射针来确定螺钉头部的位置以用于将其钻出,这是较难完成的。此外,人们不得不用手术来去除螺钉,因为螺钉头部是球形的,支撑在细的颈状部分上,所以螺钉头部可能会卡住足跟骨骼的边缘,这肯定是没有益处的。
第五个问题存在于再吸收螺钉(resorptive screw)(如果被这样植入-因此意大利作者),在放置螺钉的六个月之后,螺钉就已经断裂了,因此需要三十个月的长期矫正过程就成问题了。根据盎格鲁撒克逊作者(anglo-saxon author),这种植入物是不稳定的,并且会在所需矫正时期完成之前脱落。我们还确实充分知道材料是如何影响身体的,材料在其被植入期间断裂并被再次吸收。本发明的螺钉通过其形状和结构解决了所有这些问题,即它可以通过克氏导线(Kirschners’s guide-wire)(其是中空的)的引导来穿过小的皮肤开口(skin gap)而被插入。螺钉的杆/体是更坚固且更大的,因此,需要更大的力才能引起螺钉断裂,且即使其断裂了,也可以较容易地移除螺钉,且对周围组织的损害要少的多。螺钉的尖端具有顶点螺纹(apex thread),这在定位螺钉时也减少了对骨骼的损坏。因为螺钉头部是更大的且是锥形形状的,因此螺钉不具有细的颈状部分。当定位螺钉时,螺钉通过自紧而移动到骨骼中。因此,螺钉很少松动。螺钉不会生长到骨骼组织中,因为其具有锥形头部且没有螺钉头部和螺纹之间的细的颈状部分,因此当矫正过程完成时,很容易移除螺钉。
螺钉由钛合金制成,这给予其特别的强度,并且如果在螺钉被植入期间,患者需要任何磁性探伤检查,患者都可以接受那样的磁性探伤检查。
3.背景技术
到目前为止,用于矫正扁平足的外科手术方法“跟骨生长停止法(Calcaneo stop)”的技术使用不同的螺钉,这些螺钉被置于已提到的顺行(anterograde)(距骨)方向和逆行(retrograde)(跟骨)方向中的足部骨骼中。再吸收螺钉放置在凹处(sinus)中,即所提到的骨骼之间的缝隙中。
当放置公知的螺钉时,人们不得不露出凹处,即手术区域以显示人们将要在其中将螺钉放置在正确位置的骨骼。到目前为止,所用的螺钉如下:
普通的多孔螺钉(spongious screw),其顺行地放置在距骨中,在5-10%的患者中横向断裂。如果不打开手术区域,那么是不能足够正确地放置螺钉的。根据我们和来自世界其余地方的分析,当定位和放置螺钉时,在4-9%的患者中发生了螺钉的不正确的方向。螺钉头部是圆的,因此它在矫正过程期间下沉到足跟骨骼中,并且足跟骨骼(跟骨)轴的矫正效果随时间而变得更小。
Casteman螺钉也是顺行地放置在距骨中。定位,即螺钉的精确放置是成问题的(没有螺钉导向),这与普通的多孔螺钉相同。作者提到其在5-7%的患者中发生过早松动。螺钉的颈状部分是圆锥形的并比螺纹部分窄,因此没有自紧的效果,所以骨骼组织(bone mass)可以生长到其中,这在移除螺钉时可能会引起问题。
再吸收Giannini螺钉,其被放置在凹处中,即足跟骨骼和距骨之间的缝隙中,这样,其在放置一年后经常会断裂并慢慢分解,所以矫正质量成为问题(其不能足够长期地将足部支撑在矫正位置),并且我们并不充分了解关于再吸收的材料的影响。一些作者指出,再吸收Giannini螺钉会过早地松动并会过早地脱离定位位置,因此他们不推荐这样的螺钉。
逆行Nogarin螺钉,其被逆行地放置在足跟骨骼(跟骨)中,还通过很大程度地打开手术区域而被实施。作者指出,5%的患者中螺钉会松动,且6%的患者中螺钉会穿透进入距骨。这种螺钉没有头部,但有颈状部分,该颈状部分比螺纹部分窄,因此不能实现自紧,所以其会较容易地穿透距骨。
4.发明实质
