CN104703557A - 柔性可伸展电极和管腔内递送脉冲功率的方法 - Google Patents
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Abstract
本发明公开了一种诸如电消融装置的外科器械,包括细长构件,沿该细长构件设置有第一电极,该第一电极沿轴线延伸。第一可伸展部分沿轴线延伸并且限定第一电极的第一周边并且具有相对于轴线的相关联第一直径。该第一可伸展部分包括第一框架,该第一框架能够选择性伸展以使第一可伸展部分从收缩状态转变到伸展状态。第一框架能够选择性收缩以使第一可伸展部分从伸展状态转变到收缩状态。当第一框架伸展时,第一直径伸展并且第一可伸展部分从收缩状态转变到伸展状态。当第一框架收缩时,第一直径收缩并且第一可伸展部分从伸展状态转变到收缩状态。
Description
背景技术
电消融疗法已在医学中用来治疗不良组织,诸如(例如)患病组织、癌症、恶性与良性肿瘤、包块、消融灶和其它异常组织生长。用于常规消融疗法的设备、系统和方法可包括电消融疗法(诸如,例如高温热疗法,包括聚焦超声消融、射频(RF)消融和间质性激光凝固)、其中将化学药剂注入不良组织以引起消融的化学疗法、外科切除、冷冻疗法、放射疗法、光动力疗法、莫式显微外科手术、使用5-氟尿嘧啶的局部治疗、以及激光消融。
常规电消融疗法的缺点包括因暴露于热能而对环绕不良组织的健康组织造成永久性损伤的风险和/或缺乏由电消融装置产生的控释能量。同样地,当不良组织发生在或起源于关键结构处或附近且外科切除会增加与对关键结构造成的损伤相关联的发病率的风险时,常规电消融疗法可为无法令人满意的替代方案。有时,施加控释能量来消融目标区内的细胞的能力可受目标区和/或由消融电极提供的可到达施加位置的一个或多个特性影响。上述问题的解决方案通常为侵入式的并且与最佳外科效果冲突。因此,需要一种能够准确地使消融电极瞄准目标部位、并且递送控释能量以消融目标区内的细胞、同时保持周围组织的必要基础架构的微创电消融疗法。
发明内容
在一个总的方面,各种实施例涉及一种电消融装置。所述电消融装置的一个实施例包括细长构件,沿所述细长构件设置有第一电极,所述第一电极沿轴线延伸。所述第一电极具有近侧端部和表面,所述近侧端部能够联接到能量源,所述表面能够联接到组织治疗区域并递送消融能量。第一可伸展部分沿所述轴线延伸并且限定所述第一电极的第一周边并且具有相对于所述轴线的相关联第一直径。所述第一可伸展部分包括第一框架,所述第一框架包括至少一个第一框架构件。所述第一框架能够选择性伸展以使所述第一可伸展部分从收缩状态转变到伸展状态。所述第一框架能够选择性收缩以使所述第一可伸展部分从所述伸展状态转变到所述收缩状态。当所述第一框架伸展时,所述第一直径伸展并且所述第一可伸展部分从所述收缩状态转变到所述伸展状态。当所述第一框架收缩时,所述第一直径收缩并且所述第一可伸展部分从所述伸展状态转变到所述收缩状态。
在另一个总的方面,一种使用本文所述的电消融装置来治疗组织的方法包括将所述第一电极递送到包括生物内腔的组织治疗区域并且使所述第一电极伸展。使所述第一电极与待治疗组织近侧的所述内腔的壁接触。通过下述方式来治疗组织:对所述第一电极施加一个或多个电脉冲序列以通过不可逆电穿孔来诱导所述组织中的细胞死亡。
附图说明
结合附图考虑下述说明可更好地理解本文所述的电消融装置、系统及其方法的各种实施例。
图1示出了根据本文所述的某些实施例的电消融系统。
图2示出了根据本文所述的某些实施例的图1所示的手柄和细长构件的实施例,其中电极的可伸展部分部署并且处于伸展状态。
图3示出了根据本文所述的某些实施例的沿细长构件的远侧部分设置的电极,其中可伸展部分部署并且处于伸展状态。
图4示出了根据本文所述的某些实施例的沿细长构件的远侧部分设置的两个电极,其中相应可伸展部分部署并且处于伸展状态。
图5示出了根据本文所述的某些实施例的沿细长构件的远侧部分设置的三个电极,其中相应可伸展部分部署并且处于伸展状态。
图6示出了根据本文所述的某些实施例的沿细长构件的远侧部分设置的电极的柔性部分。
图7示出了根据本文所述的某些实施例的电极的处于伸展状态的部署可伸展部分。
图8示出了根据本文所述的某些实施例的被接收于限定在护套内的通道内的可伸展部分的剖面图,其中可伸展部分处于收缩状态。
图9示出了根据本文所述的某些实施例的从护套的远侧端部部署并且处于伸展状态的图8所示的可伸展部分。
图10示出了根据本文所述的某些实施例的处于伸展状态的部署可伸展部分。
图11示出了根据本文所述的某些实施例的从收缩状态转变到伸展状态的部署可伸展部分。
图12示出了根据本文所述的某些实施例的处于伸展状态的可伸展部分。
图13示出了根据本文所述的某些实施例的从收缩状态转变到伸展状态的可伸展部分。
图14示出了根据本文所述的某些实施例的处于伸展状态的图13所示的可伸展部分。
图15示出了根据本文所述的某些实施例的从收缩状态转变到伸展状态的可伸展部分。
图16示出了根据本文所述的某些实施例的处于伸展状态的图15所示的可伸展部分。
图17示出了根据本文所述的某些实施例的从收缩状态转变到伸展状态的可伸展部分。
图18示出了根据本文所述的某些实施例的处于收缩状态的部署可伸展部分。
图19示出了根据本文所述的某些实施例的处于伸展状态的图18所示的可伸展部分。
图20示出了根据本文所述的某些实施例的处于伸展状态的图18所示的可伸展部分的另外的实施例。
图21示出了根据本文所述的某些实施例的部分部署并且处于收缩状态的可伸展部分。
图22示出了根据本文所述的某些实施例的处于伸展状态的图21所示的可伸展部分。
图23示出了根据本文所述的某些实施例的处于伸展状态的图21和图22所示的可伸展部分的另外的实施例。
图24示出了根据本文所述的某些实施例的处于伸展状态的可伸展部分。
图25示出了根据本文所述的某些实施例的处于收缩状态的图24所示的可伸展部分。
图26示出了根据本文所述的某些实施例的包括手柄和细长构件的电消融装置。
图27示出了根据本文所述的某些实施例的包括手柄和细长构件的电消融装置。
图28A-图28B包括根据本文所述的某些实施例的在接收电消融之后的猪肝脏组织的照片。
图29包括根据本文所述的某些实施例的在接收电消融之后的猪心脏组织的照片。
图30为根据本文所述的某些实施例的电消融系统的使用的图示。
具体实施方式
本发明整体涉及电外科领域。具体地讲,本发明涉及(但不完全)电外科装置。更具体地讲,本发明涉及(但不完全)电消融系统、装置和方法。
本发明描述了电消融系统、装置及其方法的各种实施例的各种元件、特征、方面、和优点。应当理解,各种实施例的某些说明已被简化成仅示出与更清楚地理解本发明所公开的实施例有关的那些元件、特征和方面,而为简洁和清晰起见去除了其它的元件、特征和方面。对“各种实施例”、“某些实施例”“一些实施例”、“一个实施例”、或“实施例”的任何提及通常是指所述实施例中所述的特定元件、特征和/或方面包括在至少一个实施例中。短语“在各种实施例中”、“在某些实施例中”、“在一些实施例中”、“在一个实施例中”、或“在实施例中”可能不是指相同的实施例。此外,短语“在一个这样的实施例中”或“在某些这样的实施例中”,虽然通常是指并且详细阐述前述实施例,但并非旨在表明由所述短语引入的实施例的元件、特征和方面局限于前述实施例;相反,提供所述短语用于帮助读者理解本文所公开的各种元件、特征和方面,并且应当理解,本领域的普通技术人员将认识到,引入的实施例中所呈现的这些元件、特征和方面可与本发明所公开的实施例中所呈现的元件、特征和方面的其它各种组合和子组合结合应用。应当理解,本领域的普通技术人员在考虑本文说明后将认识到各种实施例与其它元件、特征和方面的各种组合或子组合在特定具体实施或应用中可为可取的。然而,由于此类其它元件、特征和方面可易于由本领域的普通技术人员在考虑本文说明后确定,并且不是完全理解本发明所公开的实施例所必要的,故可不提供对此类元件、特征和方面的说明。同样地,应当理解,本文所列举的说明仅为对本发明所公开的实施例的例示和举例说明而非旨在限制本发明的范围,本发明的范围仅由权利要求书限定。
除非另有说明,否则本文所述的所有数值量均为近似的,从而表示术语“大约”可在没有明确规定时推论出。本文所公开的数值量应当理解为不严格限于所引用的精确数值。相反,除非另有说明,否则每个数值均旨在表示所引用的值以及围绕该值的功能上等同的范围两者。最低程度上说,丝毫没有将等同原则的应用限制于权利要求保护的范围的意思,至少应该根据所报告的数值的有效数位并通过应用惯常的四舍五入法来解释每个数值参数。
尽管本文所述的数值量为近似值,但还是尽可能精确地报告出实际测量值在特定例子中所述的数值量。本文所述的所有数值范围包括其中所包含的所有子范围。例如,“1至10”的范围旨在包括介于所引用的最小值1和所引用的最大值10之间并且包括所引用的最小值1和所引用的最大值10的所有子范围。本文所引用的任何上限值均旨在包括所有更低的限值。本文所引用的任何下限值均旨在包括所有更高的限值。另外,在一些示例性实施例中,参数、测量、转移或范围可为给定的。应当理解,任何这样的参数、测量、转移或范围均作为实施例的示例性例子或实例而提供并且并非旨在限制该实施例或其它实施例。
如本文通常所用,术语“近侧”和“远侧”通常是指临床医生调控用于治疗患者的器械的一个端部。术语“近侧”通常是指最靠近临床医生的器械的部分。术语“远侧”通常是指离临床医生最远定位的部分。还应当理解,为简明和清楚起见,本文可以参考所示实施例使用诸如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械可在多个方向和位置中使用,并且这些术语并不意味着是限制性的且绝对的。
如本文通常所用,术语“消融”通常是指通过在电场内供应能量来直接或间接移除细胞,并且可包括通过细胞功能丧失、细胞裂解、细胞坏死、细胞凋亡和/或不可逆电穿孔来移除。“消融”可相似地指通过消融形成消融灶。另外,术语“不良组织”、“目标细胞”、“患病组织”、“患病细胞”、“肿瘤”、“细胞团块”以及诸如此类通常贯穿全文用于指通过消融整体地或部分地移除的或待移除的细胞,并且并非旨在限制本文所述的系统、装置或方法的应用。例如,此类术语包括消融患病细胞和某些周围细胞两者,尽管未确切指出这些周围细胞为患病的。相似地该等术语包括消融位于生物内腔(诸如,例如血管、管腔或道区域)周围的细胞,以形成供外科医生通过消融或其它方法来切除另外的细胞的边际。
根据某些实施例,一种消融系统通常包括第一电极和第二电极,所述第一电极和所述第二电极联接到能量源,所述能量源操作以当所述第一电极和所述第二电极与组织接触并且通电时在这些电极之间形成电场。供应至所述电场的电流在所述第一电极和所述第二电极之间传导穿过所述组织。不希望受限于任何特定的理论,据信电流至少部分地经由电子和/或电解质载体传播穿过导电组织。电消融装置通常可包括一个或多个电极,所述一个或多个电极能够定位于组织治疗区域(例如,目标区域)中的不良组织(例如,目标细胞、目标部位、治疗部位、患病组织、患病细胞、肿瘤、细胞团块)处或附近。一般而言,所述电极可包括导电部分(例如,医疗级不锈钢、镀金等)并且可能够电联接到能量源。一旦定位于不良组织处或附近,则可对所述电极施加通电电势以形成电场,所述不良组织暴露于所述电场。所述通电电势(和所得电场)可以各种参数为特征,诸如(例如)频率、振幅、脉冲宽度(脉冲的持续时间或脉冲长度)、和/或极性。根据期望的应用(例如,待呈现的诊断性治疗或疗法治疗),特定电极可被配置为阳极或阴极,或者多个电极可被配置成其中至少一个电极被配置为阳极而至少另一个电极被配置为阴极。不管最初的极性构型如何,电极的极性可通过逆转能量源的输出的极性来加以逆转。在一些实施例中,可在消融之前对组织施加外源性电解质以增加传导性。在某些实施例中,施加外源性电解质可增大或减小电场的有效面积或密度。
在某些实施例中,合适的能量源可包括电波形发生器。能量源产生在频率、振幅、脉冲宽度和极性方面具有合适的特征波形输出的电场。电极可使用各种频率、振幅、脉冲宽度和极性的DC电压和传导电流来通电。电极也可使用适于呈现期望的疗法的振幅和频率的时变电压和电流来通电。合适的能量源可包括电波形发生器,所述电波形发生器适于向电极递送以频率、振幅、脉冲宽度和/或极性为特征的DC和/或时变通电电势。电流在电极之间流动并且与施加到电极的电势(例如,电压)成比例地穿过组织。在各种实施例中,所供应的电流由能量源提供并且包括施加到组织的脉冲序列。例如,能量源可在适合期望的应用的一个或多个脉冲序列中供应各种波形。2011年2月28日提交的名称为“ELECTRICAL ABLATION DEVICES ANDMETHODS”的共同拥有美国专利申请13/036,908和2012年1月18日提交的名称为“ELECTRICAL ABLATION DEVICES AND METHODS”的美国专利申请13/352,495公开了用于电消融治疗的许多此类波形、脉冲序列及其施加方法,所述专利的内容以引用方式并入。
