CN101416874A - 能够用于压力感测的导管 - Google Patents
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Abstract
本发明涉及能够用于压力感测的导管。一种医疗探针包括:柔性插入管,具有用于插入到患者体腔的远端;远侧尖端,置于插入管的远端并被设置成接触体腔内的组织。弹性部件将远侧尖端耦接到插入管的远端,并配置成当远侧尖端接合组织时响应于施加到远侧尖端上的压力而产生变形。探针内的位置传感器感测远侧尖端相对于插入管的远端的位置,其响应于弹性部件的变形而发生变化。
Description
技术领域
本发明总体上涉及侵入性的医疗装置,尤其涉及感测施加到患者体内的导管(例如探针)上的压力的方法和装置。
背景技术
心脏内的射频(RF)消融术是一种公知的治疗心律失常的方法。一般地,远侧尖端带有电极的导管通过患者的血管系统而插入到心脏的腔室中。电极接触到心内膜上的一个位置(或者多个位置),射频能量通过导管施加到电极以消融这一位置上的心脏组织。为了达到理想的治疗效果而不对组织造成过度的伤害,确保在消融过程中电极和心内膜之间合适的接触是很重要的。
已经提出了大量的技术用以验证电极与组织的接触。例如,美国专利6,695,808,其公开的内容在这里引入作为参考,描述了治疗选定的患者组织或者器官区域的设备。探针具有接触表面,可以压迫所述区域,从而产生接触压力。压力传感器测量该接触压力。这种设置通过向器械使用者提供指示接触力是否存在及其大小的信息,满足了医疗器械必须稳固地放置而不与解剖表面有过度接触的过程的需要。
另外一个例子,美国专利6,241,724,其公开的内容在这里引入作为参考,描述了用分段电极组件在身体组织造成损害的方法。在一实施例中,导管上的电极组件带有压力传感器,其感测与组织的接触并将信号传递到压力接触模块。该模块识别与压力传感器信号相关联的电极元件,然后命令能量发生器传递射频能量到这些元件,而不是传递到只与血液接触的其他元件。
另外一个例子,美国专利6,915,149中介绍的,其公开的内容在这里引入作为参考。这项专利描述了一种用带有尖端电极的导管描绘心脏图的方法,该尖端电极用来测量局部电活动。为了避免尖端和组织的不良接触产生的伪影,尖端和组织间的接触压力通过压力传感器来测量以确保稳定的接触。
美国专利申请公开号2007/0100332,其公开的内容在这里引入作为参考,描述了组织消融中评估电极—组织接触的系统和方法。导管杆内的机电传感器产生与导管杆远端部分中的电极的运动量相对应的电信号。输出装置接收电信号以评估电极和组织间的接触程度。
发明内容
下文中描述的本发明的实施例提供了一种侵入性深针(例如导管)的新设计,和利用这样一种探针的系统和方法。这一设计对于实现和确认探针远侧尖端和组织之间的合适接触尤其有用,其中探针在体内与组织接合(engage)。
在一些实施例中,探针包含柔性的插入管,该插入管带有用于插入到患者的体腔内的远端。探针的远侧尖端通过弹性部件耦接到插入管的远端,所述弹性部件例如是弹簧,其响应于所述远侧尖端与组织接合时施加于该远侧尖端上的压力而变形。探针内的位置传感器感测所述远侧尖端相对于插入管的远端的位置,以指示弹性部件的变形,进而可以给出压力的指示。
在一公开的实施例中,传感器包含在远侧尖端中的磁场传感器,这样探针可以用作用磁场测量体内远侧尖端坐标的系统的一部分。出于这个目的,置于患者的体外的第一磁场发生器,在体内产生磁场。插入管的远端包含第二(一般小得多)磁场发生器。远侧尖端内的传感器响应于第一和第二磁场发生器的磁场而产生信号。通过处理这些信号,既可以确定体内远侧尖端的坐标,也可以检测远侧尖端相对于插入管的远端的位置变化,所述坐标和位置变化可指示弹性部件的变形,进而指示施加在远侧尖端上的压力。
