CN115590609A - 用于改善组织接触和电流递送的偏置电极 - Google Patents

用于改善组织接触和电流递送的偏置电极 Download PDF

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CN115590609A
CN115590609A CN202210797699.3A CN202210797699A CN115590609A CN 115590609 A CN115590609 A CN 115590609A CN 202210797699 A CN202210797699 A CN 202210797699A CN 115590609 A CN115590609 A CN 115590609A
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given
electrode
ridge
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medical probe
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A·戈瓦里
C·T·比克勒
J·T·凯斯
J·G·利希特
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Biosense Webster Israel Ltd
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Abstract

本发明公开一种医疗探头，该医疗探头包括具有近侧端部和远侧端部的柔性插入管，以及位于该柔性插入管的该远侧端部处的篮状物组合件。在本发明的实施方案中，该篮状物组合件包括多个脊状物和多个电极，这些电极中的每个电极具有穿过该电极的装配给定脊状物的内腔。

Description

用于改善组织接触和电流递送的偏置电极
相关申请的交叉引用
本申请要求2020年9月10日提交的美国临时专利申请63/076,614的权益，该临时专利申请以引用方式并入本文。
技术领域
本发明整体涉及医疗探头，并且具体地涉及制造用于篮状物导管的偏置电极。
背景技术
心律失常是通常由产生不规则心跳的心脏组织的小区域导致的异常心脏节律。心脏消融是一种医疗规程，可执行该医疗规程以通过破坏导致不规则心跳的心脏组织的区域来治疗心律失常。一些医疗系统使用不可逆电穿孔(IRE)来消融心脏组织。IRE是基于由递送到组织的高电压的短脉冲引起的细胞膜的不可恢复的透化作用的非热消融方法。
授予Mathur等人的美国专利申请2013/0282084描述了一种用于治疗支架内再狭窄的设备。该设备包括具有径向可膨胀结构的细长柔性导管主体，该细长柔性导管主体包括多个电极或其它电外科能量递送表面，以在结构膨胀时接合组织。电极可被制造为形成篮状物的撑杆的一部分。在一些实施方案中，电极可比撑杆更宽。
授予He的美国专利6,569,162描述了一种用于被动自冷却消融电极的设计。该电极包括更大的表面积，该更大的表面积允许电极更有效地将热量耗散到血池，并且增加热质量，由此改善电极和组织之间的热传递，以实现对组织的更加受控的加热和消融。电极包括具有厚壁的基本上实心的电极主体，这导致热质量和热导率增加。在一个实施方案中，电极可在电极主体的远侧端部处具有基本上弯曲的外表面以便使用尖端电极，或具有延伸穿过电极主体的中心内腔以便使用环形电极。在另一实施方案中，在电极的外表面内一体形成的多个突起基本上平行于电极的轴线延伸以形成多个轴向翅片。
授予Krishnan等人的美国专利6,582,429描述了一种用于具有覆盖电极的消融导管的设计。该导管包括具有弯曲远侧端部区域的轴，该弯曲远侧端部区域具有内表面和外表面以及定位在轴的远侧端部处的多个带状电极。电极的配置可包括沿着导管护套的远侧段以基本上线性阵列布置的十二个带状电极。在一些实施方案中，电极可包括尖端电极。
