CN111278376B - 使用超声波确定球囊导管与解剖结构的接触 - Google Patents
使用超声波确定球囊导管与解剖结构的接触 Download PDFInfo
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Abstract
本发明提供了一种医疗系统,该医疗系统包括轴、可充胀球囊、超声换能器的径向阵列和处理器。轴被构造用于插入患者的身体中。可充胀球囊联接到轴的远侧端部并且被构造成对周围解剖结构执行治疗。超声换能器围绕轴的远侧端部周向分布在球囊内部,并且被配置成在相应径向方向上传输超声波并接收相应超声波反射。处理器被配置成基于从超声换能器接收的超声波反射来估计球囊与周围解剖结构之间的机械接触程度并将该机械接触程度输出给使用者。
Description
技术领域
本发明整体涉及侵入式医疗器械,并且具体地涉及采用超声波的体内医疗探头。
背景技术
侵入式超声技术已用于评估身体内的解剖结构。例如,美国专利申请公布2003/0208119描述了一种用于形成身体内的组织的图像的医疗装置。该装置包括承载成像装置诸如旋转超声换能器的轴。该装置任选地包括可充胀球囊。
又如,美国专利5,588,432描述了一种在心脏内使用的声学成像系统,该系统包括导管、结合到导管的超声装置和安装在导管上的电极。超声装置将超声信号导向心脏中的内部结构以产生超声图像,并且电极被布置用于与内部结构电接触。安装在导管上的声学标记物在受到电激发时发出声波。中央处理单元创建内部结构的图形表示,并且将数据项叠加到表示对应于多个数据项的内部结构内的相应多个位置的位置处的图形表示上。显示系统显示其上叠加有多个数据项的图形表示。
美国专利5,190,046描述了一种用于在腔体或通道的壁附近成像的超声波成像球囊导管。该设备包括具有主内腔的细长导管,该主内腔具有被球囊包封的远侧开口。承载超声换能器元件的预成形超声导管可被推进穿过导管并插入充胀的球囊中。超声导管的远侧部分的形状将超声换能器元件径向地定位在导管内腔的外侧,并且优选地与球囊的壁相邻,因此将图像居中靠近腔体或通道的壁,从而在所关注的壁的部分处赋予更深的图像深度。
美国专利申请公布2003/0105509描述了一种导管系统,该导管系统包括围绕其远侧端部附近的公共内腔设置的球囊血管成形术装置。球囊导管预装有在球囊充胀时部署的支架。公共内腔与导管主体的近侧区域内的多个内腔连通,以允许将导管定位在可移动导丝上并且方便地将成像或介入装置递送到待治疗的身体通道的期望区域。用于支架部署的规程任选地包括以下步骤:在支架部署之前和之后通过超声对内腔进行成像以识别需要支架的部位,以确认支架正在并已部署在不与身体通道的分支段重叠的纵向位置处,并且确保支架已径向地打开至最佳直径。
发明内容
本发明的一个实施方案提供了一种医疗系统,该医疗系统包括轴、可充胀球囊、超声换能器的径向阵列和处理器。轴被构造用于插入患者的身体中。可充胀球囊联接到轴的远侧端部并且被构造成对周围解剖结构执行治疗。超声换能器围绕轴的远侧端部周向分布在球囊内部,并且被配置成在相应径向方向上传输超声波并接收相应超声波反射。处理器被配置成基于从超声换能器接收的超声波反射来估计球囊与周围解剖结构之间的机械接触程度并将该机械接触程度输出给使用者。
在一些实施方案中,可充胀球囊被构造成执行RF消融、微波消融、不可逆电穿孔、低温消融、血管成形术、瓣膜成形术和肺扩张治疗中的至少一者。
在一些实施方案中,超声换能器的径向阵列被配置成在相应径向方向上传输超声波并在相应径向方向上接收覆盖可充胀球囊的整个圆周的相应超声波反射。
在一些实施方案中,径向方向中的一个或多个指向设置在可充胀球囊上的RF消融电极。
在一个实施方案中,处理器被配置成基于超声波反射来计算可充胀球囊上的多个位置与周围解剖结构的表面上的多个相应位点之间的相应径向距离,以及基于径向距离来估计球囊与周围解剖结构的表面之间的机械接触程度。
在另一个实施方案中,处理器被配置成通过分析包括指示相应径向距离的峰的相应一维回波轮廓来计算径向距离。
在一些实施方案中,超声换能器中的每一个被配置成在相应径向方向上产生相应一维回波轮廓。
在一个实施方案中,处理器被配置成独立于其它回波轮廓来分析沿相应径向方向的每个回波轮廓。
在另一个实施方案中,处理器被配置成以图形方式向使用者呈现径向距离。
在一个实施方案中,处理器被配置成以给定速率或通过请求来更新显示的径向距离。
