CN101132741B - 用于骨植入物的骨水泥强化的装置 - Google Patents

用于骨植入物的骨水泥强化的装置 Download PDF

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Publication number
CN101132741B
CN101132741B CN2005800488762A CN200580048876A CN101132741B CN 101132741 B CN101132741 B CN 101132741B CN 2005800488762 A CN2005800488762 A CN 2005800488762A CN 200580048876 A CN200580048876 A CN 200580048876A CN 101132741 B CN101132741 B CN 101132741B
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China
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hollow cylinder
bone
perforation
bone cement
rear end
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Expired - Fee Related
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CN2005800488762A
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CN101132741A (zh
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R·弗里格
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AO Technology AG
Synthes GmbH
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Synthes AG Chur
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Abstract

用于骨水泥强化的装置。它包括A)具有纵向轴线(2)的空心圆筒(1)，所述空心圆筒(1)适合于接纳未硬化的骨水泥(20)，并且还包括适合于***骨(30)中的前端(3)、后端(4)和带有至少一个穿孔(6)的壳体(5)；以及B)可从空心圆筒(1)的后端(4)***空心圆筒中的骨植入物(10)。

Description

用于骨植入物的骨水泥强化的装置
技术领域
本发明涉及用于骨植入物的骨水泥强化的装置。
背景技术
骨水泥强化在骨外科手术中已知好几年了。这种强化应用在骨质疏松的骨中，其中骨固定装置例如螺钉、销、钉等等不能牢固地固定。
依照现有技术，骨水泥注入到骨中，适合于作为用于随后***植入物的固定基体。就骨水泥而言，每种骨填充材料已知的是可通过聚合物、液压或依照其它的反应机理来硬化的。它们必须在骨水泥硬化之前注入，以致于骨水泥可以附加在植入物上。这种现有技术的缺陷在于，施加骨水泥很复杂，并且确定植入物在骨水泥复合物内的正确位置很复杂。
为了解决这些问题，已经发展了特殊的植入物，其允许当放置植入物时施加骨水泥。此外，已经使用植入物和特别的螺钉，其包括插管，骨水泥可以通过该插管填充到骨中。这种技术需要高粘度的骨水泥，其可通过相对小的插管注入。而且，骨水泥在骨中的量值和位置不能充分控制。具有较低粘度的骨水泥相对于不能再吸收的并且在高温下硬化的骨水泥而言具有显著的生物学优点，但不适合与这些适合的植入物结合使用。
例如TRONZO的DE-A-3 508 759公开的髋骨螺钉(hip screw)，其设置有中心通孔，该通孔在开式螺钉尖端开口，并且在螺纹壁之间具有侧面开口。通过这样的髋骨螺钉，一方面实现了在骨中的特大尺寸和尖头螺纹的固定，另一方面使弱化的骨材料增强，后者是通过由上述中心孔注入骨水泥和通过侧面的开口流出骨水泥而实现。事实上，上述技术的主要缺点是，普通的骨植入物不可以使用，而必须采用专门制造的、昂贵的且复杂的植入物(髋骨螺钉)。