授予Govari等人的美国专利8,475,450描述了一种带有冲洗的双用途套索导管。该套索导管包括电极，该电极在电极的外表面上方凸出，以便增加与心脏组织接触的表面积，并且因此当电极用于消融时降低电阻。
以上描述给出了本领域中相关技术的总体概述，并且不应当被解释为承认了其包含的任何信息构成对抗本专利申请的现有技术。
发明内容
根据本发明的一个实施方案，提供一种外科成像系统，该外科成像系统包括具有近侧端部和远侧端部的柔性插入管；位于柔性插入管的远侧端部处的篮状物组合件，该篮状物组合件包括多个脊状物(spine)；以及多个电极，这些电极中的每个电极具有穿过该电极的装配给定脊状物的内腔。
在一个实施方案中，脊状物具有相应的外侧和内侧，并且每个给定电极包括朝向该给定电极的相应脊状物的外侧偏置的导电材料。
在另一实施方案中，脊状物具有相应的外侧和内侧，并且每个给定电极还具有位于内腔和该给定电极的相应脊状物的内侧之间的凹口。
在一些实施方案中，每个给定脊状物包括附连到给定脊状物的内侧的导线，并且凹口包括在每个给定电极和导线之间形成电连接件的焊料材料。
在另外的实施方案中，外科成像系统还包括施加到每个给定电极的内表面的粘合剂材料，并且内表面由每个给定电极的内腔限定。
在另一个实施方案中，电极中的每个电极具有一个或多个平滑边缘。
在补充实施方案中，医疗探头还包括一组喷雾端口，该组喷雾端口被配置成将冲洗流体递送到电极。
在另一实施方案中，医疗探头还包括一组喷雾端口，该组喷雾端口被配置成在脊状物之间递送冲洗流体。
根据本发明的一个实施方案，还提供一种方法，该方法包括：提供具有多个脊状物的医疗探头；提供导电材料的挤出管；在挤出管上执行切割操作以便形成电极主体；以及将所形成的电极主体装配在给定脊状物周围。
在一个实施方案中，多个脊状物在医疗探头的远侧端部处形成篮状物组合件。
在另一实施方案中，切割操作在电极主体上形成锋利边缘，并且该方法还包括使锋利边缘平滑。
在另外的实施方案中，挤出管限定内腔，其中管不是关于内腔径向对称的。
在另一个实施方案中，给定脊状物具有外侧和内侧，其中将所形成的电极主体装配在给定脊状物上包括将电极主体朝向给定脊状物的外侧偏置。
在补充实施方案中，给定脊状物具有外侧和内侧，其中切割操作包括在内腔和给定脊状物的内侧之间切割出凹口。
在一些实施方案中，给定脊状物包括附连到给定脊状物的内侧的导线，并且该方法还包括用焊料填充凹口，以便在导线和电极主体之间形成电连接件。
在另外的实施方案中，将所形成的电极主体装配在给定脊状物周围包括在电极主体和给定脊状物之间形成粘结体。
在另一个实施方案中，该方法还包括提供一组喷雾端口，该组喷雾端口被配置成将冲洗流体递送到电极。
在另一实施方案中，该方法还包括提供一组喷雾端口，该组喷雾端口被配置成在脊状物之间递送冲洗流体。
附图说明
本文参照附图，仅以举例的方式描述本公开，其中：
图1是根据本发明的一个实施方案的包括医疗探头的医疗系统20的示意性图解，该医疗探头的远侧端部包括具有偏置电极的篮状物组合件；
图2是示出根据本发明的一个实施方案的给定偏置电极的成角度视图的示意性图解；
图3A和图3B(在本文也统称为图3)是根据本发明的一个实施方案的医疗探头的远侧端部的示意性图解；
图4是示意性地示出根据本发明的一个实施方案的制造偏置电极以及将偏置电极装配到篮状物组合件的脊状物的方法的流程图；
图5A-图5C(在本文也统称为图5)是示出根据本发明的一个实施方案的由导电材料的挤出管制造给定偏置电极的示意性图解；并且
图6和图7是根据本发明的一个实施方案的将给定电极主体的内腔装配在给定脊状物上，使得给定电极主体朝向给定脊状物的外侧偏置的纵向视图。
具体实施方式
概述
