CN105848571A - 用于提供血管压力测量的双管腔导管 - Google Patents
用于提供血管压力测量的双管腔导管 Download PDFInfo
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Abstract
揭示了一种用于提供在血管病变处的压力测量的导管。该导管包括管状部件,该管状部件具有沿其至少一个区段的双管腔,其中第一管腔充当压力入口,并且第二管腔允许导管在导丝上被跟踪。多个开口沿着管状部件的远侧区段定位,其在设置在体内时允许血液流入第一管腔中。压力传感器位于导管的柄部部件内或管状部件内,以与第一管腔的近端流体连通。当导管定位在血管病变处时,第一管腔经由所述多个窗口充满血液,使得压力传感器能够感测在导管的远端处的血液的压力。
Description
技术领域
本发明涉及一种用于提供血管压力测量的导管。
背景技术
通过获得相对于给定狭窄的近侧和远侧压力测量值并且使用这些测量值来计算血流储备分数(FFR)的值,可以评估血管中狭窄或病变的严重度。FFR被定义为在狭窄远侧获得的远侧压力测量值(Pd)和在通常在主动脉内的狭窄近侧获得的近侧压力测量值(Pa)的比率。常规地,置于诸如导丝的柔性介入装置的远侧部分上的传感器用来获得远侧压力测量值Pd,同时外部压力换能器经由管材流体连接到引导导管以用于获得近侧或主动脉压力测量值Pa。FFR值的计算提供了狭窄的功能严重度的病变特有指标,以便确定堵塞是否将血管内的血流限制到需要治疗的程度。健康血管中的FFR的最佳或正常值为1.00,而小于约0.80的值一般被认为是显著的并且需要介入治疗。常见的介入治疗方案包括球囊血管成形术和/或支架植入。
通过冠状动脉的血流受到在病变近侧(例如,在主动脉中)出现的压力波动以及在病变远侧(例如,在微循环中)出现的压力波动的影响。因此,不可能通过简单地测量横跨病变的压差而准确地评估冠状动脉病变的严重度,因为在病变远侧获得的压力测量值不纯粹是从血管的主动脉端传递的压力的残余。结果,为了有效地计算冠状动脉内的FFR,有必要减小血管内的血管阻力。当前,诸如腺苷的药理充血剂被施用以减小并稳定冠状动脉内的阻力。这些血管扩张剂减小阻力中的急剧波动,以获得相对稳定和最小的阻力值。
虽然已提出各种解决方案来提供远侧压力测量值Pd以用于计算FFR值,但本领域仍然需要用于获得适合在计算给定狭窄的FFR值的过程中使用的压力测量值的备选装置和方法。
发明内容
本发明的实施例涉及用于提供在血管病变处的压力测量的导管。在一个实施例中,导管包括:柄部部件,其具有设置在其中的压力传感器;和细长的管状轴,其联接到柄部部件。管状轴具有在其近端和远端之间延伸的血压管腔以及用于接纳穿过其中的导丝的导丝管腔,该导丝管腔在血压管腔内从远侧侧端口延伸至管状轴的远侧顶端。血压管腔在管状轴的近端处的柄部部件内的压力传感器和在管状轴的远端处的多个侧壁窗口之间提供流体连通。在根据本发明的方法中,当导管定位在血管病变的目标部位处时,血压管腔经由所述多个侧壁窗口充满血液,以使得压力传感器能够感测在管状轴的远端处的血液的压力。
在另一个实施例中,导管包括细长的管状部件,其具有近侧区段、过渡区段和远侧区段。近侧区段在管状部件的近端和过渡区段之间延伸,并且远侧区段在过渡区段和管状部件的远端之间延伸。远侧区段包括第一和第二管腔,其中,第二管腔被构造用于接纳穿过其中的导丝并且设置在第一管腔的至少一部分内,以在管状部件的过渡区段中的侧端口和管状部件的远侧顶端开口之间延伸。压力传感器至少部分地设置在第一管腔的近端处的过渡区段的管腔空间内,其中,第一管腔在压力传感器和远侧区段中的多个侧壁开口之间提供流体连通,所述多个侧壁开口被定位成邻近管状部件的远端。在根据本发明的方法中,当导管定位在血管病变的目标部位处时,第一管腔经由所述多个侧壁窗口充满血液,以使得压力传感器能够感测在管状部件的远端处的血液的压力。
