CN101188978A - 用于组织烧灼的装置 - Google Patents

用于组织烧灼的装置 Download PDF

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CN101188978A
CN101188978A CNA2006800183650A CN200680018365A CN101188978A CN 101188978 A CN101188978 A CN 101188978A CN A2006800183650 A CNA2006800183650 A CN A2006800183650A CN 200680018365 A CN200680018365 A CN 200680018365A CN 101188978 A CN101188978 A CN 101188978A
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约瑟夫·埃德
卡姆兰·内扎特
本杰明·西奥多·诺代尔二世
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Abstract

本发明涉及烧灼和切除组织。在相对的组织表面上设置一对电极,通过所述电极应用射频功率,以烧灼电极之间的组织块。在实现烧灼后,可以最小的流血或者没有流血的情况下,沿烧灼区内的平面切除所述组织,然后移除所述组织块。

Description

用于组织烧灼的装置
技术领域
本发明一般涉及组织烧灼,特别地,本发明涉及用于组织烧灼的改进的电极。
背景技术
在许多用于各种目的的外科处理中需要进行组织和器官切除。在所有的组织切除处理中主要关心的是止血即停止流血。必须通过缝合或者烧灼,封闭所有的供应被切除的器官或者组织部分的血管,以抑制切除组织时的流血。举例来说,当在子宫切除手术中切除子宫时,必须抑制被切除的子宫颈中的流血以及沿子宫侧面为其供血的血管的流血。类似地,当为了切除肿瘤或者其他的目的而切除部分肝脏时,肝脏中的血管必须被个别地封闭。肝脏是高度血管化的器官,封闭血管是非常耗时的。实现止血在开放手术处理和微创手术处理是必须的。尽管如此,在后一种情况中,由于通过插管和其它小通道的有限入口,封闭血管就更加耗时,而且非常成问题。
在腹腔镜和切除前必须切碎器官或者其他组织的其他的限制入口的处理中,止血是特别重要的。大部分器官由于太大而不能整体通过插管或者其他的限制入口的通道中移出,从而需要该组织在切除前被切碎,如切、磨或者相反地打碎成小片。应当理解,血管化的组织的切碎是非常成问题的。
因此,需要提供改进的方法、系统和装置,以实现与器官和组织切除处理有关的止血。特别地,需要使外科医生以高效率的方式利用可用的外科设备如下面所述的射频电源在降低病人的风险和损伤的同时,实现止血的方法和系统。优选地,所述方法和系统可用于大范围的组织的切除处理,至少包括子宫切除、肝脏组织切除、胆囊切除、前列腺切除、肺切除等。优选地,所述方法可以实现被切除组织的整个体积的完全或者充分完全的血凝固和止血,以有助于该处理作为后续的切碎。实现如最小化流血的情况切碎组织对腹腔镜和其他的微创处理以及其他的外科处理具有很大的益处。
利用射频(RF)能使身体器官或者器官的部分坏死是公知的。美国专利No.4,979,948描述了一种气球电极(balloon electrode),该气球电极在子宫内部膨胀,用于施加RF能量以使子宫的内皮内衬(endothelial lining)坏死。美国专利No.3,845,711描述了一种在拇指和中指上设置有柔性电极的手套,所述手套用于把RF电流传导到传统的镊子、解剖刀等。美国专利No.4,972,846描述了一种作为直接与心外膜接合的去纤颤器导线(defibrillator lead)使用的电极片(electrode patch)。美国专利No.5,178,618和No.5,078,736描述了一种支架(stent),该支架可以被通电,以在身体内腔的内部上施加RF能。Lorentzen等人(1996)Min.Ivas.Ther.Allied Technol.5:511-516描述了一种可以在组织内旋转以避免组织体积(tissue volume)的环状电极。
美国专利No.6,203,541公开了一种控制外科手术器械的具有一对双击电极的自动电路。所述电路包括:用于测量一对电极之间的电流的装置;与所述电流测量装置电气通信的阻抗检测电路;与所述阻抗检测电路电气通信的比较器;以及,与所述比较器电连接的控制器。所述阻抗检测电路根据测量到的电流计算电极之间的阻抗并产生表示计算的阻抗的第一信号。比较器处理所述第一信号,如果所述计算出的阻抗落在阻抗的预定范围内,所述比较器产生启动信号;如果所述计算出的阻抗超过停用阀值,则比较器产生停用信号。所述控制器接收启动信号和停用信号,开响应启动信号而把第一控制信号发送到射频能量输出台以激活电极,响应停用信号而把第二控制信号发送到射频输出台以停用电极。
美国专利No.6,398,779公开了一种电外科学地封闭组织的方法,所述方法包括以下步骤:向组织施加RF能量初始脉冲,所述脉冲具有选择的特性,从而不会过度地加热组织;测量组织的阻抗值,并响应施加的脉冲;根据测量到的阻抗值,确定在第一RF能量脉冲施加到组织期间使用的脉冲参数的初始设置。所述发明根据至少一个在后续RF能量脉冲期间发生的电瞬态改变后续RF能量脉冲的个别脉冲的脉冲参数。在确定所述电瞬态不存在或者达到了最小输出电压后,所述方法停止产生后续RF能量脉冲。