发明内容
因此，本发明打算提供补救措施。本发明基于这样的目的，即提供一种装置，依靠该装置可以简化现有的和/或新颖的骨固定装置(或其他骨植入物)的骨水泥强化。
本发明依靠用于骨植入物的骨水泥强化的装置来解决提出的问题。本发明提供了用于骨水泥强化的装置，该装置具有：适合于接纳未硬化骨水泥的空心圆筒，所述空心圆筒具有纵向轴线、适合于***骨中的前端、后端和带有至少一个穿孔的壳体，其中，空心圆筒的后端构造成带有内螺纹的钻孔；带有外螺纹的接骨螺钉，该接骨螺钉可从空心圆筒的后端***空心圆筒中，所述外螺纹与空心圆筒的内螺纹配合；和所述空心圆筒具有总长度L，并且穿孔到前端的距离最大值为L/2。
依照本发明的装置把特殊的强化与待增强的植入物分开，由此内部操作的处理简化了，同时增加了治疗技术的安全性。
在本发明的情况中，预先填充骨水泥的穿孔的空心圆筒被***到骨中。取决于实际情况，在骨中必须准备好用于空心圆筒的座。这可以通过钻孔和/或铰孔实施。一旦空心圆筒就座，与所述空心圆筒对应的骨固定部件(例如接骨螺钉、板片、螺旋板片、骨钉)***空心圆筒，从而通过空心圆筒中的穿孔而把骨水泥排出到周围的骨中。流出骨水泥的数量等于固定装置的体积。根据空心圆筒中穿孔的位置和数量，可以在期望的部位进行强化。由于用于植入物的强化装置的分离，骨水泥强化可以通过使用普通的商品化植入物实施。
骨水泥的施加不是象已知的强化那样很复杂地在骨中实施，而是以可控制的方式在手术台上施加到空心圆筒中。一旦实施了填充，所述空心圆筒可以***到预先准备好的在骨中的座中。
基本上，空心圆筒可以在任何位置施加，只要在该位置对普通固定装置来说骨材料不能给出足够的刚性，例如靠近骨关节、脊椎骨、颌骨、骨盆等等的部位。
本发明具有多方面的优点：
-在体外施加骨水泥
i)骨水泥的操作简单
ii)填充步骤是可控制的和可定剂量的
iii)在骨水泥中不夹杂血液、体液和组织
-通过穿孔的方向、位置、数目和尺寸，骨水泥被导入到解剖学上的预定位置；
-排出空心圆筒的骨水泥数量可通过骨固定部件的体积控制；和
-避免了由于不可控制的阻力下降(在治疗区域自发的骨折)导致的大量骨水泥不受控制地在骨折部位损失的风险，因为骨水泥排出量通过植入物的***控制，而不是通过施加抵抗骨阻力的压力控制。
在本发明的优选的实施例中，空心圆筒至少部分地填充尚末硬化的骨水泥。
在更进一步的实施例中，空心圆筒和骨固定部件是互相配合的，以便在骨固定部件***空心圆筒中时，尚末硬化的骨水泥通过空心圆筒壳体中的至少一个穿孔流出。
在更进一步的实施例中，空心圆筒在其前端封闭。这样的优点是，骨水泥仅在最合适的侧向流出，因为在空心圆筒前面硬化的骨水泥团可能是不利的，因为在植入物进一步拧入时，骨水泥团会刺入位于它前面的皮层。例如在TRONZO的例子中，在骨水泥硬化之后，骨固定部件不能在轴向朝前拧动，因为通过开口尖端流出的且已硬化的骨水泥，不允许这样。在前端封闭的空心圆筒的另外优点是通过将它在靠近骨关节处应用的例子中实现的。
在更进一步的实施例中，空心圆筒的后端构造成用于与骨水泥注射器连接的接头。特别的是，空心圆筒的后端可以是***式连接，以用于与骨水泥注射器连接的转接器。这种不渗透的连接一方面防止了压力损失，另一方面防止了骨水泥在空心圆筒后端的不希望的流出。
在更进一步的实施例中，空心圆筒的后端构造为具有内螺纹的钻孔。特别的是，骨固定部件可以构造为具有与空心圆筒的内螺纹配合的外螺纹的接骨螺钉。
在更进一步的实施例中，空心圆筒的后端设置有具有骨植入物横截面的孔隙，例如用于板片的螺纹或槽的形式。
在更进一步的实施例中，空心圆筒具有的总长度为L，穿孔到前端的距离最大值是L/2，优选为L/3。骨水泥仅仅在可以提供最大优点的空心圆筒前部流出。骨水泥在后部的流出在临床上是非常不利的。
在更进一步的实施例中，空心圆筒的后端配置为具有多边形横截面的腔或TORX腔，以允许接纳相应的多边形或TORX螺丝刀。