附图说明
本发明的前述和其它特征和优点将从在附图中示出的本发明的实施例的以下描述显而易见。并入本文并形成说明书一部分的附图还用来说明本发明的原理,并且使得相关领域的技术人员能够制作和使用本发明。附图未按比例绘制。
图1是根据本发明的实施例的导管的侧视图。
图1A是沿着图1中的线A-A截取的图1所示导管的截面图。
图1B是图1A中的区域B的放大截面图。
图2是图1所示导管的远侧部分的透视图。
图2A是沿着图2中的线A-A截取的图2所示导管远侧部分的截面图。
图2B是根据本发明的另一个实施例的导管远侧部分的截面图。
图2C是沿着图2B中的线C-C截取的图2B所示导管远侧部分的横截面图。
图3是根据本发明的另一个实施例的导管的侧视图。
图3A是沿着图3中的线A-A截取的图3所示导管的截面图。
图4是根据本发明的另一个实施例的导管的远侧区段的一部分的透视图。
图4A是沿着图4中的线A-A截取的图4所示导管的远侧区段的部分的截面图。
图5A和图5B是根据本发明的另一个实施例的导管的远侧区段的一部分的截面图。
图6是根据本发明的另一个实施例的导管的远侧区段的一部分的透视图。
图7是根据本发明的另一个实施例的导管的侧视图。
图7A是沿着图7中的线A-A截取的图7所示导管的柄部部分的截面图。
图7B是图7所示导管的柄部部分的透视局部截面图。
图8是根据本发明的实施例的横跨脉管系统中的病变定位的导管的远侧部分的描绘。
图9是根据本发明的实施例的与外部CPU和显示器通信的压力传感器的描绘。
具体实施方式
现在将参照附图描述本发明的具体实施例,其中,类似的附图标记指示相同的或功能上类似的元件。术语“远侧的”和“近侧的”在下面的描述中结合相对于治疗临床医生的位置或方向而使用。“远侧的”和“向远侧”是背离临床医生的位置或在远离临床医生的方向上,并且“近侧的”和“向近侧”是靠近临床医生的位置或在朝向临床医生的方向上。
以下详细描述在本质上仅为示例性的,而并非意图限制本发明或本发明的应用和用途。虽然本发明的实施例的描绘是在诸如冠状动脉、颈动脉和肾动脉的血管的治疗的背景下进行,但本发明也可以用来测量在心脏瓣膜上的压力梯度,并且也可以在认为有用的任何其它身体通道中使用。此外,不打算受限于此前的技术领域、背景技术、发明内容或以下的具体实施方式中所提供的任何明示的或隐含的理论。
图1是根据本发明的实施例的用于提供在狭窄或病变的目标部位处的压力测量的导管100的侧视图,图1A是沿着图1的线A-A截取的导管的截面图。导管100包括具有近端101和远端103的细长的管状轴或部件102。柄部部件104联接到管状轴102的近端101,以便可由使用者触及以进行操纵。
管状轴102具有近侧区段106、过渡区段108和远侧区段110。近侧区段106在管状轴的近端101和过渡区段108之间延伸并且限定第一或压力管腔112的近侧部分111。压力管腔近端111也可以被描述为在管状轴的近端101和过渡区段108之间纵向延伸。
远侧区段110在管状轴的过渡区段108和远端103之间延伸,远端103在本文中也被称为导管100的远侧顶端103。参照图2和图2A,图2描绘了导管100的过渡区段108和远侧区段110的透视图,图2A描绘了沿着图2的线A-A截取的远侧区段110的一部分的截面图,远侧区段110包括聚合物外管120和聚合物内管或导丝管122。第一管腔112的远侧部分113限定在外管120的内表面119和内管122的相对的外表面121之间,使得第一管腔112的远侧部分113可以被描述为具有环状横截面。远侧区段110的内管122限定第二管腔114,第二管腔114在第一管腔112的远侧部分113内延伸并且与远侧部分113同轴。第二管腔114尺寸设计成接纳穿过其中的导丝并且可以被称为导丝管腔。第一管腔112的远侧部分113和第二管腔114中的每一个也可以被描述为在过渡区段108和管状轴远端103之间纵向延伸,其中第二管腔114限定远侧顶端开口124。
