CN104337570B - 有具有两件式构造的改善的灌注末端电极的导管及制造法 - Google Patents
有具有两件式构造的改善的灌注末端电极的导管及制造法 Download PDFInfo
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Abstract
本发明公开了一种导管，所述导管具有两件式末端电极，该末端电极具有通过多个冗余机构彼此固定的外壳和支撑结构以便降低程序期间末端分离的风险。末端电极包括将外壳附接到支撑结构的至少两个不同的焊缝以提供双重失效模式。一个焊缝包括接缝焊缝并且另一个焊缝包括熔透焊缝。
Description
技术领域
本发明涉及电生理(EP)导管，具体地，用于消融心脏组织的EP导管。
背景技术
心脏组织消融是熟知的心律失常的治疗方法。例如，在射频(RF)消融中，将导管插入到心脏中并在目标位置处与组织接触。为了阻断组织中的致心律失常性电流路径的目的，然后RF能量透过导管上的电极施加到心脏组织至破坏性温度以便创建消融灶。
灌注导管现在常常用于消融程序中。灌注提供许多益处，包括冷却电极和组织，这防止组织过热，否则可导致相邻血液形成炭和凝结物。灌注末端电极是已知的，包括具有两件式构造的末端电极，该两件式构造具有内部支撑结构和安装在其上的外壳。在支撑结构和外壳之间形成腔体以提供充气腔室，该充气腔室使流体能够经由外壳中形成的流体口更均匀流出末端电极。然而，两件式构造要求额外安全措施，以当末端电极在患者体内时将外壳从支撑结构脱离的风险最小化。
因此，希望带有两件式末端电极的导管至少具有使外壳和支撑结构彼此固定的双重失效模式，以将外壳脱离的风险最小化。在外壳和支撑结构彼此焊接在一起的情况下，希望外壳和支撑结构由至少两种不同类型的焊缝的多于一种独立焊缝来附接。
发明内容
本发明涉及具有带有安装的外壳的末端电极的导管，该外壳由多个冗余的机构固定以便降低程序期间末端脱离的风险。末端电极包括将外壳附接到末端支撑结构的至少两个不同的焊缝以提供双重失效模式。一个焊缝包括接缝焊缝并且另一个焊缝包括熔透焊缝。
在一个实施例中，导管具有伸长的导管主体、位于导管主体近侧的控制手柄，和位于导管主体远侧的末端电极，该末端电极具有焊缝接合的外壳和支撑构件，该焊缝具有至少一个接缝焊缝和至少一个熔透焊缝。
在一个实施例中，至少一个接缝焊缝和至少一个熔透焊缝具有轴向重叠和/或周向重叠。
在一个实施例中，外壳具有边缘且支撑结构具有环形脊，并且末端电极在边缘和环形脊彼此接触处具有接头接缝，并且其中焊缝在周向上至少部分地围绕接头接缝延伸。
在一个实施例中，接缝焊缝包括在边缘和环形脊之间的对接焊缝，并且熔透焊缝包括延伸穿过边缘壁并进入支撑结构的一部分中的键孔焊缝。
在一个实施例中，接缝焊缝包括至少一个周向围绕末端电极延伸的接缝焊缝区段，并且熔透焊缝包括至少一个周向围绕末端电极延伸的熔透焊缝区段。
在一个实施例中，接缝焊缝包括多个周向围绕末端电极延伸的接缝焊缝区段，并且熔透焊缝包括多个周向围绕末端电极延伸的熔透焊缝区段，并且其中每个接缝焊缝区段与至少一个熔透焊缝区段重叠。
在更具体的实施例中，该至少一个接缝焊缝与相邻的接缝焊缝具有范围在约50％和80％之间的周向重叠。
在更具体的实施例中，该至少一个接缝焊缝和该至少一个熔透具有范围在约50％和80％之间的轴向重叠。
在更具体的实施例中，相邻的接缝焊缝区段和熔透焊缝区段具有范围在5-15弧长之间的相对周向重叠。
在更具体的实施例中，该至少一个接缝焊缝轴向跨越接缝，并且该至少一个熔透焊缝径向穿透外壳壁并进入支撑结构中。
附图说明
