CN1753703A - 带标识的导线 - Google Patents
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Abstract
本发明涉及一种导线,它包括具有近端部分和远端部分的细长芯部。导线的近端或远端部分中的一个或另一个具有憎水性涂层。憎水性涂层包括憎水性墨。
Description
相关申请的交叉引用
本申请要求2002年12月4日提交的美国临时申请60/430,835的优先权,该临时申请的公开内容,包括其中所参考的附件引入本文作为参考。
关于联邦资助研究或开发的声明
不适用
技术领域
本发明大体涉及医疗器材领域。更具体地,本发明涉及被称为导线的器材。导线是用在多种医疗方法中的器材。更具体地,导线通常用于在放置诸如导管的分离的医疗器材以进行治疗或诊断过程之前或与之一起通过人体的脉管系统。
背景技术
在经皮腔内冠状动脉成形术(PTCA)手术中,首先使引导导管在患者的脉管系统中前进,直到引导导管的末端位于预期的冠状动脉的小孔中。导线首先从引导导管的远端移出进入患者的冠状动脉中,直到导线的远端穿过要被扩张的损伤处。在其远端部分上具有可膨胀气囊的扩张导管越过先前引入的导线进入到患者的冠状动脉中,直到扩张导管的气囊跨过损伤处被适当安放。一旦被适当安放,扩张气囊由于膨胀流体被膨胀一次或多次而达到处于较高压力下的预定尺寸,使得狭窄紧靠动脉壁而被压缩并且壁被膨胀以张开脉管通道。通常,气囊膨胀后的直径近似与要被扩张的体内腔的先天直径相同,以便完成扩张但又不使动脉壁过度膨胀。在气囊被最终扩张后,血流恢复通过扩张后的动脉和扩张导管,并且导线可从其中取出。很多相同的手术也用在表面(即,非冠状)脉管系统中,这些方法被称为血管腔内成形术(PTA)。
在这种血管成形术手术后,可能会有动脉的再狭窄,即再形成动脉堵塞,这样需要另一种血管成形术手术或修复或强化扩张区域的一些其它方法。为了仅仅降低血管成形术的再狭窄率并强化扩张区域,医生现在通常将被称作支架的血管内修补物在损伤处植入动脉。支架也可用于修复具有内膜瓣或剖开部的脉管以强化脉管的被削弱的部分或维持它的开放性。
支架通常在导管的气囊上以收缩状态被输送到期望位置,其在很多方面非常类似于气囊血管成形导管,并在患者的脉管系统内通过膨胀气囊而被膨胀到更大的直径。在支架部署(deployment)后,将气囊放气,导管被取出,支架被留在脉管内扩张的损伤或被支持的脉管的适当位置处。因此,支架用于保持变窄的脉管张开并通过留在脉管内来强化扩张区域。支架可以安装在气囊导管上并且在气囊被膨胀以扩张狭窄区域的同时被部署,而不是首先使用一个导管以扩张体内腔并且在扩张之后使用第二导管来部署支架。
在上述手术中的任意一个中,医生可能想要估计狭窄或被削弱区域的长度以确定要用于扩张手术的气囊的长度和/或要部署的支架的长度,该狭窄或被削弱区域要被扩张或者支架要被部署在其中。在此以前,还曾建议在导线或导管的远端部分上设置多种标识,以确定狭窄的长度。很多这些现有努力包括在导线的远端部上的不透射线的多个标识之间设置不同间隔,以允许医生利用动脉内适当位置处的导线和横跨狭窄区域的标识用荧光检查法进行长度确定。但是,由于荧光检查法的两维特性,这些现有方法因为狭窄部的方向的原因不能总是非常精确,并且狭窄内的导线不能总是适合于精确的长度确定。
本发明大体上涉及改进的方法和设备,其用于观察导线已经被插入患者脉管系统中的距离,并且一方面用于测量患者体内腔内非视觉上可观测的距离。本发明特别适用于这样一种优选类型的导线,即具有光滑、通常为亲水性的涂层的导线。
发明内容
由于多种原因,包括上面讨论的那些原因,对于导线的使用者来说能辨认从股动脉入口处已经进入到患者脉管系统的导线的长度有时很有用。具体地,导线通常具有远端段和近端段。导线的远端段进入患者的脉管系统并被插入和通过脉管系统到达要进行医疗手术的地点。使用者来所关心的是参考视觉上可感知或可视标记能够辨别已经进入脉管系统的导线的长度。在本文中可视标记是指印刷、喷涂、写在或以其它方式印在导线主体上,以便在患者体内或体外在视觉上可感知的均匀间隔的标记或其它的标记。基本上,本发明的带标识的导线特征能用在导线主体上的任何地方,且其近端段位置优选地适用于多种用途。