多个开口或窗口126形成为穿过远侧区段110的侧壁127以与第一管腔远侧部分113流体连通。如在图2和图2A中最清楚所示,第一管腔112的环状远侧部分113的远端115在邻近或靠近远侧顶端开口124处封闭或加盖,使得血液流入第一管腔112的唯一远侧通路由远侧侧壁开口或窗口126提供。在一个实施例中,导管100的远侧顶端103可以是单独的无创伤顶端部件,该部件封闭或加盖于第一管腔112的远侧部分113的远端115。在另一个实施例中,第一管腔112的远侧部分113的远端115可以通过使用激光、热箱或粘合剂使顶端区域中的内管和外管的聚合物回流来封闭或加盖。
在图1所示实施例中,所述多个侧壁开口126为正方形孔口,其以相等数目的组或列等间距地围绕远侧区段110的圆周。在图2B和图2C所示的另一个实施例中,多个侧壁开口226不等间距地围绕远侧区段210的圆周,而是穿过远侧区段210的外管220的一侧形成,以与第一管腔212的远侧部分213流体连通。同样在图2B和图2C的实施例中,由远侧区段210的内管222限定的第二管腔214与远侧区段210的纵向轴线LA错开,使得第二管腔214与第一管腔212的远侧部分213不同心。第一管腔212为压力管腔,以用于接纳来自所述多个侧壁开口226的血液并且使血液与近侧放置的传感器流体连通。第二管腔214尺寸设计成接纳穿过其中的导丝并且可以被称为导丝管腔。第一管腔212的环状远侧部分213的远端215在邻近或靠近第二管腔214的远侧顶端开口224处封闭或加盖,使得血液流入第一管腔212的唯一远侧通路由所述多个侧壁开口226提供。
在根据本发明的其它实施例中,所述多个侧壁开口可以具有任何合适的形状、数目和尺寸。在图6所示的另一个实施例中,在根据本发明的导管的远侧区段610内的螺旋切口626可以用来将血液引入导管的压力管腔的远侧部分中,而不是多个侧壁开口中。在一个实施例中,根据图6的实施例的导管的所有其它特征类似于参照图1的实施例描述的特征。在另一个实施例中,根据图6的实施例的导管的所有其它特征类似于参照图3的实施例描述的特征。
参照描述图1A的快速交换接头区域B的放大截面图的图1B,管状轴102的过渡区段108之所以如此命名是因为它是导管100的这样一部分:其中,管状轴102的单管腔近侧区段106过渡到管状轴102的双管腔远侧区段110。过渡区段108形成为包括远侧侧端口116,远侧侧端口116有时被称为快速交换接头,并且限定接合第一管腔112的近侧部分111和远侧部分113的管腔空间128。换句话说,如从以上描述显而易见的,过渡区段108可以被视为在近侧区段106和远侧区段110之间纵向延伸,使得管腔空间128在第一管腔112的近侧部分111和远侧部分113之间提供流体连通。导管100的侧端口116设置在过渡区段108内并且提供到第二管腔114和远侧顶端开口124的通路,以用于接纳穿过其中的导丝(未示出)。因此,导管100为快速交换导管,使得在微创经皮介入手术期间,仅导管的相对短的远侧区段110在导丝上被跟踪。同样根据本发明的实施例,导管100为微导管,其具有最小外径,以使得导管能够定位成横跨狭窄或病变,而不会不期望地破坏穿过其中的血流。