或者,所述远侧尖端可包含磁场发生器,它产生的磁场由插入管的远端内的和体外的传感器测量,以便检测远侧尖端上的感测压力和远侧尖端的位置坐标。
为此,按照本发明的一实施例,提供一种医疗探针,其包括:
柔性插入管,具有用于插入到患者的体腔内的远端;
远侧尖端,置于插入管的远端,并且配置成与体腔内的组织接触;
弹性部件,将远侧尖端耦接到插入管的远端,并配置成响应于所述远侧尖端与组织接合时施加于该远侧尖端上的压力而变形;和
探针内的位置传感器,用于感测远侧尖端相对于插入管的远端的位置,该位置响应于弹性部件的变形而发生变化。
在公开的实施例中,方位传感器设置成产生指示远侧尖端相对于插入管的远端的轴向位移和方向的信号。在一些实施例中,方位传感器配置成响应于在远侧尖端附近所产生的磁场而产生信号。在一个实施例中,方位传感器置于插入管的远端内,探针包括在远侧尖端内用于产生磁场的磁场发生器。在另一个实施例中,方位传感器置于远侧尖端内,探针还包括在插入管的远端内用于产生磁场的磁场发生器。一般地,方位传感器和磁场发生器包括线圈。
在一个实施例中,弹性部件包括弹簧,方位传感器设置成响应于弹簧的变形而产生信号,该信号指示施加在远侧尖端上的压力。
在一公开的实施例中,远侧尖端包括电极,设置成与组织电接触,其中电极耦合成施加电能量到组织从而消融组织的区域。
按照本发明的一个实施例,也提供用于执行患者体内的医疗过程的装置。该装置包括:
第一磁场发生器,置于患者的体外,在体内产生第一磁场;
探针,包括:
插入管,具有用于插入到患者体腔的远端;
第二磁场发生器,在插入管的远端内,用于产生第二磁场;
远侧尖端,柔性耦接到插入管的远端;和
传感器,置于远侧尖端内,配置成响应于第一和第二磁场而产生第一和第二
信号;和
处理器,接收和处理第一信号以确定体内远侧尖端的坐标,接收和处理第二
信号从而检测远侧尖端相对于插入管的远端的方位变化。
在一些实施例中,远侧尖端是刚性的,探针包括弹性部件,耦合远端尖端和插入管的远端。一般地,弹性部件设置成响应于当远侧尖端接触体内的组织时施加在远侧尖端上的压力而发生变形,远侧尖端的方位变化指示了弹性部件的变形,处理器设置成响应于该变形而产生指示远侧尖端上施加的压力的输出。可选的,处理器可设置成响应于第一和第二信号而产生控制输入,该控制输入用于自动控制体腔内探针的运动。
按照本发明的一实施例,还提供在患者体腔内接触组织的方法,包括:
插入探针到体腔内,探针包括柔性插入管和远侧尖端,通过弹性部件将远侧尖端耦接到插入管的远端,探针还包括方位传感器,产生指示远侧尖端相对于插入管的远端的方位的信号,其响应于弹性部件的变形而发生变化;
使探针在体腔内前进,使得远侧尖端接合组织并对组织施加压力,从而引起弹性部件变形;
当远侧尖端接触组织时处理信号从而提供指示压力的信号。
在一公开的实施例中,使探针前进包括:使得远侧尖端上的电极与组织电接触,该方法包括施加电能量到电极从而消融与远侧尖端接合的组织区域。施加电能量可以包括响应于压力指示而控制能量的施加,从而使得只有当压力在预期的范围内时电能量才施加到电极。
按照本发明的一个实施例,更进一步的,提供在患者体内执行医疗过程的装置,包括:
探针,包括:
插入管,具有用于插入到患者体腔内的远端;
远侧尖端,柔性耦接到插入管的远端;
磁场发生器,置于远侧尖端内,设置成产生磁场;和
第一传感器,在插入管的远端内,响应于磁场产生第一信号;和
第二传感器,置于患者的体外,响应于磁场产生第二信号;
处理器,接收和处理第二信号从而确定体内远侧尖端的坐标,接收和处理第一信号从而检测远侧尖端相对于插入管的远端的方位变化。
结合以下附图通过下文的实施例的具体描述可以更好地理解本发明。
附图说明
附图1是一示意图,图示说明按照本发明的一个实施例的基于导管的医疗系统;
