CN100571645C - 妇科医学烧蚀系统 - Google Patents
妇科医学烧蚀系统 Download PDFInfo
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Abstract
一种用于治疗诸如子宫平滑肌瘤的肿瘤的方法包括将烧蚀器件(22)插入骨盆区域中并将烧蚀器件(22)定位到骨盆肿瘤中。该方法还包括使用腹腔镜(12)和诸如超声机的成像器件(16)以确认骨盆肿瘤的位置和烧蚀器件(22)的放置。该方法还包括通过该烧蚀器件向骨盆肿瘤传送电磁能或其它能量以直接烧蚀肿瘤。还提供一种用于烧蚀骨盆肿瘤的外科系统。
Description
相关申请
本申请是在2001年7月31日提交的美国专利申请No.09/920425(美国专利No.6840935)的部分继续,该美国专利申请要求在2000年8月9日提交的美国临时专利申请No.60/224191的优先权。本申请与在2004年5月24日提交的美国专利申请No.10/853599有关。这些在先的专利申请出于所有目的在这里被加入作为参考。
技术领域
本发明涉及用于治疗妇科病症的过程和系统。更具体地,本发明涉及腹部骨盆肿瘤的治疗。
背景技术
在腹部和骨盆中可能发生良性肿瘤和恶性肿瘤。例如,子宫平滑肌瘤是77%的育龄妇女发生的肌肉细胞瘤。虽然子宫平滑肌瘤很少(0.1%)发展为癌症,但这些肿瘤可导致经血过多、出血不规律、怀孕失败、不孕、尿频和闭尿、腰围增加和骨盆和/或腹部由于性生活、月经或日常活动而受压或疼痛。患有子宫平滑肌瘤的妇女在治疗这些肿瘤的努力中常常承受外科手术(例如子宫切除术、子宫扩张术和刮除术、肌瘤烧蚀术、子宫内膜烧蚀和子宫镜检查)、药物和激素疗法、光顾诊所和各种应用辐射疗法(例如,超声、CAT扫描和MRI)。仅在美国每年子宫平滑肌瘤就导致约200000次子宫切除术,直接成本超过20亿美元。在北美,子宫切除术的发病率为1%,每年造成2000个死亡病例和240000例并发症。
子宫平滑肌瘤大部分常常是多样的,并且可能位于浆膜下(即,从子宫向外鼓胀)、壁内(即,在子宫壁内生长)、粘膜下(即,部分扩展到或完全包含于子宫腔内)或者是有肉茎的(即,以茎状基部向外生长)。由于病人可能在不同的部位具有多个子宫平滑肌瘤,因此当前的保守外科可包含腹部和阴道(子宫镜)两种方法,由此必须两个过程。
研究者已利用激光或双极烧灼以执行肌肉分解或这些肿瘤的破坏,但当前这些方法均不被大量执行。这些方法为了治疗肿瘤必须破坏正常的上覆的和周围的组织。结果,子宫的完整性受到损害,并且会出现有害的疤痕组织(例如,粘附)。以前的方法也仅治疗子宫外部表面上可见的那些肿瘤。因此,需要改进的不损坏上覆组织的治疗良性和恶性骨盆肿瘤的方法。这种改进的方法可对希望晚些怀孕并随后分娩的妇女使用。还需要能够治疗所有部位中的所有尺寸的浆膜下、壁内、粘膜下和带肉茎的肿瘤的单一方法。还需要可缓解腹部或骨盆疼痛/受压、腰围增加、异常的子宫出血、尿频和闭尿、不孕和流产的大部分或全部症状的单一方法。另外,希望方法和系统与常规的骨盆肿瘤的治疗方法相比更好地保护子宫,同时入侵性更小、成本更低、更安全、更美容,并具有更快和更短的疼痛恢复期。
发明内容
也被称为“Halt过程”的本发明是利用电磁能以有效烧蚀骨盆肿瘤的创新的门诊病人过程。本发明应用使用射频(RF)能量的烧蚀器件以治疗骨盆肿瘤,同时不伤害周围的正常组织。虽然在本发明中使用的烧蚀器件具有切换软组织肿瘤的FAD批准,但对于烧蚀器件应用于子宫平滑肌瘤或其它的骨盆肿瘤在医学文献中没有已知的报道。另外,当前的结果显示,与其它的保守疗法相比,本方法是十分有效的。迄今,本发明已对由子宫平滑肌瘤导致的大多数类型的症状提供缓解。并且,本发明是通用的、安全的,并易于被病人接受。本发明的优点包含恢复期短,一般不超过一周,并且大大节省成本。更重要的是,本发明提供实际有效的基于门诊病人实现子宫保护的方式。
