CN104869930A - 肾神经调制装置和方法 - Google Patents
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Abstract
本发明公开了用于神经和组织调制的系统。一种实例系统可包括血管内神经调制系统,其包括具有近端区和远端区的细长轴。所述系统可进一步包括一个或多个被附至所述细长轴的所述远端区的消融电极。可设置一个或多个接地垫电极并将其连接至处理器,所述处理器被配置成调制在所述消融电极和所述接地垫之间所完成的每个电路的阻抗。
Description
相关申请的交叉参考
本申请根据美国法典第35编第119条要求于2012年10月10日提交的序列号为61/712,138的美国临时申请的优先权,其整个内容以引用方式并入本文。
技术领域
本发明涉及医疗器械以及制造和使用医疗器械的方法。更具体地,本发明涉及进行肾神经调制的医疗器械和方法。
背景技术
某些治疗需要临时或永久中断或修改选择的神经功能。一种实例治疗为肾神经消融,其有时用于治疗与充血性心力衰竭或高血压相关的状况。肾脏对充血性心力衰竭产生交感神经响应,除了别的影响以外,其增加了对水和/或钠的不需要的保留。对延伸至肾脏的一些神经的消融可减少或消除这种交感神经功能,其可相应地减少相关联的不想要的症状。
许多神经,包括肾神经,沿血管壁或紧靠血管延伸且因此可经血管接触。在一些情况下,可能需要使用射频能量来消融血管周围的肾神经。在所有电路中,使用电阻最小的路径完成电路。在涉及身体的射频消融电路中,电阻最小的路径通常是通过肌肉的。由于肌肉的阻抗比结缔组织低,因此如果同时存在有结缔、脂肪和肌肉组织,那么产生不一致损伤的倾向则可能会更大。在这种情况下,根据组织的存在和类型,所产生的损伤可能具有更小或更大的深度。此外,可能会发生肠或腰肌烧伤。可能需要提供用于减少意外的损伤和改善在可变身体结构中损伤一致性的替代系统和方法。
发明内容
本发明是针对医疗器械结构和总成的几种替代设计、材料和用途替代方案。一种实例用途可包括一种用于进行血管内肾神经调制的方法。该方法可包括提供一种神经调制系统,其包括具有近端区和远端区的细长轴以及一个或多个位于邻近细长轴的远端区处的消融电极。该系统也可包括两个或更多的接地垫、电耦合至一个或多个消融电极的控制单元以及电耦合至两个或更多的接地垫的处理器。调制系统可推进通过内腔,从而使远端区邻近目标区。然后,可向一个或多个消融电极施加电压,其中能量在一个或多个消融电极和两个或更多的接地垫之间流动以形成各个电路。在接地垫和消融电极之间形成的电路中的至少一个的电阻也可进行调整。
一种实例医疗器械可包括血管内神经调制系统。神经调制系统可包括具有近端区和远端区的细长轴以及位于邻近细长轴的远端区处的消融电极。该系统也可包括至少两个接地垫、电耦合至一个或多个消融电极的控制单元以及电耦合至两个或更多接地垫的处理器。
上面有关一些实例实施例的概述并不旨在描述本发明的每个所公开的实施例或每个实施方式。下面的附图及具体实施方式更具体地举例说明了这些实施例。
附图说明
结合附图考虑下面有关各种实施例的详细描述可更完全地理解本发明,其中:
图1为示出一种肾神经调制系统就位的示意图;
图2为示出一种肾神经调制系统就位的另一个示意图;以及
图3为示出一种肾神经调制系统就位的另一个示意图;
虽然本发明可被修改成各种改型和替代形式,但是在附图中以示例方式已示出细节并将进行详细描述。然而,应理解的是本发明并不旨在将本发明的各方面限制于所述的特定实施例。相反地,本发明旨在涵盖落在本发明的精神和范围内的所有修改、等同物和替代方案。
具体实施方式
对于下面定义的术语而言,这些定义应是适用的,除非在权利要求中或本说明书的其他地方给出了不同的定义。
在本文中,不论是否明确指出,所有数值都被假定为可用术语“大约”进行修饰。术语“大约”通常是指本领域的技术人员将认为等同于所记载的值的一个范围内的值(即,具有相同功能或结果)。在许多情况下,术语“大约”可以表示为包括被四舍五入至最近的有效数字的数值。
经端点表述的数值范围包括在该范围中的所有数字(例如,1至5包括1、1.5、2、2.75、3、3.80、4和5)。
尽管公开了属于各种组件、特性和/或规格的一些合适的尺寸范围和/或数值,但受本发明的驱使,本领域的技术人员将理解所需的尺寸、范围和/或数值可能偏离所明确公开的那些。
如在本说明书和所附权利要求中所使用的,单数形式“一”、“一个”以及“该(所述)”包括复数对象,除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外。
出于本发明的目的,“近侧”指在使用中较接近于装置操作员的一端,且“远侧”指在使用中距离装置操作员较远的一端。
应参照附图阅读下面的详细描述,其中在不同的附图中相似的元件具有相同的编号。详细描述和不一定是按比例绘制的附图描述了说明性实施例且不旨在限制本发明的范围。所描绘的说明性实施例仅仅是示例性的。任何说明性实施例的选定特性可被并入其他的实施例中,除非明确说明与此相反以外。
某些治疗需要临时或永久中断或修改选择的神经功能。一种实例治疗为肾神经消融,其有时用于治疗与充血性心力衰竭或高血压相关的状况。肾脏对充血性心力衰竭产生交感神经响应,除了别的影响以外,其增加了对水和/或钠的不需要的保留。对延伸至肾脏的一些神经的消融可减少或消除这种交感神经功能,其可相应地减少相关联的不想要的症状。
