CN105283143A - 电外科装置和方法 - Google Patents

电外科装置和方法 Download PDF

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CN105283143A
CN105283143A CN201380043100.6A CN201380043100A CN105283143A CN 105283143 A CN105283143 A CN 105283143A CN 201380043100 A CN201380043100 A CN 201380043100A CN 105283143 A CN105283143 A CN 105283143A
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electrode
pulse
energy
tissue
electrosurgical system
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CN105283143B (zh
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G·L·朗
G·J·巴科斯
D·N·普莱西亚
P·K·夏尔斯
W·J·鲍尔斯
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613—Irreversible electroporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00815—Temperature measured by a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar

Abstract

本发明公开了一种电外科系统，所述电外科系统通常可包括联接到能量源的第一电极和第二电极，所述能量源操作以生成并传送双相射频(RF)波形的脉冲以处理患者体内的不良组织。所述脉冲可引起所述患者的组织中的非热性细胞死亡，而不引起所处理的患者体内的肌肉收缩或引起所处理的患者体内最小限度的肌肉收缩。所述脉冲可被集合成猝发，其中猝发内的所述脉冲以特定脉冲频率重复。

Description

电外科装置和方法
背景技术
电外科疗法已在医学中用来处理不良组织，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装置、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、手术切除、冷冻疗法、放射疗法、光动力疗法、显微外科手术、使用5-氟尿嘧啶的局部治疗、和激光烧蚀。常规电消融治疗可具有下述局限性中的一些：成本、恢复时间的长短和对患者造成的难以忍受的痛苦。具体来讲，常规电消融疗法的一个缺点可为因有害热效应而对不良组织周围的健康组织的任何永久性损伤，所述热效应由使组织暴露于由电消融装置产生的热能而引起。例如，对周围健康组织的永久性损伤可在使用高温热疗法以使不良组织暴露于足以引起细胞坏死的电势时发生。因此，需要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的用于治疗不良组织的电外科装置、系统和方法。
附图说明
本发明的各种实施例的新颖特征在随附权利要求书中会特别阐述。然而，结合附图参照下述说明可最好地理解关于手术的组织和方法两者的本发明的各种实施例、连同其另外的目的和优点。
图1示出了根据本文所述的某些实施例的电外科系统。
图2示出了根据本文所述的某些实施例的电外科系统的第一电极和第二电极的至少远侧部分。
图3示出了根据本文所述的某些实施例的包括传感器的电外科系统的第一电极和第二电极的至少远侧部分。
图4示出了根据本文所述的某些实施例的包括温度传感器的电外科系统的第一电极和第二电极的至少远侧部分。
图5是根据本文所述的某些实施例的可应用于不良组织的AC波形的图示。
图6是根据本文所述的某些实施例的可应用于不良组织的图5所示AC波形的一系列电脉冲的图示。
图7是根据本文所述的某些实施例的可应用于不良组织的图5所示AC波形的由脉冲形成的多个猝发的图示。
图8是根据本文所述的某些实施例的可应用于不良组织的一系列电脉冲期间的电极温度的图示。
图9是响应于DC单相脉冲的猪模型肌肉电活动的图示。
图10是根据本文所述的某些实施例的响应于双相AC波形的脉冲的猪模型肌肉电活动的图示。
图11是根据本文所述的某些实施例的电外科系统的电路框图。
图12是根据本文所述的某些实施例的由电外科系统生成并递送的处理方案的图示。
图13是根据本文所述的某些实施例的在接收可应用于不良组织的电脉冲之后的猪肝脏的照片。
图14是根据本文所述的某些实施例的由电外科系统生成并递送的处理方案的图示。
图15是根据本文所述的某些实施例的在接收可应用于不良组织的电脉冲之后的猪肝脏的照片。
图16是根据本文所述的某些实施例的由电外科系统生成并递送的处理方案的图示。
图17是根据本文所述的某些实施例的在接收可应用于不良组织的电脉冲之后的猪肝脏的照片。
发明内容
一种电外科系统包括能量源、第一电极和第二电极。所述第一电极和所述第二电极中的每个具有能够联接到所述能量源的第一端部并且各自具有第二导电端部，所述第二导电端部能够向与其电接触的组织递送能量，其中所述能量源操作以产生双相射频(RF)波形的脉冲并将所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部，并且其中所述脉冲引起与所述第一电极和所述第二电极的所述第二导电端部电接触的组织中的非热性细胞死亡。
一种电外科系统包括能量源、第一电极和第二电极。所述第一电极和所述第二电极中的每个具有能够联接到所述能量源的第一端部，并且各自具有第二导电端部，所述第二导电端部能够向与其电接触的组织递送能量，其中所述能量源操作以产生双相射频(RF)波形的脉冲并将所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部，并且其中所述脉冲引起与所述第一电极和所述第二电极的所述第二导电端部电接触的组织中的细胞膜上的电势的变化。
