CN102238920B - 用于组织消融的方法和装置 - Google Patents

用于组织消融的方法和装置 Download PDF

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CN102238920B
CN102238920B CN200980148816.6A CN200980148816A CN102238920B CN 102238920 B CN102238920 B CN 102238920B CN 200980148816 A CN200980148816 A CN 200980148816A CN 102238920 B CN102238920 B CN 102238920B
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维兰德.K.沙马
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Abstract

本发明涉及一种对组织进行消融的装置。该装置包括具有消融介质可以通过的轴的导管，在第一位置连接于导管轴的第一定位元件和在第二位置连接于导管轴的第二定位元件。该轴还具有可释放消融介质的端口。

Description

用于组织消融的方法和装置
技术领域
本发明涉及一种医疗器械及其制造方法，本发明更特别涉及一种用于消融中空器官中的组织的装置，该装置包括定中心或定位附件以便将该装置定位成与待切除组织始终保持一致的距离。
背景技术
在50岁以上的人群中，几乎有25％的人都患有结肠息肉。尽管多数息肉都可通过结肠镜检查到并且通过勒除器可以很容易地去除，然而，使用勒除器技术很难去除广基扁平息肉，并具有如出血、穿孔等并发症的高风险。近年来，随着成像技术的发展，更多的扁平息肉被发现。内窥镜不能消融的息肉需要通过外科手术去除。大多数结肠癌都是从结肠息肉发展而来的，因此为防止结肠癌，必需将这些息肉安全、彻底地切除。
巴雷特食管是癌症前期的症状，具有胃食管反流病(GERD)的美国人中有10-14％的人具有该症状，并已被证实是食管腺癌的前期损害，是发达国家中上升最快的癌症。癌症的发生率在过去的二十年里已经升高了6倍，死亡率升高了7倍。食道癌的5年死亡率为85％。研究表明消融巴雷特上皮细胞能防止其发展成食道癌。
30％的育龄妇女都患有功能失调性子宫出血(DUB)，或者月经过多。这些症状已经大大地影响了女性的健康和生活质量。这种情况通常是通过子宫内膜切除或子宫切除来治疗。在这些女性中手术介入的比率非常高。几乎30％的美国女性在60岁时都会遭遇到子宫切除，其中50-70％的女性是因为月经过多或功能失调性子宫出血而做的手术。FDA(食品及药物管理局)已经证实子宫内膜切除术对于女性非正常子宫出血和小于2cm的肌瘤有效。已经表明，子宫黏膜下肌瘤的出现以及大子宫尺寸降低了标准子宫内膜切除的功效。在五种FDA认可的全球切除装置(即，子宫热球治疗系统、热水灌注法、诺舒、Her Option、和微波子宫内膜去除术)中，只有微波子宫内膜去除术(MEA)被证实对于小于3cm且不封闭子宫内膜腔的子宫黏膜下肌瘤，以及大到14cm的子宫有效。
已知的巴雷特食管的消融治疗方法包括激光治疗(Ertan等，Am.J.Gastro.，90-2201-2203[1995])，超声波消融(Bremner等，Gastro.Endo.，43：6[1996])，利用光敏剂的光动力性疗法(PDT)(Overholt等，Semin.Surq.Oncol.，1：372-376(1995))，利用Bicap探针等的多极电凝法(Sampliner等)，氩等离子体凝结法(APC；)，射频消融(Sharma等，Gastrointest Endosc)和冷冻消融法(Johnston等，Gastrointest Endosc)。在内窥镜以及穿过内窥镜的通道或沿着内窥镜的装置的帮助下进行治疗。
然而，常规的技术存在一些固有的缺陷，在临床上没有得到广泛的应用。首先，大多数的手持消融装置(Bicap探针、APC、冷冻消融法)都是产生小消融焦点的定焦(point and shoot)装置。该消融机构依赖于操作者、麻烦并且耗时。第二，因为目标组织因患者移动、呼吸运动、正常蠕动和血管搏动而移动，因而目标组织的消融深度不一致，会产生不均匀的消融。表面的消融会产生不彻底的消融，将残余的肿瘤组织留下。而较深的消融结果会产生出血、形成狭窄和穿孔等并发症。在常规装置中，这些缺点和并发症都被报导过。
例如，射频消融利用刚性双极气囊电极和射频热能。通过将电极与患病的巴雷特食管直接接触来输送热能，可以相对均匀地、大面积的消融。然而，刚性电极不适应食道尺寸的变化，因此对于消融弯曲的食道、作为朝向顶部变窄的近端食道病变以及胃肠接合处的食道因食道直径的变化而没有效果。巴雷特食管中的瘤状疾病也不能利用刚性双极射频电极来治疗。由于其尺寸和刚度，电极不能穿过该范围。此外，脱落组织对电极的粘附作用会阻碍射频能量的输送，因而会产生不完全的消融。电极尺寸被限制到3cm，因而在处理具有较大长度的巴雷特食管时需要反复应用。
光动力疗法(PDT)是两个分开的步骤，包括注入被肿瘤和肿瘤发生前的组织吸收和保留的光敏剂。然后将该组织曝光到所选波长的光中，激活光敏剂并破坏该组织。PDT会带来形成狭窄等并发症，并且其光敏性仅限于使用在疾病的最高阶段。另外，光敏剂的不规则吸收产生不完全的消融和残余的肿瘤组织。
已经对动物模型和人类进行了与液氮直接接触对食道组织进行冷冻消融的研究(Rodgers等，Cryobiology，22：86-92(1985)；Rodgers等，Ann.Thorac.Surq.55：52-7[1983])，并已用来治疗巴雷特食管(Johnston等，GastrointestEndosc)和早期食道癌(Grana等，Int.Surg.，66：295[1981])。直接喷射液态氮气或二氧化碳(冷冻消融)或者氩(APC)来消融食道中的巴雷特组织的喷射导管已被说明。这些技术存在常规手持装置的缺点。使用该探针进行治疗比较麻烦，并且需要操作者通过直接观察内窥镜来控制操作。食道因呼吸或心脏或动脉博动或运动的连续移动会造成消融介质不均匀地被分布，并产生不均匀和/或不完全的消融。导管对表面上皮细胞的靠近或直接接触会造成较深的组织损伤，产生穿孔、出血或形成狭窄。而因食道移动将导管太远布置则会产生不完全的巴雷特消融，需要多次治疗时间或掩盖损伤，存在食道癌的连续风险。食道中低温气体的膨胀会带来不可抑制的恶心，可能会产生食道撕裂或穿孔，因而需要连续抽吸冷冻剂。
