CN108670503A - 一种含有钛镍记忆合金倒刺的生物型股骨柄及其使用方法 - Google Patents
一种含有钛镍记忆合金倒刺的生物型股骨柄及其使用方法 Download PDFInfo
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Abstract
本发明的一种含有钛镍记忆合金倒刺的生物型股骨柄及其使用方法,包括股骨柄,所述股骨柄的一端设置有球头,所述股骨柄表面设置有钛镍记忆合金材质的倒刺,所述倒刺朝向远离球头的方向设置;当股骨柄插入到股骨髓腔中后,所述倒刺抵触股骨髓腔内壁。本发明能够提高股骨柄在髓腔中的初始固定强度,并提供假体对骨界面更有效和更大范围的力学刺激,从而提高假体‑骨界面远期骨长合(骨长上和骨长入)的能力。
Description
技术领域
本发明属于人工髋关节置换术领域,尤其涉及一种含有钛镍记忆合金倒刺的生物型股骨柄及其使用方法。
背景技术
人工全髋关节置换术是将包含臼杯、衬垫、球头和股骨柄的人工髋关节植入人体来替代病变的人体髋关节,从而提高病人的生活质量,临床应用比较广泛。
股骨柄植入有骨水泥型和生物型。骨水泥型股骨柄对于骨质要求较低。初期可获得稳定的锚固。弊端在于骨水泥植入偶尔会发生心率失常,心梗和严重低氧血症等一系列并发症。渗入骨折端的骨水泥可能会影响骨折愈合,并且翻修困难。
生物型股骨柄植入理念:股骨柄的生物固定是将股骨柄植入股骨的髓腔后,通过压配皮质骨与股骨柄间的松质骨,从而达到股骨柄与股骨紧密结合的初期稳定,以及预留的松质骨在一定的应力环境下进一步与股骨柄表面长合(骨长上与骨长入),或进入股骨柄表面图层三维立体交联空隙中达到生物交锁,实现股骨柄在股骨中的远期稳定固定的方式。
生物固定理念都必须考虑假体的初始稳定性和后期的骨-假体界面的骨长和(骨长上与骨长入),这就要求股骨柄在置入股骨髓腔后与骨界面有良好的力学压配与锁定,并持续给骨界面以应力刺激,目前采用的方法就是尽量选用与股骨髓腔形态相匹配的不同规格的假体来实现。但股骨的髓腔是不规则的空间形态,真正起固定作用的仅仅是髓腔峡部4-5厘米的部分,假体的近端和远端很难实现力学上要求的严密压配,容易出现应力遮挡而导致远期失败。
发明内容
本发明所要解决的技术问题是针对背景技术的不足提供了一种含有钛镍记忆合金倒刺的生物型股骨柄及其使用方法,其能够提高股骨柄在髓腔中的初始固定强度,并提供假体对骨界面更有效和更大范围的力学刺激,从而提高假体-骨界面远期骨长合(骨长上和骨长入)的能力。
本发明为解决上述技术问题采用以下技术方案:
一种含有钛镍记忆合金倒刺的生物型股骨柄,包括股骨柄,所述股骨柄的一端设置有球头,所述股骨柄表面设置有钛镍记忆合金材质的倒刺,所述倒刺朝向远离球头的方向设置;当股骨柄插入到股骨髓腔中后,所述倒刺抵触股骨髓腔内壁。
进一步的,所述股骨柄表面设置有容纳倒刺的容纳槽。
进一步的,相邻倒刺之间的距离为1—30mm。
进一步的,所述股骨柄由多空材料制成。
进一步的,所述倒刺和股骨柄的夹角为0—89度。
进一步的,所述倒刺的长度为0.2—10mm。
一种含有钛镍记忆合金倒刺的生物型股骨柄的使用方法,包括如下步骤:
步骤一,将股骨柄放入冰水中浸泡,钛镍合金材料在低温下便于塑性,然后将倒刺弯折使其进入容纳槽内并贴服在股骨柄表面;
步骤二,将塑性后的股骨柄插入到股骨髓腔中,并调整角度和插入深度;