结合附图参照以下具体实施方式，将更好地理解本发明的这些以及其它特征和优点。应当理解，所选择的结构以及特征尚未在某些附图中示出，以更好地呈现其余结构和以及特征。
图1为根据本发明实施例的导管的透视图。
图2A为根据本发明实施例，沿第一直径的导管主体和中间挠曲节段之间的接合处的侧面剖面图。
图2B为沿大致垂直于第一直径的第二直径截取的图2A的接合处的侧面剖面图。
图3为沿线A-A截取的图2A和图2B的中间挠曲节段的端部剖面图。
图4为根据本发明实施例，带有外壳和支撑结构的末端电极的透视图。
图5为图6的末端电极的透视图，其中示出外壳为透明的。
图6为沿线A-A截取的图5的末端电极的端部剖面图。
图7为图6的外壳的透视图。
图8为图4的末端电极的接缝焊缝区段和熔透焊缝区段的详细视图。
图9A为沿线B-B截取的图4的末端电极的端部剖面图。
图9B为根据另一个实施例的末端电极的端部剖面图。
图10为沿线A-A截取的图4的末端电极的侧面剖面图。
图11示出根据实施例的激光束照射设备的概念。
图12为示出图11的设备的光纤的透视图；
图13示出根据另一个实施例的激光束照射设备的概念。
具体实施方式
图1示出带有2件式灌注消融末端电极的导管10的实施例，所述电极具有冗余的附接机构。导管具有带近端和远端的伸长的导管主体12、在导管主体12远端处的可挠曲的中间节段14，和带有末端电极17的远侧节段15。导管还包括位于导管主体12的近端处的控制手柄16，以用于控制中间节段14相对于导管主体12的挠曲(单向或双向)。
参照图2A和图2B，导管主体12包括具有单个、轴向或中心内腔18的伸长的管状构造。导管主体12为柔性的，即可弯曲，但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。目前优选的构造包括由聚氨酯或PEBAX制成的外壁20。外壁20包括不锈钢等的嵌入式编织网，以增加导管主体12的扭转刚度，使得当旋转控制手柄16时，导管10的中间节段14将以相应的方式旋转。
导管主体12的外径不是关键性的，但优选地为不大于约8弗伦奇，更优选地7弗伦奇。同样，外壁20的厚度也不是关键性的，但足够薄，使得中心内腔18可容纳牵拉构件(如，牵拉线)、导线和任何其它所需的线材、缆线或管。如果需要，则外壁20的内表面衬有加强管22以提供改善的扭转稳定性。在本发明所公开的实施例中，导管具有外壁20，所述外壁20具有约0.090英寸至约0.94英寸的外径和约0.061英寸至约0.065英寸的内径。
通过用聚氨酯胶等形成胶接23，将加强管22和外壁20的远端固定地附接到导管主体12的远端附近。利用干燥较慢但较强效的胶(如聚氨酯)在加强管22和外壁20的近端之间形成第二胶接(未示出)。
在控制手柄16和可挠曲节段14之间延伸的组件穿过导管主体12的中心内腔18。这些组件包括用于在远侧节段15上承载的末端电极17和多个环形电极21的导线30T和30R、用于将流体递送到末端电极的灌注管38、用于在远侧节段15中承载的电磁位置传感器34的缆线33、用于使中间节段14挠曲的牵拉线32a、32b，和用于感测远侧节段15处的温度的一对热电偶线41、42。
图2A、图2B和图3中还示出了包括一小段管19的中间节段14的实施例。该管还具有编织网构造而带有多个内腔，例如偏轴内腔26a、26b、27、28。第一内腔26a承载用于中间节段挠曲的牵拉线32a。对于双向挠曲，直径相对的第二内腔26b承载第二牵拉线32b。第三内腔27承载导线30T和30R、热电偶线41和42，以及传感器缆线33。第四内腔28承载灌注管38。
