CN106963474A - 具有消融和凝结功能的导丝 - Google Patents
具有消融和凝结功能的导丝 Download PDFInfo
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Abstract
本发明题为“具有消融和凝结功能的导丝”。本发明公开了一种设备,该设备包括导丝和球囊,所述导丝具有远侧端部,该远侧端部的尺寸被设计成刺入到鼻窦中,该球囊邻近所述远侧端部被套在所述导丝之上。存在膨胀通道,该膨胀通道沿所述导丝行进并且被耦合以将加压流体输送到所述球囊中以便使所述球囊膨胀。该设备还包括第一电极和第二电极,该第一电极固定地附接至所述导丝的远侧末端,并且该第二电极在邻近所述远侧末端的位置处固定地附接至所述导丝。存在传导引线,该传导引线沿所述导丝行进并且被耦合以在所述第一电极和所述第二电极之间施加电势。
Description
相关申请的交叉引用
本专利申请要求2015年11月17日提交的美国临时专利申请62/256,295的权益,该临时专利申请的内容在此以引用方式并入本文。
技术领域
本发明整体涉及外科手术,并且具体地涉及鼻窦外科手术。
背景技术
鼻窦球囊扩张术包括将导丝插入到患者鼻腔中的期望位置中,并且使球囊滑动到鼻窦中待扩张的位点。一旦球囊处于合适位置,那么球囊可膨胀以便使得与球囊接触的区域扩展和扩张。在扩张之后,球囊然后可收缩,与导丝一起从患者体内移除。
以引用方式并入本专利申请的文献将视为本专利申请的整体部分,但不包括在这些并入的文献中以与本说明书中明确或隐含地给出的定义相冲突的方式定义的任何术语,而只应考虑本说明书中的定义。
发明内容
本发明的实施例提供了设备,所述设备包括:
导丝,该导丝具有尺寸被设计为刺入鼻窦中的远侧端部;
球囊,该球囊邻近该远侧端部被套在导丝之上;
膨胀通道,该膨胀通道沿导丝行进并且被耦合以将加压流体输送到球囊中以便使该球囊膨胀;
第一电极,该第一电极固定地附接至导丝的远侧末端;
第二电极,该第二电极在邻近远侧末端的位置处固定地附接至导丝;和
传导引线,该传导引线沿导丝行进并且被耦合以在该第一和第二电极之间施加电势。
公开的实施方案包括发生器,该发生器被配置成产生电势以作为低频AC(交流)电势,并且被连接至传导引线以便在该第一和第二电极之间施加该低频AC电势以凝结邻近鼻窦的材料。通常,低频AC电势具有多至5W的功率和多至30kHz的频率。
公开的实施方案包括发生器,该发生器被配置成产生电势以作为高频AC(交流)电势,并且被连接至传导引线以便在该第一和第二电极之间施加该高频AC电势以消融邻近鼻窦的材料。通常,高频AC电势具有多至20W的功率和比30kHz更高的频率。
在另一个公开的实施方案中,该设备包括绝缘节段,该绝缘节段将远侧端部分成包括远侧末端的远侧节段和包括邻近远侧末端的位置的近侧节段。
本发明的另一个实施例提供了一种设备,所述设备包括:
导丝,该导丝具有远侧端部和邻近该远侧端部且与其绝缘的传导节段,该远侧端部和该节段的尺寸被设计为刺入鼻窦中;
球囊,该球囊邻近该远侧端部被套在导丝之上;
膨胀通道,该膨胀通道沿导丝行进并且被耦合以将加压流体输送到球囊中以便使该球囊膨胀;
电极,该电极固定地附接至导丝的远侧末端;和
传导引线,该传导引线沿导丝行进并且被耦合以在电极和导丝的近侧传导节段之间施加电势。
另一个实施方案提供了方法,所述方法包括:
提供导丝,该导丝具有尺寸被设计为刺入鼻窦中的远侧端部;
使球囊邻近该远侧端部套在导丝之上;
使膨胀通道沿导丝行进,所述膨胀通道被耦合以将加压流体输送到球囊中以便使该球囊膨胀;
将第一电极固定地附接到导丝的远侧末端;
在邻近远侧末端的位置将第二电极固定地附接到导丝;和
使得被耦合以在第一电极和第二电极之间施加电势的传导引线沿该导丝行进。
本发明的另一个实施例提供方法,所述方法包括:
提供导丝,该导丝具有远侧端部和邻近该远侧端部且与其绝缘的传导节段,该远侧端部和该节段的尺寸被设计为刺入鼻窦中;
使球囊邻近该远侧端部套在导丝之上;
使被耦合以将加压流体输送到球囊中以便使该球囊膨胀的膨胀通道沿导丝行进;
将电极固定地附接至导丝的远侧末端;以及
使得被耦合以在电极和导丝的近侧传导节段之间施加电势的传导引线沿导丝行进。
结合附图,通过以下对本发明实施例的详细说明,将更全面地理解本发明,其中:
附图说明
图1为根据本发明的实施方案的鼻窦外科手术系统的示意图;
