CN108434586A - 用于溅射多球囊导管远侧端部的行星齿轮组件 - Google Patents
用于溅射多球囊导管远侧端部的行星齿轮组件 Download PDFInfo
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Abstract
本发明题为“用于溅射多球囊导管远侧端部的行星齿轮组件”。本发明公开了一种设备,所述设备包括组件和中空模板。所述组件包括安装于其上的多个铰链。所述组件被配置成围绕第一轴线旋转,并且所述铰链中的每一个被另外配置成围绕相应的第二轴线旋转。所述中空模板被装配在所述相应的铰链上并且各自被配置成容纳医疗器械的基于球囊的远侧端部,每个模板具有图案化开口,一个或多个电极通过所述图案化开口沉积在所述远侧端部上。
Description
技术领域
本发明整体涉及导管,并且具体地讲,涉及用于制造球囊导管的方法和系统。
背景技术
球囊导管可用于各种医疗应用诸如心脏病学中。用于制造球囊导管的若干技术在本领域中是已知的。
例如,公开内容以引用方式并入本文的美国专利8,460,333描述了一种金属球囊导管。金属球囊导管可为其中主管状主体和球囊由金属制成的单一一体式金属导管,或者其可由聚合物主管状主体和金属球囊组成。
发明内容
本文所述的本发明的实施方案提供了一种包括组件和中空模板的设备。所述组件包括安装于其上的多个铰链。所述组件被配置成围绕第一轴线旋转,并且铰链中的每一个被另外配置成围绕相应的第二轴线旋转。中空模板被装配在相应的铰链上并且各自被配置成容纳医疗器械的基于球囊的远侧端部。每个模板具有图案化开口,一个或多个电极通过所述图案化开口沉积在远侧端部上。
在一些实施方案中,所述设备包括马达组件,所述马达组件被配置成使所述组件围绕第一轴线沿第一方向以第一角速度旋转并且使铰链中的至少一个围绕相应的第二轴线沿第二方向以第二角速度旋转。在其他实施方案中,第一方向不同于第二方向。在其他实施方案中,所述设备包括被配置成控制马达组件的控制器。
在一个实施方案中,所述设备包括真空室,所述真空室被配置成将所述组件容纳在真空环境中。在另一个实施方案中,所述设备包括由给定材料制成的溅射靶,所述溅射靶被配置成在真空室中溅射给定材料的原子或离子。
在一些实施方案中,中空模板中的每一个包括侵入部,所述侵入部装配在基于球囊的远侧端部上的突起部。在其他实施方案中,中空模板中的每一个包括突起部,所述突起部装配在基于球囊的远侧端部上的侵入部。
根据本发明的一个实施方案,另外提供了一种用于制造医疗器械的方法。所述方法包括医疗器械的相应基于球囊的远侧端部插入到多个中空模板内。将中空模板装配在安装在可旋转组件上的多个相应可旋转铰链上。通过使所述组件围绕第一轴线并且使铰链中的每一个围绕相应的第二轴线同时旋转来旋转远侧端部。通过模板中的图案化开口来将电极沉积在旋转的远侧端部上。
根据本发明的一个实施方案,另外提供了一种用于制造可旋转组件的方法。所述方法包括提供被配置成围绕第一轴线旋转的可旋转组件。将被配置成围绕相应的第二轴线旋转的多个可旋转铰链安装到可旋转组件上。将所述组件和铰链连接到马达组件。将具有图案化开口的多个中空模板装配在多个可旋转铰链上。
以下结合附图根据本发明的实施方案的详细说明将更全面地理解本发明,在附图中:
附图说明
图1为根据本发明的实施方案的基于导管的跟踪和消融系统的示意性图解;
图2为根据本发明的实施方案的用于溅射多个球囊组件上的电极的处理室的示意性图解。并且
图3A和图3B为根据本发明的实施方案的容纳在中空模板中的球囊组件的示意性剖面图。
具体实施方式
概述
球囊导管用于各种介入心脏规程中,诸如通过形成阻断沿着患者心脏中的组织路径的电传导的病灶来治疗心律失常。阻断非期望的心脏内电信号的病灶可利用各种技术来形成,诸如通过组织的电生理(EP)标测并且随后在选定位置处对组织施用射频(RF)消融。
一种可能的消融解决方案是将具有消融电极阵列的可膨胀球囊组件插入到期望的消融部位。用于将电极沉积到球囊表面的常规制造技术通常一次支持仅一个球囊的制造并且因此为缓慢的。