一种与电外科系统一起使用的能量源包括可变电压功率源、由所述可变电压功率源充电的至少一个电容器、以及从所述至少一个电容器接收能量的切换放大器。所述切换放大器能够输出双相射频(RF)波形的脉冲，所述脉冲能够通过引起组织中的非热性细胞死亡来处理所述组织，而在所述组织的处理期间患者体内不引起肌肉收缩或者引起最小限度的肌肉收缩。
具体实施方式
本专利申请的申请人还拥有名称为“METHODSFORPROMOTINGWOUNDHEALING”的美国专利申请序列号_____________，(代理人案卷号END7119USNP/120085)，该专利申请与本文同一天提交并且全文以引用方式并入本文中。
各种实施例涉及用于处理不良组织同时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的电外科系统和方法。
本公开内容描述了电外科系统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，对各种实施例的某些说明已被简化以仅示出与对本发明所公开的实施例的更清晰的理解有关的那些元件、特征和方面，而为了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”、“一些实施例”、“一个实施例”、或“实施例”的任何提及均大体表示所述实施例中所述的具体元件、特征和/或方面包含于至少一个实施例中。短语“在各种实施例中”、“在一些实施例中”、“在一个实施例中”、或“在实施例中”可能不是指同一实施例。本领域的普通技术人员在考虑本文说明后将认识到，在具体实施或应用中可能需要各种实施例与其它元件、特征和方面的各种组合或子组合。然而，由于此类其它元件、特征和方面可容易由本领域的普通技术人员在考虑本文说明后确定，并且并非对完全理解本发明所公开的实施例必不可少，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本发明所公开的实施例的示例性例子而并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为近似的，从而表示术语“大约”可在没有明确规定时推断出。本文所公开的数值量应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和围绕那个值的功能上等同的范围两者。在最低程度上说，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图，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，还是尽可能精确地报告出实际测量值的特定示例中所述的数值量。
本文所述的所有数值范围均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之间的所有子范围并且包括所引用的最小值1和所引用的最大值10。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数值均旨在包括所有更高的限值。
如本文通常所用，术语“近侧”和“远侧”通常是指临床医生操纵用于处理患者的器械的一个末端。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。
在各种实施例中，电外科系统通常可包括联接到能量源的第一电极和第二电极。所述能量源可产生双相射频(RF)波形的脉冲并将所述脉冲递送到患者的组织。所述脉冲可非热处理和/或杀死患者体内的不良组织中的细胞。所述能量源可包括交流电(AC)电波形发生器。
在各种实施例中，一种电外科系统通常可包括联接到能量源的第一电极和第二电极。所述能量源可产生双相射频(RF)波形的脉冲并将所述脉冲递送到患者的组织。所述脉冲可引起组织中的细胞膜上的电势的变化。所述能量源可包括交流电(AC)电波形发生器。
在各种实施例中，AC波形发生器能够产生AC波形的脉冲并将所述脉冲递送到患者的组织。所述AC波形可通过峰间电压幅值和在本文中被称作“基频f”的频率来表征。所述电脉冲可通过各种参数诸如(例如)频率、幅值、脉冲宽度(持续时间)、脉冲总数、和脉冲之间的延迟来表征。
在各种实施例中，一种处理不良组织的方法通常可包括对不良组织施加双相RF波形的脉冲以非热处理和/或杀死不良组织中的细胞。在其它实施例中，一种治疗不良组织的方法通常可包括对不良组织施加双相射频(RF)波形的脉冲以引起不良组织中的细胞膜上的电势发生变化。
在各种实施例中，一种治疗不良组织的方法通常可包括向患者的组织传送AC波形的脉冲。AC波形可通过峰间电压幅值和基频f来表征。电脉冲可通过各种参数诸如(例如)频率、幅值、脉冲宽度(持续时间)、脉冲总数、和脉冲之间的延迟来表征。
不希望受限于任何特定的理论，可在治疗之后立即发生所处理的不良组织中的细胞死亡。作为另外一种选择，可因各种生物机制而稍后发生细胞死亡。按照一种理论，可因不可逆电穿孔(IE)而发生细胞死亡。由外部施加的电场所引起的细胞质膜的导电性和渗透性的中的电穿孔或电透化显著增加。电穿孔通常在分子生物学中用作将一些物质引入细胞的方式，诸如分子探针、可改变细胞功能的药物、或一块编码脱氧核糖核酸(DNA)。电穿孔为相依于细胞膜上每个点处的局部跨膜电压的动态现象。通常认为，对于给定脉冲持续时间和形状而言，针对电穿孔现象的表现存在特定跨膜电压阈值(从0.5V到1V)。不可逆电穿孔被认为是在特定细胞的跨膜阈值被超过从而导致细胞外膜上的不稳定电势并导致在脂质双层中形成永久性纳米级缺陷时发生。细胞膜的永久性透化导致细胞稳态的变化和细胞死亡。
按照另一种理论，可因细胞凋亡而发生细胞死亡。细胞凋亡为程序性细胞死亡。细胞凋亡涉及一系列导致各种形态变化的生物化学事件，包括对细胞膜的改变(诸如膜不对称性和附着的丧失)、细胞收缩、核断裂、染色质凝聚、和染色体DNA断裂。
