CN106308790A - 具有带一致长度脊的闭合电极组件的导管 - Google Patents

具有带一致长度脊的闭合电极组件的导管 Download PDF

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CN106308790A
CN106308790A CN201610507421.2A CN201610507421A CN106308790A CN 106308790 A CN106308790 A CN 106308790A CN 201610507421 A CN201610507421 A CN 201610507421A CN 106308790 A CN106308790 A CN 106308790A
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S.吴
S.民
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Biosense Webster Israel Ltd
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Abstract

本发明题为“具有带一致长度脊的闭合电极组件的导管”。本发明涉及一种导管，所述导管包括细长导管主体，和在导管主体远侧的电极组件，所述组件包括多个脊，其中每个脊具有连接到至少一个其他脊的远侧端部的远侧端部，其中每个脊具有电极承载部分，所述组件的所有脊的电极承载部分在单个共用平面中，并且其中所述组件的所有脊具有一致的暴露总长度。

Description

具有带一致长度脊的闭合电极组件的导管
技术领域
本发明涉及导管，具体地，涉及用于组织诊断和消融的血管内导管。
背景技术
当心脏组织区域异常地向相邻组织传导电信号时，便会发生心率失常诸如心房纤颤，从而扰乱正常的心动周期并导致心律不齐。不期望的信号的重要来源位于组织区域中，例如，心房中的一个和心室中的一个。无论来源如何，无用信号在别处传导通过心脏组织，在心脏组织中这些信号可引发心律失常或使心律失常继续。
用于治疗心律失常的操作包括以外科手术方式扰乱造成心律失常的信号来源，以及扰乱用于此类信号的传导通路。最近，已发现通过标测心内膜和心脏容量的电学性质，并通过施加能量选择性地消融心脏组织，可停止或改变无用电信号从心脏的一部分到另一部分的传播。消融过程通过形成非传导性的消融灶来破坏无用电通路。
在这个两步操作中(标测，然后消融)，通常通过将包括一个或多个电传感器的导管推进到心脏中并获取多个点处的数据来感测并测量心脏中各个点的电活动。然后利用这些数据来选择将要进行消融的目标区域。
为实现更好的标测分辨率，希望标测导管通过使用多个感测小区域(例如，约一平方厘米)内电活动的电极来提供非常高密度的信号标测。对于心房或心室(例如，心室的顶点)内的标测，希望电极组件在较短时间跨度内收集较大量的数据信号。还希望此电极组件可适于不同的组织表面，例如，平坦的、弯曲的、不规则的或非平面的表面组织，但在感测和标测期间仍保持在大体维持电极空间关系的预定构型中。在更复杂的电极几何形状的情况下，也希望电极组件可易于塌缩以推进通过引导护套。
发明内容
本发明包括一种具有虽然几何形状复杂但易于塌缩的远侧电极组件或阵列的导管。在一些实施方案中，本发明的导管包括细长导管主体，和在导管主体远侧的电极组件，所述组件包括多个脊，其中每个脊具有连接到至少一个其他脊的远侧端部的远侧端部，其中每个脊具有电极承载部分，所述组件的所有脊的电极承载部分在单个共用平面中，并且其中所述组件的所有脊具有一致的暴露总长度。
在更详细的实施方案中，电极承载部分为线性的，其中电极承载部分可彼此平行。
在更详细的实施方案中，电极承载部分与导管的纵向轴线平行。
在更详细的实施方案中，阵列具有纵向对称性，其中每个脊可具有对应的脊。
在更详细的实施方案中，每个脊具有至少一个分开的近侧部分并且/或者每个脊具有至少一个会聚的远侧部分。