为了在IRE(不可逆电穿孔)规程中递送脉冲场消融(PFA)，电极与被消融的组织接触的表面积应尽可能大。本发明的实施方案提供一种具有篮状物组合件的医疗探头，该篮状物组合件包括电极，这些电极在横截面中偏置，使得在组织接触侧上存在更多材料，同时使非组织接触侧上的非必要材料最小化。如下所述，医疗探头包括具有近侧端部和远侧端部的柔性插入管，以及位于柔性插入管的远侧端部处的篮状物组合件。篮状物组合件包括多个脊状物和多个电极，每个给定电极具有穿过该电极的装配给定脊状物的内腔。
将电极偏置使得在组织接触侧上存在更多材料允许实施本发明的实施方案的医疗探头的篮状物组合件塌缩成小护套。该电极设计的另一方面确保偏置(即，突出部)是无创伤的。在一些实施方案中，通过使电极中的任何锋利边缘平滑来实施无创伤性。使锋利边缘平滑防止对组织或护套造成任何损坏，并且有助于防止可能导致电弧放电的高电流密度。
系统描述
图1是根据本发明的一个实施方案的包括医疗探头22和控制台24的医疗系统20的示意性图解。医疗系统20可基于例如由Biosense Webster Inc.(31Technology Drive,Suite 200,Irvine,CA 92618USA)生产的
Figure BDA0003736330110000051
系统。在下文所述的实施方案中，医疗探头22可用于诊断或治疗处理，诸如用于在患者28的心脏26中执行消融规程。另选地，加上必要的变更，可将医疗探头22用于心脏中或其它身体器官中的其它治疗和/或诊断目的。
探头22包括柔性插入管30和联接到插入管的近侧端部的手柄32。在医疗规程期间，医疗专业人员34可将探头22通过患者28的血管系统插入，使得医疗探头的远侧端部36进入体腔，诸如心脏26的腔室。在远侧端部36进入心脏26的腔室后，医疗专业人员34可部署附连到远侧端部36的篮状物组合件38。篮状物组合件38包括附连到多个脊状物的一组电极40(在本文也称为电极主体40)，如下文参考图3、图6和图7的描述中所描述的。
为了开始执行诸如不可逆电穿孔(IRE)消融的医疗规程，医疗专业人员34可以操纵手柄32以定位远侧端部36，使得电极40在期望的一个或多个位置处接合心脏组织。
在图1所示的配置中，控制台24通过缆线42连接到体表电极，该体表电极通常包括附连到患者28的粘合剂皮肤贴片44。控制台24包括处理器46，该处理器与电流跟踪模块48结合，基于在粘合剂皮肤贴片44和附连到篮状物组合件38的电极40之间测量的阻抗和/或电流来确定远侧端部36在心脏26内的位置坐标。除了在医疗规程期间用作位置传感器之外，电极40还可执行其它任务，诸如消融心脏中的组织。
如上所述，处理器46可与电流跟踪模块48结合，基于在粘合剂皮肤贴片44和电极40之间测量的阻抗和/或电流来确定远侧端部36在心脏26内的位置坐标。此类确定通常在已经执行了将阻抗或电流与远侧端部的已知位置相关联的校准过程之后。虽然本文呈现的实施方案描述(也)被配置成将IRE消融能量递送到心脏26中的组织的电极40，但是将电极40配置成将任何其它类型的消融能量递送到任何体腔中的组织被认为是在本发明的实质和范围内。
处理器46可包括通常被配置为现场可编程门阵列(FPGA)的实时降噪电路50以及模数(A/D)信号转换集成电路52。处理器可编程为执行本文所公开的一种或多种算法，一种或多种算法中的每种算法包括下文所述的步骤。处理器使用电路50和电路52，以及下文更详细地描述的模块的特征，以便执行该一种或多种算法。
尽管图1所示的医疗系统使用基于阻抗或电流的感测来测量远侧端部36的位置，但可使用其它位置跟踪技术(例如，使用基于磁的传感器的技术)。基于阻抗和电流的位置跟踪技术在例如美国专利5,983,126、6,456,864和5,944,022中有所描述。上文所述的位置感测的方法在上述
Figure BDA0003736330110000061
系统中实现，并且详细地描述于上文引用的专利中。
控制台24还包括输入/输出(I/O)通信接口54，该输入/输出(I/O)通信接口使得控制台24能够传递来自电极40和粘合剂皮肤贴片44的信号，并且/或者将信号传递到该电极和粘合剂皮肤贴片。在图1所示的配置中，控制台24还包括IRE消融模块56和切换模块58。