在一个实施例中,能量源可能够产生适于热加热和/或电消融组织治疗区域中的细胞的预先确定的频率、振幅、脉冲宽度和/或极性的RF波形。合适的RF能量源的一个例子可为市售常规、双极/单极电外科RF发生器,诸如可得自Erbe股份有限公司的型号ICC 350。在一个实施例中,能量源可包括微波能量源,所述微波能量源能够产生适于热加热和/或电消融组织治疗区域中的细胞的预先确定的频率、振幅、脉冲宽度和/或极性的微波波形。微波功率源(诸如可得自Boston Scientific的MicroThermx)可联接到微波天线,以提供处于从915MHz到2.45GHz的频率范围内的微波能量。
在一个实施例中,能量源可能够产生适于诱导热加热和/或不可逆电穿孔的不稳定电势(例如,场)。不稳定电势可呈适于诱导热加热和/或不可逆电穿孔的双极/单极单相电脉冲的形式。适于以双极模式或单极模式产生热加热和/或不可逆电穿孔电场脉冲的市售能量源为脉冲DC发生器,诸如可得自Boston,MA的BTX分子递送系统(Molecular Delivery Systems)的型号ECM 830。在双极模式中,第一电极可电联接到能量源的第一极性并且第二电极可电联接到能量源的第二(例如,相反)极性。双极/单极单相电脉冲可以各种频率、振幅、脉冲宽度和/或极性产生。与可能需要将高功率级和高能量级递送到组织以加热并热破坏组织的RF消融系统不同,不可逆电穿孔可能仅需要对组织施加非常少的能量,以使用电场电势而不是热量来加热并杀死不良组织中的细胞。因此,不可逆电穿孔系统可避免由RF消融系统带来的有害热效应。
本文所述的电消融系统、装置和方法的各种实施例利用电穿孔或电透化技术对细胞膜施加外电场(电势)以显著增加细胞的质膜的渗透性。不可逆电穿孔(IRE)为通过使跨细胞膜的电势增加达长时间周期来杀死细胞的过程。IRE提供了用于破坏细胞同时避免一些热诱导疗法的消极并发症的有效方法。即,IRE杀死细胞而不会使周围组织的温度升高到可使支撑结构或区域脉管系统发生永久性损伤的水平。大的不稳定IRE电势可在施加于组织中以增大局部电场的大约数百伏特到大约数千伏特的范围内。电场的增大将使在大约数毫米的距离上的膜电势增大例如达相对长的时间周期。当跨细胞膜的电势达到临界水平时,不稳定电势在细胞膜中形成孔,从而通过被称为细胞凋亡和/或细胞坏死的过程使细胞死亡。
对细胞施加IRE脉冲可为用于消融大量不良组织而几乎没有对周围健康组织的有害热效应的有效方法。同样地,在一些实施例中,IRE可与本文所公开的各种电极和/或其它电消融装置结合使用,以执行一个或多个微创外科手术操作或治疗。不希望受限于任何特定的理论,据信IRE破坏细胞而几乎没有热量,并且因此,可不破坏细胞支撑结构或区域脉管系统。适于使细胞死亡而不诱导对周围健康组织的大量热损伤的不稳定不可逆电穿孔脉冲可具有在数百伏特到数千伏特范围内的振幅,并且通常可在数毫米的距离上跨生物膜施加例如达1μs到100ms的相对长的持续时间。因此,可通过递送不稳定电场快速导致细胞坏死而使不良组织在体内消融。
在某些实施例中,能量源可包括无线发射器,所述无线发射器用于经由一个或多个远程定位的天线使用无线能量传递技术将能量递送到电极。本领域的技术人员将理解,无线能量传递或无线功率传输是指在没有互连线的情况下将电能从能量源传输到电力负荷的过程。在一个实施例中,能量源可通过有线连接或无线连接联接到第一电极和第二电极。在有线连接中,能量源可通过电导体联接到电极。在无线连接中,电导体可由联接到能量源的第一天线和联接到电极的第二天线取代,其中第二天线可自第一天线远程定位。在一个实施例中,能量源可包括无线发射器,所述无线发射器用于经由一个或多个远程定位的天线使用无线能量传递技术将能量递送到电极。如前所述,无线能量传递或无线功率传输为在不使用互连电导体的情况下将电能从能量源传输到电力负荷(例如,组织治疗区域中的异常细胞)的过程。电变压器为无线能量传递的最简单例子。变压器的初级电路和次级电路可不直接连接并且能量传递可经由被称为互感的过程通过电磁联接来进行。功率也可使用RF能量而被无线传递。
如将理解,电消融装置、系统和方法可包括可经由皮肤(例如,在经由针刺皮肤来进入内部器官或其它组织的情况下)插入到组织治疗区域中的部分。电消融装置的其它部分可通过内窥镜的套管针或通道、通过小的切口或透过皮肤(例如,在电脉冲通过皮肤递送到组织治疗区域的情况下)用内窥镜(例如,用腹腔镜和/或用胸腔镜)引入到组织治疗区域中。
用于电消融疗法的系统、装置和方法可适用于微创外科手术操作,所述微创外科手术操作用于进入各种解剖位置中的组织治疗区域,诸如(例如)大脑、肺、乳房、肝脏、胆囊、胰腺、前列腺、以及由以下限定的各种内部身体内腔或生物内腔(例如,自然身体孔口):食道、胃、肠、结肠、动脉、静脉、肛门、阴道、子宫颈、输卵管、以及腹膜腔。微创电消融装置可使用套管针通过形成于患者体内的小开口或使用被称为自然孔口透内腔内窥镜式外科手术(NOTES)TM的透内腔进入技术通过自然身体孔口(诸如嘴、肛门或阴道)引入到组织治疗区域,在透内腔进入技术中,电消融装置可首先通过自然身体孔口引入并且随后通过刺破内部身体内腔的壁推进至组织治疗部位。在各种实施例中,电消融系统可适于使用一个或多个以如下方式定位的电极来治疗大脑、肺、乳房、肝脏、胆囊、胰腺或前列腺中的不良组织:经由皮肤、透过皮肤、透过内腔、微创、和/或通过开放外科技术、或它们的任何组合。
在某些实施例中,所述系统、装置、和方法可被配置用于微创消融治疗细胞团块、肿瘤、生长物、或其它不良组织。微创消融治疗不良组织可以能够通过下述方式减少创伤为特征:通过一个或多个生物内腔(例如,自然身体孔口、血管、管腔或道区域)准确地瞄准不良组织,并且以受控和聚焦方式施加电场以消融不良组织,同时保持周围健康组织的细胞基础构架。根据各种实施例,将电极递送到生物内腔和以受控方式接触内腔壁提供了增加的电极消融准确性,从而可减少不良消融灶,增加良性周边消融区的概率,和/或保持周围组织中的必要基础架构。例如,可更精确地聚焦或控制电场在由各种电极建立的电场的特定区域上的均匀性和/或密度和/或回路。在某些实施例中,以受控方式接触内腔壁包括在围绕治疗部位处或附近的壁的圆周的两个或更多个位置处(例如,在分开例如15°、30°、90°或180°的围绕壁的圆周的两个位置处或一带)周向接触内腔壁。此类接触可为连续的(诸如连接两个点的接触)或不连续的(诸如在第一点处和在第二点处接触,而沿介于第一点和第二点之间的内腔壁的至少中间部分不接触)。
当组织治疗区域例如位于生物内腔(诸如血管、管腔、腔体、孔口或道区域)处或附近时,包括电极的微创电消融装置可如本文所述通过人造内腔(例如,内窥镜、护套、套管、套管针的通道)和/或通过一个或多个生物内腔递送到组织治疗区域。在各种实施例中,电消融装置(例如,电极或沿包括细长构件的探头设置的电极)可通过例如内窥镜、套管针、护套、套管或通道内的生物内腔馈送。电消融装置还可能够通过生物内腔“赤裸”(即,在没有上述器械的协助的情况下)馈送。例如,电极可能够通过一个或多个生物内腔柔性馈送或引导至治疗区域。在一些实施例中,电极可沿包括探头的细长构件的远侧部分设置。细长构件由此可能够将一个或多个电极递送到组织区域。电极近侧的细长构件的部分可响应于来自临床医生的信号,而引导沿细长构件的长度的此类位置中的一个或多个移动。例如,细长构件可响应于信号而在递送到组织区域期间在沿其长度的所述一个或多个位置处弯曲。一旦电消融装置(例如,电极)被递送或定位于治疗区域中的不良组织处或附近,则电极可被部署成接触内腔组织并应用消融治疗。此类弯曲因此可帮助在递送、部署期间或在消融治疗期间或之后通过生物内腔或在生物内腔内导航和/或放置电消融装置。
在特定实施例中,电极可能够例如当部署时或一旦定位于组织区域内的不良组织处或附近则周向伸展。伸展可为部署、致动伸展(或在一些情况下收缩)的电、机械、化学或热信号的结果。在一些实施例中,电极可能够在至少一个维度上伸展。例如,电极可能够在直径上伸展。电极还可能够在长度上伸展,诸如延伸电极的长度。在一些实施例中,长度的延伸可独立于直径的伸展。例如,电极可在长度上伸展而不在直径上伸展或者可在直径上伸展而不在长度上伸展。然而,在其它实施例中,直径或长度伸展可伴随着直径或长度增大或减小。在某些实施例中,电极可能够仅在直径或长度上伸展。在各种实施例中,可在一个或多个维度上伸展的电极可相似地能够在一个或多个维度上收缩。此类电极可被认为能够在伸展状态和收缩状态之间转变。在一些实施例中,一种或多种伸展状态和一种或多种收缩状态之间的转变可响应于由临床医生提供的信号。因此,在一些实施例中,临床医生能够选择性使电极转变到期望的伸展和/或收缩状态以有利地使电极适合于期望的应用,诸如手术操作和/或生物结构。在某些情况下,选择伸展状态可例如使内腔的圆周周围的接触增加,由此形成更精确限定的电场并且增加电场电势的可控性。在各种实施例中,电极可包括天线(诸如微波天线),其中当电极处于相比于收缩状态的伸展状态时,邻接或靠近天线定位的不良组织可更充分暴露于消融能量。例如,包括天线的电极的直径、长度和/或表面积可在伸展状态下增大,使得不良组织完全暴露于消融能量。
根据一个实施例包含电消融装置12的电消融系统10示于图1中并且包括细长构件18,沿所述细长构件设置有连接器19,所述连接器能够联接到能量源11、手柄14、第一电极21(未示出)和远侧末端28。手柄14能够为临床医生提供调控点,以例如调控和/或操纵细长构件18。细长构件18包括导电结构,所述导电结构包括引线17,能量可通过所述引线在连接器19和第一电极21之间传输。然而,应当理解,在一些实施例中,细长构件18或电极21可无线联接到能量源11或者可通过本领域中已知的各种方法联接到能量源11。手柄14包括从其远侧端部延伸穿过保护套管38的护套40。在所示实施例中,手柄14和护套40限定通道15,所述导电结构延伸穿过所述通道。套管38可例如包括绝缘材料(诸如热收缩材料),并且可固定到手柄14。如图所示,护套40包括柔性绝缘体(诸如非导电材料),电流可由所述柔性绝缘体绝缘。如应当理解,细长构件18和/或护套40的相应长度将最通常相依于期望的应用;因此,本文所示的长度并非旨在按比例绘制。
在图1中,第一电极21(未示出)处于撤回或非部署位置并且接收在护套40内。在各种实施例中,包括护套40的细长构件18的远侧部分可被配置为递送平台,第一电极21可从所述平台调控递送到治疗区域并随后部署在治疗部位。因此,手柄14可包括致动器,所述致动器能够部署第一电极(未示出)。在所示实施例中,手柄14包括致动器,所述致动器包括滑动构件30,所述滑动构件能够可滑动穿过孔隙32并且联接到滑动组件34,所述滑动组件包括活塞35,所述活塞可平移穿过限定在手柄14内的气缸36。滑动组件34操作地联接到细长构件18,使得滑动构件30的移动使细长构件18的远侧部分相对于手柄14的远侧端部缩回或推进。在该实施例中,护套40相对于手柄14的远侧端部固定。然而,在某些实施例中,护套40可使用致动器(诸如(例如)滑动构件30)相对于手柄14的远侧端部移动。细长构件18的远侧部分可通过例如物理推进细长构件18而递送到组织治疗区域,诸如在护套40、人造内腔、自然孔口或生物内腔内将细长构件18馈送到患者中。在一些实施例(其中一个示于图2中)中,细长构件18可被推进以部署第一电极21并使其暴露在手柄12、护套40、内窥镜(未示出)或其它递送装置(例如,通道)的远侧端部以外。在某些实施例中,细长构件18还可相对于手柄14、护套40、内窥镜(未示出)或其它递送装置的远侧端部缩回。如图1和图2所示,临床医生可重新定位滑动构件30以选择性地使细长构件18相对于护套40的远侧端部延伸并缩回。例如,朝远侧定位滑动构件30使细长构件18相对于护套的远侧端部延伸而使第一电极21暴露,并且随后朝近侧重新定位滑动构件30使细长构件18相对于护套的远侧端部缩回,从而将第一电极21接收于护套40内。
图1所示的电消融系统10还包括第二电极22,所述第二电极联接到能量源11。在该特定实施例中,第二电极22包括回路垫。在各种实施例中,第二电极22可为沿细长构件18的远侧部分设置的回路垫、针、夹具、第二细长构件或第二电极。值得注意的是,本领域的普通技术人员将理解,第二电极22的最佳类型将大体相依于系统10的期望的应用。
在一些实施例中,电极21,22可向不良组织递送电场脉冲。此类电场脉冲可以各种参数为特征,诸如(例如)脉冲形状、振幅、频率、脉冲宽度、极性、脉冲总数和持续时间。在各种实施例中,电场脉冲可足以诱导不良组织中的热加热,而不诱导不良组织中的不可逆电穿孔。在某些实施例中,电场脉冲可足以诱导不良组织中的不可逆电穿孔。所诱导的效应可相依于各种条件,诸如(例如)组织类型、细胞大小和电场脉冲参数。例如,特定组织类型的透膜电势可主要相依于电场振幅和脉冲宽度。
在一个实施例中,能量源11的输入可通过插塞(未示出)连接到商用功率源。能量源11的输出联接到电极21,22,所述电极可使用手柄14上的启动开关(未示出)或安装在足部启动踏板(未示出)上的启动开关来通电。能量源11可被配置产生适于诱导治疗区域中的不良组织中的热加热或诱导不可逆电穿孔以消融治疗区域中的大量不良组织的预先确定的频率、振幅、脉冲宽度和/或极性的电脉冲。DC脉冲的极性可从正到负或从负到正逆转或反转预先确定的次数,以诱导不可逆电穿孔以消融治疗区域中的大量不良组织。