虽然本文所述的装置和方法是关于肾神经调制而进行讨论的,可以预期的是装置和方法也可用于其他治疗位置和/或应用中,其中需要神经调制和/或其他组织调制包括加热、活化、阻断、中断或消融,例如但不限于:血管、尿管或在经套管针和插管接触的其他组织。例如,本文所述的装置和方法可被应用至增生组织消融、肿瘤消融、良性前列腺增生疗法、神经激发或阻断或消融、肌肉活动力的调制、组织的热疗或其他加温等。在一些情况下,可能需要使用射频能量来消融血管周围的肾神经。
虽然本文所述的装置和方法是关于通过血管壁的肾神经调制而进行讨论的,但可以预期的是装置和方法也可用于其他需要神经调制和/或消融的应用中。术语调制是指可改变受影响的神经的功能的消融和其他技术。
在所有电路中,使用电阻最小的路径完成电路。在涉及身体的射频消融电路中,电阻最小的路径通常是通过肌肉的。由于肌肉的阻抗比结缔组织低,因此如果同时存在有结缔、脂肪和肌肉组织,那么产生不一致损伤(lesions)的倾向则可能会更大。在这种情况下,根据组织的存在和类型,所产生的损伤可能具有更小或更大的深度。此外,可能会发生肠或腰肌烧伤。
图1为示出一种肾神经调制系统10就位(in situ)的示意图。系统10可包括元件12,其用于将电力提供至被布置在中央细长轴14周围和/或其中且可选地位于护套16内的神经调制元件。元件12的近端可被连接至控制和电力元件18,其供给必需的电能以激活位于元件12远端或接近远端的一个或多个调制元件或电极。当适当地进行激活时,电极能够消融组织。术语电极可被认为是等同于能够消融邻近组织的元件。在一些情况下,一个或多个返回电极贴片22a、22b、22c和22d(统称为22a-d)可设置在腿上或患者身体的另一个常规位置上以完成电路。控制和电力元件18可包括用于监控参数,如功率、温度、电压、脉冲大小和/或形状和其他合适的参数,以及用于进行所需过程的合适控制。在一些情况下,电力元件18可控制控制射频(RF)消融电极和/或一个或多个感测电极。可以预期的是也可设置一个以上的电力元件18。消融电极可被配置成在约为460kHz的频率上运行。可以预期的是可使用在RF范围内的任何所需的频率,例如100-500kHz。然而,可以预期的是可按照需要使用RF频谱外的不同类型的能量,例如但不限于用于进行消融的超声波、微波和激光。虽然本文中使用了术语消融电极,但可以预期的是可根据用于进行消融的能量选择调制元件和调制频率。例如,当使用超声波能量时,超声波换能器可被选择作为调制元件且调制频率可位于MHz范围内。
细长轴14可从近端24向远端延伸至远端,其中远端被配置成在体腔内被推进至所需的治疗区。细长轴14的近端24可包括附至其上的毂(未明确示出),其用于连接其他治疗装置或提供端口以便进行其他治疗。可以预期的是可修改细长轴14的刚性以形成调制系统10,从而用于各种脉管直径以及血管树中的各个位置上。为此,用于制造细长轴14的材料可包括任何合适的生物相容性材料,例如但不限于聚合物、金属和合金,其可以进行组合或单独使用。所使用的材料可具有足够的刚性以用于各种内腔直径中,且可具有足够的柔韧性以操纵通过曲折和/或狭窄的内腔,从而避免任何不想要的组织损伤。
细长轴14可进一步包括延伸通过其的一个或多个内腔。例如,细长轴14可包括导丝腔和/或一个或多个辅助腔。可按本领域已知的任何方式配置内腔。例如,导丝腔可延伸细长轴14的整个长度,如在导丝上的(over-the-wire)导管中,或可沿细长轴14的远端部分延伸,如在单人交换(single operator exchange,SOE)型导管中。这些实例并不旨在限制而是作为一些可能构造的实例。虽然未明确示出,但调制系统10可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定导丝尖端、导丝腔、外部护套和/或其他组件以便在脉管系统中使用和推进系统10。
虽然未明确示出,但调制系统10可包括一个或多个被布置在细长轴14的外表面上邻近远端区的消融电极。然而,消融电极可按照需要被置于沿细长轴14的任何纵向位置上。可进一步预期的是,在一些实施例中,调制系统10可包括一个或多个定位元件,如可膨胀球囊或可扩张的篮状物,其位于邻近细长轴14的远端处以协助对一个或多个电极的定向。在一些情况下,消融电极可位于一个或多个定位元件的表面上。可以预期的是消融电极可位于可膨胀球囊的外表面上或可扩张的篮状物的框架上。在其他情况下,消融电极可位于可膨胀球囊内,如位于延伸通过的细长轴上的或位于内表面上。
可以预期的是调制系统10可按照需要包括任何数量的消融电极,如但不限于一个、两个、三个、四个或更多。如果设有多个消融电极,按照需要消融电极可沿纵向、径向和/或周向间隔。在一些情况下,消融电极可以是围绕细长轴14的外周延伸的圆周电极。圆周电极可允许进行圆周消融且同时减少和/或消除对电极和/或细长轴14进行圆周重新定位的需要。在一些实施例中,消融电极可能并非一直围绕细长轴14的外周延伸。可以预期的是多个消融电极可绕细长轴14的外周周向定位以减少和/或消除沿圆周重新定位细长轴14以进行360°消融的需要。