图2为根据本发明的实施方案的用于该系统的导丝的一部分的示意图;
图3为根据本发明的实施方案的用于该系统的另选的导丝的一部分的示意图;并且
图4为根据本发明的实施方案的用于该系统的另外的另选的导丝的一部分的示意图。
具体实施方式
概述
尽管鼻窦球囊扩张术通常不涉及组织切割或移除,但是存在需要组织切割或移除的情况,例如为了获得鼻窦具体部分的适当通路。通常,这种切割或移除由独立的清创器和/或由组织消融器执行。
不是需要两个独立的器械,而是本发明的实施方案将消融器和鼻窦球囊扩张术导丝的功能方面结合到单个导丝内。被配置成接收用于鼻窦球囊扩张术的球囊的导丝具有固定地附接到导丝的远侧端部的两个电极。使得适当的高频交流电流在电极之间流过,通过该流过的电流对组织进行消融。
另选地或除此之外,低频交流电流可在电极之间通过。该低频电流使得与电极接触或者紧邻电极紧密的材料凝结。具体地讲,在已经移除了组织的情况下(通常产生血液/黏液/颗粒混合物的流动),这种混合物的凝结增强手术的功效。
一个实施方案提供导丝,该导丝具有尺寸被设计为刺入鼻窦中的远侧端部。球囊邻近远侧端部被套在导丝上,并且膨胀通道沿该导丝行进并且被耦合以将加压流体输送到球囊中以便使球囊膨胀。第一电极固定地附接至该导丝的远侧末端,并且第二电极在邻近该远侧末端的位置处固定地附接至导丝。传导引线沿导丝行进并且被耦合以在该第一和第二电极之间施加电势。
另选的实施方案提供导丝,该导丝具有远侧端部和传导节段,该传导节段在该远侧端部的近侧并且与该远侧端部绝缘。该远侧端部和传导节段的尺寸被设计为刺入鼻窦中。球囊邻近远侧端部被套在导丝上,并且膨胀通道沿该导丝行进并且被耦合以将加压流体输送到球囊中以便使球囊膨胀。电极固定地附接至导丝的远侧末端;并且传导引线沿导丝行进并且被耦合以在电极和导丝的近侧传导节段之间施加电势。
因此,本发明的实施方案提供具有如下三个功能的单个导丝:递送球囊扩张术的球囊,消融该导丝远侧端部近侧的组织,以及凝结该远侧端部近侧的流体材料。
详细的描述
现在参考图1,其为根据本发明的一个实施例的鼻窦外科手术系统20的示意图。系统20通常在包括鼻窦球囊扩张术的侵入式手术期间用于患者22的鼻窦上,并且该系统包括用于鼻窦球囊扩张术中的导丝28,如下文更详细所述。
对于实际手术,一组磁场发生器24被放置在患者头部近侧。如下文更详细所述,导丝28在其远侧端部32处包括磁场传感器30,并且在远侧端部已被插入到患者鼻窦内之后来自发生器24的场能够追踪传感器的位置和取向,从而追踪导丝远侧端部的位置和取向。利用磁场发生器(例如发生器24)追踪插入患者体内的传感器的系统在授予Govari等人的美国专利申请14/792,823、授予Gliner的美国临时专利申请62/209,946、以及还授予Gliner的美国临时专利申请62/221,367中有所描述,上述专利申请以引用方式并入本文。此外,由Biosense Webster,of Diamond Bar,CA生成的系统利用类似于本文所述的追踪系统,以用于寻找线圈在磁场所辐射的区域中的位置和取向。
系统20的元件可受系统处理器40的控制,该系统处理器包括与一个或多个模块(例如磁追踪模块42)通信的处理单元(PU)41,该模块允许处理单元控制发生器24并且追踪传感器30。处理单元还可与消融和凝结模块44以及鼻窦球囊扩张术模块46通信,上述模块的功能如下文所述。
处理器40可被安装在控制台48上,该控制台包括操作控制装置50,该操作控制装置50通常包括键盘和/或指向设备(诸如鼠标或轨迹球)。控制台48还连接系统20的其他元件,诸如导丝28的近侧端部52。医师54利用操作控制装置与处理器交互,同时执行手术,并且处理器可将系统20产生的结果呈现在屏幕56上。
处理器40使用存储在所述处理器的存储器中的软件来操作系统20。例如,该软件可以电子形式通过网络下载到处理器40,或者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,磁存储器、光学存储器,或电子存储器)上。
图2为根据本发明的实施方案的导丝28的一部分的示意图。导丝28通常被形成为不锈钢丝的线圈58,并且在一个实施方案中具有0.9mm的外径。然而,本发明的其他实施方案的导丝可具有大于或小于0.9mm的外径。图2示出了导丝28的远侧端部32,和导丝的远侧端部和近侧端部52(图1)之间的节段60。