美国专利No.5,443,463提供了一种用于选择性地凝结血管或者包含血管的组织的凝结镊子。所述方法涉及在镊子的尖头之间放置血管或者包含血管的组织,其中镊子的爪包含多个通过射频电源激发的电极。多个传感器与所述电极连接,并与血管或者组织相接触,以测量组织或者血管的温升,从而向射频电源提供反馈以控制加热从而进行凝结血管或者组织。该发明还提供装置的上部尖头可以被分离成两部分,同时在所述两个上部部分之间设置切割刀片,以在凝结后切断凝结的血管。
发明内容
本发明提供有助于与对经历多种处理(procedure)的病人进行组织切除(resection)或者移除(removal)有关的组织烧灼的方法、系统和装置。所述处理可以涉及整个器官的移除如子宫切除、胆囊切除、前列腺移除、肺切除等。可选地,所述方法可以涉及器官或者其他组织的部分移除,如通常从高度血管化的器官如肝、肺等中移除肿瘤等。所述方法一般包括两个步骤,其中,组织首先利用射频能量坏死或者烧灼整体或者部分。特别地,至少沿组织内的所需切除平面进行烧灼。然后,沿所述平面切除组织。有利地,已经发现充分最小化在坏死的或者经过烧灼的组织内的切除,并且在某些情况下甚至可以消除由组织切除引起的流血。优选地,组织烧灼在组织的目标体积上进行,所述目标体积典型地为整个器官或者器官的一部分,如子宫、肝叶、部分肺、前列腺等。通过实施目标组织体的充分完全的烧灼,减小或者消除了该组织的流血量,从而有助于后续的切碎和组织移除。由此,大幅度地降低了器官和组织移除的流血和手术处理所需的时间。
在第一特定方面,本发明的方法包括靠着组织块的间隔开的表面接合至少第一电极结构和第二电极结构,典型地,靠着组织块的相对的表面。所述第一和第二电极结构可以具有一般相似的几何结构,以对称的方式与组织相接触。可选地,所述电极结构可以具有不相似的几何结构,如一个电极结构被配置成插入到自然身体孔口,而另一个电极结构被配置成与所述孔口间隔开的外部组织表面相接合。在一些实例中,可以使用多于两个的电极结构,但是至少两个电极结构(或者单个结构的独立区域)被加上极性相反的电压,以向组织施加射频能量。在另外一些实例中,电极结构可以是作为例如单弹性管或弹性壳的单个支撑结构的一部分形成的不同区域,所述单个支撑结构可以置于器官或其他组织之上,并在其上形成两个或者两个以上的电极表面。当然,所述不同的电极表面在用于施加相反极性的高频能量时被相互隔离。同时,使具有相同极性的电极不接触也是同样重要的。在又一些实例中,单电极结构可以具有多个导电区或者活性区,其中所述导电区可以被施加相同或者相反极性的电压。在其他的实例中,电极结构可以具有组织穿透元件,以增强电极和组织的接触并增加电极结构上的导电区的总可用面积,以传递高频能量到组织。这种组织穿透元件可以和适合的或者刚性表面电极一起使用,也可以代替适合的或者刚性表面电极使用。在所有的实例中,电极结构或者它的导电区被配置成与具有下述的最小面积的组织表面的充分连续的片段或者部分的接合。当使用组织穿透元件时,它们典型地以大体均匀的方式分散在电极结构的导电区上。
高频(通常称为射频)电源通过电极结构的导电区被施加到组织块,所述电源被施加一定的时间和足够烧灼或者坏死所述电极之间的组织的数量,优选地至少沿所需的切除平面。通常,大块组织通过切碎如磨、粉碎、切成小片等切除。目标组织体的坏死可以极大地有助于这种切碎。坏死意味着组织的细胞被杀死,组织的流血在后续的切除中已经被充分抑制了。组织通常沿坏死的组织块中的平面切除,切除时仅有上述的最小流血量。
电极结构的导电区的面积至少为1cm2,更常见的为至少2cm2,一般为5cm2或者更大,更一般地为10cm2或者更大,较佳地为50cm2或者更大。所述电极具有很多种特性,并可以通常是刚性的、柔性的、弹性的、延展性的、适合的等。优选地,所述电极为柔性的,以促进电极和组织表面顺应地接合。在至少一些实例中,需要提供柔性的、弹性的可以与组织或者器官表面的外部边缘相匹配的电极,其中电极的弹性保证稳固地接合和电极接触。但是,在其他的实例中,电极可以被特别地配置成具有与特定组织表面接合所需的几何结构。
施加到器官或者组织的高频能量一般以射频提供,其中,所述射频典型地介于但不限制于100kHZ至10MHZ的范围内,通常介于200kHZ至750kHZ。功率级取决于处理的组织的表面积和体积,但一般介于10W至500W的范围内,一般介于25W至250W,更一般地介于50W至200W。能量一般以介于1W/cm2至500W/cm2的级别施加,更一般地介于10W/cmm2至100W/cm2。能量被施加足够把处理的组织块中的组织温度提升到高于烧灼或者坏死所需的阀值水平的时间,一般该阀值水平高于至少60℃,通常为高于70℃,时常为高于80℃或者更高。但是,需要限制应用的能量,以使附近的组织不被大幅度地加热而损坏。在这方面,使用相反的双极电极是特别有利地,原因在于双击电极在电极之间集中能通量并限制对没有被限定在该相反的电极之间的邻近组织的影响。因此得到的坏死的组织可以充分包括整个被处理的器官,或者在其他的情况下可以包括更窄的区域如平面区域。