在带标识的导线的另一应用中,医生利用可视标记来确定导线已经被插入到诊断或治疗导管中多远。一旦所关心的近端段标识到达导管衬套,医生就开始用荧光检查法观察导线。医生知道将导线进一步插入到导管会使得导线的远端进入到脉管。如果没有可视标记,在手术中医生就必须过早地开始用荧光检查法观察,以便导线不会进入到脉管中且没有被监控。因而,本发明使患者少受到荧光镜辐射。
一方面,本发明包括导线的使用,该导线在其远端上具有可被医生观察的(即,荧光镜检查法)至少一个标识或其它位置标记。导线被安放在患者体内且远端标识被放在或靠近要被测量的体内位置的一端,然后导线被再安放使得相同的远端标识被放在或靠近体内位置的另一端。当远端标识在要被测量体内位置的两端之间移动时,延伸到患者体外的那部分导线也移动相同的距离,测量导线的体外移动以确定体内位置的长度。
伸出患者之外的导线的近端部分的移动能以各种方式测量。例如,可以看得见或可能被感觉到的尺状标记(即,横脊或横槽)可以放在伸出患者之外的导线的近端部分的表面上。为了进行内部测量,导线被安放到患者体内使得导线上的远端标识被定位在或靠近要被测量的体内位置的一端。导线近端上的标记的第一外部位置然后相对于外部参考点(即,引导导管的适配器的近端)核对位置。当导线移动到远端标识处于体内位置的另一端处的位置时,导线近端上的标记同样地移动,它移动的距离就是要测量的体内距离。通过在视觉上或用手参考尺状标记到外部参考点的相对移动,医生或其它操作员可以确定两个体内位置之间的距离。
当改变远端标识的位置时,其它方法也能用于确定导线行进的距离。有轮的距离感测构件可被压到与伸出患者之外的导线的近端的表面配合。类似地,电光系统也能用来测量导线移入脉管系统的距离。也可以采用各种其它方法进行距离测量。这些距离测量系统必须参考适当的基底,即引导导管的近端上的适配器,使得能够正确地探测导线的轴向移动。为了确保不失去导线的远端位置,优选地首先将导线上的远端标识定位在近端体内位置处,然后在体腔内将导线移向远端,直到远端标识靠近远端体内位置。也可以采用相反的过程,即首先将远端标识放在狭窄的远端处,然后再放到狭窄的近端处,但是在这种情况下导线必须在损伤处来回移动,这样比较耗时。但是,通过首先将远端标识放在损伤的最远端,然后向近端撤回导线以将远端标识移到损伤的近端能确保导线中出现的任何松弛都会被消除,并从而确保更精确的测量。
因此,本发明一方面提供一种改进的方法和设备,其用于测量患者脉管系统内的两个位置间的距离,即血管内或被削弱的脉管段的损伤的长度。参考示例性附图阅读下面本发明的详述后,本发明的这些以及其它优点将更加明显。
附图说明
图1是体现本发明特征的导线的局部剖开的示意性主视图;
图2是图1的导线沿线2-2的横剖视图;
图3是图1的导线系统沿线3-3的横剖视图;
图4是本发明第二实施例局部剖开的示意性主视图;
图5A是位于患者血管内且远端标识靠近动脉狭窄的近端的导线的主视图;
图5B是与图5A类似的主视图,除了远端标识靠近动脉狭窄的远端之外;
图6A和6B是可选系统的主视图,该系统用于测量第一和第二体内位置间的距离,其中可滑动鞘设在具有用于测量导线移动的标记的导线芯部上;
图7是本发明的又一实施例;
图8显示图7所示导线的远端末梢的构造。
具体实施方式
为了光滑的目的,市售的导线倾向于具有诸如聚四氟乙烯(PTFE)的不粘或低摩擦涂层。历史上,涂有PTFE的导线难以可靠并永久地作记号以便它们的主体(通常指近端)能在视觉上被监控。本发明在一个实施例中通过采用基于四氟乙烯的墨(ink)来在涂有PTFE的导线的主体上产生可视标记克服了现有技术中的这个困难。本领域内普通技术人员将能注意到,也可以采用本发明意图内的其它光滑涂层。例如,除了PTFE外,也可采用TFE、FEP、ETFE以及在导线使用的背景中具有相似性能的各种涂层。虽然适于用在本发明的许多涂层都是含氟聚合物,但是本发明并不限于由于其效用被广泛流传的任何特定的聚合物类。
