CN103002838B - 植入物装入装置 - Google Patents

植入物装入装置 Download PDF

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CN103002838B
CN103002838B CN201180034759.6A CN201180034759A CN103002838B CN 103002838 B CN103002838 B CN 103002838B CN 201180034759 A CN201180034759 A CN 201180034759A CN 103002838 B CN103002838 B CN 103002838B
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C·阿波塔
J·阿舍菲尔德
R·汉内斯
H·蒙斯塔特
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Abstract

本发明涉及一种装置,其包括血管内的植入物(1)和插入辅助元件(2),所述植入物用于装入到人体或动物身体的血管或体腔内,植入物(1)和插入辅助元件(2)通过分离元件(3)彼此连接,该分离元件构造成可电解腐蚀的,因此在植入物(1)被装入到身体中之后通过施加电压实现分离元件(3)至少部分分解并且植入物(1)与插入辅助元件(2)分离,所述分离元件(3)由钴铬合金制成,其包括质量百分比至少为20%的钴和质量百分比为10~40%的铬。

Description

植入物装入装置
技术领域
本发明涉及一种装置,其包括血管内的植入物和插入辅助元件,所述植入物用于装入到人体或动物身体的血管或体腔内,植入物和插入辅助元件通过分离元件彼此连接,该分离元件构造成可电解腐蚀的,因此在植入物被装入到身体中之后通过施加电压实现分离元件至少部分分解并且植入物与插入辅助元件分离。
背景技术
用于闭塞体腔或血管如动脉、静脉、输卵管或血管畸形(例如血管动脉瘤)的血管内技术的使用是已知的现有技术。在此借助用作插入辅助元件的血管内导向丝将所谓的闭塞螺旋件通过导管插入到并且存放于待闭塞的空腔内。也已知其它植入物、例如支架的装入。
从现有技术已知各种分离植入物与插入辅助元件的方法。除机械方法外,电解分离不锈钢钢丝尖端已证明是特别有效的,该方法首次记载于1979年Thompson等人以及McAlister等人在针对电凝法的描述中(Radiology133:335-340,1979年11月;AJR132:998-1000,1979年6月)。以此为基础,EP0484468B1也描述了一种基于电解分离置入闭塞螺旋件的装置。
与具体待装入的植入物的类型无关,对于治疗医生来说始终重要的是,使分离时间尽可能短,由此例如在分离期间植入物不会移位或者不会出现其它不可预料的事情。出于该原因,过去已经将不同的材料用于设置在植入物和插入辅助元件之间的分离元件,该分离元件能够在施加电压时迅速分解。例如WO03/017852A1中使用不锈钢,其经受通过热处理的预腐蚀过程。
发明内容
因此,本发明的任务在于在开头所提类型的装置的基础上提供进一步减少植入物与插入辅助元件的分离时间的措施。
根据本发明,该任务通过一种装置来解决,该装置包括血管内的植入物和插入辅助元件,植入物用于装入到人体或动物身体的血管或体腔内,植入物和插入辅助元件通过分离元件彼此连接,该分离元件构造成可电解腐蚀的,因此在植入物被装入到身体中之后通过施加电压实现分离元件至少部分分解并且植入物与插入辅助元件分离,分离元件由钴铬合金制成,其包括质量百分比至少为20%的钴和质量百分比为10~40%的铬。
意想不到地已表明,基于钴铬合金的分离元件在被施加电压时允许极短的分离时间。该分离时间通常低于30s(2V,2mA)。仅5s的分离时间也是可能的,在此分离时间当然也与分离元件的厚度有关。与现有技术相比,例如在WO2005/070308A2中在其它条件相同时为20至40s,这构成明显的改进。
作为钴铬合金可使用例如作为由Deloro公司销售的钴铬合金。在此是指可含有钨、镍、钼、铁和其它元素的钴铬合金。非常耐磨,因此其尤其用于承受高负荷的构件。更意想不到的是这样的认识,即由制成的分离元件可特别迅速地电解分解。
钴的质量百分比含量优选最大为70%,质量百分比含量在30~60%之间尤为有利。铬的质量百分比含量尤其可为15~30%。
其它元素可改善分离元件的特性。因此有利的是,合金包含质量百分比为4~12%的钼和/或质量百分比为5~20%的钨。
在需要时,镍、锰或铁的含量可明显更高并且在此情况下,锰和铁的质量百分比最大为30%。镍的质量百分比含量可在8~40%之间。
可用的钴铬合金例如是以名称销售的钴铬合金。德国材料号为2.4711。该合金含有质量百分比为40%的钴、质量百分比为20%的铬、质量百分比为16%的铁、质量百分比为15%的镍和质量百分比为7%的钼以及可能少量的锰、碳、硅、磷、硫和铍。
另一可使用的合金是25。该合金含有质量百分比约为50%的钴、质量百分比为20%的铬、质量百分比为10%的镍和质量百分比为15%的钨。另一例子为21,其具有质量百分比约为63%的钴、质量百分比为28%的铬和质量百分比为6%的钼。
插入辅助元件优选为传统的导向丝,其已证明适合于将闭塞螺旋件或支架通过导管送入其规定位置。插入辅助元件连接到植入物的近端,即沿医生将植入物推进的方向。
