CN1494931A - 运行具有双能源的消融发生器的系统 - Google Patents
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Abstract
一种导管系统,具有RF导管、超声波导管和消融发生器,所述消融发生器与RF发生器和超声波发生器连接。所述消融发生器能够产生RF能量和超声波能量。
Description
技术领域
本发明涉及医用装置系统,其应用于心内标测和消融。具体地,本发明涉及一种消融发生器,这种消融发生器既能够向导管发送射频能量也能够向导管发送超声波能量,用于治疗各种形式的心律失常。
背景技术
异常心律的症候统称为心律失常,而异常的快心律称为心动过速。心房内致心律失常区或旁道的存在可以使正常通路旁路或短路,可能导致非常快的心脏收缩,本文称为心房扑动。心房扑动一般以带有ECG的下壁导联负向偏离的锯齿波型为特征,而心房率在每分钟240至340搏的范围。心房纤颤是更复杂的多重心房扑动情况,造成心律不规则及无序。异常的快心律还可出现在心室,这是较常称为室性心动过速的病情。
心房扑动和心房纤颤(AFib)的治疗可以用各种方法进行,包括药物、手术、植入起搏器/除纤颤器,以及导管消融。尽管可为许多患者选择药物治疗,但是药物治疗只是掩盖症状,而不能治愈根本病因,而且还引起副作用。另外,植入装置只能在心律失常发生后加以矫正。另一方面,通常是通过消融异常的致心律失常作用组织或者导致心动过速的旁道,事实上手术和基于导管的治疗能治愈病情。
心房纤颤被认为是心房内的电信号异常传导的结果,造成电活动的传播无序使得心房颤动地收缩的情况。曾经认为AFib是良性的紊乱,但现在已经广泛地认为是重要的致病和致死的病因。AFib的最危险后果是造成血液郁积的血栓栓塞和中风,后者是由于心房的紊乱收缩而引起。这又可导致凝块形成并且可能导致栓塞性中风。根据美国心脏医学会的数据,每年约75,000例中风与AFib相关。
使用当前的导管设计,尽管射频(RF)导管消融产生了有前景的结果,但是公知的导管通常只有一个大的消融用电极。发送到导管头端电极的RF能量引起组织温度在数毫秒内快速下降,从而满足大多数旁道的治疗和房室结折返性心动过速的治疗。
然而,RF能量并非总是合适的。例如,与冠状动脉缺血性心脏病有关的大多数室性心律失常需要穿透较多的组织才能进行成功的消融。左侧消融可引起中风,而在起源于肺静脉的AFib用RF消融可造成狭窄。在AFib患者中,由于在心房内同时发生折返性电脉冲的多重微波,因此需要通过产生心内直线损伤而同时地或相继地阻断该多重折返脉冲。
已提出使用超声波(US)能量,这在较厚心肌产生较深损伤上可能有前景,并且在肺静脉口之类的孔形区域产生圆周形损伤方面也可能有前景。超声波是通过介质内粒子运动作为机械波传播的振动能形式(每秒18,000周以上)。这引起粒子的浓缩化及稀薄化,从而传播与粒子机械运动相联系的压力波。在吸收性介质中,连续地吸收超声波能量并且在介质内转化成热量。如果温度上升足够高并且保持特定的时间,就可发生组织损伤。这种热效应与使用具有相同热暴露的其它加热系统得到的热效应相似。
发明内容
因此,本发明的目的是提供改进的基于导管的消融系统,所述消融系统在单个发生器单元中具有双能源(RF和US),用于治疗各种致心律失常的临床指征,譬如室上性心动过速、心房扑动、心房纤颤,以及室性心动过速。
为了达到本发明的目的,本发明提出一种导管系统,具有:RF导管、超声波导管,和消融发生器,所述消融发生器连接到RF发生器和超声波发生器上。所述消融发生器能够产生RF能量和超声波能量。
附图说明
图1为系统简图,示出本发明所述的基于导管的消融系统的部件。
图2为图1所示系统的消融发生器的方框图。
图3为流程图,示出图1所示系统的工作程序。
图4示出图1的系统如何在消融过程中发送超声波能量。
图5示出图1的系统如何在消融过程中发送RF能量。
具体实施方式
以下的详细说明是执行本发明最佳实施形式的预期模式。本说明不应当认为是有限制意义,而仅用于阐述本发明的一般实施原则。本发明的范围由所附权利要求书很好地加以定义。
图1示出本发明所述的基于导管的消融系统10的部件。系统10包括第一导管装置12,所述导管装置12用于向进行消融的治疗位置提供RF能量。系统10还包括第二导管装置14,所述导管装置14用于向进行消融的治疗位置提供超声波能量。可以用RF导管和超声波导管领域内公知的导管结构分别地提供装置12和14,并且可以用本领域内公知的RF和超声波原理操作,所以本文不对其结构和操作详细说明。
