CN1220590A - 用于接触电凝的水分传输系统 - Google Patents

用于接触电凝的水分传输系统 Download PDF

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CN1220590A
CN1220590A CN97195178A CN97195178A CN1220590A CN 1220590 A CN1220590 A CN 1220590A CN 97195178 A CN97195178 A CN 97195178A CN 97195178 A CN97195178 A CN 97195178A CN 1220590 A CN1220590 A CN 1220590A
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electrode
tissue
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C·特鲁凯
D·C·奥斯
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Novacept Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1485Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0475Tracheal tubes having openings in the tube
    • A61M16/0477Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • A61B2017/4216Operations on uterus, e.g. endometrium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • A61B2018/1246Generators therefor characterised by the output polarity
    • A61B2018/126Generators therefor characterised by the output polarity bipolar
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Abstract

供实现器官和其它组织切除用的装置和方法包括一个实际上吸收和/或可透过水分的电极携带装置。该装置装在细长心轴的远端,且在其表面装有电极阵列。在将切除装置与被切除组织接触之后,使用RF发生器把RF能量传给电极,由此由电极产生流向被切除的组织的电流。当电流加热组织时,水分(如水蒸汽或液体)离开组织,使组织脱水。电极携带装置的透水性/或吸水性使水分离开切除位置,防止水分提供电流的导电路径。

Description

用于接触电凝的水份传输系统
本发明总的涉及用于切除或凝固人体器官内表面的装置和方法,更特殊地,涉及用于切除人体组织内壁,如子宫和胆囊的装置和方法。
切除人体器官内壁是一种包括把器官内壁加热到破坏内壁细胞的温度,或为了止血凝固组织蛋白的手术。这种手术可以作为对许多情况之一的治疗来完成,例如,子宫内膜层的慢性出血,或胆囊粘膜层异常。现有的有效切除方法包括在器官内循环加热的液体(是直接地或者是在气囊内),用激光处置器官内壁,和用RF能量施加到被切除组织上电阻加热。
美国专利US-5,084,044公开了一种内膜切除的装置,其中,气囊插入子宫内。然后,加热的液体通过气囊循环,以便使气囊膨胀到与内膜接触,和热切除内膜。美国专利US-5,443,470公开了一种用于内膜切除的装置,其中,膨胀气囊的外表面上带有电极。装置在子宫内定位后用不导电的气体或液体灌注气囊,推动电极与内膜表面接触。对电极施加RF能量,以便用电阻加热切除内膜组织。
这些切除装置用于实现切除手术尚可,然而,由于没有数据或反馈信息可以用来指导医生组织切除已进展到多深,用这些装置控制切除深度和切除形状只可以用估计地进行。