在一些实施例中,可施加一个或多个电脉冲串以诱导IRE。在一个实施例中,定时电路可联接到能量源11的输出以产生电脉冲。定时电路可包括一个或多个合适的开关元件以产生电脉冲。例如,能量源11可产生由m个电脉冲(其中m为任何正整数)组成的串和由n个电脉冲(其中n为任何正整数)组成的串,所述m个电脉冲具有小于坏死阈值的足够振幅和持续时间以在施加所述m个电脉冲时诱导不良组织中的热加热,所述n个电脉冲具有足够的振幅和持续时间以在施加所述n个电脉冲时诱导适于组织消融的不可逆电穿孔。在各种实施例中,电脉冲可具有固定的或可变的脉冲宽度、振幅和/或频率。
电消融装置12可以双极模式(例如,电极可彼此相对靠近)或单极模式(例如,电极离得很远并且一个电极通常具有大得多的表面积)操作。例如,电极21,22可部署在其中第一电极21相对于另一个电极22具有正极性的双极电消融系统中。在单极模式中,如例如图1所示接地垫可用电极21,22中之一代替。在一些实施例中,第二电极22包括沿细长构件18设置的电极、沿第二细长构件设置的电极、针状电极或夹具之一。在某些实施例中,电极21,22可用于其中每个电极21,22的极性交替的双相电消融系统中。在双相模式中,第一电极21可电连接到第一极性并且第二电极22可电连接到相反极性。在单极模式中,第一电极21可联接到规定电压并且第二电极22可设定为接地。能量源11可能够与电消融系统10一起以双相模式或单相模式操作。在双极模式中,第一电极21可电连接到一个极性的规定电压并且第二电极22可电连接到相反极性的规定电压。当使用多于两个电极时,电极的极性可交替,以使得任何两个邻近电极均可具有相同或相反极性。
回到图2,第一电极21包括可在至少一个维度上伸展的可伸展部分20。具体来讲,图2所述的可伸展部分20包括与当被接收于护套40内时可伸展部分20的直径相比的伸展直径。当被接收于护套40内时,护套40限定具有大于所接收的可伸展部分20的直径的通道。然而,当从护套40部署并且伸展时,如图2所示,可伸展部分20伸展,使得可伸展部分20的直径大于限定在护套40内的通道的直径。因此,当被接收时,可伸展部分20处于收缩状态,而当部署和/或伸展时,可伸展部分20处于伸展状态。
在各种实施例中,细长构件18沿其长度的全部或一部分可为柔性的。此类柔性部分可例如为可弯曲的、可变形的或弹性的。柔性部分还可例如为有条件柔性的或有条件刚性的。在一些实施例中,细长构件18包括柔性部分,所述柔性部分可以机械方式弯曲,使得细长构件18的部分可响应于信号而枢转或者可以其它方式调控。在一些实施例中,细长构件18可相对于手柄14朝近侧和/或朝远侧推进。例如,细长构件18相对于手柄14的远侧端部的远侧推进可与细长构件18相对于手柄14的近侧端部的远侧推进同时发生。在某些实施例中,当推进细长构件18增大远离手柄14的远侧端部的细长构件18的长度时,所述长度增大与手柄14近侧的近侧端部的细长构件18的长度减小同时发生。在各种实施例中,细长构件18相对于手柄14的远侧端部的近侧推进与细长构件18相对于手柄14的近侧端部的近侧推进同时发生。在某些实施例中,当推进细长构件18减小远离手柄14的远侧端部的细长构件18的长度时,所述长度减小与手柄14近侧的近侧端部的细长构件18的长度增大同时发生。虽然图1所示的细长构件18被绘示为具有大体圆柱形形状,但应当理解,细长构件18可具有任何合适的形状或横截面。例如,细长构件18或其部分的横截面可大体由例如圆形、三角形、矩形、五边形、六边形或任何合适的限界形状(无论是规则的几何形状或不规则的几何形状)限定。
在一些实施例中,细长构件18的一个或多个部分可盘绕、嵌套或以其它方式包含于手柄14或细长构件18的远侧部分内。在一些这样的实施例中,细长构件18相对于手柄14的远侧端部的远侧推进不与细长构件18相对于手柄14的近侧端部的远侧推进同时发生。在一个这样的实施例中,细长构件18相对于手柄14的远侧端部的近侧推进不与细长构件18相对于手柄14的近侧端部的近侧推进同时发生。在某些实施例中,当推进细长构件18增大远离手柄14的远侧端部的细长构件18的长度时,手柄14近侧的近侧端部的细长构件18的长度保持相同。在一个这样的实施例中,当推进细长构件18减小远离手柄14的远侧端部的细长构件18的长度时,手柄14近侧的近侧端部的细长构件18的长度保持相同。
在某些实施例中,电消融系统10包括相对柔性细长构件18,并且可在护套40内引入、引导和递送到组织治疗区域。护套40可为中空镗孔,诸如(例如)管。在一些实施例中,护套40为半钢性的并且可用于准确地将第一电极21递送到组织治疗区域。细长构件18可平移穿过中空镗孔以交替地撤回和部署一个或多个电极21,22或其一部分。在一些实施例中,细长构件18包括可延伸部分,诸如可延细长度。长度可通过例如下述方式延伸:使细长构件18朝远侧延伸,使得细长构件18相对于手柄14的远侧端部朝远侧延伸,从而推进或部署第一电极21或其一部分。相似地,可提供致动器(诸如滑动组件34)以使细长构件18延伸。例如,细长构件18可通过朝远侧馈送细长构件18的另外的长度来推进或部署第一电极21或其一部分。应当理解,细长构件18的延伸并不受限于从手柄14朝远侧馈送另外的细长构件18。在一些实施例中,细长构件18的一部分可通过使细长构件18的第一部分相对于细长构件18的第二部分移动来延伸。细长构件18的第一部分和第二部分可位于嵌套部分的两侧的侧面,使得细长构件18的第一部分和第二部分之间的相对移动由此可由细长构件18的长度的伸缩延伸或缩回引起,从而增大或减小细长构件18的总长度。细长构件18的第一部分和第二部分还可位于细长构件18的折叠部分的两侧的侧面,使得细长构件18的第一部分和第二部分之间的相对移动由此可由折叠部分的折叠或展开而引起,从而导致细长构件18的长度的手风琴状延伸或缩回。第一部分和第二部分之间的相对移动可通过任何已知机构实现,诸如(例如)滑轮、往复式延伸构件、滑动安装座、齿轮和/或轨道。在一些实施例中,细长构件18可通过渐进释放细长构件18内的偏置件来推进或部署第一电极21。在图1所示实施例中,致动器能够从护套40的远侧端部部署第一电极21。然而,在其它实施例中,可不提供护套40并且临床医生可通过下述方式来部署第一电极21:从能够接收细长构件18并将第一电极21递送到目标区域的内窥镜、套管针或其它人造内腔的远侧端部推进第一电极21。在这些和其它实施例中,护套40或人造内腔可能够通过推进或缩回以暴露或接收第一电极21或其部分来部署或撤回第一电极21或其部分。
如前所述,细长构件18可包括朝远侧定位的末端28。在某些实施例中,末端28可包括能够阻挡电流传导的绝缘体。应当理解,可提供各种尺寸的末端28以适合特定应用。例如,在一些实施例中,末端28的长度可长于第一电极21,同时中末端28的长度可短于第一电极21。各种长度的末端28可有利地增加消融期间第一电极21的稳定性或通过例如增加细长构件18的可操纵性来帮助递送第一电极21。在各种实施例中,末端28的直径可大于或小于处于收缩状态的第一电极21的直径。在一些这样的实施例中,末端28可包括多个直径。包括多个直径的末端28可能够帮助递送、放置和/或定位第一电极21。例如,设置在末端28的多个直径周围的轮廓可被设计成将第一电极21锚固或适当定位于治疗部位处或附近。此类轮廓还可包括一个或多个表面特征结构,所述特征结构能够夹持接合治疗区域处或附近的组织。在各种实施例中,末端28包括远侧端部,所述端部能够帮助递送、放置和/或定位第一电极21。例如,末端28的远侧端部可包括平端和钝端,如例如图1所示。在一些实施例中,末端28的远侧端部包括相对尖点,所述尖点能够沿表面和在通道内引导细长构件18。图3示出了包括这样的末端28的实施例。具体地讲,图3示出了沿细长构件18的远侧部分设置的第一电极21。细长构件18的远侧端部包括末端28。末端28渐缩至相对尖点。应当理解,渐缩度可根据期望的应用大于或小于图1或图3所示。在一些实施例中,末端28可为能够刺穿组织和/或锚固第一电极21的尖点。末端28还可包括例如能够排出流体的细导管。如下文将更详细解释,在某些实施例中,末端28可执行任何数量的功能,诸如感测功能(例如,光学、温度、位置等)和/或电解质递送。应当理解,在一些实施例中,电极21可包括末端28并且能够递送或接收电流。例如,在一些实施例中,末端28可为针状电极。
在各种实施例中,滑动组件34操作地联接到护套40,使得滑动构件30沿第一方向的移动使护套40相对于手柄14的远侧端部推进,并且滑动构件30沿第二方向的移动使所述护套相对于手柄14的远侧端部缩回。在一些实施例中,所述护套可相对于手柄14的远侧端部缩回,以暴露第一电极21或将其递送到治疗部位处或附近的部署位置。在一些实施例中,护套40可相对于手柄14的远侧端部推进,以包封第一电极21或将其撤回到撤回位置。应当理解,细长构件18可例如由除滑动构件30以外的布置(诸如杠杆、触发器、致动器或按钮)推进,并且推进和缩回可例如以手动方式、以电方式和/或以机械方式来实现。在一个实施例中,细长构件18可通过增大或减小细长构件18的长度来推进或缩回。例如,细长构件18的一个或多个电极21或其它部分可包括可调节长度,所述可调节长度由弹性材料或可以其它方式延伸或压缩的材料构成,使得长度的调节实现细长构件18的推进或缩回。在一些实施例中,细长构件18的远侧推进将第一电极21部署在目标组织,并且细长构件18的近侧缩回将第一电极21从目标组织撤回。在一些实施例中,一个或多个致动器可能够将第一电极21部署在治疗区域,将第一电极21从治疗区域撤回,使第一电极21延伸或折曲,和/或使可伸展部分20在收缩状态和伸展状态之间转变。在一些实施例中,多种转变可由相同的或不同的致动器致动。例如,用于在收缩状态和伸展状态之间转变的致动信号可与用于撤回或部署第一电极21的致动信号联接。
在各种实施例中,第一电极21和第二电极22可沿细长构件18的远侧部分设置并且可用来更精确地限定治疗区域,以例如消融不良组织,同时减少邻接组织中的肌肉收缩。图4示出了包括沿细长构件18的远侧部分设置的第一电极21和第二电极22的图1所示的电消融装置12和系统10的实施例。第一电极21可被配置为正电极,并且第二电极22可被配置为负电极。第一电极21可电联接到导电结构,所述导电结构可联接到能量源11的正极端子。第二电极22可电联接到导电结构(诸如导电引线或导线),所述导电结构可联接到能量源11的负极端子。除了与相应电极21,22电连接以外,所述导电结构可彼此电绝缘并且与周围结构电绝缘。第一电极21和第二电极22可使用类似于参照第一电极21所述的致动方法来部署。例如,第一电极21可通过重新定位滑动构件(未示出)或其它致动器来撤回或推进。第二电极22可相似地通过重新定位相同的或不同的滑动构件或其它致动器来撤回或推进。在一些实施例中,推进第一电极21或第二电极22使相应电极21,22从护套40的远侧端部部署。一个或两个电极21,22可联接到滑动构件,或者可提供另外的滑动构件以推进和/或撤回电极21,22和/或部署电极21,22。另外,应当理解,在某些实施例中,第一电极21和第二电极22能够选择性部署。因此,临床医生可通过选择性部署仅第一电极21或仅第二电极22而任选地使用第一电极21或第二电极22。这样,临床医生可在对第一电极21和/或第二电极22施加功率之前或之后独立地定位另外的电极,从而提供在电消融装置12的单次插入期间形成各种电场的灵活性。应当理解,在一些实施例中,能够选择性改变或切换第一电极21、第二电极22或另外的电极的特性。例如,在一个实施例中,可禁用第一电极21的功能性,并且将第二电极22的特性切换到第一电极21的先前特性。
在一些实施例中,在细长构件包括多个电极的情况下,电极之间的距离“d”可调节。再次参见图4,所示实施例包括第一电极21和第二电极22之间的可调节距离。这样的可调节距离可例如在2mm和25mm之间调节,并且可用于灵活地限定治疗区域。临床医生因此可在使用之前通过例如在电极21,22之间插入一个或多个延伸器或插入件来调节电极21,22之间的距离“d”。可提供合适长度的多个延伸器或插入件以使得临床医生能够定制电极21,22之间的距离,并使长度适合期望的用途。在一些实施例中,电极21,22之间的距离可通过下述方式来调节:通过致动位于手柄14上的一个或多个滑块或致动器来使第一电极21相对于第二电极22推进或旋转。例如,电极21,22可围绕螺纹沿细长构件或沿另一轨道通过螺纹或以能够滑动的方式设置。在各种实施例中,介于电极21,22之间的细长构件的中间长度可伸展,由此增大距离。
图5示出了包括沿细长构件18的远侧部分设置的第一电极21和第二电极22的图1所示的电消融装置12和系统的另外的实施例。电极21,22被示出处于各种程度的伸展状态下。例如,第一电极和第二电极22两者均围绕轴线伸展。然而,第二电极22也沿轴线延伸并且包括大于第一电极21的长度。在一些实施例中,可提供非对称电极,使得当电极21,22伸展时,电极21,22包括相异尺寸。然而,在其它实施例中,可提供对称电极(例如,包括相同的或基本上类似的尺寸的电极)。相异尺寸可包括例如不同的直径和/或长度,如图5所示。选择相对于两个或更多个电极21,22的最佳相异尺寸通常将取决于期望的应用。值得注意的是,并且如下文将更详细解释,第一电极21和第二电极22可作为选择性伸展的结果、作为伸展方法的副产物、或由于构造而在一个或多个维度上分开。例如,处于收缩状态的第一电极21的长度既可相同于也可不同于处于收缩状态的第二电极22的长度,然而,这两个电极21,22的长度仍然可在各自伸展状态下为相同的长度。图5所示的实施例还包括沿细长构件18的远侧部分设置的第三电极23。第三电极23远离第一电极21,并且在一些实施例中,可在细长构件18或第一电极21的远侧末端28处或附近的连接部处附接到第一电极21。在一些实施例中,第三电极23被配置为回路或包括不同于第一电极21和/或第二电极22的极性的极性。然而,在其它实施例中,第三电极23能够使第一电极21或第二电极22的电特性延伸。