植入物可以是闭塞螺旋件或支架。此外,植入物也可以是用于影响血流的类似支架的系统,其通过编织的、借助激光切割的金属箔或塑料薄膜或通过适合的塑料膜片构造。但本发明原则上可用于所有类型的血管内的植入物,其应借助插入辅助元件被送入其规定位置并且在那里与插入辅助元件分离。植入物也可以是这样的物体,其仅构造成选择性可分开的,并且根据治疗过程保留在身体中或被再次取出,一个例子为用于去除或排挤血栓的可分离的支架取回系统。
有利的是,分离元件包括一个或多个丝。丝可很好地传导推进力或拉力,使得治疗医生不仅可简单地推进,而且也可简单地拉回植入物。为了使医生能够精确地将植入物送入希望的规定位置,简单的定位性是重要的。
丝可具有圆形、多角形、椭圆形或管状的横截面。在此也可任意组合,例如丝由圆形和多角形的丝组成。通常通过将原材料牵拉到相应的最终横截面来制备丝。通过该牵拉过程可控制分离元件的组织结构和因此控制分离特性。通过改变丝的横截面和形状,丝可最佳地适配于使用目的。
为了进一步简化分离,可在分离元件上进行表面处理。例如使表面粗糙会加速分解,因为这增大了分离元件的表面。也已知其它的可能性,例如已经提到的WO03/017852A1公开了通过附加处理使分离元件加速分解,在此引用该文献。分离元件例如可经受析出工艺意义中的热处理,通过该析出工艺金属的组织这样改变,使得在施加电压时金属在电解液中特别迅速地分解。可借助激光器在炉中或借助感应线圈来进行这种热处理。冷却适宜以淬火的形式相对快速地进行。通过这种方式产生促进电解分解的组织状态。
钴在加热和冷却时显示出可逆的同素异形体的相变。在高温下,面心立方相(α-钴)是稳定的,在冷却时在约420℃下转换为六角ε-钴。ε-钴的可成形性非常差,而亚稳的α-钴的延展性则更好。两相之间的转换温度可通过选择不同合金添加剂来改变。原则上,添加剂铬、钼或钨稳定六角相并且减少堆垛层错能,而元素铁、镍和锰则有利于立方相并且增加堆垛层错能。在固溶退火后,合金通常主要由α-钴构成,接着通过冷成形(例如拉丝)和/或析出工艺提高ε-钴的含量。通过析出硬化可从合金中析出金属间相,由此提高了合金的易腐蚀性。最后合金应主要作为亚稳的α-钴存在,但也含有一定量的ε-钴。
也可进行其它方式的附加处理、例如预腐蚀、例如通过表面蚀刻。此外也可通过与设计有关地构造局部腐蚀元件来被动地加速分离。在不同贵金属的相邻布置中形成这种腐蚀元件,也就是说,分离元件由不同于植入物和/或插入辅助元件的非贵金属制成。
分离元件的分解通过施加电压进行。在此既可以是交流电也可以是直流电。小的电流强度(<3mA)即可。在此分离元件构成阳极,在其上发生金属的氧化和分解。
为了能更好地主动影响分解,适宜这样在结构上设计分离元件,即避免上述局部腐蚀元件。这例如可通过使分离元件与相邻的装置区域绝缘、例如通过分离元件和植入物之间绝缘的粘接来实现。
通过借助电源在分离元件上施加电压来进行电解分离。分离元件在此用作阳极,而阴极定位在身体表面上。当然,分离元件必须相应导电地、尤其是通过插入辅助元件与电源连接。在此情况下插入辅助元件本身也必须是导电的。由于出现的腐蚀流受阴极表面控制,所以阴极表面应选择成明显大于阳极表面。在一定程度上分离元件的分解速度可通过相对于阳极表面调节阴极表面来控制。本发明也相应涉及一种装置,其包括电源以及可能包括可放置在身体表面上的电极。
代替或附加地,可采取其它措施来辅助分离元件的分解或分离。在此情况下可使用光波、声波(超声波)或磁力。
此外适宜使安全器件通过植入物。该安全器件优点在于,在植入物被错误定位的情况下,可明显更加可靠地在导管中拉回植入物。在没有安全器件的情况下拉回例如闭塞螺旋件具有以下危险:部分螺旋线可因拉应力或扭应力被拉开并且因此不可逆地塑性变形。在极端情况下,螺旋线可断裂或断开,这可导致危及生命的栓塞。已经公开由柔性聚合物线制成的和由具有形状记忆特性的材料制成的安全器件。
也已经公开包括多个分离元件的装置,使得在必要时不同长度的植入物可被放置到规定位置上。这例如允许将长度正好的闭塞螺旋线放置到动脉瘤中。关于这点可参见WO01/32085A1。
这种在多个位置上可被电解腐蚀的植入物的应用基于这样的认识,即在电流被施加到这种装置上时,最接近导管远端的分离位置通过电解分解,其原因在于:一方面导管内的分离位置通过导管与离子介质隔离并因此不能被电解,另一方面,由于电阻向远端逐渐增加,电流强度从近端向远端降低。因此向远端作为第一个连接到导管远端上的、构造成可被电解腐蚀的位置承受最强的电解处理并且优先分解。
尤其是铂或铂合金已被证明适于用来制造植入物。铂或铂合金的优点还在于,它们不透X射线并且因此植入物的装入能够简单地被可视化。用于分离元件的钴铬合金通常是MR兼容的并且因此也能够被可视化。
根据本发明的装置也可直接与微导管组合,通过微导管借助插入辅助元件将植入物送入其规定位置中。在此所用的导管和植入物应在其尺寸上协调一致。如必要,导管也可向植入物施加约束,以致植入物只有在从该约束中被解除之后才具有事先制成的次级结构。附加地,导管还设有不透X射线的标记,该标记允许借助已知的成像方法在目标区域中定位。
通常分离元件具有0.05~0.5mm的长度、尤其是约0.2mm的长度,并且具有0.04~0.5mm的直径、尤其是约0.1mm的直径。
附图说明
下面借助图1详细说明本发明。图1示出根据本发明装置的示意性结构。
具体实施方式
该装置由植入物1、插入辅助元件2和分离元件3组成。在此,插入辅助元件2位于近端,植入物1位于远端,即沿装置的推进方向。植入物1通过在图中未示出的导管中推进插入辅助元件2而被送入其规定位置。

