CN106109005B - 弹簧加载球囊 - Google Patents
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Abstract
本发明题为“弹簧加载球囊”。本发明公开了一种心导管插入术,使用具有球囊组件的探头来实施心导管插入术,其中弹簧具有静止的沿轴向伸长的构型和扭转的沿轴向缩短的构型。能够膨胀的球囊围绕弹簧扭曲并且机械地连接到弹簧。柔性护套被设置成在球囊内围绕弹簧,护套和球囊的壁限定室,所述室含有在其中和从其流动以用于膨胀和收缩所述球囊的流体以便为弹簧供能并且使弹簧去能。
Description
背景技术
1.技术领域
本发明涉及医疗装置。更具体地,本发明涉及心导管插入术的改进。
2.相关领域的描述
当心脏组织区向相邻组织异常地传导电信号时,发生心律失常,诸如心房纤颤,从而扰乱正常的心动周期并造成心律不齐。
用于治疗心律失常的手术包括以外科的方式来扰乱造成心律失常的信号源,以及扰乱用于此类信号的传导途径。通过经由导管施加能量来选择性地消融心脏组织,有时可以停止或修改不需要的电信号从心脏的一部分传播到另一部分。消融方法通过形成非导电消融灶来破坏不需要的电通路。
已创建了在肺静脉口处或靠近肺静脉口的周边消融灶以治疗房性心律失常。均授予Lesh的美国专利第6,012,457号和第6,024,740号公开了包括射频电极的可径向扩张的消融装置。为了建立周边传导阻滞,已提出使用该装置将射频能量递送到肺静脉,从而将肺静脉与左心房电隔离。
因此,共同转让的且以引用方式并入本文的Schwartz等人的美国专利第6,814,733号描述了导管引入设备,所述导管引入设备具有作为射频发射器的可径向扩张的螺旋线圈。在一个应用中,以经皮的方式引入该发射器,并且该发射器经间隔地推进至肺静脉口。为了使该发射器与肺静脉的内壁周边接触,该发射器为径向扩张的,这可以通过使锚固球囊膨胀来完成,该发射器围绕锚固球囊进行包裹。线圈由射频发生器供能,并且周边消融灶在肺静脉的心肌袖中产生,这有效地阻滞肺静脉和左心房之间的电传播。
在Maguire等人的美国专利第7,340,307号中发现提出组织消融系统和方法的另一个示例,所述组织消融系统和方法通过消融在肺静脉从心房延伸的位置处的组织的周边区来治疗房性心律失常。所述系统包括具有消融元件的周边消融构件,并且包括用于将消融构件递送到所述位置的递送组件。周边消融构件在不同构型之间一般是可调节的,以允许通过递送护套向心房中的递送以及消融元件和组织的周边区之间的消融耦接两种情况。
发明内容
以引用方式并入本文的共同转让的共同未决申请第14/578,807号描述了球囊导管如何可用盐水注入并且用于消融肺静脉口。本文解决了改进的球囊导管的此应用及其它应用。
在本发明的实施方案中,弹簧和用于弹簧的柔性保护套管插入球囊中。在球囊的收缩(完全抽空)状态下,弹簧未压缩且解捻,并且处于其静止状态。解捻、未压缩的弹簧被配置成使收缩的球囊保持在弹簧周围,以使得收缩的球囊紧密地且整洁地围绕弹簧来布置。
球囊通过用盐水溶液注入而膨胀。膨胀迫使弹簧从其静止状态压缩和扭曲。当球囊膨胀时,弹簧处于其压缩、扭曲状态且具有扭矩。当球囊完全收缩时,弹簧延伸、解捻且无变形。
通过结合如上所述既压缩又扭曲的弹簧,本发明的实施方案使得收缩的球囊能够有效地和整洁地存储以用于通过引导护套递送,而膨胀的球囊维持呈其正确的膨胀形状。