IRE消融模块56被配置成生成具有在几十千瓦范围内的峰值功率的IRE脉冲。如下所述，医疗系统20通过将IRE脉冲递送到电极对40来执行IRE消融。在一些实施方案中，给定电极对包括两组电极40，其中这些组中的每个组具有至少一个电极40。使用切换模块58，IRE消融模块56可以独立于电极对中的每个电极对递送一个或多个IRE脉冲。
为了散热和改善消融过程的效率，系统20经由插入管30中的通道(未示出)向远侧端部36供应冲洗流体(例如，盐溶液)。控制台24包括冲洗模块60来监测和控制冲洗参数，诸如冲洗流体的压力和温度。
基于从电极40和/或粘合剂皮肤贴片44接收的信号，处理器46可生成示出远侧端部36在患者体内的位置的电解剖标测图62。在规程期间，处理器46可在显示器64上将标测图62呈现给医疗专业人员34，并且将表示电解剖标测图的数据存储在存储器66中。存储器66可包括任何合适的易失性存储器和/或非易失性存储器，诸如随机存取存储器或硬盘驱动器。
在一些实施方案中，医疗专业人员34可使用一个或多个输入装置68操纵标测图62。在另选的实施方案中，显示器64可包括触摸屏，该触摸屏可被配置成除了呈现标测图62之外，还接受来自医疗专业人员34的输入。
图2是示出根据本发明的一个实施方案的给定电极40的成角度视图的示意性图解。每个电极40由生物相容性导电材料制成，具有穿过该电极的电极内腔70，并且具有从电极的外表面74延伸到内腔的凹口72。除了外表面74之外，每个给定电极40具有由该给定电极的相应内腔70限定的内表面76。
图3A和图3B(在本文也统称为图3)是根据本发明的一个实施方案的包括篮状物组合件38的远侧端部36的示意性图解。图3A示出了诸如由于在远侧端部36处推出插入管内腔80而不受约束地处于膨胀配置的篮状物组合件38，并且图3B示出了位于插入管30内处于塌缩配置的篮状物组合件。如图3B所示，当篮状物组合件38在插入管30内塌缩时，电极40的向外偏置使得脊状物82能够与轴84齐平。
以举例的方式，如图3A所示，篮状物组合件38包括多个柔性脊状物82，这些柔性脊状物形成在管状轴84的端部处并且在它们的近侧端部和远侧端部处连接。在医疗规程期间，医疗专业人员34可通过将管状轴84从插入管30延伸来部署篮状物组合件38。脊状物82可具有椭圆形(例如，圆形)或矩形(可呈现为平坦的)横截面，并且通常包括柔性的弹性材料(例如，形状记忆合金，诸如镍钛，也称为镍钛诺)。在篮状物组合件的膨胀配置中，篮状物组合件38具有膨胀布置(图3A)，其中脊状物82径向向外弯曲；以及塌缩布置(图3B)，其中脊状物大体沿插入管30的纵向轴线86布置。
在图3所示的配置中，一个或多个电极40螺纹连接到每个给定脊状物82上，以便将电极装配到脊状物。下文参考图6和图7的描述中描述了将给定电极40装配到给定脊状物82。
在本文所述的实施方案中，电极40可被配置成将消融能量递送到心脏26中的组织。除了使用电极40递送消融能量之外，电极还可用于确定篮状物组合件38的位置和/或测量生理特性诸如心脏26中的组织上的相应位置处的局部表面电势。
每个脊状物82具有外侧88和内侧90。在本发明的实施方案中，对于装配到给定脊状物82的给定电极40，给定脊状物在给定电极处是平面的，其中平面不对称地划分给定电极，使得在(平面的)外侧上比在内侧上存在更多的导电材料。在这些实施方案中，电极40(即，当装配到脊状物82时)朝向脊状物82的外侧偏置，因为与给定电极在内侧上的表面积相比，给定电极在外侧上具有更大的表面积。
理想地适合于形成电极40的材料的示例包括金、铂和钯(以及它们的相应合金)。这些材料还具有非常高的热导率，这允许在组织上生成的最小热量(即，通过递送到组织的消融能量)通过电极传导到电极的背面(即，电极在脊状物的内侧上的部分)，并且然后传导到心脏26中的血池。
