CN116617541A - 血管成形术导丝 - Google Patents
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- A61M25/00—Catheters; Hollow probes
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- A61M25/00—Catheters; Hollow probes
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- A61M25/09—Guide wires
- A61M25/09041—Mechanisms for insertion of guide wires
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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Abstract
本发明题为:“血管成形术导丝”。本发明公开了一种由中空管组成的导丝,该中空管含有纵向内腔且具有切入管中的螺旋通道,并且具有远侧端部。该导丝具有位于纵向内腔内的细长挠性芯。该导丝还具有导电线圈,该导电线图在接近远侧端部的内腔内的位置处缠绕芯并且被耦合以便响应于施加到导丝的磁场而输出信号。
Description
相关申请的交叉引用
本申请与下述申请相关:与本申请同一日提交的且以引用方式并入本文的名称为Navigation of an Angioplasty Guidewire(血管成形术导丝的操纵)的美国专利申请。
技术领域
本发明整体涉及侵入性医疗过程,并且具体地,涉及用于此类过程的导丝。
背景技术
用于医疗过程的导丝具有许多冲突限制,诸如要求导丝足够刚性以使得其能够从患者外部推动,同时足够小以便减少对患者的创伤。许多不同的导丝在本领域中是已知的。
美国专利申请2006/0074442描述了一种用于穿越闭塞或狭窄的导丝,所述专利申请授予Noriega等人,其公开内容以引用方式并入本文。所述导丝据称为中空的,并且具有细长的管状导丝主体,所述主体具有轴向内腔。
美国专利申请2007/0021731描述了一种用于在人体腔中操纵医疗装置的方法,所述专利申请授予Garibaldi等人,其公开内容以引用方式并入本文。导丝在其远侧端部上提供有磁铁,所述磁铁可通过向所述磁铁施加磁场来取向或取向和运动。
美国专利申请2013/0072943描述了一种用于放置针对血管内操纵启用的装置的系统,所述专利申请授予Parmar,其公开内容以引用方式并入本文。所述系统的变体据说包括用于操纵穿过患者的脉管系统的导丝,所述导丝在导丝的前端或附近具有基于电磁(EM)的跟踪部件。
美国专利8,473,030描述了一种血管定位和成像设备,所述专利授予Greenan等人,其公开内容以引用方式并入本文。所述公开内容涉及一种血管成形术导管,并且涉及一种或多种跟踪元件或标记物,所述元件或标记物通过任何合适的装置附接到导管的远侧端部分。
美国专利8,372,017描述了一种可跟踪导丝,所述专利授予Schiff等人,其公开内容以引用方式并入本文。所述导丝据称包括被布置成预定图案以形成导丝的主体的多条线,其中所述多条线被配置成提供信号的导电性。
美国专利申请2014/0046216描述了一种导丝,所述导丝具有线圈,其中线圈绕组侧具有线圈绕组之间的固体物理连接,以防止所连接的线圈绕组侧因致动构件施加力而伸展,所述专利申请授予Palme等人,其公开内容以引用方式并入本文。
美国专利5,372,144描述了一种包括用于在内腔中操纵的远侧端部的医疗导丝,所述专利申请授予Mortier等人,其公开内容以引用方式并入本文。所述远侧端部包括具有用于在内腔中操纵导丝的长度的芯。在所述芯的远侧端部包括可成形的远端末端,且套管元件在小于所述芯的大部分长度上基本上围绕所述芯。所述套管元件能够相对于所述芯旋转,并且从所述可变形的远侧末端朝近侧偏移,使得所述可变形的远侧末端能够独立于所述套管元件运动。