根据本文所公开的电消融系统、装置和方法的各种实施例,电极21可包括柔性部分和/或可伸展部分。在一些情况下,此类柔性部分和/或可伸展部分可包括框架,所述框架包括一个或多个框架构件,所述构件可向所述柔性部分和/或可伸展部分提供结构。在各种实施例中,框架限定可伸展部分的能够选择性伸展的周边和/或直径,并且可包括一个或多个能量递送表面,所述表面能够接触组织并且递送消融能量。在本文中,可伸展部分和/或柔性部分的总体形状和周边表面通常可被称作篮状物。应当理解,图2-图5和图7中的电极包括篮状物的一个或多个总体图,并且因此,并非旨在相对于框架的外观和构造限制本发明。值得注意的是,如在下文中将变得显而易见,柔性部分和/或可伸展部分可包括篮状物,所述篮状物包括各种框架构造,所述构造具有各种周边和横截面,包括例如螺旋形、圆形、三角形、矩形、五边形、六边形或任何其它合适的形状,无论是规则的几何形状或不规则的几何形状。此外,虽然在一些实施例中框架可包括例如具有能够施加消融能量的能量递送表面的导电套管,所述导电套管既可设置在也可不设置在布置在内部的框架构件周围,但各种其它实施例中的篮状物无需包括连续表面。例如,在某些实施例中,篮状物包括由框架限定的不连续表面,所述框架具有两个或更多个包括组织接触区域的框架构件,所述区域具有能够接触组织并递送消融能量的能量递送表面。还应当理解,虽然电极21及其部分的实施例可被称作可伸展的或柔性的,但这两者不相互排斥。实际上,在某些实施例中,电极21包括柔性部分和可伸展部分,其中所述可伸展部分的至少一部分包括所述柔性部分的至少一部分。即,可伸展部分的至少一部分和电极21的柔性部分重叠。然而,在一些实施例中,可伸展部分和柔性部分可能不重叠或者可能只有当电极21处于收缩状态或伸展状态时才重叠。
框架构件可能够沿一个或多个方向折曲或弯曲,并且可包括表现出弹性和/或反射性性能的柔性材料。例如,框架构件可包括诸如塑料、聚合物、合金、金属或其它弹性材料(包括超弹性材料)的材料。框架构件可相似地包括例如能够在接头或承窝周围折曲或弯曲的刚性材料或有条件刚性材料。在一些实施例中,临床医生可通过利用柔性电极21来减少与将电极引导穿过曲折的生物内腔相关联的创伤。柔性电极21可有利地到达原本可被视为不宜动手术的目标区域中的不良组织。在各种实施例中,柔性电极21还可增加柔性电极21的组织接触区域与不良组织之间的接触面积。如本领域的技术人员所将认识到,柔性电极21可因例如在不良组织部分地阻碍生物内腔时提供对应用的更大控制而特别有用。
图6示出了根据某些实施例的柔性部分16。柔性部分16沿细长构件18的远侧部分设置并且包括圆柱形框架50,所述框架包括盘式框架构件52(例如,弹簧)。框架50沿由柔性部分16限定的纵向轴线延伸。所述框架还包括近侧联接器54和远侧联接器56。近侧联接器54和远侧联接器56能够将框架构件52联接到细长构件23和末端28。在所示实施例中,末端28提供钝的圆形终点并且柔性部分16被柔性配置用于插入到生物内腔中,使得其可例如响应于内腔的曲率而折曲或弯曲。电极21还可有利地在通过人造递送通道(诸如,例如内窥镜、套管针或内腔)或赤裸(即,被暴露或不位于人造递送通道内)递送到组织治疗区域期间弯曲或折曲。这样,柔性部分16可以微创方式柔性递送到目标区域。
在各种实施例中,电极21可在任何物理维度(诸如,例如宽度或高度)上伸展。例如,在一些实施例中,电极21的伸展可被描述为电极21的直径的增大。如本文中通常所用,术语“直径”通常是指两个点之间的直线距离,所述点沿可伸展部分20的周边定位,使得所述直线穿过可伸展部分20的轴线。可伸展部分20的周边可包括可伸展部分20的周边或外表面。例如,在一些实施例中,框架50限定可伸展部分20的周边,并且直径可为所述框架的相对侧面上的两个组织接触区域之间的距离。应当理解,所述直径并不限于特定几何形状或横截面并且包括例如螺旋形、圆形、三角形、矩形、五边形、六边形或任何其它合适的形状,无论是规则的几何形状或不规则的几何形状。
除伸展性和/或柔性以外,电极21还可延伸。即,电极21的长度可通过使电极21的可移动部分相对于电极21的固定部分延伸来延伸。例如,在图6所示的柔性电极21的一个实施例中,临床医生可通过下述方式来使柔性电极21延伸:致动近侧联接器54和远侧联接器56之间的相对移动,使得柔性部分16的长度增大。这样的延伸可降低也可不降低柔性部分16的柔性。如本领域的技术人员可认识到,在本文所公开的电极的各种实施例中,可延细长度可由临床医生用来增加应用面积以有利地减少原本可由多个消融治疗而引起的创伤。
在各种实施例中,电消融装置12包括一个或多个可伸展电极21。可伸展电极21(诸如,例如图2、图3和图4所示的那些)可包括框架50,所述框架包括一个或多个框架构件52。应当理解,框架构件52可具有相关联第一形式和相关联第二形式。在一些实施例中,第一形式包括记忆形式并且第二形式包括保持形式。保持形式可包括呈除记忆形式以外的形式的框架构件52的布置或取向。例如,在保持形式中,框架构件52可由于通过例如保持结构的调控而变形、阻释或以其它方式拉紧。调控可包括对一个或多个框架构件52施加应力(诸如扭矩、压缩和/或张力),使得可伸展部分20包括增大的或减小的直径。在一些实施例中,调控可导致塑性变形。在某些实施例中,呈保持形式的框架构件52可通过释放或移除将框架构件52保持呈保持形式的保持结构转变到记忆形式。在某些实施例中,呈保持形式的框架构件52还可通过调控恢复到记忆形式,所述调控包括对一个或多个框架构件52施加扭矩、压缩和/或张力,使得可伸展部分20和/或框架50包括增大的或减小的直径。
可伸展部分20的尺寸可伸展到的程度可为所述尺寸的原值的许多倍。例如,处于第一状态的可伸展部分20的尺寸可具有1的值,并且处于第二状态的可伸展部分20的尺寸可具有2、3、10、20或更大(诸如40)的值。在某些实施例中,伸展度仅受处于第一状态的可伸展部分20的长度的限制。在一些实施例中,提供可变伸展特征结构。可变伸展特征结构可使得临床医生能够调节电极21伸展到的程度。例如,临床医生可在手术操作之前或期间将伸展度调节到预先确定的直径。可变伸展特征结构还可能够适应手术操作或向临床医生提供反馈,使得伸展度可调节。例如,在发生特定伸展度之后,伸展力的量级可为有限的和/或标称的,使得当对抗伸展的外部阻力达到或接近预先确定的阈值时(例如,当壁或结构阻碍完全伸展时),伸展度可受到限制。这样的可变伸展特征结构可进一步调节以适合特定应用。例如,包括导电球囊的电极21可插入到内腔中,并由可控压力充气以基本上符合内腔的形状。这样的互补形状可增加内腔周围的周边接触而不对组织施加侵入力。相似地,在各种实施例中,当可伸展部分20处于伸展状态时,框架构件52保持至少部分柔性。例如,框架构件52可朝轴线向内折曲和/或由轴线向外折曲。细长构件18和/或可伸展部分20可相似地以各种角度和方向远离轴线折曲。在一些实施例中,可适应特征结构包括其中可伸展部分20的长度可调节的电极21。例如,在一些实施例中,可伸展部分20可被撤回或被接收于护套40内,使得当可伸展部分20选择性转变到伸展状态时仅可伸展部分20的保持部署的部分伸展。
图7示出了根据各种实施例的沿细长构件18设置的可伸展部分20的实施例。可伸展部分20被示出为从护套40部署并且处于伸展状态。框架50界定围绕可伸展部分20的轴线的大体周边(例如,篮状物),并且包括与所述轴线分开大约50°的第一渐缩长度24a、基本上平行于所述轴线延伸的第二长度24b、和朝所述轴线分开大约50度的第三渐缩长度24c。在各种实施例中,篮状物可表示例如金属球囊、金属覆盖物、或类似于图9、图13或图24的实施例,其中伸展度随第一渐缩长度和/或第三渐缩长度以及所述渐缩长度相对于所述轴线分开的程度而变化。细长构件18还包括远侧末端28,所述远侧末端提供渐缩成尖点的终点。在收缩状态(未示出)下,可伸展部分20的直径减小至少8倍,使得可伸展部分20可被接收于限定在护套40内的通道内。当从护套40部署的远侧端部时,可伸展部分20可通过本发明所公开的任何方法伸展。由图可见,伸展度可随第一渐缩长度24a和/或第三渐缩长度24c以及渐缩长度24a,24c分别相对于所述轴线分开或会聚的程度而变化。例如,增大或减小第一渐缩长度24a和/或第三渐缩长度24c的分开度或会聚度分别增大或减小伸展度同时还分别减小或增大可伸展部分20的长度。另外,增大或减小第一渐缩长度24a和/或第三渐缩长度24c分别增大或减小伸展度。在例如其中第一渐缩长度24a和/或第三渐缩长度24c可延伸的实施例中,可伸展部分20的长度可在伸展状态和收缩状态之间的转变期间不增大或减小。然而,在其中第一渐缩长度24a和/或第三渐缩长度24c不延伸的实施例中,伸展可减小可伸展部分20的长度。
根据各种实施例,电极21或其可伸展部分20可在收缩状态和一种或多种伸展状态之间选择性转变。图8-图25示出了包括框架50和框架构件52的电极21的可伸展部分20的各种非限制性实施例、以及使可伸展部分20伸展和/或收缩的方法的各种非限制性实施例。然而,在论述这些实施例之前,将介绍这些实施例和其它实施例的多个有利的方面以帮助本领域的技术人员理解所述各种实施例。
在一些实施例中,使可伸展部分20从收缩状态转变到伸展状态可通过伸展力来促成。可对一个或多个框架构件52施加伸展力以实现伸展。伸展力可包括任何已知的力,诸如(例如)扭矩、压缩或张力。例如,在一个实施例中,内部压力的变化利用注入到限定在框架50内的腔体中或从所述腔体释放的可注入剂(诸如固体、液体或气体)促成转变。内部压力的增大可使框架50在框架50的一个或多个区域中伸展到平衡压力,或者可通过增大框架50的腔体周围的张力来促成进一步伸展。相似地,可对一个或多个框架构件52施加收缩力以促成收缩,诸如伸展状态和不太伸展状态之间的收缩。收缩力可包括任何已知的力,诸如(例如)扭矩、压缩和张力,以减小尺寸。例如,在一个实施例中,内部压力的变化利用注入到限定在框架50内的腔体中或从所述腔体释放的可注入剂(诸如固体、液体或气体)促成转变。内部压力的减小(诸如,可注入剂的释放)可因减轻腔体周围的张力而使框架50在框架50的一个或多个区域中收缩到平衡压力,或者可通过下述方式来促成进一步收缩:释放另外的可注入剂,由此使得外部压力能够压缩框架50并且占据腔体。
在各种实施例中,电消融装置12可采用压缩、张力和/或旋转来使电极21或可伸展部分20在收缩状态和伸展状态之间转变。在一些实施例中,框架构件52的压缩可减小可伸展部分20的长度同时增大可伸展部分20的直径。例如,受到压缩的框架构件52可由轴线外向拉紧、翘曲或弯曲以减轻压缩应力。压缩还可促成框架构件52在框架50内的重新定位,以实现增大可伸展部分20的直径而不减小可伸展部分20的长度的转变。例如,一个或多个框架构件52或其部分可由轴线向外或沿细长构件18推动,从而导致那些或其它框架构件52的重新定位和可伸展部分20的尺寸的增大。在一些实施例中,框架构件52的张力可增大可伸展部分20的长度,同时减小可伸展部分20的直径。例如,以其它方式翘曲或向外延伸的框架构件52可被绷紧成朝轴线向内拉紧、拉伸或拉直,以减轻张应力。张力还可促成框架构件52在框架50内的重新定位,以实现增大可伸展部分20的直径而不减小可伸展部分20的长度的转变。例如,可朝轴线向内或沿细长构件18牵拉一个或多个框架构件52或其部分,从而导致那些或其它框架构件52的重新定位和可伸展部分20的尺寸的减小。在一些实施例中,能够联接实现框架构件52或其部分之间的相对移动的调控的第一联接器相对于第二联接器的旋转可增大或减小框架构件52或其部分之间的距离。例如,距离的减小可压缩一个或多个中间部分或其它框架构件52,而距离的增大可绷紧一个或多个中间部分或框架构件52。
在各种实施例中,框架构件52包括记忆材料。记忆材料可包括能够在移除变形应力之后恢复到记忆取向或布置的反射性材料和/或弹性材料。例如,在一些实施例中,框架构件52能够通过高于或低于弹性极限的变形应力而变形,并且在移除变形应力和/或后续调控(诸如温度的变化)时恢复到记忆形式。在某些实施例中,记忆材料包括具有单向和/或双向记忆效应的形状记忆材料。记忆材料还可包括可通过调控而变形和重整的材料。例如,线圈的两个部分之间的第一反向旋转可部分地退绕线圈,而与第一反向旋转相反的第二反向旋转可重绕线圈。具有这样的性能的材料为本领域已知的并且包括聚合物(诸如记忆泡沫、塑料、弹性体和橡胶)以及金属和合金。应当理解,这样的材料包括超弹性材料和形状记忆材料,诸如合金(例如,NiTi)、陶瓷、以及包括凝胶、泡沫和固体的聚合物。值得注意的是,当框架构件52包括作为不良导体的记忆材料时,可使用导电材料来建立待传输并递送到组织的消融能量的电路径。例如,可使用导电涂层、线、套管和/或组织接触区域来将能量传输和递送到组织。在一些实施例中,框架构件52的弹性极限可由于框架构件52的布置和/或取向而增大。例如,框架构件52可包括线圈或编织物的构型,所述构型包括由于例如分布式应变所致的增大的弹性极限。
