CN101123924B - 用于经子宫颈输卵管闭塞术的系统 - Google Patents
用于经子宫颈输卵管闭塞术的系统 Download PDFInfo
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Abstract
描述一种用于闭塞输卵管的医疗设备和手术过程。将输卵管闭塞设备插入到子宫腔中。该设备包括RF施加器头,RF施加器头又包括其上具有一个或多个双极性电极的电极载体。在插入过程中,RF施加器头处于闭合位置。将RF施加器头定位在输卵管峡处,以便将RF施加器头的远端推进入输卵管峡。将RF施加器头展开成打开位置,以便RF施加器头近似子宫腔在输卵管峡区域的形状。使电流通过一个或多个双极性电极流到输卵管峡,将组织破坏到已知深度,这促成了周围组织的愈合反应,所述愈合反应经过一段时间使输卵管结疤并且闭塞。
Description
技术领域
本发明涉及一种医疗设备和手术过程。
背景技术
女性绝育通常涉及闭塞输卵管,以防止精子进入女性输卵管内的卵子中。一种传统的女性绝育手术过程是腹腔镜下的输卵管闭塞术(laparoscopic tubal occlusion)。在这种手术过程中,在腹壁上做一个切口以提供进入输卵管的通路。借助于腹腔镜,采用外科手术,例如利用双极或单极电凝术使输卵管闭塞。腹腔镜下的输卵管闭塞术是有创的,需要多个切口,并且需要使几种仪器和气态扩张媒体进入患者的腹部。已经报告了对周围组织和器官造成的热和机械损伤。
最近使用了用于女性绝育的微创经子宫颈方法(minimallyinvasive transcervical approach)。这样一种手术过程涉及将小型的,挠性设备放置到输卵管内;经过子宫颈将该设备插入到子宫腔中,提供了进入输卵管的通路。该装置由聚酯纤维和金属制成,并且一旦就位,人体组织就生长到该设备中,并且阻塞输卵管。该设备将永久留在患者体内,假定在该设备中有导电金属部件,这引起了人们对于植入设备对在子宫内随后的潜在外科介入的长期影响和限制的关注。
已经研制出单极射频技术,其包括使小直径电线(有源电极)经过子宫颈穿过子宫腔和输卵管峡(ostium)到达输卵管。在体外安置大的无源电极。在这两个电极之间的电流路径未被明确定义,并可导致不慎烧伤。该技术并不成功,已经被废弃。该技术既不能管理输卵管峡处子宫内膜组织的厚度变化,也不能管理对于输卵管内破坏深度所需要的紧密公差(tight tolerance)。
发明内容
本发明涉及一种医疗设备和手术过程。一般而言,在一方面,本发明给出一种用于输卵管闭塞术的方法的特点。输卵管闭塞设备被插入到子宫腔中。该设备包括RF施加器头,RF施加器头又包括其上具有一个或多个双极性电极的电极载体。在插入过程中,RF施加器头处于闭合位置。将RF施加器头定位在输卵管的输卵管峡处,以便将RF施加器头的远端推进输卵管峡内。将RF施加器头展开成打开位置,以便RF施加器头近似子宫腔在输卵管峡区域的形状。使电流通过一个或多个双极性电极到达输卵管峡,从而将组织破坏到已知深度,这促成了周围组织的愈合反应(healing response),该愈合反应经过一段时间使输卵管结疤并闭塞。
本发明的实现方式包括下列一个或多个特点。使电流通过一个或多个双极性电极到达输卵管峡以破坏组织包括汽化子宫内膜和破坏表浅子宫肌层。将输卵管闭塞设备插入到子宫腔中包括将带有处于闭合位置的RF施加器头的输卵管闭塞设备插入,并且在使电流通过一个或多个双极性电极前,将RF施加器头展开成打开位置。通过电极载体施加吸力抽取周围组织至与电极相接触,并且抽取在切除过程中产生的水分,使水分远离该电极,从而基本上防止在电极上形成低阻抗液体层。使电流通过一个或多个双极性电极包括向一个或多个双极性电极输送射频能量。