下文所述的本发明的实施方案提供了利用具有可接受成本的溅射技术来将电极同时沉积到多个球囊上的改进技术。一种示例沉积方法为溅射,其中真空室在溅射之前被抽吸成真空基础压力并且在溅射之后被通风至大气压力以便设置该室以用于接受需要溅射的下一个物体。
在一些实施方案中,行星齿轮组件用于利用需要仅一个设置操作的单个处理周期来处理一批多个球囊组件。因为本发明所公开的行星齿轮组件在真空室中在每次会话期间处理多个球囊组件,所以每个球囊的设置时间被显著地缩短。
在一个实施方案中,齿轮组件被配置成围绕其纵向轴线旋转,而且同时,安装在齿轮组件上的多个铰链各自被被配置成围绕其自身的相应纵向轴线旋转。每个铰链装配有相应的球囊形的中空模板,所述球囊形的中空模板被配置成容纳其上将被定位电极的球囊组件。在一个实施方案中,每个模板具有图案化开口,在批量溅射处理期间一个或多个电极以高侧向分辨率沉积在相应的球囊组件上。
本发明所公开的技术允许以降低的成本和周期进行多个球囊组件的批量处理,而不会损害利用溅射技术沉积的电极层的均匀度。
系统说明
图1为根据本发明的实施方案的基于导管的跟踪和消融系统20的示意性图解。系统20包括导管22(在本示例中为心脏导管)和控制台24。在本文所述的实施方案中,导管22可用于任何合适的治疗目的和/或诊断目的,诸如心脏中的组织(未示出)的消融。
控制台24包括处理器41(通常为通用计算机),所述处理器41具有合适的前端和接口电路38,以用于经由导管22接收信号并且用于控制本文所述的系统20的其他部件。
现在参见插图23。医师30将导管22穿过躺在手术台29上的患者28的血管系统的血管26插入。导管22包括装配在其远侧端部处的球囊组件40。在一些实施方案中,组件40包括由聚对苯二甲酸乙二酯(PET)或任何其他合适的柔性材料制成的可膨胀球囊(未示出)。在一些实施方案中,球囊组件40包括电极42,所述电极42可用于多个目的,诸如组织的电生理(EP)标测或者心脏的目标位置处的组织的消融。
在一些实施方案中,消融电极42利用合适的几何图案沉积在球囊组件40的外表面上,所述几何图案适配所考虑器官的形状和相应的医疗规程(例如,EP标测,组织消融)。
若干技术可用于施加沉积,诸如溅射技术,这将在下文中相对于图2、图3A和图3B进行详细地描述。
在导管22的插入期间,球囊组件40以塌缩位置容纳在护套(未示出)中。在一个实施方案中,医师30通过利用靠近导管的近侧端部的操纵器32操纵导管22而在心脏中的目标位置附近对球囊组件40进行导航。导管22的近侧端部连接到处理器41中的接口电路。
在一个实施方案中,在将组件40导航到目标位置之后,医师30可膨胀球囊组件40以便在电极42与目标位置处的组织之间形成物理接触。在一个实施方案中,电极42被配置成经由延伸穿过导管22的合适线接收电消融信号诸如射频(RF)信号并且对患者心脏中的目标位置处的组织进行消融。
在一些实施方案中,通过磁位置跟踪系统的位置传感器(未示出)测量球囊组件40在心脏腔室中的位置。在这种情况下,控制台24包括驱动电路34,所述驱动电路34驱动被放置在躺在手术台29上的患者28体外的已知位置处(例如,患者的躯干下方)的磁场发生器36。位置传感器被配置成响应于来自场发生器36的所感测的外部磁场来生成位置信号。位置信号指示球囊组件40在位置跟踪系统的坐标系中的位置。
该位置感测方法在各种医疗应用中实现,例如在由Biosense Webster Inc.(Diamond Bar,Calif.)生产的CARTOTM系统中实现,并且详细地描述于美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089、PCT专利公布WO 96/05768,以及美国专利申请公布2002/0065455 A1、2003/0120150 A1和2004/0068178 A1中,这些专利的公开内容全部以引用方式并入本文。