根据本发明实施方案提供了一种包括探头的消融设备,所述探头具有空心轴、纵向轴线和在远侧设置的球囊组件。所述球囊组件包括弹簧,所述弹簧具有静止的沿轴向伸长的构型和扭转的沿轴向缩短的构型。能够膨胀的球囊机械地连接到所述弹簧。柔性护套被设置成在所述球囊内围绕所述弹簧,所述护套和所述球囊的壁限定室,所述室含有在其中和从其流动以用于膨胀和收缩所述球囊的流体。膨胀将所述弹簧推动成所述扭转的沿轴向缩短的构型且收缩允许所述弹簧恢复到所述静止的沿轴向伸长的构型。
在所述设备的一个方面,所述设备包括附接到所述球囊和所述护套的近侧耦合器和远侧耦合器。所述近侧耦合器和所述远侧耦合器能够独立地围绕所述探头的所述纵向轴线旋转。
根据所述设备的另一个方面,所述近侧耦合器和所述远侧耦合器具有用于通过其可滑动地接收挤出物的内腔。
根据所述设备的另一个方面,所述近侧耦合器和所述远侧耦合器中的至少一者具有在其中形成的口,以经由所述轴在所述室与流体源之间建立流体连通。
根据所述设备的另一个方面,在所述静止的沿轴向伸长的构型中,所述球囊围绕所述弹簧被包裹。
根据所述设备的另一个方面,所述球囊组件能够通过可操纵引导护套部署。
根据本发明的实施方案还提供了一种通过将具有空心轴和在远侧设置的球囊组件的探头插入受检者的心脏来实施的方法。所述球囊组件包括弹簧和能够膨胀的球囊,所述弹簧具有静止的沿轴向伸长的构型和扭转的沿轴向缩短的构型,所述球囊机械地连接到所述弹簧并且包封所述弹簧。所述方法还通过下述方式来实施:通过使流体流入所述室中从而使所述球囊膨胀来将所述弹簧推动成所述扭转的沿轴向扭曲的构型,并且通过从所述室移除所述流体来使所述球囊收缩以允许所述弹簧呈现所述静止的沿轴向伸长的构型。
根据所述方法的另一个方面,所述球囊组件还包括附接到所述球囊的近侧耦合器和远侧耦合器。
根据所述方法的另一个方面,所述近侧耦合器和所述远侧耦合器能够独立地围绕所述纵向轴线旋转。
根据所述设备的再一个方面,所述近侧耦合器和所述远侧耦合器具有用于通过其可滑动地接收挤出物的内腔。
根据所述方法的又一个方面,所述近侧耦合器和所述远侧耦合器中的至少一者具有在其中形成的口,且使流体流动是通过使所述流体经由所述轴在所述室与流体源之间流动来执行的。
根据所述方法的另一个方面,在所述静止的沿轴向伸长的构型中,所述球囊围绕所述弹簧被包裹,且使所述球囊膨胀包括围绕所述弹簧展开所述球囊。使所述球囊收缩包括围绕所述弹簧包裹所述球囊。
所述方法的一个方面包括通过可操纵引导护套来部署所述球囊组件。
附图说明
为了更好地理解本发明,以举例的方式参见应结合以下图式阅读的本发明的详细说明,其中相同的元件被赋予相同的参考编号,并且其中:
图1是根据本发明的公开实施方案用于对心脏执行导管插入手术的系统的说明图;
图2是根据本发明的实施方案的图1所示导管的远侧部分的视图;
图3是根据本发明的实施方案的图1所示导管的远侧部分的另一个视图;
图4是根据本发明的实施方案的球囊组件的一系列示意三侧正视图;
图5是根据本发明的实施方案的贯通探头的纵向轴线的剖面图;
图6是根据本发明的实施方案被结合在球囊组件中的弹簧的正视图;并且
图7是根据本发明的实施方案的心导管插入方法的流程图。
具体实施方式
在下文说明中,阐述了众多具体细节以便透彻地理解本发明的各种原理。然而,本领域的技术人员应当理解,实施本发明不一定需要所有这些细节。在此实例中,未详细示出众所周知的电路、控制逻辑、以及用于常规算法和过程的计算机程序指令的细节,以免不必要地使一般概念模糊不清。
系统描述