在各种实施例中，一种电外科系统通常可包括两个或更多个电极，所述电极能够定位到组织处理区域(例如，靶部位、或手术部位)中的不良组织中或附近。所述组织处理区域可具有异常组织生长的证据。一般而言，所述电极可包括导电部(例如，医疗级不锈钢、镀金等)，并且能够电联接到能量源。一旦所述电极定位到不良组织中或附近，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。
适于与本公开一起使用的各种电极设计在以下专利中有所描述：2008年1月15日提交的名称为“IN-LINEELECTROSURGICALFORCEPS”的共同拥有美国专利申请公布No.2009/0182332A1，所述专利的全部公开内容以全文引用的方式并入本文中；和2007年10月31日提交的名称为“ENDOSCOPICOVERTUBES”的共同拥有美国专利申请公布No.2009/0112063A1，所述专利的全部公开内容以全文引用的方式并入本文中。
参见图1，图中示出了电外科系统10。电外科系统10可用于利用电能来处理组织处理区域中的不良组织，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。所述电外科系统10能够利用电能来处理组织处理区域中的多个消融灶和骨病灶(ostepathologies)，包括转移性消融灶、肿瘤、骨伤、感染部位和发炎部位。电外科系统10能够定位在患者的天然身体孔口(例如，嘴、肛门和阴道)内，和/或推进穿过内部身体内腔或腔(例如，食道、胃、肠、结肠、子宫颈和尿道)，以到达组织处理区域。电外科系统10能够使用套管针被定位和通过小切口或键孔，以到达组织处理区域，这些小切口和键孔穿过患者的皮肤或腹壁而形成。组织处理区域可位于患者的大脑、肺、乳房、肝脏、胆囊、胰腺、前列腺、由以下限定的各种内部身体内腔中：食道、胃、肠、结肠、动脉、静脉、肛门、阴道、子宫颈、输卵管和腹膜腔。电外科系统10可结合内窥镜、腹腔镜、胸腔镜、经由小切口或键孔的开放式外科手术、经皮技术、穿皮技术、和/或外部无创技术、和它们的任何组合。
一旦定位到组织处理区域中或附近，则电外科系统10可被致动(例如，被通电)以治疗不良组织。在一个实施例中，电外科系统10能够可通过口腔进入来处理胃肠道、食道、肺、和/或胃中的患病组织。在另一个实施例中，电外科系统10可适于使用穿腔进入技术(诸如(例如)NOTESTM技术)来处理肝脏或其它器官中的不良组织，在所述穿腔进入技术中，电外科系统可首先通过天然身体孔口引入且随后通过刺破内部身体内腔的壁推进至组织处理部位。在各种实施例中，电外科系统10可适于使用一个或多个以下述方式定位的电极来处理大脑、肺、乳房、肝脏、胆囊、胰腺或前列腺中的不良组织：经皮、穿皮、穿腔、微创、和/或通过开放式外科技术、或它们的任何组合。
还参见图1，电外科系统10可结合以下使用：柔性内窥镜12、以及刚性内窥镜、腹腔镜、或胸腔镜，诸如可得自OlympusCorporation的GIF-100型。在一个实施例中，内窥镜12可以下述方式引导至组织处理区域：以穿过肛门的方式穿过盲肠、以穿过口腔的方式食道和胃、以穿过阴道的方式穿过子宫颈、穿过皮肤、或经由结合套管针形成于腹腔中的外部切口或键孔。电外科系统10可使用内窥镜12插入和引导至组织处理区域中或附近。在其它实施例中，不使用内窥镜12，而是可使用其它技术来确定手术期间的适当器械放置，诸如(例如)超声层析成像或计算机层析成像(CT)扫描。
如图1所示，内窥镜12包括内窥镜手柄34和细长的相对柔性轴32。柔性轴32的远侧端部可包括光源和观察口。任选地，柔性轴32可限定用于接收各种器械(诸如(例如)电外科系统)穿过其的一个或多个通道。在所述观察口的视野内的图像可由通常位于内窥镜12内的光学装置(诸如(例如)包括电荷耦合装置(CCD)的照相机)接收并传送到患者体外的显示监视器(未示出)。在一个实施例中，电外科系统10可包括多个电导体18、包括启动开关62的手持件16、和能量源14(诸如(例如)电波形发生器)，所述能量源电耦合到启动开关62和电外科系统10。电外科系统10可包括相对柔性构件或轴22(图4)，所述柔性构件或轴可使用上文所述的技术中任何技术(诸如开放切口和套管针)通过内窥镜12的通道中的一个或多个经由皮肤或穿过皮肤引导至组织处理区域。
参见图1-图4，诸如第一电极24a和第二电极24b的一个或多个电极(例如，针状电极、球囊电极)可从电外科系统10的远侧端部伸出。第一电极24a可被配置为正电极并且第二电极24b可被配置为负电极。第一电极24a可电连接到第一电导体18a或类似的导电引线或线材，所述第一电导体或类似导电引线或线材可通过启动开关62耦合到能量源14的正极端子。第二电极24b可电连接到第二电导体18b或类似的导电引线或线材，所述第二电导体或类似导电引线或线材可通过启动开关62耦合到能量源14的负极端子。除了与相应电极24a,24b电连接之外，电导体18a,18b可彼此电绝缘并且与周围结构电绝缘。
在某些实施例中，电外科系统10能够使用内窥镜12(腹腔镜或胸腔镜)、开放式外科手术、和/或外部和无创医疗手术引入至组织处理区域中或附近。电极24a,24b可在本文中被称作内窥镜电极或腹腔镜电极，但其变型可穿过皮肤或经由皮肤插入。在各种实施例中，一个或两个电极24a,24b可适于且能够以可滑动的方式移进和移出限定于柔性轴22内的插管、内腔或通道。
当电极24a,24b在期望的位置处定位到组织处理区域中或附近时，电极24a,24b可通过致动手持件16上的启动开关62连接到能量源14或去制动手持件16上的启动开关62与所述能量源断开。例如，启动开关62可手动地操作或者可安装在脚踏开关(未示出)上。电极24a,24b可将电场脉冲递送到不良组织。所述电场脉冲可通过各种参数来表征，诸如(例如)脉冲形状、幅值、频率、脉冲宽度(持续时间)、和脉冲总数。
