CN1120926A - 股骨假体 - Google Patents

股骨假体 Download PDF

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CN1120926A
CN1120926A CN95109962A CN95109962A CN1120926A CN 1120926 A CN1120926 A CN 1120926A CN 95109962 A CN95109962 A CN 95109962A CN 95109962 A CN95109962 A CN 95109962A CN 1120926 A CN1120926 A CN 1120926A
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prosthese
resilient sleeve
bone
femoral prosthesis
bar
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尼斯·伯索德
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Merck Patent GmbH
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Merck Patent GmbH
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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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Abstract

本发明涉及粘接移植用的股骨假体，假体杆(2)上有一个从基部伸向末端的纵向钻孔，以便让骨粘固剂贯穿假体，假体杆(2)套着一种由具有生物相容性的聚合材料制成的弹性套(4)，在施加粘固剂时，从末端向基部往套中注入粘固剂，当杆(2)和骨床(6)之间的空隙(5)被完全充满后，骨床(6)受到挤压。

Description

股骨假体
本发明涉及用于修复髋关节的内用假体，更确切地讲，涉及植入股骨中的假体，下文简称为股骨假体。
一般说来，假体植入股骨有两种技术：一种是将假体用粘固办法移植在事先处理好的股骨某一部位，在这种情况下，是将假体杆用骨粘固剂固定在骨床上。另一种是把作好的股骨假体部分用非粘固技术来移植，这就是用假体杆和骨床之间的摩擦来达到固定的效果。
本发明是涉及采用粘固办法植入的股骨假体，其在外科技术、移植效果和假体使用寿命方面有相当大的改进。
尽管现在在优化假肢设计、外科技术和粘固技术等方面已具有较高水平，但移植效果还是受到诸多因素的影响，特别是受操作者技术水平高低的影响。粘接过程中值得重视的难点在于将假体和人体骨骼恰当地对齐、固定和在这种情况下选择合适的粘固剂。
当使用市售的高粘性粘固剂时，将假体插入，定心、固定在预先准备好的要涂上粘固剂的骨床上，这样就会进行得比较顺利和可靠。硬化完成后，假体就几乎不能再改变其位置了。不过，同质而又无气孔的高粘性骨粘固剂的调制非常困难，而且，比如用骨粘固压力器或骨粘固剂枪涂这种粘固剂时也需要很大力量。因为涂的过程中骨粘固剂流动性低，几乎不可能在骨床和假体表面之间形成连续、均匀的涂层。但是，为使粘接牢固、永久，从而使假体有较长的使用寿命，把高粘性粘固剂均匀涂在滑床和假体表面之间是非常必要的。
使用同样是市售的低粘性粘固剂形成连续均匀的涂层会比较容易，但是，这样一来，假体定位和固定却很困难。所以，一般必须采用另外的措施来固定假体的配合面。
使用低粘性粘固剂进行粘接，要对正位置，将假体插入骨床，并用定心设备进一步调整好位置，然后再将骨床中剩余的空隙注满粘固剂。注入粘固剂的办法是用粘固剂枪注入或/和借助真空装置吸入。粘接是在假体植入并固定后，使用这种粘固技术中另外的特定装置将骨粘固剂贯穿假体完成的。适用这种方法的股骨假体是在假体杆上有一个从基部伸向末端的纵向钻孔，通过钻孔将骨粘固剂从末端到基部注入骨床。这种技术的一个实例公开于EP0434604A1。这种技术也有不足，影响手术的成功和假体的使用寿命。举例来说，它不能排除假体表面被血、渗出物或/和冲洗液等污染，或在硬化过程中血流进粘固剂涂层。这样会大大减弱假体、粘固剂、骨床之间的粘接牢固程度，以至于移植好的假体过早松动或折断。
本发明的目的就是设计一种股骨假体，它适用于粘固剂贯穿假体这种方法，但又不会发生假体表面和所用粘固剂的涂层被血、伤口渗出物和冲洗液污染的情况。
按照本发明，上述目的是通过在股骨假体杆上套上一种具有生物相容性(biocompatible)的聚合材料制成的弹性套来实现的。
本发明涉及用粘接方法移植的股骨假体，假体杆上有一个从基部伸向末端的纵向钻孔，以便让骨粘固剂能贯穿假体。假体杆周围套上一种具有生物相容性的弹性套，在粘接过程中，弹性套渐渐地从末端到基部被注满骨粘固剂，当假体杆和骨床之间的空隙被完全充满后，就挤压骨床。
借助下图举例详细说明本发明。
图1分三个连续的阶段(a)(b)(c)来说明本发明的股骨假体粘接过程。
在阶段(a)，股骨假体1已经插入除去髁状突、刮掉海绵体的处理好的股骨中。假体杆2上有一个从基部伸向末端的纵向钻孔3。假体杆2紧紧地被弹性套4包着，弹性套4由具有生物相容性(bio-compatible)的聚合材料制成。杆2和骨床6之间剩余空隙5用来灌注骨粘固剂。在基部有一个垫片7，7a是用来定位和固假体的。在假体杆的末端下面，为防止骨粘固剂渗透到髓腔中，安置了一个髓腔堵块8。
在阶段(b)，骨粘固剂枪(图中未表示)的排出孔9放在假体杆2的纵向钻孔3的基部孔10上。骨粘固剂11，11a已经注满纵向钻孔3，并从末端孔流出，开始从末端向基部推进(13)，灌注在杆2和骨床6之间的空隙5，弹性套4挤压骨床6。
在阶段(c)，杆2和骨床6之间的空隙5完全被骨粘固剂11b填满，弹性套4全面受压，挤压骨床6。
挤压程度可由加在粘固剂上的压力控制。运用这种压力，既可以使粘固剂更加紧密，进一步提高其机械性能，加固假体和粘固剂涂层之间的粘接，特别是对于粗糙的或经过表面成型(Surface—Pro-filecl)处理的假体。
为使粘接以最佳方式完成，在整个移植过程中，将假体/粘固剂的接触区同污染物分开尤为重要。
当粘固剂硬化时，粘接过程就全部完成。
本发明可用另外的实施例加以改进。举例来说，用已经或将要安装在假体基部区域的垫片7来将弹性套固定在上述区域。这些垫片是用来在基部定心，对准和固定假体的。它们可以是单独的成形件，也可以是和假体本身结合在一起的凸形物、圆缘或完整的环形。相应的实施例在有关的现有技术中是公知的。
此外，在末端将弹性套4和髓腔堵块8连接起来也很便利。这种情况下可以将髓腔堵块和假体在一个步骤中插入股骨。
当然，也可以在髓腔堵块上适当地装备假体定心装置，或者可以设计成通过髓腔堵块使假体末端在插入时即将其固定到位。髓腔堵块以及假体杆末端的相应实施例在有关的现有技术中是公知的。
在另一种实施例中，弹性套上有孔，这些孔在往套中注入骨粘固剂时扩大，以便让粘固剂接触到骨床。其优点在于，在这些孔的点上，骨质和粘固剂形成特别密切的接触，这就使得骨床、粘固剂和假体之间的粘接更加牢固。
适宜制作假体杆上套着的弹性套的材料，总的说来，只要是能压成薄片的所有具有生物相容性的聚合材料都行。大多数的传统的合成聚合材料和很多天然高分子材料都具备这种特性。可以提到的人工合成材料有：烯烃、氟化物、乙烯基和丙烯酸聚合物、聚酯、聚酰胺和聚胺酯。特别值得推荐的天然聚合材料是那些能被生物吸收的聚合物，也就是说它们能被人体分解，变成内生物质。这适用于基于聚交酯和聚乙交酯的材料和基于多肽多糖的生物聚合物，如骨胶原、几丁质和壳聚糖。
这些聚合材料的准备以及将其加工成薄片和薄片产品的技术都是公知的。本发明中，这些材料很方便地被处理成薄片泡或长统袜形状，以适应特定的假体杆并能紧紧地套在假体杆上。
本发明的另一个优点是可以往制套的材料中加入能加快治愈过程的添加剂。这种添加剂可以是骨吸收和/或具有骨导性的添加剂，比如钙化物中的氧化钙、碳化钙和磷酸钙特别是羟磷灰石和磷酸三钙。这些物质可能促进骨的生长，特别是能促进骨床矿化，这有利于假体移植能稳定下来。特别是把抗生素和/或骨生长素等药剂灌注在套中更加有效。比如灌入抗生素中的庆大霉素、氯洁霉素和肽生长素中的FGF与BMP系列。
这样做最突出的优点是药剂能准确地用到最需要的地方，并在与骨床接触处发生功效。和传统的用带药剂的骨粘固剂粘接技术比起来，将药剂准确地用到合适的部位可以减少药剂的散失。
本发明特别推荐的实施例是设计一个移植用具包。一套这种移植用具包组成如下：
粘接用的股骨假体，假体杆上有一个从基部到末端的纵向钻孔，使骨粘固剂能贯穿假体，由具有生物相容性的聚合物制成的弹性套，套和假体杆的形状、尺寸相适应；用具包里准备好可以使用的骨粘固剂。
在另一个实施例中，带有假体定心设备的髓腔堵块可以粘在本移植用具包中的套的末端。
上述实施例提供能够实际操作和移植手术所需的器材。