根据本发明的实施方案,还提供了一种方法,该方法包括将联接到轴的远侧端部的可充胀球囊插入患者的身体中,以用于对周围解剖结构执行治疗。超声波在相应径向方向上传输,并且使用超声换能器的径向阵列接收相应超声波反射,该超声换能器围绕轴的远侧端部周向分布在球囊内部。基于从超声换能器接收的超声波反射来估计球囊与周围解剖结构之间的机械接触程度并将该机械接触程度输出给使用者。
结合附图,通过以下对本发明的实施方案的详细描述,将更全面地理解本发明,其中:
附图说明
图1是根据本发明的实施方案的包括可充胀球囊和超声探头的基于导管的消融系统的示意性图解;
图2A和图2B是举例说明根据本发明的实施方案的由超声探头产生的回波轮廓的曲线图;
图3A和图3B是根据本发明的实施方案的与肺静脉的口部分接触的射频(RF)消融可充胀球囊壁的示意性图解;
图4是根据本发明的实施方案的在监视器上向医师显示的可充胀球囊壁与肺静脉的口之间的径向距离的图解的示意性图解;并且
图5是示意性地示出根据本发明的实施方案的用于定量地估计球囊壁与周围解剖结构之间的接触程度的方法的流程图。
具体实施方式
概述
一些心脏消融规程使用其上具有消融电极的可充胀球囊来执行。此类规程通常要求可充胀球囊将被定位成与目标周围解剖结构的表面完全接触。完全接触是指可充胀球囊壁与围绕球囊的整个圆周延伸的目标周围解剖结构表面之间的连续接触。
本文所述的本发明的实施方案提供了基于超声的侵入式医疗器械以及超声数据分析和可视化的方法,该方法使得治疗医师能够在治疗之前和治疗期间均验证盐水充胀的球囊壁确实与待治疗的周围解剖结构的表面完全接触。
在一些实施方案中,医疗器械(例如导管)的远侧端部包括轴和可充胀球囊,该可充胀球囊具有联接到轴的远侧端部的消融电极。多个超声换能器的阵列围绕轴的轴线径向分布在球囊的内部中。
在例如将球囊定位在心脏的左心房内期间,球囊壁将初始仅部分地接触周围解剖结构表面(即,相对于在球囊的整个圆周上实现球囊与组织之间的接触的目标)。在本发明所公开的实施方案中,球囊壁与周围解剖结构的接近程度通过多换能器超声探头在围绕球囊的多个相应径向方向上进行的重复测量来表征。
在一些实施方案中,处理器被配置成接收此类测量结果组,以及根据该测量结果计算分布在球囊壁上的一组相应位置与分布在周围解剖结构的表面上的多个相应位点之间的一组相应径向距离。
在一个实施方案中,围绕球囊的给定圆周分布的一组此类径向距离在监视器上以图形方式呈现给医师。呈现内容可包括示出相对于周围解剖结构的球囊圆周的剖面图解,其中还呈现了径向距离以量化该图解。导航球囊的医师可使该图解以给定的刷新率更新和/或可命令对该图解进行更新。另选地或除此之外,可以任何其它可更新的格式在监视器上提供径向距离组。在一个任选的实施方案中,在监视器上以图形方式向医师呈现一定百分比的周向接触,其中百分之百(100%)是指整个盐水充胀的球囊圆周与解剖结构接触。
本发明所公开的技术为医师提供了一种工具,以帮助他导航可充胀球囊并以高度置信度定位球囊,使得球囊与患者的目标解剖结构完全接触。因此,本发明所公开的技术通过改善球囊导管治疗的安全性和功效而具有独特的附加价值。
此外,本发明所公开的技术通常是快速的并且仅要求适度的计算复杂度。例如,每个超声换能器在特定径向方向上仅产生一维回波轮廓。处理器通常分别分析每个回波轮廓,以便计算球囊壁与该径向方向上的组织之间的距离。
系统描述
图1是根据本发明的实施方案的包括可充胀球囊40和超声探头50的基于导管的消融系统20的示意性图解。系统20包括导管21,其中导管的轴22的远侧端部穿过护套23而插入躺在工作台29上的患者28的心脏26中。导管21的近侧端部连接到控制台24。在本文所述的实施方案中,导管21可用于任何合适的治疗目的和/或诊断目的,诸如心脏26中的组织的电感测和/或消融。
医师30通过使用靠近导管的近侧端部的操纵器32操纵轴22来将轴22的远侧端部导航至心脏26中的目标位置,以及/或者使轴的远侧端部相对于护套23偏转。在轴22的插入期间,球囊40由护套23保持在塌缩构型中。通过将球囊40包含在塌缩构型中,护套23还用于使目标位置沿途的血管创伤最小化。
在一个实施方案中,插图25中所示的可充胀球囊40被构造成在心脏26的目标位置处执行治疗,诸如RF消融、低温消融、血管成形术、瓣膜成形术、肺扩张、微波消融和/或不可逆电穿孔。插图45示出了导航至肺静脉的口54的可充胀球囊40。如在插图45中所见,轴远侧端部22在球囊40内部包括超声探头50。超声探头50包括多个超声换能器52的阵列,该多个超声换能器的阵列在轴远侧端部处围绕轴远侧端部周向分布(参见下面的图3A)。
控制台24包括:处理器41,通常为通用计算机,具有合适的前端;和接口电路38,用于接收来自导管21的信号,以及用于经由导管21对心脏26进行治疗,并用于控制系统20的其它部件。