通常利用勒除器切除术，同时使用或不使用单极电灼术，来切除结肠息肉。在进行勒除器切除术之后，利用氩等离子体凝聚或激光对扁平息肉或残余息肉进行治疗。这两种治疗方法，具有前面提到的缺陷。因此，大多数扁平息肉需经历外科手术切除，由于利用传统内窥镜切除或消融技术具有出血、穿孔和残余疾病的高风险。
传统上用于组织消融的大部分常规气囊导管，对气囊本身或安装在气囊上的射频(RF)线圈等加热元件进行加热或冷却。这需要气囊导管与被消融表面直接接触。当气囊导管缩小时，上皮细胞粘附在导管上并去除，因而产生出血。血会干扰能量的输送，即减小能量。此外，能量的再应用会对已脱落的表面衬里的区域产生更深的烧灼。而且，不能利用气囊导管来治疗非圆筒形器官，像子宫或鼻窦，并且也不能提供中空器官中的非圆周形或焦点消融。此外，如果使用在加热后按指数规律地膨胀的作为消融介质的冷冻剂，则气囊导管可能产生封闭的腔体并俘获逸出的冷冻剂，产生诸如穿孔和撕裂等并发症。
因此，本领域需要一种用于将消融介质输送到组织表面的改进的方法和系统，以便为目标组织提供连续、可控并且均匀的消融，并减少将消融介质导入患者所带来的不利效果。
发明内容
本发明涉及一种对子宫内膜组织进行消融的装置，包括：导管，具有消融介质可以通过的轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成将所述导管居中定位在子宫颈的中央；以及在第二位置连接于所述导管轴的第二定位元件，其中所述轴包括多个端口，所述消融介质可以通过所述端口从所述轴释放，并且其中所述端口位于所述第一位置与第二位置之间。
可选地，第一定位元件是锥形的。第一定位元件包括绝缘膜，该绝缘膜可被配置成防止热能通过子宫颈逸出。第二定位元件是盘形的。第二定位元件具有可用于确定子宫腔大小的尺寸。第二定位元件具有可用于计算消融子宫内膜组织所需的热能的量的尺寸。该装置还包括至少一个温度传感器，用于控制蒸汽等消融介质的输送。
可选地，第二定位元件隔开待消融的子宫内膜组织大于0.1mm的距离。第一定位元件是绝缘(covered)线网。第一定位元件是具有0.1mm-10cm直径的圆形体。第二定位元件是椭圆形的，其中所述椭圆形具有0.1mm-10cm的长轴和0.1mm-5cm的短轴。
在另一个实施方式中，本发明涉及一种对子宫内膜组织进行消融的装置，包括：导管，具有可以输送蒸汽的中空轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件是锥形的并被配置成使所述导管居中位于子宫颈的中央；在第二位置连接于所述导管轴的第二定位元件，其中所述第二定位元件是盘形的，多个端口一体地形成在导管轴上，其中蒸汽可以从端口被释放出来并导向子宫内膜组织，其中所述端口位于第一位置与第二位置之间；和至少一种温度传感器。
可选地，第二定位元件具有可用于确定子宫腔大小的尺寸。第二定位元件具有可用于计算消融子宫内膜组织所需热能的量的尺寸。温度传感器用于控制所述消融介质的输送。第一定位元件包括线网。第二定位元件是椭圆形的盘，椭圆形具有0.1mm-10cm的长轴和0.1mm-5cm的短轴。
一种对中空器官中的组织进行消融的装置，包括：导管，具有消融介质可以从中通过的轴；在第一位置连接于所述导管的轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位于距待消融组织预定距离处；其中所述轴包括一个或多个端口，所述消融介质可以通过所述端口从所述轴中释放。
可选地，该装置还包括在不同于所述第一定位元件的位置连接于所述导管轴的第二定位元件。第一定位元件是锥形、盘形，或与中空容器的形状相适配的自由成形形状中的至少一个。第二定位元件具有预定尺寸，其中所述预定尺寸用于确定待消融的中空器官的尺寸。第一定位元件包括绝缘膜，该绝缘膜被配置成防止热能逸出。第二定位元件是锥形、盘形，或与中空容器的形状相适配的自由成形形状中的至少一个。第二定位元件具有预定尺寸，其中所述预定尺寸用于确定待消融的中空器官的尺寸。第二定位元件具有预定尺寸，其中所述预定尺寸用于计算消融组织所需热能的量。该装置还包括至少一个温度传感器。温度传感器用于控制所述消融介质的输送。所述消融介质是蒸汽。第一定位元件是绝缘线网。第一定位元件包括具有0.01mm-10cm直径的圆形体。第一定位元件是椭圆形的，其中所述椭圆形具有0.01mm-10cm的长轴，和0.01mm-9cm的短轴。
在另一个实施方式中，本发明涉及一种对中空器官中的组织进行消融的装置，包括：导管，具有可以输送蒸汽的中空轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位到距中空器官表面预定距离的位置；在第二位置连接于所述导管轴的第二定位元件，其中所述第二定位元件的形状被配置成将所述导管定位到距中空器官表面预定距离的位置；一体形成在所述导管轴上的多个端口，其中蒸汽可以从所述端口被释放出来并导向待消融的组织，其中所述端口位于所述第一位置与所述第二位置之间；和至少一个温度传感器。
可选地，第一定位元件具有预定尺寸，其中所述尺寸用于确定待消融的中空器官的尺寸。第二定位元件具有预定尺寸，其中所述尺寸用于计算消融组织所需的热能的量。温度传感器用于控制所述消融介质的输送。第一定位元件包括线网。第二定位元件具有椭圆形的盘形，其中所述椭圆形具有0.01mm-10cm的长轴，和0.01mm-9cm的短轴。
在另一个实施方式中，本发明涉及一种对胃肠组织进行消融的装置，包括：导管，具有消融介质可以通过的轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位于距待消融的胃肠组织固定距离处，其中所述第一定位元件离开消融区域0mm-5cm的距离；和位于第二位置且与所述导管轴流体连通以接收所述消融介质的注入口，其中所述轴包括一个或多个端口，所述消融介质可以通过所述端口从所述轴释放。
可选地，第一定位元件是充气气囊、线网或锥体中的至少一种。通过将所述消融介质导入到所述消融区域中，装置产生等于或小于5atm的胃肠压力。消融介质具有-100-200摄氏度的温度。导管还包括温度传感器。导管还包括压力传感器。第一定位元件被配置成在布置于胃贲门中时接靠胃肠接点。端口位于所述第一位置与第二位置之间。定位元件的直径在0.01mm-100mm范围内。消融介质是蒸汽。第一定位元件包括具有0.01mm-10cm直径的圆形体。
