CN103221148B - 具有嵌在挠性箔片内的超声波换能器的医疗设备 - Google Patents
具有嵌在挠性箔片内的超声波换能器的医疗设备 Download PDFInfo
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Abstract
本发明涉及适用于心脏消融监测和肿瘤消融监测中最低限度侵入的超声波诊断设备的超声波成像方法和装置。本发明提出通过将换能器片嵌入箔片表面上的孔隙中来在图案化挠性箔片上制造换能器组件和系统。这可以很好地对该换能器的声学性能进行控制。
Description
发明领域
本发明涉及适用于最低限度侵入的超声波诊断设备的超声波成像装置。本发明可用于在心脏消融监测和肿瘤消融监测中使用的介入设备的制造。
背景技术
射频(RF)导管消融是用于将故障电途径从有可能发展成心律不齐如心房颤动(AF)的患者去除的一种介入式过程。在AF消融过程中,将肺静脉的完全电绝缘作为目标,这种目标通过产生具有消融导管的损害线来实现。
大多数导管消融过程用“单点消融导管”来进行。可通过顺序点到点消融用这些导管来产生损害线。为了实现肺静脉的完全电绝缘,产生满足透壁和连续两个要求的损害线。
对RF导管的要求是一种更加充分的控制。能够提供组织内损害进展的实时反馈并且能够提供在治疗位置的组织厚度方面的损害的深度的实时信息的系统往往能够避免(RF)导管消融过程中的过热所导致的伤害和可能的死亡,而加热不足会导致心律失常的复发。现已证明高频超声波能够用于监测M型成像中的损害边界的演化。
将超声波换能器嵌在消融导管内使损害前沿的演化的实时反馈成为可能。
US7,846,101公开了一种包括换能器组件的血管内超声波成像装置。该组件包括挠性电路,该挠性电路包括附接到挠性基板的多个换能器元件。然而,由于该挠性基板是形成该组件的材料堆的一部分,所以该挠性箔片可产生不利于这些换能器元件的性能的声学影响。
本发明的发明人已经认识到改进的换能器组件是有利的,结果构思出了本发明。实现具有仅依赖于换能器元件材料的声学性能的换能器组件将会是特别有益的。而且还希望使RF导管的用户能够在RF导管消融过程期间获得组织中的损害进展的实时反馈。
发明内容
从总体上而言,本发明优选寻求单独或以任何组合的方式减少、减轻或消除上面所提及的一个或多个缺陷。特别地,可将提供一种解决现有技术中的上面所提及的问题或其它问题的方法视为本发明的目的。
为了较好地处理这些问题中的一个或多个,在本发明的第一方面,提供一种超声波换能器组件,该超声波换能器组件包括挠性箔片、一个或多个压电元件以及一个或多个导电层,该挠性箔片具有从该挠性箔片的顶面延伸到底面的开口,所述一个或多个压电元件包含在这些开口中并且紧固到这些开口的内缘,且所述一个或多个导电层沉积在该挠性箔片和所述一个或多个压电元件上。
通过将这些压电元件置入该挠性箔片的这些开口内,压电元件的性能就不会受到该挠性箔片的材料的影响,并因此而能够获得该换能器组件性能的理想调整。由于该换能器组件包括嵌入该挠性箔片内的一个或多个压电元件,所以该挠性箔片并不对该换能器的声学性能造成影响。该挠性箔片的开口的内边即内缘紧固到该压电元件,即该压电元件的外边。
该挠性箔片可以是一种,例如,Kapton箔片,这种箔片用,例如,铜金属化,并且具有开口,即用于容纳压电元件的孔。这些压电元件是,例如,压电片。
在一些实施例中,该挠性箔片包括金属化迹线。
在一些实施例中,所述一个或多个导电层沉积在该挠性箔片的顶面和底面上以及所述一个或多个压电元件的顶面和底面上。