现在参见附图,首先参见图1,图1是根据本发明的公开实施方案构造和操作的系统10的说明图,所述系统用于评估电活动并且对活体受检者的心脏12执行消融手术。所述系统包括导管14,由操作者16将导管14经由皮肤穿过患者的血管系统插入心脏12的心室或血管结构中。通常为医师的操作者16使导管的远侧末端18例如在消融目标位点处与心脏壁接触。可根据在美国专利第6,226,542号和第6,301,496号以及共同转让的美国专利第6,892,091号中所公开的方法制备电激活图,这些专利的公开内容均以引用方式并入本文中。一种实施系统10的元件的商品可以商品名3系统购自Biosense Webster,Inc.,3333Diamond Canyon Road,Diamond Bar,CA 91765。所述系统可由本领域的技术人员进行修改以体现本文所述的本发明的原理。
例如通过评估电激活图而被确定为异常的区域可通过施加热能量(例如,通过经由导管中的线将射频电流传递到对心肌施加射频能量的远侧末端18处的一个或多个电极)来消融。能量在组织中被吸收,从而将组织加热到在其下组织永久性地失去其电兴奋性的点(通常高于60℃)。当成功时,此过程在心脏组织中形成非传导消融灶,所述非传导消融灶中断导致心律失常的异常电通路。本发明的原理可应用于不同的心脏腔室,以诊断并治疗多种不同的心律失常。
导管14通常包括柄部20,在所述柄部上具有合适的控制件,以使得操作者16能够根据消融的需要操纵、定位和取向导管的远侧端部。为了帮助操作者16,导管14的远侧部分含有向位于控制台24中的处理器22提供信号的位置传感器(未示出)。处理器22可履行如下所述的若干处理功能。
线材连接35使控制台24与体表电极30和定位子系统的其它部件相连接,所述定位子系统用于测量导管14的位置和取向坐标。处理器22或另一个处理器(未示出)可以是定位子系统的元件。导管电极(未示出)和体表电极30可以用于在消融位点处测量组织阻抗,如授予Govari等人的美国专利第7,536,218号中所教导的那样,所述专利以引用方式并入本文。通常为热电偶或热敏电阻器的温度传感器(未示出)可以如下所述安装在导管14的远侧部分上的消融表面上。
控制台24通常包括一个或多个消融功率发生器25。导管14可适于使用任何已知消融技术(例如,射频能量、超声能量和激光产生的光能)将消融能量传导到心脏。这些方法公开在以引用方式并入本文的共同转让的美国专利第6,814,733号、第6,997,924号和第7,156,816号中。
在一个实施方案中,定位子系统包括磁定位跟踪构造,所述磁定位跟踪构造通过下述方式来确定导管14的位置和取向:使用场产生线圈28,在预定工作容积中产生磁场并且在导管处感测这些场。定位子系统公开在以引用方式并入本文的美国专利第7,756,576号中,并且公开在上述美国专利第7,536,218号中。
如上所述,导管14耦接到控制台24,这使得操作者16能够观察并调控导管14的功能。控制台24包括处理器,优选地为具有适当信号处理电路的计算机。处理器被耦接以驱动监视器29。信号处理电路通常接收、放大、过滤并数字化来自导管14的信号,包括由例如电传感器、温度传感器和接触力传感器等传感器以及位于导管14的远侧的多个位置感测电极(未示出)产生的信号。数字化信号由控制台24和定位系统接收并使用,以计算导管14的位置和取向以及分析来自电极的电信号。
为了生成电解剖标测图,处理器22通常包括电解剖标测图发生器、图像对准程序、图像或数据分析程序和被配置成在监视器29上呈现图形信息的图形用户界面。