例如,加热液体的方法是一种依赖于组织的热传导性的非常被动的且低效的加热过程。该过程没有考虑各种因素的变化,如气囊和在其下面的组织之间的接触量,或者血液通过组织循环的冷却效应。RF切除技术可以实现更有效的切除,因为它依赖于使用RF能量的组织的主动加热,但是,目前使用RF技术的切除深度只能由医生估计,因为尚不可能提供作为实际切割深度的反馈信息。
加热液体技术和最新的RF技术这两者都必须非常小心地进行防止过切除。通常在切除过程中对组织表面的温度进行监视,以保证温度不超过100℃。如果温度超过100℃,组织内的液体开始汽化并由此产生蒸汽,由于切除是在体内密闭的体腔内进行,蒸汽无法选散,反而可能迫使其更深地进入组织,或者它可以通过靠近被切除区域的区域,导致栓塞或者非故意烫伤。
况且,在已有技术的RF装置中,从组织中引出的水产生一个导电路径,流经电极的电流将通过该导电路径流动,这可能使电流无法流入待切除组织。然而,这种围绕电极的电流路径的存在能连续地从电极拉出电流。该电流加热从组织中引出的液体,于是把切除过程变回到被动加热方法,其中,围绕电极的被加热液体使热切除在所要求的切割深度之外继续。
已有技术的切除装置的另一个问题是医生难于发现切除已进行到组织内所要求的深度,于是,在切除手术时,经常出现切除的组织过多或者不足的情况。
因此,希望提供一种切除装置,该装置能消除上述在切除位置产生的蒸汽和液体。另一个要求是提供一种切除方法和装置,所述的装置能控制切除深度,且在达到所要求的深度时能自动地停止切除。
用于实现器官或其它组织的切除或凝固的装置和方法包括一个电极携带装置,该装置实际上能吸收和/或可透过水份和气体,例如蒸汽,并与体腔相适合。抽吸装置用于协助去掉在切除手术时存在或产生的水份,和/或气体,和/或液体。电极阵列被安装并配置在电极携带装置的表面上,以便使切除延伸到预定的深度。所述电极可装有通过改变电极密度或电极间的中心距可变地控制切除深度的装置。
在放置切除装置使其与被切除的组织接触后,用RF发生器把RF能量传到电极上,从而把电流由电极引到待切除的组织。当电流加热组织时,水份(如蒸汽或液体)离开组织,使组织脱水。电极携带装置的透水性和/或吸水性使水份能离开切除位置,从而避免水份为电流提供导电路径。
图1是按照本发明的具有以剖面表示的手柄和处于关闭状态的RF发热电极头的切除装置的前视图;
图2是按照本发明的具有以剖面表示的手柄以及处于开启状态的RF发热电极头的切除装置的前视图;
图3是图2所示切除装置的侧视图;
图4是图2所示切除装置的顶视图;
图5A是图2所示切除装置的发热电极头和主体部份的前视图,且主体以剖面表示;
图5B是沿图5A的5B-5B所示的平面得到的主体的剖面图;
图6是图1所示的切除装置在插入子宫之后但在引导器的壳体缩回和弹簧件起作用之前的子宫示意图;
图7是图1所示的切除装置在插入子宫之后引导器的壳体缩回且RF发热电极头展开时的子宫示意图;
图8是图1装置的RF发热电极头和主体远端部份的剖视图,所示的RF发热电极头处于关闭状态;
图9是图1装置的RF发热电极头和主体远端部份的剖视图,示出了RF发热电极头在外壳已经缩回,但弹簧件通过轴的近端运动释放前的情形;
图10是图1装置的RF发热电极头和主体远端部份的剖视图,所示RF发热电极头在外壳已经缩回,且弹簧件已经释放成完全展开状态的情形;
图11是按照本发明的使用另一种弹簧件结构的RF发热电极头的剖视图;
图12是按照本发明的切除装置远端部份的另一个实施例的侧视图;
图13是图12的切除装置的顶视图;
图14所示是出血的血管,说明使用图12的切除装置控制一般的止血;
图15和图16所示是子宫,说明使用图12的切除装置作子宫内膜切除;
图17所示是前列腺,说明使用图12的切除装置作前列腺切除;
图18是作切除的目标组织的剖面图,显示切除电极与组织表面接触,并说明双极切除时产生的能量场;
图19A-19C是作切除的目标组织的剖视图,显示电极与组织表面接触,并说明如何使用变化的激励电极密度来改变切除深度;
图20是类似于图2所示装置的侧视图,说明按照本发明的切除装置,其中,电极携带装置包括一个可充气的气囊。为清楚起见,未示出电极携带装置的上的电极。
参照图1和图2,按照本发明的切除装置总的包括三个主要部件:RF发热电极头2,主体4和手柄6。主体4包括一个心轴10,RF发热电极头2包括一个装在心轴10远端上的电极携带装置12和在电极携带装置12的表面上组成的电极阵列14。一个RF发生器16电连接到电极上,向它们提供单极或双极的RF能量。