中间节段14的管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。适用于管19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。每个内腔的尺寸不是关键性的，但应足以容纳延伸穿过其中的相应组件。
图2A和图2B示出用于将导管主体12附接到中间节段14的装置。中间节段14的近端包括外周向凹口25，所述外周向凹口25接收导管主体12的外壁20的内表面。中间节段14和导管主体12通过胶等附接。
如果需要，则可将垫片(未示出)定位在加强管(如果提供)的远端和中间节段的近端之间的导管主体内。垫片提供导管主体与中间节段的接合处的柔性过渡，由此允许此接合平滑地弯曲且不存在折叠或扭结。具有此类垫片的导管在美国专利号5,964,757中有所描述，其公开内容以引用方式并入本文。
每条牵拉线32a和32b都优选地涂覆有Teflon.RTM。牵拉线可由任何合适的金属，如不锈钢或镍钛诺制成，且特氟隆涂层赋予牵拉线润滑性。牵拉线优选地具有约0.006至约0.010英寸范围内的直径。
如图2B所示，导管主体12中的每条牵拉线的一部分穿过压缩线圈35，该压缩线圈35与其牵拉线处于包围关系。每个压缩线圈35从导管主体12的近端延伸至中间节段14的近端或中间节段14的近端附近。压缩线圈由任何合适的金属制成，优选地为不锈钢，并且压缩线圈自身紧密地缠绕，以提供柔韧性，即弯曲性，但抗压缩。压缩线圈的内径优选地稍大于牵拉线的直径。压缩线圈35远侧的牵拉线的每个部分均可延伸穿过相应的护套39，以防止牵拉线在挠曲期间切入中间节段14的管19中。
牵拉线32a和32b的近端锚固在控制手柄16中。牵拉线32a和32b的远端锚固在远侧节段15中，如下文另外描述。通过适当操纵控制手柄16的挠曲构件，实现牵拉线相对于导管主体12的单独且独立的纵向移动，从而分别导致中间节段14沿着平面挠曲。合适的挠曲构件和/或挠曲组件在以下文献中有所描述：2010年7月1日公布的名称为DEFLECTABLESHEATH INTRODUCER(可挠曲护套置入器)的共同未决的美国专利公布号US2010/0168827A1，以及2008年10月16日公布的名称为STEERING MECHANISM FOR BI-DIRECTIONALCATHETER(双向导管的操纵机制)的美国专利公布号US2008/0255540 A1，二者的全部公开内容以引用方式并入本文。
参照图7，中间节段14的远端处是远侧末端节段15，其包括末端电极17以及在末端电极17和中间节段14之间的相对短的一截非导电连接器管或覆盖物24。在图示实施例中，连接器管24具有单个内腔44，所述内腔容纳位置传感器34并允许包括电极导线30T和30R、传感器缆线33、热电偶线41和42，以及灌注管38的组件的通路进入远侧节段15和末端电极17中。连接器管24的单个内腔44允许这些组件自己按需从中间节段14中它们的相应内腔朝它们在远侧节段15和末端电极17内的位置重新定向。在公开的实施例中，管24为保护管，如PEEK管，其具有范围在6mm和12mm之间，更优选地为约11mm的长度。
参照图6、图7和图8，灌注末端电极具有两件式构造，所述两件式构造包括导电穹顶外壳50和导电内部支撑构件52，它们共同限定由外壳50和支撑构件52围绕并包围的内压腔室51的腔体。外壳50具有中空圆柱体50B，所述中空圆柱体带有适用于组织接触的开放非消融近侧部分50P和闭合消融远侧部分50D。远侧部分50D具有穹顶形的防止损伤的远端53。近侧部分50P具有周向边缘55限定的开放近端54。外壳壁63中形成有多个流体口56，所述流体口允许腔体51和外壳50外部之间的流体连通。