参见图4，保护套或护套26可以能够滑动的方式被设置在柔性轴22上方和手柄28内。在另一实施例中，护套26可以能够滑动的方式被设置在柔性轴22和手柄28内。护套26可为可滑动的并且可位于电极24a,24b的上方以保护套管针，并阻止当电外科系统10被推进穿过其时的意外刺穿。电极24a,24b之一或二者可适于且能够以可滑动的方式移进和移出形成于柔性轴22内的插管、内腔、或通道。电极24a,24b之一或二者可被固定就位。电极24a,24b之一可提供枢轴，其它电极可围绕所述枢轴沿弧形运动到组织处理区域中的其它点，以处理无法通过将电极24a,24b二者固定在一个位置中来处理的患病组织的更大部分。在一个实施例中，电极24a,24b之一或二者可适于并且能够以可滑动的方式移进和移出形成于内窥镜12的柔性轴32内的工作通道，或者可独立于内窥镜12定位。
参见图1，第一电导体18a和第二电导体18b可设置穿过手柄28。第一电极24a可使用滑动构件30以能够滑动的方式移进和移出柔性轴22的远侧端部，以缩回和/或推进第一电极24a。第二电极24b可使用滑动构件30或不同的滑动构件以能够滑动的方式移进和移出柔性轴22的远侧端部，以缩回和/或推进第二电极24b。一个或两个电极24a,24b可联接到滑动构件30或附加的滑动构件，以推进和缩回电极24a,24b并对电极24a,24b进行定位。这样，可使用滑动构件30来推进和缩回第一电极24a和第二电极24b，所述电极可在限定于柔性轴22内的插管、内腔或通道内以能够滑动的方式运动。如图1所示，联接到第一电极24a的第一电导体18a可联接到滑动构件30。这样，可使用滑动构件30来推进和缩回第一电极24a，所述电极可在柔性轴22内的插管、内腔或通道内以能够滑动的方式运动。在一个实施例中，各种滑动构件(诸如滑动构件30)均可为可旋转的。从而，滑动构件30的旋转可使电外科系统10的远侧端部处的一个(多个)相应电极旋转。
参见图1，换能器或传感器29可位于电外科系统10的手柄28(或其它合适的位置)中以感测电极24a,24b用以穿透组织处理区域中的组织的力。此反馈信息可用于确定电极24a,24b之一或二者是否已适当地插入组织处理区域中。作为尤其众所周知的，与健康组织相比，癌肿瘤组织往往更致密，并且因此通常可能需要更大的力来将电极24a,24b插入癌肿瘤组织中。换能器或传感器29可向操作者、外科医生或临床医生提供反馈，以物理感测电极24a,24b何时放置在癌肿瘤内。由换能器或传感器29提供的反馈信息可由位于能量源14内部或外部的电路处理并显示。传感器29读数可用于确定电极24a,24b是否已适当地位于癌肿瘤内，从而确保已达到定位电极24a,24b的合适误差幅度。传感器29读数还可用于确定是否需要调节脉冲参数以达到期望的结果，诸如(例如)降低患者体内肌肉收缩的强度。
参见图2，电外科系统10可包括容纳第一电极24a的第一柔性轴22a和容纳第二电极24b的第二柔性轴22b。电外科系统10可包括设置在第一柔性轴22a和第二柔性轴22b中的至少一者上方的第一保护套或护套(未示出)。电外科系统10可包括设置在第一柔性轴22a上方的第一保护套或护套(未示出)和设置在第二柔性轴22b上方的第二保护套或护套(未示出)。第一柔性轴22a的长度可不同于第二柔性轴22b的长度。第一柔性轴22a的长度可大于或等于第二柔性轴22b的长度。第一保护套或护套的长度可不同于第二保护套或护套的长度。第一保护套或护套的长度可大于或等于第二保护套或护套的长度。
参见图1-图4，电外科系统10能够测量温度和压力中的至少一者。换能器或传感器29可包括温度传感器25(图3)和压力传感器27(图3)中的至少一者。在某些实施例中，温度传感器25和压力传感器27中的至少一者可位于电外科系统10中或附近温度传感器25和/或压力传感器27可位于手柄28内。温度传感器25和/或压力传感器可位于保护套或护套26内。如图3的实施例所示，温度传感器25和/或压力传感器27可位于柔性轴22内。温度传感器25和/或压力传感器27可位于柔性轴22的远侧端部处。保护套或护套26和/或柔性轴22可包括一个或多个通气孔31，所述通气孔被配置用于测量组织处理区域的温度和压力中的至少一者。温度传感器25和/或压力传感器27可位于电极24a,24b内。压力传感器27可邻近通气孔31中的至少一个。在一个实施例中，压力传感器27可邻近通气孔31中的至少一个，并且温度传感器25可位于柔性轴22的远侧端部处。图4为包括光学温度传感器29的电外科系统的照片，所述传感器位于柔性轴22的远侧端部处的电极24a的中空内腔内。
在某些实施例中，所述温度传感器和/或压力传感器可与电外科系统10分开。电外科系统10可包括温度传感器25，并且压力传感器可与电外科系统10分开。电外科系统10可包括压力传感器27，并且温度传感器可与电外科系统10分开。
根据某些实施例，温度传感器25可测量组织处理区域的温度。温度传感器25可测量不良组织的温度。温度传感器25可测量围绕电极的组织的温度。温度传感器25可测量处理之前、期间、和/或之后的温度。
根据某些实施例，压力传感器27可测量组织处理区域的压力。压力传感器27可测量电极之间的空间的压力。压力传感器27可测量围绕电极的压力。压力传感器27可测量处理之前、期间、和/或之后的压力。
不希望受限于任何特定的理论，电外科系统10可处理和/或杀死不良组织中的细胞而不对所处理的组织施加热量或施加最小限度的热量，并且因此，可不破坏细胞支撑结构或区域脉管系统。在各种实施例中，使用电外科系统10治疗的组织的温度可保持低于或等于60℃。在其它实施例中，组织温度可保持低于或等于50℃。在另一个实施例中，组织温度可保持低于或等于40℃。组织的温度可使用图4所示的温度传感器来监测。
在一个实施例中，能量源14的输出联接到电极24a,24b，所述电极可使用手持件16上的启动开关62或安装在足部启动踏板(未示出)上的启动开关来通电。一旦电能量源14联接到电极24a,24b，则可在电极24a,24b的远侧端部处形成电场。
电极24a,24b可具有从0.5mm到1.5mm(诸如(例如)0.5mm、0.75mm、1mm、和1.5mm)的直径或半径。在各种实施例中，第一电极24a的直径可不同于第二电极24b的直径。电极间距可为从0.5cm到3cm。在各种实施例中，从第一电极24a到第二电极24b的距离可为从0.5cm到3cm，诸如(例如)1cm,1.5cm、2.0cm、和3cm。在一个实施例中，电外科系统10可包括多个针状电极。
