CN106132294A - 用于提供血管压力测量的导管 - Google Patents

用于提供血管压力测量的导管 Download PDF

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CN106132294A
CN106132294A CN201580004600.8A CN201580004600A CN106132294A CN 106132294 A CN106132294 A CN 106132294A CN 201580004600 A CN201580004600 A CN 201580004600A CN 106132294 A CN106132294 A CN 106132294A
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conduit
pressure transducer
distal tip
internal part
interior axle
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G·麦卡弗瑞
F·斯维尼
B·奥康奈尔
C·墨菲
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Medtronic Vascular Galway ULC
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    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0001—Catheters; Hollow probes for pressure measurement
    • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters

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Abstract

在此披露一种用于提供血管病变处的压力测量值的导管。该导管包括外部部件，该外部部件具有用于横向进入其管腔的侧开口；以及内部部件，该内部部件可滑动地设置在该管腔内。该内部部件具有带有近侧端口的导丝管腔。当该内部部件相对于该外部部件纵向地平移时，通过该外部部件的该侧开口可进入该内部部件的该侧端口，以便横向接取导丝。第一压力传感器被设置成靠近该外部部件的远端并且第二压力传感器被设置成靠近该内部部件的远端，这样使得该内部部件与该外部部件之间的相对纵向平移允许该第一压力传感器与该第二压力传感器之间的距离变化。

Description

用于提供血管压力测量的导管
发明领域
本发明涉及一种用于提供血管压力测量的导管。
发明背景
血管中的狭窄或病变的严重性可通过获取相对于给定狭窄的近端压力测量值和远端压力测量值以及使用那些测量值用于计算血流储备分数(FFR)的值来评估。FFR被定义为在狭窄的远侧上取得的远端压力测量值(Pd)与在通常位于主动脉内的狭窄的近侧上取得的近端压力测量值(Pa)的比率。常规地，放置在柔性介入装置(诸如导丝)的远端部分上的传感器用来获取远端压力测量值Pd，而外部压力换能器经由管道流体地连接到导引导管上以用于获取近端或主动脉压力测量值Pa。FFR值的计算向病变提供狭窄的功能严重性的特定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的最佳值或正常值为1.00，而小于约0.80的值通常被视为重要的并且需要介入治疗。常见介入治疗选项包括气囊血管成形术和/或支架植入术。
通过冠状动脉的血流受到靠近病变(例如，在主动脉中)的压力产生的波动的影响，并且受到远离病变(例如，在微循环中)的压力产生的波动的影响。因此，不可能通过简单地测量跨病变的压力差来准确评估冠状动脉病变的严重性，这是因为在病变的远侧取得的压力测量值不纯粹是从血管的主动脉端传输的压力的余量。因此，对于冠状动脉内的FFR的有效计算来说，必须降低血管内的血管阻力。目前，药物充血活性剂(诸如腺苷)有助于降低并且稳定冠状动脉内的阻力。这些血管舒张剂降低阻力的显著波动以获取相对稳定和最小的阻力值。