消融电极可通过绝缘电导体,如图1中所示的元件12而被连接至控制单元18。一旦已将调制系统10推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及从系统10获得的反馈确定被传送至消融电极的能量的量。可基于组织的阻抗对消融的功率水平和持续时间进行相应的调整。例如,较多的能量可能导致更大和更深的损伤。随着向消融电极施加电压,电流可通过紧邻治疗区的组织以及位于治疗区和皮肤之间的其他的身体组织并到达皮肤接触的接地垫22a-d。虽然接地垫22a-d被示为位于身体的单侧上(后侧或前侧),但可以预期的是接地垫也可按照需要位于身体的一侧或两侧。虽然所示的系统10包括四个接地垫22a-d,但可以预期的是按照需要可具有少于四个或多于四个的接地垫。在一些情况下,可以预期的是系统10可包括八个或更多的接地垫。例如,在一些实施例中,系统10可包括四个位于身体后侧的接地垫以及四个位于身体前侧的接地垫。接地垫可均匀地分布在所需治疗区的周围。在一些情况下,两个接地垫可置于前侧的上半身上且两个接地垫可置于前侧的下半身上。同样地,两个接地垫可置于后侧的上半身上且两个接地垫可置于后侧的下半身上。然而,这种布置仅是示例性的。可以预期的是可按任何合适的方式布置任何数量的接地垫以用于所需的治疗。
除了肌肉血管壁外,身体组织可包括外膜和结缔组织、神经、脂肪、流体等。每个垫22a、22b、22c和22d可具有给定的阻抗以完成电路且每个垫的阻抗可根据存在于治疗区和接地(垫)的位置之间的组织类型而为不同的。每个接地垫22a、22b、22c和22d可通过单独的电导体26a、26b、26c和26d而被连接至处理器或处理单元20的各个通道。在一些情况下,处理器20可经接地通道输出28被电连接至电力单元18或以其他方式与其相连通。由于每个垫22a、22b、22c和22d均可被单独地连接至处理器20的通道中的独立接地处,因此电连接26a、26b、26c和26d的电阻可单独地进行调整。例如,可以预期的是每个通道可包括用于各自调整各个单独电路的独立可变电阻器。可以预期的是处理器20可按照需要包括任何数量的通道,从而可个别地调整在处理器20和接地垫22a-d之间的电连接。
如上面所指出的,每个接地垫22a、22b、22c和22d可具有某个阻抗以完成电路(例如,位于被布置在体内的消融电极和位于身体的外表面上的接地垫之间的路径)。由于电流是沿着最小电阻的路径流动的,因此可以预期的是电流将优先在消融电极和具有最小阻抗量的接地垫之间行进以完成电路。就这点而言,可能会出现不一致或意外的损伤。这可能会因患者的不同而导致治疗位置之间的病变大小和深度的变化。可以预期的是,一旦连接上,处理器20则可使所有电路的阻抗增加至同一水平,从而使电流均匀地分布在消融电极和接地垫22a-d之间。在下面的表1中给出了说明性而非限制性的实例。为每个接地垫给出的阻抗仅仅是示例性的且并不旨在以任何方式进行限制或指示治疗区和垫的所示位置之间的实际阻抗。
表1
阻抗(初始) | 阻抗(处理后) | |
垫1(22a) | 97Ω | 145Ω |
垫2(22b) | 145Ω | 145Ω |
垫3(22c) | 123Ω | 145Ω |
垫4(22d) | 111Ω | 145Ω |
在“阻抗(初始)”列中的值为当其可自然存在时的阻抗值,而在“阻抗(处理后)”列中的值则为处理器20已调整各个电路的阻抗后的阻抗值。可以看出,在处理前,在每个接地垫22a、22b、22c和22d和消融电极之间的阻抗对于每个接地垫22a、22b、22c和22d都不同。可以预期的是,在不进行任何调整的情况下,最低阻抗的路径(例如,在该实例中,其位于焊垫22a和消融电极之间)可在垫22a的方向上牵引电流。然而,处理器20可用于增加垫22a、22c和22d的电路阻抗以使其等于垫22b的阻抗。可以预期的是处理器20可通过改变在接地垫和处理器20之间的电阻而电子性地增加电路的阻抗,从而使电流均匀地分布在消融电极和接地垫22a-d之间。
例如,能量可从消融电极沿球面行进。在一些情况下,处理器20可使用一些可变电阻器以增加电路的阻抗。可进一步预期的是可通过重新定位接地垫22a、22b、22c和22d而进一步地操纵电路阻抗。在一些情况下,接地垫22a-d可策略性地位于患者身体上以控制电流的流动方向。由于电流的路径可基于电路的阻抗、接地垫22a-d的位置或接地垫22a-d的阻抗和位置的组合而进行操纵,因此可更容易地控制病变的大小和形状,从而减少和/或消除意外的损伤。
在一些实施例中,处理器20可在施加电力前和/或在消融过程中自动平衡和/或调整电路的阻抗。可以预期的是,在一些情况下,一旦已将电力施加至消融电极,则将不允许自动调整阻抗。然而,在消融过程中可监控在消融电极和接地垫22a-d之间的阻抗。可以预期的是调制系统10可包括为消融过程的变量设置点极限值,如但不限于功率和温度。例如,在一些情况下,通过电力单元18供给的电力可能不会超过预定阈值和/或电力单元可包括用于保持目标区的温度超过预定的阈值温度的控制算法。
可进一步预期的是利用通过单个电源供电的多个消融电极的调制系统10可能经历每个消融或有源电极(active electrode)的阻抗变化。这种消融电极的阻抗变化可能导致损伤的大小和/或距离每个电极的深度的变化。提供每一个均具有调制阻抗的多个接地位置,如接地垫22a-d,可更均匀地牵引通过每个消融电极的电流/电力。例如,能量可从消融电极沿球面行进。操纵电流路径可减少损伤大小和深度的变化,从而在治疗位置产生更一致的损伤。