在另一方面,本发明包括具有至少多个电极和电源的系统,其中,所述电源连接到所述电极以在电极之间施加高频功率如双极高频功率。电极可以一般地按上述进行配置,并通常由电外科学的探针携带,以便于使用。所述探针可以具有很多种配置,但通常包括至少轴和用于操作轴的手柄。所述电极安装在轴的远端,并通常从轴的近端操作以使它们彼此相对地打开或者关闭以与它们之间的器官或者其他的组织块接合或者捕获该器官或者其他的组织块。所述电极可以具有上述的任何性质,并可以特别地包括可以与组织表面弹性接合并匹配的金属的或者金属化的网孔(mesh)。所述电外科学的探针可以以通常的双极模式使用,即每个电极被施加相反的极性。可选地,该电极表面可以被施加相同的极性,而其它的电极用于完成高频电路。典型地,该另外的电极是可以插入到自然身体孔口或者内腔的或者被插入到器官或者其他的组织块中的一个或者多个探针的形式。所述探针可以与自然内腔相匹配,和/或盐水或其它的导电流体可以被引入到内腔中,以帮助建立导电路径。
在特定实施例中,一种电外科学的装置包括单个适合的结构,例如弹性地或者非弹性地膨胀的管状元件,例如可膨胀管状编织网。所述电极形成在所述适合的支撑结构上的多个位置上,并通常如通过应用绝缘或者依靠适合的支撑结构的固有的非传导特性相互隔离。
附图说明
图1概念性地示出了本发明的使用多个刚性板电极的系统和方法;
图2示出了包括电极结构配置的电外科学的探针,其中,每个电极结构包括多个电绝缘的活性区;
图3为示出了本发明的发电机的示意性方块图;以及
图4为示出了本发明的用于功率调制的算法的流程图。
具体实施方式
本发明的方法、系统和装置用于处理病人的多种器官、部分器官或者其他的固体组织区。所述器官或者其他的组织块具有间隔开的组织表面,通常为相对的组织表面,电极结构可以接近这些组织表面,以在所述表面之间施加射频能量。所述组织表面可以容易地接近或者需要预处理如钝器解剖、利用传统的外科技术切除小的组织或血管等以获得入口。本发明可以处理的器官包括子宫、肝、前列腺、肾、肠、胰腺、肺、胸部、肌肉等。
利用对准由间隔开放置的电极结构限定的目标组织区的双极射频能量处理器管和其他的组织。所述射频能量可以由工作在任何接受的频率上的传统的通用电外科学的的电源供应,所述频率典型地介于上述说明的范围内。电源可以使用传统的正弦或者非正弦波型并以固定的或者可控的能量级别操作,其中在可控的能量级别中,可以选择电压和/或电流。适当的电源由供应商如Valleylab、Aspen和Bovie提供。在一些实例中,需要在电源和电极之间使用阻抗匹配变压器,以提高能量传送效率。
电极可以配置成适于和组织表面接合的任何方式。从而,电极可以是刚性的、柔性的、弹性的、无弹性的(非膨胀性的)、平面的、非平面的等,并可以任选地使用组织穿透元件,以增强电极结构和组织之间的电接触,同时增加电极区。优选的电极配置可以是适合的,以使它们可以与普遍不同的组织表面接合和相匹配(参见如美国专利申请No.11/371,988(代理人编号ARGA0003),这里引入其全部内容作为参考);优选的电极也可以被特别的配置成具有和特定的器官或者组织的几何结构相接合的几何结构。在上述两种实例中,电极结构还可以具有组织穿透元件。下文中将讨论该每个实例。
一种电极配置使用金属化的网孔,该网孔为柔性的且具有弹性。这种网孔适合于使用在可伸缩电极如用于微创处理的可伸缩电极上。所述网孔可以悬挂在更多的刚性框架元件之上或之间,其中,刚性框架元件自身可以膨胀或者缩小以使用网孔电极。这种网孔还可以用于制作可以像鞋内衬底一样放置在器官或者组织块上的弹性管或者弹性壳。在这种管状电极的情况下,经常需要在单个网孔上形成两个或者更多的分离的电极表面,其中,通常利用网孔自身的材料性质将所述电极表面隔离,即它们是聚合物的且不具有传导性。弹性网格可以是编织结构或者其他的机织织物结构如美国专利No.5,431,676、No.5,234,425、No.4,018,230所描述的,这里引入这些专利的全部公开作为参考。使用可径向膨胀的编织结构是有利的,因为组织接收内腔那里的直径可以通过轴向拉长控制,即,编织结构可通过缩短其长度实现膨胀,通过拉长其长度可以实现收缩。所有这些网孔和编织结构可以通过传统的无电的喷镀技术(electroless plating technique)金属化。适合于喷镀的金属包括金、银、铜、不锈钢、以及它们的组合和合金。适合的弹性的网孔材料包括很多种弹性体。适合的编织网孔材料包括尼龙和其他的一般不可膨胀的聚合体。
所行类型的电极结构部可以被配置成具有传导表面和非传导表面。这通常利用把一个表面作为暴露的金属面,而电极的其他表面被覆盖或者隔离。对刚性电极的情况,所述隔离可以是层压的、涂层的或者直接应用到相对的表面的其它方式。对柔性且具有弹性的电极,绝缘层也必须是柔性的,以使它可以与电极一起膨胀和收缩而不会损失或者移动。在一些情况下,需要使用与电极一起膨胀的单片材料,该单片材料覆盖需要绝缘的表面。
参考图1,本发明的系统10包括第一复合电极12、第二电极14和射频电源16。第一电极包括独立连接到电源16的一个极上的多个刚性板,第二电极为连接到电源16的相反的极上的刚性板。在其他的实施例中,第二电极可以是非刚性的并且也可以提供多个电极。实际上,在某些情况下,多个回路电极是较佳的。电极12和14可以与组织块T相接合以与组织块T的相对的表面相接合。然后,射频电源被选择性地通过形成电极12(将在下面详细叙述)的多个刚性板的任意组合应用到组织,以完全烧灼捕获在电极12和14之间的组织块。在组织被烧灼之后,可以沿组织的烧灼区中的线将其切除。有利地,在烧灼组织内的切除最小化流血并简化止血。