支撑构件52与外壳50的近端54在可见的或接头的接缝77处形成不透流体的密封。支撑构件52密封外壳50的内部腔体51，并且外壳50和支撑构件52有利于在腔体内提供压力通风条件；即，流体被迫进入或递送至其中，以通过形成于外壳壁63中的流体口56的更均匀分布。
支撑构件52具有带有远侧部分52D和近侧部分52P的大致圆柱体。远侧部分52D具有延伸至外壳50的腔体中的较小直径，并且近侧部分52P具有尺寸设定用于外壳50的近端54中的过盈配合的较大直径。在远侧部分52D的外表面68上，提供环形脊67以邻接外壳50的边缘55的近侧表面。近侧部分52P还包括用于插入到导管10的可挠曲节段14的远端中的并与导管10的可挠曲节段14的远端连接的大致管状部分61。脊67具有与外壳壁63的厚度T相对应的高度H，使得当外壳50安装在支撑构件52上时，在边缘55和脊67之间的可见接缝接头77处提供平滑的外部轮廓。脊67位于近侧部分52P的远端的近侧的预定距离D，使得外表面68接触紧靠边缘55远侧的外壳50的内表面69。
如图7所示，支撑构件52的近侧部分52P具有多个轴向孔。在图示实施例中，近侧部分52P的近侧表面65具有四个盲孔，即，57a、57b、58和59，和一个通孔60。盲孔57a和57b与可挠曲节段14的内腔26a和26b是偏轴的、沿直径相对的并在纵向对齐的，用于容纳并锚固牵拉线。盲孔58是偏轴的并适于接收并锚固热电偶线41/42的远端。盲孔59是偏轴的并适于接收并锚固末端电极导线30T的远端。通孔60是轴向的并适于接收灌注管38的远端。
通孔60延伸穿过近侧部分52P并进入在远侧部分52D中形成的流体通道73中且与该流体通道73连接(图7)。通道73与在远侧部分52D中形成的多个流体口71连通，其允许流体经由流体口56进入末端电极的腔体51并离开至末端电极的外部。
外壳50和支撑构件52由包括生物相容性金属合金的生物相容性金属构成。合适的生物相容性金属合金包括选自不锈钢合金、贵金属合金和/或它们的组合的合金。在一个实施例中，外壳由包含按重量计约80％钯和约20％铂的合金构成。在一个替代实施例中，外壳50和构件52由包含按重量计约90％铂和约10％铱的合金构成。可通过深冲制造方法形成外壳，该方法产生足够薄但坚实的外壳壁，该外壳壁适于抓握、穿过患者的身体传送、以及标测和消融程序期间的组织接触。
如图6所示，外壳50安装在支撑构件52上，支撑构件52具有彼此邻接的边缘55和环形脊以形成周向围绕末端电极延伸的可见接缝77。外壳和支撑构件彼此通过激光束焊接(LBW)固定地接合，激光束焊接是通过使用激光用来接合金属的焊接技术。激光束提供集中的热源，导致小的热作用区。根据本发明的特征，外壳50和支撑构件52由具有提供多重(如，双重)失效模式的周向和轴向重叠的至少两个独立激光焊缝接合。在图示实施例中，一个焊缝是接缝(或传导)焊缝80并且另一个焊缝是熔透(或键孔)焊缝82。接缝焊缝80在较低级能量密度处进行以形成一系列焊接块，每个焊接块都是浅且宽的。熔透焊缝82在功率密度处进行以形成一系列延伸较深的焊缝键孔，以便穿透外壳壁并进入支撑构件中。
在图11的实施例中，用于焊接外壳和支撑结构的激光束照射设备100包括激光束发生器101，诸如气体激光器或固态激光器，和光学组件102。固态激光器可包括Nd:YAG棒杆104、闪光灯106、电源108、控制器110、全反射镜112和输出镜114。控制器110通过电源108控制闪光灯106的发光脉冲以便产生脉冲YAG激光束B。光纤105具有圆芯109(图12)，该圆芯109提供具有圆形横截面的激光束光斑S，如图4所示。光学组件102可包括入射光单元103、光纤105和发射光单元107。
