CN102138823A - 带螺旋电极的导管 - Google Patents

带螺旋电极的导管 Download PDF

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CN102138823A
CN102138823A CN2010106156513A CN201010615651A CN102138823A CN 102138823 A CN102138823 A CN 102138823A CN 2010106156513 A CN2010106156513 A CN 2010106156513A CN 201010615651 A CN201010615651 A CN 201010615651A CN 102138823 A CN102138823 A CN 102138823A
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A·戈瓦里
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Abstract

本发明提供了一种侵入式探针，所述侵入式探针包括插入管，所述插入管包括中央腔和远端部分，所述中央腔用于提供冲洗流体，而所述远端部分具有多个穿过其中的穿孔，所述穿孔在所述插入管的所述中央腔和外表面之间提供流体连通。所述插入管的所述远端部分上装配有至少一个螺旋电极。

Description

带螺旋电极的导管
技术领域
本发明整体涉及医疗装置，具体地讲，涉及冷却侵入式探针在身体内所接触的组织的方法。
背景技术
在一些医疗程序中，将能量以浓缩剂量局部地施加到身体组织，并且希望将处理区域冷却以减少附带的组织损伤。
例如，使用心脏消融疗法来治疗心律失常，方法为通过用射频(RF)电能加热组织以在心肌内产生不导电的损伤。已经发现的是，冷却消融位点区域会减少组织焦化和血栓形成。出于此目的，Biosense Webster Inc.(Diamond Bar，California)提供了作为其集成式消融系统一部分的
Figure BSA00000406401500011
冲洗顶端导管。该金属导管顶端以RF电流供能来消融组织，并且具有若干个用于冲洗处理位点的周边孔，这些孔环绕该顶端周边分布。连接到导管的泵将盐水溶液输送到导管顶端，并且该溶液在所述过程中经周边孔流出，从而冷却导管顶端和组织。
发明内容
下文描述的本发明的实施例提供了用于创伤性医疗手术的冲洗探针(例如用于RF消融的冲洗导管)，以及制备此类探针的有效方法。
因此根据本发明的实施例提供了侵入式探针，该探针包括插入管和远端部分，其中插入管包括用于提供冲洗流体的中央腔，而远端部分具有多个穿过其中的穿孔，这些穿孔在插入管的中央腔和外表面之间提供流体连通。插入管的远端部分上装配有至少一个螺旋电极。
通常，探针包括穿过插入管并电连接到上述至少一个螺旋电极的一根或多根线材。除此之外或作为另外一种选择，该至少一个螺旋电极覆盖一些穿孔。
在一个实施例中，该至少一个螺旋电极包括多个螺旋电极，这些电极沿远端部分分布。
在本发明所公开的实施例中，插入管被构造为用于穿过血管插入受试者的心室，从而让该至少一个螺旋电极接触心脏内的心内膜组织。
通常，多个穿孔包括至少八个穿孔，并可能包括至少五十个穿孔。穿孔通常具有小于0.5mm、并可能小于0.2mm的直径。穿孔可具有根据其相应纵向位置而变化的相应尺寸。
在一个实施例中，该至少一个螺旋电极包括螺旋缠绕在插入管远端部分周围的线圈。在另一个实施例中，该至少一个螺旋电极包括沿螺旋图案切割的管。
根据本发明的实施例还提供了包括用于插入受试者体内的探针的医疗设备。该探针包括插入管和远端部分，其中插入管包括中央腔，而远端部分具有多个穿过其中的穿孔，这些穿孔在插入管的中央腔和外表面之间提供流体连通；同时，插入管远端部分上装配有至少一个螺旋电极，并配置为接触体内组织。能量产生器连接到探针，以向上述至少一个螺旋电极提供电能。冲洗泵连接到中央腔，用来经中央腔和穿孔向组织供应冲洗流体。
在本发明所公开的实施例中，连接的能量产生器用于向该至少一个螺旋电极供电，以消融组织。例如，探针可以被构造为用于穿过血管插入受试者的心脏，以消融心脏内的心肌组织。