处理器41通常包括通用计算机,所述通用计算机以软件编程以执行本文描述的功能。该软件可以电子形式经网络而被下载到计算机,例如作为另外一种选择或除此之外,该软件可被提供和/或存储在非临时性有形介质诸如磁性存储器、光学存储器、或电子存储器上。
利用行星齿轮组件对多个球囊上的电极的同时溅射
图2为根据本发明的实施方案的用于溅射多个球囊组件40上的电极42的处理室44的示意性图解。在一些实施方案中,室44被配置成在大约10-6托的真空基础压力下操作以便允许球囊组件上的电极42的溅射。
在一些实施方案中,室44包括行星齿轮组件50。溅射靶66被定位在室44的壁58上。在一个实施方案中,靶66由金或者任何其他合适材料制成,所述金或者任何其他合适材料将被沉积在球囊组件40上以便用作电极42中的导电性生物相容性材料。
在一些实施方案中,组件50包括安装到中央铰链54上的两个平板52,所述两个平板52彼此基本上平行并且基本上平行于靶66。在一个实施方案中,中央铰链54被配置成围绕其纵向轴线顺时针地(如通过箭头56所示)或逆时针地(未示出)旋转。
在一些实施方案中,组件50包括安装在板52之间的多个铰链62。在一些实施方案中,铰链62以正交于板52并且彼此平行的方式进行安装。
在一些实施方案中,中空模板诸如掩模组件60安装在每个铰链62上。在一个实施方案中,每个掩模组件60被配置成容纳正被制造的相应球囊组件40、或者医疗器械的任何其他基于球囊的远侧端部。
在一个实施方案中,掩模组件60具有图案化开口,在溅射处理期间穿过所述图案化开口将电极42沉积在被所述图案化开口暴露的组件40的选定位置上。其他实施方案涉及通过图案化开口的靶材料(例如,金)的沉积,如下文在图3A和图3B中详细所述。
在一些实施方案中,每个铰链62被配置成独立于其他铰链62围绕其纵向轴线逆时针地(如通过箭头64所示)或顺时针地(未示出)旋转。换句话讲,铰链62可沿着与铰链54的旋转相反的方向(或另选地,沿着相同方向)旋转,以便获得球囊组件40上的电极42的均匀沉积。在一个实施方案中,每个掩模组件60与其上安装有该掩模组件的相应铰链62一起旋转。
在一个实施方案中,在溅射处理期间,电子束(未示出)照射到靶66上(在如上所述的环境真空条件下)以便从靶66溅射金原子或粒子。溅射的金原子经由掩模组件60中的开口沉积在球囊组件40的适当位置上,以便形成电极42。
在一些实施方案中,组件50围绕轴线54以第一角速度连续地旋转。此外,每个铰链62与其相应的掩模组件60一起围绕其自身的纵向轴线以第二角速度旋转。在一个实施方案中,第一角速度和第二角速度为同步的,使得掩模组件60在将下一个掩模组件传送到靶66时完成一次或多次完整旋转,由此导致金在多个组件40中的每一个上的均匀沉积。在另一个实施方案中,可施用第一角速度和第二角速度的任何合适布置以便获得金在多个组件40中的每一个上的均匀沉积。
在一些实施方案中,在电极42形成之后,每个组件40(其制造已完成)可被装配到导管22的远侧端部并且可在护套内折叠成其塌缩位置,使得导管22准备被医师30使用。
在一些实施方案中,齿轮组件50包括马达组件(未示出),所述马达组件包括齿轮和一个或多个电动马达。每个马达连接到齿轮,所述齿轮将马达的旋转转换成铰链54和62的相应旋转。
在一个实施方案中,马达组件包括齿轮系统和单个电动马达。马达的旋转被齿轮系统转换以便旋转铰链54和全部铰链62。在此实施方案中,马达组件可被定位在室44的外部(例如,壁58的下方)或者另选地被定位在室中。
在另一个实施方案中,可使用马达和齿轮的任何合适布置。
在一个实施方案中,为了执行上文所述的溅射处理,控制器(未示出)被配置成例如通过控制马达组件来控制铰链54和62的运动。在一些实施方案中,控制器还被配置成控制各种处理参数,诸如室44内的真空水平和照射到靶66上的电子束(未示出)的属性。