本发明的螺钉(植入物)能在手术后(即刻)实现完全矫正。仅需要做出进入皮肤8mm的切口(等于植入物的直径)。螺钉被引导穿过切口,而其他组织仅被简单地推向一边而并不切割(例如韧带),因此螺钉可以被定位在它的临时位置(足部骨骼)中。再也不必手术打开30-50mm的区域,即不必再伤害周围组织。因为它的中空形状,本发明的植入物易于在用荧光显影(fluorograph)检查它时利用克氏导线来穿过皮肤中的小开口(3维显示)而被正确地放置,如果需要尝试几次来正确地定位螺钉(植入物)的话,这不会伤害软骨也不会伤害距骨。
螺钉的尖端具有减少骨骼组织损伤的顶点螺纹。其允许植入物更容易的穿过和更容易地定位在骨骼中。
被植入的螺钉体是较大的,因此其更能抵抗横向断裂。如果植入的螺钉过一定时间之后确实断裂了,因为它的中空形状,螺钉也能更容易被移除。边缘较宽的且以45°±25%的角度倾斜的螺纹类型减少了螺钉松动,更大地接触多孔骨骼的表面,因此,具有螺钉对横向力的更大的稳定性。
螺钉头部的形状是圆锥形。多孔螺纹延伸进入圆锥形头部,其对于螺钉头部的顶部是光滑的。这使得走路时跟骨相对于距骨能自由移动,即跟骨不卡在螺钉头部处,而是其逐步引导骨骼的正确运动,即位置。不具有细的颈状部分的螺钉(带有细的颈状部分的螺钉被证明在5-10%的患者中会断裂)是更坚固的。引向螺纹的圆锥形头部使自紧进入多孔骨骼成为可能并阻止螺钉的过早松动。
圆锥形头部不允许螺纹生长到皮质(强壮)骨中,所以当需要移除植入物/螺钉时是不存在问题的。圆锥形头部允许足跟骨骼上的永久压力(矫正期间),而不(像其他螺钉那样)卡在骨骼组织上,因此植入物不会在足跟骨骼上留下印记,即,其不穿透进入到骨骼中。这种螺钉在整个矫正期间,即三年期间都具有相同的效果。螺钉由更坚硬的钛合金制成,因此其阻止螺钉在插入骨骼的区域中断裂。如果出现另一种疾病而需要MR(磁共振)检查的话,这种螺钉允许做这种MR检查。
5.附图简介
图1显示了将螺钉放置到距骨中的过程。显示了螺钉被插入到哪个骨骼中,螺钉是在哪个角度下使用克氏导线和中空套筒(imbus)来放置的。
图2显示了螺钉自身的技术数据。存在螺钉的圆锥形头部以及螺钉的螺纹,在尖端上具有顶点螺纹。整个螺钉都是中空的,所以可以较容易地引导它。
图3显示了螺钉和工具(克氏导线和套筒),这些工具用于将螺钉放置到足部骨骼中时的手术过程。
图4以螺钉的前视图和后视图显示了螺钉。
6.本发明实施方式的详细描述
从前面的图片来看,螺钉的放置和插入的过程以及用于放置螺钉的工具都是很清楚的。螺钉用于积极治疗年龄8-12岁儿童的痛苦的可矫正扁平足(第3-4阶段),而不会产生神经系统麻痹。
螺钉在患者经受通常的气管内麻醉时插入,在局部麻醉下移除。在手术前的足部清理之后,在皮肤上做出8mm的手术切口。使用小的手术剪刀将纤维组织带(筋膜)和韧带纵向地移到旁边。螺钉(植入物)的插入位置和进入距骨的方向取决于所使用的钻和直径1.8mm的克氏导线,其定位由荧光显影来控制,荧光显影首先确定导线的插入位置和方向,之后螺钉以身体的正中矢状面(sagittal centerline plane)上的35°和额状面(frontal plane)上的45°顺行进入距骨。螺钉长度取决于其他导线,其与第一导线的长度相同;之后使用4.5mm厚的中空钻,在皮质骨中做出开口,接着将螺钉放置在导线上并因此使用中空套筒扳手(imbus spanner)钻入距骨。
检查足踝的活动性并矫正足跟骨骼轴,也矫正足部的纵弓。此后,钻出克氏导线。重新定位韧带,并通过缝合来分别闭合纤维组织带(筋膜)和皮肤。
手术过程之后两天,患者可以起床走动而不使用任何固定物。
螺钉保持植入在足部中直到30个月,这取决于患者首次插入植入物时的年龄。
如人们希望的,使用局部麻醉来移除螺钉。同时,患者可以从事运动而没有任何障碍。
由钛合金制成的螺钉有4种长度,其根据需要,即足部骨骼的尺寸而被放置,因此推荐长度L(图2):
25mm±25%,推荐25mm±10%,并尤其推荐25mm;