根据本发明的一个实施例,一种治疗肿瘤的方法包括:将烧蚀器件插入骨盆区域中,该烧蚀器件包含电极;将电极定位在肿瘤内;通过电极传送第一量的能量以对肿瘤进行预热;在肿瘤内暴露该电极的更大区域;以及通过电极传送第二量的能量以直接烧蚀肿瘤。
根据本发明的另一个实施例,一种治疗骨盆肿瘤的方法包括:将烧蚀器件插入骨盆区域中,该烧蚀器件包含电极;用与烧蚀器件分开的成像探针将电极定位在骨盆肿瘤内;以及通过电极传送能量以直接烧蚀骨盆肿瘤。
根据本发明的又一个实施例,一种用于烧蚀骨盆肿瘤的外科系统包括:包含用于插入骨盆肿瘤中的电极的烧蚀器件;与烧蚀器件分开用于将电极定位在骨盆肿瘤内的成像探针;以及与烧蚀器件耦合用于向电极提供能量以直接烧蚀骨盆肿瘤的能源。
可以通过腹腔镜(即,放置范围通常在脐部附近)、具有或没有腹腔镜引导的腹透方式、经阴道方式或子宫镜方式执行本发明过程。Halt过程常常利用常规的腹腔镜,另外放置:(1)耻骨弓上端口或套管(10mm),被放在用于插入腹内超声探针的子宫的顶端;(2)烧蚀器件,也通常在接近要被治疗的肿瘤的下腹部位中。Halt过程还通过以下技术被执行:腹透技术;利用常规的腹透超声并在使用腹腔镜确认的情况下以腹透方式放置烧蚀器件;以及经阴道和经子宫颈技术。
本发明的范围由权利要求限定,这些权利要求被加入本部分中作为参考。通过考虑以下对一个或更多实施例的详细说明,本领域技术人员能够更完整地理解本发明的实施例及其附加优点的实现。将参照首先被简要说明的附图。
附图说明
图1是根据本发明的实施例的用于烧蚀骨盆肿瘤的外科系统的透视图。
图2是图1的外科系统的顶视平面图,示出相对于躺在手术台上的病人的某个设备的配置。
图3是根据本发明的另一个实施例的用于烧蚀骨盆肿瘤的外科系统的预视平面图。
图4是示出根据本发明的实施例的用于烧蚀骨盆肿瘤的方法的流程图。
不同附图中的相同的附图标记表示类似或相同的项目。还应注意附图可能没有按比例绘制。
具体实施方式
首先参照图1,用于烧蚀骨盆肿瘤的外科系统10包含腹腔镜12、与腹腔镜12相关的视频监视器14、成像器件16、与成像器件16相关的视频监视器18、能源20和烧蚀器件22。
被插入病人P体内的腹腔镜12与光源和用于显示来自腹腔镜12的图像的视频监视器14连接。如下面更详细地解释的那样,腹腔镜12使得外科医生能够观察骨盆和腹部中的结构并将烧蚀器件22插入和放入病人的骨盆或腹部区域中。诸如VCR、DVD或CD记录器的标准记录器件可被用于记录腹腔镜图像并将其编制成文档。
在一个例子中,成像器件16与视频监视器18连接,以提供病人的骨盆区域的图像。在一个例子中,显示于视频监视器18上的这些图像使得外科医生能够确定骨盆肿瘤的存在和位置。在一个实施例中,图1所示的成像器件16包含成像探针24,并且在一个例子中是包含腹内超声探针的超声机。诸如VCR、DVD或CD记录器的记录器件可被放在沿信号路径的各个位置上用于文件编制和存储。作为腹内超声探针的替代,换能器(未示出)可与超声机耦合,用于腹透超声成像。另外,作为超声机的替代,与任意的适当的成像探针结合的诸如MRI机器或CT设备的其它的成像器件也可被使用。
烧蚀器件22是消毒的电外科器件,它包含至少一个电极并可包含多个收缩式电极或臂状构件26。图1表示在骨盆肿瘤28中被展开的烧蚀器件22的臂状构件26。烧蚀器件22的各臂状构件26是用于传送能量的收缩式弯曲电极,并具有位于末端的热电偶(未示出)。在一个实施例中,多普勒换能器也可被加入电极的末端。虽然图1将烧蚀器件22示为包含可展开的臂状构件,但没有任何臂状构件的烧蚀器件也可被使用。作为替代方案,烧蚀器件或多个烧蚀器件可包含可被插入肿瘤内的两个或更多个针。虽然在这里说明使用一个烧蚀器件,但使用多个烧蚀器件也在本发明的范围内。
可应用的烧蚀器件的例子包含但不限于:可从RITA MedicalSystems,Inc.of Mountain View,California得到的Model 30Electrosurgical Device和StarBurstTM XL;可从Valleylab ofBoulder,Colorado得到的Cool-tipTM RF Ablation System电极或簇电极;可从Radio Therapeutics Corporation of Sunnyvale,California得到的LeVeen Needle Electrode;以及可从Prosurg Inc.of San Jose,California得到的R.F.gel电极和OPAL/OPALflex器件。