控制器通常包括通用处理器,所述通用处理器以软件编程以执行本文描述的功能。该软件可以电子形式经网络而被下载到计算机,例如作为另外一种选择或除此之外,该软件可被提供和/或存储在非临时性有形介质诸如磁性存储器、光学存储器、或电子存储器上。
图2所示的齿轮组件50的配置是完全为了概念清楚而选择的示例配置。在另选的实施方案中,可使用任何其他合适的配置。例如,板52可以相对于彼此和相对于靶66的任何其他合适取向安装到铰链54上,并且铰链62可以相对于板52的任何其他合适取向进行安装。在图2的示例中,铰链54顺时针地旋转并且全部铰链62逆时针地旋转。在另一个实施方案中,组件50的控制器可使每个铰链62以任何合适的方向和角速度旋转,以用于实现电极42的期望沉积均匀度水平。
在另选的实施方案中,取代使用电子束,可使用其他技术诸如等离子体辅助溅射来执行溅射处理。在此实施方案中,将惰性气体诸如氩气(例如,使用射频(RF)功率)进行离子化,使得离子化气体照射到靶66上(取代电子束),从而通过图案化开口沉积金原子以形成电极42。此类处理通常使用大约数毫托(mTorr)溅射压力下的具有大约15标准立方厘米/分钟(sccm)的流速的氩气。
图3A为根据本发明的实施方案的容纳在掩模组件60内的球囊组件40的示意性剖面图。在一个实施方案中,图3A所示的配置对应于通常由溅射处理操作者进行溅射处理的准备阶段。
在一些实施方案中,掩模组件60具有大体球形形状并且可包括两个可拆卸半球(未示出)。在一个实施方案中,半球在球囊组件40插入到掩模组件60内期间彼此分离并且重新附接在一起以便将组件40容纳在其中。
在一些实施方案中,掩模组件60由金属或任何其他合适刚性材料制成,所述金属或任何其他合适刚性材料适于经受施加在室44中的真空而其形状不变形。
在一些实施方案中,球囊组件40在插入到掩模组件60内之前通常利用惰性气体80诸如氩气进行膨胀(部分地或完全地)。在另选的实施方案中,球囊组件可在插入到掩模组件60内之后或者利用任何其他合适的膨胀顺序进行膨胀。
在一个实施方案中,掩模组件60可包括一个或多个侵入部74,所述一个或多个侵入部74对应于球囊组件40的突起部72。突起部72和侵入部74可用于使组件40和60彼此对准,以便允许电极42在组件40上的预期位置处的精确成形。
例如,球囊组件40的突起部72可用作膨胀套袖,所述膨胀套袖在其远侧端部处进行密封并且在球囊组件膨胀到扩张位置时显著窄于组件40的最大直径。在一个实施方案中,突起部72和侵入部74可分别位于组件40和60的上侧孔76和下侧孔78处。在此实施方案中,组件40的突起部72装配到组件60的侵入部74内,从而使组件40和60彼此对准。在其他实施方案中,可使用任何合适的另选对准技术。
在一些实施方案中,组件40可膨胀到一定程度,使得(在插入到组件60内之后)在组件40和60之间留有间隔70(由空气填充)。在一些实施方案中,操作者可在组件60安装到铰链62上之前利用间隔70来细调组件40和60之间的对准。
图3B为根据本发明的实施方案的容纳在掩模组件60内的球囊组件40的示意性剖面图。在一个实施方案中,图3B所示的配置对应于组件60被保持在真空室内期间的实际溅射处理。
在一些实施方案中,在如上文图3A所述使每对组件40和60对准之后,操作者将每个组件60安装到其相应铰链62上并且将空气泵出室44以便在其中产生真空。
由于真空环境,惰性气体80在组件40内扩张,从而将径向力82施加到组件40(由柔性PET制成)的内表面上,使得组件40被向外推压以附接到掩模组件60并且间隔70内的空气被泵出室44。换句换讲,在存在真空的情况下,球囊组件40的可变形外表面附接到掩模组件60的内表面。在一个实施方案中,组件40和60彼此附接,使得溅射原子穿过组件60的图案化开口并且仅在组件40的外表面上的预期位置处沉积在组件40上,以便在其上形成电极42。
因为气体80为惰性气体,所以其不与任何化学元素发生化学反应。在一些实施方案中,在气体从组件40漏出的情况下(例如,由于球囊组件40中的破裂),存在于球囊组件40内的惰性气体80防止室44和电极42的化学污染或溅射处理期间的任何其他干扰。