附图2是一显示按照本发明的一个实施例的导管的远端细节的剖面图;
附图3是一示意图,详细显示按照本发明的一个实施例,与心内膜组织接触的导管的远侧尖端。
具体实施方式
附图1是一示意图,图示说明按照本发明的一个实施例的用于心脏导管插入术的系统20。系统20基于,例如,由Biosense Webster Inc.(Diamond Bar,California)生产的CARTOTM系统。。此系统包含形式为导管28的侵入性探针和控制台34。在下文描述的实施例中,假定导管28用于消融心脏内组织,这是本领域公知的。或者,导管加以必要的修改,也可用于心脏内或其他身体器官内其他治疗和/或诊断目的。
操作者26,如心脏病专家,通过患者24的血管系统插入导管28,从而使得导管的远端30进入患者心脏22的腔室。操作者使导管前进,从而导管的远侧尖端在一个或多个预期的位置接合心脏内组织。导管28通常通过其近端处的合适的连接器连接到控制台34。控制台包含射频(RF)发生器40,其经由导管提供高频电能量,以消融心脏内与远侧尖端接合的位置处的组织,这一点将在下文进一步描述。或者,导管和系统可配置成通过本领域公知的其他技术进行消融操作,比如冷冻消融。
控制台34采用磁定位感测来确定心脏22内远端30的方位坐标。出于这个目的,控制台34内的驱动电路38驱动磁场发生器32,在患者24体内产生磁场。一般地,所述磁场发生器包含线圈,在患者外部已知的位置置于患者躯干下。这些线圈在预先确定的工作体积内产生磁场,该工作体积包含心脏22。导管28的远端30内的磁场传感器(见附图2)响应于这些磁场而产生电信号。信号处理器36处理这些信号以确定远端的方位坐标,一般包括位置和方向坐标。这种方位感测的方法在上述CARTO系统中实现并在美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089,PCT专利公开号WO96/05768和美国专利申请公开号2002/0065455A1,2003/0120150A1和2004/0068178A1中有详细描述,上述公开的内容在此引入作为参考。
处理器36一般包含通用计算机,具有用于接收来自导管28的信号和控制控制台34的其他部件的适当的前端和接口电路。处理器可以编程在软件中以实现在此所述的功能。例如,软件可以通过网络,以电子形式下载到控制台34,或者可以提供在有形介质上,比如光的、磁的或者电子存储介质。或者,处理器36的一些或全部的功能由专用的或可编程的数字硬件部件实现。基于从导管和系统20的其他部件接收到的信号,处理器36驱动显示器42以给操作者26关于患者体内远端30的方位的视觉反馈,以及关于正进行的过程的状态信息和指导。
作为替代或附加地,系统20可包含用于在患者24体内操纵和操作导管28的自动机构。这种机构一般可以控制导管的纵向移动(前进/缩回)和导管远端的横向移动(偏转/转向(steering))。出于这一目的,一些这类机构例如可以使用直流电磁场。在这些实施例中,基于导管内的磁场传感器提供的信号,处理器36产生控制输入用于控制导管的移动。这些信号指示了导管的远端的方位和在远端上施加的力,这些将在下文进一步解释。
附图2是导管28的远端30的示意性剖面图,显示了按照本发明的一个实施例的导管结构的细节。导管28包含柔性插入管54,远侧尖端52在结56处与管54的远端连接。插入管覆盖了柔性的绝缘材料60,如或。结56的区域也覆盖了柔性的绝缘材料,其可与材料60一样,或者可以专门适于允许所述结不受阻碍地弯曲和压缩,(为了显示导管内部的结构,在图2内未显示这一材料)。远侧尖端52至少部分可被电极50覆盖,电极50一般由金属材料制成,如铂/铱合金。或者,也可以用对本领域技术人员而言显而易见的其他合适的材料。更进一步或者,远侧尖端可制成不带有覆盖电极。与柔性插入管相比,远侧尖端一般相对刚性。