通常,系统10包括其它元件,但为了简洁起见未在图中示出这些元件。例如,系统10可包括心电图(ECG)监视器,所述监视器被耦接成从一个或多个体表电极接收信号,以便向控制台24提供ECG同步信号。如上所述,系统10通常还包括基准定位传感器,所述基准定位传感器位于附接到受检者身体的外部的外部施加基准贴片上,或者位于插入心脏12中并相对于心脏12保持在固定位置的内置导管上。提供了用于使液体循环穿过导管14以冷却消融位点的常规泵和管路。系统10可从诸如MRI单元等外部成像模态接收图像数据并且包括可结合到处理器22中或由处理器22调用以用于产生并显示图像的图像处理器。
球囊组件
现在参见图2,图2是根据本发明的实施方案的导管14的轴40的远侧端部处的球囊组件38的远侧部分的斜视图。延伸穿过轴40的内腔并且突起超过末端的是柔性聚合物挤出物42。挤出物42可用于装置进入,例如用于协助引入导管的导丝。口44被提供用于冲洗和聚合物球囊46的膨胀。流体被允许通过小孔47退出膨胀的球囊。
弹簧机构48包括上覆挤出物42的活塞式共轴压缩弹簧50,通过耦合器52,54附接到轴40。弹簧50刚性粘结到球囊46的近侧端部和远侧端部或粘结到耦合器52,54。连接到耦合器52,54的柔性套管56由球囊46包封。套管56环绕弹簧50并且防止由套管56的外壁与球囊46的内壁限定的室中的流体通过弹簧50的间隙逸出。
在制造期间,当弹簧50处于其原位置且不受外力影响时,球囊46的近侧端部固定到球囊组件38的近侧端部或耦合器52。球囊46然后沿轴向拉伸约1cm,并且在固定到球囊组件38的远侧端部或耦合器54之前沿轴向扭曲(约一半至一个完整的扭曲)。当球囊46膨胀时,内部流体压力使其解捻并且沿轴向缩短约1cm。由于球囊46机械地连接到球囊46,故角向力通过解捻的球囊传输穿过耦合器52,54到达弹簧50,从而在弹簧50之上产生扭转并且压缩弹簧50。由于弹簧50从静止的沿轴向伸长的构型转变为扭转的沿轴向缩短的构型,故整个球囊组件38变为沿轴向缩短且球囊变为沿轴向扩大。
现在参见图3,图3是根据本发明的实施方案的导管14(图1)的远侧部分的视图。套索引导件58已通过导管14部署且与肺静脉60的壁接合。球囊46已膨胀,且由紧贴血管壁锚定的套索引导件58稳定。球囊46在肺静脉60中的正确放置可通过将造影剂注入穿过导管14来加以验证。除此之外或另选地,造影剂可注入到球囊46中。球囊46可提供有如上述申请第14/578,807号中所教导的电极62。电极62可用于标测或消融。
现在参见图4,图4是根据本发明的实施方案的处于膨胀和收缩的各种阶段的球囊组件38的一系列示意三侧正视图。球囊46和弹簧机构48由耦合器52,54启用以在挤出物42上滑动并且自由地且相对于彼此独立地围绕挤出物42(即,围绕导管的纵向轴线)旋转。球囊46因由通过孔64进入球囊46的流体施加的压力而膨胀。伸展的球囊沿着其纵向轴线缩短但在横径(线A-A)上增大。在最上面的图像中,球囊46完全膨胀。由于内部流体压力和球囊的随之发生的变形,弹簧50被推动成完全压缩和最大扭转状态,从而有效地缩短其长度尺寸(D-D)。
在中间图像中,内部流体压力的释放,例如通过阀门(未示出)已允许球囊46在弹簧50的恢复力的帮助下部分地收缩。弹簧50尝试通过延长、解捻和对抗球囊46中的内部流体压力,从而帮助流体通过孔64逸出来恢复到其静止状态。除此之外或另选地,流体可通过孔47逸出。在中间图像中,弹簧50部分地解捻,且其长度尺寸(线E-E)大于其在最上面的图像中的长度尺寸(线D-D)。
在最下面的图像中,球囊46完全收缩且球囊组件38完全塌缩。在此构型中,球囊组件38可通过导管的内腔引入并且在医疗过程完结时抽出。弹簧50处于静止状态,完全延伸且不对机构施加扭力。其长度尺寸(F-F)相对于长度尺寸D-D、E-E为最大的。