在另一个实施方式中，本发明涉及一种对食管组织进行消融的装置，包括：导管，具有可以运输蒸汽的中空轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成在布置于胃贲门中时接靠胃肠接点；以及在第二位置并与所述导管轴流体连通以接收所述蒸汽介质的输入口，其中所述轴包括多个端口，所述蒸汽可以通过所述端口从所述轴释放。其中所述端口位于所述第一位置与第二位置之间。该装置还包括温度传感器，其中所述温度传感器用于控制所述蒸汽的释放。第一定位元件包括线网盘、线网锥形，或充气气囊中的至少一个。第一定位元件隔开消融区域0mm-1cm距离。第一定位元件的直径在1mm和100mm之间。
在另一个实施方式中，本发明涉及一种对胃肠组织进行消融的装置，包括：导管，具有可以运输蒸汽的中空轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成接靠胃肠接点；以及位于第二位置并与所述导管轴流体连通以接收所述蒸汽的输入口，其中所述轴包括一个或多个端口，所述蒸汽可以通过所述端口从所述轴释放到所述胃肠组织。
可选地，该装置还包括温度传感器，其中所述温度传感器用于控制所述蒸汽的释放。第一定位元件包括线网盘和线网锥形中的至少一种。第一定位元件的直径为0.1mm-50mm。该装置用于进行非圆周形消融。
在另一个实施方式中，本发明涉及一种对子宫内膜组织进行消融的装置，包括：导管，具有消融介质可以通过的轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件被配置成将所述导管居中定位在子宫颈的中央；轴包括多个端口，所述消融介质可以通过所述端口从所述轴释放。
可选地，该装置还包括在第二位置连接于所述导管轴的第二定位元件。第一定位元件是锥形的。第一定位元件包括绝缘膜，该绝缘膜被配置成防止热能经由子宫颈逸出。第二定位元件盘形的。第二定位元件具有预定尺寸，其中所述尺寸用于确定子宫腔的尺寸。第二定位元件具有预定尺寸，其中所述尺寸用于计算消融子宫内膜组织所需热能的量。该装置还包括至少一个温度传感器，其中所述温度传感器用于控制所述消融介质的输送。所述消融介质是蒸汽。第一定位元件是绝缘线网。第一定位元件包括具有0.01mm-10cm直径的圆形体。第二定位元件是椭圆形的，其中所述椭圆形具有0.01mm-10cm的长轴，和0.01mm-5cm的短轴。
在另一个实施方式中，本发明涉及一种对子宫内膜组织进行消融的装置，包括：导管，具有蒸汽可以输送的中空轴；在第一位置连接于所述导管轴的第一定位元件，其中所述第一定位元件是锥形的，且被配置成将所述导管居中定位在子宫颈的中央；在第二位置连接于所述导管轴的第二定位元件，其中第二定位元件是椭圆形的；一体形成在所述导管轴上的多个端口，其中蒸汽可以通过所述端口从所述轴释放并导向子宫内膜组织上，其中所述端口位于所述第一位置与第二位置之间；和至少一个温度传感器。
可选地，第二定位元件具有预定尺寸，其中所述尺寸用于确定子宫腔的尺寸。第二定位元件具有直径，其中所述直径用于计算消融子宫内膜组织所需的热能的量。温度传感器用于控制所述消融介质的输送。第一定位元件包括线网。第二定位元件具有椭圆形的盘形，其中所述椭圆形具有0.01mm-10cm的长轴和0.01mm-5cm的短轴。
可选地，第二定位元件可以使用红外线、电磁、声或射频能量中的一种或多种源，来测量中空腔的尺寸。该能量从传感器中发射并反射回传感器中的检测器。反射数据可用于确定中空腔的尺寸。
附图说明
通过在附图中示出的实施方式描述本发明，其中
图1示出根据本发明一个实施方式的消融装置；
图2A示出其上带有分配口的消融装置的纵截面；
图2B示出其上带有分配口的根据本发明一个实施方式的消融装置的横截面；
图2C示出根据本发明另一个实施方式的消融装置上的分配口的横截面；
图2D示出根据本发明一个实施方式的消融装置的导管；
图3A示出根据本发明一个实施方式，布置在具有巴雷特食管的上胃肠道中以选择地消融巴雷特组织的消融装置；
图3B示出根据本发明另一个实施方式，布置在具有巴雷特食管的上胃肠道中以选择地消融巴雷特组织的消融装置；
图3C示出使用根据本发明一个实施方式的消融装置的基本程序步骤的流程图；
图4A示出根据本发明一个实施方式，布置在结肠中以消融扁平结肠息肉的消融装置；
图4B示出根据本发明另一个实施方式，布置在结肠中以消融扁平结肠息肉的消融装置；
图5A示出根据本发明一个实施方式的具有同轴导管设计的消融装置；
图5B示出根据本发明一个实施方式的局部展开的定位装置；
图5C示出根据本发明一个实施方式的完全展开的定位装置；
图5D示出根据本发明一个实施方式的具有锥形定位元件的消融装置；
图5E示出根据本发明一个实施方式的具有盘形定位元件的消融装置；
图6示出上胃肠道，其中根据本发明一个实施方式的消融装置正在对该出血脉管病变进行治疗；
图7示出利用根据本发明一个实施方式的消融装置对女性子宫执行的子宫内膜消融；
图8示出利用根据本发明一个实施方式的消融装置对鼻通道执行的窦消融；
图9示出利用根据本发明一个实施方式的消融装置对肺部系统执行的支气管和大疱的消融；
图10示出利用根据本发明一个实施方式的消融装置对男性生殖系统中的增大前列腺执行的前列腺消融；
图11示出利用根据本发明一个实施方式的消融装置对女性子宫执行的子宫纤维瘤消融；
图12示出利用射频加热器为根据本发明一个实施方式的消融装置输送蒸汽的蒸汽输送系统；和
图13示出利用电阻加热器为根据本发明一个实施方式的消融装置输送蒸汽的蒸汽输送系统。
具体实施方式
本发明提供一种消融装置，包括导管，在导管的一个或多个端部具有一个或多个定中心或定位附件，以使导管及其注入口固定在距离消融组织固定距离的位置上，其不会受到器官移动的影响。一个或多个喷射口的布置允许对消融介质的均匀喷射，对诸如巴雷特食管等大面积产生均匀的消融。利用微处理器来控制消融介质的流动，并依赖于待消融组织的长度或区域、待消融组织的类型和深度以及从待消融组织到注入口的距离中的一个或多个。
“治疗”及其变形是指与健康状况有关的一个或多个症状或预兆中的任何程度、频率，或强度的减轻。
“持续时间”及其变形是指从开始到结束的处方治疗的周期，该治疗是否因为健康状况得到改善或是治疗因其它原因中止而结束。在治疗的持续时间中，可规定多个治疗周期，在这些治疗周期中，对目标执行一个或多个处方刺激。
“周期”是指作为处方治疗计划一部分对目标执行一“剂”刺激的时间。
术语“和/或”是指一个或所有列出的元素或者所列元素中任何两个或多个的组合。
在说明书和权利要求书中出现的术语“包含”及其变形，不具有限制的意思。
除非另有规定，否则“一个”、“一个或多个”以及“至少一个”可以互换使用，意味着一个或一个以上。