步骤三,股骨柄在患者体温的影响下逐渐升温,升温后的倒刺回复到张开的形态,倒刺张开后抵触股骨髓腔的内壁,从而将股骨柄固定;
步骤四,股骨髓腔内的松质骨长入股骨柄表面的多空空隙中形成生物交锁,三维互锁与倒刺固定相辅相成,达到良好的固定。
本发明采用以上技术方案与现有技术相比,具有以下技术效果:
1、本发明能够提高股骨柄在髓腔中的初始固定强度,利用钛镍记忆合金倒刺在复温以后张开嵌入松质骨中,在原有的髓腔压配固定的基础上,在髓腔近端和远端更长的范围内增加了多点倒刺固定,增强股骨柄抗下沉和抗扭转的力学性能,可以实现患者早期负重功能锻炼的目的。
2、本发明能够提供假体对骨界面更有效和更大范围的力学刺激,从而提高假体-骨界面远期骨长合(骨长上和骨长入)的能力。利用钛镍记忆合金倒刺在复温以后张开嵌入松质骨中给骨壁以持续的应力刺激,能更好地实现假体-骨界面的力学诱导,使得股骨柄各个位置处的表面孔隙和松质骨能够均匀地长合,形成三维互锁,避免股骨近端和远端出现应力遮挡引起的继发性骨质疏松,延长假体的使用寿命。
3、本发明的假体表面在钛镍记忆合金倒刺之间的区域可以结合使用生物涂层技术,如选用人造HA作为涂覆层或磷酸三钙作为生物活性涂层,进一步增强假体-骨界面远期骨长合(骨长上和骨长入)的能力。
4、倒刺倾斜向下设置,便于术后翻修,在向上拔出股骨柄时,倒刺不会卡在髓腔中。
附图说明
图1为本实施例的整体结构示意图;
图2为图1中A处的放大图。
图中,1、股骨柄; 11、球头;12、倒刺;121、容纳槽。
具体实施方式
下面结合附图对本发明的技术方案做进一步的详细说明:
一种含有钛镍记忆合金倒刺的生物型股骨柄,如图1和2所示,包括股骨柄1,股骨柄1的一端设置有球头11,股骨柄1表面设置有钛镍记忆合金材质的倒刺12,股骨柄1表面设置有容纳倒刺的容纳槽121。倒刺12朝向远离球头11的方向设置;并且,当股骨柄插入到股骨髓腔中后,所述倒刺抵触股骨髓腔内壁。
倒刺12和股骨柄1的夹角为0—89°,本实施例选取60度;倒刺12的长度为0.2—10mm,本实施例选取倒刺长度为2mm。相邻倒刺12之间的距离为1—30mm,本实施例选用20mm。
股骨柄材料选择:即便体内能检测到的钴铬钼浓度比较低,也会造成细胞毒性。相反,钛合金在体内的碎屑和离子释放都比较多,但是细胞对钛的耐受性比较好。
钛合金具有更好的生物相容性。且由于应力传递是影响假体远期效果的重要因素,所以材料的弹性模量就显得非常重要。就这一点而言,钛合金是比较有优势的,因为钛合金的弹性模量与骨的弹性模量最接近,大约是钴铬钼弹性模量的一半。长入组织与假体表面的多孔空隙构成三维互锁,具有优异的机械稳定性。
因此,本实施例中股骨柄选用多孔材料的钛镍记忆合金制成,股骨柄和钛镍记忆合金倒刺一体设置,也能够提高钛镍记忆合金和股骨柄之间的连接稳定性。
股骨柄表面涂覆有透明质酸(人造HA)或者磷酸三钙。人造HA或磷酸三钙作为生物活性物质或骨传导物质被用于假体涂层以增大骨在假体表面的长入范围。HA的钙/磷比为1.67,性能稳定,与磷酸三钙(钙/磷比为1.5)相比,在体内不容易被溶解掉,因此,本发明选用人造HA作为涂覆层。
人造HA应用于股骨柄表面时,一般用等离子沉积的方法,股骨柄一般选用钛合金,因为钛合金与涂层的结合强度比钴铬钼要高。涂层越薄,机械强度越好。涂层的典型厚度为50微米。
本发明还提供一种含有钛镍记忆合金倒刺的生物型股骨柄的使用方法,包括如下步骤:
步骤一,将股骨柄放入冰水中浸泡,钛镍合金材料在低温下便于塑性,然后将倒刺弯折使其进入容纳槽内并贴服在股骨柄表面。
步骤二,将塑性后的股骨柄插入到股骨髓腔中,并调整角度和插入深度。
步骤三,股骨柄在患者体温的影响下逐渐升温,升温后的倒刺回复到张开的形态,倒刺张开后抵触股骨髓腔的内壁,从而将股骨柄固定。
步骤四,髓腔内的松质骨长入股骨柄表面的人造HA覆层以及股骨柄表面的多空空隙中形成三维互锁,三维互锁与倒刺固定相辅相成,达到良好的固定。
倒刺倾斜向下设置,便于术后翻修,在向上取出股骨柄时,倒刺不会卡在髓腔中。
本技术领域技术人员可以理解的是,除非另外定义,这里使用的所有术语(包括技术术语和科学术语)具有与本发明所属领域中的普通技术人员的一般理解相同的意义。还应该理解的是,诸如通用字典中定义的那些术语应该被理解为具有与现有技术的上下文中的意义一致的意义,并且除非像这里一样定义,不会用理想化或过于正式的含义来解释。
以上实施例仅为说明本发明的技术思想,不能以此限定本发明的保护范围,凡是按照本发明提出的技术思想,在技术方案基础上所做的任何改动,均落入本发明保护范围之内。上面对本发明的实施方式作了详细说明,但是本发明并不限于上述实施方式,在本领域普通技术人员所具备的知识范围内,还可以再不脱离本发明宗旨的前提下做出各种变化。
Claims (7)
1.一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:包括股骨柄,所述股骨柄的一端设置有球头,所述股骨柄表面设置有钛镍记忆合金材质的倒刺,所述倒刺朝向远离球头的方向设置;当股骨柄插入到股骨髓腔中后,所述倒刺抵触股骨髓腔内壁。
2.根据权利要求1所述的一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:所述股骨柄表面设置有容纳倒刺的容纳槽。
3.根据权利要求1所述的一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:相邻倒刺之间的距离为1—30mm。
4.根据权利要求1所述的一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:所述股骨柄的表面由多空材料或涂层材料制成。
5.根据权利要求1所述的一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:所述倒刺和股骨柄的夹角为0—89度。
6.根据权利要求1所述的一种含有钛镍记忆合金倒刺的生物型股骨柄,其特征在于:所述倒刺的长度为0.2—10mm。
7.一种含有钛镍记忆合金倒刺的生物型股骨柄的使用方法,其特征在于:包括如下步骤:
步骤一,将股骨柄放入冰水中浸泡,钛镍合金材料在低温下便于塑性,然后将倒刺弯折使其进入容纳槽内并贴服在股骨柄表面;
步骤二,将塑性后的股骨柄插入到股骨髓腔中,并调整角度和插入深度;
步骤三,股骨柄在患者体温的影响下逐渐升温,升温后的倒刺回复到张开的形态,倒刺张开后抵触股骨髓腔的内壁,从而进一步将股骨柄固定;
步骤四,股骨髓腔内的松质骨长入股骨柄表面的多空空隙中形成生物交锁,三维互锁与倒刺固定相辅相成,达到良好的固定。
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