为了在烧灼如子宫的组织中使用,适合的电极可以被放置在子宫的相对的外部表面上。与上面描述的不同,电极通过电源的公共极性供电,而不是施加相反极性的高频能量。可以把探针插入到子宫腔中,并给该探针施加相反的极性。这样,相对的组织表面一方面包括子宫腔的内衬(interior lining)另一方面包括子宫的外部表面。对子宫的情况,通常需要烧灼可能除了子宫颈之外的充分整个组织块。但是,对其他身体器官和组织块的情况,可以只需要烧灼组织的一部分。通过选择电极的配置,高频能量可以集中在组织的有限部分。
优选地,所述电极包括多个不同的导电区,其中导电区可以是相互绝缘的也可以是相互电性连接。单电极结构可以包括三个、四个、五个以及高达十个或者更多分离的导电区。这种导电区通常由它们之间的电绝缘区或结构限定。当需要两个或者两个以上导电区电连接时,可以设置小的电连接线路以桥接导电区之间的绝缘。通常,电极结构上的至少一些绝缘的导电区被电连接到相反的极性,在一些实例中,本发明的方法可以仅利用具有多个导电区的单电极结构。可选地,单电极结构上的绝缘的导电区可以电连接到相同的极性,其中不同导电区的主要目的在于控制或者配置传送到组织块中的高能电通量。例如,可能需要传送高频电能到组织块的间隔开的区域而不烧灼被烧灼的区域附近或者之间的其他区域。在这种情况下,电极结构可以通过适当地放置导电区进行设置。
图2示出了包括一对电极结构302和304的系统300。至少一个电极结构304包括多个单独的导电带310,该多个导电带310相互间隔开以使它们相互电绝缘。在其他的实施例中,导电带可以由电绝缘材料分开。导电带3 10可以以实际上任何样式选择性地电连接到不同的极性。通常,需要接通导电带以使相邻的导电带具有相反的极性。熟悉本领域的技术人员应当理解,电极可以是不连续的,或者电极可以利用如屏蔽、电极沉积等技术形成。
本说明书中,电极结构的导电表面一般包括具有连续表面几何结构的刚性或者适合的部件,即选择所述几何结构以产生与组织表面的连续接触面,靠着该连续接触面它们接合。在一些实例中,可能需要在电极结构上设置附加的结构或部件,以提高或者增加电极结构和组织表面之间的有效电接触面积。特别地,经常需要在电极结构上设置组织穿透元件以提高电接触即减小电极和组织之间的电阻抗,同时更重要地,增加了电极和组织之间的总表面接触面积。组织穿透元件可以是针、钉、突出、通道等,但通常为具有尖锐的末梢尖端的钉,以使它们可以穿透组织表面进入到下面的组织块。所述钉的深度可以介于1mm至5cm,一般介于2mm至1cm。钉的直径可以介于0.1mm至5mm,一般介于0.5mm至3mm。通常,钉均匀地分布在电极结构的组织接触区上,钉的密度可以介于0.1个钉/cm2至10个钉/cm2,一般介于0.5个钉/cm2至5个钉/cm2。经常,除了导电的适应的或者刚性的电极表面之外还设置钉或者其他的组织穿透元件,但在一些实例中,钉可以提供电极结构的总导电或活性区域。
包括多对电极结构的系统可以包括通过例如由绝缘棒分离的导电带。但是,此外,组织穿透钉可以沿每个导电带设置。优选地,多个钉沿每个导电带的长度设置。电极结构一般是弯曲的结构,以使它们可以放置管状身体结构或者组织块上。但是,应当理解,导电带可以由允许电极结构变平以呈现很多种其他的配置的适合的网孔形成。此外,绝缘结构也可以利用柔性的或者适合的材料形成,以允许进一一步地重新配置电极结构。
导电带可以以交替极性的方式接通。最简单地,相邻的导电带连接到单个电源的相反电极。无论如何,重新设置电连接以以实际上任何样式接通导电带是很简单的事情。此外,也可以使每个导电带的不同区域绝缘,如1和2,以向这些区域施加不同的极性。
利用系统300可以通过选择性地接通电极表面或区域的不同部分实现多种不同的组织烧灼样式。通过选择性地以双极的方式接通两个相邻的电极表面,同时不接通所有其他的表面,可以烧灼限定的组织区。相比之下,通过接通其他的电极表面如4、5、6和7,可以烧灼更大的区域。通过精确地控制电极表面的极性的样式可以实现略微不同的样式。电极表面可以以交替电极(+、-、+、-)的样式接通以产生组织烧灼样式。(+、+、-、-)、  (+、-、-、+)和(-、+、+、-)等的样式也可以用于产生略微不同的组织烧灼的样式。
图2示出了包括一对爪(jaw)56的电外科学探针50,所述爪56具有远端58和近端60。可选地,该探针可以包括典型地为圆柱体的轴,所述轴的尺寸设置成可以通过微创手术中使用的常规插管中导入。从而,所述轴的直径可以介于5mm至15mm,通常为标称5mm、10mm或者12mm,以与常规的插管相符。轴的长度典型地介于10cm至30cm之间,其特定范围取决于所要进行的处理。
电外科学探针50包括连接到爪56的近端60的手柄组件62。所述手柄组件包括杆组件64,用于在电极展开后驱动所述电极304。所述手柄组件还包括用于连接电极和上述的电外科学的电源的同轴线接插件,虽然所述电极也可以由传统的电源供电。
可以使用电外科学的探针50烧灼并切除部分肝脏。举例来说,探针可以通过插管引入,电极前进并打开,以使它们捕获需要被切除的部分肝L。在电极接触肝的相对的表面后,施加上述的射频能量。在组织被完全烧灼后,可以沿坏死的组织块中的任何线将其切除。可选地电外科学的探针可以用于烧灼一连串的相互靠近的组织块,以烧灼并切除比仅使用单独应用射频能量更大的组织块。