在更详细的实施方案中，至少一个脊具有分开的近侧部分和会聚的近侧部分，会聚的近侧部分在分开的近侧部分的远侧。
在更详细的实施方案中，至少一个脊具有会聚的远侧部分和分开的远侧部分，分开的远侧部分在会聚的远侧部分的近侧。
在更详细的实施方案中，多个脊的范围介于约2个与8个之间，并且更优选地介于约3个与6个之间。
附图说明
通过参考以下结合附图考虑的详细说明，将更好地理解本发明的这些和其他特征以及优点，其中：
图1为根据一些实施方案的本发明的导管的透视图。
图2A为沿第一直径截取的图1的导管的侧面剖视图，其包括在导管主体与偏转节段之间的接合部。
图2B为沿大体垂直于第一直径的第二直径截取的图1的导管的侧面剖视图，其包括图2A的接合部。
图2C为沿线C-C截取的图2A和图2B的偏转节段的端部剖视图。
图3A为沿第一直径截取的图1的导管的侧面剖视图，其包括在偏转节段与远侧电极组件之间的接合部。
图3B为沿大体垂直于第一直径的第二直径截取的图3A接合部的侧面剖视图。
图3C为沿线C-C截取的图3A和3B的偏转节段的端部剖视图。
图3D为沿线D-D截取的图3A的接合部的端部剖视图。
图4为偏转节段与远侧电极组件之间的接合部的透视图，其中部分被剖开。
图5A为图1的远侧电极组件的透视图。
图5B为沿线B-B截取的安装在图5A的脊上的环形电极的端面剖视图。
图5C为图5A的远侧电极组件的脊支撑件和安装杆的透视图。
图5D为图5C的脊支撑件和安装杆的侧视图。
图5E为根据本发明一个实施方案的电极阵列的两个脊的顶视图。
图6A为根据一个实施方案的安装在脊上的灌注型环形电极的透视图。
图6B为沿线B-B截取的图6A的灌注型环形电极的侧面剖视图。
图6C为沿线B-B截取的图6B的灌注型环形电极的端部剖视图。
具体实施方式
如图1所示，导管10包括细长导管主体12、中间偏转节段14、具有多个脊25的远侧电极组件或阵列15以及附接到导管主体12的近侧端部的偏转控制把手16。根据本发明的特征，远侧电极阵列15包括多个脊支撑件，脊支撑件能够使脊以有效利用空间的方式安装到导管的远侧末端，该方式容纳更复杂的脊的几何形状同时改善电极到组织的接触并且改善导管的可制造性。
参考图2A和图2B，导管主体12包括具有单个轴向管腔或中心管腔18的细长管状构造。导管主体12是柔性的，即能够弯曲的，但是沿其长度基本上不可压缩。导管主体12可具有任何合适的构造并且可由任何合适的材料制成。在一些实施方案中，导管主体12包括由聚氨酯或PEBAX制成的外壁20。外壁20包括不锈钢等的嵌入式编织网，以增大导管主体12的扭转刚度，使得当控制把手16旋转时，导管10的中间节段14以对应的方式进行旋转。
导管主体12的外径并非关键。同样，外壁20的厚度也不是关键的，但要足够薄，使得中心管腔18可容纳牵拉线、一根或多根引线和任何其他所需的线材、缆线或管。如果需要，外壁20的内表面衬有刚性管22，以提供改善的扭转稳定性。
如图2A、图2B和图2C所示，中间节段14包括管19的较短节段，管19具有多个管腔，例如，四个偏轴管腔31、32、33和34。第一管腔31承载用于安装在阵列15上的环形电极37的多根引线40S。第二管腔32承载第一牵拉线24。第三管腔33承载用于电磁位置传感器42的缆线36以及用于在远侧电极阵列15近侧的导管上承载的远侧环形电极38D和近侧环形电极38P的多根引线40D和40P。第四管腔34(例如，在例示的实施方案中与第二管腔32沿直径相对)承载第二牵拉线26。管19由合适的无毒材料制成，所述材料优选地比导管主体12更具柔性。用于管19的一种合适的材料为编织聚氨酯，即具有嵌入的编织不锈钢等的网的聚氨酯。每个管腔的尺寸并非关键，但足以容纳引线、牵拉线、缆线和任何其他部件。
导管的可用长度，即除远侧电极阵列15以外可插入体内的部分，可根据需要变化。优选地，可用长度在约110cm至约120cm的范围内。中间节段14的长度是可用长度的相对较小部分，并且优选地在约3.5cm至约10cm的范围内，更优选地在约5cm至约6.5cm的范围内。