尽管提出不同解决方案已经用来提供用于计算FFR值的近端压力测量值和远端压力测量值(Pa、Pd)，但本领域仍存在对于用于获取适合在计算针对给定狭窄的FFR值中使用的压力测量值的可替代装置和方法的需要。
发明概述
本文实施例涉及一种用于提供血管病变处的压力测量值的导管。该导管包括外部部件，该外部部件具有用于横向进入其管腔的侧开口；以及内部部件，该内部部件可滑动地设置在管腔内。内部部件具有带有近侧端口的导丝管腔。当内部部件相对于外部部件纵向地平移时，通过外部管状部件的侧开口可进入内部部件的侧端口，以便横向接取(accessto)导丝。第一压力传感器被设置成靠近外部部件的远端并且第二压力传感器被设置成靠近内部部件的远端，这样使得内部部件与外部部件之间的相对纵向平移允许第一压力传感器与第二压力传感器之间的距离变化。
附图简述
在如附图中所示的其实施例的下述描述中，本发明的前述和其他特征和优势将更加清楚。附图(结合在此并且形成说明书的一部分)进一步用来解释本发明的原理并且允许相关领域的技术人员实现和利用本发明。这些图不必按比例绘制。
图1是根据本文实施例的导管的透视侧视图。
图1A是沿着图1的线A-A截取的图1的导管的远端部分的放大截面图。
图1AA是根据另一实施例的用于图1的导管的替代尖端构造的放大截面图。
图1B是沿着图1的线B-B截取的图1的导管的近端部分的放大截面图。
图1C是沿着图1的线C-C截取的图1的导管的截面图。
图1D是图1的导管的远端尖端的透视图。
图2A是处于输送构型中的图1的导管的远端部分的部分截面的侧视图。
图2B是带有以距离D间隔开的其第一压力传感器和第二压力传感器的图1的导管的远端部分的部分截面的侧视图。
图2C是带有以距离D最大间隔开的其第一压力传感器和第二压力传感器的图1的导管的远端部分的部分截面的侧视图。
图3描绘根据本文实施例的导管的邻近脉管系统中的病变定位的远端部分。
图4描绘根据本文实施例的导管的跨脉管系统中的病变定位的远端部分。
图5是根据本文实施例的导管的与外部CPU/显示装置通信的手柄部件的描绘。
发明详细说明
现在参考图描述本发明的特定实施例，其中相同参考数字指示相同或功能类似的元件。术语“远端”和“近端”相对于治疗临床医师的位置或方向用在以下描述中。“远端”或“向远端”是远离临床医师或处于离开其方向的位置。“近端”或“向近端”是接近临床医师或朝向其方向的位置。
以下详细说明在本质上仅是示例性的，并且绝非旨在限制本发明或应用以及本发明的使用。尽管本文实施例的描述是在诸如冠状动脉、颈动脉和肾动脉的血管的治疗的情境中，但本发明还可以用来测量心脏瓣膜上方的压力梯度并且还可以用在被视为有用的任意其他身体通道中。此外，不旨在受到在前述技术领域、背景、简述或下述详细描述中出现的所表达或暗示的理论的束缚。
图1是根据本文实施例的用于提供狭窄或病变的目标部位处的压力测量值的导管100的透视侧视图。图1A是沿着图1的线A-A截取的导管100的截面图。图1B是沿着图1的线B-B截取的导管100的截面图。导管100包括细长外轴或管状部件102、细长内轴或部件104和手柄部件106。外轴102的近端101被附接到手柄部件106上并且外轴102的远端103具有靠近或邻近其附接的第一压力传感器120。在实施例中，压力传感器120至少部分地嵌入外轴102内以便减小该外轴轮廓，这可以通过将传感器定位到凹槽中并且施加粘合剂以将其保持在外轴中来实现。封装材料(诸如硅树脂)可以用来绝缘和保护传感器，并且还可以用来将传感器保持在适当位置。外轴102限定从其近端101到其远端103的管腔105，并且包括用于横向进入管腔105的侧开口110。侧开口110是具有第一端或近端115和第二端或远端117的纵向延伸的狭槽。在图1和图1A中示出的实施例中，压力传感器120被设置在侧开口110的远端并且与其对准。在其他实施例中，在不脱离本文范围的情况下，压力传感器120可以设置在围绕外轴102的圆周的另一位置处，该另一位置不与侧开口110对准。