对于在此公开的包括具体步骤的任何方法，可以以任何可行的顺序来进行这些步骤。而且，适当地，可同时进行两个或多个步骤的任何组合。
同时，在此，数值范围端点的列举包括在该范围内包含的所有数字(例如，1-5包括1、1.5、2、2.75、3、3.80、4、5等)。除非另有规定，否则在说明书和权利要求书中使用的表示组件数量、分子量等所有数字都应被理解成在所有例子中都可由术语“左右”修改。因此，除非另有规定，否则在说明书和权利要求书中提到的数字参数都是近似值，都可以根据本发明所要获得的预期性能进行变化。一点也不是意图将等同原则限制到权利要求的保护范围，至少应该根据提供的有效数字并运用普通的四舍五入技术得到的数字来解释每个数字参数。
尽管提出的本发明较宽范围的数值范围和参数是近似值，但是，在具体实施例中提出的数值都尽可能精确。然而，所有数值固有地包含在其各自试验测量中发现的从标准偏差中产生的必要的范围。
诸如蒸汽、加热气体等消融介质，或者诸如但不限于液氮等冷冻剂，廉价且容易得到，经由注入口导入到组织上，保持固定且连续的距离，以进行消融。这样允许将消融介质均匀地分布在目标组织上。微处理器根据预定方法并基于待消融组织的特征、需要消融的深度，以及从组织到注入口的距离，来控制消融介质的流动。微处理器可以利用温度、压力或其它感应数据来控制消融介质的流动。此外，设置一个或多个抽吸口，从目标组织附近抽吸消融介质。可以通过连续注入消融介质，或者通过由微处理器确定和控制的注入和去除消融介质的循环，对目标段进行治疗。
应该理解的是，在此描述的装置和实施方式与包含用来执行控制命令的微处理器的控制器一致执行。该控制器可以是任何形式的计算机装置，包括桌上型、膝上型，和移动装置，并且可以通过有线或无线形式与消融装置进行控制信号的通信。
提供下面的公开以使本领域普通技术人员能够实现本发明。本领域技术人员应该非常清楚，所提供的示例性实施方式只是出于说明的目的，还可以进行各种变形。在不脱离本发明的精神和范围内，在此限定的基本原理可被应用到其它实施方式和应用中。此外，为描述示例性实施方式所使用的术语和用语不应被认为具有限制作用。因而，本发明应被给予包含与所公开的原理和特征一致的多种变型、改进和等同替换的最宽的保护范围。为了简化，没有详细描述在本发明的相关技术领域中已知的技术材料的有关细节，以免不必要地混淆本发明。现在参考附图中示出的实施方式的内容来讨论本发明。
图1示出根据本发明一个实施方式的消融装置。该消融装置包括导管10，其具有末端定中心或定位附件即可充气气囊11。导管10由绝缘材料制成或由绝缘材料覆盖，以防止消融能量从导管本体中逸出。消融装置包括一个或多个用于注入消融介质的注入口12，和一个或多个用于去除消融介质的抽吸口13。在一个实施方式中，注入口12和抽吸口13是相同的。消融介质存储在连接于导管10的储存器14中。消融介质的输送由微处理器15控制，治疗的启动由治疗医师利用诸如脚踏板等输入装置来控制。在其它实施方式中，输入装置可以是语音识别系统(对诸如“开始”、“更多”、“更少”等命令作出响应)、鼠标器、开关、脚垫(footpad)，或者本领域普通技术人员已知的任何其它输入装置。在一个实施方式中，微处理器15将来自输入装置的信号，例如置于脚踏板上的压力或提供“更多”或“更少”消融介质的声音命令，转变成确定是否分配更多或更少消融介质的控制信号。可选择的传感器17监控消融组织或其附近的变化以引导消融介质流。可选择的红外线、电磁、声或射频能发射体和传感器18测量中空组织的尺寸。
在一个实施方式中，可充气气囊具有1mm-10cm的直径。在一个实施方式中，可充气气囊可以与端口分开1mm-10cm的距离。在一个实施方式中，端口开口的尺寸为1μm-1cm。应该理解的是，使用可充气气囊来固定装置，因此被配置成与消融区域不接触。该可充气气囊可以具有与中空器官在3个或更多点接触的任何形状。本领域普通技术人员利用三角测量可以计算损害到导管的距离。可选地，红外线、电磁、声或射频能发射体和传感器18能够测量中空器官的尺寸。红外线、电磁、声或射频能量从发射体18发射出并从组织反射到发射体18的检测器中。可以使用反射数据来确定中空腔的尺寸。应该理解的是，发射体与传感器18可以合并成既能够发射能量又能够检测反射能的一个收发两用机。
图2A示出消融装置的纵截面，示出注入口的分配。图2B示出根据本发明一个实施方式的消融装置上的注入口的分配的横截面图。图2A和2b中分别示出导管10的纵截面和横截面，示出可均匀分配消融介质21的注入口12的一种配置，以在中空器官20中提供圆周形的消融区域。图2C示出根据本发明另一实施方式的消融装置的注入口的分配的横截面图。图2C中示出注入口的布置12产生消融介质21的聚焦或病灶分配(focal distribution)和在中空器官20中的消融的聚焦或病灶区域(focal area)。
对于在此所述的所有实施方式，应该理解的是，端口的尺寸、端口的数目，以及端口之间的距离由所需消融介质的量、中空器官能够承受的压力、从端口到表面的距离测量出的中空器官的尺寸、待消融组织的长度(大致是待消融的表面区域)、待消融组织的特征和所需消融的深度来决定。在一个实施方式中，具有至少一个直径为1μm-1cm端口开口。在另一个实施方式中，具有两个直径为1μm-1cm且围绕该装置的圆周等距隔开的端口开口。
图2D示出消融装置的另一个实施方式。蒸汽消融导管包括具有已知长度23的一个或多个定位附件22的绝缘导管21。蒸汽消融导管具有一个或多个蒸汽注入口25。具有注入口25的蒸汽消融导管21的长度24由待消融组织的长度或区域决定。蒸汽29通过蒸汽注入口25输送。导管21优选地被布置在定位附件22的中心，注入口25被周向布置以沿圆周方向来消融和输送蒸汽。在另一个实施方式中，可以朝向定位附件22的周缘来布置导管21，可以非周向地布置注入口25，优选地线性地布置在一侧以病灶性消融和输送蒸汽。定位附件23是充气气囊、上面有或没有绝缘膜覆盖的线网盘、圆锥形附件、环形附件或被设计成适于所需中空身体器官或中空身体通道的自由成形附件中的一种，下文会进一步描述。可选的红外线、电磁、声或射频能发射体和传感器28可被并入，以测量中空器官的尺寸。
蒸汽消融导管还可以包括可选的同轴薄板(coaxial sheet)27，以便以与冠状金属支架类似的方式限制定位附件22。在一个实施方式中，盘由具有压缩线性形式和非压缩形式定位附件形状的记忆金属或记忆材料制成。可选地，内窥镜的通道可以通过例如充当约束套管来执行限制定位附件的功能。可选的传感器26配置在导管上以测量与蒸汽输送或消融有关的变化。传感器是温度、压力、图像或化学传感器中的一种。