Claims (9)

1.用于粘接移植的股骨假体(1)，它的杆(2)上有一个从基部伸向末端的纵向钻孔，以便让骨粘固剂贯穿假体，其特征在于：假体杆(2)被具有生物相容性的聚合材料制成的弹性套套住，在施加粘接剂时，弹性套从末端向基部被灌注骨粘固剂，当杆(2)和骨床(6)之间的空隙(5)被完全充满后，骨床(6)受到挤压。
2.如权利要求1所述的股骨假体，其特征在于，在假体基部，弹性套被固定在用来使假体定心和对准的垫片(7)上。
3.如权利要求1或2所述的股骨假体，其特征在于，在假体末端，弹性套固定在髓腔堵块(8)上。
4.如权利要求1到3所述的股骨假体，其特征在于，弹性套上有孔，当往套中注入骨粘固剂时，这些孔变大，让骨粘固剂接触到骨床。
5.如权利要求1到4所述的股骨假体，其特征在于，弹性套由一种具有生物相容性的聚合材料制成。
6.如权利要求1到5所述的股骨假体，其特征在于，弹性套由含骨吸收和/或具有骨导性添加剂的聚合材料制成。
7.如权利要求1到6所述的股骨假体，其特征在于，弹性套中灌注了含有抗生素和/或促进骨生长的药剂。
8.移植用具包，它包括：
(a)用于粘接移植的股骨假体，在假体杆上有一个从基部伸向末端的纵向钻孔，以便让骨粘固剂贯穿假体，
(b)弹性套，它由一种弹性的，具有生物相容性的聚合材料制成，它的形状和尺寸与假体杆相适应，并将其套在杆的适当位置，
(c)调制好的或待用的骨粘固剂。
9.如权利要求8所述的移植用具包，其特征在于，在适当部位带有假体定心设备的髓腔堵块附在弹性套的末端。
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