内轴104在外轴102的管腔105内可滑动地延伸。内轴104的近端107可操作地联接到手柄部件106的致动机构108上。防止损伤的远端尖端124形成内轴104的远端109和远端端口123。远端尖端124具有附接到其上的第二压力传感器122，这样使得压力传感器122靠近或邻近内轴104的远端109设置。内轴104包括细长近端部分或区段112和远端部分或区段114。近端部分112被构造成具有柱状强度以便可推动并且根据本文实施例可以至少部分地由推丝(push wire)或海波管(hypotube)形成。远端部分114是从近端部分112延伸的聚合物管，该聚合物管的大小被设定成具有最小外直径以便允许内轴104跨狭窄或病变设置，而不会不希望地扰乱遍及其中的血流。远端部分114的远端121被紧固到远端尖端124上。远端部分114的近端119被构造用于形成内轴104的侧端口或开口116。如在图1A中所示，导丝管腔118从侧端口116延伸到内轴104的远端端口123并且因此由远端部分114和远端尖端124限定。导管100被构建成维持内轴104的侧端口116与外轴102的侧开口110的对准以便由此允许横向接取有待可滑动地接收通过导丝管腔118的导丝。在与此一致的另一实施例中，内轴104可以是带有近端部分112(具有用于增加的刚度的编织层和/或外部聚合物护套)和远端部分114(被形成为包括限定侧端口116的快速交换接头)的聚酰亚胺管。可替代地，部分或整个内轴104可以由聚醚嵌段酰胺(PEBAX)，或者带有或不带有编织层和/或通过利用海波管的另一热塑材料形成。
在图1、图1A、图1C和图1D中示出的实施例中，远端尖端124具有聚合材料并且可以包覆成型到远端部分114上或者形成为单独部分并且结合到其上。如在图1A和图1C中所示，由远端尖端124形成的导丝管腔118的部分相对于其中心轴线CA偏离中心。压力传感器122被容纳在传感器凹槽125中，该传感器凹槽形成在位于与导丝管腔118相反的中心轴线CA的侧面上的远端尖端124的厚壁TW内。远端尖端124的传感器凹槽125被形成为具有深度D，该深度允许压力传感器122设置在位于内轴104的远端部分114的外表面140下方的远端尖端124内。传感器凹槽125还向近端在远端部分114的远端121之上延伸以容纳压力传感器122的电连接126的外部部分，其中这些电连接的剩余部分在这些电连接延伸到手柄部件106时嵌入内轴104内和/或缠绕到内轴104上。远端尖端124包括锥形近端部分127，该锥形近端部分的大小被设定成在导管100处于输送构型中时可滑动地接收在外轴102的管腔105内，如下文参考图2A所描述。在此描述的远端尖端构造的优势在于，整体减小的外直径可被实现用于导管100以及具体的说内轴104，由于压力传感器122可以被设置成比压力传感器安装在远端部分114的外表面140上时(如在图1AA中所示以及下文所描述)更接近于内轴104的纵向轴线LA(如在图1A中所示)。
更具体地说，在图1AA中示出的替代实施例中，远端尖端124A可以包覆成型到内轴104的远端部分114的远端121的外表面140上，这样使得远端尖端124A环绕远端部分114。在这样一个实施例中，远端部分114延伸通过远端尖端124A的长度，这样使得导丝管腔118和远端端口123通过远端部分114形成。尽管图1AA的尖端构造可以产生更大的整体外直径，但由于远端尖端124A被整体设置在内轴104上，该构造提供更稳定的远端尖端以及通过内轴104的远端部分114的连续导丝管腔，从而可以改善跟踪性能。
在图1和图1B中示出的实施例中，致动机构108包括在手柄部件106的相应狭槽113内滑动的滑动件111。当滑动件111在狭槽113内向远端或向近端平移时，滑动件111使内轴104沿着纵向方向相对于外轴102相应地平移，以便由此使位于内轴104的远端109处的压力传感器122与位于外轴102的远端103处的压力传感器120之间的距离DV变化。在内轴104在外轴102的管腔105内的纵向平移过程中，内轴104的侧端口116在侧开口110的第一相对端115与第二相对端117之间相应地是可滑动的以便在不论什么时候通过导丝进入。因此，导管100是快速交换导管，这样使得在微创经皮介入手术过程中，仅导管的相对较短远端区段由导丝跟踪。参考图2A-2C，例如，当导管100处于不同构型中时，导丝130被示出延伸通过侧开口110、侧端口116和导丝管腔118。