可选地，红外线、电磁、声或射频能发射体和传感器28可以测量中空器官的尺寸。红外线、电磁、声或射频能从发射体18中发射出来并从组织反射回到发射体18中的检测器。可以使用反射数据来确定中空腔的尺寸。在一个或多个点进行测量以获得中空器官尺寸的精确估计。还可以使用数据来产生中空器官的局部解剖图像。
图3A示出根据本发明一个实施方式的置于具有巴雷特食管的上胃肠道中以选择性地消融巴雷特组织的消融装置。上胃肠道包括巴雷特食管31、胃贲门32、胃食管接点33和移位鳞柱交接部34。胃食管接点33和移位鳞柱交接部34之间的区域是要消融的目标巴雷特食管31。贲门32的远端是胃35，而贲门32的近端是食管36。消融装置穿过食管36，定位装置11设置在胃贲门32中接靠胃食管接点33。这样将消融导管10及其端口12固定在食管36的中央并允许将消融介质21均匀地输送到巴雷特食管31。在一个实施方式中，在进行消融之前，首先将定位装置固定到不是待消融的解剖结构上。如果患者是进行周缘消融或是第一次消融时，优选地将定位附件布置在胃贲门中，接靠胃食管接点。如果患者是进行任何残余疾病的聚焦消融，则优选地使用图4b所示的导管系统，后面会进一步描述。在一个实施方式中，定位附件必须隔开消融区域超过0mm，最好地为1mm，理想地为1cm的距离。在一个实施方式中，定位装置的尺寸在10-100mm，优选地为20-40mm范围内，尽管本领域普通技术人员应该理解精确尺寸依赖于患者食管的尺寸。
消融介质21通过注入口12的输送由与消融装置连接的微处理器15控制。消融的输送依赖于待消融的组织和所需的消融深度，由预定程序指令引导。在一个实施方式中，目标程序温度会需要大致-100-200摄氏度，优选地为50-75摄氏度，在后面的表格中会进一步示出。在一个实施方式中，食管压应该不超过5atm，优选地低于0.5atm。在一个实施方式中，在不到1分钟内，优选地在不到5秒钟内获得目标程序温度，并且能够保持高达10分钟，优选地为1-10秒钟，然后冷却到身体温度。本领域普通技术人员会知道可以进行重复治疗直到获得所需的消融效果为止。
可选的传感器17监控温度和压力等动脉参数并可以通过注入口12增加或减少消融介质21的流动以获得足够的加热或冷却，产生足够的消融。传感器17监控诸如温度和压力等动脉参数，可以通过可选的抽吸口13增加或减少消融介质21的去除量，以获得足够加热或冷却，以便对巴雷特食管31进行足够的消融。图3b示出根据本发明另一个实施方式的置于具有巴雷特食管的上胃肠道中以选择性地消融巴雷特组织的消融装置。如图3b所示，定位装置11是线网盘。在一个实施方式中，定位附件必须与消融区域隔开超过0mm，优选地为1mm，理想地为1cm的距离。在一个实施方式中，定位附件可去除地固定在贲门或EG接口(对于远端附件)或固定食管中位于巴雷特组织的大致最高程度上面超过0.1mm，优选地为大约1cm处(对于近端附件)。
图3B是定位元件11为线网盘的巴雷特消融装置的另一个实施方式。线网可以具有可选的绝缘膜以防止消融介质逸出。在当前实施方式中，使用两个线网盘将消融导管定位在食管中央。两个盘之间的距离由待消融组织的长度来确定，在此情况下，该长度就是巴雷特食管的长度。可选的红外线、电磁、声或射频能发射体和传感器18可以被并入以测量食管的直径。
图3C是示出根据本发明一个实施方式使用消融装置的基本程序步骤的流程图。在步骤302中，将消融装置的导管插入到待消融的中空器官中。例如，为了对患者的巴雷特食管进行消融，导管经由患者的食管插入到巴雷特食管中。
在步骤304中，使用消融装置的定位附件。在一个实施方式中，如果定位元件是气囊，则气囊被充气以将消融装置定位到距离待消融组织的已知预定距离处。中空器官的直径既可以通过使用诸如钡X射线或计算机X线断层摄影术(CT)扫描等放射性试验来确定，也可以通过使用压力体积循环即通过确定所需体积以将压力升高到固定体积的气囊的固定水平(例如1atm)。在另一个实施方式中，如果定位装置是盘形的，则设置周缘环以便使操作的医生从视觉上了解中空器官的直径。在本发明的各个实施方式中，定位装置可以使消融装置的导管在非圆周身体腔中居中，腔的体积由导管的长度或子宫探子来测量。
可选地，可以使用一个或多个红外线、电磁、声或射频能发射体和传感器来测量中空器官的尺寸。红外线、电磁、声或射频能从发射体发射出并从组织反射到发射体的检测器中。可以使用反射数据来确定中空腔的尺寸。可以在一个或多个点进行测量来获得对中空器官尺寸的精确估计。还可以使用来自多个点的数据来产生中官器官的局部解剖图像或者用来计算中空器官的体积。
在一个实施方式中，定位附件必须与端口距离0mm以上，优选地为大于0.1mm，更优选地为1cm。定位装置的尺寸依赖于待消融的中空器官的尺寸并且从1mm-10cm变化。在一个实施方式中，定位元件的直径为0.01mm-100mm。在一个实施方式中，第一定位元件包括具有0.01mm-10cm范围内直径的圆形体。
在步骤306中，通过经由设置在导管上的注入口自动输送例如蒸汽等消融介质来消融器官。消融介质通过注入口的输送由与消融装置连接的微处理器来控制。消融介质的输送，依赖于待消融组织和所需消融的深度，由预定程序指令来引导。在本发明的一个实施方式中，如果消融介质是蒸汽，则消融介质的剂量通过进行剂量测定研究来确定，以确定消融子宫内膜组织的剂量。能够确定消融介质总剂量的变量是待治疗组织的体积(质量)，其是通过利用导管的长度和器官(对于圆筒形器官而言)的直径来计算的。然后利用微处理器控制的蒸汽发生器来输送所确定剂量的消融介质。
在一个实施方式中，首先确定治疗病症和期望组织效果，然后发现对应的温度，从而提供剂量，如下表所示：
此外，所需的消融深度确定最大温度的保持时间。对于表面消融(巴雷特)，最大温度的保持时间非常短(迅速灼烧)，不允许热量被输送到更深层。这样会防止损坏最深层的正常组织，因此可以防止患者不适和并发症。对于较深组织消融，最大温度的保持时间会更长一些，因而允许热量被渗透得更深一些。
图4A示出根据本发明一个实施方式的置于结肠中用来消融扁平结肠息肉的消融装置。消融导管10穿过结肠镜40。定位装置11布置在正常结肠42中靠近待消融的扁平结肠息肉41。定位装置11是充气气囊、带有或不带有覆盖其上的绝缘膜的线网盘、锥形附件、环形附件或被设计成适于结肠内腔的自由成形附件中的一种。定位装置11具有导管10，朝向定位装置11的圆周布置，将其靠近息肉41布置以进行非周周形的消融。因此，定位装置11将导管固定到结肠42中与息肉41隔开预定距离，以便均匀并集中地输送消融介质21。消融介质21通过注入口12的输送由连接于消融装置的微处理器15来控制，并依赖于组织和所需消融的深度。消融介质21的输送依赖于待消融组织和所需消融的区域和深度，由预定程序指令来引导。消融装置允许对患病息肉粘膜进行集中消融而不损坏远离导管端口的正常结肠粘膜。