Anderson等人的美国专利6,428,512所述的导线(假设其中描述的导线要被涂上PTFE)是本发明能够使用的一个例子。Anderson等人的美国专利6,428,512的公开在此引入作为参考。如果本发明要用在Anderson等人的‘512专利中,则要在导线的近端段上使用可视的或可触知探测的标记。
应注意,本发明最具体地涉及光滑、喷涂有憎水性涂层的导线,特别是那些其上具有PTFE涂层的导线。在另一实施例中,本发明也可用于喷涂有亲水性涂层的导线。在本发明该方面的一个实施例中,亲水性或基于亲水性的墨或染料用于在例如导线的近端段上产生可视标志。由于亲水性涂层易于具有外部显现或定向的活性官能团,因此许多视觉上可感知的墨、染料或其它标识化学品可能会耦合到这种亲水性涂层官能团,以产生永久的近端段导线标识。
图1显示了体现本发明的导线的局部剖开的示意性主视图。导线1为细长导线结构,且它的近端4通过部分4中的近端设置到左侧而被设置到左侧,而它的远端部分5则通常被设置到右侧。应理解,导线的近端和远端通常应该从医生或其它医学专业人士的观点出发来理解。因此,导线的远端段或远端部分5通常被部署在患者的脉管结构内,而近端段或近端部分4则是医学专业人士处理和在视觉上或用手接触的部分。图1的导线为喷涂有憎水性涂层的导线,其包括金属芯部和憎水性涂层6。一种示意性但不是限制性的光滑、憎水涂层为PTFE。图1中还示出了基于憎水性墨的标记7,在所示实施例中该标记7为1、2、3和4的组。很明显,有关标记数量、间隔、宽度以及化学成分的选择的各种主题以及变化对于本领域普通技术人员来说都是公知的。
与本发明一起使用的基于憎水性墨或标识流体具有几个相关特性。所有可使用的标识流体都能“湿润”诸如PTFE的工作表面。此外,这种适用的标识流体都会侵略性地粘附到憎水性表面或涂层,在适当固化或随后固化、加热、辐射或其它粘结步骤或粘附后这些标识流体被施加到憎水性表面或涂层。一种适当的标识流体是可获得各种颜色和各种等级的含水的TFE悬浮液,其可从GEM Gravure,Inc.of West Hanover,Ma,U.S.A买到。另一种适当的标识流体可从Kimberly-Clark Formulabs,Neenah,Wisconsin U.S.A买到。应注意,所选择的标识流体的颜色通常应该与底层涂层的颜色形成对比。因此,例如,白色的TFE标识流体适合于绿色的憎水性底涂层。
一旦上述标识流体已经根据它们的规定被施加了,则流体必须被固化加热到600°F到大约950°F的范围内的温度。一旦适当固化后,永久的标记就产生了。
图4显示了本发明的另一实施例。体内导线10通常包括细长芯部构件11,该芯部构件11带有细长近轴部分12和锥形远轴部分13以及绕锥形远轴部分13布置并固定到其上的螺旋线圈14。锥形远轴部分13可以具有一个或多个锥形部分或段15以及一个或多个等径部分16、16′。平面成形板条(ribbon)17延伸到圆形塞子(plug)18,该塞子18是在线圈14的远端被焊接到平面成形板条17的远端的时候形成的。通常线圈14还通过锡焊或铜焊连接到远轴部分13的中间位置19和它的近端20。远端不透射线的标识21被固定到靠近成形板条17的等径部分16,使得板条能不移动标识21地成形。优选地,将标识21定位得尽可能靠近中间位置19,使得导线10在被安放到靠近要被扩张的损伤处的远端以测量损伤处的长度的时候不需要被布置到远侧太远。