美国专利申请2011/0130750描述了一种射频消融系统,所述专利授予Ormsby等人,其公开内容以引用方式并入本文。所述公开内容涉及一种电磁场发生器,所述电磁场发生器产生包括在所述系统的传感器线圈中感应电压的电磁场。信号处理单元使用感应电压来计算导管的远侧端部或末端在患者身体中的位置和取向。
以引用方式并入本专利申请的文献将视为本专利申请的整体部分,不同的是如果在这些并入的文献中定义的任何术语与在本说明书中明确或隐含地给出的定义在某种程度上相冲突,则应只考虑本说明书中的定义。
发明内容
本发明的实施例提供一种导丝,所述导丝包括:
中空管,该中空管含有纵向内腔且具有切入所述管的螺旋通道,并且具有远侧端部;
细长挠性芯,该细长挠性芯位于所述纵向内腔内;和
导电线圈,该导电线圈在接近所述远侧端部的所述内腔内的位置处缠绕所述芯并且被耦合以便响应于施加到所述导丝的磁场而输出信号。
在本发明所公开的一个实施例中,所述螺旋通道包括连续螺旋,所述连续螺旋具有第一间距和不同于所述第一间距的第二间距。
在本发明所公开的另一个实施例中,所述细长挠性芯包括线。
在本发明所公开的另一个实施例中,所述导丝包括覆盖所述中空管的绝缘生物相容性套管。通常,至少一个电极覆叠所述绝缘套管。
在一个另选实施例中,所述中空管由镍钛诺形成、具有0.8mm的外径和0.5mm的内径。
在本发明所公开的另一个另选实施例中,所述导电线圈具有0.3mm的外径。
所述导丝可被配置成插入人类患者的内腔中,且所述信号可指示所述远侧端部在所述人类患者的所述内腔中的位置。
在一个实施例中,所述中空管和所述导电线圈具有公共的对称轴。
根据本发明的实施例,还提供了一种方法,所述方法包括:
在含有纵向内腔的中空管中切割螺旋通道,所述中空管具有远侧端部;
将导电线圈缠绕在细长挠性芯上,所述导电线圈被耦合以便响应于施加到所述线圈的磁场而输出信号;以及
在所述缠绕之后,使所述导电线圈和所述细长挠性芯在所述纵向内腔内滑动,以便接近所述远侧端部来定位所述导电线圈。
结合附图,通过以下对本公开实施例的详细说明,将更全面地理解本公开,其中:
附图说明
图1为根据本发明的实施例的导丝跟踪系统的示意图;
图2为根据本发明的实施例的导丝的远侧部分的示意性透视图;并且
图3A和图3B为根据本发明的实施例的导丝的示意性剖视图。
具体实施方式
综述
本领域中已知的导丝可由线形成,所述线通常通过将所述线的一侧拉动抵靠在硬表面上而被弯曲成紧螺线。所形成的螺旋导丝具有足够的挠性和刚性,以使得其能够在患者的内腔中用作导丝。然而,导丝的紧螺旋形式意味着螺线内几乎不存在“面积”,以至于通常必须在螺线上添加用于跟踪导丝的装置,从而增大导丝的尺寸。
本发明的实施例通过由中空管形成导丝克服了这个问题。在管中切割螺旋通道,从而在管内留下纵向内腔。内腔提供上文所提及的面积且螺旋通道提供导丝所需的挠性。缠绕在细长挠性芯上的导电线圈,通常为线,位于接近中空管的远侧端部的内腔中。线圈被耦合以便响应于施加到导丝的磁场而输出信号,从而使得能够跟踪导丝的远侧端部。
实施为此形式的导丝允许构造为极小同时仍具有内部可用空间的功能导丝。例如,在本发明所公开的一个实施例中,导丝的中空管具有约0.8mm的外径和约0.5mm的内径。
对系统的描述
现在参见图1,图1为根据本发明的实施例的导丝跟踪系统20的示意图。为简明和清晰起见,除非另有说明,否则下述说明呈现其中系统20的操作者22(在本文中假定为医师)将导丝24插入患者28的内腔26中的血管成形术过程。血管成形术过程可例如在慢性完全闭塞的情况下指示。通常,在所述过程中,首先将导丝插入患者中,直到导丝的远侧部分32到达患者的心脏34中或接近患者的心脏34的所期望位置,之后使用所述导丝来将诸如球囊导管的外科设备引导至所期望的位置。