在另外的一些实施例中,所述一个或多个导电层为两层,第一层沉积在该挠性箔片的顶面上以及所述一个或多个压电元件的顶面上,且第二层沉积在该挠性箔片的底面上以及所述一个或多个压电元件的底面上。通过这些导电层的沉积,该组件设有在这些压电元件上的顶部电极以及在这些压电元件上的底部电极,该顶部电极连接到该挠性箔片的顶部金属化层,且该底部电极连接到该挠性箔片的底部金属化层。
在另外的一些实施例中,所述一个或多个导电层为一层,该导电层沉积在该挠性箔片的底面上以及所述一个或多个压电元件的底面上。这为保护该换能器的电信号不受外部微扰的不利影响提供了很多优点,并且有利于实现该底部电极周围的法拉第笼,从而避免了消融期间的RF信号对超声波信号的干扰。
在本发明的第二方面,提供一种超声波换能器系统,该超声波换能器系统包括:置于基部结构内的根据本发明的第一方面的超声波换能器组件;包括腔体的基部结构,其中用衬底材料填充这些腔体;涂覆层,该涂覆层沉积在该超声波换能器组件的外表面上。
在一些实施例中,该超声波换能器系统的至少一个腔体从该基部结构的顶面延伸到底面。可将该基部结构的这些腔体视为该基部结构中的孔隙,这些孔隙提供接近置于该基部结构上的压电元件的背侧或背面的通路。该基部结构中的这些腔体可相互连通,例如,在存在多个压电元件时,或者能够单独地接近这些腔体。
可将置于该基部结构上的超声波换能器组件胶合在该基部结构上面或周围。在将该超声波换能器组件置于该基部结构上面时,这些换能器元件的位于背侧(即底面)的这些空的腔体用衬底材料填充。这样,该换能器的性能就仅取决于这些压电材料和衬底材料,且并不受该挠性箔片的影响。该挠性箔片并不支撑这些压电元件,且这些压电元件嵌入该挠性箔片内。
在将该超声波换能器组件置于该基部结构上时,挠性箔片的这些开口位于与该基部结构的这些腔体相对应的位置,其中压电元件例如利用胶水紧固在所述开口中。因此,可穿过该基部结构的这些腔体进入这些压电元件的背侧或底面。添加该衬底材料的这种形态允许对材料的适当选择进行自由而良好的控制。例如,可通过以流体状态穿过该基部结构中的通道(conduct)注入来将这种填充材料分配到这些腔体之中。填充材料的实例包括粘合剂,这种粘合剂在暴露在UV线和/或可见光时能够快速地粘附到塑料和金属。填充材料的成分也可包括微球,如陶瓷或玻璃球体,这些微球可以是中空的、重量轻而且具有高的耐压强度。
在根据本发明的第一方面的超声波换能器组件的其他的一些实施例中,这种紧固包括将一个或多个压电元件的至少一个侧壁胶合到这些开口的内缘。通过仅胶合这些压电元件的侧面的或侧向(later)的壁,该压电系统的声学性能不会受到该挠性箔片的影响。
本发明具有很多优点,尤其是在制造高频(HF)换能器时。在传统的HF换能器中,该挠性箔片包括在该换能器堆中且这些换能器元件置于该挠性箔片上。由于频率越高这些压电元件的厚度越小,所以传统的HF换能器失败的几率很高,这种失败由高的击穿风险所致,因为从压电材料的前侧到背侧的电极相互之间变得太近。通过将这些压电元件嵌入该挠性箔片内,本发明提供了一种解决方案,这种解决方案因此而特别地有利于HF换能器。
在一些实施例中,一个或多个压电元件用不导电胶水胶合。
在一些实施例中,通过绝缘层,即具有绝缘性能的层,将一个或多个压电元件紧固到这些开口的内缘。
在其他的一些实施例中,根据本发明的第一方面的超声波换能器组件还包括沉积到该超声波换能器组件的外表面上的绝缘层。这种电绝缘层可以是一种匹配层,这种匹配层将该超声波换能器组件涂覆,以将这些换能器元件的声学性能最大化。
在本发明的第三方面,提供一种导管尖端,该导管尖端包括根据本发明的第一方面的超声波换能器组件。
