CN113116509A - 用于导管的多用途感测和射频(rf)消融螺旋电极 - Google Patents
用于导管的多用途感测和射频(rf)消融螺旋电极 Download PDFInfo
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Abstract
本发明题为“用于导管的多用途感测和射频(RF)消融螺旋电极”。本发明公开了一种电气设备,该电气设备包括螺旋电极和接口电路。螺旋电极被设置在探头的远侧端部上,以用于插入患者的身体中。该接口电路被配置成(a)将射频(RF)消融信号传输到电极以用于消融身体中的组织,(b)响应于外部磁场输出跨电极形成的电压,以用于测量远侧端部在身体中的位置,以及(c)将电流传输通过电极以用于测量电阻率,该电阻率指示电极附近的组织温度。
Description
技术领域
本发明整体涉及医疗探头,并且具体地涉及心脏感测和消融导管。
背景技术
用于组织消融的心脏导管可在它们的远侧端部处包括多个传感器和消融电极,其中不同的装置通常彼此电隔离。例如,温度传感器可被嵌入由消融电极覆盖的区域中以测量该电极的消融温度,但具有单独的电导体。
发明内容
本发明的一个实施方案提供一种电气设备,该电气设备包括螺旋电极和接口电路。螺旋电极被设置在探头的远侧端部上,以用于插入患者的身体中。该接口电路被配置成(a)将射频(RF)消融信号传输到电极以用于消融身体中的组织,(b)响应于外部磁场输出跨电极形成的电压,以用于测量远侧端部在身体中的位置,以及(c)将电流传输通过电极以用于测量电阻率,该电阻率指示电极附近的组织温度。
在一些实施方案中,螺旋电极被配置为单轴线圈位置传感器。
在一些实施方案中,螺旋电极被设置在印刷电路板(PCB)的第一小面上,其中螺旋电极的第一端部被设置在第一小面上,并且螺旋电极的第二端部通过通孔被连接到PCB的第二小面。
在一个实施方案中,接口电路包括RF消融信号的源和电极之间的导体上的高通滤波器。
在另一个实施方案中,电气设备还包括表面电极,该表面电极被配置成闭合用于由螺旋电极施加的RF消融信号的电路。
在一些实施方案中,接口电路包括螺旋电极和RF消融信号的源之间的电导体上的隔离电容器。
根据本发明的另一个实施方案,另外提供了一种方法,该方法包括将被设置在探头的远侧端部上的螺旋电极插入患者的身体中。射频(RF)消融信号被传输到电极以用于消融身体中的组织。响应于外部磁场的跨所述电极形成的电压被输出用于测量所述远侧端部在所述身体中的位置。电流被通过电极传输以用于测量电阻率,该电阻率指示电极附近的组织温度。
根据本发明的另一个实施方案,还提供了一种制造方法,该制造方法包括将螺旋电极设置在探头的远侧端部上以用于插入患者的身体中。接口电路被连接到所述螺旋电极,其中所述接口电路被配置成(a)将射频(RF)消融信号传输到所述电极以用于消融所述身体中的组织,(b)响应于外部磁场输出跨所述电极形成的电压,以用于测量所述远侧端部在所述身体中的位置,以及(c)将电流传输通过所述电极以用于测量电阻率,所述电阻率指示所述电极附近的组织温度。
在一些实施方案中,设置螺旋电极包括将螺旋电极,包括电极的第一端部,设置在印刷电路板(PCB)的第一小面上,以及通过通孔将螺旋电极的第二端部连接到PCB的第二小面。
结合附图,通过以下对本发明的实施方案的详细描述,将更全面地理解本发明,其中:
附图说明
图1为根据本发明的一个实施方案的基于导管的定位-跟踪和射频(RF)消融系统的示意性图解;
图2为根据本发明的一个实施方案的图1的包括螺旋多用途电极及其导体的导管的导管末端的示意性图解;并且
图3为根据本发明的一个实施方案的示意性地示出用于使用图2的导管末端的螺旋电极以用于位置感测、射频(RF)消融和温度感测的方法的流程图。
具体实施方式
概述
用于射频(RF)消融的导管需要能够递送消融功率的电极。此外,导管位置可被跟踪,并且电极温度在消融期间被测量。这三个条件可由三个单独的系统服务:电极、跟踪装置(诸如单轴或三轴磁传感器)和温度传感器(诸如热电偶)。这三个单独的系统需要三组单独的连接,所述连接中一些连接本身可能是有问题的。(例如,铜-康铜热电偶中的康铜是易碎的并且容易断裂。)尽管存在问题,但在导管末端的末端上集成三个单独的系统本就是复杂的。
下文中所述的本发明的实施方案使用一个能够提供三种功能的电极。在一些实施方案中,螺旋电极被设置在探头的远侧端部上,以用于插入患者的身体中。电气设备的接口电路被配置成(a)将射频(RF)消融信号传输到所述电极以用于消融所述身体中的组织,(b)响应于外部磁场输出跨所述电极形成的电压,以用于测量所述远侧端部在所述身体中的位置,(c)以及将电流传输通过所述电极以用于测量电阻率,所述电阻率指示所述电极附近的组织温度。