在各种实施例中,呈记忆形式的框架构件52可被调控或以其它方式变形或通过保持力保持,并且在移除保持力之后,所述材料至少部分地恢复到记忆形式。具有记忆形式的框架构件52可以任何合适的方式布置在可伸展部分20内,使得框架构件52将在移除保持力之后或在调控时恢复到记忆形式。例如,包括导电涂层并且包括框架构件52(包括泡沫聚合物)的框架50可能够在移除保持力时在至少一个维度上伸展,而在施加所述保持力时在所述至少一个维度上收缩。在某些实施例中,所述保持力由其中接收可伸展部分20的通道(例如,限定在内窥镜、套管针或护套内的人造通道)提供。也可使用其它保持结构来施加保持力。例如,在某些实施例中,可使用钩、锁、或可压缩环或其它保持机构来保持框架构件52和/或防止框架构件52转变到一种或多种记忆形式。
框架构件52可单独地或共同地具有一种或多种记忆形式和/或保持形式。例如,框架构件52可响应于保持力而变形,并且在所述保持力被移除时恢复到记忆形式。作为另外一种选择,框架构件52可包括第一记忆形式和第二记忆形式,其中当一个或多个框架构件52呈第一记忆形式时,可伸展部分20处于伸展状态,并且其中当一个或多个框架构件52呈第二记忆形式时,可伸展部分20处于收缩状态。在某些实施例中,记忆形式可对应于伸展状态并且因此包括相比于保持形式的增大的直径,或者可对应于收缩状态并且因此包括相比于保持形式的减小的直径。当然,在一些实施例中,保持力可与第二、第三或多个另外的力组合和或联接到所述力,以实现收缩状态和伸展状态之间的主动转变。
框架构件52可能够当框架构件52朝轴线压缩或以其它方式保持时变形或拉紧以减小可伸展部分20的直径。这样,电极21可在收缩状态下在人造通道内引导到组织治疗区域并且可在组织治疗部位处或附近部署时和/或响应于移除保持力而伸展。在一个实施例中,包括偏置件(诸如弹簧、泡沫或其它记忆材料)的第一框架构件52由轴线向外(诸如径向地)偏置。当可伸展部分20在具有小于处于伸展状态的可伸展部分20的直径的直径的通道内推动、牵拉或旋转时,所述通道将第一框架构件52朝轴线压缩,从而将其保持呈保持形式。然而,当可伸展部分20从所述通道推动、牵拉或旋转时,第一框架构件52不再由所述通道保持,并且因此,在部署时转变到记忆形式并且由轴线向外延伸。在另一个实施例中,当可伸展部分20部署并且处于伸展状态时,第二框架构件52朝所述通道的近侧延伸。第二框架构件52包括近侧唇缘和远侧压缩表面,所述表面联接到第一框架构件52的向外延伸部分。当可伸展部分20被接收于所述通道内时,所述近侧唇缘被渐进拉动到所述通道中,从而使远侧压缩表面朝轴线杠杆传动,压缩第一框架构件52,并且减小可伸展部分20的直径。
图8示出了沿细长构件18的远侧部分设置的可伸展部分20。可伸展部分20处于收缩状态,并且在限定在护套40内的人造通道内。所述通道具有小于处于伸展状态的可伸展部分20的直径的直径,并且将框架构件52保持呈保持形式。护套40操作地连接到手柄14(未示出)。所述手柄包括可类似于图1所示的滑动构件30的致动器(未示出),所述致动器能够从护套40的远侧端部部署并撤回可伸展部分20。在一些实施例中,可伸展部分20可通过将可伸展部分20朝护套40的远侧推进来部署。因此,推进可伸展部分20可包括相对于手柄14朝近侧撤回护套40或朝远侧推进可伸展部分20。当可伸展部分20被接收于护套40内时,通过所述通道对可伸展部分20施加保持力,从而将可伸展部分20限制处于收缩状态。然而,如图9所示,当可伸展部分20从护套40部署时,框架构件52不再由所述通道保持,并且因此转变到记忆形式。在该实施例中,记忆形式对应于可伸展部分20的伸展状态。
仍然参见图9,所述可伸展部分可通过将可伸展部分20撤回到所述通道内而转变到收缩状态。当可伸展部分20被接收于所述通道内时,所述通道对框架构件52施加保持力,由此将框架构件52保持呈保持形式。可采用主动力(诸如压缩、张力和/或扭矩)来撤回和/或部署可伸展部分20。例如,可从或向所述通道推动、牵拉或旋转可伸展部分20。推动、牵拉或旋转可伸展部分20还可与由所述通道施加的压缩组合,以迫使框架构件52朝轴线变形并使可伸展部分20转变到收缩状态,如图8所示。在一些实施例中,使可伸展部分20转变到收缩状态包括对一个或多个框架构件52施加张力。张力也可例如与旋转组合。在一些实施例中,近侧张力可迫使框架构件52朝轴线变形,并且可与框架构件52的远侧压缩组合。
处于图9所示的可伸展状态的可伸展部分20包括框架构件52,所述框架构件包括线性部分25b,所述线性部分两侧有远侧渐缩部分25c和近侧渐缩部分25a。在记忆形式中,近侧渐缩部分25a以第一角度远离轴线分开,并且远侧渐缩部分25c以第二角度朝轴线会聚。如图可见,伸展度随渐缩部分25a,25c的长度以及分开度和会聚度而变化。例如,增大渐缩部分25a,25c的长度增大可伸展部分20的直径。另外,伸展度随着分开度和会聚度接近90°而增大。在一些实施例中,这样的直径伸展还伴有可伸展部分20的长度减小。虽然图8和图9示出了包括呈篮状物布置的四个框架构件52的框架50,但框架50可包括任意数量的框架构件52。例如,在一些实施例中,框架50包括沿轴线延伸的两个框架构件52。根据期望的应用,分开渐缩长度和会聚渐缩长度以及它们限定的角度可增大以增大伸展度或减小以减小伸展度。在某些实施例中,多个(5个、10个、20个或更多个)框架构件52可沿轴线延伸,并且可伸展到预先确定的直径。在某些实施例中,框架构件52可由框架材料片或管形成。例如,可例如使用激光来切割或蚀刻包括片或管的框架50,使得当可伸展部分20处于伸展状态时,一个或多个框架构件52或其部分可远离轴线伸展。在某些实施例中,框架50包括合金管体,所述合金管体包括沿管体激光蚀刻的一个或多个纵向框架构件52,并且当可伸展部分20处于伸展状态时,所述一个或多个框架构件52由轴线向外延伸。
图8和图9所示的框架构件52可包括记忆材料,诸如超弹性材料。包括超弹性材料的记忆材料(诸如形状记忆材料)可能够在释放保持力时或在调控时伸展或收缩到记忆形式。包含超弹性材料的框架构件52因此可包括相关联记忆形式和相关联保持形式。保持形式可对应于马氏体形态而记忆形式可对应于奥氏体形态。例如,在奥氏体温度下,框架构件52可由保持结构保持,例如,以马氏体形态压缩在通道内,而当不再由保持结构保持时(例如当从护套40的远侧端部部署时)恢复到包括增大的直径的奥氏体形态。相似地,在马氏体温度下,框架构件52可以塑性变形到马氏体形态中的减小的直径,并且随后在升高到奥氏体转变温度时恢复到奥氏体形态中的伸展的直径。相似地,框架构件52可以奥氏体形态接收于护套40的通道内并且随后以奥氏体形态从所述护套的远侧端部部署。一旦被部署,则包括框架构件52或其部分之间的距离的相对减小的保持力或使框架构件52或其部分由轴线向外延伸的内部延伸部可将框架构件52压缩或拉紧成包括增大的直径的马氏体形态。在奥氏体温度下移除保持力时,框架构件52恢复到包括减小的直径的奥氏体形态。在马氏体温度下移除保持力时,框架构件52可通过施加变形应力或升高奥氏体温度而恢复到减小的直径。在一些实施例中,框架构件52具有双向记忆。例如,框架构件52可包括至少两种记忆形式并且可响应于调控而在所述至少两种记忆形式之间转变。例如,在一些实施例中,框架构件52包括低温记忆形式和高温记忆形式。框架构件52由此可经由包括高于和低于相关联转变温度的温度变化的调控在这两种记忆形式之间转变。当然,如本领域的普通技术人员可从本发明推断,可采用单向和双向形状记忆的无数变型以达到本文中所述的可伸展部分20的期望的转变,并且因此对所有可能变型的进一步描述是不必要的。
在一些实施例中,框架构件52被布置为占据可伸展部分的一部分的环形线圈、编织物或折痕的规则或不规则分组。在各种实施例中,框架构件52可包括当负荷在相关联弹性极限内时赋予框架构件52记忆形式的材料、取向和/或布置。例如,框架构件52可包括弹簧(例如,弓形弹簧、压缩弹簧、扭转弹簧或张力弹簧),所述弹簧具有相关联记忆形式和相关联弹性极限。所述弹簧可响应于施加或移除负荷而在尺寸上增大或减小。当弹簧为绕在轴线上的线圈或螺旋线时,框架构件52可在可伸展部分20处于收缩状态时至少部分地退绕,并且框架构件52可在可伸展部分20处于伸展状态时重绕。包括线圈或螺旋线的框架构件52还可包括在施加或移除负荷时(例如,在负荷纵向拉紧弹簧时)改变的直径。这样,临床医生可例如通过压缩压缩弹簧或释放施加到张力弹簧的张力来增大框架构件52的直径。相似地,临床医生可例如通过释放施加到压缩弹簧的压缩负荷或对张力弹簧施加张力来减小框架构件52的直径。因此,构架构件52可在保持形式中经历变形应变(诸如线性或扭转)而在移除或逆转负荷或力时转变到记忆形式。
图10示出了沿包括末端28的细长构件18的远侧部分设置的可伸展部分20。可伸展部分20被示出为从护套40部署并且处于伸展状态。包括弹簧的盘式框架构件52绕在轴线上并且被示出为呈包括增大的直径的记忆形式。应当理解,图10中的可伸展部分20的直径可能够随着线圈之间间距的变化而增大。例如,随着间距减小并且弹簧的长度接近其压并高度,弹簧的直径增大。图10中的可伸展部分20可通过将框架构件52撤回到限定在护套40内的通道(或单独的通道)内转变到收缩状态,所述通道包括小于处于伸展状态的可伸展部分20的直径的直径。例如,当对可伸展部分20施加近侧张力时,可伸展部分20被接收于所述通道内,以迫使框架构件52纵向延伸,从而减小弹簧的直径并使框架构件52转变成保持形式。当框架构件52保持在所述通道内时,可伸展部分20的长度增大并且可伸展部分20的直径减小。如果需要,临床医生随后可通过从护套40的远侧端部部署可伸展部分20来使可伸展部分20从收缩状态转变到伸展状态(如图9所示)。部署可伸展部分20释放保持力并且使得框架构件52能够从保持形式转变到记忆形式。在一些实施例中,通道还可配有例如能够从通道精确部署一定长度的弹簧或一定数量的线圈的间隔开的沟槽、螺纹或道。
在各种实施例中,框架构件52可被编织成沿可伸展部分20的长度形成一个或多个篮状物。在一个实施例中,框架构件52被编织成如图11所示的大体圆柱形或管状布置。可伸展部分20被示于伴随着收缩状态和伸展状态之间的转变而从护套40的远侧端部部署的过程中。框架构件52包括导电编织物,所述编织物具有相关联保持形式和记忆形式。框架构件52能够在移除保持力时伸展到记忆形式,由此使可伸展部分20从收缩状态转变到伸展状态。例如,当可伸展部分20处于伸展状态时,其可朝近侧撤回并接收于包括较小直径的通道内并且转变到收缩状态。当可伸展部分20朝近侧撤回到通道的较小直径中时,对编织物施加张应力,从而推动编织物以增大长度同时减小直径。然后,通道的减小的直径保持对编织物的压缩并且保持编织物内的张应力。在收缩状态下,可伸展部分20可在通道内递送到组织治疗区域。一旦递送到组织治疗区域,则可伸展部分20可从护套40的远侧端部部署,由此去掉编织物的压力并减轻张应力。因此,当编织物从保持形式转变到记忆形式时,编织物长度减小并在其直径周围伸展。因此,移除保持力会减轻编织物内的张应力,从而导致编织物的长度的减小和编织物的直径的增大。同样地,在移除保持力时,可伸展部分20可从收缩状态转变到伸展状态。
在另外的实施例中,框架构件52可布置在围绕轴线布置的框架构件52的一个或多个同心线圈(例如,毛圈或包装材料)中。线圈的外带由此可相对于线圈的内带旋转,使得可伸展部分20可通过带之间的相对旋转在收缩状态和伸展状态之间转变。此类框架构件52还可包括相关联记忆形式和相关联保持形式,使得带之间的相对旋转包括保持力并使可伸展部分20从伸展状态转变到收缩状态,并且保持力的释放使可伸展部分20从收缩状态转变到伸展状态。然而,在其它实施例中,带之间的相对旋转可使可伸展部分20从收缩状态转变到伸展状态,并且保持力的释放可使可伸展部分20从伸展状态转变到收缩状态。应当理解,包括多个带的多个线圈可相对于彼此旋转,使得沿可伸展部分20的长度的各种直径可用于调节可伸展部分20的直径以满足各种应用。
在各种实施例中,电消融装置12包括可移动部分。可移动部分可包括框架联接器和/或可移动元件,所述元件包括围绕或沿细长构件18设置的环、块或卡圈。可移动部分可例如沿道滑动,围绕螺纹旋转,或沿细长构件18的距离移动。细长构件18和/或可伸展部分20还可包括可调节距离,使得可移动部分不沿细长构件18物理转变,而是由于所述可移动部分和另一个可移动部分之间的相对距离的减小或增大而移动或沿细长构件18或相对于轴线定位。例如,细长构件18可包括可调节距离,其中调节距离导致第一可移动部分相对于第二可移动部分移动。在某些实施例中,可移动部分之间的距离可通过例如使所述可调节距离的折叠部分或嵌套部分延伸或缩回来加以调节。延伸或缩回可通过例如相对旋转、释放偏置件和/或在两个部分之间施加反力或相对力来实现。在一个实施例中,电消融装置12包括可移动部分,诸如块、环、联接器、或包括邻接表面的其它元件。所述元件可被配置为可沿细长构件18移动并且邻接框架构件52。在一些实施例中,移动所述元件会对框架构件52施加压缩应力或减轻压缩应变。在各种实施例中,也可采用滑轮或齿轮来移动可移动部分。例如,可移动部分可沿轨道安放,所述轨道沿细长构件18限定。所述轨道可包括齿轮,所述齿轮能够移动可移动部分或例如通过嵌套细长构件18的一部分来调节可移动部分之间的细长构件18的长度。