探头22还包括将IRE消融模块56联接到电极40的一组导线92。在一些实施方案中，每个脊状物82包括附连到该脊状物的内侧90的给定导线92。将导线92连接到电极40在下文参考图7的描述中有所描述。
篮状物组合件38具有远侧端部94并且包括柄96，该柄从轴84的远侧端部朝向远侧端部94纵向延伸。如上所述，控制台24包括将冲洗流体递送到远侧端部36的冲洗模块60。柄96包括多个喷雾端口98，其中每个给定喷雾端口98成角度以旨在将冲洗流体递送到给定电极40或心脏26中的组织(即，通过旨在在两个相邻脊状物82之间递送)。
通过将电极40偏置到外侧88，电极从电极在脊状物的外侧上的部分递送更多的消融能量(即，显著多于从电极在脊状物的内侧上的部分递送的消融能量)。由于电极40不包括递送冲洗流体的喷雾端口，因此上文所述的配置使得热量能够从组织传递到电极在脊状物的内侧上的部分(即，在消融规程期间)，并且电极可通过经由喷雾端口98使冲洗流体对准电极在脊状物的内侧上的部分进行冷却。
图4是示意性地示出制造电极40并且将电极装配到脊状物82的方法的流程图，并且图5A-图5C(在本文也统称为图5)是示出根据本发明的一个实施方案的由导电材料的挤出管130制造给定电极40的示意性图解。图5A示出了挤出管130的纵向视图，图5B示出了限定管内腔132的管130的横截面纬度视图，并且图5C示出了给定挤出电极主体40的纵向视图。
在挤出步骤100中，制造商(未示出)挤出导电材料的非径向对称管130，如图5B中的管的横截面纬度视图所示。例如，管130可具有0.04英寸(±0.003英寸)的高度和0.048英寸(±0.003英寸)的宽度，内腔可具有0.017英寸(±0.001英寸)的高度和0.032英寸(±0.002英寸)的宽度，内腔下方的导电材料的厚度可以是0.003英寸(±0.001英寸)，并且内腔上方的导电材料的厚度可以是约0.02英寸。
在制造步骤102中，制造商使用切割器械来从管130切割出多个电极主体40(图5C)。在一些实施方案中，每个电极可具有约0.08英寸的长度。
在图5A所示的示例中，制造商可使用切割器械诸如放电机加工(EDM)导线134来由管130制造电极主体。在一些实施方案中，制造商可使用EDM导线134来在单个切割操作中制造电极主体(包括凹口72)中的每个电极主体，如切割路径136所示。
制造步骤102可在电极主体40上产生锋利边缘138(图5C)。如果医疗系统20用于执行高能量消融规程诸如IRE消融，则将高消融能量施加到电极40可导致来自边缘138的电弧放电。
在平滑步骤104中，制造商使所制造的电极主体上的边缘138平滑。制造商可使用的平滑过程的示例包括但不限于滚揉/鸣动和滚光。
在施加步骤106中，制造商将粘合剂140施加到电极主体40的内表面76。
在第一选择步骤108中，制造商选择给定制造电极主体40，并且在第二选择步骤110中，制造商选择用于所选择的电极主体的给定脊状物82。
在装配步骤112中，制造商将所选择的电极主体的内腔装配到所选择的脊状物，使得所选择的电极主体朝向所选择的脊状物的外侧偏置。
图6和图7是根据本发明的一个实施方案的将给定电极主体40的内腔70装配在给定脊状物82上(如由图6中的箭头150指示)，使得给定电极主体朝向给定脊状物的外侧88偏置的纵向视图。
在定位步骤114中，制造商将所选择的电极主体定位在所选择的脊状物上的具体纵向位置160处。在一些实施方案中，将所选择的电极主体定位在所需位置处使得粘合剂140能够凝固，由此在所选择的电极主体和所选择的脊状物之间形成粘结体。电极40的配置的一个优点在于，如果给定电极40和给定脊状物82之间的粘结体断裂，则给定脊状物的内腔仍将包含给定电极，由此防止给定电极从篮状物组合件38中“断开”。
在拉动步骤116中，制造商将导线从所选择的电极主体的内侧拉动(例如，“钩钓”)到所选择的电极主体的凹口中，并且在连接步骤118中，制造商用焊料材料162(例如，金-锡合金)填充凹口(即，包含拉动导线)，由此在导线和所选择的电极主体之间形成电连接件(并且由此在所选择的电极主体和消融模块56之间形成电连接件)。