柄部部件104包括设置在其中的压力传感器130,压力传感器130与管状轴102的第一管腔112流体连通,如图1A所示。如此前所讨论的,由近侧部分111和远侧部分113以及管腔空间128的至少一部分构成的第一管腔112在管状轴102的近端101和远端103之间延伸。因此,第一管腔112在管状轴近端101处的柄部部件104内的压力传感器130和在管状轴远端103处的所述多个侧壁开口126之间提供流体连通。在使用中,当导管100被推进或跟踪至体内目标部位时,第一管腔112经由所述多个侧壁开口126在与导管顶端处的血液相同的压力下充满血液,从而使柄部部件104中的压力传感器130能够感测在导管的远侧顶端103处的血液的压力。根据本发明的实施例,压力传感器130接着与CPU和显示装置通信压力测量值,如图9所示。
将传感器130设置在用于提供狭窄远侧的压力测量的导管100的柄部部件104内,而不是像在已知的压力感测导丝的实践中那样将传感器附接在导丝的远端处,这样的益处是可以使用种类更多的压力传感器。另外,柄部部件104内的外壳传感器130使得不需要诸如丝的传感器的电连接件在导管的远端和近端之间延伸,这简化了医疗装置的制造并降低了制造成本。
图3是根据本发明的另一个实施例的用于提供在狭窄或病变的目标部位处的压力测量的导管300的侧视图,图3A是沿着图3的线A-A截取的导管的截面图。本文将不再进一步详细描述类似于导管100的相同特征的导管300的特征。导管300包括细长的管状部件302,管状部件302具有近端301和远端303,远端303在本文中也称为导管300的远侧顶端303。柄部部件304联接到管状部件302的近端301,以便可由使用者触及以进行操纵。如参照此前的实施例类似地描述的,管状部件302具有近侧区段306、过渡区段308和远侧区段310,其中近侧区段306在管状部件近端301和过渡区段308之间纵向延伸,并且远侧区段310在过渡区段308和管状部件远端303之间纵向延伸。
在图3的实施例中,管状部件302的远侧区段310包括外管320和内管322。第一或压力管腔312的远侧部分313限定在外管320和内管322的相对表面之间,使得第一管腔312的远侧部分313可以被描述为具有环状横截面。过渡区段308限定管腔空间328并且形成为包括远侧侧端口316。过渡区段308的管腔空间328为第一管腔312的近侧部分,使得管腔空间328和远侧部分313一起形成导管300的压力管腔。远侧区段310的内管322限定第二管腔314,第二管腔314在过渡区段308中的侧端口316和导管300的远侧顶端开口324之间延伸。内管322可以被描述为在第一管腔312的远侧部分313内延伸。类似于此前的实施例,导管300为快速交换导管,其中侧端口316、第二管腔314和远侧顶端开口324中的每一个被构造用于接纳穿过其中的导丝。
不同于其中压力传感器设置在导管的柄部部件内的此前的实施例,在图3的实施例中的压力传感器330设置在近侧区段306的远端307处,以安放在过渡区段308的管腔空间328内,管腔空间328如上文所指形成第一管腔312的近侧部分。在其它实施例中,压力传感器330可以完全设置在近侧区段306内,或者可以设置成在近侧区段306和过渡区段308之间延伸。在图3A所示实施例中,压力传感器330设置在侧端口316近侧的过渡区段308内,以便处于过渡区段的近端处或附近。为了容纳压力传感器330的电连接件332,管状部件302的近侧区段306限定第三管腔或电导管318,电导管318不与第一管腔312或第二管腔314中的任一者流体连通,而是与其电气隔离或绝缘。第三管腔318被构造用于接纳压力传感器330的电连接件332,使得电连接件可以穿过近侧区段306延伸至管状部件近端301和/或柄部部件304。