在本发明的第四方面,提供一种导管尖端,该导管尖端包括根据本发明的第二方面的超声波换能器组件。
该导管尖端可具有冲洗孔,该超声波换能器系统通过这些冲洗孔与外部环境连通,如肺静脉。
该导管尖端还可具有其他开口,该超声波换能器系统能够通过这些开口毫无阻碍地跟随组织的消融过程,例如用于光纤。可选地,在将超声波透明介质用于消融的情形中,如用薄铂层涂覆的聚甲基戊烯,该尖端不必含有开口。
在将该超声波换能器嵌入消融导管内以使得损害前沿进展的实时反馈能够进行时,可在将该超声波换能器系统电气连接到该导管尖端并且固定在该导管尖端内之后将该消融帽安装到该导管体上。
在本发明的第五方面,提供一种制造超声波换能器组件的方法,该方法包括:提供挠性箔片,该挠性箔片具有从该挠性箔片的顶面延伸到底面的开口;将一个或多个压电元件安装到这些开口内;将一个或多个导电层沉积在该挠性箔片和所述一个或多个压电元件上。
在根据本发明的第五方面的一些实施例中,这种安装包括将所述一个或多个压电元件插入到这些开口中并且将所述一个或多个压电元件胶合到这些开口的内缘。
在根据本发明的第五方面的一些实施例中,这种沉积包括将一个或多个导电层沉积在该挠性箔片的顶面和底面上以及所述一个或多个压电元件的顶面和底面上。
在本发明的第六方面,提供一种制造超声波换能器系统的方法,该方法包括:将根据本发明的第一方面的超声波换能器组件定位于基部结构上,该基部结构包括腔体;用衬底材料填充这些腔体;将涂覆层沉积在该超声波换能器组件的外表面上。
在根据最后一个方面的一些实施例中,这种定位包括:将含有所述一个或多个压电元件的挠性箔片折叠成3D结构,并且将折叠后的挠性箔片胶合在该基部结构周围。
在根据最后一个方面的一些实施例中,这种填充包括:以流体状态分配衬底材料,并且将该衬底材料硬化。
从整体上来讲,可用在本发明的范围内的任何可能的方式将本发明的各个方面进行组合和配合。通过参考下面所描述的实施例就会明白本发明的这些和其它方面、特征和/或优点,并且将参考下面所描述的实施例对这些和其它方面、特征和/或优点进行说明。
附图说明
仅通过举例的方式参考附图对本发明的实施例进行描述。
图1示出了根据本发明实施例的带有图案化开口的挠性箔片的透视图;
图2a示出了示于图1中的挠性箔片的截面图;
图2b示出了根据本发明实施例的包括压电元件的挠性箔片的截面图;
图2c示出了根据本发明实施例的包括胶合到该挠性箔片的开口的压电元件的挠性箔片的截面图;
图3a示出了示于图2c中的挠性箔片的截面图,其中导电电极沉积在该挠性箔片处;
图3b示出了示于图3a中的位于基部结构或支撑结构上的挠性箔片的截面图;
图3c示出了示于图3b中的换能器组件的截面图,其中,用衬底材料填充该基部结构中的腔体;
图4a示出了示于图2c中的挠性箔片的截面图,其中,单导电电极沉积在该挠性箔片以及该压电元件的背面上;
图4b示出了示于图4a中的位于基部结构或支撑结构上的挠性箔片的截面图;
图4c示出了示于图4b中的换能器组件的截面图,其中,用衬底材料填充该基部结构中的腔体;
图4d示出了示于图4c中的换能器系统的截面图,其中,导电电极沉积在该换能器系统的周围;
图4e示出了示于图4d中的换能器系统的截面图,其中,匹配层或电气绝缘层沉积在该换能器系统的周围;
图5示出了根据本发明的实施例的包括换能器元件的图案化挠性箔片的俯视图;
图6示出了根据本发明的实施例的基部元件的透视图;
图7示出了根据本发明的实施例的超声波换能器系统;
图8示出了根据本发明的一个方面的用于制造超声波换能器系统的方法的流程图;
图9示出了根据本发明的实施例的包括消融帽的超声波换能器系统的透视图;