Claims (17)

1.植入物装入装置,其包括血管内的植入物(1)和插入辅助元件(2),所述植入物用于装入到人体或动物身体的血管或体腔内,植入物(1)和插入辅助元件(2)通过分离元件(3)彼此连接,该分离元件构造成可电解腐蚀的,使得在植入物(1)被装入到身体中之后通过施加电压实现分离元件(3)至少部分分解并且实现植入物(1)与插入辅助元件(2)分离,其特征在于,所述分离元件(3)由钴铬合金制成,该钴铬合金包括质量百分比至少为20%的钴和质量百分比为10~40%的铬。
2.根据权利要求1所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为70%以下的钴。
3.根据权利要求2所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为30~60%的钴。
4.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为15~30%的铬。
5.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为4~12%的钼。
6.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为8~40%的镍。
7.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为5~20%的钨。
8.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为30%以下的锰。
9.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述钴铬合金包含质量百分比为30%以下的铁。
10.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述插入辅助元件(2)是导向丝。
11.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述植入物(1)是闭塞螺旋件、支架、可分离的支架取回系统或用于影响血流的类似支架的系统。
12.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述分离元件(3)包括一个或多个丝。
13.根据权利要求12所述的植入物装入装置,其特征在于,所述丝具有圆形、多角形、椭圆形和/或管状的横截面。
14.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述分离元件(3)具有粗糙的表面。
15.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述分离元件(3)被预腐蚀。
16.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述分离元件(3)或用于制造分离元件(3)的合金被热处理。
17.根据权利要求1至3中任一项所述的植入物装入装置,其特征在于,所述植入物装入装置与微导管组合。
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