本方法还可包括一旦切除已经达到预定的切除深度时,自动终止电流流向组织。在将RF施加器头定位到输卵管峡之前,向子宫腔内吹气。在使电流通过一个或多个双极性电极之前,停止吹气,并且允许子宫腔坍塌包裹在RF施加器头上。将RF施加器头展开成打开位置包括移除鞘,暴露该电极载体。该电极载体可包括织物,织物具有导电金属区域以及在其上形成的一个或多个的非导电区域,从而产生一个或多个双极性电极。本方法还可包括将照明器和光学仪器推进到子宫腔中。在输卵管的输卵管峡处定位RF施加器头可包括利用光学仪器使输卵管峡可视。
一般而言,在另一个方面,本发明给出一种用于输卵管闭塞术的系统的特点。本系统包括输卵管闭塞设备,射频能量源,控制器和真空源。输卵管闭塞设备具有远端和近端,该远端包括其上具有一个或多个双极性电极的电极载体。在打开状态下,使该远端成形为近似适合子宫腔在要被闭塞的输卵管的输卵管峡区域内的形状。该射频能量源与一个或多个双极性电极电气耦联。该控制器配置成控制向一个或多个双极性电极输送射频能量,以便能够控制射频能量通过一个或多个双极性电极到达输卵管峡,从而将组织破坏到已知深度,这促成了周围组织的愈合反应,所述愈合反应经过一段时间使输卵管结疤并闭塞。该真空源用于抽取组织与一个或多个双极性电极相接触,并且抽取在输送射频能量过程中产生的水分,使水分远离该双极性电极。这样基本上消除了围绕该双极性电极的液体。
本发明的实现方式还包括下列一个或多个的特点。射频能量通过一个或多个双极性电极到达输卵管峡从而破坏组织可包括汽化子宫内膜和破坏表浅子宫肌层。该电极载体可包括在织物鞘内的结构支持构件,其具有导电金属区域,并具有在其上形成的一个或多个的非导电区域,从而产生一个或多个双极性电极。结构支持构件可包括在闭合状态和打开状态之间运动的挠性构件。本系统还包括与输卵管闭塞设备远端电气耦联的,用以照明子宫的照明源;以及与输卵管闭塞设备远端电气耦联的,用以提供子宫图像的光学仪器。
一般而言,在另一个方面,本发明给出一种用于闭塞输卵管的装置的特点。该装置包括伸长构件,电极载体和管子。该伸长构件具有远端,近端和内部中央空腔。该电极载体附着在伸长构件的远端,并在具有在其上形成的一个或多个双极性电极。该电极载体用于与射频能量发生器耦联,并可在闭合位置和打开位置之间运动,在闭合位置将电极载体折叠以插入子宫腔中;在打开位置使电极载体的远端成形为适合输卵管的输卵管峡。伸长构件的内部中央空腔用于与真空源连接,以抽取水分,使水分远离一个或多个电极。
本发明的实现方式可包括下列一个或多个的特点。该装置还包括附着在伸长构件的远端并且用于与照明源耦联的照明器,以及附着在伸长构件的远端并且用于与图像显示装置耦联的光学仪器。该电极载体可包括在织物鞘内的结构支持构件,其具有导电金属区域和在其上形成的一个或多个的非导电区域,从而产生一个或多个双极性电极。该结构支持构件可包括在闭合状态和打开状态之间运动的挠性构件。
本发明的实现方式能够实现下列一个或多个的优点。所描述的输卵管闭塞术过程是微创的:可经过子宫颈将输卵管闭塞设备导入到患者的子宫腔中,而无需腹部切口。该手术过程不会给患者身体留下任何异物,将感染的风险降至最低,并且消除了对于随后的外科介入的限制。该手术过程可很快完成,切除的实际持续时间约为每个输卵管一分钟。因为RF能量被限制在切除区域,所以在手术过程中对其他器官造成损伤的风险更低。本系统和手术过程针对变化的子宫内膜厚度自动补偿,有利于正确地勾勒出输卵管开口区域中组织破坏的深度。此外,不同于如上所述的需要在输卵管中植入永久性设备的技术,本技术不必使导管通过输卵管,由于输卵管很容易发生痉挛,抑制永久性装置的放置,因此使得这种手术过程难以实现。
本发明的一个或多个实施例的细节将在附图中给出,并且描述如下。,本发明的其他特点,目标和优点从说明书,附图以及权利要求是显而易见的。
附图说明
图1A是子宫的示意图;
图1B是在输卵管峡中定位的RF施加器(applicator)头的示意图;
图1C是在子宫和输卵管峡中被切除的组织区域的示意图;
图2显示了输卵管闭塞设备的侧视图;