如上文所述,导丝28用于鼻窦球囊扩张术并且被配置成接收球囊62,该球囊套在该导丝之上并且然后在手术期间滑动到节段60。该手术通常涉及预定位该导丝,使得节段60处于鼻窦的期望位置中。一旦处于期望位置中,那么处理器40利用鼻窦球囊扩张术模块46以通过连接到球囊62的孔66的膨胀通道64输送加压流体,通常为盐水溶液,以便使球囊膨胀并且从而执行鼻窦球囊扩张术。一旦终止手术,处理器40还利用鼻窦球囊扩张术模块46移除流体以便使球囊收缩,由此可利用导丝从鼻窦移除球囊。
远侧端部32的剖面节段70示出了远侧端部的内部元件。场传感器30固定地附接至该远侧端部的内部。场传感器通常为具有对称轴线的单个轴线线圈,该对称轴线平行于线圈58的对称轴线并且通常与线圈58的对称轴线一致。传导线72将传感器响应于磁场(该磁场来自发生器24并且穿过该传感器)而产生的信号传输到处理器40。另选地,该信号可无线传输到处理器40。根据所获得的信号,处理器能够计算传感器30的取向和位置,并且因此计算远侧端部32的取向和位置。
在导丝的远侧端部安装在线圈58上和线圈58之外的是两个电极:第一电极74和第二电极76,第一电极安装在导丝的远侧末端处并且第二电极安装在第一电极近侧的远侧端部处。两个电极均通过绝缘材料80与线圈58绝缘。第一电极74通常为杯的形式,并且第二电极76通常为环的形式。传导引线82在该第一电极和处理器40之间传送信号,并且传导引线84在该第二电极和该处理器之间传送信号。
在上文涉及的鼻窦球囊扩张术期间,系统20的导丝28执行多种功能。一旦导丝已经插入到由处理器40利用来自传感器30的信号确定的患者鼻窦中的期望位置和取向,那么球囊62可沿该导丝滑动,如上文所述。球囊可膨胀以执行鼻窦球囊扩张术,并且一旦手术结束则收缩并且被移除,还如上文所述。
执行鼻窦球囊扩张术的同时,或者在该手术之前或之后,执行与该手术相关的其他动作可为期望的。例如,清创器可用于移除该手术区域中的组织,该清创器通常在血液/黏液混合物中产生颗粒物。另选地或除此之外,可通过消融移除组织,还产生颗粒/血液/黏液混合物。凝结所产生的混合物可为有利的,以便将其从手术区域中移除。
如下文所述,第一电极和第二电极可通电以提供凝结和消融两者。电极之间的低频AC电势可通过处理器40利用消融和凝结模块44产生。通常,低频AC处于音频频率(多至约30kHz以及多至大约5W的功率水平),并且这种AC电势被已知为能够凝结流体,例如血液或者血液/颗粒/黏液混合物。凝结材料中的至少一些通常将其自身附接到电极。另选地或除此之外,处理器40和模块44可被实施以在两个电极之间产生高频AC电势。施加高频AC电势可用于消融与电极接触的组织或者电极近侧的组织。用于消融的AC频率通常显著高于用于凝结的频率。通常AC电势具有大约150kHz的频率和多至大约20W的功率,但是该频率和功率可根据期望的消融而变化。
图3为根据本发明的另选实施方案的导丝28A的一部分的示意图。除了下文所述的不同之外,导丝28A的操作与导丝28(图2)的操作大体上相似,并且在导丝28和28A中由相同参考数字指示的元件在结构上和操纵上大体上相似。
为简单起见,节段60(球囊62在其上滑动)未示于图3中。相反,该图只示出了远侧端部32。相比于导丝28,导丝28A的线圈58分成两个节段,远侧线圈节段58A和近侧线圈节段58B。该两个节段通常由绝缘的管状节段90隔开,该管状节段通常由生物相容性塑料形成。在一些实施例中,绝缘管状节段为有凹槽的以便为柔性的以绕过某些解剖结构。如该图所示,第一电极74被安装在远侧线圈节段58A的远侧末端,并且传导引线82在第一电极和处理器40之间传送信号。第二电极76与远侧线圈节段58B叠层,并且传导引线84(图2)在第二电极和处理器40之间传送信号。
图4为根据本发明的另外的另选实施方案的导丝28B的一部分的示意图。除了下文所述的不同之外,导丝28B的操作与导丝28A(图3)的操作大体上相似,并且在导丝28B和28A中由相同参考数字指示的元件在结构上和操纵上大体上相似。
相比于导丝28A,在导丝28B中不存在与近侧线圈节段58B叠层的第二电极76。相反,在导丝28B中,近侧线圈节段58B用作第二电极。
应当理解,导丝28、28A和28B能够执行的多个功能(包括鼻窦球囊扩张术、消融和凝结)相比于现有技术的导丝而言,显著增强导丝操作的功效。