图2A和图2B中示出了用于将导管主体12附接到中间节段14的装置。中间节段14的近侧端部包括接收导管主体12的内表面的外周边凹口27。中间节段14和导管主体12通过胶等附接。
如果需要，可在导管主体内将间隔件(未示出)定位在刚性管(如果提供)的远侧端部与中间节段的近侧端部之间。该间隔件在导管主体和中间节段的接合部处提供柔性过渡区，柔性过渡区允许此接合部平滑地弯曲而不折叠或扭结。具有此间隔件的导管在美国专利No.5,964,757中有所描述，其公开内容以引用方式并入本文。
如图3A和图3B所示，远侧电极阵列15包括安装于中间节段14的管19的远侧端部上的呈短管形式的安装构件或杆46。应当理解在导管不包括偏转节段的情况下，杆可安装在导管主体12的远侧端部上。杆46具有中心管腔48以容纳各种部件。中间节段14和杆46通过胶等附接。杆46可由任何合适材料构成，包括镍钛诺。
如图4所示，杆46容纳各种部件，包括例如电磁位置传感器42，以及用于牵拉线24和牵拉线26的远侧锚定件。在所公开的实施方案中，远侧锚定件包括一个或多个垫圈，例如，远侧垫圈50D和近侧垫圈50P，其中垫圈中的每个具有多个匹配的轴向通孔，所述通孔允许部件在偏转节段14与杆46之间通过，同时使这些部件相对于导管10的纵向轴线95维持轴向对准。如图3D和图4所示，通孔包括孔54和孔56，所述孔54和孔56分别与管19的第二管腔32和第四管腔34轴向对准，以分别接收牵拉线24和牵拉线26的远侧端部。应当理解，牵拉线24和牵拉线26可实际形成单个拉伸构件，该拉伸构件具有穿过孔54和孔56的远侧U形弯曲节段。利用由牵拉线24和牵拉线26的U形弯曲节段施加于垫圈50D和垫圈50P上的张力，垫圈牢固且固定地邻接偏转节段14的管19的远侧端部，以朝远侧锚定U形弯曲节段。
如图3D和图4所示，每个垫圈还包括通孔58，通孔58与第一管腔31轴向对准并允许引线40S从偏转节段14通过并且进入杆46的管腔48中。每个垫圈还包括通孔57，通孔57与第三管腔33轴向对准并且允许传感器缆线36从偏转节段14通过，进入其中容纳电磁位置传感器42的杆46的管腔48中。引线40D还穿过孔57以进入管腔48，用于经由形成于杆46的侧壁中的开口(未示出)附接到杆46的外表面上所承载的远侧环形电极38D，引线40D的远侧端部通过所述开口焊接到或以如在本领域中已知的其他方式附接到远侧环形电极38D。承载于中间偏转节段14的远侧端部附近的管19的外表面上的近侧环形电极38P经由形成于管19的侧壁中的开口87(图3B)连接到引线40P，开口87在第三管腔33与管19外部之间的提供连通。引线的远侧端部焊接到或以如在本领域中已知的其他方式附接到近侧环形电极38P。
远侧电极阵列15从偏转节段14的管19的远侧端部延伸(或者在导管无偏转节段的情况下，从导管主体12的远侧端部延伸)。如图5A的实施方案所示，阵列15包括多个细长脊25，细长脊25的远侧端部25T中的每个接合到至少另一个脊25的远侧端部25T。因此，阵列15具有闭合构型，在闭合构型中阵列无其远侧端部自由并且未连接到另一个脊的任何脊。在一些实施方案中，阵列15的每个脊25具有从纵向轴线95分开的至少一个近侧部分25PD和朝向纵向轴线95会聚的至少一个远侧部分25D。阵列15还包括所选择的脊，所述脊具有朝向纵向轴线95会聚的至少一个近侧部分25PC，和从纵向轴线95分开的至少一个远侧部分25DD，所述近侧部分25PC在分开的近侧部分25PD的远侧，所述远侧部分25DD在会聚的远侧部分25DC的近侧。多个脊的范围可介于约2个与8个之间，更优选地介于约4个与6个之间。
在一些实施方案中，阵列15纵向地对称，其中每个脊25跨越纵向轴线95具有相对的镜像对应部分，使用镜像对应部分，脊的远侧端部25T连接到脊的对应部分的远侧端部25T。