由管腔空间328和远侧部分313构成的第一管腔312在近侧区段306的远端307和导管的远端303之间延伸,使得第一管腔312在压力传感器330和远侧区段310中的多个侧壁开口或窗口326之间提供流体连通。如在参照图2和图2A的此前的实施例中类似地所述,第一管腔312的环状远侧部分313的远端(未示出)在邻近或靠近远侧顶端开口324处封闭或加盖,使得血液流入第一管腔312的唯一远侧通路由远侧侧壁开口或窗口326提供。在使用中,当导管300被推进或跟踪至体内目标部位时,第一管腔312经由所述多个侧壁开口326在与导管顶端处的血液相同的压力下充满血液,从而使压力传感器330能够感测在导管的远侧顶端303处的血液的压力。
将传感器330放置在快速交换过渡接头的近侧(即,在不存在导丝管腔的过渡区段308的近端处)的益处在于:可以使用比目前已知附接在压力感测导丝的远端处的压力传感器更多种类的压力传感器。另外,在近侧区段306的远端处的外壳传感器330允许电连接件332从传感器延伸至在近侧区段306的第三管腔318内的导管的近端,这简化了医疗装置的制造并降低了制造成本。
在上述实施例中的每一个中,第一管腔的环状远侧部分的远端在邻近或靠近其远侧顶端开口处封闭或加盖。图4和图4A描绘了管状部件的远侧区段410的一部分,以用于在其中不采用远侧侧壁开口的根据本发明的另一个实施例的导管中使用。根据该实施例的导管的所有其它特征类似于参照此前的实施例所述的特征,并且在本文中不再详细地描述。远侧区段410包括外管420和内管422。内管422限定第二管腔414,其被尺寸设计成接纳穿过其中的导丝,并且可以被称为导丝管腔。在远侧区段410的远侧顶端403处的环状开口434被限定在外管420和内管422各自的相对的内表面419和外表面421之间。环状开口434与导管的第一或压力管腔的远侧部分413流体连通,第一或压力管腔也被限定在外管420和内管422各自的相对的内表面419和外表面421之间。根据本发明的一个实施例,来自远侧顶端403的血流通过环状开口434和压力管腔的远侧部分413流体连通至安放在柄部部件内的压力传感器,如图所示并且如在图1的实施例中所述。根据本发明的另一个实施例,来自远侧顶端403的血流通过环状开口434和压力管腔的远侧部分413流体连通至安放在过渡区段内的压力传感器,如图所示并且如在图3的实施例中所述。
图5A和图5B描绘了管状部件502的远侧区段510的一部分,以用于在其中不采用远侧侧壁开口的根据本发明的另一个实施例的导管中使用。根据该实施例的导管的所有其它特征类似于参照此前的实施例所述的特征,并且在本文中不再详细地描述。管状部件502包括在其远侧顶端503处的环状开口534,环状开口534限定在远侧区段510的外管520和内管522各自的相对的内表面519和外表面521之间。环状开口534与导管的第一或压力管腔512流体连通。然而,不同于图4的实施例,环状开口534经由形成于环形间隔件或支撑构件538内的多个横向开口536与压力管腔512流体连通,环形间隔件或支撑构件538横向地设置在相对的外表面519和内表面521之间。虽然横向开口536在图5B中示出为具有四边多边形形状,但在根据本发明的各种其它实施例中,横向开口可以具有任何合适的形状,例如正方形或圆形,可以是数目上更少或更多,和/或可以具有任何合适的尺寸或各种尺寸。这样,在使用期间,围绕远侧顶端503的血流经由环状开口534和所述多个横向开口536流体连通至第一管腔512。根据本发明的一个实施例,在第一管腔512内的血液流体连通至安放在柄部部件内的压力传感器,如图所示并且如在图1的实施例中所述。根据本发明的另一个实施例,在第一管腔512内的血液流体连通至安放在其过渡区段内的压力传感器,如图所示并且如在图3的实施例中所述。
图7是根据本发明的另一个实施例的用于提供在狭窄或病变的目标部位处的压力测量的导管700的侧视图。图7A是沿着图7的线A-A截取的导管700的柄部部件704的截面图。图7B是部分截面的柄部部分704的透视端视图。导管700包括具有近端701和远端703的细长的管状轴或部件702。柄部部件704联接到管状轴702的近端701,以便可由使用者触及以进行操纵。