图3A显示了图2中具有处于闭合位置的RF施加器头的输卵管闭塞设备的顶视图;
图3B显示了图2中具有处于打开位置的RF施加器头的输卵管闭塞设备的顶视图;
图4A和4B显示了分别处于闭合位置和打开位置的RF施加器头的结构体的一个实施例;
图4C是处于打开位置的RF施加器头的示意图;
图4D是图4C中的RF施加器头的电极中心线的示意图;
图4E中是图2和3中输卵管闭塞设备主体的横截面视图;
图5A-D是显示与切除组织相接触的电极的横截面示意图;
图6是显示输卵管闭塞术过程的流程图;
图7A-D是输卵管闭塞术过程的步骤的示意图;
图8是RF施加器头的结构体的另一个实施例的示意图;
在各个附图中同样的参考符号代表同样的元件。
具体实施方式
本发明描述了一种用于闭塞女性输卵管的方法和系统,其提供了用于女性绝育的微创替代方法。参考图1A,显示了子宫3的示意图,其包括被子宫组织(亦即,子宫内膜组织7a和子宫肌肉组织7b)包裹的子宫腔5。输卵管11在输卵管峡9处与子宫腔5相连接。将输卵管峡9闭塞阻止了精子进入输卵管11,并且阻止精子给卵子授精,因此使女性绝育。
参考图1B,经过子宫颈可将RF(射频)施加器头2引入到子宫腔中,并将其定位在输卵管峡9处。如图1C中的区域11所示,通过RF施加器头2发送RF能量,以切除子宫组织7a,7b和输卵管峡9内的组织。在输卵管峡9处的组织破坏后,愈合反应使得输卵管9和输卵管11的邻近部分闭塞,从而导致绝育。再参考图1C,从A-A到B的目标破坏大约为1.5至2.5毫米,从A-A到C的目标破坏大约为10至20毫米,深度D-D通常大约为2.0至3.5毫米.
参考图2,3A和3B,显示了输卵管闭塞设备15的一个实施例。输卵管闭塞设备15通常包括三个主要部件:RF施加器头2,主体4,和手柄6。图2显示了输卵管闭塞设备15的侧视图,图3A和3B显示了其顶视图。图3A显示了具有在鞘32内处于闭合位置的RF施加器头2的输卵管闭塞设备15,并且图3B显示了伸出鞘32外处于打开位置的RF施加器头2。RF施加器头2包括固定在轴10远端的电极载体12,以及在电极载体12表面形成的电极14。RF发生器16与电极14电气连接,从而为电极14提供单极或双极RF能量。
主体4包括轴10。轴10是个内部空腔的伸长构件。在一个实施例中,轴10大约有30厘米长,其横截面直径大约为4毫米。轴10伸展开是在其远端形成有多个孔17a的吸入/吹气管17(见图4A和4B)。
特别参考图3B,电极导线18a和18b穿过轴10从轴10的远端20伸展到轴10的近端22。在轴10的远端20,导线18a和18b中的每一个都与电极14中相应的一个耦联。在轴10的近端22,导线18a和18b通过电连接器21与RF发生器16电气连接。使用过程中,导线18a和18b从RF发生器16传送RF能量到电极14。导线18a和18b中的每一个都是绝缘的,并且导线18a和18b可以连接到RF发生器16的相对端上。当对交流电极或电极组施加相反的极性时,电极对(即,一个带正电和一个带负电的电极或电极组)可被称为双极性电极。在这里提及的任何双极性电极都是指这种电极对。
参考图4A-C,使RF施加器头2近似成形为要被切除的区域的形状。图4C所示的RF施加器头2的实施例具有V字形状,这种形状能够适合子宫腔5的转角,并能伸进输卵管峡9中。图4A和4B显示了没有电极载体12的RF施加器头2,从而展现出RF施加器头2的结构体100。挠性构件19附着在主体的轴10远端以及管17的远端上。弯曲部分(flexure)22附着在管17以及挠性构件19的内表面上。在图4A所示的闭合位置上,弯曲部分22被压缩在挠性构件19的内表面和管17之间形成的空间内,并且RF施加器头2的结构体100的形状大体为圆柱形。在一个实施例中,弯曲部分22以及挠性构件19都由不锈钢制成,并且弯曲片22以及挠性构件19的厚度大约为0.012英寸,且基本上为平面。