30mm±25%,推荐30mm±10%,并尤其推荐30mm;
35mm±25%,推荐35mm±10%,并尤其推荐35mm;
40mm±25%,推荐40mm±10%,并尤其推荐40mm。
随着螺钉长度L的变化,螺钉头部长度H相应地改变(图2):
10mm±25%,推荐10mm±10%,并尤其推荐10mm;
12mm±25%,推荐12mm±10%,并尤其推荐12mm;
14mm±25%,推荐14mm±10%,并尤其推荐14mm;
16mm±25%,推荐16mm±10%,并尤其推荐16mm。
与长度L无关,形成植入物(螺钉)中空的孔道(图2)直径C=2mm±25%,推荐2mm±10%,并尤其推荐2mm。
螺杆直径D(图2)是4.8mm±25%,推荐4.8mm±10%,并尤其推荐4.8mm。
螺纹外径E是7.1mm±25%,推荐7.1mm±10%,并尤其推荐7.1mm。
带有螺纹的螺钉部分直接延伸进入所述头部和螺纹之间的圆锥形头部(没有窄的颈状部分)。
圆锥形头部的最大直径A(图2)是8mm±25%,推荐8mm±10%,并尤其推荐8mm。
头部的圆锥形形状允许自紧到插入螺钉的骨骼中,当螺钉被插入时,这给予螺钉稳定性。因此,螺钉的松动和断裂是最小限度的。
头部之间的、引向杆的圆锥形部分允许在螺钉的较大表面上逆行骨骼,即在螺钉压力点上没有足跟骨骼的骨骼结构的骨质溶解(osteolysis)(因为压力被减少了),所以矫正是永久性的,并且在螺钉的植入期间具有相同的效果。
已经证明,具有螺钉头部和杆之间的台阶状(step-like)部分的螺钉会卡在足跟骨骼的边缘处并因此限制会移动。
本发明的螺钉从其被放置在那儿的时刻起就不限制移动。螺钉头部(图2)中用于套筒扳手的六边形孔的凹口是B=4.5mm,制成4.5mm±25%,推荐4.5mm±10%,尤其推荐4.5mm。
螺纹具有通常的2.7mm的上升以用于多孔骨骼(spongious bone)(图2)。其边缘被增厚(图2)。螺纹边缘终止于角度Q=45°±25%,推荐45°±10%,并尤其推荐45°。这个角度允许螺纹边缘以更大的表面靠在多孔骨骼上,即在螺钉的相同直径处,实现了骨骼和植入物(螺钉)之间的更大的接触表面,其允许对于横向力的更大的稳定性,且因此具有更少松动的可能性。在螺钉的终止于90°角度的尖端上,在顶点螺纹上,有120°角度的三等分切口(trisect cut)。顶点螺纹边缘以55°角度切割。在螺钉尖端的最顶部处,顶点螺纹的三等分切口伸进孔道内螺纹的1.5mm的长度。
本发明的植入物(螺钉)的特征在于,简单的、最低限度地侵害的放置方式。直径1.8mm的克氏导线的使用确定了螺钉方向和螺钉长度(正中矢状面上的35°和额状面上的45°顺行)。之后,用套筒扳手将螺钉插入到距骨中。在顶点螺纹上有三等分切口,这自动地排除了攻丝设备(tapping device)的使用。因为没有头部和螺纹之间的窄的部分(颈状部分),所以皮质骨不会阻止螺钉。这使得三年矫正之后的螺钉的移除更容易和更简单。
7.发明益处
所发明的植入物-螺钉使手术过程更简单,并且使对于身体和周围组织的损害最小。术后期间被尽可能的缩短。足部矫正是完全且永久的。
当与公知方法和螺钉(植入物)比较时,例如由于螺钉的不正确定位、松动和/或断裂而引起的复杂性最小。其允许有更高百分比的令人满意的术后结果。
因为手术区域减少了,所以术后感染的可能性也更小。当螺钉被植入时,如果患者需要MR检查,那么患者也可以通过MR来检查,因为螺钉是由钛合金制成的。而对于其他合金而言,这种检查是被禁止的。
Claims (25)
1.用于矫正儿童扁平足的中空钛螺钉,其特征在于:
a)杆的直径是D=4.8mm±25%;
b)所述螺钉是中空的,所述中空的直径是C=2mm±25%;
c)螺纹高度是1.15mm±25%;