图10示出了根据本发明的实施例的包括消融帽的超声波换能器系统的截面图。
具体实施方式
图1示出了根据本发明的一个方面的制造超声波换能器的方法的三个步骤。在挠性箔片1上产生所希望的图案,如开口2,开口2从顶面6延伸到底面7。压电元件,如压电元件3,位于这些开口中,如开口2,并且紧固到开口2的内缘8。不导电胶水4可用于将压电元件3紧固到开口2的内缘8。
图2a示出了在包括这些压电元件之前的挠性箔片的截面图。如图2b所示,用压电元件3填充开口2。压电元件3(如压电片)的安装通过将这些片胶合在开口2的缘或边的指定区域中来实现。在一些实施例中,压电元件3的安装可通过将压电片3的薄的外围环形区域胶合在挠性箔片1上来实现。
图2b示出了具有开口2的挠性箔片1,其中,压电元件3位于开口2内。
图2c示出了图2b中的换能器组件,其中,通过胶水4将压电元件3,即压电元件3的外边,紧固到挠性箔片1的开口2的内边,即内缘。这种胶水可以是非导电性胶水,以提供压电元件3(如压电片)与挠性箔片1的绝缘。
图3a示出了导电层5沉积在挠性箔片1和压电元件2上之后图2c中的换能器组件。特别地,导电层5a沉积在挠性箔片1的顶面和压电元件2的顶面上,从而提供顶部电极,而导电层5b沉积在挠性箔片1的底面和压电元件2的底面上,从而提供底部电极。
在图3b中,随后将图3a中的换能器组件置于基部结构6上,这种基部结构以腔体11为特征,这些腔体从基部结构6的顶面12延伸到底面13。如图3c所示,用衬底材料7填充该换能器组件。
在其他的一些实施例中,将一个层沉积在该挠性箔片的底面上以及该一个或多个压电元件的底面上。图4a示出了示于图2c中的挠性箔片的截面图,其中,单导电层17沉积在挠性箔片1的背面上以及压电元件3上。然后将图4a中的换能器组件置于基部结构18上,该基部结构以腔体19为特征,这些腔体从基部结18的顶面20延伸到底面21,如图4b所示。
用衬底材料22填充置于基部结构18上的换能器组件,如图4c所示。
在图4d中,将涂覆层23至少部分地绕着示于图4c中的换能器系统沉积。还可用沉积在该换能器系统周围的匹配层或电气绝缘层24涂覆示于图4d中的换能器系统。
示于图4中的实施例是示于图3中的实施例的一种备选方案,并且为电信号绝缘提供了很多优点。
图5示出了根据本发明的实施例的包括换能器元件的图案化挠性箔片的俯视图。将挠性箔片28图案化以具有十字形状,这种十字形状具有五个开口10,压电元件16将会被引入到这些开口中。开口的形状和数量取决于要使用的基部结构并且取决于要紧固的压电元件的数量。这是本领域中技术人员的公知常识。挠性箔片28设计为以具有匹配构造的三维结构折叠,例如,在一个实施例中,以具有如图6所示的腔体14的基部结构9的形状折叠。通过将该超声波换能器组件折叠并胶合到该基部结构上,产生如图7所示的超声波换能器系统15。将紧固到挠性箔片28的开口10中的这些压电元件16定位成朝向基部结构9的这些腔体14。然后用衬底材料填充这些腔体14。这种填充可通过将衬底材料以流体状态注入然后进行硬化来实现。硬化可通过在空气中固化、通过暴露至高温、暴露至UV线或提供使用化学制品(如化学催化剂)来实现。在用UV线暴露进行硬化的情形中,基部结构9用UV线能够透过的材料制成。
另一个涂覆层沉积在超声波换能器组件15的外表面上,以提供与外部扰动(如RF消融)的电气绝缘。
在心脏消融监测中,可将该超声波换能器系统连接并固定在导管的导管尖端内,从而允许消融过程中的前向和侧向监测。在将该超声波换能器系统电气连接并固定在该导管尖端之后,可将该消融帽(如示于图9和图10中的铂消融帽25)安装在该导管体上。该消融尖端可具有孔隙,该超声波换能器系统能够通过这些孔隙跟随该消融过程。可选地,可使用一种材料,如用薄铂层涂覆的聚甲基戊烯,超声波能够透过这种材料。这样就避免了在该消融尖端开孔的需求。