电源108被连接在闪光灯106和控制器110之间。控制器110将电力从电源108供应到闪光灯。通过电源108，控制器110控制激光束发生器101的输出和激光束B的特性。
全反射镜112定位在离棒杆104近端的预定的距离，以便从棒杆近端输出的任何激光束B反射回近端。输出镜114定位在离棒杆104的远端的预定的距离。输出镜114是半透明的使得只允许来自棒杆104的固体激光束B穿过。
包括焦距f1的聚光透镜115的入射光单元103将从输出镜114输出的激光束B聚焦到光纤105的输入端105in上。
光纤105是通过使用文中提供的芯109传输激光束B的光学导波器。在入射光单元103和发射光单元107之间提供光纤105，发射光单元107接收来自光纤105的输出端105out的激光束B。发射光单元107用从光纤105的输出端发射的激光束B照射末端电极17。发射光单元107包括准直器透镜116和角镜117和光发射透镜118。准直器透镜116定位在离光纤105的输出端该透镜焦距f2的预定距离处。合适的激光束照射设备在美国专利号8,378,255中有所描述，其全部公开内容以引用方式并入本文。
如为本领域的普通技术人员所理解的，每个脉冲产生的焊缝通过峰值功率密度和脉冲持续时间测定。每秒的脉冲数、脉冲重叠和焊接速度还限定接缝焊缝。在那点上，峰值功率密度控制焊缝熔深，并且是纤维类型和芯直径、聚焦光学和激光峰值控制输出的函数。脉冲宽度控制进入部件中的热、焊缝宽度和热循环。脉冲重复率或脉冲频率还控制进入部件的热和热循环。脉冲间距受激光光斑尺寸、脉冲频率，以及支撑构件和安装在其上的外壳的旋转速度控制。激光光斑S的尺寸(例如，直径)(例如，约0.010英寸)取决于芯直径，并受到由相应的控制器执行的焊接计划表和相应的光学单元的焦距控制。激光器焊接参数作为焊接计划表在每个控制器内存储。聚焦设置受接缝焊缝激光光学单元和熔透焊缝激光光学单元上的聚焦旋钮测微器控制。
参照图4，接缝焊缝80和熔透焊缝82中的每个以激光束圆形光斑S的预定周向重叠OL(c)进行，该预定周向重叠OL(c)处于范围在约50-90％之间，并且优选在约70-80％之间的相对高的值。为讨论的目的，多个此类重叠光斑S形成区段，并且一个或多个区段形成接缝焊缝或熔透焊缝。
接缝焊缝80将在外壳50的边缘55和支撑构件52的环形脊67之间的可见接缝接头77(或“邻接”接头)焊接在一起。在图示实施例中，激光束光斑S定位在接缝77上方以与边缘55至少一部分和脊67至少一部分轴向重叠。接缝焊缝80可包括多个周向延伸不连续区段S1—Sn。在图9A的图示实施例中，n＝2使得接缝焊缝80包括第一区段S1和第二区段S2，其中每个区段彼此沿直径相对并在弧长上在约90-110度之间，并且优选约100度延伸。在图9B的图示实施例中，n＝4使得接缝焊缝80包括区段S1-S4，每个区段与相邻区段等距并具有相同的周长。四个区段形成两对，一对的每个区段与它的配对沿直径相对。应当理解n的最小值为2并且可具有与围绕圆周的接缝和熔透区段的总数除以2相等的最大值。
如图10所示，边缘55和脊67通过接缝焊缝区段Si焊接在轴向并列构型中，其每个均具有焊缝深度DS，该焊缝深度DS在支撑构件52的脊67和外壳50的外壳壁63中大致相等。如本领域的普通技术人员所理解的，每个接缝焊缝区段Si具有充分跨越并横跨脊67和边缘55的轴向宽度Ws(由于每个激光光斑S具有直径Ws)。侧向公差对确保可见接缝77在激光束下的位置足够精确，使得当外壳50和支撑结构52在激光束B下旋转时激光束不错过可见接缝77是重要的。不对准公差是聚焦束直径的函数并在较小的意义上是接头设计的函数。为此，由于接缝焊缝通常是不需要在焊接期间添加填充材料的自生过程，因此对接缝中配合边缘的平直度以及外壳50和支撑构件52的主轴/纵轴的共线性的控制是期望的。