应当理解,上述实施例以举例的方式引用,并且本发明并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述各种特征的组合和亚组合以及它们的变化形式和修改形式,本领域的技术人员在阅读上述说明时将会想到所述变化形式和修改形式,并且所述变化形式和修改形式并未在现有技术中公开。
Claims (22)
1.一种设备,包括:
导丝,所述导丝具有尺寸被设计为刺入鼻窦中的远侧端部;
球囊,所述球囊邻近所述远侧端部被套在所述导丝之上;
膨胀通道,所述膨胀通道沿所述导丝行进并且被耦合以将加压流体输送到所述球囊中以便使所述球囊膨胀;
第一电极,所述第一电极固定地附接至所述导丝的远侧末端;
第二电极,所述第二电极在邻近所述远侧末端的位置处固定地附接至所述导丝;和
传导引线,所述传导引线沿所述导丝行进并且被耦合以在所述第一电极和所述第二电极之间施加电势。
2.根据权利要求1所述的设备,包括发生器,所述发生器被配置成产生所述电势作为低频AC(交流)电势,并且被连接至所述传导引线以便在所述第一电极和所述第二电极之间施加所述低频AC电势以凝结邻近所述鼻窦的材料。
3.根据权利要求2所述的设备,其中所述低频AC电势具有多至5W的功率和多至30kHz的频率。
4.根据权利要求1所述的设备,包括发生器,所述发生器被配置成产生所述电势作为高频AC(交流)电势,并且被连接至所述传导引线以便在所述第一电极和所述第二电极之间施加所述高频AC电势以消融邻近所述鼻窦的材料。
5.根据权利要求4所述的设备,其中所述高频AC电势具有多至20W的功率和大于30kHz的频率。
6.根据权利要求1所述的设备,包括绝缘节段,所述绝缘节段将所述远侧端部分成包括所述远侧末端的远侧节段和包括邻近所述远侧末端的位置的近侧节段。
7.一种设备,包括:
导丝,所述导丝具有远侧端部和邻近所述远侧端部且与其绝缘的传导节段,所述远侧端部和所述节段的尺寸被设计为刺入鼻窦中;
球囊,所述球囊邻近所述远侧端部被套在所述导丝之上;
膨胀通道,所述膨胀通道沿所述导丝行进并且被耦合以将加压流体输送到所述球囊中以便使所述球囊膨胀;
电极,所述电极固定地附接至所述导丝的远侧末端;和
传导引线,所述传导引线沿所述导丝行进并且被耦合以在所述电极和所述导丝的近侧传导节段之间施加电势。
8.根据权利要求7所述的设备,包括发生器,所述发生器被配置成产生所述电势作为低频AC(交流)电势,并且被连接至所述传导引线以便在所述第一电极和所述第二电极之间施加所述低频AC电势以凝结邻近所述鼻窦的材料。
9.根据权利要求8所述的设备,其中所述低频AC电势具有多至5W的功率和多至30kHz的频率。
10.根据权利要求7所述的设备,包括发生器,所述发生器被配置成产生所述电势作为高频AC(交流)电势,并且被连接至所述传导引线以便在所述第一电极和所述第二电极之间施加所述高频AC电势以消融邻近所述鼻窦的材料。
11.根据权利要求10所述的设备,其中所述高频AC电势具有多至20W的功率和大于30kHz的频率。
12.一种方法,包括:
提供导丝,所述导丝具有尺寸被设计为刺入鼻窦中的远侧端部;
使球囊邻近所述远侧端部套在所述导丝之上;
使膨胀通道沿所述导丝行进,所述膨胀通道被耦合以将加压流体输送到所述球囊中以便使所述球囊膨胀;
将第一电极固定地附接到所述导丝的远侧末端;
将第二电极在邻近所述远侧末端的位置处固定地附接至所述导丝;并且
使传导引线沿所述导丝行进,所述传导引线被耦合以在所述第一电极和所述第二电极之间施加电势。
13.根据权利要求12所述的方法,包括产生所述电势作为低频AC(交流)电势,并且将所述电势施加到所述电极以便凝结邻近所述鼻窦的材料。
14.根据权利要求13所述的方法,其中所述低频AC电势具有多至5W的功率和多至30kHz的频率。
15.根据权利要求12所述的方法,包括产生所述电势作为高频AC(交流)电势,并且将所述电势施加到所述电极以便消融邻近所述鼻窦的材料。
16.根据权利要求15所述的方法,其中所述高频AC电势具有多至20W的功率和大于30kHz的频率。
17.根据权利要求12所述的方法,包括定位绝缘节段,所述绝缘节段用于将所述远侧端部分成包括所述远侧末端的远侧节段和包括邻近所述远侧末端的位置的近侧节段。
18.一种方法,包括:
提供导丝,所述导丝具有远侧端部和邻近所述远侧端部且与其绝缘的传导节段,所述远侧端部和所述节段的尺寸被设计为刺入鼻窦中;
使球囊邻近所述远侧端部套在所述导丝之上;
使膨胀通道沿所述导丝行进,所述膨胀通道被耦合以将加压流体输送到所述球囊中以便使所述球囊膨胀;