现在参见图5,图5是根据本发明的实施方案的贯通探头66的纵向轴线的剖面图。空心内轴68延伸穿过探头66的内腔。其功能是支撑球囊组件70并且为导丝(未示出)提供入口。球囊72通过周边密封件76附着到探头66的近侧节段74。球囊72通过周边密封件80附着到不连续远侧节段78。内腔82通向由轴68的外表面、探头66的内表面86且由密封件88,90限定的歧管84。探头92允许流动穿过内腔82和歧管84的流体的连通以使球囊72膨胀和收缩。
现在参见图6,图6是根据本发明的实施方案被结合在球囊组件中的弹簧94的正视图。弹簧94可由例如PEEKTM等弹性塑性材料或例如镍钛诺或不锈钢等金属制成。弹簧94具有轴96,所述轴可如由箭头100所示围绕其纵向轴线98扭曲和解捻,以使得弹簧在松驰伸长状态与扭转压缩状态之间交变。当转变成压缩状态时,分隔开线圈104的间隙102变窄,且弹簧94在纵向轴线98上缩短。耦合器106通过焊接附接到轴96,以形成一个整体单元,或通过其它方式。耦合器中的一者在图6中被省去。纵向狭槽108形成于轴96中。所述纵向狭槽提供用于将盐水路由到球囊中的口。
操作
现在参见图7,图7是根据本发明的实施方案的使用球囊导管的心导管插入方法的流程图。此示例涉及肺静脉口处的操作;然而,以必要的变更,所述方法可适用于心脏中的其它结构和手术。为了呈现清楚起见,以具体的线性顺序示出了过程步骤。然而,将显而易见的是,许多这些操作可并行、异步或以不同的顺序执行。此外,实施所述方法可能不需要所有示出的过程步骤。为了说明清楚,所述方法结合前述图公开,但也可适用于球囊组件的其它实施方案和构型。
在初始步骤83处,将心脏导管以常规方式引入心脏的左心房中。可采用引导护套来部署套索引导件和球囊。DestinoTM12-F可操纵引导护套适于此目的。
接下来,在步骤85处,将套索引导件部署并定位成接合肺静脉的内壁。在此阶段,球囊组件38中的弹簧50完全延伸且处于非扭转状态。将球囊46和套管56包裹在其最大范围周围并且塌缩至其最大范围。当球囊46完全膨胀时,使弹簧50相对于其初始位置压缩且完全扭曲。
接下来,在步骤87处,通过使流体流动通过口44进入由球囊46的内壁与套管56限定的室来使球囊在套索引导件上延伸并膨胀。当发生膨胀时,盐水通过口44进入球囊46。弹簧50对抗由伸展的球囊施加的力压缩并扭曲。
接下来,在步骤89处,将球囊指引至与肺静脉口周边接触以便遮蔽所述口。
接下来,在任选步骤91处,将不透射线的造影剂注入穿过导管的内腔并且穿过导管的适当冲洗口进入肺静脉以便确认球囊相对于肺静脉口处于正确的位置。造影剂不进入球囊。
控制现在进行至其中判断球囊是否正确定位的决策步骤93。如果在决策步骤93处的判断是否定的,则控制返回至步骤89,并且做出对球囊定位的另一个尝试。
如果在决策步骤93处的判断是肯定的,则控制进行至其中使用导管上的适当消融电极来执行医疗过程,例如,标测或消融的步骤95。
在完成消融之后,所述过程可通过抽出球囊和套索引导件58来使用另一个肺静脉口进行迭代。然后控制可以返回到步骤85。另选地,可通过在最终步骤97处移除导管来结束所述过程。在移除导管之前,使球囊收缩。再次参见图4,所述过程实质上是膨胀过程的反转,且在弹簧50的作用的协助下,所述弹簧延伸且解捻,从而协助球囊围绕弹簧50和下伏轴(例如,挤出物42)压缩并折叠。球囊46的流体内容物通过孔47离开球囊。