在一些实施方案中，每个脊具有在近侧部分25PD远侧的电极承载部分，一个或多个环形电极37安装在电极承载部分上。在一些实施方案中，每个脊的多个环形电极37的范围可介于约6个与12个之间，优选地介于约6个与9个之间，并且更优选为约8个。在一些实施方案中，这些电极承载部分为线性的，彼此平行并且/或者与纵向轴线95平行地延伸。在一些实施方案中，这些电极承载部分也全部位于单个共用平面中，即使其中近侧部分25PD并不位于单个共用平面中。在一些实施方案中，这些电极承载部分一致地侧向分开预定距离。
每个脊25包括形状记忆构件26和环绕的非导电管或覆盖件64。覆盖件64具有中心管腔65，形状记忆件26连同用于环形电极37的引线40S延伸穿过所述中心管腔65，如图5B所示。覆盖件64从杆46的远侧到脊的远侧尖端端部延伸脊25的暴露部分的长度。
在一些实施方案中，阵列15的每个脊的总暴露长度相等或一致。例如，如图5E所示，阵列的脊X和脊Y具有相等的总暴露长度XT和YT，其中XT＝YT，XT和YT中的每个限定如下。值得注意的是，长度X5和长度Y8为暴露长度，它们在杆46的远侧测量，以排除在杆46内部延伸的任何部分。
XT＝X1+X2+X3+X4+X5 (等式1)
YT＝Y1+Y2+Y3+Y4+Y5+Y6+Y7+Y8 (等式2)
有利地，带有具有相等暴露总长度的脊的阵列易于塌缩成细长布置，细长布置可更易于通过引导护套送入。阵列的纵向对称还有利于阵列塌缩成细长布置。
在一些实施方案中，形状记忆支撑构件62和杆46由具有形状记忆的材料制成，即，在施加力时该材料可从其初始形状暂时拉直或弯曲，并且能够在不存在所述力或去除所述力的情况下基本恢复至其初始形状。
一种用于支撑构件的合适材料为镍/钛合金。此类合金通常包括约55％的镍和45％的钛，但也可包括约54％至约57％的镍，剩余为钛。镍/钛合金为具有良好形状记忆性以及延展性、强度、抗腐蚀性、电阻率和温度稳定性的镍钛诺。脊支撑件可由片材料形成，所述片材料被例如冲切或激光切割成基座和脊的构型。非导电覆盖件64可由任何合适的材料制成，并且优选地由生物相容性塑料诸如聚氨酯或PEBAX制成。
在远侧电极阵列15和杆46的接合部，每个脊25的非导电覆盖件64可通过聚氨酯等在其近侧端部处附接并密封到杆46。
对于每个脊25，一个或多个环形电极37安装在覆盖件64上。在阵列15近侧，用于环形电极37的引线40S延伸穿过保护性聚合物管68。引线40S在聚合物管68的远侧端部附近分开，并且朝向它们相应的脊25延伸进入相应的非导电覆盖件64的管腔65中。如图5B所示，每根引线40S经由形成于覆盖件64的侧壁中的相应开口69连接到其相应的环形电极37，引线的远侧端部通过所述开口到达覆盖物64的外部并焊接到或以其他方式附接到其环形电极37。
在其他实施方案中，灌注型环形电极37I承载于脊25上，如图6A、图6B和图6C所示。脊25由多管腔的管80覆盖，管80具有例如用于形状记忆构件26的第一管腔81、用于引线40S的第二管腔82和第三管腔83，第三管腔83用于经由形成于管80的侧壁中的通道88将灌注流体传递到环状空间间隙G，所述间隙G在管80的外壁和形成有流体端口85的环形电极37I的侧壁之间。
分别用于脊环环形电极37及用于远侧环形电极38D和近侧环形电极38P的引线40S、40D和40P的近侧端部电连接到控制手柄16的远侧端部中的合适连接器(未示出)，所述连接器连接到如在本领域中已知的消融能量例如RF能量源。引线40S、40D和40P延伸穿过导管主体12的中心管腔18(图2B)。引线40S延伸穿过中间节段14的管19的第一管腔31，而引线40D和40P延伸穿过管19的第三管腔33(图2C和图3C)。穿过垫圈50D和垫圈50P中的孔58，引线40S延伸穿过保护性聚合物管68，聚合物管68保护引线40S免遭孔58损坏(图3D)。
在示出的实施方案中，延伸穿过导管主体12的中心管腔18和偏转节段14中的第一管腔31的引线40S可包封在护套94内，以防止与导管中的其他部件接触。护套可用任何合适的材料制成，优选的材料为聚酰亚胺。正如本领域的技术人员可认识到的，护套可根据需要被消除。