根据某些实施例，电外科系统10可(例如)通过套管针引导至组织处理区域中，或者穿过皮肤、经由皮肤或通过其它合适的技术插入到组织处理区域。在一个实施例中，限定于柔性轴22内的插管、内腔或通道可包括切割刃(诸如斜面边缘或其它锋利边缘)，以帮助刺破/刺穿组织。
图5为根据如本文所述的某些实施例的由能量源14产生的AC波形80的图示。时间(t)示出为沿着水平轴线，并且电压(VAC)示出为沿着垂直轴线。AC波形80具有基频f和峰间电压幅值(VApp)。在各种实施例中，AC波形80可具有在大约330KHz到大约900KHz的范围内的基频f和在大约200VAC到大约12,000VAC的范围内的峰间电压幅值(VApp)。在其它实施例中，AC波形80可具有在大约400KHz到大约500KHz的范围内的基频f和在大约5,000VAC到大约12,000VAC的范围内的峰间幅值电压(VApp)。在一个实施例中，AC波形80可具有500KHz的基频f和12,000VAC的峰间电压幅值(VApp)。
能量源14能够生成并在多个脉冲中传送AC波形80，以处理位于处理区域中大量的不良组织而没有对周围组织造成热损伤或造成最小限度的热损伤。每个脉冲可具有以脉冲周期T1或脉冲频率f1＝1/T1递送的持续时间Tw。定时电路可联接到能量源14的输出以生成电脉冲。定时电路可包括一个或多个合适的开关元件以生成电脉冲。
能量源14能够生成并在若干个猝发中传送AC波形80，每个猝发均包括若干个脉冲。处理方案可包括由足够的时间Tb间隔开的若干个猝发，以使得所处理的组织的温度能够保持低于最高温度。猝发可以猝发周期T2或猝发频率f2＝1/T2递送。可在特定处理方案中改变脉冲频率和猝发频率二者以有效地处理靶组织，同时使所处理的组织温度保持低于最高温度。
图6为由能量源14生成并递送的AC波形80的电脉冲猝发的图示。时间(t)示出为沿着水平轴线，并且电压(VAC)示出为沿着垂直轴线。波形80具有基频f和电压峰间幅值(VApp)。在该示例性实施例中，所述猝发包括三个脉冲。每个脉冲具有以脉冲周期T1或脉冲频率f1＝1/T1递送的持续时间Tw。本领域的普通技术人员将了解，可通过改变电压峰间幅值(VApp)、和/或基频f、脉冲宽度Tw、和/或脉冲频率f1来改变由每个猝发传送到组织的总能量。
在各种实施例中，每个脉冲可具有在大约5微秒到大约100微秒的范围内的脉冲持续时间Tw。在其它实施例中，每个脉冲可具有在大约10微秒到大约50微秒的范围内的脉冲持续时间Tw。在一个实施例中，每个脉冲可具有20微秒的脉冲持续时间Tw。在各种实施例中，脉冲可以在大约1Hz到大约500Hz的范围内的脉冲频率f1传送。在某些实施例中，脉冲频率f1可为在大约1Hz到大约100Hz的范围内。在一个实施例中，脉冲频率f1可为(例如)4Hz。
图7为由能量源14生成并递送的多个电脉冲猝发的图示。时间(t)示出为沿着水平轴线，并且电压(VAC)示出为沿着垂直轴线。在该示例性实施例中，能量源14分三个猝发生成并递送波形80。每个猝发包括四个脉冲。每个脉冲具有以脉冲周期T或脉冲频率f1＝1/T1递送的持续时间Tw。此外，所述猝发由足够的时间Tb间隔开以使得所处理的组织的温度能够保持低于最高温度。所述猝发以猝发频率f2＝1/T2
重复。在各种实施例中，所述猝发能够以在大约0.02Hz到大约500Hz的范围内的猝发频率f2重复。在某些实施例中，猝发频率f2可在大约1Hz到大约100Hz的范围内。也可改变处理方案中生成并递送的猝发数以使组织温度保持低于最高温度。猝发数可在大约1到大约100个猝发的范围内。在某些实施例中，猝发数可在大约5到大约50个猝发的范围内。
不希望受限于任何特定的理论，在一个方面，可使温度与电极之间的距离相关。如图8所示，1.5cm的电极间距在正电极处产生大约51℃的最高温度，并且1.0cm的电极间距在正电极处产生大约59℃的最高温度。如图8所示，温度随着电极之间距离的减小而增大。还可使温度与由电外科系统10递送到组织的总能量相关。在特定处理方案期间，可改变波形80的各种参数以确保有效处理，而不会使所处理的组织不期望的过热。
在各种实施例中，电外科系统10可处理和/或杀死不良组织中的细胞，而不会使所处理的患者体内产生肌肉收缩或产生最小限度的肌肉收缩。众所周知，神经细胞和肌肉细胞为电兴奋的，即，其可因电流而受到刺激。据信，神经细胞和肌肉细胞对电场的敏感性归因于存在于其细胞膜中的电压门控离子通道。在患者体内，这样的刺激可引起剧痛、肌肉痉挛、乃至心脏骤停。通常，对电刺激的敏感性随着频率的增大而减小。此外，还据信，神经细胞和肌肉细胞对直流电更敏感。为了使肌肉刺激和神经刺激的影响最小化，电外科系统10能够生成并递送双相AC波形的电脉冲，所述波形以高基频f(诸如在大约330KHz到大约900KHz的范围内)和大约200VAC到大约12,000VAC的峰间电压幅值(VApp)操作。
在各种实施例中，可在不施用麻痹剂的情况下使用电外科系统10来处理患者。通常在使用单相脉冲来处理患者时施用麻痹剂以减少骨骼肌收缩事件和心脏事件。
图9和图10为猪模型中的肌肉收缩的烈度的图示，在图9中使用单相脉冲来处理猪模型而在图10中使用电外科系统10来处理猪模型。时间(t)示出为沿着水平轴线，并且电压(V)示出为沿着垂直轴线。每种处理在不存在麻痹剂的情况下经由在猪肝脏中间隔开1.5cm的两根针经由皮肤递送。利用一种标准BIOPAC系统(易得自BIOPACSystemsInc.atGoleta,CA)来记录响应于每种治疗的肌肉电活动的变化。图9示出了在施用两个单相猝发时的肌肉收缩的烈度。相比之下，图10示出了在施用由电外科系统10生成并递送的两个猝发时的肌肉收缩的烈度。在这个示例中，电外科系统10能够生成并递送以500KHz的基频f操作的AC波形的两个猝发。每次记录的电压幅值的变化对应于肌肉电活动的变化。如通过对比图9和图10显而易见，在不存在麻痹剂的情况下，肌肉收缩的烈度在单相脉冲的情况下高出数个数量级。