管状轴702是双管腔结构,其具有第一或压力管腔712和第二或导丝管腔714。导管700的压力管腔712在设置在柄部部件704内的压力传感器730和设置在管状轴702的远端703近侧的多个侧壁开口726之间纵向延伸。相比在此前的实施例中描述的导管,导管700的导丝管腔714从柄部部分704的近侧端口766延伸至在远端703处的远侧顶端开口(未示出)。因此,导管700可以被描述为在丝上的导管。在一个实施例中,管状轴702可以由外管和内管构成,其中压力管腔限定在外管和内管的相对表面之间,并且导丝管腔由内管限定。在这样的实施例中,内管可以与外管同轴,如在图2A的实施例中类似地所示,或者可以与导管的纵向轴线错开,如在图2B中类似地所示。在另一个实施例中,管状轴702可以完全或部分地由双管腔挤出管形成,其具有沿着其长度或部分长度并排延伸的压力管腔和导丝管腔。
如在此前的实施例中且特别地参照图2和图2A类似地所述,压力管腔712的远端(未示出)在邻近或靠近远端703处被封闭或加盖,使得血液流入压力管腔712的唯一远侧通路由侧壁开口726提供。在使用中,当导管700被推进或跟踪至体内目标部位时,压力管腔712经由所述多个侧壁开口726在与导管的远端703处的血液相同的压力下充满血液,从而使压力传感器730感测在导管远端703处的血液的压力。
在根据本发明的方法中,引导导管(未示出)被跟踪通过脉管系统,直到其远端设置在所关注的病变或狭窄所处的分支血管的口近侧的主动脉内。参照图8(其示出了穿过具有病变L的血管的一部分的血流Bf),导丝G被推进通过引导导管以横跨病变L设置。然后,根据本发明的一个实施例的导管100、300、700在留置导丝G上被跟踪至病变L的目标部位,并且被定位成使得远侧顶端103、303和其压力入口侧壁开口或窗口126、326、726被定位在病变远侧,如图8所示。因此,压力传感器130、330在由导管100、300、700进行的远侧压力测量期间保持在病变L近侧。在一个实施例中,在部位处冠状动脉内施用、推注或通过连续输注在静脉内施用腺苷,以提供FFR值的准确的远侧压力测量值(Pd)。然后获得近侧压力测量值Pa(其由与引导导管相关联的外部AO压力换能器在主动脉中测得)和利用导管100、300、700的压力传感器130、330、730测得的同时的压力测量值Pd,以提供病变的FFR值,即,Pd/Pa。导管100、300、700可以接着被从患者完全撤出,或重新定位在体内另一病变处,并且重复过程。
图9描绘了柄部部件104、704内的传感器130、730,其与CPU和显示装置通信压力测量值。如上文此前所讨论的,传感器130、730连接到导管的压力管腔,该压力管腔被用加压至Pd的血柱充满。在一个实施例中,传感器130、730将感测的压力通信至放大和滤波装置,然后通信至模数转换器(ADC),模数转换器与外部的CPU和显示装置通信。在一个备选实施例中,CPU可以包含在柄部部件中或与显示装置一体化。用于将感测到的压力通信至CPU和/或显示装置的类似的布置可以在柄部部件304中使用,所不同的是,压力传感器330仍设置在过渡区段308内。
在本发明的实施例中,细长的管状轴或部件和/或其区段可以由聚合物材料形成,聚合物材料的不完全示例包括层合、共混或共挤出的聚对苯二甲酸乙二醇酯(PET)、聚丙烯、聚乙烯、聚醚-酰胺嵌段共聚物(PEBA)、聚酰胺、含氟聚合物、和/或它们的组合。在根据本发明的细长的管状轴或部件的其它实施例中,其近侧区段可以是医用级不锈钢的海波管,其中管状轴或部件的远侧区段的外管和内管由上文所列聚合物材料中的任一种形成。