通过使管17相对于轴10来运动,RF施加器头2能够展开成如图4B所示的打开位置。在一个实施例中,将轴10朝该轴的近端(即,远离RF施加器头2)拉伸。连接到挠性构件19的轴10的运动使得挠性构件19也在同一方向上运动,从而使弯曲部分22朝远离管17的方向横向运动。如图4B所示,挠性构件19向外变形,远离管17,并在RF施加器头2的远端形成V字形状。该远端的形状依据轴10和管17相对于彼此运动的大小而不同。
在替换实施例中,将管17朝挠性构件19的近端(即,朝RF施加器头2)推,从而使管17相对于轴10运动。这种相对运动也有如上所述的同样效果,亦即,挠性构件19向外变形,并在远端形成V字形状。
图4C显示了在结构体上带有电极载体12的RF施加器头2的远端。电极载体12是由在结构体上伸展的织物(fabric)形成的;该织物在形成电极14的区域中被金属处理。电极14是导电的,并且能够在正负极性(如上所述被称为“双极性电极”的电极对)之间交替变化。在描绘的实施例中,有四个电极14(或2双极性电极),在电极载体12的每一侧各有两个。非导电的绝缘体23将电极载体12分成双极性电极14。
在一个实施例中,织物由复合丝形成,该复合丝具有热塑性弹性体(TPE)芯以及缠绕在TPE周围作为包裹的多个复丝尼龙束(polyfilament nylon bundles)。该尼龙束镀有薄金属导电层。优选地,尼龙被用金属处理过,而TPE芯不用金属处理。这种结构有利于伸展;当TPE芯被伸长时,无须敲裂金属层,尼龙绕组就将其线圈打开。TPE芯便于从伸展的位置恢复,从而将尼龙线圈拉回到其初始配置。
在另一实施例中,电极载体12可以是袋子,组成该袋子的材料是非导电的,可渗透水分,且能被压缩到很小的体积,并在压力消除后能够释放回其自然尺寸。用于电极载体12的材料的例子包括泡沫,棉,织物或棉类材料,或任何具有所需要特点的其他材料。电极14可例如通过沉积或其他附着机制附着在电极载体12的外表面上。电极14可由具有一定长度的银,金,铂或其他任何导电材料制成。电极14可通过电子束沉积在电极载体12上形成,或者使电极14形成为线圈形的电线,并且利用挠性粘合剂结合到电极载体12上。或者,可以利用其他附着电极的方式,例如将它们缝在电极载体12的表面上。
可以勾勒出目标组织的破坏深度以实现可重复的、预定的深度。如下文将进一步讨论的,可以将例如电极结构,施加到电极的功率(功率密度或电极每单位面积上的功率),以及功率被终止处的组织阻抗的变量,用于影响组织破坏的深度。
选择电极间的间距(即,相邻电极的中心间的距离)和电极宽度,使得尤其在通过电极输送最大功率时,切除将到达组织内的预定深度。最大功率是能实现低阻抗,低电压切除的水平。例如,参考图4D,线19a和19b代表了图4C中RF施加器头的电极14的中心线,即间距。中心线是分开的,其在远端I处最接近,而在近端H处进一步分离。中心线离的越近,破坏深度越浅。亦即,在操作中,在输卵管峡9内或最接近输卵管峡9处定位的在远端的破坏深度最小。
参考图5A,优选地,每个电极被以与其相邻电极极性相反的极性激励。这样,如图5A中描绘的52,53和54,在电极点之间产生能量场模式,从而有助于引导电流通过组织T的流动,以形成切除区A。如图5A可以看出,如果通过例如每第三个或第五个电极,而非全部电极激励增加电极间距,该能量模式将延伸到更深的组织中。例如,参见模式53,其由电极间具有一个非激励电极的电极激励而产生,或模式54,其由电极间具有两个非激励电极的电极激励产生的。
切除的深度也受电极密度(即,与有源电极表面相接触的目标组织区域的百分比)的影响,并且通过预先选择该有源电极覆盖的量可以调节切除的深度。例如,当有源电极表面覆盖超过10%的目标组织时,切除的深度要比当有源电极表面只覆盖1%的目标组织时大得多。