心轴10是一个内部中空的细长件,心轴10优选的长12英寸,截面直径约为4mm。在心轴10外表面上的近端处有一个环13。图6和图7中所示得最清楚,被动的弹簧件15连接在心轴10的远端。
抽取/吹气管17(图6-9)穿过轴10,在其远端有多个孔17a。一个弧形的主动弹簧件19连接在被动弹簧件15的远端和吸取/吹气管17的远端之间。
参照附图2,电极引线18a和18b从心轴的远端20穿过心轴10延伸到近端22。在心轴10的远端20,每个引线18a和18b连接到相应的一个电极14上,在心轴10的近端22,引线18a,18b通过电连接器21连接到RF发生器16上。使用时,引线18a,18b把RF发生器的RF能传输给电极。每个引线18a,18b是绝缘的,且每个引线传透的能量的极性与另一个相反。
电绝缘的传感器引线23a和23b也通过心轴10延伸(图5A和5B)。接触传感器25a,25b分别连接在传感器引线23a,23b的远端并装在电极携带装置12上。使用时,传感器引线23a,23b通过所述的连接器21连接到RF发生器的监视模块上,该模块测量传感器25a,25b之间的阻抗。或者,把一个参考板置于与患者接触的位置上,并测量传感器之一和参考板之间的阻抗。
参考图5B,电极引线18a,18b和传感器引线23a,23b延伸通过管17的外壁和心轴10的内壁间的心轴10,连接到电连接器21上,该连接器优选地是装在心轴10上的环13上。连接到RF发生器16的连接器21至少包括四个相应于每个引线18a,18b,23a,23b的导电触环21a-21d(图1和图2)。环21a,21b分别接收来自RF发生器的正极性和负极性RF能量。环21c,21d分别把来自左右传感器的信号传输给RF发生器16中的监视模块。
参照图5A,电极携带装置12装在心轴10的远端20上。位于电极携带装置12内的心轴远端部分20上有多个孔24。
电极携带装置12优选地具有接近待切除的人体器官的形状。例如,图1至图11所示的装置具有适合于宫内切除的双角形。在这些图中所示的电极携带装置12包括使用时定位在子宫角部区域内的并沿输卵管延伸的角部区域26。
电极携带装置12优选地是用非导电材料做成一个袋状,且可透过水份和/或具有吸收水份能力,并能压缩成较小体积且在去掉压缩时基本上可以回复到原来大小的材料。优选用于电极携带装置的材料例子包括海绵、泡沫塑料,棉花,织物或类似棉花的材料,或者具有所要求特征的其它任何材料。另一方面,电极携带材料也可以做成金属化的织物。为方便起见,术语“垫”可以与术语电极携带装置互换,表示由上述任何材料或者具有所列特性的材料制成的电极携带装置。
电极14优选地装在电极携带装置12的外表面上,例如通过沉积或其它的连接机构。电极优选地用银、金、铂或任何其它导电材料做成细长条。电极可以用电子束沉积连接到电极携带装置12上,或者可以做成螺旋导线并用柔性的粘结剂连接到电极携带装置上。当然,也可以使用其它连接电极的方法,例如把它们缝在携带装置的表面。如果电极携带装置12可以做成金属化的织物,可以在织物表面上刻蚀一个绝缘层,只让电极部分暴露在外。
选择电极间的间隔(亦即相邻电极中心间的距离)和电极的宽度,使得切除可以达到组织内的预定深度,特别是通过电极传输最大功率时(在此所说的最大功率是低阻抗,低压切除时的功率水平)。
切除深度也受电极密度(亦即与激励电极表面接触的目标组织面积的百分比)的影响,且可以通过预选这种激励电极的覆盖量来调节。例如,当激励电极表面覆盖超过10%的目标组织时的切除深度要比激励电极表面覆盖1%的目标组织时要大得多。
例如,当激励电极表面覆盖超过10%的目标组织面积时,用3-6mm间隔和约0.5-2.5mm电极宽度,在9-16cm2的目标组织面积上约传输20-40瓦能量,将使切除深度大约为5-7mm。在达到深度后,组织的阻抗将变得很大,以至于如本发明操作部分所述的切除将自己终止。
通过对此可以看到,当激励电极表面覆盖小于1%的目标组织面积时,用相同的功率、间隔、电极宽度和RF频率所产生的切除深度仅2-3mm。参照图19A将可以更好地理解,图中,高表面密度电极以14A表示,低表面密度电极以14B表示。为了比较低和高表面密度电极,每个低密度电极线板组被认为是一个单个的电极,由此,其电极宽度W和间隔S如在图19A中所示的延伸。
从图19A中显而易见,具有与其下组织T接触的更多激励面积的电极14A产生的切除区域A1比由低密度电极14b产生的切除区域A2更多地深入组织T,即使高和低密度电极为电极间隔和宽度是相同的。