在各种实施例中,框架构件52可相对于细长构件18移动。一个或多个框架构件52或其部分可能够沿细长构件18滑动或相对于所述细长构件18枢转。例如,框架构件52的第一部分可在第一位置处固定到或以能够枢转的方式固定到细长构件18,并且框架构件52的第二部分可在第二位置处固定到或以能够枢转的方式固定到细长构件18。图12示出了处于伸展状态的可伸展部分20的实施例。可伸展部分20包括沿细长构件18的远侧部分设置的多个纵向框架构件52。为简明起见,图中只示出了两个纵向框架构件52。纵向框架构件52在包括近侧联接器54的近侧可移动部分和邻近末端28的远侧联接器56之间沿轴线延伸。近侧联接器54包括可旋转部分,所述可旋转部分可在设置在细长构件18周围的螺纹60之上沿细长构件18旋转移动。近侧联接器54沿第一方向的旋转使近侧联接器54朝近侧移动,并且近侧联接器54沿第二方向的旋转使近侧联接器54朝远侧移动。近侧联接器54的近侧移动和远侧移动对应于近侧联接器54和远侧联接器56之间的相对移动。在一个实施例中,当近侧联接器54朝远侧移动时,近侧联接器54和远侧联接器56之间的距离减小并且对纵向框架构件52施加压缩应力。压缩应力导致以纵向框架构件52由轴线向外翘曲为特征的变形应变,从而增大可伸展部分20的直径。作为另外一种选择,当近侧联接器54朝近侧移动时,近侧联接器54和远侧联接器56之间的距离增大并且压缩应力减轻。压缩应力的减轻使得纵向框架构件52能够向内松弛并且沿轴线纵向对齐,从而减小可伸展部分20的直径。在另一个实施例中,近侧联接器54的近侧移动对纵向框架构件52施加张应力,从而导致以纵向框架构件52向内定位为特征的变形应变,从而减小可伸展部分20的直径。作为另外一种选择,近侧联接器54的远侧移动减轻张应力,使得纵向框架构件52能够由轴线向外松驰,从而增大可伸展部分20的直径。在一些实施例中,压缩应力包括保持力,并且近侧联接器54包括保持结构。因此,在记忆形式中,纵向框架构件52可向内延伸或由轴线向外翘曲,并且在保持形式中,纵向框架构件52可被压缩成由轴线向外翘曲或被绷紧成伸直并且朝轴线向内径向地对齐。在一些实施例中,框架构件52不对应于近侧或远侧联接器56的旋转而旋转。例如,联接器可包括邻接表面,所述邻接表面能够紧贴或相对于框架构件52的第二部分压缩框架构件52的第一部分。在某些实施例中,联接器可包括轨道,框架构件52的第一部分可在所述轨道之上相对于框架构件52的第二部分保持轴向定位。相似地,联接器可包括套管,框架构件52的第一部分联接在所述套管之上。所述套管可在轴承之上围绕联接器的内部旋转,使得框架构件52的第一部分可对应于联接器内部的移动而保持轴向定位。
应当理解,提供近侧取向和远侧取向以帮助理解本文所公开的系统、装置和方法。在某些实施例中,取向和/或布置可颠倒,使得转变可伸展部分的目标仍然是相同的。例如,远侧联接器56可在例如设置在远侧联接器56附近的螺纹之上旋转移动。此类取向变型并不背离本发明。实际上,在一个实施例中,近侧联接器54和远侧联接器56可围绕设置在细长构件18的表面周围的螺纹旋转。相似地,在另一个实施例中,远侧联接器56可沿细长构件18以能够卡入的方式移动。在另外的实施例中,一系列框架50布置和/或可伸展部分20可沿细长构件18的远侧部分设置。这样的一系列框架50布置和/或可伸展部分20可针对期望的应用而配置并且在生物内腔或治疗部位内提供可定制的消融区。
图13示出了包括四个构件篮状物的可伸展部分20的实施例。框架构件52联接于近侧联接器54和远侧联接器56处。近侧联接器54可相对于远侧联接器56移动,使得联接器54,56之间的距离的减小会增大可伸展部分20的直径,如图14所示,并且联接器54,56之间的距离的增大会减小可伸展部分20的直径,如图13所示。如图14所示,在伸展状态下,框架构件52具有限定大约80°的内角的近侧渐缩部分26a和远侧渐缩部分26b。在一些实施例中,伸展度随长度26a,26b和在它们之间限定的角而变化。例如,增大长度26a,26b可增大伸展度并且减小在长度26a,26b之间限定的角可增大伸展度。在一些实施例中,细长构件18的一部分可平移穿过近侧联接器54并相对于远侧联接器56固定,使得相对于近侧联接器54缩回细长构件18减小近侧联接器54和远侧联接器56之间的距离,而相对于近侧联接器54推进细长构件18增大近侧联接器54和远侧联接器56之间距离。因此,当细长构件18朝近侧撤回时,远侧联接器56朝近侧移动并且框架构件52压缩并以对应于可伸展部分20的伸展状态的保持形式向外翘曲。相似地,框架构件52可包括对应于可伸展部分20的伸展状态的记忆形式,使得当细长构件18朝近侧撤回时,远侧联接器56朝近侧移动并且框架构件52拉紧并以对应于可伸展部分20的收缩状态的保持形式向内伸直。如图14所示,压缩框架构件52可导致框架构件52由轴线向外径向翘曲,从而增大可伸展部分20的直径。根据期望的应用,沿轴线布置的多个框架构件52的多种构型可能够响应于应力而折曲、弯曲、变形或以其它方式拉紧。例如,框架构件52可能够在两个或更多个位置处折曲、弯曲、变形或以其它方式拉紧,从而形成类似于图9所示篮状物的篮状物。在一些实施例中,可提供5个、6个、8个、15个或更多个框架构件52,所述构架构件沿多个位置折曲、弯曲、变形或以其它方式拉紧并且例如在伸展状态下呈现球形。
图15示出了可伸展部分20的另一个实施例。在该实施例中,框架构件52之间的相对移动使可伸展部分20类似于伞伸展。具体来讲,提供包括延伸器53的一个或多个框架构件52。延伸器53的第一端部53a以能够枢转的方式联接到可沿细长构件18的长度定位的近侧联接器54。延伸器53的第二端部53b以能够枢转的方式联接到包括肋51的一个或多个另外的框架构件。肋51可包括柔性材料(例如,一系列弹性接合框架构件、或柔性覆盖物的一部分)或在一些实施例中包括刚性材料,并且可在邻近远侧末端28的远侧联接器56处固定联接到细长构件18,使得延伸器53的延伸使肋51的部分由轴线向外延伸。延伸器53优选为足够刚性的以通过例如使肋51由轴线向外弯曲、折曲或摆动来使肋51延伸。在所示实施列中,收缩状态和伸展状态之间的转变包括近侧联接器54和远侧联接器56之间的相对移动。例如,从收缩状态到伸展状态的转变包括减小联接器54,56之间的距离。联接器54,56之间的相对移动可以任何合适的方式来实现。例如,在一个实施例中,临床医生可通过下述方式朝远侧重新定位近侧联接器54:使用设置在手柄上的致动器(未示出)朝近侧牵拉包括远侧联接器56的细长构件18的嵌套部分。图16示出了处于伸展状态的图15所示的可伸展部分20的实施例。如图可见,延伸器53响应于近侧联接器54和远侧联接器56之间的相对移动而支撑肋51或使肋51由轴线向外延伸。在该实施例中,近侧联接器54包括可旋转部分,所述可旋转部分可在设置在细长构件18的邻近表面周围的螺纹60之上旋转。延伸器53可通过朝远侧旋转近侧联接器54来延伸,并且可通过朝近侧旋转近侧联接器54来收缩。在各种实施例中,近侧联接器54可通过使联接器52沿细长构件18朝近侧或朝远侧滑动而重新定位。在另外的实施例中,第二延伸器或第三延伸器可与第一延伸器53相关联。例如,第二延伸器可包括第一端部和第二端部,所述第一端部以能够枢转的方式联接到第一延伸器的中心部分,所述第二端部以能够枢转的方式联接到另外的框架构件,诸如肋51。第三延伸器可相似地配置。第二延伸器和第三延伸器可向可伸展部分20提供另外的结构和或支撑或增加伸展。在其它实施例中,延伸器53可为具有能够接合并支撑助51的接合表面的楔。例如,随着所述楔和远侧联接器56之间的距离减小,所述楔沿肋51的下侧渐进移动,使肋51由轴线向外摆动,并使可伸展部分20的直径伸展。
图18示出了包括两个以能够枢转的方式联接的构架构件52a,52b的可伸展部分20的另一个实施例。可伸展部分20被示出为处于稍微伸展状态。框架构件52a,52b在邻近端部处围绕接头62(例如,铰链、销或柔性部分)以能够枢转的方式联接。每个框架构件52a,52b均在相应近侧联接器54和远侧联接器56处围绕另外的接头62以能够枢转的方式联接到细长构件18。近侧联接器54和远侧联接器56可相对于彼此相对移动。在该实施例中,使可伸展部分20从收缩状态转变到伸展状态包括使近侧联接器54和远侧联接器56相对移动并且包括嵌套细长构件18的中间部分。例如,将远侧部分嵌套在细长构件18的近侧部分内会减小近侧联接器54和远侧联接器56之间的距离,从而导致框架构件52a,52b的邻近端部的向外枢转,增大可伸展部分20的直径,并且由此使可伸展部分20伸展。相反,使远侧部分与近侧部分解嵌套会增大近侧联接器54和远侧联接器56之间的距离,从而导致框架构件52a,52b的邻近端部的向外枢转,减小可伸展部分20的直径,并且由此使可伸展部分20收缩。为简明起见,图18只包括两个联接的框架构件52a,52b;然而,另外的框架构件可相似地联接到框架构件52a,52b。例如,第三框架构件可联接在图18所示的两个框架构件52a,52b之间,使得近侧联接器54和远侧联接器56之间的相对移动使第三框架构件与轴线相对平行由轴线向外延伸。也为简明起见,图18只包括两组联接的框架构件52a,52b;在另外的实施例中,三组或更多组联接的框架构件52a,52b设置在细长构件18的圆周周围,以进一步增大处于伸展状态的可伸展部分20的直径。
在某些实施例中,框架构件52可包括线圈,所述线圈在第一位置处操作地连接到细长构件18。在这样的实施例中,第一部分和第二部分之间的相对反向旋转至少部分地退绕所述线圈并且对应于可伸展部分20的直径的增大。例如,当框架构件52为右手线圈或螺旋线时,近侧位置相对于远侧位置的顺时针旋转使可伸展部分20在收缩状态和伸展状态之间转变,而近侧位置相对于远侧位置的逆时针旋转使可伸展部分20从伸展状态转变到收缩状态。相似地,当框架构件52为左手线圈或螺旋线时,远侧位置相对于近侧位置的顺时针旋转使可伸展部分20从收缩状态转变到伸展状态,而远侧位置相对于近侧位置的逆时针旋转使可伸展部分20从伸展状态转变到更收缩状态。在类似实施例中,近侧位置和远侧位置之间的纵向距离也可调节。例如,近侧位置可朝远侧位置滑动,从而减小这两者之间的距离。在一个实施例中,一个或两个位置可通过螺纹围绕细长构件18旋转,使得所述位置的旋转增大或减小近侧位置和远侧位置之间的距离。在其它实施例中,一个或两个位置可沿细长构件18以能够卡入的方式或以能够滑动的方式定位。应当理解,线圈可在多个位置处旋转,使得沿可伸展部分20的长度的各种直径可调节以满足各种应用。
图18示出了包括盘式框架构件52的处于收缩状态的可伸展部分20的实施例。线圈在邻近远侧末端28的远侧联接器56处联接到细长构件18,使得可伸展部分20从收缩状态到伸展状态的转变包括远侧联接器56和框架构件52的近侧位置58之间的反向旋转,如图19所示。应当理解,线圈可朝近侧联接到护套40或相对于所述护套固定或以其它方式独立于远侧联接器56的旋转朝近侧固定。图19示出了图18所示的可伸展部分20的实施例,所述可伸展部分在远侧联接器56相对于线圈的近侧部分58的多次顺时针旋转之后处于伸展状态。根据该实施例,远侧联接器56相对于线圈的近侧部分58的逆时针旋转使可伸展部分20从伸展状态转变到不太收缩状态。图20示出了图18和图19所示的可伸展部分20的另一个实施例,并且包括通过减小可伸展部分20的长度来进一步增大所述可伸展部分的伸展度的方法。例如,临床医生可将细长构件18的一部分撤回到护套40内同时保持部署在其远侧端部的框架构件52的长度。这样,可伸展尺寸可进一步被定制成适合多种期望的应用中的任何一种。
图21示出了包括框架构件52的可伸展部分20,所述框架构件被取向成沿细长构件18的远侧部分延伸的管状编织物。可伸展部分20被示出为处于部分部署的位置并且处于收缩状态。编织物的近侧端部联接到近侧联接器54(以剖面图示出)。编织物的远侧端部联接到邻近远侧末端28的远侧联接器56。在该实施例中,近侧联接器54和远侧联接器56之间的相对移动使可伸展部分20在收缩状态和伸展状态之间转变。值得注意的是,在一些实施例中,可提供护套40,所述护套可在某些情况下至少部分地用作近侧联接器54。例如,如图22所示,当远侧联接器56相对于近侧联接器54朝近侧移动时,编织物被压缩。框架构件52的编织物取向还使得能够松开编织物,使得框架构件52在编织物内的各个重叠之间的距离响应于压缩应力而增大。由于所部署的编织物的长度不会减小到近侧联接器54和远侧联接器56之间的相对移动的程度,故可伸展部分20的尺寸(或在此情况下,直径)增大。作为另外一种选择,当近侧联接器54和远侧联接器56之间的相对移动导致相应联接器54,56之间的距离的增大时,框架构件52上的张力使编织物减压,从而使可伸展部分20的直径减小到不太伸展状态。在一些实施例中,从伸展状态到收缩状态的完全转变包括近侧联接器54和远侧联接器56之间的相对移动,所述相对移动增大这两个联接器之间的距离,使得施加到编织物的张应力足以使编织物收缩到预先确定的直径。