通过示例,当有源电极表面覆盖超过10%的目标组织区域时,利用3-6毫米间距和约为0.5-2.5毫米的电极宽度,在9-16平方厘米的目标组织面积上输送约为20-40瓦的能量将会造成约为5-7毫米的切除深度。在达到这一切除深度之后,组织阻抗将会变得很大,以致切除自己终止。相比之下,当有源电极表面覆盖不到1%的目标组织区域时,采用相同的功率,间距,电极宽度和RF频率,将产生只有2-3毫米的切除深度。参考图5B能够更好地理解这种情况,其中51a代表高表面密度电极,51b代表低表面密度电极。为了在低和高表面密度电极之间进行比较,每个括入的低密度电极组被看作单一电极。这样,电极宽度W和间距S如图5B所示延伸。
从图5B中很明显得到,即使高和低密度电极的电极间距和宽度都是一样的,与由低密度电极51b产生的切除区域A2相比,具有与其下组织T相接触的更大有源区域的电极51a产生的切除区域A1延伸到更深的组织T中。具有超过10%有源电极表面覆盖的间距的电极宽度,和基于切除区域6平方厘米、功率20-40瓦所得到的切除深度的一些例子在下表中给出:
电极宽度 间距 大约深度
1毫米 1-2毫米 1-3毫米
1-2.5毫米 3-6毫米 5-7毫米
1-4.5毫米 8-10毫米 8-10毫米
具有少于1%有源电极表面覆盖的间距的电极宽度,和基于切除区域6平方厘米、功率20-40瓦所得到的切除深度的一些例子在下表中给出:
电极宽度 间距 大约深度
1毫米 1-2毫米 0.5-1毫米
1-2.5毫米 3-6毫米 2-3毫米
1-4.5毫米 8-10毫米 2-3毫米
因此可以看出,当有源电极表面覆盖减少时,切除深度明显减少。
参考图5C,如果在电极载体构件上提供多个,间距紧密的电极51,使用者可以设置RF发生器以激励电极,这将产生想要的电极间距和有源电极区域。例如,如图5C所示,可以交替地激励电极,使前三个受激励电极具有正极性,紧接的三个电极具有负极性等。所有这六个电极在一起可以称为是一个双极性电极。作为另一个例子,如图5D所示,如果想要更大的切除深度,可以将前五个电极激励为正极性,将第七个到第十一个电极激励为负极性,而保留第六个电极不活动,以提供足够的电极间距。因此,在一种实现方式中,使用者能够通过控制电极的激励,以产生想要的破坏深度。
再次参考图3A和3B,在一种实现方式中,为了实现想要的切除深度,包含在RF发生器16中的控制器可监视在RF施加器头2的远端的组织阻抗,并且一旦检测到阈值阻抗,控制器自动关闭。由于RF能量使组织脱水,因此液体流失,并且使用真空通过管17将液体从该区域中抽出,管17可经吸入/吹气端口38连接到吸入/吹气单元40(图3A,3B)。该吸入抽取切除过程中组织释放的水分,使其远离电极载体12,并且阻止在切除过程中在电极14周围形成低阻抗液体层。随着越来越多的组织脱水,电极14处的阻抗也越来越高。考虑到系统阻抗(如,电缆中的电感等),通过校准RF发生器16可将阈值阻抗水平设定成与想要的切除深度相一致。
一旦检测到阈值阻抗,控制器关闭RF能量,以防止过多的组织破坏。例如,当发射每平方厘米5.5瓦的RF能量到组织时,50欧姆的组织阻抗可以指示破坏深度在近端H大约为3至4毫米,而在远端I大约为2.5毫米。在替换实施例中,可将RF发生器16配置成使得在阈值阻抗水平以上,RF发生器输送RF功率的能力大大降低,这样有效地自动终止能量输送。
再次参考图3A和3B,导引器鞘(introducer sheath)32便于将输卵管闭塞设备15插入子宫腔5中,以及从子宫腔5中移除该设备。鞘32是在轴10上可滑动的管状构件。如图3A所示,鞘32可在远端状态和近端状态之间滑动,其中远端状态是指其中将RF施加器头2压缩进鞘内的状态,而近端状态是指使鞘32向近侧运动,以使RF施加器头2从鞘32中释放出来的状态(图3)。通过将电极载体12压缩为小体积,RF施加器头2可很容易地经子宫颈插入子宫腔5中。