导线10的近轴部分12的近端部分设有诸如脊、带、板条、或凹槽的尺状标记22,以便当导线上的远端标识从第一体内位置移到第二体内位置时,允许医生或其它操作员在视觉上或可能用手探测导线相对于诸如引导导管(未图示)近端上的适配器23(图5A和5B所示)的近端的参考点轴向地移动了多远。在该实施例中,标记间的间隔为标准长度单位,使得医生能够将标志的数字转化为长度测量。如图所示,标记可以具有靠近提供诸如毫米或英寸的单位度量的标记的适当的数字。标记22为基于亲水性墨的标识。标记22已经被印刷、描绘或喷射到已经被布置在至少一部分近轴部分12上的憎水性、光滑涂层6之上或上面。如相对于图1的导线1要注意到的,标记22不会显著地改变导线10的总直径,并且因而显示为较暗线条,虽然它们可以可选地具有足以使它们在视觉上可感知的相当大的宽度和深度或密度。标记22还可以具有足够的深度或密度,使得它们能用手感觉到或感受到,而又没有改变导线10的总直径或应用。
在下面将要更彻底讨论的本发明的另一方面中,螺旋线圈14自身能具有憎水性、光滑涂层。因此,可能存在这样的应用:其中线圈14在其上具有憎水性涂层,并且对于线圈需要具有视觉上可感知或用手可感知的标记。在那样的实施例中,根据本发明,可以在线圈14本身上部署基于憎水性的墨。
应注意,本发明可用于可靠地将浓密的和永久的标记以基本上任何形式设在基本上任何憎水性涂层上。因此,虽然这里主要讨论带,但是纵向标识(线条)、横向标识、或基本上任何其它类型的标识也落在本发明的预期内。
图5A和5b显示通过图4所示的导线10测量患者血管31内的损伤30的长度的方法。在图5A中,可以看到导线10被安放在血管31内,使得不透射线的标识21靠近损伤30的近端32。在图5B中,导线10的位置已经被改变,使得不透射线的标识21靠近损伤30的远端33。损伤30的近端32与远端33之间的距离L1能够通过从患者伸出的芯部11的近端部分处示出的距离L2减去L3确定。
用于测量距离的另一种方法和系统如图6A和6B所示。在该系统中,可滑动轴套或其它构件60安装在从患者伸出的芯部构件11的近端部分的外部上。轴套60优选地安装到芯部构件11的近端部分,使得它可滑动但也足够紧密地装配以防止无意的相对运动。当导线10上的远端标识(未显示)放在或靠近损伤30的近端32时,芯部构件11上的轴套60的位置被可滑动地调节,直到轴套60的远端61靠近引导导管(未显示)的近端上的适配器23的近端。这样就设置了轴套上的基准测量,在这种情况下该基准测量即为零。当将导线10的位置向远端移动,以将远端标识(未显示)移到损伤的远端时,轴套60随着导线移到适配器23的近端开口中。移动的距离可以从轴套上靠近适配器23近端的标记读出。
导线的近端部分上的标记通常会延伸大约3到40厘米的距离,以允许测量遍及患者冠状动脉或外部脉管系统的损伤。利用大约175厘米的常规导线,优选地芯部构件的近端部分上的标识从距导线近端大约40到85厘米的位置处开始,以确保标识被正确地设置用于测量体内长度。利用鞘或诸如图6A和6B所示的其它可滑动构件,标记需要仅仅延伸最长损伤或预期要被测量的其它体内位置的最大长度。
图7显示了本发明的又一实施例。在本发明的这个实施例中,导线100具有其上设有缠绕线圈102的细长金属丝芯部构件101。在该实施例中,线圈102被缠绕在芯部金属丝101的整个长度上。芯部构件101具有通向设在远端的较小直径段106和终端108的第一锥形部104。如图所示,芯部构件101终止在线圈102内并且不达到线圈102的最远端112。因此,线圈101通过保险丝110耦合到导线100的最远端末梢112。线圈102包括具有PTFE(聚四氟乙烯)光滑憎水性涂层的金属丝。包括基于憎水性墨的一系列标记114设在线圈102的近端段。可以看出图7的导线具有“J”构造。在图中116处所示为相同导线的稍微伸直的形式。实际上,导线的使用者可以根据本领域普通技术人员所公知的方法将它用指头弄直。