下表给出了某些电极宽度和最终的切除深度的例子,电极的间隔超过10%激励电极表面覆盖率,最终的切除深度是根据6cm2的切除区域和20-40W的功率得出的。
电极宽度     间隔 大致的深度
 1mm     1-2mm     1-3mm
 1-2.5mm     3-6mm     5-7mm
 1-4.5mm     8-10mm     8-10mm
下表列出电极宽度和最终切除面积的实例,间隔小于1%激励电极表面覆盖率,且最终切除深度是根据6cm2的切除面积和20-40瓦的功率得出的。
 电极宽度     间隔 大致的深度
    1mm     1-2mm     0.5-1mm
    1-2.5mm     3-6mm     2-3mm
    1-4.5mm     8-10mm     2-3mm
由此可以看出,当激励电极表面覆盖率降低时,切除深度明显地减小。
在该优选实施例,优选的电极间隔在角形区域约为8-10mm,且激励电极表面覆盖大约1%的目标区域。在颈部区域内(图中标号为28)优选的电极间隔约为1-2mm(10%的激励电极覆盖率),而在主体区域优选的为3-6mm(以超过10%的激励电极表面覆盖率)。
RF发生器16的组成中包括一个控制器,该控制器使使用者能选择在特定的应用过程应该激励哪些电极,以便使使用者能控制切除深度。例如,在要求深度切除的应用过程中,使用者可以选取发生器激励每两个电极中的一个,由此,使电极间的有效间隔最佳,并降低激励电极表面覆盖率的百分比,正如下面对图18所说明的。
尽管在附图中所示的电极是按特定的图案配置的,应该明白,电极可以按任何图案配置,以提供所要求深度的切除。
参照图6和图7,引导器外壳32有利于将装置插入被切除的人体器官或从中取出。外壳32是一个可伸缩地在整个心轴10上滑动的管状件,它可以在图6所示的远端状态和近端状态之间滑动。在远端状态,电极携带装置12被压入外壳内;在近端状态,外壳32移向近端,以便从其内释放电极携带装置(图7)。通过把电极携带装置12压缩成较小的体积,电极携带装置和电极可以很容易地插入体腔内(如通过阴道口插入子宫)。
装在外壳32上的手柄34提供了手指的握持点,以便控制外壳32。手柄34可滑动地装在手柄轨道35上,它包括一个套33,一个指孔37和一对在套33和指孔37之间延伸的隔开的轨道35a,35b。心轴10和外壳32可滑动地通过套33和在轨道35a,35b之间延伸。管17也通过套33和在轨道35a,35b之间延伸,且它的近端固定到接近指孔37的手柄轨道35上。
压簧39围绕着轨道35a和35b之间的抽吸/吹气管17的最近端部份,压簧39的一端抵在心轴10上的环13上,其另一端则抵在手柄轨道35上。使用时,通过朝指孔37挤压手柄34,以便使外壳32在远端方向上滑动,使外壳32从电极携带装置12中缩回。当手柄34朝环13方向前进时,固定在环13上的心轴10被迫在近端方向上滑动,使弹簧39压在手柄轨道35上。心轴10相对于抽吸/吹气管17的移动,将心轴10拉向被动弹簧件15上的近端。被动弹簧件15的近端运动反过来又朝主动弹簧件19拉,使它能移到在图7中所示的打开状态。除非心轴保持在该收缩状态,压簧39将推动环,并由此将心轴向远端推,迫使RF发热电极头闭合。锁紧机构(未示出)用来将心轴保持在完全收缩状态,以防止在切除手术时无意中闭合弹簧件。
弹簧15,19伸展的程度可以通过操纵手柄34来控制,以便使心轴10(通过环13)向近端或远端滑动,心轴10的这种滑动使弹簧件15,19产生类似于钳形的运动。
在手柄轨道35内形成一个流动通道36,该通道与抽吸/吹气口38相连,抽吸/吹气管17的近端与液体流动通道相通,因此,气体、液体可以通过抽吸/吹气口38引入或导出取抽吸/吹气管17。例如,可以使用抽吸/吹气单元40对流体端口38进行抽吸。这就使在子宫腔内的水蒸气通过可透过的电极携带装置,再通过孔17a进入抽吸/吹气管17,然后,经过管17,并经由端口38进入抽吸/吹气单元40。如果需要向子宫腔吹进气体,吹进的气体,例如二氧化碳,可以通过端口38引入抽吸/吹气管17,吹进的气体经管17,孔17a和透气的电极携带部件12进入子宫腔。