在使用过程中,例如,通过使远端手柄构件34朝近端手柄构件37运动,从而使鞘32沿远端方向滑动,可使电极载体12缩回到鞘32中。使远端手柄构件34朝近端手柄构件27运动,也可沿近端方向推进轴10。轴10相对于吸入/吹气管17的运动造成轴10向近侧拉紧挠性构件19。挠性构件19的近端运动反过来拉动弯曲部分22,造成弯曲部分22运动到如图3B所示的打开状态(参见图4B)。在一个实施例中,需要锁紧机构(图未示)在完全抽出的状态下把持住轴,以防止在切除手术过程中RF施加器头2的意外关闭。
挠性构件19从管17中向外的变形量能够通过操纵手柄6在轴10上沿着近端或远端滑动来控制。轴10相对于管17的滑动量控制挠性构件19的形状。
如上所述,在替换实施例中,手柄6能够配置为使得管17能够相对于轴10向远端运动。管17的远端运动反过来使挠性构件19向外变形。挠性构件19从管17中向外的变形量能够通过操纵手柄6从而沿着近端或远端滑动管17来控制,并且管17相对于轴10运动的量控制挠性构件19的形状。
如图3A所示,从RF施加器头2到吸入/吹气端口38形成流动路径36。吸入/吹气管17的近端流体耦联到该流动路径,使得经吸入/吹入端口38将气体流体引入吸入/吹气管17,或从其中抽回。例如,利用吸入/吹气单元40在吸入/吹气端口38上施加吸力。这就导致子宫腔5内的水汽通过可渗透的电极载体12,经孔17a进入吸入/吹气管17,通过管17,并经端口38通过吸入/吹气单元40。如果想要往子宫腔5里吹气,可以经端口38往吸入/吹气管17中导入吹入气体,例如二氧化碳。吹入气体穿越管17,通过孔17a,并且通过可渗透的电极载体构件12进入子宫腔5。
为了内窥镜可视化的目的,可提供一个或多个附加部件。例如,如图4E所示在导引器鞘32的壁上可以形成管腔42,44和46。光学仪器可用来提供子宫腔内的图像。例如,参考图3B和4E,成像导管,例如光学纤维束,从官腔42中延伸,并经照相机电缆43耦联到照相机45。照相机所拍摄的图像可显示在监视器47上。照明光纤50从官腔44中延伸并耦联到照明光源49。可选的第三个管腔46可以是仪器通道,如果需要,手术仪器可以通过它被引入到子宫腔5内。在替换实施例中,轴10的壁上形成一个或多个管腔42,44和46。
因为在使用过程中,电极载体12表面上的电极14最好保持与子宫腔5和输卵管峡9的内表面相接触,所以电极载体12可以在其内部具有附加部件,当电极载体12在患者体内展开时,可以为电极载体装置增加结构完整性。
参考图1A-C,5和6A-D,应该描述用于利用输卵管闭塞设备15使女性绝育的过程58。将输卵管闭塞设备15通过阴道和子宫颈插入到子宫3底部处的内口13(步骤59)。经吸入/吹气管17将气体例如二氧化碳输送到子宫腔5内,以扩张子宫腔5(步骤60)。然后将输卵管闭塞设备15推进子宫腔5中(步骤61)。
使用者利用照相机45所提供的图像使输卵管峡9在监视器47上可视(步骤62)。图7A是输卵管闭塞设备15进入宫腔5时使用者可以看到的示意图;输卵管峡9是远距离的相对小点。如图7B所示,当将输卵管闭塞设备15推进输卵管峡9中时,很容易使输卵管峡9可视。如图7C所描述,将仍在鞘32内的RF施加器头2的远端定位到输卵管峡9处(步骤63)。如图7D所描述,抽回鞘32,以暴露电极14(步骤64),并且将RF施加器头2展开成打开位置(步骤65)。
停止吹气,并且允许子宫腔5坍塌包裹在RF施加器头2上(步骤66)。经吸入/吹气管17在RF施加器头2上施加真空,以抽取周围组织至与电极14接触(步骤67)。开启RF发生器16,以给电极14提供RF能量(步骤68)。一旦切除了想要的组织量,马上停止RF能量(步骤69)。在一种实现方式中,每平方厘米的电极表面积供应5.5瓦特的RF功率,直到达到预定阻抗阈值,在这点上终止功率。