穿孔的直径一般介于0.9毫米到3.3毫米之间，优选的是1.5-2.5毫米。穿孔的数量一般至少是20，优选的是至少40。穿孔的最大数量一般最多为100，优选的是最多为60。优选的是，D/F的比值，即单位为毫米的空心圆筒的外径D和单位为平方毫米的穿孔的总出流面积F的比值的范围是0.19至0.36mm-1。空心圆筒的壁厚(外径D减去内径d)优选的是0.1至2.0毫米。穿孔具有栅极网孔的形式
就材料而言，普通的植入物材料如钢或钛是适合的，但是也可以使用合成物例如PEEK或可再吸收的或非可再吸收的聚合物。空心圆筒可以由网、编织物或完全地或部分地穿孔管构成。通过穿孔的位置、直径和数量，可以根据部位和数量来控制骨水泥的流出，并适应于使用的骨水泥。
根据需要，前端的表面可开启或关闭。关闭的实施例防止了骨水泥的面流出，这在一些应用(如靠近骨关节的应用)中是很重要的。
附图说明
接下来将参照几个实施例的局部示意图来对本发明及其附加的结构做更详细的解释。
其中显示的是：
图1是用于依照本发明所述装置的空心圆筒的透视图；
图2是依照图1的空心圆筒的透视图，以及用于将骨水泥压入空心圆筒中的骨水泥注射器的纵截面；
图3是依照图1的充满骨水泥的空心圆筒的透视图，其中***了接骨螺钉，所述接骨螺钉将一部分的骨水泥压入周围的骨。
图4是依照图1的空的空心圆筒的纵截面；
图5是依照图1的充满骨水泥的空心圆筒和骨水泥注射器的纵截面图。
图6是依照图1的充满骨水泥的空心圆筒和***在该空心圆筒中的接骨螺钉的纵截面图，所述接骨螺钉将一部分骨水泥压入周围的骨。
具体实施方式
图1所示的实施例基本上包括具有前端3、后端4和纵向轴线2的空心圆筒1。该空心圆筒1具有平行于纵向轴线2延伸的总长度L和垂直于纵向轴线2测量的外径D。空心圆筒1的腔9具有垂直于纵向轴线2测量的内径d。该空心圆筒1的腔9沿着总长度L被壳体5包围，其中壳体5局部具有穿孔6。所有穿孔6加起来形成的总出口面积F小于壳体5的表面积。
空心圆筒1的前端3可以开启或关闭，关闭的实施例是有利的，因为可以防止在空心圆筒1前面形成骨水泥团块。在空心圆筒1的后端4设置有通向腔9的钻孔7，它适合于作为骨水泥的进口。在更进一步的实施例中，钻孔7可以设置有内螺纹8(图3)。
图2显示的实施例包括具有空心圆筒1，空心圆筒1具有壳体5，壳体5上设置有穿孔6，空心圆筒1还具有前端3和后端4。钻孔7从前端3穿过空心圆筒1，该钻孔7适合于从骨水泥注射器40(纵截面)将骨水泥20注入到空心圆筒1的腔9中。
图3包括充满骨水泥20并具有闭合前端3的空心圆筒1。在后端4，钻孔7设置有在空心圆筒1中的内螺纹8。这里，骨植入物10设置为接骨螺钉形式的骨固定部件15。内螺纹8与骨固定部件15的外螺纹匹配，以便骨固定部件15能拧入空心圆筒1中。因为壳体5设置有穿孔6，所以借助于骨固定部件15，一部分骨水泥20通过穿孔6从空心圆筒1中径向挤出。
图4显示的实施例描绘了通过依照图1的空的空心圆筒1的纵截面，其中空心圆筒1的前端3是关闭的，并且在后端4上钻孔7设置有内螺纹8。空心圆筒1具有外径D和内径d。空心圆筒1的壳体5在从前端3起测量的一部分长度X上设置有穿孔6，X＜L。
图5显示了空心圆筒1的纵截面，该空心圆筒1充满骨水泥20并且具有闭合的前端3以及在后端4的钻孔7。此外，图5描绘了充满骨水泥20的骨水泥注射器40的纵截面。
图6描绘了充满骨水泥20的空心圆筒1的一个实施例的纵截面，所述空心圆筒1具有闭合的前端3和设有钻孔7的后端4。骨固定部件15***到位于后端4的钻孔7中，所述骨固定部件15设置有与钻孔7中的内螺纹8配合的外螺纹11。通过***骨固定部件15，骨水泥20通过穿孔6从空心圆筒1中被挤出到周围的骨30中。
下面，将对依照本发明用于骨固定部件的外科方法作简短的描述：
a)在骨中准备好空心圆筒的支座；这可以通过例如在骨上铰孔实施；
b)在根据长度和直径选择出的空心圆筒中充满骨水泥-在患者体外通过普通的方式实施；
c)为了避免骨水泥通过圆筒壳体的穿孔流出，举例来说，该空心圆筒可以***具有对应孔眼的插座；
d)将预充满的空心圆筒***到骨中；
e)将骨固定部件(例如接骨螺钉)通过空心圆筒的后端***到空心圆筒中。在整个过程中，骨水泥通过穿孔被挤入到围绕该空心圆筒的骨结构中；
f)当骨水泥硬化后，骨水泥生成了一个包括骨、空心圆筒和骨固定装置的组件。