本领域的技术人员应当理解,本发明并不限于上文中特别示出和描述的内容。相反,本发明的范围包括上文所述各种特征的组合与子组合两者,以及不在现有技术范围内的其变型和修改,所属领域的技术人员在阅读上述说明时应当想到这些变型和修改。
Claims (5)
1.一种消融设备,包括:
探头,所述探头具有空心轴、纵向轴线和在远侧设置的球囊组件,所述轴具有穿过其延伸的挤出物,所述球囊组件包括:
包括弹簧的弹簧机构,所述弹簧具有静止的沿轴向伸长的构型和扭转的沿轴向缩短的构型,所述弹簧机构上覆所述挤出物;
能够膨胀的球囊,所述球囊机械地连接到所述弹簧并且包封所述弹簧,所述球囊具有壁;
柔性护套,所述柔性护套被设置成在所述球囊内围绕所述弹簧,所述护套和所述球囊的壁限定室,所述室含有在其中和从其流动以用于膨胀和收缩所述球囊的流体,其中膨胀将所述弹簧推动成所述扭转的沿轴向缩短的构型并且收缩允许所述弹簧恢复到所述静止的沿轴向伸长的构型;以及
近侧耦合器和远侧耦合器,所述近侧耦合器和远侧耦合器附接到所述球囊和所述护套并且将所述弹簧机构附接到所述轴,其中,所述近侧耦合器和所述远侧耦合器具有用于通过其可滑动地接收所述挤出物的内腔,所述近侧耦合器和所述远侧耦合器能够围绕所述挤出物旋转;
其中,所述弹簧刚性地粘结到所述球囊的近侧端部和远侧端部或粘结到所述近侧耦合器和远侧耦合器。
2.根据权利要求1所述的设备,其中所述近侧耦合器和所述远侧耦合器能够独立地围绕所述纵向轴线旋转。
3.根据权利要求1所述的设备,其中所述近侧耦合器和所述远侧耦合器中的至少一者具有在其中形成的口,以经由所述轴在所述室与流体源之间建立流体连通。
4.根据权利要求1所述的设备,其中在所述静止的沿轴向伸长的构型中,所述球囊围绕所述弹簧被包裹。
5.根据权利要求1所述的设备,其中所述球囊组件能够通过可操纵引导护套部署。
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RU2016116802A3 (zh) | 2019-08-16 |
JP2016209585A (ja) | 2016-12-15 |
CN106109005A (zh) | 2016-11-16 |
IL269281A (en) | 2019-11-28 |
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AU2016202412A1 (en) | 2016-11-24 |
IL245171A0 (en) | 2016-08-31 |
CA2928076A1 (en) | 2016-11-07 |
EP3090696B1 (en) | 2019-04-10 |
ES2725467T3 (es) | 2019-09-24 |
IL269281B (en) | 2021-02-28 |
EP3572021B1 (en) | 2024-02-07 |
US20160324571A1 (en) | 2016-11-10 |
US9907610B2 (en) | 2018-03-06 |
US10828099B2 (en) | 2020-11-10 |
DK3090696T3 (da) | 2019-06-24 |
RU2016116802A (ru) | 2017-11-02 |
IL245171B (en) | 2019-09-26 |
EP3572021A1 (en) | 2019-11-27 |
JP6749785B2 (ja) | 2020-09-02 |
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