此外，根据本发明的实施例提供了处理方法(包括将探针插入受试者体内)。该探针包括插入管和远端部分，其中插入管包括中央腔，而远端部分具有多个穿过其中的穿孔，这些穿孔在插入管的中央腔和外表面之间提供流体连通；同时，插入管远端部分上装配有至少一个螺旋电极。该至少一个螺旋电极与体内的组织接触。电能通过该至少一个螺旋电极施加到组织，而冲洗流体经中央腔和穿孔供应到组织。
通常，供应冲洗流体是为了冷却远端部分和组织。
根据本发明的实施例还提供了制造医疗装置的方法，该方法包括穿过包括中央腔的插入管的远端部分的外表面生成多个穿孔，从而在插入管的中央腔和外表面之间提供流体连通。包含导电材料的至少一个螺旋电极在插入管远端部分上滑动。然后将该至少一个螺旋电极固定到插入管远端部分的外表面上。
通过以下结合附图的实施例的详细说明，将更全面地理解本发明：
附图说明
图1为根据本发明实施例的用于心脏消融疗法的系统的示意性说明图；
图2为根据本发明实施例的穿孔导管插入管的示意性侧视图；
图3为根据本发明实施例的线圈电极的示意性侧视图；
图4为根据本发明实施例的装配有线圈电极的穿孔导管的远端部分的示意性侧视图；
图5为图4的导管沿V-V线截取的示意性剖视图；以及
图6为根据本发明实施例的装配有线圈电极的环状标测导管的示意性侧视图。
具体实施方式
在上述RF电消融手术中，冲洗消融位点区域可减少组织焦化、血栓形成，以及消融电极和组织之间的粘合。到目前为止，用于冲洗的方法和装置需要将电极本身穿孔，以使得冲洗流体可经穿孔由导管进入处理区域。此类穿孔电极和制备穿孔的方法在(例如)2008年7月15提交的美国专利申请12/173,150中有所描述，该专利申请转让给本专利申请的受让人，并且其公开内容以引用方式并入本文中。然而，制备穿孔既浪费时间，成本也太高，并且可能削弱电极结构。
下文描述的本发明的实施例提供了制备具冲洗功能的环形电极的简便而经济的方法。侵入式探针(例如导管)在其外壁上即将设置环形电极的区域内具有多个穿透外壁的穿孔。这些穿孔与探针内用于将冲洗流体传输到穿孔的中央腔连通。导电性线圈电极(该电极通常具有螺旋弹簧的形状和回弹性)在电极目标位置处装配并固定到探针。该线圈电极连接到穿过探针的一根或多根线材上，这些线材可用于(例如)向线圈提供用于消融疗法的RF电能。虽然设置的线圈电极通常会覆盖探针壁内一些穿孔，但位于线圈匝之间的间隙内的其他穿孔不会被线圈电极覆盖。操作过程中，从这些开放的穿孔中流出的冲洗流体可冲洗到整个处理区域。
上文所述和随后的附图所示出的设计既方便制造，又成本低廉。该设计不仅具备穿孔冲洗电极可实现的有益效果，还避免了在电极中形成穿孔将会遇到的困难和高昂的成本。这种电极结构可用于沿导管或其他结构(例如套索结构)的长度形成多个环形电极。
图1为根据本发明实施例的用于心脏消融疗法的系统20的示意性说明图。操作员26将导管28穿过血管插入受试者22的心脏24的腔室内，操纵该导管以使导管的远端部分32接触心内膜待处理的区域。在导管的远端部分穿孔，以允许冲洗处理区域，如下文所示和所述。然而，在其他方面，系统20类似于本领域中已知的用于心脏消融处理的系统(例如上述Biosense Webster系统)，并且此类系统的组件可适用于系统20。
在将导管28的远端部分32定位于消融位点、并确保远端部分的电极(如下所示)接触该位点的心内膜之后，操作员26启动控制台42内的射频(RF)能量产生器44，以通过电缆38向电极供应RF能。同时，冲洗泵48通过管40和导管28内的中央腔向远端部分供应冷却流体(例如盐水溶液)。可调节RF能量产生器和冲洗泵的操作，以在消融过程中提供适当体积的冲洗流体来冷却电极和组织，而不会向心脏加入过多的冲洗流体。远端部分32中的温度传感器(图中未示出)可以向控制台42提供反馈信息用于控制RF能量剂量和/或冲洗流体体积。
图2为根据本发明实施例的导管28的插入管50的一部分的示意性侧视图。图中示出了在将电极组装到远端部分32上之前的制造阶段的插入管远端部分。管50通常包含合适的生物相容性塑料(例如聚氨酯)，并通常具有约2.3mm的直径和约0.15mm的壁厚。然而，这些尺寸仅以举例方式给出，根据应用要求可使用更大或更小的尺寸。