如果需要,可以提供用于内窥镜目视观察目的的附加组件。例如,如图5B中所示,在引入器外壳32壁上形成管腔42,44和46。一个成象导管,例如光缆48,穿过管腔42并通过摄象机光缆43连接到摄象机45,摄象机获取的图象可以在监视器56上显示。照明光纤50通过管腔44延伸并连接到光源54上。第三个管腔46是一个器械通道,如有必要,手术器械可通过该通道引入子宫腔内。
由于使用时最希望在电极携带装置12表面上的电极14与被切除组织的内表面保持接触,电极携带装置12内却可以有一个附加组件,在将电极携带装置置于体内时可增加其结构上的整体性。
例如,参照附图11,另一种弹簧件15a,19a可以连接到心轴10并偏置,使得当处于松驰状态时,弹簧件位于在图11所示的完全松驰状态。当外壳32从RF发热电极头2缩回时,该弹簧件应弹到松驰状态。
另一方面,如图20所示,在电极携带装置12内装有一对可充气的气囊52,并通到穿过心轴10并进入气囊52的管(未示出)。在装置插入组织且外壳32缩回后,利用与抽吸/吹气装置40类似的装置,经由与端口38类似的端口向气囊内充入充气媒质,例如空气,使气囊52膨胀。
通过在抽取/吹气管17的近端22的抽吸作用还可以增加电极携带装置12在结构上的完整性。使用抽吸/吹气装置40的抽吸作用将人体器官组织朝电极携带装置12拉,从而与电极14更好地接触。
图12和图13示出了按照本发明的切除装置的另一个实施例。在该实施例,电极携带装置12a的形状通常为管状,由此,该装置不是专用于任何特定的器官形状。具有这种通用形状的切除装置可用于体内需要切除或凝固的任何部位。例如,该实施例可在腹腔镜手术(图14),前列腺内的组织切除(图17),以及宫内切除(图15和16)时用于止血。
操作:
下面将说明按照本发明的切除装置的操作。
参照图1,所示是装置的初始外形,通过沿心轴10远端定位引导器外壳32来使用,这样,它把电极携带装置12压入其壁内。
此时,把电连接器21连到RF发生器16,并把光缆48,照明光缆50接到照明光源,监视器和摄象机54,56和45上。抽吸/吹气装置40接在手柄轨道35上的抽吸/吹气端口38上。抽吸/吹气装置40优选地用于输送吹气压力为20-200mmHg的二氧化碳。
然后,装置的远端插入图6所示的阴道口V并进入子宫U,直到引导器外壳32的远端接触子宫底部F。同时,将二氧化碳经端口38导入管17并进入子宫腔,由此,使扁平三角形的子宫腔扩展成高1-2cm的三角形腔。医生可以通过经管腔42插入的光缆48检测的图象,用摄象机45或监视器56观察内腔。如果在观察时医生决定需要组织活检和其它手术时,所需的器械可以通过器械通道46插入子宫腔。
插入后,缩回手柄34直到靠在环13上。同时,外壳32使电极携带装置12暴露,但此时的电极携带装置12还没有完全展开(图9),这是因为弹簧件15,19还没有移到它们的张开位置。将手柄34进一步往回拉,使心轴10相对于抽吸/吹气管17向近端移动,使被动弹簧件15拉动主动弹簧件19,使它们张开到如图10所示的张开状态。
医生通过显示来自光缆的图象的监视器56检查电极携带装置12是否位于正确位置。
再用接触传感器25a,25b检查装置是否在正确位置且电极携带装置12和内膜是否充分接触。RF发生器的监视模块用传统的方式测量这些传感器之间的阻抗,如果传感器和内膜之间接触良好,测得的阻抗应在20-180欧姆之间,这取决于子宫内膜的含水量。
把传感器放在双角形电极携带装置12的远端,使用时,被置于子宫内最难与子宫内膜的良好接触的地方内。因此,由传感器25a,25b发出的传感器和子宫内膜间的接触良好指示表明电极与子宫内膜已实现良好的接触。
接下去停止供气,通过抽吸/吹气管17注入大约1-5cc的生理盐水,初步地一把电极弄湿,以改进电极与组织间的电接触。引入生理盐水后,将抽取/吹气器40转到抽吸模式。如上所述,通过抽吸/吹气管17对RF发热电极头进行抽吸,使在RF发热电极上的子宫腔塌陷,由此实现电极和子宫内膜组织间的良好接触。
如果使用图12和13的管状装置,在切除手术时,装置以一定角度与子宫的一侧接触。切除完成后,装置(或一个新的装置)再定位与另一侧接触并重复切除过程,见图15和16。