在一些实施例中,当在元件12的远端或远端附近设有多个有源或消融电极时,系统10可在双极模式下运行。在这种情况下,被布置在治疗位置的两个(或更多的)电极可具有180°的相位差,从而使一个电极充当接地电极(例如,一个阴极和一个阳极)。可以预期的是处理器20可按与上述相类似的方式在施加电力前自动平衡和/或调整电路的阻抗。例如,必要时,处理器20可通过改变在充当接地电极的有源电极和处理器20之间的电阻而电子性地增加电路的阻抗,从而使电流均匀地分布在消融电极和接地电极之间。
可按本领域中任何已知的方式推进调制系统10通过脉管系统。例如,系统10可包括导丝腔以允许在先前定位的导丝上方推进系统10。在一些实施例中,可在引导护套,如护套16内推进或部分推进调制系统10。一旦调制系统10的消融电极已被置于邻近所需的治疗区处,则可布置定位机构,如定心篮状物(如果设有该定心篮状物的话)。
一旦已将调制系统10推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及系统10所提供的反馈确定被传送至消融电极的能量的量。随着能量被供给至电极,处理单元20可分析通过每个接地垫22a、22b、22c和22d形成的电路的阻抗。然后,处理单元20可增加一个或多个电路的阻抗,从而使所有的电路具有相同的阻抗。可以预期的是随着所需治疗区消融的进展,由于损伤的形成,电路的阻抗可能发生改变。因此,处理器20可被配置成在整个消融过程的持续期间连续调整在消融电极和接地垫22a、22b、22c和22d之间形成的电路中每一个的电阻。在一些情况下,处理器20可被配置成按预定的时间间隔调整电路中每一个的电阻。
在一些情况下,细长轴14可旋转且可在围绕脉管圆周的多个位置上进行额外的消融。在一些情况下,缓慢自动的“电转烤肉架式”旋转可用于围绕脉管圆周工作或更快的回旋可用于同时围绕整个圆周进行消融。回旋可通过微型电机或通过使驱动轴回旋而实现。可通过所存在的消融电极的数量和大小确定在给定的纵向位置上细长轴14旋转的次数。一旦特定位置已消融,则可能需要在不同的纵向位置上进行进一步的消融过程。一旦细长轴14已进行纵向重新定位,则可再一次地将能量传送至消融电极。如果有必要,则可旋转细长轴14以在每个纵向位置上围绕脉管的圆周进行消融。该过程可在所需的任何数量的纵向位置上进行重复。可预期的是,在一些实施例中,系统10可包括沿调制系统10的长度位于各个位置上的消融电极,从而可治疗较大的区域而无需进行细长轴14的纵向位移。
图2为示出另一种说明性肾神经调制系统100的就位示意图。系统100可具有与本文所讨论的其他调制系统相类似的形式和功能。系统100可包括用于将电力提供至被布置在中央细长轴114周围和/或其中且可选地位于护套116内的神经调制元件的元件112。元件112的近端可被连接至控制和电力元件18,其供给必需的电能以激活位于元件112远端或接近远端的一个或多个调制元件或电极。当适当地进行激活时,电极能够消融组织。在一些情况下,一个或多个返回电极贴片122a和122b(统称为122a-b)可设置在患者的身体上以完成电路。在一些情况下,第一返回电极122a可被设置在患者身体的后侧102a上而第二返回电极122b则可被设置在患者身体的前侧102b上。
控制和电力元件118可包括监控元件,用于监控参数,如功率、温度、电压、脉冲大小和/或形状和其他合适的参数,以及用于进行所需过程的合适的控制。在一些情况下,电力元件118可控制射频(RF)消融电极和/或一个或多个感测电极。可以预期的是也可设置一个以上的电力元件118。消融电极可被配置成在约为460kHz的频率上运行。可以预期的是可使用在RF范围内的任何所需的频率,例如100-500kHz。然而,可以预期的是可按照需要使用RF频谱外的不同类型的能量,例如但不限于用于进行消融的超声波、微波和激光。虽然本文中使用了术语消融电极,但可以预期的是可根据用于进行消融的能量选择调制元件和调制频率。例如,当使用超声波能量时,超声波换能器可被选择作为调制元件且调制频率可在MHz范围内。
细长轴114可从近端124向远端延伸至远端,其中远端被配置成在体腔内被推进至所需的治疗区。细长轴114的近端124可包括附至其上的毂(未明确示出),其用于连接其他治疗装置或提供端口以便进行其他治疗。可以预期的是可修改细长轴114的刚性以形成调制系统100,从而用于各种脉管直径以及血管树中的各个位置上。细长轴114可进一步包括延伸通过其的一个或多个内腔。例如,细长轴114可包括导丝腔和/或一个或多个辅助腔。可按本领域已知的任何方式配置内腔。虽然未明确示出,但调制系统100可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定导丝尖端、导丝腔、外部护套和/或其他组件以便在脉管系统中使用和推进系统100。
虽然未明确示出,但调制系统100可包括一个或多个被布置在邻近远端区的细长轴114的外表面上的消融电极。然而,消融电极可按照需要被置于沿细长轴114的任何纵向位置上。可进一步预期的是,在一些实施例中,调制系统100可包括一个或多个定位元件,如可膨胀球囊或可扩张的篮状物,其位于邻近细长轴114的远端处以协助对一个或多个电极的定向。在一些情况下,消融电极可位于一个或多个定位元件的表面上。可以预期的是消融电极可位于可膨胀球囊的外表面或可扩张的篮状物的框架上。在其他情况下,消融电极可位于可膨胀球囊内,如位于延伸通过球囊的细长轴上或位于内表面上。