图8示出了根据本发明的一个方面的制造超声波换能器系统的方法的流程图。
在步骤(S1)101中,提供一种挠性箔片,该挠性箔片具有从顶面延伸到底面的开口。该挠性箔片可具有在前面和背面上的金属化,如铜,或者替代地具有在该压电材料(如PZT)的前面和后面中的一个面上的图案化的金属化迹线。
在步骤(S2)102中,将一个或多个压电元件安装到这些挠性箔片开口内。安装包括将所述一个或多个压电元件插入到该挠性箔片的这些开口中并紧固,这例如通过将所述一个或多个压电元件胶合到该挠性箔片的这些开口的内缘来进行。
在步骤(S3)103中,将一个或多个导电层沉积在该挠性箔片和所述一个或多个压电元件上。沉积包括将一个或多个导电层沉积在该挠性箔片的顶面和/或底面上以及所述一个或多个压电元件的顶面和/或底面上。
在步骤(S4)104中,将在前三个步骤中所产生的超声波换能器组件定位于包括腔体的基部结构上。将该超声波换能器组件定位于该基部结构上包括将含有所述一个或多个压电元件的挠性箔片折叠成3D结构,并且将折叠后的挠性箔片胶合在该基部结构周围。
在步骤(S5)105中,用衬底材料填充该基部结构的这些腔体。这种填充包括以流体状态分配衬底材料,并且将该衬底材料硬化。
在步骤(S6)106中,将涂覆层沉积在该超声波换能器组件的外表面上。
虽然在附图和前面的描述中已经详细例示和描述了本发明,但这些图示和说明应认为是图示性的或示例性的,而不是限制性的;本发明不必仅限于所公开的实施例。在实施所要求保护的本发明时,本领域中技术人员能够通过对这些附图、公开内容和所附的权利要求书的研究来理解和实施所公开的实施例的变型。在权利要求书中,词语“包括”并不排除其他的元件或步骤,且不定冠词“一”或“一个”并不排除多个。单一的处理器或其他单元可实现权利要求书中所列举的数个物件的功能。在相互之间不同的从属权利要求中陈述某些度量并不表明这些度量的组合不能够用来产生有益效果。可将计算机程序存储/分布在适当的介质上,如与其它硬件一起提供或作为硬件的一部分而提供的光存储介质或固态介质,但也可以以其他的形式分布,如通过国际互联网或其他的有线或无线通信系统。权利要求书中的任何附图标记不应理解为对范围进行限制。
Claims (15)
1.一种超声波换能器组件,包括:
挠性箔片,所述挠性箔片具有从所述挠性箔片的顶面延伸到底面的开口;
一个或多个压电元件,所述一个或多个压电元件包含在所述开口中并且紧固到所述开口的内缘;
绝缘层,所述绝缘层将所述一个或多个压电元件紧固到所述开口的内缘;
一个或多个导电层,所述一个或多个导电层沉积在所述挠性箔片和所述一个或多个压电元件上。
2.根据权利要求1所述的超声波换能器组件,其特征在于,紧固所述一个或多个压电元件的所述绝缘层是在所述一个或多个压电元件的至少一个侧壁和所述开口的内缘之间的胶水层。
3.根据权利要求1所述的超声波换能器组件,其特征在于,将所述一个或多个导电层沉积在所述挠性箔片的顶面和底面上以及所述一个或多个压电元件的顶面和底面上。
4.根据权利要求1所述的超声波换能器组件,其特征在于,所述挠性箔片包括金属化迹线。
5.一种超声波换能器系统,包括:
置于基部结构中的根据权利要求1所述的超声波换能器组件,所述基部结构包括腔体,其中,用衬底材料填充所述腔体;
涂覆层,所述涂覆层沉积在所述超声波换能器组件的外表面上。
6.根据权利要求5所述的超声波换能器系统,其特征在于,所述腔体中的至少一个从所述基部结构的顶面延伸到底面。