图23示出了图21和图22所示的可伸展部分20的另一个实施例,所述可伸展部分包括另外的特征结构以定制伸展度。在该实施例中,临床医生可通过调节近侧联接器54和远侧联接器54之间的距离选择性控制或选择可伸展部分20伸展的程度。如图可见,联接器54,56之间的距离的减小增大了可伸展部分20的直径,而联接器54,56之间的距离的增大减小了所述直径。这样,临床医生可有利地控制可伸展部分20的直径。此外,当提供可至少部分地用作近侧联接器54的护套40时,临床医生可通过下述方式来补偿所部署的可伸展部分20的长度的减小:部署也可被压缩以增大可伸展部分20的直径的另外的可伸展部分20(诸如框架构件52)。
如前所述,可采用一种或多种方法来实现包括框架构件50的近侧部分的第一可移动部分(诸如近侧联接器)和包括框架构件52的远侧部分的第二可移动部分(诸如远侧联接器)之间的相对移动。例如,在一些实施例中,临床医生可接合信号致动界面或第一部分和第二部分之间的相对移动。致动信号可触发通过机械元件和/或电元件实现的转变。在某些实施例中,致动器包括调控器,所述调控器能够手动地使框架构件52的部分和/或细长构件18的部分延伸或缩回。信号可导致联接器围绕带螺纹的轨道的旋转(如在例如图12中一样)或第一可移动部分相对于第二可移动部分的滑动(如在例如图14中一样)。细长构件18还可配有其中第一可移动部分和/或第二可移动部分可转变的纵向轨道或轨。在一些实施例中,介于第一可移动部分和第二可移动部分之间的细长构件18的中间跨度可通过伸缩地嵌套或折叠到邻近跨度中(如在例如图17中一样)来减小长度。细长构件18的中间跨度的长度的这种减小可由能够使中间跨度以可释放的方式延伸或缩回的偏置件辅助。在某些实施例中,框架构件52和/或细长构件18可配有能够使其部分相对移动的齿轮。
图24示出了根据各种实施例的处于伸展状态的可伸展部分20。可伸展部分20包括多个框架构件52,所述框架构件包括限定篮状物的热敏性形状记忆材料。框架构件52沿轴线延伸并且每个框架构件均包括线性部分27b,所述线性部分两侧有远侧渐缩部分27c和近侧渐缩部分27a。如图所示,每个框架构件52的近侧渐缩部分27a均以第一角度远离轴线分开,并且每个框架构件52的远侧渐缩部分27c均以第二角度朝轴线会聚。如图可见,伸展度随渐缩部分27a,27c的长度以及它们远离轴线的分开度和朝轴线的会聚度而变化。例如,增大渐缩部分27a,27c的长度增大可伸展部分20的直径。另外,伸展度随着分开度和会聚度接近90°而增大。在一些实施例中,这样的直径伸展还伴有可伸展部分20的长度减小。当可伸展部分20如图25所示处于收缩状态时,近侧渐缩部分27a、线性部分27b和远侧渐缩部分27c沿轴线相对线性延伸,使得可伸展部分20可由限定在护套40内的通道接收。
在图24和图25所示的实施例中,框架构件52呈现双向记忆。即,框架构件52包括至少两种记忆形式,并且可响应于温度变化而在所述至少两种记忆形式之间转变。在等于或低于低转变温度的温度下,框架构件52呈低温形式。在等于或高于高转变温度的温度下,框架构件52呈高温形式。根据期望的应用,低温形式可对应于伸展状态或收缩状态,并且高温形式可对应于伸展状态或收缩状态。临床医生可通过位于手柄上的致动器(未示出)用信号通知包括温度变化的转变。致动可导致向框架构件52传输足以升高框架构件52的温度并实现至高温形式的转变的能量,诸如振动。在一些实施例中,致动还可包括部署在生物环境中。例如,转变温度可设定成等于或低于生物温度,使得当框架构件52暴露于生物温度时,可伸展部分20经历转变。
在一些实施例中,不提供护套40并且电极21可在另一个递送装置内递送到目标区域。在一些这样的实施例中,电极21可赤裸(即,不在人造通道内)递送到目标区域。在这些和其它实施例中,电极21可通过将细长构件18推进穿过生物孔口或内腔递送到目标区域。一旦递送到目标区域,则电极21可响应于致动信号而伸展。图26所示的电消融装置12被配置用于使用和在人造递送通道内或赤裸递送到目标区域。装置12包括手柄14,导电细长构件18延伸穿过所述手柄。靠近手柄14的近侧端部,细长构件18包括连接器19,所述连接器用于将细长构件18连接到功率源(未示出)。细长构件18从手柄14的远侧端部朝远侧延伸并且包括沿其长度的远侧部分设置的电极21和远侧末端28。电极21包括可伸展部分20,所述可伸展部分包括多个框架构件52,所述框架构件被布置成类似于图24所示的实施例的篮状物。手柄14包括致动器31,所述致动器能够通过任何合适的方法使可伸展部分20在收缩状态和伸展状态之间转变。
在各种实施例中,细长构件18可沿其长度的全部或一部分为柔性的。此类柔性部分可为例如可弯曲的、可变形的或有弹性的。柔性部分还可为有条件柔性的或有条件刚性的。在一些实施例中,细长构件18包括柔性部分,所述柔性部分可以机械方式弯曲,使得细长构件18的部分可响应于信号而枢转或者可以其它方式调控。在一个实施例中,细长构件18包括可操纵部分,所述可操纵部分能够在生物内腔(诸如,例如血管、管腔、腔体、孔口或道区域)内操纵,并且将电极21递送到目标部位。在一个实施例中,心脏导管平台包括一个或多个电极21,所述电极沿柔性和/或可操纵细长构件18的远侧部分设置,所述细长构件能够将所述一个或多个电极21递送到心脏的室、血管或表面中,以心内消融例如用于治疗心房纤颤的位点。所述一个或多个电极21可在收缩状态和伸展状态之间选择性伸展。在一些实施例中,多个电极21沿细长构件18的远侧部分设置并且间隔开以在严格控制的电场内将能量递送到心脏组织。在一些这样的实施例中,沿细长构件18的远侧部分的电极21之间的距离可调节以匹配特定手术操作。
参见图27,图中示出了根据各种实施例的心脏导管平台。所述平台包括导管组件,所述组件包括沿细长构件18的远侧部分设置的电极21。所述平台还包括手柄14,所述手柄能够在至心脏中的成像期间操纵细长构件18和电极21,以心内消融作为治疗心房纤颤的位点或点。在所示实施例中,细长构件18配备有位于细长构件18的远侧端部处的长的绝缘末端28。末端28可能够有利地提高临床医生将细长构件18和电极21穿过、引导或导航至组织治疗区域的能力。在各种实施例中,心脏导管平台可包括可伸展部分20,所述可伸展部分包括与某些其它实施例相比相对增大的长度。增大的长度因使得临床医生能够更容易沿期望的消融灶行连接消融点而在某些治疗应用中可为有利的。在一些实施例中,可提供如前所述的包括可调节长度的可伸展部分20,以将可伸展部分20定制成灵活地适应特定外科应用。在一些实施例中,所述长度可在组织治疗部位处或附近方便地调节。这样的特征结构可因使得临床医生能够调节电极21的伸展长度以在手术操作期间自适应性地连接消融点而无需完全移除导管而有利地减少治疗时间。再次参见图27,包括所示心脏导管的系统还可包括第二电极22(未示出),所述电极能够联接到能量源(未示出)。第二电极22可为沿细长构件18的远侧部分设置的回路垫、针、夹具、第二探头、或第二电极。
图28A包括根据各种实施例的在消融治疗之后的消融区的照片。使用本文所述的血管内方法,将电极21放置在猪的肝管中并将包括回路的第二电极22放置在皮肤上。如图可见,在消融治疗之后,消融区80环绕血管。在所述回路的部位周围的组织处未观察到消融灶或灼伤。图28B包括根据各种实施例的在消融治疗之后的消融区80的照片。使用本文所述的血管内方法,将电极21设置在猪的肝血管中并将第二针状电极22放置到肝实质中。如图可见,在消融治疗之后,消融区80环绕血管。图29包括根据各种实施例的在消融治疗之后的心内消融区80的照片。使用本文所述的血管内方法,使电极21与猪的心脏组织接触。在消融治疗之后,观察到包括沿心脏组织的消融灶行的消融区80。
在各种实施例中,电消融装置12包括辅助特征结构,诸如光学器件、施用装置和传感器。例如,换能器或传感器可位于手柄14或末端28或其它合适的位置中,以感测例如使电极21伸展所需力。反馈信息可用于确定电极21是否已适当地定位于组织治疗部位处或附近的生物内腔内。手动致动可伸展部分20可相似地向临床医生提供关于使可伸展部分20完全伸展所需的力的反馈。这样,临床医生可决定可伸展部分20的完全伸展是不必要的或可以其它方式导致不必要的创伤并相应地调节伸展度。在某些实施例中,向临床医生提供反馈以物理感测电极21何时放置在组织治疗部位处或附近。在一些实施例中,由换能器或传感器提供的反馈信息可由位于能量源11内部或外部的电路处理和显示。可采用传感器读数,例如以确定电极21是否已适当定位于组织治疗部位处或附近,由此确保已在定位电极21时达到合适的误差范围。也可采用传感器读数,例如以确定是否需要调节脉冲参数以达到期望的结果,诸如(例如)降低患者体内的肌肉收缩的强度。
在一个实施例中,电消融装置12包括辅助特征结构,所述结构包括电解质施用装置。电解质施用装置可能够在组织治疗部位处或附近施加或递送外源电解质。电解质施用装置可包括递送部分和贮存部分。在一些情况下,递送部分可包括贮存部分。贮存部分可被配置为容纳用于递送的电解质。递送部分可被配置为在组织治疗部位处或附近递送电解质。在一些实施例中,递送部分包括邻近细长构件18或护套40或在所述细长构件或护套内的通道。在一个实施例中,递送部分包括末端28。临床医生可致动位于手柄14上的致动器,例如以从递送部分递送电解质。在某些实施例中,递送部分可独立于电极21从内腔或人造通道部署。在一些实施例中,递送部分、贮存部分或电解质施用装置可与电消融系统10分开。在各种实施例中,电解质施用装置的递送部分可在治疗之前或期间对治疗区域施加水性电解质溶液以增加传导性。然而,在其它实施例中,可不添加溶液或者可将单独的或相同的辅助特征结构配置成对治疗区域施加吸力,以例如在治疗之前或期间移除流体。
在某些实施例中,温度传感器和压力传感器中的至少一个可位于电消融系统10中或附近。温度传感器和/或压力传感器可位于手柄14、保护套38、护套40、细长构件18内,位于细长构件18的远侧端部(诸如末端28)处,或位于一个或多个电极21内。在某些实施例中,温度传感器和/或压力传感器可与电消融系统10分开。温度传感器和压力传感器可向操作者、外科医生或临床医生提供反馈以对不良组织施加电场脉冲。压力传感器和/或温度信息可用于确定是否可治疗不良组织而对周围健康组织具有减少的有害热效应或毫无有害热效应。根据某些实施例,温度传感器可在治疗之前、期间和/或之后(诸如在将第一电脉冲序列和/或第二电脉冲序列递送到组织之前和/或之后)测量组织治疗区域、不良组织或环绕一个或多个电极的区域的温度。根据某些实施例,压力传感器可在治疗之前、期间和/或之后(诸如在将第一电脉冲序列和/或第二电脉冲序列递送到组织之前和/或之后)测量组织治疗区域、电极之间的空间和/或环绕一个或多个电极的区域的压力。
电消融系统10可用于消融脆弱区中或关键结构附近的不良组织,并且通过生物内腔(诸如血管、管腔或道区域)部署。电消融系统10可能够使用电能来治疗组织治疗区域中的多个消融灶和骨病理,包括转移性消融灶、肿瘤、骨折、感染部位和炎症部位。电消融装置12可能够定位于患者的自然身体孔口(例如,嘴、肛门和阴道)内,和/或推进穿过内部身体内腔或腔体(例如,食道、胃、肠、结肠、子宫颈和尿道),以到达组织治疗区域。例如,细长构件18可能够使用套管针定位并穿过形成穿过患者的皮肤或腹壁的小切口或键孔,以到达组织治疗区域。组织治疗区域可位于患者的脑、肺、乳房、肝脏、胆囊、胰腺、前列腺、由食道、胃、肠、结肠、动脉、静脉、肛门、阴道、子宫颈、输卵管限定的各种内部身体内腔、以及腹膜内腔中。电消融系统10可经由小切口或键孔、经皮技术、透皮技术、和/或外部非侵入式技术、以及它们的任何组合与内窥镜、腹腔镜、胸腔镜、开放式外科手术结合使用。
在一个实施例中,电消融装置12可与人造通道(例如,柔性内窥镜、以及刚性内窥镜、腹腔镜或胸腔镜,诸如可得自Olympus公司的GIF-100型)结合使用。在一个实施例中,内窥镜可结合套管针以下述方式引导至组织治疗区域:透过肛门穿过结肠、透过口腔穿过食道和胃、透过阴道穿过子宫颈、透过皮肤、或经由在腹腔中形成的外部切口或键孔。电极21由此可经由插入递送到组织治疗区域并使用内窥镜引导到组织治疗区域中或附近。这样的递送也可使用其它各种人造通道来实现。内窥镜或其它人造通道可限定一个或多个通道,所述通道用于接收另外的装置,诸如光源和观察口。观察口视野内的图像可由包括通常位于内窥镜内的电荷耦合装置(CCD)的光学装置(诸如(例如)照相机)接收,并且传输到患者体外的显示监视器(未示出)。在其它实施例中,不使用内窥镜,并且电消融装置12包括例如光源和/或观察口。但是另外的实施例采用其它技术来确定适当的器械放置,诸如,例如超声波或计算机层析成像(CT)扫描。