系统20可由系统处理器40控制,所述系统处理器包括与存储器44通信的处理单元42。处理器40通常被安装在控制台46中,所述控制台包括操作控制件38,所述操作控制件通常包括操作者22用来与处理器互动的定点装置,例如鼠标或轨迹球。所述处理器使用存储器44中存储的软件来操作系统20。处理器40所进行的操作的结果在显示器48上呈现给操作者,所述显示器通常呈现由患者28中的导丝24所采取的路径的视觉表示。例如,所述软件可以电子形式通过网络下载到处理器40,或者另选地或除此之外,所述软件可被提供和/或存储在非临时性有形介质(例如磁存储器、光学存储器、或电子存储器)上。
为了跟踪导丝24的路径,本发明的实施例使用类似于美国专利6,690,963中所述且类似于由加利福尼亚州钻石吧市的Biosense-Webster公司(Biosense-Webster ofDiamond Bar,CA)生产的CartoTM系统中所使用的电磁跟踪系统,所述专利授予Ben-Haim等人,其公开内容以引用方式并入本文。所述电磁跟踪系统包括多个磁场发生器,所述磁场发生器在本文中假定包括三组发生器66,每组包括三个正交线圈,以使得所述多个发生器包括共九个线圈。发生器66被放置在患者28下面的已知位置中,所述已知位置限定所述发生器的参照系。跟踪模块36控制由所述发生器产生的交变磁场的振幅和频率。
所述交变磁场与下文更详细说明的线圈相互作用,所述线圈位于导丝24内和所述导丝的远侧部分处,以便在所述线圈中产生交变电极电位,且所述电极电位由跟踪模块36作为信号接收。所述模块,连同处理单元42,分析所接收的信号,且根据所述分析,能够确定导丝线圈在定义的参照系中的位置,即,位置和取向。
系统处理器40使用导丝线圈的位置和取向来跟踪导丝的远侧部分。通常,可在显示器48上视觉呈现所述跟踪,例如通过将表示导丝远侧部分的图标结合到患者28的图像以及由所述图标所采取的路径中。
图2为导丝24的远侧部分32的示意性透视图,且图3A和图3B为根据本发明的实施例的导丝的示意性剖视图。在图2中,远侧部分的末端部分已被切掉以示出导丝的内部结构。导丝24是由具有内部纵向内腔86和对称轴72的中空弹性金属管70形成。在本发明所公开的一个实施例中,所述管的材料为镍钛合金,且所述管具有大约0.8mm的外径和大约0.5mm的内径。管70通过在所述管中激光切割螺旋通道74而形成为螺旋形。通常,当所述管是通过激光切割所述通道而形成时,改变所述通道的间距,以使得存在两个或更多个不同的间距。不同的节距赋予导丝其在导丝的不同节段中具有不同的挠性的性能。
由绝缘线制成的小导电线圈76插入内腔86中,以使得其位于所述管的远侧端部78处。图3B为在线圈的位置处截取的导丝24的剖视图。在插入之前,将所述线圈卷绕在细长的挠性芯80上,所述芯在本文中假定包括线,且在本文中也称之为线80。在已形成所述线圈之后,将所述线和线圈插入内腔86中,以使得所述线大致沿轴72伸展,且使得所述线圈与轴72具有公共对称轴。在上文所提到的本发明所公开的实施例中,线圈76具有约0.3mm的外径。线82将线圈76的两个端部连接到导丝的近侧端部,且所述线的近侧端部连接到跟踪模块36,以使得所述模块接收在所述线圈中产生的交变电极电位信号。模块36能够分析所述信号,以便确定所述线圈的位置,且因此远侧端部78的位置。
管70的外表面由生物相容性绝缘聚合物薄层84覆盖,所述层充当所述管的套管。层84防止来自患者28的流体接触管70的外表面,和/或渗透到内腔86中。所述层还用来机械加强导丝。在一些实施例中,通常呈环的形式的电极90附接到层84且覆叠层84。图3A为在电极的位置处截取的导丝24的剖视图。在一些实施例中,可存在多于一个这样的电极。绝缘线94从内腔86馈入穿过螺旋通道74和在层84中形成的孔96,并且连接到所述电极。所述线经由导丝的近侧端部从电极向处理单元42传送信号。
导丝24通常用于将诸如球囊导管的导管引导至接近线圈76的位置,且此已通过来自线圈的信号识别。
应当理解,上述实施例以举例的方式引用,并且本发明并不限于上文具体示出并描述的内容。相反,本发明的范围包括上述各种特征结构的组合和子组合以及它们的变型和修改,本领域的技术人员在阅读上述说明时将会想到所述变型和修改,并且所述变型和修改并未在现有技术中公开。
Claims (12)
1.一种导丝,包括:
中空管,所述中空管含有纵向内腔且具有切入所述管的螺旋通道,并且具有远侧端部,并且具有至少足够长的长度,以在所述导丝被插入患者中来执行过程时从由操作者操纵的手柄延伸到所述患者的心脏中或接近所述患者的心脏的所期望位置,所述螺旋通道至少从所述患者外部的第一点沿所述中空管的所述长度延伸;
细长挠性芯,所述细长挠性芯位于所述纵向内腔内;
导电线圈,所述导电线圈在接近所述远侧端部的所述内腔内的芯位置处缠绕所述芯并且被耦合以便响应于施加到所述导丝的磁场而输出信号;
覆盖所述中空管的绝缘生物相容性套管;以及
覆叠所述绝缘套管的至少一个电极,其中所述电极是环状的,
绝缘线,所述绝缘线从所述内腔馈入穿过所述螺旋通道,其中所述绝缘线连接到所述电极,并且所述绝缘线将至少一个信号从所述电极传送到处理单元;
所述导电线圈具有第一端和第二端,其中两条线圈连接线分别将所述导电线圈的所述第一端和所述第二端连接到所述导丝的近侧端部,其中所述两条线圈连接线被连接到电磁跟踪系统,其中所述电磁跟踪系统接收在所述导电线圈中产生的交变电极电位信号,
其中所述管的材料是镍钛合金,
其中所述管具有0.8mm的外径,以及0.5mm的内径,
其中所述管形成为螺旋形,
其中所述通道的间距是变化的,其中存在至少两个不同的间距,
其中所述导丝在所述导丝的不同节段具有不同的挠性。
2.根据权利要求1所述的导丝,其中,所述细长挠性芯包括线。
3.根据权利要求1所述的导丝,其中,所述导电线圈具有0.3mm的外径。
4.根据权利要求1所述的导丝,其中,所述导丝被配置成插入人类患者的内腔中,并且其中所述信号指示所述远侧端部在所述人类患者的所述内腔中的位置。
5.根据权利要求1所述的导丝,其中,所述中空管和所述导电线圈具有公共的对称轴。
6.根据权利要求1所述的导丝,其中,所述螺旋通道在所述芯位置之前的第二点处结束,使得所述中空管的所述远侧端部在所述芯位置处不具有所述螺旋通道。
7.一种方法,包括:
在含有纵向内腔的中空管中切割螺旋通道,所述中空管具有远侧端部,并且具有至少足够长的长度,以在所述导丝被插入患者中来执行过程时从由操作者操纵的手柄延伸到所述患者的心脏中或接近所述患者的心脏的所期望位置,所述螺旋通道至少从所述患者外部的第一点沿所述中空管的所述长度延伸;
将导电线圈缠绕在细长挠性芯上,所述导电线圈被耦合以便响应于施加到所述线圈的磁场而输出信号;以及
在所述缠绕之后,使所述导电线圈和所述细长挠性芯在所述纵向内腔内滑动,以便接近芯位置处的所述远侧端部来定位所述导电线圈;以绝缘生物相容性套管覆盖所述中空管;以及
以至少一个电极覆叠所述绝缘套管,其中所述电极是环状的,
将绝缘线从所述内腔馈入穿过所述螺旋通道,其中所述绝缘线连接到所述电极,并且所述绝缘线将至少一个信号从所述电极传送到处理单元,
所述导电线圈具有第一端和第二端,其中两条线圈连接线分别将所述导电线圈的所述第一端和所述第二端连接到所述导丝的近侧端部,其中所述两条线圈连接线被连接到电磁跟踪系统,其中所述电磁跟踪系统接收在所述导电线圈中产生的交变电极电位信号,
其中所述管的材料是镍钛合金,
其中所述管具有0.8mm的外径,以及0.5mm的内径,
其中所述管形成为螺旋形,
其中所述通道的所述间距是变化的,其中存在至少两个不同的间距,其中所述导丝在所述导丝的不同节段具有不同的挠性。
8.根据权利要求7所述的方法,其中,所述细长挠性芯包括线。
9.根据权利要求7所述的方法,其中,所述导电线圈具有0.3mm的外径。
10.根据权利要求7所述的方法,其中,中空管、所述细长挠性芯和所述导电线圈被配置为用于插入人类患者的内腔中的导丝,并且其中所述信号指示所述远侧端部在所述人类患者的所述内腔中的位置。
11.根据权利要求7所述的方法,其中,所述中空管和所述导电线圈具有公共的对称轴。
12.根据权利要求7所述的方法,其中,所述螺旋通道在所述芯位置之前的第二点处结束,使得所述中空管的所述远侧端部在所述芯位置处不具有所述螺旋通道。
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