远侧尖端52通过弹性部件58与插入管54的远端连接。在附图2中,弹性部件表现为螺旋弹簧的形式,但是其他形式的弹性部件也可替代地用于这一目的。例如,弹性部件58可包含具有理想的弹性和强度特性的聚合物,如硅树脂、聚亚安酯或其他塑料。弹性部件58允许响应于施加在远侧尖端上的力,尖端52和插入管54之间有限范围的相对移动。当消融过程中远侧尖端压迫心内膜时,会遇到这样的力。为了在消融过程中使远侧尖端和心内膜之间的电接触良好,理想的压力为大约20-30克。在这个实施例中作为弹性部件的弹簧可配置成,例如,响应于预期的压力,允许远侧尖端轴向位移(即沿着导管28的轴侧向移动)约1-2mm,以及远侧尖端相对于插入管的远端角偏转达到约30°。
如上所述,远侧尖端52包含磁方位传感器62。传感器62可包含一个或多个微型线圈,一般包含沿不同轴取向的多个线圈。或者,传感器62可包含其他形式的磁传感器,如霍尔效应或磁阻传感器。由磁场发生器32产生的磁场引起这些线圈产生电信号,其幅度指示传感器62相对于磁场发生器32的固定参考系的位置和方向。处理器36通过贯穿导管28的导线(未显示于附图中)接收这些信号,并处理这些信号以得到在该固定参考系中远侧尖端52的位置和方向坐标,就如上述引用的专利和专利申请中所述的那样。
另外,插入管54在其远端附近包含微型磁场发生器64。一般地,磁场发生器64包含由从控制台34传导通过导管28的电流驱动的线圈。产生该电流是为了产生与磁场发生器32产生的场在时间和/或频率上可区别的磁场。例如,提供给磁场发生器64的电流可以以约16kHz到25kHz之间的选定频率产生,而以其他频率驱动磁场发生器32。作为替代或附加地,发生器32和64的操作可以是时分多路复用的(time-multiplexed)。
由磁场发生器64产生的磁场引起传感器62内的线圈产生具有磁场发生器64的驱动频率的电信号。这些信号的幅度会根据远侧尖端52相对于插入管54的位置和方向而变化。处理器36处理这些信号以确定远侧尖端相对于插入管的轴向位移和角偏转量。(由于线圈产生的磁场轴对称,只有偏转量可以用磁场发生器64内的单个线圈检测到,而偏转方向则不能。可选地,磁场发生器64可包含两个或更多个线圈,此时偏转方向也可被确定。)位移和偏转的读数,通常分别精确到几十毫米和约一度内。位移和偏转的量可用矢量加法组合,以给出远侧尖端52相对于插入管54的远端的总运动量。
远侧尖端与插入管的远端的相对运动给出了弹性部件58的变形的度量。总的来说,这种变形与施加到弹性部件上的力是成比例的,该力大致等于远侧尖端所接触的心脏组织施加在远侧尖端上的力。因此,磁场发生器64与传感器62的组合用作压力传感系统,用于确定心脏内组织施加在导管的远侧尖端上的压力的近似值(或者等同地,电极50施加在心脏内组织上的压力)。通过位移和偏转的组合感测,该压力传感系统正确地读取压力而不管电极正面还是成角度地接合心内膜。这种压力读取对温度变化不敏感,并且不受漂移影响,不像例如压电传感器那样。
附图3是一示意图,详细地显示了按照本发明的一个实施例,与心脏22的心内膜70接触的导管28的远端30。由远侧尖端施加到心内膜上的压力使得心脏内组织轻微地变形,因此,电极50在相对较大的区域上接触组织。由于电极成角度地接合心内膜,而不是正面(face-on)地接合,远侧尖端52相对于导管的插入管在结56处弯曲。这样的弯曲促进了电极和心脏内组织之间的最佳接触。