将电极固定地附接至所述导丝的远侧末端;以及
使传导引线沿所述导丝行进,所述传导引线被耦合以在所述电极和所述导丝的近侧传导节段之间施加电势。
19.根据权利要求18所述的方法,包括产生所述电势以作为低频AC(交流)电势,并且将所述电势施加到所述电极和所述近侧传导节段以便凝结邻近所述鼻窦的材料。
20.根据权利要求19所述的方法,其中所述低频AC电势具有多至5W的功率和多至30kHz的频率。
21.根据权利要求12所述的方法,包括产生所述电势作为高频AC(交流)电势,并且将所述电势施加到所述电极以便消融邻近所述鼻窦的材料。
22.根据权利要求21所述的方法,其中所述高频AC电势具有多至20W的功率和大于30kHz的频率。
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US201562256295P | 2015-11-17 | 2015-11-17 | |
US62/256295 | 2015-11-17 | ||
US15/293472 | 2016-10-14 | ||
US15/293,472 US11213344B2 (en) | 2015-11-17 | 2016-10-14 | Guidewire with ablation and coagulation functionality |
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JP (1) | JP6945990B2 (zh) |
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CN (1) | CN106963474B (zh) |
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US11272980B2 (en) * | 2019-04-04 | 2022-03-15 | Biosense Webster (Israel) Ltd. | Medical instrument with coagulation |
US20240000497A1 (en) | 2022-06-29 | 2024-01-04 | Biosense Webster (Israel) Ltd. | Apparatus and method for transseptal puncture based on impedance |
US20240000504A1 (en) | 2022-06-29 | 2024-01-04 | Biosense Webster (Israel) Ltd. | Apparatus and method for transseptal puncture and dilation |
US20240099768A1 (en) | 2022-09-22 | 2024-03-28 | Biosense Webster (Israel) Ltd. | Two-segment deflectin catheter with side exit guidwire lumen |
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AU2016253574A1 (en) | 2017-06-01 |
IL248878B (en) | 2022-02-01 |
US11213344B2 (en) | 2022-01-04 |
JP2017094081A (ja) | 2017-06-01 |
IL248878A0 (en) | 2016-11-30 |
JP6945990B2 (ja) | 2021-10-06 |
KR20170057841A (ko) | 2017-05-25 |
US20220142703A1 (en) | 2022-05-12 |
EP3173045A1 (en) | 2017-05-31 |
CN106963474B (zh) | 2021-08-27 |
CA2947717A1 (en) | 2017-05-17 |
EP3173045B1 (en) | 2022-03-16 |
US20170135754A1 (en) | 2017-05-18 |
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