在一个实施例中,电极可以用于如烧灼并切除子宫。子宫包括具有从每侧延伸的输卵管的主体。除了输卵管之外,几个大血管沿子宫的中线充分延伸。电极可以放置在子宫的前表面和后表面,且输卵管保持附着在电极结构之间并从电极结构之间向外延伸。根据该处理,在一些情况下输卵管会被包括在封闭的、烧灼的且切碎的区域,在另外一些情况下,可以选择不封闭并烧灼输卵管。这个决定取决于卵巢是否连同子宫一起被切除。然后,向子宫施加射频能量,直到子宫体充分完全坏死,其中,对介于10秒至20分钟的时间,射频能量的典型的能量级别介于10W/cm2至100W/cm2之间。由于电极的几何结构,坏死的子宫体沿一般子宫的子宫颈端部处的线并沿邻近输卵管的线终止。然后,沿烧灼的组织区内并靠近子宫颈和输卵管的线将子宫切除。在子宫的烧灼区中进行的切除很大程度上最小化了流血并有助于止血。然后,如果是开放式手术,则整体移出子宫,如果是微创手术,在移出子宫前需要将其随意地切碎(分割成小片)。
在本发明的一个实施例中,沿装置设置平行的电极,从而在相对的爪和电极接触时,避免正负极接触。在这个实施例中,安装在同一个爪中的相反极性的电极必须安装在非传导材料中,以避免短路。
爪可以通过软的可压缩材料如泡沫橡胶偏移,以避免电极接触同时保证与所有的中间组织可靠地接触。本发明的这个实施例可以适应变化的组织厚度,该厚度很可能超过5至10cm。
为了避免高阻抗的局部区域影响沿整个电极的总系统阻抗从而由于电压达到了最大值而可能地降低整个系统的能量输出,多个电极可以物理上串联设置。这些电极可以同时地或者重复顺序地或者其他顺序地接通。这些电极也可以整体相互独立地接通。在这种方式中,如果一个区域已经被良好地封闭了并从而达到了较高的阻抗值,这不影响组织还没有封闭的从而具有较小的阻抗的其他区域,即封闭后阻抗上升,这可以限制电力传输。根据特定电极所在地/位置中的组织的性质,每个电极或者电子对可以具有唯一的功率和能量传送曲线。
从这里公开的内容可以容易地理解,利用更长的电外科学电极或者其他的高能封闭阻抗机构来在许多手术中节约手术时间是有利的。例如,根据所涉及的组织的组成和其沿需要被烧灼的组织的长度的厚度,可以最优化两个电外科学爪的几何结构的变化和电源,以促进手术移除特定器官的全部或者一部分。
举例来说,子宫的连接组织和韧带相对较薄并具有相对较低的阻抗,即根据动物模型,在能量传送到组织之前,该阻抗在很多情况下小于3欧姆。但是,沿需要被烧灼的组织的长度以及在烧灼过程中,这个阻抗不是恒定的。从而,具有如小于100伏特容量的电源对完全封闭和烧灼支撑器官的所有组织和血管是不充分的,因为在开始施加能量以烧灼组织之后,经常必需根据随着封闭和烧灼处理的进行而增加的阻抗斜升电压以保持能量级别。此外,对更厚的组织或者器官如肝、肺、或肠或者组织的更长的片段,很有可能需要更高的电压。对更脆弱的组织或者器官,高压功率能级可能是不安全的。此外,由于这些器官和组织中的一些具有较高的阻抗,电源必须具有充足的截止(cut-off),以在封闭循环的结尾处的停止传送到器官的能量。因此,一旦电源确定完成了封闭循环,电源应该自动地终止传送到组织的电流。虽然手动停止能量传送也是可选的,由于它是主管的切不太可能包括对组织或者器官的条件的精确分析,手动停止不太符合需要。这里公开的自动反馈系统避免过度加热或者灼伤周围的健康的组织和器官,同时最小化粘附到电极上的组织,并可以保证充分的血管封闭。因此,这里的电源具有使用者可以根据处理的器官进行选择的多个可调整设置。每个器官的先前特征为每个特定的器官决定预设的电压极限和曲线以及取决于时间、阻抗、电压、电流、温度或者能量数据或者它们的组合的最终停止(终点)参数。从而,使用为每个特定处理最优化安全性和功效的处理。根据血管分布的程度和血管的尺寸,各种组织和器官也可能需要不同的设置。
本发明的另一个实施例进行短时间周期(即小于5秒)内以较低的安全功率级别通过组织的电流的测试脉冲。这个时间周期内产生的曲线数据是迅速地(即小于5秒)并被自动地编入到算法中,该算法根据在测试周期内确定的条件最优化安全有效地封闭组织或者器官的电压、能量、时间和/或功率输出。
类似地,可以为每个适应症最优化爪/电极的几何结构。爪和手柄段的长度为组织的长度和所要封闭和切碎的位置最优化。爪产生的力和/或最小压缩间隙为选择的组织最优化。需要最小的力来确保在组织的整个长度上均匀地封闭。但是,过大的力导致组织损坏并在封闭处理之前引起大量的流血。最优的压缩力为每个器官预先确定,或者压缩手柄被设计成为特定的器官施加预定的力。在本发明的一个实施例中,这通过类似的转矩扳手的滑动离合器(clutch)型机构或者通过爪的行程限制器控制。从而,存在为每个应用设计的单独的装置,或者可以具有多个单独设置的一次性装置,其中所述多个单独设置为器官或者需要手术的或者移除的器官的厚度调整到预定的设置。在一些实施例中,通过沿设置有一个或者多个应变计的一个或者两个爪的长度检测压力,可以自动动态地调整力。
在其他的实施例中,可以通过爪自身的材料限制通过爪施加的力。在器官或者组织需要较小的力以安全地压缩并封闭的情况下,具有较小的弯曲模量的材料是比较适当的,而对可以安全地以更大的力夹紧以保证有效地封闭的组织,可以使用弯曲模量较大的材料。
在另一个实施例中,通过利用加压的流体膨胀爪内的中空腔来调整爪的厚度。
装置的手柄和爪之间的角度也可以为应用最优化。这主要由外科手术环境中处理的迎角决定。所述装置对某些应用可以具有平缓的或者渐进的曲线,而不是陡角。