处理器36接收和处理由传感器62响应于磁场发生器64的磁场而产生的信号,以得到远侧尖端52施加到心内膜70上的压力的指示。如前所述,为了良好地消融,压力在约20-30克是理想的。较低的压力意味着电极50和心脏内组织接触不充分。这样导致的结果就是,很多或者所有的射频能量被心脏内的血液带走,并且组织无法充分消融或者根本不消融。较高的压力意味着电极对心脏内组织压得太紧。这类过度的压力也许会引起组织内严重的空蚀(cavitation),导致大量的组织损伤甚至可能导致心脏壁穿孔。
为了避免这些不测事件,控制台34向操作者26输出用传感器62测得的压力的指示,如果压力太低或太高则可发出警报。任选地,射频发生器40可被联锁,使得只有当施加在组织上的压力在预期的范围内时才向电极50提供射频能量。作为替代或附加地,压力指示可用于操纵和操作导管28的自动机构的闭环控制中,如前文所述,以确保该机构使得导管的远端在合适的位置与心内膜接合并施加合适的压力到组织。
在一个备选实施例中,传感器62和磁场发生器32和64的角色可互换。换句话说,驱动电路38可驱动远侧尖端52内的磁场发生器以产生一个或多个磁场。磁场发生器32和64内的线圈可配置成感测和产生指示这些磁场的分量的幅度的信号。处理器36接收和处理这些信号,以确定远侧尖端施加在组织上的压力和心脏内远侧尖端的方位坐标。
尽管用于感测压力的传感器62和磁场发生器64的操作已于上文就基于导管的消融术进行描述,但是本发明的原理可类似地应用于其他在心脏内和其他身体器官内使用侵入性探针的治疗和诊断应用中。例如,加以必要的修改,在系统20内实现的方位和压力感测装置和技术,可以用于引导和控制导管插入鞘的使用。如果鞘的位置没有得到适当的控制,将过度的力用于它的插入,则鞘可能会将心脏壁或血管组织穿孔。这些不测的事件可通过感测鞘的远侧尖端的位置和其上的压力来避免。在这点上,用于这里的术语“远侧尖端”应理解为包含探针远端处的任何种类的结构,所述结构可以被弯曲和/或相对探针的主体移位。
应当认为上述实施例只是通过举例方式引入,但本发明并不局限于上述的内容。更进一步的,本发明的范围包含将上述不同的特征进行组合和次组合,以及本领域技术人员在阅读了前文的描述后进行的变更和修改,该变更和修改未被现有技术公开。
Claims (31)
1、一种医疗探针,包含:
柔性插入管,具有用于插入到患者体腔内的远端;
远侧尖端,置于插入管的远端并被配置成接触体腔内的组织;
弹性部件,将远侧尖端耦接到插入管的远端,并配置成响应于当远侧尖端接合组织时施加到远侧尖端上的压力而变形;
探针内的方位传感器,用于感测远侧尖端相对于插入管的远端的方位,该方位响应于弹性部件的变形而发生变化。
2、根据权利要求1的探针,其中方位传感器配置成产生指示远侧尖端相对于插入管的远端的轴向位移和方向的信号。
3、根据权利要求1的探针,其中方位传感器配置成响应于在远侧尖端附近产生的磁场产生指示远侧尖端的方位的信号。
4、根据权利要求3的探针,其中方位传感器置于插入管的远端内,并且其中探针包含远侧尖端内的用于产生磁场的磁场发生器。
5、根据权利要求3的探针,其中方位传感器置于远侧尖端内,并且其中探针包含在插入管的远端内的用于产生磁场的磁场发生器。
6、根据权利要求5的探针,其中方位传感器和磁场发生器包括线圈。
7、根据权利要求1的探针,其中弹性部件包括弹簧。
8、根据权利要求1的探针,其中方位传感器配置成响应于所述变形而产生指示施加在远侧尖端上的压力的信号。
9、根据权利要求1的探针,其中远侧尖端包含电极,所述电极配置成与组织电接触。
10、根据权利要求9的探针,其中所述电极耦合成施加电能量到组织以消融组织的区域。
11、一种在患者体内执行医疗过程的装置,该装置包含:
第一磁场发生器,置于患者的体外,在体内产生第一磁场;
探针,包含:
插入管,具有用于插入到患者体腔内的远端;
第二磁场发生器,置于插入管的远端内,用于产生第二磁场;
远侧尖端,柔性耦接到插入管的远端;和
传感器,置于远侧尖端内,并配置成分别响应于第一和第二磁场而产生第一和第二信号;和