在一些实施方案中,处理器41可被配置成接收来自超声换能器52的多个测量结果,以及根据这些测量结果计算球囊40的壁与围绕球囊40的整个圆周的周围口54的解剖结构接触的程度(圆周的示例在图3B和图4中示出)。在一个实施方案中,球囊40的壁接近球囊40的整个圆周上的周围解剖结构的程度以例如图解55的图形形式在监视器27上呈现给医师30。
处理器41通常包括通用计算机,该通用计算机以软件编程以执行本文描述的功能。该软件可例如通过网络以电子形式被下载到计算机,或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。
图1所示的示例性构型是完全为了使概念清楚而选择的。可使用其它系统部件和设置类似地应用本发明所公开的技术。例如,系统20可包括其它部件并执行非心脏导管治疗。
使用超声波确定球囊导管与解剖结构的接触
图2A和图2B是举例说明根据本发明的实施方案的由超声探头50产生的一维回波轮廓的曲线图。一维回波轮廓由分别从不同方向A和B反射的超声波生成,其中超声波初始由超声换能器52中的两个(参见图3A)生成。附图示出了在一些分析之后的一维回波轮廓,其以随距换能器的距离而变化的电压的形式提供。
在本发明的上下文中,术语“回波轮廓”是指指示反射超声波的振幅随距换能器的距离而变化的任何表示。每个回波轮廓为一维的,由相应换能器52产生,并且与相对于导管轴线的相应径向方向相关。
如图所示,图2A中的回波轮廓的包络包括两个不同的特征,以约200×10-3英寸为中心的峰62以及以约550×10-3英寸为中心的峰64。这些峰由球囊壁和周围解剖结构表面的反射生成。如图2A所示,球囊40的壁和周围解剖结构表面沿给定方向A由径向距离“s”66分隔开,处理器41可被配置成计算该径向距离。在下文的描述中,距离“s”66一般地用于识别球囊40的壁与周围解剖结构的表面之间的一个或多个距离的任意组。
图2B示出了另一个回波轮廓,其中仅看到单个峰67,该峰以约400×10-3英寸为中心。峰67与单个反射表面相关联。该信号指示球囊壁和周围解剖结构表面不能沿方向B在空间上区分,从而指示接触。
图3A和图3B是根据本发明的实施方案的与肺静脉的口54部分接触的射频(RF)可充胀球囊40的壁的示意性图解。下文中还使用附图来可视化图2A和图2B中所提供的数据的类型。如图所示,球囊40包括RF消融电极51,其中期望电极51的表面中的每一个的一部分将在开始对口54进行RF消融治疗之前接触口54。
图3A提供了球囊40相对于口54定位的侧视示意图。显然,球囊40尚未被最佳定位,例如,球囊40的壁尚未在整个球囊圆周上与口54完全接触,并且因此应进一步推进轴远侧端部22以满足要求。该情况通过图2A和图2B中所示的分别从不同的方向A和B接收的两个信号举例说明。
A和B方向上的一维回波轮廓向医师30提供关于消融电极51的接触质量的信息,超声波通过该接触来传播并反射。如图所示,径向距离“s”66定量地提供沿方向A设置在球囊40的壁上的电极与口54之间的间隙的量度。为了能够测量围绕球囊40的整个圆周的径向距离“s”66,超声探头50位于球囊40内部,并且包括在轴远侧端部22内周向分布的多个超声换能器52。
图3B提供了球囊40与口54之间的空间关系的正视图。从另一个角度来看,它还证实了球囊40的壁与口54之间的接触的偏向性,如沿方向A和B的测量结果证实的,如图2A和图2B所示。如图3B所示,球囊40的壁包括多个圆周44。将与周围解剖结构实现完全接触的具体圆周取决于该周围解剖结构。如图3B所示,充分理解球囊40与口54之间的空间关系需要围绕球囊40的整个圆周44在多个方向上的多个径向距离测量结果。
在一些实施方案中,超声换能器52的径向方向与球囊40上的电极51的位置对齐。换句话讲,每个换能器52被配置成在相应电极52的方向上传输超声波,以及接收来自该方向的超声波反射。该构型的基本原理是接触质量在电极处是尤其重要的并且在其它地方通常具有较小的关注度。然而,在另选的实施方案中,换能器52可定位在相对于电极52的任何其它合适位置处。
图2中的示例性数据以及该数据所引用的图3中的图解完全是为了概念清晰而选择的。可使用其它系统架构类似地应用本发明所公开的技术。例如,根据所需的径向分辨率,超声探头50可包括不同数量的换能器。超声探头50可包括两排或更多排超声换能器52,这些超声换能器可几乎同时或同时围绕球囊40的多个相应不同的整个圆周44生成两组或更多组测量结果。在这种情况下,方向A和B各自表示沿口54的界面的方向的“阵列A”和“阵列B”。此外,处理器41可在球囊40的壁与球囊的一个或多个整个圆周44上的周围解剖结构表面之间生成径向距离“s”66的二维阵列。处理器41还可生成图形体积,诸如前瞻性标测图,以引导医师30如何将球囊40进一步导航成使球囊处于最佳位置,其中在球囊40的整个圆周44上实现完全接触。