然后,优选的以500KHz,约30瓦的恒定功率的RF能量施加到电极上,如图5A所示,优选使每个电极与相邻的电极以相反的极性激励。这样做,将在电极间产生图18中标号100,102和104所示的能量场图形,从而有助于引导电流流过组织T,形成切除区域A。正如在图18所看到的,如果通过激励每第三或第五个电极而不是全部电极来使电极间距增大,能量图形将深入组织内部(见附图,例如,图形102是通过激励中间隔着一个未激励电极的电极得到的结果,图104是通过激励中间隔着两个未激励电极的电极得到的结果)。
而且,切除深度可以由如上所述的在电极携带装置的区域上提供低表面密度的电极来控制,所述的电极携带装置将与需要较低切除深度的组织区域(图19A)接触。
参照图19B,如果电极携带装置上具有多个密排的电极14,使用者可以设置RF发生器,以激励产生所要求的电极间隔和有源电极区域的电极。例如,可以如图19B所示交替激励电极,且前三个激励电极的极性为正,后三个的极性为负。
图19C示出另一个例子,如果要求较大的切除深度,前五个电极可以以正极性激励,第七个到第十二个电极以负极性激励,而第六个电极保持非激励状态,以提供足够的电极间隔。
当子宫内膜组织加热时,水份开始从组织中选出,水份透过电极携带装置12并从电板引开。水份经过在抽吸/吹气管17上的孔17a并经端口38在抽吸/吹气管17的近端排出,如图7所示。还可以用抽吸/吹气装置40对心轴10进行抽吸,以便从切除位置去除水份。
从切除位置去掉水份可以防止围绕电极形成液体层。如上所述,在切除位置形成的液体层是有害的,因为它形成了一个导电层,即使切除达到了预定的深度,该导电层也能从电极带走电流。这种连续的电流加热液体和周围的组织,并由此使切除受不可预计的热传导方式而继续。
已切除的组织已经脱水,因此导电性也随之下降。通过防止水份离开切除位置并由此防止液体积累,因此,在使用本发明的切除装置时,在切除区域不存在液体导电体。由此,当切除已达到所要求的深度,组织表面的阻抗将变成足够大,使电流停止或接近于停止流入组织。RF切除由此停止,而热切除也不会明显地发生。如果RF发生器配有阻抗监视器,使用该切除装置的医生可以监视电极处的阻抗,并将了解在阻抗上升到一定水平然后保持基本不变后切除已自行中断。相反,如果已有技术的双极RF切除装置与阻抗监视器一起使用,电极周围存在的液体使阻抗监视器给出低阻抗的读数,该读数与已进行的切除深度无关,这是因为电流仍继续通过低阻抗的液体层流动。
还可以采用其它监视和中断切除的装置。例如,可以在一定深度的组织中插入热电偶或其它的温度传感器,以便监视组织的温度,当组织已达到所要求的切除温度时,中止RF能量的供应或者向使用者发信号。
一旦手术过程已经自行中止,可通过抽吸/吹气管17注入1-5cc的生理盐水并保持一小段时间,以便有助于电极从组织表面脱离。然后切换抽吸/吹气装置40,以20-200mmHg的气压输送二氧化碳。输送的气压有助于将被切除的组织从RF发热电极头2上移开,并由此易于闭合RF发热电极头。通过向远端滑动手柄34,使RF发热电极头2移至闭合的位置,以使弹簧件15、19沿装置的轴折叠并使引导器外壳32滑到折叠的RF发热电极头上;医生可以用监视器目视判断切除的满意效果。最后,将装置从子宫腔内取出。
按POT10条的修改
权利要求书
1.一种切除和/或凝固组织的方法,包括如下步骤:
(a)提供一个在其上具有电极的电极携带装置;
(b)把电极定位在与被切除组织接触的位置上;
(c)使电流经电极到达组织,使组织脱水;和
(d)使在步骤(c)脱水时产生的水份能通过电极携带装置和离
开组织。
2.按照权利要求1所述的方法,其中组织具有一个表面,且其中的步骤(b)包括使电极携带装置与组织表面形状一致的步骤。
3.按照权利要求1所述的方法,其中步骤(a)包括提供一个细长管,其中提供电极携带装置的步骤包括在管的远端部分提供电极携带装置,其中步骤(d)包括使至少一部份水份由电极携带装置通过所述管的步骤。
4.按照权利要求3所述的方法,其中步骤(d)包括对管进行抽吸的步骤,以通过管除去水份。
5.按照权利要求1所述的方法,其中该方法还包括下列步骤:
(e)一旦切除已接近于达到预定的深度或脱水水平,自动地中
断流入组织的电流。
6.按照权利要求1所述方法,其中该方法还包括如下步骤:
(e)监视正在切除的组织的阻抗;
(f)一旦阻抗已达到预定水平,自动停止切除手术。
7.按照权利要求1所述方法,其中步骤(c)包括使电流通过所选定的一些电极的步骤。
8.按照权利要求1所述的方法,包括通过电极携带装置进行抽吸的步骤,以便使组织与电极携带装置接触,以利于去掉水份。