子宫腔5能够被二次吹气,RF施加器头2折叠到闭合位置,并且输卵管闭塞设备15旋转大约180°。然后RF施加器头2能够定位在另一个输卵管峡9并且重复上述手术过程,以切除在另一个输卵管峡9上的组织。然后关闭输卵管闭塞设备15,并从患者的身体中取回。在切除手术后,在输卵管峡9处组织的愈合和结疤反应将永久闭塞输卵管11,而无需任何异物留在女性的身体内,也不用任何切口来进入女性的腹部。这种手术过程在输卵管闭塞术中是快速,微创,和高效的。
参考图8,显示了RF施加器头2的结构体70的替换实施例。该结构体70包括外部海波管(external hypotube)72和内部海波管(internalhypotube)74。如果在如上所述的输卵管闭塞设备15的实施例中实现结构体70,外部海波管72能够是轴10,而内部海波管74能够是吸入/吹气管17。在内部海波管74上形成罩78,所述内部海波管74在远端79处配置成V字形状,以便能够到达输卵管峡9。罩78可以是由记忆材料,如镍制成的编制的或编织的结构。
罩78能够通过将内部海波管74相对于外部海波管72的运动,例如通过推动内部海波管74向远端远离外部海波管72,坍塌成窄圆柱配置。在坍塌状态下,例如,当RF施加器头2处于闭合位置时,罩78能够适合在如上所述的鞘32内。一旦去掉鞘32,内部海波管74就运动回相对于外部海波管72的打开位置,制作罩78的材料性质将罩78扩展成所描述的想要的形状。电极载体,例如由上述金属织物制成的电极载体12,能够安装在结构体70上,完成RF施加器头。
已经描述了本发明的一些实施例。尽管如此,应该理解的是:只要不背离本发明的精神和范围,可以对本发明实施方案进行各种修改。因此,其他实施例将包括在以下权利要求范围内。
Claims (5)
1.一种用于输卵管闭塞术的系统,其包括:
具有远端和近端的输卵管闭塞设备,其中,所述远端包括其上具有一个或多个双极性电极的电极载体,并且在打开状态下,所述远端成形为近似子宫腔在要被闭塞的输卵管的输卵管峡区域内的形状,其中,所述输卵管闭塞设备包括内部空腔的伸长构件,通过所述伸长构件伸展开的是在其远端形成有多个孔的吸入/吹气管;
与所述一个或多个双极性电极电气耦联的射频能量源;
控制器,其配置为控制射频能量向所述一个或多个双极性电极的输送,以便能够控制射频能量通过所述一个或多个双极性电极到达所述输卵管峡,从而将组织破坏到已知深度,这促成了周围组织的愈合反应,其经过一段时间使所述输卵管结疤并闭塞所述输卵管;以及
真空源,其用于抽取所述组织至与所述一个或多个双极性电极相接触,并且抽取在向所述一个或多个双极性电极输送射频能量过程中产生的水分,使水分远离所述一个或多个双极性电极,并且基本上消除所述一个或多个双极性电极周围的液体;
其中,所述电极载体包括织物鞘内的结构支持构件,其具有导电金属区域,并且具有在其上形成的一个或多个的非导电区域,从而产生所述一个或多个双极性电极;
其中,所述结构支持构件包括可在闭合状态和打开状态之间运动的挠性构件,弯曲部分附着在所述吸入/吹气管以及所述挠性构件的内表面上,所述挠性构件附着在所述伸长构件的远端以及所述吸入/吹气管的远端上,所述挠性构件的变形取决于所述伸长构件和所述吸入/吹气管相对于彼此运动的大小。
2.根据权利要求1所述的系统,其中,射频能量通过所述一个或多个双极性电极到达所述输卵管峡从而破坏组织包括汽化子宫内膜和破坏表浅子宫肌层。
3.根据权利要求1所述的系统,还包括:
与所述输卵管闭塞设备的远端电气耦联的,用于照明所述子宫的照明源;以及
与所述输卵管闭塞设备的远端电气耦联的,用于提供所述子宫的图像的光学仪器。
4.一种用于闭塞输卵管的装置,包括:
伸长构件,其具有远端,近端和内部中央空腔,所述内部中央空腔用于与真空源耦联,并用于抽取水分,使水分远离一个或多个电极,其中,通过所述伸长构件伸展开的是在其远端形成有多个孔的吸入/吹气管;
附着在所述伸长构件的远端的电极载体,所述电极载体具有其上形成的所述一个或多个双极性电极,并且所述电极载体用于与射频能量发生器耦联,所述电极载体可在闭合位置和打开位置之间运动,在所述闭合位置,使所述电极载体折叠以便插入到子宫腔中;在所述打开位置,使所述电极载体的远端成形为适合输卵管的输卵管峡的形状;