熔透焊缝82在脊67远侧的位置处将外壳50的外壳壁63和支撑构件52的近侧部分52P(或“搭接”接头)焊接在一起。熔透焊缝可包括多个周向延伸不连续区段P1-Pm。在图9A的图示实施例中，m＝2使得周边焊缝包括第一区段P1和第二区段P2，每个区段彼此沿直径相对并在弧长上在约90-110度之间，并且优选约100度延伸。在图9B的图示中，m＝4使得接缝焊缝80包括区段P1-P4，每个区段与相邻区段等距离并具有相同的周长。四个区段来自两对，一对的每个区段与它的配对沿直径相对。应当理解n的最小值为2并且可具有与围绕圆周的接缝和熔透区段的总数除以2相等的最大值。
如图10所示，外壳壁63通过熔透焊缝82以径向顶到底式构型焊接到近侧部分52P上，该熔透焊缝82具有穿透外壳壁63整个厚度并进入支撑构件52中的焊缝深度。如本领域的普通技术人员所理解的，熔透焊缝具有足够键孔穿过边缘55并进入支撑构件52中的径向深度。在那点上，垂直公差(或焦深)涉及确保在接头处的聚焦光斑具有足够的能量密度以制造键孔。在外壳50和支撑结构52之间的气隙度或配合公差对于确保激光束充分耦合两个组件和键孔穿过边缘55并进入支撑构件52中也是重要的。
如上文所提及的，在每个接缝焊缝区段Si和每个熔透焊缝区段Pi内，激光光斑S具有预定的周向重叠OL(c)。在每个接缝焊缝区段Si和每个熔透焊缝区段Pi的端部处，所述端部在相邻的接缝焊缝区段Si和熔透焊缝区段Pi之间具有预定的相对周向重叠OL(rc)，其范围可在弧长上约5-15度之间，并优选在弧长上约10度。
端部中的激光光斑S在相邻的接缝焊缝区段Si和熔透焊缝区段Pi之间也具有轴向重叠OL(a)，其范围可在约50-80％并优选约60-70％之间。根据本发明的结构，在接缝焊缝区段和熔透焊缝区段之间的重叠(轴向或周向)保持在最小值，以避免当在末端电极中仍提供双重失效模式时，一个焊缝损坏或以其它方式减弱其它焊缝的完整性。在图示实施例中，熔透焊缝82定位在接缝77远侧约0.002英寸处。接缝焊缝被定位使得光斑中心以固定量定位在外壳50和支撑构件52之间的分型线远侧。
接缝焊缝区段Si和熔透焊缝区段Pi的区段的组合或“联接”在弧长上覆盖周向围绕末端电极的360度(或大于360度，如果包括一种或多种周向重叠)，使得充气腔室51围绕接缝77具有不透流体的密封。
在如图13示出的替代实施例中，具有第二激光束发生器201和第二光学单元203的第二激光束照射设备200与第一激光束照射设备100一起使用，以提供用于产生单独第二焊缝的单独过程，其中第一焊缝和第二焊能够达到最小拉伸强度要求。第二激光束发生器201和第二光学单元203具有与如上所述的与第一激光束发生器101和第二光学单元103类似的组件，并且因此通过类似的参考数字识别。在图示实施例中，第一激光束发生器101和第一光学单元103被配置成在末端电极17上产生熔透焊缝区段Pi，并且第二激光束发生器201和第二光学单元203被配置成在末端电极17上产生接缝焊缝区段Si。提供单独的电源108和电源208以及单独的控制器110和控制器210。
应当理解本发明可包括多于两种独立的焊缝和多种其它焊缝构型。接缝焊缝区段将以约120度弧长或其它20度倍数的弧长排列。此外，接缝焊缝和/或熔透焊缝在周向上可以是非线性的，如Z字形，以便沿着接缝调控表面积用于改善的负载。除了提供的接缝焊缝和熔透焊缝之外，可提供满足空间要求的附接的第三方法。