环形电极37、37I和38D及38P由任何合适的固体导电材料诸如铂或金，优选地铂和铱的组合制成，并且可用胶等安装到非导电覆盖件64和杆46上。另选地，环形电极可通过用导电材料例如铂、金和/或铱涂覆非导电覆盖件64和杆46而形成。可使用溅射、离子束沉积或等同技术来涂敷该涂层。
在一些实施方案中，承载于脊25上的每个环形电极相对短，其具有从约0.4mm至约0.75mm范围内的长度。此外，电极可成对布置，其中相比于它们与其他电极对的间隔，一对的两个电极彼此间隔更加紧密。相对于远场心房信号，紧密间隔的电极对允许更准确地检测近场肺静脉电势，这在试图治疗心房纤颤时非常有用。具体地，近场肺静脉电势为极小的信号，而位于极接近肺静脉处的心房提供大得多的信号。因此，即使当标测阵列被放置于肺静脉区域中时，医师仍可能难以确定信号是小的近电势(来自肺静脉)还是较大的较远电势(来自心房)。紧密间隔的双极性电极允许医师更准确地确定他正看着近信号还是远信号。因此，通过具有紧密间隔的电极，能够精确瞄准具有肺静脉电势的心脏组织的位置，并且因此允许临床医生将治疗递送至特定组织。此外，紧密间隔的电极允许医师通过电信号确定孔/口的精确解剖位置。
在一些实施方案中，近侧电磁位置传感器42容纳在杆的管腔中(图4)。传感器缆线36从位置传感器42的近侧端部延伸，并且通过垫圈50的孔57(图3D)、偏转节段14的管19的第三管腔33(图2C)和导管主体12的中心管腔18(图2B)。缆线36附接到控制手柄16中的如在本领域中已知的印刷电路板。在一些实施方案中，一个或多个远侧电磁位置传感器可容纳在阵列中，例如，在阵列的一个或多个远侧位置中。传感器缆线36D可延伸穿过脊覆盖件64的管腔65(图5B)或管80的第四管腔84(图6B)。
如图2A和图2C所示，提供牵拉线24和牵拉线26(无论是作为两个独立的拉伸构件还是单个拉伸构件的部分)用于中间节段14的双向偏转。牵拉线24和牵拉线26由控制把手16中的机构致动，所述机构响应于拇指控制旋钮或偏转控制旋钮11。美国专利No.6,123,699、No.6,171,277、No.6,183,435、No.6,183,463、No.6,198,974、No.6,210,407和No.6,267,746中公开了合适的控制手柄，这些专利的全部公开内容均以引用方式并入本文。
牵拉线24和牵拉线26延伸穿过导管主体12的中心管腔18(图2A)并且分别穿过偏转节段14的管19的第二管腔32和第四管腔34(图2C)。如图3A和图3C所示，它们分别延伸穿过垫圈50的孔54和孔56。在牵拉线为单个拉伸构件的一部分的情况下，单个拉伸构件在远侧垫圈50D的远侧面处具有U形弯曲部24/26U(图3A)，U形弯曲部24/26U锚固牵拉线的远侧端部。关于这一点，U形弯曲部延伸穿过短的保护管70以保护牵拉线不受孔54和孔56的影响。另选地，在牵拉线为独立拉伸构件的情况下，其远侧端部可经由如在本领域中已知的并在例如美国专利No.8,603,069中描述的T形条锚固，该专利的全部内容以引用方式并入本文。在任一种情况下，牵拉线24和牵拉线26均由任何合适的金属制成，诸如不锈钢或镍钛诺，并且各自优选地涂覆有特氟隆等。涂层赋予牵拉线润滑性。牵拉线的直径优选在约0.006英寸至约0.010英寸的范围内。
压缩线圈66位于导管主体12的中心管腔18内，与每根牵拉线24成环绕关系，如图2B所示。每个压缩线圈66从导管主体12的近侧端部延伸至中间节段14的近侧端部。压缩线圈66由任何合适的金属制成，优选的金属为不锈钢。每个压缩线圈66紧紧地缠绕在它自身上，以提供柔性，即弯曲性，但可抗压缩。压缩线圈66的内径优选地稍大于其牵拉线的直径。每根牵拉线上的特氟隆涂层允许其在其压缩线圈内自由滑动。
压缩线圈66通过近侧胶接头(未示出)在其近侧端部处锚固到导管主体12的外壁20，并且通过远侧胶接头92在其远侧端部处锚固到中间节段14。两个胶接头均可包括聚氨酯胶等。可使用注射器等通过在导管主体12和管19的侧壁形成的孔来涂敷胶。此孔可通过例如刺穿被充分加热以形成永久性孔的侧壁的针等形成。然后将胶通过孔引入到压缩线圈66的外表面，并围绕外圆周芯吸，以围绕压缩线圈的整个圆周形成胶接头。