系统10还包括消融发生器16。所述消融发生器16具有连接到患者回流电极垫20的无关电极18,所述回流电极垫20附着在患者的背上以完成RF回路,而在使用超声波导管14时不需要它。消融发生器16还包括RF患者连接器22,所述RF患者连接器连接到RF导管12上以向导管12提供超声波能量。消融发生器16还包括超声波患者连接器24,所述超声波患者连接器24连接到超声波导管14上向超声波导管14提供超声波能量。超声波导管14具有封闭在球囊中的超声波换能器,所述球囊设在导管的远端部分。在RF导管2的远端部分布置有多个电极,通过RF导管12的内腔而伸长的导线把每个分开的电极连接到导管柄近端的连接器销栓上。
图2为方框图,示出消融发生器16的主要部件。消融发生器16具有接收AC输入的AC电源进线口30。AC电源进线口30的输出端连接到绝缘变压器32的输入,所述绝缘变压器起到把患者与系统10的电路绝缘的作用。变压器32的输出连接到DC电源34和RF电路板36。DC电源34将AC电压转换成DC电压。把DC电源34的输出提供到彩色LCD显示器和微控制器38的输入、RF电路板36的输入、热电偶和热敏电阻电路板48的输入,和超声波电路板50的输入。彩色LCD显示器和微控制器38控制显示屏42(见图1)上的信息显示,并且控制发生器16的功率、温度和阻抗。彩色LCD显示器和微控制器38的输入和输出、变压器32的输出和DC电源34的一个输出连接到RF电路板36上。RF电路板36还接受无关电极18的输出。RF电路板36产生约500kHz并且约150瓦特的功率信号,并且向RF分流器电路板40的输入提供输出。RF分流器电路板40把来自RF电路板36的功率信号分入四个槽路。RF分流器电路板40具有连接到RF绝缘的患者连接器22上的输入端,并且该输出端还连接到低通滤波器44的输入。对低通滤波器44的另一个输入来自超声波患者连接器24。
低通滤波器44的输出连接到心电图(ECG)连接器46的输入。彩色LCD显示器和微控制器38的输入和输出提供到超声波电路板50,而超声波电路板50的输出提供到超声波患者连接器24。超声波电路板50产生约7-8MHz和约50瓦特的超声波能量。设在超声波电路板50中的锁相环电路把经超声波换能器发送的声能最大化。相位检测器设在锁相环电路中并且检测超声波导管14中的超声波换能器的阻抗,以使发生器16能够提供适当的超声波消融频率。尤其是,所述相位检测器扫描适当的电流和电压相位,并且将其调节至零相位及扫描最小的换能器阻抗。最小的换能器阻抗让超声波换能器能够以其本征频率或者谐振频率振动,这种振动是最大振动能。
另外,彩色LCD显示器和微控制器38经双通连接器连接热电偶和热敏电阻电路板48。起温度放大器作用的热电偶和热敏电阻电路板48还具有接收来自DC电源34、RF绝缘的患者连接器22和超声波患者连接器24的输出的输入端。
还在RF导管12的每个电极的近端,和在超声波导管14的球囊上或超声波换能器附近设有温度传感器(未示)。所述传感器不停地监测身体组织的温度,并且把温度转发给彩色LCD显示器和微控制器38。
从而DC电源34向RF电路板36和超声波电路板50提供所需电力。RF电路板36向RF导管12提供RF能量,而超声波电路板50向超声波导管14提供超声波能量,全部都受彩色LCD显示器和微控制器38的控制。在彩色LCD显示器和微控制器38中提供软件程序或者算法,以控制RF或超声波能量的供给。尤其是,微控制器38向分流器电路板40提供信号,后者用于在预定温度范围内控制每个电极的RF能量量输出。微控制器38还向超声波电路板50提供信号,以控制微控制器从微控制器38发出的电压和电流,以使超声波换能器的超声波能量输出最大化。发送到每个电极或超声波换能器的且在预定温度范围内的RF和超声波能量输出的总持续时间之和是个别地预先设定的。
RF能量密度量提供到四个电极的每个,在选择提供声能时,也是提供到导管上的超声波换能器。本文中“RF能量量密度”定义为每单位组织接触表面积上传送的的RF能量。另外发生器16包括具有温度传感器(可以与上述的温度传感器相同)的每个电极的闭环控制装置(设在微控制器38中)。为了更好地控制所希望的损伤特性,可以在从某电极检测出的组织接触温度相对低的时候向该电极提供较多的RF能量。另一方面,在测出的组织接触温度相对高的时候可以减少RF能量。发生器16还具有编程的控制装置,用于通过RF分流器电路板40独立地选择和控制RF导管12的消融电极。在此情况下可以用以下方式之一选择和控制消融的电极数:同时方式、依次模式、个别模式,或者以上模式的组合。
为了较好的控制损伤特性,在测量出的组织接触温度相对低的时候提供较多超声波能量。反之,在检测出的组织接触温度相对高的时候提供较少超声波能量。
图3为流程图,示出图2所示的消融发生器16的运行。如图3所示,发生器16首先判断使用的是超声波导管14还是RF导管12。一旦判断了导管的属性或者类型,就设定消融的模式、功率和温度,然后通过向导管12或14提供选取的能量(RF或超声波)而开始消融。发生器16还将检查温度、阻抗、相位和功率(适用时)是否在预选的限度内,并且如果任一参数在预选的范围之外就停止消融。另一方面,只要这些参数在预选的限度内就继续进行消融。