图4是根据本发明的实施方案在监视器27上显示给医师30的径向距离的图解的示意性图解。图解55向医师30示出了在球囊40的整个圆周44上球囊40的壁与目标周围口54之间的多个径向距离“s”66。此外,图解55向医师30呈现径向距离“s”66的突出显示的数值68。
图4所示的示例性构型是完全为了使概念清楚而选择的。有多种其它方式可用于以图形方式和数字方式向医师30呈现距离信息。例如,可在任何给定时间在监视器27上并行显示两个或更多个整个圆周44和相应的径向距离“s”66的组。
图5是示意性地示出根据本发明的实施方案的用于定量地估计球囊40的壁与周围解剖结构之间的接触程度的方法的流程图。该规程开始于医师30发起测量周期,以在他将球囊定位在周围解剖结构内时评估球囊接触的质量。测量周期从在围绕球囊的圆周的多个径向方向上获取多个超声测量结果开始。为此,超声换能器52在测量步骤70处沿覆盖球囊40的整个圆周44的相应多个径向方向生成多个测量结果。此类测量结果的示例在图2中提供。
在计算步骤72处,处理器41计算球囊40与围绕圆周44的径向方向上的周围解剖结构的表面之间的多个相应径向距离“s”66,其中相应测量方向覆盖整个圆周44。
监视器27在显示步骤74处向医师30显示径向距离“s”66的图解55。在评估步骤76之后,医师30在决定步骤79处决定接触质量是否令人满意。如果医师30(在步骤79处)判定接触质量确实令人满意,则医师30在治疗步骤78处开始执行计划的医疗规程,诸如消融治疗。如果医师30(在步骤79处)对接触质量不满意,则他将在重新对齐步骤80处重新定位球囊。该规程循环回到步骤70和72并继续,直至医师30完成球囊接触过程。
图5所示的示例性流程图完全是为了概念清晰而选择的。在另选的实施方案中,本发明所公开的技术可使用任何其它合适的导航和定位辅助方案,包括例如使得基于向医师呈现标度,例如提供球囊与目标解剖结构之间的接触程度的百分比或等级,范围从百分之零(其中球囊圆周与解剖结构之间没有接触)至百分之百(100%)(其中整个球囊圆周与解剖结构接触)。在任选的实施方案中,监视器27可向医师30显示视觉引导或方向,以用于进一步将球囊40导航到其在目标周围解剖结构内的最佳定位位置。在另一个任选的实施方案中,控制台24可基于接触的自动确定来启用或禁用针对单个RF电极的RF功率递送(即,使得RF功率仅能够递送到被发现与组织接触的电极)。
尽管本文描述的实施方案主要涉及心脏治疗,但是本文描述的方法和系统也可以用于其它应用,诸如耳鼻喉科、神经病学、鼻窦成形术、食道扩张和肺血管成形规程中。
因此应当理解,上面描述的实施方案以举例的方式被引用,并且本发明不限于上文特定示出和描述的内容。相反,本发明的范围包括上文描述的各种特征的组合和子组合以及它们的变型和修改,本领域的技术人员在阅读上述描述时将会想到该变型和修改,并且该变型和修改并未在现有技术中公开。以引用方式并入本专利申请的文献被视为本申请的整体部分,不同的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,则应仅考虑本说明书中的定义。
Claims (10)
1.一种医疗系统,包括:
轴,所述轴用于插入患者的身体中;
可充胀球囊,所述可充胀球囊联接到所述轴的远侧端部,所述可充胀球囊包括设置在所述可充胀球囊上的多个消融电极并且被构造成对周围解剖结构执行治疗;
超声换能器的径向阵列,所述超声换能器围绕所述轴的所述远侧端部周向分布在所述球囊内部,并且被配置成在相应径向方向上传输超声波并接收相应超声波反射,其中,所述超声换能器的所述相应径向与所述多个消融电极中的相应消融电极的位置对齐;以及
处理器,所述处理器被配置成基于从所述超声换能器接收的所述超声波反射来估计所述球囊与所述周围解剖结构之间的机械接触程度并将所述机械接触程度输出给使用者。
2.根据权利要求1所述的医疗系统,其中所述可充胀球囊被构造成执行RF消融、微波消融、不可逆电穿孔、低温消融、血管成形术、瓣膜成形术和肺扩张治疗中的至少一者。
3.根据权利要求1所述的医疗系统,其中所述超声换能器的径向阵列被配置成在相应径向方向上传输所述超声波并在所述相应径向方向上接收覆盖所述可充胀球囊的整个圆周的所述相应超声波反射。
4.根据权利要求3所述的医疗系统,其中所述径向方向中的一个或多个指向设置在所述可充胀球囊上的电极。