管50远端部分的外表面被多个穿孔52穿透，这些穿孔纵向(即沿与导管28的纵向轴线平行的方向)和环向(沿围绕轴的周长的方向)分布在远侧顶端的表面上。可通过本领域已知的任何合适方法在管50内形成穿孔，例如，在制造管时预先模制穿孔，或者在挤出管之后通过冲孔或钻孔方式(使用激光器或机械装置)在管内形成穿孔。
远端部分32包括内部贮存器56，该贮存器由管50内的中央腔58供应冲洗流体。穿孔52在贮存器56和管50的外表面之间延伸。在附图所示实施例中，贮存器56具有内表面54，内表面可通过(例如)在管50内装配直径较小的管形成。作为另外一种选择，贮存器可占据管50远侧顶端处的整个内部空间，然后再由邻近远侧顶端的塞子(未示出)封堵，并连通中央腔58。可供选择的贮存器构型对于本领域的技术人员将显而易见，并将被视为在本发明的范围内。
通常，管50具有至少8个穿孔，穿孔直径小于0.5mm，这样的结构可在远端部分32的整个区域上同时纵向和环向分配冲洗流体，而不会使流向心脏的冷却流体过量。然而，发明人已发现有利的是在远端部分内具有至少50个穿孔，并且穿孔直径不大于0.2mm、并可能小至约0.1mm。穿孔尺寸可任选地在远侧顶端的整个长度上变化，以补偿压力变化，并确保在整个长度上的流量相等。出于此目的，与更靠近冲洗流体入口的较近侧的穿孔相比，可将顶端最远侧部分和其附近的穿孔制备得稍大。
图3为根据本发明实施例的线圈电极60的示意性侧视图。该电极装配在管50上，如下文中的附图所示。电极60通常包含有回弹力的生物相容性导电材料，例如金、铂或铱线材，或者这些金属的合金。线圈电极可包括缠绕成螺旋线圈的线材(如图所示)，其形状与卷簧类似。作为另外一种选择，线圈电极可由管制成，通过(例如)激光切割法将该管沿螺旋图案切开，以形成螺旋形状。线圈电极具有等于或略小于管50的外径的内径，以使得线圈正好贴合到管上。
现在参见图4和5，图中示意性地示出根据本发明实施例的导管28的远端部分32，该部分是通过将线圈电极60装配到管50上而制成的。图4为侧视图，而图5为沿图4的V-V线截取的剖视图。将电极60滑移到管50上的所需位置处，然后采用粘合或其他方式使电极紧紧固定在管上的该位置处。管50内部的一根或多根线材62穿透管的外表面(可能穿过其中一个穿孔52)，并且焊接到电极60上或以其他方式与电极60结合在一起。类似地，本领域已知的可用于与环形电极建立电连接的任何合适的技术都可以用于此目的。线材62穿过导管28的近端，并在这里通过电缆38连接到RF能量产生器44(图1)。
由图4和5可知，当电极60紧固到管50上时会覆盖一些穿孔(在图5中标记为52B)。然而，足够多的穿孔(标记为52A)仍保持开放，以对电极接触的区域进行充分的冲洗。此布置方法是有利的，因为这样可回避在管50内形成穿孔52时、以及将电极60设置到管上时的高位置精度需要。在消融手术过程中，中央腔58(图2)将冲洗流体从冲洗泵48(图1)输送到贮存器56。在电极60传送RF能消融组织的同时，冲洗流体经穿孔52A由管50流出进入周围组织。
图6为根据本发明实施例的装配有线圈电极76的环状标测导管70的示意性侧视图。环状标测导管插入管被成形为其轴72的远端部分74大致呈圆形套索形状。这种套索形状可用于(例如)在治疗心房纤颤时沿环肺静脉口的路线消融心肌组织。
要沿所需路线同时消融多处位置，需将电极76分布在远端部分74的周围。采用上述方式将每个电极滑移到所需位置，并紧固和电连接到导管70内的线材上。远端部分74也可具有用于冲洗的穿孔(图中未示出)，就像在导管28内的那样。同样，可以沿其他类型导管的长度、以及在其他类型的管状探针上分布多个线圈电极。
虽然上述实施例具体涉及心脏内的RF消融处理中使用的导管，但本发明的原理可相似地适用于其他器官和其他类型的诊断治疗过程，尤其是涉及向身体组织施加能量的过程。例如，可以将具有相似类型冲洗顶端的装置用于包括使用微波或超声波加热组织的治疗过程。又如，也可在不对其他类型的导管和管状探针进行冲洗的情况下使用上述类型的线圈电极。
因此，应当理解，上述实施例是以举例的方式进行阐述，本发明不仅限于上文所具体示出和描述的内容。并且，本发明的范围包括上述各种特征的组合和子组合、以及本领域技术人员在阅读上述说明书时可能想到的并且现有技术中未公开的变型形式和修改形式。