根据本发明的实施例的压力感测导管可以用于除了提供用于计算FFR值的远侧压力测量值(Pd)之外的目的。例如,根据本发明的实施例的压力感测导管可以用来提供在沿着脉管系统的任何位置或其中的特定病变处的体内压力测量。另外,本发明的实施例可以用来提供在可能认为有用的心脏瓣膜、静脉瓣膜或身体内的其它瓣膜位置处或横跨这些位置的体内压力测量。
虽然上文已描述了各种实施例,但应当理解,这些实施例仅作为本发明的例示和示例提供,而不以任何方式进行限制。相关领域的技术人员应理解,在不脱离本发明的精神和范围的情况下,可以在这些实施例中进行形式和细节上的各种改变。因此,本发明的广度和范围不应受上述示例性实施例中任一个的限制,而应仅根据所附权利要求和它们的等同物限定。还应当理解,本文所讨论的每个实施例的每个特征以及本文所引用的每个参考文献都可结合任何其它实施例的特征使用。本文所讨论的所有专利和公开以引用方式全文并入本文中。
Claims (20)
1.一种用于提供在血管病变处的压力测量的导管,包括:
柄部部件,其具有设置于其中的压力传感器;
细长的管状轴,其联接到所述柄部部件,所述管状轴具有近端和远端、在所述近端和远端之间延伸的第一管腔以及在所述第一管腔内从所述管状轴中的远侧侧端口延伸至所述导管的远侧顶端的第二管腔,
其中,所述第一管腔提供在所述管状轴的所述近端处的所述压力传感器和在所述管状轴的所述远端处的一个或多个远侧开口之间的流体连通,并且所述第二管腔接纳穿过其中的导丝,并且
其中,当所述导管的所述远侧顶端定位在所述血管病变的目标部位处时,所述第一管腔经由所述一个或多个远侧开口充满血液,以使得所述压力传感器感测所述导管的所述远侧顶端处的血液的压力。
2.根据权利要求1所述的导管,其特征在于,所述第二管腔至少部分地由聚合物内管形成,所述聚合物内管固连以在所述管状轴的所述第一管腔内从所述远侧侧端口延伸至所述导管的所述远侧顶端。
3.根据权利要求2所述的导管,其特征在于,所述一个或多个远侧开口是限定在所述管状轴的相对表面和在所述导管的所述远侧顶端处的所述内管之间的环状开口。
4.根据权利要求2所述的导管,其特征在于,所述一个或多个远侧开口是形成于所述管状轴的相对表面和在所述导管的所述远侧顶端处的所述内管之间的多个开口。
5.根据权利要求1所述的导管,其特征在于,所述一个或多个远侧开口是穿过所述管状轴的侧壁的多个开口。
6.根据权利要求1所述的导管,其特征在于,所述管状轴还包括从所述近端到所述管状轴的过渡区段的海波管,所述海波管形成所述第一管腔的近侧部分。
7.根据权利要求6所述的导管,其特征在于,所述管状轴还包括从所述过渡区段到所述导管的所述远侧顶端的双管腔聚合物轴,所述双管腔聚合物轴包括所述第二管腔和所述第一管腔的远侧部分。
8.根据权利要求7所述的导管,其特征在于,所述过渡区段包括所述远侧侧端口。
9.根据权利要求1所述的导管,其特征在于,所述压力传感器在远侧压力测量期间保持在所述目标部位的近侧。
10.一种用于提供在血管病变处的压力测量值的导管,包括:
细长的管状部件,其具有近侧区段、过渡区段和远侧区段,所述近侧区段在所述管状部件的近端和所述过渡区段之间延伸,所述远侧区段则限定第一和第二管腔,其中,所述第二管腔在所述第一管腔的至少一部分内延伸以在所述管状部件的所述过渡区段中的侧端口和所述导管的远侧顶端开口之间提供流体连通,所述第二管腔被构造用于接纳穿过其中的导丝;以及
压力传感器,其至少部分地设置在所述第一管腔的近端处的所述过渡区段的管腔空间内,其中,所述第一管腔在所述压力传感器和所述远侧区段中的多个侧壁开口之间提供流体连通,所述多个侧壁开口被定位成邻近所述管状部件的远端,其中,当所述导管的远侧顶端定位在所述血管病变的目标部位处时,所述第一管腔经由所述多个侧壁开口充满血液,以使得所述压力传感器感测在所述导管的所述远侧顶端处的血液的压力。