在一些实施方案中,电极在柔性印刷电路板(PCB)的一侧上形成为平面高密度螺旋件,其中螺旋件的一个端部被连接在PCB的一个小面上。PCB的另一小面被用于通过PCB中的镀覆保持件(“通孔”)连接到螺旋件的另一端部。螺旋件通常由金属诸如金形成。在一个实施方案中,螺旋件为大约4mm×4mm正方形的形式,螺旋件的线为隔开大约25μm的大约25μm宽。直线、曲线或曲线螺旋形式的任何大致螺旋形状均是可能的,并且具体地可利用椭圆形或圆形形状。
如本文所用,针对任何数值或数字范围的术语“约”或“大约”指示允许部件或部件的集合执行如本文所述的其预期目的的合适尺寸公差。更具体地,“约”或“大约”可指列举值的值±20%的范围,例如“约90%”可指71%至99%的值范围。
螺旋件具有较大面积,并且因此能够传输RF消融功率并充当消融电极。此外,由于消融RF功率被连接到螺旋件的两端,如下文所示,因此没有RF功率沿着螺旋件的线传输。相反,所有功率通过患者从螺旋表面传输出去,并且传输到附接到患者的皮肤的返回电极。消融RF功率通常具有350kHz至500kHz的频率范围,在一个实施方案中,该频率范围通过隔离电容器(或其他合适的高通滤波器)提供给螺旋电极,如下文所示。
由于电极为螺旋件的形式,因此其可充当响应于横贯螺旋电极的交变磁场的单轴磁传感器,所述场跨螺旋件的两个端部生成电势Vf。(交变磁场具有通常等于大约20kHz的频率,所以它们可使用例如隔离电容器来容易地与消融功率隔离)。电势Vf可被用于找到传感器的位置和取向,使得电极充当位置传感器。
金属(例如金)螺旋件的比电阻以非常熟知的关系随其温度改变(金的温度系数为0.003715℃-1)。因此,测量螺旋件的电阻R提供了对温度的测量。例如,在20℃下具有30δΩ的电阻(上述4mm×4mm螺旋件的近似电阻)的金螺旋件在21℃下具有30.1Ω的电阻。螺旋件的电阻R可使用阻抗读取电路来测量,例如通过将螺旋件连接为惠斯通(Wheatstone)电桥的一个臂。因此,电极可充当电阻温度计。在一个实施方案中,前述电隔离电容器确保测量的电阻为螺旋件的电阻。
关于本发明的可使用的螺旋件的导管的类型没有限制,即,螺旋件可结合到局灶性导管、篮状导管、球囊导管、套索导管或其他类型的导管中。
也不需要实施螺旋件的所有三种功能。因此,在一些实施方案中,仅使用一种功能,在其他实施方案中,仅使用三种功能中的两种,并且在其他实施方案中,使用所有三种功能。
通过提供如上所述的导管的多用途电极,导管的复杂性和价格可被降低,并且从而增加基于导管的RF消融治疗的可用性。
系统描述
图1为根据本发明的一个实施方案的基于导管的定位-跟踪和射频(RF)消融系统20的示意性图解。系统20包括导管末端40(见于插图25中),该导管末端适配在导管21的轴22的远侧端部22a处。RF消融末端40包括进一步充当磁传感器并充当温度传感器的螺旋电极50(在图2中详细描述)。在本文所述的实施方案中,螺旋电极50用于消融心脏26中的PV的口51的组织。
导管21的近侧端部被连接到包括RF消融功率源45的控制台24。包括消融参数的消融方案存储在控制台24的存储器48中。
医师30将轴22的远侧端部22a通过护套23插入到躺在工作台29上的患者28的心脏26中。医师30通过使用靠近导管的近侧端部的操纵器32操纵轴22来将轴22的远侧端部推进至心脏26中的目标位置,以及/或者使轴的远侧端部相对于护套23偏转。在插入远侧端部22a期间,导管末端40被保持在护套23内部,以最小化沿着到达目标位置的路径的血管创伤。
在一个实施方案中,医师30通过跟踪导管末端40的方向来将轴22的远侧端部导航到目标位置。在心脏26中导航远侧端部22a期间,控制台24在导管末端40处从螺旋电极50接收信号,该导管末端响应于来自外部场发生器36的磁场而充当磁传感器。磁场发生器36放置在患者28外部的已知位置处,例如,在患者的工作台29下方。控制台24还包括被配置成驱动磁场发生器36的驱动电路34。
例如,使用该信号,系统的处理器41估计导管末端40在心脏中的方向,并且任选地在显示器27上呈现所跟踪的方向,例如,相对于口51的近似对称的轴线的取向。在一个实施方案中,控制台24驱动显示器27,该显示器显示导管末端40在心脏26内侧的跟踪位置。