可以预期的是调制系统100可按照需要包括任何数量的消融电极,如但不限于一个、两个、三个、四个或更多。如果设有多个消融电极,按照需要消融电极可沿纵向、径向和/或周向间隔。在一些情况下,消融电极可以是围绕细长轴114的外周延伸的圆周电极。圆周电极可允许进行圆周消融且同时减少和/或消除对电极和/或细长轴114进行圆周重新定位的需要。在一些实施例中,消融电极可能并非一直围绕细长轴114的外周延伸。可以预期的是多个消融电极可围绕细长轴114的外周周向定位以减少和/或消除沿圆周重新定位细长轴114以进行360°消融的需要。
消融电极可通过绝缘电导体,如图2中所示的元件112而被连接至控制单元118。一旦已将调制系统100推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及从系统100获得的反馈确定被传送至消融电极的能量的量。可基于组织的阻抗对消融的功率水平和持续时间进行相应的调整。例如,较多的能量可能导致更大和更深的损伤。随着向消融电极施加电压,电流可通过紧邻治疗区的组织以及位于治疗区和皮肤之间的其他的身体组织并到达皮肤接触的接地垫122a-b。
虽然接地垫122a-b被示为位于身体的相对侧上(后侧和前侧),但可以预期的是接地垫也可按照需要位于身体的一侧或两侧。虽然所示的系统100包括两个接地垫122a-b,但可以预期的是按照需要可具有少于两个或多于两个的接地垫。在一些实施例中,系统100可包括位于身体的每一侧102a和102b上的一个、两个、三个、四个或更多个接地垫。在一些情况下,尽管未明确示出,但接地垫122a-b可均匀地分布在所需治疗区的周围。然而,可以预期的是可按任何合适的方式布置任何数量的接地垫以用于所需的治疗。
除了肌肉血管壁外,身体组织可包括外膜和结缔组织、神经、脂肪、流体等。每个垫122a和122b可具有给定的阻抗以完成电路且每个垫的阻抗可根据存在于治疗区和接地(垫)的位置之间的组织类型而为不同的。每个接地垫122a和122b可通过独立的电导体126a和126b而被连接至处理器或处理单元120的各个通道以形成各个电路。在一些情况下,处理器120可经接地通道输出128被电连接至电力单元118或以其他方式与其相连通。由于每个垫122a和122b均可被单独地连接至处理器120的通道中的单独接地,因此电连接126a和126b的电阻可单独地进行调整。例如,可以预期的是每个通道可包括用于单独调整各个电路的独立的可变电阻器。可以预期的是处理器120可按照需要包括任何数量的通道,从而可分别地调整在处理器120和接地垫122a-b之间的电连接。
如上面所指出的,每个接地垫122a和122b可具有某个阻抗以完成电路(例如,位于被布置在体内的消融电极和位于身体的外表面上的接地垫之间的路径)。由于电流是沿着最小电阻的路径流动的,因此可以预期的是电流将优先在消融电极和具有最小阻抗量的接地垫之间行进以完成电路。就这点而言,可能会出现不一致或意外的损伤。这可能会导致治疗位置之间的损伤大小和深度的变化并且因患者的不同而变化。可以预期的是,一旦连接上,处理器120则可使所有电路的阻抗增加至同一水平,从而使电流均匀地分布在消融电极和接地垫122a-b之间。例如,能量可从消融电极沿球面行进。处理器20可通过改变在接地垫122a-b和处理器120之间的电阻而电子性地增加电路的阻抗。在一些情况下,处理器120可使用一些可变电阻器以增加电路的阻抗。可进一步预期的是可通过重新定位接地垫122a和122b而进一步地操纵电路阻抗。在一些情况下,接地垫122a-b可策略性地位于患者身体上以控制电流的流动方向。由于电流的路径可基于电路的阻抗、接地垫122a-b的位置或接地垫122a-b的阻抗和位置的组合而进行操纵,因此可预期的是可更容易地控制损伤的大小和形状,从而减少和/或消除意外的损伤。
可进一步预期的是利用通过单个电源提供电力的多个消融电极的调制系统100可能经历每个消融或有源电极的阻抗变化。这种消融电极的阻抗变化可能导致损伤的大小和/或距离每个电极的深度的变化。提供每一个均具有调制阻抗的多个接地位置,如接地垫122a-b可更均匀地牵引电流/电力通过每个消融电极。例如,能量可从消融电极沿球面行进。操纵电流路径可减少损伤大小和深度的变化,从而在治疗位置产生更一致的损伤。
可按本领域中任何已知的方式推进调制系统100通过脉管系统。例如,系统100可包括导丝腔以允许在先前定位的导丝上方推进系统100。在一些实施例中,可在引导护套,如护套116内推进或部分推进调制系统100。一旦调制系统100的消融电极已被置于邻近所需的治疗区处,则可布置定位机构,如定心篮状物(如果设有该定心篮状物的话)。
一旦已将调制系统100推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及系统100所提供的反馈确定被传送至消融电极的能量的量。随着能量被供给至电极,处理单元120可分析通过每个接地垫122a和122b形成的电路的阻抗。然后,处理单元120可增加一个或多个电路的阻抗,从而使所有的电路具有相同的阻抗。可以预期的是随着所需治疗区消融的进展,由于损伤的形成,电路的阻抗可能发生改变。因此,处理器120可被配置成在整个消融过程的持续期间连续调整在消融电极和接地垫122a和122b之间形成的电路中每一个的电阻。在一些情况下,处理器120可被配置成按预定的时间间隔调整电路中每一个的电阻。