烧蚀器件22与向烧蚀器件22的臂状构件26中的每一个供能的能源20耦合。在一个例子中能源20可以是RF发生器,该RF发生器包含一般被用于切割和凝结的外科过程中的标准射频发生器。从能源20向烧蚀器件22和扩散式电极30的RF能量的供给由手术员控制装置来控制,诸如通过脚踏开关32。RF能量的施加导致肿瘤温度的升高。在足够高的温度下,例如,在65摄氏度和更高的温度下,出现细胞死亡,由此破坏肿瘤。
可应用的能源的例子包含但不限于:可从RITA Medical Systems,Inc.of Mountain View,California得到的Model 500 Generator或Model 1500 RF Generator;以及可从RadioTherapeuticsCorporation of Sunnyvale,California得到的RF 3000发生器。
能源20还可包含允许烧蚀器件22利用常规的单极或双极烧灼治疗非常小的、表面的肿瘤以及烧蚀在插入烧蚀器件22的过程中形成的痕迹的单极或双极能源。烧灼烧蚀器件痕迹会减少或防止在将烧蚀器件22插入器官或从器官抽出时出血。
如图2中更好地示出,根据本发明的实施例,外科系统10的设备以非常规的配置被设置在病人周围。图2示出以仰卧位躺在手术台34上的病人P。
支撑用于腹腔镜12的视频监视器14和用于成像器件16的视频监视器18的塔状构件36位于病人腰部附近而不是手术台34的台尾。由于外科医生S位于手术台34的与塔状构件36相对的另一侧,因此外科医生S可以直接观察监视器14和18。视频监视器14和18不需要被设置在塔状构件36上;它们可被悬挂于天花板上并位于手术台34的与外科医生S相对的另一侧。有利的是,由于外科医生不需要向手术台34的台尾回头观察监视器14和18,因此,在较长的外科过程中,与外科医生直接相对的视频监视器14和18的位置对于外科医生来说很方便,并且对于病人来说很安全。
虽然图1和图2分别示出用于腹腔镜12和成像器件16的分开的视频监视器14和18,但诸如画中画监视器的能够同时显示来自腹腔镜和成像器件的多个图像的单一监视器也可被使用。单一监视器位于手术台的与外科医生S相对的一侧并可被安装在与塔状构件36类似的塔状构件上、悬挂于天花板上、或另外位于病人的与外科医生相对的一侧,以便于外科医生观察。
塔状构件36可包含附加的设备(未示出),诸如吹气机、打印机、光源和VCR。塔状构件36可具有轮子,使得它可很容易地在手术室周围移动。
还可在外科助手A对面设置用于腹腔镜12的附加监视器37,该外科助手A大致在病人的胸部水平上坐于或站在手术台的与外科医生S相对的一侧。因此,附加监视器37可位于外科医生S附近。附加监视器37可被安装在可移动塔状构件(未示出)上、悬挂于天花板上或另外大致位于助手A对面。
不位于塔状构件36上的成像器件16的定位状态是,沿着手术台34、在外科医生S对面,并向着手术台34的台尾。例如,成像器件16可位于病人的膝盖附近。
现在参照图3,示出根据本发明的另一个实施例的用于烧蚀骨盆肿瘤的外科系统11的顶部平面图。与示于图2的系统10中的设备类似的设备被使用,并且相同的附图标记指示与图2相同或类似的项目。但是,在图3中,能源20被设置在塔状构件36上,并且,用于成像器件的视频监视器18被设置在通过臂状构件17固定到塔状构件36上的可移动平台上。
如图3所示,包含视频监视器14、能源20和吹气机(未示出)、打印机(未示出)、光源(未示出)、和VCR或数字记录器件(未示出)的塔状构件36被放在病人的腰部附近并与外科医生S相对。视频监视器18被放在可移动平台上,使得外科医生S不必大幅扭头就可无障碍地观看监视器。外科助手A1大致在病人的胸部水平位于手术台的与外科医生S相对的一侧,使得塔状构件36位于助手A1后面并进一步靠近手术台34的台尾。