其中,所述电极载体包括织物鞘内的结构支持构件,其具有导电金属区域,并且具有在其上形成的一个或多个的非导电区域,从而产生所述一个或多个双极性电极;
其中,所述结构支持构件包括可在闭合状态和打开状态之间运动的挠性构件,弯曲部分附着在所述吸入/吹气管以及所述挠性构件的内表面上,所述挠性构件附着在所述伸长构件的远端以及所述吸入/吹气管的远端上,所述挠性构件的变形取决于所述伸长构件和所述吸入/吹气管相对于彼此运动的大小。
5.根据权利要求4所述的装置,还包括:
附着在所述伸长构件的所述远端且用于与照明源耦联的照明器;以及
附着在所述伸长构件的所述远端且用于与图像显示设备耦联的光学仪器。
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-
2004
- 2004-12-20 US US11/019,580 patent/US7731712B2/en not_active Expired - Fee Related
-
2005
- 2005-12-05 CN CN2005800484403A patent/CN101123924B/zh not_active Expired - Fee Related
- 2005-12-05 AU AU2005319524A patent/AU2005319524A1/en not_active Abandoned
- 2005-12-05 MX MX2007007443A patent/MX2007007443A/es not_active Application Discontinuation
- 2005-12-05 KR KR1020077016667A patent/KR20070100306A/ko not_active Application Discontinuation
- 2005-12-05 WO PCT/US2005/043850 patent/WO2006068808A1/en active Application Filing
- 2005-12-05 EP EP05825814A patent/EP1830731A1/en not_active Withdrawn
- 2005-12-05 BR BRPI0519155-6A patent/BRPI0519155A2/pt not_active IP Right Cessation
- 2005-12-05 CA CA002591545A patent/CA2591545A1/en not_active Abandoned
-
2010
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BRPI0519155A2 (pt) | 2008-12-30 |
CA2591545A1 (en) | 2006-06-29 |
KR20070100306A (ko) | 2007-10-10 |
MX2007007443A (es) | 2007-09-04 |
AU2005319524A1 (en) | 2006-06-29 |
EP1830731A1 (en) | 2007-09-12 |
US7731712B2 (en) | 2010-06-08 |
CN101123924A (zh) | 2008-02-13 |
US20060135956A1 (en) | 2006-06-22 |
US20100228245A1 (en) | 2010-09-09 |
WO2006068808A1 (en) | 2006-06-29 |
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