处理的切割或者切碎部分也可以为特定的器官最优化。对利用锋利的刀片进行切割的情况,根据需要被移除的器官或者组织的厚度,刀片的宽度也是变化的。也可以根据特定厚度/组织切割的容易度最优化切割材料的厚度。更强韧的组织可能需要更多的拉锯动作或者更厚的或者带有锯齿的刀片或者剪断装置,这也由特定的应用预先确定。如果高能系统用于切碎组织,如之前在上述电源部分说明的,这也可以根据应用进行最优化。
关于这里公开的多个电极的算法,每个电极在能量传送、RF周期监测、调制和终止方面被单独地对待。本发明的优选实施例中被监测的参数为电流、电压、阻抗、能量、功率以及温度。也可以监测这些参数的任意组合以及其他的参数值。这些值在数学模型中被监测,该数学模型将这些值组成单独的根据之前的经验分析确定RF封闭处理的品质的算法。可以调制能量和/或功率输出以在最短的时间内,在不产生过多的可能损坏周围的健康组织的热传递或者不会产生使组织粘结到电极表面的过度加热的前提下,最优化动脉和静脉密封,其中,该最短的时间优选地小于1分钟,通常需要小于30秒。周期的最优化可以根据功率发生器软件/固件中的算法程序进行。所述软件/固件调制并在条件被满足时最终终止周期,其中,所述条件根据经验确定为安全地并且重复地满足正在进行的外科处理的条件。举例来说,达到一定的阻抗和/或温度值,并在超过这个点的预定时间内继续功率级,或者一旦达到一定的阻抗和压力或者温度阀值就降低(或者相反地增加)功率级。
一旦已经发生脱水,阻抗倾向于达到稳定的水平并对脱水已经发生的点之后的封闭处理的质量只能进行较小的测量。因此,单独的阻抗测量不能精确地判定血管/组织封闭。因此,提供对功率、电压和/或能量进行的多个调制、阶梯函数或者连续改变,以最优化封闭周期。所述周期变化或者调制可以产生向上或向下的复合变量改变(complex variable change),以最优化血管/组织封闭条件。其结果是,作为用于与特定电极接触的特定组织片段的反馈数据的结果,每个电极或者电极对可以具有不同的周期时间和功率、电流、电压和能量曲线。所述调制/决定程序可以是基于监测多个变量并响应预订条件的组合以调整终止周期的复杂算法。
关于这些变量,下面的是一些典型的变量:
功率10至1000瓦特/通道或者电极对,典型地为100至500瓦特/通道或者电极对;
阻抗2至500欧姆,典型地为2至200欧姆;
电压5至500伏特,典型地为50至250伏特;
时空(time space)1至1200秒,典型地为5至30秒;以及
能量1至30,000焦耳,典型地为1000至10,000焦耳。
在目前的优选实施例中,与恒定电压或者恒定电流设计相反,功率发生器由恒定功率输出设计构成。在发明的设计中,功率输出基于系统上的负载表示。从而,如果系统处理非常高的阻抗负载,则电压被保持在合理的级别上,以避免产生电弧。在使用功率发生器的应用即电烧灼中,在烧灼组织的过程中,阻抗范围可以介于如2欧姆之150欧姆之间变化。通过应用恒定功率,本发明的功率源在低阻抗时提供充足的电流以在组织开始烧灼时实现初始脱水,随着烧灼继续进行,功率源施加更高的电压以完成组织封闭处理。从而,本发明在开始烧灼处理时提供更大的电流和更小的电压,而在处理的封闭阶段提供更大的电压和更小的电流。这种功率发生器的控制只需要系统监测能量。
在目前的优选实施例中,功率源具有设定所需功率的装置。这可以与曲线或者下面讨论的其他方面一致。脉冲宽度调制连同反馈变压器一起使用。所述系统改变反馈变压器的原线圈并产生经过调节的输出。次级线圈可以被调节为如对应所需的安培数的15伏特以产生所需的功率输出。根据由原线圈上的脉冲宽度确定的周期,可以确定功率曲线。从而,本发明确定反馈变压器的原线圈中的某个功率级别,且次级线圈为负载即组织的阻抗提供相同的功率级别。
在本发明的优选实施例中,功率发生器是电外科应用中的多个电极的功率源。因此,功率发生器具有多个输出通道,每个通道都是单独可调的。在图3中给出了示出包括多个上面结合图1和图2说明的电极310的电外科器械300的方块图。所述电外科器械包括用于从功率发生器16接收功率的传导通道55和提供接地通道和/或为功率发生器提供反馈的返回通路360,其中,所述传导通道55典型地包括多个导体,每个导体对应功率发生器的一个输出通道,所述反馈可以包括涉及电流、电压、阻抗、能量、功率和温度的任何信息。在电外科器械中设置有适当的传感器。例如,热敏电阻可以用于监测温度,而阻抗可以在电机的任意两个或者多个之间测量。可选地,可以在电外科器械的一个爪上设置接地平面,单独的电极可以放置在电外科器械的另一个爪上,以从电极提供通过返回电极的路径。从而,一个爪可以为放置在另一个爪上的电极建立接地平面。此外,功率发生器可以连接到电极的正极/负极端子。因此,功率发生器内的电子可以实时地再分配极性和/或器械内的各种接线端310的使用。例如,电极或者接线端中的一个可以作为阻抗检测元件保留。在本发明的其他实施例中,这个元件可以用于检测整个处理期间的阻抗。
功率发生器16由功率源335构成,所述功率源335具有多个由电子控制设备50控制并被连接到电外科器械中的单独电极的输出,如上所述。所述多个输出通过微处理器或者其他的控制机构330独立地操作并被容易地调制和再分配。从而,在烧灼周期的操作中的特定点上,一个输出可以被分配到电极元件中的一个或者多个,并可以在周期的其他点上被动态地重新分配。例如,如果功率源为四通道功率源且所述电外科装置具有16个电极,从而,每个通道可以支持电外科器械中的四个电极。尽管如此,可以改变这个设置,以使一些通道比其他通道支持更多的电极。