在图2A中，导管100被示出为在初始或输送构型中由导丝130跟踪，其中内轴104的远端尖端124的锥形近端部分127被接收在外轴102的远端103内并且传感器120、传感器122以最小距离“D最小”间隔开。在图2A的输送构型中，内轴104的侧端口116邻近外轴102的侧开口110的近端115设置。在图2B中示出的导管100的构型中，内轴104被示出为沿着导丝130相对于外轴102纵向平移以便将传感器120、传感器122以距离“D”间隔开，由此侧端口116被居中地设置在侧开口110的近端115与远端117之间。在图2C中示出的导管100的构型中，内轴104被示出为沿着导丝130相对于外轴102纵向平移以便将传感器120、传感器122以最大距离“D最大”间隔开，由此侧端口116邻近侧开口110的远端117设置。
在与此一致的方法中，导引导管(未示出)被跟踪通过脉管系统直到其远端被设置在分支血管的孔的主动脉近端内，感兴趣的病变或狭窄位于该分支血管内。参考图3，图3示出通过具有病变L的血管的一部分的血流Bf，导丝130前进通过跨病变L设置的导引导管。其后，图2A中示出的处于输送构型中的导管100由内在的导丝130跟踪来锁定病变L的目标部位并且被定位成使得内轴104的远端109靠近病变L。致动机构108的滑动件111接着在手柄部件106的狭槽113内向远端滑动以便使内轴104相对于外轴102向远端推进直到该内轴上的远端尖端124和压力传感器122定位在病变L的远端，如在图4中所示。因此，外轴102上的压力传感器120保持在病变L的近端。在一个实施例中，腺苷通过在冠状动脉内在该部位处推注给药，或者通过静脉连续输液给药以增强FFR值的压力测量值(Pa、Pd)的准确性。利用压力传感器120的近端压力测量值(Pa)和利用压力传感器122的远端压力测量值(Pd)接着被同时获得以提供病变的FFR值，即Pd/Pa。导管100接着可以完全从患者体内收回或者在体内重新定位在另一病变处并且过程被重复。
图5描绘手柄部件106，该手柄部件将压力测量值(Pa、Pd)与具有显示装置的CPU无线地通信。在一个实施例中，传感器120、122可以将所感测的压力传递给放大和过滤装置和包含在手柄部件106内的模数转换器(ADC)，该手柄部件与外部CPU和显示装置通信。在替代实施例中，CPU可以包含在手柄部件中或者是与显示装置分离的部件。
在本文实施例中，细长轴或管状部件和/或其部分或层可以由聚合物材料形成，这些聚合物材料的非穷尽实例包括聚对苯二甲酸乙二酯(PET)、聚丙烯、聚乙烯、聚醚嵌段酰胺共聚物(PEBA)、聚酰胺、氟聚合物和/或它们的分层的、混合的或共挤出的组合。在与此一致的细长轴或管状部件的其他实施例中，其近端部分可以是医用级不锈钢的海波管，其中其远端部分由上文列举的聚合物材料中的任一种形成。
用于第一压力传感器和第二压力传感器的电连接(诸如电源线)从对应传感器延伸到导管的手柄部件。在与此一致的细长轴或管状部件的其他实施例中，轴或其一部分可以由覆盖有电源线层和聚合物外护套的管状聚合物内衬形成。在一个这样的实施例中，用于内轴和外轴的对应压力传感器的电源线可以缠绕到对应轴的内衬上用于所有轴或者至少轴的一部分并且通过聚合物外护套紧固在适当位置中以便嵌入轴内。在另一个这样的实施例中，用于内轴和外轴的对应压力传感器的电源线针对区段或者针对轴的整个长度可以是笔直的并且通过聚合物外护套抵靠内衬紧固在适当位置中以便嵌入轴内。
根据本文实施例的压力感测导管可以用在除了提供用于计算FFR值的近端压力测量值和远端压力测量值(Pa、Pd)的其他地方。例如，根据本文实施例的压力感测导管可以用来提供沿着脉管系统或其中特定病变的的任意位置的体内压力测量值。同样，本文实施例可以用来提供跨心脏瓣膜、静脉瓣或可以被视为有用的身体内的其他瓣膜位置的体内压力测量值。
虽然以上已经描述了不同实施例，但应理解，这些实施例仅作为本发明的说明和实例而不是通过限制性的方式来呈现。相关领域技术人员将明白的是，在不背离本发明的精神和范围的情况下，可以做出形式上和细节上的不同变化。因此，本发明的宽度和范围不应当由上述示例性实施例中的任一个来限制，但是应当仅根据所附权利要求和它们的等同物来限定。还将理解，在此所论述的每个实施例的每个特征，以及在此所引用的每个参考的每个特征可以结合任意其他实施例的特征使用。在此所论述的所有专利和公开以其整体通过引用结合在此。