可操作地与能源20耦合的计算机19紧挨着塔状构件36并靠近手术台34的台尾。计算机19记录来自烧蚀过程的数据,包含但不限于温度、功率、阻抗和烧蚀时间长度。用于记录数据的软件可从RITAMedical Systems,Inc.得到。助手A2可接近计算机19以操作能源20和/或计算机19。成像器件16的定位状态是,在手术台34旁边、与助手A1在同一侧、并靠近手术台34的台尾。附加监视器37大致在病人的胸部水平上被定位在外科助手A1的对面。用于手术器械的桌子21可如图所示沿手术台34的台尾被放置。
现在将参照图4所示的流程图说明根据本发明的一个实施例的治疗骨盆肿瘤的方法。该方法50使用用于烧蚀骨盆肿瘤的腹腔镜技术。
在步骤51中,任选地在手术前执行术前评估。在一个实施例中,术前研究可包含子宫的体检、腹透和阴道内超声检查和/或多普勒成像,以分析子宫肌层和肿瘤自身内的血流并将其局部化。病人的骨盆区域的三维超声绘图也可被用于对多个肿瘤进行成像和绘制。
在术前研究后,以下结合图1~3概述的外科过程可包含步骤52~94,但不必包含所有的步骤。首先,在步骤52中,通过放置扩散式电极30并将其适当地粘附到病人的大腿和/或下背上以允许耗散来自烧蚀器件的电流,使病人为腹腔镜检查做好准备。
在步骤54中,病人被置于全身麻醉状态,然后被定位用于由外科医生对病人的骨盆区域进行检查。这种检查允许外科医生确认可触知的肿瘤的位置和步骤51中的术前研究的分析的各个部分。诸如挟钩的操纵器38(图1)被放在病人的子宫颈上,在一个实施例中,将挟钩的前后唇捏在一起,以将挟钩用作子宫操纵器。有利的是,操纵器38没有被放在子宫内,由此降低由于与其它器械或能源相互作用导致感染和/或并发症的可能性。14Fr.Foley导管被插入病人的膀胱中,用于在外科过程中将膀胱排空。
在步骤56中,使病人处于仰卧位,使得她的胳膊放在两侧而不是像飞机那样向外张开,并且毯子和手术单被放在病人身体上面。这种位置提供给外科医生和外科助手更大的活动空间。由于仰卧位减小神经伤害的情况并提供更好的循环,因此仰卧位对于病人来说也是比蛙腿位或切石位更安全的姿势。另外,仰卧位不需要使用顾客台布和顾客镫。手术单包含用于至少一个腹腔镜索的肚袋。串行的压缩设备(未示出)被放在病人的腿上并被激活以改善整个外科过程中的循环并降低血栓症的可能性。另外,病人可被放在负载环抱系统(bear huggersystem)(未示出)中,以在病人处于全身麻醉时帮助维持其体温。
在步骤58中,在本发明的一个实施例中,设备被有利地配置在手术台34之上。图2和图3示出用于烧蚀骨盆肿瘤的外科系统的两个实施例,该系统已在上面参照图2和图3被说明。
在步骤60中,外科医生S然后进行脐下或脐部下或其它的腹部切割,用于安全、有利地放置Verres针和腹腔镜套针和套管。Verres针然后通过切口被插入并以标准腹腔镜技术被插入腹膜腔中。吹气机然后被用于用二氧化碳气体对腹部吹气,直到腹压为约14~20mmHg,由此向外科医生提供可视的窗口。
然后,在步骤62中,3、5、7或10mm套针和套管通过脐下或脐部下切口被插入。套针然后被取出,并且腹腔镜12被插入套管中。腹腔镜12和监视器14然后被用于验证腹腔镜12在腹膜腔中的正确放置和不存在任何损伤。套管被固定到二氧化碳气体供应上,并包含用于控制腹膜腔的腹压的阀。
上述的步骤60和62说明了封闭的腹腔镜过程。对于外科医生感觉开放的腹腔镜检查有利的病人,外科医生会进行脐下或脐部下切割并使用钝的和锐利的经皮下组织解剖的组合。外科医生然后会利用用于暴露的牵开器。当筋膜可被看到时,它被用一个或更多个夹钳抓住、被抬高并被切开。这使得可看见下面的腹膜,该腹膜可以以钝的或锐利的方式被切开。然后,放置适当的腹腔镜套管,并将二氧化碳气体吹入腹部。腹腔镜然后通过套管被插入腹膜腔内。