箭头116显示本发明的基于憎水性墨的标识的狭小形式(例如,1.0-2.0毫米),而箭头118显示根据本发明的更宽标识(例如,2.0-4.0毫米)。标识(标记)或标识组之间的分隔距离取决于预期的导线用途。代表性的尺寸可以从图7和表1算出。导线100的“J”构造120的纵向长度大约为2厘米。图7所示的导线在侧躺着的时候可以是大体平直的。可选地,实际上“J”的远端段可以不和现有技术公知的那样与导线的近端段共面。本发明的这样的实施例显示在图8中,其是导线从远端段看向近端段的侧视图。
图7通过符号“A”、“B”、“C”、“E”、“G”和“H”显示依据本发明的导线的各种尺寸。用于那些字母符号的标称值包括在表1中。一般而言,所示的导线尺寸是本领域普通人员将会选择的尺寸。
“A”导线直径+.0005-.0010 | “B”芯部直径(REF) | “E”未喷涂部分的长度 | “G”长度cm± | “H”长度cm±1cm | “C”以厘米表示的导线长度 |
.0320 | .013 | .040-.080 | 65 | 75 | 35-75厘米80-260厘米 |
.0330 | .013 | .040-.080 | 65 | 75 | |
.0350 | .016 | .040-.080 | 65 | 75 | |
.0380 | .016 | .050-.090 | 65 | 75 |
表1
也可以采用本领域普通技术人员公知的各种其它装置来探测导线的移动,该移动然后能被转化为患者体内的长度测量。本发明提供了能够很容易进行这种测量的基础。
从前面说明很明显可以看出,虽然是描述和显示了本发明的特定形式,但是在不偏离本发明的实质和范围的情况下可以作出各种修改。例如,虽然本发明是参考导线进行描述,但是根据本发明,其它类似装置,例如通管丝(stylettes)和弹簧导杆对于本领域普通技术人员来说也是很明显的。此外,本领域普通技术人员会意识到在一个实施例中所示的特征可以用在其它实施例中。
Claims (6)
1、一种导线,包括具有近端部分和远端部分的细长芯部,导线的近端或远端部分中的一个或另一个在其上具有憎水性涂层,憎水性涂层上具有包括憎水性墨的标记。
2、如权利要求1所述的导线,其特征在于,近端部分的一部分喷涂有憎水性涂层,并且在近端部分上有至少大约3个标记。
3、如权利要求1所述的导线,其特征在于,有多个标记,并且该多个标记彼此均匀间隔开。
4、如权利要求1所述的导线,其特征在于,有多个标记,并且标记间隔大约0.5到3毫米。
5.如权利要求1所述的导线,其特征在于,芯部构件的近端部分上的最近端标记从芯部构件的近端延伸至少大约40厘米。
6、如权利要求1所述的导线,其特征在于,近端部分的最近端部没有被喷涂。
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EP1572284A4 (en) | 2006-12-27 |
CA2508784C (en) | 2012-03-06 |
JP2006508744A (ja) | 2006-03-16 |
ATE476213T1 (de) | 2010-08-15 |
AU2003299583A8 (en) | 2004-06-23 |
EP1572284B1 (en) | 2010-08-04 |
WO2004049970A2 (en) | 2004-06-17 |
CA2508784A1 (en) | 2004-06-17 |
EP1572284A2 (en) | 2005-09-14 |
WO2004049970A3 (en) | 2004-08-19 |
CN100581612C (zh) | 2010-01-20 |
DE60333667D1 (de) | 2010-09-16 |
US20150374957A1 (en) | 2015-12-31 |
US20050148902A1 (en) | 2005-07-07 |
AU2003299583A1 (en) | 2004-06-23 |
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