在一个实施方式中，定位附件必须离开消融区域大于0.1mm的距离，理想地为超过5mm的距离。在一个实施方式中，定位元件接近结肠息肉。对于此应用，图4B所示的实施方式是优选的。
图4B示出根据本发明另一个实施方式置于结肠中以消融扁平结肠息肉的消融装置。如图4B所示，定位装置是位于导管顶部的锥形附件。锥形附件具有已知长度“l”和直径“d”，用于计算消融扁平结肠息肉所需的热能的量。在一个实施方式中，定位附件必须离开消融区域大于0.1mm、优选地为1mm、更优选地为1cm的距离。在一个实施方式中，长度“l”大于0.1mm，优选地为5-10mm。在一个实施方式中，直径“d”依赖于息肉的尺寸，并且可以是1mm-10cm，优选是为1-5cm。还可以使用本实施方式来消融在内窥镜用绞断器切除掉较大的广基型结肠息肉之后在边缘上残余的赘生组织。
图5A示出根据本发明一个实施方式的具有同轴导管设计的消融装置。同轴设计具有手柄52a、注入口53a、内鞘54a和外鞘55a。外鞘55a用于将定位装置56a限制在闭合位置并包围端口57a。图5B示出部分展开的定位装置56b，端口57b仍然位于外鞘55a内。通过将导管54b从鞘55a推开来部分展开定位装置56b。
图5C示出完全展开的定位装置56c。注入口57c离开鞘55c。包含注入口57c的导管54c的长度“l”和定位元件56a的直径“d”是预定的/已知的，用于计算所需热能的量。图5D示出定位元件的锥形设计。定位元件56d是具有已知长度“l”和直径“d”的锥形，已知长度“l”和直径“d”用于计算消融所需热能的量。图5e示出定位元件56e的盘形设计，包括圆周环59e。圆周环59e设置于固定的预定距离处，并用于估计患者身体的中空器官或中空通道的直径。
图6示出利用根据本发明一个实施方式的消融装置进行治疗的具有出血的血管病变的上胃肠道。血管病变是溃疡62底部中的可见脉管61。消融导管63穿过内窥镜64的通道。锥形定位元件65布置在可见脉管61上方。锥形定位元件65具有已知的长度“l”和直径“d”，用于计算用于凝固可见脉管以止血所需的热能的量。锥形的定位元件具有可选的绝缘膜，防止热能或蒸汽从患病位置逃逸。
在一个实施方式中，定位附件必须离开消融区域大于0.1mm、优选地为1mm、更优选地为1cm的距离。在一个实施方式中，长度“l”大于0.1mm、优选地为5-10mm。在一个实施方式中，直径“d”依赖于病变的尺寸，可以位于1mm-10cm范围内，优选地为1-5cm。
图7示出使用根据本发明一个实施方式的消融装置进行女性子宫的子宫内膜消融。示出了包括阴道70、子宫颈71、子宫72、子宫内膜73、输卵管74、叶鞘75和子宫底部76的女性生殖道的横截面图。消融装置的导管77经子宫颈71插入子宫72中。在一个实施方式中，导管77具有两个定位元件：锥形定位元件78和盘形定位元件79。定位元件78是锥形的，具有覆盖锥形定位元件78的绝缘膜。锥形元件78将导管77定位在子宫颈71的中央，绝缘膜防止热能或消融介质通过子宫颈71逸出。第二盘形定位元件79在子宫底部76附近展开，将导管71定位在空腔的中间。消融介质778通过注入口777，将消融介质778均匀地输送到子宫腔中。消融段导管的预定长度“l”和定位元件79的直径“d”允许对腔尺寸进行估计，并用于计算消融子宫内膜衬里热能的量。可选地，靠近子宫内膜表面配置的温度传感器7可用于控制消融介质778的输送。可选地，利用多重红外线、电磁、声或射频能发射体和传感器的局部照相测绘，可用于定义子宫腔的尺寸和因纤维瘤等情况而不规则或变形的子宫腔的形状。
在一个实施方式中，消融介质是蒸汽，冷却后会收缩。与致冷剂会膨胀或是在热消融中使用的热流体保持体积不变相比，蒸汽变成水时体积会变小。对于致冷剂和热流体二者来说，增加能量输送会增大消融介质体积，进而需要去除消融介质的机构，否则药的供应会产生并发症。然而，蒸汽在冷却之后变成水占据明显小的体积；因此，能量输送增加与剩余消融介质的体积增加无关，因而无需进一步去除消融介质。这进一步降低经由输卵管74或子宫颈71泄漏热能的风险，因而减小热损伤附近健康组织的风险。
在一个实施方式中，定位附件必须与消融区域隔开大于0.1mm、优选地为1mm、更优选地为1cm的距离。在另一个实施方式中，定位附件可以位于消融区域中，只要不覆盖很大的表面区域即可。对于子宫内膜的消融，不需要消融全部组织以获得预期的治疗效果。
在一个实施方式中，优选的远端定位附件是靠近中央本体区域定位的未覆盖线网。在一个实施方式中，优选的定位装置是覆盖的线网，其被拉入子宫颈、将装置定中心，并封闭子宫颈。一个或多个这种定位装置对于补偿子宫中解剖变化可能是有利的。近端定位装置优选地是椭圆形的，具有0.1mm-10cm(优选地为1-5cm)的长轴和0.1mm-5cm(优选地为0.5cm-1cm)的短轴。远端定位装置优选地为圆形，具有0.1mm-10cm、优选地为1cm-5cm的直径。
图8示出利用根据本发明一个实施方式的消融装置在鼻通道中执行的窦消融。示出了包括鼻孔81、鼻通道82、额窦83、筛窦84，以及患病的窦上皮细胞85的鼻通道和鼻窦的横截面图。导管86经鼻孔81和鼻通道82插入额窦83或筛窦84中。
在一个实施方式中，导管86具有两个定位元件：锥形定位元件87和盘形定位元件88。定位元件87是锥形的，具有覆盖锥形定位元件的绝缘膜。锥形元件87将导管86定位在窦开口80的中央，绝缘膜防止热能或消融介质通过开口逸出。第二盘形定位元件88在额窦腔83或筛窦腔84中展开，将导管86定位在任一窦腔的中间。消融介质8通过注入口89，将消融介质8均匀地输送到窦腔中。消融段导管的预定长度“l”和定位元件88的直径“d”允许对腔尺寸进行估计，并用于计算消融患病的窦上皮细胞85所需的热能的量。可选地，靠近患病的窦上皮细胞85配置的温度传感器888可控制消融介质8的输送。在一个实施方式中，消融介质是蒸汽，冷却后会收缩。这进一步降低泄漏热能的风险，因而减小热损伤附近健康组织的风险。在一个实施方式中，定位元件的尺寸范围与在子宫内膜的应用中的尺寸范围类似，优选的最大范围是其一半。可选地，利用多重红外线、电磁、声或射频能发射体和传感器的局部照相测绘，可用于定义腔的尺寸和因鼻息肉等情况而不规则或变形的腔的形状。