使用外部磁场的方向感测方法在各种医疗应用中实现,例如在由BiosenseWebster Inc.生产的CARTOTM系统中实现,并且在美国专利5391199、6690963、6484118、6239724、6618612和6332089、PCT专利公布WO 96/05768以及美国专利申请公布2002/0065455A1、2003/0120150A1和2004/0068178A1中有详细描述,这些现有申请据此全文以引用方式并入本文中,如同全文在本申请中列出,并且副本附于附录中。在一个实施方案中,来自螺旋电极50的信号还用于使用前述CARTOTM系统进行位置感测。
一旦轴22的远侧端部22a已到达心脏26,医师30就缩回护套23,并且进一步操纵轴22以将导管末端40导航至肺静脉的口51。接下来,当导管末端40接触组织时,医师致使RF电流在末端40上的螺旋电极50与无关(即,中性)电极贴片之间传递,该无关电极贴片在外部联接到受试者,例如联接到受试者的背部。贴片可为单个电极或由若干电极诸如电极38制成,所述电极被示出为通过在缆线37中延伸的线材被连接。处理器41通过向生成电流的RF发生器45输出适当的指令来调节消融电流的参数。
为了进一步执行其功能,处理器41包括温度感测模块47。在示例性系统中,温度感测模块47接收电阻抗信号,该电阻抗信号在螺旋电极50的两个端部之间被测量并且通过延伸穿过轴22的线材传导到处理器41。
处理器41通常为通用计算机,具有合适的前端部以及(a)ECG接口电路44,以用于接收来自电极38的ECG信号,和(b)电接口电路55,以用于接收来自导管21的信号,以及用于经由导管21将RF能量治疗施加于心脏26的左心房中,并用于控制系统20的其他部件。处理器41通常包括系统20的存储器48中的软件,该软件被编程为实施本文所述的功能。该软件可通过网络以电子形式被下载到计算机,例如或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。具体地,处理器41运行如本文所公开的被包括在图3中的专用算法,该专用算法使得处理器41能够执行本发明所公开的步骤,如下文进一步所述。
虽然图1描述了末端导管,但是本技术的原理也适用于具有适配有多个电极的远侧端部的任何导管,诸如五射线和八射线导管(由Biosense-Webster制成)。
用于导管的多用途感测和RF消融螺旋电极
图2为根据本发明的一个实施方案的图1的包括螺旋多用途电极50及其电接口电路55的导管的导管末端40的示意性图解。电接口电路55包括导体(52、54、46、49)和电容器(57、59)或其他合适的高通滤波器,并且被用于(a)将射频(RF)消融信号传输到电极50以用于消融身体中的组织,(b)响应于外部磁场输出跨电极50形成的电压,以用于测量远侧端部在身体中的位置,以及(c)通过电极50传输电流,以用于测量指示电极50附近的组织温度的电阻率。
如所见,电极50形成为2D平面高密度金属螺旋件。虽然所示的螺旋电极的轮廓为正方形,但任何大致直线、曲线或曲线螺旋形状均是可能的,并且具体地为椭圆形或圆形形状。在一个实施方案中,在横截面可见,金属螺旋件被设置在柔性PCB 60上。然而,可使用可被制造成适形于末端的形状的其他类型的基底。如进一步所见,螺旋件的中心使用PCB 60中的通孔62来电连接到PCB背面上的导体52。螺旋件的周边被连接到导体54。
螺旋电极50能够传输RF消融功率并充当消融电极。此外,由于消融RF功率被连接到螺旋件的两端,即,通过将导体52和54短路成单个导体49(在隔离电容器57和59的近侧),因此没有RF功率沿着螺旋件的线传输,其中所有功率由导体49通过患者从螺旋表面传输到附接到患者皮肤的返回电极38,并且进一步经由缆线37以闭合发生器45输出引线处的电路。
还示出了导体46。螺旋电极50可充当响应于横贯螺旋电极的交变磁场的单轴磁传感器,场跨导体46的两个端部生成电势Vf。(交变磁场具有通常等于大约20kHz的频率,所以它们可使用电容器57和59来容易地与消融功率隔离)。低频电势Vf可被用于找到传感器的位置和取向,使得电极充当位置传感器。
螺旋件的金属以非常熟知的关系随温度改变其比电阻,这取决于电极材料的组成。因此,测量螺旋件的导体46之间的电阻R提供了使用模块47的温度测量。因此,螺旋电极可充当电阻温度计。在一个实施方案中,前述电隔离电容器57和59确保测量的电阻是螺旋件本身的电阻,而不是例如由发生器45的输出电阻加权的电阻。
如图2的插图130所示,所公开的螺旋电极150可另选地被设置在导管的三维圆顶形远侧末端140上,由此具有螺旋迹线的柔性PCB适形于圆顶上方。如进一步所见,螺旋电极150以该三维形状被设置,其中螺旋件的中心被电连接到导体152,并且螺旋件的周边被连接到导体154。
图2中所示的绘画侧视图是以示例的方式选择的,其中其他实施方案也是可能的。例如,在另一个实施方案中,冷却流体经由电极50中的灌洗孔(未示出)流动以冷却所消融的组织。