在中间偏转节段14的第二管腔32和第四管腔34内，每根牵拉线24和26延伸穿过塑料优选地为特氟隆的牵拉线护套39(图2A和图2C)，牵拉线护套39防止牵拉线在偏转节段14偏转时切入偏转节段14的管19的壁中。
在一些实施方案中，在阵列15近侧的环形电极38D和环形电极38P用作参考电极，用于3-D标测系统上的导管的可视化，所述标测系统为诸如可购自强生公司(BiosenseWebster,Inc.)的CARTO.RTM 3系统，该系统自动定位EM传感器42，处理来自电极38D和电极38P的参考位置值，电极38D和电极38P处于距一个或多个EM传感器42恒定位置处，并确定电极37和电极37I的位置且使电极阵列15的其余部分可视化。
已参考本发明的当前优选实施方案来呈现前述描述。本发明所属技术领域内的技术人员将会认识到，在未有意脱离本发明的原则、精神和范围的前提下，可对所述结构作出变更和更改。如本领域中的普通技术人员应理解的，附图未必按比例绘制。另外，不同实施方案的不同特征可按需或适当地组合。此外，本文所述的导管可被配置成施加各种能量形式，包括微波、激光、射频和/或冷冻剂。因此，上述描述不应视为仅与附图中所描述和示出的精密结构有关，而应视为符合以下具有最全面和合理范围的权利要求书，并作为权利要求书的支持。

Claims (15)

1.一种导管，包括：
细长导管主体；和
在所述导管主体远侧的电极组件，所述组件包括多个脊，
其中每个所述脊具有远侧端部，所述远侧端部连接到至少一个其他脊的所述远侧端部，
其中每个所述脊具有电极承载部分，所述组件的所有脊的所述电极承载部分在单个共用平面中，并且
其中所述组件的所有脊具有一致的暴露总长度。
2.根据权利要求1所述的导管，其中所述电极承载部分为线性的。
3.根据权利要求2所述的导管，其中所述电极承载部分彼此平行。
4.根据权利要求2所述的导管，其中所述电极承载部分与所述导管的纵向轴线平行。
5.根据权利要求1所述的导管，其中所述阵列具有纵向对称性。
6.根据权利要求1所述的导管，其中每个所述脊具有镜像对应的脊。
7.根据权利要求1所述的导管，其中每个所述脊具有至少一个分开的近侧部分。
8.根据权利要求1所述的导管，其中每个所述脊具有至少一个会聚的远侧部分。
9.根据权利要求1所述的导管，其中至少一个所述脊具有分开的近侧部分和会聚的近侧部分，所述会聚的近侧部分在所述分开的近侧部分的远侧。
10.根据权利要求1所述的导管，其中至少一个所述脊具有会聚的远侧部分和分开的远侧部分，所述分开的近侧部分在所述会聚的远侧部分近侧。
11.根据权利要求1所述的导管，其中每个所述脊具有非导电覆盖件。
12.根据权利要求1所述的导管，其中每个所述脊具有至少一个环形电极。
13.根据权利要求1所述的导管，其中每个所述脊具有至少一个灌注型环形电极。
14.根据权利要求1所述的导管，其中所述多个脊的范围在介于约2个与8个之间。
15.根据权利要求1所述的导管，其中所述多个脊的范围介于约3个与6个之间。
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CN106308790B (zh) 2021-06-08
US20200221966A1 (en) 2020-07-16
RU2016124801A (ru) 2017-12-27
IL246416B (en) 2020-11-30
US20190175043A1 (en) 2019-06-13
US10575742B2 (en) 2020-03-03
US10602948B2 (en) 2020-03-31
CA2934209A1 (en) 2016-12-30

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