在一些情况下,细长轴114可旋转且可在围绕脉管圆周的多个位置上进行额外的消融。在一些情况下,缓慢自动的“电转烤肉架式”旋转可用于围绕脉管圆周工作或更快的回旋可用于同时围绕整个圆周进行消融。回旋可通过微型电机或通过使驱动轴回旋而实现。可通过所存在的消融电极的数量和大小确定在给定的纵向位置上细长轴114旋转的次数。一旦特定位置已消融,则可能需要在不同的纵向位置上进行进一步的消融过程。一旦细长轴114已进行纵向重新定位,则可再一次地将能量传送至消融电极。如果有必要,则可旋转细长轴114以在每个纵向位置上围绕脉管的圆周进行消融。该过程可在所需的任何数量的纵向位置上进行重复。可预期的是,在一些实施例中,系统100可包括沿调制系统100的长度位于各个位置上的消融电极,从而可治疗较大的区域而无需进行细长轴114的纵向位移。
图3为示出另一种说明性肾神经调制系统200就位的示意图。系统200可具有与本文所讨论的其他调制系统相类似的形式和功能。系统200可包括用于将电力提供至被布置在中央细长轴214周围和/或其中且可选地位于护套216内的神经调制元件的元件212。元件212的近端可被连接至控制和电力元件18,其供给必需的电能以激活位于元件212远端或接近远端的一个或多个调制元件或电极。当适当地进行激活时,电极能够消融组织。在一些情况下,一个或多个返回电极贴片222a、222b、222c、222d、222e、222c、222d和222e(统称为222a-e)可设置在患者的身体上以完成电路。在一些情况下,第一和第二返回电极222a、222b、222c、222d和222e可被设置在患者身体的后侧202a上而第三和第四返回电极222d和222e则可被设置在患者身体的前侧202b上。在一些情况下,第五电极222c可被设置在患者身体的横向侧上,从而使其位于后侧202a和前侧202b之间。虽然未明确示出,但可以预期的是一个或多个额外的电极也可被设置在患者身体的相对的横侧上。
控制和电力元件218可包括监控元件,用于监控参数,如功率、温度、电压、脉冲大小和/或形状和其他合适的参数,以及用于进行所需过程的合适的控制。在一些情况下,电力元件218可控制控制射频(RF)消融电极和/或一个或多个感测电极。可以预期的是也可设置一个以上的电力元件218。消融电极可被配置成在约为460kHz的频率上运行。可以预期的是可使用在RF范围内的任何所需的频率,例如100-500kHz。然而,可以预期的是可按照需要使用RF频谱外的不同类型的能量,例如但不限于用于进行消融的超声波、微波和激光。虽然本文中使用了术语消融电极,但可以预期的是可根据用于进行消融的能量选择调制元件和调制频率。例如,当使用超声波能量时,超声波换能器可被选择作为调制元件且调制频率可位于MHz范围内。
细长轴214可从近端224向远端延伸至远端,其中远端被配置成在体腔内被推进至所需的治疗区。细长轴214的近端224可包括附至其上的毂(未明确示出),其用于连接其他治疗装置或提供端口以便进行其他治疗。可以预期的是可修改细长轴214的刚性以形成调制系统200,从而用于各种脉管直径以及血管树中的各个位置上。细长轴214可进一步包括延伸通过其的一个或多个内腔。例如,细长轴214可包括导丝腔和/或一个或多个辅助腔。可按本领域已知的任何方式配置内腔。虽然未明确示出,但调制系统200可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定导丝尖端、导丝腔、外部护套和/或其他组件以便在脉管系统中使用和推进系统200。
虽然未明确示出,但调制系统200可包括一个或多个被布置在邻近远端区的细长轴214的外表面上的消融电极。然而,消融电极可按照需要被置于沿细长轴214的任何纵向位置上。可进一步预期的是,在一些实施例中,调制系统200可包括一个或多个定位元件,如可膨胀球囊或可扩张的篮状物,其位于邻近细长轴214的远端处以协助对一个或多个电极的定向。在一些情况下,消融电极可位于一个或多个定位元件的表面上。可以预期的是消融电极可位于可膨胀球囊的外表面上或可扩张的篮状物的框架上。在其他情况下,消融电极可位于可膨胀球囊内,如位于延伸通过球囊的细长轴上或位于内表面上。
可以预期的是调制系统200可按照需要包括任何数量的消融电极,如但不限于一个、两个、三个、四个或更多。如果设有多个消融电极,按照需要消融电极可沿纵向、径向和/或周向间隔。在一些情况下,消融电极可以是围绕细长轴214的外周延伸的圆周电极。圆周电极可允许进行圆周消融且同时减少和/或消除对电极和/或细长轴214进行圆周重新定位的需要。在一些实施例中,消融电极可能并非一直围绕细长轴214的外周延伸。可以预期的是多个消融电极可围绕细长轴214的外周沿圆周定位以减少和/或消除沿圆周重新定位细长轴214以进行360°消融的需要。