已经参照本发明的当前优选实施例来呈现前述描述。本发明的所属领域以及技术中的技术人员将会了解，在不有意背离本发明的原理、实质以及范围的情况下，可以实践所述结构中的更改以及变化。因此，以上描述不应视为仅与未必按比例绘制的附图所述和所示的精确结构有关，而应视为符合具有其全部最完整且合理的范围的下列权利要求书，并作为权利要求书的支持。
Claims (15)
1.一种电生理导管，具有：
伸长的导管主体；
位于所述导管主体近侧的控制手柄；
位于所述导管主体远侧的末端电极，所述末端电极具有通过焊缝接合的外壳和支撑构件，
其特征在于，所述焊缝具有至少一个接缝焊缝和至少一个熔透焊缝。
2.根据权利要求1所述的导管，其中所述至少一个接缝焊缝和所述至少一个熔透焊缝具有轴向重叠。
3.根据权利要求1所述的导管，其中所述至少一个接缝焊缝和所述至少一个熔透焊缝具有周向重叠。
4.根据权利要求1所述的导管，其中所述外壳具有边缘且所述支撑结构具有环形脊，并且所述末端电极在所述边缘和所述环形脊彼此接触处具有接头接缝，并且其中所述焊缝至少部分地围绕所述接头接缝延伸。
5.根据权利要求4所述的导管，其中所述至少一个接缝焊缝包括在所述边缘和所述环形脊之间的对接焊缝。
6.根据权利要求4所述的导管，其中所述至少一个熔透焊缝包括延伸穿过所述边缘的壁并进入所述支撑结构的一部分中的键孔焊缝。
7.根据权利要求1所述的导管，其中所述至少一个接缝焊缝包括周向围绕所述末端电极延伸的至少一个接缝焊缝区段。
8.根据权利要求1所述的导管，其中所述至少一个熔透焊缝包括周向围绕所述末端电极延伸的至少一个熔透焊缝区段。
9.根据权利要求1所述的导管，其中所述至少一个接缝焊缝包括周向围绕所述末端电极延伸的多个接缝焊缝区段，并且所述至少一个熔透焊缝包括周向围绕所述末端电极延伸的多个熔透焊缝区段，并且其中每个接缝焊缝区段与至少一个熔透焊缝区段重叠。
10.根据权利要求1所述的导管，其中所述至少一个接缝焊缝与相邻的接缝焊缝具有范围在50%和80%之间的周向重叠。
11.根据权利要求1所述的导管，其中所述至少一个接缝焊缝和所述至少一个熔透焊缝具有范围在50%和80%之间的轴向重叠。
12.根据权利要求9所述的导管，其中相邻的接缝焊缝区段和熔透焊缝区段具有范围在5-15度弧长之间的相对周向重叠。
13.根据权利要求1所述的导管，其中所述外壳具有近侧边缘并且所述支撑结构具有环形脊，并且所述焊缝沿着所述边缘和所述环形脊之间的接缝。
14.根据权利要求13所述的导管，其中所述至少一个接缝焊缝轴向跨越所述接缝。
15.根据权利要求13所述的导管，其中所述至少一个熔透焊缝径向穿透所述外壳的壁并进入所述支撑结构中。
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| US13/958455 | 2013-08-02 | ||
| US13/958,455 US10828089B2 (en) | 2013-08-02 | 2013-08-02 | Catheter with improved irrigated tip electrode having two-piece construction, and method of manufacturing therefor |
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| JP6415888B2 (ja) | 2018-10-31 |
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| US10828089B2 (en) | 2020-11-10 |
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