微处理器330可以通过许多曲线340配置以利用功率曲线操作装置并根据需要进行的处理操作各种电极之中的功率分配。从而,对子宫切除可以为电外科学器械建立特定的曲线,而对肝处理可以建立不同的曲线。此外,可以设置智能卡阅读器365,用于为特定的处理设置系统并为记录关于在处理期间功率发生器的操作的信息提供存储器。例如,捕捉应用到每个通道的功率、检测到的阻抗、检测到的温度等,以为处理提供文件。
图4为示出了本发明的功率调制的流程图。在处理的开始,用户确定应用于特定处理的曲线(400)。例如,某些组织或者处理需要较高的初始功率级别,然后在烧灼处理期间提供减小的功率级别。
放置探针(电外科学器械)(405)并接通功率源的电源(410)。系统自身初始化(415),如通过沿电外科学器械中的各种电极捕获初始阻抗读数,以为需要烧灼的组织产生曲线。初始化也可以包括获取初始温度读数、表示沿外科器械表面的组织厚度的应变压力读数和其他的读数。控制信号可以通过电外科学器械传递,以确定这些值。例如,可以提供初始的较低的电压以测量阻抗,这样,可以为实际的组织建立实时曲线,这个实时曲线可以作为对为特定处理预先建立的曲线的修改使用。从而,为处理建立的曲线可以根据与需要烧灼的组织相关的测量进行修改。
然后,系统设定确定接近终点的时间的阀值(420),这些阀值可通过测量如阻抗、电流、电压、能量、功率和温度确定。所述阀值也可以与时间元素结合操作。从而,当达到阀值时系统可以继续操作一定的时间周期,以确保达到适当的终点,以完成烧灼。在一些实施例中,分配给已经达到终点的部分组织的电极的功率发生器通道可以重新分配给那些仍活跃地烧灼组织的电极,以为处理提供额外的功率,从而加速使其结束。
向电外科学器械施加能量(425)以开始烧灼。在这个处理中系统检测两个或者更多参数,并确定何时达到阀值(430)。一旦达到阀值,执行终点处理(435)。终点处理可以像斜降功率一样简单,或者也可以包括设定计时器。需要注意,对大范围的阻抗保持恒定的同时,可以在烧灼过程期间调制应用的功率,以对处理应用功率曲线。由于本发明为多个电极提供功率的多个通道,一些电极可能在其他电极之前达到终点。这种情况下,传送到这些电极的功率被停止,而向其他的电极继续传送功率。从而,每个电极可以具有不同的功率曲线,该功率曲线被实时地进行调整。如果所有的终点都没有达到(440),处理继续(445);否则,关闭传送到系统的功率(445),完成处理。
根据算法,电外科学器械包括用于实时地捕获各种处理参数的传感器。从而,可以测量选择的电极对质监或者电极组之间的阻抗;可以与一个或者多个物理变化沿器械的表面测量温度;以及,可以利用沿一个或者两个爪的长度设置的应变器测量烧灼的效果(在这个实施例中,应变器也可以用于预计算烧灼轮廓)。在这点上,每个电极可以被认为是沿为与探针爪接触的组织表面的特定区域单独操作的单独装置。
虽然这里参考优选实施例对本发明进行了说明,但熟悉本领域的技术人员可以容易地理解在不背离本发明的精神和范围的情况下,可以利用其它的应用替代这里说明的实施例。例如,在一些实施例中,功率发生器在开始烧灼时通过测量阻抗、压力中的任一个或者它们的组合和/或其他的参数,来检测组织是否组织出现于每个电极的位置。如果任意电极对处都没有出现组织,则这个电极对是空闲的,且表示这个结果的指示被提供给功率发生器的操作者。功率发生器也可以为每个电极对设置状态指示器,用于指示关于每个电极对是否封闭周期被激活或者完成。在这个实施例中,每个电极对可以包括模式状态指示器如LED,一旦烧灼周期开始,用于表示空闲、活跃、完成条件任何一个。
因此,本发明仅通过下面的权利要求限定。

Claims (25)

1.一种用于烧灼组织的装置,包括:
多个电极,用于和组织块的处理表面接合;
电源,连接到所述电极,用于选择性地向电极施加高频功率,以烧灼所述处理表面之间的组织;以及
用于检测直接传送到所述电极和/或直接传送到所述组织的高频功率的装置,所述装置还用于根据电流、电压、阻抗、能量、功率、时间和温度中的任意两个调制所述高频功率。
2.根据权利要求1所述的装置,其特征在于,所述电极中的至少一个包括适合的导电表面。
3.根据权利要求1所述的装置,其特征在于,所述电极中的至少一个包括刚性导电表面。
4.一种用于组织烧灼的装置,包括:
多个电极,用于和所述组织的一个或者多个表而接合;
电源,所述电源具有多个通道,所述多个通道选择性地连接到所述电极,以选择性地向电极施加射频能量,所述电源提供基于需要烧灼的组织的多个可选择的调整设置;
自动反馈系统,用于根据在烧灼过程中监测的电流、电压、阻抗、能量、功率、时间和温度中的任何一个实时地调制所述电源;以及
用于从所述电源向所述电极供应射频能量的装置,以通过所述电极向所述组织施加能量以选择性地使所述的电极中的不同电极,所述装置还通过所述电极中的至少两个独立地在一定时间内向所述组织施加可以烧灼与所述电极接触的组织的足量功率;
其中,根据能量传输和射频周期监测、调制和终止独立地处理每个电极;以及
每个电极可以具有实时调制的差分功率曲线。
5.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括:用于监测参数的装置,所述参数包括电流、电压、阻抗、能量、功率、时间和温度中的任何一个和它们的任意组合。