5.根据权利要求1所述的医疗系统,其中所述处理器被配置成基于所述超声波反射来计算所述可充胀球囊上的多个位置与所述周围解剖结构的表面上的多个相应位点之间的相应径向距离,以及基于所述径向距离来估计所述球囊与所述周围解剖结构的所述表面之间的所述机械接触程度。
6.根据权利要求5所述的医疗系统,其中所述处理器被配置成通过分析包括指示所述相应径向距离的峰的相应一维回波轮廓来计算所述径向距离。
7.根据权利要求6所述的医疗系统,其中所述超声换能器中的每一个被配置成在相应径向方向上产生相应一维回波轮廓。
8.根据权利要求6所述的医疗系统,其中所述处理器被配置成独立于其它回波轮廓来分析沿所述相应径向方向的每个回波轮廓。
9.根据权利要求5所述的医疗系统,其中所述处理器被配置成以图形方式向所述使用者呈现所述径向距离。
10.根据权利要求9所述的医疗系统,其中所述处理器被配置成以给定速率或通过请求来更新显示的径向距离。
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US15/792,404 US10959784B2 (en) | 2017-10-24 | 2017-10-24 | Determining balloon catheter contact with anatomy using ultrasound |
PCT/US2018/055134 WO2019083727A1 (en) | 2017-10-24 | 2018-10-10 | DETERMINING A BALLOON CATHETER CONTACT WITH ANATOMY USING ULTRASOUNDS |
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US10905329B2 (en) | 2016-06-09 | 2021-02-02 | Biosense Webster (Israel) Ltd. | Multi-function conducting elements for a catheter |
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US20190314083A1 (en) | 2018-04-11 | 2019-10-17 | Biosense Webster (Israel) Ltd. | Flexible Multi-Arm Catheter with Diametrically Opposed Sensing Electrodes |
US11045628B2 (en) | 2018-12-11 | 2021-06-29 | Biosense Webster (Israel) Ltd. | Balloon catheter with high articulation |
US11850051B2 (en) | 2019-04-30 | 2023-12-26 | Biosense Webster (Israel) Ltd. | Mapping grid with high density electrode array |
US20210169568A1 (en) * | 2019-12-09 | 2021-06-10 | Biosense Webster (Israel) Ltd. | Oriented irreversible-electroporation (ire) pulses to compensate for cell size and orientation |
US11950930B2 (en) | 2019-12-12 | 2024-04-09 | Biosense Webster (Israel) Ltd. | Multi-dimensional acquisition of bipolar signals from a catheter |
US11517218B2 (en) | 2019-12-20 | 2022-12-06 | Biosense Webster (Israel) Ltd. | Selective graphical presentation of electrophysiological parameters |
US11987017B2 (en) | 2020-06-08 | 2024-05-21 | Biosense Webster (Israel) Ltd. | Features to assist in assembly and testing of devices |