图9示出根据本发明一个实施方式的消融装置在肺系中执行的支气管和大疱的消融。示出了具有支气管91、正常肺泡92、大疱病变93，以及支气管肿疡94的肺系的横截面。
在一个实施方式中，导管96通过支气管镜的通道插入支气管91并进而进入到大疱病变93中。导管96具有两个定位元件：锥形定位元件97和盘形定位元件98。定位元件97是锥形的，具有绝缘膜罩。锥形元件97将导管96定位在支气管91的中央，绝缘膜防止热能或消融介质通过开口逸出到正常支气管中。第二盘形定位元件98在大疱腔93中展开，将导管96定位在大疱腔93的中间。消融介质9通过注入口99均匀地输送到空腔中。导管96消融段的预定长度“l”和定位元件98的直径“d”允许对支气管腔尺寸进行估计，并用于计算消融患病的大疱腔93所需的热能的量。可选地，可以利用胸部CT扫描或核磁共振成像(MRI)的放射学估计来计算腔的尺寸。可选地，温度传感器在大疱腔93的表面的附近设置，以控制消融介质9的输送。在一个实施方式中，消融介质是在蒸汽，在冷却后会收缩。这进一步降低了热能泄漏到正常支气管中的风险，从而降低了热损伤附近正常组织的风险。
在一个实施方式中，定位附件必须与消融区域隔开超过0.1mm，优选地为1mm，更优选地为1cm的距离。在另一个实施方式中，定位附件可以位于消融区域中，只要不占据很大的表面区域即可。
在一个实施方式中，优选地具有两个定位附件。在另一个实施方式中，使用内窥镜作为一个定位元件的一个固定点。定位装置为0.1mm-5cm(优选地为1mm-2cm)。远端定位装置优选地为圆形的，具有0.1mm-10cm、优选地为1-5cm的直径。
在支气管肿疡94的另一个实施方式中，导管96通过支气管镜95的通道插入支气管91并进而进入到支气管肿疡94中。定位元件98是盘形的，具有绝缘膜罩。定位元件98将导管定位在支气管91的中央，绝缘膜防止热能或消融介质通过开口逸出到正常支气管中。消融介质9以非圆周方式通过注入口99以均匀地将消融介质输送到支气管肿疡94中。导管消融段的预定长度“l”和定位元件98的直径“d”用来计算消融支气管肿疡94所需的热能的量。
图10示出利用根据本发明一个实施方式的装置对男性泌尿系统中的增大前列腺执行前列腺消融。示出了包含增大的前列腺101、膀胱102，和尿道103的男性泌尿生殖道的横截面。尿道103被增大的前列腺101挤压。消融导管105通过置于障碍物远端的尿道103中的膀胱镜104。定位元件106展开以将导管定位在尿道103的中央，绝缘针107被穿过以刺入前列腺101。蒸汽消融介质108通过绝缘针107，因而对患病的前列腺组织进行消融，从而使前列腺收缩。
在一个实施方式中，定位附件必须隔开消融区域大于0.1mm、优选地为1mm-5mm、不超过2cm的距离。在另一个实施方式中，定位附件可以在膀胱中展开，并向后拉入到尿道开口/膀胱的颈部中，从而固定导管。在一个实施方式中，定位装置为0.1mm-10cm。
图11示出利用根据本发明一个实施方式的消融装置对女性子宫执行的纤维瘤消融。示出了包含子宫纤维瘤111、子宫112，和子宫颈113的女性生殖道的横截面。消融导管115通过置于子宫内子宫纤维瘤111远端的子宫镜114。消融导管115具有穿刺尖120，有助于刺入子宫纤维瘤111。定位元件116展开以导管定位在纤维瘤111的中央，绝缘针117被穿过以刺穿纤维瘤组织111。蒸汽消融介质118通过针117，因而对子宫纤维瘤111进行消融，使纤维瘤收缩。
图12示出使用射频加热器的蒸汽输送系统以将蒸汽提供给根据本发明一个实施方式的消融装置。在一个实施方式，使用蒸汽作为本发明所述的消融装置所使用的消融介质。射频加热器64位于含有液体44的压力容器42附近。射频加热器64加热容器42，而容器42加热液体44。液体44温度升高并开始蒸发，使容器42中的压力增大。可以通过提供用来控制电阻加热器64的热开关46，使容器42中的压力保持相对稳定。一旦液体44的温度达到预定温度，则热开关46切断射频加热器64。可以通过控制阀50来释放压力容器42中所产生的蒸汽。当蒸汽排出容器42时，在容器中产生压力降，使温度降低。热开关46测量到温度降低，射频加热器64重新开始加热液体44。在一个实施方式中，可以将容器42的目标温度设置成108℃左右，提供连续的蒸汽供给。当蒸汽被释放时，产生压力降，使蒸汽的温度减小到大约90-100℃。当容器42中的液体44蒸发，蒸汽排出容器42，液体44的量缓慢减少。可选地，容器42经由在感应到容器42中的压力或温度降低之后由控制器24启动以将更多液体44输送到容器42中的泵49，连接于包含液体44的储存器43。
蒸汽输送导管16经由液体连接器56连接于容器42。当控制阀50打开时，容器42经由连接器56流体连接于输送导管16。控制开关60可用于通过致动器48开启和关闭蒸汽输送。例如，控制开关60可以通过致动器48物理地打开和关闭阀50，以控制来自容器42的蒸汽流的输送。开关60可被配置成控制蒸汽的其它属性，例如方向、流速、压力、体积、喷射直径或其它参数。
作为物理地控制蒸汽属性的替代方案或者附加手段，开关60还可以与控制器24电连通。控制器24控制射频加热器64，而射频加热器64响应于操作者对开关的致动来控制蒸汽的属性。此外，控制器24可以控制与导管16或容器42相关联的阀温度或者压力调节器。可以使用流量计来测量经由导管16输送的蒸汽的流速、压力，或体积。控制器24控制容器42中的温度和压力，以及流经控制阀50的蒸汽的时间、速率、流量和体积。这些参数可以由操作者11设定。利用108℃的目标温度，在容器42中产生的压力，可相当于25磅每平方英寸(psi)(1.72巴)。
图13示出使用电阻加热器的蒸汽输送系统以将蒸汽提供给根据本发明一个实施方式的消融装置。在一个实施方式，将所产生的蒸汽用作本发明所述的消融装置所使用的消融介质。电阻加热器40位于压力容器42附近。容器42含有液体44。电阻加热器40加热容器42，而容器42加热液体44。因此，液体44加热并开始蒸发。在液体44开始蒸发时，容器42中的蒸汽使容器中的压力增大。可以通过提供用来控制电阻加热器40的热开关46，使容器42中的压力保持相对稳定。当液体44的温度达到预定温度时，热开关46切断电阻加热器40。可以通过控制阀50来释放压力容器42中所产生的蒸汽。当蒸汽排出容器42时，容器42中产生压力降。容器42中的压力降使温度降低。热开关46测量到温度降低，电阻加热器40重新开始加热液体44。在一个实施方式中，可以将容器42的目标温度设置成108℃左右，提供连续的蒸汽供给。在蒸汽被释放时，产生压力降，使蒸汽的温度减小到大约90-100℃。当容器42中的液体44蒸发并且蒸汽排出容器42时，液体44的量缓慢减少。容器42经由在感应到容器42中的压力或温度降低之后由控制器24启动以将更多液体44输送到容器42中的泵49，连接于包含液体44的另一个储存器43。