在步骤64中,外科医生然后使用腹腔镜12,同时触摸子宫底的顶部,以确定腹下超声探针的最佳位置。最佳位置一般在子宫沿中线的最向头部的位置而不是在耻骨弓上或侧向。这通常提供观察子宫的整个表面的有利位置。被手术医生视为合适的其它位置也可被利用。
然后在该位置进行切割,并且,3、5、7或10mm套针和套管被插入。套针被取出,并且成像探针24被插入套管中。作为例子,成像探针24可以是供Aloka SSD 1400型超声机使用的AlokaUST-5526L-7.5MHz型探针。成像探针24将信号传送给成像器件16,该成像器件16基于该信号在视频监视器18上显示骨盆区域的图像。因此,外科医生可同时观察视频监视器14和18上的图像。如上所述,作为分开的监视器14和18的替代,同时显示来自腹腔镜12和成像器件16的图像的单一监视器可被使用。
在步骤66中,外科医生检查整个骨盆和腹部以确认任何可见的病理状况的有无。外科医生还使用腹腔镜12和成像探针24以使诸如子宫平滑肌瘤的任何肿瘤可视化。特别地,外科医生注意所有肿瘤的数量、位置和尺寸,并将该信息与以前从步骤51中的术前评估和步骤54中的骨盆检查获取的数据相比较。有利的是,成像探针24允许实时子宫操纵和成像。
在步骤68中,外科医生订出和/或修改现有的烧蚀计划并确定治疗肿瘤的次序。该次序基于各种肿瘤的尺寸和位置、肿瘤是否可从烧蚀器件的单一插入点接近以及是否需要多个位置被确定。例如,如果两个肿瘤大致沿着烧蚀器件22的同一轨迹,那么外科医生可首先烧蚀更深的肿瘤并在缩回烧蚀器件22时烧蚀剩余的肿瘤。另外,对于需要多重交叠烧蚀的较大的肿瘤,外科医生可选择首先烧蚀肿瘤远离该肿瘤的脉管系统的一部分并向着脉管系统操作,或者以相反的次序进行。
在步骤70中,外科医生对烧蚀器件22进行测试以保证其适当地操作。烧蚀器件22与能源20连接,并且,如果存在热电偶,那么来自热电偶的适当的反馈被观察。特别地,外科医生操作脚踏开关32或其它任何适当的手术员控制装置,以激活RF能量从能源20的供给,并注意温度的适当的升高和任何峰值。烧蚀器件22也可在使用前被生理盐溶液冲洗,以使电极保持低温并减少焦化的出现。
在步骤72中,外科医生切割适于烧蚀第一肿瘤的约2.5~3.0mm长的切口并将烧蚀器件22插入腹部。通过使用腹腔镜12观察烧蚀器件22的进入。外科医生使用成像探针24以使肿瘤相对于烧蚀器件22的尺寸和位置可视化。只要有可能,可使得烧蚀器件22的放置和使用与成像探针24相关,使得对于最有效放置的烧蚀器件22、烧蚀器件22的电极和成像探针24的换能器基本上相互平行。成像探针24可能不是在所有情况下均基本上与烧蚀器件22平行。
然后,在步骤74中,挟钩38和成像探针24被用于对子宫定位并使其稳定。在其它的实施例中,其它的子宫操纵器可被用于操纵子宫并使其稳定。刺穿或伤害子宫的浆膜表面的稳定化器件的固定一般要被避免。有利的是,根据本发明,在不用多次刺穿子宫的情况下成像探针24、烧蚀器件22和子宫的位置被控制。
在步骤76中,在外科医生使子宫稳定并对肿瘤定位后,外科医生将烧蚀器件22引导到子宫壁内。在一个实施例中,外科医生可在不穿过的情况下用烧蚀器件挤压或轻敲子宫,以用成像器件验证进入点的位置。外科医生可如上所述通过改变子宫相对于烧蚀器件22的位置引导烧蚀器件22。另外,外科医生可旋转烧蚀器件,用于在子宫更少移动的情况下更好地穿过子宫壁。烧蚀器件的旋转对于穿入高密度肿瘤中或从高密度肿瘤退出也是有益的。也可以在向针施加能量的同时插入烧蚀器件以使痕迹聚合并使得插入变得容易。烧蚀器件22具有多个使得外科医生能够注意器件22的穿入深度的标记(未示出)。通过腹腔镜12和成像探针24提供烧蚀器件22的定位和放置的确认。成像探针24在多个平面中(例如,径向和横向)被利用,以确认与烧蚀器件22有关的电极的位置。