消融电极可通过绝缘电导体,如图2中所示的元件212而被连接至控制单元218。一旦已将调制系统200推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及从系统200获得的反馈确定被传送至消融电极的能量的量。可基于组织的阻抗对消融的功率水平和持续时间进行相应的调整。例如,较多的能量可能导致更大和更深的损伤。随着向消融电极施加电压,电流可通过紧邻治疗区的组织以及位于治疗区和皮肤之间的其他的身体组织并到达皮肤接触的接地垫222a-e。
虽然接地垫222a-e被示为位于身体的多侧上(例如后侧、前侧和横向侧),但可以预期的是,按照需要,接地垫222a-e也可单独地位于每一侧上(后侧、前侧或横向侧)或接地垫222a-e也可位于后侧、前侧和横向侧的任何组合上。虽然所示的系统200包括五个接地垫222a-e,但可以预期的是按照需要可具有少于五个或多于五个的接地垫。在一些实施例中,系统200可包括位于身体各侧(后侧、前侧或横向侧)上的一个、两个、三个、四个或更多个接地垫。虽然未明确示出,但可以预期的是一个或多个额外的电极也可被设置在患者身体的相对的横向侧上。可以预期的是,将额外的接地垫置于身体的横向侧上可允许通过在额外的方向上牵引电流而实现更均匀的电流分布。在一些情况下,尽管未明确示出,但接地垫222a-e可均匀地分布在所需治疗区的周围。然而,可以预期的是可按任何合适的方式布置任何数量的接地垫以用于所需的治疗。
在一些情况下,可选择接地垫222a-e的分布以允许区域控制选项。例如,如果需要对右和左肾动脉进行神经消融,除了前侧和后侧外,可能还需要使接地垫位于身体的两个横向侧。在右肾神经的消融期间,除了位于前侧和/或后侧上的任何接地垫以外,可激活位于身体的右横向侧上的接地垫,而位于身体的左横向侧上的接地垫则保持为不起作用的。同样地,在左肾神经的消融期间,除了位于前侧和/或后侧上的任何接地垫以外,可激活位于身体的左横向侧上的接地垫,而位于身体的右横向侧上的接地垫则保持为不起作用的。处理器220可包括反馈回路以允许在多个治疗区之间进行选择。然而,可以预期的是可基于所需的治疗分配接地垫的区域,且系统200并不旨在仅限于所提供的实例区域。
除了肌肉血管壁外,身体组织可包括外膜和结缔组织、神经、脂肪、流体等。每个垫222a、222b、222c、222d和222e可具有给定的阻抗以完成电路且每个垫的阻抗可根据存在于治疗区和接地(垫)的位置之间的组织类型而为不同的。每个接地垫222a、222b、222c、222d和222e可通过独立的电导体226a、226b、226c、226d和226e而被连接至处理器或处理单元220的各个通道以形成各个电路。在一些情况下,处理器220可经接地通道输出228被电连接至电力单元218或以其他方式与其相连通。由于每个垫222a、222b、222c、222d和222e均可被单独地连接至处理器220的通道中的独立接地处,因此电连接226a、226b、226c、226d和226e的电阻可单独地进行调整。例如,可以预期的是每个通道可包括用于单独调整各个电路的独立的可变电阻器。可以预期的是处理器220可按照需要包括任何数量的通道,从而可个别地调整在处理器220和接地垫222a-e之间的电连接。进一步地,处理器220可被配置成断开一个或多个接地垫222a-e与电路的连接,从而可按照需要激活接地垫222a-e,如用于创建区域控制。
如上面所指出的,每个接地垫222a、222b、222c、222d和222e可具有某个阻抗以完成电路(例如,位于被布置在体内的消融电极和位于身体的外表面上的接地垫之间的路径)。由于电流是沿着最小电阻的路径流动的,因此可以预期的是电流将优先在消融电极和具有最小阻抗量的接地垫之间行进以完成电路。就这点而言,可能会出现不一致或意外的损伤。这可能会导致治疗位置之间的损伤大小和深度的变化以及因患者的不同而变化。可以预期的是,一旦连接上,处理器220则可使所有电路的阻抗增加至同一水平,从而使电流均匀地分布在消融电极和接地垫222a-e之间。例如,能量可从消融电极沿球面行进。处理器220可通过改变在接地垫222a-e和处理器220之间的电阻而电子性地增加电路的阻抗。在一些情况下,处理器220可使用一些可变电阻器以增加电路的阻抗。可进一步预期的是可通过重新定位接地垫222a、222b、222c、222d和222e而进一步地操纵电路阻抗。在一些情况下,接地垫222a-e可策略性地位于患者身体上以控制电流的流动方向。由于电流的路径可基于电路的阻抗、接地垫222a-e的位置或接地垫222a-e的阻抗和位置的组合而进行操纵,因此可预期的是可更容易地控制损伤的大小和形状,从而减少和/或消除意外的损伤。
可进一步预期的是利用通过单个电源提供电力的多个消融电极的调制系统200可能经历每个消融或有源电极的阻抗变化。这种消融电极的阻抗变化可能导致损伤的大小和/或距离每个电极的深度的变化。提供每一个均具有调制阻抗的多个接地位置,如接地垫222a-e可更均匀地通过每个消融电极牵引电流/电力。例如,能量可从消融电极沿球面行进。操纵电流路径可减少损伤大小和深度的变化,从而在治疗位置产生更一致的损伤。
可按本领域中任何已知的方式推进调制系统200通过脉管系统。例如,系统200可包括导丝腔以允许在先前定位的导丝上方推进系统200。在一些实施例中,可在引导护套,如护套216内推进或部分推进调制系统200。一旦调制系统200的消融电极已被置于邻近所需的治疗区处,则可布置定位机构,如定心篮状物(如果设有该定心篮状物的话)。