6.根据权利要求5所述的装置,其特征在于,还包括:
把所述监测到的参数结合到算法中的数学模型,所述算法根据之前的经验分析决定组织封闭的质量;
其中,调制电源输出以通过在特定条件被满足时终止烧灼周期来最优化组织封闭,所述特定条件根据经验确定为安全并且重复地满足进行的处理的条件。
7.根据权利要求6所述的装置,其特征在于,所述条件包括阻抗和/或温度和/或压力值中的任意一个;以及
所述调制包括在超过预定点后在预定时间内继续功率级别,或者一旦达到特定阻抗和压力或者温度阀值就降低(或者相反地增加)所述功率级别。
8.根据权利要求6所述的装置,其特征在于,所述算法包括多个调制、阶梯函数或者功率、电压和/或能量的连续变化中的任意一个,以最优化组织封闭周期;
其中,作为接触特定电极的特定组织片段的反馈数据的结果,每个电极可以具有不同的周期时间和功率、电流、电压和能量曲线。
9.根据权利要求4所述的装置,其特征在于,所述电源还包括恒定功率输出电路。
10.根据权利要求4所述的装置,其特征在于,所述电源还包括用于根据曲线设定所需功率的装置。
11.根据权利要求4所述的装置,其特征在于,所述功率供应多个输出通道,每个输出通道可以独立地调整,以为多个电极中的每一个提供功率源。
12.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括一个或者多个传感器。
13.根据权利要求4所述的装置,其特征在于,所述电源通过一个或者多个曲线被配置成根据所需的烧灼处理利用功率曲线和电极间的功率分布操作。
14.根据权利要求4所述的装置,其特征在于,还包括:
智能卡阅读器,用于读取智能卡,以在为特定烧灼处理配置所述电源时使用,所述智能卡阅读器还用于记录表示所述烧灼处理期间电源的操作的信息。
15.根据权利要求4所述的装置,其特征在于,所述电源还包括:
用于捕获需要被烧灼的组织的实时轮廓的装置,所述装置还用于利用所述实时轮廓为特定烧灼处理调整预先建立的曲线;
其中,根据需要烧灼的组织的实时轮廓修改之前为特定烧灼处理建立的曲线。
16.根据权利要求4所述的装置,其特征在于,所述电源还包括:
用于设置阀值的装置,所述阀值决定何时接近终点;
其中,所述阀值通过测量结果确定,所述测量结果可以包括阻抗、电流、电压、能量、功率、温度和时间元素中的任意一个或者它们的组合。
17.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括用于在烧灼期间监测两个或者两个以上参数的装置,所述装置还用于决定何时达到阀值。
18.根据权利要求17所述的装置,其特征在于,一旦达到所述阀值,执行终点处理。
19.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括用于测量选择的电极对或者电极组之间的阻抗的装置。
20.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括用于测量温度的装置,所述温度与沿所述电极的一个或者多个相关联的器械的表面的一个或者多个物理变化有关。
21.根据权利要求4所述的装置,其特征在于,所述自动反馈系统还包括用于利用局部应变器测量烧灼效果的装置,其中,所述应变器沿与所述电极中的一个或多个相关联的至少一个探针爪的长度设置。
22.根据权利要求21所述的装置,其特征在于,所述应变器预计算烧灼轮廓。
23.根据权利要求4所述的装置,其特征在于,所述电源还包括在周期的开始利用阻抗、压力或者它们的任意组合和/或其他的参数检测是否组织出现在每个电极处;其中,没有出现组织的任何电极对成为空闲,所述电源指出那个(些)电极处于空闲。
24.根据权利要求23所述的装置,其特征在于,所述电源还包括用于每个电极对的指示器,所述指示器提供表示所述周期是活动的还是已经完成的烧灼周期的状态。
25.根据权利要求24所述的装置,其特征在于,一旦所述周期启动,为每个电极提供三个模式状态“灯”或者其他的可视状态指示器,用于指示所述周期所处的空闲、活动和完成三个状态中的任意一个。
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US20060259034A1 (en) 2006-11-16
WO2006124601A3 (en) 2007-11-15
KR101007106B1 (ko) 2011-01-10
EP1895921A1 (en) 2008-03-12
CA2608152A1 (en) 2006-11-23
US20060271041A1 (en) 2006-11-30
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US7942874B2 (en) 2011-05-17
US7862565B2 (en) 2011-01-04
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US20110202058A1 (en) 2011-08-18
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WO2006124601A2 (en) 2006-11-23
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