参见图1，能量源14可包括可变电压功率源、由所述可变电压功率源充电的电容器、和从所述电容器接收能量的切换放大器。所述切换放大器能够输出双相射频(RF)波形的脉冲，所述脉冲能够通过在组织中引起非热性细胞死亡来处理组织而在组织的治疗期间不会使患者体内产生肌肉收缩或产生最小限度的肌肉收缩。
所述切换放大器为具有第一操作阶段和第二操作阶段的全桥式放大器。所述全桥式放大器能够在第一操作阶段期间输出正电压，并在第二操作阶段期间输出负电压。此外，全桥式放大器能够在第一操作阶段与第二操作阶段之间交替。全桥式放大器可包括四个切换腿部。每个切换腿部可具有至少一个切换元件和用于控制所述至少一个切换元件的至少一个驱动电路。在某些实施例中，能量源14还可包括驱动逻辑，所述驱动逻辑用于在第一操作阶段期间同时驱动所述切换腿部中的至少两个的驱动电路，并且用于在第二操作阶段期间同时驱动至少两个其它切换腿部的驱动电路。
能量源14还可包括具有能量输入侧和能量输出侧的隔离变压器。能量输入侧能够从切换放大器接收能量。隔离变压器能够使从能量输入侧到能量输出侧的低频能量感应最小化。在至少一个实施例中，能量源14还可包括能够从切换放大器的输出移除低频能量的阻塞电容器。
在各种实施例中，能量源14可包括如图11所示的构型，能量源14可包括系统输入/输出(I/O)板102、可变电压功率源104和切换放大器106。功率源104可为具有在大约0VDC到大约3000VDC的范围内的电压幅值的高压直流(DC)功率源。能量源14还可包括控制功率源104输出的系统输入/输出(I/O)板102。可使用计算机界面来与系统I/O板102进行交互，以设定功率源104的DC电压输出量。
在各种实施例中，功率源104可对若干个电容器109进行充电。在某些实施例中，电容器109能够储存大量能量。适合此目的的电容器109包括大型库、高品质和高脉冲电流金属化聚丙烯电容器。电容器109可在切换放大器106的“关断(OFF)”时间期间由功率源104充电。在将切换放大器106切换到“接通(ON)”位置时，电容器109可将存储于其中的能量释放到切换放大器106中。
在某些实施例中，如图11所示，切换放大器106可被配置为全桥式放大器。在至少一个实施例中，切换放大器106可被配置为D类全桥式放大器。切换放大器106可包括多个切换腿部111。在至少一个实施例中，如图11所示，切换放大器可包括四个切换腿部111。每个切换腿部111均可包括功率双极场效应晶体管(BiFET)108和相关的驱动电路110。以举例的方式，如图11所示，每个切换腿部111均可包括三个功率BiFET108和相关的驱动电路110。在某些实施例中，为了能够承受来自功率源104的高电压应力，每个切换腿部111的功率BiFET108可串联配置。这就是说，不应将其它构型(诸如并联)排除于本公开的范围之外。在某些实施例中，切换腿部111可在D类操作中同时接通以有效地将来自由功率源104充电的电容器109的能量传递到输出电路中。
在某些实施例中，如图11所示，切换放大器106被配置有第一操作阶段(阶段1)和第二操作阶段(阶段2)。在某些实施例中，切换放大器106能够在阶段1期间输出正电压而在阶段2期间输出负电压。驱动逻辑102能够在适当的时间操作每个阶段。在某些实施例中，驱动逻辑102能够在阶段1与阶段2之间交替。
在某些实施例中，阶段1在对电容器109进行充电之后开始。在阶段1期间，可在输出变压器112的一侧上产生正电压。阶段2在阶段1结束后开始。在阶段2期间，可在输出变压器的同一侧上产生负电压。在某些实施例中，阶段1与阶段2之间的抗重叠时间确保在阶段2开始时不存在通过电流。在大多数情况下，抗重叠时间非常小以至其在输出波形中无法被看到。可在重复循环之前应用附加的抗重叠时间。切换放大器106的输出为切换、双相波形。
在某些实施例中，输出变压器112可为隔离变压器。在至少一个实施例中，输出变压器112可为能够使输出波形的电压增加一倍的1：2隔离变压器。例如，如果将电容器109充电到3000VDC，则输出变压器112可使输出波形的电压增加到6000V正峰值和6000V负峰值。在某些实施例中，输出变压器112可包括使用双重绝缘材料隔离的初级绕组113和次级绕组115。初级绕组113和次级绕组115的隔离保护并隔离次级绕组115免受输出变压器112的初级绕组113内所包含的DC电压特性影响。这样的隔离可帮助消除低频能量。
在某些实施例中，如图11所示，输出变压器112的每个腿部均连接到阻塞电容器116。阻塞电容器116能够传递高频能量并且阻塞低频能量，以确保能量源14向所处理的组织递送高频双相电流。
在各种实施例中，能量源14可包括用于监测组织温度的热敏电阻器。如图11所示，在正引线处采用第一热敏电阻器118，并且在负引线处采用第二热敏电阻器120。隔离的热感测电路122可记录温度并将此信息报告给系统I/O板102。然后可处理此信息并且调节能量源14的输出以保持适当的温度。
在各种实施例中，能量源14可包括电流传感器以监测流过切换放大器106的电流。如图11所示，电流传感器124可包括电流感测电路126和电流感测隔离变压器128。电流传感器通过在操作电流达到过量的情况下终止所述系统来保护切换放大器106的BiFET108免受功率过载影响。
本文所述的电外科系统的实施例可使用微创或开放外科手术技术引入患者体内。在某些情况下，可能有利的是使用微创和开放外科手术技术的组合来将电外科系统引入患者体内。微创技术可更加精确和有效地触及用于诊断和处理过程的处理区域。为了到达患者体内的内部处理区域，本文所述的电外科系统可插入穿过身体的天然开口，例如嘴、肛门和/或阴道。借助将各种医疗器械通过患者的天然开口而引导至患者体内来实施的微创手术在本领域中已知为NOTESTM手术。外科装置(诸如电外科系统)可通过内窥镜的通道而引导至处理区域，来执行关键外科活动(KSA)，包括(例如)使用不可逆电穿孔能量的组织电外科。电外科系统的一些部分可经由皮肤或通过小键孔切口引导至组织处理区域。