图3为根据本发明的一个实施方案的示意性地示出用于使用图2的导管末端40的螺旋电极50以用于位置感测、射频(RF)消融和温度感测的方法的流程图。根据所呈现的实施方案,算法执行过程,该过程始于在导管末端导航步骤80处,医师30使用螺旋电极50作为磁感应器,将导管末端40导航至患者的心脏26内的目标组织位置,诸如口51处。
接下来,在导管末端定位步骤82处,医师30将导管末端定位在口51处。在该过程中,医师30使导管末端40与目标组织进行接触。
接下来,在电极温度测量步骤84处,处理器41使用阻抗感测模块47测量螺旋电极50的电阻,以确定电极温度。
接下来,在RF消融步骤86处,医师30控制接口电路44以将螺旋电极50连接到RF功率源45并且经由螺旋电极50施加消融能量。
在施加消融能量期间,在温度检查步骤88处,处理器41测量电极50温度并将所测量的温度与预设的最大温度进行比较。
如果温度低于预设的最大温度,则在继续的RF功率施加步骤90处,处理器41控制接口电路44以继续经由电极50施加RF功率。
另一方面,如果温度高于预设的最大温度,则在切换RF功率关步骤92处,处理器41控制接口电路44以将RF功率源与电极50断开。
图3中所示的示例性流程图完全是为了概念清晰而选择的。在另选的实施方案中,可执行另外的步骤,诸如将电极50的温度与最小预设温度进行比较,并且如果电极50的温度在开始施加消融RF能量(指示电极浸没在血液中)之后的给定持续时间内尚未超过最小预设温度,则将电极50与RF功率源断开。
尽管本文所述的实施方案主要涉及肺静脉隔离,但是本文所述的方法和系统也可用于需要身体组织的RF消融的其他应用中,诸如例如肾神经切除、脑血管应用中和耳鼻喉学中。
因此应当理解,上面描述的实施方案以举例的方式被引用,并且本发明不限于上文特定示出和描述的内容。相反,本发明的范围包括上文描述的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上述描述时将会想到该变型和修改,并且该变型和修改并未在现有技术中公开。以引用方式并入本专利申请的文献被视为本申请的整体部分,不同的是如果这些并入的文献中限定的任何术语与本说明书中明确或隐含地给出的定义相冲突,则应仅考虑本说明书中的定义。
Claims (9)
1. 一种电气设备,包括:
螺旋电极,所述螺旋电极被设置在探头的远侧端部上,以用于插入患者的身体中;和
接口电路,所述接口电路被配置成:
将射频(RF)消融信号传输到所述电极以用于消融所述身体中的组织;
响应于外部磁场输出跨所述电极形成的电压,以用于测量所述远侧端部在所述身体中的位置;以及
通过所述电极传输电流以用于测量电阻率,所述电阻率指示所述电极附近的组织温度。
2.根据权利要求1所述的电气设备,其中所述螺旋电极被配置为单轴线圈位置传感器。
3.根据权利要求1所述的电气设备,其中所述螺旋电极被设置在印刷电路板(PCB)的第一小面上,其中所述螺旋电极的第一端部被设置在所述第一小面上,并且所述螺旋电极的第二端部通过通孔被连接到所述PCB的第二小面。
4.根据权利要求1所述的电气设备,其中所述接口电路包括所述RF消融信号的源和所述电极之间的导体上的高通滤波器。
5.根据权利要求1所述的电气设备,并且包括表面电极,所述表面电极被配置成闭合用于由所述螺旋电极施加的所述RF消融信号的电路。
6.根据权利要求1所述的电气设备,其中所述接口电路包括所述螺旋电极和所述RF消融信号的源之间的电导体上的隔离电容器。
7.一种方法,包括:
将被设置在探头的远侧端部上的螺旋电极插入患者的身体中;
将射频(RF)消融信号传输到所述电极以用于消融所述身体中的组织;
响应于外部磁场输出跨所述电极形成的电压,以用于测量所述远侧端部在所述身体中的位置;以及
通过所述电极传输电流以用于测量电阻率,所述电阻率指示所述电极附近的组织温度。
8. 一种制造方法,包括:
将螺旋电极设置在探头的远侧端部上,以用于插入患者的身体中;以及
将接口电路连接到所述螺旋电极,所述接口电路被配置成:
将射频(RF)消融信号传输到所述电极以用于消融所述身体中的组织;
响应于外部磁场输出跨所述电极形成的电压,以用于测量所述远侧端部在所述身体中的位置;以及
通过所述电极传输电流以用于测量电阻率,所述电阻率指示所述电极附近的组织温度。
9.根据权利要求8所述的制造方法,其中设置所述螺旋电极包括将所述螺旋电极,包括所述电极的第一端部,设置在印刷电路板(PCB)的第一小面上,以及通过通孔将所述螺旋电极的第二端部连接到所述PCB的第二小面。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US16/730128 | 2019-12-30 | ||