Claims (22)

1.一种侵入式探针，包括：
插入管，所述插入管包括中央腔和远端部分，所述中央腔用于提供冲洗流体，而所述远端部分具有多个穿过其中的穿孔，所述穿孔在所述插入管的所述中央腔和外表面之间提供流体连通；以及
至少一个螺旋电极，装配在所述插入管的所述远端部分上。
2.根据权利要求1所述的探针，还包括穿过所述管并电连接到所述至少一个螺旋电极的一根或多根线材。
3.根据权利要求1所述的探针，其中所述至少一个螺旋电极覆盖一些所述穿孔。
4.根据权利要求1所述的探针，其中所述至少一个螺旋电极包括多个螺旋电极，所述多个螺旋电极沿所述远端部分分布。
5.根据权利要求1所述的探针，其中所述插入管被构造为用于穿过血管插入受试者的心室，从而让所述至少一个螺旋电极接触所述心脏内的心内膜组织。
6.根据权利要求1所述的探针，其中所述多个穿孔包括至少8个穿孔。
7.根据权利要求6所述的探针，其中所述多个穿孔包括至少50个穿孔。
8.根据权利要求1所述的探针，其中所述穿孔的直径小于0.5mm。
9.根据权利要求8所述的探针，其中所述穿孔的直径小于0.2mm。
10.根据权利要求1所述的探针，其中所述穿孔具有根据所述穿孔相应纵向位置而变化的相应尺寸。
11.根据权利要求1所述的探针，其中所述至少一个螺旋电极包括螺旋缠绕在所述插入管的所述远端部分周围的线圈。
12.根据权利要求1所述的探针，其中所述至少一个螺旋电极包括沿螺旋图案切割的管。
13.医疗设备，包括：
探针，用于插入受试者体内，所述探针包括：
插入管，所述插入管包括中央腔和远端部分，所述远端部分具有多个穿过其中的穿孔，所述穿孔在所述插入管的所述中央腔和外表面之间提供流体连通；以及
至少一个螺旋电极，装配在所述插入管的所述远端部分上，并且被构造为接触所述身体内的组织；
能量产生器，用于连接到所述探针，以向所述至少一个螺旋电极提供电能；以及
冲洗泵，用于连接到所述中央腔，以经所述中央腔和所述穿孔向所述组织供应冲洗流体。
14.根据权利要求13所述的设备，其中所述能量产生器被连接以向所述至少一个螺旋电极供应电能，以消融所述组织。
15.根据权利要求13所述的设备，其中所述探针被构造为用于穿过血管插入所述受试者的心脏，以消融所述心脏内的心肌组织。
16.一种处理方法，包括：
将探针插入受试者体内，所述探针包括：
插入管，所述插入管包括中央腔和远端部分，所述远端部分具有多个穿过其中的穿孔，所述穿孔在所述插入管的所述中央腔和外表面之间提供流体连通；以及
至少一个螺旋电极，装配在所述插入管的所述远端部分上；
将所述至少一个螺旋电极与所述身体内的组织接触；
通过所述至少一个螺旋电极向所述组织施加电能；以及
通过所述中央腔和所述穿孔向所述组织供应冲洗流体。
17.根据权利要求16所述的方法，其中插入所述探针包括将所述探针经血管穿入所述受试者的心脏，并且其中施加所述电能包括消融所述心脏内的心肌组织。
18.根据权利要求16所述的方法，其中供应所述流体包括冷却所述远端部分和所述组织。
19.一种用于制备医疗装置的方法，包括：
穿过包括中央腔的插入管的远端部分的外表面形成多个穿孔，从而在所述插入管的所述中央腔和外表面之间提供流体连通；
在所述插入管的所述远端部分上滑动包含导电材料的至少一个螺旋电极；以及
将所述至少一个螺旋电极固定到所述插入管的所述远端部分的所述外表面上。
20.根据权利要求19所述的方法，还包括将一根或多根线材穿过所述管，并将所述线材电连接到所述至少一个螺旋电极上。
21.根据权利要求19所述的方法，其中所述至少一个螺旋电极覆盖一些所述穿孔。
22.根据权利要求19所述的方法，其中滑动所述至少一个螺旋电极包括沿所述远端部分定位多个螺旋电极。
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