然后,在步骤78中,外科医生使烧蚀器件22的尖端前进到用于治疗肿瘤的适当的深度。在这样做时,针只进行非常小的穿刺。例如,具有16规格的针的烧蚀器件可产生直径为约1~2mm的穿刺点。适当的深度依赖于肿瘤的尺寸和烧蚀器件22的特性。手术员可基于术前以及诸如多普勒超声的术内成像研究的发现以使得最有效地烧蚀肿瘤的血液供给的方式选择对烧蚀器件22进行定位。当烧蚀器件22已被插入适当的深度时,如图1所示,烧蚀器件22的臂状构件26在肿瘤28中被展开到适当的程度。通过成像探针24和腹腔镜12的可视化被用于保证所有的臂状构件26保持在肿瘤的界限内并且不延伸到器官的外面。臂状构件26可有效地将烧蚀器件22锚定在肿瘤28中。
在步骤80中,外科医生然后记录肿瘤的基线温度,该基线温度通常为39~42摄氏度。肿瘤的温度是通过位于烧蚀器件22的臂状构件26的末端的热电偶获得的。
在步骤82中,外科医生然后通过从发生器20向烧蚀器件22供给RF能量烧蚀肿瘤。当发生器20被激活时,监视烧蚀器件的所有部分的温度或阻抗是十分重要的。如果烧蚀器件22的任意部分的温度或阻抗异常,那么可指示器件的该部分在器官外面。
在一个实施例中,RF能量被施加到肿瘤上,以升高肿瘤的温度,使得它在约65℃~100℃的范围中保持约14分钟。在约65℃的温度下出现细胞死亡。但是,用于烧蚀骨盆肿瘤的优选的目标温度范围为85℃~100℃,以促进热在整个烧蚀区域的传导。对于较小的肿瘤,目标时间可为约3~10分钟。但本领域技术人员可以理解,少于3分钟的烧蚀时间也可能是足够的。
在一个实施例中,特别致密的肿瘤可被预热以调节肿瘤,以便于穿入以及实现导致最大烧蚀体积的电极的完全展开。为了预热肿瘤,烧蚀器件电极可被展开,直到进一步展开遇到很大的阻力。发生器然后被激活,并且肿瘤被预热到低于目标温度的温度。一旦肿瘤和烧蚀臂状构件26被加热,烧蚀器件就根据需要被进一步展开到更大的程度。在极端的情况下可能需要多阶段加热以实现最佳的展开。在一个实施例中,如果希望的展开长度为约4cm,但肿瘤具有较高的密度并且展开较困难,那么臂状构件可被展开到约2cm,并且肿瘤区域被预热到约90摄氏度以软化纤维瘤和加热臂状构件26。臂状构件然后可更容易和更有效地在被加热的纤维瘤中被展开到希望的长度,用于完全实现烧蚀器件的烧蚀体积。常规的烧蚀不利地将低温的电极展开到未加热的用于烧蚀的目标肿瘤中。
烧蚀器件22也可在被激活的同时被插入肿瘤或器官中,以有利于放入特别致密的肿瘤或器官中。在另一个实施例中,电极可结合轴的缩回被展开以将烧蚀体积的形状从球形改变为卵形,以有利地烧蚀非球形肿瘤。
由热电偶提供的各点上的肿瘤的温度被监视和记录。因此,对于各次烧蚀,至少基线开始温度、半时间温度和烧蚀结束期温度被记录。当RF能量被传送给肿瘤时,外科医生观察监视器14和18以保证烧蚀器件22的臂状构件26均不延伸到肿瘤外。子宫可能在烧蚀过程中收缩,从而导致烧蚀器件22的臂状构件26从肿瘤突出并接触正常组织,该正常组织会被RF能量损伤。当肿瘤已被充分烧蚀时,来自能源20的能量被切断。
如步骤84所示,在烧蚀之间,周期性地用诸如普通生理盐溶液或Lactated Ringer的流体冲洗子宫。流体保持浆膜湿润并防止由于在腹腔镜检查中吹入腹部的二氧化碳气体变干。冲洗并去除血液,由此防止可能触发粘连形成的血纤蛋白的形成。
如果肿瘤比给定烧蚀器件的烧蚀能力大,那么在步骤86中,外科医生可能需要重复步骤76~84以在肿瘤的另一部分中对烧蚀器件22进行重新定位和重新供给RF能量。因此,如果肿瘤的尺寸比烧蚀器件22的烧蚀能力大,或者如果出现烧蚀器件的次优的展开或放置,那么可能需要可能交叠的多次烧蚀以烧蚀肿瘤块。但是,对于小于5cm的肿瘤,单次施加RF能量通常是足够的。可以以单次施加能量实现7cm烧蚀的烧蚀器件当前是可用的。
电力被传送给烧蚀器件22的速率可被控制以使烧蚀效率最佳化。电力可随着时间被传送,直到以使得禁止臂状构件26附近焦化或组织脱水的方式达到目标温度。臂状构件26周围的焦化是不希望有的,因此它妨碍热传导并且可能导致烧蚀不彻底或不规则。对于较小的肿瘤,可以通过手动电力控制更迅速地传送电力,由此更快地实现目标温度,由此减少总的手术时间。也可以与轨迹烧蚀模式类似不展开电极而是用烧蚀器件轴的活性尖端治疗浆膜下纤维瘤。因此,可以使用三种烧蚀方法,这些方法包括但不限于:使用用于向烧蚀器件施加电力的算法、用能量发生器的手动电力控制进行加热和在不展开电极的情况下破坏肿瘤。