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US4938761A (en) * | 1989-03-06 | 1990-07-03 | Mdt Corporation | Bipolar electrosurgical forceps |
US5391199A (en) | 1993-07-20 | 1995-02-21 | Biosense, Inc. | Apparatus and method for treating cardiac arrhythmias |
ATE188108T1 (de) | 1994-08-19 | 2000-01-15 | Biosense Inc | Medizinisches diagnose-, behandlungs- und darstellungssystem |
US6690963B2 (en) | 1995-01-24 | 2004-02-10 | Biosense, Inc. | System for determining the location and orientation of an invasive medical instrument |
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EP0891152B1 (en) | 1996-02-15 | 2003-11-26 | Biosense, Inc. | Independently positionable transducers for location system |
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US7729742B2 (en) | 2001-12-21 | 2010-06-01 | Biosense, Inc. | Wireless position sensor |
US20040068178A1 (en) | 2002-09-17 | 2004-04-08 | Assaf Govari | High-gradient recursive locating system |
US9795442B2 (en) * | 2008-11-11 | 2017-10-24 | Shifamed Holdings, Llc | Ablation catheters |
US20110213355A1 (en) * | 2010-03-01 | 2011-09-01 | Vivant Medical, Inc. | Sensors On Patient Side for a Microwave Generator |
US8543190B2 (en) * | 2010-07-30 | 2013-09-24 | Medtronic, Inc. | Inductive coil device on flexible substrate |
US20130281851A1 (en) * | 2012-04-19 | 2013-10-24 | Kenneth L. Carr | Heating/sensing catheter apparatus for minimally invasive applications |
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EP3319510B1 (en) * | 2015-07-08 | 2020-05-13 | The Johns Hopkins University | Tissue ablation and assessment |
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US20180280658A1 (en) | 2017-04-03 | 2018-10-04 | Biosense Webster (Israel) Ltd. | Balloon catheter with ultrasonic transducers |
US11246644B2 (en) * | 2018-04-05 | 2022-02-15 | Covidien Lp | Surface ablation using bipolar RF electrode |
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