9.一种用于向切除组织输送能量的切除和/或凝固装置,该装置包括:
一个可透过水份和/或可吸收水份的电极携带装置;
多个装在电极携带装置上的电极;
用于把射频能量传输到电极的装置;和
能够将水份吸入电极携带装置或通过它的装置。
10.一种用于向切除组织输送能量的切除和/或凝固装置,该装置包括:
一个可透过水份和/或可吸收水份的电极携带装置;
多个装在电极携带装置上的电极;
用于把射频能量输送到电极上的装置;和
一个细长的管,其中,电极携带装置装在管内,且其中所述的管包括多个在电极携带装置之下的通气孔。
11.按照权利要求9所述的装置,共中能够抽吸水份的装置包括用于将水份从电极携带装置除去的抽吸装置。
12.按照权利要求9所述的装置,其中装置还包括一个细长的管,其中电极携带装置装在管内,且其中能够抽吸水份的装置包括通过管将水份从电极携带装置除去的吸取装置。
13.按照权利要求9所述的装置,其中电极携带装置是由海绵制成。
14.按照权利要求9所述的装置,其中电极携带装置是由泡沫塑料制成。
15.按照权利要求9所述的装置,其中电极携带装置是由多孔充填材料制成。
16.按照权利要求9所述的装置,其中电极携带装置还由可顺从(conformable)的材料制成。
17.按照权利要求9所述的切除装置,还包括在电极携带装置内的结构支承装置。
18.按照权利要求17所述的切除装置,其中结构支承装置包括一个可充气的气囊。
19.按照权利要求17所述的切除装置,其中结构支承装置包括位于电极携带装置内的多个弹簧件。
20.按照权利要求19所述的切除装置,其中弹簧件可在闭合状态和开启状态之间移动。
21.按照权利要求9所述的装置,还包括至少一个由电极携带装置携带的接触传感器和测量阻抗的装置。
22.一种用于宫内切除的装置,包括:
一个细长的管,
一个装在管内且形状上接近子宫形状的电极携带垫;
一个装在垫上的电极阵列;
用于把RF能量输送到电极上使电流从电极流到被切除组织的装置;和
用于当基本达到预定的切除深度时自动地中断由电极流向组织的电流。
23.按照权利要求22所述的装置,还包括用于将来自正在切除的组织的水份吸入电极携带垫的装置。
24.一种切除组织的方法,包括如下步骤:
(a)提供一个其上具有电极的电极携带装置;
(b)把电极定位到与被切除组织接触的位置;
(c)选择实施切除的深度;
(d)把RF能量通过选定的一些电极传送到组织上,以便使组织
的切除基本达到所选择的切除深度。
25.按照权利要求24所述的方法,其中步骤(d)包括选择产生接近于所要求的切除深度的切除的有效电极间隔和向选定的一些电极输送RF能量的步骤,使被激励的电极间的间隔基本上是选定的有效电极间隔。
26.按照权利要求24所述的方法,其中步骤(d)包括选择产生接近于所要求的切除深度的切除的电极表面密度和向一些选定的电极输送RF能量的步骤,使被激励的电极的电极表面密度基本上是选定的电极表面密度。
27.按照权利要求9所述的装置,其中电极携带装置和电极是由金属化的织物制成。
28.按照权利要求27所述的装置,其中金属化的织物包括刻蚀在其上的绝缘层,以使电极隔离。

Claims (26)

1.一种切除和/或凝固组织的方法,包括如下步骤:
(a)提供一个其上具有电极的电极携带装置;
(b)使电极与被切除组织接触;
(c)使电流经电极流向组织,从而使组织脱水;和
(d)使在步骤(c)脱水过程中产生的水份进入电极携带装置并
   离开组织。
2.按照权利要求1所述的方法,其中组织具有一个表面,且其中步骤(b)包括使电极携带装置与组织表面形状一致的步骤。
3.按照权利要求1所述的方法,其中步骤(a)包括提供一个细长的管,其中提供电极携带装置的步骤包括在管的远端部分提供电极携带装置,且其中步骤(d)包括至少使部份水份从电极携带装置通过所述的管的步骤。
4.按照权利要求3所述的方法,其中步骤(d)包括对管子进行抽吸的步骤,以便从管中抽出水份。
5.按照权利要求1所述的方法,其中所述方法还包括下列步骤:
(e)一旦切除已基本达到预定的深度或脱水水平,自动中断流
   入组织的电流。
6.按照权利要求1所述方法,其中所述方法还包括以下步骤:
(e)监视经受切除的组织的阻抗;
(f)一旦阻抗已达到预定水平即中止切除过程。
7.按照权利要求1所述方法,其中步骤(c)包括使电流通过所选一部份电极的步骤。