内窥镜式微创外科手术和诊断医学过程用来通过将小管插入体内来评估和治疗内部器官。内窥镜可具有刚性或柔性管。柔性内窥镜可通过天然身体开口(例如，嘴、肛门、和/或阴道)引入。刚性内窥镜可经由套管针通过相对小的键孔切口的切口(通常为0.5cm到1.5cm)引入。内窥镜可用来观察内部器官的表面状况，包括异常或患病的组织，例如消融灶和其它表面状况，并且捕获图像，以用于视觉检测和摄影。内窥镜可适于和配置为具有通道，以用于将医疗器械引导至处理区域来进行活组织检查、检查异物和/或执行外科手术。
一旦电外科系统插入人体中，则可使用穿过器官的或穿过内腔的外科手术来到达内部器官。可使用内窥镜穿腔进入技术将电外科系统推进至处理部位以在内腔上打孔，并且接着将电外科系统和内窥镜推进至腹膜腔中。用于在内腔壁上打孔、将内腔窥镜插入并推进穿过打孔的内腔壁的穿腔进入手术和用于对腹膜腔吹气并闭合或缝合打孔的内腔壁的气腹装置为已知的。在穿腔进入手术期间，必须在胃壁中或胃肠道中形成穿孔以进入腹膜腔。一种经常用来形成这样的穿孔的装置为针形刀，所述针形刀插入穿过内窥镜的通道，并且利用能量来穿透组织。然后将导丝馈送穿过内窥镜并使其通过胃壁中的穿孔并进入至腹膜腔中。移除针状刀，留下导丝作为占位器。气囊导管随后穿过导丝上方并通过内窥镜的通道，以使所述气囊定位在胃壁中的开口内。然后可给球囊充气以增大开口的尺寸，从而使得内窥镜能够推挤球囊的后部并且能够馈送穿过开口并且进入至腹膜腔中。一旦内窥镜定位在腹膜腔内，则可通过内窥镜的通道来执行多种手术。
内窥镜可连接至摄影机(单芯片或多芯片)并且可附接至光纤缆线系统，所述光纤缆线系统连接至“冷”光源(卤素或氙气)，以照亮手术视野。摄影机提供处理区域的直接视线视图。如果在腹腔中工作，则可用二氧化碳(CO2)气体来对腹腔吹气以形成工作和观察空间。腹腔基本上被吹胀得像个气球(被吹气的)，从而使腹腔壁升高到内部器官之上像个圆顶。可使用CO2气体，因为其对人体是常见的，并且可在其通过组织被吸收的情况下由呼吸系统去除。
一旦电外科系统位于靶部位处，则可使用本文所述的电极的各种实施例来电消融或电破坏患病的组织。电极的放置和定位可能对于有效和高效电外科疗法很重要。例如，电极可以内窥镜方式或穿过皮肤方式(经由皮肤方式)邻近处理区域(例如，靶部位或工作部位)定位。在一些具体实施中，可能有必要使用内窥镜技术、经皮技术、和/或开放技术的组合来将电极引入患者体内。电极可通过内窥镜的通道、套管、或套管针引导至组织处理区域，并且在一些具体实施中，可通过经由皮肤方式或通过小键孔切口引入。
优选地，在外科手术之前将对本文所述的装置的各种实施例进行处理。首先，获取新的或用过的器械，并在必要时对器械进行清洁。然后可对器械进行消毒。在一种灭菌技术中，将器械置于封闭并密封的容器中，诸如塑料或口袋中。然后将容器和器械置于能够穿透所述容器的辐射场内，诸如γ辐射、x-射线或高能电子。辐射将器械上和容器中的细菌杀死。然后将消毒后的器械储存在无菌容器中。该密封的容器将器械保持无菌，直到在医疗设施中打开该容器为止。
当结合下述代表性实例阅读时，可更好地理解本文所述的各种实施例。包括下述实例是为了举例说明目的而非限制目的。
使用根据某些实施例的电外科系统以在一系列体外电猝发中将AC波形80递送到健康的猪肝脏(剂量1)，所述电外科系统包括第一电极和第二电极、及温度传感器，所述第一电极和第二电极联接到能量源，所述能量源包括AC波形发生器。如图12所示，剂量1包括100个猝发。每个猝发具有猝发周期T2或0.5Hz的猝发频率f2＝1/T2。每个猝发包括2个脉冲。每个脉冲具有以脉冲周期T1或4Hz的脉冲频率f1＝1/T1递送的20微秒的持续时间Tw。AC波形80以500KHz的基频操作并且具有12,000V的峰间电压幅值(VApp)。使用图4所示的温度传感器来监测温度，并且使温度保持低于或等于60℃。图13包括在使用剂量1治疗之后的猪肝脏的照片。在此情况下，第一电极和第二电极相距1.5cm定位。
使用根据某些实施例的电外科系统以在一系列体外电猝发中将AC波形80传送到健康的猪肝脏(剂量2)，所述电外科系统包括第一电极和第二电极、及温度传感器，所述第一电极和第二电极联接到能量源，所述能量源包括AC波形发生器。如图14所示，剂量2可包括60个猝发。每个猝发具有猝发周期T2或0.2Hz的猝发频率f2＝1/T2。每个猝发包括5个脉冲。每个脉冲具有以脉冲周期T1或4Hz的脉冲频率f1＝1/T1递送的20微秒的持续时间Tw。AC波形80以500KHz基频操作并且具有12,000V的峰间电压幅值(VApp)。使用图4所示的温度传感器来监测温度，并且使温度保持低于或等于60℃。图15包括在使用剂量2治疗之后的猪肝脏的照片。在此情况下，第一电极和第二电极相距1.5cm定位。
使用根据某些实施例的电外科系统以在一系列体外电猝发中将AC波形80传送到健康的猪肝脏(剂量3)，所述电外科系统包括第一电极和第二电极、及温度传感器，所述第一电极和第二电极联接到能量源，所述能量源包括AC波形发生器。如图16所示，剂量3包括250个脉冲。每个脉冲具有以脉冲周期T1或500Hz的脉冲频率f1＝1/T1递送的20微秒的持续时间Tw。AC波形80以500KHz的基频操作并且具有12,000V的峰间电压幅值(VApp)。使用图4所示的温度传感器来监测温度，并且使温度保持低于或等于60℃。图17包括在使用剂量3治疗之后的猪肝脏的照片。在此情况下，第一电极和第二电极相距1.5cm定位。
可将本发明所公开的装置设计为单次使用后即进行处理，或者可将它们设计为可多次使用。然而在任一种情况下，该器械均可重新恢复，以便在至少一次使用后再次使用。重新恢复可包括如下步骤的任意组合：拆卸所述装置、然后清洗或替换特定元件、以及随后重新组装。具体来讲，所述装置可以拆卸，并且可以任意组合对装置的任意数目的特定元件或部件进行选择性地更换或移除。清洗和/或替换特定部件后，所述装置可以在重新恢复设施处重新组装以随后使用，或者在即将进行外科手术前由外科团队重新组装。本领域的技术人员将会知道，装置修复可以利用多种技术进行拆卸、清洗/更换以及重新组装。此类技术的使用和所得修复装置全都在本申请的范围内。