根据一个实施例,电消融组织的方法包括将第一电极21递送到组织治疗区域。第一电极21可能够联接到能量源并且联接到位于内腔内或附近的组织治疗区域。在一个实施例中,第一电极21通过中空镗孔(诸如人造通道)递送或引导到组织治疗区域处或附近的内腔中。第一电极21随后可部署在组织治疗部位处或附近。一旦被部署,则第一电极21的可伸展部分20可在至少一个维度(例如,直径或长度)上伸展并随后与内腔壁接触。第二电极22可联接到第一电极21和患者,使得第二电极22通过患者与第一电极21导电通信,并且呈现相对于第一电极21的电势差。例如,在一些实施例中,第二电极22可为与患者接触或导电通信的接地或回路垫、针状电极或医疗夹具。在各种实施例中,第二电极22可为单独放置的电极(诸如,例如导电材料、回路垫、针或夹具),可位于附近的或邻近的组织、表面或内腔处。一旦递送到组织治疗区域,则第一电极21可致动(例如,部署、伸展和通电)以消融不良组织。
在一些实施例中,使第一电极21的可伸展部分20伸展包括使可伸展部分20从收缩状态转变到伸展状态。使电极21从收缩状态转变到伸展状态可包括增大电极21的至少一个维度。在某些实施例中,当可伸展部分20从收缩状态转变到伸展状态时,可伸展部分20的直径按比例减小长度。然而,在其它实施例中,可伸展部分20的直径不与长度减小成比例地伸展。
在一些实施例中,第一电极21能够在收缩状态和伸展状态之间交替或选择性转变。在某些实施例中,从收缩状态到伸展状态的转变包括框架或框架构件52的两个部分之间的相对移动。相对移动可为旋转的或纵向的。例如,框架50或框架构件52的两个部分之间的距离的减小可使可伸展部分20从收缩状态转变到伸展状态。相对移动可导致一个或多个框架构件52由轴线向外延伸。向外延伸可为一个或多个框架构件52的翘曲的结果。由轴线向外延伸的框架构件52可相似地由轴线向外支撑、延伸或以其它方式重新定位其它框架构件52。框架构件52的各种记忆材料和取向可用于帮助使可伸展部分20在收缩状态和伸展状态之间转变。例如,框架构件52可被布置为弹簧、线圈、编织物、多构件篮状物、伞和可注入腔体并且可包括刚性、接缝或记忆材料,包括形状设定记忆超弹性材料。例如,框架构件52可包括金属、合金、像胶、塑料、聚合物、以及各种导电材料。
在各种实施例中,使电极伸展包括使可伸展部分的直径或半径伸展达处于收缩状态的电极的直径或半径的许多倍。根据期望的应用,电极可在直径或半径上伸展达2倍、5倍、10倍、20倍、40倍或更多倍,以伸展到匹配包括生物内腔(诸如,例如喉头)的组织治疗区域的直径的直径。在各种实施例中,第一电极的直径可不同于第二电极的直径。相似地,在一些实施例中,第一电极可具有不同于第二电极的长度。再次,根据期望的应用,这样的变型被设想出并且被认为在本发明范围内。如应当理解,当多个电极沿细长构件的远侧部分设置时,电极之间的各种间距也可为可取的。在一些这样的实施例中,从第一电极到第二电极的距离可从0.5cm调节到3cm,诸如,例如1cm、1.5cm、2.0cm、和3cm。然而,在其它应用中,可能需要显著增大第一电极和第二电极之间的距离,以例如根据特定应用定制电场的大小。
可根据上述方法中的任一方法引入、递送、部署电极21、或使其伸展,并且随后使其与内腔壁接触。与内腔壁的接触优选地为至少部分周边的。然后可以各种脉冲功率输出来施加电流,诸如(例如)单相方波、双相方波、RF调制高压、或纳秒脉冲持续时间。可针对期望的应用和临床目标来定制所施加的电流和波形以提供各种组织效应,诸如细胞裂解、细胞凋亡、或不可逆电穿孔。
图30为根据各种实施例的电消融系统和装置的代表性使用。细长构件18采用本文所公开的方法将可伸展部分20递送到包括内腔82(例如,肝静脉)的组织区域。细长构件18'的替代递送布置还由虚线轮廓指示。可伸展部分20然后从护套40的远侧端部部署至目标部位(例如,环绕肝静脉的肿瘤)。一旦被部署,则可伸展部分20伸展,例如从收缩状态转变到伸展状态。在图30中,在治疗(未示出)之前将盐水溶液引入到内腔中以提高导电率。然后使可伸展部分20与内腔壁接触并且应用消融治疗。图30示出了在这样的治疗之后的经消融的细胞的消融区80。如在该图中可见,在一些实施例中,内腔中的可伸展部分20的尺寸可确定所述区的大小。
虽然文中结合某些公开的实施例对装置的多种实施例作了描述,但这些实施例的许多修改和变型也可被实现。例如,可采用不同类型的端部执行器,诸如末端、电极和细长构件。另外,在公开了用于某些部件的材料的情况下,均可使用其他材料。上述描述和以下权利要求旨在涵盖所有此类修改和变型。
以引用方式全文或部分地并入本文的任何专利、专利公开或其它公开材料均仅在所并入的材料不与本发明所述的现有定义、陈述或其它公开材料相冲突的范围内并入本文。由此,在必要程度下,本文所明确阐述的公开内容将会取代以引用的方式并入本文中的任何相冲突的材料。如果据述以引用的方式并入本文但与本文所述现有定义、陈述或者其它公开材料相冲突的任何材料或其部分,仅在所并入的材料与现有公开材料之间不产生冲突的程度下并入本文。
Claims (20)
1.一种电消融装置,包括:
细长构件;
第一电极,所述第一电极沿所述细长构件设置并且沿轴线延伸,所述第一电极具有近侧端部和表面,所述近侧端部能够联接到能量源,所述表面能够联接到组织治疗区域并施加消融能量;
第一可伸展部分,所述第一可伸展部分具有近侧端部和远侧端部并且沿所述轴线延伸,所述第一可伸展部分限定所述第一电极的第一周边并且具有相对于所述轴线的相关联第一直径,其中所述第一可伸展部分包括第一框架,所述第一框架包括至少一个第一框架构件;和
所述第一框架能够选择性伸展以使所述第一可伸展部分从收缩状态转变到伸展状态,并且所述第一框架能够选择性收缩以使所述第一可伸展部分从所述伸展状态转变到所述收缩状态,其中当所述第一框架伸展时,所述第一直径伸展并且所述第一可伸展部分从所述收缩状态转变到所述伸展状态,并且其中当所述第一框架收缩时,所述第一直径收缩并且所述第一可伸展部分从所述伸展状态转变到所述收缩状态。
2.根据权利要求1所述的电消融装置,其中所述第一电极包括第一柔性部分,并且其中所述第一可伸展部分的至少一部分包括所述第一柔性部分的至少一部分。
3.根据权利要求1所述的电消融装置,其中所述第一框架能够伸展以使所述第一直径伸展成在围绕生物内腔的圆周的两个或更多个位置处周向接触生物内腔。
4.根据权利要求1所述的电消融装置,其中一个或多个第一框架构件具有相关联记忆形式和相关联保持形式,并且其中所述一个或多个第一框架构件能够在所述记忆形式和所述保持形式之间转变,以使所述第一框架伸展和收缩。
5.根据权利要求4所述的电消融装置,还包括保持结构,所述保持结构能够使所述一个或多个第一框架构件保持呈所述保持形式。
6.根据权利要求5所述的电消融装置,其中所述保持结构包括限定通道的护套,所述通道能够在其远侧部分内接收一个或多个第一框架构件,其中所述一个或多个第一框架构件能够从所述护套的所述远侧部分的远侧端部部署,其中所述一个或多个第一框架构件当从所述护套的所述远侧端部部署时从所述保持形式转变到所述记忆形式,并且其中所述保持形式对应于所述收缩状态并且所述记忆形式对应于所述伸展状态。
7.根据权利要求6所述的电消融装置,其中所述一个或多个第一框架构件包括编织物,其中所述编织物在所述可伸展部分的所述近侧端部和所述远侧端部之间延伸,其中所述可伸展部分能够当所述编织物从所述护套的所述远侧端部部署时从所述收缩状态转变到所述伸展状态,并且其中所述第一框架的长度在所述收缩状态下比在所述伸展状态下大。
8.根据权利要求1所述的电消融装置,其中所述第一框架在所述第一可伸展部分内限定腔体,所述腔体具有当所述第一可伸展部分处于所述收缩状态时的第一相关联容积和当所述第一可伸展部分处于所述伸展状态时的第二相关联容积,其中所述第一容积基本上与所述第二容积相同。
9.根据权利要求1所述的电消融装置,其中一个或多个第一框架构件能够在相关联低温形式和相关联高温形式之间转变,所述低温形式对应于所述收缩状态并且所述高温形式对应于所述伸展状态,其中所述可伸展部分从所述收缩状态到所述伸展状态的转变包括足以使所述一个或多个第一框架构件从所述低温形式转变到所述高温形式的温度的升高。
10.根据权利要求1所述的电消融装置,其中所述第一框架还包括近侧联接器和远侧联接器,所述近侧联接器和所述远侧联接器能够联接所述第一框架内的一个或多个第一框架构件,其中所述近侧联接器和所述远侧联接器分开一段距离,并且其中从所述收缩状态到所述伸展状态的转变包括所述近侧联接器和所述远侧联接器之间的所述距离的减小。
11.根据权利要求10所述的电消融装置,其中所述近侧联接器和所述远侧联接器之间的所述距离的减小使所述一个或多个第一框架构件之一的至少一部分由所述轴线向外枢转。
12.根据权利要求10所述的电消融装置,其中所述一个或多个第一框架构件包括在所述近侧联接器和所述远侧联接器之间延伸的编织物,其中所述近侧联接器联接到所述编织物的近侧部分并且所述远侧联接器联接到所述编织物的远侧部分。
13.根据权利要求1所述的电消融装置,其中从所述收缩状态到所述伸展状态的转变包括一个或多个第一框架构件的近侧部分和远侧部分之间的相对旋转。
14.根据权利要求13所述的电消融装置,其中所述一个或多个第一框架构件包括线圈,其中所述第一框架还包括近侧联接器和远侧联接器,所述近侧联接器联接到所述线圈的近侧部分,所述远侧联接器联接到所述线圈的远侧部分,其中所述近侧联接器和所述远侧联接器分开一段距离,并且其中从所述收缩状态到所述伸展状态的转变还包括所述近侧联接器和所述远侧联接器之间的所述距离的减小。
15.根据权利要求1所述的电消融装置,还包括:
第二电极,所述第二电极沿所述细长构件设置并且沿所述轴线延伸,所述第二电极具有近侧端部和表面,该近侧端部能够联接到能量源,该表面能够联接到所述组织治疗区域;
第二可伸展部分,所述第二可伸展部分具有近侧端部和远侧端部并且沿所述轴线延伸,所述第二可伸展部分限定所述第二电极的第二周边并且具有相对于所述轴线的相关联第二直径,其中所述第二可伸展部分包括第二框架,所述第二框架包括一个或多个第二框架构件;和
所述第二框架能够选择性伸展以使所述第二可伸展部分从收缩状态转变到伸展状态,并且所述第二框架能够选择性收缩以使所述第二可伸展部分从所述伸展状态转变到所述收缩状态,其中当所述第二框架伸展时,所述第二直径伸展并且所述第二可伸展部分从所述收缩状态转变到所述伸展状态,并且其中当所述第二框架收缩时,所述第二直径收缩并且所述第二可伸展部分从所述伸展状态转变到所述收缩状态。
16.根据权利要求15所述的电消融装置,其中所述第一电极和所述第二电极沿所述细长构件分开一段距离,并且其中所述第一电极和所述第二电极之间的所述距离能够选择性调节。
17.一种电外科治疗组织的方法,包括:
获得根据权利要求1所述的装置;
将所述第一电极递送到包括生物内腔的组织治疗区域;
使所述第一电极伸展;
使所述第一电极与待治疗组织近侧的所述内腔的壁接触;以及
通过下述方式来治疗组织:使用所述第一电极,对待治疗的所述组织施加足以通过不可逆电穿孔诱导所述组织中的细胞死亡的一个或多个电脉冲序列。
18.根据权利要求17所述的电外科治疗组织的方法,其中所述框架构件包括沿所述可伸展部分延伸的线圈,并且其中治疗组织还包括使所述线圈在所述内腔内沿第一方向旋转以连续治疗整个内腔。
19.一种包括可伸展电极的电消融装置,所述可伸展电极沿轴线延伸并且具有近侧端部和表面,所述近侧端部能够联接到能量源,所述表面能够联接到组织治疗区域并施加消融能量,所述可伸展电极包括:
可伸展部分,所述可伸展部分限定周边,所述周边具有围绕所述轴线的相关联直径,其中所述可伸展部分能够在收缩状态和伸展状态之间转变,并且其中所述直径当所述可伸展部分从所述收缩状态转变到所述伸展状态时增大,并且其中所述直径当所述可伸展部分从所述伸展状态转变到所述收缩状态时减小;和
一个或多个框架构件,所述一个或多个框架构件沿所述可伸展部分设置,其中所述一个或多个框架构件中的至少一个包括形状记忆弹性体,其中所述一个或多个框架构件中的所述至少一个能够由保持结构保持呈与所述可伸展部分的所述收缩状态相关联的马氏体形态,并且其中在奥氏体温度下,所述一个或多个框架构件中的所述至少一个当由所述保持结构释放时能够恢复到与所述可伸展部分的所述伸展状态相关联的奥氏体形态。
20.根据权利要求19所述的可伸展电极,其中所述保持结构包括护套,所述护套限定通道,所述通道能够在其远侧部分内接收所述一个或多个框架构件中的所述至少一个,其中所述一个或多个框架构件中的所述至少一个能够从所述护套的所述远侧部分部署,并且其中所述一个或多个框架构件中的所述至少一个当从所述护套的所述远侧部分部署时由所述保持结构释放。
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WO2014022221A1 (en) | 2014-02-06 |
BR112015002311B1 (pt) | 2022-05-03 |
BR112015002311A2 (pt) | 2017-07-04 |
JP6377613B2 (ja) | 2018-08-22 |
EP2879606A1 (en) | 2015-06-10 |
IN2015DN00815A (zh) | 2015-06-12 |
CN104703557B (zh) | 2018-11-16 |
JP2015524310A (ja) | 2015-08-24 |
US20140039491A1 (en) | 2014-02-06 |
US10314649B2 (en) | 2019-06-11 |
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