US12076071B2 (en) | 2020-08-14 | 2024-09-03 | Kardium Inc. | Systems and methods for treating tissue with pulsed field ablation |
US11844567B2 (en) | 2020-08-28 | 2023-12-19 | Biosense Webster (Israel) Ltd. | Fitting and directing an expandable catheter based on automatic pulmonary veins anatomical characterization |
US12048479B2 (en) | 2020-09-10 | 2024-07-30 | Biosense Webster (Israel) Ltd. | Surface mounted electrode catheter |
US11950840B2 (en) | 2020-09-22 | 2024-04-09 | Biosense Webster (Israel) Ltd. | Basket catheter having insulated ablation electrodes |
US11950841B2 (en) | 2020-09-22 | 2024-04-09 | Biosense Webster (Israel) Ltd. | Basket catheter having insulated ablation electrodes and diagnostic electrodes |
US12082875B2 (en) | 2020-09-24 | 2024-09-10 | Biosense Webster (Israel) Ltd | Balloon catheter having a coil for sensing tissue temperature and position of the balloon |
US11974803B2 (en) | 2020-10-12 | 2024-05-07 | Biosense Webster (Israel) Ltd. | Basket catheter with balloon |
WO2022120836A1 (zh) * | 2020-12-11 | 2022-06-16 | 深圳先进技术研究院 | 不可逆声穿孔设备、装置及计算机可读存储介质 |
US11918383B2 (en) | 2020-12-21 | 2024-03-05 | Biosense Webster (Israel) Ltd. | Visualizing performance of catheter electrodes |
US12064170B2 (en) | 2021-05-13 | 2024-08-20 | Biosense Webster (Israel) Ltd. | Distal assembly for catheter with lumens running along spines |
US12004804B2 (en) | 2021-09-09 | 2024-06-11 | Biosense Webster (Israel) Ltd. | Basket catheter with mushroom shape distal tip |
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CN111278376A (zh) | 2020-06-12 |
EP3700450B1 (en) | 2023-06-07 |
EP3700450C0 (en) | 2023-06-07 |
IL273503B2 (en) | 2023-07-01 |
IL273503B1 (en) | 2023-03-01 |
WO2019083727A1 (en) | 2019-05-02 |
US10959784B2 (en) | 2021-03-30 |
IL273503A (en) | 2020-05-31 |
JP2021500163A (ja) | 2021-01-07 |
EP3700450A1 (en) | 2020-09-02 |
JP7171717B2 (ja) | 2022-11-15 |
US20190117315A1 (en) | 2019-04-25 |
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