7.根据权利要求5所述的超声波换能器系统,其特征在于,所述超声波换能器系统还包括沉积在所述超声波换能器组件的外表面上的绝缘层。
8.一种导管尖端,包括:根据权利要求1所述的超声波换能器组件。
9.一种导管尖端,包括:根据权利要求5所述的超声波换能器系统。
10.一种制造超声波换能器组件的方法,所述方法包括:
提供挠性箔片,所述挠性箔片具有从所述挠性箔片的顶面延伸到底面的开口;
将一个或多个压电元件安装到所述开口内;
将一个或多个导电层沉积在所述挠性箔片和所述一个或多个压电元件上。
11.根据权利要求10所述的方法,其特征在于,所述安装包括将所述一个或多个压电元件插入到所述开口中并且将所述一个或多个压电元件胶合到所述开口的内缘。
12.根据权利要求10所述的方法,其特征在于,所述沉积包括将一个或多个导电层沉积在所述挠性箔片的顶面和底面上以及所述一个或多个压电元件的顶面和底面上。
13.一种制造超声波换能器系统的方法,所述方法包括:
将根据权利要求1的超声波换能器组件定位到基部结构上,所述基部结构包括腔体;
用衬底材料填充所述腔体;
将涂覆层沉积在所述超声波换能器组件的外表面上。
14.根据权利要求13所述的制造超声波换能器系统的方法,其特征在于,所述定位包括:将含有所述一个或多个压电元件的所述挠性箔片折叠成3D结构,并且将折叠后的所述挠性箔片胶合在所述基部结构周围。
15.根据权利要求13所述的制造超声波换能器系统的方法,其特征在于,所述填充包括:以流体状态分配衬底材料,并且将所述衬底材料硬化。
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RU2013127518A (ru) | 2014-12-27 |
BR112013012197A8 (pt) | 2019-02-05 |
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US20230355208A1 (en) | 2023-11-09 |
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EP2640528B1 (en) | 2015-12-30 |
US20140148703A1 (en) | 2014-05-29 |
CN103220996B (zh) | 2016-04-13 |
IN2013CN03726A (zh) | 2015-08-07 |
EP2640298A1 (en) | 2013-09-25 |
EP3441036B1 (en) | 2020-03-18 |
EP2640528A1 (en) | 2013-09-25 |
US10405828B2 (en) | 2019-09-10 |
CN103220996A (zh) | 2013-07-24 |
RU2573443C2 (ru) | 2016-01-20 |
JP2013542828A (ja) | 2013-11-28 |
JP5878930B2 (ja) | 2016-03-08 |
BR112013012197A2 (pt) | 2016-08-09 |
JP2014503239A (ja) | 2014-02-13 |
US10238364B2 (en) | 2019-03-26 |
WO2012066430A1 (en) | 2012-05-24 |
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