Claims (13)

1.用于骨水泥强化的装置，该装置具有：
适合于接纳未硬化骨水泥(20)的空心圆筒(1)，所述空心圆筒(1)具有纵向轴线(2)、适合于***骨(30)中的前端(3)、后端(4)和带有至少一个穿孔(6)的壳体(5)，其中，空心圆筒(1)的后端(4)构造成带有内螺纹(8)的钻孔(7)；
带有外螺纹(11)的接骨螺钉(10)，该接骨螺钉可从空心圆筒(1)的后端(4)***空心圆筒(1)中，所述外螺纹(11)与空心圆筒(1)的内螺纹(8)配合；和
所述空心圆筒(1)具有总长度L，并且穿孔(6)到前端(3)的距离最大值为L/2。
2.根据权利要求1所述的装置，其中，空心圆筒(1)至少部分地填充尚未硬化的骨水泥(20)。
3.根据权利要求1或2所述的装置，其中，空心圆筒(1)和接骨螺钉(10)互相配合，以致于当接骨螺钉(10)***空心圆筒(1)时，尚未硬化的骨水泥(20)就穿过在空心圆筒(1)的壳体(5)中的至少一个穿孔(6)。
4.根据权利要求1或2所述的装置，其中，空心圆筒(1)在其前端(3)封闭。
5.根据权利要求1或2所述的装置，其中，空心圆筒(1)的后端(4)构造成用于与骨水泥注射器(40)连接的接头。
6.根据权利要求1或2所述的装置，其中，空心圆筒(1)的后端(4)设置有与接骨螺钉(10)的横截面相对应的开口。
7.根据权利要求1或2所述的装置，其中，空心圆筒(1)的后端(4)配置为多边形的腔或TORX腔，以接纳相应的多边形或TORX螺丝刀。
8.根据权利要求1或2所述的装置，其中，穿孔(6)的直径是0.9～3.3毫米。
9.根据权利要求1或2所述的装置，其中，穿孔(6)的数量至少是20。
10.根据权利要求1或2所述的装置，其中，穿孔(6)的数量最大是100。
11.根据权利要求1或2所述的装置，其中，D/F的比值，即单位为毫米的空心圆筒(1)的外径D和单位为平方毫米的穿孔(6)的总出口面积F的比值是0.19至0.36mm-1。
12.根据权利要求1或2所述的装置，其中，空心圆筒(1)的壁厚是0.1至2.0毫米。
13.根据权利要求1或2所述的装置，其中，穿孔(6)具有栅极网孔的形式。
CN2005800488762A 2005-03-24 2005-03-24 用于骨植入物的骨水泥强化的装置 Expired - Fee Related CN101132741B (zh)

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CA2602201A1 (en) 2006-09-28
TW200633676A (en) 2006-10-01
JP4709892B2 (ja) 2011-06-29
AU2005329715A1 (en) 2006-09-28
EP1861033B1 (en) 2012-06-13
CA2602201C (en) 2013-03-12
WO2006099751A1 (en) 2006-09-28
TWI428116B (zh) 2014-03-01
EP1861033A1 (en) 2007-12-05
US9326800B2 (en) 2016-05-03
CN101132741A (zh) 2008-02-27
BRPI0519961A2 (pt) 2009-04-07
JP2008532716A (ja) 2008-08-21
KR20070121638A (ko) 2007-12-27
US20080119945A1 (en) 2008-05-22
KR101239453B1 (ko) 2013-03-18

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