d)在所述螺钉的终止于90°角度的尖端上,在顶点螺纹上是120°角度的三等分切口;所述顶点螺纹的边缘以55°角度切割;在所述螺钉的所述尖端的最顶部处,所述顶点螺纹的所述三等分切口沿所述螺钉的长度方向伸进孔道内1.5mm。
2.根据权利要求1所述的螺钉,其特征在于:
a)所述螺纹是2.75mm的上升以用于多孔骨骼,其边缘被增厚;
b)螺纹边缘终止于角度Q=45°±25%,所述螺纹以更大的表面靠在多孔骨骼上,即,在所述螺钉的相同直径处,实现了骨骼和所述螺钉之间的较大的接触表面,其允许对于横向力的更好的稳定性,因此具有更少松动的可能性。
3.根据权利要求2所述的螺钉,其特征在于:
a)所述螺纹的外径E是7.1mm±25%;
b)所述螺钉的带有所述螺纹的部分直接延伸进入光滑的圆锥形头部,没有窄的颈状部分;
c)所述螺钉的所述圆锥形头部的最大直径A是8mm±25%;
d)所述头部中的六边形凹口,其用于带有尺寸B=4.5mm的套筒扳手,凹口尺寸F=4.5mm±25%。
4.根据权利要求3所述的螺钉,其特征在于:
a)所述螺钉的长度L和所述螺钉的所述圆锥形头部的长度H选自以下组合:
L=25mm±25%,H=10mm±25%;
L=30mm±25%,H=12mm±25%;
L=35mm±25%,H=14mm±25%;
L=40mm±25%,H=16mm±25%;
b)所述螺钉由钛合金制成。
5.根据权利要求4所述的螺钉,其特征在于:
a)不带有窄的部分的所述螺纹延伸进入被加宽的所述圆锥形头部中;
b)所述头部的圆锥形形状允许自紧到其中插入所述螺钉的骨骼中,其使所述螺钉的定位更稳定,因此使所述螺钉的断裂和松动最小化。
6.根据权利要求5所述的螺钉,其特征在于:所述头部是圆锥形形状而不是台阶状,所以所述头部和所述螺纹之间的部分允许所述螺钉在所述螺钉的更大表面上逆行足部骨骼,即因为压力被减少了,在所述螺钉的压力点没有足跟骨骼结构的骨质溶解,所以所述矫正是永久的,并且在所述螺钉的植入期间具有同样的效果。
7.根据权利要求6所述的螺钉,其特征在于:即在所述螺钉的所述头部和所述螺纹之间没有可能卡在足跟骨骼边缘处的台阶状部分,且因此从放置所述螺钉的时刻起,活动就是完全自由的/不受限制的。
8.根据权利要求7所述的螺钉,其特征在于:
所述螺钉的放置过程,因为所述螺钉的中空杆,所以所述放置过程是非常简单的、最低限度地侵害身体的,其是通过使用直径1.8mm的克氏导线引导所述螺钉来插入身体的,方式为正中矢状面上的35°和额状面上的45°顺行,而且上述克氏导线的使用还决定了所述螺钉的必要长度;之后通过所述套筒扳手将所述螺钉插入距骨;具有所述三等分切口的所述顶点螺纹排除了攻丝设备的使用。
9.根据权利要求8所述的螺钉,其特征在于:所述螺钉不具有所述头部和所述螺纹之间的窄的部分,所以皮质骨不会长到所述螺钉上,使得3年后的所述螺钉的移除更加容易和更加简单。
10.根据权利要求1所述的螺钉,其特征在于:
所述杆的直径是D=4.8mm±10%。
11.根据权利要求1所述的螺钉,其特征在于:
所述杆的直径是D=4.8mm。
12.根据权利要求1所述的螺钉,其特征在于:
所述中空的直径是C=2mm±10%。
13.根据权利要求1所述的螺钉,其特征在于:
所述中空的直径是C=2mm。
14.根据权利要求1所述的螺钉,其特征在于:
所述螺纹高度是1.15mm±10%。
15.根据权利要求1所述的螺钉,其特征在于:
所述螺纹高度是1.15mm。
16.根据权利要求2所述的螺钉,其特征在于:
所述螺纹边缘终止于角度Q=45°±10%。
17.根据权利要求2所述的螺钉,其特征在于:
所述螺纹边缘终止于角度Q=45°。
18.根据权利要求3所述的螺钉,其特征在于:
所述螺纹的外径E是7.1mm±10%。
19.根据权利要求3所述的螺钉,其特征在于:
所述螺纹的外径E是7.1mm。
20.根据权利要求3所述的螺钉,其特征在于:
所述螺钉的所述圆锥形头部的最大直径A是8mm±10%。
21.根据权利要求3所述的螺钉,其特征在于:
所述螺钉的所述圆锥形头部的最大直径A是8mm。
22.根据权利要求3所述的螺钉,其特征在于:
所述凹口尺寸F=4.5mm±10%。
23.根据权利要求3所述的螺钉,其特征在于:
所述凹口尺寸F=4.5mm。
24.根据权利要求4所述的螺钉,其特征在于:
所述螺钉的长度L和所述螺钉的所述圆锥形头部的长度H选自以下组合:
L=25mm±10%,H=10mm±10%;
L=30mm±10%,H=12mm±10%;
L=35mm±10%,H=14mm±10%;
L=40mm±10%,H=16mm±10%。
25.根据权利要求4所述的螺钉,其特征在于:
所述螺钉的长度L和所述螺钉的所述圆锥形头部的长度H选自以下组合:
L=25mm,H=10mm;
L=30mm,H=12mm;
L=35mm,H=14mm;
L=40mm,H=16mm。
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-
2006
- 2006-03-20 CN CN2006800104803A patent/CN101150996B/zh not_active Expired - Fee Related
- 2006-03-20 EP EP06727213A patent/EP1885269B1/en active Active
- 2006-03-20 WO PCT/HR2006/000005 patent/WO2006103481A2/en not_active Application Discontinuation
- 2006-03-20 AT AT06727213T patent/ATE537771T1/de active
- 2006-03-20 US US11/887,258 patent/US8267977B2/en not_active Expired - Fee Related
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GB2355505A (en) * | 1998-12-18 | 2001-04-25 | Acumed Inc | Axial tension screw having an unthreaded intermediate section |
Also Published As
Publication number | Publication date |
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ATE537771T1 (de) | 2012-01-15 |
CN101150996A (zh) | 2008-03-26 |
US8267977B2 (en) | 2012-09-18 |
EP1885269B1 (en) | 2011-12-21 |
HRP20050295A9 (hr) | 2010-09-30 |
EP1885269A2 (en) | 2008-02-13 |
WO2006103481A2 (en) | 2006-10-05 |
HRP20050295B1 (en) | 2010-11-30 |
US20090082818A1 (en) | 2009-03-26 |
HRP20050295A2 (en) | 2007-02-28 |
WO2006103481A3 (en) | 2006-11-16 |
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