在烧蚀后可以执行腹内多普勒研究以确认对肿瘤的血液的有效停止。被加入烧蚀器件22或成像探针24的末端的至少一个多普勒换能器可被用于执行多普勒分析。在一个实施例中,超声探针可传送用于成像以及用于多普勒分析的超声波。
在另一个实施例中,基于多普勒分析,成像探针24可然后被用于通过对插入子宫的位置的所关心的动脉施加物理压力阻塞子宫动脉。因此,可减少通过子宫的血液,由此减少来自血液循环的冷却效果并由此更有效地烧蚀纤维瘤。
在又一个实施例中,一旦烧蚀器件的臂状构件被展开并被锚定到纤维瘤中,子宫就可通过烧蚀器件22的提升被悬起或提升以检查另外隐藏在视线外的骨盆区域。
在步骤88中,外科医生然后在下一个肿瘤上对烧蚀器件22进行重新定位。如果下一个肿瘤沿着相同的接近路线,那么外科医生可将烧蚀器件22留在同一轨迹中。外科医生会缩回臂状构件26、根据需要使烧蚀器件22前进或后退,然后将烧蚀器件22插入下一个肿瘤中。外科医生然后会重复上述的步骤78~86的烧蚀次序。
如果随后的肿瘤处于不同的位置,那么外科医生可缩回烧蚀器件22的臂状构件26、并从子宫缩回烧蚀器件22,同时施加单极烧灼以减少或防止从烧蚀器件轨迹出血。作为替代方案,外科医生不是重复步骤72~86完全缩回烧蚀器件22并在新的进入点重新插入烧蚀器件22,而是可以缩回烧蚀器件22直到它仅在子宫内0.5~1cm深,并调整子宫直到获得希望的接近角度。烧蚀器件22然后可以以前面说明的方式被插入新的肿瘤中。有利的是,成像探针24和子宫操纵器38可被用于调整子宫。
在多次烧蚀的情况下,烧蚀器件可完全从病人体内取出并用水和软刷清洗,以从针轴和臂状构件26去除粘附的死细胞和组织。
可以通过使用不同的技术烧蚀较小的表面的浆膜下纤维瘤(例如,小于1cm)。在一个例子中,单极烧灼可在步骤90中被使用。如果纤维瘤从子宫壁延伸,那么还可以使用双极刮刀。类似地,如果肿瘤有肉茎,那么外科医生可处理和/或切入肉茎。单极或双极烧灼可被施加到浆膜下、壁内、和粘膜下平滑肌瘤上。另外,适当情况下其它的骨盆病症被治疗。
在所有的肿瘤都被烧蚀后,在步骤92中,外科医生确认止血、缩回烧蚀器件22、并且必要时用烧蚀器件22向穿刺点施加单极烧灼。少量的冲洗液可被留在骨盆中。
最后,在步骤94中,获得包括录像带、超声照片和来自腹腔镜的照片的文件。套管被打开以允许二氧化碳气体逸出,并且局部麻醉剂被注入皮肤切口中。外科医生然后通过使用可吸收的缝合线和S牵开器修理10mm切口的筋膜以有利于可视化。AlisTM夹钳或其它的无创伤夹钳被用于夹紧和提升用于缝合的筋膜边。皮肤和皮下组织以标准的方式被缝合。外科医生然后去除扩散式电极30和Foley导尿管,并检查周围的皮肤。
病人被送到恢复室,她将在该恢复室内停留,直到她可以接受流食、在有辅助的情况下可以走动并充分地排泄。
如果病人的子宫非常大(例如,16周或更大),那么上述腹腔镜技术效果会很差。因此,可以用腹腔镜主导确认(例如,最小腹内超声确认)完成烧蚀器件22直接腹透插入。在这种方法中,以与上述步骤52相同的方式使病人做准备。如以上的步骤54~62那样,外科医生也执行骨盆检查、将病人定位、放置Foley导尿管和串行压缩设备、配置设备、进行脐下切入、对病人的腹部吹气、插入腹腔镜12。特别地,外科医生检查腹部并证明在没有外科校正的情况下会使得该方法不合适的肠粘接或其它病症状况的有无。可以根据需要执行腹部粘接消散以建立正常的剖析。然后可执行射频烧蚀如下。
然后,外科医生从病人的腹部释放CO2气体,从而允许腹壁与子宫的前部接触。换能器上的消毒盖布允许通过使用未消毒的换能器(未示出)进行腹透超声成像。超声波被用于对肿瘤进行定位和测量。
外科医生然后为烧蚀器件22制作切口,并且经由皮肤并透过腹部插入烧蚀器件22,在插入的同时使用腹透超声图记录仪以引导其插入。
如上面关于腹腔镜方法说明的那样,烧蚀器件22被定位在肿瘤上,并且臂状构件26在肿瘤中被展开。在向肿瘤施加RF能量之前,外科医生对腹部吹气并执行腹腔镜检查以确认烧蚀器件22的臂状构件26均不延伸到子宫组织外面。