最后，在决策步骤120中，如果仍存在尚未被选择用于篮状物组合件38的任何电极主体40(即，在步骤108中)，则该方法继续步骤108，其中制造商可选择先前未选择的电极主体40。当不再有用于篮状物组合件38的未选择的电极主体40时，该方法结束。例如，图2所示的篮状物组合件包括十二个电极40(即，六个脊状物82，其中两个电极主体装配到脊状物中的每个脊状物)。因此，该方法在完成将两个电极固定到每个脊状物82时结束。
应当理解，上述实施方案以举例的方式被引用，并且本发明不限于上文具体显示和描述的内容。相反，本发明的范围包括上述各种特征的组合和子组合以及它们的变型和修改，本领域的技术人员在阅读前述说明时应当想到这些变型和修改，并且这些变型和修改并未在现有技术中公开。

Claims (18)

1.一种医疗探头，包括：
柔性插入管，所述柔性插入管具有近侧端部和远侧端部；
篮状物组合件，所述篮状物组合件位于所述柔性插入管的所述远侧端部处，所述篮状物组合件包括多个脊状物；以及
多个电极，所述电极中的每个电极具有穿过所述电极的装配给定脊状物的内腔。
2.根据权利要求1所述的医疗探头，其中，所述脊状物具有相应的外侧和内侧，并且其中每个给定电极包括朝向所述给定电极的相应脊状物的所述外侧偏置的导电材料。
3.根据权利要求1所述的医疗探头，其中，所述脊状物具有相应的外侧和内侧，并且其中每个给定电极具有位于所述内腔和所述给定电极的相应脊状物的所述内侧之间的凹口。
4.根据权利要求3所述的医疗探头，其中，每个给定脊状物包括附连到所述给定脊状物的所述内侧的导线，并且其中所述凹口包括在所述每个给定电极和所述导线之间形成电连接件的焊料材料。
5.根据权利要求1所述的医疗探头，并且还包括施加到每个给定电极的内表面的粘合剂材料，并且其中所述内表面由所述每个给定电极的所述内腔限定。
6.根据权利要求1所述的医疗探头，其中，所述电极中的每个电极具有一个或多个平滑边缘。
7.根据权利要求1所述的医疗探头，并且还包括一组喷雾端口，所述一组喷雾端口被配置成将冲洗流体递送到所述电极。
8.根据权利要求1所述的医疗探头，并且还包括一组喷雾端口，所述一组喷雾端口被配置成在所述脊状物之间递送冲洗流体。
9.一种方法，包括：
提供具有多个脊状物的医疗探头；
提供导电材料的挤出管；
在所述挤出管上执行切割操作以便形成电极主体；以及
将所形成的电极主体装配在给定脊状物周围。
10.根据权利要求9所述的方法，其中，所述多个脊状物在所述医疗探头的远侧端部处形成篮状物组合件。
11.根据权利要求9所述的方法，其中，所述切割操作在所述电极主体上形成锋利边缘，并且所述方法还包括使所述锋利边缘平滑。
12.根据权利要求9所述的方法，其中，所述挤出管限定内腔，并且其中所述管不是关于所述内腔径向对称的。
13.根据权利要求9所述的方法，其中，所述给定脊状物具有外侧和内侧，并且其中将所形成的电极主体装配在所述给定脊状物上包括将所述电极主体朝向所述给定脊状物的所述外侧偏置。
14.根据权利要求9所述的方法，其中，所述给定脊状物具有外侧和内侧，并且其中所述切割操作包括在所述内腔和所述给定脊状物的所述内侧之间切割出凹口。
15.根据权利要求14所述的方法，其中，所述给定脊状物包括附连到所述给定脊状物的所述内侧的导线，并且所述方法还包括用焊料填充所述凹口，以便在所述导线和所述电极主体之间形成电连接件。
16.根据权利要求9所述的方法，其中，将所形成的电极主体装配在所述给定脊状物周围包括在所述电极主体和所述给定脊状物之间形成粘结体。
17.根据权利要求9所述的方法，并且还包括提供一组喷雾端口，所述一组喷雾端口被配置成将冲洗流体递送到所述电极。
18.根据权利要求9所述的方法，并且还包括提供一组喷雾端口，所述一组喷雾端口被配置成在所述脊状物之间递送冲洗流体。
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