蒸汽输送导管16经由液体连接器56连接于容器42。当控制阀50打开时，容器42经由连接器56流体连接于输送导管16。控制开关60可用于通过致动器48开启和关闭蒸汽输送。例如，控制开关60可以通过致动器48物理地打开和关闭阀50，以控制来自容器42的蒸汽流的输送。开关60可被配置成控制蒸汽的其它属性，例如方向、流速、压力、体积、喷射直径或其它参数。作为物理地控制蒸汽属性的替代方案或者附加手段，开关60还可以与控制器24电连通。控制器24控制电阻加热器40，而电阻加热器40响应于操作者对开关60的致动来控制蒸汽的属性。此外，控制器24可以控制与导管16或容器42相关联的阀温度或者压力调节器。可以使用流量计52来测量经由导管16输送的蒸汽的流量、压力，或体积。控制器24控制容器42中的温度和压力，以及流经控制阀50的蒸汽的时间、速率、流量和体积。这些参数可以由操作者11设定。利用108℃的目标温度，在容器42中产生的压力，可相当于25磅每平方英寸(psi)(1.72巴)。
本发明的装置和方法可用来对目标组织实现受控的病灶或周缘消融，以可重新形成上皮的完全治愈方式来变化深度。可以基于组织的类型和所需消融的深度来调节治疗的剂量和方式。该消融装置不仅可以用于治疗巴雷特食管、食管发育不良、扁平结肠息肉、胃肠出血病变、子宫内膜消融、肺部消融，还可以用于治疗任何粘膜、粘膜下层或周缘病变，例如炎性病变、瘤、息肉和脉管病变。消融装置还可用于治疗身体中空器官或中空身体通道的病灶或周缘粘膜或粘膜下层病变。中空器官可以是胃肠道、胰腺道、生殖道、呼吸道或诸如血管等脉管结构。消融装置可以通过内窥镜、放射线、外科手术方式或直接目测地布置。在各个实施方式中，可以将无线内窥镜或单纤维内窥镜并入到装置中作为装置的一部分。
尽管在本文中已经描述和示出了本发明的示例性实施方式，然而应该理解的是，这些实施方式仅仅是出于说明的目的。本领域普通技术人员应该知道，在不脱离本发明的精神和范围的情况下，还可以对形式和细节进行各种变形。

Claims (18)

1.一种对中空器官中的组织进行消融的装置，包括：
a.导管，具有蒸汽能够从中通过的轴；
b.在第一位置连接于所述导管的轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位于距待消融组织预定距离处；以及
c.其中所述轴包括一个或多个端口，所述蒸汽能够通过所述端口从所述轴中释放，
其特征在于，所述蒸汽的流动由微处理器控制，所述装置还包括在不同于所述第一定位元件的位置处连接于所述导管的轴的第二定位元件，所述第二定位元件具有预定尺寸，所述导管的长度和所述第二定位元件的所述预定尺寸被用来计算组织的消融所需热能的量。
2.如权利要求1所述的装置，其中所述第一定位元件是锥形、盘形，或与中空器官的形状相适配的自由成形形状中的至少一个。
3.如权利要求1所述的装置，其中所述预定尺寸用于确定待消融的中空器官的尺寸。
4.如权利要求1所述的装置，其中所述第一定位元件包括绝缘膜，其中所述绝缘膜被配置成防止热能逸出。
5.如权利要求1所述的装置，还包括声、电磁、红外线或射频能量传感器中的至少一个，其中所述传感器用于测量中空器官的尺寸。
6.如权利要求1所述的装置，其中所述第二定位元件是锥形、盘形，或与中空器官的形状相适配的自由成形形状中的至少一个。
7.如权利要求6所述的装置，其中所述预定尺寸用于确定待消融的中空器官的尺寸。
8.如权利要求1所述的装置，还包括至少一个温度传感器。
9.如权利要求8所述的装置，其中所述温度传感器用于控制所述蒸汽的输送。
10.如权利要求1所述的装置，其中所述第一定位元件是绝缘线网。
11.如权利要求1所述的装置，其中所述第一定位元件包括直径在0.01mm和10cm之间的圆形体。
12.如权利要求1所述的装置，其中所述第一定位元件是椭圆形的，其中所述椭圆形的长轴在0.01mm和10cm之间，短轴在0.01mm和9cm之间。
13.一种对中空器官中的组织进行消融的装置，包括：
a.导管，具有从中能够输送蒸汽的中空轴；
b.在第一位置连接于所述导管的中空轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位于距所述中空器官的表面预定距离处；
c.在第二位置连接于所述导管的中空轴的第二定位元件，其中所述第二定位元件的形状被设置成将所述导管定位于距所述中空器官的表面预定距离处；
d.一体形成在所述导管的中空轴上的多个端口，其中蒸汽能够从所述端口中被释放并导向待消融的组织，并且其中所述端口位于所述第一位置与所述第二位置之间；和
e.至少一个温度传感器，
其中所述第一定位元件具有预定尺寸，其中所述尺寸用于确定所述中空器官的尺寸；所述第二定位元件具有预定尺寸，其中所述第二定位元件的所述预定尺寸用于计算消融组织所需的热能的量。
14.如权利要求13所述的装置，其中所述至少一个温度传感器用于控制所述蒸汽的输送。
15.如权利要求13所述的装置，其中所述第二定位元件是椭圆形的盘形，其中所述椭圆形的长轴在0.01mm和10cm之间，短轴在0.01mm和9cm之间。
16.一种对子宫内膜组织进行消融的装置，包括：
a.导管，具有蒸汽能够从中通过的轴；
b.在第一位置连接于所述导管的轴的第一定位元件，其中所述第一定位元件被配置成使所述导管居中位于子宫颈的中央；
c.轴包括多个端口，所述蒸汽能够通过所述端口从所述轴中释放，以及
d.在第二位置连接于所述导管的轴的第二定位元件，
其中，所述蒸汽的流动由微处理器控制，并且所述导管的长度和所述第二定位元件的预定尺寸被用来计算组织的消融所需热能的量。
17.一种对胃肠组织进行消融的装置，包括：
a.导管，具有蒸汽能够从中通过的轴；
b.在第一位置连接于所述导管的轴的第一定位元件，其中所述第一定位元件被配置成将所述导管定位于距待消融的胃肠组织固定距离处；以及
c.在第二位置处与所述导管的轴流体连通以接收所述蒸汽的输入口，其中所述轴包括一个或多个端口，所述蒸汽能够通过所述端口从所述轴中释放，
其特征在于，所述蒸汽的流动由微处理器控制，并且所述导管的长度和所述第一定位元件的预定尺寸被用来计算组织的消融所需热能的量。
18.如权利要求17所述的装置，其中所述端口位于所述第一位置与所述第二位置之间。
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