Claims (20)

1.一种导管，包括：
外部管状部件，该外部管状部件具有用于横向进入其管腔的侧开口并且包括靠近其远端设置的第一压力传感器；以及
内部部件，该内部部件具有在该内部部件的侧端口与远端端口之间延伸的导丝管腔，并且包括靠近其远端设置的第二压力传感器，
其中该内部部件被配置成在该外部管状部件的管腔内是纵向可平移的，使得该内部部件的侧端口在该外部管状部件的侧开口的第一相对端与第二相对端之间是可滑动的，并且其中该内部部件相对于该外部管状部件的纵向平移允许该第一压力传感器与该第二压力传感器之间的距离变化。
2.如权利要求1所述的导管，其中该第二压力传感器被设置在该内部部件的远端尖端内。
3.如权利要求2所述的导管，其中当该导管处于用于跟踪通过脉管系统到达治疗部位的输送构型中时，该远端尖端的锥形近端部分被接收在该外部部件的远端内。
4.如权利要求2所述的导管，其中该内部部件包括附接到该远端尖端的管状远端部分并且其中该管状远端部分和该远端尖端限定该内部部件的该导丝管腔。
5.如权利要求4所述的导管，其中该导丝管腔在该远端尖端内延伸的一部分相对于该远端尖端的中心轴线偏离中心。
6.如权利要求2所述的导管，其中该第二压力传感器和从其延伸的电连接的至少一部分被设置在该远端尖端的传感器凹槽内。
7.如权利要求1所述的导管，其中该内部部件的近端可操作地联接到致动机构，该致动机构被配置成使该内部部件相对于该外部部件纵向地平移，以藉此改变该第一压力传感器与该第二压力传感器之间的距离。
8.如权利要求7所述的导管，其中该致动机构是在手柄部件的相应狭槽内可滑动的滑动件。
9.如权利要求7所述的导管，其中该内部部件的至少近端部分是推丝和海波管中的一者。
10.如权利要求1所述的导管，其中该第一压力传感器被嵌入该外部部件的壁内以藉此减小该导管的整体轮廓。
11.如权利要求1所述的导管，其中该内部部件的侧端口与该外部部件的侧开口的对准允许横向接取有待可滑动地接收在该导丝管腔内的导丝。
12.一种导管，包括：
外轴，该外轴限定从其近端到其远端的管腔并且具有用于横向进入该管腔的侧开口，该外轴具有设置在其上的第一压力传感器，该第一压力传感器被定位在该侧开口的远端；以及
内轴，该内轴限定从该内轴的侧端口到该内轴的远端端口的导丝管腔，
其中该内轴在该外轴的管腔内是纵向可平移的，使得通过该外轴的侧开口可进入该内轴的侧端口，以便通过该内轴的侧端口可滑动地接收导丝，并且
其中该内轴包括具有设置在其上的第二压力传感器的远端尖端，使得该内轴相对于该外轴的纵向平移允许该第一压力传感器与该第二压力传感器之间的距离变化。
13.如权利要求12所述的导管，其中当该导管处于用于跟踪通过脉管系统到达治疗部位的输送构型中时，该远端尖端的锥形近端部分被接收在该外轴的远端内。
14.如权利要求12所述的导管，其中该内轴包括附接到该远端尖端的管状远端部分，该管状远端部分具有大小被设定成可滑动地接收在该外轴的管腔内的外直径并且具有限定该内轴的侧端口的近端。
15.如权利要求14所述的导管，其中该管状远端部分和该远端尖端限定该内轴的该导丝管腔。
16.如权利要求15所述的导管，其中该导丝管腔在该远端尖端内延伸的一部分相对于该远端尖端的中心轴线偏离中心。
17.如权利要求12所述的导管，其中该内轴进一步包括可操作地联接到致动机构的近端，该致动机构被配置成使该内轴相对于该外轴纵向地平移，以藉此改变该第一压力传感器与该第二压力传感器之间的距离。
18.如权利要求17所述的导管，其中该致动机构是在手柄部件的相应狭槽内可滑动的滑动件。
19.如权利要求17所述的导管，其中该内轴的至少近端部分是推丝和海波管中的一者。
20.如权利要求12所述的导管，其中该第一压力传感器被嵌入该外轴内并且该第二压力传感器被嵌入该内轴的远端尖端内以藉此减小该导管的整体轮廓。
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Application publication date: 20161116