8.照权利要求1所述的方法,包括对电极携带装置进行抽吸的步骤,以便使组织与电极携带装置和电极接触,从而利于去掉水份。
9.一种用于向切除组织输送能量的切除和/或凝固装置,该装置包括:
一个可透过水份和/或可吸收水份的电极携带装置;
装在电极携带装置上的多个电极;和
用于将射频(RF)能量输送到电极上的装置。
10.按照权利要求9所述的装置,其中所述装置进一步包括一个细长管,其中电极携带装置装在管内,且其中所述管包括多个在电极携带装置之下的通气孔。
11.按照权利要求9所述的装置,还包括一个用于将水份从电极携带装置除去的抽取装置。
12.按照权利要求9所述的装置,其中装置还包括一个细长的管,其中电极携带装置装在管内,且其中所述的装置还包括用于通过管将水份从电极携带装置除去的吸取装置。
13.按照权利要求9所述的装置,其中电极携带装置由海绵制成。
14.按照权利要求9所述的装置,其中电极携带装置由泡沫塑料制成。
15.按照权利要求9所述的装置,其中电极携带装置由多孔充填材料制成。
16.按照权利要求9所述的装置,其中电极携带装置由可顺从(conformable)材料制成。
17.按照权利要求8所述的切除装置,还包括在电极携带装置内的结构支承装置。
18.按照权利要求17所述的切除装置,其中结构支承装置包括可充气的气囊。
19.按照权利要求17所述的切除装置,其中结构支承装置包括位于电极携带装置内的多个弹簧件。
20.按照权利要求19所述的切除装置,其中弹簧件可在关闭状态和开启状态之间移动。
21.按照权利要求8所述的切除装置,还包括至少一个由电极携带装置携带的接触传感器和用于测量阻抗的装置。
22.一种用于宫内切除的装置,包括:
一个细长的管,
一个装到管内且形状接近于子宫形状的电极承载垫;
一个装在垫上的电极阵列;
用于把RF能量输送到电极的装置,以便使电流从电极流到被切除的组织;
用于在基本达到预定切除深度时自动切断从电极流向组织的电流的装置。
23.按照权利要求22所述的装置,还包括用于将来自正在切除的组织的水份引入电极携带垫的装置。
24.一种切除组织的方法,包括下列步骤:
(a)提供一个在其上具有电极的电极携带装置
(b)把电极定位在与被切除的组织接触的位置上;
(c)选择需进行切除的深度;和
(d)通过选定的一些电极把RF能量传输到组织上,使组织切除
   到接近所选的切除深度。
25.按照权利要求24所述的方法,其中步骤(d)包括选择产生接近于所要求的切除深度的切除的有效电极间隔以及向选定的一些电极传输RF能量的步骤,使被激励的电极间的间隔基本上就是所选择的有效的电极间隔。
26.按照权利要求24所述的方法,其中步骤(d)包括选择产生接近于所要求的切除深度的切除的电极表面密度和向一些选定的电极传输RF能量的步骤,使被激励电极的电极表面密度基本上就是所选择的电极表面密度。
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DE69733556D1 (de) 2005-07-21
EP0898465B1 (en) 2005-06-15
DE69739697D1 (de) 2010-01-21
ATE451066T1 (de) 2009-12-15
AU2558597A (en) 1997-11-07
KR20000005488A (ko) 2000-01-25
BR9708644A (pt) 2000-01-04
CA2251216A1 (en) 1997-10-23
ATE297696T1 (de) 2005-07-15
EP0898465A2 (en) 1999-03-03
NO984741D0 (no) 1998-10-09
WO1997038637A1 (en) 1997-10-23
EP1415607B1 (en) 2009-12-09
DE69733556T2 (de) 2006-07-20
JP3942639B2 (ja) 2007-07-11
NO984741L (no) 1998-12-08
US5769880A (en) 1998-06-23
IL126471A0 (en) 1999-08-17
AU721648B2 (en) 2000-07-13
EP1415607A1 (en) 2004-05-06

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