一旦已将调制系统200推进至治疗区,则可将能量供给至消融电极。可根据所需的治疗以及系统200所提供的反馈确定被传送至消融电极的能量的量。随着能量被供给至电极,处理单元220可分析通过每个接地垫222a、222b、222c、222d和222e形成的电路的阻抗。然后,处理单元220可增加一个或多个电路的阻抗,从而使所有的电路具有相同的阻抗。可以预期的是随着所需治疗区消融的进展,由于损伤的形成,电路的阻抗可能发生改变。因此,处理器220可被配置成在整个消融过程的持续期间连续调整在消融电极和接地垫222a、222b、222c、222d和222e之间形成的电路中每一个的电阻。在一些情况下,处理器220可被配置成按预定的时间间隔调整电路中每一个的电阻。
在一些情况下,细长轴214可旋转且可在围绕脉管圆周的多个位置上进行额外的消融。在一些情况下,缓慢自动的“电转烤肉架式”旋转可用于围绕脉管圆周工作,或更快的回旋可用于同时围绕整个圆周进行消融。回旋可通过微型电机或通过使驱动轴回旋而实现。可通过所存在的消融电极的数量和大小确定在给定的纵向位置上细长轴214旋转的次数。一旦特定位置已被消融,则可能需要在不同的纵向位置上进行进一步的消融过程。一旦细长轴214已进行纵向重新定位,则可再一次地将能量传送至消融电极。如果有必要,则可旋转细长轴214以在每个纵向位置上围绕脉管的圆周进行消融。该过程可在所需的任何数量的纵向位置上进行重复。可预期的是,在一些实施例中,系统200可包括沿调制系统200的长度位于各个位置上的消融电极,从而可治疗较大的区域而无需进行细长轴214的纵向位移。
本领域的技术人员将认识到,除了本文所述和考虑的具体实施例外,本发明可表现为多种形式。因此,在不脱离如在所附权利要求中所述的本发明的范围和精神的前提下,可在形式和细节上有所背离。
Claims (15)
1.一种血管内神经调制系统,其包括:
具有近端区和远端区的细长轴;
位于邻近所述细长轴的所述远端区处的消融电极;
至少两个接地垫;
电耦合至所述消融电极的控制单元;以及
电耦合至所述至少两个接地垫的处理器。
2.根据权利要求1所述的血管内神经调制系统,其中所述控制单元将电压供给至所述消融电极。
3.根据权利要求2所述的血管内神经调制系统,其中各个电路形成于所述消融电极和所述至少两个接地垫中的每一个的之间。
4.根据权利要求3所述的血管内神经调制系统,其中所述处理器被配置成监控所述各个电路中每一个的阻抗。
5.根据权利要求3-4中任一项所述的血管内神经调制系统,其中所述处理器被配置成调制所述各个电路中至少一个的电阻。
6.根据权利要求5所述的血管内神经调制系统,其中所述处理器调制所述各个电路的电阻,从而使每个电路具有大致相同的阻抗。
7.根据权利要求1-6中任一项所述的血管内神经调制系统,其进一步包括第二消融电极。
8.根据权利要求1-7中任一项所述的血管内神经调制系统,其中所述至少两个接地垫包括第一接地垫和第二接地垫,且其中所述第一接地垫位于邻近所需治疗位置的第一侧处且所述第二接地垫位于邻近所需治疗位置的第二侧处。
9.根据权利要求8所述的血管内神经调制系统,其进一步包括第三接地垫,其位于邻近所需治疗位置的第三侧处。
10.一种医疗器械,其包括:
具有远端区的导管轴;
消融电极,其位于邻近所述导管轴的所述远端区;
至少两个接地垫,其被设计为沿患者的外表面而布置;
电耦合至所述消融电极的控制单元;
电耦合至所述至少两个接地垫的处理器;
其中各个电路形成于所述消融电极和所述至少两个接地垫中的每一个的之间;
其中所述处理器被配置成监控所述各个电路中每一个的阻抗;
其中当所述各个电路被所述处理器监控时,所述至少两个接地垫中的至少一些具有不同阻抗;以及
其中所述处理器调制所述各个电路的电阻,从而使每个电路具有大致相同的阻抗。
11.根据权利要求10所述的医疗器械,其中所述控制单元将电压供给至所述消融电极。
12.根据权利要求10-11中任一项所述的医疗器械,其进一步包括第二消融电极。
13.根据权利要求10-12中任一项所述的医疗器械,其中所述至少两个接地垫包括第一接地垫和第二接地垫,且其中所述第一接地垫位于邻近所需治疗位置的第一侧处且所述第二接地垫位于邻近所需治疗位置的第二侧处。
14.根据权利要求13所述的医疗器械,其进一步包括第三接地垫,其位于邻近所需治疗位置的第三侧处。
15.根据权利要求10-14中任一项所述的医疗器械,其中所述医疗器械被配置成调制位于肾动脉周围的肾神经。
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US10835305B2 (en) | 2020-11-17 |
US20140100562A1 (en) | 2014-04-10 |
CN104869930B (zh) | 2020-12-25 |
JP6074051B2 (ja) | 2017-02-01 |
JP2015531304A (ja) | 2015-11-02 |
EP2906135A2 (en) | 2015-08-19 |
WO2014059165A2 (en) | 2014-04-17 |
WO2014059165A3 (en) | 2014-07-10 |
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