图4示出图1的系统如何在消融过程中发送超声波能量。超声波导管14连接到超声波患者连接器24上,并且用最低侵入方式经皮把导管14送进患者心脏内的治疗区域中。图5示出图1的系统如何在消融过程中发送RF能量。RF导管12连接到RF患者连接器22上,并且用最低侵入的方式经皮把导管12送进患者心脏内的治疗区域中。患者回流电极垫20连接到无关电极18上,并且附着在患者的背上,以完成RF回路。
尽管上面参照本发明的特定实施进行了说明,但是应当理解可以进行许多修改而不偏离本发明的精神。所附权利要求书旨在涵盖所有落入本发明的范围和精神内的修改。
Claims (1)
1.一种导管系统,包括:
RF导管;
超声波导管;和
消融发生器,所述消融发生器与RF发生器和超声波发生器连接,并且具有产生RF能量和超声波能量的装置。
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US10/143,100 | 2002-05-07 | ||
US10/143,100 US20030212390A1 (en) | 2002-05-07 | 2002-05-07 | System for operating an ablation generator with dual energy source |
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US (1) | US20030212390A1 (zh) |
EP (1) | EP1360938A1 (zh) |
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CN113229892A (zh) * | 2016-08-09 | 2021-08-10 | 柯惠有限合伙公司 | 外科发生器和手术系统 |
WO2022148152A1 (zh) * | 2021-01-08 | 2022-07-14 | 北京迈迪顶峰医疗科技股份有限公司 | 消融装置和射频消融设备 |
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DE10203265A1 (de) * | 2002-01-29 | 2003-07-31 | Ina Schaeffler Kg | Anlaufscheibe eines Planetengetriebes |
US20060089637A1 (en) | 2004-10-14 | 2006-04-27 | Werneth Randell L | Ablation catheter |
US8617152B2 (en) | 2004-11-15 | 2013-12-31 | Medtronic Ablation Frontiers Llc | Ablation system with feedback |
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-
2002
- 2002-05-07 US US10/143,100 patent/US20030212390A1/en not_active Abandoned
-
2003
- 2003-05-06 JP JP2003128248A patent/JP2004000595A/ja active Pending
- 2003-05-06 CN CNA031234046A patent/CN1494931A/zh active Pending
- 2003-05-06 EP EP03010176A patent/EP1360938A1/en not_active Withdrawn
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CN113229892A (zh) * | 2016-08-09 | 2021-08-10 | 柯惠有限合伙公司 | 外科发生器和手术系统 |
WO2022148152A1 (zh) * | 2021-01-08 | 2022-07-14 | 北京迈迪顶峰医疗科技股份有限公司 | 消融装置和射频消融设备 |
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US20030212390A1 (en) | 2003-11-13 |
JP2004000595A (ja) | 2004-01-08 |
EP1360938A1 (en) | 2003-11-12 |
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