11.根据权利要求10所述的导管,其特征在于,所述压力传感器设置在所述侧端口近侧的所述过渡区段内。
12.根据权利要求10所述的导管,其特征在于,所述近侧区段限定第三管腔,所述第三管腔不与所述第一或第二管腔中的任一者流体连通。
13.根据权利要求12所述的导管,其特征在于,所述压力传感器的电连接件在所述第三管腔内从所述管状部件的所述近端延伸至所述压力传感器。
14.根据权利要求13所述的导管,其特征在于,所述近侧区段为海波管,并且所述远侧区段包括一个或多个聚合物管。
15.根据权利要求10所述的导管,其特征在于,所述多个侧壁开口等间距地围绕所述远侧区段的圆周。
16.根据权利要求10所述的导管,其特征在于,所述第二管腔至少部分地由所述远侧区段的内管形成,所述内管固连以在所述远侧区段的所述第一管腔内从所述侧端口延伸至所述导管的所述远侧顶端开口。
17.根据权利要求16所述的导管,其特征在于,所述第一管腔具有形成于所述远侧区段的外管的相对的表面和所述内管之间的环状部分,其中所述第二管腔的所述环状部分的远端在靠近所述导管的所述远侧顶端开口处封闭。
18.根据权利要求10所述的导管,其特征在于,所述压力传感器在远侧压力测量期间保持在所述目标部位的近侧。
19.一种用于提供在血管病变处的压力测量的导管,包括:
柄部部件,其具有设置在其中的压力传感器;
细长的管状轴,其联接到所述柄部部件,所述管状轴具有一个或多个远侧开口;
第一管腔,其在所述压力传感器和所述管状轴的所述远端之间延伸,其中所述第一管腔在所述柄部部件内的所述压力传感器和所述管状轴的所述一个或多个远侧开口之间提供流体连通;以及
第二管腔,其延伸穿过所述柄部部件和所述管状轴至所述导管的远侧顶端,其中所述第二管腔接纳穿过其中的导丝,并且
其中,当所述导管的所述远侧顶端定位在所述血管病变的目标部位处时,所述第一管腔经由所述一个或多个远侧开口充满血液,以使得所述压力传感器感测在所述导管的所述远侧顶端处的血液的压力。
20.根据权利要求19所述的导管,其特征在于,所述一个或多个远侧开口为穿过所述管状轴的侧壁的多个开口。
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US14/080,484 US10130269B2 (en) | 2013-11-14 | 2013-11-14 | Dual lumen catheter for providing a vascular pressure measurement |
US14/080,484 | 2013-11-14 | ||
PCT/US2014/064991 WO2015073423A1 (en) | 2013-11-14 | 2014-11-11 | Dual lumen catheter for providing a vascular pressure measurement |
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US (1) | US10130269B2 (zh) |
EP (1) | EP3068291B1 (zh) |
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EP3068291A1 (en) | 2016-09-21 |
WO2015073423A1 (en) | 2015-05-21 |
US20150133800A1 (en) | 2015-05-14 |
EP3068291B1 (en) | 2018-05-23 |
US10130269B2 (en) | 2018-11-20 |
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