优选地，在外科手术之前将对本文所述的各种实施例进行处理。首先，获取新的或用过的器械，并在必要时对器械进行清洁。然后对器械进行消毒。在一种消毒技术中，器械放置在闭合并密封的容器、诸如塑料袋或TYVEK袋中。然后将容器和器械置于能够穿透所述容器的辐射场内，诸如γ辐射、x-射线或高能电子。辐射将器械上和容器中的细菌杀死。然后将消毒后的器械储存在无菌容器中。该密封的容器将器械保持无菌，直到在医疗设施中打开该容器为止。
器械优选地经过消毒。这可通过为本领域的技术人员所熟知的许多方式来进行，包括β或γ辐射、环氧乙烷、蒸汽、高压灭菌、在消毒液中浸泡、或其它已知方式。
尽管本文已述了各种实施例，但可实施对所述实施例的许多修改和变形。例如，可采用不同类型的端部执行器。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 (25)

1.一种电外科系统，包括：
能量源；以及
第一电极和第二电极，所述第一电极和所述第二电极各自具有能够联接到所述能量源的第一端部并且各自具有第二导电端部，所述第二导电端部能够向与其电接触的组织递送能量，其中所述能量源操作以生成双相射频(RF)波形的脉冲并将所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部，并且其中所述脉冲引起与所述第一电极和所述第二电极的所述第二导电端部电接触的组织中的非热性细胞死亡。
2.根据权利要求1所述的电外科系统，其中所述能量源包括交流电(AC)波形发生器。
3.根据权利要求1所述的电外科系统，其中所述双相射频(RF)波形以大约330KHz到大约900KHz的基频操作。
4.根据权利要求1所述的电外科系统，其中所述双相射频(RF)波形包括大约200ACV到大约12,000ACV的峰间电压幅值。
5.根据权利要求1所述的电外科系统，其中所述能量源操作以生成所述脉冲并将处于猝发中的所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部。
6.根据权利要求5所述的电外科系统，其中所述猝发中的每个猝发内的所述脉冲能够以大约1Hz到大约500Hz的脉冲频率重复。
7.根据权利要求5所述的电外科系统，其中所述猝发能够以大约0.02Hz到大约500Hz的猝发频率重复。
8.根据权利要求1所述的电外科系统，还包括温度传感器，所述温度传感器与所述第一电极和所述第二电极中的至少一者相邻定位。
9.根据权利要求1所述的电外科系统，其中所述脉冲在所述组织的处理期间不引起患者体内的肌肉收缩或引起患者体内最小限度的肌肉收缩。
10.一种电外科系统，包括：
能量源；以及
第一电极和第二电极，所述第一电极和所述第二电极各自具有能够联接到所述能量源的第一端部并且各自具有第二导电端部，所述第二导电端部能够向与其电接触的组织递送能量，其中所述能量源操作以生成双相射频(RF)波形的脉冲并将所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部，并且其中所述脉冲引起与所述第一电极和所述第二电极的所述第二导电端部电接触的组织中的细胞膜上的电势的变化。
11.根据权利要求10所述的电外科系统，其中所述能量源包括交流电(AC)波形发生器。
12.根据权利要求10所述的电外科系统，其中所述双相射频(RF)波形以大约330KHz到大约900KHz的基频操作。
13.根据权利要求10所述的电外科系统，其中所述双相射频(RF)波形包括大约200ACV到大约12,000ACV的峰间电压幅值。
14.根据权利要求10所述的电外科系统，其中所述能量源操作以产生所述脉冲并将处于猝发中的所述脉冲递送到所述第一电极和所述第二电极的所述第二导电端部。
15.根据权利要求10所述的电外科系统，其中所述猝发中的每个猝发内的所述脉冲能够以大约1Hz到大约500Hz的脉冲频率重复。
16.根据权利要求10所述的电外科系统，其中所述猝发能够以大约0.02Hz到大约500Hz的猝发频率重复。
17.根据权利要求9所述的电外科系统，所述系统还包括温度传感器，所述温度传感器与所述第一电极和所述第二电极中至少一者相邻定位。
18.根据权利要求9所述的电外科系统，其中所述脉冲在所述组织的治疗期间不引起患者体内的肌肉收缩或者引起患者体内最小限度的肌肉收缩。
19.一种与电外科系统一起使用的能量源，包括：
可变电压功率源；
至少一个电容器，所述电容器由所述可变电压功率源充电；和
切换放大器，所述切换放大器从所述至少一个电容器接收能量，其中所述切换放大器能够输出双相射频(RF)波形的脉冲，所述脉冲能够通过引起组织中的非热性细胞死亡来处理所述组织，而在所述组织的处理期间不引起患者体内的肌肉收缩或引起患者体内最小限度的肌肉收缩。
20.根据权利要求19所述的能量源，其中所述切换放大器为全桥式放大器，所述全桥式放大器具有第一操作阶段和第二操作阶段，其中所述全桥式放大器能够在所述第一操作阶段期间输出正电压，并在所述第二操作阶段期间输出负电压，并且其中所述全桥式放大器能够在所述第一操作阶段和所述第二操作阶段之间交替。
21.根据权利要求19所述的能量源，其中所述切换放大器包括至少四个切换腿部，每个切换腿部包括至少一个切换元件以及用于控制所述至少一个切换元件的至少一个驱动电路。
22.根据权利要求21所述的能量源，还包括驱动逻辑，所述驱动逻辑用于在第一操作阶段期间同时驱动所述切换腿部中的至少两个的所述驱动电路，并在第二操作阶段期间同时驱动至少两个其它切换腿部的所述驱动电路。
23.根据权利要求19所述的能量源，还包括隔离变压器，所述隔离变压器具有能量输入侧和能量输出侧，其中所述能量输入侧从所述切换放大器接收能量，其中所述隔离变压器能够使从所述能量输入侧到所述能量输出侧的低频能量的感应最小化。
24.根据权利要求19所述的能量源，还包括至少一个阻塞电容器，所述至少一个阻塞电容器能够从所述切换放大器的所述输出移除低频能量。
25.根据权利要求19所述的能量源，还包括电流监测构件以确保递送到所述切换放大器的所述电流量保持低于预先确定的最大值。
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