尽管本文所述的实施方案主要解决球囊导管上的溅射,但本文所述的方法和系统也可用于其他应用,诸如溅射任何可扩展医疗装置上的电极。
应当理解,上述实施方案以举例的方式被引用,并且本发明不限于上文具体示出和描述的内容。相反,本发明的范围包括上文所述的各种特征的组合和子组合,以及本领域技术人员在阅读上述说明时会想到且未在现有技术中公开的其变型和修改。以引用方式并入本专利申请的文献被视为本专利申请的整体部分,但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,则应只考虑本说明书中的定义。
Claims (20)
1.一种设备,包括:
组件,所述组件包括安装在其上的多个铰链,其中所述组件被配置成围绕第一轴线旋转,并且所述铰链中的每一个被另外配置成围绕相应的第二轴线旋转;和
中空模板,所述中空模板被装配在所述相应的铰链上并且各自被配置成容纳医疗器械的基于球囊的远侧端部,其中每个模板具有图案化开口,一个或多个电极通过所述图案化开口沉积在所述远侧端部上。
2.根据权利要求1所述的设备,并且包括马达组件,所述马达组件被配置成使所述组件围绕所述第一轴线沿第一方向以第一角速度旋转并且使所述铰链中的至少一个围绕所述相应的第二轴线沿第二方向以第二角速度旋转。
3.根据权利要求2所述的设备,其中所述第一方向不同于所述第二方向。
4.根据权利要求2所述的设备,并且包括控制器,所述控制器被配置成控制所述马达组件。
5.根据权利要求1所述的设备,并且包括真空室,所述真空室被配置成将所述组件容纳在真空环境中。
6.根据权利要求5所述的设备,并且包括由给定材料制成的溅射靶,所述溅射靶被配置成在所述真空室中溅射所述给定材料的原子或离子。
7.根据权利要求1所述的设备,其中所述中空模板中的每一个包括侵入部,所述侵入部将突起部装配在所述基于球囊的远侧端部上。
8.根据权利要求1所述的设备,其中所述中空模板中的每一个包括突起部,所述突起部将侵入部装配在所述基于球囊的远侧端部上。
9.一种用于制造医疗器械的方法,所述方法包括:
将所述医疗器械的相应基于球囊的远侧端部插入到多个中空模板内;
将所述中空模板装配在安装在可旋转组件上的多个相应可旋转铰链上;
通过使所述组件围绕第一轴线并且使所述铰链中的每一个围绕相应的第二轴线同时旋转来旋转所述远侧端部;以及
通过所述模板中的图案化开口将电极沉积在所述旋转的远侧端部上。
10.根据权利要求9所述的方法,其中插入所述基于球囊的远侧端部包括插入由聚对苯二甲酸乙二酯(PET)制成的可膨胀球囊。
11.根据权利要求9所述的方法,其中插入所述基于球囊的远侧端部包括利用惰性气体膨胀所述基于球囊的远侧端部。
12.根据权利要求9所述的方法,其中沉积所述电极包括通过所述图案化开口溅射原子或离子。
13.根据权利要求12所述的方法,其中溅射所述原子或离子包括将电子或离子照射到溅射靶上。
14.根据权利要求9所述的方法,并且包括在通过所述图案化开口沉积所述电极之前,通过在所述基于球囊的远侧端部周围产生真空来将所述基于球囊的远侧端部的外表面附接到所述中空模板的内表面。
15.根据权利要求9所述的方法,其中插入所述远侧端部包括将所述中空模板的侵入部装配到所述基于球囊的远侧端部的突起部。
16.根据权利要求9所述的方法,其中插入所述远侧端部包括将所述中空模板的突起部装配到所述基于球囊的远侧端部的侵入部。
17.根据权利要求9所述的方法,其中旋转所述远侧端部包括使所述组件围绕所述第一轴线沿第一方向以第一角速度旋转并且使所述铰链中的至少一个围绕所述相应的第二轴线沿第二方向以第二角速度旋转。
18.根据权利要求17所述的方法,其中所述第一方向不同于所述第二方向。
19.根据权利要求17所述的方法,其中所述第一角速度不同于所述第二角速度。
20.一种用于制造可旋转组件的方法,包括:
提供被配置成围绕第一轴线旋转的可旋转组件;