处理器,耦合成接收和处理第一信号以确定远侧尖端在体内的坐标,并接收和处理第二信号以检测远侧尖端相对于插入管的远端的方位变化。
12、根据权利要求11的装置,其中由处理器检测的远侧尖端的方位变化包括相对于插入管的远端,远侧尖端的轴向位移和远侧尖端的偏转。
13、根据权利要求11的装置,其中远侧尖端是刚性的,并且其中探针包含弹性部件,其将远侧尖端耦接到插入管的远端。
14、根据权利要求13的装置,其中弹性部件配置成响应于当远侧尖端接合体内组织时施加在远侧尖端上的压力而变形,并且其中远侧尖端的方位变化指示了弹性部件的变形。
15、根据权利要求14的装置,其中处理器配置成响应于所述变形而产生指示施加在远侧尖端上的压力的输出。
16、根据权利要求11的装置,其中传感器和第二磁场发生器包括线圈。
17、根据权利要求11的装置,其中弹性部件包括弹簧。
18、根据权利要求11的装置,其中远侧尖端包含配置成与组织电接触的电极。
19、根据权利要求18的装置,其中所述电极耦合成施加电能量到组织以消融组织的区域。
20、根据权利要求11的装置,其中处理器配置成响应于第一和第二信号而产生控制输入,该控制输入用于自动地控制探针在体腔内的运动。
21、一种接触患者体腔内组织的方法,该方法包含:
将探针插入到体腔内,该探针包含柔性插入管和远侧尖端,远侧尖端通过弹性部件耦接到插入管的远端,该探针还包含方位传感器,其产生指示远侧尖端相对于插入管的远端的方位的信号,该方位响应于弹性部件的变形而发生变化;
使探针在体腔内前进,使得远侧尖端接合组织并施加压力到组织,从而引起弹性部件变形;
和
当远侧尖端接合组织时处理所述信号以提供压力的指示。
22、据权利要求21的方法,其中所述信号指示远侧尖端相对于插入管的远端的轴向位移和方向。
23、根据权利要求21的方法,其中使探针前进包括:使得远侧尖端上的电极与组织电接触。
24、根据权利要求23的方法,还包括:施加电能量到电极以消融与远侧尖端接合的组织的区域。
25、根据权利要求24的方法,其中施加电能量包括:响应于压力指示而控制能量的施加,使得只有当压力在预期的范围时才施加电能量到电极。
26、根据权利要求21的方法,其中方位传感器配置成响应于远侧尖端附近的磁场而产生信号。
27、根据权利要求26的方法,其中方位传感器置于远侧尖端内,并且其中探针包含插入管的远端内的用于产生磁场的磁场发生器。
28、根据权利要求27的方法,其中插入管的远端内的磁场发生器产生的磁场是第一磁场,方位传感器响应于第一磁场而产生的信号是第一信号,并且其中该方法还包含:
在体腔外的固定参考系中产生第二磁场;和
处理由方位传感器响应于第二磁场信号而产生的第二信号,以确定体腔内远侧尖端的坐标。
29、根据权利要求26的方法,其中方位传感器置于插入管的远端内,并且其中探针还包含在远侧尖端内的用于产生磁场的磁场发生器。
30、根据权利要求29的方法,其中方位传感器响应于磁场而产生的信号是第一信号,且其中该方法还包含:
感测体腔外固定参考系中预定位置处的磁场以产生第二信号;和
处理第二信号以确定体腔内远侧尖端的坐标。
31、一种在患者体内执行医疗过程的装置,该装置包含:
探针,包含:
插入管,具有用于插入到患者体腔内的远端;
远侧尖端,柔性耦接到插入管的远端;
磁场发生器,置于远侧尖端内,配置成产生磁场;
第一传感器,置于插入管的远端内,响应于所述磁场而产生第一信号;和
第二传感器,置于患者的体外,响应于所述磁场而产生第二信号;
处理器,耦合成接收和处理第二信号以确定远侧尖端在体内的坐标,并且接收和处理第一信号以检测远侧尖端相对于插入管的远端的方位变化。
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