外科医生然后以与上述步骤80~84相同的方式向肿瘤施加RF能量,包括记录基线、半时间和烧蚀结束期温度。外科医生可使用与上述相同的方法以烧蚀多个骨盆肿瘤。一旦缩回烧蚀器件22,外科医生就在通过腹腔镜实现可视化的条件下用单极烧灼电灼烧蚀器件轨迹。因此,剩余的步骤与上述步骤86~94相同。
上述方法使得外科医生能够从单一的烧蚀器件穿刺点基本上烧蚀所有的肿瘤,但对于较大肿瘤必需多次穿刺。另外,根据肿瘤的位置,可从单一穿刺点烧蚀多个肿瘤。这些方法还使得外科医生能够治疗骨盆和/或腹部的任何区域中的所有尺寸的肿瘤。
本发明的上述实施例仅意味着是例示性而不是限制性的。在不背离本发明的较宽方面的情况下,可以提出各种变化和变更方式。例如,虽然关于子宫平滑肌瘤的治疗对本发明进行了说明,但本发明也可被用于治疗其它骨盆肿瘤,诸如存在于卵巢中的肿瘤。除了上述腹腔镜和腹透技术以外,可以通过使用经子宫颈、子宫镜或经阴道技术执行本发明。因此,所附的权利要求包含落入本发明的真实精神和范围内的所有这些变化和变更方式。
Claims (11)
1.一种用于烧蚀骨盆肿瘤的外科系统,包括:
包含用于插入骨盆肿瘤中的电极的烧蚀器件;
与烧蚀器件分开、用于将电极定位在骨盆肿瘤内的成像探针,所述烧蚀器件的电极被配置成要被展开到不同的程度;和
与烧蚀器件耦合、用于向电极提供能量以直接烧蚀骨盆肿瘤的能源,所述能源在所述电极被展开到第一程度时向所述电极提供能量,并在所述电极被展开到进一步的程度时进一步向所述电极提供能量。
2.根据权利要求1的外科系统,其中,烧蚀器件包含三个或更多个可从尖端展开的电极。
3.根据权利要求1的外科系统,其中,成像探针包含腹内超声探针。
4.根据权利要求1的外科系统,其中,成像探针能够操纵烧蚀器件在病人的骨盆区域内的位置。
5.根据权利要求1的外科系统,其中,能源选自包含RF能源、微波能源、光能源和声能源的组。
6.根据权利要求1的外科系统,还包括腹腔镜,其中,腹腔镜和成像探针可操作地与至少一个监视器耦合。
7.根据权利要求1的外科系统,其中,该至少一个监视器沿手术台的第一侧被定位,并且,能源被定位为沿着手术台的第一侧邻近该至少一个监视器。
8.根据权利要求1的外科系统,还包括沿手术台的第二侧被定位的第二监视器。
9.根据权利要求1的外科系统,还包括可操作地与能源耦合并沿手术台的第二侧被定位的手术员控制装置。
10.根据权利要求1的外科系统,其中,手术员控制装置是脚踏开关。
11.根据权利要求1的外科系统,其中,所述能源在两个或更多个离散展开位置提供能量。
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CA2593988A1 (en) | 2006-07-20 |
EP1835858A1 (en) | 2007-09-26 |
WO2006076181A1 (en) | 2006-07-20 |
MX2007008362A (es) | 2008-02-12 |
JP2008526362A (ja) | 2008-07-24 |
US20050149013A1 (en) | 2005-07-07 |
TWI377931B (en) | 2012-12-01 |
TW200628120A (en) | 2006-08-16 |
AU2006205199A1 (en) | 2006-07-20 |
KR20070117552A (ko) | 2007-12-12 |
IL184446A0 (en) | 2007-10-31 |
AU2006205199B2 (en) | 2011-02-03 |
US7678106B2 (en) | 2010-03-16 |
CN101141924A (zh) | 2008-03-12 |
BRPI0606386A2 (pt) | 2009-11-17 |
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