将多个可旋转铰链安装在所述可旋转组件上,所述多个可旋转铰链被配置成围绕相应的第二轴线旋转;
将所述组件和所述铰链连接到马达组件;以及
将具有图案化开口的多个中空模板装配在所述多个可旋转铰链上。
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US15/433528 | 2017-02-15 | ||
US15/433,528 US10758716B2 (en) | 2017-02-15 | 2017-02-15 | Planetary gear assembly for sputtering multiple balloon catheter distal ends |
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EP (1) | EP3363477B1 (zh) |
JP (1) | JP2018130544A (zh) |
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AU (1) | AU2018201072A1 (zh) |
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US10758716B2 (en) * | 2017-02-15 | 2020-09-01 | Biosense Webster (Israel) Ltd. | Planetary gear assembly for sputtering multiple balloon catheter distal ends |
US11690982B1 (en) | 2018-08-16 | 2023-07-04 | Professional Plating Inc. | Microminiature patterned metal on medical grade balloons |
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- 2018-02-08 IL IL257419A patent/IL257419B/en active IP Right Grant
- 2018-02-13 CN CN201810151226.XA patent/CN108434586A/zh active Pending
- 2018-02-14 EP EP18156630.8A patent/EP3363477B1/en active Active
- 2018-02-14 JP JP2018023800A patent/JP2018130544A/ja not_active Abandoned
- 2018-02-14 AU AU2018201072A patent/AU2018201072A1/en not_active Abandoned
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US20180229011A1 (en) | 2018-08-16 |
IL257419A (en) | 2018-04-30 |
JP2018130544A (ja) | 2018-08-23 |
US20200391015A1 (en) | 2020-12-17 |
EP3363477A1 (en) | 2018-08-22 |
CA2994453A1 (en) | 2018-08-15 |
AU2018201072A1 (en) | 2018-08-30 |
EP3363477B1 (en) | 2020-11-18 |
IL257419B (en) | 2021-03-25 |
US10758716B2 (en) | 2020-09-01 |
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